Patent Eligibility: Handling Disputed Issues of Material Fact

Following the Federal Circuit’s decisions in Berkheimer, AATRIX, and ATS, the role of evidence and factual conclusions in the eligibility analysis is in a somewhat confused state. That setup makes Cleveland Clinic’s recent petition for writ of certiorari quite timely.

Cleveland Clinic Foundation v. True Health Diagnostics LLC, Supreme Court Docket No. 17-997 (2018) questions presented:

In this case, the patents were fully examined by the PTO and found to be novel and not obvious, including for one of the patents, confirmation after two ex parte reexaminations. The PTO further found that the prior art taught away from the claimed inventions. Notwithstanding …, the district court declared [the patents] invalid at the pleading stage. It gave the patents a cursory review, and refused to construe any claim terms. It took 55 separate claims – each claiming a distinct invention with many different limitations – and analyzed them as if all of the claimed inventions were a single method with two simplistic steps. The court did not permit evidentiary submissions or development of the record, and while the district court purported to take judicial notice of the prosecution history, it ignored the PTO record in its analysis. The Federal Circuit affirmed the lower court, invalidating valuable patent rights in a new and nonobvious diagnostic method using known techniques to detect an element in blood, but where the inventors had discovered that adapting known techniques for an entirely new purpose yielded medically-relevant data not known in the prior art and, in fact, taught away from by the prior art.

The questions presented are:

1. Whether the court below erred in holding, contrary to Mayo, that a method involving natural phenomena is ineligible for patent protection if it claims known techniques that have been adapted for a new use and purpose not previously known in the art.

2. Whether Mayo authorizes a district court to invalidate valuable patent rights on the pleadings when there are disputed questions of fact, a disputed question of claim construction or scope, and/or an undeveloped evidentiary record, notwithstanding the presumption of patent validity and settled procedural and Seventh Amendment safeguards that ordinarily prevent the resolution of such disputed questions on the pleadings.

The petition was filed in January and was supported by an Amicus brief filed by Raymond Mercado.  In the wake of Berkheimer and AATRIX the petitioner then filed a supplemental brief setting up the conflict between Judges Moore and Stoll on the one hand and Judge Reyna on the other (Judge Reyna was also author of the Cleveland Clinic decision).

The defendant in this case, True Health Diagnostics, has waived its right to respond to the petition. If the Supreme Court has any interest in the case, the most likely next step would be to ask True Health for responsive briefing — likely followed by a request for the views of the Solicitor General.

46 thoughts on “Patent Eligibility: Handling Disputed Issues of Material Fact

    1. 10.1

      ya I had actual work to do presenting to a Fortune 200 company this morning. In the Google application, I see the auto’s computer systems as the consumer of the information, and thus is should be eligible. I didn’t look at the claims in detail but I imagine to any reasonable PHOSITA, they would be obvious, but perhaps not.

      and ahem, I conduct discussions on these boards, while the resident artiste of the soliloquy without reference to anything anyone has said would have to be the nameless one.

  1. 9

    A patent application published Thursday from the self-driving arm of Google’s parent company detailed an elaborate system to prevent motion sickness in its vehicles.

    The method involves determining routes that could minimize motion sickness. For example, sensitive passengers would be given a relaxed ride on gentle roads. Those people who are more in a rush could select a faster but slightly rougher trip.

    Everyone involved with this application should be ashamed of themselves except perhaps for the three year old who wrote it.

    This is pure g@ rbage. Up next: the robot who “determines” the best route for people with sensitive eyes.

    Jeebus cripes can we pull the plug on this logic patent b.s. already.

  2. 7

    This is a 101 case and it turns on whether the invention is patentable subject matter. Thus when the question present never tells you what the invention is (but instead talks about novelty and nonobviousness, I know there is a severe problem with patentable subject matter off the bat such that I can reliably (if I am a clerk) set this petition to one side without missing something important.

    I don’t know why people spend so much time, effort and money trying to pull the wool.

    1. 7.1

      Thus when the question present never tells you what the invention is

      What did Congress say about that, Ned?

      Here let me help you (emphasis added):

      35 USC 112(b): (b) Conclusion.—
      The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.

      As I have noted recently, this law is NOT just a requirement – it is an allocation of exactly who is responsible for setting “the invention” and how that it is done.

  3. 6

    The “personalized medicine” lobby and its water carriers function in exactly the same way as the ammo se xu al lobby.

    Any attempt to stop these people from enriching themselves at everyone else’s expense will be greeted with dust-kicking and the recitation of false, self-serving talking points about “saving the children” and “promoting progress.”

    Patenting correlations doesn’t “promote progress.” It promotes patenting. It makes the already rich even richer and everyone else gets the shaft. This is so obvious that it shouldn’t even need to be said. But the sad fact is that there is tiny incredibly loud-voiced army of self-proclaimed professional l i a rs and shills out there who’ve made it their life’s work to destroy the patent system and s ck up to the least “innovative” people on the planet.

    Just stop it already.

    1. 6.1

      But the sad fact is that there is tiny incredibly loud-voiced army of self-proclaimed professional l i a rs and shills out there who’ve made it their life’s work to destroy the patent system and s ck up to the least “innovative” people on the planet.

      The Accuse Others meme is stultifying.

      Just stop it already.

      Heed your own advice, please.

      1. 6.1.1

        There is no “accusing”. This is all laid open for the world, “anon”. You’re the poster boy, sitting on Cryin’ Kevs filthy lap.

        1. 6.1.1.1

          Your putting accusing in quotes and then contrasting that with some notion of “laid open for the world” clearly shows that you do not understand what the word means (ignorance) or are trying to dissemble (inte11ectually DIShonest) or both.

          It matters not at all how “laid open” anything is in relation to whether or not accusing is going on.

    2. 6.2

      It’s not merely correlations. It’s ancient techniques in trivially different situations, such as collecting several steps in a routine and giving them a single command to execute. It’s differences that amount to stylistic choices, such as a GUI layout. It’s teachings that amount to “there’s gold in them thar hills”.

      What is common to all of it is a problem of trying to “protect”, with patents, items of information, which can appear in all kinds of contexts. Anything less than patents for every shade of distinction of every human activity is anti-patent. Of course.

      1. 6.2.1

        Right. And cue up the howling that “trivially different situations” is for obvious. And the cue up the same people arguing that a database of information X is totally different from a database with information Y. And babbling about “commercial success” like that would somehow makes it less trivial.

        Been there. Done that. The plug is pulled and now we have to endure the sad sound of the record player as the battery runs out.

        1. 6.2.1.1

          because conflation is somehow appropriate when the Ends are all that matter to you….

          Been there. Done that

          yes – just not in the way that you are attempting to portray.

        1. 6.2.2.1

          ahem. Anything less than patents for every shade of distinction of every human activity is anti-patent. Of course

          Of course, two threads down I pasted a case where a patent was bounced on a 12(b)6 that I thought should have been eligible, was a good invention, and should have been protected for its inventor for 20 years. But your confirmation bias is so overwhelming….

          1. 6.2.2.1.1

            I am not the one with confirmation bias – as is clearly demonstrated when you “leak” your feelings. I noted why your “compromise” was not, but you have not engaged on that point (or the other points) and instead merely want to be lazy and accuse me of what you do.

            As I said: your alignment with Malcolm goes W A Y beyond the one item.

            1. 6.2.2.1.1.1

              “but you have not engaged on that point (or the other points) and instead merely want to be lazy”

              I notice Marty that this reference of yours on another thread (to which I responded) is yet another conversation thread that you have left dangle….

              You are picking up another bad habit of Malcolm’s: the drive-by monologue.

  4. 5

    By the way, Cleveland v. True Health is a precedential CAFC opinion. I bring this up because there seemed to be some confusion in the discussion with respect to Berkheimer as to whether crushing a junk patent under 101 at the pleadings stage had ever happened before. The fact is that it’s happened lots of times. And there’s nothing wrong with that. On the contrary, it’s an expected and necessary event and it will occur with a frequency that is perfectly correlated with the frequency with which junky ineligible patents are asserted against defendants with competent attorneys before competent judges.

    Now, will mistakes occasionally be made? Sure. But they’ll be made in both directions (in the plaintiff’s favor, and in the defendant’s favor). It’s the CAFC’s job to police that. The Supreme Court has way bigger fish to fry.

    There is never going to be a rule saying that “Patent claims can’t be tanked under 101 on the pleadings.” So give it up already.

    And to the extent patentees with junky “determine and infer claims” are trying to use procedural games to extract value out of that crap, rest assured that you are going to get the hammer. We’re watching.

    There is no reversing Prometheus v. Mayo. Cry your crocodile tears and fill up an ocean with them. It isn’t going anywhere because there’s nowhere to go. You can’t protect correlations with patents and it doesn’t matter what prior art context you couch the correlations in, nor does it matter whether the prior art data collection method was “conventional” or just “new”. Those claim are all cr @p and if you assert them then you are a cr@ ppy person. That’s about as simple and obvious as a correlation can get.

    So when is it inappropriate to kill a junky “determine and infer” claim on the pleadings? The answer is: when there is bona fide dispute about the non-obviousness of the data-gathering step on its own terms (i.e., regardless of what happens to the gathered data). This has always been the case (and I’ve been explaining why for nearly a decade now). And the fact is that in nearly ever case where claims with non-obvious data gathering steps are asserted, those claims sail right through the pleadings stage (as they should). The maximalists, of course, only see their favorite incredibly junky claims getting slapped down and the maximalist blogosphere turns up the propaganda machine. You guys are a j 0 ke. Seriously.

    Also, note again, for the zillionth time, that claims which purport to protect information content or information-processing (e.g., correlations) in any context are always going to present eligibility issues. This is as it should because information and logic are ineligible for patenting. This is foundational, bottom-line stuff that is never ever going away. Stop crying about it and get used to it. Eventually the plug will be pulled on logic patenting and a lot of this silliness will disappear and the system will return to promoting what it should be promoting, i.e., non-vaporous innovations.

    1. 5.1

      So when is it inappropriate to kill a junky “determine and infer” claim on the pleadings? The answer is: when there is bona fide dispute about the non-obviousness of the data-gathering step on its own terms (i.e., regardless of what happens to the gathered data).

      Adding again: in which case, the non-obvious data-gathering method itself should be claimed. Because that’s the most valuable and broad claim you can get. Why wouldn’t you claim that? Why would you try to hide an eligible non-obvious data gathering method in a data processing claim?

      The answer is: nobody does that. What does happen is people attempt to protect ineligible subject matter (i.e., information, correlations, data “processing” logic) by reciting some prior art data gathering steps or prior art machines. That’s the game.

      Game over. Game. Set. Match.

      1. 5.1.1

        The answer is: nobody does that.

        Your rants indicate otherwise.

        Clearly.

        or prior art machines

        Feel free to actually use the proper patent doctrine of inherency.
        It is noted that you never seem able to do that. There’s a game afoot alright – and you are the one playing it. Just not very well (or in any sense of inte11ectual honesty).

        Game over. Game. Set. Match.

        Just not how you wish to portray.

    2. 5.2

      whether crushing a junk patent under 101 at the pleadings stage had ever happened before.

      Confusion on whose part? Marty’s? That would be hardly surprising.

      There is never going to be a rule saying that “Patent claims can’t be tanked under 101 on the pleadings.” So give it up already.

      I do not recall anyone saying that.
      What I DO recall is that the proper treatment of the law includes the proper treatment of the factual predicate to the legal determination of 101.
      I DO recall – telling you directly – that the case of ATS needed to be read because that case was easily distinguishable on its facts.

      Maybe you are referring to Prof. Crouch’s line of “the role of evidence and factual conclusions in the eligibility analysis is in a somewhat confused state.

      If so – I would agree with you if your position is that there really is NO confusion as to the role of evidence and factual conclusions in the eligibility analysis.

      That the courts and the PTAB (especially) may have been confused (albeit I still await an Article III court decision with a holding directly on point as to the factual predicate issue that is in contradiction to the series of Berkheimer, and AAT – a dissent without citations does not count).

      Alas, it is not certain that THAT is actually your position.

      as to “We’re watching.” is that “we” you and this “Billy” character? you and your sockpuppets (seeing as YOU are the one noted for most use of sockpuppets in the last 6 years now)? you and your immense, oversized ego?

      as to “data-gathering step on its own terms (i.e., regardless of what happens to the gathered data). ” that is wrong on its face. IF what happens, happens to be a claim element, you simply cannot parse THAT element out. Your attempt to make some global statement is a must-fail.

      as to “maximalist blogosphere turns up the propaganda machine

      again – the Accuse Others meme – your favorite t001….

      Just not compelling at all Malcolm.

      purport to protect information content or information-processing

      You do realize that those are two very different things, eh?

      are always going to present eligibility issues.

      LOL – is present “issues” or is it (as you have stated previously) de facto ineligible. What are your feelings today?

      Eventually the plug will be pulled on logic patenting

      Your implicit canard about software being logic is noted. How is that project to obtain copyright on logic coming along? If you don’t like the question, then maybe you should drop your dissembling canard. That’s some easy vapor to eliminate – and all within your immediate control.

      1. 5.2.1

        the proper treatment of the law includes the proper treatment of the factual predicate to the legal determination of 101.

        Deep deep stuff.

        is that “we” you and this “Billy” character

        No, it’s the vast majority of reasonable people who will not accept you and your cohorts running around telling us that we can’t “determine” what some data means.

        I hope this is plain enough for you to understand. It should be. I know the world outside of your echo chamber is a scary place — filled with brown people, women, gays, and (OMG!) liberals who vastly outnumber you and always will.

        1. 5.2.1.1

          LOL – your “we” is “of course” reasonable people while anyone else is “cohorts.”

          Your last paragraph is a horrible miss of ISMs – especially as you have no clue as to my race, gender or orientation. But hey – just throw out the ad hominem and pretend that you has said something (anything) meaningful…

          As usual.

          1. 5.2.1.1.1

            you have no clue as to my race, gender or orientation

            LOL

            I have way more than “clues”, my friend.

            You funny.

            1. 5.2.1.1.1.1

              I have way more than “clues”, my friend.

              ooooh, sounds so scary….

              What do you have and how have you come by it?

              Tell us you internet tough guy you.
              Because right now, all you come across as is a blowhard – an empty wagon prattling along, full of noise and fury and lacking substance.

              Into your 13th year.

  5. 4

    #1 Have a hard time believing this ‘pleading stage’ punch out passes muster under due process when there is even a colorable issue as to disputed facts. This isn’t summary judgment – its the pleadings. #2 How could it not require a claim by claim analysis? This is truly the verboten ‘gist’ or ‘heart of invention’ test of the 2nd Circuit, as I recall, that was specifically abolished by the Patent Act of ’52.

    1. 4.1

      disputed facts

      Exactly what “fact” is being disputed here?

      And by the way: what “fact” was in dispute in Prometheus’ claims? Do you remember? I do. And guess what: that “fact” isn’t being disputed here.

      I’ll give you a hint: Prometheus’ own expert testified as to this fact and that testimony was what destroyed any chance Prometheus’ had of winning their case.

    2. 4.2

      Iwasthere: “This is truly the verboten ‘gist’ or ‘heart of invention’ test of the 2nd Circuit

      Do you have a link to the 2nd circuit test?

  6. 3

    The independent claims are an awful lot like Mayo. The dependent claims go on to add specific analytic techniques, but I don’t see any claim for the techniques themselves. But here is the rub: Could it be that it’s not “routine” to use an otherwise routine analytic assay when (as evidently occurred here) someone else published a paper to the effect that such a method, using the same assay, is not worthwhile for the purpose at hand? Does that negate the conclusion that the claims only use “routine” methods to implement the discovery? Might that at least be a question of fact? Is it time for the Supreme Court to rule on this emerging issue?

    1. 3.1

      I suppose your questions may reflect the emerging appreciation that the factual predicate for the 101 legal question provides a more severe level of evidentiary support than the similar factual predicates for the 102 and 103 legal questions.

      But that really does not need any court to rule on it – that is merely reflected in the words that the Court has already used.

    2. 3.2

      recursor: I don’t see any claim for the techniques themselves.

      Isn’t that interesting? Gee, I wonder why that is. Regular readers of this blog know that the lack of any claims directed towards the data collection methods themselves is a recurring feature of “detect and infer” claims with fatal eligibility problems. (a similar pattern holds for logic patents, which invariably fail to claim “by themselves” the arrangement of objectively structural components, e.g., the servers, the processors, the sensors, etc). Professional patent attorneys should know better than to leave out the important inventions of broadest scope … and they do know better. They also know it’s a waste of money to pursue those claims because they’re invalid, and almost always laughably so. So what happens? Dust kicking and scrivening and the recitation of vapor that isn’t eligible.

      someone else published a paper … using the same assay

      Right. The assay was anticipated. It’s in the prior art.

      such a method, using the same assay, is not worthwhile

      The case law is crystal clear that a reference which teaches a method and then disparages the method (“not worth it”) nevertheless teaches that method (and still anticipates). And, as far as can tell, the data-collection method here was taught in other references and not disparaged. It’s simply not a new data-collection method.

      When you talk about the “purpose” of the data-collection method, you’re really just talking about the allegedly “new” downstream “processing” (in this instance, the “correlating”) of the data that is being collected by the method and it’s that downstream activity that is the source of the eligibility issue (why? because “correlating” and “correlations” and “data” and “data processing” are ineligible subject matter; whether you call them abstractions or natural phenomena or laws of nature, you can’t protect them with patents, in any context, no matter how narrow).

      Is it time for the Supreme Court to rule on this emerging issue?

      What exactly is the “issue”? Nobody is saying that “every patent claim should be struck down on the pleadings.” Nobody is saying that “every patent claim that recites an ineligible element should be struck down on the pleadings.”

      So what’s the “issue”? The Supreme Court is never going to say “no patent claim can be struck down on the pleadings.” That would be absurd.

      So what’s the “issue”?

  7. 2

    Not sure that the title of the blog post evinces the topic.

    That title: “Handling Disputed Issues of Material Fact” has a pretty clear, non controversial, and not in challenge protocol per the applicable Federal Rules.

  8. 1

    Never underestimate the ability of attorneys who have been deprived of oxygen for far too long to simply get up in front of the Supreme Court and spew ridiculous self-serving b@ loney.

    supported by an Amicus brief filed by Raymond Mercado.

    Like that’s going to help.

    The brief: In this case, the patents were fully examined by the PTO and found to be novel and not obvious, including for one of the patents, confirmation after two ex parte reexaminations.

    Utterly irrelevant.

    [The district court] gave the patents a cursory review, and refused to construe any claim terms.

    So? Were there claim terms whose meanings were legitimately in dispute and whose differing constructions would have affected the eligibility analysis? If not, then this whining is irrelevant.

    It took 55 separate claims – each claiming a distinct invention with many different limitations – and analyzed them as if all of the claimed inventions were a single method with two simplistic steps.

    That’s perfectly appropriate, depending on the claims and the specifics of the eligibility issue … and if the patentee failed to explain why the claims that were analyzed by the district court were not representative (keep reading, folks).

    1. Whether the court below erred in holding, contrary to Mayo, that a method involving natural phenomena is ineligible for patent protection if it claims known techniques that have been adapted for a new use and purpose not previously known in the art.

    Nothing in Mayo states that using known techniques that “adapted for a new use and purpose” (whatever the h-ll that means) means that the claim is eligible. More on this in a bit.

    Whether Mayo authorizes a district court to invalidate valuable patent rights on the pleadings

    Mayo has nothing to do with “authorizing” the invalidation of patent rights “on the pleadings.” Prometheus’ claims were tanked on summary judgment.

    Mayo was about whether process claims reciting the use of prior art data-collection methods to collect data are eligible when the only additional novel element is the recitation of ineligible subject matter (e.g., a “correlation”). The Supreme Court said “no way.” 9-0. A predictable, correct and necessary result that was (as readers of his blog are well aware) predicted a long long time before the decision.

    The claims in this case are indistinguishable from those in Prometheus v. Mayo. A correlation between a metabolite and a disease was allegedly discovered. The claims use known methods to measure a metabolite and then there is a subsequent “determination” step (e.g., the result of measurement “indicates a risk b l ah b la h b la h”). There’s nothing else going on here.

    People everywhere: you can’t use the patent system to own or “protect” information. That means information in any prior art context, no matter how specifically defined that prior art context is. Learn it. It’s easy. It’s correct. Without this rule, the gates are wide open to a massive flood of the absolute worse b.s. that any patent system could possibly endure. The experiment has already been performed. It was a failure. And “personalized medicine” doesn’t “progress” by making an exception for this kind of cr @p. On the contrary, all that happens when you let this cr @p through the gates is that some rich people (and their rich attorneys) will get even richer by selling you the “right” to make decisions in view of information about your own body. That’s it.

    Oh, and this, too, from the CAFC opinion (10a of the appendix): [T]hough Cleveland Clinic objected to treating any claims as representative of others, the district court found it appropriate to consider the above asserted claims representative because “plaintiff fail[ed] to point out any claim that is not represented by the aforementioned claims.”

    Oops. So sad.

    Oral argument at CAFC is here, by the way: link to cafc.uscourts.gov Always worth listening to these to get a better sense as to whether the patentee has a clue or is simply flailing away …

    1. 1.1

      you can’t use the patent system to own or “protect” information. That means information in any prior art context, no matter how specifically defined that prior art context is. Learn it. It’s easy. It’s correct. Without this rule, the gates are wide open to a massive flood of the absolute worse b.s. that any patent system could possibly endure.

      I really can’t repeat this enough. It’s not just the “field” of “personalized medicine” (gag) that will be swamped. Literally every area of endeavor where data can be collected and correlated can and will be papered over with cr @pola. And most of it will be the pure unadulterated kind of cr @pola because coming up with a “correlation” is right down there with “inventing” a new description of content for transmission from a “remote server” to your “handheld device.” And, as the Mayo Clinic discovered, it won’t matter to the patentee what you actually “determine” when you collect the data. What matters to the patentee is that (1) you are collecting the data and (2) you know about the information that is taught (i.e., dedicated to the public) in the patent specificatoin. And if you practice the data gathering method you’re definitely going to know about the patent and what it teaches because the patentee is going to tell you about it. See how that works? Fun game, although a bit expensive on the receiving end.

      Raymond Mercado knows all about this, by the way. Right, Raymond? But he won’t talk about it. Nevertheless, he’s a very serious person. Very very serious and deep thinking.

    2. 1.2

      People everywhere: you can’t use the patent system to own or “protect” information. That means information in any prior art context, no matter how specifically defined that prior art context is. Learn it. It’s easy. It’s correct.

      It is too bad that your hobby horse does not properly reflect the situation.

      Your tendencies to over-project “protection of information” – through your self-anointed role as the watcher over the fields of patent rye – is plain error.

      Sadly, through your propaganda, you have spawned the likes of Marty, who also continues to not bother taking the time to understand the actual patent law, the actual mechanisms of innovation, and the actual facts of how items like software are tied to innovation.

      Any redeeming points that you may have buried in the mountain of C R P that you simply love to “just say it again” loses all of its value because you refuse to stop, look read or listen, understand, acknowledge, and integrate those counter points presented to you.

      Your refusal to do so – combined with your wretched blight (now going into its 13th year), which or course includes not only mindless ad hominem, refusal to engage with any inte11ectual honesty, and your number one meme of Accuse Others Of That Which You Do – merely diminishes the position that you so desperately seek to advocate for.

      Further, for those that drink up your pablum, their efforts further diminish the credibility of that position.

      I ask (again) that you step back, take a “deep think” yourself, and when you return, do so with inte11ectual honesty in dealing with the counter points presented to you.

      (hey, miracles happen, so why not ask?)

      1. 1.2.1

        MM didn’t spawn me. Thousands of generations of hominids did, conditioned by the sad fact that the United States patent system has been the single most immoral actor ever to affect my life on this small planet by granting rights to multiple “inventors” who had no moral right to what they claimed.

        You can whine all you want anon, but I’m never, ever going to stop until I see that system reformed. MM and I agree on much (since that’s the nature of objective reality) but disagree too on how this is likely going to shake out. Whatever it is that you want (return to the halcyon days of 1952 maybe?) is not going to happen, so waaaaa.

        1. 1.2.1.2

          And is most certainly is NOT “the nature of objective reality” that reflects those items for which you and Malcolm align.

          Quite the opposite.

        2. 1.2.1.3

          the single most immoral actor

          who had no moral right

          YOUR view, your feelings, imposing some sense of “morality” that is solely of your own domain, is simply not in accord with law, facts, or reality.

          What this is, Marty, is you revealing far more than you think that you realize.

          You clearly have an irrational vendetta. It does not take much for the gloss that you attempt to hide that vendetta with to come off.

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