Rule2023-11365
Adoption of Updated WIPO Standard ST.26; Revision to Incorporation by Reference
Primary source
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Published
May 26, 2023
Effective
July 1, 2023
Issuing agencies
Commerce DepartmentPatent and Trademark Office
Abstract
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.
Full Text
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="/cdn-cgi/l/email-protection#f9b4988b80d7ad909595b98c8a898d96d79e968f"><span class="__cf_email__" data-cfemail="7a371b0803542e1316163a0f090a0e15541d150c">[email protected]</span></a> or 571-272-7755; or
Ali Salimi, Senior Legal Advisor, Office of Patent Legal
Administration, Office of the Deputy Commissioner for Patents, at
<a href="/cdn-cgi/l/email-protection#8ccde0e5a2dfede0e5e1e5ccf9fffcf8e3a2ebe3fa"><span class="__cf_email__" data-cfemail="07466b6e2954666b6e6a6e47727477736829606871">[email protected]</span></a> 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 <a href="https://www.wipo.int/export/sites/www/standards/en/pdf/03-26-01_v1_6.pdf">https://www.wipo.int/export/sites/www/standards/en/pdf/03-26-01_v1_6.pdf</a>. 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 <a href="https://www.uspto.gov/patents/apply/sequence-listing-resource-center">https://www.uspto.gov/patents/apply/sequence-listing-resource-center</a>.
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.
* * * * *
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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]
BILLING CODE 3510-16-P
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