On Jan. 10, the U.S. Patent and Trademark Office (USPTO) published guidelines on the enablement requirement under 35 U.S.C. 112(a) in view of the recent hallmark decision by the U.S. Supreme Court, Amgen v. Sanofi, 143 S. Ct. 1243 (2023) (Amgen). The Supreme Court unanimously affirmed the determination that Amgen's claims covering a genus of monoclonal antibodies were invalid due to a lack of enablement. The asserted claims were directed to potentially millions of antibodies, and the specification only disclosed amino acid sequences for 26 antibodies. The court held that to make and use the claimed antibodies would require an unreasonable amount of experimentation, and thus, the claims were not enabled.