What are the examination procedures for biological material deposits in patent applications?

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.

The examination procedures for biological material deposits in patent applications are outlined in 37 CFR 1.809. These procedures establish the process by which examiners address deposit issues during patent examination. The key points are:

• The USPTO initially bears the burden of establishing that access to a biological material is necessary for meeting the statutory requirements for patentability under 35 U.S.C. 112.
• Once the USPTO meets this burden, the responsibility shifts to the applicant or patent owner.
• The applicant or patent owner must then demonstrate one of the following:
  • Access to the biological material is not necessary
  • Access is already available
  • A deposit of the material will be made in accordance with the regulations

As stated in the MPEP: “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. Once the Office has met this burden, the burden shifts to the applicant or patent owner to demonstrate that access to such biological material either is not necessary, or is already available, or that a deposit of such material will be made in accordance with these regulations.”