[Federal Register Volume 89, Number 137 (Wednesday, July 17, 2024)]
[Notices]
[Pages 58128-58138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15377]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No.: PTO-P-2024-0026]


2024 Guidance Update on Patent Subject Matter Eligibility, 
Including on Artificial Intelligence

AGENCY: Patent and Trademark Office, Department of Commerce.

ACTION: Examination guidance.

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SUMMARY: In accordance with Executive Order 14110 on the ``Safe, 
Secure, and Trustworthy Development and Use of Artificial 
Intelligence'' (October 30, 2023) (Executive Order), the United States 
Patent and Trademark Office (USPTO) is issuing a guidance update on 
patent subject matter eligibility to address innovation in critical and 
emerging technologies (ET), especially artificial intelligence (AI). 
This guidance update will assist USPTO personnel and stakeholders in 
evaluating the subject matter eligibility of claims in patent 
applications and patents involving inventions related to AI technology 
(AI inventions). This update also announces a new set of examples that 
are intended to assist USPTO personnel in applying the USPTO's subject 
matter eligibility guidance to AI inventions during patent examination, 
appeal, and post-grant proceedings. In addition to addressing issues 
especially relevant to AI inventions, this guidance update addresses 
feedback from our stakeholders and includes discussions of recent 
Federal Circuit decisions on patent subject matter eligibility. This 
guidance update, together with the guidance provided in the Manual of 
Patent Examining Procedure (MPEP), is to be used by USPTO personnel 
when applying subject matter eligibility law.

DATES: 
    Applicability date: This guidance is effective on July 17, 2024.
    Comment deadline date: Written comments must be received on or 
before September 16, 2024.

ADDRESSES: Comments must be submitted through the Federal eRulemaking 
Portal at www.regulations.gov. To submit comments via the portal, enter 
docket number PTO-P-2024-0026 on the homepage and select ``Search.'' 
The site will provide a search results page listing all documents 
associated with this docket. Find a reference to this document and 
select the ``Comment'' icon, complete the required fields, and enter or 
attach your comments. Attachments to electronic comments will be 
accepted in Adobe[supreg] portable document format (PDF) or Microsoft 
Word[supreg] format. Because comments will be made available for public 
inspection, information that the submitter does not desire to make 
public, such as an address or phone number, should not be included in 
the comments.
    Visit the Federal eRulemaking Portal for additional instructions on 
providing comments via the portal. If electronic submission of comments 
is not feasible due to a lack of access to a computer and/or the 
internet, please contact the USPTO using the contact information below 
for special instructions.

FOR FURTHER INFORMATION CONTACT: Carolyn Kosowski, Senior Legal

[[Page 58129]]

Advisor, at 571-272-7688; Nalini Mummalaneni, Senior Legal Advisor, at 
571-270-1647; or Matthew Sked, Senior Legal Advisor, at 571-272-7627, 
all with the Office of Patent Legal Administration, Office of the 
Deputy Commissioner for Patents.

SUPPLEMENTARY INFORMATION:

I. Background

    Recognizing that ``[r]esponsible AI use has the potential to help 
solve urgent challenges while making our world more prosperous, 
productive, innovative, and secure,'' President Biden issued Executive 
Order 14110.\1\ As its guiding principle, the Executive Order explains 
that:
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    \1\ Executive Order 14110, Safe, Secure, and Trustworthy 
Development and Use of Artificial Intelligence, 88 FR 75191 
(November 1, 2023).
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    Promoting responsible innovation, competition, and collaboration 
will allow the United States to lead in AI and unlock the technology's 
potential to solve some of society's most difficult challenges. This 
effort requires investments in AI-related education, training, 
development, research, and capacity, while simultaneously tackling 
novel intellectual property (IP) questions and other problems to 
protect inventors and creators.
    Section 5.2 (Promoting Innovation) of the Executive Order 
specifically provides that:
    (c) To promote innovation and clarify issues related to AI and 
inventorship of patentable subject matter, the Under Secretary of 
Commerce for Intellectual Property and Director of the United States 
Patent and Trademark Office (USPTO Director) shall:
* * * * *
    (ii) subsequently, within 270 days of the date of this order, issue 
additional guidance to USPTO patent examiners and applicants to address 
other considerations at the intersection of AI and IP, which could 
include, as the USPTO Director deems necessary, updated guidance on 
patent eligibility to address innovation in AI and critical and 
emerging technologies.
    In accordance with Executive Order 14110,\2\ the USPTO is issuing a 
guidance update on patent subject matter eligibility to address AI 
inventions. Pursuant to 35 U.S.C. 101, four categories of invention are 
appropriate subject matter for a patent: processes, machines, 
manufactures, and compositions of matter. On the other hand, the courts 
have found abstract ideas, laws of nature, and natural phenomena 
(including products of nature) to be outside of, or exceptions to, the 
appropriate subject matter for patents.\3\ This guidance update will 
assist USPTO personnel and stakeholders in evaluating the subject 
matter eligibility of claims in patent applications and patents 
involving AI inventions. This guidance update provides background on 
the USPTO's efforts related to AI and subject matter eligibility, an 
overview of the USPTO's existing patent subject matter eligibility 
guidance, and additional discussions of certain areas of the guidance 
that are particularly relevant to AI inventions.
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    \2\ Executive Order 14110, Safe, Secure, and Trustworthy 
Development and Use of Artificial Intelligence, 88 FR 75191 
(November 1, 2023).
    \3\ See MPEP 2106.
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    In addition to addressing AI inventions, this guidance update 
addresses feedback from our stakeholders and provides further 
explanation of Step 2A of the USPTO's subject matter eligibility 
analysis, which asks whether a claim is directed to a judicial 
exception that the courts have found to be outside of, or exceptions 
to, the four statutory categories of invention.\4\ Step 2A of the 
USPTO's subject matter eligibility analysis is a two-pronged inquiry in 
which USPTO personnel evaluate: (1) whether a claim recites an abstract 
idea or other judicial exception (at Step 2A, Prong One); and (2) if 
so, whether the claim as a whole integrates the recited judicial 
exception into a practical application of the exception, and thus is 
not ``directed to'' the judicial exception (at Step 2A, Prong Two). 
This guidance update also addresses the subject matter eligibility of 
AI-assisted inventions, which are inventions created by natural persons 
using one or more AI systems. Finally, it announces a new set of 
examples that are intended to assist USPTO personnel in applying the 
USPTO's subject matter eligibility guidance to AI inventions during 
patent examination, appeal, and post-grant proceedings. This guidance 
update, together with the direction provided in the MPEP, is to be used 
by USPTO personnel when making determinations of subject matter 
eligibility.
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    \4\ See MPEP 2106, 2106.04.
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A. The USPTO's AI/ET Efforts

    In August 2019, the USPTO issued a request for comments on 
patenting AI inventions.\5\ Among the various policy questions raised 
in the notice, the USPTO requested comments on whether there are any 
patent eligibility considerations unique to AI inventions. In October 
2020, the USPTO published a report titled ``Public Views on Artificial 
Intelligence and Intellectual Property Policy,'' which took a 
comprehensive look at the stakeholder feedback received in response to 
the questions posed in the August 2019 notice.\6\ According to the 
report, ``[a] majority of commenters agreed that AI is viewed best as a 
subset of computer-implemented inventions. Therefore, this majority 
felt that current USPTO guidance, especially on patent subject matter 
eligibility and disclosure of computer-implemented inventions, is 
equipped to handle advances in AI.'' \7\ However, some commenters were 
concerned that AI inventions are at risk under the subject matter 
eligibility analysis because they can be characterized as abstract 
ideas.\8\
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    \5\ Request for Comments on Patenting Artificial Intelligence 
Inventions, 84 FR 44889 (August 27, 2019).
    \6\ The full report is available at www.uspto.gov/sites/default/files/documents/USPTO_AI-Report_2020-10-07.pdf.
    \7\ Id. at iii.
    \8\ Id. at 8.
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    In June 2022, the USPTO held its inaugural AI/ET Partnership 
meeting, which included a panel discussion on ``Subject Matter 
Eligibility and the Impact of AI/ET Innovation.'' \9\ Following the 
inaugural meeting, the USPTO held numerous events in 2022 and 2023, 
including an AI and Biotech event, an AI-Driven Innovation event, and 
an AI Tools and Data event. Also in 2023, the USPTO issued a request 
for comments seeking stakeholder input on the current state of AI 
technologies and inventorship issues that may arise in view of the 
advancement of such technologies, especially as AI plays a greater role 
in the innovation process.\10\ Additionally, in 2023 the USPTO held 
public listening sessions on inventorship for AI-assisted inventions at 
the USPTO headquarters and at Stanford University. Recently, the USPTO 
issued several Federal Register Notices on AI. For example, on February 
13, 2024, the USPTO issued ``Inventorship Guidance for AI-Assisted 
Inventions,'' explaining the level of human contribution necessary for 
the USPTO to issue a patent on AI-assisted inventions.\11\ On April 11, 
2024, the USPTO issued ``Guidance on Use of Artificial Intelligence-
Based Tools in Practice Before the United States Patent and Trademark 
Office,'' informing practitioners and the public of the important 
issues that patent and trademark professionals, innovators,

[[Page 58130]]

and entrepreneurs must navigate while using AI in matters before the 
USPTO.\12\ On April 30, 2024, the USPTO issued a ``Request for Comments 
Regarding the Impact of the Proliferation of Artificial Intelligence on 
Prior Art, the Knowledge of a Person Having Ordinary Skill in the Art, 
and Determinations of Patentability Made in View of the Foregoing.'' 
\13\ This notice built on the USPTO's recent AI-related efforts 
associated with Executive Order 14110,\14\ including the ``Inventorship 
Guidance for AI-Assisted Inventions'' \15\ published on February 13, 
2024.
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    \9\ The recording is available at www.uspto.gov/about-us/events/aiet-partnership-series-1-kickoff-uspto-aiet-activities-and-patent-policy.
    \10\ Request for Comments Regarding Artificial Intelligence and 
Inventorship, 88 FR 9492 (February 14, 2023).
    \11\ Inventorship Guidance for AI-Assisted Inventions, 89 FR 
10043 (February 13, 2024).
    \12\ Guidance on Use of Artificial Intelligence-Based Tools in 
Practice Before the United States Patent and Trademark Office, 89 FR 
25609 (April 11, 2024).
    \13\ Request for Comments Regarding the Impact of the 
Proliferation of Artificial Intelligence on Prior Art, the Knowledge 
of a Person Having Ordinary Skill in the Art, and Determinations of 
Patentability Made in View of the Foregoing, 89 FR 34217 (April 30, 
2024).
    \14\ Executive Order 14110, Safe, Secure, and Trustworthy 
Development and Use of Artificial Intelligence, 88 FR 75191 
(November 1, 2023).
    \15\ Inventorship Guidance for AI-Assisted Inventions, 89 FR 
10043 (February 13, 2024).
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B. USPTO's Patent Subject Matter Eligibility Efforts

    The USPTO's ongoing efforts include monitoring subject matter 
eligibility developments in the courts, soliciting input from 
stakeholders, and issuing examination guidance to assist USPTO 
personnel and stakeholders. In 2019, the USPTO published two 
eligibility guidance documents: the ``2019 Revised Patent Subject 
Matter Eligibility Guidance'' (2019 PEG) \16\ and the ``October 2019 
Patent Eligibility Guidance Update'' (October 2019 Update).\17\ The 
2019 PEG and the October 2019 Update revised USPTO procedures for 
identifying abstract ideas and for determining whether a claim in a 
patent application (or patent) is directed to a judicial exception 
(laws of nature, natural phenomena, and abstract ideas) under Step 2A 
of the USPTO's subject matter eligibility guidance.\18\
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    \16\ 2019 Revised Patent Subject Matter Eligibility Guidance, 84 
FR 50 (January 7, 2019).
    \17\ October 2019 Patent Eligibility Guidance Update, 84 FR 
55942 (October 18, 2019).
    \18\ 2019 Revised Patent Subject Matter Eligibility Guidance, 84 
FR 50 (January 7, 2019); October 2019 Patent Eligibility Guidance 
Update, 84 FR 55942 (October 18, 2019).
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    The 2019 PEG and the October 2019 Update were incorporated into the 
MPEP in the June 2020 publication of the 9th Edition, Rev. 10.2019. 
This guidance on subject matter eligibility continues to be available 
in sections 2103-2106.07 of the current MPEP (9th Edition, Rev. 
07.2022), published in February 2023 and is the primary source for the 
USPTO's patent eligibility guidance.
    As part of its continued efforts to bring clarity and consistency 
to the application of the subject matter eligibility analysis, the 
USPTO has also issued 46 examples providing analysis of various fact 
patterns to assist USPTO personnel and stakeholders in evaluating 
subject matter eligibility. The examples address a wide range of 
technologies, including AI, biotechnology, business methods, diagnostic 
and treatment methods, pharmaceutical treatments, precision medicine, 
and software.\19\
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    \19\ A copy of the examples and the index are available on the 
USPTO's website at www.uspto.gov/PatentEligibility.
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    Following the issuance of the 2019 PEG and the October 2019 Update, 
the USPTO released a report titled ``Adjusting to Alice,'' which 
focuses on two USPTO patent examination outcomes and evaluates how 
these outcomes changed in response to the Supreme Court's decision in 
Alice Corp. v. CLS Bank International and the USPTO's guidance changes 
(e.g., the 2019 PEG).\20\ The report discusses a study undertaken by 
the USPTO's Office of the Chief Economist in April 2020, which found 
that the 2019 revisions to the eligibility guidance resulted in a 25% 
decrease in the likelihood of Alice-affected technologies, including 
AI, receiving a first office action with a rejection for patent 
ineligible subject matter. The report also found that uncertainty about 
determinations of subject matter eligibility for the relevant 
technologies decreased by a remarkable 44% as compared to the previous 
year.
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    \20\ The report is available at www.uspto.gov/sites/default/files/documents/OCE-DH_AdjustingtoAlice.pdf; Alice Corp. v. CLS Bank 
Int'l, 573 U.S. 208 (2014).
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    In June 2022, the USPTO published a report titled ``Patent eligible 
subject matter: Public views on the current jurisprudence in the United 
States,'' which summarized public views on how the current state of 
patent eligibility jurisprudence impacts investment and innovation in 
critical technologies, including AI.\21\ This report was requested by 
U.S. Senators Thom Tillis, Chris Coons, Mazie Hirono, and Tom Cotton, 
and summarized comments the USPTO received from a diverse group of 
stakeholders in response to a request for information the USPTO 
published in July 2021.\22\ According to the report, some commenters 
discussed how current subject matter eligibility jurisprudence impacts 
AI/ET and expressed ``concerns that uncertainty and unpredictability in 
the law are undermining U.S. economic and innovative development.'' 
\23\ In contrast, while ``all commenters recognized the importance of 
fostering AI and quantum computing technologies, not all commenters 
held the view that stronger or more robust patent rights for these 
areas would achieve such results,'' and some commenters even 
``advocated that AI innovations should be excluded from [subject 
matter] eligibility.'' \24\
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    \21\ Patent eligible subject matter: Public views on the current 
jurisprudence in the United States, available at www.uspto.gov/sites/default/files/documents/USPTO-SubjectMatterEligibility-PublicViews.pdf.
    \22\ Patent Eligibility Jurisprudence Study, 86 FR 36257 (July 
9, 2021).
    \23\ Patent eligible subject matter, 37.
    \24\ Id. at 38.
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    On July 25, 2022, the USPTO published a ``Director's Blog'' 
authored by Katherine K. Vidal, Under Secretary of Commerce for 
Intellectual Property and Director of the United States Patent and 
Trademark Office, titled ``Providing clear guidance on patent subject 
matter eligibility.'' The Director's Blog summarized the USPTO work on 
subject matter eligibility and emphasized that ``there is more work to 
be done'' to ``achieve a more consistent examination under Section 
101.'' \25\ The blog invited the public to comment on the subject 
matter eligibility guidance in MPEP 2106. The USPTO extended the period 
to comment on the blog via a Federal Register Notice.\26\
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    \25\ The blog is available at www.uspto.gov/blog/director/entry/providing-clear-guidance-on-patent?utm_campaign=subscriptioncenter&utm_content=&utm_medium=email&utm_name=&utm_source=govdelivery&utm_term=.
    \26\ Submission of Comments Regarding the Patent Subject Matter 
Eligibility Guidance, 87 FR 53736 (September 1, 2022).
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    As illustrated above, the USPTO has actively engaged with our 
stakeholders and has received extensive input from the public on 
subject matter eligibility and AI. In accordance with recent 
stakeholder feedback on the USPTO's subject matter eligibility guidance 
and the Executive Order 14110, and to continue its mission to drive 
U.S. innovation, inclusive capitalism, and global competitiveness as AI 
technology continues to advance and as judicial precedent evolves, the 
USPTO is providing a guidance update on determining subject matter 
eligibility for AI inventions to promote clarity, consistency, and 
address innovation in AI and critical and emerging technologies.

[[Page 58131]]

C. Summary of Guidance Update and Impact on Examination Procedure and 
Prior Examination Guidance

    Section II of this guidance update provides an overview of the 
USPTO's existing patent subject matter eligibility guidance. Section 
III provides an update on certain areas of the USPTO's subject matter 
eligibility guidance that are particularly relevant to AI inventions, 
including: (1) whether a claim recites an abstract idea (at Step 2A, 
Prong One of the USPTO's subject matter eligibility analysis); and (2) 
whether a claim integrates a recited judicial exception into a 
practical application because the claimed invention improves the 
functioning of a computer or another technology or technical field (at 
Step 2A, Prong Two of the USPTO's subject matter eligibility analysis). 
Section IV of this guidance update addresses AI-assisted inventions. 
Section V announces Examples 47-49, which are intended to assist 
examiners in applying the USPTO's subject matter eligibility guidance 
to AI inventions during the patent examination process. The USPTO has 
also produced an updated index of examples that includes the new set of 
examples. A copy of the examples and the index are available on the 
USPTO's website (www.uspto.gov/PatentEligibility).
    While this guidance update is focused on AI inventions, portions of 
this guidance can apply to other types of inventions. This guidance is 
not intended to announce any new USPTO practice or procedure and is 
meant to be consistent with existing USPTO guidance. However, if any 
earlier guidance from the USPTO, including any section of the current 
MPEP, is inconsistent with the guidance set forth in this notice, USPTO 
personnel are to follow this guidance. This guidance update will be 
incorporated into the MPEP in due course.
    This guidance does not constitute substantive rulemaking and does 
not have the force and effect of law. The guidance sets out agency 
policy with respect to the USPTO's interpretation of the subject matter 
eligibility requirement of 35 U.S.C. 101 in view of decisions by the 
Supreme Court and the United States Court of Appeals for the Federal 
Circuit (Federal Circuit). The guidance does not create any right or 
benefit, substantive or procedural, enforceable by any party against 
the USPTO. Rejections will continue to be based on the substantive law, 
and it is those rejections that are appealable to the Patent Trial and 
Appeal Board and the courts.

II. Overview of the USPTO's Patent Subject Matter Eligibility Guidance

    The USPTO's subject matter eligibility guidance is found in MPEP 
sections 2103-2106.07(c) and is used to analyze claims across all 
technologies, including AI inventions, which are generally considered 
to be computer-implemented inventions. For context for the AI-related 
discussion that follows, this subsection summarizes some of the 
existing guidance in the MPEP for those readers unfamiliar with the 
existing subject matter eligibility guidance.
    The guidance in the MPEP combines the criteria for eligibility into 
a single analysis, shown in the following flowchart, that applies to 
all categories of claims (i.e., process, machine, manufacture, and 
composition of matter) and all types of judicial exceptions (i.e., an 
abstract idea, law of nature, or natural phenomenon).\27\
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    \27\ MPEP 2106, subsection III provides a flowchart and an 
accompanying summary of the subject matter eligibility analysis. The 
flowchart in MPEP 2106, subsection III has been updated, as shown, 
to include reference to Alice/Mayo Steps 1 and 2 and to include a 
dotted line around Step 2A (Alice/Mayo Step 1).
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BILLING CODE 3510-16-P

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[GRAPHIC] [TIFF OMITTED] TN17JY24.000

BILLING CODE 3510-16-C
    Step 1 of the USPTO's subject matter eligibility analysis addresses 
whether the claimed invention falls into at least one of the four 
categories recited in 35 U.S.C. 101.\28\ Step 2 of the USPTO's subject 
matter eligibility analysis applies the Supreme Court's two-part 
framework (Alice/Mayo Steps 1 and 2 in the above flowchart) to identify 
claims that are directed to a judicial exception and to then evaluate 
if additional elements of the claim provide an inventive concept.
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    \28\ Prior to examining claims for eligibility, it is essential 
that the broadest reasonable interpretation (BRI) of the claim as a 
whole be established. The BRI sets the boundaries of the coverage 
sought by the claim and will influence whether the claim seeks to 
cover subject matter that is beyond the four statutory categories or 
encompasses subject matter that falls within the exceptions. See 
MPEP 2106, subsection II and 2111 for more information on 
determining the BRI. In addition, more information about Step 1 is 
provided in MPEP 2106.03.
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    Step 2A \29\ is a two-pronged inquiry as shown in the flowchart 
below.\30\
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    \29\ Step 2 corresponds to Step 1 of the Alice/Mayo test.
    \30\ This flowchart differs from the one in MPEP 2106.04, 
subsection II.A because it no longer refers to Step 2A as 
``Revised'' and includes the addition of the explanatory block 
``Step 2A: YES The claim is directed to a judicial exception.'' More 
information about Step 2A is provided in MPEP 2106.04 and its 
subparts.

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[GRAPHIC] [TIFF OMITTED] TN17JY24.001

    The first prong (Step 2A, Prong One) is a determination of whether 
a claim recites (i.e., sets forth or describes) a judicial 
exception.\31\ As explained in MPEP 2106.04, subsection II.A.1, a claim 
``recites'' a judicial exception when the judicial exception is ``set 
forth'' or ``described'' in the claim. If the claim does not recite a 
judicial exception, it is considered eligible, and the eligibility 
analysis ends. But if the claim does recite a judicial exception, the 
eligibility analysis continues to the second prong of Step 2A. This 
prong (Step 2A, Prong Two) is used to determine whether the claim 
integrates the recited judicial exception into a practical application 
of the exception (in which case the claim is eligible) or whether the 
claim is ``directed to'' the exception (in which case the claim 
requires further analysis at Step 2B). The Step 2A, Prong Two analysis 
requires an evaluation of the judicial considerations identified in 
MPEP 2106.04(d), subsection I; 2106.04(d)(1); 2106.04(d)(2); and 
2106.05(a)-(c) and (e)-(h), such as whether the additional element(s) 
is(are) insignificant extra-solution activity; whether the additional 
element(s) is(are) mere instruction to apply an exception; or whether 
the claim reflects an improvement in the functioning of a computer, or 
an improvement to another technology or technical field.\32\ If the 
additional element(s) in the claim integrates the judicial exception 
into a practical application of the exception, the claim is not 
``directed to'' the judicial exception, and the claim is eligible.\33\
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    \31\ For a detailed discussion of the judicial exceptions (i.e., 
an abstract idea, law of nature, or natural phenomenon) and how 
USPTO personnel determine whether a claim recites a judicial 
exception, see MPEP sections 2106.04(a)-(c).
    \32\ See MPEP 2106.04(d) for a discussion of Step 2A, Prong Two.
    \33\ Note that claims that are eligible at Step 2A, Prong 2 are 
also eligible at Step 2B. In addition, the improvements analysis 
performed at Step 2A, Prong 2 can also be performed at Step 2B. See 
MPEP 2106.04(d)(1) (``While the courts usually evaluate 
`improvements' as part of the `directed to' inquiry in part one of 
the Alice/Mayo test (equivalent to Step 2A), they have also 
performed this evaluation in part two of the Alice/Mayo test 
(equivalent to Step 2B).'' (citation omitted)).
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    If the claim is found to be directed to a judicial exception in 
Step 2A, the analysis continues to Step 2B \34\ to evaluate whether the 
claimed additional elements amount to significantly more than the 
recited judicial exception itself.\35\ Step 2A, Prong Two is similar to 
Step 2B in that both analyses involve evaluating a set of judicial 
considerations to determine if the claim is eligible.\36\ Although most 
of these judicial considerations overlap (i.e., they are evaluated in 
both Step 2A, Prong Two and Step 2B), Step 2B includes a consideration 
of whether the additional element (or combination of elements) is a 
well-understood, routine, conventional activity.\37\ A claim may be 
found to lack significantly more (and thus be ineligible) based on one 
or more of these judicial considerations (e.g., a conclusion that the 
additional limitation(s) is(are) insignificant extra-solution activity 
or mere instructions to apply an exception), in which case USPTO 
personnel will reject the claim under 35 U.S.C. 101 as lacking 
eligibility. If an eligibility rejection is based on a conclusion that 
an additional element or combination of elements is

[[Page 58134]]

well-understood, routine, conventional activity in the field, the 
rejection should contain factual support for this conclusion, in 
accordance with MPEP sections 2106.05(d), subsection I and 
2106.07(a).\38\
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    \34\ Step 2B corresponds to the second part of the Alice/Mayo 
test.
    \35\ See MPEP 2106.05, subsection I.
    \36\ See MPEP 2106.05(a)-(h) for the list of considerations that 
are evaluated at Step 2B.
    \37\ MPEP 2106.05, subsection II; MPEP 2106.07(a), subsection 
II. See also MPEP 2106.05(d).
    \38\ However, as explained in MPEP 2106.07(a), subsection III, 
``[a]t Step 2A Prong Two or Step 2B, there is no requirement for 
evidence to support a finding that the exception is not integrated 
into a practical application or that the additional elements do not 
amount to significantly more than the exception unless the examiner 
asserts that additional limitations are well-understood, routine, 
conventional activities in Step 2B.''
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    If USPTO personnel determine in Step 2B that the additional 
elements do amount to significantly more than the judicial exception, 
the claim is patent eligible. If the additional elements do not amount 
to significantly more, USPTO personnel will reject the claim under 35 
U.S.C. 101 as lacking patent eligibility, and the applicant will be 
given a chance to respond, for example, by amending the claim or by 
making a showing of why the claim is patent eligible.\39\ Regardless of 
whether an eligibility rejection is made, the USPTO personnel will also 
evaluate the claim to determine whether it meets the other requirements 
for patentability, such as novelty and non-obviousness and the 
requirements under 35 U.S.C. 112.
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    \39\ For more information on how examiners formulate rejections 
for a lack of subject matter eligibility and evaluate applicant 
responses thereto, see MPEP 2106.07 and its subparts.
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III. Update on Certain Areas of the USPTO's Patent Subject Matter 
Eligibility Guidance Applicable to AI Inventions

    While the Alice/Mayo test for analyzing subject matter eligibility 
has not changed, the MPEP has been updated to consolidate and 
incorporate all prior USPTO guidance and will continue to be updated as 
appropriate (e.g., to include recent court decisions).\40\ Feedback 
from our stakeholders indicates that when considering the subject 
matter eligibility of AI inventions, there are certain areas of 
particular concern: (1) the evaluation of whether a claim recites an 
abstract idea in Step 2A, Prong One; and (2) the evaluation of the 
improvements consideration in Step 2A, Prong Two.
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    \40\ Note, the current version of the MPEP [R-07.2022], 
published in February 2023, was up-to-date as of July 31, 2022. The 
revisions to MPEP 2103-2106.07(c) were to update case citations and 
did not update the subject matter eligibility guidance in the MPEP 
[R-10.2019], published in June 2020. See Change Summary and Title 
Page for the 9th Edition, Rev. 07.2022 of the MPEP.
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    Therefore, this guidance update provides a discussion of how to 
evaluate whether a claim recites an abstract idea (i.e., mathematical 
concepts, certain methods of organizing human activity, and mental 
processes) in Step 2A, Prong One based on the USPTO's current subject 
matter eligibility guidance. This inquiry can be challenging for AI 
inventions. This guidance update includes recent case law regarding 
mathematical concepts, certain methods of organizing human activity, 
and mental processes, which may be useful to USPTO personnel and 
stakeholders in evaluating Step 2A, Prong One. In addition, this 
guidance update provides further discussion of the evaluation of the 
improvements consideration in Step 2A, Prong Two based on the USPTO's 
current subject matter eligibility guidance. This discussion includes 
an explanation of how to demonstrate an improvement for AI inventions 
and recent case law that may be helpful in demonstrating such an 
improvement.

A. Evaluation of Whether a Claim Is Directed to a Judicial Exception 
(Step 2A)

    Claims directed to nothing more than a judicial exception (i.e., 
abstract ideas, natural phenomena, and laws of nature) are not eligible 
for patent protection.\41\ The Supreme Court has explained that the 
judicial exceptions reflect the Court's view that abstract ideas, laws 
of nature, and natural phenomena are ``the basic tools of scientific 
and technological work,'' and are thus excluded from patentability 
because ``monopolization of those tools through the grant of a patent 
might tend to impede innovation more than it would tend to promote 
it.'' \42\ Even if the judicial exception is narrow (e.g., a particular 
mathematical formula or detailed mental process), the Court has held 
that a claim may not preempt that judicial exception.\43\
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    \41\ See MPEP 2106.04, subsection I.
    \42\ Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216 
(2014) (quoting Association for Molecular Pathology v. Myriad 
Genetics, Inc., 569 U.S. 576, 589 (2013), and Mayo Collaborative 
Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71 (2012)).
    \43\ See Mayo, 566 U.S. at 79-80, 86-87 (2012). See also SAP 
Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1169 (Fed. Cir. 2018) 
(discussing how claims narrowing mathematical resampling operations 
to particular types of resampling ``add nothing outside the abstract 
realm'' and are still directed to ineligible abstract ideas).
---------------------------------------------------------------------------

    In applying subject matter eligibility law, the USPTO has developed 
the analysis discussed in section II above that uses a two-pronged 
inquiry to implement the first step of Alice (Step 2A of the USPTO's 
subject matter eligibly analysis). The first inquiry (Step 2A, Prong 
One, which asks whether a claim recites a judicial exception) is used 
to determine whether the claim is the type of claim that warrants 
further analysis under the law. There is no need to move to Step 2A, 
Prong Two if the claim does not recite a judicial exception in the 
first instance. Since all inventions ``at some level embody, use, 
reflect, rest upon, or apply laws of nature, natural phenomena, or 
abstract ideas,'' \44\ ``an invention is not rendered ineligible for 
patent simply because it involves'' a judicial exception.\45\ If the 
claim recites a judicial exception, that alone is not enough for the 
claim to be ``directed to'' the judicial exception. Under Step 2A, 
Prong Two, USPTO personnel must assess whether the claim as a whole 
integrates the judicial exception into a practical application of the 
exception, which is discussed below in section III.A.2.\46\
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    \44\ Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 
U.S. 66, 71 (2012).
    \45\ See Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 
217 (2014) (``[W]e tread carefully in construing this exclusionary 
principle lest it swallow all of patent law.'').
    \46\ MPEP 2106.04, subsection II.A.2.
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1. Evaluation of Whether a Claim Recites an Abstract Idea (Step 2A, 
Prong One)
    While it is common for claims to AI inventions to involve abstract 
ideas, USPTO personnel must draw a distinction between a claim that 
``recites'' an abstract idea (and thus requires further eligibility 
analysis) and one that merely involves, or is based on, an abstract 
idea.\47\ To assist in this evaluation, MPEP 2106.04(a)(1) provides 
non-limiting hypothetical examples of claims that do and do not recite 
an abstract idea. The USPTO has also issued examples that illustrate an 
analysis of claims that do and do not recite an abstract idea.\48\
---------------------------------------------------------------------------

    \47\ This guidance update specifically addresses the abstract 
idea exception, which is discussed in MPEP 2106.04(a). This guidance 
update does not specifically address laws of nature, natural 
phenomena, and products of nature, which are discussed in MPEP 
2106.04(b)-(c).
    \48\ These examples are available at www.uspto.gov/PatentEligibility.
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    This guidance update provides the following additional non-limiting 
hypothetical examples of claims that do not recite an abstract idea:
     An application-specific integrated circuit (ASIC) for an 
artificial neural network, the ASIC comprising: a plurality of neurons 
organized in an array, wherein each neuron comprises a register, a 
processing element and at least one input, and a plurality of synaptic 
circuits, each synaptic circuit including a memory for storing a 
synaptic weight, wherein each neuron is connected to at least one other 
neuron via one of the plurality of synaptic circuits.\49\
---------------------------------------------------------------------------

    \49\ Example 47 (claim 1), available at www.uspto.gov/PatentEligibility.

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[[Page 58135]]

     A system for monitoring health and activity in a herd of 
dairy livestock animals comprising: a memory; a processor coupled to 
the memory programmed with executable instructions, the instructions 
including a livestock interface for obtaining animal-specific 
information for a plurality of animals in the herd, wherein the animal-
specific information comprises animal identification data and at least 
one of body position data, body temperature data, feeding behavior 
data, and movement pattern data; and a herd monitor including (a) a 
radio frequency reader for collecting the animal-specific information 
from a plurality of animal sensors attached to the animals in the herd 
when the animal sensors are within proximity to the radio frequency 
reader, each animal sensor having a radio frequency transponder, and 
(b) a transmitter for transmitting the collected animal-specific 
information to the livestock interface.\50\
---------------------------------------------------------------------------

    \50\ Example 46 (claim 4), available at www.uspto.gov/PatentEligibility.
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     A treatment method comprising administering rapamycin to a 
patient identified as having Nephritic Autoimmune Syndrome Type 3 (NAS-
3).\51\
---------------------------------------------------------------------------

    \51\ Example 43 (claim 5), available at https://www.uspto.gov/PatentEligibility.
---------------------------------------------------------------------------

    MPEP 2106.04(a) instructs USPTO personnel to ``determine whether a 
claim recites an abstract idea by (1) identifying the specific 
limitation(s) in the claim under examination that the examiner believes 
recites an abstract idea, and (2) determining whether the identified 
limitations(s) fall within at least one of the groupings of abstract 
ideas'' (i.e., mathematical concepts, certain methods of organizing 
human activity, or mental processes) distilled from the relevant case 
law.\52\ The groupings of abstract ideas are defined in MPEP 
2106.04(a)(2). In addition to the examples already present in MPEP 
2106.04(a)(2), the following examples from Federal Circuit cases are 
informative. MPEP 2106.04(a)(2) will be updated in due course to 
include these examples, and the addition of these examples does not 
change the boundaries of the abstract idea groupings.
---------------------------------------------------------------------------

    \52\ See MPEP 2106.04(a) for additional information on abstract 
ideas.
---------------------------------------------------------------------------

a. Mathematical Concepts
    The USPTO's guidance on the ``mathematical concepts'' abstract idea 
grouping is found in MPEP 2106.04(a)(2), subsection I. USPTO guidance 
defines the mathematical concepts abstract idea grouping as 
mathematical relationships, mathematical formulas or equations, and 
mathematical calculations.\53\ A claim does not recite a mathematical 
concept (i.e., the claim limitations do not fall within the 
mathematical concept grouping) if it is only based on or involves a 
mathematical concept.\54\
---------------------------------------------------------------------------

    \53\ See MPEP 2106.04(a)(2), subsection I for further discussion 
of the mathematical concepts grouping.
    \54\ Id.
---------------------------------------------------------------------------

    As an example of claims that do not recite an abstract idea (e.g., 
a mathematical concept) or other judicial exception, in XY, LLC v. 
Trans Ova Genetics, 968 F.3d 1323, 1330-32 (Fed. Cir. 2020), the 
Federal Circuit determined that claims to a method of operating a flow 
cytometry apparatus to classify and sort particles into at least two 
populations in real time to more accurately classify similar particles 
was not directed to ``the abstract idea of using a `mathematical 
equation that permits rotating multi-dimensional data' '' even though 
they may have involved mathematical concepts.\55\ Applying the USPTO's 
guidance to the facts of this case would likewise result in a 
conclusion that the claims are not directed to an abstract idea. 
Specifically, these claims are eligible as not reciting a judicial 
exception at Step 2A, Prong One.
---------------------------------------------------------------------------

    \55\ See also MPEP 2106.04(a)(2), subsection I, which discusses 
Thales Visionix, Inc. v. United States, 850 F.3d 1343, 1348-49 (Fed. 
Cir. 2017) as an example of a claim that does not recite a 
mathematical concept.
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b. Certain Methods of Organizing Human Activity
    The USPTO's guidance on the ``certain methods of organizing human 
activity'' abstract idea grouping is found in MPEP 2106.04(a)(2), 
subsection II and describes concepts related to fundamental economic 
principles or practices (including hedging, insurance, mitigating 
risk); commercial or legal interactions (including agreements in the 
form of contracts, legal obligations, advertising, marketing or sales 
activities or behaviors, and business relations); and managing personal 
behavior or relationships or interactions between people (including 
social activities, teaching, and following rules or instructions). The 
term ``certain'' qualifies the ``certain methods of organizing human 
activity'' grouping, and as a result, not all methods of organizing 
human activity are abstract ideas.\56\ In addition, except in rare 
circumstances, this grouping should not be expanded beyond the activity 
within the enumerated sub-groupings of fundamental economic principles 
or practices, commercial or legal interactions, and managing personal 
behavior or relationships or interactions between people.\57\
---------------------------------------------------------------------------

    \56\ MPEP 2106.04(a)(2), subsection II (citation omitted).
    \57\ MPEP 2106.04(a)(3) explains the rare circumstances in which 
this grouping could be expanded.
---------------------------------------------------------------------------

    A discussion of concepts that are ``certain methods of organizing 
human activity'' is found in MPEP 2106.04(a)(2), subsection II. Below, 
the USPTO provides three additional examples of ``certain methods of 
organizing human activity'' based on Federal Circuit cases, which are 
not intended to change the scope of this abstract idea grouping:
     Claims to ``collect[ing] information on a user's movements 
and location history [and] electronically record[ing] that data'' 
(i.e., ``creating a digital travel log''), Weisner v. Google LLC, 51 
F.4th 1073, 1082 (Fed. Cir. 2022) (citation omitted). Under the USPTO's 
guidance, this is an example of ``managing personal behavior or 
relationships or interactions between people.''
     A claim to ``monitoring the location of a mobile thing and 
notifying a party in advance of arrival of that mobile thing [ ] 
amount[s] to nothing more than the fundamental business practice of 
providing advance notification of the pickup or delivery of a mobile 
thing,'' agreeing with the district court that ``business practices 
designed to advise customers of the status of delivery of their goods 
have existed at least for several decades, if not longer.'' Elec. 
Commc'n Techs., LLC v. ShoppersChoice.com, LLC, 958 F.3d 1178, 1181 
(Fed. Cir. 2020). Under the USPTO's guidance, this is an example of a 
fundamental economic principle or practice.
     Claims to methods for detecting fraud in financial 
transactions during a payment clearing process, including determining 
when there is a match between two financial records, sending a 
notification to a bank with authorization to process the financial 
transaction when there is a match, and sending a notification to a bank 
to not process the financial transaction when there is not a match, 
Bozeman Fin. LLC v. Fed. Reserve Bank of Atlanta, 955 F.3d 971, 978 
(Fed. Cir. 2020). Under the USPTO's guidance, this is an example of a 
fundamental economic principle or practice.
c. Mental Processes
    The USPTO's guidance on the ``mental processes'' abstract idea 
grouping is found in MPEP 2106.04(a)(2), subsection III. As

[[Page 58136]]

explained in the MPEP, ``[t]he courts consider a mental process 
(thinking) that `can be performed in the human mind, or by a human 
using a pen and paper' to be an abstract idea.'' \58\ USPTO guidance 
defines the ``mental processes'' abstract idea grouping as concepts 
performed in the human mind and explains that claims recite a mental 
process when they contain limitations that can practically be performed 
in the human mind, including, for example, observations, evaluations, 
judgments, and opinions.\59\ In contrast, USPTO guidance explains that 
claims do not recite a mental process when they contain limitations 
that cannot practically be performed in the human mind, for instance 
when the human mind is not equipped to perform the claim 
limitations.\60\ The mental processes grouping is not without limits, 
and as such, claim limitations that only encompass AI in a way that 
cannot practically be performed in the human mind do not fall within 
this grouping.
---------------------------------------------------------------------------

    \58\ MPEP 2106.04(a)(2), subsection III (citing CyberSource 
Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372 (Fed. Cir. 
2011)).
    \59\ MPEP 2106.04(a), subsection III.A.
    \60\ MPEP 2106.04(a)(2), subsection III.A (citing SRI Int'l, 
Inc. v. Cisco Sys., Inc., 930 F.3d 1295, 1304 (Fed. Cir. 2019) 
(declining to identify the claimed collection and analysis of 
network data as abstract because ``the human mind is not equipped to 
detect suspicious activity by using network monitors and analyzing 
network packets as recited by the claims''); CyberSource, 654 F.3d 
at 1376 (distinguishing Research Corp. Techs. v. Microsoft Corp., 
627 F.3d 859 (Fed. Cir. 2010), and SiRF Tech., Inc. v. Int'l Trade 
Comm'n, 601 F.3d 1319 (Fed. Cir. 2010), as directed to inventions 
that ``could not, as a practical matter, be performed entirely in a 
human's mind'').
---------------------------------------------------------------------------

    A discussion of concepts performed in the human mind, as well as 
concepts that cannot practically be performed in the human mind and 
thus are not ``mental processes,'' is found in MPEP 2106.04(a)(2), 
subsection III.A. Below, the USPTO provides further examples based on 
recent Federal Circuit cases. These additional examples are not 
intended to change the scope of the ``mental processes'' abstract idea 
grouping.
    Under the USPTO's guidance, an additional example of a claim that 
does not recite a mental process because it cannot be practically 
performed in the human mind includes:
     A claim to ``a specific, hardware-based RFID serial number 
data structure'' (i.e., an RFID transponder), where the data structure 
is uniquely encoded (i.e., there is ``a unique correspondence between 
the data physically encoded on the [RFID transponder] with pre-
authorized blocks of serial numbers''), ADASA Inc. v. Avery Dennison 
Corp., 55 F.4th 900, 909 (Fed. Cir. 2022).
    Additional examples of mental processes are:
     A claim to a method of ``(1) receiving user information; 
(2) providing a polling question; (3) receiving and storing an answer; 
(4) comparing that answer to generate a `likelihood of match' with 
other users; and (5) displaying certain user profiles based on that 
likelihood'' could practically be performed in the human mind (i.e., 
``[a] human mind could review people's answers to questions and 
identify matches based on those answers''), Trinity Info Media, LLC v. 
Covalent, Inc., 72 F.4th 1355, 1362 (Fed. Cir. 2023).
     A claim to ``the collection of information from various 
sources (a Federal database, a State database, and a case worker) and 
understanding the meaning of that information (determining whether a 
person is receiving SSDI benefits and determining whether they are 
eligible for benefits under the law),'' where `` `[t]hese steps can be 
performed by a human, using ``observation, evaluation, judgment, [and] 
opinion,'' because they involve making determinations and 
identifications, which are mental tasks humans routinely do,' '' and 
thus can practically be performed in the human mind, In re Killian, 45 
F.4th 1373, 1379 (Fed. Cir. 2022).
     Claims to ``the use of an algorithm-generated content-
based identifier to perform the claimed data-management functions,'' 
which include limitations to ``controlling access to data items,'' 
``retrieving and delivering copies of data items,'' and ``marking 
copies of data items for deletion,'' where the claims cover ``a medley 
of mental processes that, taken together, amount only to a multistep 
mental process,'' such that the steps can be practically performed in 
the human mind, PersonalWeb Techs. LLC v. Google LLC, 8 F.4th 1310, 
1316-18 (Fed. Cir. 2021).
2. Evaluation of Whether the Claim as a Whole Integrates the Judicial 
Exception Into a Practical Application of That Exception (Step 2A, 
Prong Two)
    If it is determined that a claim recites a judicial exception in 
Step 2A, Prong One, USPTO personnel evaluate whether the claim as a 
whole integrates the recited judicial exception into a practical 
application of the exception, and thus is not ``directed to'' the 
judicial exception, in Step 2A, Prong Two.\61\ USPTO personnel evaluate 
integration into a practical application by: (1) identifying whether 
there are any additional elements recited in the claim beyond the 
judicial exception(s), and (2) evaluating those additional elements 
individually and in combination to determine whether they integrate the 
exception into a practical application of that exception. As explained 
in MPEP 2106.04(d), subsection III, the Step 2A, ``Prong Two analysis 
considers the claim as a whole. That is, the limitations containing the 
judicial exception as well as the additional elements in the claim 
besides the judicial exception need to be evaluated together to 
determine whether the claim integrates the judicial exception into a 
practical application.''
---------------------------------------------------------------------------

    \61\ See MPEP 2106.04(d) for further discussion on evaluating 
whether a judicial exception is integrated into a practical 
application of that exception in Step 2A, Prong Two.
---------------------------------------------------------------------------

    This analysis is performed using one or more considerations 
identified by the courts, such as whether the additional elements 
improve the functioning of a computer or another technology, whether 
the claim generally links the judicial exception to a particular 
technological environment or field of use, or whether there is a step 
in the claim that applies or uses the judicial exception to effect a 
particular treatment or prophylaxis for a disease or medical 
condition.\62\ Step 2A, Prong Two specifically excludes consideration 
of whether the additional elements represent well-understood, routine, 
conventional activity. Instead, analysis of well-understood, routine, 
conventional activity is done in Step 2B. A claim that integrates a 
judicial exception into a practical application of the exception will 
apply, rely on, or use the judicial exception in a manner that imposes 
a meaningful limit on the judicial exception, such that the claim is 
more than a drafting effort designed to monopolize or preempt the 
judicial exception.
---------------------------------------------------------------------------

    \62\ The considerations evaluated in Step 2A, Prong Two are 
discussed in MPEP 2106.04(d), subsection I, and in more detail in 
MPEP 2106.04(d)(1), 2106.04(d)(2), 2106.05(a)-(c), and 2106.05(e)-
(h).
---------------------------------------------------------------------------

a. Evaluating Improvements in the Functioning of a Computer, or an 
Improvement to Any Other Technology or Technical Field
    One way to demonstrate integration of the judicial exception into a 
practical application is to show that the claimed invention improves 
the functioning of a computer or improves another technology or 
technical field.\63\ ``This consideration has also been referred to as 
the search for a technological solution to a technological problem.'' 
\64\

[[Page 58137]]

The application or use of the judicial exception in this manner 
meaningfully limits the claim by going beyond generally linking the use 
of the judicial exception to a particular technological environment, 
and thus transforms the claim into patent eligible subject matter.\65\ 
Such claims are eligible at Step 2A because they are not ``directed 
to'' the recited judicial exception.
---------------------------------------------------------------------------

    \63\ See MPEP 2106.04(d)(1) for a discussion of the improvements 
consideration in Step 2A, Prong Two.
    \64\ MPEP 2106.05(a).
    \65\ Diamond v. Diehr, 450 U.S. 175, 187-88 (1981) (Reasoning 
that ``a claim drawn to subject matter otherwise statutory does not 
become nonstatutory simply because it uses a mathematical formula,'' 
and holding that a ``process of curing synthetic rubber'' that 
``employ[ed] a well-known mathematical equation'' was patent 
eligible, even though the equation itself was not).
---------------------------------------------------------------------------

    Many claims to AI inventions are eligible as improvements to the 
functioning of a computer or improvements to another technology or 
technical field. While the courts have not provided an explicit test 
for how to evaluate the improvements consideration, they have instead 
illustrated how it is evaluated in numerous decisions. These decisions 
and a detailed explanation of how USPTO personnel should evaluate this 
consideration are provided in MPEP sections 2106.04(d)(1) and 
2106.05(a).
    A key point of distinction to be made for AI inventions is between 
a claim that reflects an improvement to a computer or other technology 
described in the specification (which is eligible) and a claim in which 
the additional elements amount to no more than (1) a recitation of the 
words ``apply it'' (or an equivalent) or are no more than instructions 
to implement a judicial exception on a computer, or (2) a general 
linking of the use of a judicial exception to a particular 
technological environment or field of use (which is ineligible).\66\ 
``An important consideration in determining whether a claim improves 
technology is the extent to which the claim covers a particular 
solution to a problem or a particular way to achieve a desired outcome, 
as opposed to merely claiming the idea of a solution or outcome.'' \67\ 
AI inventions may provide a particular way to achieve a desired outcome 
when they claim, for example, a specific application of AI to a 
particular technological field (i.e., a particular solution to a 
problem).\68\ In these situations, the claim is not merely to the idea 
of a solution or outcome and amounts to more than merely ``applying'' 
the judicial exception or generally linking the judicial exception to a 
field of use or technological environment. In other words, the claim 
reflects an improvement in a computer or other technology.\69\
---------------------------------------------------------------------------

    \66\ See MPEP 2106.05(a), (f), and (h) for guidance on these 
considerations.
    \67\ MPEP 2106.05(a).
    \68\ Example 47, claim 3, claiming a specific application of AI 
to the field of network intrusion detection; and Example 48, claims 
2 and 3, claiming a specific application of AI to the field of 
speech signal processing, which are available at uspto.gov/PatentEligibility.
    \69\ MPEP 2016.05(a); MPEP 2106.05(a), subsection II (``it is 
important to keep in mind that an improvement in the abstract idea 
itself (e.g., a recited fundamental economic concept) is not an 
improvement in technology''). See also in re Board of Trs. of Leland 
Stanford Junior Univ., 991 F.3d 1245, 1251 (Fed. Cir. 2021) 
(Stanford II) (concluding that the claims are ineligible because the 
improvement in ``the accuracy of a mathematically calculated 
statistical prediction'' is an improvement to the abstract idea 
(i.e., mathematical calculations) rather than an improvement to 
another technology).
---------------------------------------------------------------------------

    An improvement in the judicial exception itself is not an 
improvement in the technology.\70\ For example, in In re Board of 
Trustees of Leland Stanford Junior University, 989 F.3d 1367, 1370, 
1373 (Fed. Cir. 2021) (Stanford I), the applicant claimed methods of 
resolving a haplotype phase involving steps of determining an 
inheritance state based on received allele data using a Hidden Markov 
Model. The applicant further claimed determining a haplotype phase 
based on the pedigree data, the earlier-calculated inheritance state, 
transition probability data, and population linkage disequilibrium data 
using a computer system.\71\ The applicant argued that the claimed 
process was an improvement over prior processes because it ``yields a 
greater number of haplotype phase predictions,'' but the court found it 
was not ``an improved technological process'' and instead was an 
improved ``mathematical process.'' \72\ The court explained that such 
claims were directed to an abstract idea because they describe 
``mathematically calculating alleles' haplotype phase,'' like the 
``mathematical algorithms for performing calculations'' in prior 
cases.\73\ Notably, the Federal Circuit found that the claims did not 
reflect an improvement to a technological process, which would render 
the claims eligible.\74\
---------------------------------------------------------------------------

    \70\ See MPEP 2106.05(a), subsection II.
    \71\ Id.
    \72\ Id. at 1373.
    \73\ Id. at 1372-73.
    \74\ Id. at 1373-74.
---------------------------------------------------------------------------

    In contrast, an improvement can be provided by one or more 
additional elements or by the additional element(s) in combination with 
the recited judicial exception.\75\ An exemplary case illustrating such 
an improvement is McRO, Inc. v. Bandai Namco Games America Inc., 837 
F.3d 1299 (Fed. Cir. 2016), which is discussed extensively in the MPEP 
at, e.g., 2106.04(d)(1) and 2106.05(a). In McRO, the claims were to a 
rule-based system to animate the lip synchronization and facial 
expressions of three-dimensional characters.\76\ The Federal Circuit 
relied on the specification's explanation of how the claimed rules 
enabled the automation of specific animation tasks that previously 
could not be automated.\77\ The court indicated that it was the 
incorporation of the particular claimed rules in computer animation 
that ``improved [the] existing technological process.'' \78\ The court 
also noted that the claims at issue described a specific way (use of 
particular rules to set morph weights and transitions through phonemes) 
to solve the problem of producing accurate and realistic lip 
synchronization and facial expressions in animated characters, rather 
than merely claiming the idea of a solution or outcome, and thus the 
claims reflected the disclosed improvement in computer animation.\79\ 
Therefore, the court found the claims were not directed to an abstract 
idea.\80\ USPTO personnel accordingly should analyze the claim as a 
whole when determining whether the claim provides an improvement to the 
functioning of a computer or an improvement to another technology or 
technical field.\81\
---------------------------------------------------------------------------

    \75\ MPEP 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., 
Inc., 879 F.3d 1299, 1303-04 (Fed. Cir. 2018)) and 2106.05(a).
    \76\ McRO, Inc. v. Bandai Namco Games America Inc., 837 F.3d 
1299, 1307 (Fed. Cir. 2016).
    \77\ Id. at 1313.
    \78\ Id. at 1314-15.
    \79\ Id. at 1315.
    \80\ Id. at 1316.
    \81\ MPEP 2106.04(d)(1); MPEP 2106.05(a).
---------------------------------------------------------------------------

    Examples of claims that improve technology and are not directed to 
a judicial exception are found in MPEP sections 2106.04(d)(1) and 
2106.05(a). In addition, below the USPTO identifies other examples of 
claims that improve technology and are not directed to a judicial 
exception from Federal Circuit decisions:
     Claim to ``a specific, hardware-based RFID serial number 
data structure'' (i.e., an RFID transponder), where the data structure 
is uniquely encoded (i.e., there is ``a unique correspondence between 
the data physically encoded on the [RFID transponder] with pre-
authorized blocks of serial numbers''), such that it is ``a hardware-
based data structure focused on improvements to the technological 
process by which data is encoded,'' ADASA, 55 F.4th at 909.
     Claims to performing error correction and detection 
encoding where the information bits appear in a variable number of 
subsets were directed to an improvement of encoding data that relies in 
part on irregular

[[Page 58138]]

repetition and not an abstract idea, Cal. Inst. of Tech. v. Broadcom 
Ltd, 25 F.4th 976, 988 (Fed. Cir. 2022).
     Claims to a packet monitor to identify disjointed 
connection flows as belonging to the same conversational flow were 
directed to an improvement in computer technology and not an abstract 
idea, Packet Intel. LLC v. NetScout Sys., Inc., 965 F.3d 1299, 1308-10 
(Fed. Cir. 2020).
     Claims to a primary station for use in a communication 
system, where an additional data field is added to enable the primary 
station to simultaneously send inquiry messages and poll parked 
secondary stations, were directed to an improvement in computer 
functionality, namely the reduction of latency experienced by parked 
secondary stations in communication systems and not an abstract idea, 
Uniloc USA, Inc. v. LG Elec. USA, Inc., 957 F.3d 1303, 1305, 1307-08 
(Fed. Cir. 2020).
     Claims to a cardiac monitoring device that analyzes the 
variability in the beat-to-beat timing for atrial fibrillation and 
atrial flutter to more accurately detect the occurrence of these 
cardiac conditions were directed to an improvement in cardiac 
monitoring technology and not an abstract idea, CardioNet, LLC v. 
InfoBionic, Inc., 955 F.3d 1358, 1368-69 (Fed. Cir. 2020).
     Claims to varying the way check data is generated by 
modifying the permutation applied to different data blocks were 
directed to an improvement in a technological process for detecting 
systemic errors in data transmission and not an abstract idea, 
Koninklijke KPN N.V. v. Gemalto M2M GmbH, 942 F.3d 1143, 1150-51 (Fed. 
Cir. 2019).

IV. Applicability of the USPTO Eligibility Guidance to AI-Assisted 
Inventions

    For the subject matter eligibility analysis under 35 U.S.C. 101, 
whether an invention was created with the assistance of AI is not a 
consideration in the application of the Alice/Mayo test and USPTO 
eligibility guidance and should not prevent USPTO personnel from 
determining that a claim is subject matter eligible. In other words, 
how an invention is developed is not relevant to the subject matter 
eligibility inquiry. Instead, the inquiry focuses on the claimed 
invention itself and whether it is the type of innovation eligible for 
patenting.
    In contrast, the USPTO recently issued guidance on inventorship for 
AI-assisted inventions, which are inventions created by natural persons 
using one or more AI systems.\82\ The guidance explains that current 
statutes (e.g., 35 U.S.C. 101 and 115) do not provide for recognizing 
contributions by tools such as AI systems (or other advanced systems) 
for inventorship purposes, even if those AI systems were instrumental 
in the creation of the invention. However, AI-assisted inventions are 
not categorically unpatentable. Patent protection may be sought for AI-
assisted inventions where one or more persons made a significant 
contribution to the claimed invention.
---------------------------------------------------------------------------

    \82\ Inventorship Guidance for AI-Assisted Inventions, 89 FR 
10043, 10044 FN1 (February 13, 2024).
---------------------------------------------------------------------------

V. Examples

    The USPTO has developed new subject matter eligibility examples for 
AI inventions. The examples provide exemplary subject matter 
eligibility analyses under 35 U.S.C. 101 of hypothetical claims.
    Example 47 illustrates the application of the eligibility analysis 
to claims that recite limitations specific to AI, particularly the use 
of an artificial neural network to identify or detect anomalies. 
Example 48 illustrates the application of the eligibility analysis to 
claims that recite AI-based methods of analyzing speech signals and 
separating desired speech from extraneous or background speech. Example 
49 illustrates the analysis of method claims reciting an AI model that 
is designed to assist in personalizing medical treatment to the 
individual characteristics of a particular patient.
    These examples are intended to assist USPTO personnel and the 
public in understanding the proper application of the USPTO's subject 
matter eligibility guidance in certain fact-specific situations, such 
as whether a claim recites an abstract idea or whether a claim 
integrates the abstract idea into a practical application, because the 
claimed invention improves the functioning of a computer or another 
technology or technical field and thus is not ``directed to'' the 
abstract idea. The USPTO has also produced an updated index of 
examples, which includes examples issued prior to the publication of 
this guidance. A copy of the examples and the index are available on 
the USPTO's website (www.uspto.gov/PatentEligibility).

Katherine K. Vidal,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2024-15377 Filed 7-16-24; 8:45 am]
BILLING CODE 3510-16-P