What happens if a biological deposit referenced in a patent application becomes unavailable?

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.

If a biological deposit referenced in a patent application becomes unavailable, the examiner will treat the application as if no deposit existed. According to MPEP 2407.01:

“When the Office is so informed or otherwise becomes aware that samples of the deposited material cannot be furnished by the depository, the examiner will treat the application as if no deposit existed.”

In such cases, a replacement or supplemental deposit may be necessary to satisfy the requirements for patentability under 35 U.S.C. 112.