How does the reasonable expectation of success requirement apply in unpredictable arts?
The reasonable expectation of success requirement applies to all fields of invention, but it can be more challenging to establish in unpredictable arts, such as biotechnology or pharmaceuticals. In these fields, the level of predictability is generally lower, which can affect the analysis of obviousness.
The MPEP 2143.02 provides guidance on this issue, citing relevant case law:
“In OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019), the court stated: ‘These references provide no more than hope—and hope that a potentially promising drug will treat a particular cancer is not enough to create a reasonable expectation of success in a highly unpredictable art such as this.'”
In unpredictable arts, courts and examiners may require more evidence to establish a reasonable expectation of success. Factors that may be considered include:
- The level of predictability in the art
- The amount of guidance provided in the prior art
- The presence or absence of working examples
- The nature of the invention
- The state of the prior art
It’s important to note that even in unpredictable arts, absolute certainty is not required. The key is whether a person of ordinary skill in the art would have had a reasonable expectation of success based on the information available at the relevant time.
To learn more: