MPEP § 2412.03(d) — “Nucleotide” (Annotated Rules)
§2412.03(d) “Nucleotide”
This page consolidates and annotates all enforceable requirements under MPEP § 2412.03(d), 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.
“Nucleotide”
This section addresses “Nucleotide”. Primary authority: 37 CFR 1.831(b) and 37 CFR 1.831. Contains: 2 permissions and 2 other statements.
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). 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.]
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:
- (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”.
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:
(ii) the backbone moiety is either:
…
(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”.
Sequence Listing Format
[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.]
Citations
| Primary topic | Citation |
|---|---|
| Sequence Listing Content Sequence Listing Format | 37 CFR § 1.831(b) |
| Sequence Listing Content | MPEP § 2412.03(a) |
| Sequence Listing Content | MPEP § 2412.03(e) |
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(d) — “Nucleotide”
Source: USPTO2412.03(d) “Nucleotide” [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). 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 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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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:
- (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”.