15 March 2024

USPTO Releases Post-Amgen Guidance For Determining Enablement

While the factors USPTO examiners consider for ascertaining enablement remain unchanged, patent practitioners may expect greater scrutiny of broad genus claims.
United States Intellectual Property
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TAKEAWAY: While the factors USPTO examiners consider for ascertaining enablement remain unchanged, patent practitioners may expect greater scrutiny of broad genus claims.

On January 10, 2024, the USPTO published updated guidance for ascertaining compliance with the enablement requirement of 35 U.S.C. 112(a). This was in direct response to the Supreme Court's decision in Amgen Inc. et al. v. Sanofi et al., 143 S. Ct. 1243 (2023), a much-anticipated decision that addressed the patentability of genus claims when a limited number of species within the genus had been identified.

The Amgen case centered on a number of claims over multiple patents to a broad class of antibodies based on their functional attributes. The patent specifications identified 26 exemplary antibodies that performed the recited function, while the claims at issue were directed to a class that included potentially millions of antibodies. The Court upheld the decision of the Federal Circuit that undue experimentation would be needed to identify a sufficient number of viable candidates to satisfy the enablement requirement, and thus the patents were invalid.

The recent USPTO guidance maintains that examiners should apply the following factors first enumerated by the Federal Circuit in In re Wands, 858 F.2d 731 (Fed. Cir. 1988): (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.

While the Supreme Court did not specifically address Wands, in the underlying case the Federal Circuit weighed the Wands factors to conclude that: (i) the scope of the claims was far broader in functional diversity than the disclosed examples, (ii) the invention was in an unpredictable field of science with respect to satisfying the full scope of the functional limitations, and (iii) there was not adequate guidance in the specification. The Federal Circuit relied on evidence suggesting millions of antibodies fit the broad genus and that it would be necessary to first generate and then screen each candidate to determine whether it met the functional limitations.

The USPTO guidance confirms that, "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. . . . The Wands analysis should provide adequate explanation and reasoning for a lack of enablement finding . . . ." As a practical matter, it may be advisable to identify a common characteristic of a genus recited in a claim that is helpful to identifying species that meet the claim limitation. Additionally, including narrower claims to specific species claims alongside broader genus claims can serve as a strategic safeguard in case of invalidation of a broad genus claim.

Originally published February 23, 2024

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