MPEP 2412.03
Nucleotides and Amino Acids Included and Excluded From a "Sequence Listing XML"

Ninth Edition of the MPEP, Revision 07.2022, Last Revised in February 2023

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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 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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  • (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."