by Dennis Crouch
In Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, the Federal Circuit reaffirmed its general ruling that newly invented diagnostic methods will generally be seen as directed toward unpatentable natural laws absent some new machinery for performing the method. Athena’s patented method is a three-step process for identifying MuSK antibodies in body fluid (such as blood): Mixing labelled MuSK with the body fluid; immunoprecipitating any antibody/MuSK complex from the fluid; and monitoring for the label in the left-over precipitate. The test is important because the existence of MuSK helps diagnose a particular form of Myasthenia gravis (MG).
In its decision, the Federal Circuit found that the core discovery here is the relationship between MuSK antibodies in the body and MG. That relationship though is a natural law. The court then looked to the particular steps in the method and found no inventive concept. Even though the claims required specific chemical reactions, the specification also made clear that development of the particular steps would be within reach of one skilled in the art — once they understand that MuSK is important. The Federal Circuit decision was penned by Judge Lourie and joined by Judge Stoll. Judge Newman wrote in dissent. A 7-5 court then denied Athena’s petition for en banc rehearing — writing effectively that its hands were tied by Mayo & Alice. The Athena denial is interesting because it includes eight opinions (seven substantive) that generally lament the current situation.
Athena then filed a petition asking the Supreme Court to take-up the case on the following question:
Whether a new and specific method of diagnosing a medical condition is patent-eligible subject matter,where the method detects a molecule never previously linked to the condition using novel man-made molecules and a series of specific chemical steps never previously performed.
[Petition]. Now, 11 amici briefs have filed in support of review. Each of the briefs have lots to say, but I have included below one thought from each that I see as an important contribution:
- Professors Jeffrey A. Lefstin and Peter S. Menell (Congress intended for patents to cover practical applications of scientific discoveries; We should all reread the original cases on the topic from England – Nielson)
- Chicago Patent Attorneys (Noonan) (the court should focus on preemption)
- Intellectual Property Law Association of Chicago (The test here is unduly biased against methods)
- The Chartered Institute of Patent Attorneys (UK) (Athena conflicts “with international treaties to which the United States is a party, as well as established international practice”)
- Biotechnology Innovation Organization (BIO) (The Federal Circuit has created a heightened inventive concept test for diagnostic methods)
- Freenome Holdings, Inc. and New Cures For Cancers, Inc. (Alice and Mayo are inconsistent with Dawson Chem. Co. v. Rohm & Haas Co., 448 U.S. 176 (1980)).
- New York Intellectual Property Law Association (The Mayo test was not intended as the exclusive test)
- Blaine Laboratories, Inc. (See Henry Schein, Inc. v. Archer & White Sales, Inc., 139 S.Ct. 524 (2019) (judicial exceptions to broad statutes are inappropriate))
- Pharmaceutical Research and Manufacturers of America (PhRMA) (patent eligibility for diagnostic methods is a critical incentive for advancement in the field).
- Intellectual Property Owners Association (Look to the USPTO guidance to see the trouble — especially its diagnostic method examples)
- Honorable Paul R. Michel (ret.) (“Never before has the Federal Circuit been so splintered on a fundamental doctrine of patent law.”)
These are very interesting and important briefs. Yes, they show support, but they also include useful legal analysis.
Mayo’s responsive brief is due on November 22, 2019 with any amici in support of the current-state-of-affairs due shortly thereafter.
Re: “Honorable Paul R. Michel (ret.) (“Never before has the Federal Circuit been so splintered on a fundamental doctrine of patent law.”)”
While there are certainly “splintered” Fed. Cir. Alice 101 decisions, what “splintering” has there been on Mayo 101 decisions on pure diagnostic claims covering a nature discovery not limited to any new method or apparatus or new treatment based on that discovery?
[W]hat “splintering” has there been on Mayo 101 decisions on pure diagnostic claims covering a nature discovery not limited to any new method or apparatus or new treatment based on that discovery?
The Athena denial of en banc review (and also the Sequenom denial of en banc review.
No, Greg. That’s incorrect. Read what Paul wrote.
There has been no splintering on cases following the Mayo fact pattern. On the contrary, those kinds of tanked claims are never even appealed, or they are Rule 36’d, or they are unanimously upheld without ado.
Dishonorable Judge Michel is an industry shill and I look forward to humiliating him in public. He’s an embarrassment to the patent community.
“and I look forward to humiliating him in public.”
ooooohhh – more internet tough guy schtick from Malcolm.
And how are you going to do that Malcolm? By publishing that book that you have been writing?
I’ll just ask him to follow through on the logical consequences of his own statements.
Then he’ll either put his tail between his legs or he’ll double down. Either way, he stinks. That’s the way elitist t0-0ls like him always crumble.
“ I’ll just ask him to follow through on the logical consequences of his own statements.”
Wow, heed your own advice first, son.
“ That’s the way elitist t0-0ls like him always crumble.”
Classic Malcolm Accuse Others mode.
That you seem absolutely incapable of seeing this is just so Trump of you.
Five points to the first year law student who can write a plainly ineligible claim that demonstrates the awesome vapidity of Paul Cole’s “argument” at comment 9.
Shouldn’t take more than two minutes. Good luck!
One of the important points made in the CIPA brief is that the most representative claim invokes THREE out of the FOUR eligible categories of section 101 – novel compositions of matter – manufacture (the 3-component final product) – and process. The majority of the judges in the Federal Circuit simply turn a blind eye to these inconvenient truths and have done so repeatedly in many eligibility decisions for years.
A lawyer who considers only the exceptions in a provision of a statute without considering its substantive provisions arguably suffers from educational deficiencies raising issues of fitness to practice.
The last two sentences of the CIPA summary:
“Under U.S. domestic law, the most representative claims at issue here relate to subject matter falling unequivocally and not merely through the draftsman’s art within three of the four eligible categories of Section 101, namely composition of matter, manufacture and process. The claimed subject matter therefore exhibits unusually strong positive statutory eligibility, which should not be denied by judicial exception as a claim to a natural law without issues arising concerning the balanced construction of Section 101 and the doctrine of separation of powers.”
I understand why the brief uses the emphasis that it does in relation to “not merely the draftman’s art,” but this to me is a weakness, rather than a strength. The larger point here is that Congress explicitly provides that the power and responsibility for defining the invention goes TO that draftsman (and NOT to the Court). There is a certain “kowtowing” TO the Court on a direct point that the Court is at fault at: Gisting the claim to be whatever Ends the Court wants that claim to be. Instead of a firm shot across the now informing the Court where they misstepped, the argument loses its impact and comes across as a petulant plea that “this claim(s)” really is different and NOT a “draftman’s game.”
Whether or not multiple statutory categories are implicated thus loses its effect, because all previous claims that the Court has Gisted also directly implicated the statutory categories!
Paul, shall we revisit Alice and the express implications there? I still have that link to PatentDocs if you need that reminder.
Interestingly (and separately), CIPA also cites to Schein (so no doubt Greg “I use my real name” DeLassus will summarily dismiss this brief as well).
Damm autocorrect…
“Across the now” ==> “across the bow”
As they say in the “Game of Thrones” books, “strength to your arm,” Mr. Cole. This is a worthy argument that your brief is making, but I fear that you may be in the business of casting pearls before swine here.
LOL
That’s a “worthy argument” only in Paul’s fantasy world where the massive failings of this ridiculous statute were never addressed.
Good grief that’s the kind of argument that should be sanctioned. Then again, this is the same Paul Cole who ran around for years screeching about Mayo without understanding the most basic and critical facts of the case … until he was schooled right here in these comments. By me.
You are a legend in your own mind.
(and only there)
How very Trump of you.
Maybe you can also “humiliate him in public” (and maybe NOT try to dish this off to someone else to actually make the argument like you did at your post at 11).
Anybody can write a *claim* that recites multiple “statutory categories” but which is still plainly ineligible.
Good grief, Paul Cole, please retire and give us all a break fyy try on your childish whining. You stink.
“Thinking” is a process and “a new recipe book” is a new article of manufacture and a composition.
Somehow Paul Cole is super impressed by this and believes that it’s sooooo unfair that methods of writing new recipe books aren’t eligible for patenting. He’s a very serious person! Except that he also didn’t know what Mayo was even about until I educated him on the facts quite recently.
Boo hoo.
Your strawman canard is noted.
As is typical when you do so, let me remind you of the invitation to partake in an inte11ectually honest discussion of the exceptions to the judicial doctrine of printed matter (and the direct and straight forward English language presentation of the Simple Set explication).
“Derp derp simple set DERP.”
Paul Cole called. He needs his patent crack pipe back.
Yay, Malcolm’s Derp Dance.
I think that the fundamental problem with many of the CAFC rulings is the majority court’s judges lacking scientific and engineering training to appreciate the inventive step by Athena in this case. Congress needs to modify the patent law to require all of the judges on the CAFC to have the requisite scientific and engineering background to even rule on these type of decisions. Judge Newman, bless her soul, has been the voice of reason on the CAFC for years due to her expertise in both technology as a former science major and law as a former patent attorney who actually prosecuted patent applications. We need 8 more Judge Newmans.
What was the “inventive step” in this claim, asks the attorney with a Ph.D in biochemistry.
Labeling a protein?
Where is “inventive step” in the words of Congress?
Step aside, son. Nobody’s talking to you.
That’s not an answer — try again.
I discover a new dart frog in the rain forest. I use an off-the-shelf microscope to look at it, which is the easiest way to determine if it’s a different frog from the previously known frogs.
Have I invented anything?
Of course not.
Let’s say that the presence of this frog in the wild indicates a 2% higher likelihood of edible chickens within a five mile radius of the frog.
Have I invented anything?
No.
The end. Anybody who discusses this case or any case like it without addressing this basic issue is a hack or a shill or simply doesn’t “get it” at all. It’s that simple. And yes so-called professors who fail in this regard should be ashamed of themselves.
Hmm, You seem to be reading OUT of the statute the word “discover.”
In addition to 35 USC 100(a), may I suggest that you give the recent briefs by Sherry Knowles a decent read.
Nobody believes that just because I “discover” something that I am automatically entitled to own that thing.
Grow up.
That does not answer the point.
Try again (it’s easy – both the words of Congress and the writings of Miss Knowles are easily accessible).
It does respond to the “point”, Bildo. You and Sherry can w@ nk each other off all day but the fact remains that you can’t own natural phenomena that you “discover.” You can’t own them outright, and you can prevent people from using the prior art to detect them.
Got it? Tell Sherry I’m here everyday to point out her b.s. to the world, over and over. She’s a hack. The only people who don’t know that are also hacks.
[shrugs]
“…can’t prevent…”
bland (and only) ad hominem STILL does not answer the point.
Do you have anything beyond insults?
Anything?
Sherry Knowles is a peanert-brained patent huffer and is so full of sh-t she could fertilize every farm in America.
Anything?
In its decision, the Federal Circuit found that the core discovery here is the relationship between MuSK antibodies in the body and MG.
Relationships are abstractions. Abstractions are items of information.
Night @ 1 demands that information processing is s physical process. Fair enough: you cannot process information without some chemical, mechanical, or nuclear change. However, what does it actually mean that the process is physical?
What matters is the character of the utility. Information used by people should not be point of novelty of a patent eligible invention. On the other hand, no human mind, no abstraction. The reason that abstractions and patents can’t mix is because that abstractions are literally in the mind’s eye of the beholder- beyond state control and never the same from person to person.
The unprecedented split, persisting for years, on this topic demonstrates that its a philosophical and political problem more than a logical or efficiency problem. A compromise is needed that reflects the concerns of all parties. Mine does.
Okay, Martin, put down the crack pipe.
Layering meaning on top of an observation is not a “physical process”. Metaphysical maybe?
Asserting otherwise in the legal context is opening up a silly can of worms for the worst possible reasons (e.g., making the rich richer, at the expense of everyone else).
In fact, Martin, it’s just legal problem. A better statute would address all of these “problems” expressly. The “problems” arise primarily from the patent maximalists refusal to accept any meaningful restrictions on what can be patented. The statute was written by a narcissist patent huffer. The proposed revisions floating around now were written by narcissist patent huffers.
To repeat: the solution is simplify to codify the exceptions. That means protecting correlations is ineligible. That means that software is ineligible. If there is some super important exception that can be justified, then the statute should lay out that exception as plainly as possible. But the maximalists can’t stand that kind of direct approach because playing games and claiming abstractions is their modus d0perondi.
“The statute was written by a narcissist patent huffer.”
Thank you Malcolm — your feelings expose that fact that you believe that the law — as written — is not how you feel that the law should be.
This is an admission against your interests.
Take a moment to realize what this means as to your “arguments” and the (lack of) intersection with inte11ectual honesty.
As everyone knows, section 101 “as written” is so laughably unconstitutional that literally nobody suggesting that it be interpreted “as written” has ever been taken seriously except in Big J-e-ans glibertarian fever swamp.
“Dishonorable Judge Michel is an industry shill and I look forward to humiliating him in public.”
Ooooh, the world awaits.
Literally nobody with more than half a b-r-a-I-n believes that 101 is Constitutional or not ridiculous “as written.”
LOL – you want to make a Constitutional argument against 101 — as written — by all means let’s see you make an actual cogent Constitutional argument (your feelings and had waving about the First Amendment don’t cut it).
And then let me know which Branch of the government (the sole branch) is authorized to WRITE (as opposed to interpret) the statutory law that is patent law.
I have both facts and law to pound. You? You have that table of your feelings.
How nice for you.
MM, I doubt you ever went to law school or ever read Art I, Section 8, of the Constitution. FYI, the Supreme Court said the Patent Law complied with the constitutional in Graham v. Deere, and no justice in the last 66 years has declared 101 unconstitutional.
But, please, explain your position in detail.
MM, I doubt you ever went to law school…
I frequently wonder about this myself. What is the actual, discernible evidence that either MM or anon actually went to law school? It is hard to think of any.
The most convincing evidence in favor of the idea that either went to law school is that each devotes a substantial amount of time to posting around here, and it is hard to think of a reason why anyone other than a lawyer would care enough to devote so much time to the work. The actual content of those posts, however, never bespeaks an actual legal understanding more sophisticated than that which one might acquire from watching School House Rocks and Law & Order.
Lol – says the guy who snipes from the sidelines because he gets upset when he is shown to be wrong.
Ah, Greg, what a card.
“ That means that software is ineligible.”
Once again Malcolm misses the fact that software is nothing but a design choice and is fully patent-equivalent to the other “wares” in the computing arts.
All he is doing here is pounding his feelings.
Marty,
A relationship is there whether humans observe it or not, thus — per your own dictates, this cannot be an abstraction.
Where is “there”?
A relationship is there whether humans observe it or not, thus — per your own dictates, this cannot be an abstraction
Precisely. When humans observe it, it’s an abstraction. When non-human actors observe it, the information is a machine component.
Once that distinction is made, all of the other requirements of patentability are reasonably manageable.
MM the physicality of data processing is a red-herring, but there is only the metaphysical when human beings use information to further whatever their human goals may be.
You very badly miss the point here Marty.
An item (in and of itself) does NOT jump in and out of being an abstraction based on whether or not a human is present to make an observation.
Your logic – as usual – is severely flawed (as you are trapped in your own pet imaginings).
This is a Mayo case about discovering existing naturally occurring chemicals or relationships, not an Alice case about claiming “abstractions.” And as Dennis notes below, the usual meaning of “abstract” claims since at least Wyeth v. Stone, 30 F. Cas. 723 (C.C.D. Mass. 1840) (Justice Story) is about preemptive claiming, not just any meaning of that word.
Nice try, Blaine Labs, but that argument is going to carry you just as far as the wreck of the Titanic might.
The Titanic did go one direction fairly rapidly …
Maybe Greg can do more than express his feelings about the arguments provided in the Blaine brief.
Perhaps respond as to why Greg has his feelings, or provide any specific counter points to the items that Blaine provides.
My bet is that the Court won’t answer any of those particulars either.
And THAT is very much part of the problem.
Laws of nature, abstract ideas, and natural phenomena per se are neither a new machine, a new manufacture, a new composition of matter, or a new process. So calling those things exceptions is misleading. The exceptions are in fact the new machines, manufactures, compositions of matter, or processes that are « directed » to laws of nature, abstract ideas, and natural phenomena.
My reading of Bilski, in particular the rejection of the MOT test, is that the Supreme Court does not want interpret 101 as being a formal requirement on the claims, but a substantial requirement. It is simply not enough to disguise ineligible subject matter to pass 101. So, the « directed to » is here to emphasis that 101 is to be applied to the form, as well as to the substance of the claims. I have not seen yet a credible argument that Congress intended 101 to only apply to the form of the claims.
So the Blaine Labs brief seems to miss the issue at stake, which to me is that relying on the substance of a claim to decide eligibility of a claim, while laudable, is too subjective to be effective in practice.
“It is simply not enough to disguise ineligible subject matter to pass 101.”
What does that even mean?
The claim is — or is not — to a statutory category.
Period.
The whole NONSENSE of “disguise” or “accusation of scrivining” and the “application” of GISTING is nothing more than Judicial Over-reach.
Congress provided directly that it is NOT the Court that decides “what the invention is directed to, but instead this power and responsibility is to the applicant.
The notion of “mere form” as somehow “not being enough” has ZERO basis in the statute as written.
Your wanting some credible argument that Congress intended 101 to not only apply to the form of the claims is a WANT that has ZERO basis in the statute as written. The “form of the claim” IS the form (VERY broadly) that the innovation is to be communicated into. MORE THAN THAT — more than “the form of statutory category” can ONLY fall into one other portion of the statutory text — and the Court has never attempted to pin its scrivening to that other portion.
You seem to want substantiation in order to “prove a negative” or to support a condition not present (and ONLY being discussed because the Supreme Court is attempting to legislate from the bench).
What you want simply NEED NOT be provided. Instead, what is to be provided is simply a clear understanding of the law as written by Congress (and hence, not only the Blaine Labs, but the CIPA brief highlighting the Schein case).
The “intention of Congress” in 35 USC 101 is undeniably clear — and is NOT what the Supreme Court has re-written in their own scrivening. There are but two aspects of 35 USC 101 (ALL else is covered elsewhere):
1) the innovation can be — in form — claimed in at least one of the statutory categories (and make note that innovations OFTEN can be — and are — claimed in more than one statutory category); and
2) the utility of the innovation, as claimed, falls within the Useful Arts.
To this last point then, the Blaine labs brief very much does NOT miss the issue at stake.
The score board is broken — THAT is very much the issue at stake.
“So calling those things exceptions is misleading.”
That’s not my scrivening.
Put aside the brief by the silly academic hacks who refuse to discuss the issues and all you’ve got is industry lobby groups lobbying like their lives depend on it (hint: they’re already wealthy) and one ex-judge whose fine nothing except shill for maximalist since he retired (get a life).
Drawing the line at the recitation of a non-obvious transformation of matter or a non-obvious objective physical structure is very reasonable (to say the least). To suggest that pharma companies or “innovators” can’t or won’t innovate if faced with that burden is a serious indictment of our priorities and our patent system.
Remember that the issue here boils down very quickly to the severe problem created for researchers when patentees are given ownership of the use of prior art tools (e.g., “labels”) to detect natural phenomena. Unless that problem is acknowledged and addressed head-on, what you are you looking at by these amici is nothing more than shilling for the private medical industry players who want to rake in billions at the huge expense of everyone else.
With slight amendment for sake of emphasis:
“ Drawing the line [for eligibility] at the recitation of a non-obvious transformation of matter** or
a non-obvious objective physical structure***
is very reasonable (to say the least).
In this case, saying the least is simply not saying enough (if you want to be inte11ectually honest).
First thing to note is your confusing and conflating eligibility and other sections of law.
But you already know that.
Second thing to note is your archaic reliance on transformation of matter. The “matter” angle is NOT a necessary part of the (9-0 debunked) Machine or Transformation clue.
But you already know that too.
The third thing to note is that you attempt — yet again — to make an optional claim format to be something other than optional (and at a foundation level of eligibility to boot).
That is NOT how the law is currently written.
None of these counter points are new. That you continue to advocate without regard to them only highlights that you don’t care for anything but your own feelings.
(not that such would in any way surprise anyone)
The so-called “judicial exceptions” are baked into “the law”, Bildo.
Everything I wrote is consistent with enforcing those exceptions. Everything you write is consistent with lining the pockets of greedy @ -h—o-les at the expense of everyone else.
[shrugs]
LOL – baked in….
By that “patent huffer” you were in such a hurry to denigrate?
Suuuureee…..
Are you suggesting a return to the machine-or-transformation test?
Codification of the MoT as the test for subject matter eligibility would be an improvement over the status quo.
While I was only seeking a clarification of MM’s position, I agree that codification of the MoT would be a significant improvement in terms of predictability.
Alas, as we all know, the Supreme Court in Bilski expressly rejected MoT as not only “the” test, but as a legally binding “test” (making it merely a clue.
And they did so 9-0.
Since the issue in this thread is codification–not Supreme Court rulings, your input is less helpful than usual.