MPEP § 2412.03(c) — “Modified Amino Acid” (Annotated Rules)
§2412.03(c) “Modified Amino Acid”
This page consolidates and annotates all enforceable requirements under MPEP § 2412.03(c), 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.
“Modified Amino Acid”
This section addresses “Modified Amino Acid”. Primary authority: 37 CFR 1.831(b) and 37 CFR 1.831. Contains: 2 requirements, 2 prohibitions, 4 guidance statements, 1 permission, 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). 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, 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.
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.
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.
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.
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.
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.]
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.
Citations
| Primary topic | Citation |
|---|---|
| Sequence Listing Content Sequence Listing Format | 37 CFR § 1.831(b) |
| Sequence Listing Content | MPEP § 2412.03(b) |
| Sequence Listing Content Sequence Listing Format | MPEP § 2413.01(g) |
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(c) — “Modified Amino Acid”
Source: USPTO2412.03(c) “Modified Amino Acid” [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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- (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.
| Abbreviation | Modified Amino acid |
|---|---|
| Aad | 2-Aminoadipic acid |
| bAad | 3-Aminoadipic acid |
| bAla | beta-Alanine, beta-Aminopropionic acid |
| Abu | 2-Aminobutyric acid |
| 4Abu | 4-Aminobutyric acid, piperidinic acid |
| Acp | 6-Aminocaproic acid |
| Ahe | 2-Aminoheptanoic acid |
| Aib | 2-Aminoisobutyric acid |
| bAib | 3-Aminoisobutyric acid |
| Apm | 2-Aminopimelic acid |
| Dbu | 2,4 Diaminobutyric acid |
| Des | Desmosine |
| Dpm | 2,2′-Diaminopimelic acid |
| Dpr | 2,3-Diaminopropionic acid |
| EtGly | N-Ethylglycine |
| EtAsn | N-Ethylasparagine |
| Hyl | Hydroxylysine |
| aHyl | allo-Hydroxylysine |
| 3Hyp | 3-Hydroxyproline |
| 4Hyp | 4-Hydroxyproline |
| Ide | Isodesmosine |
| alle | allo-Isoleucine |
| MeGly | N-Methylglycine, sarcosine |
| Melle | N-Methylisoleucine |
| MeLys | 6-N-Methyllysine |
| MeVal | N-Methylvaline |
| Nva | Norvaline |
| Nle | Norleucine |
| Orn | Ornithine |
Reproduced from WIPO Standard ST.26, Annex I, Section 4.