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 2409, viability testing must be performed on deposited biological materials at regular intervals. The MPEP states, “The regulations require that deposited biological material be viable at the time of deposit and at any time during the term of the patent.” However, the specific frequency of testing may vary depending on the nature of the material and the depository’s practices. It’s important to note that the USPTO does not dictate a specific schedule for viability testing, but rather relies on the depository to maintain the viability of the material throughout the patent term.