CareDx v. Natera – Are Processing Steps Known to the Art Always “Conventional”?

In CareDx (Stanford U.) v. Natera Civ. Action No. 19-0567-CFC-CJB Consolidated (Sept. 28, 2021, D. Delaware), Choose Connolly dominated that the diagnostic technique claimed in U. S. Pat. No. 8,703,652 and two others was a patent-ineligible pure phenomenon. The strategy relies upon the recognized correlation between the presence of donor-specific cell-free DNA (cfDNA) in a transplant recipient’s tissue and transplant rejection. Since the correlation was recognized, CareDx was left to argue that the enchancment in sensitivity supplied by the mixture of recognized steps—which enchancment was even recited in declare 1—was enough to fulfill the Mayo/Alice take a look at for patent eligibility. Nevertheless, by now we all know that even discovery of a pure correlation and the discovery of its utility as a diagnostic is just not sufficient to fulfill the requirement for the additional “inventive concept” required by Step 2 of the Mayo/Alice take a look at.

As virtually a side-note, the Choose opined that the assertion in Athena that Step 1 of the Mayo/Alice take a look at could possibly be glad by claims that recite solely a pure regulation mixed with “standard techniques for observing it”  each meet the “directed to” requirement of Step 1, and show the lack of any additional “inventive concept” required for patent eligibility in Step 2 of the take a look at. The choose cited case regulation asserting that “the two steps of the Alice inquiry overlap.” So when you fail Step 1 you immediately fail Step 2?

Though declare 1 is a web page lengthy, the steps of declare 1 had been boiled down to 4: 1. Acquiring a pattern from the transplant recipient, 2. Genotyping the transplant donor and/or recipient to develop polymorphism or SAP “profiles”, 3. Sequencing the cfDNA from the pattern(s) utilizing multiplex or high-throughput sequencing or utilizing digital PCR; and 4. Figuring out or quantifying the quantity of donor cfDNA.

The Choose then went on to discover the written description in the patent “is replete with characteristics of the techniques that confirm their conventionality.” See fn. 5 on pages 9-10. CareDx argued that “the challenged claims recite a series of specific, non-conventional laboratory techniques for detecting cell-free DNA with a high degree of sensitivity, in a manner that improves upon prior art methods of attempting such detection” [eds. Note: what happened to quantification?]. Nevertheless the Choose framed the query:

“Because the asserted claims are directed to the detection of these natural phenomena, the dispositive inquiry under both steps of the Alice inquiry is whether the claimed methods are conventional (i.e., standard or routine). The patentee’s unequivocal and binding admission in the written description that the recited detection methods are conventional ends the matter before me.”

Oddly, the Therasense requirements for inequitable conduct earlier than the PTO are cited as assist for a type of reverse prosecution historical past estoppel by argument. To paraphrase, as a result of CareDx made representations throughout prosecution that the steps of the claimed technique are typical, it can’t take the reverse place throughout litigation. However how is a competitor harmed by a patentee who later argues {that a} step described as routine is, actually, unconventional?  Patentee is just not arguing that any recited step is inoperable and so the declare is invalid underneath s. 112. Patentee is arguing that patentee had used early stage expertise in a profitable mixture—even when they didn’t invent it.

Issues go downhill from right here. The choose accuses CareRx of falsely arguing that digital PCR is an “emerging technique” after he reads a paragraph from the specification describing the benefits of utilizing digital PCR over prior PCR strategies. The choose additionally describes as “not true”, CareDx’s assertion that the specification states that the inventors “applied a never-before-used combination of techniques to better measure the correlation.” However even when the specification solely broadly asserts that the claimed technique is superior to prior artwork strategies, ought to that matter if the argument about the novelty of the mixture is, actually, true?

I feel that the Choose is simply unsuitable when he disregards CareDx’s argument that “the novelty of the recited techniques to the detection of donor-specified [specific?] cfDNA makes the techniques nonconventional…Alice step two’s requirement of ‘additional features that must be new and useful’ is simply not met in this case because the asserted method claims recite standard detection techniques applied to naturally occurring phenomena…the asserted patents do not claim an ordered combination of the recited techniques[!]” The Choose himself characterised the claimed technique has having 4 recited steps.

I’m not a litigator however, if I had been, I’d not attempt so onerous to argue that the particular person steps are unconventional, and deal with the enhancements due to the use of the steps in ordered mixture. I’d even have argued that the technique resulted in the quantification of the cfDNA, not simply its detection, to keep away from the Ariosa buzz-saw. I feel the Choose obtained irritated by what he felt had been mischaracterizations of the specification and easily discounted the “ordered combination” when he lastly obtained to it. Sport, set, match.

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