37 CFR 1.832 — Representation of nucleotide and/or amino acid sequence data in the “Sequence Listing XML” part of a patent application filed on or after July 1, 2022
Ninth Edition, Revision 01.2024
- (a) Each disclosed nucleotide or amino acid sequence that meets the requirements of § 1.831(b) must appear separately in the “Sequence Listing XML.” Each sequence set forth in the “Sequence Listing XML” must be assigned a separate sequence identifier. The sequence identifiers must begin with 1 and increase sequentially by integers as defined in paragraph 10 of WIPO Standard ST.26 (incorporated by reference, see § 1.839 ).
- (b) The representation and symbols for
nucleotide sequence data shall conform to the requirements of
paragraphs (b)(1) through (4) of this section.
- (1) A nucleotide sequence must be represented in the manner described in paragraphs 11–12 of WIPO Standard ST.26.
- (2) All nucleotides, including nucleotide analogs, modified nucleotides, and “unknown” nucleotides, within a nucleotide sequence must be represented using the symbols set forth in paragraphs 13–16, 19, and 21 of WIPO Standard ST.26.
- (3) Modified nucleotides within a nucleotide sequence must be described in the manner discussed in paragraphs 17, 18, and 19 of WIPO Standard ST.26.
- (4) A region containing a known number of contiguous “a,” “c,” “g,” “t,” or “n” residues for which the same description applies may be jointly described in the manner described in paragraph 22 of WIPO Standard ST.26.
- (c) The representation and symbols for
amino acid sequence data shall conform to the requirements of
paragraphs (c)(1) through (4) of this section.
- (1) The amino acids in an amino acid sequence must be represented in the manner described in paragraphs 24 and 25 of WIPO Standard ST.26.
- (2) All amino acids, including modified amino acids and "unknown" amino acids, within an amino acid sequence must be represented using the symbols set forth in paragraphs 26–29 and 32 of WIPO Standard ST.26.
- (3) Modified amino acids within an amino acid sequence must be described in the manner discussed in paragraphs 29 and 30 of WIPO Standard ST.26.
- (4) A region containing a known number of contiguous “X” residues for which the same description applies may be jointly described in the manner described in paragraph 34 of WIPO Standard ST.26.
- (d) A nucleotide and/or amino acid sequence that is constructed as a single continuous sequence derived from one or more non-contiguous segments of a larger sequence or of segments from different sequences must be listed in the “Sequence Listing XML” in the manner described in paragraph 35 of WIPO Standard ST.26.
- (e) A nucleotide and/or amino acid sequence that contains regions of specifically defined residues separated by one or more regions of contiguous “n” or “X” residues, wherein the exact number of “n” or “X” residues in each region is disclosed, must be listed in the “Sequence Listing XML” in the manner described in paragraph 36 of WIPO Standard ST.26.
- (f) A nucleotide and/or amino acid sequence that contains regions of specifically defined residues separated by one or more gaps of an unknown or undisclosed number of residues must be listed in the “Sequence Listing XML” in the manner described in paragraph 37 of WIPO Standard ST.26.
[Added 87 FR 30806, May, 20, 2022, effective July 1, 2022]
Cited authority
Cited by
- 2412.02 Definition of “Sequence Listing XML”
- 2412.03 Nucleotides and Amino Acids Included and Excluded From a “Sequence Listing XML”
- 2412.04 Use of Sequence Identifiers to Denote Sequences Disclosed in the Description, Drawings or Claims
- 2412.05(a) Use of Sequentially Numbered Sequence Identifiers in the “Sequence Listing XML”
- 2412.05(e) Presentation of Special Situations
- 2412.06 The Requirement for Exclusive Conformance; Sequences Presented in Drawing Figures
- 2413.01(g) The “Sequence Listing XML” Must Contain a Sequence Data Part
- 2416 Form Paragraphs
- 608.01 Specification
- 608.05 “Sequence Listing,” “Large Tables,” or “Computer Program Listing Appendix” Submitted in ASCII Plain Text or a “Sequence Listing XML” Submitted as XML File Text
- 37 CFR 1.52 Language, paper, writing, margins, read-only optical disc specifications
- 37 CFR 1.831 Requirements for patent applications filed on or after July 1, 2022, having nucleotide and/or amino acid sequence disclosures
- 37 CFR 1.833 Requirements for a “Sequence Listing XML” for nucleotide and/or amino acid sequences as part of a patent application filed on or after July 1, 2022