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

Published date03 May 2024
Record Number2024-09618
Citation89 FR 36677
CourtPatent And Trademark Office
SectionRules and Regulations
Federal Register, Volume 89 Issue 87 (Friday, May 3, 2024)
[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 []
                [FR Doc No: 2024-09618]
                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
                ACTION: Final rule.
                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
                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
                (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
                 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 WIPO Standard
                ST.26 is also available on the USPTO's 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
                 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.
                 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
                 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,
                 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
                1. The authority citation for part 1 continues to read as follows:
                 Authority: 35 U.S.C. 2(b)(2), unless otherwise noted.
                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
                * * * * *
                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]
                BILLING CODE 3510-16-P

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