Diagnosis: Ineligible

by Dennis Crouch

Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (Fed. Cir. 2019)

There is a lot to unpack in this decision, and so this is just a small discussion of an important Federal Circuit opinion – DC

Mayo is involved in another diagnostic method patent dispute — and again has come out on-top with a finding that the asserted patent claims are ineligible under 35 U.S.C. 101. That district court finding has now been affirmed on appeal, although subject to a strong dissent from Judge Newman.

The named inventors on Athena’s patent were working on a subset of Myasthenia gravis (MG) patients who did not exhibit the usual acetylcholine receptor antibodies.  The researchers discovered that these patients were instead generating excess antibodies to a muscle-specific tyrosine kinase (MuSK) that the body uses in neuromuscular junctions. So, the key discovery here was the relationship between MuSK autoantibody production and MG.

The patent at issue is not directed a this relationship per se, but rather a method for diagnosing MuSK related disorders by looking for those MuSK autoantibodies.  The particular claims at issue include a basic diagnostic method involving: mixing a person’s “bodily fluid” with a labeled antigen to the MuSK antibodies; immunoprecipitating any MuSK complexes from the fluid; and then looking for the label in the precipitate.  Some claims indicate that the label is a radioactive iodine isotope.

Conventional Techniques: As we get into the eligibility analysis, it makes sense to note here that the claimed method is basically the one that any biochem PhD researcher would have come up with after learning about the importance of the MuSK autoantibody — i.e., it probably would be obvious if the relationship between MuSk and MG were in the prior art. However, the claimed method does involve creating non-naturally-occurring labeled antigens and then causing a chemical reaction that does not naturally-occur.

Under Mayo v. Prometheus, 566 U.S. 66 (2012) a law of nature may not be patented.  In that case, the provided an example of a law of nature — the correlation between the a blood metabolite and the appropriate treatment dosage.  The court explained explain that it is proper to have a claim “directed to” a law of nature, so long as the claim also includes “something more” such as an inventive practical application.  In other words: “Laws of nature are not patentable, but applications of such laws may be patentable.” Athena.

Here, the Federal Circuit agreed with the lower court that the claims at issue are directed to a law of nature: “the correlation between the presence of naturally-occurring MuSK autoantibodies in bodily fluid and MuSK-related neurological diseases like MG.”  This correlation exists in nature, even if only recently discovered by humans, and “there can thus be no dispute that it is an ineligible natural law.”

Here, although the claims include “certain concrete steps,” the court still determined that they were – as a whole – directed to the abstract idea “because the claimed advance was only in the discovery of a natural law, and . . . the additional recited steps only apply conventional techniques to detect that natural law.”  To support this conclusion, the court cited to portions of the specification explaining that “the actual steps [are] known per se in the art” or are “standard techniques in the art.”

Regarding the required creation and use of a man-made molecule.  The court held that “the use of a man-made molecule is not decisive if it amounts to only a routine step in a conventional method for observing a natural law.”  I will note here that the molecule itself would likely be eligible — to the extent they were created by the researchers.

In its analysis, the court also distinguishes its recent decision in Vanda, which found a method of treatment based upon genotype to be eligible.

We consider it important at this point to note the difference between the claims before us here, which recite a natural law and conventional means for detecting it, and applications of natural laws, which are patent-eligible. See Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d 1117, 1133–36 (Fed. Cir. 2018) (holding that method of treatment by administering drug at certain dosage ranges based on a patient’s genotype was not directed to a natural law). Claiming a natural cause of an ailment and well-known means of observing it is not eligible for patent because such a claim in effect only encompasses the natural law itself. But claiming a new treatment for an ailment, albeit using a natural law, is not claiming the natural law.

Within step-one of the Mayo/Alice analysis the court basically answered step-two as well — does the claim include “something more.” Here, the court appears to have added the notion that step-one should focus only on the claim as a whole while step-two includes an element-by-element analysis.  Regardless, the court found that the application steps were all simply recitations of steps known in the art.

Because the specification defines the individual immunoprecipitation and iodination steps and the overall radioimmunoassay as conventional techniques, the claims fail to provide an inventive concept. . . .  [A]pplying standard techniques in a standard way to observe a natural law does not provide an inventive concept.

Although conventionality can now be seen as an issue of fact, the court found that it was effectively admitted within the specification.

Judge Lourie penned the majority opinion and was joined by Judge Stoll. Judge Newman wrote in dissent. Judge Newman argued that the claims should be seen at face value:

The claims … preparation of the new radioactive entities and their chemical reactions to detect autoantibodies to the protein muscle-specific tyrosine kinase (MuSK).

This, according to Judge Newman is “not a law of nature.”

Note here Footnote 4 from the majority opinion — agreeing with the dissent that “the public interest is poorly served by adding disincentive to the development of new diagnostic methods” and lamenting their inability to act. “Our precedent leaves no room for a different outcome here.”

154 thoughts on “Diagnosis: Ineligible

  1. 23

    If the diagnostic method had been developed before detection of radioactive complexes were routine it would not have been considered abstract according to the current framework. But if the method uses currently conventional techniques, the invention as a whole though nonobvious at the time of invention and not actually an abstract idea, through an irrational fiction, is allegedly transformed into an abstract idea (which is logically impossible, based on when the invention was made) whereby patentability is negatived according to the manner invented. What a neat convolution within a convolution. Suitable for the funny farm.

    1. 23.1

      The terms you use strike (and should strike) a resonating chord with those who understand patent law and patent law history (vis a vis the Act of 1952 and the reason Congress acted to remove the Common Law authority to “define” invention by way of “Gist of the invention” (and dozens of similar sounding terms) and instead introduce the notion of “obviousness” (once again, see the writings of Judge Rich, who helped Congress write that change).

      Sadly, certain people simply do not want to see the real issue here: the score board is broken.

  2. 22

    Not so cut and dry Paul Morgan. Law of nature has never been defined by the SCOTUS. And as pointed out many times, any invention can be characterized as a law of nature.

    | | | | | |
    v v v v v

    1. 22.1

      Re: “any invention can be characterized as a law of nature.”
      If that were really true it would be a common application rejection and a common defense in patent litigation, rather than being so rare everywhere except in some blog comments.

      1. 22.1.1

        Not so Paul.

        Your statement would be better off as:

        If that were legitimately true it would be a common application rejection and a common defense in patent litigation,…

        Once again, you clench tight your eyes to the real problem here (and do your own wandering) by not accepting the plain fact that the score board is broken.

        That you attempt to belittle this with the attempted slight of “except in some blog comments” shows that you have been away too long from the side of actually obtaining patent protection for innovators.

        Like Malcolm, maybe you need to check again the explicit words of Director Iancu when he says the Common Law law writing of the courts has created a Gordian Knot of contradictions….

  3. 21

    While almost no one is happy with the current Fed. Cir. status re the long-established Sup. Ct. judicial exceptions to 101 patentable subject matter, at least “laws of nature” [as here] is not as ambiguous as “abstract ideas.” “Laws of nature” decisions seem more accurately described as “already existing in nature” and thus not novel. Note:
    “The Court’s precedents provide three specific exceptions to § 101’s broad patent-eligibility principles: laws of nature, physical phenomena, and abstract ideas. While these exceptions are not required by the statutory text, they are consistent with the notion that a patentable process must be “new and useful.” And, in any case, these exceptions have defined the reach of the statute as a matter of statutory stare decisis going back 150 years.”
    Bilski v. Kappos, 561 U.S. 593, 601–02 (2010).

    1. 21.1

      It is interesting to note in this respect that Gottschalk v. Benson, 409 U.S. 63, 72 (1972) somewhat differently expressed “laws of nature” as “[p]henomena of nature, though just discovered.”

    2. 21.2

      Your posts (and spin) remain most odd Paul.
      (Yes, the Court did attempt its spin with “long standing” and “150 years” – but all of that was false and attempts to NOT pay due heed to what happened well within that 150 year window (the Act of 1952).

      The blame needs to be put squarely where it belongs (in the first instance).

      The score board is broken — and it will not be fixed by closing one’s eyes to the fact that the score board is broken.

  4. 20

    Since the Count Filter is acting up, I will post a small collection of responses here at the top and indicate the points to which these response apply:

    Two items in reply to the thread at the 2.3.1 point – dealing with Les and Random (but it’s factual):

    Les,

    A comment is snagged in the Count Filter, which corrects your errant response and points out that Random’s “fact” IS actually a tougher road to hoe FOR the Office. As a fact matter, THEY have to abide by APA requirements to establish that (higher than anticipation/obviousness) factual basis – and cannot use their “official notice” path — the item being a “state of the art” item.

    As typical, Random has jumped without looking.

    AND

    No, Les, “conventionality” is NOT determined under 102.

    Anticipation is determined under 102. Obviousness determines under 103, and — critically — the courts have already determined that the determination of “conventionality,” while BEING a determination related to the state of the art***, requires MORE than either of a reference (or references) that show anticipation or obviousness.

    It is a higher</b bar for the Office to show “widespread adaptation” (one of the hallmarks of conventionality).

    This is a critical point (first described by yours truly following the Berkheimer case) that has had a direct effect in the new Iancu protocols.

    *** also worth reminding folks: the fact that “conventionality” is a “state of the art” consideration also has a direct effect as to what the Office may — and may not — do in regards to “taking official notice” or otherwise complying with APA dictated basis of evidence for their positions.

    This is also (as I pointed out) WHY the Berkheimer decision is so important.

    AND

    To the mindless cheerleading at post 11:

    Everyone understands that Malcolm and RG are completely wrong because your view wants too much and parses eligibility down to less than the claim as a whole.

    Perfectly eligible claims exist with nothing more than ALL elements “being conventional.”

    Perfectly eligible claims exist with nothing more than conventional elements and “ineligible”*** elements.

    *** – here in quotes because eligibility is NOT a “by an element” determination.

    IF eligibility WERE to be a “by an element” determination, then entire statutory categories would disappear because entire statutory categories could be viewed as NOTHING but configurations of the elementary particles of protons, neutrons, and electrons, which — of themselves (at that ‘by an element view’ — are NOT eligible; and further, are only configured according to Laws of Nature.

    The continued choice to ignore the facts of this counterpoint do not make those facts and thus counterpoint disappear.

    Every time you reach for your canard, this counterpoint is available to rebut your canard.

    1. 20.1

      The infamous post 11 seems to say: There exists no valid claim which combines a conventional activity with a law of nature.
      Your post seems to say: ‘There are plenty of valid claims with all conventional elements.’. This is certainly true but not on point.
      To prove your point, I think you would need to post instead ‘There are plenty of valid claims which contain only a single law of nature and a single conventional element.’

      1. 20.1.1

        Not at all.

        They propose something for which I need but put one hole into. They want something that must answer any of the points I provide.

        Clearly what they have does not and thus f a i 1 s.

      2. 20.1.2

        Thanks for identifying “anon”s favorite strawman, SDR. It’s a favorite rhetorical game of his.

        People are learning.

        1. 20.1.2.1

          No strawman was identified because I have no strawman.

          Do you need me (again) to post a definition of strawman…?

          You (apparently) are having trouble following along here, Malcolm.

          That is not altogether Unsurprising.

      1. 20.2.1

        Yes, “widespread adoption.”

        You have a problem with the notion that conventional means more than merely known exactly (as in anticipation) or possibly known in combination (as in obviousness)?

        That would be odd, given your “railing” against the use of the word (and your failure to acknowledge the introduction of that word by the Supreme Court).

        Then again, this is you, so I suppose that the position being odd is something to be expected.

        As to “widespread adoption,” think: “based on or in accordance with what is generally done” or “conforming or adhering to accepted standards.”

        (maybe you recognize those English words… if not, then try google or pick up a fricken dictionary and inform yourself )

  5. 19

    Not so cut and dry Paul Morgan. You presume that the conclusion in your statements. As an example, law of nature has never been defined by the SCOTUS.

    vvvvv

  6. 18

    Comments below wander off on numerous arguments other than the one that counts here. In a legitimate legal system a lower court is bound by directly applicable decisions of its superior court unless the legislature overrules it or the superior court overrules itself.

    1. 18.1

      While wandering may occur, the more important point here Paul is — as noted by Director Iancu — the Common Law has become a Gordian Knot, and it is simply NOT POSSIBLE to fully follow the “applicable decisions.”

      The score board IS broken.

      1. 18.1.1

        the Common Law has become a Gordian Knot,

        LOL. You’re such a w @ nker, Billy. And a total hack.

        There’s nothing wrong with this decision.

        t is simply NOT POSSIBLE to fully follow the “applicable decisions.”

        Sure it is. You just have to ignore the CAFC decisions that don’t make any sense whatsoever. Of course, if you do that then you have to kiss logic and information patenting goodbye (and say goodbye to Iancu’s favorite “customers”, the Silly Con Valley Bros and their b0tt0m feeding attorneys). And that of course is the real problem, not this mythical “confusion” created by the Supremes.

        1. 18.1.1.2

          How convenient. The law doesn’t contradict itself as long as you ignore half the decisions! We have a legal scholar here folks!

          1. 18.1.1.2.1

            First comment caught in Filter, but Malcolm’s Accuse Others on display with “w @ nk ing” and his earlier attempted outright dismissal of Judge Newman’s points.

          2. 18.1.1.2.2

            …or reminiscent of someone else who engages in that type of “alt-facts,” eh?

            Trump that.

  7. 17

    Any jurisprudence that is this complicated is obviously wrong. Just put aside the 101 wars for a moment. No jurisprudence should be this complicated.

    1. 17.1

      “Complicated” is not the right word.

      That word is “contradictory.”

      To that End [pun intended], the majority choice of words here of “Our precedent leaves no room for a different outcome here.” is both disingenuous and part of the problem. Ignoring the broken score board will never be a correct move (in fixing that broken score board).

      Heck, even Iancu was explicit in noting that the current Common Law law writing of 101 has rendered 101 into a Gordian Knot of contradictions.

      Void for Vagueness is both a cause and effect here.

      Want other Constitutional infirmities? I can give you at least two more (extremely detailed) planks.

      Tired of the Gordian Knot? I have an answer to that too (courtesy of the newest Justice and his handy Scissors from the recent oral arguments of the California Franchise Tax Board v Hyatt case.

      1. 17.1.1

        “Complicated” is not the right word.

        If Night Wiper thinks subject matter eligibility is too hard of a concept to digest, then he has every right to express himself, Billy. It’s not up to you to determine whether something is too difficult for Night Wiper to understand. Gosh knows you have great difficulty understanding a lot of things that were just too “complicated” for you (e.g., 271(f)). That’s okay. We all make mistakes.

      2. 17.1.2

        even Iancu

        LOL

        “Even” Iancu? Since when has Fraud Iancu been a reliable source on subject matter eligibility jurisprudence? He’s just another f cking id I 0t covered with flop sweat from Big Jeans echo chamber.

        Man, the maximalists never cease to crack me up with their hero worship. Paul Cole (LOL)! And of course we have the brilliant genius David Stein. And before that it was Hal “Tour de Farce” Wegner.

        1. 17.1.2.1

          Your obsess10n is showing and if you think the Director of the USPTO’s opinion is “just another” then your bathing in your cognitive dissonance has once again caused you to put your feelings above any sense of reason.

  8. 16

    Here’s a claim to a law of nature (stuff makes sound and with two sensors you can tell where it is).

    1. A method of detecting the direction of a source of sound which consists in towing a pair of detecting devices a fixed distance apart, obtaining a binaural balance, changing the course of the towing vessel, obtaining a second binaural balance and deducing from these balances the direction of the source of sound.

    So, I guess this patent is invalid.

    link to patents.google.com

    Simply absurd.

      1. 16.1.1

        Really? What part was new? Detecting devices? (that reads on ears and microphones don’t it?) towing? Vessels? Binaural? (you know, like naturally occurring ears), changing course? listening a second time? deducing?

          1. 16.1.1.1.1

            1) is it a method? Yes

            2) what is the result of the method? comparing binaural balances for a vector sum

            3) is the result a species of information? Yes

            4) does the utility of the result arise from human consumption of the information? No, the information is consumed by a multiplexed display device

            Eligible

            I am not a PHOSITA for sonar, so i can’t say if it was obvious at the time.

            1. 16.1.1.1.1.1

              Also to be sure: the multiplexer could be claimed as a machine, but using it to compare sounds could not be eligible as a method, since the information output of that method would be consumed by a human being.

                1. Les,

                  Generally speaking, method claims are not required to expressly claim devices.

                  (One of the subtleties that MANY — including courts — seem unable to grasp)

    1. 16.2

      I think you are trying to apply

      “the additional recited steps only apply conventional techniques to detect that natural law”

      to the case of

      a) towing a pair of detecting devices a fixed distance apart
      b) obtaining a binaural balance
      c) changing the course of the towing vessel
      d) obtaining a second binaural balance
      e) deducing from these balances the direction of the source of sound.

      Which of these techniques was conventional? e) in particular looks un-conventional to me.

      1. 16.2.1

        That’s what you do when a dog barks and you look in the general direction of the bark, the dog barks again and you make a second adjustment and see the dog.

        1. 16.2.1.1

          If the inventor had claimed ‘Dragging a patent attorney behind a boat in two directions and asking them ‘Can you hear a submarine?’ then it could well have been an abstract idea implemented with a conventional technique.

          The inventor added quite a bit more un-conventional uses of existing technology and so avoids the abstract idea problem.

          1. 16.2.1.1.1

            Quite a bit of unconventional use? What? Towing? Steering? Listening? Deducing?

            Directed to the abstract idea of listening to determine from which way a sound is coming. Recited steps are all conventional and do not add significantly more.

            Boom 101ed.

      2. 16.2.2

        >>diagnosing neurotransmission or developmental disorders related to interference of the agrin/MuSK/AChR pathway within a mammal comprising the step of detecting in a bodily fluid of said mammal autoantibodies to an epitope of muscle specific tyrosine kinase (MuSK).

        How is the above conventional or different from (e)?

        1. 16.2.2.1

          Short answer:

          MUSK: Uses conventional means to detect the operation of an unconventional law of nature. Mayo disallows this.

          SUBMARINE: Uses unconventional means to detect the operation of a conventional law of nature. Mayo does not disallow this.

          Long answer:

          As I understand your general point of view:

          1)Before this claim, there was no conventional means of “diagnosing neurotransmission or developmental disorders related to interference of the agrin/MuSK/AChR pathway within a mammal “. This is inarguable, it was an undiscovered law of nature.

          2)Since there was no conventional means, it follows that “comprising the step of detecting in a bodily fluid of said mammal autoantibodies to an epitope of muscle specific tyrosine kinase (MuSK).” must not be conventional.

          3)Since it is an unconventional means of “diagnosing neurotransmission or developmental disorders related to interference of the agrin/MuSK/AChR pathway within a mammal ” it should be a valid claim even under Mayo.

          4)The 1919 patent describes
          using an unconventional arrangement of binaural detectors
          to detect the operation of a law of nature (sound related)
          to locate a point sound source.

          5)The MUSK claim describes
          using an unconventional measurement of ‘autoantibodies to an epitope of muscle specific tyrosine kinase’
          to detect the operation of a law of nature (development disorder related)
          to diagnose a development disorder

          The described “arrangement of binaural detectors” had never been seen before (we suppose) and so it is correct to call it unconventional even though the law of nature used is well known.

          The described “measurement of ‘autoantibodies to an epitope of muscle specific tyrosine kinase'” had been seen before, it was even in the specification. The measurement is conventional and according to Mayo we cannot turn a law of nature into a claim just by adding conventional elements to it.

          1. 16.2.2.1.1

            The 1919 patent describes
            using an unconventional arrangement of binaural detectors

            “Unconventional” is a legally meaningless term in this context. The issue is whether the arrangement is non-obvious.

            Anticipated arrangements could be “unconventional.” But rest assured that an anticipated arrangement of these binaural detectors is going to dramatically affect the eligibility of the claim. This is one of the key reasons (probably easiest to undertand anyway) that the “unconventional” test is illegal and wrong.

            according to Mayo we cannot turn a law of nature into a claim just by adding conventional elements to it.

            That’s true but the Supreme Court never suggested that mere “unconventionality” would suffice. Adding anticipated or obvious elements won’t render the claim eligible, either, regardless of the fact that barely anyone practices those elements.

            1. 16.2.2.1.1.1

              The narrative you want on “unconvential” is simply not correct.

              Here you confuse and conflate with an attempt to bring into the discussion the different aspects of 102 and 103 (anticipation and obviousness). The Court rebuked what you are attempting.

              Don’t like this “conventionality” thing? Blame the Supreme Court — it’s their scrivining.

            2. 16.2.2.1.1.2

              I understood NW to be asking, in general, why Mayo does not apply to anti-submarine warfare.
              When NW wrote ‘How is the above conventional..’, I believe NW was referring to the ( probably non-meaningless) phrase “…this step simply tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists in the field..” from the Mayo decision.

          2. 16.2.2.1.3

            “4)The 1919 patent describes
            using an unconventional arrangement of binaural detectors
            to detect the operation of a law of nature (sound related)
            to locate a point sound source. ”

            You keep saying binaural detectors were unconventional but “Clément Ader demonstrated the first two-channel audio system in Paris in 1881

            “Modern stereophonic technology was invented in the 1930s by British engineer Alan Blumlein at EMI, who patented stereo records, stereo films, and also surround sound.”

            link to en.wikipedia.org

            Why do you keep saying is unconventional?

            So, if you think you’re ready, come down to Crazy Eddie.
            The man who knows the most in stereo sound…..

            …and so da stories told…trueout da whole wide woooiiild:

            Crazy Eddie will not be under sooooooolllllddd.

  9. 15

    Here’s an invalid claim to a law of nature (fire release heat).

    1. The method of locating a submarine from aircraft which comprises traversing an area to be patrolled and scanning the surface thereof with fairly directional heat detectors, substan- 6 tially insensitive to light waves within the visible and higher portions of the spectrum, one of the said detectors being oscillated fore and aft and another of the said detectors being oscillated laterally to scan two strips of said surface, and locating thereby the heat track of a submarine.

    So, I guess this patent was invalid:

    link to patents.google.com

  10. 14

    >>This, according to Judge Newman is “not a law of nature.”

    This is the core of the argument. And J. Newman is 100 percent right. “Law of nature.” That could mean any invention that has every been made and could ever be made. Are there inventions that do not behave in accordance with the “laws of nature”? Not possible. So, any invention can be seen as nothing more than having discovered a law of nature.

    1. 14.1

      An internal combustion engine could be seen as a claim to a law of nature. Fiber optic cable could be seen as a claim to a law of nature. Etc.

      But–let’s be honest here fellas. Lourie is one weird bird. That man needs to retire. He has come to hate patents in his long career and he never updated his scientific mind. He is a dinosaur that needs to go. Stoll is a Google appointment who has known personality problems. Thanks Obama for stacking the CAFC.

      1. 14.1.1

        Note too that I should have added that since it is an invention that it is new. So its operation would be a new operation of nature or law of nature as the less than distinguished CAFC judges say.

        (I don’t think there has ever been a less respected federal court than the CAFC as it is regarded now.)

    2. 14.2

      …the “logic” (and hence, our-down of those using that “logic”) that you reference here is captured in my “Big Box of Protons, Neutrons, and Electrons” comment.

  11. 13

    So Mayo/Alice boils down to this:

    You need one (claimed) invention to satisfy the Constitution.

    And a second (claimed) invention to satisfy SCOTUS.

    Both contained in the same (claimed) invention.

    Unconstitutional.

  12. 11

    Putting RG’s comment at the top because it is about as clear, correct and succinct as you can get:

    If I tell you of the natural fact that rain causes a sound when it hits glass, and that fact was previously “undiscovered” – a claim to a conventional act of “listening for sound” isn’t eligible, nor is “listening for sound on glass and concluding it’s raining” (i.e. conventional + the natural law) nor is “listening for sound on glass, concluding it’s raining, and then taking an umbrella when going outside (i.e. conventional act + natural law + conventional solution). The law doesn’t depart from this concept no matter how complicated the underlying subject matter is. The only question is whether the other acts would require any kind of inventive step beyond the disclosure of the ineligible subject matter.

    Dennis, do you understand this? Simple yes or no question.

    1. 11.1

      By this absurd reasoning, one could not get a patent for passive sonar, active sonar, sonograms or radar.

      1. 11.1.1

        …or any (and every) thing that happens to be configured from ineligible elementary particles of protons, neutrons and electrons (our together – gasp – according to the Law of Nature)…

  13. 10

    From the dissent:

    This court’s decisions on the patent-ineligibility of diagnostic
    methods are not consistent, and my colleagues today
    enlarge the inconsistencies and exacerbate the judgemade
    disincentives to development of new diagnostic methods,
    with no public benefit. I respectfully dissent.

    Can you say “Void for Vagueness?”

    The Gordian Knot just keeps on getting bigger with more rope of more decisions….

  14. 9

    Page 13:

    Preemption is sufficient to
    render a claim ineligible under § 101, but it is not necessary.
    Flook, 409 U.S. at 71–72 (holding claim involving
    mathematical formula invalid under § 101 that did not
    preempt a mathematical formula);

    This is the direct point overturned by Diehr.

  15. 8

    The only takeaway from this case is how wrongly decided Vanda was.

    If I tell you of the natural fact that rain causes a sound when it hits glass, and that fact was previously “undiscovered” – a claim to a conventional act of “listening for sound” isn’t eligible, nor is “listening for sound on glass and concluding it’s raining” (i.e. conventional + the natural law) nor is “listening for sound on glass, concluding it’s raining, and then taking an umbrella when going outside (i.e. conventional act + natural law + conventional solution). The law doesn’t depart from this concept no matter how complicated the underlying subject matter is. The only question is whether the other acts would require any kind of inventive step beyond the disclosure of the ineligible subject matter.

    If the only non-obvious act occurs in the disclosure of the natural law, your claim is directed to that natural law, and your claim is ineligible because you’re trying to claim the discovery of ineligible subject matter.

    Some people don’t like that discovering natural laws are ineligible. After all, they provide utility. So does “discovering” the location of oil, or “discovering” america. That doesn’t change the fact that the “discovery” preexisted in nature, and that giving patent protection for the discovery would lead to a host of ridiculous outcomes, like a person de facto owning the moon for 20 years just because he got there first, or the oil under land that belongs to someone else, or (and this is just as silly) the interactions between chemicals in the human body.

    1. 8.1

      The law doesn’t depart from this concept no matter how complicated the underlying subject matter is.

      Diehr and the Arrhenius equation. Discuss.

      Then be ready to discuss the Big Box of Protons, Neutrons and Electrons.

      1. 8.1.1

        Diehr and the Arrhenius equation. Discuss.

        I have – Diehr was not “Here’s a new equation I came up with, and when you use it things are improved” Diehr was “I invented a new machine that obtains previously unobtainable information, and because we now have that information we can use the previously-known Arrhenius to improve things.”

        Diehr is a claim to a novel, non-obvious sensor which would have been eligible on its own. The inventor went further, and said using my new invention we can also improve molding if we use Arrhenius. The claim was eligible and inventive based on the sensor, Arrhenius was an unnecessary tack on.

        In other words, Diehr is like inventing the umbrella in a world without umbrellas, but rather than claiming just the umbrella itself, saying you can use a natural law to determine the optimal time to bring an umbrella with you. The eligibility lies in the invention on the umbrella, and the additional (ineligible) subject matter does not destroy that eligibility.

        The situation is entirely different than the instant case, or the hypothetical, if for no other reason than the Diehr court expressly found the claim was not directed to the equation, and this court found it was directed to the law, just as my hypothetical is directed to the law.

        1. 8.1.1.1

          Ahh ha ha ha ha

          Dave stein wiped the floor and your “its a sensor” nonsense.

          Diehr is NOT at all as you suggest – all of the components were OLD.

          Your other points are equally nonsensical (as has been pointed out so many times now).

          1. 8.1.1.1.1

            “Diehr is NOT at all as you suggest – all of the components were OLD.”

            Only conveniently there was no record of such on the record.

            1. 8.1.1.1.1.1

              Look again 6.

              Was any claim particularly to ANY new single component?

              As the answer is no, the record does NOT reflect the desired narrative that Random wants to spin.

              As I noted, Dave Stein previously wiped the floor with Random and this attempted narrative.

              1. 8.1.1.1.1.1.1

                … and make sure that you recognize the distinguishment of “configuration of” known components…

                (hint: this is s severe sticking point in the application of the Berkheimer memorandum in relation to the requirement of the Office to establish “conventionality” of NOT just individual claim elements, but of the claim as a whole and as an ordered combination.)

              2. 8.1.1.1.1.1.2

                “Was any claim particularly to ANY new single component?”

                You already know it doesn’t have to be. The applicant can claim more narrowly than that or differently than any single component if they so choose. They so chose.

                Why waste time with straw men bruh?

                “record does NOT reflect the desired narrative that Random wants to spin.”

                Seems to. You’re just still fighting a battle long lost.

                ““I invented a new machine that obtains previously unobtainable information, and because we now have that information we can use the previously-known Arrhenius to improve things.””

                That is literally true. Though the “thing improved” was less burning of cured rubber in the machine when it was on auto-opening timer (and also the ability to use auto-timed opening without burning period iirc because previously there was too much getting burned in a factory environ when auto opening was attempted)

                1. They so chose.

                  No. No, they did not.

                  already know it doesn’t have to be

                  Actually, yes, to the point at hand, it DOES have to be.

                  Why waste time with straw men bruh?

                  There be no straw from me, 6.

                  And no, the record does not “seem to” reflect the desired narrative that Random wants to spin, and such is NOT a battle long lost. Quite the contrary, Diehr STILL stands for what it stands (and thus creates the conflicts that exist in the judicial scrivining. As I pointed out in reference to YOUR new 101 protocols, even yours boss-man Iancu is making explicit reference to the contradictions in Common Law statutory law writing. Battle long lost? Pshaw, you are not even close.

                  To your last paragraph, please remember that even before Diehr, there were perfect cures with NO burning. Then recall that the process called out for is performed once and only once.

                  Back in my engineering days I was involved in autoclaving 6 – this is NOT an area that you are going to be able to things out of thin air.

                2. “To your last paragraph, please remember that even before Diehr, there were perfect cures with NO burning. ”

                  Yes but not auto opening ones. It required monitoring by personnel to stop it from burning on a per batch basis.

                  “Then recall that the process called out for is performed once and only once.”

                  Not sure what you’re talking about “the process” and that is “performed once and only once”.

                  “Back in my engineering days I was involved in autoclaving 6 – this is NOT an area that you are going to be able to things out of thin air.”

                  You weren’t alive during the days of Diehr and even if you had been, the record is clear as to what as before the office at decision time and you’re reading too much into the art available to the office when they made the decision and acting like they had perfect knowledge of every piece of art published and also likely unpublished knowledge as well. Same as before, and same as many commentors before you. The ignorance of the examiner/office during the decision making process is and was relevant here. And you’re never going to get around that, regardless of your arguing about it on the interbuts and regardless of whether I totally say “herp I agree w you”.

                3. Sorry 6 – but “auto-opening” ALSO was not novel nor non-obvious (in and of itself)

                  Again – as I posted at 8.1.1.1.1.1.1, you NEED MORE.

                  acting like they had perfect knowledge of every piece of art published

                  Not at all – merely what a Person Having Ordinary Skill In The Art would readily recognize.

                  Having BEEN IN an industry wherein such use WAS common, I understand the legal concept far better than what you (or Random) attempt to do from your armchairs. And Diehr was decided in 1981. You act like it was a million years ago…

                4. “but “auto-opening” ALSO was not novel nor non-obvious (in and of itself)”

                  Doesn’t have to be. Stop constructing straw men.

                  “Again – as I posted at 8.1.1.1.1.1.1, you NEED MORE.”

                  No, I, and the USSC, don’t. It worked out just fine.

                  “Not at all – merely what a Person Having Ordinary Skill In The Art would readily recognize.”

                  hand waving doesn’t count as you like to remind us. And like Stevens found out.

                  “Having BEEN IN an industry wherein such use WAS common”

                  I’m sure it was in the 90’s.

                  “And Diehr was decided in 1981. You act like it was a million years ago…”

                  True but irrelevant. Look at the filing date, and when prosecution was closed for what art is prior art, and what art was actually before the examiner (and eventually the majority, sans Stevens) on the record to make a decision upon. Iirc it was like 78′ and 79′ respectively with a few years to get decision from all the stages to the USSC decision. That’s like ~20 years before your exp.

                5. Doesn’t have to be. Stop constructing straw men.

                  Stop acting like Malcolm and using the accusation of straw men in situations that such are not present and the accusation does not apply.

                  No, I, and the USSC, don’t. It worked out just fine.

                  Except for the fact that the USSC Diehr case is NOT what you (or Random) think it to be.

                  That’s kind of the point here.

                  as to “hand waving doesn’t count as you like to remind us. And like Stevens found out. ” – um, ok, what does that have to do with anything?

                  78′ and 79′ respectively with a few years to get decision from all the stages to the USSC decision. That’s like ~20 years before your exp.

                  As you put it: “True but irrelevant.” As I am familiar with the tech, I can tell you that even in the 70’s NONE of the piece part items were unconventional.

                  Look again at what I am telling you 6. For all of your wanting to disagree with me, nothing that you have said (that sticks) actually rises to a disagreement with me.

                  Random is simply wrong here. Factually and legally.

                6. “I can tell you that even in the 70’s NONE of the piece part items were unconventional.”

                  Just saying it and waving your hand does not evidence of record make. And the examiner did not take official notice of anything either. Just because you or someone else could have potentially taken official notice or found evidence to support your assertions does not mean the office did, and they did not.

                7. “Look again at what I am telling you 6. For all of your wanting to disagree with me, nothing that you have said (that sticks) actually rises to a disagreement with me.”

                  Absolutely it does. You think everything was conventional, I don’t think that there was evidence of such, and I also don’t think that you necessarily can hand wave those concerns away, this is not a muh computer, muh input, muh memory, muh x y z conventional computer parts everyday 101 case. And there was no evidence supporting your claims of conventionality of all elements of record, so I do not join you in your assertion and disagree with you (at least in so far as I say there wasn’t sufficient evidence of record to establish the oldness or conventionality of such of record found in the old days by the examiner and placed on the record or submitted in an old style IDS). And I further say that the USSC did not take it all as conventional/old. Instead, I assert for the thousandth time, that they did not take it all as old/conventional and that was part of the underlying reasoning for their decision in Diehr. And, just an fyi, I’m right, and I will always be right on this, and random seems to be in the same vein, and neither me nor him changing our minds and saying “you are right anon” will ever change that. Me and random will just have changed to being wrong with you.

                  And yes I said you are “wrong”, and I’m triggering your OCPD no doubt. I’m going to stop JADEING now thx.

                8. It appears that the triggering is in the reverse of what you allege, as YOU are the one that cannot bear to be deemed wrong (even as the plain facts of the matter show that you are wrong).

                  Also, you mis-spin here with wanting my point to be “Everything is conventional.” Read my posts again. The piece parts were what were conventional. The non-conventionality was the ordered combination of those piece parts.

                  This is why the Berkheimer memo is so powerful.

                  Examiners have to show the heightened factual basis (under APA levels) of NOT ONLY individual elements, but ALSO of the particular ordered combination.

                  This is an easy point to grasp, but one that you continue to expend tremendous amount of energy in attempting to NOT grasp.

                  Like many other concepts though that have seen you eventually embrace with my help, this concept may too be embraced by you.

                9. ..let me also point out (since the late Ned Heller is not here to chime in), that one of the rebuttals to Ned’s penchant for wanting to invoke a “Point of Novelty” for patent eligibility…

                  (in total disregard for the law, taking claims as a whole — eligibility NOT being a purely ‘piece part’ thing — and not grasping the importance of the Berkheimer case even unto his end)

                  … was that for Diehr, IF one wanted to find some point of novelty, THEN that point would have been the pure software aspect that tied all of the individual (pre-existing) piece part items together.

    2. 8.2

      The only takeaway from this case is how wrongly decided Vanda was.

      Naturally, I disagree, but I will certain agree with you that this decision only really makes sense if Vanda was wrongly decided, and Vanda only really makes sense if this case is wrongly decided. I suppose, however, that the genius of a common-law system is that the precedents do not all have to fit together systematically.

      I gather that the new equilibrium that has emerged is that one cannot get a diagnostic method claim, but that one can get a method of treatment claim, wherein the only point of novelty between the claimed method of treatment and prior art methods of treatment is that one classifies the patient population that will receive the treatment based on a diagnostic method recited in the claims. That is a distinctly second best equilibrium, but I and mine can live with it.

      Live with it, that is, until the SCotUS next takes up the issue. If the current SCotUS takes a case like Vanda, I have to expect that this new equilibrium will be wiped out. If, however, the Court decides to wait a decade or two (until Breyer/Ginsberg/Sotomayor are all retired) to revisit the issue, then maybe the new equilibrium will have settled into the status quo.

      1. 8.2.1

        I gather that the new equilibrium that has emerged is that one cannot get a diagnostic method claim…

        In the interests of clarity, I should have written that one cannot get a diagnostic method claim for this sort of discovery, but that one can get a method of treatment claim for this sort of discovery. I did not mean to imply that all diagnostic method claims are ineligible (although I think that decision probably does imply that all diagnostic method claims fail step one, and survive only—if at all—by step two).

        1. 8.2.1.1

          Drats, maybe nevermind my comment at 8.2.2.

          What I get for reading a screen-at-a-time on a phone.

      2. 8.2.2

        “new equilibrium that has emerged is that one cannot get a diagnostic method claim,”

        Or rather, I guess you can say that you can only get a diagnostic claim under the new equilibrium if you have to build something new in order to be able to take advantage of the new relationship which has been found.

        1. 8.2.2.1

          I guess you can say that you can only get a diagnostic claim under the new equilibrium if you have to build something new in order to be able to take advantage of the new relationship which has been found.

          Much more accurate.

          Yes, folks: you have to build something new (or recite a series of novel physically transformative steps) to get a patent.

          There was never anything controversial about this until some greedy entitled patent attorneys decided they wanted a piece of the action. That’s when the push to lower the bar for eligibility to the lowest level possible began in earnest. Anyone can conceive of a new “functionality” for a programmable computer. No technical skill whatsoever required. You don’t have to be very smart. Hence the screeching of the maximalist patent attorneys who smelled a quick buck.

          1. 8.2.2.1.1

            your whiny rant is noted.

            As is your dripping attempt at making an optional claim format somehow not be optional again.

            As is your odd projection as if this form of innovation is merely a “greedy grab” rather than being a fifth Kondratiec wave (but then again, maybe those that actually study innovation are ALSO in that “one-bucket” of greed…) After all, YOU are a legend in your own mind and no one else is important, eh?

    3. 8.3

      else, or (and this is just as silly) the interactions between chemicals in the human body.

      Congrats, you have just wiped out every Pharma patent by removing the mechanism of their utility.

  16. 7

    Footnote 3:

    We note that the district court held that the “focus
    of the claims” was the binding of MuSK to MuSK antibodies
    in bodily fluid. Decision, 275 F. Supp. 3d at 310. Our
    cases have not described a claim to the binding of two molecules
    during a sequence of chemical manipulations (here,
    after MuSK labeling and before immunoprecipitation) as a
    claim to a natural law, even if such binding occurs according
    to natural laws. We need not resolve that issue here,
    as we agree with Mayo’s identification of the natural law.

    Cue: Big Box of Protons, Neutrons, and Electrons.

  17. 6

    Mayo pretty much controls Step One of the Alice procedure in this case. Applicant outright admits Step Two. Cue dozens of people arguing that this is crazy and that it should be overturned in three…two…one…

    The more interesting part is the attempt to distinguish Vanda, as if a new sensor (which is what this claim is) based on conventional knowledge added to a natural law is somehow different than a new treatment/cure based conventional knowledge added to a natural law.

    Note here Footnote 4 from the majority opinion — agreeing with the dissent that “the public interest is poorly served by adding disincentive to the development of new diagnostic methods” and lamenting their inability to act. “Our precedent leaves no room for a different outcome here.”

    A common refrain of people who want oversized patents. There’s incentive to develop new diganostic methods, just not patent incentive. There’s all kinds of market forces that would encourage improved diagnostics of all types. Not everything that has utility was meant to be protected by a patent. Which is why when Newman starts off with “Until discovery of the diagnostic method described in U.S. Patent No. 7,267,820 (“the ’820 patent”), some 20% of patients suffering from the neurological disorder Myasthenia Gravis were not capable of being diagnosed” my eyes roll before I even get into it.

    First, as the majority points out – the other 20% develop the same symptoms, so it’s not like they “were not capable of being diagnosed.” It’s just that after the disclosure of the natural law we know why the previous test only caught 80% of the people. Beyond that, gosh, if only there was some non-patent reason the trillion dollar medical industry would have for developing and widely disseminating a diagnostic to find 20% more MG patients.

    Also I’m not sure what the genesis of Footnote 4/the dissent quote is (whether it came from the amici, a clerk, or Newman), but I’m sure whoever germinated it as an idea is a jerk. You have to have a lot of privilege before “the government’s failure to privatize something that belongs to everyone” constitutes a “disincentive” in one’s mind. There is a world of difference between “a failure to incentivize” and “a disincentive.” Diction is important.

    1. 6.1

      Judge Newman is a jerk. That’s been clear for many years now. Heck she wanted to hand out patents on compositions that were indescribable because otherwise … indescribable things might not get patented.

      What an I d iot.

      1. 6.1.1

        Newman may not be perfect here, but she is incredibly more on point (and more cogent) than the majority.

      2. 6.1.2

        LOL….MM stooping to name-calling since he can’t refute Newman’s logic in this case. The patent claims in this case certainly isn’t indescribable…and the majority never claims it is, they merely (deliberately?) ignore what the patentee actually claimed even with Newman pointing it out clearly in her dissent.

        I’ve personally found that Newman’s mind (at 95 years old?) is much sharper than her colleagues in understanding actual patent legislation language, its intent, prior legal precedence, and all its implications on the system.

        I can fully understand why YOU wouldn’t like her….since you have zero respect for the patent system or the actual work of innovation (including the required return on investment to incentivize it) except as a candy store you can plunder….much like Dyk and Lourie.

        1. 6.1.2.1

          The “indescribable” comment is not directed to the present claims, but rather is directed to an entirely different patent issue of “product by process” claims.

          Malcolm does not like that type of optional claim format, and this is reflected in his nigh constant attempts to elevate one particular optional claim format to be the ONLY “legal” claim format.

          That Malcolm purposefully dissembles and misprepresents the law on this matter is a blight that has no posssible excuse. His actions do not “border” the unethical – they ARE unethical (he is advocating a known — and identified — error in law because of his desire to have the law be something other than what it is. He does so fully knowing that his desired optional claim format is just that: optional.

    2. 6.2

      There’s all kinds of market forces that would encourage improved diagnostics of all types.

      Too true, but those same market forces (absent patents) encourage the discoverer to keep the new knowledge secret. There is a good public policy reason why we use patents to encourage not only R&D, but also disclosure of the new info generated from the that R&D.

      1. 6.2.2

        Too true, but those same market forces (absent patents) encourage the discoverer to keep the new knowledge secret.

        Ignoring that if you’re in the business of selling drugs to treat a condition, you have incentive to disseminate methods of detecting the condition, because that increases your customer base. If you’re a doctor you have incentive to disclose for peer review purposes for the same reason you carry medical insurance – showing you don’t malpractice. The only people who don’t have an immediate incentive to disclose are diagnostic firms, and that incentive lasts exactly as long as people will keep paying them to confirm a suspected diagnosis with no proof as to why they would be an authority on the subject.

        I suppose we can debate whether Mayo would have been able to make a profit by developing a competing test absent the Athena patent disclosure, but I find it difficult to believe that *Athena* could have made a profit absent the Athena patent disclosure. I know this because the only difference between Athena’s MG test and my revitalizing tonic that cures baldness is that one of them is out in the open, subject to peer review, and licensed after being experimented with by third parties, and one is not.

        Link to video of Athena’s customer base absent a public disclosure: link to youtube.com

        1. 6.2.2.1

          Ignoring that if you’re in the business of selling drugs to treat a condition, you have incentive to disseminate methods of detecting the condition, because that increases your customer base.

          A fair point. Even under the Mayo regime there are some incentives to disclose certain diagnostic techniques.

          If you’re a doctor you have incentive to disclose for peer review purposes for the same reason you carry medical insurance – showing you don’t malpractice.

          Not really. Consider, for example, the invention at issue in Sequenom. What was the utility there—the thing for which people were willing to pay money? The claimed invention could tell you—before the child is born—whether your baby will carry a trisomy disorder like Down’s syndrome. This is a diagnostic inventions in its purist form. Nothing comes out of the practice of this claimed method except information. Nevertheless, the information is of the sort for which many people will pay money because they want to know.*

          There were, of course, prior art methods of detecting trisomy disorders before birth, but they all required puncturing the uterus, which comes at a considerable risk of inducing a miscarriage. The Ariosa inventors discovered a way that achieved information with the same degree of reliability, but with none of the risks to the well being of the pregnancy that come from puncturing the uterus.

          Imagine if—instead of filing a patent application—they had simply set up their own private clinic. Expectant parents come to them, and the clinicians take a variety of tissue samples (blood, urine, earwax, oral cavity scrapings, etc) and go into a private room in the back of the clinic. The next day they call you up with your information (yes or no on trisomy).

          I take your point about the value of peer review in validating the findings, but think of how the peer review works here. They announce in each case—before the baby is born—an anonymized list of their results. Then they publish—after the babies are born—an anonymized list of the results confirmed after birth. These data are enough for the medical community to review and agree that the diagnostic information is indeed accurate within the 99% confidence interval. No details about how the technique is performed are actually necessary to in order to achieve this sort of independent validation.

          In other words, with patent protection for the Ariosa inventors (and those like them) there is incentive for disclosure, and the disclosure in turn makes it possible for the state of the art to advance. Absent patent protection for Ariosa’s invention, the rational response for the inventor of an invention of Ariosa’s ilk is to suppress the knowledge and capitalize on it as a trade secret.

          This is bad public policy.

          * The reasons why some of those people want to know are unpleasantly dark, but those reasons not especially relevant to the point being made in this post.

          1. 6.2.2.1.2

            Not really. Consider, for example, the invention at issue in Sequenom. What was the utility there—the thing for which people were willing to pay money? The claimed invention could tell you—before the child is born—whether your baby will carry a trisomy disorder like Down’s syndrome. This is a diagnostic inventions in its purist form. Nothing comes out of the practice of this claimed method except information. Nevertheless, the information is of the sort for which many people will pay money because they want to know.*

            Ugh, this is a basic thought exercise I’d hope we’d be past by now. No, people will pay for *accurate* information, and absent the disclosure of the natural law there’s no reason to believe it’s accurate.

            Imagine if—instead of filing a patent application—they had simply set up their own private clinic. Expectant parents come to them, and the clinicians take a variety of tissue samples (blood, urine, earwax, oral cavity scrapings, etc) and go into a private room in the back of the clinic. The next day they call you up with your information (yes or no on trisomy).

            Okay well first this imaginary world lacks informed consent laws, right? Because you can’t go performing medical acts on people while refusing to disclose what you’re going to do with it, but lets say those people don’t exist – privacy and bodily integrity aren’t huge american considerations anyway.

            But if you want to pay me I can hang a shingle and poke you with a needle and tell you whether your unborn children will have down’s *right now.* I think you’re really stifling your consumer base by waiting until people get pregnant, which shows a lack of imagination on your part. Why let a little thing like conception get in the way?

            Absent the relevant disclosure which you claim only a patent ensures, someone is just as likely to pay me as Sequenom.

            Also not-unimportant: one better hope that the ability to detect the gene via Sequenom’s method is 100% accurate (spoiler: it never is) and further that the gene is interpreted to down’s accurately 100% of the time. If not, and there’s even a single misdiagnosis, let me give you an open and shut med mal case –
            Atty: “You said your patients asked you to test for Down’s syndrome. Did you test for Down’s syndrome?”
            Doc: “I did.”
            Atty: “And how did you do that?”
            Doc: “I tested the blood from the mother.”
            Atty: “And is the standard medical practice to test the blood of the mother or the fetus?”
            Soon-to-be-poor Doc: “The fetus.”

            The Ariosa inventors discovered a way that achieved information with the same degree of reliability, but with none of the risks to the well being of the pregnancy that come from puncturing the uterus.

            Prove this statement without disclosing the natural law. In fact, show me any scientific text that says it is possible to compare reliabilities absent a disclosed methodology. You can’t, because without a methodology you cannot determine what may or may not be a confounding variable.

            They announce in each case—before the baby is born—an anonymized list of their results. Then they publish—after the babies are born—an anonymized list of the results confirmed after birth. These data are enough for the medical community to review and agree that the diagnostic information is indeed accurate within the 99% confidence interval. No details about how the technique is performed are actually necessary to in order to achieve this sort of independent validation.

            That’s not how science or peer review works. The essence of science is reproducability. You can’t reproduce an undisclosed methodology. That’s like noticing that punksatawny phil correctly calls whether there’s an early spring 30 years in a row and concluding that the weather is controlled by a rodent in pennsylvania. That conclusion makes exactly as much sense as your hypothetical proves Sequenom has a reliable test.

            Between the years of 1936 and 2000, the Redskins performance in their last home game perfectly predicted whether the incumbent party would stay in power in the white house. 17-0 over *64 years.* Little did you know that your vote is actually meaningless because we live in a oligarchy spearheaded by the national football league, huh?

            Absent patent protection for Ariosa’s invention, the rational response for the inventor of an invention of Ariosa’s ilk is to suppress the knowledge and capitalize on it as a trade secret.

            Absent disclosure, Athena’s competitors will call Athena a quack, get Athena investigated, sued, dismantled and possibly jailed. The only distinction between a non-disclosing Athena and me is that I have a competitive advantage of no sunk R&D costs. At least if Athena discloses it can compete quality versus cost with me. If it doesn’t nobody will even look at it.

            This is not even a real argument. It’s one thing to argue that people will not put money into R&D in a non-patent system, which has at least some (poor) arguments going for it. It’s another thing to argue that you could survive in America performing unlicensed and undescribed medical procedures on people. This isn’t drinking a Coca-Cola, this is telling people that they or their children have life changing and life threatening diseases, the notion that you can trade-secret this is ludicrous.

            1. 6.2.2.1.2.1

              Just off the top of my head:

              Expectant parents come to them, and the clinicians take a variety of tissue samples (blood, urine, earwax, oral cavity scrapings, etc) and go into a private room in the back of the clinic. The next day they call you up with your information (yes or no on trisomy).

              This is a licensing violation, an unconsented battery, insurance fraud, wire fraud, and medical malpractice. And that assumes you get it right.

              The minute you bill medicaid for clinical labor when you’re paying your clinicians to remove earwax for a test that doesn’t use earwax, you just bought yourself five years. Unless there’s enough for it to be a RICO violation, then it’s more likely to be 20.

              1. 6.2.2.1.2.1.1

                [Y]ou can’t go performing medical acts on people while refusing to disclose what you’re going to do with it…

                I would be interested to see cite a case where a physician was held liable for want of informed consent because s/he failed to disclose the methodology of techniques performed after the samples were already collected. If such cases are common, then I concede that I have egg on my face. I am not aware of any such, however.

                That’s like noticing that punksatawny phil correctly calls whether there’s an early spring 30 years in a row and concluding that the weather is controlled by a rodent in pennsylvania.

                You are straining here, and it shows. I never postulated that a causation claim would be made. For diagnostics, a statistically significant correlation is sufficient, even without understanding or asserting a causal mechanism.

                [O]ne better hope that the ability to detect the gene via Sequenom’s method is 100% accurate (spoiler: it never is)…

                Honestly, (1) this is a routine problem in the medical industry, and it is routinely handled with the proper waiver language; and (2) it is not the case that a single malpractice suit typically does in otherwise successful medical practices.

                The minute you bill medicaid for clinical labor when you’re paying your clinicians to remove earwax for a test that doesn’t use earwax…

                I take your point, but that simply means that the private clinicians in my hypo do not take medicaid. I can well imagine that they do not take insurance at all. What of it? This not an especially uncommon state of affairs for a certain class of private clinics. The kind of patient who worries about trisomy disorders enough to pay for the diagnosis is disproportionately possessed of the means to pay the fee without insurance.

    3. 6.3

      “A common refrain of people who want oversized patents. There’s incentive to develop new diganostic methods, just not patent incentive. There’s all kinds of market forces that would encourage improved diagnostics of all types. Not everything that has utility was meant to be protected by a patent. ”

      That’s a bit of a fallacy. The question isn’t whether there is enough incentive — is there ever enough incentive to encourage people to make the world a better place to live? The question is: whether the benefits of allowing patent coverage would outweigh the detriment. I.e., would patent ownership help or hurt? Just because there is some other incentive doesn’t mean that more incentive wouldn’t be a good thing.

      1. 6.3.1

        The question is: whether the benefits of allowing patent coverage would outweigh the detriment. I.e., would patent ownership help or hurt?

        With respect to ownership of correlations (i.e., the “meaning” that can be assigned to data), the First Amendment provides a big part of the answer. And you’re going to need more than some pithy hand-waving “rational basis” before you can turn me into a criminal for thinking about the meaning of some data I legally collected, or for using my legally purchased equipment to look at a natural phenomenon.

        It’s hard to believe that this needs to even be discussed. Are you that desperate for work? I’m a biotech patent attorney and I have zero problem with these claims being tanked. Mayo v. Prometheus was one of the most important and sensible Supreme Court decisions in the 21st century and it’s never going to be overturned or, if it is overturned, you can rest assured that the US is truly a banana republic t 0 i let country of the lowest order.

        1. 6.3.1.1

          )the First Amendment provides a big part of the answer.

          Once again, you merely mouth “First Amendment” and F A I L to actually make a cogent legal argument.

          DO MORE PLEASE than merely “mouth it.”

          … and please do not attempt to move goalposts from claim elements to claims ONLY of things that you think would be ‘criminal.’ That old dog won’t hunt.

        2. 6.3.1.2

          Once again you mouth “First Amendment” and F A I 1 to make an actual cogent legal argument.

          Do as I suggested last time: inform yourself of how to make a FA argument and try to do more than mouth it (and you will note that your attempt to move goalposts for ‘criminal’ as you so often do with making a claim TOTALLY IN THE MIND (about some FA fantasy of yours) as opposed to merely a claim element: your ‘logic’ attempt may be “Arrhenius equation” contrasted with the actual total claim of Diehr.

  18. 5

    claimed method does involve creating non-naturally-occurring labeled antigens and then causing a chemical reaction that does not non-naturally-occur.

    Why the double negative in the second half of the statement?

    (never even getting to the point that Malcolm’s rant below does not rise to these [inconvenient] facts about NON-NATURAL things)…

      1. 5.1.1

        I have no idea why you responded to my post, as nothing that you say here addresses the points I present.

  19. 4

    As usual, my test works easily for these facts, and distinguishes Vanda

    1) is this a method? Yes

    2) What is the result of performing the method? Confirming the correlation between the presence of naturally-occurring MuSK autoantibodies in bodily fluid and MuSK-related neurological diseases.

    3) Is that result a species of information? Yes

    4) Does the utility arise by human consumption of that information? Yes, physicians will use this information to determine the course of treatment.

    Ineligible for patenting.

    For Vanda

    1) Is this a method? Yes

    2) What is the result of performing the method? The administration of a particular drug at a particular dosage range.

    3) Is that result a species of information? No. The result is a chemical or mechanical change in the world.

    Eligible for patenting.

    That chemical or physical change may be obvious, or anticipated, but the method is eligible.

    1. 4.1

      Is your argument that a novel sensor is eligible and the method the sensor performs is not? Or is a sensor also not eligible?

        1. 4.1.1.1

          Novel sensor method inquiry;

          Is the invention a method? Yes

          What is the result of performing the method? X indication

          Is that result of the method a species of information? Yes

          Does the utility arise by human consumption of that information?

          If Yes, ineligible.

          If No, eligible.

          End eligibility inquiry, begin patentability inquiry:

          Where is the novelty and utility such that the appropriate PHOSITA can be described?

          Is the invention obvious, anticipated, not fully described and/or not possessed by the inventor?

          1. 4.1.1.1.1

            Does the utility arise by human consumption of that information?

            If Yes, ineligible.

            If No, eligible.

            I would assume virtually all utility in the medical profession arises by human consumption of the information. The reason I go to a doctor at all is because one of us is a human that has consumed certain information that has utility, and its not me. It’s not like he makes the pills himself or puts them in my mouth, the only utility he provides arises out of consumption of information.

            So a human dispensing the proper treatment based on a natural law is ineligible, but a robot filling a vial with different amounts of liquid based on the same law would be eligible?

            May I suggest that a more accurate description of a rule would be “is there an inventive step that arises beyond the human consumption of the natural law”?

            For Vanda

            1) Is this a method? Yes

            2) What is the result of performing the method? The administration of a particular drug at a particular dosage range.

            3) Is that result a species of information? No. The result is a chemical or mechanical change in the world.

            This sounds suspiciously like the machine-or-transformation test, which is fine, but it’s a little plaguristic to say it’s your test.

            Doesn’t the difference between a claim that includes “and treat it” and a claim that doesn’t include it when the treatment is otherwise conventional seem an awful lot like the scrivening controlling the eligibility that the court has sought to avoid? I find it difficult to believe that I can, for example, state a previously-undiscovered natural law about when it is going to rain and my eligibility turns upon whether the claim commands someone to bring an umbrella or not. Doesn’t it seem more likely that the eligibility would turn on whether or not a command to bring an umbrella in response to rain was an inventive solution or simply conventional subject matter? My citation of the umbrella (and thus it’s utility) is entirely irrelevant – the entire town already knew it could bring an umbrella when it rains. Why should my eligibility freeload on the previously-existing umbrella utility, and why does the recitation of known utility convert my ineligible information-consumption method into an eligible mechanical change in the world invention?

            And again, just so you know what you’re buying into here – you would bless a claim that reported the position of previously undescribed oil or mineral deposits, just so long as the claim also included a limitation that ordered conventional drilling or mining of said location? That’s the difference between this case and Vanda, yes? Conventional means of determining your location + natural law = ineligible (“[PHOSITA] will use this information to determine the course of [performing phosita duties]”) but also + command to drill or mine and the claim becomes “a chemical or mechanical change in the world” which is eligible.

            1. 4.1.1.1.1.1

              Doesn’t the difference between a claim that includes “and treat it” and a claim that doesn’t include it when the treatment is otherwise conventional seem an awful lot like the scrivening controlling the eligibility that the court has sought to avoid?

              Exactly. I happen to think that Mayo was wrongly decided, so if Judge Lourie and the CAFC want to use “it’s not a diagnostic, it’s a method of treatment, in which the only point of novelty over the prior art is the diagnostic method that preceeds the treatment” as the way to distinguish Mayo, that suits me just fine. No one is fooled, however. This is not applying Mayo, but rather ignoring Mayo (for the good of the well functioning of the whole system).

              It is a little too cute when Judge Lourie says (as if butter would not melt in his mouth) that “precedent leaves no room for a different outcome here.” If the CAFC were really following Mayo in its straightforward sense, Vanda would not have come out as it did. I am glad that they chose to distinguish Mayo (I only wish that they had done so more aggressively, back in Sequenom), but it is hard to call this a respect for precedent.

              1. 4.1.1.1.1.1.1

                To be clear, today‘s decision respects Mayo. It is Vanda (an earlier opinion by Judge Lourie) that rather looks Mayo straight in the eye and ignores the Mayo holding.

                1. To be clear, today‘s decision respects Mayo. It is Vanda (an earlier opinion by Judge Lourie) that rather looks Mayo straight in the eye and ignores the Mayo holding.

                  Yep, we’re in total agreement. Well, except for the necessity to ignore Mayo, but I don’t expect to win you over on that one :P

            2. 4.1.1.1.1.2

              “I would assume virtually all utility in the medical profession arises by human consumption of the information”

              Really? So setting a broken arm, implanting a stent, administering drugs are all just information?

              “Doesn’t the difference between a claim that includes “and treat it” and a claim that doesn’t include it when the treatment is otherwise conventional seem an awful lot like the scrivening controlling the eligibility that the court has sought to avoid? ”

              No, it’s a difference between acts which infringe and get you sued and those that do not. Taking in some information and then doing something based on that information should not be an activity that can get you sued.

              I can, for example, state a previously-undiscovered natural law about when it is going to rain and my eligibility turns upon whether the claim commands someone to bring an umbrella or not. No, your claim turns on what the result of your method is. If the result is information about rain, and persons use that information, it’s not eligible. If your car uses that information to re-configure its ABS and turn on your wipers, the claim should be eligible- but of course not necessarily patentable.

              Its not the scrivinging that matter, but the infringing behavior that matters.

              If a claim was to method for finding oil under your couch, and then using a robotic, but otherwise conventional drilling rig to drill it, would be eligible….and obvious. If the claim was simply to tell you there was oil under your couch, not eligible.

              A claim to a non-conventional drill would be a manufacture, not a method, and a claim of a non-conventional method of drilling that did not result in a species of information, but rather a hole in the ground, would be chemical or mechanical change in the world.

              You can’t scriven your way to eligibility if the result of a method is information and a person uses that information.

              The most basic and bare meaning of “abstract” is information processed by a human mind. That comports most closely with the origin of the word, and the fact that if there is no human mind, there can be no abstraction.

              If you are talking about claims that are functional or aspirational, but not abstract in that basic sense, they are 112 or 103 issues.

              I understand that prior art has to be considered in some eligibility inquiries, just to locate the novelty/PHOISTA / infriging behavior. That locating function does need not (but could) overlap with 103/112- claims can fail for multiple reasons- but the many, many jurists and lawyers who complain about conflation of eligibility and 103/112 can’t just be waved away- as a policy and political reality based on the structure of the patent act. Want to solve that dichotomy? Rewrite the whole act. I think you can fix it with a small change to 100(b), which is currently a tautology anyway, where a process is defined as a process.

              1. 4.1.1.1.1.2.1

                Marty, move the goalposts back.

                Contrast what was said: “utility… arises by… human consumption OF…”

                with your restated “[actions] ARE just information”

                Your restatement is a strawman, and avoids the understanding of utility as derived from what humans DO with things – and humans DO with things based on knowledge/information that these things DO what they do and what they do is desirous to humans.

                Human consumption is a necessary conduit for utility to be of the patent variety of utility. We HAVE a patent system expressly so that human consumption is fostered.

        2. 4.1.1.2

          Is the invention a method? No, it’s a manufacture.

          Eligible

          See certain claims from Alice, stipulated by both parties to fully satisfy the “machine” category and yet deemed ineligible.

          (NOT an uncommon occurrence)

          1. 4.1.1.2.1

            This sounds suspiciously like the machine-or-transformation test, which is fine, but it’s a little plaguristic to say it’s your test.

            It’s certainly not the M0T because if the information result is consumed by a non-human actor, the method is eligible, yet still intangible.

            Abstract does NOT mean intangible. It means processed by a human mind. No human mind, no abstraction. E=MC2 is not an abstraction if a human mind does not apprehend it.

            1. 4.1.1.2.2.1

              There were claims in Alice that squarely were to machines. The Court did not care.

              So….

              You want your test to be only a test for one (and only one) of the statutory categories…?

              That (mis)treats that statutory category as somehow not being on the same ground as the other statutory categories. On what possible cogent, legal, (and reflective of the Constitutional grant of authority to write patent law to only one of the three branches of government) grounds can you tie your test to the law?

              1. 4.1.1.2.2.1.1

                There is virtually no disagreement about what a machine, manufacture, or composition of matter is in relation to the patent laws.

                There is ahem…wide….disagreement about that a process is in relation to the patent laws.

                Everyone knows this.

                1. You are absolutely off base in relation to “virtually no disagreement” – see Alice.

                  (are you not paying attention?)

  20. 3

    Patents are intended to provide an incentive for inventors to risk resources and disclose their inventions to the public. What incentive will any company have to spend millions if not billions to identify and apply an invention, such as the importance of the MuSK autoantibody, if the courts are going to dedicate their work to the public? Answer, none. This decision undermines the vary reason for patents and jeopardizes future medical advances.

    1. 3.1

      What incentive will any company have to spend millions if not billions to identify and apply an invention, such as the importance of the MuSK autoantibody, if the courts are going to dedicate their work to the public? Answer, none.

      Yeah, why do doctors and medical companies diagnose and treat patients if not for their patent license revenue? My doctor had his patent cancelled and now he’s stopped practicing.

      1. 3.1.1

        The “but cost” is one of the weaknesses here in Newman’s discussion.

        That “but cost” is ONLY ONE OF — and not even necessary to be present — reasons for having a patent system.

        The error in emphasizing it (all on its own) is evident in that it generates the very response that you provide – as if your response was somehow a meaningful rebuttal (it is not).

      2. 3.1.2

        RandomGuy, you are asking the wrong question. The question is not whether doctors or medical companies will “continue” to use “existing” technology without patent protection as in your scenario. The real question is whether a company or doctor would invest millions or billions of dollars to “develop” “new” technology in the first place without the possibility of patent protection to allow recouping their investment. The answer to the real question based on logic, economics, and history is a resounding “no.”

        1. 3.1.2.1

          Kent,

          Random excels at asking the wrong questions.

          Note as well that when the right questions are put to him (and it is shown why, and how, he is in the weeds, he ‘conveniently’ disappears from the dialogue.

          But you can be most assured, he will chime in again the next time the topic comes up with his same position, as if the counterpoints presented to him were never mentioned.

          He exhibits an ultra strong case of confirmation bias, and only seems capable of ‘absorbing’ those things that fit his pre-conceived narrative.

  21. 2

    Judge Newman’s hot takes on 101 are so ridiculous they’re not even worth addressing.

    Dennis writes:

    Although conventionality can now be seen as an issue of fact, the court found that it was effectively admitted within the specification.

    As is routinely the case. If there was anything “non-conventional” (especially a new composition of matter) then the applicant should have claimed that subject matter cleanly right off the bat.

    But the requirement for “conventionality” is the CAFC’s own made up nonsense, predicated on Supreme Court dicta that was never intended to qualify as a “test” for eligibility but was instead provided as an example of the sort of thing that is not “significantly more.” Do we all what else is not “significantly more” to rescues an otherwise ineligible claim? Anticipated subject matter and obvious subject matter, of course. And it doesn’t matter whether that anticipated subject matter or obvious subject matter was “routine” or “conventional”. All that matters is that it was in the prior art and (with respect to obviousness) and it’s being used in the claim for its intended purpose. How can it possibly be otherwise? The answer is that it can’t, unless you want to drive a truck through the patent system and take subject matter out of the public’s hands when someone recites that public subject matter and appends, e.g., a step of “thinking about something non-obvious” to that subject matter. Never going to happen. Judge Newman may be higher than a kite on patent crack, but none of the Supremes are.

    1. 2.1

      …it is beyond odd that you want a certain desired Ends, and cannot even handle the necessary fallout from the fairly Means-LESS Supreme Court decision that abrogates the actual words of Congress…

      Your rant against “conventional” has ZERO potency. You continue to confuse and conflate the different sections of law (even WORSE than the Supreme Court).

    2. 2.2

      So, once again we find that something is abstract because it is known. At least this time, the court is bothered by its own absurdity.

    3. 2.3

      Although conventionality can now be seen as an issue of fact, the court found that it was effectively admitted within the specification.

      Not only that, but if its an issue of fact they couldn’t overturn the district court anyway, as its not unsupported by the record.

  22. 1

    Section 101 law is all about policy. If that’s true, then courts like the panel in this case should be considering policy as well as precedent. Why is it that the court charged with oversight of patent law does not bother to ask: is this invention the kind of thing that we want to encourage? Policy concerns created a subjective rule for patent eligibility, and now the policy disappears when it is time to apply that rule. Policy concerns only take from the inventor, they never give.

    1. 1.1

      Just because some “innovation” is the “kind of thing we want to encourage” does not mean that it should be protected with a patent.

      The “policy” of 101 is that we don’t grant patent claims that allow people to protect abstractions like logic, information, correlations, and scientific facts. Every patent attorney with more than half a br@in knows that you can write patent claims that protect such things directly (e.g., by claiming the fact itself), or you can protect such things indirectly (e.g., by claiming the fact itself in a particular prior art context, or by claiming a means of observing the fact using prior art technology).

      Quite literally, it’s only patent attorneys and some academics who will bend over so far backwards to make the argument that anyone who “discovers” anything new about biology should be able to monopolize that thing for 20 years. The idea that a system permitting that would be an efficient system for promoting discovery is absurd. But it’s easy to understand why patent attorneys and glibertarian types get s u cked into the mythology. Once you start believing that “government” is the worst thing ever and rich people have all the answers (they’re rich! they must be smart!) then you are ready to pr0stitute yourself for pretty much any d um b a s s cause that makes the rich richer.

      1. 1.1.1

        Adding: Of course, the fact that glibertarian/patent maximalist types rail against the bad ol’ government out of one side of their mouth while clamoring for the expansion of the patent system and special coddling courts to enforce their claims against the public just shows what we already know: these people are hypocrites and their hypocrisy knows no bounds. They will literally do and say anything if it sounds good while they’re saying it. That’s as deep as they go, and we see examples of that here every flippin’ day.

        1. 1.1.1.1

          What you call “hypocrisy” here is nothing more than your stale Accuse Others meme showing your own cognitive dissonance.

      2. 1.1.2

        “Just because some “innovation” is the “kind of thing we want to encourage” does not mean that it should be protected with a patent.”

        Yes, of course. My point is that they don’t even _consider_ the issue. They make a subjective rule (and if you don’t think it’s subjective, you shouldn’t call yourself a lawyer) based on policy, but then policy is ignored when it comes to applying that rule. The question ought to be asked in cases like this: will allowing this patent to be eligible be good or bad for the society that the courts serve.

      3. 1.1.3

        “It’s only patent attorneys and some academics who will … make the argument that anyone who ‘discovers’ anything new about biology should be able to monopolize that thing for 20 years”.

        Well, actually the Framers, and in particular T. Jefferson, were the ones who first thought “discoveries” should be ownable:

        Article I Section 8. Clause 8 – Patent and Copyright Clause of the Constitution. [The Congress shall have power] “To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.”

        Are there not things in nature that we would like discovered and which will only become known if someone performs the kinds of things we associated with technical progress — creative thought, trial and error, experimentation, capital investment, and so on? What policy reason is there to bar ALL discovers of nature to be banned from ownership? Can we not differentiate between those discoveries that we should rightly encourage through patent-reward, and those that we shouldn’t. It is the nature of certain human activity and the net benefits to society that we should be using to guide these outcomes, not some extra-statutory law made up by judges with no way of knowing what is for the best and apparently no clue about what an efficient system of justice even looks like.

        1. 1.1.3.1

          Your facts will be ignored by Malcom, for whom the phrase “The Ends justify the Means” overcomes ANY attempt at reason.

        2. 1.1.3.2

          Discovery as used in the constitution does not mean discovery as you use it here, and even this site has written about it.

          By your logic, since columbus discovered the new world, he could have patented “sailing to the new world” and therefore controlled the entire continent for 20 years under the current statutory scheme.

          1. 1.1.3.2.1

            It certainly does not entirely mean “invention.”

            See 35 USC 100(a): (a) The term “invention” means invention or discovery.

            The second use is not (and cannot be) the same as the first use.

            (this is — another — example of understanding legal terms of art and not jumping to an errant conclusions based solely on the use of a term that has different connotations).

            1. 1.1.3.2.1.1

              See 35 USC 100(a): (a) The term “invention” means invention or discovery.

              (this is — another — example of understanding legal terms of art and not jumping to an errant conclusions based solely on the use of a term that has different connotations).

              Calm down, champ. You can’t define a term in the constitution by Congress writing a statue. They’re not even the right branch for that job, Mr. Separation of Powers.

              It certainly does not entirely mean “invention.”

              The second use is not (and cannot be) the same as the first use.

              Regardless, it is true that the constitution itself uses two terms, and that discovery is not coextensive with invention. Discovery is a more difficult standard than invention, and that has been posted about on this website before.

              1. 1.1.3.2.1.1.1

                Calm down, champ. You can’t define a term in the constitution by Congress writing a statue. They’re not even the right branch for that job, Mr. Separation of Powers.

                You jump in the wrong direction.

                The defining is the defining in the statutes and CLEARLY indicates that — as used in the statutes — the term “invention” is MEANT to include both “invention” AND “discovery.”

                You have attempted to dismiss “discovery” altogether from the patents law (and attempt to do so with NO authority), while I provide you with what the patent laws actually mean – and they mean BOTH “invention” AND “discovery” as used in the Constitution.

                The clear take-away here is that “discovery” MUST mean more than what you are willing to give credit for.

                The fact that discovery is not coextensive with the Second statutory use dictates the opposite take-away that you want to have FOR the First statutory use of the term.

                Your last sentence is without meaning, as there is only ONE standard – and that is the statutory standard (and yes, THAT does come from the Separation of Powers. (your attempted jab is so easily slipped and counter-punched – it’s like you are moving in molasses).

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