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The claims-at-issue related to a method of producing a preparation of multi-cryopreserved hepatocytes that are capable of being frozen and thawed at least two times and in which greater than 70% of the hepatocytes are viable after the final thaw.  The claims took advantage of the discovery by the patentees that hepatocytes are capable of surviving multiple freeze-thaw cycles.

The district court held that the claims were not patent eligible under Section 101, because they claimed a law of nature: the discovery that hepatocytes are capable of surviving multiple freeze-thaw cycles and did not include an “inventive concept,” because they reapplied a well-understood freezing process.

The Federal Circuit reversed.  On the issue of “abstract idea,” the court held that the question is whether the claim is “directed to” patent-ineligible subject matter.  Here, the claims are directed to a new and useful laboratory technique for preserving hepatocytes, which is not a claim directed to the law of nature, but rather is a better way for preserving hepatocytes.  It is the process of preservation that is patent eligible, not the end product. 

On the second issue of whether the claims include an “inventive concept,” the claims do so, because they apply the discovery that hepatocytes can be twice frozen to achieve a new and useful preservation process.  That each of the steps was known independently does not make the claim unpatentable, because the combination of known steps can be patentable.  Further, in these claims, the known steps are repeated, but in the prior art these steps were never repeated, which makes the claims unconventional and not routine.  

Rapid Litigation Management Ltd. v. CellzDirect, Inc., Case No. 2015-1570 (July 5, 2016); Opinion by: Prost, joined by Moore and Stoll; Appealed From: United States District Court for the Northern District of Illinois, Shadur, J.  Read the full opinion here.

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