November 26, 2022

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Boilerplate Admissions in the Patent Document Lose Eligibility Case for Stanford

by Dennis Crouch

The Federal Circuit&#8217s new eligibility decision in CareDx, Inc. v. Natera, Inc., &#8212 4th &#8212 (Fed. Cir. 2022) need to bring about patent attorneys to pause after once more as they draft patent apps and look at any characterizations of the technological know-how as &#8220regular&#8221 &#8220nicely identified&#8221 or even &#8220identified in the art.&#8221 At situations some characterization will be helpful for fulfilling disclosure prerequisites.  Even now, the statements will also most likely haunt the patentee both on the obviousness aspect and, as listed here, with eligibility.

Stanford owns quite a few biotech patents declaring techniques of diagnosing organ transplant rejection. U.S. Patents 8,703,652, 9,845,497, and 10,329,607.  Stanford and its unique licensee CareDx sued Naterta and Eurofins for patent infringement.  But, Main Choose Connolly (D.Del) dismissed the scenario&#8211acquiring the statements ineligible underneath Part 101.  On appeal, the Federal Circuit has affirmed.  This is one more big case that could established-up Supreme Court evaluation.

The technological innovation in this case is relatively related to the prenatal tests methods in the Illumina and Sequenom instances.  The important variation is that the prenatal engineering appeared for fetal DNA floating in the mother&#8217s bloodstream when this graft engineering appeared for DNA of the transplanted-organ floating in the stream.  Transplant rejection is a main immune response and will involve having-absent of the transplanted cells. That process releases bits of DNA into the bloodstream.  The Stanford researchers found that the total of Donor DNA floating in the blood stream of the receiver is indicative of regardless of whether the transplant is remaining rejected.

The promises at challenge all share a frequent four action method for detecting mobile free DNA (cfDNA) in the receiver:

  1. “obtaining” or “providing” a “sample” from the receiver that contains cfDNA
  2. “genotyping” the transplant donor and/or recipient to develop “polymorphism” or “SNP” “profiles”
  3. “sequencing” the cfDNA from the sample working with “multiplex” or “high-throughput” sequencing or doing “digital PCR” with particular mistake fees and
  4. “determining” or “quantifying” the amount of money of donor cfDNA.

Slip Feeling.  On summary judgment, the district court concluded that these statements were all directed to a patent ineligible normal phenomena. In certain, the statements are directed to &#8220the existence of donor cfDNA in a transplant receiver and the correlation involving donor cfDNA and transplant rejection.&#8221  Due to the fact the individual strategies made use of to attain and analyze the cfDNA were being all standard, the court concluded that absolutely nothing in the promises transformed their mother nature into a patent-eligible invention.

On appeal, the Federal Circuit affirmed, keeping that &#8220[t]his is not a scenario involving a method of planning or a new measurement method.&#8221

The claimed solutions are indistinguishable from other diagnostic method claims the Supreme Court docket identified ineligible in Mayo and that we located ineligible on multiple instances. . . . Here, as in Ariosa, the claims boil down to gathering a bodily sample, analyzing the cfDNA employing common tactics, including PCR, pinpointing by natural means happening DNA from the donor organ, and then applying the organic correlation in between heightened cfDNA degrees and transplant health to identify a probable rejection, none of which was creative. The claims here are equally as ineligible as all those in Ariosa.

Slip Op. If the statements in Mayo & in Ariosa are invalid, then the Federal Circuit is very likely suitable that&#8211so are the statements in this case.

= = =

Alice Action Two: A person significant caveat on conventionality of the technological innovation.  CareDx argued that the particular technological strategy was new and different from prior initiatives.  It had been theorized for years that cfDNA of the donor tissue could be used as a measure of tissue failure, prior scientists experienced consistently tried using and unsuccessful.

Irrespective of lots of makes an attempt around the adhering to ten years, even attained scientists could not invent a satisfactory way to measure donor cf-DNA in the recipient’s bloodstream sufficient to observe organ rejection. At most effective, preexisting methods worked only in a compact subset of instances. This 10 years of failure culminated in a discouraging announcement in 2008 by a distinguished research group that making use of cf-DNA to check organ rejection was “difficult” and “impractical.” . . .

Not only experienced there been quite a few documented failures and outright disbelief that a feasible cf-DNA organ rejection examination could be produced, but trying to evaluate cf-DNA, instead than mobile DNA was foreboding. As even defendants’ expert concedes, cf-DNA was considered at the time to be “more challenging” than other analytes to measure since cf-DNA is scaled-down, not random, usually existing in very low concentrations, and since this “detection investigation is hard with approaches prior to 2009.”

CareDx Opening Appellate Short.  The unique tactic that labored for the Stanford Researches was their application of recently designed digital PCR and next-technology sequencing (“NGS”) approaches.  And, people advancements are section of the statements.

The problem even though was a selection of boilerplate statements discovered within just the patent doc that the courts saw as admissions that the technological innovation was wholly regular:

The practice of the present creation employs, until normally indicated, traditional methods of immunology, biochemistry, chemistry, molecular biology, microbiology, cell biology, genomics and recombinant DNA, which are within the skill of the artwork.

&#8216607 Patent, Col 5, line 55.  The patent also talked over the availability of professional substantial throughput sequencing solutions and said that significant-throughput genotyping is &#8220regarded in the artwork.&#8221  According to the Federal Circuit, these statements from the specification characterize &#8220the claimed techniques in conditions that ensure their conventionality.&#8221  As these, the court docket observed no purpose to disturb the summary judgment obtaining.

Judges LOURIE, BRYSON, and HUGHES. Authored by LOURIE, Circuit Decide.  The situation was argued by earth course attorneys with Ed Reines (Weil Gotshal) for Stanford/CareDx Willy Jay (Goodwin Procter) for Eurofins and Gabriel Bell (Latham & Watkins) for Natera.