[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 3510-16-P