The United States Patent and Trademark Office issued new guidelines for USPTO personnel concerning the enablement requirement under 35 U.S.C. 112(a) during the examination of utility patent applications and post-grant review of utility patents. This section requires that the specification describe the invention in such terms that one skilled in the art can make and use the claimed invention.
The guidelines are issued in view of the May 2023 U.S. Supreme Court decision in Amgen Inc. et al. v. Sanofi et al. The USPTO states that the guidelines do not present a change in practice and that USPTO personnel 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. See 2024-00259.pdf (federalregister.gov).