In XY v. Trans Ova Genetics, Inc., Appeal No. 2019-1789 (Fed. Cir. July 31, 2020), a panel of Wallach, Plager and Stoll reversed the district court’s finding that claims to an improved method of cell sorting are patent ineligible under s. 101. The main claim of RE46,559 reviewed was an eight step process using flow cytometry to improve the separation of male determining cells, from female determining cells (“X from Y bearing sperm”), “an application useful in animal husbandry to ‘guarantee the sex of the offspring.’” I won’t reproduce claim 1, which is about two pages long, and begins: A method of operating a flow cytometry apparatus with at least n, [e.g.,2] detectors to analyze at least two populations of particles in the same sample. As described by the panel: “The claimed methods increase spatial separation of data corresponding to each population at least ‘by rotationally alter[ing] the n dimensional parameter data…For example, embodiments of the claimed ‘invention may involve rotating data to increase a separation of data from male-determining cells to female determining cells.’”
The district court had legally boiled the patent claims down to the abstract idea of a “’mathematical equation that permits rotating multidimensional data.’” Since the mechanical claim elements were known to the art, the claim failed the Alice/Mayo test. The panel disagreed, concluding that the asserted claims “are directed to a patent eligible improvement to a method of sorting particles using flow cytometry technology, not to an abstract idea” and reversed.
More specifically, the panel found that the “the claims are directed to a purportedly improved method of operating a flow cytometry apparatus to classify and sort particles into at least two populations in real time, wherein first and second detectors detect signals from individual particles and a processor converts the signals to n-dimensional parameter data and rotationally alter that data to increase special separation among the data, thereby facilitating classification and sorting of each individual particle.”
The panel distinguished Flook as involving an attempt to patent a mathematical formula and Cleveland Clinic as merely the use of known laboratory techniques to observe a previously unknown natural phenomenon. The panel relied heavily on Diehr and a decision I was not familiar with – Thales Visionix Inc. v. U.S., 850 F.3d 1343 (Fed. Cir. 2017). The panel explained:
“[T]he Thales claims and the asserted ‘559 patents claims both recited methods in which at least two sensors or detectors gather data about an object before mathematical operations are applied to the gathered data to generate more accurate information about the object that was previously possible in the art…As in Diehr and Thales, the asserted ‘559 patent claims ‘implement or apply [mathematical] formula[s] in a structure or process which, when considered as a whole, is performing a function which the patent laws were designed to protect.’”
Now please go back and read (or I hope, reread) my post of June 1, 2020 that discussed Illumina v. Ariosa in the context of Ariosa v. Sequenom. Judge Wallach found the claims in Ariosa v. Sequenom patent ineligible but, in XY, found the sorting claims to be patent eligible. Judges Lourie and Moore ruled that the claims in Illumina were patent eligible, and both, along with Judge Stoll, dissented from the denial of rehearing en banc in American Axel. I guess I am looking for a pattern here and not quite finding one. However if you can move your life sciences or medical device claims away from simply “detecting” and closer to “sorting”, you may have the patent eligibility yea votes of Lourie, Moore, Wallach, Plager and Stoll. However, a method for “sorting patients” into treat/don’t treat or low/high risk groups, is a much more difficult row to hoe. Take a look at Cleveland Clinic again (Lourie, Moore and Wallach). I bet that Trans Ova’s attorneys tried to sell the analogy of the XY cell sorting claims to patient sorting, but the panel wasn’t buying it. Diagnostic patents remain in Purgatory and it’s getting pretty warm down there.