What statements are required when adding a “Sequence Listing XML” to a patent application?

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 adding a “Sequence Listing XML” to a patent application, two important statements are required:

1. A statement indicating the basis for the amendment, with specific references to particular parts of the application as originally filed (specification, claims, drawings) for all sequence data in the “Sequence Listing XML”.
2. A statement that the “Sequence Listing XML” includes no new matter.

These requirements are outlined in 37 CFR 1.835(a)(3) and (4):

“(3) A statement that indicates the basis for the amendment, with specific references to particular parts of the application as originally filed (specification, claims, drawings) for all sequence data in the ‘Sequence Listing XML’; and

(4) A statement that the ‘Sequence Listing XML’ includes no new matter.”

These statements ensure that the added sequence information is properly supported by the original application and does not introduce new material.