What is considered “biological material” for patent deposit purposes?

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 2403, “biological material” is defined in terms of a non-exhaustive list of representative materials that can be deposited for patent purposes. The MPEP states:

“For the purposes of these rules, the term ‘biological material’ is defined in terms of a non-exhaustive list of representative materials which can be deposited in accordance with the procedures defined in these rules.”

While the MPEP doesn’t provide an exhaustive list, it generally refers to materials capable of self-replication, either directly or indirectly.