What are the requirements for making a replacement or supplemental biological deposit?

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.

When making a replacement or supplemental biological deposit, the following requirements must be met:

1. The deposit must meet all the requirements for making an original deposit.
2. It must be necessary to satisfy the requirements for patentability under 35 U.S.C. 112.
3. The biological material must be specifically identified and described in the application as filed.
4. The conditions in 37 CFR 1.802(b) and 37 CFR 1.804(b) must be satisfied.

According to MPEP 2407.01:

“A replacement or supplemental deposit will be accepted if it meets all the requirements for making an original deposit.”

The examiner will determine on a case-by-case basis whether the new deposit meets the requirements of 35 U.S.C. 112 with respect to the claimed subject matter.