USPTO Issues Enablement Guidelines Following Amgen v. Sanofi

On January 10, 2024, the United States Patent and Trademark Office (USPTO) released 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.^{i ii} The Guidelines are intended to inform U.S. patent examiners and the public about the process to be followed when assessing whether a claim satisfies the enablement requirement under 35 U.S.C. 112(a), after the U.S. Supreme Court’s holding in Amgen v. Sanofi.ⁱⁱⁱ

35 U.S.C. §112(a)

The enablement requirement under 35 U.S.C. 112(a) is met as to a particular claim of a patent or application when that claim is “supported” by the patent or application disclosure. If it can be demonstrated that the patent disclosure as filed contained sufficient information about the subject matter of the claim so as to enable one skilled in the pertinent art to make and use the claimed invention without “undue experimentation,” the claim is enabled. The purpose of the enablement requirement is to ensure that a patent applicant does not claim more than she has actually invented.

Amgen v. Sanofi

In Amgen, the Supreme Court upheld the lower courts’ holdings that the disputed claims directed to a genus of monoclonal antibodies were invalid for lack of enablement. The claims were directed to the antibody binding sites, and defined the antibodies functionally by what they bound (the antibody binding site). Amgen claimed an “entire genus” of antibodies that: 1) “bind to specific amino acid residues on PCSK9;” and 2) “block PSCK9 from binding to [LDL receptors].” Amgen’s patent disclosure identified 26 specific antibody amino acid sequences in its disclosure that met the claim limitations. The Supreme Court upheld the district court and Federal Circuit Court of Appeals’ finding that the claims encompassed “potentially millions more antibodies” than the 26 antibody amino acid sequences disclosed. In doing so the Court relied on precedent spanning 150 years and directed to many different and older technologies.

Importantly, the Court did not indicate that satisfying enablement required an applicant to disclose each and every possible embodiment of a genus invention. Instead, the Court noted that it might be sufficient to disclose only a few example embodiments “if the specification also discloses ‘some general quality … running through’ the class that gives it a ‘peculiar fitness for the particular purpose.’” However, the Court also noted that the skilled artisan must be given more direction than merely “advice to engage in trial and error.”

The Guidelines

The USPTO Guidelines essentially maintain the status quo for analysis of enablement, reiterating that patent examiners are to apply the factors set out in In re Wands^iv when assessing enablement. The Guidelines provide case law examples where the enablement requirement was not met. Unfortunately, no examples are provided where enablement was satisfied.

The Wands factors include, in no particular order of importance: 1) the breadth of the claims (how much is being claimed/how large is the claimed genus?); 2) the nature of the invention (how complex is the subject matter of the claimed invention?); 3) the state of the prior art (how much is already known about the subject matter of the claimed invention?); 4) the level of one of ordinary skill (what level of sophistication is expected of the person of ordinary skill in this technology?); 5) the level of predictability in the art (can the information provided in the disclosure reasonably be extrapolated to species within the genus that are not expressly disclosed?); 6) the amount of direction provided by the inventor (has the inventor provided sufficient information for the skilled artisan to make and use the invention as described with a reasonable expectation of success?); 7) the existence of working examples (has the inventor provided sufficient examples of species within the genus to support the full scope of the claim?); and 8) the quantity of experimentation needed to make and use the invention based on the content of the disclosure (will the skilled artisan be required to engage in undue trial and error/experimentation to replicate the disclosed results?).

Key takeaways:

• The Guidelines confirm that the Wands factors remain the test for assessing enablement of claimed subject matter;
• The Guidelines state that the Amgen decision applies to all technologies, not just to newer or more complex technology.
• The Guidelines are silent as to any guidance in the nature of examples of claims that satisfy enablement. The Guidelines provide several examples of what is not enough, but no examples of what is enough.

Practice tips:

• When drafting claims to a genus potentially having many species, ensure that the patent application disclosure contains as many examples of species within that genus as possible.
• As a fallback position, describe narrower sub-genera in the disclosure, provide as many examples of species within each sub-genus as are available, and draft claims directed to each sub-genus.
• Describe one or more common features (preferably structural rather than functional) of species within the genus and/or sub-genus that give the species a particular fitness for its intended purpose.
• Draft dependent claims directed to individual species or smaller groups of species that are considered to have particular commercial value.

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ⁱ89 FR 1563.
ⁱⁱGuidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court.
ⁱⁱⁱ143 S. Ct. 1243 (2023).
^iv858 F.2d 731, 737 (Fed. Cir. 1988).