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).…
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