(a) Certain material is incorporated by reference into this subpart with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the USPTO and at the National Archives and Records Administration (NARA). Contact the USPTO’s Office of Patent Legal Administration at 571–272–7701. For information on the availability of this material at NARA, email fr.inspection@nara.gov or go to www.archives.gov/federal-register/cfr/ibr-locations.html. The material may be obtained from the source(s) in paragraph (b) of this section.

(a) Certain material is incorporated by reference into this subpart with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the USPTO and at the National Archives and Records Administration (NARA). Contact the USPTO’s Office of Patent Legal Administration at 571–272–7701. For information on the availability of this material at NARA, email fr.inspection@nara.gov or go to www.archives.gov/federal-register/cfr/ibr-locations.html. The material may be obtained from the source(s) in paragraph (b) of this section.

(a) Certain material is incorporated by reference into this subpart with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the USPTO and at the National Archives and Records Administration (NARA). Contact the USPTO’s Office of Patent Legal Administration at 571–272–7701. For information on the availability of this material at NARA, email fr.inspection@nara.gov or go to www.archives.gov/federal-register/cfr/ibr-locations.html. The material may be obtained from the source(s) in paragraph (b) of this section.

(a) Certain material is incorporated by reference into this subpart with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the USPTO and at the National Archives and Records Administration (NARA). Contact the USPTO’s Office of Patent Legal Administration at 571–272–7701. For information on the availability of this material at NARA, email fr.inspection@nara.gov or go to www.archives.gov/federal-register/cfr/ibr-locations.html. The material may be obtained from the source(s) in paragraph (b) of this section.

(a) Certain material is incorporated by reference into this subpart with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the USPTO and at the National Archives and Records Administration (NARA). Contact the USPTO’s Office of Patent Legal Administration at 571–272–7701. For information on the availability of this material at NARA, email fr.inspection@nara.gov or go to www.archives.gov/federal-register/cfr/ibr-locations.html. The material may be obtained from the source(s) in paragraph (b) of this section.

For ease of access, WIPO Standard ST.26 can be found at: www.wipo.int/export/sites/www/standards /en/pdf/03-26-01.pdf

[Editor Note: This section is applicable to all applications with a filing date, or, for national phase applications, an international filing date, on or after July 1, 2022, having disclosure of one or more nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(b).]

Patent applications that disclose a nucleotide and/or amino acid sequence(s) by enumeration of its residues, as defined in 37 CFR 1.831(b), must present each sequence and associated sequence data in a standardized electronic eXtensible Markup Language (XML) format, (a “Sequence Listing XML”) as a separate part of the specification. This standardized format is set forth in the World Intellectual Property Organization (WIPO) Standard ST.26, and applies to sequence listings in international applications filed under the Patent Cooperation Treaty (PCT) and in national and regional applications filed in the intellectual property offices (IPOs) of WIPO member states. As a result, a single sequence listing in compliance with WIPO Standard ST.26 can be prepared for use in all IPOs of WIPO member states. The regulatory provisions found at 37 CFR 1.831 – 1.835 implement WIPO Standard ST.26 in the USPTO and set forth requirements for presenting sequence data in patent applications filed on or after July 1, 2022, that disclose nucleotide sequences and/or amino acid sequences.

Patent applications that disclose a nucleotide and/or amino acid sequence(s) by enumeration of its residues, as defined in 37 CFR 1.831(b), must present each sequence and associated sequence data in a standardized electronic eXtensible Markup Language (XML) format, (a “Sequence Listing XML”) as a separate part of the specification. This standardized format is set forth in the World Intellectual Property Organization (WIPO) Standard ST.26, and applies to sequence listings in international applications filed under the Patent Cooperation Treaty (PCT) and in national and regional applications filed in the intellectual property offices (IPOs) of WIPO member states. As a result, a single sequence listing in compliance with WIPO Standard ST.26 can be prepared for use in all IPOs of WIPO member states. The regulatory provisions found at 37 CFR 1.831 – 1.835 implement WIPO Standard ST.26 in the USPTO and set forth requirements for presenting sequence data in patent applications filed on or after July 1, 2022, that disclose nucleotide sequences and/or amino acid sequences.

(b) World Intellectual Property Organization (WIPO), 34 chemin des Colombettes, 1211 Geneva 20 Switzerland, www.wipo.int.

• (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 §§ 1.831 through 1.834.
• (2) [Reserved]

Patent applications that disclose a nucleotide and/or amino acid sequence(s) by enumeration of its residues, as defined in 37 CFR 1.831(b), must present each sequence and associated sequence data in a standardized electronic eXtensible Markup Language (XML) format, (a “Sequence Listing XML”) as a separate part of the specification. This standardized format is set forth in the World Intellectual Property Organization (WIPO) Standard ST.26, and applies to sequence listings in international applications filed under the Patent Cooperation Treaty (PCT) and in national and regional applications filed in the intellectual property offices (IPOs) of WIPO member states. As a result, a single sequence listing in compliance with WIPO Standard ST.26 can be prepared for use in all IPOs of WIPO member states. The regulatory provisions found at 37 CFR 1.831 – 1.835 implement WIPO Standard ST.26 in the USPTO and set forth requirements for presenting sequence data in patent applications filed on or after July 1, 2022, that disclose nucleotide sequences and/or amino acid sequences.

Patent applications that disclose a nucleotide and/or amino acid sequence(s) by enumeration of its residues, as defined in 37 CFR 1.831(b), must present each sequence and associated sequence data in a standardized electronic eXtensible Markup Language (XML) format, (a “Sequence Listing XML”) as a separate part of the specification. This standardized format is set forth in the World Intellectual Property Organization (WIPO) Standard ST.26, and applies to sequence listings in international applications filed under the Patent Cooperation Treaty (PCT) and in national and regional applications filed in the intellectual property offices (IPOs) of WIPO member states. As a result, a single sequence listing in compliance with WIPO Standard ST.26 can be prepared for use in all IPOs of WIPO member states. The regulatory provisions found at 37 CFR 1.831 – 1.835 implement WIPO Standard ST.26 in the USPTO and set forth requirements for presenting sequence data in patent applications filed on or after July 1, 2022, that disclose nucleotide sequences and/or amino acid sequences.

WIPO Standard ST.26 is incorporated by reference into the USPTO regulations by including new regulatory text at 37 CFR 1.839: