2412.03(d) âNucleotideâ [R-07.2022]
2412.03(d) “Nucleotide” [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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- (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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Under WIPO Standard ST.26, paragraphs 3(f) and (g), identify a “nucleotide” to mean any nucleotide or nucleotide analogue and includes “modified nucleotides” (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 contains:
- (i) a backbone moiety selected from:
- (1) 2’ deoxyribose 5’ monophosphate (the backbone moiety of a deoxyribonucleotide) or ribose 5’ monophosphate (the backbone moiety of a ribonucleotide); or
- (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
- (ii) the backbone moiety is either:
- (1) joined to a nucleobase, including a modified or synthetic purine or pyrimidine nucleobase; or
- (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”.