On January 10, 2024, the U.S. Patent and Trademark Office (USPTO) published new guidelines (89 Fed. Reg. 1563) on the topic of enablement in light of the Supreme Court’s May 2023 decision in Amgen Inc. v. Sanofi, Aventisub LLC, 598 U.S. 594 (2023) (“Amgen”). The guidelines are intended to inform U.S. patent examiners and the public about how to assess whether a claim meets the enablement requirement under 35 U.S.C. § 112(a), after the Supreme Court’s holding in Amgen.

The enablement requirement is governed by 35 U.S.C. § 112(a), which requires that the specification must describe the invention in such terms that one skilled in the art can make and use the claimed invention.  Section 112 had previously been interpreted by the Federal Circuit to mean that the patent disclosure must contain sufficient information about the subject matter of a claim to enable one skilled in the pertinent art to make and use the claimed invention without “undue experimentation.” In re Wands, 858 F.2d 731 (Fed. Cir. 1998). The purpose of the enablement requirement is to ensure that a patent applicant does not claim more than they have actually invented.

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 content of the disclosure.

MPEP 2164.01(a). The Federal Circuit had considered and applied Wands in its decision in the Amgen v. Sanofi, calling Wands “the ‘go to’ precedent for guidance on enablement,” in affirming the district court’s finding that the asserted claims were invalid for lack of enablement. Amgen Inc. v. Sanofi, 987 F.3d 1080 (Fed. Cir. 2021).

In Amgen, the Supreme Court affirmed the holdings below, finding that claims drawn to a genus of monoclonal antibodies, which were functionally claimed, were invalid due to a lack of enablement. Although Amgen provided 26 antibody examples and detailed instructions for generating additional antibodies within the genus, the Court determined that “Amgen offers persons skilled in the art little more than advice to engage in ‘trial and error.’” The Court concluded that the patents at issue failed to adequately enable the full scope of the genus of antibodies that performed the claimed function. While the Court acknowledged the trial-and-error nature of experimentation that could be required to practice the invention in the absence of additional guidance, it noted that the specification may still call for “a reasonable amount of experimentation” to make and use the invention. However, the Court’s decision made no citation or reference to the Wands factors or the Federal Circuit’s “undue experimentation” standard, leaving open the question of whether “a reasonable amount of experimentation” and “undue experimentation” mean something different.

Although the Supreme Court’s Amgen decision created ambiguity as to the appropriate standard for determining enablement, the USPTO’s recent guidelines reintroduce clarity, stating that the Amgen decision has not displaced the Wands factors for analyzing undue experimentation, and advising that those factors continue to apply in all fields. The USPTO guidelines also point to three post-Amgen Federal Circuit decisions which did apply or at least discuss the Wands factors in finding lack of enablement for genus claims, including for a functionally defined genus of antibodies. ¹ The guidelines summarize each case and find them all consistent with applying the Wands factors to evaluate whether the experimentation is undue or unreasonable.

The guidelines clarify that the USPTO’s framework for assessing enablement is unchanged post-Amgen and maintains the status quo for analysis of enablement. In its conclusion, the USPTO provides guidance that:

“The Wands analysis should provide adequate explanation and reasoning for a lack of enablement finding in order to facilitate the USPTO's clarity of the record goals, as well as the USPTO's goals of providing consistency between examination and post-grant challenges.”

^{[1] Baxalta Inc. v. Genentech, Inc., 81 F.4th 1362 (Fed. Cir. 2023); Medytox, Inc. v. Galderma S.A., 71 F.4th 990 (Fed. Cir. 2023); and In re Starrett, 2023 WL 3881360 (Fed. Cir. 2023) (non-precedential).}

This publication is intended for general information purposes only and does not and is not intended to constitute legal advice. The reader should consult with legal counsel to determine how laws or decisions discussed herein apply to the reader's specific circumstances.