CareDx v. Natera Patent Litigation

In CareDx (Stanford U.) v. Natera Civ. Action No. 19-0567-CFC-CJB Consolidated (Sept. 28, 2021, D. Delaware), Judge Connolly dominated that the diagnostic strategy claimed in U. S. Pat. No. 8,703,652 and two many others was a patent-ineligible organic phenomenon. The system is centered on the recognized correlation among the presence of donor-specific cell-no cost DNA (cfDNA) in a transplant recipient’s tissue and transplant rejection. Considering that the correlation was recognized, CareDx was remaining to argue that the improvement in sensitivity presented by the combination of recognized steps—which advancement was even recited in declare 1—was sufficient to fulfill the Mayo/Alice check for patent eligibility. However, by now we know that even discovery of a normal correlation and the discovery of its utility as a diagnostic is not ample to satisfy the prerequisite for the even more “inventive concept” necessary by Stage 2 of the Mayo/Alice check.

As pretty much a side-take note, the Decide opined that the statement in Athena that Move 1 of the Mayo/Alice exam could be glad by statements that recite only a normal legislation mixed with “standard techniques for observing it”  both satisfy the “directed to” requirement of Stage 1, and display the deficiency of any further “inventive concept” required for patent eligibility in Action 2 of the examination. The choose cited case legislation asserting that “the two techniques of the Alice inquiry overlap.” So if you are unsuccessful Action 1 you instantaneously fall short Stage 2?

While assert 1 is a website page extended, the techniques of claim 1 have been boiled down to 4: 1. Acquiring a sample from the transplant receiver, 2. Genotyping the transplant donor and/or receiver to produce polymorphism or SAP “profiles”, 3. Sequencing the cfDNA from the sample(s) making use of multiplex or significant-throughput sequencing or applying digital PCR and 4. Pinpointing or quantifying the total of donor cfDNA.

The Decide then went on to obtain the created description in the patent “is replete with characteristics of the techniques that affirm their conventionality.” See fn. 5 on web pages 9-10. CareDx argued that “the challenged statements recite a series of specific, non-traditional laboratory approaches for detecting mobile-no cost DNA with a large diploma of sensitivity, in a way that enhances on prior art procedures of trying these types of detection” [eds. Note: what happened to quantification?]. Even so the Decide framed the issue:

“Because the asserted promises are directed to the detection of these natural phenomena, the dispositive inquiry beneath both equally actions of the Alice inquiry is whether the claimed methods are traditional (i.e., regular or routine). The patentee’s unequivocal and binding admission in the composed description that the recited detection techniques are typical finishes the subject before me.”

Oddly, the Therasense criteria for inequitable perform right before the PTO are cited as guidance for a type of reverse prosecution historical past estoppel by argument. To paraphrase, simply because CareDx produced representations throughout prosecution that the methods of the claimed system are conventional, it cannot get the opposite posture throughout litigation. But how is a competitor harmed by a patentee who later on argues that a step described as program is, in fact, unconventional?  Patentee is not arguing that any recited phase is inoperable and so the assert is invalid under s. 112. Patentee is arguing that patentee had made use of early phase engineering in a prosperous combination—even if they did not invent it.

Things go downhill from below. The judge accuses CareRx of falsely arguing that digital PCR is an “emerging technique” after he reads a paragraph from the specification describing the pros of utilizing electronic PCR about prior PCR tactics. The choose also describes as “not true”, CareDx’s assertion that the specification states that the inventors “applied a hardly ever-in advance of-utilised mixture of procedures to greater evaluate the correlation.” But even if the specification only broadly asserts that the claimed technique is remarkable to prior artwork approaches, really should that make any difference if the argument about the novelty of the blend is, in point, real?

I consider that the Choose is just completely wrong when he disregards CareDx’s argument that “the novelty of the recited strategies to the detection of donor-specified [specific?] cfDNA would make the procedures nonconventional…Alice stage two’s necessity of ‘additional characteristics that should be new and useful’ is basically not achieved in this situation since the asserted approach claims recite common detection tactics used to the natural way happening phenomena…the asserted patents do not claim an purchased combination of the recited techniques[!]” The Judge himself characterised the claimed approach has owning 4 recited actions.

I am not a litigator but, if I were, I would not test so really hard to argue that the personal methods are unconventional, and target on the enhancements due to the use of the measures in purchased mixture. I would also have argued that the technique resulted in the quantification of the cfDNA, not just its detection, to stay away from the Ariosa buzz-observed. I feel the Decide acquired irritated by what he felt have been mischaracterizations of the specification and basically discounted the “ordered combination” when he eventually bought to it. Activity, set, match.