2412.05(c) Representation and Inclusion of Variants [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). 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.]
A primary sequence and any variant of that sequence, each disclosed by enumeration of its residues and specifically defined to meet the definition in 37 CFR 1.831(a) and 1.831(b), must each be included in the “Sequence Listing XML” and assigned its own sequence identifier. Any variant sequence, disclosed as a single sequence with enumerated alternative residues at one or more positions, must be included in the “Sequence Listing XML” and should be represented by a single sequence, wherein the enumerated alternative residues are represented by the most restrictive ambiguity symbol. Any variant sequence, disclosed only by reference to deletion(s), insertion(s), or substitution(s) in a primary sequence, should be included in the “Sequence Listing XML”. The table below indicates the proper use of feature keys and qualifiers for nucleic acid and amino acid sequence variants:
| Type of sequence | Feature Key | Qualifier | Use |
|---|---|---|---|
| Nucleic acid | variation | replace or note | Naturally occurring mutations and polymorphisms, e.g., alleles, RFLPs. |
| Nucleic acid | misc_difference | replace or note | Variability introduced artificially, e.g., by genetic manipulation or by chemical synthesis. |
| Amino acid | VAR_SEQ | note | Variant produced by alternative splicing, alternative promoter usage, alternative initiation and ribosomal frameshifting. |
| Amino acid | VARIANT | note | Any type of variant for which VAR_SEQ is not applicable. |
(Reproduced from paragraph 96 of WIPO Standard ST.26).
For additional information about the representation of sequence variants in a “Sequence Listing XML,” see MPEP § 2413.01(g), subsection XII.