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ARTICLE · 30 JANUARY 2024

USPTO Guidelines On Enablement Requirement Published 10 January 2024

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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...

United StatesIntellectual Property
Jordyn Grawe
Jordyn Grawe
Leanne M. Rakers
Leanne M. Rakers

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 Amg

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