What is required when submitting a replacement “Sequence Listing XML” under 37 CFR 1.835(b)?

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.

When submitting a replacement “Sequence Listing XML” under 37 CFR 1.835(b), the following items are required:

• A compliant replacement “Sequence Listing XML” file
• An amendment to the specification incorporating the new file by reference
• A statement identifying the location of all changes
• A statement identifying the basis for all changes
• A statement that no new matter is introduced

As stated in the MPEP: Applicant response to a notice or an Office action requiring a replacement “Sequence Listing XML” would involve submitting the following: (1) A compliant replacement “Sequence Listing XML” […] (2) An amendment to the specification to incorporate by reference the material in the XML file […] (3) A statement that identifies the location of all additions, deletions, or replacements […] (4) A statement identifying the basis for the additions, deletions, or replacements […] (5) A statement that no new matter is introduced […]