[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).]

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

1. (a) Patent applications disclosing a nucleotide and/or amino acid sequences 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 §§ 1.832 through 1.834.

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For 35 U.S.C. 111 applications and international applications filed on or after July 1, 2022, that disclose one or more nucleotide and/or amino acid sequences as enumerated by its residues, each nucleotide and/or amino acid sequence and associated sequence data must be presented as a separate part of the disclosure that comprises the sequences in computer readable XML format in accordance with WIPO Standard ST.26 as implemented by 37 CFR 1.831 - 1.834. This sequence listing is referred to as a "Sequence Listing XML" in order to distinguish it from a "Sequence Listing" submitted in an application having a filing date BEFORE July 1, 2022. For 35 U.S.C. 111 applications and international applications having a filing date before July 1, 2022, that disclose of nucleotide and/or amino acid sequences, see 37 CFR 1.821(c) and 1.821(e)(1). See also MPEP §§ 2421.01 and 2421.02.

[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).]

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

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2. (d) "Enumeration of its residues" means disclosure of a nucleotide or amino acid sequence in a patent application by listing, in order, each residue of the sequence, where the residues are represented in the manner as defined in paragraph 3(c)(i) or (ii) of WIPO Standard ST.26 (incorporated by reference, see § 1.839 ).

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WIPO Standard ST.26 specifies that "enumeration of its residues" means "disclosure of a sequence in a patent application by listing, in order, each residue of the sequence, wherein either (i) the residue is represented by a name, abbreviation, symbol, or structure (e.g., HHHHHHQ or HisHisHisHisHisHisGln); or (ii) multiple residues are represented by a shorthand formula (e.g., His6Gln) (WIPO Standard ST.26, paragraph 3(c)). See also the Guidance portion of the Standard, Annex VI, page 3.26.vi.2 for a discussion of "enumeration of its residues" and page 3.26.vi.18-19, 51, 53 for examples.