How do I submit a biological sequence listing for 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.

To submit a biological sequence listing for a patent application, follow these steps:

• Prepare the sequence listing in accordance with 37 CFR 1.821-1.825.
• Submit the sequence listing as a separate part of the application.
• If the sequence listing is 100KB or less, you can include it in the specification or submit it as a text file via EFS-Web or PatentCenter.
• For sequence listings larger than 100KB, submit them on read-only optical discs.
• Ensure the sequence listing is in ASCII text format.
• Include a statement that the content of the sequence listing is incorporated by reference in the application.

As stated in MPEP 608.05(c): “Sequence listings may be submitted in electronic form via EFS-Web or PatentCenter as ASCII text files or PDF files up to 100 megabytes, and on read-only optical discs when the sequence listing file size is over 100 megabytes.”