101 Examples 1 to 36

Examples: Abstract Ideas

The following examples should be used in conjunction with the 2014 Interim Eligibility

Guidance. As the examples are intended to be illustrative only, they should be interpreted based

on the fact patterns set forth below. Other fact patterns may have different eligibility outcomes.

This set of examples is arranged into two parts. The first part includes four fact patterns with

claims that are patent eligible, several of which draw from U.S. Court of Appeals for the Federal

Circuit decisions, and the second part includes four fact patterns with claims that were found

ineligible by the Federal Circuit. Each of the examples shows how claims should be analyzed

under the 2014 Interim Eligibility Guidance. All of the claims are analyzed for eligibility in

accordance with their broadest reasonable interpretation.

Part One

These examples show claims that would be patent eligible when analyzed under the 2014 Interim

Eligibility Guidance. The first example is a hypothetical claim and fact pattern that illustrates an

eligible software invention that is not directed to an abstract idea. The second example is a

recent Federal Circuit decision. The third and fourth examples are informed by Federal Circuit

decisions where claims were found eligible, but are drafted as hypothetical claims modified to

prominently add an abstract idea for teaching purposes to facilitate analysis under the

“significantly more” prong of the 2014 Interim Eligibility Guidance.

1. Isolating and Removing Malicious Code from Electronic Messages

Hypothetical claims 1 and 2 are not directed to an abstract idea.

Background

The invention relates to isolating and removing malicious code from electronic messages (e.g.,

email) to prevent a computer from being compromised, for example by being infected with a

computer virus. The specification explains the need for computer systems to scan electronic

communications for malicious computer code and clean the electronic communication before it

may initiate malicious acts. The disclosed invention operates by physically isolating a received

electronic communication in a “quarantine” sector of the computer memory. A quarantine sector

is a memory sector created by the computer’s operating system such that files stored in that

sector are not permitted to act on files outside that sector.

When a communication containing malicious code is stored in the quarantine sector, the data

contained within the communication is compared to malicious code-indicative patterns stored

within a signature database. The presence of a particular malicious code-indicative pattern

indicates the nature of the malicious code. The signature database further includes code markers

that represent the beginning and end points of the malicious code.

The malicious code is then extracted from malicious code-containing communication. An

extraction routine is run by a file parsing component of the processing unit. The file parsing

routine performs the following operations:

1. scan the communication for the identified beginning malicious code marker;

2. flag each scanned byte between the beginning marker and the successive end

malicious code marker;

Examples: Abstract Ideas

3. continue scanning until no further beginning malicious code marker is found; and

4. create a new data file by sequentially copying all non-flagged data bytes into the new

file, which thus forms a sanitized communication file.

The new, sanitized communication is transferred to a non-quarantine sector of the computer

memory. Subsequently, all data on the quarantine sector is erased.

Claims

1. A computer-implemented method for protecting a computer from an electronic

communication containing malicious code, comprising executing on a processor the steps of:

receiving an electronic communication containing malicious code in a computer with a

memory having a boot sector, a quarantine sector and a non-quarantine sector;

storing the communication in the quarantine sector of the memory of the computer,

wherein the quarantine sector is isolated from the boot and the non-quarantine sector in the

computer memory, where code in the quarantine sector is prevented from performing write

actions on other memory sectors;

extracting, via file parsing, the malicious code from the electronic communication to

create a sanitized electronic communication, wherein the extracting comprises

scanning the communication for an identified beginning malicious code marker,

flagging each scanned byte between the beginning marker and a successive end

malicious code marker,

continuing scanning until no further beginning malicious code marker is found,

and

creating a new data file by sequentially copying all non-flagged data bytes into a

new file that forms a sanitized communication file;

transferring the sanitized electronic communication to the non-quarantine sector of the

memory; and

deleting all data remaining in the quarantine sector.

2. A non-transitory computer-readable medium for protecting a computer from an electronic

communication containing malicious code, comprising instructions stored thereon, that when

executed on a processor, perform the steps of:

receiving an electronic communication containing malicious code in a computer with a

memory having a boot sector, a quarantine sector and a non-quarantine sector;

storing the communication in the quarantine sector of the memory of the computer,

wherein the quarantine sector is isolated from the boot and the non-quarantine sector in the

computer memory, where code in the quarantine sector is prevented from performing write

actions on other memory sectors;

Examples: Abstract Ideas

extracting, via file parsing, the malicious code from the electronic communication to

create a sanitized electronic communication, wherein the extracting comprises

scanning the communication for an identified beginning malicious code marker,

flagging each scanned byte between the beginning marker and a successive end

malicious code marker,

continuing scanning until no further beginning malicious code marker is found,

and

creating a new data file by sequentially copying all non-flagged data bytes into a

new file that forms a sanitized communication file;

transferring the sanitized electronic communication to the non-quarantine sector of the

memory; and

deleting all data remaining in the quarantine sector.

Analysis

Claim 1: Eligible.

The method claim recites a series of acts for protecting a computer from an electronic

communication containing malicious code. Thus, the claim is directed to a process, which is one

of the statutory categories of invention (Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception. The

claimed invention relates to software technology for isolation and extraction of malicious code

contained in an electronic communication. The claim is directed towards physically isolating a

received communication on a memory sector and extracting malicious code from that

communication to create a sanitized communication in a new data file. Such action does not

describe an abstract concept, or a concept similar to those found by the courts to be abstract, such

as a fundamental economic practice, a method of organizing human activity, an idea itself

(standing alone), or a mathematical relationship. In contrast, the invention claimed here is

directed towards performing isolation and eradication of computer viruses, worms, and other

malicious code, a concept inextricably tied to computer technology and distinct from the types of

concepts found by the courts to be abstract. Accordingly, the claimed steps do not recite an

abstract idea. Nor do they implicate any other judicial exception. Accordingly, the claim is not

directed to any judicial exception (Step 2A: NO). The claim is eligible.

Claim 2: Eligible.

The claim is directed to a non-transitory computer-readable medium, which is a manufacture,

and thus a statutory category of invention (Step 1: YES).

The claim recites the same steps as claim 1 stored on a non-transitory computer readable medium

such that they are executable on a processor. The invention described by those steps is not

directed towards an abstract idea, for the reasons explained above (Step 2A: NO). The claim is

eligible.

Examples: Abstract Ideas

2. E-Commerce Outsourcing System/Generating a Composite Web Page

The following claim was found eligible by the Federal Circuit in DDR Holdings, LLC v.

Hotels.com et al., 113 USPQ2d 1097 (Fed. Cir. 2014) (DDR). The patent at issue was U.S.

Patent No. 7,818,399.

Background

In affiliate commerce systems, website owners or hosts sell space on their web pages in the form

of paid advertisements. Many of these advertisements are banner ads that include links to items

offered for sale by third-party merchants. When a visitor activates (clicks on) a link, the visitor

is instantly transported away from the host’s web page to the merchant’s web page so that she

can purchase the item (a “commerce object”, e.g., a product or service) associated with the link.

The merchant pays a commission on each such sale to the host of the web page displaying the

link. While these advertising links function as a commission-based advertising program that

provides the host additional revenues, they have the disadvantage of luring visitor traffic away

from the host’s web page, which results in the host losing control of potential customers.

The inventor has addressed this problem of retaining control over customers during affiliate

purchase transactions, by creating a system for co-marketing the “look and feel” of the host web

page with the product-related content information of the advertising merchant’s web page. The

system can be operated by a third-party outsource provider, who acts as a broker between

multiple hosts and merchants. Prior to implementation, a host places links to a merchant’s web

page on the host’s web page. The links are associated with product-related content on the

merchant’s web page. Additionally, the outsource provider system stores the “look and feel”

information from each host’s web pages in a computer data store, which is coupled to a computer

server. The “look and feel” information includes visually perceptible elements such as logos,

colors, page layout, navigation system, frames, mouse-over effects or other elements that are

consistent through some or all of each host’s respective web pages.

In the inventor’s system, a customer who clicks on an advertising link is not transported from the

host web page to the merchant’s web page, but instead is re-directed to a composite web page

that combines product information associated with the selected item and visually perceptible

elements of the host web page. The outsource provider’s server responds by first identifying the

host web page where the link has been selected and retrieving the corresponding stored “look

and feel” information. The server constructs a composite web page using the retrieved “look and

feel” information of the host web page, with the product-related content embedded within it, so

that the composite web page is visually perceived by the customer as associated with the host

web page. The server then transmits and presents this composite web page to the customer so

that she effectively remains on the host web page to purchase the item without being redirected

to the third party merchant affiliate. Because such composite pages are visually perceived by the

customer as associated with the host web page, they give the customer the impression that she is

viewing pages served by the host. Further, the customer is able to purchase the item without

being redirected to the third party merchant affiliate, thus allowing the host to retain control over

the customer. This system enables the host to receive the same advertising revenue streams as

before but without the loss of visitor traffic and potential customers.

Examples: Abstract Ideas

Representative Claim

19. A system useful in an outsource provider serving web pages offering

commercial opportunities, the system comprising:

(a) a computer store containing data, for each of a plurality of first web pages,

defining a plurality of visually perceptible elements, which visually perceptible

elements correspond to the plurality of first web pages;

(i) wherein each of the first web pages belongs to one of a plurality of web

page owners;

(ii) wherein each of the first web pages displays at least one active link

associated with a commerce object associated with a buying opportunity

of a selected one of a plurality of merchants; and

(iii) wherein the selected merchant, the outsource provider, and the owner

of the first web page displaying the associated link are each third parties

with respect to one other;

(b) a computer server at the outsource provider, which computer server is coupled

to the computer store and programmed to:

(i) receive from the web browser of a computer user a signal indicating

activation of one of the links displayed by one of the first web pages;

(ii) automatically identify as the source page the one of the first web pages

on which the link has been activated;

(iii) in response to identification of the source page, automatically retrieve

the stored data corresponding to the source page; and

(iv) using the data retrieved, automatically generate and transmit to the

web browser a second web page that displays: (A) information associated

with the commerce object associated with the link that has been activated,

and (B) the plurality of visually perceptible elements visually

corresponding to the source page.

Analysis

Claim 19: Eligible.

The claim recites a system comprising a computer server and computer store. The system

comprises a device or set of devices and, therefore, is directed to a machine which is a statutory

category of invention (Step 1: YES).

Next, the claim is analyzed to determine whether it is directed to a judicial exception. This claim

recites a system “useful in outsource provider serving web pages offering commercial

opportunities,” but is directed to automatically generating and transmitting a web page in

response to activation of a link using data identified with a source web page having certain

visually perceptible elements. The claim does not recite a mathematical algorithm; nor does it

recite a fundamental economic or longstanding commercial practice. The claim addresses a

business challenge (retaining website visitors) that is particular to the Internet. The claimed

Examples: Abstract Ideas

invention differs from other claims found by the courts to recite abstract ideas in that it does not

“merely recite the performance of some business practice known from the pre-Internet world

along with the requirement to perform it on the Internet. Instead, the claimed solution is

necessarily rooted in computer technology in order to overcome a problem specifically arising in

the realm of computer networks.” No idea similar to those previously found by the courts to be

abstract has been identified in the claim. During examination, if the examiner does not identify

an abstract idea recited in the claim, the claim should be deemed to be not directed to a judicial

exception (Step 2A: NO). The claim is eligible.

Under the 2014 Interim Eligibility Guidance no further analysis would be necessary. In this

decision, however, the court went on to point out certain features of the claim that amount to an

inventive concept for resolving this particular Internet-centric problem, rendering the claims

patent eligible. An excerpt of the court’s discussion follows:

In particular, the ′399 patent's claims address the problem of retaining website visitors

that, if adhering to the routine, conventional functioning of Internet hyperlink protocol,

would be instantly transported away from a host's website after “clicking” on an

advertisement and activating a hyperlink. For example, asserted claim 19 recites a system

that, among other things, 1) stores “visually perceptible elements” corresponding to

numerous host websites in a database, with each of the host websites displaying at least

one link associated with a product or service of a third-party merchant, 2) on activation of

this link by a website visitor, automatically identifies the host, and 3) instructs an Internet

web server of an “out-source provider” to construct and serve to the visitor a new, hybrid

web page that merges content associated with the products of the third-party merchant

with the stored “visually perceptible elements” from the identified host website. [ ]

In more plain language, upon the click of an advertisement for a third-party product

displayed on a host's website, the visitor is no longer transported to the third party's

website. Instead, the patent claims call for an “outsource provider” having a web server

which directs the visitor to an automatically-generated hybrid web page that combines

visual “look and feel” elements from the host website and product information from the

third-party merchant's website related to the clicked advertisement. [ ] In this way,

rather than instantly losing visitors to the third-party's website, the host website can

instead send its visitors to a web page on the outsource provider's server that 1)

incorporates “look and feel” elements from the host website, and 2) provides visitors with

the opportunity to purchase products from the third-party merchant without actually

entering that merchant's website.

As the court cautioned, “not all claims purporting to address Internet-centric challenges are

eligible,” but in this case these additional limitations amount to more than simply stating “apply

the abstract idea on the Internet.” Therefore, when taken as a whole, the claimed invention has

additional limitations that amount to significantly more than the abstract idea. Under this

reasoning, the claim recites patent eligible subject matter (Step 2B: YES).

Examples: Abstract Ideas

3. Digital Image Processing

The following hypothetical claims are modeled after the technology in Research Corporation

Technologies Inc. v. Microsoft Corp., 627 F.3d 859 (Fed. Cir. 2010) (RCT). The patent at issue

was U.S. Patent No. 5,111,310. Hypothetical claims 1-3 are directed to an abstract idea and

have additional elements that amount to significantly more than the abstract idea because they

show an improvement in the functioning of the computer itself and also show an improvement to

another technology/technical field, either of which can show eligibility.

Background

A digital image generally consists of a discrete set of pixels arranged in columns and rows. In a

gray scale image, the value of each pixel varies among shades of gray ranging from black at the

weakest intensity to white at the strongest intensity. In contrast, a binary image includes pixels

that can only have two values, black or white. Some printing devices such as facsimile machines

and newspaper printers cannot reproduce gray scale images because they only print in black or

white. Therefore, in order to convert a gray scale image into a binary image, halftoning

techniques are used. Halftoning creates the illusion of various shades of gray in an image while

only using the pixel colors black and white. Certain halftoning techniques involve the pixel-by-

pixel comparison of the gray scale image to a two-dimensional array of threshold numbers, also

known as a “mask.” In digital implementation, the gray scale image to be halftoned is read into

memory, and a computer processor compares each pixel of the image to a threshold number at

the corresponding position of the mask stored in the computer’s memory. Based on that

comparison, a binary value representing black or white is output and these outputs are stored

together in a binary array known as the dot profile. The dot profile is then converted to a binary

display that is the halftoned image (the image for display).

In the instant application, the inventor has improved upon previous halftoning techniques by

developing an improved mask called a “blue noise” mask. The blue noise mask requires less

memory than previous masks and results in a faster computation time while improving image

quality. The blue noise mask is produced through an iterative mathematical operation that

begins with generating a dot profile with blue noise properties from an image at a 50% gray level

using a blue noise filter. Subsequently, additional dot profiles are generated at differing gray

levels. As pixels of the dot profile change across the gray levels, these changes are encoded in a

cumulative array. Once all the dot profiles are built, the cumulative array becomes the blue noise

mask.

Claims

1. A computer-implemented method for halftoning a gray scale image, comprising the steps of:

generating, with a processor, a blue noise mask by encoding changes in pixel values

across a plurality of blue noise filtered dot profiles at varying gray levels;

storing the blue noise mask in a first memory location;

receiving a gray scale image and storing the gray scale image in a second memory

location;

comparing, with a processor on a pixel-by-pixel basis, each pixel of the gray scale image

to a threshold number in the corresponding position of the blue noise mask to produce a binary

image array; and

Examples: Abstract Ideas

converting the binary image array to a halftoned image.

2. A non-transitory computer-readable medium with instructions stored thereon, that when

executed by a processor, perform the steps comprising:

generating a blue noise mask by encoding changes in pixel values across a plurality of

blue noise filtered dot profiles at varying gray levels;

storing the blue noise mask in a first memory location;

receiving a gray scale image and storing the gray scale image in a second memory

location;

comparing, on a pixel-by-pixel basis, each pixel of the gray scale image to a threshold

number in the corresponding position of the blue noise mask to produce a binary image array;

and

converting the binary image array to a halftoned image.

3. A system for halftoning a gray scale image, comprising:

a processor that generates a blue noise mask by encoding changes in pixel values across a

plurality of blue noise filtered dot profiles at varying gray levels;

a first memory for storing the blue noise mask; and

a second memory for storing a received gray scale image;

wherein the processor further compares, on a pixel-by-pixel basis, each pixel of the gray

scale image to a threshold number in the corresponding position of the blue noise mask to

produce a binary image array and converts the binary image array to a halftoned image.

Analysis

Claim 1: Eligible.

The method claim recites a series of acts for generating a blue noise mask and using that blue

noise mask to halftone a gray scale image. Thus, the claim is directed to a process, which is one

of the statutory categories of invention (Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception. The

claim recites the step of generating a blue noise mask, which as defined in the background is

produced through an iterative mathematical operation. The courts have found that mathematical

relationships fall within the judicial exceptions, often labelled as “abstract ideas.” Since the

mathematical operation of generating a blue noise mask is recited in the claim, the claim is

“directed to” a judicial exception (Step 2A: YES).

Next, the claim as a whole is analyzed to determine if there are additional limitations recited in

the claim such that the claim amounts to significantly more than the mathematical operation.

There are several additional limitations recited in the claim besides the mathematical operation

of generating a blue noise mask. First, the claim recites using a processor to generate the blue

Examples: Abstract Ideas

noise mask. The claim also recites the steps of storing the blue noise mask in a first memory

location and receiving a gray scale image and storing the gray scale image in a second memory

location. Thus, the claim uses a processor and memory to perform these steps of calculating a

mathematical operation and receiving and storing data. The addition of general purpose

computer components alone to perform such steps is not sufficient to transform a judicial

exception into a patentable invention. The computer components are recited at a high level of

generality and perform the basic functions of a computer (in this case, performing a

mathematical operation and receiving and storing data) that would be needed to apply the

abstract idea via computer. Merely using generic computer components to perform the above

identified basic computer functions to practice or apply the judicial exception does not constitute

a meaningful limitation that would amount to significantly more than the judicial exception, even

though such operations could be performed faster than without a computer.

The claim also recites the additional steps of comparing the blue noise mask to a gray scale

image to transform the gray scale image to a binary image array and converting the binary image

array into a halftoned image. These additional steps tie the mathematical operation (the blue

noise mask) to the processor’s ability to process digital images. These steps add meaningful

limitations to the abstract idea of generating the blue noise mask and therefore add significantly

more to the abstract idea than mere computer implementation. The claim, when taken as a

whole, does not simply describe the generation of a blue noise mask via a mathematical

operation and receiving and storing data, but combines the steps of generating a blue noise mask

with the steps for comparing the image to the blue noise mask and converting the resulting

binary image array to a halftoned image. By this, the claim goes beyond the mere concept of

simply retrieving and combining data using a computer.

Finally, viewing the claim elements as an ordered combination, the steps recited in addition to

the blue noise mask improve the functioning of the claimed computer itself. In particular, as

discussed above, the claimed process with the improved blue noise mask allows the computer to

use to less memory than required for prior masks, results in faster computation time without

sacrificing the quality of the resulting image as occurred in prior processes, and produces an

improved digital image. These are also improvements in the technology of digital image

processing. Unlike the invention in Alice Corp., the instant claim is not merely limiting the

abstract idea to a computer environment by simply performing the idea via a computer (i.e., not

merely performing routine data receipt and storage or mathematical operations on a computer),

but rather is an innovation in computer technology, namely digital image processing, which in

this case reflects both an improvement in the functioning of the computer and an improvement in

another technology. Taking all the additional claim elements individually, and in combination,

the claim as a whole amounts to significantly more than the abstract idea of generating a blue

noise mask (Step 2B: YES). The claim recites patent eligible subject matter.

Claim 2: Eligible.

The claim recites a non-transitory computer-readable medium with stored instructions. The term

“non-transitory” ensures the claim does not encompass signals and other transitory forms of

signal transmission. Therefore, the claim is directed to a manufacture (an article produced from

materials), which is a statutory category of invention (Step 1: YES).

The claim recites the same steps as claim 1. Therefore, the claim is directed to the same abstract

idea identified in claim 1 which is the mathematical operation of generating a blue noise mask

Examples: Abstract Ideas

(Step 2A: YES). Similarly, the claim recites the same additional elements of comparing the blue

noise mask to a gray scale image to transform the gray scale image to a binary image array and

converting the binary image array into a halftoned image. These additional elements add

significantly more to the abstract idea as evidenced by the improved functioning of the computer

in halftoning a gray scale image and the improved digital image processing. For the same

reasons set forth above, taking all the additional claim elements individually, and in combination,

the claim as a whole amounts to significantly more than the abstract idea of generating a blue

noise mask (Step 2B: YES). The claim recites patent eligible subject matter.

Claim 3: Eligible.

The claim recites a system comprising a processor, a first memory and a second memory. The

claim is directed to statutory category of invention, i.e. a machine (a combination of devices)

(Step 1: YES).

The claim recites the same abstract idea as identified with regard to claim 1, which is the

mathematical operation of generating a blue noise mask, and thus is directed to the abstract idea

(Step 2A: YES). Similarly, the claim recites the same additional elements that compare the blue

noise mask to a gray scale image to transform the gray scale image to a binary image array and

convert the binary image array into a halftoned image that add significantly more to the abstract

idea. For the same reasons set forth above, taking all the additional claim elements individually,

and in combination, the claim as a whole amounts to significantly more than the abstract idea of

generating a blue noise mask (Step 2B: YES). The claim recites patent eligible subject matter.

4. Global Positioning System

The following hypothetical claims are modeled after the technology in SiRF Technology Inc. v.

International Trade Commission, 601 F.3d 1319 (Fed. Cir. 2010) (SiRF Tech). The patent at

issue was U.S. Patent No. 6,417,801. Hypothetical claims 1 and 2 are directed to an abstract

idea and have additional elements that amount to significantly more than the abstract idea

because they show an improvement to another technology or technical field.

Background

Global Positioning Systems (GPS) use signals from multiple satellites to calculate the position of

a mobile GPS receiver on Earth. Each satellite transmits a signal containing unique pseudo-

random noise (PN) codes, satellite positioning data and absolute time information. A mobile

GPS receiver generally determines its position using the PN codes, satellite positioning data and

the absolute time information from multiple satellite signals. In areas where signal levels are

low, it is possible for the mobile GPS receiver to detect the PN codes, but is difficult to obtain

the satellite positioning data and absolute time information from the satellite signals.

This application describes systems and methods in which a server wirelessly coupled to a mobile

GPS receiver uses a mathematical model to solve for the mobile receiver position without

receiving satellite positioning data or absolute time information from a satellite. These systems

and methods improve GPS techniques by enabling the mobile GPS receiver to determine its

position more accurately and improve its signal-acquisition sensitivity to operate even in weak-

signal environments. In particular, the mobile GPS receiver is a mobile device that includes a

Examples: Abstract Ideas

GPS antenna, a GPS receiver, a microprocessor, a display, and a wireless communication

transceiver. Using mathematical formulas, the device calculates pseudo-ranges (estimated

ranges from the GPS receiver to each satellite in view) based on PN codes received from the

satellites, and the transceiver sends the pseudo-ranges to the server.

The server is a computer that uses the pseudo-ranges, along with an estimated position based on

a known location of a wireless tower and time data from the server’s own clock, in mathematical

formulas to calculate the absolute time that the GPS receiver received the signals from the

satellites. The server then creates a mathematical model that uses the pseudo-ranges and the

calculated absolute time to solve for the mobile receiver position, which is transmitted to the

mobile device for visual representation on a display. The components of the mobile device and

the server (e.g., central processing unit (CPU), clock, wireless tower location database, circuitry,

and memory) are all well-known and routine computer components.

Claims

1. A system for calculating an absolute position of a GPS receiver and an absolute time of

reception of satellite signals comprising:

a mobile device comprising a GPS receiver, a display, a microprocessor and a wireless

communication transceiver coupled to the GPS receiver, the mobile device programmed to

receive PN codes sent by a plurality of GPS satellites, calculate pseudo-ranges to the plurality of

GPS satellites by averaging the received PN codes, and transmit the pseudo-ranges, and

a server comprising a central processing unit, a memory, a clock, and a server

communication transceiver that receives pseudo-ranges from the wireless communication

transceiver of the mobile device, the memory having location data stored therein for a plurality

of wireless towers, and the central processing unit programmed to:

estimate a position of the GPS receiver based on location data for a wireless tower

from the memory and time data from the clock,

calculate absolute time that the signals were sent from the GPS satellites using the

pseudo-ranges from the mobile device and the position estimate,

create a mathematical model to calculate absolute position of the GPS receiver based

on the pseudo-ranges and calculated absolute time,

calculate the absolute position of the GPS receiver using the mathematical model, and

transmit the absolute position of the GPS receiver to the mobile device, via the server

communication transceiver, for visual representation on the display.

2. A method for calculating an absolute position of a GPS receiver and an absolute time of

reception of satellite signals comprising:

calculating pseudo-ranges, at a mobile device comprising a GPS receiver, a microprocessor,

a display, and a wireless communication transceiver, by averaging PN codes received by the

GPS receiver from a plurality of GPS satellites;

Examples: Abstract Ideas

wirelessly transmitting the calculated pseudo-ranges from the mobile device to a server,

wherein the server comprises a central processing unit (CPU);

calculating, by the server CPU, absolute time that the PN codes were sent from the GPS

satellites to the GPS receiver using the pseudo-ranges and an estimated position of the GPS

receiver;

using a mathematical model to calculate, by the server CPU, absolute position of the GPS

receiver based on the pseudo-ranges and calculated absolute time;

transmitting the absolute position from the server to the mobile device; and

displaying a visual representation of the absolute position on the display of the mobile

device.

Analysis

Claim 1: Eligible.

The claim is directed to a statutory category, because a system including a mobile device and a

server satisfies the requirements of a machine (as a combination of devices) (Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception. The

claim recites mathematical operations (e.g., calculating pseudo-ranges and absolute times, and

the mathematical model), which the courts have considered to fall within the judicial exceptions,

e.g., as abstract ideas. Because these mathematical operations are recited in the claim, the claim

is directed to a judicial exception (Step 2A: YES).

Next, the claim as a whole is analyzed to determine whether any element, or combination of

elements, is sufficient to ensure that the claim amounts to significantly more than the exception.

First, the claim recites using a central processing unit (CPU) for performing the mathematical

operations of estimating position, calculating absolute time, and calculating absolute position

using a mathematical model. The claim also recites using location data stored in a memory, and

time data from a clock. These computer components are recited at a high level of generality and

add no more to the claimed invention than the components that perform basic mathematical

calculation functions routinely provided by a general purpose computer. Limiting performance

of the mathematical calculations to a general purpose CPU, absent more, is not sufficient to

transform the recited judicial exception into a patent-eligible invention.

However, the claim is further limited to a mobile device comprising a GPS receiver,

microprocessor, wireless communication transceiver and a display that receives satellite data,

calculates pseudo-ranges, wirelessly transmits the calculated pseudo-ranges to the server,

receives location data from the server, and displays a visual representation of the received

calculated absolute position from the server. The programmed CPU acts in concert with the

recited features of the mobile device to enable the mobile device to determine and display its

absolute position through interaction with a remote server and multiple remote satellites. The

meaningful limitations placed upon the application of the claimed mathematical operations show

that the claim is not directed to performing mathematical operations on a computer alone.

Rather, the combination of elements impose meaningful limits in that the mathematical

operations are applied to improve an existing technology (global positioning) by improving the

signal-acquisition sensitivity of the receiver to extend the usefulness of the technology into

Examples: Abstract Ideas

weak-signal environments and providing the location information for display on the mobile

device. All of these features, especially when viewed in combination, amount to significantly

more than the judicial exception (Step 2B: YES). The claim is eligible.

Claim 2: Eligible.

The claim is directed to a statutory category, because a series of steps including calculating

pseudo-ranges and wirelessly transmitting those pseudo-ranges satisfies the requirements of a

process (a series of acts) (Step 1: YES).

The claim recites the same abstract ideas identified with regard to claim 1, which are the

mathematical operations of, e.g., calculating pseudo-ranges and absolute times, and the

mathematical model. Thus, this claim is also directed to a judicial exception (Step 2A: YES).

Similarly, the claim recites the same additional elements of a server CPU estimating position,

calculating absolute time, and calculating absolute position using a mathematical model, and a

mobile device comprising a GPS receiver, microprocessor, wireless communication transceiver

and a display receiving satellite data, calculating pseudo-ranges, wirelessly transmitting the

calculated pseudo-ranges to the server, receiving a calculated absolute position from the server,

and then displaying a visual representation of the received position. For the same reasons set

forth above, taking all the additional claim elements individually, and in combination, the claim

as a whole amounts to significantly more than the mathematical operations by themselves (Step

2B: YES). The claim is eligible.

Part Two

These examples show claims that were held ineligible by the Federal Circuit. The analysis

sections are informed by the court decisions but offer exemplary hypothetical analyses under the

2014 Interim Eligibility Guidance.

5. Digital Image Processing

The following claim was found ineligible by the Federal Circuit in Digitech Image Tech., LLC v.

Electronics for Imaging, Inc., 758 F.3d 1344 (Fed. Cir. 2014). The patent at issue was U.S.

Patent No. 6,128,415. The claim is directed to an abstract idea and does not have any

additional elements that could amount to more than the abstract idea itself.

Background

In general, digital image processing involves the acquisition of an image at a source device (e.g.,

digital camera, camcorder, scanner, etc.), processing the image in a desired fashion and

outputting the processed image at a destination device (e.g., monitor, printer, computer memory,

etc.). However, all image devices, whether source devices or destination devices, impose some

level of distortion of an image’s color and spatial properties. Some past solutions to address the

distortion have used a “device profile,” which describes the color properties of both the source

and destination devices, to enable a more accurate translation of the image’s pixel data into the

independent color space across the source and destination devices. The inventor has expanded

upon the prior device profile to capture both spatial as well as the color properties of the devices.

Example

: Abstract

Ideas

In this i

vention, as

een in Fig. 1 reproduce

below, a

evice profil

is created

ased on

informat

on from a s

urce devic

2, such as

digital ca

era, and fr

m a destina

ion device

such as

printer. T

e device pr

file is used to produce

he processe

image sig

al 18 from

input im

ge signal 1

. Spatial c

aracteristic informatio

12, 20 and color chara

teristic

informat

on 14, 22 a

e provided

rom each d

vice to an i

mage proce

sor 4, alon

with the i

put

image si

nal 16. Th

s characteri stic inform

tion is used to generate first data re

ating to col

informat

on content

f the imag

and secon

data relatin

g to spatial

nformation content of t

image u

ing known

athematic

l technique

, such as F

urier analy

is to yield a Wiener No

Power S

ectrum (m

thematical

rocessing t

chniques). The genera

ed data is i

corporated

into

the devi

e profile.

Represe

tative Clai

10. A method of ge

erating a d

vice profile that describ

es properties of a devic

in a digita

image re

roduction

ystem for c

pturing, tra

sforming

r rendering an image, s

id method

comprisi

generating fi

st data for

escribing a

evice depe

dent trans

rmation of color

informat

on content

f the imag

to a device independen

t color spac

through u

e of measured

chromat

c stimuli an

device res

onse chara

teristic fun

tions;

generating se cond data f

r describin

a device d

pendent tra

sformation of spatial

informat

on content

f the imag

in said dev

ce indepen

ent color s

ace throug

use of spat

stimuli a

d device r

sponse char acteristic fu

ctions; an

mbining s

id first and

econd data into the dev

ice profile.

Analysis

Claim 1

: Ineligible .

The clai

is directe

to a statuto

y category, because a s eries of ste

s for gener

ting data

satisfies

he require

ents of a pr

cess (a ser

es of acts) (

tep 1: YE

Next, th

claim is an

lyzed to de termine wh

ther it is di

ected to a j

dicial exce

tion. The

laim

recites a method of

enerating fi

st data and second data using math

matical tec

niques and

combini

g the first

nd second

ata into a d

vice profile

. In other

ords, the cl

imed meth

simply d

scribes the concept of

athering an d combinin

data by re

iting steps

f organizin

informat

on through mathematic

l relations

ips. The ga

thering and combining

erely emp

oys

mathem

tical relatio

ships to m

nipulate ex

sting infor

ation to ge

erate additi

nal inform

tion

in the fo

m of a ‘dev

ce profile,’ without lim

t to any us

of the devi

e profile.

his idea is

Examples: Abstract Ideas

similar to the basic concept of manipulating information using mathematical relationships (e.g.,

converting numerical representation in Benson), which has been found by the courts to be an

abstract idea. Therefore, the claim is directed to an abstract idea (Step 2A: YES).

The claim does not include additional elements beyond the abstract idea of gathering and

combining data. Therefore, the claim does not amount to more than the abstract idea itself (Step

2B: NO). The claim is not patent eligible.

6. The Game of Bingo

The following claim was found ineligible by the Federal Circuit in Planet Bingo, LLC v. VKGS

LLC, 576 Fed. Appx. 1005 (Fed. Cir. 2014). The patent at issue was U.S. Patent No. 6,398,646.

The claim is directed to an abstract idea and has additional elements that do not amount to

significantly more than the abstract idea.

Background

The invention relates to an automated Bingo system having the ability to print sets of numbers on

tickets on site. The system uses a computer to print the tickets, track the sale of the tickets and to

validate winning tickets. The computer stores the specific sets of Bingo numbers for a player

and prints the tickets having the player’s specific set of Bingo numbers to enable the player to

play his specific Bingo numbers for various sessions of Bingo. The automated system allows for

managing all aspects of a Bingo game, including solving tampering problems and minimizing

other security risks during Bingo ticket purchases.

Representative Claim

Claim 1. A system for managing a game of Bingo which comprises:

(a) a computer with a central processing unit (CPU) and with a memory and with a printer

connected to the CPU;

(b) an input and output terminal connected to the CPU and memory of the computer; and

(i) input of at least two sets of Bingo numbers which are preselected by a player to be

played in at least one selected game of Bingo in a future period of time;

(ii) storage of the sets of Bingo numbers which are preselected by the player as a

group in the memory of the computer;

(iii) assignment by the computer of a player identifier unique to the player for the

group having the sets of Bingo numbers which are preselected by the player wherein the player

identifier is assigned to the group for multiple sessions of Bingo;

(iv) retrieval of the group using the player identifier;

(v) selection from the group by the player of at least one of the sets of Bingo numbers

preselected by the player and stored in the memory of the computer as the group for play in a

selected game of Bingo in a specific session of Bingo wherein a number of sets of Bingo

Examples: Abstract Ideas

numbers selected for play in the selected game of Bingo is less than a total number of sets of

Bingo numbers in the group;

(vi) addition by the computer of a control number for each set of Bingo numbers

selected for play in the selected game of Bingo;

(vii) output of a receipt with the control number, the set of Bingo numbers which is

preselected and selected by the player, a price for the set of Bingo numbers which is preselected,

a date of the game of Bingo and optionally a computer identification number; and

(viii) output for verification of a winning set of Bingo numbers by means of the

control number which is input into the computer by a manager of the game of Bingo.

Analysis

Claim 1: Ineligible.

Claim 1 is directed to a system comprising a computer, an input and output terminal, and a

program enabling management of the game of Bingo. The claimed system is therefore directed

to a statutory category, i.e., a machine (a combination of devices) (Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exceptions. The

claim recites program elements (i) through (viii) that describe the steps of managing a game of

Bingo, including for example inputting and storing two sets of Bingo numbers, assigning a

unique player identifier and control number, and verifying a winning set of Bingo numbers.

Managing the game of Bingo as recited in the claim can be performed mentally or in a computer

and is similar to the kind of ‘organizing human activity’ at issue in Alice Corp. Although the

claims are not drawn to the same subject matter, the abstract idea of managing a game of Bingo

is similar to the abstract ideas of managing risk (hedging) during consumer transactions (Bilski)

and mitigating settlement risk in financial transactions (Alice Corp.) Claim 1 describes

managing the game of Bingo and therefore is directed to an abstract idea (Step 2A: YES).

Next, the claim is analyzed to determine whether there are additional limitations recited that

amount to significantly more than the abstract idea. The claim requires the additional limitations

of a computer with a central processing unit (CPU), memory, a printer, an input and output

terminal, and a program. These generic computer components are claimed to perform their basic

functions of storing, retrieving and processing data through the program that enables the

management of the game of Bingo. The recitation of the computer limitations amounts to mere

instructions to implement the abstract idea on a computer. Taking the additional elements

individually and in combination, the computer components at each step of the management

process perform purely generic computer functions. As such, there is no inventive concept

sufficient to transform the claimed subject matter into a patent-eligible application. The claim

does not amount to significantly more than the abstract idea itself (Step 2B: NO). Accordingly,

the claim is not patent eligible.

Examples: Abstract Ideas

7. E-Commerce providing Transaction Performance Guaranty

The following claim was found ineligible by the Federal Circuit in buySAFE, Inc. v. Google,

Inc., 765 F.3d 1350 (Fed. Cir. 2014). The patent at issue was U.S. Patent No. 7,644,019. The

claim is directed to an abstract idea and has additional elements that do not amount to

significantly more than the abstract idea.

Background

The invention relates to methods for conducting reliable transactions in an e-commerce

environment. More specifically, the invention relates to methods providing a performance

guaranty in a transaction. When a safe transaction service provider receives a request from a

first party for obtaining a transaction performance guaranty service, the safe transaction service

provider processes the request by underwriting the first party. If the underwriting is successful,

the transaction performance guaranty service is provided to the first party, which binds a

transaction performance guaranty to an online commercial transaction involving the first party

and guarantees the first party’s performance when the first party and second party enter the

online transaction.

Representative Claim

1. A method, comprising:

receiving, by at least one computer application program running on a computer of a safe

transaction service provider, a request from a first party for obtaining a transaction performance

guaranty service with respect to an online commercial transaction following closing of the online

commercial transaction;

processing, by at least one computer application program running on the safe transaction

service provider computer, the request by underwriting the first party in order to provide the

transaction performance guaranty service to the first party,

wherein the computer of the safe transaction service provider offers, via a computer

network, the transaction performance guaranty service that binds a transaction performance

guaranty to the online commercial transaction involving the first party to guarantee the

performance of the first party following closing of the online commercial transaction.

Analysis

Claim 1: Ineligible.

The claim is directed to a process, i.e., a series of steps or acts, for providing a performance

guaranty. A process is one of the statutory categories of invention (Step 1: YES).

Next, the claim is analyzed to determine whether it is directed to a judicial exception. The claim

recites the steps of creating a contract, including receiving a request for a performance guaranty

(contract), processing the request by underwriting to provide a performance guaranty and

offering the performance guaranty. This describes the creation of a contractual relationship,

which is a commercial arrangement involving contractual relations similar to the fundamental

economic practices found by the courts to be abstract ideas (e.g., hedging in Bilski). It is also

noted that narrowing the commercial transactions to particular types of relationships or particular

Examples: Abstract Ideas

parts of that commercial transaction (e.g., underwriting) would not render the concept less

abstract. Thus, the claim is directed to an abstract idea (Step 2A: YES).

Analyzing the claim as whole for an inventive concept, the claim limitations in addition to the

abstract idea include a computer application running on a computer and the computer network.

This is simply a generic recitation of a computer and a computer network performing their basic

functions. The claim amounts to no more than stating create a contract on a computer and send it

over a network. These generic computing elements alone do not amount to significantly more

than the judicial exception (Step 2B: NO). The claim is not patent eligible.

8. Distribution of Products over the Internet

The following claim was found ineligible by the Federal Circuit in Ultramercial v. Hulu and

WildTangent, 2014 U.S. App. LEXIS 21633 (Fed. Cir. 2014). The patent at issue was U.S.

Patent No. 7,346,545. The claim is directed to an abstract idea and has additional elements that

do not amount to significantly more than the abstract idea.

Background

The invention addresses problems with piracy of digital copyrighted media (video, audio, etc.),

especially among people who have limited access to cash and credit cards. The invention is

directed to distributing products covered by intellectual property, such as copyright, over a

telecommunications network by allowing a consumer to choose to view or interact with a

sponsor’s message in exchange for access to copyrighted material. The sponsor then pays the

holder of the underlying intellectual property, thus allowing the consumer to obtain the product

without paying with cash or credit. The invention uses a series of detailed steps that accomplish

the exchange of products.

Representative Claim

1. A method for distribution of products over the Internet via a facilitator, said method

comprising the steps of:

a first step of receiving, from a content provider, media products that are covered by

intellectual property rights protection and are available for purchase, wherein each said media

product being comprised of at least one of text data, music data, and video data;

a second step of selecting a sponsor message to be associated with the media product,

said sponsor message being selected from a plurality of sponsor messages, said second step

including accessing an activity log to verify that the total number of times which the sponsor

message has been previously presented is less than the number of transaction cycles contracted

by the sponsor of the sponsor message;

a third step of providing the media product for sale at an Internet website;

a fourth step of restricting general public access to said media product;

a fifth step of offering to a consumer access to the media product without charge to the

consumer on the precondition that the consumer views the sponsor message;

Examples: Abstract Ideas

a sixth step of receiving from the consumer a request to view the sponsor message,

wherein the consumer submits said request in response to being offered access to the media

product;

a seventh step of, in response to receiving the request from the consumer, facilitating the

display of a sponsor message to the consumer;

an eighth step of, if the sponsor message is not an interactive message, allowing said

consumer access to said media product after said step of facilitating the display of said sponsor

message;

a ninth step of, if the sponsor message is an interactive message, presenting at least one

query to the consumer and allowing said consumer access to said media product after receiving a

response to said at least one query;

a tenth step of recording the transaction event to the activity log, said tenth step including

updating the total number of times the sponsor message has been presented; and

an eleventh step of receiving payment from the sponsor of the sponsor message

displayed.

Analysis

Claim 1: Ineligible.

The claim is directed to a process; i.e., a series of steps or acts, for distributing media and

advertisements over the Internet. A process is one of the statutory categories of invention (Step

1: YES).

The claim is then analyzed to determine whether it is directed to an exception. The claim recites

an eleven step process for displaying an advertisement in exchange for access to copyrighted

media. That is, the claim describes the concept of using advertising as an exchange or currency.

This concept is similar to the concepts involving human activity relating to commercial practices

(e.g., hedging in Bilski) that have been found by the courts to be abstract ideas. The addition of

limitations that narrow the idea, such as receiving copyrighted media, selecting an ad, offering

the media in exchange for watching the selected ad, displaying the ad, allowing the consumer

access to the media, and receiving payment from the sponsor of the ad, further describe the

abstract idea, but do not make it less abstract. The claim is directed to an abstract idea (Step 2A:

YES).

Next, the claim as a whole is analyzed to determine whether it amounts to significantly more

than the concept of using advertising as an exchange or currency. The claim has additional

limitations to the abstract idea such as accessing and updating an activity log, requiring a request

from the consumer to view the advertising, restricting public access, and using the Internet as an

information transmitting medium.

Viewing the limitations individually, the accessing and updating of an activity log are used only

for data gathering and, as such, only represent insignificant pre-solution activity. Similarly,

requiring a consumer request and restricting public access is insignificant pre-solution activity

because such activity is necessary and routine in implementing the concept of using advertising

as an exchange or currency; i.e., currency must be tendered upon request in order for access to be

Examples: Abstract Ideas

provided to a desired good. Furthermore, the Internet limitations do not add significantly more

because they are simply an attempt to limit the abstract idea to a particular technological

environment.

Viewing the limitations as a combination, the claim simply instructs the practitioner to

implement the concept of using advertising as an exchange or currency with routine,

conventional activity specified at a high level of generality in a particular technological

environment. When viewed either as individual limitations or as an ordered combination, the

claim as a whole does not add significantly more to the abstract idea of using advertising as an

exchange or currency (Step 2B: NO). The claim is not patent eligible.

Nature-Based Products

The following examples should be used in conjunction with the 2014 Interim Eligibility Guidance. They

replace the examples issued with the March 2014 Procedure For Subject Matter Eligibility Analysis Of

Claims Reciting Or Involving Laws Of Nature/Natural Principles, Natural Phenomena, And/Or Natural

Products and related training. As the examples are intended to be illustrative only, they should be

interpreted based on fact patterns set forth below. Other fact patterns may have different eligibility

outcomes.

1. Gunpowder and Fireworks: Product Claims That Are Not Directed To An Exception

This example illustrates the application of the markedly different characteristics analysis to a nature-

based product produced by combining multiple components (claim 1), and also provides a sample of a

claimed product that when viewed as a whole is not nature-based, and thus is not subjected to the

markedly different characteristics analysis in order to determine that the claim is not directed to an

exception (claim 2).

Claims:

1. Gunpowder comprising: an intimate finely-ground mixture of 75% potassium nitrate, 15% charcoal

and 10% sulfur.

2. A fountain-style firework comprising: (a) a sparking composition, (b) calcium chloride, (c) the

gunpowder of claim 1, (d) a cardboard body having a first compartment containing the sparking

composition and the calcium chloride and a second compartment containing the gunpowder, and (e) a

plastic ignition fuse having one end extending into the second compartment and the other end

extending out of the cardboard body.

Analysis of Claims:

These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. Both

claims are directed to a statutory category, e.g., a composition of matter or manufacture (Step 1: YES).

Claim 1: Eligible. Because the claim is a nature-based product, i.e., a combination of three naturally

occurring substances (potassium nitrate, charcoal and sulfur), the nature-based product (the combination)

is analyzed to determine whether it has markedly different characteristics from any naturally occurring

counterpart(s) in their natural state. In this case, there is no naturally occurring counterpart to the claimed

combination (the components do not occur together in nature), so the combination is compared to the

individual components as they occur in nature. None of the three claimed substances are explosive in

nature. When the substances are finely-ground and intimately mixed in the claimed ratio, however, the

claimed combination is explosive upon ignition. This explosive property of the claimed combination is

markedly different from the non-explosive properties of the substances by themselves in nature.

Accordingly, the claimed combination has markedly different characteristics, and is not a “product of

nature” exception. Thus, the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible

subject matter.

Claim 2: Eligible. Although the claim recites two nature-based products (calcium chloride and

gunpowder), analysis of the claim as a whole indicates that the claim is focused on the assembly of

components that together form the firework, and not the nature-based products. Thus, it is not necessary

to apply the markedly different characteristics analysis in order to conclude that the claim is not directed

to an exception (Step 2A: NO). The claim qualifies as eligible subject matter.

2. Pomelo Juice: Process Claim That Is Directed To An Exception And Product Claim That Is

Not Directed To An Exception

This example illustrates the eligibility analysis of a process (claim 1) that focuses on a nature-based

product and a product (claim 2) that is nature-based but is not directed to an exception because it has

markedly different characteristics from its naturally occurring counterpart.

Nature-Based Products

Background: The pomelo tree (Citrus maxima) is a naturally occurring tree that is native to South and

Southeast Asia. Pomelo fruit is often eaten raw or juiced, and has a mild grapefruit-like flavor. Naturally

occurring pomelo juice spoils over the course of a few days even when refrigerated, due to the growth of

bacteria that are naturally present in the juice. The specification indicates that suitable preservatives for

fruit juices are known in the art, and include naturally occurring preservatives such as vitamin E, and non-

naturally occurring preservatives such as preservative X. The specification defines an “effective amount”

of these preservatives as an amount sufficient to prevent juice from spoiling for at least three weeks, e.g.,

by retarding the growth of bacteria in the juice.

Claims:

1. A method comprising providing a pomelo fruit.

2. A beverage composition comprising pomelo juice and an effective amount of an added preservative.

Analysis of Claims:

These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. All

of the claims are directed to a statutory category, e.g., a process or composition of matter (Step 1: YES).

Claim 1: Ineligible. Although the claim is a process claim, it has been drafted such that there is no

difference in substance from a product claim to the pomelo fruit itself. Accordingly, this process claim is

focused on the pomelo fruit per se (a nature-based product), and must be analyzed for markedly different

characteristics, to determine whether the claimed pomelo fruit is a “product of nature” exception. There is

no indication in the specification that the claimed fruit has any characteristics (structural, functional, or

otherwise) that are different from the naturally occurring fruit provided by pomelo trees. Thus, the

claimed fruit does not have markedly different characteristics from what occurs in nature, and is a

“product of nature” exception. Accordingly, the claim is directed to an exception (Step 2A: YES). Because

the claim does not include any additional features that could add significantly more to the exception (Step

2B: NO), the claim does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. §

101.

Claim 2: Eligible. Because the claim is a nature-based product, i.e., a combination of a naturally occurring

substance (pomelo juice) with an added preservative, the nature-based combination is analyzed to

determine whether it has markedly different characteristics from any naturally occurring counterpart(s) in

their natural state. In this case, there is no naturally occurring counterpart to the claimed combination, so

the combination is compared to the individual components as they occur in nature. The specification

indicates that the preservative can be natural or non-natural in origin, but that regardless of its origin,

when an effective amount of preservative is mixed with the pomelo juice, the preservative affects the

juice so that it spoils much more slowly (spoils in a few weeks) than the naturally occurring juice by itself

(spoils in a few days). This property (slower spoiling) of the claimed combination is markedly different

from properties of the juice by itself in nature. Accordingly, the claimed combination has markedly

different characteristics, and is not a “product of nature” exception. Thus, the claim is not directed to an

exception (Step 2A: NO), and qualifies as eligible subject matter.

3. Amazonic Acid, Pharmaceutical Compositions, & Methods of Treatment

This example illustrates the application of the markedly different characteristics analysis to single-

element product claims (claims 1, 2 and 3) and to a product-by-process claim (claim 4). It also

demonstrates that changes in chemical structure (claims 2 and 3), physical form (claim 5), or

chemical/physical properties (claim 6), as compared to a product’s natural counterpart can demonstrate

markedly different characteristics. Additionally, this example provides samples of claimed processes that

when viewed as a whole are not directed to a nature-based product, and thus are not subjected to the

markedly different characteristics analysis in order to determine that the claim is not directed to an

exception (claims 7 and 8).

Nature-Based Products

Background: The Amazonian cherry tree is a naturally occurring tree that grows wild in the Amazon

basin region of Brazil. The leaves of the Amazonian cherry tree contain a chemical that is useful in

treating breast and colon cancers. Many have tried and failed to isolate the cancer-fighting chemical from

the leaves. Applicant has successfully purified the cancer-fighting chemical from the leaves and has

named it amazonic acid. The purified amazonic acid is structurally and functionally identical to the

amazonic acid in the leaves. Applicant has created two derivatives of amazonic acid in the laboratory. The

first derivative (called 5-methyl amazonic acid), is structurally different from amazonic acid because a

hydrogen has been replaced with a methyl group, and is functionally different because it stimulates the

growth of hair in addition to treating cancer. The second derivative (called deoxyamazonic acid), was

created by removing a hydroxyl group from amazonic acid and replacing it with a hydrogen. Applicant

has not identified any functional difference between deoxyamazonic acid and amazonic acid.

Amazonic acid is absorbed through the lining of the human stomach and is rapidly metabolized by the

body. It is also insoluble in water. Applicants disclose an example of a solid pharmaceutical composition

demonstrating that when a core of amazonic acid is enveloped by a layer of a natural polymeric material,

the resulting manufacture does not release the amazonic acid until it reaches the colon. This colonic

release greatly improves the bioavailability of amazonic acid, and is particularly advantageous in the

treatment of colon cancer. The specification defines “natural polymeric material” as being a naturally

occurring polymer that is not easily digestible by human enzymes, so that it passes through most of the

human digestive system intact until it reaches the colon. Specific disclosed examples are shellac and

inulin. Applicants disclose an example of an aqueous composition, in which they were able to achieve a

stable solution of amazonic acid in water by including a solubilizing agent in the solution. The

solubilizing agent can be a naturally occurring product such as a sugar or polyol, or it can be a non-

naturally occurring product such as a polysorbate surfactant.

Claims:

1. Purified amazonic acid.

2. Purified 5-methyl amazonic acid.

3. Deoxyamazonic acid.

4. A composition comprising an acid produced by a process which comprises: providing amazonic acid;

and replacing the hydroxyl group of the amazonic acid with a hydrogen.

5. A pharmaceutical composition comprising: a core comprising amazonic acid; and a layer of natural

polymeric material enveloping the core.

6. A stable aqueous composition comprising: amazonic acid; and a solubilizing agent.

7. A method of treating colon cancer, comprising: administering a daily dose of purified amazonic acid

to a patient suffering from colon cancer for a period of time from 10 days to 20 days, wherein said

daily dose comprises about 0.75 to about 1.25 teaspoons of amazonic acid.

8. A method of treating breast or colon cancer, comprising: administering an effective amount of

purified amazonic acid to a patient suffering from breast or colon cancer.

Analysis of Claims:

These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. All

of the claims are directed to a statutory category, e.g., a composition of matter or process (Step 1: YES).

Because claims 1-6 are nature-based products (e.g., amazonic acid, 5-methyl amazonic acid, or

deoxyamazonic acid), the markedly different characteristics analysis is used to determine if the nature-

based products are exceptions. Although claims 7-8 recite nature-based products (amazonic acid), a full

eligibility analysis of these claims is not needed because the claims clearly do not seek to tie up all

practical uses of the nature-based products.

Nature-Based Products

Claim 1: Ineligible. Although applicant has discovered that amazonic acid naturally occurs in the leaves

of the Amazonian cherry tree, this discovery does not, by itself, render amazonic acid patent eligible.

Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 2117 (2013)

(“Myriad”). Instead, the claimed acid is analyzed to determine if separating the acid from its surrounding

material in the leaf has resulted in the purified amazonic acid having markedly different characteristics

from its naturally occurring counterpart. Based on the limited background information, there is no

indication that purified amazonic acid has any characteristics (structural, functional, or otherwise) that are

different from naturally occurring amazonic acid. The claim therefore encompasses amazonic acid that is

structurally and functionally identical to naturally occurring amazonic acid. Because there is no difference

between the claimed and naturally occurring acid, the claimed acid does not have markedly different

characteristics from what occurs in nature, and thus is a “product of nature” exception. Accordingly, the

claim is directed to an exception (Step 2A: YES). Because the claim does not include any additional

features that could add significantly more to the exception (Step 2B: NO), the claim does not qualify as

eligible subject matter, and should be rejected under 35 U.S.C. § 101.

Claim 2: Eligible. The claimed 5-methyl amazonic acid has a different structural characteristic than

amazonic acid (its chemical structure is different due to the addition of the 5-methyl group). Because 5-

methyl amazonic acid is a unique molecule that is distinct from, and does not prevent others from using,

naturally occurring amazonic acid, its different structural characteristic rises to the level of a marked

difference. Accordingly, the claimed 5-methyl amazonic acid is not a “product of nature” exception. This

conclusion is bolstered by the fact that the different structural characteristic has resulted in a different

functional characteristic (the stimulation of hair growth). Thus, the claim is not directed to an exception

(Step 2A: NO), and qualifies as eligible subject matter.

Claim 3: Eligible. The claimed deoxyamazonic acid has a different structural characteristic from

amazonic acid (its chemical structure is different due to the removal of a hydroxyl group). Based on the

limited background information, this change in structure has not resulted in any different functional

characteristics. However, because deoxyamazonic acid is a unique molecule that is distinct from, and

does not prevent others from using, naturally occurring amazonic acid, its different structural

characteristic rises to the level of a marked difference. Accordingly, the claimed deoxyamazonic acid is

not a “product of nature” exception. Thus, the claim is not directed to an exception (Step 2A: NO), and

qualifies as eligible subject matter.

Claim 4: Eligible. During examination, a product-by-process claim is not limited to manipulations of the

recited steps, but instead is only limited to the structure implied by the steps. In this case, the specification

describes that removing a hydroxyl group from amazonic acid and replacing it with a hydrogen results in

deoxyamazonic acid. Thus, the acid produced by the claimed process steps is deoxyamazonic acid. As

explained with respect to claim 3, deoxyamazonic acid has markedly different characteristics than

naturally occurring amazonic acid, and is not a “product of nature” exception. Thus, the claim is not

directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.

Claim 5: Eligible. The claim is limited to a particular pharmaceutical composition having two naturally

occurring substances physically joined together into a non-natural structure (core of amazonic acid

surrounded by a layer of natural polymeric material). The claimed composition thus is structurally

different from the naturally occurring substances, and this structural difference results in the claimed

composition having different functional characteristics in vivo (e.g., amazonic acid is not released until

the composition reaches the colon, due to the relative indigestibility of the natural polymeric material,

thus increasing the bioavailability of the amazonic acid) than the naturally occurring substances by

themselves. These different structural and functional characteristics rise to the level of a marked

difference, and accordingly the claimed composition is not a “product of nature” exception. Thus, the

claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.

Nature-Based Products

Claim 6: Eligible. In nature, amazonic acid is insoluble in water. As explained in the specification,

however, when amazonic acid is combined with a solubilizing agent, it becomes soluble in water and

forms a stable solution. This changed property (solubility) between amazonic acid as a part of the claimed

stable aqueous composition and amazonic acid in nature is a marked difference. Accordingly, the claimed

composition has markedly different characteristics, and is not a “product of nature” exception. Thus, the

claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.

Claim 7: Eligible. Although the claim recites a nature-based product (amazonic acid), analysis of the

claim as a whole indicates that the claim is focused on a process of practically applying the product to

treat a particular disease (colon cancer), and not on the product per se. Thus, it is not necessary to apply

the markedly different characteristics analysis in order to conclude that the claim is not directed to an

exception (Step 2A: NO). The claim qualifies as eligible subject matter.

Claim 8: Eligible. Although the claim recites a nature-based product (amazonic acid), analysis of the

claim as a whole indicates that the claim is focused on a process of practically applying the product to

treat a particular disease (breast or colon cancer), and not on the product per se. Thus, it is not necessary

to apply the markedly different characteristics analysis in order to conclude that the claim is not directed

to an exception (Step 2A: NO). The claim qualifies as eligible subject matter.

4. Purified Proteins

This example illustrates that changes in physical/chemical structure (claims 2-5) as compared to a

product’s natural counterpart can demonstrate markedly different characteristics, whether or not

accompanied by changes in biological/pharmacological function or chemical/physical properties.

Background: Newly discovered Streptomyces arizoneus bacteria produce Antibiotic L, which exhibits

antibiotic activity in nature (e.g., it kills other bacterial species in its natural environment). Naturally

occurring Antibiotic L is a protein that occurs in the form of hexagonal-pyramidal crystals (each crystal

has the shape of a six-sided pyramid) that are stored inside the bacteria. The specification describes

several processes that yield Antibiotic L having the same hexagonal-pyramidal crystal form as naturally

occurring Antibiotic L. The specification also discloses a process that yields purified Antibiotic L in the

form of tetrahedral crystals (each crystal has the shape of a tetrahedron or triangular pyramid). The

specification discloses that naturally occurring Antibiotic L has the amino acid sequence of SEQ ID NO:

2, and has a bacillosamine N-glycan on residue 49. In the specification, applicants describe recombinant

yeast that are able to synthesize Antibiotic L (naturally occurring yeast cannot synthesize Antibiotic L or

bacillosamine). Purified Antibiotic L expressed by these recombinant yeast has a high mannose (instead

of a bacillosamine) N-glycan on residue 49, and has lower immunogenicity to humans and a different

half-life in vivo than naturally occurring Antibiotic L. The specification defines “purified Antibiotic L” as

only being either Antibiotic L in the tetrahedral crystal form or Antibiotic L having a high mannose N-

glycan on residue 49.

Applicants disclose substitution modifications of Antibiotic L, e.g., peptides having one or more amino

acids substituted with different amino acids relative to SEQ ID NO: 2. No substitution modifications of

Antibiotic L are known to occur in nature. Some of the modifications result in altering the function of the

peptide, for example by increasing its ability to penetrate the cell membrane of a target organism. The

modified peptides have 90% or greater identity to SEQ ID NO: 2.

Claims:

1. Antibiotic L.

2. Purified Antibiotic L.

3. The Antibiotic L of claim 1, which is in a tetrahedral crystal form.

4. The Antibiotic L of claim 1, which is expressed by recombinant yeast.

Nature-Based Products

5. A purified antibiotic comprising an amino acid sequence that has at least 90% identity to SEQ ID NO:

2 and contains at least one substitution modification relative to SEQ ID NO: 2.

Analysis of Claims:

These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation.

Because all of the claims are directed to a statutory category, e.g., a composition of matter (Step 1: YES),

and are nature-based products (Antibiotic L or a derivative thereof), the markedly different characteristics

analysis is used to determine if the nature-based products are exceptions.

Claim 1: Ineligible. As described in the specification, some Antibiotic L produced by the applicants is in

its naturally occurring hexagonal-pyramidal crystal form, while other Antibiotic L is in a non-natural

form, e.g., tetrahedral crystals. The claim thus encompasses antibiotic that is identical to the natural

antibiotic, and antibiotic that is changed. Because there is no difference in characteristics (structural,

functional, or otherwise) between the claimed and naturally occurring antibiotic for at least some of the

embodiments encompassed by the claim, the claimed Antibiotic L does not have markedly different

characteristics from what exists in nature, and thus is a “product of nature” exception. Accordingly, the

claim is directed to an exception (Step 2A: YES). Because the claim does not include any additional

features that could add significantly more to the exception (Step 2B: NO), the claim does not qualify as

eligible subject matter, and should be rejected under 35 U.S.C. § 101.

Claim 2: Eligible. Based on the specification’s definition of purified Antibiotic L, the claim is limited to

Antibiotic L in the form of tetrahedral crystals or having a high-mannose N-glycan on residue 49. The

claim does not encompass naturally occurring Antibiotic L (which forms hexagonal-pyramidal crystals,

and has a bacillosamine N-glycan on residue 49). The claimed antibiotic has particular structural/physical

characteristics that are different from the naturally occurring antibiotic (e.g., different crystalline form or

different N-glycan). The person of ordinary skill in the art would understand that these structural

differences may result in the claimed antibiotic having different functional characteristics (e.g., different

powder flow behavior or lower immunogenicity and different half-life) than the naturally occurring

antibiotic. These differences rise to the level of a marked difference, and thus the claimed antibiotic is not

a “product of nature” exception. Thus, the claim is not directed to an exception (Step 2A: NO), and

qualifies as eligible subject matter.

Claim 3: Eligible. The claim is limited to Antibiotic L in the form of tetrahedral crystals, and does not

encompass the naturally occurring hexagonal-pyramidal crystals. Although the claimed antibiotic is

chemically unchanged from nature, the claimed antibiotic has particular structural/physical characteristics

that are different from the naturally occurring antibiotic (e.g., different crystalline form). The person of

ordinary skill in the art would understand that these structural differences may result in the claimed

antibiotic having different functional characteristics (e.g., powder flow behavior) than the naturally

occurring antibiotic. These differences rise to the level of a marked difference, and thus the claimed

antibiotic is not a “product of nature” exception. Thus, the claim is not directed to an exception (Step 2A:

NO), and qualifies as eligible subject matter.

Claim 4: Eligible. During examination, a product-by-process claim is not limited to manipulations of the

recited steps, but instead is only limited to the structure implied by the steps. In this case, the specification

describes that Antibiotic L produced by recombinant yeast has a different structure (high-mannose N-

glycan) than the natural antibiotic (bacillosamine N-glycan). The claim is therefore limited to a

structurally different Antibiotic L having a high-mannose N-glycan. This structural difference results in a

change to the properties of the claimed antibiotic (lower immunogenicity and different half-life than the

natural antibiotic). These differences rise to the level of a marked difference, and thus the claimed

antibiotic is not a “product of nature” exception. Thus, the claim is not directed to an exception (Step 2A:

NO), and qualifies as eligible subject matter.

Nature-Based Products

Claim 5: Eligible. The claim is limited to peptides in which the amino acid sequence has at least 90%

identity to SEQ ID NO: 2, but has been changed to contain at least one non-naturally occurring

substitution modification relative to SEQ ID NO: 2. All of the claimed peptides have different structural

characteristics (e.g., one or more amino acids have been changed relative to the natural sequence). Some

of the claimed peptides may have different functional characteristics, but at least for some conservative

modifications there may be no observable functional difference. Because the structural differences

between the claimed peptides and their natural counterparts are enough to ensure that the claim is not

improperly tying up the future use of naturally occurring Antibiotic L, they rise to the level of a marked

difference, and thus the claimed antibiotic is not a “product of nature” exception. Thus, the claim is not

directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.

5. Genetically Modified Bacterium

This example illustrates that a naturally occurring product that is unchanged from its natural state does

not have markedly different characteristics (claim 1), but that changes in biological function between a

claimed product and its natural counterpart can demonstrate markedly different characteristics (claim 2).

Background: Stable energy-generating plasmids that provide hydrocarbon degradative pathways exist

within certain bacteria in nature. Different plasmids provide the ability to degrade different hydrocarbons,

e.g., one plasmid provides the ability to degrade camphor, and a different plasmid provides the ability to

degrade octane. Pseudomonas bacteria are naturally occurring bacteria. Naturally occurring Pseudomonas

bacteria containing one stable energy-generating plasmid and capable of degrading a single type of

hydrocarbon are known. There are no known Pseudomonas bacteria in nature that contain more than one

stable energy-generating plasmid. In the specification, applicant discloses genetically modifying a

Pseudomonas bacterium to include more plasmids than are found in a single naturally occurring

Pseudomonas bacterium.

Claims:

1. A stable energy-generating plasmid, which provides a hydrocarbon degradative pathway.

2. A bacterium from the genus Pseudomonas containing therein at least two stable energy-generating

plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway.

Analysis of Claims:

These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation.

Because both claims are directed to a statutory category, e.g., a manufacture or composition of matter

(Step 1: YES), and are nature-based products (plasmid or bacterium), the markedly different

characteristics analysis is used to determine if the nature-based products are exceptions.

Claim 1: Ineligible. Based on the limited background information, there is no indication that the claimed

plasmid has any characteristics (structural, functional, or otherwise) that are different from naturally

occurring energy-generating plasmids. Because there is no difference between the claimed and naturally

occurring plasmid, the claimed plasmid does not have markedly different characteristics, and thus is a

“product of nature” exception. Accordingly, the claim is directed to an exception (Step 2A: YES). Because

the claim does not include any additional features that could add significantly more to the exception (Step

2B: NO), the claim does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. §

101.

Claim 2: Eligible. The claimed bacterium has a different functional characteristic from naturally

occurring Pseudomonas bacteria, i.e., it is able to degrade at least two different hydrocarbons as

compared to naturally occurring Pseudomonas bacteria that can only degrade a single hydrocarbon. The

claimed bacterium also has a different structural characteristic, i.e., it was genetically modified to include

more plasmids than are found in a single naturally occurring Pseudomonas bacterium. The different

functional and structural characteristics rise to the level of a marked difference, and accordingly the

Nature-Based Products

claimed bacterium is not a “product of nature” exception. Thus, the claim is not directed to an exception

(Step 2A: NO), and qualifies as eligible subject matter.

The bacterium of claim 2 was held to be patent-eligible subject matter in Diamond v. Chakrabarty, 447

U.S. 303 (1980). Recently, the Supreme Court looked back to this claim as an example of a nature-based

product that is patent-eligible because it has markedly different characteristics than naturally occurring

bacteria, as explained in Myriad, 133 S. Ct. at 2116-17:

In Chakrabarty, scientists added four plasmids to a bacterium, which enabled it to break

down various components of crude oil. 447 U. S., at 305, 100 S. Ct. 2204, 65 L. Ed. 2d

144, and n. 1. The Court held that the modified bacterium was patentable. It explained

that the patent claim was “not to a hitherto unknown natural phenomenon, but to a

nonnaturally occurring manufacture or composition of matter--a product of human

ingenuity ‘having a distinctive name, character [and] use.’” Id., at 309-310, 100 S. Ct.

2204, 65 L. Ed. 2d 144 (quoting Hartranft v. Wiegmann, 121 U. S. 609, 615, 7 S. Ct.

1240, 30 L. Ed. 1012 (1887); alteration in original). The Chakrabarty bacterium was new

“with markedly different characteristics from any found in nature,” 447 U. S., at 310, 100

S. Ct. 2204, 65 L. Ed. 2d 144, due to the additional plasmids and resultant “capacity for

degrading oil.”

6. Bacterial Mixtures

This example illustrates the application of the markedly different characteristics analysis to nature-based

product claims produced by combining multiple components.

Background: Rhizobium bacteria are naturally occurring bacteria that infect leguminous plants such as

clover, alfalfa, beans and soy. Each species of bacteria will only infect certain types of plants, for example

R. meliloti will only infect alfalfa and sweet clover, and R. phaseoli will only infect garden beans. It was

assumed in the prior art that all Rhizobium species were mutually inhibitive, because prior art

combinations of different bacterial species produced an inhibitory effect on each other when mixed

together, with the result that their efficiency was reduced. Applicant has discovered that there are

particular strains of each Rhizobium species that do not exert a mutually inhibitive effect on each other,

and that these strains can be isolated and used in mixed cultures. Applicant has also discovered that

certain Rhizobium species, when mixed together, exhibit biological properties that are different than in

nature. For example, in nature or by itself, R. californiana will only infect lupine. When mixed with R.

phaseoli, however, R. californiana will infect both lupine and wild indigo. R. californiana and R. phaseoli

are not known to occur together in nature.

Claims:

1. An inoculant for leguminous plants comprising a plurality of selected mutually non-inhibitive strains

of different species of bacteria of the genus Rhizobium, said strains being unaffected by each other in

respect to their ability to fix nitrogen in the leguminous plant for which they are specific.

2. An inoculant for leguminous plants comprising a mixture of Rhizobium californiana and Rhizobium

phaseoli.

Analysis of Claims:

These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation.

Because both claims are directed to a statutory category, e.g., a composition of matter (Step 1: YES), and

are nature-based products (a mixture of bacteria), the markedly different characteristics analysis is used to

determine if the nature-based products are exceptions.

Claim 1: Ineligible. There is no indication in the specification that the claimed mixture of bacteria has any

characteristics (structural, functional, or otherwise) that are different from the naturally occurring

Nature-Based Products

bacteria. Thus, the mixture does not have markedly different characteristics from what occurs in nature,

and is a “product of nature” exception. Accordingly, the claim is directed to an exception (Step 2A: YES).

Because the claim does not include any additional features that could add significantly more to the

exception (Step 2B: NO), the claim does not qualify as eligible subject matter, and should be rejected

under 35 U.S.C. § 101.

The inoculant of claim 1 was held to be ineligible subject matter in Funk Brothers Seed Co. v. Kalo

Inoculant Co., 333 U.S. 127, 131 (1948):

Discovery of the fact that certain strains of each species of these bacteria can be mixed

without harmful effect to the properties of either is a discovery of their qualities of non-

inhibition. It is no more than the discovery of some of the handiwork of nature and hence

is not patentable. The aggregation of select strains of the several species into one product

is an application of that newly-discovered natural principle. But however ingenious the

discovery of that natural principle may have been, the application of it is hardly more

than an advance in the packaging of the inoculants. Each of the species of root-nodule

bacteria contained in the package infects the same group of leguminous plants which it

always infected. No species acquires a different use. The combination of species

produces no new bacteria, no change in the six species of bacteria, and no enlargement of

the range of their utility. Each species has the same effect it always had. The bacteria

perform in their natural way. Their use in combination does not improve in any way their

natural functioning. They serve the ends nature originally provided and act quite

independently of any effort of the patentee.

Recently, the Supreme Court looked back to this claim as an example of ineligible subject matter, stating

that “the composition was not patent eligible because the patent holder did not alter the bacteria in any

way.” Myriad, 133 S. Ct. at 2117.

Claim 2: Eligible. In nature, R. phaseoli only infects garden beans, and R. californiana only infects

lupine. When mixed together as claimed, the combination now infects a third species of plant: R.

californiana infects both lupine and wild indigo, but R. phaseoli continues to only infect garden beans.

The combination of species thus has changed R. californiana such that, when combined with R. phaseoli,

it has a different characteristic (biological function) than it had in nature, i.e., the claimed combination

infects a new group of leguminous plants (wild indigo) as compared to the naturally occurring bacteria by

themselves. This functional difference rises to the level of a marked difference, and accordingly the

claimed mixture is not a “product of nature” exception. Note that unless the examiner can show that this

particular mixture of bacteria exists in nature, this mere possibility does not bar the eligibility of this

claim. See, e.g., Myriad, 133 S. Ct. at 2119 n.8 (“The possibility that an unusual and rare phenomenon

might randomly create a molecule similar to one created synthetically through human ingenuity does not

render a composition of matter nonpatentable” (emphasis in original)). Thus, the claim is not directed to

an exception (Step 2A: NO), and qualifies as eligible subject matter.

7. Nucleic Acids

This example illustrates that changes in genetic information/structure (claims 2 and 4), or physical

structure (claim 3), as compared to a product’s natural counterpart can demonstrate markedly different

characteristics.

Background: Virginia nightshade is a naturally occurring plant that grows wild in the Shenandoah Valley

of Virginia. When damaged, the leaves of Virginia nightshade produce a hormone called Protein W,

which activates chemical defenses against herbivores. Protein W is naturally encoded by Gene W, which

is part of chromosome 3 in Virginia nightshade and has the nucleic acid sequence disclosed as SEQ ID

NO: 1. The specification also discloses substitution modifications of Gene W, e.g., nucleic acids having

one or more nucleotide bases that are substituted with different bases relative to SEQ ID NO: 1. For

Nature-Based Products

example, one of the disclosed modifications changes a naturally occurring adenine to a guanine, e.g., the

first nine nucleotides are “TAC GGG AAA” in naturally occurring Gene L and “TAC GGG AAG” in the

modified nucleic acid. Some of the modifications are silent, meaning that no change occurs in the

encoded protein. It is known in the art that some silent modifications affect characteristics of nucleic acid

such as transcription rate and splicing, and that some do not. No substitution modifications of Gene W are

known to occur in nature. The modified nucleic acids have 90% or greater identity to SEQ ID NO: 1. The

specification discloses labeling the nucleic acids, e.g., with a fluorescent or radioactive label.

The specification discloses vectors comprising SEQ ID NO: 1 and a heterologous nucleic acid. The

specification defines “heterologous” nucleic acid sequences as nucleic acid sequences that do not

naturally occur in Virginia nightshade, e.g., sequences from other plants, bacteria, viruses, or other

organisms. Disclosed heterologous nucleic acids include plant viral vectors such as tobacco mosaic virus,

and viral promoters such as the cauliflower mosaic virus (CaMV) 35S promoter. The viral promoters

cause different expression of Gene W as compared to its natural expression levels in Virginia nightshade,

e.g., Gene W is expressed all the time (constitutively) as opposed to only in response to leaf damage.

Claims:

1. Isolated nucleic acid comprising SEQ ID NO: 1.

2. Isolated nucleic acid comprising a sequence that has at least 90% identity to SEQ ID NO: 1 and

contains at least one substitution modification relative to SEQ ID NO: 1.

3. The isolated nucleic acid of claim 1, further comprising a fluorescent label attached to the nucleic

acid.

4. A vector comprising the nucleic acid of claim 1 and a heterologous nucleic acid sequence.

Analysis of Claims:

These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation.

Because all of the claims are directed to a statutory category, e.g. a composition of matter (Step 1: YES),

and are nature-based products (a nucleic acid), the markedly different characteristics analysis is used to

determine if the nature-based products are exceptions.

Claim 1: Ineligible. The claimed nucleic acid has a different structural characteristic than naturally

occurring Gene W, because the chemical bonds at each end were severed in order to isolate it from the

chromosome on which it occurs in nature, but has the same nucleotide sequence as the natural gene. The

claimed nucleic acid has no different functional characteristics, i.e., it encodes the same protein as the

natural gene. Under the holding of Myriad, this isolated but otherwise unchanged nucleic acid is not

eligible because it is not different enough from what exists in nature to avoid improperly tying up the

future use and study of naturally occurring Gene W. In other words, the claimed nucleic acid is different,

but not markedly different, from its natural counterpart in its natural state (Gene W on chromosome 3),

and thus is a “product of nature” exception. Accordingly, the claim is directed to an exception (Step 2A:

YES). Because the claim does not include any additional features that could add significantly more to the

exception (Step 2B: NO), the claim does not qualify as eligible subject matter, and should be rejected

under 35 U.S.C. § 101.

Claim 2: Eligible. The claim is limited to nucleic acids in which the nucleotide sequence has been

changed to contain at least one non-naturally occurring substitution modification relative to SEQ ID NO:

1. All of the claimed nucleic acids have different structural characteristics than the naturally occurring

nucleic acid, e.g., one or more nucleotides have been changed relative to the natural sequence. Some of

the claimed nucleic acids may have different functional characteristics, e.g., they may encode a different

protein than the natural gene. Because the structural differences between the claimed nucleic acids and

their natural counterparts are enough to ensure that the claim is not improperly tying up the future use of

naturally occurring Gene W, they rise to the level of a marked difference, and so the claimed nucleic acids

Nature-Based Products

are not a “product of nature” exception. Thus, the claim is not directed to an exception (Step 2A: NO), and

qualifies as eligible subject matter.

Claim 3: Eligible. The claim is limited to a molecule that includes a nucleic acid and a fluorescent label,

which combination does not occur in nature as a single molecule. The claimed molecule thus has different

structural characteristics than the naturally occurring nucleic acid and label (single molecule vs. two

separate molecules). It also has different functional characteristics (the labeled nucleic acid is now

fluorescent, whereas the natural gene is not). These differences rise to the level of a marked difference,

and so the claimed molecule is not a “product of nature” exception. Thus, the claim is not directed to an

exception (Step 2A: NO), and qualifies as eligible subject matter.

Claim 4: Eligible. The claim is limited to vectors comprising a non-natural combination of Gene W (SEQ

ID NO: 1) with a sequence from another organism, and thus does not read on the naturally occurring

chromosome in Virginia nightshade. This non-natural combination results in the vectors having a

different genetic structure and sequence than the naturally occurring nucleic acids, i.e., different structural

characteristics. Some of the claimed vectors may have different functional characteristics, depending on

the selected heterologous sequence. These differences rise to the level of a marked difference, and so the

claimed vector is not a “product of nature” exception. Thus, the claim is not directed to an exception (Step

2A: NO), and qualifies as eligible subject matter.

8. Antibodies

This example illustrates that products created by human manipulation of natural processes (claims 2 and

3), as well as products that are changed in structure as compared to a product’s natural counterpart

(claims 4 and 5), can have markedly different characteristics.

Background: Newly discovered Staphylococcus texana bacteria have an antigen called Protein S on their

outer surface. The specification describes the discovery of naturally occurring antibodies to Protein S in

mice and wild coyotes living in Texas. No human antibodies to Protein S are naturally occurring.

Antibodies have two types of domains: (1) constant domains such as the Fc domain, which are unvarying

in antibodies of a particular class (e.g., IgA) within a species; and (2) variable domains comprising

complementarity determining regions (CDRs) that bind to an antigen and that vary from antibody to

antibody.

The specification describes multiple types of antibodies to Protein S, including:

 murine antibodies, that were created by injecting laboratory mice with Protein S;

 human antibodies, that were created by injecting transgenic mice with Protein S;

 chimeric antibodies (defined as antibodies that have murine variable domains and human constant

domains);

 humanized antibodies (defined as antibodies having murine CDRs but are otherwise human); and

 antibodies with variant Fc domains (defined as antibodies having an Fc domain that is engineered

to comprise at least one amino acid modification relative to a wild-type Fc domain).

It is well-known in the art that murine antibodies have different constant domains than human and coyote

antibodies, and that murine antibodies may cause allergic reactions and anaphylactic shock when

administered to humans or coyotes. The specification discloses a particular murine antibody created by

applicants, comprising SEQ ID NOs: 7-12 as its six CDR sequences. There is no naturally occurring

antibody that has this particular combination of CDR sequences. It is well-known in the art that chimeric

and humanized antibodies are less immunogenic to humans than murine antibodies. It is also well-known

that antibodies with variant Fc domains may exhibit different characteristics (e.g., increased cytotoxicity

and/or serum half-life) than antibodies with wild-type Fc domains.

Claims:

1. An antibody to Protein S.

Nature-Based Products

2. The antibody of claim 1, wherein the antibody is a human antibody.

3. The antibody of claim 1, wherein the antibody is a murine antibody comprising complementarity

determining region (CDR) sequences set forth as SEQ ID NOs: 7-12.

4. The antibody of claim 1, wherein the antibody is a chimeric or humanized antibody.

5. The antibody of claim 1, wherein the antibody comprises a variant Fc domain.

Analysis of Claims:

These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation.

Because all of the claims are directed to a statutory category, e.g., a composition of matter (Step 1: YES),

and are nature-based products (an antibody), the markedly different characteristics analysis is used to

determine if the nature-based products are exceptions.

Claim 1: Ineligible. As described in the specification, some antibodies to Protein S are naturally occurring

in mice and wild coyotes living in Texas, while other antibodies to Protein S (such as chimeric

antibodies) have non-natural forms and may contain domains from multiple species. The claim thus

encompasses antibodies that are structurally identical to naturally occurring antibodies, and antibodies

that are structurally changed. Because there is no difference in characteristics (structural, functional, or

otherwise) between the claimed and naturally occurring antibodies for at least some of the embodiments

encompassed by the claim, the claimed antibodies do not have markedly different characteristics, and thus

are a “product of nature” exception. Accordingly, the claim is directed to an exception (Step 2A: YES ).

Because the claim does not include any additional features that could add significantly more to the

exception (Step 2B: NO), the claim does not qualify as eligible subject matter, and should be rejected

under 35 U.S.C. § 101.

Claim 2: Eligible. The claim is limited to human antibodies to Protein S. No human antibodies to Protein

S are naturally occurring. The claimed antibodies have different complementarity determining regions

(CDRs) than what exists in nature, and therefore have different structural (e.g., different amino acid

sequences and three-dimensional structures) and functional (e.g., bind to different antigens)

characteristics. These differences rise to the level of a marked difference, and so the claimed antibodies

are not “product of nature” exceptions. Thus, the claim is not directed to an exception (Step 2A: NO), and

qualifies as eligible subject matter.

Claim 3: Eligible. The claim is limited to murine antibodies comprising complementarity determining

region (CDR) sequences set forth as SEQ ID NOs: 7-12. Some murine antibodies to Protein S occur in

nature, and it is possible that nature might randomly create a murine antibody having the CDR sequences

of SEQ ID NOs: 7-12. But unless the examiner can show that this particular murine antibody exists in

nature, this mere possibility does not bar the eligibility of this claim. See, e.g., Myriad, 133 S. Ct. at 2119

n.8 (“The possibility that an unusual and rare phenomenon might randomly create a molecule similar to

one created synthetically through human ingenuity does not render a composition of matter

nonpatentable” (emphasis in original)). Because the claimed antibodies have different CDRs than what

exists in nature, they have different structural (e.g., different amino acid sequences and three-dimensional

structures) and functional (e.g., bind to different antigens) characteristics. These differences rise to the

level of a marked difference, and so the claimed antibodies are not “product of nature” exceptions. Thus,

the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.

Claim 4: Eligible. The claim is limited to chimeric and humanized antibodies, which are defined as fusion

proteins formed by physically fusing together part of a murine antibody (CDRs or variable domains) and

part of a human antibody (constant domains). The claimed antibodies have different structural

characteristics than natural antibodies, because the combination of murine and human antibody fragments

into a single antibody molecule does not exist in nature. There may also be differences in functional

characteristics, e.g., chimeric antibodies are typically less immunogenic to humans than murine

Nature-Based Products

antibodies. These differences rise to the level of a marked difference, and so the claimed antibodies are

not “product of nature” exceptions. Thus, the claim is not directed to an exception (Step 2A: NO), and

qualifies as eligible subject matter.

Claim 5: Eligible. The claim is limited to antibodies comprising a variant Fc domain, which is defined as

an Fc domain that is engineered to comprise at least one amino acid modification relative to a wild-type

Fc domain. The claimed antibodies have different structural characteristics (e.g., different amino acid

sequences and three-dimensional structures) than natural antibodies, and may also have different

functional characteristics (e.g., different cytotoxicity and/or serum half-life). These differences in

characteristics rise to the level of a marked difference, and so the claimed antibodies are not “product of

nature” exceptions. Thus, the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible

subject matter.

9. Cells

This example illustrates that a man-made product identical to a naturally occurring product does not

have markedly different characteristics (claim 1), but that changes in phenotype caused by human

manipulation can result in markedly different characteristics (claims 2 and 3). It also demonstrates the

application of the “significantly more” analysis to claims directed to a “product of nature” exception

(claims 4 and 5).

Background: Human stem cells are naturally occurring cells that can develop, through a process called

differentiation, into many different types of cells, such as cardiac cells, skin cells, and so on. Stem cells

have utility in regenerative medicine, which involves repairing diseased tissues or organs. One type of

diseased tissue that often needs repair is the heart’s pacemaker, which is formed from pacemaker cells

that generate electrical impulses to control heart rate. In nature, pacemaker cells can be identified via a

protein called marker P located on the cell surface. The pacemaker cells contain genes that are capable of

expressing a protein called marker Z, but in nature these genes are never expressed (there are no naturally

occurring pacemaker cells that have marker Z on their surface).

Applicant’s specification discloses differentiating stem cells into pacemaker cells, for use in regenerating

damaged heart tissue. Applicant discloses isolating stem cells from human volunteers, and then culturing

those cells in a particular growth medium in the presence of growth factor A, at various temperatures.

Isolation does not change the cells in any way, but applicant’s culture conditions cause the stem cells to

differentiate into pacemaker cells. Some of the man-made pacemaker cells produced by applicant are

genetically and phenotypically identical (e.g., express marker P) to naturally occurring pacemaker cells.

Other man-made pacemaker cells produced by applicant are genetically identical, but have a different

phenotype (e.g., express marker Z and exhibit increased efficiency in utilizing oxygen) than naturally

occurring pacemaker cells. Isolation of these man-made cells does not change them in any way.

The increased oxygen utilization efficiency of the pacemaker cells expressing marker Z is advantageous

in the regeneration of heart tissue in patients who are recovering from damage to the heart, such as that

caused by a myocardial infarction (heart attack). Applicant has discovered that a mixed population of

pacemaker cells that is about 10-15% positive for marker Z (i.e., about 10-15% of the cells in the

population express marker Z), and about 85-90% positive for marker P (i.e., about 85-90% of the cells in

the population express marker P), can be injected into a patient’s heart in order to regenerate a pacemaker

in vivo (in a patient’s body). This successful regeneration is possible because the cells interact with each

other to affect their growth rates, e.g., the cells expressing marker P grow faster in the mixed population

than when they are by themselves. However, a cell population with fewer (or no) cells expressing marker

Z is not capable of regenerating a pacemaker, because the cell population is starved of oxygen before it

can become established in the patient.

The specification discloses compositions including populations of pacemaker cells in containers, such as

flasks and petri dishes, which are routinely and conventionally used in laboratories to hold cells. Also

Nature-Based Products

disclosed are compositions including populations of pacemaker cells in biocompatible three-dimensional

scaffolds. The specification defines “biocompatible three-dimensional scaffolds” as being three-

dimensional structures constructed of naturally occurring materials (such as polysaccharides or proteins)

that are unchanged from their natural state, in which they are associated with non-cardiac cells, but that

have been removed from their natural environment. The specification specifically excludes cardiac tissue

from the definition of “biocompatible three-dimensional scaffolds”. The specification also discloses that

compositions including populations of pacemaker cells in the biocompatible three-dimensional scaffolds

can be implanted directly into a patient, where they facilitate faster tissue regeneration than when

pacemaker cells are implanted by themselves, because the scaffold provides mechanical support for the

implanted cells to grow.

Claims:

1. An isolated man-made human pacemaker cell.

2. An isolated man-made human pacemaker cell expressing marker Z.

3. A population of human pacemaker cells, wherein the population is about 10-15% positive for marker

Z, and 85-90% positive for marker P.

4. A composition comprising a population of isolated man-made human pacemaker cells in a container.

5. A composition comprising a population of isolated man-made human pacemaker cells in a

biocompatible three-dimensional scaffold.

Analysis of Claims:

These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. All

of the claims are directed to a statutory category, e.g., a composition of matter (Step 1: YES).

Claim 1: Ineligible. Because the claim is a nature-based product, i.e., a cell, the nature-based product is

analyzed to determine whether it has markedly different characteristics from any naturally occurring

counterpart(s) in their natural state. As described in the specification, some of the man-made cells are

identical to what exists in nature (e.g., same genotype and phenotype), while others are phenotypically

different from what exists in nature (e.g., express marker Z and have increased oxygen utilization), and

these difference arose due to applicant’s efforts. The claim thus encompasses cells that are identical (no

difference in characteristics) to naturally occurring cells, and cells that are phenotypically different.

Because there is no difference between the claimed and naturally occurring cells for at least some of the

embodiments encompassed by the claim, the claimed cells do not have markedly different characteristics,

and thus are a “product of nature” exception. In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1338-39

(Fed. Cir. 2014). Accordingly, the claim is directed to an exception (Step 2A: YES). Because the claim

does not include any additional features that could add significantly more to the exception (Step 2B: NO),

the claim does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.

Claim 2: Eligible. The claim is limited to human pacemaker cells that express marker Z, which are nature-

based products. No human pacemaker cells expressing marker Z are naturally occurring. As described in

the specification, the claimed cells are exact genetic replicas of naturally occurring pacemaker cells, that

were produced from naturally occurring stem cells. However, the claimed cells are phenotypically

different than natural pacemaker cells, in that they express marker Z and have increased oxygen

utilization efficiency. Further, these phenotypic differences were created by applicant’s efforts (e.g., by

culturing the stem cells in a particular growth medium in the presence of growth factor A, at various

temperatures), and were not the work of nature. These phenotypic differences rise to the level of a marked

difference, and accordingly the claimed cell is not a “product of nature” exception. Thus, the claim is not

directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.

Claim 3: Eligible. The claim is limited to a population of human pacemaker cells, where about 10-15% of

the cells express marker Z, and about 85-90% express marker P. Because the claim is a nature-based

Nature-Based Products

product, i.e., a combination of cells, the nature-based product (the population) is analyzed to determine

whether it has markedly different characteristics from any naturally occurring counterpart(s) in their

natural state. As discussed above with respect to claims 1 and 2, the cells expressing marker Z have

markedly different characteristics than naturally occurring cardiac pacemaker cells because of their

phenotypic differences, but the cells expressing marker P do not have markedly different characteristics

because they are identical to naturally occurring pacemaker cells. However, as described in the

specification, when these cells are mixed together in the claimed ratio to form the claimed population, the

cells interact with each other to affect their growth rates, e.g., the cells expressing marker P grow faster in

the mixed population than when they are by themselves. Naturally occurring pacemaker cells do not grow

at this rate in their natural state. This difference in biological properties (rate of cell growth) between the

claimed cell population and naturally occurring human pacemaker cells rises to the level of a marked

difference, and accordingly the claimed population is not a “product of nature” exception. Thus, the claim

is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.

Claim 4: Ineligible. Because the claim recites a nature-based product, i.e., the population of cells, the

nature-based product is analyzed to determine whether it has markedly different characteristics from any

naturally occurring counterpart(s) in their natural state. As explained with respect to claim 1, isolated

man-made pacemaker cells do not have markedly different characteristics due to their isolation or human

manufacture. There is no indication in the specification that placing the cells in a generic container results

in the cells having any characteristics (structural, functional, or otherwise) that are different from the

naturally occurring cells in their natural state. Thus, the claimed population of cells does not have

markedly different characteristics from what occurs in nature, and is a “product of nature” exception.

Accordingly, the claim is directed to an exception (Step 2A: YES). Next, the claim as a whole is analyzed

to determine whether any element, or combination of elements, is sufficient to ensure that the claim

amounts to significantly more than the exception. Although the claim recites a container, use of a

container to hold cells is not only well-understood, routine and conventional activity already engaged in

by the scientific community, it is also required for growing and using the cells. Additionally, the claim

recites the container at such a high level of generality that it merely tells a scientist to use whatever

container she wishes to use. Therefore, the claim as a whole adds nothing significantly more to the

“product of nature” itself. Thus, the claim does not amount to significantly more than the judicial

exception itself (Step 2B: NO). The claim does not qualify as eligible subject matter, and should be

rejected under 35 U.S.C. § 101.

Claim 5: Eligible. Because the claim is a nature-based product, i.e., a combination of cells and a scaffold,

the nature-based product (the combination) is analyzed to determine whether it has markedly different

characteristics from any naturally occurring counterpart(s) in their natural state. As explained with respect

to claim 1, isolated man-made pacemaker cells do not have markedly different characteristics due to their

isolation or human manufacture. There is also no indication in the specification that placing the cells into

a biocompatible three-dimensional scaffold results in the cells or the scaffold having any characteristics

(structural, functional, or otherwise) that are different from the naturally occurring cells or scaffold in

their natural state. Thus, the claimed population of cells, and the claimed scaffold, do not have markedly

different characteristics from what occurs in nature, and are “product of nature” exceptions. Accordingly,

the claim is directed to an exception (Step 2A: YES). Next, the claim as a whole is analyzed to determine

whether any element, or combination of elements, is sufficient to ensure that the claim amounts to

significantly more than the exception. The recitation of the biocompatible three-dimensional scaffold in

combination with the pacemaker cells is not required for growing or using the cells, because the cells can

be grown or used in other containers, and is not recited at a high level of generality. The addition of the

pacemaker cells to the scaffold confines the claim to a particular useful application of the scaffold (repair

of cardiac tissue), because the pacemaker cells are not routinely required for all practical uses of the

scaffold. Further, the combination of these elements does more than generally link these two judicial

exceptions together; as described in the specification, this combination improves the technology of

regenerative medicine, by facilitating faster tissue regeneration than when pacemaker cells are implanted

Nature-Based Products

by themselves. Thus, the claim amounts to significantly more than the judicial exception itself (Step 2B:

YES), and qualifies as eligible subject matter.

10. Food

This example illustrates the difference between a nature-based product claim having multiple components

that are unchanged because they are not combined (claim 1), and a nature-based product claim having

multiple components that are changed by their combination (claim 2).

Background: Goats are naturally occurring animals that produce milk to feed their young. Humans have

consumed goat milk and products made from goat milk (e.g., cheese and yogurt) for centuries. One well-

known method of making goat yogurt is to create a starter culture by mixing raw goat milk with bacteria,

and then heating the starter culture to about 115 degrees Fahrenheit for several hours so that the bacteria

can ferment the milk. The fermentation causes the conversion of lactose (milk sugar) in the goat milk into

lactic acid, and this chemical change results in a physical change (the thickened consistency of the yogurt

as compared to the goat milk). The lactic acid also makes the yogurt have a tangy flavor. Multiple species

of bacteria are known as useful in making yogurt, including Streptococcus thermophilus (a naturally

occurring bacterial species).

Applicant has discovered a new naturally occurring bacterial species that it named Lactobacillus

alexandrinus. Goat milk yogurt made with L. alexandrinus has a pleasant tangy flavor. Neither S.

thermophilus nor L. alexandrinus occur naturally in goat milk, and these bacteria do not occur together in

nature. Applicant has also discovered that when mixed, S. thermophilus and L. alexandrinus have

different properties than either bacteria has alone: (1) the mixed bacteria act synergistically to ferment

goat milk at twice the speed than either bacteria can ferment by itself; and (2) the resultant goat yogurt is

much lower in fat than either bacteria can produce when used by itself. Applicant discloses compositions

comprising a goat milk starter comprising goat milk mixed with S. thermophilus and L. alexandrinus.

Applicant also discloses kits for preparing goat milk yogurt. The kits comprise a separate packet of S.

thermophilus, and a separate packet of L. alexandrinus, and may also comprise instructions for combining

the two bacterial species with goat milk to make yogurt.

Claims:

1. A kit for preparing goat milk yogurt comprising: Streptococcus thermophilus and Lactobacillus

alexandrinus.

2. A yogurt starter culture comprising: goat milk mixed with Streptococcus thermophilus and

Lactobacillus alexandrinus.

Analysis of Claims:

These claims have been analyzed for eligibility in accordance with their broadest reasonable

interpretation. Because both claims are directed to a statutory category, e.g., a composition of matter (Step

1: YES), and are nature-based products (goat milk and/or bacteria), the markedly different characteristics

analysis is used to determine if the nature-based products are exceptions.

Claim 1: Ineligible. As described in the specification, both S. thermophilus and L. alexandrinus are

naturally occurring bacteria. There is no indication in the specification that the claimed bacteria have any

characteristics (structural, functional, or otherwise) that are different from the naturally occurring

bacteria. Because the bacterial species in the kit are not mixed, but instead are separate from each other,

their inclusion in the same kit does not change their characteristics. Although the user of the kit may

choose to mix the bacteria together at some time in the future, that mixture, which may or may not exist in

the future is not a part of the claimed invention. In re Venezia, 530 F.2d 956, 958-59 (CCPA 1976). Thus,

the bacterial species in the kit do not have markedly different characteristics from their natural

counterparts in their natural state, and are “product of nature” exceptions. Accordingly, the claim is

directed to an exception (Step 2A: YES). Because the claim does not include any additional features that

Nature-Based Products

could add significantly more to the exceptions (Step 2B: NO), the claim does not qualify as eligible

subject matter, and should be rejected under 35 U.S.C. § 101.

Claim 2: Eligible. As described in the specification, when S. thermophilus and L. alexandrinus are mixed,

the two bacterial species have different characteristics than either species does on its own, e.g., they act

together to ferment milk into a lower fat yogurt than either bacteria can produce when individually mixed

with the milk. Thus, the mixture of the bacteria and milk has different functional characteristics (lower fat

content) than the naturally occurring bacteria (or milk) by itself. These differences rise to the level of a

marked difference, and accordingly the claimed starter culture is not a “product of nature” exception.

Thus, the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.

Streamlined Example 1

1. A hip prosthesis comprising:

a femoral component and

an acetabular cup,

wherein the acetabular cup has

an inner concave surface for

engaging the femoral component,

and an outer convex surface for

engaging a patient’s acetabulum,

and

wherein the outer convex surface

is coated with hydroxyapatite.

• The claim recites a nature-based

product (hydroxyapatite is a

naturally occurring mineral).

• However, the claim clearly does

not seek to tie up the mineral.

Instead, the claim is focused on

the assembly of the femoral

component and the cup that

together form the hip prosthesis.

• No need to perform the markedly

different characteristics analysis

on the mineral.

The claim qualifies as eligible

subject matter without a full

analysis.

Streamlined Example 2

2. A robotic arm assembly

comprising:

a robotic arm having an end

effector that is capable of movement

along a predetermined motion path,

a sensor that obtains movement

information about the end effector,

and

a control system that uses the

movement information from the

sensor to adjust the velocity of the

end effector in order to achieve a

smooth motion along the

predetermined motion path.

• The claim operates using certain

mathematical relationships, e.g.,

velocity is a relationship between

the position of an object with

respect to time.

• However, the claim clearly does

not seek to tie up these

mathematical relationships. For

example, others are clearly free to

use velocity in other applications

such as in a radar gun.

The claim qualifies as eligible

subject matter without a full

analysis.

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July 2015 Update Appendix 1: Examples

The following examples should be used in conjunction with the 2014 Interim Guidance on

Subject Matter Eligibility (2014 IEG). As the examples are intended to be illustrative only,

they should be interpreted based on the fact patterns set forth below. Other fact patterns

may have different eligibility outcomes. While some of the fact patterns draw from U.S.

Supreme Court and U.S. Court of Appeals for the Federal Circuit decisions, each of the

examples shows how claims should be analyzed under the 2014 IEG. All of the claims are

analyzedfor eligibility inaccordancewiththeirbroadestreasonable interpretation.

Note that the examples herein are numbered consecutively beginning with number 21,

because 20 examples were previously issued. A comprehensive index of all examples for

usewiththe 2014 IEGisprovided inAppendix2totheJuly2015Update.

21. Transmission Of Stock Quote Data

The following hypothetical claims and background are modeled after the technology in

Google Inc. v. Simpleair, Inc., Covered Business Method Case No. CBM 2014‐00170 (Jan. 22,

2015), but are revised to emphasize certain teaching points. The patent at issue was U.S.

Patent No. 7,035,914 entitled “System and Method for Transmission of Data.” Hypothetical

claim 1 is directed to an abstract idea and does not have additional elements that amount to

significantly more than the abstract idea. Hypothetical claim 2 also recites an abstract idea

but does contain additional elements that amount to significantly more because there are

meaningful limitations beyond generally linking the use of the abstract idea to a particular

technological environm ent.

Background

The invention is directed to a stock quote alert subscription service where subscribers

receive customizable stock quotes on their local computers from a remote data source. At

the time of the invention, stock quote subscription services over the Internet were known

in the art. However, existing services experienced challenges when attempting to notify a

subscriber whose computer was offline (not connected to the Internet) at the time of the

alert, since many stock quotes are time sensitive. Further, many previous subscription

services simply transmitted all available stock quote information to the user at a given

time, which required the subscriber to sort through large amounts of data to identify

relevant stock quotes, and often sent information at an inconvenient time (e.g., after the

stock exchanges are closed). The stock quote alert subscription service of the present

inventionaddressestheseproblems.

During enrollment to the subscription service, the subscriber provides preference

information in the form of stocks of interest, stock price threshold (e.g., when the price

reaches $100 per share), a destination address of a wireless device (e.g., a number for a

cellular phone, pager or PDA), preferred format of the alert, and a transmission schedule

indicating the time/date that alerts should be sent. The subscription service uses a

transmission server to receive data from a data source and send selected data to

subscribers. The transmission server includes a memory, a transmitter, and a

microprocessor. The subscription service provides a stock viewer application to

subscribers for installation on their individual computers. After a subscriber enrolls, the

service receives stock quote information sent from a data source to the transmission

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July 2015 Update Appendix 1: Examples

server.Theserver filters the stock quoteinformation basedupon the subscriberpreference

information that is stored in memory on the server. That is, the server compares the

received stock quote information to the stored stocks of interest and stock price threshold

preferences to determine which stock quotes to drop and which to further process. Next, a

stock quote alert is built containing the filtered stocks’ name and price information and a

universal resource locator (URL) to a web page at the data source which contains further

informationonthestockquote. Thealertisthenformattedintodata blocksbaseduponthe

alert format preference information. Subsequently, the formatted data blocks are

transmitted to the subscriber’s wireless device in accordance with the transmission

schedule. After receiving the alert, the subscriber can connect the wireless device to the

subscriber’scomputer.Thealert causesthesubscriber’scomputertoauto‐launchthestock

viewer application provided by the service to display the alert. When connected to the

Internet, the subscriber may then click on the URL in the alert to use the stock viewer

application to access more detailed information about the stock quote from the data

source.

Claims

1. A method of distributing stock quotes over a network to a remote subscriber computer,

themethodcomprising:

receiving stock quotes at a transmission server sent from a data source over the

Internet, the transmission server comprising a microprocessor and memory that stores the

remote subscriber’s preferences for information format, destination address, specified

stockprice values,and transmission schedule,whereinthe microprocessor

filters the received stock quotes by comparing the received stock quotes to the

specifiedstockpricevalues;

generates a stock quote alert from the filtered stock quotes that contains a stock

name, stock price and a universal resource locator (URL), which specifies the location of

thedatasource;

formats the stock quote alert into data blocks according to said information format;

and

transmits the formatted stock quote alert to a computer of the remote subscriber

baseduponthedestinationaddressandtransmissionschedule.

2. A method of distributing stock quotes over a network to a remote subscriber computer,

themethodcomprising:

providing a stock viewer application to a subscriber for installation on the remote

subscribercomputer;

receiving stock quotes at a transmission server sent from a data source over the

Internet, the transmission server comprising a microprocessor and a memory that stores

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July 2015 Update Appendix 1: Examples

the remote subscriber’s preferences for information format, destination address, specified

stockprice values,and transmission schedule,whereinthe microprocessor

filters the received stock quotes by comparing the received stock quotes to the

specifiedstockpricevalues;

generates a stock quote alert from the filtered stock quotes that contains a stock

name, stock price and a universal resource locator (URL), which specifies the location of

thedatasource;

formats the stock quote alert into data blocks according to said information format;

and

transmits the formatted stock quote alert over a wireless communication channel to

a wireless device associated with a subscriber based upon the destination address and

transmission schedule,

wherein the alert activates the stock viewer application to cause the stock quote

alertto display on theremote subscriber computer andto enable connection via the URL to

the data source over the Internet when the wireless device is locally connected to the

remotesubscribercomputerandtheremotesubscribercomputercomesonline.

Analysis

Claim1:Ineligible

The claim recites a series of acts for distributing stock quotes to selected remote devices.

Thus,theclaimisdirectedtoa process,whichisoneofthestatutory categories ofinvention

(Step 1: YES).

Next, the claim is analyzed to determine whether it is directed to a judicial exception. The

claim recites the steps of receiving, filtering, formatting and transmitting stock quote

information. In other words, the claim recites comparing and formatting information for

transmission. This is simply the organization and comparison of data which can be

performed mentally and is an idea of itself. It is similar to other concepts that have been

identified as abstract by the courts, such as using categories to organize, store and transmit

information in Cyberfone, or comparing new and stored information and using rules to

identify options in SmartGene. Therefore, the claim is directed to an abstract idea (Step 2A:

YES).

Next, the claim as a whole is analyzed to determine whether any element, or combination

of elements, is sufficient to ensure that the claim amounts to significantly more than the

exception.Theclaimrecitestheadditionallimitationsofusingatransmissionserverwitha

memory that stores subscriber preferences, a transmitter that receives and sends

information over the Internet, and a microprocessor that performs the generic functions of

comparing and formatting information. The transmission server is recited at a high level of

generality and its broadest reasonable interpretation comprises only a microprocessor,

memory and transmitter to simply perform the generic computer functions of receiving,

processingand transmitting information. Generic computers performing generic computer

functions, alone, do not amount to significantly more than the abstract idea. Finally, the

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July 2015 Update Appendix 1: Examples

Internet limitations are simply a field of use that is an attempt to limit the abstract idea to a

particular technological environment and, so do not add significantly more. Viewing the

limitations as an ordered combination does not add anything further than looking at the

limitations individually. When viewed either individually, or as an ordered combination,

the additional limitations do not amount to a claim as a whole that is significantly more

thantheabstract idea(Step 2B: NO).Theclaimisnot patenteligible.

A rejection of claim 1 should identify the exception by pointing to the filtering, generating

and formatting steps and explain that the comparing and formatting of information is a

mental process that is similar to the concepts that courts have previously found abstract.

The rejection should also identify the additional limitations regarding the transmission

server and explain why those limitations comprise only a generic computer performing

genericcomputerfunctionsthat donotimposemeaningfullimits ontheclaimedmethod.

Claim2:Eligible

The claim recites a series of acts for distributing stock quotes to selected remote devices.

Thus,theclaimisdirectedtoa process,whichisoneofthestatutory categories ofinvention

(Step 1: YES).

The claim is then analyzed to determine if the claim is directed to a judicial exception. As

discussed above, the recited steps of comparing and organizing data for transmission are a

mental process and similar to other concepts found to be abstract by the courts. The claim

isdirected to anabstractidea(Step 2A: YES).

Next, the claim as a whole is evaluated to determine if there are additional limitations that

amount to significantly more than the abstract idea. The claim recites the additional

limitations of using a transmission server with a microprocessor and a memory to store

subscriber preferences, transmitting a stock quote alert from the transmission server over

a data channel to a wireless device, and providing a stock viewer application that causes

the stock quote alert to display on the subscriber computer and enables a connection from

the subscriber computer to the data source over the Internet when the subscriber

computer comes online. It is noted that, as discussed above, some of the limitations when

viewed individually do not amount to significantly more than the abstract idea (such as

storing subscriber preferences or transmitting an alert). However, when looking at the

additional limitations as an ordered combination, the invention as a whole amounts to

significantly more than simply organizing and comparing data. The claimed invention

addresses the Internet‐centric challenge of alerting a subscriber with time sensitive

information when the subscriber’s computer is offline. This is addressed by transmitting

the alert over a wireless communication channel to activate the stock viewer application,

which causes the alert to display and enables the connection of the remote subscriber

computer to the data source over the Internet when the remote subscriber computer

comes online. These are meaningful limitations that add more than generally linking the

use of the abstract idea (the general concept of organizing and comparing data) to the

Internet, because they solve an Internet‐centric problem with a claimed solution that is

necessarily rooted in computer technology, similar to the additional elements in DDR

Holdings. These limitations, when taken as an ordered combination, provide

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July 2015 Update Appendix 1: Examples

unconventional steps that confine the abstract idea to a particular useful application.

Therefore, theclaimrecitespatent eligiblesubjectmatter (Step 2B: YES).

If the examiner believes that the record would benefit from clarification, remarks could be

added to an Office action or reasons for allowance indicating that the claim recites the

abstract idea of comparing and organizing data for transmission. However, the claim is

eligible because it recites additional limitations that when considered as an ordered

combination demonstrates a technologically rooted solution to an Internet‐centric problem

and thus amounts to significantly more than comparing and organizing information for

transmission.

22. Graphical User Interface For Meal Planning

The following claim was found ineligible by the Southern District of New York, and the

judgment was affirmed by the Federal Circuit in Dietgoal Innovations LLC v. Bravo Media LLC,

599 Fed. Appx. 956 (Fed. Cir. Apr. 8, 2015). The patent at issue was U.S. Patent 6,585,516. The

claim is directed to an abstract idea, and the additional elements do not amount to

significantly more than the abstract idea, but merely implement the idea using generic

computer technology. The exemplary analysis shows how an examiner would apply the 2014

IEG analysis to the claim when making a rejection.

Background

The invention addresses a way to solve the issue of obesity, specifically by using visuals to

assist users to follow diet programs designed by health professionals for the purpose of

modifying diet behavior. In particular, the invention is a computer system that “includes[s]

a User Interface (UI), a Meal Database, a Food Database, Picture Menus and Meal Builder.”

The UI functions to receive commands from the user and display results to the user. The

Food and Meal Databases are databases of food information and preselected combinations

of foods that have been compiled into a single repository. The Picture Menus display

pictures of meals on the UI so the user can make a plan by mixing and matching foods to

meet customized eating goals. The Meal Builder permits the user to design meals and view

the impact of the food choices on customized eating goals in real time. In practice, the

invention permits a user to choose meals for a particular day, as well as modify one or

more of the meals to create new meals, while seeing the impact on their dietary plan. The

objectoftheinvention istoinfluenceaperson’s eatingbehavior.

Claim

2.Asystemofcomputerized mealplanning,comprising:

aUserInterface;

aDatabaseoffoodobjects;and

a Meal Builder, which displays on the User Interface meals from the Database and

wherein a user can change content of said meals and view the resulting meals’ impact on

customizedeatinggoals.

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July 2015 Update Appendix 1: Examples

Analysis

Claim2:Ineligible.

The broadest reasonable interpretation of the claim encompasses a computer system (e.g.,

hardware such as a processor and memory) that implements a user interface, a database,

and a food data selection program. The system comprises a device or set of devices and,

therefore, isdirectedtoamachine,whichisastatutorycategoryofinvention(Step 1: YES).

The claim is then analyzed to determine if the claim is directed to a judicial exception. The

claim recites a system for selecting and modifying meals based upondietarygoals. In other

words, the claim describes a process of meal planning. Meal planning is the organization

and comparison of information to develop a guideline for eating. It is a mental process of

managing behavior that could be performed in the human mind, or by a human using a pen

and paper. Such a basic concept is similar to other mental processes found abstract by the

courts such as comparing new and stored information and using rules to identify options in

SmartGene,andobtainingandcomparing intangibledatain Cybersource.Therefore,claim2

isdirected to anabstractidea (Step 2A: YES).

Next, the claim is analyzed to determine if there are additional claim limitations that

individually, or as an ordered combination, ensure that the claim amounts to significantly

more than the abstract idea. The only additional limitations in the claim relate to

computerizationofmealplanning withaninterface,adatabase offood objects,anda“meal

builder,” which is a computer program that allows selection and comparison of food data.

The meal builder would require a processor and memory in order to perform basic

computer functions of accepting user input, retrieving information from a database,

manipulating that information and displaying the results. These components are not

explicitly recited and therefore must be construed at the highest level of generality. The

interface is also recited at a high level of generality with the only required function of

displaying, which is a well‐known routine function of interfaces. Further, the database

performs only its basic function of storing information, which is common to all databases.

Thus, the recited generic computer components perform no more than their basic

computer functions. These additional elements are well‐understood, routine and

conventional limitations that amount to mere instructions to implement the abstract idea

of meal planning on a computer. Taking these computer limitations as an ordered

combination adds nothing that is not already present when the elements are taken

individually. Therefore, the claim does not amount to significantly more than the recited

abstractidea (Step 2B: NO).Theclaimisnotpatenteligible.

A rejection of this claim should identify the abstract idea of selecting meals for a

customized eating goal, which is similar to concepts of obtaining and comparing data that

were found to be abstract by the courts. The rejection should also identify the additional

elements and explain the reasons why they amount to no more than merely implementing

theideaof mealplanningusing genericcomputercomponents.

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July 2015 Update Appendix 1: Examples

23. Graphical User Interface For Relocating Obscured Textual Information

The following claims are hypothetical. Claim 1 demonstrates a claim that is not directed to an

abstract idea. Claims 2 and 3 are directed to an abstract idea and do not recite significantly

more. Claim 4 recites an abstract idea, but there are additional limitations in the claim that

amount to significantly more than the abstract idea.

Background

The invention relates to a graphical user interface (GUI). A GUI manages the interaction

between a computer system and a user through graphical elements such as windows on a

display. Windows display various types of outputs for various computer processes and

may contain controls to accept user input for those processes. In some instances, multiple

windows are displayed at the same time; due to limited display space, however, the

windowsmayoverlapandobscure thecontentofunderlyingwindows.

In the instant application, the inventor has improved upon previous GUIs by dynamically

relocating obscured textual information of an underlying window to become automatically

viewable to the user. In particular, in a graphical user interface that comprises multiple

windows, the invention continuously monitors the boundaries of the windows to ascertain

an overlap condition indicating that the windows overlap such that the textual information

of an underlying window is obscured from a user’s view by the overlapping window. Only

when the textual information of the underlying window is detected to be obscured, the

invention re‐formats and moves the textual information in the underlying window to an

unobscured portion of the underlying window so that the textual information is viewable

by the user. When the overlap condition no longer exists, the textual information is

returnedtoitsoriginalformatandlocation.

The inventor’s process is performed by modifying the vertical and horizontal margins of

the underlying window in accordance with the overlap and utilizing a word wrap function

to wrap the text around the obscured area based upon the new margins, and, where

necessary, reducing the text size to permit the entirety of the textual information to be

viewable in the unobscured portion. The textual information is scaled based upon a scaling

factor that is calculated using a mathematical algorithm. First, an area of the underlying

window and an area of the unobstructed portion of the underlying window are calculated.

Next,the scalingfactoriscalculatedwhich isproportional to the differencein areabetween

the underlying window and the unobstructed portion of the underlying window. Finally,

the font size of the textual information is changed in accordance with the scaling factor.

The new scaled textual information is then moved as described above to the unobstructed

portion of the underlying window. When the windows no longer overlap, the textual

information is returned to its original format and location by resetting the vertical and

horizontal margins of the window to their original values and no longer applying the

scaling factor to the font size. By permitting textual information to be dynamically

relocated based upon an overlap condition, the computer’s ability to display information

andinteract withtheuseris improved.

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July 2015 Update Appendix 1: Examples

Claims

1. A computer‐implemented method for dynamically relocating textual information within

anunderlyingwindowdisplayed inagraphicaluserinterface, themethodcomprising:

displaying a first window containing textual information in a first format within a

graphicaluserinterface onacomputerscreen;

displaying a secondwindowwithinthegraphicaluserinterface;

constantlymonitoringthe boundaries of the first windowand the second window to

detect an overlap condition where the second window overlaps the first window such that

thetextualinformation inthe first windowis obscuredfroma user’sview;

automatically relocating the textual information, by a processor, to an unobscured

portion of the first window in a second format during an overlap condition so that the

textualinformation isviewableonthecomputerscreenby theuser; and

automatically returning the relocated textual information, by the processor, to the

firstformat within thefirstwindow whentheoverlapcondition nolongerexists.

2. A computer‐implemented method of resizing textual information within a window

displayed inagraphicaluserinterface, themethodcomprising:

generating first datafordescribingtheareaofafirstgraphicalelement;

generating second data for describing the area of a second graphical element

containingtextualinformation; and

calculating a scaling factor for the textual information which is proportional to the

differencebetweenthe first dataandseconddata.

3. A computer‐implemented method of resizing textual information within a window

displayed inagraphicaluserinterface, themethodcomprising:

generating first datafordescribingtheareaofafirstgraphicalelement;

generating second data for describing the area of a second graphical element

containingtextualinformation; and

calculating, by the computer, a scaling factor for the textual information which is

proportionaltothedifferencebetween thefirstdataand seconddata.

4. A computer‐implemented method for dynamically relocating textual information within

anunderlyingwindowdisplayed inagraphicaluserinterface, themethodcomprising:

displaying a first window containing textual information in a first format within a

graphicaluserinterface onacomputerscreen;

displaying a secondwindowwithinthegraphicaluserinterface;

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July 2015 Update Appendix 1: Examples

constantlymonitoringthe boundaries of the first windowand the second window to

detect an overlap condition where the second window overlaps the first window such that

thetextualinformation inthe first windowis obscuredfroma user’sview;

determining the textual information would not be completely viewable if relocated

toanunobstructedportionof thefirstwindow;

calculating a first measure of the area of the first window and a second measure of

theareaoftheunobstructedportionofthefirstwindow;

calculating a scaling factor which is proportional to the difference between the first

measureandthesecond measure;

scalingthe textualinformationbaseduponthescalingfactor;

automatically relocating the scaled textual information, by a processor, to the

unobscured portion of the first window in a second format during an overlap condition so

that the entire scaled textual information is viewable on the computer screen by the user;

and

automatically returning the relocated scaled textual information, by the processor,

tothefirstformatwithinthefirst windowwhentheoverlapconditionnolonger exists.

Analysis

Claim1:Eligible.

The claim recites a series of steps for relocating textual information in an underlying

window to an unobscured portion of the underlying window. Thus, the claim is directed to

aprocess, whichisoneofthestatutorycategoriesof invention(Step 1: YES).

Next, the claim must be analyzed to determine whether it is directed to a judicial exception.

Here, the claimed method relates to addressing a problem with overlapping windows

within a graphical user interface. In particular, the claim recites dynamically relocating

textual information within a window displayed in a graphical user interface based upon a

detected overlap condition. When the windows overlap, textual information is reformatted

and relocated to an unobscured portion of the underlying window; when the windows no

longer overlap, the textual information is returned to its original format and location. The

claim does not recite a basic concept that is similar to any abstract idea previously

identified by the courts. For example, the claim does not recite any mathematical concept

or a mental process such as comparing or categorizing information that can be performed

in the human mind, or by a human using a pen and paper. Accordingly, the claim does not

set forth or describe an abstract idea. Instead, the claimed method is necessarily rooted in

computer technology to overcome a problem specifically arising in graphical user

interfaces. Additionally, the claim does not recite any other judicial exception. Therefore,

theclaimis notdirectedtoajudicialexception (Step 2A: NO).Theclaimispatenteligible.

If the examiner believes that the record would benefit from clarification, remarks could be

added to an Office action or reasons for allowance indicating that the claim is not directed

toanyjudicialexception.

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July 2015 Update Appendix 1: Examples

Claim2:Ineligible.

The claim is directed to a series of steps for calculating a scaling factor, and thus is a

processwhichisastatutorycategoryofinvention(Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exceptions.

The claim recites the steps of calculating a first area and a second area and using the areas

to calculate a scaling factor. This concept is similar to the other types of basic concepts that

have been found by the courts to be abstract. In particular, the courts have found

mathematical algorithms to be abstract ideas (e.g., a mathematical procedure for

converting one form of numerical representation to another in Benson, or an algorithm for

calculating parameters indicating an abnormal condition in Grams). Therefore, the claim is

directedto anabstract idea (Step 2A: YES).

Next, the claim is analyzed to determine whether there are additional limitations recited in

the claim that amount to significantly more than the abstract idea, either individually or as

an ordered combination. The body of the claim does not recite any additional limitations

besides the mathematical algorithm for calculating a scaling factor. However, the preamble

of the claim does provide the additional limitations that the process is computer‐

implemented and textual information is contained in a window in a graphical user

interface. These limitations indicate the claimed process is used in a graphical user

interface environment. Where the preamble only states the purpose or the field of use of

an invention, the preamble does not limit the scope of the claim. Such a limitation does not

give “life, meaning and vitality to the claim.” (See MPEP 2111.02.) Therefore, the

limitations in the preamble do not limit the claim and there are no additional limitations

beyond the mathematical algorithm. Therefore, the claim does not amount to significantly

morethantheabstract idea itself (Step 2B: NO). Theclaimisnotpatenteligible.

A rejection of claim 2 should identify the exception by pointing to the generating and

scalingstepsandexplainthat the steps are a mathematical algorithmsimilarto thosefound

by the courts to be abstract. The rejection should also note that the preamble does not

limit the scope of the claim and, therefore, there are no additional limitations in the claim

besidesthe abstractidea.

Claim3:Ineligible.

The claim is directed to a series of steps for calculating a scaling factor, and thus is a

processwhichisastatutorycategoryofinvention(Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exceptions.

The claim recites the steps of calculating a first area and a second area and using the areas

to calculate a scaling factor. As discussed above, these steps describe a mathematical

algorithm which has been found by the courts to be an abstract idea. Therefore, the claim

isdirected to anabstractidea (Step 2A: YES).

The claim is then analyzed to determine whether it is directed to any judicial exceptions.

The claim recites that the step of calculating a scaling factor is performed by “the

computer”(referencing thecomputerrecited inthepreamble). Such alimitationgives“life,

meaning and vitality” to the preamble and, therefore, the preamble is construed to further

limit the claim. (See MPEP 2111.02.) Thus, the claim recites the additional limitations that

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July 2015 Update Appendix 1: Examples

the mathematical algorithm is implemented by a computer in a graphical user interface

environment. However, the mere recitation of “computer‐implemented” is akin to adding

the words “apply it” in conjunction with the abstract idea. Such a limitation is not enough

to qualify as significantly more. With regards to the graphical user interface limitation, the

courts have found that simply limiting the use of the abstract idea to a particular

technological environment is not significantly more. (See, e.g., Flook.) Even though the

disclosed invention may improve computer technology, the claimed invention provides no

meaningful limitations such that this improvement is realized. Therefore, the claim does

not amount to significantly more than the abstract idea itself (Step 2B: NO). The claim is

notpatent eligible.

A rejection of claim 3 should identify the exception by pointing to the generating and

scalingstepsandexplainthat the steps are a mathematical algorithmsimilarto thosefound

by the courts to be abstract. The rejection should also note that the preamble is limiting on

the scope of the claim, but the additional limitations do not amount to significantly more

because they merely require the abstract idea to be performed by a computer and in a

particulartechnologicalenvironment.

Claim4:Eligible.

Asdiscussedabove,theclaimrecitesaseriesofactsandthus isaprocess (Step 1: YES).

Next, the claim is evaluated to determine if the claim is directed toa judicial exception. The

claim recites similar steps to those recited in claim 2; notably calculating a first measure of

the area of a first window and a second measure of the area of the unobstructed portion of

the first window and calculating a scaling factor that is proportional to the difference

between the first and second measure. As explained with regards to claim 2, the courts

have previously found mathematical algorithms to be abstract ideas. Therefore, the claim

isdirected to anabstractidea (Step 2A: YES).

The claim must be analyzed to determine if the claim recites additional limitations that

amount to significantly more than the abstract idea. The claim recites the additional

limitations of a computer screen and processor. The recitation of the computer screen for

displaying and the processor for moving data is not enough by itself to transform the

exception into a patentable invention, because these limitations are generic computer

components performing generic computer functions at a high level of generality. Merely

using these generic computer components to perform the identified basic functions does

not constitute meaningful limitations that would amount to significantly more than the

abstractidea.

However, when viewing these computer limitations as an ordered combination with the

remaining limitations, the claim amounts to significantly more than the abstract idea. The

claim further recites the limitations of displaying a first and second window, detecting an

overlap condition indicating the windows overlap such that textual information in the first

window is obscured from view, determining the textual information is too large to fit in an

unobstructed portion of the first window, scaling the textual information based upon the

calculated scale factor, automatically relocating the scaled textual information to an

unobstructed portion of the first window so that it is viewable by the user, and

automatically returning the textual information to its original format when the overlap

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July 2015 Update Appendix 1: Examples

condition no longer exists. These limitations are not merely attempting to limit the

mathematical algorithm to a particular technological environment. Instead, these claim

limitations recite a specific application of the mathematical algorithm that improves the

functioning of the basic display function of the computer itself. As discussed above, the

scaling and relocating the textual information in overlapping windows improves the ability

ofthecomputertodisplayinformationandinteractwiththeuser.

Takingall the claim elements bothindividually and asan ordered combination, the claimas

a whole amounts to significantly more than the mathematical algorithm of calculating a

scalingfactor (Step 2B: YES).Thus,theclaimrecitespatenteligiblesubjectmatter.

If the examiner believes that the record would benefit from clarification, remarks could be

added to an Office action or reasons for allowance indicating that the claim recites a

mathematical algorithm which is an abstract idea. However, the claim is eligible because it

recites additional limitations that when considered as an ordered combination

demonstrate an improvement to the computer’s basic ability to display information and

interactwiththeuser.

24. Updating Alarm Limits

The following claim was held ineligible by the Supreme Court in Parker v. Flook, 437 U.S. 584

(1978) (Flook). The claim is directed to an abstract idea, and has additional elements that do

not amount to significantly more than the abstract idea. This exemplary analysis illustrates a

rejection of the claim using the 2014 IEG analysis.

Background

Applicant has invented a method for updating alarm limits using mathematical formulae.

An “alarm limit” is a number. During catalytic conversion processes, operating conditions

suchastemperature, pressure, andflow rates are constantlymonitored.Whenanyofthese

“process variables” exceeds a predetermined alarm limit, an alarm may signal the presence

of an abnormal condition indicating either inefficiency or perhaps danger. At certain points

in the catalytic conversion processes, it may be necessary to update the alarm limits

periodically.

Applicant’s patent application describes a method of updating alarm limits consisting of

three steps that are known in the art: an initial step which merely measures the present

value of the process variable (e.g., the temperature); an intermediate step which calculates

an updated alarm‐limit value; and a final step in which the actual alarm limit is adjusted to

the updated value. Applicant also describes mathematical formulae used to calculate the

updated alarm‐limit value in the second step, which were discovered by applicant and are

expressedas

=B

(1.0‐F) + PVL(F), where B

isthenewalarmbase,B

isthecurrentalarmbase,

F is a weighting factor greater than zero and less than 1.0, and PVL is the present

valueofaprocessvariable(e.g.,temperature);and

UAV=B

+K, where UAV is the updated alarm limit, and K is a predetermined alarm

offset that represents a margin of safety.

     

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July 2015 Update Appendix 1: Examples

Using the formulae, an operator can calculate an updated alarm limit once he knows the

original alarm base, the appropriate margin of safety, the time interval that should elapse

between each updating, the current temperature (or other process variable), and the

appropriate weighting factor to be used to average the original alarm base and the current

temperature. The formulae for updating alarm limits are used in a catalytic conversion

processing system; however, applicant’s specification contains no disclosure relating to

that system, such as the chemical processes at work, the monitoring of process conditions,

the determination of variables in the formulae from process conditions, or the means of

setting off an alarm or adjusting an alarm system. Applicant’s specification makes it clear

thatthemethodisimplementedonacomputerforautomaticadjustmentof alarmsettings.

Claim

1. A method for updating the value of at least one alarm limit on at least one process

variable involved in a process comprising the catalytic chemical conversion of

hydrocarbons wherein said alarm limit has a current value of B

+K wherein B

is the

currentalarmbaseandKisapredeterminedalarmoffset which comprises:

(1) Determining the present value of said process variable, said present value being

defined as PVL;

(2)Determining anew alarmbase B

,usingthefollowing equation:

=B

(1.0‐F)+PVL(F)

whereFisapredeterminednumbergreater thanzero andlessthan1.0;

(3)Determininganupdatedalarmlimitwhichisdefined asB

+K;and thereafter

(4)Adjustingsaid alarm limittosaidupdated alarmlimit value.

Analysis

Claim1:Ineligible.

The claim is analyzed for eligibility in accordance with its broadest reasonable

interpretation,whichherecoversperformanceofthemethodby handorbyacomputer.

The claim recites a series of acts including determining the value of a process variable,

calculating a new alarm base and an updated alarm limit, and adjusting the alarm limit to

the updated alarm limit value. Thus, the claim is directed to a process, which is one of the

statutorycategoriesof invention(Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception.

The claim recites a formula for updating alarm limits that comprises the limitations of

calculatingthealarmbaseusingthe mathematicalformulaB

=B

(1.0‐F)+PVL(F),andthen

calculating the updated alarm limit (UAV) using the mathematical formula UAV=B

+K.

These limitations set forth a judicial exception, because mathematical relationships have

been characterized by the courts as abstract ideas (e.g., the mathematical formula in

     

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             

                

              

July 2015 Update Appendix 1: Examples

Mackay Radio). It should be noted that in this case, the formula is novel, yet is an abstract

idea. Thus,theclaimis directedto anexception(Step 2A: YES).

Next, the claim as a whole is analyzed to determine whether any element, or combination

of elements, is sufficient to ensure that the claim amounts to significantly more than the

exception. The claim recites additional elements/steps of determining the value of an

unspecified processvariableinvolvedincatalyticchemicalconversionofhydrocarbonsand

adjusting the alarm limit to the calculated updated alarm limit value. The preamble

specifies the field of use, which is catalytic conversion of hydrocarbons, but in this case

imposes no limits on the process of calculating an alarm limit value using the specified

equation.

Taken alone, none of the additional elements amounts to significantly more than the

exception. Determining the value of an unspecified process variable is mere data gathering

and the claimed adjusting the alarm limit to an updated limit is mere post‐solution activity

that could be attached to almost any formula. By failing to explain how the process variable

is selected, integrate the formula into any specified chemical processes at work in the

catalytic conversion, or specify the means of setting off an alarm or adjusting the alarm

limit, the claim fails to improve the recited technological field. The steps merely calculate a

result using a novel equation and do not add any meaningful limits on use of the equation.

Taken alone or as an ordered combination, these additional elements do not amount to a

claim as a whole that is significantly more than the exception. (Step 2B: NO). The claim is

noteligible.

For purposes of discussion, it is noted that if the broadest reasonable interpretation of this

claim were limited to a computer implementation, adding a generic computer to perform

generic functions that are well‐understood, routine and conventional, such as gathering

data, performing calculations, and outputting a result would not transform the claim into

eligible subject matter. Generic computer‐implementation of the method is not a

meaningful limitation that alone can amount to significantly more than the exception.

Moreover, when viewed as a whole with such additional elements considered as an

ordered combination, the claim modified by adding a generic computer would be nothing

more than a purely conventional computerized implementation of applicant’s formula in

the general field of industrial chemical processing and would not provide significantly

morethanthejudicialexception itself.

A rejection of claim 1 should identify the exception by pointing to the formula in the claim

and explain that the formula is a mathematical relationship similar to those found by the

courts to be abstract. The rejection should also identify the additional elements in the

claim and explain why they do not amount to significantly more, in this case, because they

merelyadd datagathering andafieldofuse.

25. Rubber Manufacturing

The following illustrates an exemplary analysis using the 2014 IEG for actual and

hypothetical claims modeled after the technology in Diamond v. Diehr, 450 U.S. 175 (1981)

(Diehr). As the claims in this example are eligible, no written analysis would be provided in an

Office action. The application at issue was granted as U.S. Patent No. 4,344,142. Actual claim

     

 

               

          

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             

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July 2015 Update Appendix 1: Examples

1 recites a method that is directed to a mathematical relationship and steps that could be

performed mentally and has additional elements/steps that amount to significantly more

than the abstract ideas because as a whole they transform a particular article to a different

state or thing and use the abstract ideas to improve another technology/technical field, either

of which can show eligibility. Claim 2 is a hypothetical claim in the form of computerized

instructions. Claim 2, which also is directed to the mathematical relationship and steps that

could be performed mentally, is eligible due to the additional elements/steps that use the

abstract ideas to improve another technology/technical field.

Background

Applicant has invented a process of controlling a rubber molding press with a computer to

precisely shape uncured material under heat and pressure and then cure the synthetic

rubber in the mold to obtain a product that retains its shape. Raw (uncured) synthetic

rubber comprises independent polymeric chains, e.g., a mixture of isobutylene and

isoprene polymers. Curing cross‐links the polymeric chains together, thereby changing the

rubber from its raw state into a more durable form that will retain a molded shape. Proper

curing depends upon several factors including the thickness of the article to be molded, the

temperature of the molding process, and the amount of time that the article is allowed to

remainin thepress.

At the time of applicant’s invention, the usual way of operating rubber‐molding presses is

for the operator to load and close the press manually. Closure of the press operates a timer

that is preset for an estimated cure time. Due to the manual operation, the actual mold

temperature may vary, and result in overcured or undercured rubber because the preset

timeis not equivalent totheactualtimerequiredforpropercuring.

In the instant application, applicant’s process improves upon conventional molding

processes by constantly measuring the actual temperature inside the mold using a

thermocouple, and automatically feeding these temperature measurements into a standard

digital computer that repeatedly recalculates the cure time by use of the Arrhenius

equation. The Arrhenius equation has long been used to calculate the cure time in rubber‐

molding processes, and can be expressed as ln v = CZ+x, where ln is natural logarithm

conversiondata,visthetotal requiredcuretime,Cisthe activationenergyconstantunique

to each batch of said compound being molded, Z is the temperature of the mold, and x is a

constant dependent upon the geometry of the particular mold of the press. When the

recalculated time equals the actual time that has elapsed since the press was closed, the

computersignalsadevicetoopenthepress.Applicant’sprocessobtainsuniformlyaccurate

cures, which results in substantially reducing the number of defectively cured batches that

must be discarded. The improved process also substantially reduces the amount of time in

whichthepresses areclosedunnecessarily,therebyresultinginmoreefficient employment

ofthemoldandoperator.

Claims

1. A method of operating a rubber‐molding press for precision molded compounds with

theaidof a digitalcomputer,comprising:

providing said computer with a data base for said press including at least, natural

logarithm conversion data (ln), the activation energy constant (C) unique to each batch of

     

 

  



  



   

    

  

    

      



  

   



   

 

    

     

  



     



July 2015 Update Appendix 1: Examples

said compound being molded, and a constant (x) dependent upon the geometry of the

particular moldofthepress,

initiating an interval timer in said computer upon the closure of the press for

monitoring theelapsed timeofsaid closure,

constantly determining the temperature (Z) of the mold at a location closely

adjacenttothemoldcavity inthepressduring molding,

constantlyprovidingthecomputerwiththetemperature (Z),

repetitively calculating in the computer, at frequent intervals during each cure, the

Arrhenius equation for reaction time during the cure, which is ln v = CZ+x, where v is the

totalrequiredcuretime,

repetitively comparing in the computer at said frequent intervals during the cure

each said calculation of the total required cure time calculated with the Arrhenius equation

andsaidelapsedtime,and

opening thepressautomaticallywhenasaidcomparisonindicatesequivalence.

2. A non‐transitory computer readable medium with computer executable instructions

stored thereon executed by a processor to perform the method of controlling a rubber‐

molding press having a mold with a cavity for precision molded compounds, the method

comprising:

accessing a data base in the computer including at least, natural logarithm

conversion data (ln), the activation energy constant (C) unique to each batch of said

compoundbeingmolded,andaconstant(x) dependentuponthegeometryoftheparticular

moldofthepress,

initiating an interval timer in the computer upon the closure of the press for

monitoring theelapsed timeofthe closure,

constantly receiving data relating to the temperature (Z) of the mold at a location

closelyadjacenttothe moldcavity inthepress duringmolding,

repetitively calculating in the computer, at frequent intervals during each cure, the

Arrhenius equation for reaction time during the cure, which is ln v = CZ + x where v is the

totalrequiredcuretime,

repetitively comparing in the computer at the frequent intervals during the cure

each calculation of the total required cure time calculated with the Arrhenius equation and

theelapsed time,and

initiating a signal that controls the press to open when the comparison indicates

equivalence,meaningthatthemoldedproductiscured.

     

 



     

 

    



 

     

       

  

 



 

   

 

  



  

   

  

 

   



July 2015 Update Appendix 1: Examples

Analysis

Claim1:Eligible.

The claim recites a series of acts including determining the temperature of the mold and

providing that temperature to the computer. Thus, the claim is directed to a process, which

isoneof thestatutory categories ofinvention(Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception.

The claim recites a limitation of repetitively calculating the Arrhenius equation (the

mathematical formula: ln v = CZ+x) for reaction time during the cure. This limitation sets

forth a judicial exception, because calculating the reaction time using the Arrhenius

equation is a mathematical relationship that the courts have held is representative of a law

of nature (e.g., the mathematical formula in Flook). Mathematical relationships such as this

have also been characterized by the courts as abstract ideas. Additionally, the claim

limitations of performing repetitive calculations and comparisons between the calculated

time and the elapsed time could be performed by a human using mental steps or basic

critical thinking, which are types of activities that have also been found by the courts to

represent abstract ideas (e.g., the mental comparison in Ambry Genetics). Thus, the claim is

directedtoatleastoneexception(Step 2A: YES).

Next, the claim as a whole is analyzed to determine whether any additional element, or

combination of elements, is sufficient to ensure that the claim amounts to significantly

more than the exceptions (the mathematical relationship and the critical thinking steps of

calculating and comparing). Since there are multiple abstract ideas recited in the claim, the

Step 2B analysis needs to be conducted for each abstract idea individually, until the

analysisshowsineligibilityfor one oreligibilityforall.

The Step 2B analysis is first conducted for the mathematical relationship. Besides the

mathematical relationship, the claim recites additional elements of providing a digital

computerwithadata baseofvalues,initiatinganintervaltimer,constantlydeterminingthe

temperature of the mold, constantly providing the computer with the temperature, using

the computer to perform the calculations and comparisons, and opening the press

automatically when the comparison indicates equivalence. Some of the additional

elements/steps, such as accessing a database and using a computer to perform calculations

and comparisons, are routine computer activities or generic functions performed by a

computer that taken alone do not add significantly more to the process instructions in the

claim. By themselves, these limitations are recited at a high level of generality and perform

the basic functions of a computer that are well‐understood, routine and conventional (e.g.,

accessing a data base to receive and store data, and performing mathematical operations

on a computer). Likewise, initiating a timer and determining a temperature, taken alone,

are mere data gathering steps to obtain data necessary to calculate the time using the

Arrheniusequation.

However, when viewing the claim as a whole, the combination of all these steps taken

together, including the constant determination of the temperature of the mold, the

repetitive calculations and comparisons, and the opening of the press based on the

calculations, amount to significantly more than simply calculating the mold time using the

Arrhenius equation because they add meaningful limits on use of the equation. The claim

     

 

   

 

   

       

      

 



    

 



  

   

    



   

    

  



 

   

     



  

   

 

     



 

    

   

  

July 2015 Update Appendix 1: Examples

does not merely recite the equation in isolation, but integrates these ideas into the molding

process. The additional steps specifically relate to the particular variables used, how the

variables are gathered, the process by which the rubber is molded and cured, and how the

result of the cure time calculation is used. The totality of the steps act in concert to

improve another technical field, specifically the field of precision rubber molding, by

controlling theoperationofthe mold.Inaddition,theclaimedsteps takenasacombination

effect a transformation of the raw, uncured synthetic rubber into a different state or thing,

i.e.,acuredandmoldedrubberproduct.Thus,theclaimamountstosignificantlymorethan

themathematicalrelationship(i.e.,theabstractideaof the Arrhenius equation).

Because the claim is eligible with respect to the first abstract idea, it is expected that the

additional limitations will amount to significantly more than the second abstract idea (the

critical thinking steps of calculating and comparing). This is true in this example. The

additional limitations discussed above are significantly more than the critical thinking

skills of calculating and comparing results. As previously stated, evaluating the additional

limitations both individually and as an ordered combination demonstrates that the claim

improves the technical field of precision rubber molding and transforms the raw, uncured

synthetic rubber into a different state or thing. Taking all the claim elements both

individually and as an ordered combination, the claim as a whole amounts to significantly

more than the abstract ideas (Step 2B: YES). The claim recites patent eligible subject

matter.

If the examiner believes that the record would benefit from clarification, remarks could be

added to an Office action or reasons for allowance indicating that the claim recites

exceptions including the Arrhenius equation, which is a law of nature or abstract idea.

However,theclaimiseligiblebecauseit recitesadditionallimitationsthatwhenconsidered

as an ordered combination provide meaningful limits on the use of the equation and

improvethetechnicalfieldofprecisionrubbermolding.

Claim2:Eligible.

The claim recites a non‐transitory computer‐readable medium with stored instructions

that are used to control a rubber molding press. The claim is directed to a manufacture (an

article produced from materials), which is a statutory category of invention (Step 1: YES).

Note that the term “non‐transitory” ensures the claim does not encompass signals and

othernon‐statutory transitory formsofsignal transmission.

The claim recites the same steps of performing repetitive calculations of the reaction time

using the Arrhenius equation and comparing the results as claim 1, albeit in the form of

computer executable instructions. Therefore, the claim is directed to the same abstract

ideas identified inclaim1(Step 2A: YES).

Conducting the Step 2B analysis for the first abstract idea (the Arrhenius equation), the

claim recites additional elements including computer instructions to access a database,

initiate an interval timer, constantly receive data, and initiate a signal to control the press.

Thestepsalsoincludecomputer instructionstoimplementtheequation.Whilesomeofthe

elements taken alone are well‐understood, routine and conventional use of a computer, or

mere data gathering, the combination of the additional elements when the claim is viewed

as a whole amounts to significantly more than simply calculating the mold time using the

     

 



  



  

 



       

     

    

  

    

  

   

 

     

 

  

   

    

  



 

   

            

               

              

    



   

    

     



  

 

    

July 2015 Update Appendix 1: Examples

Arrhenius equation. The totality of the steps governed by the claimed instructions provides

software that improves another technical field, specifically the field of precision rubber

molding, through controlling the operation of the mold by initiating a signal to control the

press to open when the comparisonindicatesequivalenceandthe moldedproductiscured.

This software enhances the ability of a specific rubber molding device to open the press at

the optimal time for curing the rubber therein. This process does not merely link the

Arrhenius equation to a technical field, but adds meaningful limitations on the use of the

mathematical relationship by specifying the types of variables used (temperature and

time), how they are selected (their relationship to the reaction time), how the process uses

the variables in rubber molding, and how the result is employed to improve the operation

of the press. For at least these reasons, the elements/steps recited in addition to the

mathematical formula, particularly taken in combination, show that claim 2 is not directed

to instructions to use the formula in isolation, but rather integrate the concept into an

eligiblecontrolschemetoimproveanother technologicalprocess.

Similarly, the claim recites additional limitations that when viewed as an ordered

combination amount to significantly more than the second abstract idea (the critical

thinking steps of calculating and comparing the timing data). As already discussed, these

additional limitations demonstrate an improvement in the field of precision rubber

molding technology and amount to more than simple instructions to perform the

calculating/comparing steps in isolation. Thus, the claim amounts to significantly more

thanthejudicialexceptions(Step 2B: YES).Theclaimrecitespatent eligiblesubjectmatter.

If the examiner believes that the record would benefit from clarification, remarks could be

added to an Office action or reasons for allowance indicating that the claim recites

exceptions including the Arrhenius equation, which is a law of nature or abstract idea.

However,theclaimiseligiblebecauseit recitesadditionallimitationsthatwhenconsidered

as an ordered combination provide meaningful limits on the use of the equation and

improvethetechnicalfieldofprecisionrubbermolding.

26. Internal Combustion Engine

This hypothetical example demonstrates the use of the st reamlined analysis. The claim below

is based on the technology from U.S. Pat. 5,533,489. As a streamlined analysis would not result

in a written rejection, the discussion sets forth exemplary reasoning an examiner might use in

drawing a conclusion of eligibility.

Background

Nitrogen oxides are constituents of exhaust gas that are produced during the operation of

an internal combustion engine. It is generally understood that nitrogen oxides are harmful

to our atmosphere and cause air pollution. The amount of nitrogen oxides produced in the

exhaust gas is relative to the temperature that the fuel and air mixture burns in the engine.

Therefore, exhaust gas recirculation (EGR) has been developed to recirculate the exhaust

gas back to the air intake, which reduces the amount of oxygen in the combustion mixture

and causes it to burn at a lower temperature, thereby reducing the amount of nitrogen

oxides produced. However, as the amount of EGR increases there may be a resulting

decline inengineperformance(e.g.,adecreaseinpoweroutput).

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July 2015 Update Appendix 1: Examples

The invention is an internal combustion engine that solves this problem by automatically

modifying the amount of EGR based upon current engine operations. In particular, the

inventor has discovered that engine performance can be optimized by turning off the EGR

during acceleration, which permits the engine to operate at maximum power output while

retaining the reduction in nitrogen oxides. Therefore, the invention uses a control system

to control the opening and closing of an exhaust gas recirculation valve based upon a rate

ofchangeof theenginethrottle, inordertomodifytheamount ofEGR.

Claim

1.Aninternalcombustionengine providingexhaustgasrecirculationcomprising:

anairintakemanifold;

anexhaust manifold;

a combustion chamber to receive air from the air intake manifold, combust a

combination of the received air and fuel to turn a drive shaft, and output resulting exhaust

gastothe exhaustmanifold;

athrottlepositionsensortodetect theposition ofan engine throttle;

an exhaust gas recirculation valve to regulate the flow of exhaust gas from the

exhaustmanifoldtotheair intake manifold;and

a control system, comprising a processor andmemory, to receive the engine throttle

position from the throttle position sensor, calculate a position of the exhaust gas

recirculationvalvebasedupon the rateof changeof the engine throttleposition andchange

theposition oftheexhaustgasrecirculationvalvetothecalculatedposition.

Analysis

Claim1:Eligible.

The claim recites an internal combustion engine with an intake manifold, exhaust manifold,

combustion chamber, throttle position sensor, exhaust gas recirculation valve and a control

system comprising a processor and memory. Thus, the claim is directed to a machine (a

combination of mechanical parts), which is one of the statutory categories of invention

(Step 1: YES).

Next, the claim must be evaluated to determine if the claim is directed to a law of nature,

natural phenomenon or abstract idea. But when the claim is reviewed, it is immediately

evident that although the claim operates by calculating the rate of change, which is a

mathematical relationship describing how a variable changes over a specific period of time,

the claim clearly does not seek to tie up this mathematical relationship so that others

cannot practice it. In particular, the claim’s description of an internal combustion engine

having manifolds, valves, and sensors forming a specific structure that uses the control

system to optimize exhaust gas recirculation makes it clear that the claim as a whole would

clearly amount to significantly more than any recited exception. The claim as a whole adds

meaningful limitations to the use of the mathematical relationship. Additionally, use of the

mathematical relationship improves engine technology. Thus, eligibility of the claim is self‐

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July 2015 Update Appendix 1: Examples

evident, and there is no need to perform the full eligibility analysis (e.g., Steps 2A and 2B).

Theclaimis patenteligible.

If the examiner believes that the record would benefit from clarification, remarks could be

added to an Office action or reasons for allowance indicating that while the claim may

recite a mathematical relationship, the claim clearly amounts to significantly more than the

rate of change by providing meaningful limitations to the mathematical relationship and

improving engine technology.

27. System Software ‐BIOS

This example demonstrates the use of the streamlined analysis. The claim below is taken from

U.S. Pat. 5,230,052 and was suggested as an example by comments received in response to the

June 2014 Preliminary Examination Instructions. As a streamlined analysis would not result

in a written rejection, the discussion sets forth exemplary reasoning an examiner might use in

drawing a conclusion of eligibility.

Background

BIOS is an acronym that stands for Basic Input/Output System. When a computer is

powered on, BIOS code runs to initialize and test the hardware components. BIOS also acts

as an insulation layer between the hardware and software of a computer, by providing an

interfacebetweentheapplicationprogram/operatingsystemand thehardware devices.At

the time of the invention, conventional computers stored BIOS code in non‐volatile read

only memory (ROM) on the computer’s motherboard. However, as computers have grown

more sophisticated, two disadvantages have arisen. First, the size of the BIOS code has

increased such that it exceeds the memory space in ROM. Second, storing BIOS code in

ROM also makes it difficult to modify or rewrite the code as new input/output devices are

added.

In order to overcome these disadvantages, the inventors utilize a local area network (LAN)

to store the BIOS code remotely from the computer. Upon startup, a computer connected

to the LAN loads code to initialize and test only those system components and functions

necessary to load the BIOS from a remote computer. Subsequently, the computer requests

a remote memory location, which is also connected to the LAN, for the BIOS code. In

response to the request, the remote system builds the appropriate BIOS for that computer

including a master boot record and transmits the BIOS to the local computer system. The

local computersystem stores the receivedBIOS codein random access memory (RAM), and

usesthemasterbootrecordtoloadandexecutetheBIOS.

Claim

15. A method for loading BIOS into a local computer system which has a system processor

andvolatilememoryandnon‐volatilememory,themethodcomprising thestepsof:

(a) responding to powering up of the local computer system by requesting from a

memory location remote from the local computer system the transfer to and storage in the

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July 2015 Update Appendix 1: Examples

volatile memory of the local computer system of BIOS configured for effective use of the

localcomputersystem,

(b)transferring andstoringsuchBIOS,and

(c)transferringcontrolofthelocalcomputersystemtosuchBIOS.

Analysis

Claim15:Eligible.

The claim recites a series of steps for loading BIOS on a local computer system from a

remote storage location. Thus, the claim is directed to a process, which is one of the

statutorycategoriesof invention(Step 1: YES).

Next, the claim must be evaluated to determine if the claim is directed to a law of nature,

natural phenomenon or abstract idea. But when the claim is reviewed, it is immediately

evident that even if the claim did recite a judicial exception, the claim is not attempting to

tie up any such exception so that others cannot practice it. In particular, the claim’s

description of initializing a local computer system using BIOS code stored at a remote

memory location, by triggering the processor to transfer BIOS code between two memory

locations upon a powering up of the computer and transferring control of the processor

operations to that BIOS code, makes it clear that the claim as a whole would clearly amount

to significantly more than any potential recited exception. Thus, eligibility of the claim is

self‐evident in the streamlined analysis, without needing to perform the full eligibility

analysis(e.g.,Steps2A and2B).Theclaimispatenteligible.

It is important to point out as well that there is no apparent exception recited in the claim,

which alone would be sufficient for eligibility. While computers operate on mathematical

theory, that underlying operation should not trigger an eligibility analysis – computers and

computer operations are not automatically subjected to an eligibility analysis. The cases in

which courts find mathematical relationships to represent abstract ideas (thus raising

eligibility issues) are those in which the mathematical relationship is recited in the claim as

part of the invention, such as a method of performing a mathematical calculation to obtain

a result. Courts have found computers and computer implemented processes to be

ineligible when generic computer functions are merely used to implement an abstract idea,

suchasanideathatcould bedonebyhumananalog(i.e.,byhandorbymerelythinking).

If the examiner believes that the record would benefit from clarification, remarks could be

added to an Office action or reasons for allowance, indicating that the claim is not directed

toanyjudicialexception.

Subject Matter Eligibility Examples: Life Sciences

1 May 2016

The following examples should be used in conjunction with the 2014 Interim Guidance on Subject

Matter Eligibility (2014 IEG). As the examples are intended to be illustrative only, they should be

interpreted based on the fact patterns set forth below. Other fact patterns may have different

eligibility outcomes. While some of the fact patterns draw from U.S. Supreme Court or U.S. Court of

Appeals for the Federal Circuit decisions, each of the examples shows how claims should be analyzed

under the 2014 IEG. All of the claims are analyzed for eligibility in accordance with their broadest

reasonable interpretation.

Note that the examples herein are numbered consecutively beginning with number 28, because 27

examples were previously issued. A comprehensive index of all examples for use with the 2014 IEG

is provided in the attached appendix (which is an updated version of Appendix 2 to the July 2015

Update).

28. Vaccines

This example illustrates the application of the markedly different characteristics and significantly more

analyses to claims reciting hypothetical nature-based products. It also illustrates the importance of

applying the broadest reasonable interpretation in the eligibility analysis, and how that interpretation

assists in the identification of appropriate naturally occurring counterparts of claimed nature-based

products. Hypothetical claims 1, 2 and 4-6 are eligible in Step 2A, because the claimed nature-based

products have markedly different characteristics from what exists in nature. Hypothetical claim 3 is

ineligible, because the claimed nature-based product lacks markedly different characteristics from what

exists in nature, and the claim fails to amount to significantly more than the exceptions. Hypothetical

claim 7 is eligible in Step 2B, because although the claim is directed to an exception, it recites a

particular and unconventional device that amounts to significantly more than the exception.

Background

Applicant discloses an influenza A viral strain, which was named the “Pigeon flu” because it was

discovered in pigeons. Applicant filed an application disclosing several types of Pigeon flu vaccines,

and evaluating their functional characteristics (such as immunogenicity) in terms of their

seroprotection rate, i.e., the percentage of vaccinated patients who developed immunity to the Pigeon

flu. The disclosed vaccines include:

• Vaccines comprising “live attenuated Pigeon flu virus”, which the specification defines as a

live mutant virus that has been attenuated so that it has at least one mutation (i.e., a change

in the nucleotide sequence) of its polymerase gene, which reduces its virulence as compared

to naturally occurring Pigeon flu virus. No mutations of this polymerase gene are known to

occur in nature. Applicant created this mutant attenuated virus by isolating Pigeon flu virus

from infected pigeons, and passaging the isolated virus through a cell culture at least 50 times

until the desired mutation occurred. The live attenuated Pigeon flu virus is safe (unable to

cause disease in pigeons or other test animals) and strongly immunogenic, e.g., it has a high

seroprotection rate of about 85%.

• Vaccines comprising “inactivated Pigeon flu virus”, which the specification defines as a dead

virus that is formalin-inactivated, i.e., the naturally occurring Pigeon flu virus was contacted

with a chemical solution called formalin that causes structural changes to the virus (e.g., it

chemically modifies the viral nucleic acids in a manner that does not occur in nature) so that

it can no longer reproduce. Because the inactivated virus can no longer replicate, it is unable

to cause disease in pigeons or other test animals, but it is still strongly immunogenic, e.g., it

has a high seroprotection rate of about 75%.

Subject Matter Eligibility Examples: Life Sciences

2 May 2016

• Vaccines comprising Peptide F (a naturally occurring peptide isolated from the Pigeon flu

virus) either alone or mixed with a pharmaceutically acceptable carrier such as water. Prior

to applicant’s invention, and at the time of filing the application, water was routinely and

conventionally used as a carrier for peptide vaccines. Isolation does not change any structural

or functional characteristics of Peptide F. Applicant discloses vaccines where the suitable

pharmaceutically acceptable carrier is selected from a group consisting of a cream, emulsion,

gel, liposome, nanoparticle, or ointment. Applicant discloses that although the carriers in this

group comprise naturally occurring components (such as water and oil), when the

components are assembled into the carrier form, the carrier has changed structural and

physical characteristics that distinguish it from the closest counterpart in nature. E.g., a

pharmaceutically acceptable cream comprising water and vegetable oil has a form (a semi-

solid homogeneous emulsion) that is structurally and physically distinct from the water and

oil in nature. These vaccines are weakly immunogenic, e.g., they have a low seroprotection

rate of about 30%, meaning that many people who are vaccinated with these vaccines will

not develop immunity to the Pigeon flu.

• Vaccines comprising Peptide F mixed with aluminum salt adjuvants (a well-known class of

adjuvants) such as aluminum phosphate (AlPO

). While many of these adjuvants including

aluminum phosphate are naturally occurring, none of them occur together with Peptide F in

nature. Adjuvants are commonly added to vaccines in order to improve their functional

characteristics, e.g., by increasing the strength of the immune response that the vaccines

produce (immunogenicity). The amount of adjuvant sufficient to increase a vaccine’s

immunogenicity to a level high enough to effectively vaccinate a typical patient is called the

“immuno-effective amount”, and those skilled in the art understand that this amount may

vary depending on the particular adjuvant and formulation selected. Adjuvants can increase

immunogenicity in several ways, such as by slowing the release of Peptide F to tissue around

the injection site, and/or by improving the delivery of Peptide F to the patient’s lymph nodes.

On their own or combined with water or other common carriers, Peptide F induces only a

weak protective immune response to Pigeon flu virus (seroprotection rate of 30%), and the

adjuvants do not induce any protective immune response to Pigeon flu virus (seroprotection

rate of 0%). When immuno-effective amounts of the disclosed adjuvants are combined with

Peptide F, however, the combined vaccine induces a strong immune response to Pigeon flu

virus (seroprotection rate of 80%).

Applicant also discloses vaccine delivery devices comprising coated microneedle arrays for delivery

of a vaccine comprising Peptide F. Prior to applicant’s invention, and at the time the application was

filed, it was routine and conventional in the field to use syringes, but not coated microneedle arrays,

for vaccine delivery. A pre-filled syringe is a tube that has been loaded with a vaccine dose prior to

distribution of the vaccine to health professionals. The syringe can be fitted with a hollow needle

about 5/8” to 1.5” long to administer the vaccine subcutaneously or intramuscularly. A coated

microneedle array comprises a plurality of very small solid needles (e.g., less than 0.05” long) that

are coated with a vaccine formulation, which is placed against a patient’s skin to administer the

vaccine into the skin (transcutaneously). Because the microneedles are very small, administration of

a vaccine with a microneedle array is virtually painless.

Claims

1. A vaccine comprising live attenuated Pigeon flu virus.

2. A vaccine comprising inactivated Pigeon flu virus.

Subject Matter Eligibility Examples: Life Sciences

3 May 2016

3. A vaccine comprising:

Peptide F; and

a pharmaceutically acceptable carrier.

4. A vaccine comprising:

Peptide F; and

a pharmaceutically acceptable carrier selected from the group consisting of a cream,

emulsion, gel, liposome, nanoparticle, or ointment.

5. A vaccine comprising:

Peptide F; and

an immuno-effective amount of an aluminum salt adjuvant.

6. A vaccine comprising:

Peptide F;

an immuno-effective amount of an aluminum salt adjuvant; and

a pharmaceutically acceptable carrier.

7. A vaccine delivery device comprising a microneedle array that is coated with a vaccine

comprising Peptide F.

Analysis

Claim 1: Eligible.

The claim recites a vaccine comprising live attenuated Pigeon flu virus. Based on the plain meaning

of “vaccine”, and the specification’s definition of “live attenuated Pigeon flu virus”, the broadest

reasonable interpretation of the claim is live mutant Pigeon flu virus that has been attenuated so that

it has at least one mutation (i.e., a change in its nucleotide sequence) that reduces its virulence as

compared to naturally occurring Pigeon flu virus, in an amount sufficient to produce an immunogenic

response in a typical patient. Because viruses are composed of matter, the claim is directed to a

statutory category, e.g., a composition of matter (Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception. The recited

live attenuated virus is a nature-based product that must be compared to its naturally occurring

counterpart to determine if it has markedly different characteristics than the counterpart. Here, the

closest natural counterpart is the naturally occurring Pigeon flu virus from which the live attenuated

virus was mutated. When the live attenuated virus is compared to this counterpart, the comparison

indicates that the live attenuated virus has a different structural characteristic (the nucleotide

sequence of its polymerase gene was changed due to the mutation), which has resulted in the live

attenuated virus having a different functional characteristic (reduced virulence). No mutations of this

gene are known to occur in nature. Thus, under the holding in Myriad, this structural difference is a

markedly different characteristic, because it causes the claimed virus to have a nucleotide sequence

that is different from anything found in nature. Association for Molecular Pathology v. Myriad

Genetics, Inc., 133 S. Ct. 2107, 2119 (2013). While in other fact patterns, a functional change may be

enough by itself to confer eligibility, for this claim the functional change is a result of the structural

change and thus is inseparable from it. Because the live attenuated virus has markedly different

characteristics from what exists in nature, it is not a “product of nature” exception. Thus, the claim is

not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.

Note that because the analysis of this claim ends at Step 2A, the Step 2B analysis is not performed.

Thus, the examiner would not need to evaluate the significantly more considerations for this claim.

Subject Matter Eligibility Examples: Life Sciences

4 May 2016

If the examiner believes that the record would benefit from clarification, remarks could be added to

an Office action or reasons for allowance, indicating that the claim is not directed to any judicial

exception.

Claim 2: Eligible.

The claim recites a vaccine comprising inactivated Pigeon flu virus. Based on the plain meaning of

“vaccine”, and the specification’s definition of “inactivated Pigeon flu virus”, the broadest reasonable

interpretation of the claim is dead Pigeon flu virus that has been structurally altered by contacting it

with formalin so that its nucleic acids are chemically modified in a manner that does not occur in

nature and it can no longer reproduce, in an amount sufficient to produce an immunogenic response

in a typical patient. Because viruses are composed of matter, the claim is directed to a statutory

category, e.g., a composition of matter (Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception. The recited

inactivated virus is a nature-based product that must be compared to its naturally occurring

counterpart to determine if it has markedly different characteristics than the counterpart. Here, the

closest natural counterpart is the naturally occurring Pigeon flu virus. When the inactivated virus is

compared to this counterpart, the comparison indicates that the inactivated virus has a different

structural characteristic (its exposure to formalin has chemically modified its nucleic acids in a

manner that does not occur in nature), which has resulted in the inactivated virus having different

functional characteristics (inability to replicate or cause disease). Like the Chakrabarty bacterium,

which had markedly different characteristics “due to the additional plasmids and resultant ‘capacity

for degrading oil,’” Myriad, 133 S. Ct. at 2117, the inactivated virus has markedly different

characteristics, due to the non-natural chemical modification of its nucleic acids and the resultant

change in the virus’s ability to replicate or cause disease. While in other fact patterns, a functional

change may be enough by itself to confer eligibility, for this claim the functional change is a result of

the structural change and thus is inseparable from it. Because the inactivated virus has markedly

different characteristics from what exists in nature, it is not a “product of nature” exception. Thus,

the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.

Note that because the analysis of this claim ends at Step 2A, the Step 2B analysis is not performed.

Thus, the examiner would not need to evaluate the significantly more considerations for this claim.

If the examiner believes that the record would benefit from clarification, remarks could be added to

an Office action or reasons for allowance, indicating that the claim is not directed to any judicial

exception.

Claim 3: Ineligible.

The claim recites a vaccine comprising Peptide F and a pharmaceutically acceptable carrier. Based

on the plain meaning of “vaccine” and “pharmaceutically acceptable carrier”, the broadest reasonable

interpretation (BRI) of the claim is a sufficient amount of Peptide F to produce an immunogenic

response in a typical patient, which is mixed with a pharmaceutically sufficient amount of a carrier

such as water. Thus, one embodiment within the BRI is a mixture of Peptide F and water. Because the

peptide and carrier are composed of matter, the claim is directed to a statutory category, e.g., a

composition of matter (Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception. The recited

mixture of Peptide F and water is a nature-based product that must be compared to its closest

naturally occurring counterpart to determine if it has markedly different characteristics than the

counterpart. Because Peptide F and water do not occur together in nature, there is no naturally

occurring counterpart mixture for comparison, and so the claimed mixture is compared to its

naturally occurring components, i.e., Peptide F, and water. Peptide F is naturally occurring, and water

Subject Matter Eligibility Examples: Life Sciences

5 May 2016

is naturally occurring, so neither would be eligible as claimed on their own. While the mixture of

these two naturally occurring components is novel and does not occur in nature, there is no

indication that mixing these components changes the structure, function, or other properties of the

peptide or water. For example, the claim encompasses a mixture where the peptide is

heterogeneously dispersed in the water, but such heterogeneous mixing does not change the

structure, function, or other properties of the peptide or the water in any marked way. Instead, the

peptide retains its naturally occurring structure and function, and is merely dispersed in the water,

which also retains its naturally occurring structure and function. Thus, for at least one embodiment

within the broadest reasonable interpretation, the claimed mixture as a whole does not display

markedly different characteristics compared to the naturally occurring counterparts. Accordingly,

each component (the peptide and the carrier) is a “product of nature” exception, and the claim is

directed to at least one exception (Step 2A: YES).

Next, the claim as a whole is analyzed to determine whether any additional element, or combination

of elements, is sufficient to ensure that the claim amounts to significantly more than the exceptions.

Because the component elements (the peptide and carrier “product of nature” exceptions) do not

occur together in nature and are not markedly changed by their combination into a mixture, each is

considered as an additional element to the other. This consideration provides an opportunity to

explore whether this combination of “products of nature” amounts to significantly more than the

products themselves. As discussed above, mixing the peptide with a carrier such as water does not

markedly change the characteristics of either component, because each component continues to have

the same properties in the mixture as it had alone. In addition, using a carrier in a peptide vaccine

was well-understood, routine & conventional prior to applicant’s invention and at the time of filing

the application, so the mixing of the peptide and carrier, when recited at this high level of generality,

does not meaningfully limit the claim. Thus, the claim as a whole does not amount to significantly

more than each “product of nature” by itself (Step 2B: NO). The claim does not qualify as eligible

subject matter.

A rejection of claim 3 should identify the exceptions by pointing to the nature-based products in the

claim (the peptide and carrier) and explaining why they lack markedly different characteristics from

their naturally occurring counterparts, e.g., because there are no changes in structure, function, or

other characteristics. The rejection should also explain that combining the peptide and carrier does

not amount to significantly more than the exceptions, because their combination is well-understood,

routine and conventional in the field.

If the examiner believes that it would be helpful to cite an analogous court decision, the rejection

could include an explanation of how the claimed mixture is like the novel bacterial mixture of Funk

Brothers, which was held ineligible because each species of bacteria in the mixture (like each

component in the peptide-carrier mixture) continued to have “the same effect it always had”, i.e., it

lacked markedly different characteristics. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127,

131 (1948), discussed in Myriad Genetics, 133 S. Ct. at 2117 (explaining that the bacterial mixture of

Funk Brothers “was not patent eligible because the patent holder did not alter the bacteria in any

way”).

Claim 4: Eligible.

The claim recites a vaccine comprising Peptide F in a pharmaceutically acceptable carrier selected

from the group consisting of a cream, emulsion, gel, liposome, nanoparticle, or ointment. Based on

the plain meaning of “vaccine” and “pharmaceutically acceptable carrier”, the broadest reasonable

interpretation (BRI) of the claim is a sufficient amount of Peptide F to produce an immunogenic

response in a typical patient, which is mixed with a sufficient amount of other substances to produce

a carrier form suitable for administration to a patient. The BRI thus encompasses, for example, a

Subject Matter Eligibility Examples: Life Sciences

6 May 2016

vaccine comprising Peptide F in a carrier that is a cream. Because the plain meaning of a “cream” in

the pharmaceutical arts is a semi-solid homogeneous emulsion comprising water and oil, the

recitation of a cream necessarily requires (i) the presence of water and an oil (such as naturally

occurring cottonseed oil) in addition to Peptide F, and (ii) that the water and oil be structurally

arranged into a homogenous emulsion to produce a semi-solid form. Thus, one embodiment within

the BRI is an emulsion comprising Peptide F mixed with small uniform droplets of cottonseed oil that

are homogenously dispersed in water. Because the peptide and the carrier are composed of matter,

the claim is directed to a statutory category, e.g., a composition of matter (Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception. The claimed

cream containing Peptide F, cottonseed oil, and water is a nature-based product that must be

compared to its closest naturally occurring counterpart to determine if it has markedly different

characteristics than the counterpart. Here, all three substances (the peptide, cottonseed oil, and

water) do not occur together in nature, so there is no naturally occurring counterpart mixture for

comparison. The mixture is therefore compared to its naturally occurring components, i.e., Peptide

F, cottonseed oil, and water. The claimed cream has different structural and physical characteristics

than its naturally occurring components, for example the oil droplets are small, uniform in size, and

homogenously dispersed in the water, which causes the resultant cream to have a semi-solid and

non-flowable form at room temperature as compared to the oil and water, which are both flowable

liquids at room temperature in nature. Because the oil and water are emulsified, the cream will also

adhere to a patient’s skin or mucous membranes much longer than oil or water in their natural non-

emulsified form, thus permitting a sufficient amount of peptide to transfer from the cream into the

patient’s tissues where it will then stimulate an immune response. In contrast, the oil or water, if used

in their natural state, would simply slide off the patient’s skin after a short time. The cream’s changed

form and adherence are marked differences in structural and physical characteristics as compared

to the natural counterparts, and therefore the cream is not a “product of nature” exception. Thus, the

claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.

Note that because the analysis of this claim ends at Step 2A, the Step 2B analysis is not performed.

Thus, the examiner would not need to evaluate the significantly more considerations for this claim.

If the examiner believes that the record would benefit from clarification, remarks could be added to

an Office action or reasons for allowance, indicating that the claim is not directed to any judicial

exception.

Practice Note: The BRI of claim 4 also encompasses cream embodiments in which the oil is a non-

naturally occurring oil, or is a naturally occurring oil other than cottonseed oil, or in which the

homogenous emulsion is a water-in-oil emulsion instead of an oil-in-water emulsion, as well as

embodiments in which the carrier is something other than a cream, e.g., a liposome or nanoparticle

carrier. If the examiner were to analyze such embodiments for markedly different characteristics, the

analysis may differ slightly due to the choice of different counterparts, but the same result of

eligibility would be achieved because in every embodiment, the plain meaning of each carrier recited

in the claim requires that the carrier have structural and physical characteristics that distinguish it

from the closest counterpart in nature.

Claim 5: Eligible.

The claim recites a vaccine comprising Peptide F and an immuno-effective amount of an aluminum

salt adjuvant. Based on the plain meaning of “vaccine” and “immuno-effective amount”, the broadest

reasonable interpretation (BRI) of the claim is a mixture of (i) a sufficient amount of Peptide F to

produce an immunogenic response in a typical patient, and (ii) a sufficient amount of an aluminum

salt adjuvant (e.g., aluminum phosphate; AlPO

) to increase the vaccine’s immunogenicity (measured

here by seroprotection rate) to a level high enough to effectively vaccinate a typical patient. Thus,

Subject Matter Eligibility Examples: Life Sciences

7 May 2016

one embodiment within the BRI is a mixture of Peptide F with a sufficient amount of aluminum

phosphate to increase the vaccine’s immunogenicity. Because the peptide and adjuvant are

composed of matter, the claim is directed to a statutory category, e.g., a composition of matter (Step

1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception. The claimed

mixture of Peptide F and aluminum phosphate is a nature-based product that must be compared to

its closest naturally occurring counterpart to determine if it has markedly different characteristics

than the counterpart. Because Peptide F and aluminum phosphate do not occur together in nature,

there is no naturally occurring counterpart mixture for comparison, and so the claimed mixture is

compared to its naturally occurring components, i.e., Peptide F, and the adjuvant (e.g., aluminum

phosphate). There is no indication that mixing these components changes the structure of the peptide

or aluminum phosphate. However, the mixture has a changed functional property, in that the

immunogenicity of the mixture is different (higher) than the mere “sum” of the immunogenicity of

the individual components. In other words, the peptide by itself has poor immunogenicity (30%

seroprotection rate) and the adjuvant by itself has no immunogenicity (0% seroprotection rate) with

respect to Pigeon flu virus, but when combined, the resultant mixture has a greatly enhanced

immunogenicity (80% seroprotection rate) with respect to Pigeon flu virus. The mixture’s changed

immunogenicity is a marked difference in functional characteristics as compared to the natural

counterparts, and therefore the mixture is not a “product of nature” exception. Thus, the claim is not

directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.

Note that because the analysis of this claim ends at Step 2A, the Step 2B analysis is not performed.

Thus, the examiner would not need to evaluate the significantly more considerations for this claim.

If the examiner believes that the record would benefit from clarification, remarks could be added to

an Office action or reasons for allowance, indicating that the claim is not directed to any judicial

exception.

Practice Note: The BRI of claim 5 also encompasses embodiments in which the adjuvant is a non-

naturally occurring aluminum salt, or is a naturally occurring aluminum salt other than aluminum

phosphate. If the examiner were to analyze such an embodiment for markedly different

characteristics, the analysis may differ slightly due to the choice of different counterparts, but the

same result of eligibility would be achieved because in every embodiment, the immuno-effective

amount of the adjuvant will result in the claimed mixture exhibiting the same marked difference in

immunogenicity described in the preceding analysis.

Claim 6: Eligible.

The claim recites a vaccine comprising Peptide F, an immuno-effective amount of an aluminum salt

adjuvant, and a pharmaceutically acceptable carrier. Based on the plain meaning of “vaccine”,

“immuno-effective amount”, and “pharmaceutically acceptable carrier”, the broadest reasonable

interpretation of the claim is a mixture of (i) a sufficient amount of Peptide F to produce an

immunogenic response in a typical patient, (ii) a sufficient amount of an aluminum salt adjuvant (e.g.,

aluminum phosphate; AlPO

) to increase the vaccine’s immunogenicity (measured here by

seroprotection rate) to a level high enough to effectively vaccinate a typical patient, and (iii) a

pharmaceutically sufficient amount of a carrier such as water. Thus, one embodiment within the BRI

is a mixture of Peptide F, a sufficient amount of aluminum phosphate to increase the vaccine’s

immunogenicity, and water. Because the peptide, adjuvant, and carrier are composed of matter, the

claim is directed to a statutory category, e.g., a composition of matter (Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception. The claimed

mixture of Peptide F, aluminum phosphate, and water is a nature-based product that must be

Subject Matter Eligibility Examples: Life Sciences

8 May 2016

compared to its closest naturally occurring counterpart to determine if it has markedly different

characteristics than the counterpart. Here, all three substances (the peptide, aluminum phosphate,

and water) do not occur together in nature, so there is no naturally occurring counterpart mixture

for comparison. However, aluminum phosphate does occur naturally in combination with water (e.g.,

in soil). Accordingly, the closest naturally occurring counterparts to which the claimed mixture is

compared are Peptide F, and the naturally occurring water/aluminum phosphate combination. There

is no indication that mixing the peptide with the water/aluminum phosphate combination changes

the structure of either component, but the mixture does have a changed functional property, in that

the immunogenicity of the mixture is different (higher) than the mere “sum” of the immunogenicity

of the individual components. In other words, the peptide by itself has poor immunogenicity (30%

seroprotection rate), and the water/aluminum phosphate combination by itself has no

immunogenicity (0% seroprotection rate) with respect to Pigeon flu virus, but when combined, the

resultant mixture has a greatly enhanced immunogenicity (80% seroprotection rate) with respect to

Pigeon flu virus. The mixture’s changed immunogenicity is a marked difference in functional

characteristics as compared to the natural counterparts, and therefore the mixture is not a “product

of nature” exception. Thus, the claim is not directed to an exception (Step 2A: NO), and qualifies as

eligible subject matter.

Note that because the analysis of this claim ends at Step 2A, the Step 2B analysis is not performed.

Thus, the examiner would not need to evaluate the significantly more considerations for this claim.

If the examiner believes that the record would benefit from clarification, remarks could be added to

an Office action or reasons for allowance, indicating that the claim is not directed to any judicial

exception.

Practice Note: The BRI of claim 6 also encompasses embodiments in which the adjuvant is a non-

naturally occurring aluminum salt, or is a naturally occurring aluminum salt other than aluminum

phosphate, and embodiments in which the carrier is something other than water. If the examiner

were to analyze such an embodiment for markedly different characteristics, the analysis may differ

slightly due to the choice of different counterparts, but the same result of eligibility would be

achieved because in every embodiment, the immuno-effective amount of the adjuvant will result in

the claimed mixture exhibiting the same marked difference in immunogenicity described in the

preceding analysis.

Claim 7: Eligible.

The claim recites a vaccine delivery device comprising a microneedle array that is coated with a

vaccine comprising Peptide F. Based on the plain meaning of “microneedle array” and “vaccine”, the

broadest reasonable interpretation (BRI) of the claim is an array of small solid needles coated with a

sufficient amount of Peptide F to produce an immunogenic response in a typical patient. Thus, one

embodiment within the BRI is an array of small solid needles (the microneedle array) coated with

Peptide F. The microneedle array is a manufacture and the peptide is composed of matter; thus, the

claim is directed to at least one statutory category, e.g., a manufacture and/or a composition of matter

(Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception. The

microneedle array is not a nature-based product, but the Peptide F is a nature-based product that

must be compared to its closest naturally occurring counterpart (naturally occurring Peptide F) to

determine if it has markedly different characteristics than the counterpart in its natural state as part

of the virus. There is no indication in the specification that isolation changes any structural or

functional characteristics of Peptide F, or that coating the needles in the array with Peptide F results

in the peptide having any characteristics (structural, functional, or otherwise) that are different from

the naturally occurring peptide in its natural state. Thus, the claimed peptide does not display

Subject Matter Eligibility Examples: Life Sciences

9 May 2016

markedly different characteristics compared to the naturally occurring counterpart. Accordingly, the

peptide is a “product of nature” exception, and the claim is directed to at least one exception (Step

2A: YES).

Next, the claim as a whole is analyzed to determine whether any additional element, or combination

of elements, is sufficient to ensure that the claim amounts to significantly more than the exception.

Besides the exception, the claim recites an additional element of the microneedle array, which is

coated with the peptide. Prior to applicant’s invention, and at the time the application was filed,

coated microneedle arrays were known to most scientists in the field, but were not routinely or

conventionally used to administer vaccines. The conventional delivery device was a syringe that was

routinely pre-filled with the vaccine. Thus, the claim’s recitation of a microneedle array coated with

the peptide is an application of the exception with a particular manufacture that is not a conventional

delivery device, and thus is more than a mere instruction to “apply” the peptide (the exception) using

a well-understood, routine or conventional device in the field. It is an unconventional limitation that

confines the exception to a particular useful application of the exception. Thus, the recitation of the

coated microneedle array yields a claim as a whole that amounts to significantly more than the

“product of nature” exception itself (Step 2B: YES). The claim is eligible.

If the examiner believes that the record would benefit from clarification, remarks could be added to

an Office action or reasons for allowance indicating that the peptide is a “product of nature” exception

because it lacks markedly different characteristics from its naturally occurring counterpart, e.g.,

because there are no changes in structure, function, or other characteristics. However, the claim is

eligible because it recites a particular, unconventional limitation (the coated microneedle array) that

confines the exception to a particular useful application, and that is more than a mere instruction to

“apply” the exception using a well-understood, routine or conventional device in the field.

29. Diagnosing and Treating Julitis

This hypothetical example illustrates the application of the significantly more analysis to diagnostic and

treatment claims using a hypothetical disease. Claims 1 and 7 are eligible in Step 2A, because they are

not directed to any judicial exception. Claim 2 is ineligible, because it is directed to a judicial exception

that could be termed either a law of nature or an abstract idea, and the recited additional elements do

not amount to significantly more than the exception. Claims 3-6 are directed to the same exception, but

are eligible in Step 2B because they recite specific and unconventional reagents and/or treatments that

amount to significantly more than the exception.

Background

“Julitis” is an autoimmune disease affecting more than 17 million people in North America, which

develops when the immune system mistakes normal skin cells for pathogens. Julitis causes chronic

inflammation of the skin that results in an itchy and extremely painful rash on the face, hands, and

feet. Conventionally, julitis is diagnosed by a physical examination of the characteristic rash.

However, because the rash caused by julitis looks similar to rashes caused by rosacea, doctors often

misdiagnosed people as having rosacea when they actually had julitis.

Applicant has discovered that the presence of a protein known as “JUL-1” in a person’s body is

indicative that the person has julitis. All julitis patients have JUL-1 in their plasma, skin, hair and nails,

but this protein is not found in persons who do not have julitis (e.g., patients with rosacea). Applicant

discloses detecting JUL-1 by routine and conventional methods such as (i) physical biopsies of skin,

hair or nails, or (ii) immunoassays in which a sample from a patient (e.g., a plasma or skin sample) is

contacted with an antibody to the protein being detected, and then binding between the antibody

and the protein is detected using a laboratory technique such as fluoroscopy. In particular, applicant

Subject Matter Eligibility Examples: Life Sciences

10 May 2016

discloses detecting JUL-1 using anti-JUL-1 antibodies that may be naturally occurring (e.g., a human

anti-JUL-1 antibody isolated from a patient known to have julitis), or non-naturally occurring (e.g., a

porcine anti-JUL-1 antibody created by injecting pigs with JUL-1, or a specific monoclonal antibody

named “mAb-D33” that was created by applicant). Prior to applicant’s invention, and at the time the

application was filed, the use of porcine antibodies in veterinary therapeutics was known to most

scientists in the field, but these antibodies were not routinely or conventionally used to detect human

proteins such as JUL-1.

Prior to applicant’s invention, and at the time the application was filed, julitis was conventionally

treated with anti-tumor necrosis factor (TNF) antibodies, but for unknown reasons, some patients

do not respond well to this conventional treatment. Because rosacea treatments (e.g., antibiotics) are

not effective against julitis, julitis patients who were misdiagnosed as having rosacea also did not

respond well to the treatments they were given. Some anti-TNF antibodies are naturally occurring in

patients with other autoimmune diseases such as lupus. Applicant has successfully treated julitis

patients (even those who are non-responsive to anti-TNF antibodies) with topical vitamin D. Prior to

applicant’s invention, and at the time the application was filed, vitamin D was commonly used as an

oral supplement to maintain bone health (e.g., in fortified dairy products), but doctors were not

commonly or routinely administering topical vitamin D to patients with julitis or other diseases.

Claims

1. A method of detecting JUL-1 in a patient, said method comprising:

a. obtaining a plasma sample from a human patient; and

b. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample

with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody.

2. A method of diagnosing julitis in a patient, said method comprising:

a. obtaining a plasma sample from a human patient;

b. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample

with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody; and

c. diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is

detected.

3. A method of diagnosing julitis in a patient, said method comprising:

a. obtaining a plasma sample from a human patient;

b. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample

with a porcine anti-JUL-1 antibody and detecting binding between JUL-1 and the porcine

antibody; and

c. diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is

detected.

4. A method of diagnosing julitis in a patient, said method comprising:

a. obtaining a plasma sample from a human patient;

b. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample

with antibody mAb-D33 and detecting binding between JUL-1 and antibody mAb-D33;

and

c. diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is

detected.

5. A method of diagnosing and treating julitis in a patient, said method comprising:

a. obtaining a plasma sample from a human patient;

Subject Matter Eligibility Examples: Life Sciences

11 May 2016

b. detecting whether JUL-1 is present in the plasma sample;

c. diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is

detected; and

d. administering an effective amount of topical vitamin D to the diagnosed patient.

6. A method of diagnosing and treating julitis in a patient, said method comprising:

a. obtaining a plasma sample from a human patient;

b. detecting whether JUL-1 is present in the plasma sample;

c. diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is

detected; and

d. administering an effective amount of anti-tumor necrosis factor (TNF) antibodies to the

diagnosed patient.

7. A method of treating a patient with julitis, the method comprising administering an effective

amount of anti-TNF antibodies to a patient suffering from julitis.

Analysis

Claim 1: Eligible.

The claim recites a series of steps or acts, including detecting the presence of JUL-1 in a plasma

sample. Thus, the claim is directed to a process, which is one of the statutory categories of invention

(Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception. The claim

recites steps of obtaining a plasma sample from a patient (step a) and detecting whether JUL-1 is

present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and

detecting resultant binding between JUL-1 and the antibody (step b). These steps do not recite or

describe any recognized exception. See, e.g., Mayo Collaborative Svcs. v. Prometheus Labs., 566 U.S.

__, 132 S. Ct. 1289, 1297 (2012) (recited steps of administering a drug to a patient and determining

the resultant level of 6-thioguanine in the patient “are not themselves natural laws”). Accordingly,

the claim is not directed to an exception (Step 2A: NO), and is eligible.

Note that although nature-based product limitations are recited in the claim (e.g., the plasma sample

and JUL-1), analysis of the claim as a whole indicates that the claim is focused on a process of

detecting whether JUL-1 is present in a plasma sample, and is not focused on the products per se.

Thus, there is no need to perform the markedly different characteristics analysis on the recited

nature-based product limitations. In addition, note that because the analysis of this claim ends with

eligibility at Step 2A, the Step 2B analysis does not need to be performed. Thus, the examiner would

not need to evaluate the significantly more considerations for this claim.

If the examiner believes that the record would benefit from clarification, remarks could be added to

an Office action or reasons for allowance, indicating that the claim is not directed to any judicial

exception.

Claim 2: Ineligible.

The claim recites a series of steps or acts, including detecting the presence of JUL-1 in a plasma

sample. Thus, the claim is directed to a process, which is one of the statutory categories of invention

(Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception. In step c, the

claim recites diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is

detected, which describes a correlation or relationship between the presence of JUL-1 in a patient’s

Subject Matter Eligibility Examples: Life Sciences

12 May 2016

plasma and the presence of julitis in the patient. This limitation sets forth a judicial exception, because

this type of correlation is a consequence of natural processes, similar to the naturally occurring

correlation found to be a law of nature by the Supreme Court in Mayo). Additionally, step c could be

performed by a human using mental steps or basic critical thinking, which are types of activities that

have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry

Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about

the results in Grams). Thus, the claim is directed to at least one exception (Step 2A: YES), which may

be termed a law of nature, an abstract idea, or both. Note that although the claim recites several

nature-based product limitations (e.g., the plasma sample and JUL-1), the claim as a whole is focused

on a process of detecting whether JUL-1 is present in a plasma sample, and is not focused on the

products per se. Thus, there is no need to perform the markedly different characteristics analysis on

the recited nature-based product limitations.

Next, the claim as a whole is analyzed to determine whether any element, or combination of elements,

is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the

law of nature, the claim recites additional steps of obtaining a plasma sample from a human patient

(step a), and detecting whether JUL-1 is present in the plasma sample by contacting the plasma

sample with an anti-JUL-1 antibody and detecting resultant binding between JUL-1 and the antibody

(step b). Obtaining a sample in order to perform tests is well-understood, routine and conventional

activity for those in the field of diagnostics. Further, the step is recited at a high level of generality

such that it amounts to insignificant presolution activity, e.g., a mere data gathering step necessary

to use the correlation. Detecting whether JUL-1 is present in the plasma sample merely instructs a

scientist to use any detection technique with any generic anti-JUL-1 antibody. When recited at this

high level of generality, there is no meaningful limitation, such as a particular or unconventional

machine or a transformation of a particular article, in this step that distinguishes it from well-

understood, routine, and conventional data gathering activity engaged in by scientists prior to

applicant’s invention, and at the time the application was filed, e.g., the routine and conventional

techniques of detecting a protein using an antibody to that protein. Further, it is well established that

the mere physical or tangible nature of additional elements such as the obtaining and detecting steps

does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp.

v. CLS Bank Int’l, 134 S.Ct. 2347, 2358-59 (2014)).

Consideration of the additional elements as a combination also adds no other meaningful limitations

to the exception not already present when the elements are considered separately. Unlike the eligible

claim in Diehr in which the elements limiting the exception are individually conventional, but taken

together act in concert to improve a technical field, the claim here does not invoke any of the

considerations that courts have identified as providing significantly more than an exception. Even

when viewed as a combination, the additional elements fail to transform the exception into a patent-

eligible application of that exception. Thus, the claim as a whole does not amount to significantly

more than the exception itself (Step 2B: NO). The claim is not eligible.

A rejection of claim 2 should identify step c as an exception by pointing to it in the claim and

explaining why it is an exception, e.g., that the recited correlation is a law of nature because it is a

consequence of a natural process in the body, and/or that the critical thinking step is an abstract idea

similar to those found by the courts to be an exception. The rejection should also identify the

additional elements in the claim and explain why they do not amount to significantly more, in this

case, because they merely add data gathering and well-understood, routine and conventional

activities that do not impose meaningful limits on the law of nature.

Subject Matter Eligibility Examples: Life Sciences

13 May 2016

Claim 3: Eligible.

The claim recites a series of steps or acts, including detecting the presence of JUL-1 in a plasma

sample. Thus, the claim is directed to a process, which is one of the statutory categories of invention

(Step 1: YES). Because claim 3 recites the same correlation and critical thinking step (step c) as claim

2, which as explained above is a law of nature and/or an abstract idea, the claim is directed to a

judicial exception (Step 2A: YES). Although this claim recites several nature-based product limitations

(the plasma sample, JUL-1, and the antibody), there is no need to perform the markedly different

characteristics analysis on them, for the reasons discussed above for claim 2.

Next, the claim as a whole is analyzed to determine whether any element, or combination of elements,

is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the

exception, the claim recites additional steps of obtaining a plasma sample from a human patient (step

a), and detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample

with a porcine anti-JUL-1 antibody and detecting resultant binding between JUL-1 and the antibody

(step b). The additional element of obtaining a plasma sample (step a) does not by itself add

significantly more, for the reasons discussed above for claim 2. Step b, however, also requires

detecting using a porcine anti-JUL-1 antibody. Prior to applicant’s invention, and at the time the

application was filed, the use of porcine antibodies in veterinary therapeutics was known to most

scientists in the field. But significantly, there is no evidence that porcine antibodies were routinely or

conventionally used to detect human proteins such as JUL-1. Thus, the claim’s recitation of detecting

JUL-1 using a porcine antibody is an unconventional step that is more than a mere instruction to

“apply” the correlation and critical thinking step (the exception) using well-understood, routine or

conventional techniques in the field. Whether taken alone or as a combination with the other

additional elements, the recitation of detecting JUL-1 using a porcine anti-JUL-1 antibody yields a

claim as a whole that amounts to significantly more than the exception itself (Step 2B: YES). The claim

is eligible.

If the examiner believes that the record would benefit from clarification, remarks could be added to

an Office action or reasons for allowance indicating that the correlation and critical thinking step

(step c) is a law of nature and/or an abstract idea. However, the claim is eligible because it recites

additional limitations that when considered as a combination are unconventional steps that are more

than a mere instruction to “apply” the exception using well-understood, routine or conventional

techniques in the field.

Claim 4: Eligible.

The claim recites a series of steps or acts, including detecting the presence of JUL-1 in a plasma

sample. Thus, the claim is directed to a process, which is one of the statutory categories of invention

(Step 1: YES). Because claim 4 recites the same correlation and critical thinking step (step c) as claim

2, which as explained above is a law of nature and/or an abstract idea, the claim is directed to a

judicial exception (Step 2A: YES). Although this claim recites several nature-based product limitations

(the plasma sample, JUL-1, and the antibody), there is no need to perform the markedly different

characteristics analysis on them, for the reasons discussed above for claim 2.

Next, the claim as a whole is analyzed to determine whether any element, or combination of elements,

is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the

exception, the claim recites the additional elements of obtaining a plasma sample from a human

patient (step a) and detecting the presence of JUL-1 in the sample by contacting the plasma sample

with antibody mAb-D33 and detecting resultant binding between the antibody and JUL-1 (step b).

The additional element of obtaining a plasma sample (step a) does not add significantly more by itself,

for the reasons discussed above for claim 2. Step b, however, requires detecting using a specific anti-

Subject Matter Eligibility Examples: Life Sciences

14 May 2016

JUL-1 antibody (mAb-D33). Prior to applicant’s invention, and at the time the application was filed,

antibody mAb-D33 was not routinely or conventionally used to detect human proteins such as JUL-

1. Thus, the claim’s recitation of detecting JUL-1 using mAb-D33 is an unconventional step that is

more than a mere instruction to “apply” the correlation and critical thinking step (the exception)

using well-understood, routine or conventional techniques in the field. Whether taken alone or as a

combination with the other additional elements, the recitation of detecting JUL-1 using mAb-D33

yields a claim as a whole that amounts to significantly more than the exception itself (Step 2B: YES).

The claim is eligible.

If the examiner believes that the record would benefit from clarification, remarks could be added to

an Office action or reasons for allowance indicating that the correlation and critical thinking step

(step c) is a law of nature and/or an abstract idea. However, the claim is eligible because it recites

additional limitations that when considered as a combination are unconventional steps that are more

than a mere instruction to “apply” the exception using well-understood, routine or conventional

techniques in the field.

Claim 5: Eligible.

The claim recites a series of steps or acts, including detecting the presence of JUL-1 in a plasma

sample. Thus, the claim is directed to a process, which is one of the statutory categories of invention

(Step 1: YES). Because claim 5 recites the same correlation and critical thinking step (step c) as claim

2, which as explained above is a law of nature and/or an abstract idea, the claim is directed to a

judicial exception (Step 2A: YES). Although the claim recites several nature-based product limitations

(the plasma sample, JUL-1, and vitamin D), there is no need to perform the markedly different

characteristics analysis on them, for the reasons discussed above for claim 2.

Next, the claim as a whole is analyzed to determine whether any element, or combination of elements,

is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the

exception, the claim recites the additional elements of obtaining a plasma sample from a human

patient (step a) and detecting the presence of JUL-1 in the sample (step b). When considered

individually, steps a and b by themselves do not add significantly more to the exception for the

reasons discussed above for claim 2 (e.g., step b in this claim is recited at an even higher level of

generality than in claim 2, that encompasses any protein detection method, whether or not it uses

antibodies). However, this claim further recites an additional element of administering an effective

amount of topical vitamin D to the diagnosed patient (step d). Vitamin D was known to doctors, and

was routinely and conventionally used as an oral supplement to maintain bone health prior to

applicant’s invention, and at the time the application was filed. However, mere knowledge of vitamin

D or its use in other ways to treat other medical conditions does not make the administration of

topical vitamin D to treat julitis a conventional step that those in this field would routinely practice.

The evaluation turns on whether the use of topical vitamin D was widely prevalent in the field at the

time the invention was made and the application was filed. Because it was not, the recitation of

administering topical vitamin D is an unconventional step that is more than a mere instruction to

“apply” the correlation and critical thinking step (the exception) using well-understood, routine or

conventional techniques in the field. Whether taken alone or as a combination with the other

additional elements, the recitation of administering topical vitamin D yields a claim as a whole that

amounts to significantly more than the exception itself (Step 2B: YES). The claim is thus eligible.

If the examiner believes that the record would benefit from clarification, remarks could be added to

an Office action or reasons for allowance indicating that the correlation and critical thinking step

(step c) is a law of nature and/or an abstract idea. However, the claim is eligible because it recites

additional limitations that when considered as a combination are unconventional steps that are more

Subject Matter Eligibility Examples: Life Sciences

15 May 2016

than a mere instruction to “apply” the exception using well-understood, routine or conventional

techniques in the field.

Claim 6: Eligible.

The claim recites a series of steps or acts, including detecting the presence of JUL-1 in a plasma

sample. Thus, the claim is directed to a process, which is one of the statutory categories of invention

(Step 1: YES). Because claim 6 recites the same correlation and critical thinking step (step c) as claim

2, which as explained above is a law of nature and/or an abstract idea, the claim is directed to a

judicial exception (Step 2A: YES). Although the claim recites several nature-based product limitations

(the plasma sample, JUL-1, and the anti-TNF antibodies), there is no need to perform the markedly

different characteristics analysis on them, for the reasons discussed above for claim 2.

Next, the claim as a whole is analyzed to determine whether any element, or combination of elements,

is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the

exception, the claim recites the same additional elements of obtaining a plasma sample from a human

patient (step a) and detecting the presence of JUL-1 in the sample (step b) as claim 5. When

considered individually, steps a and b do not by themselves add significantly more to the exception

for the reasons discussed above for claims 2 and 5. This claim further recites an additional element

of administering an effective amount of anti-TNF antibodies to the diagnosed patient (step d). Prior

to applicant’s invention, and at the time the application was filed, however, administering these

antibodies to treat a patient diagnosed with julitis was well-understood, routine and conventional

activity engaged in by doctors in the field. Further, it is well established that the mere physical or

tangible nature of additional elements such as the obtaining, detecting, and administering steps does

not automatically confer eligibility on a claim directed to an exception (see, e.g., Alice Corp., 134 S.Ct.

at 2358-59).

When the additional elements are viewed as a combination, however, the additional elements (steps

a, b and d) amount to a claim as a whole that adds meaningful limits on the use of the exception (the

correlation and critical thinking step). The totality of these steps including the recitation of a

particular treatment (administration of an effective amount of anti-TNF antibodies) in step d

integrate the exception into the diagnostic and treatment process, and amount to more than merely

diagnosing a patient with julitis and instructing a doctor to generically “treat it.” Further, the

combination of steps, which is not routine and conventional, ensures that patients who have julitis

will be accurately diagnosed (due to the detection of JUL-1 in their plasma) and properly treated with

anti-TNF antibodies, as opposed to being misdiagnosed as having rosacea as was previously

commonplace. See Diamond v. Diehr, 450 U.S. 175, 188 (1981) (“a new combination of steps in a

process may be patentable even though all the constituents of the combination were well known and

in common use before the combination was made”). Thus, the administration of anti-TNF antibodies,

when considered as a combination with the other additional elements, yields a claim as a whole that

amounts to significantly more than the exception itself (Step 2B: YES). The claim is eligible.

If the examiner believes that the record would benefit from clarification, remarks could be added to

an Office action or reasons for allowance indicating that the correlation and critical thinking step

(step c) is a law of nature and/or an abstract idea. However, the claim is eligible because it recites

additional limitations that when considered as a combination are a meaningful way of applying the

exception that is more than a mere instruction to “apply” the exception.

Claim 7: Eligible.

The claim recites at least one step or act, e.g., administering an effective amount of anti-TNF

antibodies to a patient suffering from julitis. Thus, the claim is directed to a process, which is one of

the statutory categories of invention (Step 1: YES).

Subject Matter Eligibility Examples: Life Sciences

16 May 2016

The claim is then analyzed to determine whether it is directed to any judicial exception. Although the

claim recites a nature-based product limitation (the anti-TNF antibodies), analysis of the claim as a

whole indicates that the claim is focused on a process of practically applying the product to treat a

particular disease (julitis), and not on the product per se. Accordingly, it is not necessary to perform

the markedly different characteristics analysis on the antibodies. The recited step of administering

antibodies to a patient suffering from julitis does not recite or describe any recognized exception.

See, e.g., Mayo, 132 S. Ct. at 1297 (recited steps of administering a drug to a patient and determining

the resultant level of 6-thioguanine in the patient “are not themselves natural laws”). Thus, the claim

is not directed to an exception (Step 2A: NO). The claim is eligible.

Note that because the analysis of this claim ends in eligibility at Step 2A, the Step 2B analysis does

not need to be performed. Thus, the examiner would not need to evaluate the significantly more

considerations for this claim.

If the examiner believes that the record would benefit from clarification, remarks could be added to

an Office action or reasons for allowance, indicating that the claim is not directed to any judicial

exception.

30. Dietary Sweeteners

This example illustrates the application of the markedly different characteristics and significantly more

analyses to claims reciting hypothetical nature-based products including mixtures. It also illustrates the

importance of applying the broadest reasonable interpretation in the eligibility analysis, and how that

interpretation assists in the identification of appropriate naturally occurring counterparts of claimed

nature-based products. Hypothetical claims 1 and 2 are ineligible, because the claimed nature-based

products lack markedly different characteristics from what exists in nature, and the claims fail to

amount to significantly more than the exceptions (even though claim 2 recites specific amounts of the

components in the nature-based product). Hypothetical claims 3-6 are eligible in Step 2A, because the

claimed nature-based products have markedly different characteristics from what exists in nature.

Background

The “Texas mint” plant is a relative of stevia, which has a thin liquid sap containing about 10% texiol

(a newly discovered glycoside similar to rebaudioside A). When the Texas mint plant is damaged, e.g.,

by a leaf or stem breaking, sap is released from the injury site, and over time dries to form irregular

crystals of texiol. Texiol is lower in calories and tastes sweeter than table sugar, but it has a bitter

aftertaste. Texiol can be used as crystals or as a powder, and is soluble in water at various

concentrations. Applicant filed an application defining a “dietary sweetener” as one of the following

formulations, noting that all percentages are by weight:

• A dietary sweetener comprising texiol mixed with other components such as water to form a

heterogeneous or homogenous mixture, e.g., a solution or suspension. Applicant discloses

that trained sensory panels reviewed formulations having varying concentrations of texiol in

water, and found that the sensory perceptions of texiol’s sweetness and bitter aftertaste both

increased with concentration, e.g., higher concentrations of texiol were perceived as having

stronger sweet and bitter tastes. Based on the panel’s review, and from a consumer’s

perspective, applicant discloses a preferred dietary sweetener comprising 1-5% texiol and at

least 90% water. This preferred sweetener retains the naturally occurring texiol’s sweetness

and bitter aftertaste.

• A dietary sweetener comprising texiol mixed with water and Compound N (a natural flavor

excreted from mushrooms and having a mild umami taste). Applicant discloses that when

combined with texiol in particular amounts, Compound N neutralizes the bitter aftertaste of

Subject Matter Eligibility Examples: Life Sciences

17 May 2016

texiol. Applicant discloses that this neutralization does not involve a chemical reaction. The

same sensory panel tasted mixtures having various concentrations of Compound N and texiol,

and found that a formulation comprising 1-5% texiol, 1-2% Compound N, and the balance

water produced the most palatable results for a dietary sweetener with no bitter aftertaste.

When Compound N is added in the specified amount, the changed taste perception occurs

whether or not the texiol is fully dissolved, e.g., even when large crystals of texiol are used.

• A dietary sweetener solid gel formulation comprising 5% texiol mixed with water and/or

fruit juice and sufficient pectin to provide a solid gel. The Texas mint plant does not contain

pectin in nature. Solid gel formulations are useful commercial sweeteners because their solid,

jelly-like consistency makes them spreadable onto other foods, such as bread, cake layers, or

pastry dough. Solid gels can also be formed into candies such as jellybeans. Applicant

discloses that the same sensory panel tasted the gel formulation and found that it had

improved organoleptic properties (e.g., a more pleasant mouthfeel) and a solid but easily-

spreadable consistency as compared to naturally occurring texiol (either in the sap or

crystallized).

• A dietary sweetener comprising texiol in granular form for use by consumers. Naturally

occurring texiol forms irregular crystals that aggregate into large chunks of varying size and

shape. Due to this variation, sweeteners formed from these irregular crystals do not have

consistent and commercially acceptable dissolution rates. For example, a consumer

attempting to sweeten iced tea with irregular texiol crystals will typically experience a need

to add more than the expected amount of texiol in order to obtain the desired level of

sweetness, because the larger particles of texiol dissolve more slowly (if at all) than the

smaller particles even with vigorous stirring. The presence of these undissolved crystals may

also cause an undesirable gritty mouth feel as the sweetened tea is consumed. To solve the

problem of inconsistent and slow dissolution rates, applicant has produced granulated texiol

formulations having even and regular particle size distributions, e.g., by grinding or milling

coarse texiol crystals into an even and regular powder, or by crystallizing texiol in a

controlled manner that forms regularly sized and shaped crystals. Granular texiol having a

particle size of X10 of 80 microns and X90 of 300 microns is preferred, because this particle

size distribution results in a greatly increased (and consistent) dissolution rate in water-

based liquids as compared to naturally occurring texiol crystals. The terms “X10” and “X90”

refer to the median diameter of the particles, as measured on a volume basis by a laser

diffraction particle sizing system. For “X10”, 10 percent of the particles have a diameter

smaller than the specified size, and 90 percent of the particles have a larger diameter, and for

“X90”, 90 percent of the particles have a diameter smaller than the specified size, and 10

percent of the particles have a larger diameter.

• A dietary sweetener comprising texiol in a controlled release formulation. Applicant discloses

that the same sensory panel, upon tasting naturally occurring texiol, reported perceiving an

immediate burst of sweetness that rapidly dissipated. Applicant discloses formulations that

achieve controlled release (e.g., release of specific amounts of texiol from the formulation at

specific time intervals, or over a prolonged period of time) by mixing the texiol with other

substances such as polymers and/or changing the form of the texiol so that a controlled

perception of sweetness is achieved. For example, in one such formulation, texiol particles

are encapsulated in a polymer-emulsifier mixture that delays release of the texiol as

compared to unencapsulated (e.g., naturally occurring) texiol particles. These controlled

release formulations prolong enjoyment of a texiol-sweetened product such as chewing gum,

by altering the time over which texiol’s sweetness is perceived.

Subject Matter Eligibility Examples: Life Sciences

18 May 2016

Claims

1. A dietary sweetener comprising:

texiol; and

water.

2. A dietary sweetener comprising:

1-5 percent texiol; and

at least 90 percent water.

3. A dietary sweetener comprising:

1-5 percent texiol;

at least 90 percent water; and

1-2 percent Compound N.

4. A dietary sweetener comprising:

5 percent texiol;

water, fruit juice, or a combination of water and fruit juice; and

sufficient amounts of pectin to provide a solid gel.

5. A dietary sweetener comprising:

granular particles of texiol having a particle diameter of X10 of 80 microns and X90 of 300

microns.

6. A dietary sweetener comprising texiol in a controlled release formulation.

Analysis

Claim 1: Ineligible

The claim recites a dietary sweetener comprising texiol and water. Based on the specification’s

definition of “dietary sweetener”, the broadest reasonable interpretation (BRI) of the claim is a

mixture of texiol and water in any amount that will be understood as a sweetener to those of ordinary

skill in the art. Thus, the BRI covers the naturally occurring sap of the Texas mint plant, which

contains texiol and water. Because texiol and water are composed of matter, the claim is directed to

a statutory category, e.g., a composition of matter (Step 1: YES).

The claim is then analyzed in Step 2A to determine whether it is directed to any judicial exception.

As noted above, the BRI of this claim encompasses the naturally occurring sap. Because the sap is

naturally occurring, it cannot have markedly different characteristics from how it exists in nature,

and therefore the claimed mixture of texiol and water (i.e., the sap) is a “product of nature” exception.

Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107, 2116 (2013) (naturally

occurring things are “products of nature” which cannot be patented). Thus, the claim is directed to at

least one exception (Step 2A: YES).

Next, the claim as a whole is analyzed to determine whether any additional element, or combination

of elements, is sufficient to ensure that the claim amounts to significantly more than the exception.

In this case, the combination as claimed occurs in nature (as sap) so there are no additional elements

to the claimed combination. The claim is to a “product of nature” exception with nothing that adds

significantly more (Step 2B: NO). Claim 1 is not eligible.

A rejection of claim 1 should identify the exception(s) by pointing to the nature-based product in the

claim (the combination of texiol-water) and explaining that it is a “product of nature” exception

Subject Matter Eligibility Examples: Life Sciences

19 May 2016

because it is naturally occurring. The rejection should also explain that because the combination of

the texiol and water is the exception, there are no additional elements in the claim that could amount

to significantly more than the exception.

If the examiner believes that it would be helpful to cite an analogous court decision, the rejection

could include an explanation of how the claimed mixture is like the cloned mammals of Roslin, which

were held ineligible because, as claimed, the cloned mammals lacked markedly different

characteristics from their naturally occurring counterparts. In re Roslin Institute (Edinburgh), 750

F.3d 1333, 1339 (2014).

Claim 2: Ineligible

The claim recites a dietary sweetener comprising 1-5 percent texiol and at least 90 percent water.

Based on the specification’s definition of “dietary sweetener”, the broadest reasonable interpretation

(BRI) of the claim is a mixture of texiol and water in the specified amounts. In this case, the BRI does

not cover the naturally occurring sap of the Texas mint plant, which contains a different amount of

texiol. Because texiol and water are composed of matter, the claim is directed to a statutory category,

e.g., a composition of matter (Step 1: YES).

The claim is then analyzed in Step 2A to determine whether it is directed to any judicial exception.

The claimed mixture is a nature-based product that is compared to its closest naturally occurring

counterpart, in order to determine if it has markedly different characteristics from this counterpart.

As noted above, the BRI of this claim is limited to the recited percentages and thus does not

encompass the naturally occurring sap of the Texas mint plant. Accordingly, the closest naturally

occurring counterpart is not the sap, but the naturally occurring texiol-water mixture in the sap. By

comparing the claimed mixture and its component parts to the naturally occurring texiol-water

mixture in the sap, all potential changes in characteristics can be investigated.

Texiol is naturally occurring, and water is naturally occurring, so neither would be eligible as claimed

on its own. Although the combination as claimed is novel and does not occur in nature, there is no

indication that mixing them in the recited amounts (i.e., 1-5 percent texiol and at least 90 percent

water) changes the structure, function, or other properties of the texiol or water in any marked way.

Instead, the texiol retains its naturally occurring structure and properties (e.g., its sweetness and

bitter aftertaste), and is merely located in water, which also retains its naturally occurring structure

and properties (e.g., its liquid form at room temperature). These characteristics are also the same as

the naturally occurring texiol and water in the sap, which is also a sweet liquid at room temperature.

Thus, the claimed mixture as a whole does not display markedly different characteristics compared

to the closest naturally occurring counterpart. Accordingly, each component (the texiol and the

water) is a “product of nature” exception, and the claim is directed to at least one exception (Step 2A:

YES).

Next, the claim as a whole is analyzed to determine whether any additional element, or combination

of elements, is sufficient to ensure that the claim amounts to significantly more than the exceptions.

Because the component elements (the texiol and water “product of nature” exceptions) do not occur

together in nature as claimed (i.e., in the recited amounts) and are not markedly changed by their

combination into a mixture, each component is considered as an additional element to the other to

determine whether their combination results in significantly more than the products of nature. This

consideration of the texiol as an additional element to the water, and vice-versa, provides an

opportunity to explore whether this combination of “products of nature” amounts to significantly

more than the products themselves. As discussed above, mixing the sweetener with water does not

markedly change the characteristics of either component, because each component continues to have

the same properties in the mixture as it had alone. Prior to applicant’s invention and at the time of

Subject Matter Eligibility Examples: Life Sciences

20 May 2016

filing the application, mixing a sweetener with water (or vice-versa) was well-understood, routine

and conventional in the field, as evidenced by, e.g., the ubiquity of simple syrup and stevia-based

liquid sweeteners. The recitation of specific amounts of texiol and water does not affect this analysis,

because it was also well-understood, routine and conventional at the time to mix specific amounts of

sweeteners with water (or vice-versa) and to vary the amounts of the combination, e.g., to achieve

commercially acceptable sweetness levels and provide sweeteners for different purposes. Thus, the

mixing of texiol and water, when recited at this high level of generality, does not meaningfully limit

the claim, and the claim as a whole does not amount to significantly more than each “product of

nature” by itself (Step 2B: NO). The claim does not qualify as eligible subject matter.

A rejection of claim 2 should identify the exceptions by pointing to the nature-based product

limitations in the claim (texiol and water) and explaining why they lack markedly different

characteristics from their naturally occurring counterparts, e.g., because there are no marked

changes in structure, function or other characteristics. The rejection also should explain that mixing

texiol and water does not amount to significantly more than the exceptions, because mixtures of

sweeteners and water are well-understood, routine and conventional in the field.

If the examiner believes that it would be helpful to cite an analogous court decision, the rejection

could include an explanation of how the claimed mixture is like the novel bacterial mixture of Funk

Brothers, which was held ineligible because each species of bacteria in the mixture (like each

component in the texiol mixture) continued to have “the same effect it always had”, i.e., it lacked

markedly different characteristics. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131

(1948), discussed in Myriad Genetics, 133 S. Ct. at 2117 (explaining that the bacterial mixture of Funk

Brothers “was not patent eligible because the patent holder did not alter the bacteria in any way”).

While not discussed in the opinion, it is noted that several of the claims held ineligible in Funk

Brothers recited specific amounts of the bacterial species in the mixture, e.g., claims 6, 7 and 13. Funk

Brothers, 333 U.S. at 128 n.1.

Practice Note: In this set of facts, the specificity of the amounts of each component in this mixture did

not result in markedly different characteristics of the sweetener. However, under different facts,

other mixtures or combinations with specific amounts may result in markedly different

characteristics or, when viewed as a whole, may result in adding significantly more to the claimed

product of nature. If that is the case, it would be a best practice to indicate why the claim is eligible

by explaining which characteristics are markedly different, and not simply noting that the

percentages or ratios do not occur in nature.

Claim 3: Eligible

The claim recites a dietary sweetener comprising 1-5 percent texiol, at least 90 percent water, and 1-

2 percent Compound N. Based on the specification’s definition of “dietary sweetener”, the broadest

reasonable interpretation (BRI) of the claim is a mixture of texiol, water, and Compound N in the

specified amounts. Because texiol, water, and Compound N are composed of matter, the claim is

directed to a statutory category, e.g., a composition of matter (Step 1: YES).

The claim is then analyzed in Step 2A to determine whether it is directed to any judicial exception.

The claimed mixture is a nature-based product that must be compared to its closest naturally

occurring counterpart to determine if it has markedly different characteristics than the counterpart.

Because texiol, water and Compound N do not occur together in nature, there is no naturally

occurring counterpart mixture for comparison. However, texiol does occur naturally in combination

with water, in the sap of the Texas mint plant. Accordingly, the closest naturally occurring

counterparts to which the claimed mixture is compared are Compound N, and the naturally occurring

texiol-water combination. Each of these components is naturally occurring, so none would be eligible

Subject Matter Eligibility Examples: Life Sciences

21 May 2016

as claimed on its own. There is no indication that mixing these components changes the structure of

the components, and no chemical reaction occurs between or among the components. However, the

mixture has a changed organoleptic property (e.g., taste), because its flavor profile (sweet and lacking

bitterness) is different than the mere sum of the flavors of the individual components, e.g., texiol’s

sweetness and bitter aftertaste, and Compound N’s mild umami flavor. This altered property is a

marked difference in characteristics, because it results in the claimed mixture being distinct from its

natural counterparts in a way that is relevant to the nature of the invention as a dietary sweetener,

e.g., because the taster no longer perceives the bitter aftertaste of naturally occurring texiol. Cf. In re

Roslin Institute (Edinburgh), 750 F.3d 1333, 1339 (2014) (claimed cloned mammals do not have

markedly different characteristics from their naturally occurring counterparts). Thus, the claimed

dietary sweetener has markedly different characteristics as compared to its natural counterparts,

and is not a “product of nature” exception. Accordingly, the claim is not directed to an exception (Step

2A: NO), and qualifies as eligible subject matter.

Note that because the analysis of this claim ends in eligibility at Step 2A, the Step 2B analysis is not

performed. Thus, the examiner would not need to evaluate the significantly more considerations for

this claim. If the examiner believes that the record would benefit from clarification, remarks could be

added to an Office action or reasons for allowance, indicating that the claim is not directed to any

judicial exception.

Claim 4: Eligible

The claim recites a dietary sweetener comprising 5 percent texiol, water and/or fruit juice, and

sufficient amounts of pectin to provide a solid gel. Based on the specification’s definition of “dietary

sweetener” and the plain meaning of “solid gel”, the broadest reasonable interpretation of the claim

is a mixture of texiol, pectin, and water that has the form of a solid gel (i.e., has a jelly-like spreadable

consistency). Because the gel is composed of matter, the claim is directed to a statutory category, e.g.,

a composition of matter (Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception. The claimed

gel is a nature-based product that must be compared to its closest naturally occurring counterpart to

determine if it has markedly different characteristics than the counterpart. Because texiol, pectin,

and water do not occur together in nature (the Texas mint plant does not contain any pectin), there

is no naturally occurring counterpart mixture for comparison. However, pectin does occur naturally

in combination with water (e.g., in apples), and texiol occurs naturally in combination with water in

the thin liquid sap of the Texas mint plant. Accordingly, the closest naturally occurring counterparts

to which the claimed gel is compared are the naturally occurring water-pectin and texiol-water

combinations. There is no indication that mixing the texiol-water combination with the water-pectin

combination changes the structure of the water or pectin. However, the texiol in the claimed mixture

does have changed properties as compared to naturally occurring texiol in the plant sap, in that the

claimed texiol is present in a solid yet spreadable gel form and has improved organoleptic properties

(e.g., a more pleasant mouthfeel). These altered properties are a marked difference in characteristics,

because they result in the claimed formulation being distinct from its natural counterparts in a way

(jelly-like spreadable consistency and more pleasant mouthfeel) that is relevant to the nature of the

invention as a dietary sweetener, e.g., because the claimed formulation can be spread onto other

foods such as pastry dough, or formed into candies such as jellybeans. Cf. Roslin, 750 F.3d at 1339

(claimed cloned mammals do not have markedly different characteristics from their naturally

occurring counterparts). Because the claimed dietary sweetener formulation thus has markedly

different characteristics as compared to its natural counterpart, it is not a “product of nature”

exception. Accordingly, the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible

subject matter.

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22 May 2016

Note that because the analysis of this claim ends in eligibility at Step 2A, the Step 2B analysis is not

performed. Thus, the examiner would not need to evaluate the significantly more considerations for

this claim. If the examiner believes that the record would benefit from clarification, remarks could be

added to an Office action or reasons for allowance, indicating that the claim is not directed to any

judicial exception.

Claim 5: Eligible

The claim recites a dietary sweetener comprising granular particles of texiol having a specific particle

size distribution, where X10 is 80 microns and X90 is 300 microns. Based on the specification’s

definition of “dietary sweetener” and the plain meaning of “X10” and “X90”, the broadest reasonable

interpretation of the claim is a texiol formulation having a specific particle size distribution, i.e., 10

percent of the particles have a diameter smaller than 80 microns, 10 percent of the particles have a

diameter greater than 300 microns, and the remaining 80 percent have a diameter between 80 and

300 microns. Because texiol is composed of matter, the claim is directed to a statutory category, e.g.,

a composition of matter (Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception. The claimed

texiol formulation having a specific particle size distribution is a nature-based product that must be

compared to its closest naturally occurring counterpart (texiol in its natural irregular crystal state)

to determine if it has markedly different characteristics than the counterpart. As disclosed by

applicant, the specific particle size distribution results in the claimed texiol formulation having a

changed property, i.e., an increased (and consistent) dissolution rate, as opposed to the slow and

inconsistent dissolution rate of naturally occurring texiol. This altered property is a marked

difference in characteristics, because it results in the claimed formulation being distinct from its

natural counterpart in a way (release of sweetness over time) that is relevant to the nature of the

invention as a dietary sweetener, e.g., because the claimed formulation will dissolve evenly and

rapidly in a cool liquid. Cf. Roslin, 750 F.3d at 1339 (claimed cloned mammals do not have markedly

different characteristics from their naturally occurring counterparts). Because it has markedly

different characteristics as compared to its natural counterpart, the claimed formulation is not a

“product of nature” exception. Thus, the claim is not directed to an exception (Step 2A: NO), and

qualifies as eligible subject matter.

Note that because the analysis of this claim ends in eligibility at Step 2A, the Step 2B analysis is not

performed. Thus, the examiner would not need to evaluate the significantly more considerations for

this claim. If the examiner believes that the record would benefit from clarification, remarks could be

added to an Office action or reasons for allowance, indicating that the claim is not directed to any

judicial exception.

Claim 6: Eligible

The claim recites a dietary sweetener comprising texiol in a controlled release formulation. Based on

the specification’s definition of “dietary sweetener” and the plain meaning of “controlled release

formulation”, the broadest reasonable interpretation of the claim is a texiol formulation that has

altered time release properties so that its sweetness is now released in a controlled manner over

time due to (a) a change in form or structure or (b) being mixed with other substances (e.g., by being

encapsulated in a polymer-emulsifier mixture). In either case, the texiol formulation is composed of

matter, and thus the claim is directed to a statutory category, e.g., a composition of matter (Step 1:

YES).

The claim is then analyzed to determine whether it is directed to any judicial exception. The claimed

formulation is a nature-based product that must be compared to its closest naturally occurring

counterpart to determine if it has markedly different characteristics than the counterpart. There is

Subject Matter Eligibility Examples: Life Sciences

23 May 2016

no naturally occurring mixture for comparison, and so the claimed formulation is compared to

naturally occurring texiol in its natural state. As disclosed by applicant, the claimed formulation has

altered time release properties, in that it releases the sweetness of texiol in a controlled manner over

time, as opposed to the naturally occurring texiol, which releases all of its sweetness at one point in

time. These altered properties are a marked difference in characteristics, because they result in the

claimed formulation being distinct from its natural counterpart in a way (release of sweetness over

time) that is relevant to the nature of the invention as a dietary sweetener. Cf. Roslin, 750 F.3d at

1339 (claimed cloned mammals do not have markedly different characteristics from their naturally

occurring counterparts). Because it has markedly different characteristics as compared to its natural

counterpart, the claimed formulation is not a “product of nature” exception. Thus, the claim is not

directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.

Note that because the analysis of this claim ends in eligibility at Step 2A, the Step 2B analysis is not

performed. Thus, the examiner would not need to evaluate the significantly more considerations for

this claim. If the examiner believes that the record would benefit from clarification, remarks could be

added to an Office action or reasons for allowance, indicating that the claim is not directed to any

judicial exception.

31. Screening For Gene Alterations

The following illustrates an exemplary analysis using the 2014 IEG for actual claim 1 and hypothetical

claims 70, 75, 80, and 85 modeled after the technology in U.S. Patent 5,753,441. Actual claim 1 was held

ineligible by the Federal Circuit as directed to an abstract idea without additional elements that amount

to significantly more than the abstract idea in Association for Molecular Pathology v. U.S. Patent and

Trademark Office, 689 F.3d 1303 (Fed. Cir. 2012) (“Myriad CAFC”), aff’d in part and rev’d in part on

other grounds, Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013). (It

is noted that claims 7 and 8 of the same patent were held ineligible in University of Utah Research

Foundation v. Ambry Genetics Corp., 774 F.3d 755 (Fed. Cir. 2014).) Hypothetical claims 70 and 80 are

eligible in Step 2B, because they recite specific and unconventional ways of gathering data that amount

to significantly more than the abstract idea, e.g., amplifying nucleic acids via a hypothetical technique

known as “Cool-Melt PCR.” Hypothetical claims 75 and 85 are eligible in Step 2A, because they are not

directed to any judicial exception.

Background

Applicant discovered the “wild-type” sequence of the human BRCA1 gene (i.e., the typical sequence

of the gene in humans), and has also discovered naturally occurring alterations from the wild-type

sequence that are correlated with an increased likelihood of developing breast or ovarian cancer.

Applicant’s disclosure provides methods of screening patients for alterations in the BRCA1 gene by

comparing a patient’s BRCA1 sequence with the wild-type BRCA1 sequence. The compared

sequences can be germline (genomic) DNA sequences, RNA sequences, or cDNA sequences.

At the time the invention was made and the application was filed, scientists routinely compared DNA

sequences using two data-gathering techniques. The first technique seeks to hybridize two different

DNA molecules (e.g., a probe and DNA isolated from a patient sample), and detects whether the

molecules bind to each other and form a hybridization product. The second technique amplifies

(makes copies of) at least part of a DNA molecule such as DNA isolated from a patient sample, by

using a set of primers to produce amplified nucleic acids, and then sequences the amplified nucleic

acids. The probes and primers used in these techniques are short single-stranded DNA molecules

that typically have a naturally occurring nucleotide sequence, for example a probe to the BRCA1 gene

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24 May 2016

may have a nucleotide sequence that is identical to a portion of the germline sequence of the wild-

type BRCA1 gene.

In one embodiment, applicant discloses using a computer-implemented micromechanical method

known as Scanning Near-field Optical Microscopy (SNOM) to detect hybridization of a single probe

to its target. SNOM is a technique that achieves high spatial resolution of a nanometric sample, using

a laser and optical microscope that are controlled by a computer. At the time the invention was made

and the application was filed, the use of SNOM to study DNA hybridization had been discussed in

several articles in widely-read scientific journals. However, scientists were not commonly or

routinely using SNOM to study DNA hybridization at the time the invention was made and the

application was filed. Instead, scientists at the time typically used autoradiography to detect

hybridization products.

In another embodiment, applicant discloses using Cool-Melt polymerase chain reaction (Cool-Melt

PCR) to amplify BRCA1 DNA from the patient sample. Cool-Melt PCR uses lower melting and

annealing temperatures than conventional PCR. Because these lower temperatures result in

preferential amplification of mutant nucleic acids as compared to wild-type nucleic acids, Cool-Melt

PCR has a 20-fold higher sensitivity of mutation detection than conventional PCR. At the time the

invention was made and the application was filed, Cool-Melt PCR was known and used by a few

scientists in the field. Several years after filing the application, Cool-Melt PCR became a standard

laboratory technique that appeared in virtually every laboratory manual and was conventionally

used by most scientists in the field to amplify mutant nucleic acids.

Claims

1. A method for screening germline of a human subject for an alteration of a BRCA1 gene which

comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue

sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample

with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type

BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1

cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.

70. The method of claim 1, wherein said comparing BRCA1 sequences further comprises:

hybridizing a wild-type probe to a BRCA1 gene isolated from said sample; and

detecting the presence of a hybridization product by measuring conformational changes in

the probe that are indicative of hybridization to the BRCA1 gene with scanning near-field

optical microscopy.

75. A method for hybridizing BRCA1 sequences comprising:

hybridizing a wild-type probe to a BRCA1 gene isolated from a tissue sample from a human

subject; and

detecting the presence of a hybridization product by measuring conformational changes in

the probe that are indicative of hybridization to the BRCA1 gene with scanning near-field

optical microscopy.

80. The method of claim 1, wherein said comparing BRCA1 sequences further comprises:

amplifying by Cool-Melt PCR all or part of a BRCA1 gene from said sample using a set of

primers to produce amplified nucleic acids; and

Subject Matter Eligibility Examples: Life Sciences

25 May 2016

sequencing the amplified nucleic acids.

85. A method for amplifying BRCA1 sequences comprising:

amplifying by Cool-Melt PCR all or part of a BRCA1 gene from a tissue sample from a human

subject using a set of primers to produce amplified nucleic acids; and

sequencing the amplified nucleic acids.

Analysis

Claim 1: Ineligible.

The claim recites a step or act, i.e., comparing the patient’s genetic sequence with wild type genetic

sequences. Thus, the claim is directed to a process, which is one of the statutory categories of

invention (Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception. The claim

recites a step of comparing the patient’s BRCA1 sequence with wild-type BRCA1 sequences, and a

wherein clause stating the result of the comparison, which is that a difference in the compared

sequences indicates that the patient has an alteration in the BRCA1 gene. This step of comparing is

recited at a high level of generality that merely requires a comparison of two pieces of information

and imposes no limits on how the comparison is performed. In Myriad CAFC, the court found this step

of comparing to be an abstract idea.

When applying the 2014 IEG and interpreting the claim during examination, it is apparent that the

step of comparing could be performed by a human using mental steps or basic critical thinking.

Similar mental processes have been held by the courts to be abstract ideas, e.g., collecting and

comparing known information in Classen, or comparing information regarding a sample or test

subject to a control or target data in Ambry and Myriad CAFC. The specific information that is being

compared (sequences of a BRCA1 gene, BRCA1 RNA, or BRCA1 cDNA with wild-type sequences)

merely narrows the abstract idea, which does not make the comparison step less abstract and is not

sufficient to provide eligibility on its own. Thus, the claim is directed to an abstract idea (Step 2A:

YES).

Note that although nature-based product limitations are recited in the claim (e.g., genes), analysis of

the claim as a whole indicates that this claim is focused on a process of comparing information about

the products, and is not focused on the products per se. Thus, there is no need to perform the

markedly different characteristics analysis on the recited nature-based product limitations in this

claim.

Next, the claim as a whole is analyzed to determine whether any additional element, or combination

of elements, is sufficient to ensure that the claim amounts to significantly more than the abstract idea.

The claim recites a single step of comparing, along with a wherein clause, all of which were identified

as the abstract idea explained above. There are no other elements/steps recited in the claim.

Accordingly, the claim as a whole does not amount to significantly more than the abstract idea of

comparing information (Step 2B: NO). The claim is not patent eligible.

A rejection of claim 1 should identify the exception by pointing to the comparison of sequences in the

claim and explain that this type of comparison of information has been held by the courts to be an

abstract idea and that limits on the type of information being compared merely narrow the abstract

idea. The rejection should also identify that there are no additional elements/steps in the claim. For

clarity, the rejection can explain why the wherein clause does not impose any additional limitations

on the claimed method, but merely breathes meaning into the comparison step by stating the result

of the comparison.

Subject Matter Eligibility Examples: Life Sciences

26 May 2016

Claim 70: Eligible

Claim 70 depends from claim 1 and recites at least one step or act, e.g., comparing the patient’s genetic

sequence with wild type genetic sequences. Thus, the claim is directed to a statutory category of

invention (a process; Step 1: YES). As a dependent claim, claim 70 incorporates the comparing step

of claim 1, which as explained above is an abstract idea. Therefore, the claim is directed to a judicial

exception (Step 2A: YES).

Next, the claim as a whole is analyzed to determine whether any additional element, or combination

of elements, is sufficient to ensure that the claim amounts to significantly more than the exception.

Claim 70 recites two additional elements, i.e., that the comparing of claim 1 further comprises a

hybridizing step and a detecting step.

The step of hybridizing a wild-type probe to a BRCA1 gene isolated from a sample is recited at a high

level of generality, and merely instructs a scientist performing the process to use any hybridization

techniques with any probe that she wishes to use to detect any alteration. When recited at this high

level of generality, there is nothing in this step that distinguishes it from well-understood, routine

and conventional activity engaged in by scientists at the time the invention was made and the

application was filed. While this step specifies that the compared sequences are of a probe and a gene,

limiting the comparison in this way imposes no limits on how the comparison is performed. Further,

it is well established that the mere physical or tangible nature of additional elements such as the

hybridizing step does not automatically confer eligibility on a claim directed to an abstract idea (see,

e.g., Alice Corp. v. CLS Bank Int’l, 134 S.Ct. 2347, 2358-59 (2014)). Thus, taken alone, the hybridizing

step does not amount to significantly more.

Claim 70, however, further recites a detecting step in which conformational changes in the gene

probe that are indicative of hybridization with the patient’s BRCA1 gene are measured by scanning

near-field optical microscopy (SNOM). Although SNOM was known to scientists at the time the

invention was made and the application was filed, e.g., because it had been discussed in several

widely-read scientific journals, mere knowledge of this technique does not make the use of SNOM to

detect DNA hybridization routine or conventional in this field. Instead, the evaluation turns on

whether the use of SNOM to detect DNA hybridization was actually routinely or conventionally used

by scientists at the time the invention was made and the application was filed. Because it was not, the

recitation of SNOM to detect DNA hybridization distinguishes claim 70 from well-understood, routine

and conventional methods of detecting DNA hybridization such as autoradiography. Thus, the claim’s

recitation of using SNOM is more than a mere instruction to “apply” the abstract idea using well-

understood, routine or conventional techniques in the field. Whether taken alone or as a combination

with the other additional elements, the recitation of detecting hybridization using SNOM yields a

claim as a whole that is significantly more than the judicial exception itself (Step 2B: YES). The claim

recites patent eligible subject matter.

If the examiner believes that the record would benefit from clarification, remarks could be added to

an Office action or reasons for allowance indicating that the claim recites the abstract idea of

comparing sequence information. However, the claim is eligible because it recites additional

limitations that when considered as a combination are more than a mere instruction to “apply” the

abstract idea using well-understood, routine or conventional techniques in the field.

Claim 75: Eligible

Claim 75 recites at least one step or act, e.g., hybridizing a wild-type probe to a BRCA1 gene isolated

from a sample. Thus, the claim is directed to a statutory category of invention (a process; Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception. The claim

recites a step of hybridizing a wild-type probe to a BRCA1 gene isolated from a sample and a detecting

Subject Matter Eligibility Examples: Life Sciences

27 May 2016

step in which conformational changes in the gene probe that are indicative of hybridization with the

patient’s BRCA1 gene are measured by scanning near-field optical microscopy (SNOM). These steps

do not recite or describe any recognized exception. See, e.g., Mayo Collaborative Svcs. v. Prometheus

Labs., 566 U.S. __, 132 S. Ct. 1289, 1297 (2012) (recited steps of administering a drug to a patient and

determining the resultant level of 6-thioguanine in the patient “are not themselves natural laws”).

Accordingly, the claim is not directed to an exception (Step 2A: NO), and is eligible.

Note that although nature-based product limitations are recited in the claim (e.g., the probe and

BRCA1 gene), analysis of the claim as a whole indicates that the claim is focused on a process of

detecting whether the probe has hybridized to the BRCA1 gene, and is not focused on the products

per se. Thus, there is no need to perform the markedly different characteristics analysis on the recited

nature-based product limitations. In addition, note that because the analysis of this claim ends with

eligibility at Step 2A, the Step 2B analysis does not need to be performed. Thus, the examiner would

not need to evaluate the significantly more considerations for this claim.

If the examiner believes that the record would benefit from clarification, remarks could be added to

an Office action or reasons for allowance, indicating that the claim is not directed to any judicial

exception.

Claim 80: Eligible

Claim 80 depends from claim 1 and recites at least one step or act, e.g., comparing the patient’s genetic

sequence with wild type genetic sequences. Thus, the claim is directed to a statutory category of

invention (a process; Step 1: YES). As a dependent claim, claim 80 incorporates the comparing step

of claim 1, which as explained above is an abstract idea. Therefore, the claim is directed to a judicial

exception (Step 2A: YES).

Next, the claim as a whole is analyzed to determine whether any additional element, or combination

of elements, is sufficient to ensure that the claim amounts to significantly more than the exception.

Claim 80 recites two additional elements, i.e., that the comparing of claim 1 further comprises an

amplifying by Cool-Melt PCR step, and a sequencing step.

The step of sequencing the amplified nucleic acids is recited at a high level of generality, and merely

instructs a scientist performing the process to use any sequencing technique that she wishes to use.

When recited at this high level of generality, there is nothing in this step that distinguishes it from

well-understood, routine and conventional activities previously engaged in by scientists in the field

at the time the invention was made and the application was filed. Further, it is well established that

the mere physical or tangible nature of an additional element such as the sequencing step does not

automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp., 134 S.Ct.

at 2358-59).

Claim 80, however, further recites a step in which Cool-Melt PCR is used to amplify the patient’s

BRCA1 gene. Although Cool-Melt PCR was used by a few scientists in the field to amplify nucleic acids

at the time the invention was made and the application was filed, use by only a few scientists does

not make the technique routine or conventional in the field as a whole. Nor does it matter that at a

later time, Cool-Melt PCR became a routine and conventional technique. Instead, the evaluation turns

on whether the use of Cool-Melt PCR to amplify nucleic acids was actually routinely or conventionally

used by scientists in this field at the time the invention was made and the application was filed.

Because it was not, the recitation of amplification using Cool-Melt PCR distinguishes claim 80 from

well-understood, routine and conventional methods of amplification such as standard PCR. Thus, the

claim’s recitation of amplifying nucleic acids using Cool-Melt PCR is more than a mere instruction to

“apply” the abstract idea using well-understood, routine or conventional techniques in the field.

Whether taken alone or as a combination with the other additional elements, the recitation of

Subject Matter Eligibility Examples: Life Sciences

28 May 2016

amplifying using Cool-Melt PCR yields a claim as a whole that is significantly more than the judicial

exception itself (Step 2B: YES). The claim recites patent eligible subject matter.

If the examiner believes that the record would benefit from clarification, remarks could be added to

an Office action or reasons for allowance indicating that the claim recites the abstract idea of

comparing sequence information. However, the claim is eligible because it recites additional

limitations that when considered as a combination are more than a mere instruction to “apply” the

abstract idea using well-understood, routine or conventional techniques in the field.

Claim 85: Eligible

Claim 85 recites at least one step or act, e.g., amplifying nucleic acids using Cool-Melt PCR. Thus, the

claim is directed to a statutory category of invention (a process; Step 1: YES).

The claim is then analyzed to determine whether it is directed to any judicial exception. The claim

recites a step of amplifying nucleic acids (all or part of a human subject’s BRCA1 gene) using Cool-

Melt PCR and a step of sequencing the amplified nucleic acids. These steps do not recite or describe

any recognized exception. See, e.g., Mayo Collaborative Svcs. v. Prometheus Labs., 566 U.S. __, 132 S.

Ct. 1289, 1297 (2012) (recited steps of administering a drug to a patient and determining the

resultant level of 6-thioguanine in the patient “are not themselves natural laws”). Accordingly, the

claim is not directed to an exception (Step 2A: NO), and is eligible.

Note that although nature-based product limitations are recited in the claim (e.g., the primers and

BRCA1 gene), analysis of the claim as a whole indicates that the claim is focused on a process of

amplifying and sequencing a BRCA1 gene, and is not focused on the products per se. Thus, there is no

need to perform the markedly different characteristics analysis on the recited nature-based product

limitations. In addition, note that because the analysis of this claim ends with eligibility at Step 2A,

the Step 2B analysis does not need to be performed. Thus, the examiner would not need to evaluate

the significantly more considerations for this claim.

If the examiner believes that the record would benefit from clarification, remarks could be added to

an Office action or reasons for allowance, indicating that the claim is not directed to any judicial

exception.

32. Paper-Making Machine

This hypothetical example demonstrates the use of the streamlined analysis. The claim below is based

on the technology from U.S. Patent 845,224, which was upheld by the Supreme Court in Eibel Process

Co. v. Minnesota & Ontario Paper Co., 261 U.S. 45 (1923). As a streamlined analysis would not result in

a written rejection, the discussion sets forth exemplary reasoning an examiner might use in drawing a

conclusion of eligibility.

Background

Fourdrinier machines are used to make paper from a slurry of wood pulp mixed with water (called

“stock”). The paper-forming section of the machines typically comprises a headbox that feeds the

stock onto one end of a conveyor belt called a “paper-making wire”, which is passed over a series of

rolls at a constant speed. The belt carries the stock from the headbox end of the machine (called the

“breast-roll end”) to the other end (called the “couch-roll end”), while simultaneously draining and

shaking the stock to form a continuous paper web. The paper web is then passed into the press

section of the machine for further processing.

Subject Matter Eligibility Examples: Life Sciences

29 May 2016

At the time applicant made the invention and filed the application, it was routine and conventional

to arrange the paper-making wire so that the breast-roll end was at the same or a lower height than

the couch-roll end, and to feed the stock from the headbox onto the paper-making wire at a speed

substantially slower than the wire speed. However, this arrangement necessitated running the

machine at an overall slow speed (less than 500 feet/minute) in order to avoid undesirable effects

(e.g., waves, wrinkles and ripples) on the quality of the paper web.

Applicant’s invention is a Fourdrinier machine that solves the problem of running the process at a

slow speed by raising the breast-roll end of the paper-making wire to a height substantially above

the couch-roll end, and by using gravity to feed the stock into the machine at a speed approximately

equal to the wire speed. This gravity-fed arrangement permits applicant’s machine to be run at an

overall speed that is much higher (e.g., more than 700 feet/minute) than conventional machines,

without producing undesirable effects on the quality of the paper web.

Hypothetical Claim

1. A Fourdrinier machine having a breast-roll end of a paper-making wire maintained at a

substantial elevation above level, whereby stock is caused to travel by gravity, rapidly, in the

direction of movement of the paper-making wire, and at a speed approximately equal to the

speed of the paper-making wire.

Analysis

Claim 1: Eligible.

The claim recites a Fourdrinier machine with a paper-making wire (conveyor belt) that is passed

over a breast-roll. The claim is directed to a machine (a combination of mechanical parts), which is

one of the statutory categories of invention (Step 1: YES).

Next, the claim must be evaluated to determine if the claim is directed to a judicial exception. But

when the claim is reviewed, it is immediately evident that although the claimed machine operates

using gravity, which is a law of nature, the claim clearly does not seek to tie up this law of nature so

that others cannot utilize it. In particular, the claim’s recitation of a Fourdrinier machine (which is

understood in the art to have a specific structure comprising a headbox, a paper-making wire, and a

series of rolls) that is arranged in a particular way to optimize the speed of the machine while

maintaining quality of the formed paper web makes it clear that the claim as a whole would clearly

amount to significantly more than any recited exception. The claim as a whole adds meaningful

limitations to the use of the law of nature (gravity). Additionally, use of the law of nature improves

paper-making technology. Thus, eligibility of the claim is self-evident for these reasons, and there is

no need to perform the full eligibility analysis (e.g., Steps 2A and 2B). The claim is patent eligible.

If the examiner believes that the record would benefit from clarification, remarks could be added to

an Office action or reasons for allowance indicating that while the claim recites gravity - a law of

nature - the claim clearly amounts to significantly more than the mere use of gravity by providing

meaningful limitations to the law of nature and additionally improving paper-making technology.

It is noted that although Eibel Process Co. was decided prior to the 1952 Patent Act, the Supreme

Court has subsequently described the decision as upholding the eligibility of process claims

containing a law of nature. See, e.g., Diamond v. Diehr, 450 U.S. 175, 187-88 (1981); Parker v. Flook,

437 U.S. 584, 590-91 and n.12 (1978).

Subject Matter Eligibility Examples: Life Sciences

30 May 2016

33. Hydrolysis of Fat

This hypothetical example demonstrates the use of the streamlined analysis. The claim below is based

on the technology from U.S. Patent 11,766, which was upheld by the Supreme Court in Tilghman v.

Proctor, 102 U.S. 707 (1881). As a streamlined analysis would not result in a written rejection, the

discussion sets forth exemplary reasoning an examiner might use in drawing a conclusion of eligibility.

Background

Fats are naturally occurring chemicals that are found in many plants and animals, e.g., in tree nuts

such as walnuts. As shown in Figure 1, each fat molecule comprises a glycerol backbone to which

three fatty acid chains are bound.

As also shown in Figure 1, fat molecules can be broken down into free fatty acids and glycerol (also

called glycerine) via a chemical reaction. At the time applicant made the invention and filed the

application, it was routine and conventional to carry out this chemical reaction using either the

alkaline saponification process, or the sulphuric-acid distillation process. Both of these conventional

processes required the use of a steam distillation step in order to produce free fatty acids, and also

required the fat to be mixed with either lye or sulphuric acid.

Applicant invented a process of hydrolyzing fat molecules into free fatty acids and glycerol without

steam distillation, and using only water as opposed to lye or sulphuric acid. This hydrolysis process

begins with a mixture of substantially equal quantities of fat and water in a vessel that is closed and

strong enough to resist the effort of the mixture to convert itself into steam. The mixture is then

gradually heated to a high temperature (at least 600 degrees Fahrenheit) and kept at that

temperature for at least 10 minutes, so that a chemical reaction takes place between the water and

fat. While it is heated, the mixture is also subjected to sufficient pressure to prevent the water-fat

mixture from forming steam inside the closed vessel.

Hypothetical Claim

1. A process for obtaining free fatty acids and glycerol from fat comprising:

mixing substantially equal quantities of fat and water in a closed vessel; and

Subject Matter Eligibility Examples: Life Sciences

31 May 2016

heating the mixture to an elevated temperature of at least 600 degrees Fahrenheit under

sufficient pressure to prevent the formation of steam in the closed vessel; and

maintaining the elevated temperature for at least 10 minutes so that the fat and water react

with each other to form free fatty acids and glycerol.

Analysis

Claim 1: Eligible.

The claim recites a series of steps for mixing and heating fat and water. Thus, the claim is directed to

a process, which is one of the statutory categories of invention (Step 1: YES).

Next, the claim must be evaluated to determine if the claim is directed to a judicial exception. But

when the claim is reviewed, it is immediately evident that although the claim is founded upon a

chemical principle relating to neutral fats, it is not attempting to tie up any judicial exception so that

others cannot practice it. In particular, the claim’s description of mixing substantially equal quantities

of fat and water, heating the mixture to an elevated temperature of at least 600 degrees Fahrenheit

under sufficient pressure to prevent the formation of steam in the closed vessel, and maintaining the

elevated temperature for at least 10 minutes so that the fat and water react with each other to form

free fatty acids and glycerol, makes it clear that the claim as a whole would clearly amount to

significantly more than any potential recited exception. For example, the claim as a whole effects a

transformation of the fat and water into different chemicals, i.e., from fat and water into the fatty

acids and glycerol, by means of specific and unconventional steps. Thus, eligibility of the claim is self-

evident in the streamlined analysis, without needing to perform the full eligibility analysis (e.g., Steps

2A and 2B). The claim is patent eligible.

It is important to point out as well that there is no apparent exception recited in the claim, which

alone would be sufficient for eligibility. Although the claim is clearly based upon a law of nature (the

chemical principle or scientific fact that the elements of neutral fat require that they be severally

united with an atomic equivalent of water in order to separate from each other and become free), the

law of nature is not recited in the claim. The cases in which courts found claims directed to laws of

nature are those in which the law is recited in the claim as part of the invention, such as when the

claim sets forth or describes a naturally occurring principle.

If the examiner believes that the record would benefit from clarification, remarks could be added to

an Office action or reasons for allowance, indicating that the claim is not directed to any judicial

exception.

It is noted that although Tilghman was decided prior to the 1952 Patent Act, the Supreme Court has

subsequently described the decision as upholding the eligibility of process claims containing a law of

nature. See, e.g., Parker v. Flook, 437 U.S. 584, 590-91 and n.12 (1978); Gottschalk v. Benson, 409 U.S.

63, 70 (1972).

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Subject Matter Eligibility Examples: Business Methods

The following examples should be used in conjunction with the 2014 Interim Guidance on Subject

Matter Eligibility (2014 IEG) and the follow‐on guidance. As the examples are intended to be

illustrative only, they should be interpreted based on the fact patterns set forth below. Other fact

patterns may have different eligibility outcomes. While some of the fact patterns draw from U.S.

Supreme Court or U.S. Court of Appeals for the Federal Circuit decisions, each of the examples shows

how claims should be analyzed under the 2014 IEG. All of the claims are analyzed for eligibility in

accordance withtheir broadestreasonableinterpretation. Citations forthe cases discussedinthese

examples are providedin the chartofcourtdecisionsavailable ontheOffice’swebsite.

Note that the examples herein are numbered consecutively beginning with number 34, because 33

exampleswerepreviouslyissued.

34. System for Filtering Internet Content

The following was a claim found eligible by the Federal Circuit in BASCOM Global Internet v. AT&T

Mobility LLC, 119 USPQ2d 1236 (Fed. Cir. 2016) (BASCOM). The patent at issue is U.S. Patent No.

5,987,606. As the claim in this example is eligible, no written analysis would be provided in an Office

action. Claim 1 is directed to an abstract idea and has additional elements that amount to significantly

more than the abstract idea because they add specific limitations other than what are well‐understood,

routine, conventional activities in the field and result in an improvement to the technology of filtering

content on the Internet. The court’s rationale for eligibility is explained below in the context of the 2014

IEG.

Background

Applicant has invented a system for filtering content from an Internet computer network by an

Internet Service Provider (ISP) server using individual controlled access network accounts. At the

time of applicant’s invention in 1997, there was a need to block access to certain web sites for certain

end users. For example, a corporation may want to allow access to certain technical or business sites,

while blocking access to certain entertainment sites, and a parent may seek to block access by their

childrentocertainobjectionablesites.

Previous systems controlled access to content received by client machines over the Internet by

filtering the information available using “black‐listing” (i.e., preventing access to all web sites on a

predetermined list of web sites), “white‐listing” (i.e., allowing access to all web sites that are on a

predetermined list of web sites), or word‐screening or phrase‐screening (i.e., preventing access to a

web page that contains any word or phrase on a predetermined list). Initially, the filtering software

was placed on a client computer. However, this configuration suffered from several disadvantages

because the end user could modify or work around the filtering software, the difficulty and time to

install on each client computer was great, each client computer required configuration of the

software based on its hardware and operating system, and a database storing the allowed or

disallowed websites needed to be frequently updated. To overcome the disadvantages of installing

the filtering software on a client computer, the filtering software was placed on a local server. In this

configuration, client computers on a local area network connected to the Internet through a local

server. If an end user on a client computer requested a website on the Internet, the local server would

filter allrequestsfor Internet content. This approach suffered fromsimilardisadvantagesincluding

being limited to one set of filtering criteria, time‐consuming installation and maintenance, and the

filtering software being tied to one local area network or local server platform. Finally, ISPs used a

server‐based configuration in which a filter was installed on their remote servers to prevent

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Subject Matter Eligibility Examples: Business Methods

subscribers from accessing certain websites. However, this configuration only allowed for a single

setoffilteringcriteriafor allofthesubscriber’send users.

In the instant application, applicant’s system improves upon the prior art filtering systems by

providing a system for filtering Internet content by subscribers on an individually customizable basis.

An ISP server stores a filtering scheme in memory and a database of a plurality of sets of filtering

elements associated with individual end users. The filtering scheme is executable code, including

object code, interpreted code (e.g., Java™ or Javascript™), other high‐level code, or a combination

thereof. The ISP server associates an end user account with a set of filtering elements from a plurality

of filtering elements (e.g., a master list of words or phrases that are not allowed) and one or more

filteringschemes(e.g.,aword‐screeningtype orphrase‐screening typefilteringscheme).

In applicant’s system, the ISP server receives a log‐in request from an end user. After verifying the

identity of the end user, the ISP server determines the filtering scheme and filtering elements

associated with the end user based on the end user account. The ISP server then receives a request

to access a website from the end user and identifies the particular website requested. The ISP server

implements the filtering scheme associated with the end user account utilizing the customized

filtering elements that are associated with the end user account. The ISP server then determines

whether thefiltering scheme authorizes the request. Ifthe request is authorized, it is processed and

forwarded to the Internet. If it is not authorized, the ISP server provides a rejection notice to the end

user.

In one embodiment, a request to access the Internet from an end user is partially processed while the

ISP server monitors the content for certain words or phrases using the filtering scheme (e.g., a word‐

screening orphrase‐screening scheme).Inthisembodiment,the ISPserver stores a table of logged‐

in end users associated with the filtering scheme. The request for Internet access is forwarded

directly to the Internet. The ISP server then monitors all data packets transmitted to the ISP server

to determine which packets will be forwarded to the end users stored in the table. If a data packet is

being sent to a user stored in the table, the ISP server screens the packet based on the filtering scheme

and filtering elements associated with that end user’s account. If the data packet(s) match the

filtering elements of the filtering scheme, such as by containing specific words or phrases, the

transmissionofthedatapacket(s)to theuser isterminated.

RepresentativeClaim

1.Acontent filteringsystem for filteringcontent retrieved from anInternetcomputernetworkby

individualcontrolledaccessnetworkaccounts,saidfilteringsystemcomprising:

a localclientcomputer generatingnetworkaccessrequestsfor saidindividualcontrolled

accessnetworkaccounts;

atleastonefilteringscheme;

a pluralityofsetsoflogicalfiltering elements; and

a remote ISP servercoupledtosaidclientcomputer andsaid Internetcomputernetwork,

saidISPserverassociatingeach saidnetworkaccounttoat least one filtering scheme andatleast

onesetof filtering elements,saidISPserverfurtherreceivingsaidnetworkaccessrequestsfrom

saidclientcomputerandexecutingsaidassociated filteringscheme utilizing saidassociatedsetof

logicalfilteringelements.

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Subject Matter Eligibility Examples: Business Methods

Analysis

Claim 1: Eligible

The claim recites a local client computer and a remote ISP server that implements at least one

filtering scheme and a plurality of sets of logical filtering elements. The system comprises a device

or set of devices and, therefore, is a machine, which is a statutory category of invention (Step 1: YES).

The claim is then analyzed to determine if the claim is directed to a judicial exception. The claim

recitesasystemfor filteringcontentretrieved from anInternet computer network,which generates

access requests for individual accounts, associates each account with at least one filtering scheme

and at least one set of filtering elements from a plurality of sets of filtering elements, receives the

access requests, and executes the associated filtering scheme utilizing the associated set of filtering

elements. Thus,the focusoftheclaim anditscharacter as a whole is on the idea of filtering content,

whichisimplementedby asystem thatusescomputerandnetworkingcomponents.

Filtering content is according to the court a “method of organizing human behavior” that is similar to

other concepts that have been identified as abstract by the courts, such as tracking financial

transactions to determine whether they exceed a pre‐set spending limit in Intellectual Ventures I v.

Capital One Bank; 1) collecting data, 2) recognizing certain data within the collected data set, and 3)

storingthatrecognizeddatainamemoryin Content Extraction; andorganizinginformationthrough

mathematical correlations in Digitech. Therefore, it is reasonable to conclude based on the similarity

of the idea described in this claim to several abstract ideas found by the courts that claim 1 is directed

toanabstract idea(Step 2A: Yes).

This conclusion isnot altered by Enfish, where the Federal Circuit stated that certain claims directed

to improvements in computer‐related technology, including claims directed to software, are not

necessarily abstract (Step 2A). Unlike the claims in Enfish, claim 1 is not clearly directed to an

improvement in computer‐related technology (e.g., computer functionality). Thus, because it is not

readily apparent that claim 1 is directed to a non‐abstract idea under Step 2A, it is necessary to

analyzetheadditionalelementsinclaim 1under Step 2B

.

It is noted, however, that the Federal Circuit in BASCOM described claim 1 as presenting a “close call” as

to what it is directed to. Thus, if an examiner skilled in this art recognizes that the claim is directed to

an Internet‐centric problem, for example, or clearly to an improvement in the computer technology of

filtering, it would be appropriate to find that the claim, while “involving” an abstract idea is not

“directed” to that idea standing alone, thus ending the analysis with a finding of eligibility at Step 2A.

Under Step 2B, the claim as a whole is analyzed to determine whether any element, or combination

of elements, is sufficient to ensure the claim amounts to significantly more than the abstract idea.

The claim recites the additional limitations of 1)controlled access network accounts, 2)a local client

computer to generate network access requests for the controlled access network accounts, 3)an

Internet computer network, and 4)a remote ISP server coupled to the client computer and the

Internet computer network. The remote ISP server associates each account with at least one filtering

scheme and at least one set of filtering elements from a plurality of sets of filtering elements, receives

the access requests, and executes the associated filtering scheme utilizing the associated set of

filtering elements. The local computer, ISP server, Internet computer network, and controlled access

network account are generic computer and networking components performing generic computer

and networking functions at a high level of generality. As the Federal Circuit determined, these

limitations do not amount to significantly more when “taken individually, [because they] recite

genericcomputer,networkandInternetcomponents,noneofwhichisinventivebyitself.”

However, the analysis under Step 2B (also called the “inventive concept inquiry”) requires more than

determining that each additional claim element – the controlled access network accounts, a local

December 2016 3

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Subject Matter Eligibility Examples: Business Methods

client computer, an Internet computer network, and a remote ISP server – is well known by itself.

Here, an inventive concept can be found in the unconventional and non‐generic combination of

known elements, and more specifically “the installation of a filtering tool at a specific location, remote

from the end‐users, with customizable filtering features specific to each end user” where the filtering

tool at the ISP is able to “identify individual accounts that communicate with the ISP server, and to

associate a request for Internet content with a specific individual account.” The Federal Circuit also

determined that the claimed arrangement of elements in the system results in an improvement in the

technology of filtering content on the Internet, because it offers “both the benefits of a filter on the

localcomputer,andthebenefits ofafilteronthe ISPserver.”

Further, these limitations confine the abstract idea to a particular, practical application of the

abstract idea and, as explained in the specification, this combination of limitations is not well‐

understood, routine or conventional activity. Unlike the claimed system, previous content filtering

systems were able to be modified by end users when the systems were located on local client

computers rather than on the ISP server and were dependent on hardware and software on the local

computer,or limited to aconfiguration basedon the particular local client computer, local server, or

ISP server. In addition, these limitations do not simply recite an instruction to apply the abstract idea

of filtering content on the Internet or to perform the abstract idea on a generic set of computers.

Instead, the claim recites a “technology‐based solution” of filtering content on the Internet that

overcomes the disadvantages of prior art filtering systems. Thus, when viewed as an ordered

combination, the claim limitations amount to significantly more than the abstract idea of content

filtering (Step 2B: Yes). Theclaim ispatent eligible.

In practice, if an examiner believes the record would benefit from clarification, remarks could be

addedtotheOfficeactionorreasonsfor allowanceindicating thattheclaim recitestheabstractidea

of filtering content. However, the claim is eligible because analyzing the claim limitations as an

orderedcombinationdemonstrates thattheclaimisaparticular applicationof andanimprovement

to the technology of filtering content on the Internet, rather than well‐understood, routine,

conventional activity or a simple instruction to apply the abstract idea of filtering content on the

Internetor to performthe abstractidea on a genericsetofcomputers.

Additionalexplanation of priordecisionsfrom BASCOM

The following discussion of case law is informative regarding the reasoning that led the court in

BASCOM to hold claim 1 patent‐eligible. It may be useful to examiners to recognize the similarities

and differences as identified by the Federal Circuit between claim 1 and the claims at issue in DDR,

OIP, Intellectual Ventures I, Content Extraction, Ultramercial, and Accenture. A discussion of the case

lawtothisextent isnotrequired during examination.

In DDR, the claimed invention solved the problem of retaining potential customers on a website by

“sending the viewer to a hybrid webpage that combined visual elements of the first website with the

desired content from the second website that the viewer wished to access.” The claimed invention

in DDR was not a “business method per se.” Similarly, even though claim 1 in BASCOM was

“engineered in the context of filtering content,” claim 1 is not simply directed to the abstract idea of

filtering content applied to the Internet, i.e., abstract idea + “apply it”. Instead, claim 1 recites a

“technology‐based solution” of filtering content on the Internet that overcomes the problems in the

prior art with other Internet content filtering systems rather than “an abstract‐idea‐based solution”

(i.e.,asolution “implementedwith generictechnicalcomponentsin aconventionalway”).

In contrast, in OIP, the claims were directed to the performance of the abstract idea of price

optimization on generic computer components using conventional computer functions. In other

words, the claimed invention was “simply the generic automation of traditional price‐optimization

December 2016 4

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Subject Matter Eligibility Examples: Business Methods

techniques” and was not a “technology‐based solution” of the abstract idea. Claim 1 of BASCOM

presents a “technology‐based solution” of filtering content on the Internet that overcomes the

problemsinthepriorartwithother Internet content filtering systemsasdiscussedabove.

Finally, the claims in Intellectual Ventures I, Content Extraction, Ultramercial, and Accenture are

directed to an abstract idea performed on generic computer components, “without providing a

specific technical solution beyond simply using generic computer concepts in a conventional way.”

In Intellectual Ventures I, the claims were directed to the abstract idea of tracking financial

transactions to determine whether they exceed a pre‐set spending limit simply implemented on a

generic computer and the Internet. In Content Extraction, the claims were directed to the abstract

idea of collecting data, recognizing certain data within the collected data set, and storing that

recognized data in a memory performed on generic scanning devices and computers. In Ultramercial,

the claims were directed to the abstract idea of using advertising as an exchange or currency on the

Internet. And finally, the claims in Ac centure were directed to the abstract idea of generating rule‐

based tasks for processing an insurance claim using generic computer components performing

conventional activities. Unlike the claims in Intellectual Ventures I, Content Extraction, Ultramercial,

and Accenture, claim 1 of BASCOM is not simply directed to the abstract idea of filtering content on

the Internet or on generic computer components performing conventional activities. Instead, claim

1 “carve[s] out a specific location for the filtering system (a remote ISP server) and require the

filtering system to give users the ability to customize filtering for their individual network accounts.”

35. Verifying A Bank Customer’s Identity To Permit An ATM Transaction

The following fact pattern and claims are hypothetical. Assume that the claims are presented in a

recently filed application that is under examination and thus each claim is given its broadest reasonable

interpretation in view of the specification as it would be understood by one of ordinary skill in the art.

In this example, the terms in the claim are given their plain meaning in the art because no special

definitions have been set forth in the specification. An abbreviated version of the hypothetical

specification is provided below. Claim 1 is ineligible, because it is directed to an abstract idea and does

not recite additional elements that amount to significantly more. Claims 2 and 3 are directed to the

same abstract idea, but are eligible because they have additional elements that amount to significantly

more than the abstract idea (i.e., provide an inventive concept) because they implement the abstract

idea with specific meaningful limitations.

Background

Financial institutions routinely provide automated teller machines (ATMs) for customers to conduct

banking transactions at convenient locations other than brick‐and‐mortar banks, and without the

need to interact with a bank teller. Typical ATMs include a customer interface with a keypad, function

key, display, outlet slot for statements or other information, cash dispenser slot, deposit inlet, and

oftena speakertoprovide customervoice guidance and a camera tomonitortransactions.Areader

is provided for customers to present data bearing records, which can include data corresponding to

the customer, financial accounts, or other data, and are commonly embodied as a bank card with a

magnetic strip or a contactless card with a radio frequency identification (RFID) tag. Other input

devices, such as a biometric reader to receive customer identifying inputs such as fingerprints, iris

scans, and face topography data, a camera, or speech recognition device, used to identify a user can

be providedas well. Thecustomer interface is coupled to a controller witha processor andmemory

and a network communicator to enable communication between the controller and a financial

institution to exchange information about the transactions. To conduct a transaction, a customer

typically inserts a bank card into the appropriate slot in the ATM and inputs a personal identification

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Subject Matter Eligibility Examples: Business Methods

number (PIN) that verifies that the user is an authorized user for the bank account associated with

the bank card. The account data is read from the card using the reader in the ATM and the PIN

associated with the card. The network communicator transmits the read data and PIN to a remote

computer at the financial institution, which then transmits instructions back to the ATM regarding

authorizationtocarryout therequestedtransaction.

Due to its speed and convenience, the use of ATMs to conduct banking business has become

ubiquitous, but so have problems with theft and fraud. For example, if another person illegally or

fraudulently obtains a user’s PIN, that person can gain access to funds in the account. Another

problem associated with ATMs is “skimming” where a false card reader that appears to be a

legitimate reader is affixed to an ATM to obtain an authorized user’s account information and PIN. In

skimming operations, an authorized user unwittingly presents their bank card to the skimming

device on the ATM and enters their PIN, which is then captured and stored for subsequent fraudulent

activity.

There have been various solutions attempting to reduce the instance of fraud associated with ATMs

and to improve security when verifying an authorized user. For example, some bank cards are

provided with chips that interact with a special reader to generate a unique transaction number each

time a transaction is conducted to reduce the chance that a user’s account information and PIN can

be stolen for later use (so‐called “chip and pin” cards). Bank cards have also been outfitted with RFID

tags or “smart labels” (non‐contact transponders) that allow account information to be transmitted

to an ATM without inserting the card into the machine, and thus exposing it to theft or skimming.

The smart label can contain various types of customer information, including profile data,

preferences, and unique customer identification data. To conduct a transaction using such a

contactless card, the customer brings the card into range of an ATM reader, which uses radio

frequencies to interrogate the smart label to receive information about the customer. The

interrogation can be encrypted to provide additional security. The customer can then start a

transaction, e.g.,bypressing an enter key ontheATM. Whilesuchcardscanpreventfraudbased on

skimming, these non‐contact cards have given rise to other security issues, such as allowing a

maliciouspersontoobtaincardinformation byuseof anunauthorizedRFIDreader.

Applicant has invented a method of ensuring secure transmission of data from a card using a smart

label and encryption techniques. The invention leverages the wide‐spread use of mobile personal

communication devices (smart phones) to facilitate the secure transmission. When a customer is

issued a bank card with a smart label, the financial institution also provides a downloadable software

application to the customer to install on their mobile communication device. The software

applicationis designedto assistcommunicationwithaspeciallyoutfittedATM.

The ATM in accordance with this invention includes a controller that is programmed with a time‐

variant random code generator. The code generator generates a random code when activated in

response to the reader receiving data from the customer’s bank card. In other words, when the

customer is within a certain range of the ATM with their bank card, the smart label is read from the

RFID reader in the ATM, which signals the code generator to generate a time‐variant random code,

which can be a plurality of digits, numbers and/or letters. The ATM then provides the random code

to the customer. In one embodiment, the ATM provides the random code by displaying it. The

customer is prompted to enter the displayed code into their mobile device, which already has the

institutional software installed. In another embodiment, the random code is transmitted by the ATM

to the customer’s mobile device, e.g., by a near‐field communication or Bluetooth link, if the customer

has installed the institutional software on their mobile device and registered their mobile device with

theinstitution.

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Subject Matter Eligibility Examples: Business Methods

The software provided by the institution generatesdatainresponsetotherandomcode,whichmay

be, e.g., a customer confirmation code or an encryption that includes the code data and the card’s

data. The software then causes the mobile device to communicate the responsive data to the ATM.

In one embodiment, the mobile device displays theencrypted data as an image on its display screen.

The image can be machine readable data in the form of a bar code or an image such as a colored

pattern. The customer is prompted to allow the ATM to scan the image displayed by the mobile

device. The reader of the ATM reads the encrypted image and verifies that it is authentic by, for

example, determining if it is readable, recognizable, or properly formatted. Once verified, the

processor in the ATM decrypts the data and confirms that the decrypted code matches the random

code that was generated for the current transaction session. In another embodiment, the customer

confirmation code is obtained by the ATM (e.g., by transmission over near‐field communication or

Bluetooth link), and the ATM then confirms that the customer confirmation code matches the random

code. The outcome of thecomparison between the responsive code data (e.g., the decrypted codeor

the customer confirmation code) and the random code is used to control access to the keypad. In

particular, if the responsive code data and the generated code match and the elapsed time is within

a certain time frame, the transaction is continued in conventional fashion with the customer entering

aPIN usingthekeypad. Ifthe responsivecodedata and generatedcodedonotmatchortheelapsed

time exceeds the time frame, a signal is sent to lock the keypad so that any attempts at entering a PIN

willbefutile.

Applicant’s method allows the ATM to receive user card data in a more secure and efficient manner.

Customer card data entry begins before PIN entry and verification, so if the ATM user is not the

authorized customer and does not have the appropriate verification software on their mobile device,

the transaction is concluded before entry of the PIN. This method prevents skimming and other

techniques to fraudulently obtain a customer’s PIN and even theft of the card since the downloaded

software can authenticate the userand likewise authenticate the ATMbefore thePINisproduced.

Claims

1. A method of conducting a secure automated teller transaction with a financial institution by

authenticatingacustomer’sidentity,comprisingthestepsof:

obtainingcustomer‐specificinformationfromabankcard,

comparing, by a processor, the obtained customer‐specific information with customer

informationfromthefinancialinstitutiontoverifythecustomer’sidentity,and

determining whether the transaction should proceed when a match from the comparison verifies

theauthenticityofthecustomer’s identity.

2. A method of conducting a secure automated teller transaction with a financial institution by

authenticatingacustomer’sidentity,comprisingthestepsof:

obtainingcustomer‐specificinformationfromabankcard,

comparing, by a processor, the obtained customer‐specific information with customer

informationfromthefinancialinstitutiontoverifythecustomer’s identity, by

generating a random code and transmitting it to a mobile communication device that is

registeredto thecustomer associated withthe bank card,

reading, by the automated teller machine, an image from the customer’s mobile

communication device that is generated in response to receipt of the random code, wherein

theimageincludesencryptedcodedata,

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Subject Matter Eligibility Examples: Business Methods

decryptingthecode data from the readimage, and

analyzing the decrypted code data from the read image and the generated code to

determine if the decrypted code data from the read image matches the generated code data,

and

determining whether the transaction should proceed when a match from the analysis verifies the

authenticityofthecustomer’sidentity.

3. A method of conducting a secure automated teller transaction with a financial institution by

authenticatingacustomer’sidentity,comprisingthestepsof:

obtainingcustomer‐specificinformationfromabankcard,

comparing, by a processor, the obtained customer‐specific information with customer

informationfromthefinancialinstitutiontoverifythecustomer’s identity, by

generating a random code and visibly displaying it on a customer interface of the

automatedtellermachine,

obtaining, by the automated teller machine, a customer confirmation code from the

customer’s mobile communication device that is generated in response to the random code,

and

determiningwhetherthecustomer confirmationcodematchesthe randomcode,and

automaticallysendingacontrolsignal toaninputfortheautomated teller machine to provide

accessto a keypadwhen a match fromtheanalysisverifies the authenticityofthecustomer’s

identity,andtodenyaccesstoa keypadsothat the transaction is terminated when the comparison

resultsinnomatch.

Analysis

Claim1:Ineligible

The claim recites a method of conducting a secure automated teller transaction comprising a series

of steps. Thus, the claim is directed to a process, which is a statutory category of invention (Step 1:

Yes).

The claim is then analyzed to determine if the claim is directed to a judicial exception. The claim

recites the steps of obtaining customer‐specific information, comparing the obtained customer‐

specific information with customer information from the financial institution to authenticate the

customer’s identity, and determining whether the transaction should proceed when a match from

the comparison verifies the authenticity of the customer’s identity. These steps describe a method

of fraud prevention by verifying the authenticity of the customer’s identity prior to proceeding with

a banking transaction, which is a “long prevalent” business practice that bank tellers have used for

many years. Fraud prevention by verifying the identity of the customer is as fundamental to business

as the economic concepts that were identified as abstract ideas by the Supreme Court, such as

intermediatedsettlement (Alice Corp.) andriskhedging(Bilski). The claim as a wholeis alsosimilar

to the claimed invention in CyberSource, which the Federal Circuit described as directed to an

abstractmentalprocessfordetectingfraudby obtaining and comparingintangibledatapertinentto

business risks. The method of claim 1 similarly recites steps of obtaining and comparing data

pertinent to business risks. More particularly, it describes a method of fraud prevention by

authenticating a customer’s identity. Therefore, claim 1 is directed to an abstract idea (Step 2A: Yes).

December 2016 8

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Subject Matter Eligibility Examples: Business Methods

Next, the claim as a whole is analyzed to determine whether any element, or combination of elements,

is sufficient to ensure the claim amounts to significantly more than the abstract idea. In addition to

thestepsthatdescribe the abstract idea ofpreventingfraudthrough verifyinga customer’sidentity,

the claim recites the additional limitation of obtaining customer‐specific information from a bank

card. This additional element taken individually represents a conventional action of an ATM, as

evidenced by the discussion of the prior art in the background specification. Further, the step is

recited at a high level of generality such that it amounts to insignificant pre‐solution activity, e.g., a

mere data gathering step necessary to use the abstract idea. The claim also recites the additional

element of a processor comparing data. This processor is no more than a generic computer

component, and the comparison performed by the processor does not represent any computer

function beyond what processors typically perform. Taken individually therefore, the additional

elementsof claim1 do notprovidesignificantlymore, i.e.,aninventive concept,tothe claim.

Looking at the combination of elements in claim 1 also fails to show an inventive concept. Unlike the

eligible claims in Diehr and Bascom, in which the elements limiting the exception were individually

conventional but taken together provided an inventive concept because they improved a technical

field, the claim here does not invoke any of the considerations that courts have identified as providing

significantly morethanan exception. Thecombination ofelementsis no morethan the sum oftheir

parts,andprovidesnothingmorethan mere automation of verificationstepsthatwere inyearspast

performed mentally by tellers when engaging with a bank customer. Mere automation of an

economic business practice does not provide significantly more (i.e., provide an inventive concept).

Forthesereasons,claim1isineligible (Step 2B: No).

A rejection of claim 1 should identify the abstract idea by pointing to the language of the claim that

describes fraud prevention by identity verification (i.e., obtaining customer information, comparing

the obtained customer information to customer information from a financial institution, and

determining whether the transaction should proceed when a match from the comparison verifies the

authenticity ofthecustomer’sidentity)andexplaining that fraudpreventionbyidentityverification

is similar to concepts that courts have previously found abstract. The rejection should identify the

additional limitations regarding obtaining customer‐specific information from a bank card and a

processor that compares data, and explain why those limitations are conventional or are only generic

computer components performing generic functions and are mere automation of economic business

practices.

Claim2:Eligible

The claim recites a method of conducting a secure automated teller transaction comprising a series

of steps. Thus, the claim is directed to a process, which is a statutory category of invention (Step 1:

Yes).

The claim is then analyzed to determine if the claim is directed to a judicial exception. Claim 2 recites

steps of obtaining customer‐specific information, comparing the obtained customer‐specific

information withcustomerinformation fromthefinancial institutionto authenticatethecustomer’s

identity, and determining whether the transaction should proceed when a match from the analysis

verifies the authenticity of the customer’s identity. Like the steps of obtaining and comparing

customer information in claim 1, these steps in claim 2 describe a method of fraud prevention by

identity verification before proceeding with a banking transaction, which as explained above is a

fundamental business practice and is similar to ideas found abstract by the courts. Therefore, claim

2isdirected toanabstract idea(Step 2A: Yes).

Next, the claim as a whole is analyzed to determine whether any element, or combination of elements,

is sufficient to ensure the claim amounts to significantly more than the abstract idea. In addition to

December 2016 9

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Subject Matter Eligibility Examples: Business Methods

the steps that describe the abstract idea of preventing fraud through identity verification, the claim

recites the additional limitations of obtaining customer‐specific information from a bank card, a

processor comparing data, generating a random code and transmitting it to the customer’s mobile

communication device, and the processor reading an image that was generated by the customer’s

mobile communication device in response to receipt of the random code, where the image includes

encrypted code data. The encrypted code data from the image is then used by the processor to verify

the customer’s identity by decrypting the code data and analyzing the decrypted code data.

Considered individually, the steps of obtaining information from a bank card and the comparing data

do not provide significantly more for the same reasons as in claim 1. Similarly, the processor and the

mobile communication device are recited at a high level of generality and perform programmed

functions that represent conventional and generic operations for these devices, including reading

data,generatingrandom codes,andanalyzingdata.

However, the combination of the steps (e.g., the ATM providing a random code, the mobile

communication device’s generation of the image having encrypted code data in response to the

random code, the ATM’s decryption and analysis of the code data, and the subsequent determination

of whether the transaction should proceed based on the analysis of the code data) operates in a non‐

conventional and non‐generic way to ensure that the customer’s identity is verified in a secure

manner that is more than the conventional verification process employed by an ATM alone. In

combination, these steps do not represent merely gathering data for comparison or security

purposes, but instead set up a sequence of events that address unique problems associated with bank

cards and ATMs (e.g., the use of stolen or “skimmed” bank cards and/or customer information to

perform unauthorized transactions). Thus, like in BASCOM, the claimed combination of additional

elements presents a specific, discrete implementationof the abstract idea. Further, the combination

of obtaining information from the mobile communication device (instead of the ATM keypad) and

using the image (instead of a PIN) to verify the customer’s identity by matching identification

information does not merely select information by content or source, in contrast to Electric Power,

but instead describes a process that differs from the routine and conventional sequence of events

normally conducted by ATM verification, such as entering a PIN, similar to the unconventional

sequence of events in DDR. The additional elements in claim 2 thus represent significantly more (i.e.,

provide an inventive concept) because they are a practical implementation of the abstract idea of

fraud prevention that performs identity verification in a non‐conventional and non‐generic way, even

though the steps use well‐known components (a processor and mobile communication device).

Claim2iseligible(Step 2B: Yes).

While an examiner would not be required to provide an explanation of eligibility, the record would

be enhanced if clarifying remarks were provided to point to the reason for eligibility. In this instance,

clarification could easily be made by simply pointing to the combination of elements used in the non‐

conventionalimplementationof identityverification inthemethodoffraudprevention.

Claim 3: Eligible

The claim recites a method of conducting a secure automated teller transaction comprising a series

of steps. Thus, the claim is directed to a process, which is a statutory category of invention (Step 1:

Yes).

The claim is then analyzed to determine if the claim is directed to a judicial exception. Claim 3 recites

steps of obtaining customer‐specific information, comparing the obtained customer‐specific

information withcustomerinformation fromthefinancial institutionto authenticatethecustomer’s

identity, and permitting the transaction to proceed when a match from the analysis verifies the

authenticity of the customer’s identity, and terminating the transaction when there is no match. Like

the steps of obtaining and comparing customer information in claim 1, these steps in claim 3 describe

December 2016 10

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Subject Matter Eligibility Examples: Business Methods

a method of fraud prevention by identity verification before proceeding with a banking transaction,

which as explained above is a fundamental business practice and is similar to ideas found abstract by

thecourts.Therefore,claim3isdirectedtoanabstractidea (Step 2A: Yes).

Next, the claim as a whole is analyzed to determine whether any element, or combination of elements,

is sufficient to ensure the claim amounts to significantly more than the abstract idea. In addition to

the steps that describe the abstract idea of preventing fraud through identity verification, the claim

recites the additional limitations of obtaining customer‐specific information from a bank card, a

processor comparing data, the ATM generating a random code and visibly displaying it on a customer

interface, and the ATM obtaining a customer confirmation code that was generated by the customer’s

mobile communication device in response to the random code. The customer confirmation code is

then used by the ATM to verify the customer’s identity by analyzing the customer confirmation code

with respect to the random code, and controlling the transaction by providing or preventing access

to a keypad of the ATM based on the analysis of the code data. Considered individually, the ATM

obtaining information from a bank card and the processor comparing data do not provide

significantly more for the same reasons as in claim 1. Similarly, the ATM and the mobile

communication device are recited at a high level of generality and perform programmed functions

that represent conventional and generic operations for these devices, including reading data,

generating random codes,andanalyzingdata.

However, the combination of the steps (e.g., the ATM’s provision of the random code, the mobile

communication device’s generation of the customer confirmation code in response to the random

code, the ATM’s analysis of the customer confirmation code, and the ATM’s subsequent sending of a

control signal to provide or prevent access to the keypad of the ATM and thus allow or prevent a

transaction based on the analysis of the code data sets) operates in a non‐conventional and non‐

generic way to ensure that the customer’s identity is verified in a secure manner that is more than

the conventional verification process employed by an ATM alone. In combination, these steps do not

represent merelygatheringdata forcomparison orsecuritypurposes, but instead set up a sequence

of eventsthataddressuniqueproblemsassociated withbankcardsandATMs(e.g., the use of stolen

or “skimmed” bank cards and/or customer information to perform unauthorized transactions).

Thus, like in BASCOM, the claimed combination of additional elements presents a specific, discrete

implementation of the abstract idea. Further, the combination of obtaining information from the

mobile communication device (instead of the ATM keypad) and using the customer confirmation

code (instead of a PIN) to verify the customer’s identity does not merely select information by content

or source, in contrast to Electric Power, but instead describes a process that differs from the routine

and conventional sequence of events normally conducted by ATM verification, such as entering a PIN,

similar to the unconventional sequence of events in DDR. The additional elements in claim 3 thus

represent significantly more (i.e., provide an inventive concept) because they are a practical

implementationofthe abstractidea of fraud prevention that pe

rformsidentityverificationina non‐

conventional and non‐generic way, even though the steps use a combination of well‐known

components (anATMandmobilecommunication device).Claim 3 iseligible (Step 2B: Yes).

While an examiner would not be required to provide an explanation of eligibility, the record would

be enhanced if clarifying remarks were provided to point to the reason for eligibility. In this instance,

clarification could easily be made by simply pointing to the combination of elements used in the non‐

conventionalimplementationof identityverification inthemethodoffraudprevention.

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Subject Matter Eligibility Examples: Business Methods

36. Tracking Inventory

The following fact pattern and claims are hypothetical. Assume that the claims are presented in a

recently filed application that is under examination and thus each claim is given its broadest reasonable

interpretation in view of the specification as it would be understood by one of ordinary skill in the art.

In this example, the terms in the claim are given their plain meaning in the art because no special

definitions have been set forth in the specification. An abbreviated version of the hypothetical

specification is provided below. Claim 1 is ineligible, because it is directed to an abstract idea and does

not recite additional elements that amount to significantly more. Claims 2 and 3 are directed to the

same abstract idea, but are eligible because they recite specific limitations other than what would be

well‐understood, routine, conventional activities in the field, which amount to significantly more (i.e.,

provide an inventive concept).

Background

Inventory management is a commercial practice involving the acquisition and monitoring of stocked

goods to maintain stock levels in a business. Particularly when goods are stored in large warehouses,

managing inventory requires monitoring what goods are currently in stock and where those goods

arelocatedinthewarehouseinordertofulfillordersinanefficientmanner.Somepriormethodsof

tracking inventory required items of inventory to have an attached tracking device such as a RFID or

GPS transmitter, but these methods were cumbersome to implement since each item needed a

transmitter to be affixed and detached as the item entered and exited the warehouse. In addition,

these methods could not accurately track an item if the transmitter was obscured, improperly affixed,

or detached from the item. Other prior methods used imaging technology to acquire and process

images to track the items of inventory, but these methods did not have much success because they

used the view of a single camera to track an object and attempted to identify items solely based upon

character data (such as identification codes or product names) printed on the item. Due to using the

view of a single camera to track an object, it was difficult to determine an object’s physical three‐

dimensional (3‐D) location. Therefore, these methods required items that were moved to be

reimaged or otherwise tracked through manual scanning or logging. Mistakes in data entry or failure

to scan a moved item resulted in lost or misplaced items. Accordingly, previous attempts to

implementimagerecognitionto trackitemsofinventoryhavenot achievedahighrate ofaccuracy.

Applicant has invented a system for tracking the presence and location of items of inventory in a

warehouse using an integrated camera system with computer vision technology that overcomes

many of the problems in the existing technologies typically usedintheindustry.Applicant’ssystem

overcomes the issues relating to accurately identifying items and tracking missing items by using a

high resolution video camera array with overlapping views in combination with a recognition model

that uses not only the character data of the item but also contour information (i.e. shape) from the

collected images and predictive location data. By using a combination of character and contour

recognition, applicant’s system greatly reduces the possibility of item misidentification and

significantly improves accuracy of inventory over prior techniques that used only character

information. Because the cameras in the array have overlapping views, objects can be tracked across

multiple cameras and the 3‐D location of the objects can be automatically reconstructed. Applicant’s

improvement to computer vision technology to manage inventory within existing warehouse

operations thus results in more accurate inventory tracking while eliminating the need for

proceduressuchasscanning andloggingitems.

In practice, the invention uses high resolution video cameras positioned to have overlapping fields

of view in pre‐determined locations throughout the inventory storage space. Such cameras enable

the system to automatically track an item across the entire storage space and estimate its physical

location. An inventory recognition model is also stored in the memory and comprises a mathematical

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Subject Matter Eligibility Examples: Business Methods

representationof eachitemofinventoryhandledbytheparticularwarehouse.Thismodelmaybea

Gaussian mixture model, neural network, Bayes classifier or other known pattern classifier. The

model is developed using a supervised training algorithm using numerous images of each item at

multipledistancesandpositions with respectto the camera.Duringtraining,characteristicsof each

item are extracted from the images including character information such as the item’s name and

identification code and contour information such as the shape of the item and/or the shape of the

packaging for the item. The recognition model may be updated as needed when items are added or

discontinued.

During operation, the video cameras capture an image sequence (e.g., multiple images from one or

more of the cameras) comprising overlapping images of an item, which is stored in the memory in an

inventory record. The system then uses a programmed computer to extract characteristics of an item

includingcharacterandcontourinformationfrom thehighresolution images in the image sequence

using a combination of existing text and edge detection algorithms. The programmed computer uses

the characteristics to form feature vectors, and then classify the item by processing the feature

vectors with the inventory recognition model to determine the most likely item in the image. A

positive recognition result indicates the presence of the item in the warehouse. After an item is

recognized, it is tracked in real‐time throughout the warehouse using a tracking algorithm that takes

advantage of the overlapping camera views to confirm the location of the item (thus improving

retrieval time and accuracy). Specifically, the item is tracked in the image sequence of one camera

using a known method, such as Kalman filtering, and once that item enters the field of vision of a

secondcamera, itspositioninthe first camera’sviewisused toquicklylocatetheitemin thesecond

camera’s view. The item can then be tracked similarly in the image sequence of the second and

subsequent cameras. The computer then reconstructs the 3‐D coordinates of the item based upon

the item’s location in multiple overlapping images and prior knowledge of the location and field of

view of the camera(s)thatare trackingtheitem.Finally,the computerupdatestheitem’sinventory

recordwiththe3‐Dlocationinformation.

In this hypothetical scenario, computer vision technology has not been used in the manner disclosed

bythisinventorpriortothe filingoftheapplication.

Claims

1. A system for managing an inventory record comprising a memory and processor configured

toperformthesteps of:

(a) creating an inventory record for an item of inventory comprising acquired images of the

item;

(b) addingclassificationdatarelatingto theacquiredimagesto the inventory record;

(d) updating the inventory record with a physical location of each item of inventory in the

warehouse to thereby manage the items of inventory.

2. A system for managing an inventory record by tracking the location of items of inventory in

awarehouse:

a high‐resolution video camera array, each video camera positioned at pre‐determined

locations with overlapping views, for acquiring at least one high‐resolution image sequence

ofeachitemofinventory;

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Subject Matter Eligibility Examples: Business Methods

amemoryandprocessorconfiguredtoperformthestepsof:

(a) creating an inventory recordfor an item ofinventorycomprising the acquired image

sequence of theitem from thevideocamera array;

(b) adding classification data relating to the acquired image sequence to the inventory

record;

locationdataprovidingapositionof theitem ofinventory in theimagesequence;

(d) reconstructing the 3‐D coordinates of an item of inventory using the location data

from multiple overlapping images and prior knowledge of the location and field of

viewofthecamera(s); and

(e) automatically updating the inventory record with the 3‐D coordinates of each item of

inventoryin thewarehousetothereby manage the itemsofinventory.

3. A system for managing inventory by tracking the location of items of inventory in a

warehouseusingimagerecognition,comprising:

a high‐resolution video camera array for acquiring at least one high resolution image

sequence of eachitem;

a memory for storing the acquired image sequences, classification and location data relating

tothe acquiredimagesequences,andarecognition modelrepresenting contourinformation

andcharacterinformationof eachitem; and

a processor that is configured to manage inventory by performing, for each item, the steps of:

(a) creating an inventory record for the item comprising the acquired image sequence(s)

ofthe item;

(b) extracting characteristics from the acquired image sequence(s) of an item to form

feature vectors, the characteristics comprising contour information and character

information that is stored in the inventory record as classification data relating to the

acquiredimagesequence(s);

and location data by processing the feature vectors using the stored recognition

modelandaddingtheclassification andlocation datato the inventoryrecord;

(d) determining a physical location of the item in the warehouse using the location data

relatingtotheitemintheimage sequence(s); and

(e) automaticallyupdatingtheinventory recordwith thephysical locationoftheitem.

Analysis

Claim1:Ineligible

The claim recites a system formanaging aninventory record comprising a memory and a processor

configured to perform a series of steps. The claimed system is a device or set of devices, which is a

machine and thusa statutorycategory ofinvention (Step 1: Yes).

The claim is then analyzed to determine if the claim is directed to a judicial exception. The claim

recites a system that performs the steps of (a)‐(c) storing acquired images and related classification

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Subject Matter Eligibility Examples: Business Methods

and location data, and (d) updating the inventory record with the physical location of each item of

inventory in the warehouse. That is, the claim describes the steps of managing inventory by creating

an inventory record for each item of inventory comprising images of the item, adding classification

data relating to the images to the inventory record, adding location data for each image to the

inventory record, and updating the inventory record with the physical location of each item of

inventory in the warehouse. The data collection, recognition, and storage concept described in the

claim is similar to the data collection and management concepts that were held to be abstract ideas

in Content Extraction, TLI Communications, and Electric Power Group. Although the claim enumerates

the type of information (i.e., the images, classification data, and location data) that is acquired, stored

and analyzed, the Federal Circuit has explained in Electric Power Group and Digitech that the mere

selection and manipulation of particular information by itself does not make an abstract concept any

less abstract. Further, the claim is not made any less abstract by the invocation of a programmed

computer. Unlike Enfish, where the claims were focused on a specific improvement in how the

computer functioned, the claim here merely uses the computer as a tool to perform the abstract

concepts. Therefore, based on the similarity of the concept described in this claim to abstract ideas

identified by thecourts,claim 1 isdirectedtoanabstractidea(Step 2A: Yes).

Next, the claim as a whole is analyzed to determine whether any element, or combination of elements,

is sufficient to ensure the claim amounts to significantly more than the abstract idea. The claim

recites the additional limitations of a memory and processor to perform the steps of inventory

tracking. A memory for storing data and a processor for processing data are well‐understood,

routine, conventional computer components, which in this claim are recited at a high level of

generality and perform generic computer functions (e.g., storing and processing information).

Generic computer components performing generic computer functions, alone, do not amount to

significantlymorethan theabstractidea.

Viewing the limitations in combination also fails to amount to significantly more than the abstract

idea. The claimed invention seeks to record, process, and archive digital images simply, fast, and in

such a way that the information may be easily tracked, but these functions reflect ordinary usage

typically performed by a generic computer, as would be recognized by those of ordinary skill in the

field of data processing. For example, as noted in TLI Communications, using a computer to attach

classification data, such as dates and times, to images for purposes of storing those images in an

organized manner does not add significantly more to a judicial exception. The recitation of

conventional processing technology performing well‐understood, routine, conventional functions

such as recognizing and storing data from specific data fields does not reflect an “inventive concept.”

Thus, whether viewed individually or in combination, the additional limitations do not amount to a

claim as a whole that is significantly more than the abstract idea (Step 2B: No). The claim is not patent

eligible.

A rejection of claim 1 should identify the abstract idea by pointing to the language of the claim that

describes inventory management and explaining that inventory management is similar to concepts

that courts have previously found abstract. The rejection should identify the additional limitations

regarding the memory and processor and explain why those limitations comprise only a generic

computer performing well‐understood, routine, conventional generic functions in the particular

technological environment of imageprocessing,forthereasons noted above.

Claim 2: Eligible

The claim recites a system comprising avideo cameraarray,a memory and a processor. The system

is a device or set of devices and therefore is a machine, which is a statutory category of invention

(Step 1: Yes).

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Subject Matter Eligibility Examples: Business Methods

The claim is then analyzed to determine if the claim is directed to a judicial exception. Like claim 1,

claim 2 recites a system that performs the steps of (a)‐(c) acquiring and storing images and related

data about items of inventory, and (e) updating the inventory record with the physical location of

each item of inventory in the warehouse. Claim 2 thus describes using data collection and

management techniques to practice the concept of inventory management, which as explained above

isan abstract idea. Therefore,the claim isdirected to an abstractidea(Step 2A: Yes).

Next, the claim as a whole is analyzed to determine whether any element, or combination of elements,

is sufficient to ensure the claim amounts to significantly more than the abstract idea. The claim

recites the additional limitations of a high‐resolution video camera array at predetermined positions

withoverlappingviews, memoryandprocessorto(d)reconstruct the3‐Dcoordinatesof theitemof

inventory from multiple overlapping images obtained from the camera array and prior knowledge of

the location and field of view of the camera(s). Individually, the memory and processor limitations

do not amount to significantly more for the reasons discussed above for claim 1. For example, they

are still well‐understood, routine, conventional devices that are used in this invention for their

conventional functions of processing and storing information. Similarly, high‐resolution video

cameras are widely used and, in this invention, perform their typical function of acquiring image

sequences.

However, the memory and processor in combination with a high‐resolution video camera array with

predetermined overlapping views that reconstructs the 3‐D coordinates of the item of inventory

using overlapping images of the item and prior knowledge of the location and field of view of the

camera(s) provides significantly more than the abstract idea of using data collection techniques to

manage inventory. As explained in the specification, at the time of this invention, using a high‐

resolution video camera array with overlapping views to track items of inventory was not well‐

understood, routine, conventional activity to those in the field of inventory control. In fact, the use

of this camera array provides the ability to track objects throughout the entire storage space rather

than simply the view of a single camera and determine their 3‐D location without any of the manual

steps that were required of previous methods. That is, the video camera array with reconstruction

software provides the technological solution to the technological problem of automatically tracking

objects and determining their physical position using a computer vision system. Like in DDR, the

claimed solution here is necessarily rooted in computer technology to address a problem specifically

arising in the realm of computer vision systems. The claimed limitations are not simply an attempt

to generally link the abstract idea to the technological environment of computer vision systems.

Rather, these are meaningful limitations that confine the claim to a particular useful application.

Accordingly, when viewed as a combination, the additional elements thus yield a claim as a whole

that amounts to significantly more than the abstract idea of inventory management (Step 2B: Yes).

Theclaimispatenteligible.

If the examiner believes the record would benefit from clarification, remarks could be added to the

Office action orreasonsforallowanceindicating thattheclaim recitesthe abstract idea of inventory

management. Nevertheless, the claim is eligible because analyzing the claim elements in combination

demonstrates the claim is a technology‐based solution to address a problem arising in the realm of

computer vision systems and is not simply limiting the abstract idea to a particular technological

environment.

Claim 3: Eligible

The claim recites a system comprising one or more video cameras, memory and a processor. The

system is a device or set of devices and therefore is a machine, which is a statutory category of

invention(Step 1: Yes).

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Subject Matter Eligibility Examples: Business Methods

The claim is then analyzed to determine if the claim is directed to a judicial exception. Like claim 1,

claim 3 recites a system that performs the steps of (a) & (c) storing acquired images and related

classification and location data, and (e) updating the inventory record with the physical location of

each item of inventory in the warehouse. Claim 3 thus describes using data collection and

management techniques to practice the concept of inventory management, which as explained above

isan abstract idea. Therefore,the claim isdirected to an abstractidea(Step 2A: Yes).

Next, the claim as a whole is analyzed to determine whether any element, or combination of elements,

is sufficient to ensure the claim amounts to significantly more than the abstract idea. The claim

recites the additional limitations of a high‐resolution video camera array for acquiring high

resolution image sequences of items of inventory, a memory to store the acquired images, related

data, and the recognition model, and a processor to perform step (b)’s extracting characteristics from

the acquired images, step (c)’s recognizing and tracking the position of the item using the recognition

model andstep(d)’s determining aphysicallocationoftheitemusingthepositionoftheitemin the

images. Individually, the camera array, memory and processor limitations do not amount to

significantly more for the reasons discussed above for claims 1 and 2. For example, these

components are used in this invention for their well‐understood, routine, conventional functions of

acquiring,processingand storinginformation.

In combination, however, the limitations do amount to significantly more than the abstract idea of

inventory management. As explained in the specification, the combination of the camera array’s

acquisition of high resolution image sequences, and the processor’s performance of step (b)’s

extracting contour and character information from the images to create feature vectors, step (c)’s

recognizing and tracking items of inventory using the feature vectors and a recognition model, and

step (d)’s determining the physical location of the recognized items using the position of the item in

the image sequence(s) is not well‐understood, routine, conventional activity in this field. This

combination of limitations provides a hardware and software solution that improves upon previous

inventory management techniques by avoiding the cumbersome use of RFID and GPS transmitters

and the inaccuracy issues that plagued previous computer vision solutions. This combination of

features provide meaningful limitations to the practical application of inventory tracking with

computer vision, by improving the system’s ability to identify and track objects across multiple

cameras in a three‐dimensional space. These limitations do not simply limit the abstract idea to the

technological environment of image processing, but are instead meaningful limitations that integrate

the abstract idea into a particular application that uses character and contour information from high

resolution images to recognize items of inventory. When viewed as a combination, the additional

elements thus yield a claim as a whole that amounts to significantly more than the abstract idea of

inventorymanagement(Step 2B: Yes).The claim ispatent eligible.

If the examiner believes the record would benefit from clarification, remarks could be added to the

Office action orreasonsforallowanceindicating thattheclaim recitesthe abstract idea of inventory

management. Nevertheless, the claim is eligible because analyzing the claim elements in combination

demonstrates the claim is a particular application rather than well‐understood, routine, conventional

activityorsimplylimitingthe abstract ideatoaparticulartechnologicalenvironment.

December 2016 17