The U.S. Patent Office has published updated examination guidelines regarding the enablement requirement in view of the Supreme Court’s May 2023 decision in Amgen v. Sanofi.1 The guidelines generally reiterate that (1) enablement applies to all technology areas, not just biotech, and (2) the Patent Office may increase its enforcement of the enablement doctrine against functional claims directed to a considerable amount of embodiments.
The examination guidelines indicate that Patent Office examiners will continue to utilize the long-standing undue experimentation standard and In re Wands factors when evaluating enablement:2
(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.
While the guidelines indicate that the Wands factors still apply after Amgen, the guidelines make clear that the full scope of the claimed invention must be enabled.
Practice Tips
The guidelines illustrate that broad functional language covering numerous antibodies questionably satisfies the enablement requirement without a description of the full scope of the invention, such as a detailed structural description. However, the guidelines do not provide details regarding how to evaluate enablement for structural claims. In addition, the guidelines are not clear how the Patent Office will review enablement of broad structural claims.
To the extent possible and practical, patent applicants should provide a variety of examples to supplement the functional description and to enhance their chances of satisfying the enablement requirement. In addition, it is recommended to include a variety of independent and dependent claims directed to what is believed to be the more valuable aspects of the invention and focusing the description on those more valuable aspects of the invention. Dependent claims can be used to recite narrower features of the invention, including structural features that complement the functional language in the claims.3
1 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 (January 10, 2024).
2 In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400 (Fed. Cir. 1988).
3 See also Functional Claims Have a Higher Bar for Enablement; Broad Genus of Antibodies Fails Requirement, https://www.manatt.com/insights/newsletters/intellectual-property-law/functional-claims-have-a-higher-bar-for-enab (July 20, 2021).
