How does the USPTO determine if a biological deposit is necessary for a patent application?
The necessity of a biological deposit is determined on a case-by-case basis by the USPTO. According to MPEP 2403:
“For the most part, this issue must be addressed on a case-by-case basis.”
The examiner evaluates whether the deposit is needed to satisfy the statutory requirements for patentability, particularly the enablement requirement under 35 U.S.C. 112(a). The MPEP further advises:
“The examiner is cautioned against requiring that a specific biological material be deposited where the applicant can show that a deposit of starting material that is currently not available to the public would allow the skilled artisan to make and use the claimed invention.”
This means that if an applicant can demonstrate that the deposit of a related material (e.g., a vector or hybridoma) would enable a skilled artisan to make and use the invention without undue experimentation, a deposit of the specific claimed material may not be required.
To learn more: