[Federal Register Volume 89, Number 87 (Friday, May 3, 2024)]
[Rules and Regulations]
[Pages 36677-36679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09618]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

37 CFR Part 1

[Docket No. PTO-P-2024-0018]
RIN 0651-AD80


Adoption of Updated WIPO Standard ST.26; Revision to 
Incorporation by Reference

AGENCY: United States Patent and Trademark Office, Department of 
Commerce.

ACTION: Final rule.

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SUMMARY: The United States Patent and Trademark Office (USPTO) is 
adopting version 1.7 of World Intellectual Property Organization (WIPO) 
Standard ST.26, which was approved December 8, 2023, for incorporation 
by reference into the USPTO's regulations addressing application 
disclosures containing nucleotide and/or amino acid sequences. Among 
other enhancements, version 1.7 of ST.26 provides technical terminology 
consistency and improves descriptions.
    The USPTO first amended its rules in 2022 to incorporate by 
reference certain provisions of WIPO Standard ST.26. In addition to 
simplifying the process for applicants filing in multiple countries, 
the ST.26 requirement to submit a single sequence listing in eXtensible 
Markup Language (XML) format provides better preservation, 
accessibility, and sorting of the submitted sequence data for the 
public.

DATES: This final rule is effective on July 1, 2024. The incorporation 
by reference of certain publications listed in this rule is approved by 
the Director of the Federal Register as of July 1, 2024.

FOR FURTHER INFORMATION CONTACT: Ali Salimi, Senior Legal Advisor, at 
571-272-0909; or Raul Tamayo, Senior Legal Advisor, at 571-272-7728, 
both of the Office of Patent Legal Administration; or to 
[email protected].

SUPPLEMENTARY INFORMATION: The ``WIPO Handbook on Intellectual Property 
Information and Documentation'' sets forth standards for the 
presentation of data in many contexts. One such standard is WIPO 
Standard ST.26, which is titled ``RECOMMENDED STANDARD FOR THE 
PRESENTATION OF NUCLEOTIDE AND AMINO ACID SEQUENCE LISTINGS USING XML 
(EXTENSIBLE MARKUP LANGUAGE).'' WIPO Standard ST.26 defines the 
disclosures of nucleotide and/or amino acid sequences in patent 
applications that must be presented in a sequence listing in XML format 
in the manner specified in the standard.
    In a final rule published May 20, 2022, at 87 FR 30806, the USPTO 
created new rules 37 CFR 1.831-1.839 that incorporate by reference WIPO 
Standard ST.26. 37 CFR 1.839(b)(1) specifically identifies the version 
of WIPO Standard ST.26 that has been incorporated by reference. In a 
final rule published May 26, 2023, 88 FR 34089, the USPTO updated 37 
CFR 1.839(b)(1) to reflect version 1.6 of WIPO Standard ST.26. On 
December 8, 2023, WIPO adopted a new version (version 1.7) of WIPO 
Standard ST.26. As a result, the USPTO is again updating 37 CFR 
1.839(b)(1).
    WIPO provides free online public access to view copies of its 
standards, including version 1.7 of WIPO Standard ST.26, on its website 
at www.wipo.int/standards/en/part_03_standards.html. WIPO Standard 
ST.26 is also available on the USPTO's Sequence Listing Resource Center 
at www.uspto.gov/patents/apply/sequence-listing-resource-center.
    WIPO Standard ST.26 is comprised of eight documents: the main body 
of the standard, a first annex (Annex I) setting forth the controlled 
vocabulary for use with the main body, Annex II setting forth the 
Document Type Definition (DTD) for the Sequence Listing, Annex III 
containing a sequence listing specimen (XML file), Annex IV setting 
forth the character subset from the Unicode Basic Latin Code Table, 
Annex V setting forth additional data exchange requirements for IPOs, 
Annex VI containing a guidance document with illustrated examples, and 
Annex VII setting forth recommendations for the transformation of a 
sequence listing from WIPO Standard ST.25 format to WIPO Standard ST.26 
format, including guidance on how to avoid adding or deleting subject 
matter.
    Revisions to WIPO Standard ST.26 under version 1.7 affect the main 
body and Annex VI. The changes to the main body improve the consistency 
of technical terminology. In paragraph 3(f), all instances of ``3'-
monophosphate'' were changed to ``5'-monophosphate'' to be consistent 
with paragraph 3(g) and standard nucleotide naming conventions.
    Similarly, the changes to Annex VI improve consistency and clarity 
of terminology and correct technical errors. All instances of ``3'-
monophosphate'' were changed to ``5'-monophosphate'' to be consistent 
with the changes made to the main body. In Examples 14-1 and 30-2, 
scientific and grammatical corrections were made to clarify the example 
disclosures. In

[[Page 36678]]

addition, Annex VI includes two new examples that demonstrate how 
sequences with inverted nucleotides should be included in a sequence 
listing. Finally, the ``Example Index'' in Annex VI was simplified by 
removing the ``Cross-referenced examples.''
    Thus, the changes in version 1.7 of WIPO Standard ST.26 are 
ministerial changes that will not have a meaningful substantive impact 
on disclosing parties.

Discussion of Specific Rules

    Section 1.839: Section 1.839(b)(1) is amended to provide an updated 
citation to version 1.7 of WIPO Standard ST.26 that is being 
incorporated by reference.

Rulemaking Considerations

    A. Administrative Procedure Act: The changes in this rulemaking 
involve rules of agency practice and procedure and/or interpretive 
rules. See Bachow Commc'ns Inc. v. FCC, 237 F.3d 683, 690 (D.C. Cir. 
2001) (changes to procedural rules are not subject to notice and 
comment review under the Administrative Procedure Act (APA)); Inova 
Alexandria Hosp. v. Shalala, 244 F.3d 342, 349 (4th Cir. 2001) (rules 
for handling appeals are procedural where they do not change the 
substantive standard for reviewing claims); Nat'l Org. of Veterans' 
Advocates v. Sec'y of Veterans Affairs, 260 F.3d 1365, 1375 (Fed. Cir. 
2001) (Substantive rules ``effect a change in existing law or policy or 
which affect individual rights and obligations,'' whereas 
interpretative rules ``clarify or explain existing law or regulation 
and are exempt from notice and comment'' review under the APA.).
    Accordingly, prior notice and opportunity for public comment for 
the changes in this rulemaking are not required pursuant to 5 U.S.C. 
553(b) or (c) or any other law. See Cooper Techs. Co. v. Dudas, 536 
F.3d 1330, 1336-37 (Fed. Cir. 2008) (stating that 5 U.S.C. 553, and 
thus 35 U.S.C. 2(b)(2)(B), do not require notice and comment rulemaking 
for ``interpretative rules, general statements of policy, or rules of 
agency organization, procedure, or practice'' (quoting 5 U.S.C. 
553(b)(A))).
    In addition, the USPTO finds good cause pursuant to the authority 
at 5 U.S.C. 553(b)(B) to dispense with prior notice and opportunity for 
public comment because such procedures are unnecessary in this 
instance. The changes in this rulemaking merely update the regulations 
to incorporate by reference version 1.7 of WIPO Standard ST.26, which 
was adopted on December 8, 2023, by the WIPO Committee on Standards. 
These revisions are largely procedural in nature, and do not impose any 
additional requirements or fees on applicants. Thus, the USPTO 
implements this final rule without prior notice and opportunity for 
comment.
    B. Regulatory Flexibility Act: As prior notice and an opportunity 
for public comment are not required pursuant to 5 U.S.C. 553 or any 
other law, neither a Regulatory Flexibility Act analysis nor a 
certification under the Regulatory Flexibility Act (5 U.S.C. 601 et 
seq.) is required. See 5 U.S.C. 603.
    C. Executive Order 12866 (Regulatory Planning and Review): This 
rulemaking has been determined to be not significant for purposes of 
Executive Order 12866 (September 30, 1993), as amended by Executive 
Order 14094 (April 6, 2023).
    D. Executive Order 13563 (Improving Regulation and Regulatory 
Review): The USPTO has complied with Executive Order 13563 (January 18, 
2011). Specifically, and as discussed above, the USPTO has, to the 
extent feasible and applicable: (1) reasonably determined that the 
benefits of the rule justify its costs; (2) tailored the rule to impose 
the least burden on society consistent with obtaining the agency's 
regulatory objectives; (3) selected a regulatory approach that 
maximizes net benefits; (4) specified performance objectives; (5) 
identified and assessed available alternatives; (6) involved the public 
in an open exchange of information and perspectives among experts in 
relevant disciplines, affected stakeholders in the private sector, and 
the public as a whole, and provided online access to the rulemaking 
docket; (7) attempted to promote coordination, simplification, and 
harmonization across government agencies and identified goals designed 
to promote innovation; (8) considered approaches that reduce burdens 
while maintaining flexibility and freedom of choice for the public; and 
(9) ensured the objectivity of scientific and technological information 
and processes.
    E. Executive Order 13132 (Federalism): This rulemaking pertains 
strictly to federal agency procedures and does not contain policies 
with federalism implications sufficient to warrant preparation of a 
Federalism Assessment under Executive Order 13132 (August 4, 1999).
    F. Executive Order 13175 (Tribal Consultation): This rulemaking 
will not: (1) have substantial direct effects on one or more Indian 
tribes; (2) impose substantial direct compliance costs on Indian tribal 
governments; or (3) preempt tribal law. Therefore, a tribal summary 
impact statement is not required under Executive Order 13175 (November 
6, 2000).
    G. Executive Order 13211 (Energy Effects): This rulemaking is not a 
significant energy action under Executive Order 13211 because this 
rulemaking is not likely to have a significant adverse effect on the 
supply, distribution, or use of energy. Therefore, a Statement of 
Energy Effects is not required under Executive Order 13211 (May 18, 
2001).
    H. Executive Order 12988 (Civil Justice Reform): This rulemaking 
meets applicable standards to minimize litigation, eliminate ambiguity, 
and reduce burden as set forth in sections 3(a) and 3(b)(2) of 
Executive Order 12988 (February 5, 1996).
    I. Executive Order 13045 (Protection of Children): This rulemaking 
does not concern an environmental risk to health or safety that may 
disproportionately affect children under Executive Order 13045 (April 
21, 1997).
    J. Executive Order 12630 (Taking of Private Property): This 
rulemaking will not effect a taking of private property or otherwise 
have taking implications under Executive Order 12630 (March 15, 1988).
    K. Congressional Review Act: Under the Congressional Review Act 
provisions of the Small Business Regulatory Enforcement Fairness Act of 
1996 (5 U.S.C. 801 et seq.), the USPTO will submit a report containing 
the final rule and other required information to the United States 
Senate, the United States House of Representatives, and the Comptroller 
General of the Government Accountability Office. The changes in this 
rulemaking are not expected to result in an annual effect on the 
economy of $100 million or more, a major increase in costs or prices, 
or significant adverse effects on competition, employment, investment, 
productivity, innovation, or the ability of United States-based 
enterprises to compete with foreign-based enterprises in domestic and 
export markets. Therefore, this rulemaking is not expected to result in 
a ``major rule'' as defined in 5 U.S.C. 804(2).
    L. Unfunded Mandates Reform Act of 1995: The changes set forth in 
this rulemaking do not involve a Federal intergovernmental mandate that 
will result in the expenditure by State, local, and tribal governments, 
in the aggregate, of $100 million (as adjusted) or more in any one 
year, or a Federal private sector mandate that will result in the 
expenditure by the private sector of $100 million (as adjusted) or more 
in any one year, and will not significantly or uniquely affect small 
governments. Therefore, no actions are necessary under the provisions 
of the Unfunded

[[Page 36679]]

Mandates Reform Act of 1995. See 2 U.S.C. 1501 et seq.
    M. National Environmental Policy Act of 1969: This rulemaking will 
not have any effect on the quality of the environment and is thus 
categorically excluded from review under the National Environmental 
Policy Act of 1969. See 42 U.S.C. 4321 et seq.
    N. National Technology Transfer and Advancement Act of 1995: The 
requirements of section 12(d) of the National Technology Transfer and 
Advancement Act of 1995 (15 U.S.C. 272 note) are not applicable because 
this rulemaking does not contain provisions that involve the use of 
technical standards.
    O. Paperwork Reduction Act of 1995: This final rule does not impact 
information collection requirements that are subject to review by the 
Office of Management and Budget (OMB) under the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.).
    Notwithstanding any other provision of law, no person is required 
to respond to, nor shall a person be subject to a penalty for failure 
to comply with, a collection of information subject to the requirements 
of the Paperwork Reduction Act unless that collection of information 
has a currently valid OMB control number.
    P. E-Government Act Compliance: The USPTO is committed to 
compliance with the E-Government Act to promote the use of the internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes.

List of Subjects in 37 CFR Part 1

    Administrative practice and procedure, Biologics, Courts, Freedom 
of information, Incorporation by reference, Inventions and patents, 
Reporting and recordkeeping requirements, Small businesses.

    For the reasons stated in the preamble and under the authority 
contained in 35 U.S.C. 2, as amended, the USPTO amends 37 CFR part 1 as 
follows:

PART 1--RULES OF PRACTICE IN PATENT CASES

0
1. The authority citation for part 1 continues to read as follows:

    Authority: 35 U.S.C. 2(b)(2), unless otherwise noted.


0
2. In Sec.  1.839, revise paragraph (b)(1) to read as follows:


Sec.  1.839  Incorporation by reference.

* * * * *
    (b) * * *
    (1) WIPO Standard ST.26. WIPO Handbook on Intellectual Property 
Information and Documentation, Standard ST.26: Recommended Standard for 
the Presentation of Nucleotide and Amino Acid Sequence Listings Using 
XML (eXtensible Markup Language) including Annexes I-VII, version 1.7, 
approved December 8, 2023; IBR approved for Sec. Sec.  1.831 through 
1.834.
* * * * *

Katherine K. Vidal,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2024-09618 Filed 5-2-24; 8:45 am]
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