Introduction

On January 10, 2024, the director of the United States Patent and Trademark Office (USPTO) issued new guidelines on enablement under 35 U.S.C. § 112. The enablement rule requires that a patent teach a person of ordinary skill in the art to make and use the full scope of the claimed invention without undue experimentation. The new guidelines advise USPTO employees how to apply this doctrine when examining patent applications. 

Case Law Motivating the New Guidelines

The 2023 U.S. Supreme Court decision in Amgen Inc. v. Sanofi ¹ garnered significant attention. In Amgen, the Court ruled that the patents at issue did not enable a class of antibodies that performed a certain function, because each of the millions of potential members of the class would have to be tested to determine whether it actually performed the function. 

The Court’s opinion did not cite In re Wands ², a prominent Federal Circuit case from early in the biotechnology era (1988) that set forth eight nonexclusive factors for determining whether too much experimentation was required to make and use the invention. This led to speculation over whether the Wands factors were still the controlling test for undue experimentation. The Wands factors are: (A) the breadth of the claims, (B) the nature of the invention, (C) the state of the prior art, (D) the level of one of ordinary skill, (E) the level of predictability in the art, (F) the amount of direction provided by the inventor, (G) the existence of working examples, and (H) the quantity of experimentation needed to make and use the invention based on the content of the disclosure. The new USPTO guidelines address this question in some detail.

The USPTO Finds the Wands Factors Still Apply

The guidelines state that Amgen has not displaced the Wands factors for analyzing undue experimentation. Instead, those factors continue to apply in all fields.  

Amgen oddly did not cite Wands, so the guidelines point out that Amgen affirmed the Federal Circuit, which in turn relied on the Wands factors. The guidelines further explain that, in the wake of Amgen, the Federal Circuit has decided several more enablement cases, including Baxalta Inc. et al. v. Genentech Inc.; Medytox, Inc. v. Galderma S.A.; and In re Starrett. The guidelines summarize each case and find them all consistent with applying the Wands factors to evaluate how much experimentation is undue or unreasonable.

Nonetheless, the guidelines emphasize that, under Wands, the nature of the invention and the underlying art are important considerations. They quote the Supreme Court’s observation that a single example or a handful of examples may be sufficient in some circumstances. For example, the specification may disclose some general quality common to the class, enabling a person skilled in the art to make and use the full class.

The guidelines also remind examiners of the importance of adequately explaining their enablement rejections.

Key Takeaways

The USPTO’s new guidelines primarily serve to re-confirm the Wands factors as the keys to the undue experimentation analysis for enablement.  They additionally clarify that the analysis remains fact-dependent, emphasizing that a single example may be sufficient to enable a claimed class of items if their characteristics are uniform or predictable enough. Much of the USPTO guidance discusses claims that are not enabled, but cases do hold that “a considerable amount of experimentation” is not necessarily “undue.” ³

Those prosecuting patent applications should be mindful of the nature of the invention and its field of technology.  In more predictable technologies, such as the electronic and mechanical fields, it may be easier to show an entire class or range is enabled by a small number of examples.  But even in less predictable fields, applicants could find ways to model their arguments on the Supreme Court’s observation that disclosing a general quality running through the class may be sufficient to enable the whole class. 

Patent challengers should consider any aspect of variability that runs through the class— particularly where the complete membership of a class is not objectively knowable in advance.  Thus, although Amgen is not restricted to functional claiming, as a practical matter it is likely to have the most impact in that area.

1. 143 S. Ct. 1243 (2023).↩
2. 858 F. 2d 731 (Fed. Cir. 1988).↩
3. See e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 684 (Fed. Cir. 2015); and Examining Computer-Implemented Functional Claim Limitations for Compliance with 35 U.S.C. § 112, 84 Fed. Reg. 57 (Jan. 7, 2019).↩