Enabling Practitioners: USPTO Issues Guidelines for Assessing Enablement Post-Amgen

On January 10, 2024, the United States Patent and Trademark Office (USPTO) published Guidelines for assessing enablement after the Supreme Court’s recent decision in Amgen Inc. et al. v. Sanofi et al.  The Guidelines inform Examiners and the public on the Office’s implementation of the Amgen opinion. In sum, the Guidelines maintain the status quo.   

In the Guidelines, Katherine Vidal, Under Secretary of Commerce for Intellectual Property and Director of the USPTO, explained that, regardless of technology, when assessing whether the experimentation required to enable the entire scope of the claimed invention is “unreasonable” or “undue,” USPTO personnel will continue to apply the Wands factors. Indeed, a USPTO alert about the Guidelines published January 9, 2024 stated that the Guidelines “do not present a change in practice for USPTO personnel, who will continue to use the In re Wands factors to ascertain whether the amount of experimentation required to enable the full scope of the claimed invention is reasonable.”

To assess the “reasonableness of experimentation,” the Guidelines highlight a handful of post-Amgen cases that have applied the Wands factors in assessing enablement, such as Baxalta Inc. et al. v. Genentech Inc., 2023 U.S. App. LEXIS 24863 (Fed. Cir. 2023); Medytox, Inc. v. Galderma S.A., 71 F.4th 990 (Fed. Cir. 2023); and In re Starrett, 2023 WL 3881360 (Fed. Cir. 2023) (non-precedential). 

Notably, none of the cases highlighted in the Guidelines demonstrate a case where the claims were enabled—instead, every case ultimately concludes that the claims were not enabled.  Even more, the cases highlighted in the Guidelines don’t appear to be close-calls as far as enablement is concerned.  In the Amgen and Baxalta cases, for example, the claims encompassed millions of antibodies, where only 26 or 11 exemplary antibodies, respectively, were disclosed, and the identification of new antibodies was to occur through an iterative, trial-and-error process, where each new antibody had to be screened for the appropriate activity.  In the Medytox case, the claims encompassed a method of using a botulinum toxin composition that exhibits a responder rate of 100%, but the specification did not enable one to achieve anything higher than 62%.  In the Starrett case, the claims potentially covered over 140 trillion embodiments, and the specification “fail[ed] to describe how the claim elements function.”   

The Guidelines do clarify that the Amgen decision, despite relating to biotechnology and antibodies, applies across technology fields, as it relied on precedent from cases covering a wide range of sectors.

While the Guidelines instruct USPTO employees, applicants, and patentees alike to continue adhering to the Wands factors when assessing whether one must engage in more than a reasonable amount of experimentation, they do not provide examples or feedback on cases that are a closer call.  Practitioners are continuing to see guideposts of what is not enough, but questions still remain on what is "enough" disclosure for enablement under Amgen. The application of Amgen outside of functional claims also remains murky.

Stay tuned for updates as new cases are decided.