How do I submit a large biological sequence listing on optical discs?

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 large biological sequence listing (over 100MB) on optical discs for a patent application, follow these guidelines:

• Use read-only optical discs (e.g., CD-R, DVD-R).
• Ensure the sequence listing is in ASCII text format.
• Include two copies of the optical disc containing identical sequence listings.
• Label each disc with the following information:
  • Name of the applicant
  • Title of the invention
  • Application number (if known)
  • Filing date (if known)
  • Disc number (e.g., ‘1 of 2’, ‘2 of 2’)
• Include a statement in the specification that incorporates the sequence listing by reference.

MPEP 608.05(c) states: “Sequence listings may be submitted […] on read-only optical discs when the sequence listing file size is over 100 megabytes.”

Ensure that the submission complies with the requirements set forth in 37 CFR 1.821-1.825 and follows the specific guidelines for optical disc submissions outlined in MPEP 608.05.