2412.03 Nucleotides and Amino Acids Included and Excluded From a âSequence Listing XMLâ [R-07.2022]
2412.03 Nucleotides and Amino Acids Included and Excluded From a “Sequence Listing XML” [R-07.2022]
[Editor Note: This section is applicable to all applications filed on or after July 1, 2022, having disclosures of 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) (i) A 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, the data associated with 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, the data associated with 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 nucleotides and amino acids which must be included in a “Sequence Listing XML”. 37 CFR 1.831(j) specifies that any sequences having fewer than 10 specifically defined nucleotides, or fewer than 4 specifically defined amino acids must be excluded from any “Sequence listing XML.”