The United States Patent and Trademark Office (USPTO) has published guidelines for USPTO employees to use, regardless of the technology, for ascertaining compliance with the enablement requirement under 35 U.S.C. 112(a) during the examination of utility patent applications and the review of utility patents in light 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.

“These guidelines will promote consistent analysis of the enablement requirement by examiners and Patent Trial and Appeal Board judges, which will result in clearer USPTO communications to applicants, patentees, and relevant third parties regarding any deficiencies in enablement compliance,” said Kathi Vidal, Under Secretary of Commerce for Intellectual Property and Director of the USPTO.

For more details, please see our Federal Register Notice, which is available on the Patent Related Notices webpage.