The Supreme Court in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1294, 1296-98 (2012) requires application of a two-part test for determining patent eligibility under section 101. First, one must ask whether the patent is directed to one of the patent-ineligible concepts. If the answer is no, the inquiry is over: the claim falls within the ambit of section 101. Second, if the answer is yes, one must still determine whether, considered both individually and as an ordered combination, the additional elements transform the nature of the claim into a patent-eligible application. Step two is oftn described “as a search for an inventive concept”. At step two, more is required than “well-understood, routin, conventional activity already engaged in by the scientific community”.
The Federal Circuit in Rapid Litigation Management v. Cellzdirect, Inc., (2016) points to the importance of step one in the inquiry above. In this case, the district court granted summary judgment that US patent 7,604,929 was invalid under 35 USC 101 as being directed to a patent ineligible law of nature –that hepatocytes are capable of surviving multiple freeze thaw cycles. Hepatocytes are a type of liver cell with a number of uses such as in the testing and diagnostic field. Prior to the patent, scientists frooze hepatocytes and then when needed, thawed them and recvoered the viable cells using density gradient fractionation. Applicant’s of the ‘929 patent discovered that one could actually freeze the hepatocytes twice and still obtain viable cells. Using this knowledge, the applicant’s developed a process of preserving hepatocytes and patented a claim for a process that comprised a number of steps such as subjecting previously frozen and thawed cells to density gradient fractionation to separate viable cells from non-viable ones, recoveirng the viable cells and refreezing the viable cells.
The Federal Circuit reversed the district court’s decicion on the basis that contrary to being directed to a “natural law” which was the cells capability of surviving multiple feeze thaw cycles, the claims were clearly directed to a new and useful laboratory technique for preserving hepatocytes. This type of process, carried out by an artisan to achieve “a new and useful end” is precisely the type of claim that is eligible for patenting. (citing Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347, 2355 (2014). The Court noted that while the inventors certainly discovered the cells’ ability to surive multiple feezing thaw cycles, that is not wehre they stopped, nor is what they patented. Rather, “as the first party with knowledge of” the cells’ ability, they were “in an excellent position to claim applications of that knowledge.” (citing Myriad, 133 S. Ct. 15 2120). The end result of the ‘929 patent claims was not simply an observation or detection of the ability of hepatocytes to survive multiple feeze thaw cycles. Rather, the claims are directed to a new and useful method of preserving hepatocyte cells.
Also of interest in this case is a nice contrast to other important cases where the hurdles of 101 were not met because they amounted to nothing more than observing or identifying the ineligible concept itself..
Ariosa Diagnostics, Inc., v. Sequenom, Inc., 788 F.3d 1371, 1373-74 (Fed. Cir. 2015), cert. denied, No. 15-1102, 2016 (WL 1117246 (June 27, 2016). The existence and location of cffDNA is a natural phenomenon; identifying its presence was merely claiming the natural phenomena itself. The Court determined that the claims were “directed to” the patent ineligible cffDNA itself.
Genetic Techs., Ltd. v. Merial L.L.C., 818 F.3d at 1369, 1373-74 (Fed. Cir. 2016): In this case the claim recited methods for detecting a coding region of DNA based on its relationship to non-coding regions. Becasue the relationship between coding and non-coding sequences was a law of nature, the claim amounted to nother other than identifying “information about a patient’s natrual genetic makeup.”
In re CRCA1- & CRCA2-Based Hereditary Cancer Test Patent Litig., 774 F.3d 755, 761-62 (Fed. Cir. 2014): The case recited methods for screening human germline for an altered BRCA1 gene by comparing the target DNA sequence with wild-type sequence. Comparing two sequences to detect alterations is a patent ineligible “abstract mental process”
Of further note with the Rapid litigation case, the Court stated that even if the ‘929 patent is “directed to ” hepatocytes’ natural ability to survive multiple feeze thaw cycles, the Court would find the claims patent eligible at the second step of the analysis as having transformed the process into an inventive application of the patent ineligible concept because the claims recited an improved process for preserving hepatocytes for later use. The benefits of the imporved process over the prior art methods are significant because they applied the discovery that hepatocytes can be twice frozen to acheive a new and useful presrvation process. (citing Mayo, 132 S. Ct at 1293-94 “An application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection”, quoting Diehr, 450 US at 187. While each of the claims’ individual steps (freezing, thawing, and seaprating) were known independently in the art also did not make the claim unpatentable. Instead, one must view the claim as a whole, considering their elements both individually and “as an ordered combination” (citing Alice, 134s S. Ct. at 2355, quoting Mayo 132 S. Ct. at 1298). While the individual steps of feezing and thawing were well known, a process of preserving hepatocytes by repeating those steps was itself far from routine and conventional becasue the prior art only disclosed methods having one feeze thaw cycle of hepatocytes, wehrein upon thawing, a gradient centrifugation step is required to remove the non-viable cells. Repeating a step that the art taught should be performed only once can hardly be considered routine or conventional.