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.”
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.
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.
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.
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v v v v v
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.
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….
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).
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.”
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.
Your last two posts have been of the nature of the man behind the curtain (Oz).
link to youtube.com
In a very real way, it is YOU that is “wandering off”
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.
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.’
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.
Thanks for identifying “anon”s favorite strawman, SDR. It’s a favorite rhetorical game of his.
People are learning.
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.
“Widespread adoption”?
LOL
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
)
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
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.
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.
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.
Could you try to be civil MM?
How convenient. The law doesn’t contradict itself as long as you ignore half the decisions! We have a legal scholar here folks!
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.
…or reminiscent of someone else who engages in that type of “alt-facts,” eh?
Trump that.
Any jurisprudence that is this complicated is obviously wrong. Just put aside the 101 wars for a moment. No jurisprudence should be this complicated.
“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.
“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.
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.
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.
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.
But… but… these are patents to new *applications* of laws of nature. Oh my, now I’m confused.
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?
Hey Martin – How does your test work here? Do you agree with the results?
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.
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.
Multiplexed Display Device? Where is that in the claim please?
Les that’s the device that combines the analog signals from the towed sensors.
Martin – That device is NOT RECITED in the claim.
Les,
Generally speaking, method claims are not required to expressly claim devices.
(One of the subtleties that MANY — including courts — seem unable to grasp)
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.
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.
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.
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.
>>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)?
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.
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.
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.
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.
Thanks for taking the time to explain your analysis.
“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.
Show me something – anything – that (genuinely) violates the Law of Nature….
What? Who said anything violated a law of nature?
You have missed the point there, Les.
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
>>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.
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.
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.)
…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.
Damm autocorrect- “our” —> “put”
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.
Don’t worry guys. I’m sure Iancu will bring consistency to this field soon enough.
He won’t, because he can’t.
See my very first post regarding the new protocols.
Ha!
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.
By this absurd reasoning, one could not get a patent for passive sonar, active sonar, sonograms or radar.
…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)…
Autocorrect hits again:
“our” => “put”
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….
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.