What are the requirements for representing sequence variants in a “Sequence Listing XML”?
According to MPEP 2412.05(c), there are specific requirements for representing sequence variants in a “Sequence Listing XML”:
- Each primary sequence and its variants must be included separately and assigned unique sequence identifiers.
- Variants disclosed as a single sequence with enumerated alternative residues should be represented using the most restrictive ambiguity symbol.
- Variants disclosed only by reference to deletions, insertions, or substitutions in a primary sequence should be included.
The MPEP states: “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.”
To learn more:
Topics:
MPEP 2400 - Biotechnology,
MPEP 2412.05(C) - Representation And Inclusion Of Variants,
Patent Law,
Patent Procedure