Can non-self-replicating materials be acceptable as biological deposits for patents?

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.

While the USPTO generally expects deposited biological materials to be capable of self-replication, either directly or indirectly, the MPEP 2403 does not entirely preclude the possibility of accepting non-self-replicating materials under certain circumstances. The MPEP states:

“Thus, while the Office does not currently contemplate that there would be any situations where a material that is not capable of self-replication either directly or indirectly would be acceptable as a deposit, an applicant is clearly not precluded by these rules from attempting to show in any given application why the deposit of such a material should be acceptable to satisfy the requirements of 35 U.S.C. 112.”

This means that while it’s uncommon, applicants may argue for the acceptance of non-self-replicating materials if they can demonstrate how such a deposit would satisfy the statutory requirements.