[Federal Register Volume 88, Number 102 (Friday, May 26, 2023)]
[Rules and Regulations]
[Pages 34089-34091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11365]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

37 CFR Part 1

[Docket No. PTO-P-2023-0013]
RIN 0651-AD69


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 or 
Office) is adopting the recently revised World Intellectual Property 
Organization (WIPO) Standard ST.26, version 1.6, approved November 25, 
2022, for incorporation by reference into its regulations addressing 
application disclosures containing nucleotide and/or amino acid 
sequences. The USPTO is also correcting a grammatical oversight in one 
of its sequence regulations. 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 Mark-up Language (XML) format provides better 
preservation, accessibility, and sorting of the submitted sequence data 
for the public. Among other improvements, the new version of ST.26 
clarifies requirements, improves descriptions, and corrects editorial 
mistakes.

DATES: This final rule is effective on July 1, 2023. The incorporation 
by reference of certain publications listed in this rule is approved by 
the Director of the Federal Register as of July 1, 2023.

FOR FURTHER INFORMATION CONTACT: Mary C. Till, Senior Legal Advisor, 
Office of Patent Legal Administration, Office of the Deputy 
Commissioner for Patents, at [email protected] or 571-272-7755; or 
Ali Salimi, Senior Legal Advisor, Office of Patent Legal 
Administration, Office of the Deputy Commissioner for Patents, at 
[email protected] or 571-272-0909.

SUPPLEMENTARY INFORMATION: The ``WIPO Handbook on Intellectual Property 
Information and Documentation'' (formerly the ``WIPO Handbook on 
Industrial 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 rulemaking 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 as 
``version 1.5, approved November 5, 2021.'' On November 25, 2022, WIPO 
adopted a new version (version 1.6) of WIPO Standard ST.26. As a 
result, the USPTO is updating 37 CFR 1.839(b)(1) to reflect the new 
version.
    WIPO provides free online public access to view copies of its 
standards. WIPO standards that are incorporated into Federal 
regulations are available to the public for free viewing on WIPO's 
website at https://www.wipo.int/export/sites/www/standards/en/pdf/03-26-01_v1_6.pdf. In addition to the free online availability of this 
standard on WIPO's website, WIPO Standard ST.26 is available on the 
USPTO's Sequence Listing Resource Center at https://www.uspto.gov/patents/apply/sequence-listing-resource-center.
    WIPO Standard ST.26 is composed of eight documents, namely, the 
main body of the standard, a first annex (Annex I) setting forth the 
controlled vocabulary for use with the main body, a second annex (Annex 
II) setting forth the Document Type Definition (DTD) for the Sequence 
Listing, a third annex (Annex III) containing a sequence listing 
specimen (XML file), a fourth annex (Annex IV) setting forth the 
character subset from the Unicode Basic Latin Code Table, a fifth annex 
(Annex V) setting forth additional data exchange requirements for IPOs, 
a sixth annex (Annex VI) containing a guidance document with 
illustrated examples, and a seventh annex (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 the newly adopted version 
affect the main body, Annex I, Annex II, Annex VI, and Annex VII. The 
changes to the main body serve to clarify requirements, improve 
descriptions (for example, by better defining the value

[[Page 34090]]

needed for an application number), and correct editorial mistakes. 
Similarly, the changes to Annex I, Annex II and Annex VII clarify the 
format of values for identifiers that are part of the ``Sequence 
Listing XML,'' revise grammar, and clarify values that are language-
dependent. Annex VI includes three new examples of the manner in which 
(1) a circular nucleotide sequence is exemplified, (2) a post-
translationally modified amino acid is exemplified, and (3) 
representation of a single sequence with enumerated alternative amino 
acids that may be modified amino acids is exemplified. Throughout the 
main body of WIPO Standard ST.26, reference to ``international, 
national or regional procedures'' have been updated to reflect that 
order for consistency. Furthermore, all instances of ``industrial 
property'' in the main body of WIPO Standard ST.26 have been updated to 
``intellectual property.'' Thus, the changes in newly adopted version 
1.6 of WIPO Standard ST.26 are ministerial changes that will not have a 
meaningful substantive impact on disclosing parties.
    Additionally, the USPTO revises 37 CFR 1.831(a) to correct a 
grammatical oversight. 37 CFR 1.831(d) corresponds to WIPO Standard 
ST.26, paragraph 3(c)(i) and (ii), and recites ``enumeration of its 
residues,'' but 37 CFR 1.831(a), as implemented in the May 2022 
rulemaking, recited ``enumeration of their residues.'' This grammatical 
error was an oversight, and the changes in Sec.  1.831(a) to replace 
``enumeration of their residues'' with ``enumeration of its residues'' 
do not impact compliance with how an amino acid and/or nucleotide 
sequence(s), which is enumerated by its residues, must be shown in the 
``Sequence Listing XML.''

Discussion of Specific Rules

    Section 1.831: Section 1.831(a) is amended to replace ``Patent 
applications disclosing nucleotide and/or amino acid sequences by 
enumeration of their residues . . .'' with ``Patent applications 
disclosing a nucleotide and/or amino acid sequence(s) by enumeration of 
its residues . . .'' for consistency with Sec.  1.831(d) and WIPO 
Standard ST.26, paragraph 3(c)(i) and (ii), to which Sec.  1.831(d) 
corresponds. A subsequent iteration of ``nucleotide and/or amino acid 
sequences'' in Sec.  1.831(a) is revised to ``nucleotide and/or amino 
acid sequence(s)'' for consistency.
    Section 1.839: Section 1.839(b)(1) is amended to provide an updated 
citation to the WIPO Standard ST.26 that is being incorporated by 
reference. Additionally, Sec.  1.839(b)(1) is revised to reflect an 
update to the name of the WIPO handbook. Specifically, the ``WIPO 
Handbook on Industrial Property Information and Documentation'' is now 
the ``WIPO Handbook on Intellectual Property Information and 
Documentation.''

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 Office 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 1.6 of WIPO Standard ST.26, which 
was adopted on November 25, 2022, by the WIPO Committee on Standards, 
and to make a correction to the regulations at 37 CFR 1.831(a) to 
correct a grammatical oversight in a definition. 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 (Sept. 30, 1993).
    D. Executive Order 13563 (Improving Regulation and Regulatory 
Review): The USPTO has complied with Executive Order 13563 (Jan. 18, 
2011). Specifically, to the extent feasible and applicable, the USPTO 
has: (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 does not 
contain policies with federalism implications sufficient to warrant 
preparation of a Federalism Assessment under Executive Order 13132 
(Aug. 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 (Nov. 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

[[Page 34091]]

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 (Feb. 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 (Apr. 
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 (Mar. 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 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.  1.831, revise paragraph (a) to read as follows:


Sec.  1.831  Requirements for patent applications filed on or after 
July 1, 2022, having nucleotide and/or amino acid sequence disclosures.

    (a) Patent applications disclosing a nucleotide and/or amino acid 
sequence(s) by enumeration of its residues, as defined in paragraph (b) 
of this section, must contain, as a separate part of the disclosure, a 
computer readable Sequence Listing in XML format (a ``Sequence Listing 
XML''). Disclosed nucleotide or amino acid sequences that do not meet 
the definition in paragraph (b) of this section must not be included in 
the ``Sequence Listing XML.'' The ``Sequence Listing XML'' contains the 
information of the nucleotide and/or amino acid sequence(s) disclosed 
in the patent application using the symbols and format in accordance 
with the requirements of Sec. Sec.  1.832 through 1.834.
* * * * *


0
3. 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 1.6, 
approved November 25, 2022; 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. 2023-11365 Filed 5-25-23; 8:45 am]
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