MPEP § 2412.03 — Nucleotides and Amino Acids Included and Excluded From a “Sequence Listing XML”
Ninth Edition, Revision 01.2024 · last revised R-01.2024
[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 CFR 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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- (b) Nucleotide and/or amino acid sequences, as used
in this section and §§ 1.832 through
1.835, encompass:
- (1) An unbranched sequence or linear region of a branched sequence containing 4 or more specifically defined amino acids, wherein the amino acids form a single peptide backbone; or
- (2) An unbranched sequence or linear region
of a branched sequence of 10 or more specifically defined nucleotides,
wherein adjacent nucleotides are joined by:
- (i) A 3' to 5' (or 5' to 3') phosphodiester linkage; or
- (ii) Any chemical bond that results in an arrangement of adjacent nucleobases that mimics the arrangement of nucleobases in naturally occurring nucleic acids (i.e., nucleotide analogs).
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- (j) A “Sequence listing XML” must not include any sequences having fewer than 10 specifically defined nucleotides, or fewer than 4 specifically defined amino acids.
Generally, nucleotide sequences that are an unbranched sequence or constitute a linear portion of a branched sequence of 10 or more specifically defined nucleotides are required to be listed in a “Sequence Listing XML.” See MPEP §§ 2412.03(d) and (e) for definitions of nucleotide and modified nucleotide, respectively. See MPEP § 2412.03(a) for definition of “specifically defined.”
Similarly, amino acid sequences that are an unbranched sequence or constitute a linear portion of a branched sequence of 4 or more specifically defined amino acids are required to be listed in a “Sequence Listing XML.” See MPEP §§ 2412.03(b) and (c) for definitions of amino acid and modified amino acid, respectively. See MPEP § 2412.03(a) for definition of “specifically defined.”
37 CFR 1.831(b) sets forth the nucleotide and amino acid sequences which must be included in a “Sequence Listing XML”. 37 CFR 1.831(j) specifies that any sequence having fewer than 10 specifically defined nucleotides, or fewer than 4 specifically defined amino acids must be excluded from any “Sequence listing XML.”
Contents
Cited authority
- 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 1.832 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
- 37 CFR 1.835 Amendment to add or replace a “Sequence Listing XML” in patent applications filed on or after July 1, 2022
- 2412.03(d) “Nucleotide”
- 2412.03(e) “Modified Nucleotide”
- Title Page Title Page
- 2412.03(b) “Amino Acid”
- 2412.03(c) “Modified Amino Acid”