Boilerplate Admissions in the Patent Document Lose Eligibility Case for Stanford

by Dennis Crouch

The Federal Circuit’s new eligibility decision in CareDx, Inc. v. Natera, Inc., — 4th — (Fed. Cir. 2022) should cause patent attorneys to pause once again as they draft patent applications and consider any characterizations of the technology as “conventional”; “well known”; or even “known in the art.” At times some characterization will be useful for satisfying disclosure requirements.  Still, the statements will also potentially haunt the patentee both on the obviousness side and, as here, with eligibility.

Stanford owns several biotech patents claiming methods of diagnosing organ transplant rejection. U.S. Patents 8,703,652, 9,845,497, and 10,329,607.  Stanford and its exclusive licensee CareDx sued Naterta and Eurofins for patent infringement.  But, Chief Judge Connolly (D.Del) dismissed the case–finding the claims ineligible under Section 101.  On appeal, the Federal Circuit has affirmed.  This is another major case that could set-up Supreme Court review.

The technology in this case is somewhat similar to the prenatal testing methods in the Illumina and Sequenom cases.  The key difference is that the prenatal technology looked for fetal DNA floating in the mother’s bloodstream while this graft technology looked for DNA of the transplanted-organ floating in the stream.  Transplant rejection is a major immune response and involves eating-away of the transplanted cells. That process releases bits of DNA into the bloodstream.  The Stanford researchers found that the amount of Donor DNA floating in the blood stream of the recipient is indicative of whether the transplant is being rejected.

The claims at issue all share a common four step approach for detecting cell free DNA (cfDNA) in the recipient:

  1. “obtaining” or “providing” a “sample” from the recipient that contains cfDNA;
  2. “genotyping” the transplant donor and/or recipient to develop “polymorphism” or “SNP” “profiles”;
  3. “sequencing” the cfDNA from the sample using “multiplex” or “high-throughput” sequencing; or performing “digital PCR” with certain error rates; and
  4. “determining” or “quantifying” the amount of donor cfDNA.

Slip Opinion.  On summary judgment, the district court concluded that these claims were all directed to a patent ineligible natural phenomena. In particular, the claims are directed to “the presence of donor cfDNA in a transplant recipient and the correlation between donor cfDNA and transplant rejection.”  Since the particular techniques used to obtain and analyze the cfDNA were all conventional, the court concluded that nothing in the claims transformed their nature into a patent-eligible invention.

On appeal, the Federal Circuit affirmed, holding that “[t]his is not a case involving a method of preparation or a new measurement technique.”

The claimed methods are indistinguishable from other diagnostic method claims the Supreme Court found ineligible in Mayo and that we found ineligible on multiple occasions. . . . Here, as in Ariosa, the claims boil down to collecting a bodily sample, analyzing the cfDNA using conventional techniques, including PCR, identifying naturally occurring DNA from the donor organ, and then using the natural correlation between heightened cfDNA levels and transplant health to identify a potential rejection, none of which was inventive. The claims here are equally as ineligible as those in Ariosa.

Slip Op. If the claims in Mayo & in Ariosa are invalid, then the Federal Circuit is likely correct that–so are the claims in this case.

= = =

Alice Step Two: One important caveat on conventionality of the technology.  CareDx argued that the particular technological approach was new and different from prior efforts.  It had been theorized for years that cfDNA of the donor tissue could be used as a measure of tissue failure, prior researchers had repeatedly tried and failed.

Despite many attempts over the following decade, even accomplished researchers could not invent a satisfactory way to measure donor cf-DNA in the recipient’s bloodstream sufficient to monitor organ rejection. At best, preexisting techniques worked only in a small subset of cases. This decade of failure culminated in a discouraging announcement in 2008 by a prominent research group that using cf-DNA to monitor organ rejection was “difficult” and “impractical.” . . .

Not only had there been many reported failures and outright disbelief that a viable cf-DNA organ rejection test could be developed, but attempting to measure cf-DNA, rather than cellular DNA was foreboding. As even defendants’ expert concedes, cf-DNA was believed at the time to be “more challenging” than other analytes to measure because cf-DNA is smaller, not random, typically present in low concentrations, and because this “detection analysis is difficult with techniques prior to 2009.”

CareDx Opening Appellate Brief.  The particular approach that worked for the Stanford Researches was their application of newly created digital PCR and next-generation sequencing (“NGS”) techniques.  And, those advances are part of the claims.

The problem though was a number of boilerplate statements found within the patent document that the courts saw as admissions that the technology was wholly conventional:

The practice of the present invention employs, unless otherwise indicated, conventional techniques of immunology, biochemistry, chemistry, molecular biology, microbiology, cell biology, genomics and recombinant DNA, which are within the skill of the art.

‘607 Patent, Col 5, line 55.  The patent also discussed the availability of commercial high throughput sequencing products and stated that high-throughput genotyping is “known in the art.”  According to the Federal Circuit, these statements from the specification characterize “the claimed techniques in terms that confirm their conventionality.”  As such, the court found no reason to disturb the summary judgment finding.

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

 

41 thoughts on “Boilerplate Admissions in the Patent Document Lose Eligibility Case for Stanford

  1. 7

    “This is another major case that could set-up Supreme Court review.”

    Right. And monkeys might fly out my rear.

    SCOTUS doesn’t give a @#$% about the eligibility mess it’s made. It refused cert on Sequenom, it recently refused cert on American Axle, and I’ll eat my shorts if it grants cert in this case.

    1. 7.1

      +1

      Once they passed on Sequenom, I knew that they were never going to clean up their own mess. This case is not nearly as egregious or sympathetic as Sequenom. If they can look with indifference on Sequenom, they can do so here as well.

      1. 7.1.1

        Sympathetic as Sequenom?

        How? The “inventors” made a scientific discovery. That discovery was immediately useful to those skilled in the art-with no needed changes in technology.

        A new property of a known substance worked by purely conventional means ought to still be patent eligible if the invention results in some new effect in the world: a stronger metal, a better drug; or some other difference from the prior art.

        But if the utility of the new property is realized by its bare discovery, and there is no mechanical or chemical change from the prior art as a result of the invention, how can there be an invention beyond the fact of the discovery?

        1. 7.1.1.1

          Did the world know how to diagnose transplant organ failure with this level of sensitivity and non-invasive means before the inventors’ disclosure? No. Therefore, there should be some mechanism to incentivize that disclosure. That is the purpose that the patent system is meant to serve.

          1. 7.1.1.1.1

            +1. Greg, your comment reminds me of the advent of that category of claim which begins “Use of X for purpose Y” It was EXXON who brought that through, nearly 40 years ago, in the early days of the EPO. Also back then, the argument was that i) the very purpose of the patent system is to secure early publications of contributions to the useful arts that solve a technical problem, and ii) a old thing, in the course of being put to an old use, can still piggy-back on the contribution, so there should be a form of claim to fit the circumstances. Hence the by now very well-known “use claim”.

            BTW, Exxon’s contribution was that their well-known fuel additive also inhibited corrosion. But, you being a pharma person, you know all about use claims, don’t you.

          2. 7.1.1.1.2

            If I disclose that there is gold in them thar hills, should I getz a patent?

            1. 7.1.1.1.2.1

              What statutory category are you trying to fit your “gold in them thar hills” into?

            2. 7.1.1.1.2.2

              Plus, marty, let me share this with you (again):

              link to ipwatchdog.com

              Do you have a place in your spectrum to read (and understand) this?

            3. 7.1.1.1.2.3

              “Should”? Yes. It makes perfect sense for Congress to create some sort of incentive for the disclosure of hitherto unknown sources of mineral wealth. As it happens, Congress evidently has not made provision for such a reward scheme, but they should.

              Meanwhile, Congress has already made provision of incentives for the disclosure of hitherto unknown techniques to improve human health—viz., patents. The patent should hold good here.

  2. 6

    This case reinforces the old adage that anything you say can, and will, be used against you. When I work with new associates or summer interns, one key issue I always try to emphasize is simple – every word you write needs to contribute to the application (or brief, etc.). Why are you saying it and can someone take your words and use them against you? If you can’t think of a positive way in which a word (sentence, paragraph, etc.) contributes to the document, look very closely at deleting it. Whether or not this case would have turned out differently if the invention had been characterized differently is a very tough question.

  3. 5

    It doesn’t matter what one says in a specification.

    Alice-Mayo is capricious garbage

  4. 4

    All your eligibility are belong to us!

    — Your CAFC Overlords

  5. 3

    At times some characterization will be useful for satisfying disclosure requirements. Still, the statements will also potentially haunt the patentee both on the obviousness side and, as here, with eligibility.

    I am dubious that the outcome would have been one scintilla different if the patentee had not had the language about “conventional” techniques in the application. In theory, this sort of language can help with enablement issues and hurt with obviousness/eligibility. In practice, I think that it can help (although only a little) with enablement, but it is largely harmless in an obviousness/eligibility contest.

    Even without the “conventional” language in the spec, it would not have been hard for a validity challenger to establish that these techniques were conventional as of the filing date. No one was going to be fooled by a lack of “conventional” language in the application.

    Incidentally, if the techniques really are not conventional, then the patentee is obliged to describe them in enough detail for the techniques to be reproduced. If there is not enough detail in your spec to reproduce the techniques without resort to the literature, then your argument that the technique is not conventional is—ipso facto—an argument that your claims are not enabled.

    1. 3.1

      >it would not have been hard for a validity challenger to establish that these techniques were conventional as of the filing date

      One thing that bothers me about the case from the summary is:

      (i) the underlying natural phenomena “…had been theorized for years…,” as well as the possibility of using it “as a measure of tissue failure….” i.e., this particular use case

      (ii) but “even accomplished researchers could not invent a satisfactory way” to use that information “[d]espite many attempts over … [a] decade”

      It’s easy for a Judge to say this was all “conventional,” but if so, why exactly were all those accomplished researchers (with access to the exact same ‘conventional’ tools and methods) failing? And failing for years??

      Maybe what we need is objective indicia of conventionality (ala the John Deere factors) to distinguish cases like this from those where the patentee “merely” discovers a natural phenomena.

      1. 3.1.1

        Right. I agree that the conventionality of the techniques used to operationalize the inventive insight should count against patentability. That, however, is no more than to say that I think that Mayo was wrongly decided.

        Once one grants that Mayo is the law, however, then it follows that the conventionality of such techniques can tell against patentability. In such a world, it is a hopelessly lost cause to argue that qPCR or NGS was not conventional as of the filing date.

        1. 3.1.1.1

          “… to operationalize the inventive insight should count…”

          Er, sorry, should not count.

        2. 3.1.1.2

          >the conventionality of such techniques

          Arguably, the rule in Mayo is that you can’t discover a previously unknown natural phenomena, and then simply write a claim saying “apply it.”

          OK. But…this case presents a slightly different scenario. The natural phenomena apparently *was* known to all, as well as the specific possibility of using it to diagnose this specific condition. And yet, many highly skilled researchers were failing to apply these supposedly “conventional” techniques to this problem, again and again, over many years.

          Put differently, it’s not clear to me that the techniques were actually “conventional,” factually speaking.

          1. 3.1.1.2.1

            Naturally, I would have been delighted to see the CAFC distinguish this case on those grounds. I cannot say, however, that I am surprised that they did not. I think that this is still the sort of case that the Court meant to be regarded as ineligible. If the CAFC had distinguished the case as you suggest, it might well have seen the mythical and longed-for grant of cert., merely so that the Court could shoot it down.

          2. 3.1.1.2.2

            “Put differently, it’s not clear to me that the techniques were actually “conventional,” factually speaking.”

            That incongruity appeared to me as well.

            But given applicant’s apparent inability to persausively identify any unconventional analysis technique, it seems likely that they either obviously applied existing techniques to a known goal, or they failed to enable their claim by explaining the secret sauce.

            1. 3.1.1.2.2.1

              Or the old “gist of the invention” analysis strikes again. Or the Fed. Cir. stealth-overruled Eibel Process, 261 U.S. 45 (1923)

              More generally, a definition/test for “conventional” would be very helpful. Just not sure whether it should be slotted in as Mayo/Alice part 2A, prong 2A, or part 3, prong 1 😉

          3. 3.1.1.2.3

            Why cannot it be considered a combination of known elements to yield an invention? Perhaps the natural phenomenon was known, as were the techniques used to make it useful, but the inventive activity is in the combination.

            Regardless, I keep going back to the language of 101:

            “Whoever invents OR DISCOVERS any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”

            Until the natural phenomenon is discovered and appreciated, it cannot be exploited.

            1. 3.1.1.2.3.1

              Until the natural phenomenon is discovered and appreciated, it cannot be exploited.

              Exactly!

            2. 3.1.1.2.3.2

              Nailed it. Thinking of the discovery process in litigation, and the meaning of words when the patent clause was written, the word “discovers” obviously means “making available to others the improvement in the useful arts that one has personally grasped”. The patent system is there to encourage early enabling disclosure of such improvements. In denying patentability to unobvious, new and useful subject matter the present US patent system is failing society, not to mention being in breach of the USA’s international obligations under GATT-TRIPS. What a pity SCOTUS fails to appreciate that insight.

      2. 3.1.2

        OC, I understood “CareDx argued that the particular technological approach was new and different from prior efforts” as implying the reason the proposed test did not work before was that these newer and better or different testing systems or techniques were not yet then conventionally available?
        If so, how much harder or less likely would “it would have been for a validity challenger to establish that that these test techniques were conventional as of the filing date”[without the spec admissions]? The 12(b)6 motion asserting Mayo-type unpatentable subject matter presumably asserted that conventionality? If the patent owner denied that conventionality in its response to that motion, delaying prompt early suit disposition, and that denial was proven false later, were they not likely to just have a displeased judge, no difference in end result, and just more legal expenses?
        Of course if the patent had been obtained by suggesting or implying that the claimed testing systems or techniques were not known in the art as of the filing date they would have had a worse problem – of IC.

        1. 3.1.2.1

          Please keep track of the difference between “not known” and “not conventional, Paul, as you appear to use them interchangeably (and they most definitely are not interchangeable).

          1. 3.1.2.1.1

            On the contrary, I clearly used them separately for the two different situations.

            1. 3.1.2.1.1.1

              No sir. “If so, how much harder or less likely would “it would have been for a validity challenger to establish that that these test techniques were conventional

              You need to do better.

  6. 2

    CAFC:
    “CareDx also incorrectly characterizes our precedent as limiting the conventionality inquiry to step two. On the contrary, and as the district court recognized, we have repeatedly analyzed conventionality at step one as well.”

    MPEP 2106:
    “Step 2A specifically excludes consideration of whether the additional elements represent well-understood, routine, conventional activity.”

    Thanks Iancu!

    1. 2.1

      Right, the Iancu examination analysis does not accord with the analysis that the CAFC employs. Those who say to themselves “the USPTO signed off on this, so it must be legally enforceable” are deluded or delusional.

      1. 2.1.1

        The directives EVEN PRIOR to Iancu’s suffered the same calamity — or are you conveniently forgetting about the Cleveland Clinic case?

    2. 2.2

      Ben,

      You do realize that Iancu was attempting to give examiners an “out,” right?

      Examiners STILL don’t have a clue as to how to make a case regarding conventionality (and per the Berkheimer case and resulting memorandum, this is NOT just for individual claim elements, but for a claim as a whole and as ordered combination.

      It was remarked when Iancu published those directives: he could NOT accord all of case law because all of case law does not accord with itself.

      Search back for my first comments re: the Gordian Knot.

      1. 2.2.1

        100000000% correct

      2. 2.2.2

        It was remarked when Iancu published those directives: he could NOT accord all of case law because all of case law does not accord with itself.
        Truth.

        If the agency tasked with executing the law is incapable of completely understanding the law — despite having dozens of lawyers devoted to that task — how are regular attorneys and inventors supposed to know what the law is? How are business people supposed to make rational business decisions based upon the law?

        The law’s inconsistent application does NOT promote the progress of science and useful arts.

        1. 2.2.2.1

          The law’s inconsistent application does NOT promote the progress of science and useful arts.

          +1 (or really, +1,000,000).

          The right way to think about patent law is—whenever you are confronted with words in the statutory text that are susceptible of more than one interpretation—to ask “which interpretation will best further the goal of promoting innovation?”. Mayo/Alice fails that test.

          I expect that Justice Breyer and his colleagues sincerely believed—when they promulgated Mayo—that they were enacting a rule that furthers that principle, but they were sincerely wrong. That might not have been clear at the time, but the CAFC has let them know, many times, by now that Mayo/Alice is not working. It is disheartening to see the Court’s indifference to the outworkings of its own mistake.

        2. 2.2.2.2

          “If the agency tasked with executing the law is incapable of completely understanding the law”

          I guarantee you that the USPTO is so clueless of the law they’ll lie through their teeth to pretend they know anything

          1. 2.2.2.2.1

            … and take note of the “drive-by” nature of Ben’s whining.

            He whines of Iancu’s attempt — and not on the merits, but because Ben views this as “too lenient” to patentees.

            Believe me — Ben and those that do not like this “out,” are going to like it a LOT LESS when they are forced to actually provide a case (to the proper administrative law level) of a showing that the exact cited ordered combination was widespread (which is the more exacting standard for conventionality, as opposed to any LIGHTER level of showing of mere anticipation or obviousness).

            Bookmark this IF Ben is brave enough to chime back in.

  7. 1

    While I disagree with the result inasmuch as I think the claimed innovation should be patentable in principle and that the eligibility jurisprudence is off-kilter and extremist, in this case, the patentees’ problem wasn’t that the specification admitted the techniques were conventional, the patentees’ problem was that the techniques were conventional.

    While guarding against unnecessary and harmful admissions may be sound legal practice for reasons more complicated than can be explicated in this short post, fostering a culture where admissions are taboo and constitute “the” problem is, in the long term, harmful to legal practice and to the attitudes of new lawyers in particular. Opinions such as these, to say nothing of write-ups such as this one, should do nothing to make practitioners paranoid about truthfully stating the conventionality of known, published devices, methods, and compositions in patent specifications whenever there may be benefits to doing so.

    1. 1.1

      +1

    2. 1.2

      What would be a benefit if doing so?

      Here, in particular; or if you prefer, in a more generalized setting?

      Thanks

      1. 1.2.1

        Understanding the invention?

        Prosecuted a case filed shortly after KSR. They took out everything that might be construed as “background”, and just dove into the idea. It took me multiple hours just to figure out what was going on, and then had to find prior art before the filing date to be able to explain it.

        The Examiner gave pages of 112 rejections, the vast majority of which were because the Examiner did not understand the invention because nothing about the prior art was there to allow the Examiner to do so.

        And KSR absolutely ruined many more applications. Having patent applications totally devoid of “prior art” is not a good thing.

        1. 1.2.1.1

          Thanks BobM, but such a thing as patent profanity does not cut it for me (and the fact that an Examiner made errant 112 rejections because the Examiner “could not understand” is no excuse.

          I “get” that one may pine for the days prior to the Court injecting such patent profanity, but most all of us have moved on and adapted (quite in fact, those Scriviners on the Bench are most jealous of how easily us practitioners adapt).

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