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Killing Industry: The Supreme Court Blows Mayo v. Prometheus


Written by Gene Quinn
President & Founder of IPWatchdog, Inc.
Patent Attorney, Reg. No. 44,294
Zies, Widerman & Malek
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Posted: March 20, 2012 @ 1:44 pm
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The sky is falling!  Those who feel the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. is terrible are right, although many won’t likely fully apprehend the gravity of the situation at first.  Those in the biotech, medical diagnostics and pharmaceutical industries have just been taken out behind the woodshed and summarily executed by the Supreme Court this morning.  An enormous number of patents will now have no enforceable claims.  Hundreds of billions of dollars in corporate value has been erased.  But that might be a good thing.  Immediate attention now must turn to Congress.  Thank goodness that the technical amendments to the America Invents Act are outstanding.  This will provide a perfect opportunity for Congress to save an industry that employs many millions of people, while at the same time undoing a pathetic, narrow-minded decision of the Supreme Court.

What is all the fuss about?  Earlier today the United States Supreme Court issued its decision in Mayo v. Prometheus, holding that the process claims at issue in the case are not patent eligible subject matter. To make matters worse,  Justice Breyer, writing for a unanimous Court, continually acknowledged that the claims at issue did not specifically cover a law of nature because there were “administering” and “determining” steps.  Yet, he and the other Justices determined that those “administering” and “determining” steps were well known and conventional, thus meaning that the claims lacked patent eligible subject matter.  Come again?  Did all nine of the Supreme Court Justices just conflate patent eligibility with novelty and non-obviousness?  Yes they did!  But it gets worse — they explicitly admitted doing so!  The Supreme Court also further specifically ignored the Government’s objective, reasonable and until today correct assertion that any step beyond a statement of a law of nature transforms the claim into one that displays patent eligible subject matter, with issues of whether those steps are known to be properly resolved by 102 and 103.

Where to begin?  Let’s start with the holding as explained by Justice Breyer:

We find that the process claims at issue here do not satisfy [the conditions for patent eligibility]. In particular, the steps in the claimed processes (apart from the natural laws them­selves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field. At the same time, upholding the patents would risk dis­ proportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries.

If a student were to write such nonsense in a patent law paper or on a patent law final exam they would receive little, if any, credit.  It is shocking that all 9 Justices of the Supreme Court know so little about patent law, yet the collective fate of the industry rests on those with only a cursory understanding of patent law — and that is at best!  Justice Breyer and all of the others conflate novelty and non-obviousness with patent eligibility when they base a patentable subject matter determination on the fact that the claimed processes are “well-understood, routine, convention activity previously engaged in by researchers in the field.”  Under a PROPER understanding of patent law that does not in any way, shape or form have any bearing on patent eligibility.  This rationale directly implicates the question of whether the invention is novel and non-obvious, which are two other wholly distinct patentability inquiries.

In Mayo v. Prometheus the Supreme Court took claim 1 of U.S. Patent No. 6,355,623 to be the primary claim for purposes of analysis.  Claim 1 of the ’623 patent covers:

A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointesti­nal disorder; and

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointesti­nal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently admin­istered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently ad­ ministered to said subject.

Justice Breyer explained that this claim sets forth a law of nature “namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will provide ineffective or cause harm.”  This lead Breyer to define the question facing the Court: “The question before us is whether the claims do significantly more than simply describe these natural relations. To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws?”

Justice Breyer acknowledged that the claims each recite an “administering” step, a “determining” step, and a “wherein” step.  Breyer admitted: “These additional steps are not themselves natural laws…”  He still went on to say that they do not transform the nature of the claim, which is puzzling.  Breyer and the other Justices admit that the claims do not cover a law of nature but then find the claims to be patent ineligible on a subject matter basis because they do cover a law of nature.  This is repeated over and over again.  Talk about intellectual dishonesty!

Breyer went on to say:

To put the matter more suc­cinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well­ understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.

Plain and simple, the Supreme Court missed the boat here in Mayo v. Prometheus.

In fact, it isn’t until page 21 of the decision that Breyer quotes the famous 1952 legislative history, which says that anything made by man under the sun is patentable.  In a parenthetical quote citing the legislative this is said:

A person may have ‘invented’ a machine or a manufacture, which may include anything under the sun that is made by man, but it is not necessarily patentable under section 101 unless the conditions of the title are fulfilled.”

(emphasis provide by Justice Breyer).

For crying out loud Justice Breyer makes the argument perfectly for the contrary decision.  The quote he inserts in parenthesis, likely so he didn’t have to discuss it or deal with the fact that it supports the contrary outcome, explains it all.  You are not entitled to a patent unless all of the patentability requirements are satisfied.  Patent eligible subject matter is but one of those requirements!  The legislative history, which has routinely been slavishly applied by the Supreme Court, mandates that if there is human interaction then there is patent eligible subject matter.  Whether a patent can or should issue on claims then becomes a matter of whether the claim covers a useful invention, the claim covers something that is novel and non-obvious and whether the invention has been adequately described to satisfy U.S. patent law requirements, specifically those in 35 U.S.C. 112.

But wait, there is more!  With respect to mixing the 101 patent eligibility inquiry with the 102 novelty inquiry, Breyer admits that is exactly what he is doing!  He wrote:

We recognize that, in evaluating the significance of additional steps, the §101 patent-eligibility inquiry and, say, the §102 novelty inquiry might sometimes overlap.

So not only does the Supreme Court get an “F” on patent law today, but they get an “F”, or at least a “D-” on statutory interpretation.  Interpreting different parts of the statute to cover the same thing when for the last 200+ years that has been absolutely prohibited is extraordinarily arrogant.  Imagine the gall!  Breyer went on to say:

These considerations lead us to decline the Govern­ment’s invitation to substitute §§102, 103, and 112 inquir­ies for the better established inquiry under §101.

The arrogance.  The ignorance to say “invitation to substitute §§102, 103, and 112 inquir­ies…”  The Supreme Court is well aware that the other sections of the Patent Act are intended to address the sole issue they raise — that what is covered in the claim is well known.  Nevertheless, they would rather resort to section 101 and PRETEND that section 101 is the proper place for the entirety of the patent inquiry to reside.  In other words, and more succinctly — the Supreme Court decision in Mayo v. Prometheus has nullified §§102, 103, and 112.  They are of no concern any more whatsoever in determining whether a claim is patentable.  The entire inquiry collapses down to section 101, in a “know it when you see it” kind of way I guess.

Clearly the claims at issue in this case are patent eligible subject matter.  The Supreme Court is wrong, and the fact that they have either through ignorance or intent conflated patent eligibility with novelty and non-obviousness will be a plague on the entire patent system for years to come.  In courts where this decision is applied it there will not be patent eligible subject matter where the claim covers something well known.  I wonder whether claims will be determined to be valid or allowable as a matter of law when section 101 is satisfied?  Something tells me that this will be only a one-way street.  If you don’t have something the court believes is new then no patent for you.  If you have something that clearly satisfies 101 patent eligibility we will then go through and inquire about §§102, 103, and 112.  Said another way, and more succinctly, patentees and patent applicants get screwed!

How long will it take the Federal Circuit to overrule this inexplicable nonsense?  The novice reader may find that question to be ignorant, since the Supreme Court is the highest court of the United States.  Those well acquainted with the industry know that the Supreme Court is not the final word on patentability, and while the claims at issue in this particular case are unfortunately lost, the Federal Circuit will work to moderate (and eventually overturn) this embarrassing display by the Supreme Court.  This will eventually be accomplished the same as it was after the Supreme Court definitively ruled software is not patentable in Gottschalk v. Benson, and the same as the ruling in KSR v. Teleflex will be overruled.  I have taken issue with Chief Judge Rader’s statements that nothing has changed in Federal Circuit jurisprudence as a result of KSR, which is not technically true.  What is true, however, is that the Federal Circuit continues to refine the KSR “common sense test,” narrowing the applicability in case after case and tightening the ability for “common sense” to be used against an application.  We are almost 5 years post KSR and there is still a lot of work left to be done by the Federal Circuit to finally overrule the Supreme Court’s KSR decision.  It took almost 10 years to overrule Gottschalk v. Benson, so we are likely in for a decade of work to moderate the nonsense thrust upon the industry this morning.

Indeed, Breyer’s decision is the most intellectually dishonest decision I have ever read, which is saying a lot given the utter contemptuous understanding of patent law displayed by the Supreme Court over the years.  It is truly troubling that all 9 of the Justices concurred in what history will regard as one of the worst decisions in the patent space EVER!

Yes, Congress will be asked to step in and rectify this absurd ruling, and they should.  Knowing how the legislative branch operates I cringe at the thought of  Congress coming to the rescue.  The only thing that gives me solace is that the industries summarily executed this morning have an A+ lobbying game, which in Washington, DC means everything.

To arms… to arms… the Supreme Court has come! Rally all the lawyers, collect all the lobbyists and march on Congress!

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Posted in: Biotechnology, Federal Circuit, Gene Quinn, IP News, IPWatchdog.com Articles, Medical Devices & Methods, Patentability, Patents, US Supreme Court

About the Author

is a Patent Attorney and the founder of the popular blog IPWatchdog.com, which has for three of the last four years (i.e., 2010, 2012 and 2103) been recognized as the top intellectual property blog by the American Bar Association. He is also a principal lecturer in the PLI Patent Bar Review Course. As an electrical engineer with a computer engineering focus his specialty is electronic and computer devices, Internet applications, software and business methods.

 

144 comments
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  1. At first I was surprised that this was a unanimous decision, but then I remembered these were all probably poli sci and English majors. This was outcome-driven jurisprudence, made worse by assertions that “what is well-understood, routine, conventional activity, previously engaged in by those in the field” is part of a §101 analysis.

  2. [...] IPWatchdog: Killing Industry: The Supreme Court Blows Mayo v. Prometheus [...]

  3. This SCOTUS decision is a disaster for all of patent law and future innovation within the USA. After all, all inventions rely on the thing SCOTUS refers to as “Laws of Nature” and anyone can call the next person’s details of application as “insignificant” or “insufficient”.

    More specifically, all electrical circuits are merely the routine process of coupling one electrical component to the next and the mere application of Maxwell’s equations.

    All chemical processes are merely the routine process of interacting one chemical component with the next and the mere application of Schrodinger’s equations.

    All mechanical processes are merely the routine process of interacting one mechanical component with the next and the mere application of physics equations.

    Say hello to the new “Synergy” requirement, same as the outlawed old “Synergy” requirement (section 103 shall not be negatived by the manner)

  4. Brian-

    I couldn’t agree with you more. Absolutely outcome driven, together with a healthy lack of understanding of, or perhaps complete contempt for, patent law

    -Gene

  5. I think you are missing the entire point of the decision, which is why we’re lucky you’re not a Justice.

    The decision says that when you’re trying to patent an “application” of a natural law or process and said “application” does not go much beyond “apply it,” claiming that the subject matter of the patent is the application and not the underlying law is a sham, a lawyer’s trick. You’re really just trying to patent the underlying physical law. This is an entirely different test than novelty or obviousness.

  6. john-

    No, I did not miss the entire point of the decision. We would be lucky to have me as a Justice given that I understand the law better then any of these so-called elite minds.

    I’ll try and be kind to you because it is apparent that you know nothing about patent law, and you are a lawyer-hater.

    The test is not at all different than novelty or nonobviousness, as is admitted by Justice Breyer in the opinion. You really should read the decision. He admits that he conflates 101 and 102 openly. I suppose you missed that, which on a re-read now that you have been told to look for it you should notice.

    You admit, like Justice Breyer, that the claims do not cover a law of nature. The claims relate to an application of a law of nature. Your admission, and that same admission by the Justices, ends the 101 patent eligibility inquiry in every case ever decided until this one. That is what the 1952 legislative history says, and every Supreme Court decision since 1952 has recognized that. So this decision presumably erases 60 years of patent jurisprudence. If you are going to try and pretend otherwise you should go elsewhere to places where such snake-oil is allowed without being called out.

    -Gene

  7. john-

    A question for you… what is your position on the patenting of satellite technologies? Would those things be unpatentable since a satellite remaining in orbit is an application of the law of gravity?

    Your position is nearly as absurd as Justice Breyer’s. Breyer’s is more absurd only because he is supposed to know better.

    -Gene

  8. The issue really comes down to “insignificant post-solution activity” which, according to the Supreme Court, trumps the “transformative” steps of “administering” and “determining”. Assuming that the therapeutic range for the metabolite is a law of nature, how far beyond that fact do you have to go to find patentable subject matter? Is “determining” by itself enough, or do you have to have both “administering” and “determining” to make this law of nature patentable? The overlap with 102 and 103 comes into play when evaluating what is and is not “insignificant.”

  9. I’ll tell you what’s deserving of scrutiny: your inappropriate comments of dismay regarding the SCOTUS decision.

    Just who do you think you are, in comparison to SCOTUS? Certainly someone who is disrespectful of those who are your betters, that is for sure.

  10. Gene -

    You may hope, albeit with well-founded trepidation, that Congress will address this most unfortunate opinion in technical amendments to the AIA. But even before that, there’s a chance that Chief Judge Rader will do an In re Bergy-style critique of Justice Breyer’s approach when the Myriad case gets sent back down for reconsideration (as it most likely will). May the spirit of Giles Rich inspire Chief Judge Rader to administer an appropriately vigorous smack-down!

    In future, we can also hope that Chief Judge Rader ascends to the Supreme Court, so there will be at least one Justice there who understands patent law.

  11. Must….

    Have…..

    Gobbledygook.

    Gobbledygook Grape, that is.

    I am happy to announce record sales of Kool-aid. But don’t be mad at me, I jsut supply the stuff, and if I didn’t then someone else would.

    (I don’t think a technnical amendment of the type you wish for would survive Supreme Court review). Techinically, the technical amendments must relate to the body of law already passed.

    I wonder when Pharma will realize the extent of the anti-patent fever?

  12. It is appaling that anyone would think the Supreme Court got this wrong. Are you so blinded by greed that you can see nothing except profit for your clients? I guess so, and this is a perfect reason why corporations cannot be trusted with patents, because greedy unscrupulous lawyers will twist the law to extract rents from society at the expense even of human life. The current patent system serves no useful purpose beyond the greed of lawyers and it certainly does not fulfill the purposes set forth in the Constitution. You should all be ashamed of yourselves for placing greed ahead of human life and ahead of the Constitution.

  13. Renee,

    I shouldn’t even dignify your comment with a reply but I must given that you’ve accused me (and others) of “placing greed ahead of human life and the Constitution.” I’m frankly more appalled (and offended) by your ad hominem attack that all we care about is “greed.” The patent system isn’t about “greed” but about promoting Progress of the Useful Arts (and that’s in the Constitution). Without a viable patent system, innovation doesn’t occur because no one will fund it. (Ask any VC whether they will fund a technology that has no prospects for patent coverage.) And whether you agree or not, those 9 technology-challenged Justices (also too arrogant as well as ignorant) have just created a new jurisprudential “disaster” in our area of the law that will likely cost us more American jobs. Your entitled your opinion, but I would suggest you take your “bleeding heart” liberalism elsewhere.

  14. Matt-

    Who do I think I am? I am someone who understands the patent laws, which distinguishes me significantly from those 9 Justices who just believe through their own arrogance that they know everything about everything.

    Really! Listen to yourself. Does anyone known everything about everything? You can be a mindless lemming if you want, but I prefer to be intellectually honest and call the balls and strikes as I see them. No person or group deserve unquestioned divine status like you want to place on SCOTUS. Wake up!

    -Gene

  15. Non Sequitur-

    If what is “insignificant” comes into play with respect to 101 then there is no need for 103. 103 is supposed to deal with whether the combination is trivial in light of the prior art.

    -Gene

  16. Watch out for code words like “overlap.”

    Conflation of law is committed when the law on its face does not suffice for the desired outcome. Make no mistake, this is judicial activism at its prime.

  17. The current patent system serves no useful purpose beyond the greed of lawyers

    So let’s understand your position a little more clearly.

    Say that tomorrow you invent a fabulous new computer invention that makes spreadsheets, email and internet look like yesterday’s stale sliced bread.

    You go to MicroSomething-or-other Corporation (MS for short) and gleefully tell them all about it, thinking they will buy it up from you and pay you handsomely for a job done beyond well and exceptional.

    Except they don’t. They say, “Thank you very much and please now go home.”

    The next week they come out with their super-innovative invented-by-us product that looks, feels and smells just like yours.

    You never bothered to get one of those evil patents.
    So now what do you do?
    Pound sand?
    Huff, puff and blow your nose clean?

  18. 35 U.S.C. 103 Conditions for patentability; non-obvious subject matter.

    (a) A patent may … Patentability shall not be negatived by the manner in which the invention was made.

    … unless, that is, it involves an application of a law of nature that 9 judges unanimously agree is an “insignificant” one that equates with “apply it”.

  19. The reasoning behind this decision is so new, confusing, inconsistent with existing patent law, and so utterly without guidance that it will be impossible to implement in patent examination or litigation practice. For that reason alone, we should hope that it will be quietly ignored because nobody will be able to figure out what to do with it.
    As to the comments above, about profit and greed and patient benefit: No patient will be better off because of this decision, no scientist will be any more free to do research, and no doctor will be able to treat their patients any better. Mayo’s for-profit clinical laboratory services business will be better off, that’s about it. So much for “greed:” Somebody else, in this case Mayo, wanted to make a little money too, but they were too lazy to put in the effort in court to show that Prometheus’s patent was, perhaps, anticipated, or obvious. That would have required actual work. So instead, Mayo concocted a demented theory of “laws of nature,” thought infringement, First Amendment rights, freedom of medical practice – and the perennial favorite: “I could offer a better product but the patentee won’t let me.” Anything to distract from its own profit motive – no matter how many other patents and businesses, even Mayo’s own patents, they would tear down in the process. And the Supreme Court bought it lock, stock, and barrel. I really thought they were less naive than that.

  20. this is politics

  21. Lawyers play a game of hide the pea with patents hiding them under three cups. The three cups are non-obviousness, non-novelty, and unpatentable subject matter. Patent lawyers assert that the rules of the game allow the court to look under only one cup at a time and only if the entire patent can be found hiding under one cup can it be disqualified. Those rules are arbitrary and suit nobody except patent lawyers. If all three cups could be lifted at the same time a great many many shoddy and dangerous patents would be revealed and dispensed with quite easily.

    The supreme court sets the rules. If they did look under two cups at once in this case then good on them. Perhaps the rest of us might then also be allowed to look under two cups at once, or even three cups! We could get rid of a great many rubbish patents that way. Rubbish patents harm society and benefit nobody except patent lawyers.

  22. What is a “law of nature”? Are thiopurine drugs “natural” thereby rendering the way in which they are metabolized a “law of nature”; and if they are synthetic is the way in which they are metabolized not a “law of nature”. Judge Rader’s observation about a healthy dose of innovative claim drafting in the face of new patent eligibility exclusions (in Terasense) is about to happen yet again – with all the unintended consequences that he described.

  23. Gene,

    While I agree that the Supreme Court’s reasoning is atrocious both in terms misunderstanding how claims are supposed to be interpreted and in terms of properly applying patent law, I still do no think that claim 1 of the ’623 patent should be patent eligible subject matter.

    The Supreme Court’s interpretation that the two wherein clauses are method steps is contrary to decades of legal precedents. The wherein clauses qualify what is done in step (b), i.e., the determining step.

    I also agree that contrary to the Supreme Court’s reasoning, Section 102 has nothing to do with Section 101.

    However, i still don’t think that a method claim that ends a mere determining step should be patent eligible. I don’t think the mere combination of steps (a) and (b), a qualified by the two wherein clauses, makes the Claim 1 of the ’623 patent “useful” as that term has been usually interpreted in other fields; the method of Claim 1 ends with a step, step (a) that could be performed totally in a human mind. Had the method claim included either of the following steps (c), I would feel that the claim should have been patent eligible under Section 101:

    1. (c) indicating to a user to increase or decrease the amount of said drug subsequently admin­istered to said subject based on the determination in step (b).

    2. (c) increasing or decreasing the amount of said drug subsequently admin­istered to said subject based on the determination in step (b).

    I was amazed in reviewing the claims for the ’623 patent that a claim including either type of step (c) is not present. I can understand why a claim for the 2nd type of step (c) may not be included in the claims, since you could only sue the doctor who administers the drug, but why would you not include the 1st type of step (c)?

  24. Ian,

    Your post is thinly veiled anarchy.

    Courts can and do look under more than one shell. It is when you are dishonest and call the two shells one shell that you need to watch out.

    Conflation is never good. Never.

    It allows that which you are screaming against – game playing.

    Except, you are screaming at the establishment and at people when you you truly do not know what is going around about you.

    I feel sad for you. Get well.

  25. @step back (March 20th, 2012 8:33 pm)

    Under the current system, you would go to “MicroSomething-or-other Corporation (MS for short)” at which point they would say one of
    a) Thank you very much and please now go home (MS is well known for ignoring Patents and settling after the fact anyway)
    b) Thank you very much and now please accept our lawsuit because you infringe on one of our patents… by the way you know that you’re infringing so please tell us which one.

    I’m not sure I see the advantage of the current system.

  26. > what is your position on the patenting of satellite technologies? Would those things be unpatentable since a satellite remaining in orbit is an application of the law of gravity?

    Of course a satellite remaining in orbit should not be patentable. Are you seriously arguing that it should?

    > Ask any VC whether they will fund a technology that has no prospects for patent coverage.

    Of course they do. Ever heard of a thing called Facebook?

    Here’s a VC writing about his opposition to patents: http://www.avc.com/a_vc/2011/06/enough-is-enough.html

    Here’s another VC: http://www.feld.com/wp/archives/2011/08/time-to-really-deal-with-the-broken-software-patent-system.html

    This guy (who you may have heard of) isn’t a VC, but he is a major investor: http://blogmaverick.com/2011/08/06/if-you-want-to-see-more-jobs-created-change-patent-laws/

  27. The reasoning underlying this decision, if one can call it reasoning, is shockingly and abysmally flawed. It’s the judicial equivalent of finding that the earth is flat and the sun revolves around it.

    I agree with you that it’s time for action in Congress. All of the sloppy reasoning about 101 needs to be cleared away, including the machine or transformation test. Anything new and useful (as the statute says) should be patentable. Diagnostic tests clearly have utility; they should be patentable. So should software.

  28. I know you have been following this case and the decision does not come as a surprise to you. Since you were aware that SCOTUS was going off the rails like that, why didn’t you take a little time out of your packed schedule to go down there and set them straight?

    I realize that your time is overcommited to the process of distilling money from the creative interpretation of patent law, but you must admit that we would all be better off in the long term if your clients could have spared for the hour or two it would have taken to submit an amicus brief.

    It is a sad day in our nation’s history when we are forced to turn to the supreme court in the land for our legal guidance and precedent, instead of relying on the obvious superior talent and vast knowledge of a blogger who knows more about patent law than they do.

    -Wang-Lo.

  29. Hi

    IANAL. Can someone tell me what in the claim quoted above is patentable? What does the patent preclude others from doing?

    The claim says: administer a drug; check the level of the drug in the body; if it is less than a critical level of 230 administer more; if it is more than a critical value of 400 administer less.

    Apart from the numbers 230 and 400 this algorithm describes an age-old trial-and-error process. This trial and error method cannot be patentable. Is it the numbers 230 and 400 that are patented? Could I do this process with values 235 and 395 and not violate the claim?

  30. Yea! SCOTUS got one right. Too bad for all you patent lawyers, hoping to promote those pharma/ medi-patents.

    One comment noted that we needed a functional patent system. I agree. Too bad we don’t have anything like a functioning patent system. Patents are out of control, with basically everything under the Sun being patented. The result, the killing of innovation. The exact opposite of the goal of patent law.

    I’m no patent law expert. I am however an expert in Common Sense. Something that has been long lacking in patent law. Perhaps that is about to change. To the detriment of patent lawyers caseload.

    Sorry Gene, but your expertise has blinded you to the obvious. Patent law is a mess, that needs serious fixing. Maybe soon we can throw out software patents too.

  31. Gene, I’m with you on this one, I share your frustration, and I know that you, like most of the readers of IPWatchdog, know more about patent law than any of the SCOTUS justices. But for your own sake (and ours as readers), please, please, tone down the hyperbole. Inter alia, you’ll have a lot more credibility if you do.

    I’m not sure that Congress will do anything about this, and I certainly never count on Congress to do the right thing (although I agree that the amount of wealth that stands to be lost here will spur lobbying), I think you’re right about the judges of the CAFC working to cabin in this decision. At least some of them, anyway, and fortunately Chief Judge Rader is one of the good guys in that regard.

  32. Is it just a coincidence that the era of strong patent protection for American industry and record incomes for the lawyers who service those interests neatly coincides with the decline of the United States as an industrial and economic power? I used to think it was but reading the sort of self-interested comments one finds here (and similar elsewhere) I am not so sure. It is an empirical fact that when our patent system was more selective in what it would patent or what patent lawyers and industry would think to patent, we were more innovative (creating the computer industry from scratch, doing the fundamental work that set off world-wide advances in biotechnology etc.), our middle class more secure, our exports stronger and, in relative terms, our patent lawyers and our financial services sector nowhere near as well off.

    Today we grant vast numbers of patents on things that leave most engineers and scientists scratching their heads in amazement. (“You mean you can patent that? Crazy!”) The creative types I know who actually “invent” cool new things hate patents, especially in software and cutting edge science/engineering, I mean really really hate them. To them, patents are simply a tax imposed on the creative by the least creative elements of society – its lawyers. To the very very small extent that this decision takes away some of the things that patent lawyers and MBAs can use to extract rents from the rest of society, it will be welcomed by most productive and creative people.

    Now let’s hope the Fed Circuit reads this case correctly and drives a spike through the heart of all gene patents.

  33. A unanimous decision by folks that regularly rely on medical testing in their personal lives are bound to be biased, even with their exceptional health insurance. I wonder what they will say about mandatory health insurance?

  34. How does this kill an industry? Is demand for medical diagnostics and biotechnology going to dry up?

  35. Gene,

    I agree with my brother Mark that how Prometheus claimed this drug dosage calibration method was problematical in getting over patent-eligiblity hurdle. After Bilski, I was very concerned that these data-gathering “determining steps” might not make it into the “patent-eligible zone.”

    But I also agree with Mark that Breyer’s opinion is ghastly, based on nonsenscial reasoning, Supreme Court precedent (especially Parker v. Flook) that is logically flawed, and frankly being very unhelpful in how you can turn a patent-ineligible “law of nature” into a patent-eligible application of that “law.” I’m particularly irked by Breyer’s snide remarks about using the “draftsman’s art” to make what is claimed patent-eligible. After all, doesn’t 35 USC 112, second paragraph, say the invention is defined by “one or more claims”? So if you can’t use the “draftsman’s art,” then what, pray tell, Justice Breyer can you use since your opinon also tells us we can’t rely upon steps that are “routine, conventional activity”?

  36. Nick-

    But what about the satellite itself? You dodge the question because you know if you are honest and truthful that the absurdity of your position will be shown.

    Clearly satellites rely on gravity to operate.

    Furthermore, even if the question were “should a satellite remaining in orbit be patentable,” the answer is most certainly yes. The only way to hold your narrow minded belief is to belief that after someone understands gravity that there is no challenge to keeping a satellite in orbit. Please. Go stick your head back in the sand why don’t you. People like you think nothing is unique and are doing nothing other than lying to yourself and showing just how little you really know.

    As for Facebook… spoken like a true neophyte. Pick an exception to the rule to prove that the general rule, which holds 99% of the time, isn’t correct.

    Incidentally, Facebook does have patents.

    -Gene

  37. When is the concept “when something is less, more is needed and when something is more, then less is needed, patentable? Too many blood cells or too less blood cells, then you do this or that thing. Hasn’t that “scientific” concept been around since the stone age? Ugh, you pour too much water in goat skin, try using less Ugh. Yes, I can see the downfall of medical testing every time I get poked for a blood sample and they tell me my sugar is to high I need to eat less candy. Ugh. I am not a patent attorney, so please don’t take this a legal advice, just as common sense.

  38. Nick,

    Gene is quite correct. Facebook has no less than 21 issued patents and 22 pending patent applications.

    Search “an/facebook” at http://patft.uspto.gov/netahtml/PTO/search-adv.htm
    Search “an/facebook” at http://appft1.uspto.gov/netahtml/PTO/search-adv.html

  39. If I understand those that disagree with the decision, y’all disagree with the Flook decision. If so, then this objection is a little late. According to Flook, you should evaluate “insignificant post-solution activity.” So far, I haven’t seen anyone allege that this claim survives Flook. It was undisputed that the “solution” was the therapeutic range of the metabolites. If so, then how can “administering” and “determining” be considered significant?

    If y’all disagree with Flook, that is one thing. Did anyone really expect the Supreme Court to overturn Flook?

  40. Flook had been modified by Diehr.

    What has happened is that that modification has now been obfuscated.

  41. “Flook had been modified by Diehr. What has happened is that that modification has now been obfuscated.”

    Point well taken, anon. Flook is based on flawed logic. Diehr was SCOTUS’ effort at “damage control” to keep the illogical reasoning Flook from making the patent-eligibility of all method and process claims problematic.

    Like the Bilski decision before it, SCOTUS fails (again) to tell us not just what is a patent-ineligible “law of nature,” but also how to make an application of that “law” patent-eligible. One of my biggest beefs with SCOTUS is that when the upset our patent law “applecart” like they’ve done here, they never make it their responsibility to give us “mere mortals” understandable guidance on how to “do it right” in their eyes. Breyer’s opinion is based on such nonsensical reasoning, as well as muddled (and conflicting) statements that no one (including Breyer and his 8 cohorts) can determine with any degree of predictability (or objectivity) when a claimed method/process reaches the “patent-eligible zone.” And how 6000+ patent examiners will apply this muddled reasoning gives me an Excedrin headache.

  42. Great article summarizing case law relating to the patentability of diagnostic claims: http://www.managingip.com/Article/2918685/US-personalised-medicine-Challenges-of-an-emerging-field.html

  43. Ran-

    Because the scientific concept has been around since the stone age does not mean that an invention lacks patentable subject matter, despite what the Supreme Court says.

    There are no fewer than 5 patentability requirements that an invention must satisfy in order to achieve a patent. The first requirement is patentable subject matter. The anti-patent folks here and the Supreme Court, who are also anti-patent, would rather collapse a 5 part statutory test mandated by Congress into a single inquiry.

    The patentability requirements are:

    1. Patent eligible subject matter (35 U.S.C. 101).
    2. The invention must be useful (35 U.S.C. 101).
    3. The invention must be new (i.e., novelty dictated by 35 U.S.C. 102).
    4. The invention must be non-obvious (35 U.S.C. 103).
    5. The invention must be adequately described to define what is in possession of the inventor in a manner that explains to the relevant skilled person how to make and use the invention without undue experimentation (35 U.S.C. 112 1st and 2d paragraphs primarily).

    So what the Supreme Court has done here is confuse separate requirements that each have a different statutory basis. They admit doing this, but did it despite the protestations of the Department of Justice via the Solicitor General. What the Supreme Court did was ignore the law and ignore Congress, choosing rather to legislate from the bench.

    This decision will be undone in time.

    -Gene

  44. Gene: I had a similar reaction to the opinion. I realize that especially among those who are not immersed in patent law, this seems like a good decision, especially if you accept the Court’s characterization of the facts. However, I am not nearly as troubled by the outcome on these specific facts and based on the specific claim language at issue as I am by the analysis endorsed by the Court. As you point out, the Court expressly conflates the novelty/obviousness inquiry and the statutory subject matter inquiry.

    I also believe that they were intellectual dishonest in their characterization of the Diehr case to the extent that they suggested that the elements of the Diehr claim other than the Arrhenius equation were not already well known in the art. In fact, they said that the Diehr court did not state that the other elements were obvious, and on that basis, they concluded that their reasoning was consistent with Diehr, which is rather weak reasoning. However, I am fairly confident that all of the other elements of the Diehr claim were as well known as the elements of the Prometheus claim other than the “natural law” recited in it.

    What really puzzles me about this decision is that based on the specific claim language, the “natural law” embodied in the claim appears to involve no manipulative step. It is just included in two “wherein” clauses that do not require any sort of treatment decision to be based on it:

    “wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently admin­istered to said subject and
    wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently and­ ministered to said subject.”

    That being the case, and if the Supreme Court is correct about the obviousness of the other claim elements, it would seem that the claim could be invalidated on obviousness grounds without having to further muck up the statutory subject matter jurisprudence because the “wherein” clauses should not have been given any patentable weight.

    The Supreme Court continues to make decisions that strip patent law of any clear rules and predictability. This will lead to more litigation and uncertainty in the business world. For those of you who are celebrating the death of gene patents or other diagnostics, I would not assume that they will go away. Instead, practitioners will attempt to draft their claims more artfully than the Prometheus claims, and the PTO will be left to guess as to how to apply this decision in a consistent reasoned way. The patents may continue to issue, with their validity clouded by this decision and subject to challenge in litigation.

    For those who are interested, I also analyzed the decision on my blog at hanseniplaw.com/blog.

  45. Steve-

    Feel free to provide a direct link to your blog article.

    Also, I would add… picking up on your point that they didn’t need to “muck up the statutory subject matter jurisprudence…” by pointing out that this decision seems to be one that was written and saved in a desk drawer to be pulled out at the first opportunity. They clearly went looking for a 101 issue where none existed, facts be damned. This is what Breyer has wanted to say ever since Metabolite and he wasn’t going to let the facts dictate. He and the others clearly forced 101. They will regret this, and an entire industry will be devastated based on the sloppy rationale.

    -Gene

  46. Thanks, Gene. Here is the direct link to the blog article:

    http://hanseniplaw.com/2012/03/20/today%E2%80%99s-supreme-court-decision-threatens-the-patentability-of-diagnostic-test-methods/

    I agree. It does seem that they were waiting for this opportunity, regardless of the facts.

  47. [...] sometime sparring partner Gene Quinn has written about this case. Gene is upset. I think that Gene has missed the point, because he’s too close to the forest [...]

  48. I don’t know Gene. When I run the numbers, it seems more like the U. S. Patent Office is killing industry. Quite frankly the numbers scared the hell out of me.

    Wayne

  49. [...] Watchdog: Killing Industry: The Supreme Court Blows Mayo v. Prometheus – If the headline didn’t spell it out, Gene Quinn wrote a spirited opinion piece on the [...]

  50. Steve,
    “… and if the Supreme Court is correct about the obviousness of the other claim elements, it would seem that the claim could be invalidated on obviousness grounds…”

    Good observation. But that would have required putting on actual evidence, and doing real litigation work. And it would have set less of a precedent. It’s much more fun to flush a case on summary judgment, on a 101 theory. Causes more collateral damage too.

  51. Gene, your hyperbole is heartwarming.

    For more excellent overstatement, check out hyperboleandahalf.com

  52. Wayne,

    Thanks for the link.

    However, you should check out the Tafas debacle before you post a statement like “Therefore the Patent Office will fight Congress and the Courts if they attempt to limit patentability.

  53. No matter which side of this argument you are on, it is clear that the Justices have shifted the direction of the patent system. I’m inclined to think that is exactly what they intended to do.

  54. . . . and one more painful example of why we all should keep those continuations coming.

    You never know which future legislative and judicial changes will make you thankful you have at least a shot at getting the latest, “legally acceptable” claims for you/your clients.

  55. Finally the SCOTUS has decided that the US is no different on this issue than most of the other major IP offices around the world. The types of claims struck by the 9 learned judges are of the type which render the US medical system one of the most (if not *the* most) unnecessarily expensive in the world. The exclusion clauses in several jurisdiction are the envy of many, and this decision will hopefully assist those without move foward. If this decision stands up to the corporate lobbying about to hit your Congress, then countries of subsequent filing will see applicants benefit from streamlined examination and stronger IP rights for legitimate patentable subject matter.

    Massive congratulations to the US patent system for this progressive result.

  56. Finally the SCOTUS has decided that the US is no different on this issue than most of the other major IP offices around the world. The types of claims struck by the 9 learned judges are of the type which render the US medical system one of the most (if not *the* most) unnecessarily expensive in the world. The exclusion clauses in several jurisdiction are the envy of many, and this decision will hopefully assist those without move foward. If this decision stands up to the corporate lobbying about to hit your Congress, then countries of subsequent filing will see applicants benefit from streamlined examination and stronger IP rights for legitimate patentable subject matter.

    Massive congratulations to the US patent system for this progressive result.

  57. [...] the patent lawyers have gone apoplectic, claiming that the Supreme Court is not qualified to make such decisions. The wailing and gnashing [...]

  58. The difference is that other countries achieved this “exclusion” through a legislative prohibition against patenting “methods of medical treatment.” Now we have a decision that needlessly tortures and muddies the law of statutory subject matter.

    I’ve noticed that everyone who is in favor of this decision is basing it on the outcome. That outcome could have been achieved in far better ways, such as by ruling that the “wherein clauses” in Prometheus’ claims which included the “natural law” required no manipulative steps, in which case they would have been entitled to no patentable weight, and the claims would have been obvious (at least according to the SCOTUS assessment of the other limitations).

    For everyone who is celebrating the death knell of these types of patents, I wouldn’t get too excited just yet. This decision leaves open significant questions that applicants will exploit, such as whether the claims could be drafted to recite manipulative steps based on the “natural law” and survive statutory subject matter challenges. The PTO will have to make its own guess about that and about how broadly to read this opinion. In the meantime, patent litigants on both sides of the issue will have a field day exploiting its lack of clarity and confused standards as to existing patents.

    We are in a far different situation than those jurisdictions that simply have an express prohibition against patenting methods of medical treatment.

  59. I have to agree with Mark @25 and EG @35, in that I am immersed in this patent law world (as Gene described most of us receiving this blawg) and I feel that §101 provided an adequate basis to invalidate these claims. As I read claim 1, all they are trying to do is observe a physical reaction or law of nature. Administering the drug and watching the levels in the body in response to the drug is nothing more than examining a law of nature. If there was a third step, rather than a non-action Wherein step, that claimed doing something in response to what was observed, then I can see compliance with §101. Of course, then I wonder if you run head long into §§102 and 103 but I don’t think we need to go there until we clear §101 first.

    Doing something and watching the outcome is nothing more than observing a law of nature.

    Now, this does not mean that I like the reasoning in the opinion. I simply agree with the raw basis for the decision. I think, as we often see, that SCOTUS decisions can sometimes be less than clarifying even if we feel they got the outcome right.

    With AIA, I think we can consider this Patent a technical amendment that furthers what I have heard referred to as the Patent Lawyer Employment Enhancement Act of 2011. There are now potentially thousands of patents that may need to be subjected to Post-Grant processes to ensure that all of their claims are eligible under §101. There is a new area for argument in patent infringement cases that must be briefed. Clients will be looking for new advice with regard to building new portfolios and strengthening existing portfolios.

    Quit whining about poor reasoning and get to work billing.

    ars

  60. The first part of your response is incorrect; one example of a jurisdiction lacking an explicit exclusion clause but banning such typpes of claimscan be found to your north. Canada’s definition of an invention is nearly identical to that of the US (indeed it was originally couched therefrom). Yet methods of medical treatment and higher lifeforms have been deemed non-patentable subject matter for a long time (Harvard v. Canada exemplary of the latter). It is hard to envision where else one could successfully advance the Prometheus claims. Interestingly, the first places one would try to imagine it are hardly suffering in their medical technology industries. Sure, the mechanisms entertained by SCOTUS to achieve the end result are dissatisfactory and this will need to be tested for loopholes, but great – maybe more loopholes are necessary for Congress to adopt the (progressive) shift in an explicit legislative amendment. Louder lions, etc, etc.

    Hopefully this has created a small opening of the door towards the adoption of the ‘actual invention’ requirement for both patentable subject matter and 112 satisfaction, and for its equivalents in other countries presently struggling with that issue. Let’s get a Retractable Tech. en banc on the move!

  61. Whooops, the fat fingers prefered clarity (imagine!) over patentability. Amend 112 to 102.

  62. Doing something and watching the outcome is nothing more than observing a law of nature.

    Without commenting on the underlying issue, I am not sure I buy that.

    The doing something portion on its face is more than observing. Observing is strictly a hands off activity. It’s sloppy to dismiss the first action and runs smack into the problem of not considerign the claim as a whole. Expedient? sure. But at what collateral damage?

  63. How quickly this devolves into uncivil comments.

    I was not “whining” about anything. I was merely pointing out that because of the reasoning this decision may not be the total “victory” that many seem to be celebrating . Those same people seem to condemn any criticism of the decision as the work of “greedy patent lawyers.” However, as you point, out this decision and the others from SCOTUS provide further employment opportunities for those of us in the patent bar. So yes, thank you Justice Breyer.

  64. [...] suggests that novelty and obviousness have some relevance to subject matter eligibility, despite loud protests that this conflates section 101 with issues presumably assigned to 102 and [...]

  65. Let me get t his perfectly clear. The steps of this patent are:

    Administer drug for treatment.
    Perform blood test to determine absorption level.
    Increase/decrease medication to reach desired blood saturation level.

    So… this is the exact process used in so many other treatments (Warfarin for blood clots, for instance), but because it relates to THIS drug and THIS disease, it deserves a patent.

    This is the point where I question why you think the judges understand the law so much less than you do, sir, as it is apparent you do not understand the concepts of ‘prior art,’ nor common medical practice.

  66. K Browning-

    Are you for real? You obviously know nothing about patent law, sir!

    How many patentable subject matter cases are you familiar with?

    Are you familiar with the concepts of novelty and nonobviousness?

    Are you familiar with canons of statutory construction that mandate that sections of a statue not be interpreted to make other sections of the statute superfluous?

    Are you familiar with the fact that saying that something is patent eligible subject matter is NOT the same as saying that it should be patented?

    Of course you are not, because if you were you wouldn’t make such ridiculous statements. Is administering a drug a “natural law”? No. Is performing a blood test a “natural law”? No. Is determining whether to increase or decrease medication a “natural law”? No. THEN THE CLAIM POSSESSES PATENT ELIGIBLE SUBJECT MATTER!

    You want to say that because something is not new or is obvious then it is not patent eligible subject matter. That, sir, makes you as ignorant as the Supreme Court Justices!

    Please educate yourself before commenting in the future. I prefer to have a far higher standard of substantive dialogue on IPWatchdog.

    -Gene

  67. To all:

    What has dawned on me today (and is a huge fundamental flaw in Breyer’s reasoning), is that Prometheus’ claimed method really isn’t a “law of nature” issue. Instead, it’s really an abstraction/abstract idea problem more analogous to what happened in Bilski. We may disagree on when the “transformative” step occurs in Prometheus’ claimed method, but the crux of the issue here is whether or not Prometheus’ claimed method is “crafted” correctly to be more than a mere “abstract idea” and thus a proper method claim under 35 U.S.C. § 101.

    Here are some additional thougths based Gene’s comment to my article posted yesterday:

    Gene: What do you think will be required for patent eligible subject matter? If drug dosage isn’t enough would some kind of computer program tailored to calculate the proper drug dosage based on inputs and a unique rules engine be enough? I think yes, but that leaves open a whole lot of room for others to copy without infringing.

    Me: A very good question you pose. I don’t know if even the tailored computer program you suggest would do the trick. You would hope that a unique computer program that manages the drug dosage calibration would be enough, but the Flook case and potentially even Bilski might trip you up. And that’s the problem my article points out: Breyer’s opinion leaves you with no understandable guidance on how to craft a “patent-eligible” method claim in this context. For most analytical methods, which is what Prometheus’ claimed drug dosage calibration method is part of, the results (e.g., numbers) is what they do and why they’re important. If you take the reasoning in Breyer’s opinion to its even more illogical extreme, I don’t see how many (if any) analytical methods will survive a “patent-eligibility” challenge under 35 U.S.C. § 101.

    What Breyer’s opinion does is try to determine the “patent-eligibility” question under 35 U.S.C. § 101 in a vacuum, divorced from any consideration of the other relevant patent statutes such as 35 U.S.C. § 102, and especially 35 U.S.C. §§ 112 and 103. That’s what Breyer’s opinion essentially does when he dismisses the approach suggested by the U.S. Solicitor General which I, Michael Risch, Chief Judge Rader, and many others believe is the only way you can make rational, logical, and objective determinations what is or is not “patent-eligible” under 35 U.S.C. § 101. That’s also why the Flook case that Breyer’s opinion so heavily relies upon for precedential support is so logically flawed: (1) it forces you to treat previously unknown “laws” (or relationships) as if they’re part of the prior art; (2) it dissects the claim language to try to separate out the supposed “law of nature” from the rest of the claim context. When you do either of these techniques with the claim, you do so in contravention of what 35 U.S.C. § 103 explicitly says (especially that the claimed invention should be considered “as a whole”), as well as what is implicit in 35 U.S.C. § 112, second paragraph (that claim defines what the invention is). Unless you’re willingly to address the claimed invention in the context of all of the relevant patent statutes (which Breyer and his 8 cohorts appear to be unwilling to do), determinations of patent-eligibility under 35 U.S.C. § 101 are no more objectively based than using a Ouji board.

    I frankly find the whole “law of nature” reference in Breyer’s opinion to be completely inappropriate for evaluating Prometheus’ claimed method. We’re not talking about Einstein’s “theory of relativity” or Newton’s discovery of the “law of gravity.” Instead, we’re talking about administering a specific man-made (thiopurine) drug, measuring the levels of measured metabolites (which only humans can do, even if they use instruments), and evaluating the measured level metabolites to decide whether the drug dosage needs to be adjusted because it’s too high or too low. You may fault how Prometheus’ drug dosage calibration method was claimed (the “draftsman’s art” as Breyer calls it). But doing so on the basis of this claimed method being essentially nothing more than a “law nature” in the guise of “routine, conventional activity” is totally unpersuasive and illogical reasoning.

    Where Prometheus’ claimed method needs to be “transformative” to survive “patent-eligibility” under 35 U.S.C. § 101 is after the “determining step.” That’s the conclusion my patent attorney brother Mark and I’ve come to in trying to sort out cases like this one, Bilski, and others. In other words, what the claimed method must do is either convert physical (e.g., compounds, reactants, etc.) or tangible (e.g., data) elements into something different, or cause that “conversion” to achieve useful result (e.g., adjust the drug dosage, or at least an “active” instruction to adjust the drug dosage). That “transformative” step also has to be at least partially at the crux of why the claimed method is unique. The “wherein clauses” in Prometheus’ claimed method that simply inform you that the drug dosage is too low or too high are too “passive” to make this “transformative” jump to patent-eligibility under 35 U.S.C. § 101.

    But if Breyer’s opinion prohibits consideration of such “transformative” steps if they’re judged to be “routine, conventional activity” (which is true of many analytical methods which often use a combination standard techniques or steps but in a unique way), we’re going to have difficulty making that “transformative” jump. Frankly, the whole, illogical line of Supreme Court “patent-eligibility” reasoning that starts with Gottschalk v. Benson and ends with Diamond v. Diehr needs to be “torched” and replaced with the now discarded “tangible, concrete, and useful results” (TCU) test of State Street. (What my brother Mark and I suggest for modifying Prometheus’ claimed method complies with the TCU test.) All other proposed standards for judging “patent-eligibility” under 35 U.S.C. § 101, especially those proposed by the Supreme Court, pale to subjectivity, and simply lead to nonsensical and illogical results. And the approach proposed by the U.S. Solicitor General which examines the “patent-eligibility” issue in the context of the other relevant patent statutes is also likely the only one that will get you there.

    That’s my additional thoughts for what they’re worth.

  68. I have a question for Gene, Mark and Eric. In his article Gene points out and criticizes Justice Breyer’s “overlap” language, but does not go on to talk about Justice Breyer’s attempt to justify this by saying that bringing the later sections to bear on the 101 analysis is warranted because “…to shift the patent-eligibility inquiry to these later sections [102 and 103]…[assumes] that those sections can do work they are not equipped to do. What role would laws of nature, including newly discovered (and ‘novel’) laws of nature, play in the Government’s suggested ‘novelty’ inquiry?”

    Eric also states in his related article on this site that he believes that Flook is “logically flawed” in that it treats an undiscovered algorithm as prior art.

    Assuming then that the natural correlation in this case and the algorithm in Flook are both patent-ineligible subject matter, what effect should or can such subject matter have on a patent’s 102 and 103 analyses? For instance, if a patent relies heavily on the application of a natural phenomenon but is still 101 eligible, should the court consider that phenomenon to be prior art for the purpose of a 103 analysis? Should it matter whether the phenomenon is well known or previously undiscovered?

    To perhaps explain my question a little better, if we were to agree that the correlation between drug dosage and metabolites in this case is a natural correlation and therefore patent-ineligible by itself, but we were also to agree that the patent is eligible under 101, what do we do with the natural correlation when we analyze the patent under the later sections? If nothing else in the patent is novel by itself (administering a drug, measuring metabolite levels in the blood), can the addition of something that is patent-ineligible subject matter now make the patent as a whole novel? Under 103, do we pretend that piece of the patent does not exist, since we have already disposed with the 101 analysis, even though this approach might make the patent seem less-obvious than it is in reality, or do we count the natural correlation as part of the prior art, since its existence might have informed and prompted other persons with skill in the art?

    I would like to hear your opinions on this, as well as to see pertinent cases if this has been addressed before.

    Thanks,

    J

  69. EG:

    It shouldn’t take rocket-science legal theory to figure out that the 9 brethren (/sisters) of that most supreme of courts do not understand that of which they speak. It’s all gobbledygook, pure and simple.

    But to see it, you must take the irreverent stance of a child at the Emperor’s Fashion Parade before you can utter without worry or shame, OMG, they wear no clothes!

    Unfortunately I have not the time or patience to post here a complete exegesis on the Mayo opinion. I’m starting to instead piece one together here: http://patentu.blogspot.com/2012/03/genuinely-insignificant-thoughts-from.html

  70. I can’t see how this ruling will kill the industry. I have to admit I can’t see why the patent office issued this patent. To take a slightly different look at the patent:

    1) Heat the stew to 325 Degrees F for 20 minutes
    2) Add a pinch of salt
    3) Taste stew
    4) If stew does not taste salty enough add a tiny bit more salt
    5) Taste stew again

    Any cook knows this routine. For that matter any shade tree mechanic who worked on pre-electronic cars knows this routine. That’s how I used to adjust the carb on my 1966 Chev Impala.

    However this is all really a side issue. I’m more concerned about the numbers I came up with. If my numbers are correct (and no one has yet told me I’m wrong) patents on average earn $575.00 per year.

    I don’t know what the current legal costs are to file a patent application, it’s been close to ten years since I had to worry about doing that, but my memory is that it was about $4000.00 back then, which means that you’d be in your eighth year before you’d break even – assuming that you didn’t have any financing costs.

    That assumes you have an average patent. But there is no such thing as an average patent. One percent of patents make ninety-nine percent of the profits, the other ninety-nine percent of patents make one percent of the profits.

    Doesn’t this sound like Lost Wages Nevada to you?

    Wayne

  71. patents on average

    Please don’t think you can do that. That’s like saying that humans on average have eyesight of 20/300 in their right eye and 20/325 in their left.

    Just because you can crunch numbers doesn’t that you should or that the end reuslt has the meaning you wish to ascribe to it.

  72. My natural inclination is to agree with the outcome here[1], but having read the opinion — oof! How the heck is the Patent Office supposed to implement this? At what point does the “post-solution activity” cease to be “insignificant”? With all due respect to Justice Breyer, the patent system will grind to a halt if every patent has to make it all the way to One First for the learned justices to apply their Potter Stewart test for patentable subject matter. (Not that I would expect a socially better outcome if Congress did decide to step in, given the way things work on that side of the street.) If the patent system is to have any net social benefit at all, it has to be implementable by ordinary patent examiners; this decision (even more than Bilski) seems to be little more than “sorry, not good enough, try again next time” with nothing of any substance that would help anyone figure out where the line is. So, good outcome for medicine, bad outcome for the orderly development of the law.

    [1] Particularly given that Gene hates it.

  73. Wayne,

    You need to break it into subsets.

    Take the last two major purchases of patent portfolios and run those same numbers.

  74. Mr. Quinn,

    just a little reminder:

    “The judicial Power of the United States, shall be vested in one supreme Court, and in such inferior Courts as the Congress may from time to time ordain and establish. The Judges, both of the supreme and inferior Courts, shall hold their Offices during good Behavior, and shall, at stated Times, receive for their Services a Compensation which shall not be diminished during their Continuance in Office.”

    Or did you read a different Article III of Constitution?

  75. “It shouldn’t take rocket-science legal theory to figure out that the 9 brethren (/sisters) of that most supreme of courts do not understand that of which they speak.”

    How true, SB. But if you’ve seen the verbal vitriol I’ve taken from MM (aka Malcolm Mooney) on Patently-O, you wouldn’t think so. My mistake is that there’s no reasoning MM; whatever he believes is “dogma,” and if you say otherwise, you’re a “fool,” “dense,” or worse. Whenever he resorts to “blog profanity,” and “ad hominem” attacks, I know rational debate has ended. That he relies upon a 9-0 decision written by the most “patent hostile” Justice on SCOTUS (a court that frankly has very little credence with me when it comes to patent law) to prove his point speaks volumes. Unfortunately, there are many MMs in this world who think “ignorance is bliss” when it comes to correctly interpreting our nook of the law.

  76. Only in the US does this appear to be a “diagnostic” method. Before the EPO, the UK, CA, JP, and (oops, not so much since last year), AU, this falls under a dosage regimen which is a method of medical treatment and therefore should not be available for patentability.

    The Chicken Littles proclaiming that this is the end of the medical industry as you know it should perhaps look at those other systems which, in many ways, are better and cheaper – in no small part to the bar on the skills or wisdom of a medical practitioner.

    To those whom are gesticulating wildly about the apparent lack of technical background for the 9 seat-fillers, does the SCOTUS not have an army of prothonotarial advisors or a reasonable equivalent to provide the necessary analysis to the bench? Even if the answer is no, the injection of an outside consideration of the issues is perhaps welcome; IP professionals on both side of the issues have bastardized the intent of the patent system to the worst extent (Franklin, et al. would’ve been horrified at the litigious mess that it has become). The third-party perspective that many of you would suggest has occurred in Prometheus is probably long overdue.

  77. I think I understand why you’re outraged:

    “…A question for you… what is your position on the patenting of satellite technologies? Would those things be unpatentable since a satellite remaining in orbit is an application of the law of gravity?

    Your position is nearly as absurd as Justice Breyer’s. Breyer’s is more absurd only because he is supposed to know better…”

    This may be simply a bad analogy, but in that example, the patent would not be for satellites, it would be for “utilizing newtons laws to delay the reentry of an object into earth’s atmosphere”.

    Are we supposed to think every “choose-your-own-adventure” book we read in the 80′s was patentable? “If x then y” doesn’t sound like an invention…it sounds like instructions.

  78. Whenever he resorts to “blog profanity,” and “ad hominem” attacks, I know rational debate has ended.

    EG:

    I’m going to try to develop an irreverent analysis of Mayo v. Prometheus over at my Step Notes and Marks side blog because explaining it here will just eat up too much space.

    (link to side blog: http://stepback-marks.blogspot.com/2012/03/genuinely-insignificant-thoughts-from.html#JumpIn_1.1 )

    A purely ad hominem attack against any one Justice (e.g. Bryer) is not justified because all 9 of them signed the opinion. An ad hominem attack on the entire SCt. is also not constructive because something bigger is going on here. The whole system is breaking down.

    I note with interest that Patent Docs finally feels the pain that software practitioners have felt all these years: We have met our ‘Benson’ and its name is ‘Mayo’. Ha ha. Good one. (link is here:
    http://www.patentdocs.org/2012/03/mayo-collaborative-services-v-prometheus-laboratories-what-the-courts-decision-means.html )

    Briefly, in my side blog, I will try to show that:
    1) US Sct. does not know what a “Law of Nature” is
    2) US Sct. does not know what a “step” is in a method claim
    3) US Sct. does not know what a patent is or what the claims in a patent are supposed to be doing
    4) US Sct. does not know anything about chemistry, human biology, medicine and why each of us genetically different (and phenotype wise different) biological machines responds uniquely and differently to medical “compounds” administered via our gastrointestinal systems (especially if said intake systems are diseased).
    5) US SCt. fails to understand (although it admits to it) that an “improved” dosaging system is an “improvement” and that the laws written by the US Congress (101 AND 100b) allow for the patenting of an “improvement thereof”.
    6) The PROBLEM is much bigger than just our 9 SCt. Justices not understanding basic or more involved “science”. Our whole government is crumbling due to ineptitude. Mayo is just a symptom of a much broader and more pervasive disease process.

  79. holdenSK-

    Your “little reminder” makes no sense whatsoever. You aren’t seriously suggesting that what you quoted ipso facto means that the Supreme Court is write on everything, are you? Are you suggesting that they can’t be wrong or that they can’t be legally criticized? What is it that you are trying to say?

    Please try and be less obtuse when commenting on IPWatchdog.

    -Gene

  80. J-

    Justice Breyer is 100% incorrect. Sections 102, 103 and 112 are more than adequate to have provided support for what Justice Breyer wanted to do, which is say that the claims do not contain anything other than ordinary and known steps. That is EXACTLY what 102 and 103 deal with, and Justice Breyer either knows this or he should resign from the bench. He has dealt with 102 and 103 issues before, and he knows what he is saying is not correct. The question is why would he make such an erroneous statement? Justice Breyer has wanted for a very long time to simply kill certain innovations and fields of technological advancement. All you have to do is look at his history.

    You ask: “if a patent relies heavily on the application of a natural phenomenon but is still 101 eligible, should the court consider that phenomenon to be prior art for the purpose of a 103 analysis? Should it matter whether the phenomenon is well known or previously undiscovered?”

    The court should absolutely consider the phenomenon as prior art for purpose of 103. That is done all the time with 102 and 103 analysis. That which is known cannot be patented, and that which is a trivial variation of what is known cannot be patented either. The proper analysis here would have been under 102 and 103. Using 101 and changing 60+ years of patent law was unnecessary and wrong-headed. This case overrules many previous Supreme Court decisions without even acknowledging that was what was done.

    The fact that a previously undiscovered phenomenon is now understood doesn’t change the fact that it is a natural phenomenon and not patentable. What is… or was until this week… patentable was an application of that previously undiscovered phenomenon. So this decision really prevents innovations at the intersection of science and engineering to be patented. No more can scientists discover things and engineers build services and goods that utilize those discoveries and obtain a patent. Virtually none of the equipment that empowers the wireless economy could be patented under a strict reading of this case. Thankfully, the Federal Circuit and Patent Office will ignore the decision even if Congress doesn’t explicitly overrule it by statute.

    -Gene

  81. EG-

    You raise an interesting point about abstract ideas.

    I had a reporter ask me yesterday whether this was a fair characterization of the decision:

    “is it fair to say that the US Supreme Court’s unanimous decision has essentially ruled that an abstract idea based on natural phenomena cannot be patented?”

    My answer was no, but I told her that would have been a far better rationale than the one employed by the Supreme Court. Perhaps that is what Justice Breyer was trying to say, but instead said it was well known and not new. Thus, an interested reporter who covers a niche science beat understand these issues better than the 9 folks who call themselves the Supreme Court.

    -Gene

  82. Adrian-

    Perhaps you need to inform yourself a little better.

    A patent that would cover a method for having a satellite remain in orbit would certainly be patentable as a unique and extremely non-obvious invention when it was first created.

    You say: “it sounds like instructions.”

    Spoken like a true neophyte who knows nothing about patent law and apparently knows very little about science and technology. Patents are SUPPOSED to be instructions! That is the whole point. Furthermore, method related inventions are REQUIRED to be instructions. A patent is supposed to explain the inventions so others can make and use the invention. How could anyone achieve that without having the resulting patent and claims sound like instructions?

    Please THINK before you say things that clearly demonstrate you don’t have a clue.

    -Gene

  83. Gene-

    Thank you for the helpful reply!

    Also, expanding on your last comment about abstract ideas, on page 9 of the opinion Justice Breyer pulls a Diehr quote involving abstract ideas out of *nowhere* while talking about the “administering” step. When I read it I also thought to myself (after doing a double-take) that the Court could have justified ruling that the patents were ineligible because they are abstract ideas, but of course it did not do that. The direct quote from the opinion:

    “First, the ‘administering’ step simply refers to the
    relevant audience, namely doctors who treat patients with
    certain diseases with thiopurine drugs. That audience is
    a pre-existing audience; doctors used thiopurine drugs to
    treat patients suffering from autoimmune disorders long
    before anyone asserted these claims. In any event, the
    ‘prohibition against patenting abstract ideas ‘cannot be
    circumvented by attempting to limit the use of the formula
    to a particular technological environment.” Bilski, supra,
    at ___ (slip op., at 14) (quoting Diehr, 450 U. S., at 191–
    192).”

    J

  84. I think reminder is indeed in question:

    “How long will it take the Federal Circuit to overrule [sic] this inexplicable nonsense? The novice reader may find that question to be ignorant, since the Supreme Court is the highest court of the United States. Those well acquainted with the industry know that the Supreme Court is not the final word on patentability, and while the claims at issue in this particular case are unfortunately lost, the Federal Circuit will work to moderate (and eventually overturn) this embarrassing display by the Supreme Court.”

    If any Court of Appeals can overturn decision of Supreme Court, then why do you guys indeed have one? Or will you get what Supreme means only after several summary reversals of CAFC?

  85. I agree that they can be criticized (I don’t agree with them myself may times), but it can be done differently, you know :)

  86. “is it fair to say that the US Supreme Court’s unanimous decision has essentially ruled that an abstract idea based on natural phenomena cannot be patented?”

    Gene,

    Breyer could have (and should have) gone that way but didn’t. Like my brother Mark points out, Prometheus’ method, as claimed, is simply not a proper method claim, as drafted. As Steve Hansen astutely says upthread we have no “manipulative” step (or “transformative” step as I refer to since that’s the language the courts have been using) in Prometheus’ claimed method, simply a “passive” determining step which is further defined by two “wherein clauses” that tell you (again, “passively”) what person administering the drug needs to do in terms of adjusting the dosage. If you had a claimed method which had an active “adjusting step” which required the drug dosage to be adjusted in response to the metabolite levels determined and what those ranges in the “wherein clauses” say the adjustment should be (up or down), we shouldn’t even be talking about patent-eligibility under 35 USC 101.

    In fact, and without getting into whether Prometheus’ claimed method is patentable under 35 USC 102/103 of which the U.S. Solicitor General raises some reasonable “doubts,” this claimed method is highly vunerable under 35 USC 112, 2nd paragraph, as not “particularly pointing and distinctly claiming” what the invention is. Prometheus’ mehod, as claimed, is analogous to what we used to call improperly describing a machine as “so many elements in box,” but not saying how those elements are connected and/or function together. Admittedly, the crux of what is unique (if anything) in Prometheus’ claimed method is the specifically identified ranges in the “wherein clauses” telling you whether the drug dosage is too high or too low, but those specific ranges are simply a “theoretical” exercise unless you do something with those ranges based on measuring the actual level of metabolites. I would be perfectly fine with describing Prometheus’ method, as claimed, as being too “abstract” under 35 USC 101 in view of Bilski, or incorrectly described in view of 35 USC 112, 2nd paragraph.

    But going down the “law of nature” path as Breyer did is definitely to wrong way to resolve this question. When you measure the resulting metabolites of an administered a man-made drug, we not talking a “natural phenomena,” a “law of nature” or anything of that sort because, without man intervening (i.e., making the drug and administering it), there would be no metabolites to measure. As I’ve said before, Breyer’s analogy to Einstein’s “theory of relativity” or Newton discovering the “law of gravity” is completely inapt. “Relativity” and “gravity” have existed long before man came along. But these thiopurine drugs did not.

    More significantly from a patent law jurisprudential standpoint, we’re going to have significant “collateral damage” from Breyer’s opinion going down this “law of nature” path. that has invariably happened every time our Judicial Mount Olympus hurls one of these ill-considered “thunderbolts,” as we’ve witnessed with KSR International and Bilski. Breyer’s simply doesn’t tell, in practical and understandable terms, what analytical and diagnostic method can reach the patent-eligibility zone. Instead, all it tells us is that Prometheus’ claimed method did not, in language fraught with ambiguity, inconsistency, hyperbole, and downright nonsenscial logic.

  87. holdenSK-

    You must be located in the United Kingdom where there is no First Amendment right to say what you want and believe.

    When will I get what “Supreme” means? That is laughably funny and naive all at the same time. All I did was point out reality. You might not like that, others might not like it, but that is what will happen. District Courts and the USPTO will ignore the decision as well, and step by step work to moderate it. That is just what happens in the U.S., increasingly so with the Supreme Court dipping its toe into areas they really have no hope of understanding.

    Summary reversals of the CAFC? How many of those have you ever seen? I’ll take one as an example. It just never happens.

    Think you know the law and reality better than me if you like, but in 1966 the U.S. Supreme Court said that secondary considerations of obviousness MAY be helpful, and it is now readily accepted by everyone that consideration of secondary considerations is mandatory. In the 1972 the U.S. Supreme Court ruled that software is not patentable, and today patents are granted on software every week.

    As an attorney I have an obligation to inform clients of reality, not of what some textbook says should be the case.

    _Gene

  88. “today patents are granted on software every week”

    Which is one reason why the US patent system is so comical.

  89. Mr. Quinn, you said:

    “…Patents are SUPPOSED to be instructions! That is the whole point. Furthermore, method related inventions are REQUIRED to be instructions…”

    Aren’t patents supposed to be descriptions of devices or inventions? Granted, if you are discussing an idea (a method), there is no device to describe, and all you are *left* with is instructions. I believe that a compilation of instructions is commonly protected via copyright (and/or trade secret), is that not correct? Does the fact that method-based patents have been issued mean that they should have been?

    You also said:

    “…A patent that would cover a method for having a satellite remain in orbit would certainly be patentable as a unique and extremely non-obvious invention when it was first created…”

    In my example, the method is not what causes the satellite to fail to fall to earth. What causes the satellite not to fall is a natural phenomenon related to the velocity of an object and gravitational attraction between it an another body. The method just says “apply the law”, which is what Prometheus’ patent did. Neither of those are inventions, they are observations and instructions derived from those observations. My statement was not that they weren’t unique and non-obvious, but that they weren’t inventions, but rather discoveries of natural law (which is what SCOTUS noted, as well).

    I expect nothing less than a rehash of your earlier response, and a swift dismissal of my contrary view, but hey, why not at least try to have a discussion about it :)

  90. “You must be located in the United Kingdom where there is no First Amendment right to say what you want and believe.”

    I suspect holdenSK is located in Saskatchewan, not the UK. Both, however, have mechanisms equivalent to the First Amendment (the UK did it first, FYI), they just don’t make such a big deal of it. Nor do they make a big deal of advancing women’s rights to vote earlier than the US, nor of abolition being 100 years earlier than the United States. Big deal. Free speech has been around in many countries, but without the need to codify it.

    It’s unfortunate that you had to get personal on holdenUK despite protestations against the same. Lead by example.

  91. Adrian,

    It is easy to have (and to maintain) a contrarian view when you don’t care to educate yourself about what you are talking about.

    I hope you see that it is just as easy to lose patience trying to hold a conversation with someone who doesn’t care enough to understand the basics.

    I recognize that maintaining your ignorance can be difficult work. You look thirsty. Can I interest you in (another) glass of delicious Kool-Aid?

  92. EG said:

    “Relativity” and “gravity” have existed long before man came along. But these thiopurine drugs did not.”

    Yes, so the folks who invented thiopurine get the patent for the drug, the process for making the drug and any use of the drug. They get their pro quo when the pharmacy buys them from the company and distributes them to the patient. What they shouldn’t get is money from the medical professionals who deal with individual patients, nor on the mechanisms by which thiopurine work. The invention of the *actual drug* is reliant on a law of nature (the biochemical interaction with human physiology), but does not include that law of nature.

    The practitioner-patient relationship should *never* be subject to monopolistic bar, especially when

  93. ..especially when, that is, the product supplier is already paid.

  94. Mr. Dogma,

    If you are willing to provide a coherent criticism of my contrary (and decidedly not contrarian) view, I would be glad to drink it in.

    I do not claim ignorance, only disagreement with a particular view espoused in this li’l conversation.

  95. “The practitioner-patient relationship should *never* be subject to monopolistic bar”

    ForeignExaminer, undoubtedly from a land where “socialism,” “entitlement”, and “civil code” operate, I welcome you to America, the “land of the free, home of the brave,” a “republic” which is the “land of opportunity” and “common law.” Your ignorance of U.S. law is showing. We do have a “medical practione” exception. See 35 USC 287(c).

    “What they shouldn’t get is money from the medical professionals who deal with individual patients, nor on the mechanisms by which thiopurine work.” Again, your ignorance of U.S. law is showing. See 35 USC 287(c) again. The folks who don’t get off the hook are for-profit testing labs which Mayo Collaborative Services was (contrary to how certain amici disingenuously portrayed this accused infringer).

    The fact is, you folks in socialist, “entitlement land” want a free lunch at someone else’s expense. I want no part of what you’ve got, including the significant government intrusion that comes with it. Americans are already paying extra for you folks rigging the drug system with price controls; it would be nice if you folks in socialist, “entitlement land” ponied up your fair share for the development of those drugs. Somebody has to pay for this drug development or it simply won’t happen. Like money, drug development doesn’t grow on trees.

  96. Foreign Examiner-

    You say: “Free speech has been around in many countries, but without the need to codify it.”

    You can’t really believe that, do you? You want to just trust in the benevolence of government I suppose, like so many in Europe and elsewhere who think government is the answer to all problems. There are a whole lot of folks that don’t enjoy the right to speak freely because there is no law or Constitution providing that right. Perhaps you should watch the evening news.

    As far as getting personal, I did no such thing. Exposing the bias of an individual and pointing out how that is coloring their opinions is hardly getting personal. holdenSK is wrong on the law and wrong on the facts. The only way he could hold contrary positions is if he is uninformed. I also find it peculiarly European to want to revere Judges as if they are a deity. That is not how things are done in the U.S., but then again that is because we do have a codified right to speak our mind, unlike in most other parts of the world.

    -Gene

  97. Foreign Examiner-

    You say: “The practitioner-patient relationship should *never* be subject to monopolistic bar…”

    So you believe there should be no pharmaceutical patents, no biotech patents, no personalized medicine, no medical devices, etc. etc.? You can’t be that naive, are you? Do you really believe that innovation just happens despite patents?

    Would you care to tell us where you are located and what Patent Office you allegedly work for? It would be useful to know your bias and how it is that you can be such a neophyte when it comes to the business of innovation.

    -Gene

  98. Adrian-

    You ask: “I believe that a compilation of instructions is commonly protected via copyright (and/or trade secret), is that not correct?”

    You are not correct. I was, however, correct when I said that patents are supposed to be instructional. It seems you are very poorly informed on the topic, so allow me to provide you with some basic reading suggestions to become more familiar with this topic:

    http://www.uspto.gov/web/offices/pac/mpep/documents/0600_608_01.htm#sect608.01

    http://www.uspto.gov/web/offices/pac/mpep/documents/0600_608_01_g.htm#sect608.01g

    http://www.uspto.gov/web/offices/pac/mpep/documents/0600_608_01_i.htm#sect608.01i

    http://www.uspto.gov/web/offices/pac/mpep/documents/2100_2162.htm#sect2162

    http://www.uspto.gov/web/offices/pac/mpep/documents/2100_2163.htm#sect2163

    http://www.uspto.gov/web/offices/pac/mpep/documents/2100_2164.htm#sect2164

    http://www.uspto.gov/web/offices/pac/mpep/documents/2100_2164_08.htm#sect2164.08

    http://www.uspto.gov/web/offices/pac/mpep/documents/2100_2173.htm#sect2173

    You also say: “In my example, the method is not what causes the satellite to fail to fall to earth. What causes the satellite not to fall is a natural phenomenon…”

    Exactly how does gravity provide the solution for placing the satellite into a position so that it won’t fall to earth?

    As far as a swift dismissal of your contrary view… your view is not contrary at all… it is flat wrong. You are wholly uninformed and attempting to discuss issues you know absolutely nothing about.

    -Gene

  99. Foreign Examiner-

    So you think the US is comical because we issue software patents. Do you enjoy continuing to prove you are clueless?

    Look around you. Where are all the software companies? Oh, right, you can’t find them because they are here in the U.S. where we comically protect software.

    Perhaps you have heard of a device called the “computer” and a communications medium called the “Internet.” I suspect you have since you are commenting here, but your comment about software makes me wonder whether you are familiar with those terms. I guess you haven’t noticed that we live in a digital world and the new engine that runs that digital world is software.

    You really do need to educate yourself man! You should like IBM and other hardware companies from decades ago when they thought hardware devices were the key and ignored software. Boy were they wrong! Perhaps you should open your eyes and notice the world around you.

    Finally, as far as what is REALLY comical… anyone allowing an individual like you with such a closed mind to be a patent examiner. Trust a benevolent government and ignore the importance of software in the 21st century economy. WOW! And you are willing to admit it in public.

    -Gene

  100. Just for grins, I took a look at the patents that cite the one in suit in the Prometheus case. Apparently the inventors obtained another “related” patent. This time, the claims recite an affirmative treatment step:

    To follow up on my earlier comment, the inventors in the Prometheus case obtained another patent, U.S. Patent No. 6,987,097 which issued in 2006 and is related to the one that the Supreme Court considered (U.S. Patent No. 6,355,623). However, in this patent, the claims require an affirmative treatment step based on the “natural law” at issue:

    1. A method for optimizing therapeutic efficacy in a subject in need thereof, said subject receiving a drug providing 6-thioguanine, said method comprising: (a) determining a level of 6-thioguanine in said subject; and (b) increasing the subsequent dose of said drug when said level of 6-thioguanine is less than a member selected from the group consisting of about 230, 240, 250, 260, 280, and 300 pmol per 8×10^8 red blood cells.

    This seems to be the type of claim the opinion left open. Any thoughts on whether this one should satisfy Section 101?

  101. ” We do have a “medical practione” exception. See 35 USC 287(c).”

    Nice in theory, EG.

    “I welcome you to America, the “land of the free, home of the brave,” a “republic” which is the “land of opportunity” and “common law.””. I actually laughed out loud at this; you need a passport.

    As for ponying up a fair share of drug development, EG, this is another laughable claim. I guess Pfizer is the only drug company that exists where you’ve come from. Care for a history of pharmaceutical companies and where they’ve come from? It won’t be brief, and it won’t be in English if we do it in the native language of the inventors of some of the most important medicaments of our time. It really is no surprise that patents validated in the US are struck down by EP and JP patents with regularity everywhere else (side note: those IP Watchdog articles on ‘comprehensive searching’ and ‘private inventors’ *still* suggest a search of the USPTO database is “comprehensive”; my advice to my clients has always been to file in the US, UK, CA, AU and start prosecutionin the latter three to ensure a much stronger patent).

    At best, EG, you’ve mistaken socialized medicine with socialism inasmuch as you and Gene have confused the Constitution and Congressional enactments with the standard for freedom and righteousness everywhere. Perhaps the Beckian definition of Socialism is being used in your line of expression. The most socialist country I’ve been to thus far is Cuba and I – get this – no one was afraid to talk sh*t about Castro if so inclined. They merely found it rude to be asked.

    You’ve challenged me, EG, on my knowledge of 35 USC. Passed that test, according to the USPTO, thanks very much. Care to follow suit with EPC, CPA&R, PCT or PA’77?

    Watch the evening news, Gene? Really?? I get my nightly share of MSNBC, Fox, et al., thanks. When’s the last time you watched the BBC, CBC, or TV5 to kept abreast of IP developments (or anything else, really) external to the 50 greatest? And, ok, so maybe those other countries that have had free speech for ages had codified it, a long, long time ago. Again, no need to promote democracy or republican thinking in Europe – it was “invented” there.

    So SCOTUS has taken a necessary (and evidently courageous in light of the above) step towards modernizing the US system. The fact is, you’d be hard pressed to find a jurisdiction where the Promethus claim would stand up, and for the very same reasons (however set into the language of the land). Pharma-side IP Practitioners don’t like it? Too bad. Wait until an en banc on actual v. claimed gets sorted out. That’ll be a fun one. It’ll be nice when the AIA advances the US towards 20th century practices. Not a typo.

    “So you believe there should be no pharmaceutical patents, no biotech patents, no personalized medicine, no medical devices, etc. etc.? You can’t be that naive, are you? Do you really believe that innovation just happens despite patents?”

    Not even close to what I said. As close as Pluto is to the sun. Have a look again – there is an express statement supportive of pharmaceutical patents from me above. It’s when a patent tries to get between someone making a decision about a person’s medical treatment and the person that the line needs to be drawn.

    You’ve also missed the mark on the software side. Have all the methods and systems you like once you board the plane. Software? Hello copyright. I hope that little nuance is clearer now.

    Nice professional approach with that last one, Gene. One would expect more from the progenitor of this website.

  102. Gene,

    I believe https://en.wikipedia.org/wiki/Escape_velocity explains this satellite business quite nicely. Do you really say that “An movement of the object which attains a speed in which sum of its kinetic energy and gravitational energy equals zero and is maintained through the indefinite period:” should describe a patentable invention? And by the way, you at least caught a continent, if not the country :) No, it;s not the UK. :)

  103. Steven, Gene,

    if the Prometheus patent should be patentable, then how about “A method for optimizing therapeutic efficacy in a subject in need thereof, said subject receiving a drug providing acetylsalicylic acid, said method comprising of: (a) determining a body temperature of said subject and (b) providing the subsequent dose of said drug when the body temperature of said subject does not decrease to normal body temperature”? :) Looks the same to my layman’s eyes :)

  104. I don’t believe that either Gene or I said that the Prometheus patents should be “patentable.” I do, however, think it should have been deemed statutory subject matter and compliant with 35 USC 101. Assuming the Supreme Court’s premises are correct, I believe it should have been invalidated for obviousness.

    Your claim would be anticipated, and therefore, unpatentable for lack of novelty under 35 USC 102. I do, however, believe that it constitutes a statutory process under 35 USC 101, just not a novel one.

  105. Steve,

    thanks for your thoughtful reply. For the rest of us (in technical fields mostly) is sometimes really puzzling how something that is for “person ordinarily skilled in art” an obvious (and not novel) thing, can get a patent protection,despite of these limits you describe and for myself at least, I can’t see (especially when reading about “patent wars”, e.g. Oracle v. Google, a series of Lodsys cases), how granting patents on what amounts to (roughly said) applied computation theory (see http://www.groklaw.net/article.php?story=20110908075658894) can really foster innovatiion.

  106. holdenSK-

    Steve is 100% correct. The patent attorneys here are NOT saying that the Prometheus patents should be patentable, merely that it was wholly inappropriate to deem them to be patent ineligible subject matter.

    Herein lies the problem. You are not at all familiar with patent law. You suppose that simply because something is patent eligible subject matter that a patent must issue. That is not correct. There are no fewer than 5 separate and distinct patentability requirements. Patent eligible subject matter is but the first requirement. The vast, overwhelming majority of things that are patent eligible subject matter should never receive a patent because they are not new and/or they are obvious.

    The trouble is you are engaging in a legal debate where terms and concepts have particular meanings and injecting your layman’s view.

    Next…

    I love how you cite Wikipedia as authoritative… spoken like a true layman! Nevertheless, I’ll address your point.

    You say: “Do you really say that ‘An movement of the object which attains a speed in which sum of its kinetic energy and gravitational energy equals zero and is maintained through the indefinite period…’”

    First, allow me to correct what you already know. I never said that. You are putting words in my mouth, which is the sign of someone who has been defeated in debate. So why would you so clearly attempt to make up things?

    Second, what you say focuses on the movement of the object, which is a natural phenomenon. What is NOT a natural phenomenon is the ability to get the satellite into orbit at the precise velocity and place so that it will stay in orbit.

    Look, you want to believe that once someone knows about gravity then it is trivial to put a satellite in orbit and get it to stay there. That is simply not true — pure fiction. So tell me… do you believe that it was trivial for man to go to the moon? Your reasoning so far would suggest that it would be… just strap an enormous amount of volatile high explosives onto an insulated module, point and hope for the best fingers crossed.

    If you want to learn patent law so you can make an informed decision and engage in meaningful debate please let me know. I am happy to provide you with reading assignments to bring you up to speed, first on the big picture items and then on the finer points of patent law so that you can understand the nuances that elude you.

    -Gene

    -Gene

  107. Foreign Examiner-

    You say: “Have all the methods and systems you like once you board the plane. Software? Hello copyright. I hope that little nuance is clearer now.”

    I think you have lost it now. That makes no sense whatsoever. Could it be that you are trying to make an argument that software should be copyrighted and not patented? If that is what you are trying to say it is, of course, laughable. Copyright protects expression and there is no expression to protect in the functionality of an innovation. Copyright merely protects the code, but the code is not the invention.

    Please try again.

    You say: “no need to promote democracy or republican thinking in Europe – it was “invented” there.”

    If that is true it is all the more odd that so much of Europe has abandoned democracy in favor of socialism.

    You say: “You’ve challenged me, EG, on my knowledge of 35 USC. Passed that test, according to the USPTO…”

    You must be talking about passing the patent bar exam in the US, but everyone knows that few of the 100 questions deal with 35 USC. The overwhelming majority of questions deal with the rules of practice (i.e., 37 CFR), not the specific law enacted by Congress. So you can go and save that argument for someone who can easily be mislead. Those here won’t fall for that.

    Also, how is it that a Foreign Examiner took the Patent Bar Exam? Did you lie on your application? You should have only been able to sit for the US patent bar if you are a U.S. citizen or legal resident with appropriate work papers. Did you take the exam and then go back to the EU?

    You also say: “Nice professional approach with that last one, Gene. One would expect more from the progenitor of this website.”

    What? You would expect me to have the same erroneous views of technology, innovation, US law and business as you? I would think you would expect me to understand those issues.

    Seriously, what is expected is that you keep it real. Please do so.

    -Gene

  108. Gene,

    thanks for your reply, too. However, regarding the satelllite staying in desired orbit: Yes I maintain that you have to only know about gravity (and physics in general, albeit both at deep level) to be able to do that and thus this desired patent for “[method] to get the satellite into orbit at the precise velocity and place so that it will stay in orbit. ” would amount to “apply laws of orbital mechanics to adjust the trajectory of the satellite.” That is what Adrian meant, I believe when he said that this would not be (in lawyer-speak) “patentable subject matter.” As I understand it, you would need to describe something more than that to receive a patent, right?

  109. holdenSK-

    You say: “regarding the satelllite staying in desired orbit: Yes I maintain that you have to only know about gravity…”

    And that is why it is impossible to take ANYTHING you say seriously. Either not taking this conversation seriously, or you labor under the common (yet clearly erroneous) view that innovations are easy to achieve — even pioneering innovations.

    As far as your understanding of patent law and about what you would need to describe, you are incorrect. The trouble is you continue to want to pretend that the first time a satellite was launched and successfully placed into orbit it was a trivial occurrence. That is laughably naive. Under this rationale the rockets, etc. developed for the Apollo missions were not innovative and exhibit ineligible subject matter. Over all it is just an explosion and pointing upward, right?

    You just don’t like patents and believe that innovation happens regardless of patents. There is object proof to the contrary if you just look. Observe where industry locates. All around the world where there are no or few patent rights industry cannot be found. Whenever a country adopts intellectual property laws they enjoy economic growth, prosperity and technological advancement. The proof is in. You should really look at the facts instead of engaging in thought experiments that would prefer to treat everything as commonplace and trivial.

    -Gene

  110. Steve,

    Thanks for noting U.S. Patent No. 6,987,097. Claims 1 and 13 (together) are essentially what my brother Mark and I were looking for. Combining these two claims into one might be tricky but doable (basically adjusting the dosage up or down depending on whether the level of metabolites measured is too high or too low). But togther, Claims 1 and 13 are it.

    If Claims 1 and 13 can’t pass muster under 35 USC 101, it’s hard to see how any method or process claim can. The trouble with Claims 1 and 13 is that aren’t strictly medical diagnostic method Claims. You’ll likely have a “joint infringement” patent enforcement issue with respect to a medical lab that does only the metabolite measurement. Also, any doctor, their medical assistants and so forth who simply adjust the drug dosage wouldn’t infringe these Claims and at least would almost certatinly be immune under 35 USC 287(c); this is the “big lie” perpetuated by some of the amici supporting Mayo Collaborative Services. How to recraft Prometheus’ drug dosage calibration method claim that was struck down so it passes muster under 35 USC 101, yet is assertable against an analytical lab, is what really requires some “draftman’s art” no matter how much Breyer nonsensically denigrates it.

  111. No theory about 35 USC 287(c), FE; it’s law of our land. Point me to a doctor who has been successfully sued for patent infringemetn after the enactment of this statute for carrying out a “medical treatment,” and I’ll believe. Please don’t perpetuate the “big lie” suggested so disingenuously by certain amici supporting Mayo Collaborative Services.

    Gene’s also right about passing the patent agent’s exam; it proves nothing about your knowlege of U.S patent law. Did you go to law school? Pass a state law bar exam? Practice for over 34 years doing U.S. patent prosecution like I have?

    As far as the AIA (the Abominable Inane Act) being an “advance,” you’ve been drinking far too much of the “Kool-Aid” supplied by the proponents of this bilge, including the multinational Goliaths. Have you bothered to read Section 3 which implements this “first to file” regime nonsense? It’s filled language landmines which the Goliaths deliberately had planted there to trip up the Davids.

    As far as “ponying up a fair share of drug development,” you didn’t even address my point: if the rest of the world has drug price controls, how are you going to pay for drug development? Again, drug development doesn’t grow on trees, it requires money and lots of it. If you have drug price controls in most of the world, those who do drug development (i.e., corporations) will have to get the additional money for drug development either from those places that don’t have drug price controls (i.e., U.S.) or from the government; that’s where your “socialized medicine” comes in, and whether you like it or not, “socialized medicine” is one form of “socialism.”

    Oh yes, under “socialized medicine,” the government must subsidize such drug development (because of those price controls), but the citizens still have to pay for it in terms of increased taxes; that’s problem, you need government involvement and coercion to make drug price controls work. I’m frankly not interested in being excessively taxed (as well as coerced) by my government to pay for such drug development, as Obamacare would have us do if it survives constitutional challenge; that can be done very nicely by letting “free market” forces (i.e., good old fashioned “capitalism”) insure that drug pricing is fair and even handed.

  112. Regarding the “Satellite-in Orbit” analogy, Gene stated: “Under this rationale the rockets, etc. developed for the Apollo missions were not innovative and exhibit ineligible subject matter.”

    Not so. Inventions that make it possible to put and keep an object in orbit, or on a trajectory, are certainly patentable. Although a rocket involves using the natural laws regarding optimal mixtures of compounds to produce a specific quantity of thrust. The rocket engineers could certainly patent the device that does so, but a patent that primarily consists of the ratio of fuel to oxygen should be rejected. Even a method for analyzing the the results and adjusting the valves shouldn’t be an acceptable claim, although the device that does the analysis could be.

    The Court’s ruling in this case is much the same. The device that measures the quantity of a chemical in the blood in patentable subject matter. The Supremes unanimously agree that you can’t patent a method for using that device and the results of using it. Only in the “World of IP Lawyers” is that not a clear line.

  113. CharlieB-

    You say: “Inventions that make it possible to put and keep an object in orbit, or on a trajectory, are certainly patentable.”

    I agree with you, but holdenSK would disagree based on his previous comments. He thinks this type of invention merely employs gravity and should not be patent eligible subject matter, which is absurd.

    You say: “The Supremes unanimously agree that you can’t patent a method for using that device and the results of using it.”

    That is an extreme and overbroad reading of even what Justice Breyer said in Mayo v. Prometheus. Methods for using devices have always been patentable subject matter and always will be patentable subject matter. What the Supreme Court said is that this particular method, although not merely reading on a law of nature, is still nevertheless patent ineligible because it is well known. That means it is not patent eligible subject matter because it is either not new or it is obvious. That is why the Supreme Court quite clearly got this matter wrong. They conflated 101 with 102/103, which is simply not permissible under any canon of statutory construction.

    -Gene

  114. Gene,

    please read my comment for what it is: I don’t say that you can’t patent invention by which you can attain orbit. Indeed you should be able to do that. You shoudn’t be able to patent method by which you attain orbit and manage trajectory, which, as I said would amount to “apply celestial mechanics equations to manage satellite trajectory”. Or to put it more clearly, let’s imagine you invent a highly efficient proton stream racket, by which you can attain orbital velocity very quickly and reach Mars faster that conventional fueled rockets. My position is that you should indeed be able to patent that. I am not against patents per se, just against the attitude that you should be able to patent anything under the sun, even abstract ideas or natural laws.

    So as to my layman’s eyes, what should be criteria for the patent application to successfully describe “patentable subject matter”, according to you (SCOTUS decisions notwithstanding) ?

    Thanks in advance for your reply :)

  115. Gene,

    You wrote “That is why the Supreme Court quite clearly got this matter wrong.” I would argue your interpretation of this ruling to the end of time. Interpretation of Law of the Land, including the Constitution, is exactly why the SCOTUS exists.

    If this had been a split decision, I might concede that the majority got it wrong. Even 7-2 might be arguable. 9-0 is a pretty solid statement. Your invitation “collect all the lobbyists and march on Congress” is somewhat offensive to me, as it suggests that opinions paid for by big-business dollars are a fair substitute for the opinions of SCOTUS, or even Congress. Perhaps that is what is really wrong with the system.

  116. CharlieB,

    9-0 is a pretty solid statement.

    Yes. Unfortuantely, the statement is that they solidly got the rationale wrong.

    The rationale in the opinion just cannot be defended according to how the law is written. It matters not that all nine justices agreed with the decision, the rationale offered is not correct.

    If you cannot see that it is correct, then you do not understand patent law.

    It is as simple as that.

  117. “If you cannot see that it is correct”

    should read

    “If you cannot see that it is incorrect”

    Gene, please edit.

  118. Anon,

    What is interesting about your “rationale” claim is that theirs is the only opinion that currently matters, until Congress chooses to clarify the law differently. That is what it means to be in the majority on the Supreme Court.

  119. The relationship of “what matters” to “what is the acutal law” is the driving force behind the consternation.

    CharlieB, you state the obvious about the Supreme Court’s power. But no one is arguing that. I freely admit that.

    What we are arguing about is that the Supreme Court is wrong.

    It is.

    Can you admit that?

  120. Anon, there’s the rub. If the 9 justices interpret a law a certain way, and you disagree with that interpretation, you are wrong, at least until Congress clearly says otherwise. That is the definition of what it means to be SCOTUS. The Constitution says so.

    You can disagree with them, but you are still wrong.

  121. you are wrong, at least until Congress clearly says otherwise. That is the definition of what it means to be SCOTUS. The Constitution says so.

    Not to dwell on semantics, but no, that is not correct.

    Was slavery before the civil war wrong, but still legal?

    Right/wrong is not the same as legal/illegal.

    So I will ask again, can you admit when the Supreme Court is wrong?

  122. Anon,

    Using your slavery analogy, let us assume that I believe that owning an idea is wrong, especially when that idea is merely an understanding of something that has existed since man first appeared on this planet. In that case, the Supreme Court didn’t go far enough with the ruling we’re discussing here, but it is a good start.

    The “right and wrong” that you talk about is based on a belief system. You (and Gene) seem to have an almost religious connection to the idea that exclusive ownership and an artificial monopoly on the use of intellectual property is the only way that technological progress is encouraged. This simply isn’t the case, and I can cite Unix and associated technologies as a clear example. The Posix standards have been implemented in most successful operating systems, including 15 years of Windows, yet it is the openness and freedom that made them successful.

    I realize that pharmaceutical companies are often motivated to produce drugs and apparatus by the money that can be made as a result of being granted a monopoly on their invention. However, it does not follow that profit is the only motivational tool in existence. Abraham Maslow’s Hierarchy of Needs (http://www.abraham-maslow.com/m_motivation/Hierarchy_of_Needs.asp) is regarded as the authoritative description of motivators. The higher up the pyramid you go, the more prolific and novel the resulting ideas become.

    Also, I find no evidence that Maslow applied for a patent on that idea, yet it was developed and is taught at multiple levels of education. It also happens to be right….accurate.

  123. Nice speech.

    You did not answer my question.

    So for a third time, can you admit when the Supreme Court is wrong?

  124. Anon, you question was, “So I will ask again, can you admit when the Supreme Court is wrong?”

    Honestly, my previous comment gives a clear explanation of why I cannot. I find it difficult to accept an interpretation of a law championed by someone (Gene) who has a clear financial stake in that interpretation. It becomes impossible to accept that opinion when nine self-actualized individuals who are specifically tasked with doing that very thing have a different opinion.

    I will concede one things: Perhaps the justices are reading more into 101 than was ever there before. That still doesn’t make them wrong.

  125. I grant that it is healthy to note when a party has a financial stake in the game. There is absolutely nothing wrong with recognizing that (see my comments on other recent threads).

    However, that recognition is not determinative regarding the question I put to you.

    It’s not that difficult of a question CharlieB, and further in truth, is not dependent on the number of Justices that are wrong.

    The plain fact of the matter, whether or not you can admit so, is that the Supreme Court can be wrong, even when they decide on something at a 9-0 clip.

    The fact that you cannot admit this as a possibility says more about you than your stance on Gene.

    As Gene often states, this is a YOU problem.

    Still further, you choose to ignore the fact that the nine justices do not have as firm a grasp on the legal topic as others, instead, confusing their hierarchical power with a greater specific legal knowledge. While this is an easy mistake to make for someone not versed in the legal field, your inability to accept this as a “truth” is also a YOU problem.

    By the way, your attempt at inserting a Maslowian element is unfounded and irrelevant. It really has nothing to do with the conversation except as a slight attempt by you to take some “higher path.”

  126. CharlieB and Anon,

    Let me throw some gasoline on the fire. In Canada I’ve been advocating to the Government that Copyright and Patent law be changed so that the rights involved be non-transferable except by inheritance. Anyone who wanted to use the Copyright or Patent would lease the it for a limited period of time, with automatic renewals prohibited by law.

    The aim of course is to ensure that control would remain with the creator. The idea has met some acceptance in the creative community. The Graham Henderson, President of the Canadian Recording Industry Association aka Music Canada, absolutely hates the idea. Google doesn’t like it either.

    Considering the people that don’t like it, I think it’s a move in the right direction.

    Wayne

  127. Wayne,

    That is a concept I have heard before. However, it runs counter to the overall thrust of law concerning property, which at least in the United States favors alienability, and restraints are preferred to be kept to an absolute minimum.

    You hint at a cultural thrust of who would not like it. You would have to add most of the US population to that list, as most citizens of the United States very much still value freedom and the ability to alienate their property with minimal restriction.

    To your metaphor, I would add that your gas can is empty.

  128. That is a concept I have heard before. However, it runs counter to the overall thrust of law concerning property, which at least in the United States favors alienability, and restraints are preferred to be kept to an absolute minimum.

    But property doesn’t evaporate over time, except under special circumstance, i.e. the Japanese Tsunami changed the coastline. Copyright and Patents evaporate over time by law, therefore they are not technically property.

    You hint at a cultural thrust of who would not like it. You would have to add most of the US population to that list, as most citizens of the United States very much still value freedom and the ability to alienate their property with minimal restriction.

    How do you know this? Have you canvassed stakeholders, particularly those who produce Copyrighted and Patented works? Until you do so, after first conducting a an educational session with the stakeholders first to make sure they understand the advantages and disadvantages of being able to retain control of their creations, despite industry’s interest in gaining control, before making such a statement.

    The discussion in Canada has been along those lines. Those for the current system have been almost 100% Industry Insiders and Lawyers, in other words those who benefit from the sale of Copyrights and Patents, and those who are for a change in the system are creators, who would benefit from retaining the rights.

    Wayne

  129. Wayne,

    It is becoming quite clear that you have no grounding in legal principles and that you are throwing out mere speculation as your version of law.

    If you do not know that LEGALLY intellectual property has the attributes of property, then I am afraid that we can not continue our conversation. It would be a waste of my time and a waste of your ranting.

    Please inform yourself of the basics before posting again (you may want to look into the public policy against the restraint of alienability). It is not only the “insiders” that should understand the language being spoken, but anyone who truly wants to effect change. You retard your own progress by exhibiting your ignorance on this subject.

  130. Wayne’s understanding of the law makes me feel equipped to comment. To argue about patentability and not understand what a property is… seems like you are in fear of “the man” and confused by the idea of exclusionary rights. Silly hippie, you need to remember it’s, “puff, puff, PASS.”

  131. Wayne,

    Your efforts are misguided.

    Here in the States, the originator retains control, until or unless that orignator has contracted that control away.

    You are barking up the wrong tree. Bark up the employment law tree.

    Peace out.

  132. True, I am not a lawyer. Neither were most of the founding fathers. The Constitution was written by a bunch of farmers. Having lawyers interpret it doesn’t make sense, farmers should interpret it, they would be more likely to understand the original meaning.

    Think about it.

    Wayne

  133. Wayne,

    You ask me to join you in bathing in a font of ignorance.

    I politely decline.

    As to your assertion that the founding fathers were “mere” farmers, perhaps you need to read up on the learned ways of the founding fathers before compounding your ignorance. There is thinking that needs to be done here, but alas, it is you that needs to engage in that activity.

    A new analogy for you (forgive the unoriginality): When you find yourself in a hole, the first step you should take in extricating yourself from the hole is to put down the shovel. You cannot dig yourself out of a hole you dug your way into.

  134. As to your assertion that the founding fathers were “mere” farmers

    Anyone who calls any farmer “mere” is displaying a profound amount of ignorance. The farmers who backed your rebellion were, for their time and place, immensely rich men. One Percenters in today’s terms. Probably better educated than most of the people in this forum, since most of them spoke and read Greek and Latin in addition to English.

    But they were still primarily farmers, with the exception of Ben Franklin.

    Wayne

  135. Wayne,

    Your own post then, works against you.

    Clearly, you are no such farmer of old.

  136. It’s true, the justices are not physicians, pharmacists, or practitioners in pharmaceutical industry. However, given their average age, I suspect they are all PATIENTS, most of whom probably receive medication for chronic health issues such as hypertension, cardiac arrhythmias, high cholesterol, and so forth. In each case, they would be on a medication and require periodic monitoring of either drug, metabolite, biomarker for toxicity, or biomarker for efficacy. Their physicians would then adjust the dosing accordingly. The opinion of the court granted may confuse 103 issues with 101 issues. But the unanimity of the opinion basically says that the original patent application should have died from a well deserved 103 long ago because the method described is just not new. The scare tactics that the opinion would cause irreparable harm to the “personalized medicine” industry are nonsense. This sort of “personalized medicine” — dosing, measuring, and adjusting the dose–has been carried out by physicians for decades. This is pretty standard medical practice, folks. And for that reason, I think the justices have it dead right.

  137. kakilicli,

    Please pay attention. The argument is not really over whether the claims deserve a patent. The argument has to do with why they do not deserve a patent.

    This is the critical legal question.

  138. Some of the comments on this thread, in particular those from Foreign Examiner, suggested that that it was a foregone conclusion that Europe, Canada, and other foreign jurisdictions would have deemed the Prometheus claim not to be statutory subject matter under their equivalent legal principles.

    Patently-O published a post today by a European patent attorney who comes to the opposite conclusion and believes that the EPO’s views are in line with the CAFC’s, not the Supreme Court’s. You may find it interesting:

    http://www.patentlyo.com/patent/2012/04/guest-post-prometheus-v-mayo-a-european-view.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+PatentlyO+%28Dennis+Crouch%27s+Patently-O%29

  139. [...] relevant court documents. Patently-O breaks down the opinion in a section-by-section analysis. IPWatchdog criticizes the decision, admonishing that it will kill the medical diagnostics industry. The AMA [...]

  140. “In Mayo v. Prometheus the Supreme Court took claim 1 of U.S. Patent No. 6,355,623 to be the primary claim for purposes of analysis. Claim 1 of the ’623 patent covers:

    A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

    (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointesti­nal disorder; and

    (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointesti­nal disorder,

    wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently admin­istered to said subject and
    wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently ad­ ministered to said subject.

    There is already a general and common medical practice or proceedure that goes like so…

    A. administer some drug to treat some desiease

    b. measure the metabolites

    wherein some level is not enough

    wherein some level is too much.

    The only novelty in this patent is the novelty or certain unpatentable facts or laws or nature.

    1, 6-thioguanine is suited to treat said immune-mediated gastrointesti­nal disorder;
    2. 230 pmol per 8×108 red blood cells is not enough.
    3. 400 pmol per 8×108 red blood cells is too much.

    The mayo clinic actually using different numbers, but that’s beside the point.

    The simple application of a simple fact or natural law to an already known process is not novel and therefore not eligible for patent protection. The only people that benefit from patenting such trivial things are patent lawyers and non-operating entities (patent trolls), Everyone else looses, even the companies with the patents because since they cannot avoid infringing patents must bear the cost or defensive patents and patent lawyers.

  141. Dear Gene,
    I agree that the next step is Congress.
    However, the sky is not falling. Au contraire, it’s raining pennies from heaven. As I point out in my new book “Other Peoples Bodies” http://www.lulu.com/shop/arthur-gershman/other-peoples-bodies/hardcover/product-20049226.html striking down patents such as those in Prometheus and Myriad will spur tons of litigation. I go on to cite several target patents claiming genes for the treatment of such diseases as diabetes, kidney disease and mood disorders.
    Respectfully submitted, Arthur Gershman, RN 27,035

  142. [...] add conventional steps to differentiate from the law of nature are also patent ineligible.  See Killing Industry: The Supreme Court Blows Mayo v. Prometheus.  Those familiar with Mayo v. Prometheus know that the Supreme Court deviated from precedent and [...]

  143. [...] precedent when they decided to consider matters of novelty when determining patent eligibility? See Supreme Court Blows Mayo v. Prometheus. And then in Association of Molecular Patholody v. Myriad Genetics did the Court really mean to [...]

  144. Mark Guttag,
    Neither of your suggested (c) is included in the filing is perhaps due to the concern that that would require the filer to demonstrate, through clinical trials, that the suggested steps are effective as they claimed to be. To required clinical work is enormous that may have deterred the missing claim.