The USPTO published guidelines for ascertaining compliance with the enablement requirement under 35 U.S.C. § 112 (a) during prosecution in view of the May 2023 U.S. Supreme Court decision in Amgen Inc. et al. v. Sanofi et al. The enablement requirement refers to the requirement of 35 U.S.C. § 112(a) that the specification must describe the invention in such terms that one skilled in the art can make and use the claimed invention. These 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. A link to the Federal Register Notice can be found here.
