What are the key differences between WIPO ST.25 and the new sequence rules for applications filed after July 1, 2022?

The MPEP 2420 indicates a significant change in the rules governing sequence disclosures in patent applications filed on or after July 1, 2022. The section states: “[Editor Note: This section is not applicable to applications filed on or after July 1, 2022, having disclosures of nucleotide and/or amino acid sequences as defined in 37 CFR…

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What are the WIPO ST.25 requirements for nucleotide and amino acid sequence disclosures in patent applications?

WIPO ST.25 requirements for nucleotide and amino acid sequence disclosures in patent applications are outlined in MPEP 2422. These requirements are largely harmonized with USPTO requirements, but there are some key differences: WIPO ST.25 requires that nucleotide sequences containing fewer than 10 specifically defined nucleotides be included in the sequence listing. WIPO ST.25 requires that…

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What is a “Sequence Listing” in patent applications?

A “Sequence Listing” is a separate part of a patent application that contains disclosures of nucleotide and/or amino acid sequences, along with associated information, using a standardized format and symbols. According to MPEP 2421.01, it is required for applications containing disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR…

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What does “specifically defined” mean in the context of nucleotide and amino acid sequences?

According to MPEP 2412.03(a), “specifically defined” refers to any amino acid or nucleotide as defined in paragraph 3(k) of WIPO Standard ST.26. The MPEP states: “Specifically defined” means any amino acid or nucleotide as defined in paragraph 3(k) of WIPO Standard ST.26. This definition applies to patent applications filed on or after July 1, 2022,…

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What types of sequences must be included in a Sequence Listing XML?

According to MPEP 2412.02, a Sequence Listing XML must include nucleotide and/or amino acid sequences that are disclosed by enumeration of their residues in patent applications. The MPEP cites 37 CFR 1.831(a), which states: “Patent applications disclosing nucleotide and/or amino acid sequences by enumeration of their residues, as defined in paragraph (b) of this section,…

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What sequences must be included in a “Sequence Listing XML”?

According to MPEP 2412.03, the following sequences must be included in a “Sequence Listing XML”: Unbranched sequences or linear regions of branched sequences containing 4 or more specifically defined amino acids forming a single peptide backbone Unbranched sequences or linear regions of branched sequences of 10 or more specifically defined nucleotides joined by phosphodiester linkages…

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What sequences are excluded from a Sequence Listing XML?

According to MPEP 2412.03, certain sequences must be excluded from a Sequence Listing XML: Sequences having fewer than 10 specifically defined nucleotides Sequences having fewer than 4 specifically defined amino acids The MPEP cites 37 CFR 1.831(j), which states: A “Sequence listing XML” must not include any sequences having fewer than 10 specifically defined nucleotides,…

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What types of sequences are covered by the Sequence Rules?

The Sequence Rules apply to certain types of nucleotide and amino acid sequences disclosed in patent applications. According to MPEP 2412.01, the rules cover “certain nucleotide and/or amino acid sequences disclosed in patent applications.” The specific definition of which sequences are covered is provided in 37 CFR 1.831(b). Generally, this includes sequences of a specified…

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