When does a biological material deposit need to be made?
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 MPEP 2411.02, a biological material deposit must be made on or before the date of payment of the issue fee, unless it has been made earlier in the application process. The MPEP states:
“…applicant may reply, pursuant to 37 CFR 1.809(b)(1), by either making an acceptable original, replacement, or supplemental deposit in accordance with these regulations, or assuring the Office in writing that an acceptable deposit will be made on or before the date of payment of the issue fee…”
If you provide a written assurance, you must follow through and make the deposit by the specified deadline. Failure to do so could result in the rejection being reinstated or other complications in the patent process.