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…
Read MoreWhat is the proper representation for other types of amino acid variants?
The MPEP 2412.05(c) provides guidance for representing other types of amino acid variants: Feature Key: VARIANT Qualifier: note Use: Any type of variant for which VAR_SEQ is not applicable This representation is used for amino acid variants that do not result from alternative splicing, alternative promoter usage, alternative initiation, or ribosomal frameshifting. It ensures comprehensive…
Read MoreHow should naturally occurring mutations be represented in nucleic acid sequences?
According to the table in MPEP 2412.05(c), naturally occurring mutations in nucleic acid sequences should be represented as follows: Feature Key: variation Qualifier: replace or note Use: For naturally occurring mutations and polymorphisms, such as alleles and RFLPs (Restriction Fragment Length Polymorphisms) This representation allows for proper documentation of genetic variations in patent applications related…
Read MoreHow are artificially introduced variations in nucleic acid sequences represented?
The MPEP 2412.05(c) provides guidance on representing artificially introduced variations in nucleic acid sequences: Feature Key: misc_difference Qualifier: replace or note Use: For variability introduced artificially, such as by genetic manipulation or chemical synthesis This representation is crucial for distinguishing between natural and artificial variations in biotechnology patent applications, ensuring clarity in the description of…
Read MoreHow should amino acid sequence variants produced by alternative splicing be represented?
According to the table in MPEP 2412.05(c), amino acid sequence variants produced by alternative splicing should be represented as follows: Feature Key: VAR_SEQ Qualifier: note Use: For variants produced by alternative splicing, alternative promoter usage, alternative initiation, and ribosomal frameshifting This representation allows for accurate documentation of protein variants resulting from different cellular processes, which…
Read MoreWhen is the MPEP 2412.05(c) guidance on sequence variants applicable?
The guidance provided in MPEP 2412.05(c) is applicable under specific conditions: “[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).]” This means that the requirements for representing sequence variants in the “Sequence Listing XML”…
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