What constitutes ‘undue experimentation’ in the context of biological material deposits?

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.

‘Undue experimentation’ in the context of biological material deposits refers to procedures that require excessive effort or resources beyond what is considered routine in the field. According to MPEP 2404.02:

“Deposits may be required to support the claims if an isolation procedure requires undue experimentation to obtain the desired biological material.”

This means that if obtaining the biological material involves complex, time-consuming, or particularly challenging processes that go beyond standard practices in biotechnology, a deposit may be necessary. The determination of what constitutes ‘undue experimentation’ is made on a case-by-case basis, considering factors such as the predictability of the art, the amount of direction provided in the specification, and the state of the prior art.