What are the requirements for adding a “Sequence Listing” after the application filing date?

According to 37 CFR 1.825(a), adding a “Sequence Listing” after the application filing date requires:

  • Submission of the “Sequence Listing” in one of three formats: ASCII plain text file, PDF file, or physical sheets of paper
  • A request to make the amendment by incorporation by reference or insertion into the specification
  • A statement indicating the basis for the amendment
  • A statement that the “Sequence Listing” includes no new matter
  • A new or substitute CRF (if applicable)
  • A statement that the CRF contains the same sequence information as the added “Sequence Listing” (if applicable)

The MPEP states: “If the ‘Sequence Listing’ is filed as an ASCII plain text file only, thereby serving both as a ‘Sequence Listing’ under 37 CFR 1.821(c) and a CRF under 37 CFR 1.821(e), then an incorporation by reference statement is required in the specification (replacing any prior such paragraph) (see 37 CFR 1.77(b)(5)).

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Topics: MPEP 2400 - Biotechnology, MPEP 2426 - Amendments To Add Or Replace A "Sequence Listing" And Crf Copy Thereof Subject To Wipo St. 25, Patent Law, Patent Procedure
Tags: amendment, ascii plain text, Crf, Pdf File, Physical Sheets, sequence listing