Federal Circuit Clarifies Enablement Standards: Amgen Doesn’t Apply to Anticipatory Prior Art

The Federal Circuit delivered an important clarification on the enablement standard for prior art Agilent Technologies, Inc. v. Synthego Corp., No. 2023-2186 (Fed. Cir. June 11, 2025), affirming PTAB decisions that invalidated all claims of two CRISPR gene-editing patents. The case featured arguments by IP luminaries Mark Lemley and Edward Reines, with the patent challenger, Reines, coming up on top this time.  The case distinguishes Amgen Inc. v. Sanofi, 598 U.S. 594 (2023): establishing clear boundaries between the enablement requirements for patent validity under 35 U.S.C. § 112 and the enablement standards for anticipatory prior art under § 102.

The unanimous Judge Prost decision also establishes that abandoned patent applications and research projects retain their full potency as prior art, rejecting arguments that abandonment should diminish their anticipatory effect.  The patentee's appellant brief had pointedly asked:

Did the Board err in finding that the claims were anticipated by and obvious over a prior art reference that never worked, was ultimately withdrawn, and which offered quadrillions of possible art combinations with no guidance to choose one that might work?

In rejecting the appeal, the court reinforced that prophetic examples in prior art can serve as anticipating references even in unpredictable fields, provided they contain sufficient enabling disclosure, and also concluded that the PTAB's decision was based upon substantial evidence.


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PTAB Captains Take Notice: Carefully Weigh Secondary Considerations

By Dennis Crouch

The nexus requirement serves as a threshold that must be met before secondary indicia will be even considered as relevant to the obviousness inquiry.  In its recent Volva Penta decision, the Federal Circuit found that the PTAB had  (1) created too high of a burden to prove nexus and (2) been unduly dismissive of the patentee's evidence of commercial success and copying.  The case reinforces the notion that patentees should attempt to include some claims that are largely coexistive with its product line, especially in today's world of likely copying. The case also serves as a reminder that product copying still caries significant weight in the obviousness analysis. Volvo Penta of the Americas, LLC v. Brunswick Corp., 22-1765, --- F.4th --- (Fed. Cir. August 24, 2022).


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