How does the USPTO handle enablement for microorganisms in patent applications?
The USPTO has specific guidelines for handling enablement issues related to microorganisms in patent applications. According to MPEP 2164.06(a):
Patent applications involving living biological products, such as microorganisms, as critical elements in the process of making the invention, present a unique question with regard to availability.
The MPEP cites the case of In re Argoudelis, which established that depositing a microorganism in a public depository can satisfy the enablement requirement. Specifically:
It was determined by the court that availability of the biological product via a public depository provided an acceptable means of meeting the written description and the enablement requirements of 35 U.S.C. 112, first paragraph.
Importantly, the MPEP notes that the deposit must be made “prior to issue” but need not be made prior to filing the application, citing In re Lundak. For more detailed information on microorganism deposits, refer to MPEP § 2402 – § 2411.03.
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