What is the significance of “efficacy” in determining prior art operability for patent examinations?
In patent examinations, the “efficacy” of a prior art reference is not a determining factor for its operability. As stated in MPEP 2121.02: “A prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in…
Read MoreIs proof of efficacy required for a prior art reference to be enabling for anticipation?
No, proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation. The MPEP 2122 cites a Federal Circuit decision that clarifies this point: “[P]roof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation.” – Impax Labs. Inc. v. Aventis…
Read MoreIs conclusive proof of efficacy required to show a reasonable expectation of success?
No, conclusive proof of efficacy is not required to show a reasonable expectation of success in patent law. The MPEP 2143.02 cites several court decisions that support this principle: “Conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d…
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