How can an applicant rebut the presumption of operability in prior art?

An applicant can rebut the presumption of operability in prior art by providing evidence that shows a process for making the compound was not known at the relevant time. The MPEP 2121.02 states:

“A reference is presumed operable until applicant provides facts rebutting the presumption of operability.”

To overcome this presumption, an applicant must present factual evidence demonstrating that the methods for producing the compound were not available or unsuccessful at the time of the invention (for pre-AIA applications) or before the effective filing date of the claimed invention (for AIA applications).

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Topics: MPEP 2100 - Patentability, MPEP 2121.02 - Compounds And Compositions — What Constitutes Enabling Prior Art, Patent Law, Patent Procedure
Tags: Operability, patent examination, rebuttal