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Illumina v. Ariosa – Ariosa Petitions for Cert.

The first panel decision below can be found at 952 F.3d 1367 (Fed. Cir. 2020). I posted on this decision on June 1, 2020, days before the Fed. Cir. issued a modified panel decision in August, 967 F.3d 1319 (Fed. Cir. 2020) that essentially affirmed the first panel’s holding that the claims in two Illumina patents, U. S. Pat. Nos. 9,580,751 and 9,738,931, claimed patent eligible subject matter. Please read my June post for more background. Claim 1 of the ‘751 patent reads as follows:

“1. A method for preparing a [DNA] fraction from a pregnant human female useful for analyzing a genetic locus involved in a fetal chromosomal aberration, comprising:

a. Extracting DNA from a substantially cell-free sample [cf] of blood plasma or blood serum  of a pregnant human female to obtain extracellular fetal and maternal DNA fragments,

b. Producing a fraction of the DNA extracted in (a) by:

(i)              Size discrimination of extracellular circulatory DNA fragments, and

(ii)            selectively removing the DNA fragments greater than approximately 500 base pairs, wherein the DNA fraction after (b) comprises a plurality of genetic loci of the extracellular circulatory  fetal and maternal DNA; and

c. analyzing a genetic locus in the fraction of DNA produced in (b).”

The Fed. Cir. judges agreed that the inventors had discovered a natural phenomenathe fact that maternal blood plasma contains cell-free fetal DNA that is generally smallerbelow 500 base pairs—than the other cell free DNA in the sample, that is derived from the mother. However, the majority of the panel refused to stop the Step A Mayo/Alice inquiry at that point, but went on to hold that the claim are directed to a method of preparation, and are not diagnostic claims. Therefore, the majority held that the DNA fraction that is the end product of step (b) of the claim is not directed to a natural product, e.g., a sample of concentrated cffDNA  but is a product of the hand of man—a fraction of cfDNA  that is enriched in fetal DNA.

In its Petition, Ariosa argued that the claims were indistinguishable from the isolated BRCA genes that were found to be a patent-ineligible natural product in Myriad. But the Myriad claims were noted by the Court to be composition claims, not method claims. Furthermore, in dicta, the Court stated that novel methods for manipulating the genes might well be patentable. While the Petition argues that both the Myriad claims and the present claims involve no more than isolation of naturally occurring DNA from its surroundings, in Myriad, the genes were isolated by snipping them out of the human genome, while the present claims were directed to a method for isolation of fragments of cffDNA from biological background noise.

Ironically, the Petition also relies heavily on the Ariosa decision in which PCR was used to amplify cffDNA. However, the Fed. Cir. held that the claims patent ineligible since simply “isolating” a natural product was insufficient to confer patent-eligibility. The problem I see with this argument is that, in Ariosa, the inventors essentially began with a known target stretch of DNA and then made more of it. In the present case, the “hand of man” has produced a concentrate that never existed in nature.

It is telling that the Petitioners did not cite, much less discuss the Fed. Cir’s holding in Rapid Litigation Management v. CellzDirect. Apart from the fact that the cryopreserved “hardy” hepatocytes were not a DNA fraction, Illumina’s brief in opposition to Ariosa’s Petition could be taken almost directly from CellzDirect. If one replaces “hepatocytes” with “cffDNA enriched sample” in the CellzDirect, it reads very smoothly.

Both cases are method-of-preparation cases that are based on the inventor’s discovery of a natural phenomenon. In CellzDirect, the phenomenon was that there exists a population of hepatocytes that remain viable after at least two freeze-thaw cycles. There were no claims to the cryopreserved hardy hepatocytes per se, but rather the claims were directed to a method of isolating the hardy hepatocytes from the non-viable ones after one freeze-thaw cycle, that yielded “cryopreserved” viable hepatocytes. Much as the concentrated cffDNA end product in the present case, the cryopreserved hepatocytes were found not to be a product of nature, but to require “concrete steps” taken by the hand of man to bring them out of the Jungle of Naturea term I think was used by Judge Rich in Bergy II—“to a useful end”.

As a final footnote to this piece, it is interesting that both the CellzDirect panel and the Brief dealt with Funk Bros. Seed. In CellzDirect, the panel simply found that Funk Bros. considered only composition claims. The Ariosa Brief over argues Funk Bros. as standing for the broad principle that “the mere act of changing the concentration of one naturally occurring substance relative to another…is generally not patent eligible where the constituent substances are not altered.”

The Petition underscores its arguments by citing Flookwhile the CellzDirect panel relied on Diehr, also not cited in the Petition. Maybe that is all we need to know.


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