Patenting Diagnostic methods

Interesting essay from Professor Eisenberg on patenting of diagnostic methods.  The basic takeaway is that (1) eligibility limitations mean that new diagnostic methods have little chance of being patent eligible; and (2) it is unclear whether this result is good or bad for society.

See Diagnostics Need Not Apply.

43 thoughts on “Patenting Diagnostic methods

  1. 8

    I have enormous respect for Prof. Eisenberg, but happen to disagree with her analysis in this paper. My goal is to find a way to patentability of claims to diagnostic methods after Mayo, Alice and Myriad. I was not been discussing whether or not the Supreme Court’s decisions were “correct,” but how one might deal with them now that they are the law.

    In Mayo, the Court stated:

    The “determining” step tells a doctor to measure patients’ metabolite levels, through whatever process the doctor wishes to use. Because methods for making such determinations were well known in the art, this step simply tell doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists in the field…

    The Court concluded that purely conventional or obvious pre-solution activity is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law. The Court further stated that “simply appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patentable.”

    My point is that the “high level of generality” referred to the step of “determining [6-thioguanine levels] by whatever process the doctor wishes to use”, and that a potential way to overcome (or avoid) such a 101-based rejection is to specify a particular assay method in the claim. In contrast, Prof. Eisenberg’s paper focused on the clause in the Mayo claim regarding how the results are interpreted, rather than how the data were gathered. It is possible that recitation of both a specific assay and how one would interpret the results may be needed for a claim to a diagnostic method that is allowable under 101.

    I hope one can disagree on this blog without being disagreeable.

    1. 8.1


      I hope that you did not think I was being disagreeable when I pointed out that the path you want to take cannot be taken because, as you put it, “but how one might deal with them now that they are the law.

      Look again at my post, please – and just ignore the usual Malcolm (MM) clouds of dust. Your way won’t work because your way does not overcome what the Court actually did with their “Gist/Abstract” sword. Read again their words – even if a new invention were to be made such that NO test was required, the invention would fail because the Court Gisted NOT to what was actually in the claim, but what they thought the claim was “to.”

      Old test, new test, no test – none of that matters. Please don’t make the mistake of thinking that because I am giving you an answer that you don’t want to hear, that I am being disagreeable.

  2. 7

    In contrast to Prof. Eisenberg, in my opinion the Court’s problem with the Mayo claim is the second clause, on “(b) determining the level of 6-thioguanine in said subject…” There is no indication in the clause on how the level of 6-thioguanine is determined. Assuming that there are, at least in principle, multiple analytical tests possible for measuring 6-thioguanine levels, the claim may have been saved had the clause specified a particular test. If it had read, e.g., (b) determining the level of 6-thioguanine in said subject by a thin layer chromatography assay…” rather than (by implication) determining the level of 6-thioguanine by any method whatsoever, the Court may have looked at this claim differently.

    1. 7.1

      That’s a decidedly odd take Saul.

      You are not using what the Court used.

      Your argument does not sound in 101, but in 112.

      Further, the Court was very clear that even without a test (as might happen “in the future“), the claim would STILL fail because the Court used its “Gist/Abstract” sword.

      That’s the second time today I have seen that same argument put forth and both times, the language of the decision knocks the stuffing out of that argument.

      1. 7.1.1

        It seems as if people are getting desperate not to see what the Court has plainly done.

        Instead of these bizarre new arguments which have no foundation in what the Court wrote, we should be stomping on the gas pedal to bring the Court’s “logic” to its “awesome” end as fast as possible.


          we should be stomping on the gas pedal to bring the Court’s “logic” to its “awesome” end as fast as possible.

          Tell us what happens after that, Billy.

          Go ahead. I could use the laughs.

      1. 7.2.1

        Ned – are electrons, protons and neutrons eligible subject matter?

        You “version” is simply not sustainable as a matter of logic.

        Further, your view IGNORES (once again) what I have attempted to teach you regarding disruptive innovation. You continue to post as if it is “OK” to post in clear error and this is NOT dialogue – it is monologue on your end.

        WRONG monologue at that.

        May I suggest (again) that you actually take the time to inform yourself and read up on innovation? Start with some Schumpeter, then add some Christensen. But PLEASE, stop showing your ignorance.

      2. 7.2.2

        Ned, what is it you do? You are paid to process information. That is what your brain does. That is the source of all your income. All your worth to society. You may be reduced to an information processing machine.

        Just beyond bizarre that you think that machines that do what you do should not be eligible for patentability.

        Also, reality: from my admitted limited sample–people that do this type of work are saying that if it can’t be patentable it is not going to get done. That 1) there are more interesting things to do for the researchers that can pick what they do, and 2) there is no money to focus on the diagnostic methods using DNA without a patent.

        But reality and judicial activism of burning down the patent system have little in common except in the end the reality of no patents and a severely crippled innovation engine. But, fear not—we have Google who will make sure that we get enough innovation.


          Just think about what trash we have on the Fed. Cir. now. Taranto saying that “merely implementing a mental process is per se ineligible.”

          In reality, that “merely” is the greatest scientific and innovation goal that humankind has ever faced. And yet we have trash on the Fed. Cir. that refers to it as merely.

          Unbelievable how low we have sunk as a nation.


          Night, if a machine “does” something new — like a programmed computer driving a car — then I do not and never have objected to claiming a programmed computer in such a context.

          But, even though Saul is on the right track, he still has to go one step further. The statute requires an improvement in a machine, etc. The cases are all consistent. Thus even if the one process step is particular in some fashion, it has to be improved as well, not completely old and conventional.

          Even before Mayo was decided, MM and I had discussed this. It was his point, and I came to agree with it.


            Ned, the statute does NOT require that you treat the category of process as a second class citizen.

            This has NOTHING to do with anything that Malcolm has ever said – this is only your own long held beliefs, and your view of Malcolm as an “Einstein” when he aligns with those beliefs.

            And just like Malcolm, it is no surprise that you refuse to even touch the request on the table to use the proper patent doctrine of inherency to explain how a [old box] “without change” can be seen to have a new capability with the addition of the machine component and manufacture in its own right of software.

            Your “just choosing to ignore” the valid counterpoints I have presented to you is just you wanting to monologue and employ the internet version of shouting down.

            So please do not dissemble and claim that I have been rude or have been a “Tr011” in putting these counter points to you. I have put them to you in a spectrum of pure politeness to angry denigration. But the have been put to you in an inte11ectually honest manner and your refusal to address the counter points can ONLY be seen as you lacking answers to these counter points.

            Any time you want to man up and actually join the dialogue, please do so.


              your refusal to address the counter points can ONLY be seen as you lacking answers to these counter points.

              In spite of your clinical narcissim, “anon”, Ned is right and you and Saul are both wrong.

              Do keep digging, though. The fact that you and other folks can’t grasp the basics is why you will continue to be ignored (if you’re lucky) and mocked (when you’re not lucky). And always keep NWPA right by your side! You two make a wonderful team. Seriously, you are the shining stars of intellect here. I really mean that.


    2. 7.3

      This sloppy bizarre thinking is slipping in everywhere now–thanks Lemley.

      There is nothing wrong with using a functional type of claim to represent all known solutions. In fact it is the only possible way to write a claim in modern technology without making patent application 10,000 pages long!

      What is sickening is how the judicial activist have people focused on psychotic swirling nonsense that has nothing to do with real innovation and reality.

      All the Lemleys of the world are exposed as charlatans when a real invention and real claims are considered.

      We need the amazing Randi to come after Lemley.

      1. 7.3.1

        Night, programs are described and claimed in terms of the steps of a process. Process steps are inherently functional in that they describe actions, not structure.

        That is why Lemley is off base trying to pin the Halliburton tail on the programmed computer donkey.

        Halliburton was about claim results — ideas. In this, I agree with Rich in Application of Tarczy-Hornoch, 397 F.2d 856 (C.C.P.A. 1968).



          STOP the dissembling – software is not the execution of software no matter the ease of description.

          This has NOTHING to do with how Lemley is trying to do anything.

          You are kicking up all kinds of dust by conflating points across the board. The curtain has been pulled aside – stop trying to pretend “the Great and Powerful Oz” is some big scary thing.

          Address each point on the merits of the point itself.

          Stop the conflation.

          Stop the purposeful attempts at confusion.

          Accept what must be accepted n order that inte11ectual honesty can be had in this dialogue.

    3. 7.4

      Saul: In contrast to Prof. Eisenberg, in my opinion the Court’s problem with the Mayo claim is the second clause, on “(b) determining the level of 6-thioguanine in said subject…”

      That’s not the problem with Prometheus’ claim. If you don’t understand this in 2015, Saul, you are part of the problem.

      the claim may have been saved had the clause specified a particular test. If it had read, e.g., (b) determining the level of 6-thioguanine in said subject by a thin layer chromatography assay…”

      If the specific information-gathering method was new and non-obvious (and it doesn’t sound like your method is), then the analysis turns out differently. Of course, if the information-gathering method was new and obvious on its own terms, then why not just claim it? Why bother with reciting an additional ineligible “inferring” step in the independent claim? The answer is: a decent patent attorney would leave the unnecessary limitation out to increase the likelihood of capturing infringers of the detection method.

      This is easy stuff, Saul.

      Here’s a thought for you: start paying closer attention to people who understand the Supreme Court’s reasoning and were ahead of the curve on all this stuff. The hysterical shrieking of the entitled whiners who will do and say anything to defend the worst claims ever granted by any patent system in human history isn’t doing anyone any favors and it appears to have done you a disservice in this instance.

      1. 7.4.1

        Except for the fact that those who you so denigrate have already taken Saul to task….


        Gee – that doesn’t fit your short script, now does it? Oh, what the H, mouth that short script anyway – you are not here for anything else, are you?

        America’s leading source of anti-patent propaganda – Malcolm’s by-line.

  3. 6

    I wonder if Professor Eisenberg is aware of the fact that medically useful diagnostic information was rarely deemed patent-worthy (or eligible) by the discovers of such information throughout the history of our patent system and that this fact remains true to this very day. She writes about the subject matter eligibility as if she were unware of this fact, or perhaps she simply wishes that it weren’t the case.

    But it surely is the case. And it’s not only medically useful information for which this is the case.

    I have a question for Dennis and Jason because they surely attend more pointy head academic law conferences than I do: what percentage of your peers believes that information should be protectable by patents under the laws we have now? what percentage would like to see “information” or “medically relevant information” added to the categories of subject matter that are protectable with patents?

    It’s just weird to read essays like this where a law professor goes out of her way — in an article that appears written for educated lawyers — to let everyone know that “diagnostic testing helps caregivers” but somehow dances around the fundamental issue of the ineligibility of information as if it were controversial and debatable.

    What the heck do you guys talk about at your meetings? Is it just a bunch of suits sitting around and whining about how much money they are losing because of “the Royal Nine”? Please tell me it’s not like that.

    1. 6.1

      You do realize that you are the absolute only one carrying on with your “fundamental” strawman of pure patent protecting information, right?

      The repeat-it-until-it-appears-true propaganda just isn’t working Malcolm.

      Maybe you should have another cookie.

      1. 6.1.1

        strawman of pure patent protecting information

        No idea what you’re referring to (as usual) but you’ve demonstrated hundreds of times by now that you’ve no idea what a “strawman” argument is.

        Among many other patentees with a dream that turned into dust, Prometheus attempted to use the patent system to protect information by limiting the protection sought to a specific prior art context. For reasons that any schoolchild can understand, their attempt failed. Perhaps you’re familiar with the Supreme Court case?

        I told you five years ago repeatedly: you can stick your head in the sand and pretend that you don’t understand what’s going on. That just makes you look like silly because the issue remains even when your head is in the sand. And it’s not going away. In addition to patent attorneys like myself, intelligent, non-lawyers are keeping a close eye on the broken patent system and the manner in which the broken system is discussed by academics such as Rebecca Eisenberg. It’s fascinating to watch, really. Someday someone’s going to write a really interesting book about all this.


          Wrong again – shall I start posting definitions again – like I have done before to show that your “you don’t know” accusations are baseless?

          And what’s even funnier than your baseless accusation is that you pull the Vinnie Barbarino meme of “Huh? What?” in the same post. The AccuseOthersOfThatWhichMalcolmDoes is excessively thick.

          What a chump.


            What a chump.

            Get those meds adjusted, Billy. The year ain’t over and it’s going to get rougher for you.


              Brush away the ad hominem – and yet another nothing post.

              Take your pick: Go figure folks or [shrug] – either way, your ability to contribute to the dialogue remains what it was nine years ago.

              That is sad – both for you and for this blog. For obvious reasons.

  4. 5

    It is appalling to hear anyone, much less a professor at law school, make absurd statements like “diagnostic applications do not count as patent-eligible subject matter”.

    In fact, if you believe in the boundlessness of human ingenuity, there’s an infinite number of diagnostic applications that remain eligible for patenting (absent some other flaw in the claim). They are (1) the diagnostic applications that recite new objective physical structure in objective structural (not functional) terms and (2) the diagnostic applications involving transformations of matter that were previously unknown or undescribed.

    What appears to cause Professor Eisenberg and many others endless confusion is that the PTO for many years now is always waaaaaaay behind the curve of what is reasonably patentable (under any of the statutes). That was acceptable when the number of patents being granted was an order of magnitude or two lower than where it is now after the system completely exploded. It’s not acceptable anymore.

    The obvious and glaring problems with “determine and infer” type patents — where old technology is used to collect information which is then “correlated” by the human brain or a computer through the use of patent-ineligible facts with no other purpose besides “correlating” — have been evident to many patent attorneys for a long, long, long time. It’s particularly evident to many patent attorneys who have worked with clients seeking to protect such “innovations” because most such patent attorneys (including yours truly) came from graduate science backgrounds where we routinely “innovated” correlations and dedicated them to the public because … that’s how science advances. The idea that patenting information — including but certainly not limited to diagnostic information — is somehow a path towards generating more and better information is an idea that has no legs to stand on in civilized society. Do the most richest and most entitled and self-important people in the world not own enough already?

    Cripes, what an incredibly depressing article to read on a Friday.

    1. 5.1

      I briefly scanned the article, but the article does not seem to understand that the discovery of a scientific fact of nature (or product) is what is being protected, not a new way of treatment.

      I hearken back to what Jefferson did in 1793: he dropped “discovery,” added “new” and “composition.”

      Had he left 101 the way it was, 101 would have authorized patents on discovered compositions. As it was, the change allowed only the patenting of new compositions.

      Now, Ms. Eisenberg, do you understand why Mr. Jefferson did what he did?

      “New” also modified “Art.” To the extent that a law of nature could be deemed an Art, its discovery could no longer obtain one a patent for the reason that the law of nature, albeit newly discovered, was not new.

      Do you, Ms. Eisenberg, understand what Jefferson was about?

      The basic patent law of this land was laid down in the patent act of 1793. It might be good to understand the thinking of Thomas Jefferson. Some of it was set forth in Graham v. John Deere.

    2. 5.2

      ?? Of course there are thousands of validly patentable medial diagnostics systems, or improvements thereon, utilizing new or unobvious chemical reagents, and/or new or unobvious optical, mechanical or electronic systems. Most of us have already benefited from several of them, and many more are in development.

      [We have more than enough hyperbole in the comments on this blog to need any more being offered in the blog itself.]

  5. 4

    Gaffes abound.

    Here’s a real head scratcher:

    the Court stops short of resting its determination of patent ineligibility on the fact that other claim steps were too conventional:

    “We need not, and do not, now decide whether were the steps at issue here less conventional, these features of the claims would prove sufficient to invalidate. For here, as we have said, the steps add nothing of significance to the natural laws themselves.”

    There is no question that the non-mental step(s) in Prometheus were “too conventional”: they were old, well-known steps.

    And there is no question that the indisputed fact that these non-mental steps existed in the prior art was the fact that doomed Prometheus’ claim.

    Now, why is that the case? Because adding an ineligible step of thinking about what data “means” turns people lawfully practicing the prior art steps into patent infringers when they think about such facts. That is the problem with such claims. That is how a “building block”, i.e., “information”, is removed from the public domain by a junk patent. This was plain as the nose on one’s face long well-before Prometheus v. Mayo was decided and it’s been discussed ad nauseum in very public forums.

    If law professors can’t figure this out and teach it to people in 2015, they need to take a voluntary vacation or have their vacations planned for them.

    1. 4.1

      Once again Malcolm falls to the banal “just add a step and then OH NOES” tripe.

      Claim as a whole already takes cares of your “OH NOES” Malcolm.

      ANY claim that is a mere aggregation does not pass 101
      – with or without that claim having elements that sound in mental steps,
      – with or without those elements sounding in mental steps being performed by a human (never mind then when the claim itself expressly indicates, when read properly by a Person Having Ordinary Skill In The Art, that the mental steps doctrine does not apply because no person’s mental steps are being blocked).

      Your tripe is simply overblowing literally “whatever” you can get your hands on in an attempt to make software per se ineligible.

      The problem you have – well, one of the problems you have – is that the law as written by Congress just does not support your desired ends.

      Because of that lack of support, you resort to baseless rhetorical shenanigans.

      And the blog master here turns a repeated blind eye to the nonsense, and wonders “gee, why is there so much C R P on my blog?”

      Same advice I gave to you some three years ago or so still applies Prof. Crouch.

      Funny that, it’s the same advice that others gave you nine plus year’s ago, well before I started posting here.

      It’s not as if the Merry Go Round is difficult to spot…

      I just find it incredulous that Crouch actually wonder about the perceptions that the constant propaganda spouted here creates… Maybe the good professor and Ned can have a coffee at his next conference and “figure it out.”

      In the meantime, maybe I will return to my trying to “shout down” people by asking once again for those same people to actually engage in a dialogue with the counter points long on the table of discussion…

  6. 3

    This guy is right according to the PTO. A SPE in TC 3700 told us two days ago that they are not allowing any medical diagnostic applications. At all.

    1. 3.1

      A SPE in TC 3700 told us two days ago that they are not allowing any medical diagnostic applications. At all.

      Who’s the SPE?

    2. 3.2

      Why stop at medical diagnostics? The public needs health-care… why not disallow patent rights in everything related to medicine; all treatments, all procedures, all prostheses, all pharmaceuticals?

      What right has anyone to stop the public from appropriating his/her ideas for the common good? He/she should feel privileged to have lived in a society which enabled him/her to develop the product in the first place. Is not the joy of helping others its own reward? Is not the welfare of others more important than his or her own petty self-interest?

      1. 3.2.2

        The public needs health-care… why not disallow patent rights in everything related to medicine; all treatments, all procedures, all prostheses, all pharmaceuticals?

        Deep stuff, Chicken Little.

      2. 3.2.3

        Is not the welfare of others more important than his or her own petty self-interest?

        I thought of you immediately, “Anon2”, when I read about this Seattle entrepeneur who raised his employees salaries (and cut his own) and in return was dumped by some clients who felt he was making a “political statement” and was chastised by others in CEO club for “making their lives harder.”

        You gotta love it when those true colors come out. Are you excited to vote for The Donald?


          Decidedly not…

          but due to your false dichotomies it is entirely understandable why you would think I would anything other than revile the Don and his ill concealed implicit agenda.

          As for the Seattle entrepreneur, to the extent his actions were rationally determined (given the information at hand) to the best of his ability to be in his own long term rational self-interest, perhaps due to increased performance of the employees and success of the business long term, he is to lauded. To the extent he has simply acted to sacrifice his own life to the benefit of others he is to be pitied.

          Insofar as the CEO club, insofar as their actions of dropping a mutually beneficial business arrangement were self-defeating they also are to be pitied.


            anon2 To the extent he has simply acted to sacrifice his own life to the benefit of others he is to be pitied.


            Spoken like a true ——-.

  7. 2

    A quick review of the article reveals a disappointing failure on Eisenberg’s part: the glaring impossible-to-ignore overriding issue of protecting information with patents is addressed just once. And it’s not Eisenberg’s own thinking but a throwaway remark referencing Kevin Collins’ (excellent) analysis of Prometheus v. Mayo and subject matter eligibility … in a footnote. Oy.

    1. 2.1

      …because the Holy Grail of anything-worth-anything is the alignment with the Malcolm-Information-Strawman….

      No children running through that field of rye need be afraid with Malcolm’s vigilant watch.

      /off sardonic bemusement

  8. 1

    Eisenberg: a series of decisions that, while upending a quarter century of lower court decisions and administrative practice, purport to be a straightforward application of ordinary principles of stare decisis.

    I wonder how long it will take before academics start framing the history of the information-patenting debacle in terms that recognize where/how the debacle began. Ten more years, maybe?

    1. 1.1

      …because “information” only became a concern with software…

      Um wait, no it did not.

      So, what was your point, Malcolm?

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