What happens if a viability test indicates that a biological deposit is not viable?

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.

If a viability test indicates that a biological deposit is not viable, the patent examination process is affected. According to MPEP 2409 and 37 CFR 1.807(c):

“If a viability test indicates that the deposit is not viable upon receipt, or the examiner cannot, for scientific or other valid reasons, accept the statement of viability received from the applicant, the examiner shall proceed as if no deposit has been made.”

In such cases, the examiner will notify the applicant, stating the reasons for not accepting the viability statement. The examination process will then continue as if no deposit had been made, which may affect the application’s compliance with the requirements under 35 U.S.C. 112 for enablement and written description.