What are the requirements for sequence disclosures in biotechnology patent applications?

MPEP 2401 introduces the requirements for sequence disclosures in biotechnology patent applications. These requirements are outlined in 37 CFR 1.821 – 1.825 and 37 CFR 1.831 – 1.835. The regulations cover: Nucleotide sequence disclosures Amino acid sequence disclosures Format and symbols to be used Sequence listing requirements Electronic submission procedures These rules ensure that sequence…

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What are the requirements for international applications disclosing nucleic acid or amino acid sequences?

For international applications subject to WIPO ST.25 requirements that disclose nucleic acid or amino acid sequences, specific rules apply. MPEP 2420 states: “See PCT Rule 5 and Rule 13ter, and MPEP § 1823.02 and § 2422, for the requirements under the PCT for international applications subject to WIPO ST.25 requirements and that disclose nucleic acid…

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What sequences must be included in the “Sequence Listing” of a patent application?

According to MPEP 2422.01, the following sequences must be included in the “Sequence Listing” of a patent application: All sequences, whether claimed or not, that meet the length thresholds in 37 CFR 1.821(a). Any sequence disclosed as a string of particular nucleotide bases or amino acids, regardless of whether the applicant considers it prior art.…

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How should sequences with defined regions separated by undisclosed gaps be represented in a Sequence Listing XML?

The MPEP 2412.05(e) provides specific guidance on how to represent sequences with defined regions separated by undisclosed gaps in a Sequence Listing XML: “A nucleotide and/or amino acid sequence that contains regions of specifically defined residues separated by one or more gaps of an unknown or undisclosed number of residues must be listed in the…

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How are sequences with known numbers of ‘n’ or ‘X’ residues between defined regions represented in a Sequence Listing XML?

According to MPEP 2412.05(e), sequences with known numbers of ‘n’ or ‘X’ residues between defined regions are represented as a single sequence in the Sequence Listing XML. The MPEP states: “A nucleotide and/or amino acid sequence that contains regions of specifically defined residues separated by one or more regions of contiguous ‘n’ or ‘X’ residues,…

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How should a sequence constructed from non-contiguous segments be represented in a Sequence Listing XML?

According to MPEP 2412.05(e), a sequence constructed as a single continuous sequence from non-contiguous segments must be listed in the Sequence Listing XML as a single sequence with its own identifier. Specifically, the MPEP states: “A nucleotide and/or amino acid sequence that is constructed as a single continuous sequence derived from one or more non-contiguous…

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How 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…

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