What implications can be drawn from a reference to a biological deposit in a patent application?

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 2404, the mere reference to a biological deposit in a patent application does not necessarily imply that the deposit is required or that there are any specific implications regarding the invention’s patentability. Specifically, the MPEP states:

“There is no necessary implication or presumption that can or should be made about the need for a deposit simply because reference to a deposit is made in an application disclosure.“

This means that:

• A deposit reference doesn’t automatically indicate that the deposit is necessary for patentability
• The presence of a deposit reference doesn’t imply any particular status regarding the invention’s compliance with 35 U.S.C. 112
• Examiners and others should not make assumptions about the need for a deposit based solely on its mention in the application

Each application should be evaluated on its own merits to determine whether a biological deposit is actually required to satisfy statutory requirements.