MPEP § 2412.03 — Nucleotides and Amino Acids Included and Excluded From a “Sequence Listing XML” (Annotated Rules)
§2412.03 Nucleotides and Amino Acids Included and Excluded From a “Sequence Listing XML”
This page consolidates and annotates all enforceable requirements under MPEP § 2412.03, including statutory authority, regulatory rules, examiner guidance, and practice notes. It is provided as guidance, with links to the ground truth sources. This is information only, it is not legal advice.
Nucleotides and Amino Acids Included and Excluded From a “Sequence Listing XML”
This section addresses Nucleotides and Amino Acids Included and Excluded From a “Sequence Listing XML”. Primary authority: 37 CFR 1.832, 37 CFR 1.831, and 37 CFR 1.831(b). Contains: 4 requirements and 1 other statement.
Key Rules
Sequence Listing Content
[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).]
(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).
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.”
Sequence Listing Format
(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.
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.”
Citations
| Primary topic | Citation |
|---|---|
| Sequence Listing Content Sequence Listing Format | 37 CFR § 1.831(b) |
| Sequence Listing Content Sequence Listing Format | 37 CFR § 1.831(j) |
| Sequence Listing Content | 37 CFR § 1.832 |
| Sequence Listing Content | MPEP § 2412.03(a) |
| Sequence Listing Content | MPEP § 2412.03(b) |
| Sequence Listing Content | MPEP § 2412.03(d) |
Source Text from USPTO’s MPEP
This is an exact copy of the MPEP from the USPTO. It is here for your reference to see the section in context.
Official MPEP § 2412.03 — Nucleotides and Amino Acids Included and Excluded From a “Sequence Listing XML”
Source: USPTO2412.03 Nucleotides and Amino Acids Included and Excluded From a “Sequence Listing XML” [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.”