January 22, 2024

USPTO Guidelines on Enablement Requirement published 10 January 2024

In view of the recent Supreme Court decision in Amgen Inc. et al. v. Sanofi et al., 143 S. Ct. 1243 (2023)(hereinafter Amgen), the USPTO has published guidelines for determining enablement requirement (35 U.S.C. § 112(a)) compliance among all utility patent applications regardless of technology. You can access the published guidelines here.

The guidelines are not intended to announce any major change to accessing the enablement requirement, and state that USPTO personnel will continue to use the Wands factors from In re Wands 858 F.2d 731, 737 (Fec. Cir. 1988) to ascertain whether the experimentation required to enable the full scope of the claimed invention is reasonable.

In deciding Amgen, the Supreme Court relied on precedent from a wide variety of technologies and held that Amgen’s functionally claimed genus of antibodies, even allowing for a reasonable degree of experimentation, was not enabled. Thus, the guidelines state that the principles set forth in Amgen regarding the enablement requirement apply to all fields of technology.

USPTO employees will continue to use the Wands factors, which were used by the USPTO prior to Amgen, to reasonably determine if the amount of experimentation required is enough to enable the claims. The Wands factors include: (A) the breadth of the claims, (B) the nature of the invention, (C) the state of the prior art, (D) the level of one of ordinary skill, (E) the level of predictability in the art, (F) the amount of direction provided by the inventor, (G) the existence of working examples, and (H) the quantity of experimentation needed to make and use the invention based on the content of the disclosure. See MPEP 2164.01(a).

Recent guidance on reasonable experimentation can be found in post-Amgen enablement decisions such as Baxalta, where the Federal Circuit stated “[w]e do not interpret Amgen to have disturbed our prior enablement case law, including Wands and its factors”. See Baxalta Inc. et al. v. Genentech Inc., 2023 U.S. App. LEXIS 24863, 10 (Fed. Cir. 2023). In Medytox, another post-Amgen enablement decision, the Federal Circuit stated that although the specification does not need to always “describe with particularity how to make and use every single embodiment within a claimed class, it must nevertheless enable the full scope of the invention as defined by its claims, for example by disclosing [a] general quality of the class that may reliably enable a person skilled in the art to make and use all of what is claimed.” See Medytox, Inc. v. Galderma S.A., 71 F.4th 990, 998 (Fed. Cir. 2023)

To maintain consistency between examination and post-grant proceedings, the USPTO and the PTAB will both use the Wands factors to assess the enablement requirement in all utility applications and patents, regardless of the technology, and analysis using Wands factors should include an adequate explanation and reasoning for a lack of enablement finding.




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