Though a patent specification need not always “describe with particularity how to make and use every single embodiment within a claimed class,” it must nevertheless “enable the full scope of the invention as defined by its claims,” for example by “disclosing [a] general quality” of the class that may “reliably enable a person skilled in the art to make and use all of what is claimed.” Amgen Inc. v. Sanofi, 143 S. Ct. 1243, 1254–55 (2023) (“The more one claims, the more one must enable.”).

The Wands factors for enablement under 35 U.S.C. § 112(a) include: (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. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1998).

A patent specification need not include a working example of “every possible embodiment to enable the full scope of the claims.” Bayer Healthcare LLC v. Baxalta Inc., 989 F.3d 964, 982 (Fed Cir. 2021).

But if undue experimentation is required to practice the full scope of the claims where the specification “disclose[d] only a starting point for further iterative research in an unpredictable and poorly understood field,” then the claims are not fully enabled. Wyeth & Cordis Corp. v. Abbott Lab'ys, 720 F.3d 1380, 1385–86 (Fed. Cir. 2013); see also MagSil Corp. v. Hitachi Global Storage Techs., Inc., 687 F.3d 1377, 1381 (Fed. Cir. 2012) (holding that “a patentee chooses broad claim language at the peril of losing any claim that cannot be enabled across its full scope of coverage”).

Three Examples Did Not Enable a Wide Range

In Medytox, Inc. v. Galderma S.A., No. 22-1165, – F.4th – (Fed. Cir. June 27, 2023), the Federal Circuit affirmed a PTAB decision finding a lack of enablement.

The patent-in-suit was directed to the use of an animal-protein-free botulinum toxin composition that exhibits a longer lasting effect in the patient compared to an animal protein-containing botulinum toxin composition. The defendant argued that the patent specification failed to disclose how one would modify the named formulations to achieve the claimed range.

The claimed range of “50% or greater” effectively meant between 50% and 100% (the theoretical upper limit). There were, however, at most three examples clustered together within that range, namely, 52%, 61%, and 62%. And the PTAB found that a skilled artisan “would not have been able to achieve” rates higher than the limited examples provided in the specification.

The Federal Circuit found no legal or factual error in the PTAB's determination of lack of enablement.

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