In the wake of the U.S. Supreme Court’s decision in Amgen Inc. v. Sanofi, 598 U.S. 594 (2023) (Amgen), in which the Court addressed whether Amgen’s functional antibody genus claims satisfy the enablement requirement, the U.S. Patent and Trademark Office (USPTO) released its guidelines for evaluating enablement.[1] The guidelines indicate that the USPTO will continue to use the Federal Circuit’s Wands factors when evaluating whether undue experimentation would be required in order to practice the claimed invention, and state that the Wands factors will be used “regardless of the technology.” The guidelines note that “[t]he explanation in an enablement rejection or in a PTAB determination that a claim is not enabled should focus on those factors and the reasons and evidence that led the examiner or decision-maker to arrive at their conclusion.” Thus, as was the case before the Amgen decision, USPTO personnel are required to address the following factors in an enablement analysis:

(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.

In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).

[1] “Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al.” (https://public-inspection.federalregister.gov/2024-00259.pdf)

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