Patent Lodge

Last summer, we reported on the U.S. Supreme Court’s decision regarding enablement compliance (in Amgen Inc. v. Sanofi). The U.S. Patent & Trademark Office (USPTO) has recently responded, publishing new guidelines for enablement under 35 U.S.C. § 112(a), with these guidelines being applicable regardless of the technology.

In brief, the guidelines use the factors defined in In re Wands, 858 F. 2d 731 (Fed. Cir. 1988) (the Wands factors) in determining whether the amount of experimentation required to enable the full scope of the claimed invention is reasonable.

The Wands factors include, but are not limited to:

1. the breadth of the claims,
2. the nature of the invention,
3. the state of the prior art,
4. the level of one of ordinary skill,
5. the level of predictability in the art,
6. the amount of direction provided by the inventor,
7. the existence of working examples, and
8. the quantity of experimentation needed to make and use the invention based on the contents of the disclosure.

It is interesting that while the U.S. Supreme Court did not acknowledge the Wands factors, the new guidelines do.

The newly published guidelines are meant to promote a consistent analysis and treatment of the enablement requirement, and while not presenting any major change to USPTO practice or procedure, the guidelines are guided by the Amgen decision and several post-Amgen enablement court decisions.

As background, the enablement requirement (defined by 35 U.S.C. § 112(a)) requires that the specification must describe the invention in such terms that one skilled in the art can make and use the claimed invention. Shifting to Amgen, the U.S. Court of Appeals for the Federal Circuit (the CAFC) had applied the Wands factors to assess whether the specification of Amgen’s patent provided sufficient enablement to make and use the full scope of the claimed invention. The CAFC found there was not sufficient enablement, and the U.S. Supreme Court unanimously affirmed.

The U.S. Supreme Court found that the claims, drawn to a genus of monoclonal antibodies, were invalid due to lack of enablement. In brief, Amgen had sought to monopolize an entire class of antibodies by their function, and the Court felt that scope of protection was much broader than what had been disclosed.

Shifting to the USPTO’s new guidelines, they will continue to use the Wands factors to assess whether the experimentation required by the specification to make and use the entire scope of the claimed invention is reasonable. However, the guidelines also look to the CAFC’s decision and the U.S. Supreme Court’s affirmance in Amgen.

A key takeaway from Amgen and recent subsequent decisions is their emphasis that “the specification must enable the full scope of the invention as defined by its claims” and that “the more one claims, the more one must enable.” The new USPTO guidelines echo these same propositions, even if not significantly representing change in the USPTO practices.