By Stephanie M. Lawley
On January 10, 2024, the United States Patent and Trademark Office (USPTO) published guidelines for examiners to use when examining patent applications for compliance with the enablement requirement in view of the U.S. Supreme Court decision, Amgen Inc. et al. v. Sanofi et al. These guidelines apply to all utility patent applications, regardless of the technology.
The USPTO examination guidelines do not, by themselves, constitute the rule of law. Rather, they are designed to instruct and advise examiners as to how to apply the U.S. legal standard for enablement to the examination of patent applications based on federal court decisions and the statute.
The current USPTO guidelines explain that, in order to satisfy the enablement requirement, the specification must describe the claimed invention well enough so that one of ordinary skill in the art can make and use the claimed invention. The standard for satisfying this requirement is whether the experimentation needed to make and use the invention is “undue” or “unreasonable.” Whether the experimentation is “undue” is determined based on eight factors described in In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988) (the “Wands factors”). These factors include:
- the breadth of the claims,
- the nature of the invention,
- the state of the prior art,
- the level of one of ordinary skill,
- the level of predictability in the art,
- the amount of direction provided by the inventor,
- the existence of working examples, and
- the quantity of experimentation needed to make and use the invention based on the content of the disclosure.
USPTO Manual of Patent Examining Procedure (MPEP) § 2164.01.
The recently published guidelines do not make any major changes to the current USPTO guidelines with respect to enablement. Instead, they merely incorporate guidance from the Amgen decision and the following three post-Amgen Federal Circuit decisions, which is consistent with current USPTO policy:
- Baxalta Inc. et al. v. Genentech Inc., 81 F.4th 1362 (Fed. Cir. 2023). In a case with facts similar to those of Amgen, the Federal Circuit in Baxalta affirmed the district court’s grant of summary judgment that patent claims directed to a functionally defined genus of antibodies were not enabled. The scope of the claims potentially encompassed millions of antibodies. However, the patent merely disclosed 11 antibodies and a method of producing and screening antibodies to determine whether they met the claimed functional limitations.
- Medytox, Inc. v. Galderma S.A., 71 F.4th 990 (Fed. Cir. 2023). In Medytox, the Federal Circuit affirmed a PTAB decision that the full scope of a substitute claim in a post-grant review proceeding was not enabled. The substitute claim was directed to a method of using an animal protein-free botulinum toxin composition that exhibited a longer-lasting effect in the patient than an animal protein-containing botulinum toxin composition, and included a responder rate limitation of 50% or greater. However, the specification contained only three examples of responder rates above 50%: 52%, 61%, and 62%. Applying the Wands factors, the PTAB found that one of ordinary skill in the art would not have been able to achieve higher than 62% for the responder rate limitation without undue experimentation.
- In re Starrett, 2023 WL 3881360 (Fed. Cir. 2023) (non-precedential). In Starrett, the Federal Circuit affirmed a PTAB decision in an ex parte appeal upholding an examiner's rejection for a lack of enablement of a claim to a non-transitory computer readable medium for maintaining augmented telepathic data for telepathic communication. The claim at issue contained 47 “or” clauses and potentially covered over 140 trillion embodiments. The Federal Circuit noted that the examiner’s discussion of the Wands factors properly noted that the specification failed to describe how the claim elements function, thereby indicating that the Wands factors should be used to determine whether the experimentation was reasonable.
In summary, the recently published guidelines indicate that examiners will continue to use the Wands factors to determine whether the experimentation required to enable the full scope of the claimed invention is reasonable.
The USPTO guidelines were published at 89 Fed. Reg. 1563 (January 10, 2024) and will be added to the USPTO’s Manual of Patent Examining Procedure in due course.