The USPTO has issued new guidance to examiners to aid them in determining subject matter eligibility of life sciences method claims that facilitates obtaining such patents.
The new examiner guidelines were needed because the Federal Circuit clarified the patent eligibility standards for biotechnology claims. Rapid Litigation Management Ltd. v. Cellzdirect, Inc., No. 2015 1570 (Fed. Cir. July 5, 2016). Previously, the court had held in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015), cert. denied, 136 S. Ct. 2511 (2016), that claims directed to amplification and detection of cffDNA were patent ineligible because they did no more than apply, in routine and conventional ways, the discovery that cffDNA was present in maternal serum or plasma. In Rapid Litigation, the court reached a contrary conclusion with respect to method claims directed to freezing and thawing hepatocytes, and then separating out viable cells. Although the patentee’s discovery that hepatocytes can survive multiple freeze thaw cycles was the observation of a natural phenomenon, the patentee did not simply claim that phenomenon or a method of observing or detecting it. Rather, the patentee’s method was directed to a process for obtaining a useful result ____ a preparation of multi cryopreserved viable hepatocytes ____ and thus was not patent ineligible under “step one” of Alice. The court further held that the claims passed muster under Alice “step two” because, even though “[t]he individual steps of freezing and thawing were well known . . . a process of preserving hepatocytes by repeating those steps was itself far from routine and conventional.”