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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How is unity of invention assessed for nucleotide sequences in international patent applications?

For international patent applications filed under the Patent Cooperation Treaty (PCT) and national stage applications filed under 35 U.S.C. 371, the assessment of unity of invention for nucleotide sequences follows specific guidelines. MPEP 2434 directs examiners to: “See MPEP § 1850 for treatment of claims containing nucleotide sequences that lack unity of invention in international…

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How should unbranched nucleotide sequences be presented in patent applications?

How should unbranched nucleotide sequences be presented in patent applications? According to MPEP 2421.02, unbranched nucleotide sequences in patent applications must be presented as follows: They must be listed using a single letter code for nucleotide bases. Sequences with 10 or more nucleotides must be represented in the sequence listing. Each sequence must be assigned…

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What symbols are used for termination codons in nucleotide sequences?

What symbols are used for termination codons in nucleotide sequences? According to MPEP 2412.05, termination codons in nucleotide sequences are represented by specific symbols: “The symbols “TAA,” “TGA,” or “TAG” should be used to represent termination codons.” This means that when including a termination codon in a nucleotide sequence listing, you should use one of…

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Can supplemental restriction requirements be issued for applications containing nucleotide sequences?

Generally, supplemental restriction requirements are not issued for applications that have already received an action on their merits, unless there are extenuating circumstances. MPEP 2434 states: “Note, however, that supplemental restriction requirements will not be advanced in applications that have already received an action on their merits in the absence of extenuating circumstances.” This guideline…

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Which nucleotides are considered “specifically defined” according to WIPO Standard ST.26?

According to MPEP 2412.03(a), WIPO Standard ST.26 defines “specifically defined” nucleotides as any nucleotide other than those represented by the symbol “n”. The MPEP provides a table of nucleotide symbols, where: Symbols a, c, g, and t/u represent specifically defined nucleotides Symbols like m, r, w, s, y, k, v, h, d, and b represent…

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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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