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

This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice.

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)).“