The United States Patent and Trademark Office issued a notice in the Federal Register on January 10, 2024, providing guidelines to assist USPTO personnel in assessing enablement under 35 U.S.C. 112(a), in view of and consistent with the Supreme Court decision in Amgen Inc. et al. v. Sanofi et al., 143 S. Ct. 1243 (2023) and post-Amgen Federal Circuit precedent.
In Amgen, the Supreme Court held that claims drawn to a genus of functionally claimed monoclonal antibodies were invalid due to a lack of enablement. While the Supreme Court emphasized the trial-and-error nature of experimentation that would be required to practice the invention in the absence of additional guidance, such as common structural characteristics, it maintained a patent specification may still require a reasonable amount of experimentation to make and use the invention. What is reasonable, it stated, will depend on the nature of the invention and the underlying art.
Patent practitioners will recognize that a "reasonable amount" or "reasonable degree" of experimentation is not the same wording as "undue experimentation" under the Wands factors (from In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988)) they are used to applying. The Supreme Court in Amgen did not address the Wands factors. The USPTO notice refers to the post-Amgen Federal Circuit holding in Baxalta Inc. et al. v. Genentech Inc., 2023 U.S. App. LEXIS 24863 (Fed. Cir. 2023), in which the Federal Circuit stated, "[w]e do not interpret Amgen to have disturbed our prior enablement case law, including Wands and its factors," and "[w]e see no meaningful difference between Wands' `undue experimentation' and Amgen' s `[un]reasonable experimentation' standards."
In its conclusion, the USPTO provides guidance that: "The Wands analysis should provide adequate explanation and reasoning for a lack of enablement finding in order to facilitate the USPTO's clarity of the record goals, as well as the USPTO's goals of providing consistency between examination and post-grant challenges."
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