Docket No. 2015-1570
PROST, MOORE, STOLL
July 5, 2016
Brief Summary: DC determination that claims to methods for preserving hepatocytes are ineligible under § 101 vacated and remanded (inventors “employed their natural discovery…to create a new and improved” method).
Summary: CellzDirect appealed DC SJ determination that US 7,604,929 directed to hepatocytes capable of surviving multiple freeze-thaw cycles in invalid under § 101 (claims directed to a patent-inelgible law of nature and the process lacks the requisite inventive concept). Claim 1 of the ‘929 patent encompasses a method for producing such hepatocytes (“capable of being frozen and thawed at least two times” with greater than 70% viability) requiring “subjecting hepatocytes that have been frozen and thawed to density gradient fractionation”, “recovering the separated viable hepatocytes”, an “cryopreserving the recovered viable hepatocytes…without requiring a density gradient step after thawing…for the second time, wherein the hepatocytes are not plated between the first and second cryopreservations….”) Claim 5 is also reproduced in the opinion, and is directed to the method “wherein said preparation comprises a pooled preparation of hepatocyts of multiple sources”. The DC applied the two-step Alice test and concluded “the ‘929 patent is directed to an ineligible law of nature: the discovery that hepatocytes are capable of surviving multiple freeze-thaw cycles” (step one) and “the inventors ‘simply reapplied a well-understood freezing process” (step two). The FC panel disagreed with respect to step one, finding “[t]he method requires an artisan to carry out a number of concrete steps to achieve the desired preparation” that “achieved a notable advance over prior art techniques for preserving hepatocytes” and “the claims are simply not directed to the ability of hepatocytes to survive multiple freeze-thaw cycles” “Rather, the claims…are directed to a new and useful laboratory technique.precisely the type of claim that is eligible for patenting” under Alice. It concluded the inventors “employed their natural discovery” (that the cells could survive multiple freeze-thaw cycles) “to create a new and improved” method and the claims did not amount to “nothing more than observing or identifying the ineligible concept itself” (contrasted to Genetic Techs., FC 2016 (“nothing more than identifying ‘information about a patient’s natural genetic makeup’”); Ariosa, FC 2015 (cert. denied 2016) (identifying the presence of naturally-occurring cffDNA in blood “was merely claiming the natural phenomena itself”) ; In re BRCA (FC 2014) (comparing two sequences to detect alterations is ineligible “abstract mental process”); in each of those cases, “the end result of the process, the essence of the whole, was a patent-ineligible concept”). It was alleged that claim 5 “is indistinguishable from” Funk Brothers (US 1948) (product claims to a mixture of different bacterial species ineligible because, e.g., “[n]o species acquires a different use”) but the FC panel disagreed since “the claims are directed to a new and useful process of creating that pool, not to the pool itself.” It also explained that the ‘929 claims are distinguishable from Myriad because “the processes used by Myriad…were well understood”, unlike here. It also found the claims passed step two of the Alice test because “they recite an improved process for preserving hepatocytes for later use” (“An application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.” Mayo, US 2012). The opinion also noted that “a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made” (Diehr, US 1981), as here (“Prevailing wisdom…taught that cells could be frozen only once and then had to be used or discarded.”). The opinion “end[ed] with two additional points”: 1) patent-eligiblity does not turn on ease of execution or obviousness of application, which are examined separately; and, 2) “while pre-emption is not the test for determining patent-eligibility…it is certainly the ‘concern that undergirds…§ 101 jurisprudence’”. Thus, the DC decision was vacated and remanded.