USPTO Issues “Reasonable” Guidance on Enablement Under Amgen v. Sanofi

The USPTO has issued “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.” The Guidelines set forth the U.S. Patent and Trademark Office’s (USPTO’s) stance that the Supreme Court decision applies across the board without regard to technology, and instruct USPTO personnel to continue to use the Wands factors when assessing enablement. While the Guidelines mirror the Supreme Court’s consideration of whether only a “reasonable” amount of experimentation would be required to practice the full scope of the claims instead of Wands’ focus on an “undue amount of experimentation,” the substantive standards appear to be unchanged.

The Wands Factors Remain Probative of Enablement

The Guidelines summarize the procedural history of the Amgen case, noting specifically that the Federal Circuit decision that was affirmed by the Supreme Court applied the Wands factors to assess enablement of the claims at issue. The Guidelines recognize that “[t]he Supreme Court did not explicitly address the Wands factors in Amgen,” but point out that “the Court emphasized that the specification may call for a reasonable amount of experimentation to make and use the full scope of the claimed invention.”

The Guidelines express the USPTO’s view that “[t]he Wands factors are probative of the essential inquiry in determining whether one must engage in more than a reasonable amount of experimentation.” Noting several post-Amgen Federal Circuit decisions applying Wands, the Guidelines instruct USPTO personnel to continue to use the Wands factors “to assess whether the experimentation required by the specification to make and use the entire scope of the claimed invention is reasonable.”

The Wands Factors

As a refresher, the Guidelines summarize the Wands factors, which are discussed in more detail in MPEP 2164.01(a):

• the breadth of the invention;
• 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.

Applying Wands to Assess “Reasonableness”

The Guidelines discuss Amgen (referred to as Sanofi-Aventisub) and three post-Amgen Federal Circuit decisions as examples of how the Wands factors may be applied to assess the reasonableness of the experimentation required to practice a claimed invention. The claims at issue in these cases related to antibodies, methods of treatment, and “a claim to a non-transitory computer readable medium for maintaining augmented telepathic data for telepathic communication.”

The last case cited (In re Starrett) is interesting not just because of its specific subject matter, but also because it does not pertain to life sciences technology (although according to the Federal Circuit decision it did claim to pertain to “a gadget-free extension of human senses”). The court’s endorsement of the use of the Wands factors in that case supports the guidance instructing USPTO personnel to apply the Wands factors “regardless of the technology.”

Same Standard Different Words?

While there has been much discussion on whether the Supreme Court decision in Amgen would impact how claims are analyzed for enablement under 35 USC § 112, the USPTO is holding fast to the Wands factors and instructing their use across technologies when examining patent applications and when reviewing granted patents. Although the shift in focus from “undue” to “unreasonable” experimentation may be more semantic that substantive, it seems Amgen has raised the profile of enablement issues, making it more likely that any claim reciting functional language will be scrutinized under § 112.