Summary from the Federal Register
The United States Patent and Trademark Office (USPTO) is publishing guidelines for USPTO employees to use, regardless of the technology, for ascertaining compliance with the enablement requirement of the patent laws during the examination of utility patent applications and the review of utility patents in light of the recent U.S. Supreme Court decision in Amgen Inc. et al. v. Sanofi et al. These guidelines, which also inform the public of the USPTO's practices, provide that when considering whether claims in a utility patent application or patent are enabled, 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. Publishing these guidelines will promote consistent analysis of the enablement requirement of the patent laws by USPTO employees and will result in clearer USPTO communications to applicants, patentees, and relevant third parties concerning any deficiencies in enablement compliance. These guidelines will also promote the consistent treatment of enablement, both by the patent examining corps in patent applications and reexamination proceedings and by the Patent Trial and Appeal Board (PTAB) in ex parte appeals and post-patent issuance proceedings.
Dates
These guidelines are effective January 10, 2024.