On July 5, 2016, the U.S. Court of Appeals for the Federal Circuit issued an opinion vacating the summary judgment of invalidity of U.S. Patent No. 7,604,929 (“the ’929 Patent”) and sent the case back to the District Court for the Northern District of Illinois. See Rapid Litigation Management Ltd., et al. v. CellzDirect, Inc., et al., No. 2015-1570 (Fed. Cir. Jul. 5, 2016)(“Opinion”). The ’929 Patent is directed to a method of preserving hepatocytes using multiple freeze-thaw cycles. This process is distinct from the prior art, which taught that hepatocytes would remain viable only after a single freeze-thaw cycle.

The District Court

The District Court found the ’929 Patent invalid under § 101. Under the two-step patent eligibility test of Alice v. CLS Bank, the District Court stated that (1) the method was directed to a law of nature (the discovery that certain hepatocytes may survive multiple freeze-thaw cycles) and (2) the freeze-thaw process was well-known, and thus a second freeze-thaw cycle was insufficient to generate an “inventive concept.”

The Federal Circuit

The Federal Circuit disagreed with the District Court, explaining that the claims of the ’929 Patent were not directed to a law of nature, but rather to a new and useful laboratory technique that merely “touches” on a law of nature. Specifically, the claims do not recite observing or detecting that certain hepatocytes may survive multiple freeze-thaw cycles, but instead the claims recite a “method of producing a desired preparation of multi-cryopreserved hepatocytes.” See Opinion at 8-10.

Regarding the “inventive concept” inquiry under Step 2 of the Alice test, the Federal Circuit acknowledged that the individual steps of the method (freezing cells, thawing them, and then separating viable from non-viable cells) were each known in the art. However, the Court explained that “in examining claims under step two, we must view them as a whole, considering their elements ‘both individually and as an ordered combination.’” See Opinion at 14. Here, consideration of the method steps as a whole was critical: the Court emphasized the strong evidence of unpredictability in the field, and the teaching away from multiple freeze-thaw cycles in the art. Accordingly, despite the well-known processes used in the method steps, “[r]epeating a step that the art taught should be performed only once can hardly be considered routine or conventional.” See Opinion at 15. Ultimately, the Federal Circuit vacated the grant of summary judgment of invalidity under § 101, and sent the case back to the District Court. See the related case Celsis In Vitro, Inc., v. CellzDirect, et al., No. 2010-1547 (Fed. Cir. Jan. 9, 2012) for additional discussion of the prior art.

Practical Considerations

While the Federal Circuit reiterated that “patent eligibility does not turn on ease of execution or obviousness of application” of the claimed invention, the unpredictability in the field and teaching away in the art were critical to the outcome of this case. Thus, Applicants in the life sciences may find it advantageous to provide evidence of unpredictability and teaching away to not only address obviousness under § 103, but to support a determination of patent eligibility under § 101. Moreover, this case reiterates the instruction to examine claims as a whole, rather than viewing each element in isolation. Accordingly, Applicants may combine conventional steps that together contravene conventional wisdom, for example, in a diagnostic technique that merely touches on a law of nature, as here, to render the subject matter as a whole patent eligible under § 101.

This article was originally published on knobbe.com by Partners Eric Furman, Ph.D. and Caleb A. Bates, Ph.D.