A requirement for patentability under 35 U.S.C. § 112(a) is that a patent’s written description must enable a skilled artisan to make and use the claimed invention. The Supreme Court recently interpreted 35 U.S.C. § 112(a) to require, “that a specification may call for a reasonable amount of experimentation to make and use a patented invention.” ¹ In formulating this interpretation, the Court relied on its own precedent, without any deference to the well-established Federal Circuit precedent.

In contrast to the Supreme Court’s interpretation, the Federal Circuit’s test for enablement requires a person of ordinary skill in the art to practice the claimed invention without “undue experimentation.” ² To assess if undue experimentation is necessary, the Federal Circuit’s test weighs several factors known as the Wands factors. ³ These factors are:

(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.⁴

The United States Patent and Trademark Office (USPTO) also uses the Wands factors to decide if a claim is enabled.⁵

Unfortunately, the Supreme Court did not distinguish between what constitutes a “reasonable amount of experimentation” under its rule, and “undue experimentation” under Wands and its progeny. Following the Amgen decision, a Federal Circuit panel determined that: Amgen did not change “prior enablement case law, including Wands and its factors”; and there is “no meaningful difference between Wands’ ‘undue experimentation’ and Amgen’s ‘[un]reasonable experimentation’ standards.” ⁶ Other Federal Circuit panels affirmed the Patent Trial and Appeal Board’s use of the Wands factors to assess enablement.⁷

A recent Federal Register Notice confirms that enablement in the USPTO will continue to be assessed using the Wands factors. ⁸ Specifically, “when assessing whether the claims in a utility patent application or patent are enabled, regardless of the technology, USPTO personnel will continue to use the Wands factors to ascertain whether the experimentation required to enable the full scope of the claimed invention is reasonable.” ⁹ Thus, the USPTO’s Guidelines implemented by the Notice, which are effective as of January 10, 2023, also tie the Wands factors to Supreme Court’s reasonable amount of experimentation standard.

The guidelines provide patent applicants and participants in PTAB proceedings with more certainty as to how enablement is to be assessed. However, as the USPTO noted, they, “do not constitute substantive rulemaking and therefore do not have the force and effect of law,” and do not, “announce major changes to USPTO practice or procedure.” Id. at 1564.

While the likelihood of the Supreme Court again opining on enablement is low, it is possible that the Federal Circuit may visit the issue en banc. Until then, patent applicants and participants in PTAB proceedings may want to consider framing enablement arguments in view of Wands and any dicta from the Amgen decision.

^{[1] Amgen, Inc. v. Sanofi, Inc., 598 U.S. 594, 612 (2023) (emphasis added).
[2] Amgen Inc. v. Sanofi, Aventisub LLC, 987 F. 3d 1080, 1084 (Fed. Cir. 2021), aff’d 598 U.S. 594 (2023) (emphasis added).
[3] Id.
[4] Id. (quoting In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1998)).
[5] See M.P.E.P. § 2164.01(a).
[6] Baxalta, Inc. v. Genentech, Inc., 81 F. 4th 1362, 1367, 1367 n.4 (Fed. Cir. 2023).
[7] See, e.g., In re Starrett, 2022-2209 (Fed. Cir. June 8, 2023) (nonprecedential). 
[8] Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen, Inc. et al. v. Sanofi et al., 89 Fed. Reg. 1563 (Jan. 10, 2023).
[9] Id. at 1566.}

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.