[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 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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2. (b) Nucleotide and/or amino acid sequences, as used in this section and §§ 1.832 through 1.835, encompass:
   1. (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. (2) An unbranched sequence or linear region of a branched sequence of 10 or more specifically defined nucleotides, wherein adjacent nucleotides are joined by:
      1. (i) A 3' to 5' (or 5' to 3') phosphodiester linkage; or
      2. (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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4. (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."

[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 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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2. (e) "Specifically defined" means any amino acid or nucleotide as defined in paragraph 3(k) of WIPO Standard ST.26.

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WIPO Standard ST.26, paragraph 3(k), provides that "specifically defined" means any nucleotide other than those represented by the symbol "n" and any amino acid other than those represented by the symbol "X,", wherein "n" and "X" are used in a conventional manner as shown below in Table 1 for nucleotide symbols and Table 3 for amino acids symbols.

Reproduced from WIPO Standard ST.26, Annex I, Section 1.

Reproduced from WIPO Standard ST.26, Annex I, Section 3.

[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 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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2. (f) "Amino acid" includes any D- or L-amino acid or modified amino acid as defined in paragraph 3(a) of WIPO Standard ST.26.

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WIPO Standard ST.26, paragraph 3(a), defines "amino acid" to mean any amino acid that can be represented using any of the symbols shown in Annex I, Table 3: List of Amino Acids Symbols of WIPO Standard ST.26 (reproduced in MPEP § 2412.03(a)). Such amino acids include, inter alia, D-amino acids and amino acids containing modified or synthetic side chains. Amino acids will be construed as unmodified L-amino acids unless further described in a "feature table". See MPEP § 2413.01(g), subsection I, for discussion of a "feature table". A peptide nucleic acid (PNA) residue is not considered an amino acid, but is considered a nucleotide.

[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). Formatting representations of XML (eXtensible Markup Language) elements in this section appear different than shown in Standard ST.26, which may be accessed at: www.wipo.int /export/sites/www/ standards/en/pdf/03-26-01.pdf.]

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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2. (g) "Modified amino acid" includes any amino acid as described in paragraph 3(e) of WIPO Standard ST.26.

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WIPO Standard ST.26, paragraph 3(e), defines "modified amino acid" to mean any amino acid as described in the definition of "amino acid", other than L-alanine, L-arginine, L-asparagine, L-aspartic acid, L-cysteine, L-glutamine, L-glutamic acid, L-glycine, L-histidine, L-isoleucine, L-leucine, L-lysine, L-methionine, L-phenylalanine, L-proline, L-pyrrolysine, L-serine, L-selenocysteine, L-threonine, L-tryptophan, L-tyrosine, or L-valine. See MPEP § 2412.03(b).

Modified amino acids, including D-amino acids, should be represented in the sequence as the corresponding unmodified amino acids whenever possible. Any modified amino acid in a sequence that cannot otherwise be represented by a symbol set forth in Table 3 must be represented by "X", i.e., an "other" amino acid.

A modified amino acid must be further described in a feature table. See MPEP § 2413.01(g), subsection I, for discussion of a "feature table". Where applicable, the feature keys "CARBOHYD" or "LIPID" should be used together with the qualifier "note". The feature key "MOD_RES" should be used for other post-translationally modified amino acids together with the qualifier "note". The feature key "SITE" together with the qualifier "note" should be used when the modified amino acid is not a post-translationally modified amino acid. See MPEP § 2413.01(g), subsections II and III, for discussion of a "feature key". The value for the qualifier "note" must either be an abbreviation set forth in Table 4 below or the complete, unabbreviated name of the modified amino acid. The abbreviations set forth in Table 4 or the complete, unabbreviated names must not be used in the sequence itself.

Reproduced from WIPO Standard ST.26, Annex I, Section 4.

[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). Formatting representations of XML (eXtensible Markup Language) elements in this section appear different than shown in Standard ST.26, which may be accessed at: www.wipo.int /export/sites/www/ standards/en/pdf/03-26-01.pdf.]

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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2. (h) "Nucleotide" includes any nucleotide, nucleotide analog, or modified nucleotide as defined in paragraphs 3(f) and 3(g) of WIPO Standard ST.26.

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WIPO Standard ST.26, paragraphs 3(f) and (g), identify a "nucleotide" to encompass any nucleotide or nucleotide analogue or "modified nucleotide" (see MPEP § 2412.03(e)) that can be represented using any of the symbols set forth in Table 1: List of Nucleotides Symbols (see MPEP § 2412.03(a)), wherein the nucleotide, or nucleotide analogue, or modified nucleotide contains:

1. (i) a backbone moiety selected from:
   1. (1) 2’ deoxyribose 5’ monophosphate (the backbone moiety of a deoxyribonucleotide) or ribose 5’ monophosphate (the backbone moiety of a ribonucleotide); or
   2. (2) an analogue of a 2’ deoxyribose 5’ monophosphate or ribose 5’ monophosphate, which when forming the backbone of a nucleic acid analogue, results in an arrangement of nucleobases that mimics the arrangement of nucleobases in nucleic acids containing a 2’ deoxyribose 5’ monophosphate or ribose 5’ monophosphate backbone, wherein the nucleic acid analogue is capable of base pairing with a complementary nucleic acid; examples of backbone moieties include amino acids as in peptide nucleic acids, glycol molecules as in glycol nucleic acids, threofuranosyl sugar molecules as in threose nucleic acids, morpholine rings and phosphorodiamidate groups as in morpholinos, and cyclohexenyl molecules as in cyclohexenyl nucleic acids; and
2. (ii) the backbone moiety is either:
   1. (1) joined to a nucleobase, including a modified or synthetic purine or pyrimidine nucleobase; or
   2. (2) lacking a purine or pyrimidine nucleobase when the nucleotide is part of a nucleotide sequence, referred to as an "AP site" or an "abasic site".

[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). Formatting representations of XML (eXtensible Markup Language) elements in this section appear different than shown in Standard ST.26, which may be accessed at: www.wipo.int /export/sites/www/ standards/en/pdf/03-26-01.pdf.]

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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2. (i) "Modified nucleotide" includes any nucleotide as described in paragraph 3(f) of WIPO Standard ST.26.

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WIPO Standard ST.26, paragraph 3(f), provides that a "modified nucleotide" means any "nucleotide" as explained in MPEP § 2412.03(d) other than deoxyadenosine 3’-monophosphate, deoxyguanosine 3’-monophosphate, deoxycytidine 3’-monophosphate, deoxythymidine 3’-monophosphate, adenosine 3’-monophosphate, guanosine 3’-monophosphate, cytidine 3’-monophosphate, or uridine 3’-monophosphate.