DC patent ineligibility holding for Illumina’s fetal DNA-related claims again reversed

Illumina, Inc., Sequenom, Inc. v. Ariosa Diagnostics, Inc. et al.
Docket No. 2019-1419
March 17, 2020

Update (August 3, 2020): In a revision of its March 17, 2020 opinion reversing the DC’s 101 ineligibility decision, the FC panel reversed the DC’s decision on remand finding the claims invalid under 101 for being “directed to an ineligible natural phenomenon”. The FC panel maintained its prior statements that: “This is not a diagnostic case. And it is not a method of treatment case. It is a method of preparation case.” The FC panel also maintained its position that “CellzDirect…is instructive” (the inventors “discovered that hepatocytes naturally have that ability, and they exploited that phenomenon in a patent-eligible method”). Judge Reyna dissented, writing that, e.g., “[t]he Majority avoids our claimed advance precedent by reasoning that these claims belong to a distinct category of process claims for ‘method[s] of preparation’”, which “allows claim draftsmanship to evade § 101’s safeguard at the step one inquiry”, and “[t]he method steps under review do not transform the nature of the claims into patent-eligible applications.”

Original Brief Summary: DC finding that Illumina’s fetal DNA-related claims are patent ineligible reversed.

Original Summary: Illumina appealed DC decision finding certain claims of Illumina’s US 9,580,751 and 9,738,931 as ineligible under section 101 for being directed to natural phenomenon. The independent claims of each patent are directed to methods for preparing a fraction of cell-free DNA that is enriched in fetal DNA (e.g., “extracting DNA from a substantially cell-free sample of blood”, “producing a fraction of the DNA extracted”, and “analyzing a genetic locus in the fraction”). In its analysis, the FC panel wrote: “This is not a diagnostic case. And it is not a method of treatment case. It is a method of preparation case.” It explained that “it is undisputed that the inventors of the ‘751 and ‘931 patents discovered a natural phenomenon” but also that “at step one of the Alice/Mayo test, ‘it is not enough to merely identify a patent-ineligible concept underlying the claim; we must determine whether that patent-ineligible concept is what the claim is ‘directed to’” (CellzDirect, FC 2016; see also Athena, FC 2019 (holding diagnostic claims ineligible), Endo Pharm., FC 2019 (holding method of treatment claims patent-eligible)). The question is whether the inventor “claim the discovered natural phenomenon itself versus eligible subject matter that exploits the discover of the natural phenomenon.” The FC panel adopted “Illumina’s articulation of the natural phenomenon, i.e., that cell-free fetal DNA tends to be shorter than cell-free maternal DNA in a mother’s bloodstream” and found that the claimed “process achieves more that simply observing…or detecting the presence of that phenomenon” (e.g., the claimed “methods include specific process steps…to increase the relative amount of fetal DNA as compared to maternal DNA in the sample”). The claims at issue in the earlier Ariosa decision (FC 2015) were distinguished as being “directed to a method ‘for detecting a paternally inherited nucleic acid’…or a method ‘for performing a prenatal diagnosis’”, the “only operative steps” being “amplifying”, “detecting”, and “subjecting [it]…to a test” or detecting it (e.g., “[T]he inventors…discovered that cell-free fetal DNA exists, and then obtained patent claims that covered only the knowledge that it exists and a method to see that it exists.”) This case was also distinguished from Myriad (US 2013) since “the claims here are not directed to the cell-free DNA itself” (the Myriad claims “were ineligible because they covered a gene rather than a process for isolating it”). The FC panel views CellzDirect as “instructive” in that those inventors “patented an ‘improved process of preserving hepatocytes’” and “not simply an observation or detection of the ability of hepatocytes to survive multiple freeze-thaw cycles.” Thus, the ‘751 and ‘931 claims were found not to be directed to patent ineligible subject matter under step on of the Alice/Mayo test and are therefore patent eligible. Judge Reyna dissented, arguing that “the claims are directed to [the] natural phenomena…that cff-DNA tends to be shorter than cell-free maternal DNA in a mother’s blood” and, e.g., does not “alter[] the naturally occurring substances themselves” (Genetic Techs., FC 2016; Ariosa) and should therefore be ineligible.

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