Who bears the initial burden of proof in biological material deposit cases?

In biological material deposit cases, the initial burden of proof lies with the United States Patent and Trademark Office (USPTO). According to MPEP 2411:

“The burden is initially on the Office to establish that access to a biological material is necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112.”

This means that the USPTO must first demonstrate why access to a specific biological material is essential for meeting the patentability requirements, particularly those related to enablement and written description under 35 U.S.C. 112. Only after the USPTO has successfully established this necessity does the burden shift to the applicant or patent owner.

To learn more:

• burden of proof
• biological material deposits
• USPTO
• 35 U.S.C. 112
• patent examination