Supreme Court to Revisit Patentable Subject Matter Eligibility

Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Supreme Court 2011)

by Dennis Crouch

The Supreme Court has agreed to hear Mayo’s petition on the patentable subject matter eligibility of medical diagnostic methods.  The issue raised on appeal is stated as follows: 

Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve “transformations” of body chemistry.

The claims asserted by Prometheus are directed toward a method of “optimizing therapeutic efficacy” by first administering an active drug (6-thioguanine) to a subject and then using the subject’s metabolite blood-level to adjust future doses of the drug.  (U.S. Patents 6,355,623 and 6,680,302). Thus, most of the claims are centered around three ordered-steps of:

  1. administering the drug to the subject;
  2. determining the amount of drug in the subject’s blood; and
  3. re-calibrating the drug dosage based on step-2.

A broader claim (claim 46 of the ‘632 patent) eliminates the administering step of claim 1 above.

The district court found the claims invalid as lacking patentable subject matter under 35 U.S.C. 101.  On appeal, the Federal Circuit reversed — holding that the steps of “administering a drug” and “determining the level of 6-thioguanine” were both sufficiently transformative of “a particular article into a different state or thing.”  That Federal Circut decision was based on the court’s machine-or-transformation test that was subsequently discredited by the Supreme Court in Bilski v. Kappos (2010).  In the wake of its Bilski decision, the Supreme Court vacated the Federal Circuit’s Prometheus decision and remanded for a new opinion.  On remand, the Federal Circuit again affirmed that the Prometheus claims are eligilble for patent protection. [See Rantanan's post]

246 thoughts on “Supreme Court to Revisit Patentable Subject Matter Eligibility

  1. MM I’ll just post this here since the site is being a btch.

    You said to Hardworking: “Really? Mental processes have nothing to do with eligibility under 101? Really?! You seem deeply confused, or just ignorant of the law. Or maybe you are just unable to write coherently. ”

    No, she just doesn’t understand your line of reasoning, to be sure, it is difficult to understand and I only picked it up in this thread after you’ve been trying to explain it for nigh on a year now. It is difficult or impossible for her to, under her current understanding, draw the line between an actual patenting of a mental step and an “effective” patenting of a metnal step. You haven’t done a good job of explaining the difference and why this “effective” patenting of a mental step would be related to 101. Although, even in light of your deficient teaching I have managed to pick up what you are saying. And I recognize that it is hard to teach.

    Also, she isn’t so much stoopit as she is close minded and unable to expand her horizons. You are introducing her to a new concept and she is not accepting it.

  2. “Pre-emption is not at play because the claim as a whole is directed to one use of the natural correlation”

    So you think that there are other uses?

    ” For example, a cure that uses the correlation (directly with no intermediate analysis or “thinking”) would not be covered by the claim.”

    “a cure”? What sort of cure are we talking about? A drug? A drug uses correlations? Come on NAL, there are pretty much no other uses for the correlation and certainly drugs are not a use of the correlation.

    “The effective patenting of a mental step is not at play because you have violated the notion of taking the claim as a whole, and you want to only focus on one step of the claim. ”

    Well no, that would be the “actual” patenting of a mental step. Malcolm is talking about what the claim effectively accomplishes. Be clear, they are two distinct things. And I believe he is right, although courts have not gone down the “effective patenting of a mental step” path just yet.

  3. “where the too abstract line is” is at any abstract.

    And for you Matt:

    Abstract-

    adj-Existing in thought or as an idea but not having a physical or concrete existence.

    If it don’t have na physical or concrete existence then it is abstract son.

  4. I agree Les, they should spend more time rejecting B claims. Just following orders is no excuse, they’re under oath.

  5. QUESTION: Do you believe that you can turn a new but ineligible process of “thinking about a number” into statutory subject matter merely by adding an admittedly old and unpatentable step of determining a number?”

    Hardworking ANSWER: Without anything more, as in additional steps, no. But this is not in any way related to the facts of this case either.

    Actually those are exactly the facts of this case.

    QUESTION “Do you really believe that you can turn an old and therefore unpatentable method into a patentable method merely by adding a subsequent step of thinking about something ‘new’?”

    Hardworking ANSWER: Without anything more (as in additional steps), no. But this is not in any way related to a 101 issue.

    Really? Mental processes have nothing to do with eligibility under 101? Really?! You seem deeply confused, or just ignorant of the law. Or maybe you are just unable to write coherently.

    More importantly, Hardworking, you haven’t explained why you believe that you can not turn an old and therefore unpatentable method into a patentable method merely by adding a subsequent step of thinking about something ‘new’. Please explain your answer. I’m surprised that you forgot to do that. Actually, not really. I would have been far more surprised if you actually attempted to answer the question reasonably and coherently.

    There is plenty of case law that supports the inclusion in valid patents of mental steps.

    Thank you, but that’s not the issue we’re discussing. We’re discussing a more specific set of facts. Have you forgotten those facts already? I’ve only stated and re-stated them dozens of times already. Let me know if you need me to state the facts for you one more time.

    As anyone can see, we’re starting to move closer to the really tough question: is “Hardworking” st00pit, or just a lxixaxr? Let’s see if “Hardworking” can redeem itself. I’m guessing not.

  6. If one is inclined to ask how many socks someone else has in that person’s drawer, then it is probable that that person asking is looking for more socks.

    This follows the adage that a liar thinks that everyone else is a liar.

    To be direct:

    I am not Actual Inventor.

    I have not advanced any argument that the patents at issue are perfectly legit.

    I have advanced the argument that this is not a 101 issue, but a 103 issue.

    So tell me Hans Blix, how is your errant posturing doing anything here but “kicking up dust”?

    Let’s actually try to stay focused on the issues (any pertinent issues at all).

  7. cannot possibly be patentable under 102/103. No claim with the structure of these claims can be both eligible for patenting and valid. And yet some refuse to even address the issue.

    Maybe because that there are too many people who think “maybe there’s nothing wrong with that” when conflating the issues between 101 and either 102 or 103. Maybe because “the issue” of “patent eligibility” and “patent validity” are separate and distinct issues. Maybe because it is important to recognize the difference between “patent eligibility” and “patent validity” as a basic tenant of patent law.

    Further, I am not asking you to take the time to “clear things up for [me]” – I was being gentle in a rhetorical manner in suggesting that any muddling in the discussion of this matter is on your end. One does not have to agree that the instant claims are valid to make the argument that a question of patent eligibility is not the right question to ask. In other words, it is important that the law (and the justices interpreting the law) understand the difference between eligible subject matter and a valid (or invalid) patent for failing to meet a different provision of the law than 101.

    Nevertheless, in order to move the issue forward:

    Do you really believe that you can turn an old and therefore unpatentable method into a patentable method merely by adding a subsequent step of thinking about something ‘new’?

    Without anything more (as in additional steps), no. But this is not in any way related to a 101 issue. If this were a 101 issue, the old method itself would fail the 101 test – this case does not present those facts.

    Do you believe that you can turn a new but ineligible process of “thinking about a number” into statutory subject matter merely by adding an admittedly old and unpatentable step of determining a number?

    Without anything more, as in additional steps, no. But this is not in any way related to the facts of this case either.

    Be wise to pay attention to the “without anything more” caveat – and consider your propensity for not taking claims as a whole, as you must.

    Quite plainly, the reason it must be one or the other is because it violates 101 issues (either pre-emption or the effective patenting of a mental step).
    Do you agree? If you don’t agree, explain why.

    I do not agree.

    Pre-emption is not at play because the claim as a whole is directed to one use of the natural correlation. Other uses not identified are not covered. For example, a cure that uses the correlation (directly with no intermediate analysis or “thinking”) would not be covered by the claim.

    The effective patenting of a mental step is not at play because you have violated the notion of taking the claim as a whole, and you want to only focus on one step of the claim. There is plenty of case law that supports the inclusion in valid patents of mental steps. I simply do not accept your conclusory statement that the instant claim is an effective patenting of a mental step in the way that you want to parse the claim to read.

  8. “6 is always on about pre-emption. I wonder if he agrees with that passage of the Brief.”

    Of course I do, it is the cliff’s notes of what I’m preaching on here every other week. Although they use wording that is likely to confuse the likes of Ned and other confusolots. They don’t go into the necessary detail to fully flesh out the preemption doctrine, they just scratch the surface, and that leads to misunderstanding. Luckily for us, the supremes on the bench right now seem to understand preemption just fine and don’t need the brief to hold their hand through the details.

    For instance, one might think from what they wrote that if Benson has recited what to do with the numbers then the patent would have been fine. But that is not necessarily the case. It MIGHT have been fine, and it might not have. Although in the factual situation of Benson I believe it very likely that they would have been fine.

  9. your point is just muddled to me

    Please answer the questions I posed to Casual Observer. If you are unwilling to do so or if you don’t understand the questions, it’s not worth my time trying to clear things up for you.

  10. It is irrelevant whether the methods are “well-known” for 101 purposes. I was at the Bilski SCOTUS oral argument and it was incredible how often this line was blurred by the judges.

    LOL. Maybe that’s because the degree to which a claim on the border of subject matter eligibility is perceived as obvious affects the outcome? Just maybe? And maybe there’s nothing wrong with that.

    More importantly, however, in this case the facts are such that there is no dispute between any of the parties that the claim would turn people who are practicing the “well known” prior art into infringers merely because, after the application was published, they learned an unpatentable fact.

    It’s amazing how many people comment on this case without knowing the facts. It’s almost as amazing as the people who refuse to acknowledge the fact that even if the claims are judged to be patent eligible they cannot possibly be patentable under 102/103. No claim with the structure of these claims can be both eligible for patenting and valid.

    And yet some refuse to even address the issue.

  11. Malcolm,

    It is not anticipation that would sink such a claim, as it would be obviousness.

    As such, no one is saying that anyone is allowed to ignroe the recitation of the ‘new” mental step – in fact, I keep reading that people keep on telling you to not dissect the claims.

    Either you have presented a strawman argument here, or your point is just muddled to me.

    Either way, any muddle between 102 and 103 is completely separate from 101.

  12. Three things I should have understood.
    Addressed to me only while my Mother was living in Hanover. “Quote” You have a cousin that just got killed in a car wreck. My response was who? I don’t know anyone I am related to around here.
    I mentioned a medical problem to my Mother. Her response All the manning girls have that.
    Killherforthekeys….
    You look just like your Mother.. not.. you look just like Ma.

  13. I don’t like the following from the issue presented for appeal: “simply because well known methods used to administer prescription drugs and test blood may involve “transformations” of body chemistry.”

    It is irrelevant whether the methods are “well-known” for 101 purposes. I was at the Bilski SCOTUS oral argument and it was incredible how often this line was blurred by the judges.

  14. Nope, no mention of disclosing anything:

    § 1.75 Claim(s).

    (a) The specification must conclude with a claim particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention or discovery.

    (b) More than one claim may be presented provided they differ substantially from each other and are not unduly multiplied.

    (c) One or more claims may be presented in dependent form, referring back to and further limiting another claim or claims in the same application. Any dependent claim which refers to more than one other claim (“multiple dependent claim”) shall refer to such other claims in the alternative only. A multiple dependent claim shall not serve as a basis for any other multiple dependent claim. For fee calculation purposes under § 1.16, a multiple dependent claim will be considered to be that number of claims to which direct reference is made therein. For fee calculation purposes also, any claim depending from a multiple dependent claim will be considered to be that number of claims to which direct reference is made in that multiple dependent claim. In addition to the other filing fees, any original application which is filed with, or is amended to include, multiple dependent claims must have paid therein the fee set forth in § 1.16(j). Claims in dependent form shall be construed to include all the limitations of the claim incorporated by reference into the dependent claim. A multiple dependent claim shall be construed to incorporate by reference all the limitations of each of the particular claims in relation to which it is being considered.

    (d)

    (1) The claim or claims must conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description. (See § 1.58(a)).

    (2) See §§ 1.141 to 1.146 as to claiming different inventions in one application.

    (e) Where the nature of the case admits, as in the case of an improvement, any independent claim should contain in the following order:

    (1) A preamble comprising a general description of all the elements or steps of the claimed combination which are conventional or known,

    (2) A phrase such as “wherein the improvement comprises,” and

    (3) Those elements, steps, and/or relationships which constitute that portion of the claimed combination which the applicant considers as the new or improved portion.

    (f) If there are several claims, they shall be numbered consecutively in Arabic numerals.

    (g) The least restrictive claim should be presented as claim number 1, and all dependent claims should be grouped together with the claim or claims to which they refer to the extent practicable.

    link to uspto.gov

  15. The problem is that by bypassing any 103 analysis

    I’m not suggesting that any “analysis” be bypassed.

    Do you understand the facts in this case?

    The claim recites (1) an old step of determining a number, e.g., the level of a particular metabolite in the blood (this is admitted by both parties) and (2) a mental step of thinking a “new” thought about that number.

    As I’ve pointed out numerous times, I could really care less whether you hold that a claim of this type is invalid under 101 or per se obvious/anticipated. Quite plainly, the reason it must be one or the other is because it violates 101 issues (either pre-emption or the effective patenting of a mental step).

    Do you agree? If you don’t agree, explain why. Specifically, explain why a claim that adds a “new” mental step to an old unpatentable step is not, effectively, a claim to a mental process. In your answer, consider the person whose job for years prior to the filing of the application has been practicing the old step, but who is subsequently taught the “new” mental step when they read about the “new” “correlation” in a letter sent to them by the patentee. They are now infringers when they go back to their job unless they “unlearn” what they have been taught.

    Also, be aware that this is exactly how Prometheus interprets the scope of their claim.

    Step up to the plate, “Casual Observer”. Or slink back under the rock with the rest of the dxxxchebag trolls who can’t handle the truth.

  16. the war crime that is most office actions….

    You’ve got some nerve saying that in a thread about an embarrassingly badly-drafted set of claims.

    But I suppose that’s completely different, because it’s not like we agents are ever under “orders” to draft claims in a particular way.

  17. ” Doesn’t that approach reflect any underlying prejudice against patenting certain types of subject matter?”

    Yeah, it reflects a strong underlying judicial prejudice against these things we like to call the “judicial exceptions”.

  18. Lionel The actual claims in question are ridiculous and need to be rejected uner 102/103. However, I agree that 101 should not be used.

    Lionel, is any claim in the form:

    1) Old step
    2) Mental step of contemplating result of old step in light of “new” fact taught in specification

    anticipated? Or just these particular claims? If the former, can you explain why you are allowed to ignore the recitation of the “new” mental step for the anticipation analysis?

  19. First, the claims DO have to disclose things.

    Second, I KNOW that statements of asserted utility do not have to be made in the claims.

    Third, a statement of asserted utility WAS made in this claim.

    Fourth, the claim as written evidences NO specific and substantial utility relative to the asserted utility, and is therefore describes a wholly inoperative invention.

    I can re-post the reasoning and analysis, but would prefer to link to the previous thread in which it was discussed, if only Dennis would find it.

  20. OK, you’re a Parker v. Flook fundamentalist. The problem is that by bypassing any 103 analysis the court can come in with a bias against the patentability of entire classes of technology, and never really consider obviousness. Isn’t KSR enough to deal with this? Why does 101 have to function as a super-103? Doesn’t that approach reflect any underlying prejudice against patenting certain types of subject matter?

  21. Claims don’t have to disclose anything, including utility. The requirement is that the invention BE useful.

    Clearly treating someones disease is useful.

  22. In Bilski v. Kappos, the Supreme Court basically decided that compliance with the “machine or transformation test” was neither necessary to sufficient. But the CAFC assumed in this case that compliance with the MoT test is sufficient – so it is clearly wrong!

    Anyway, the MoT test originates from Cochrane v. Deener whether it was decided to be a sufficient condition. Turning a sufficient condition into a necessary condition violates basic logic. At least the argument for the one type of condition don’t apply for the other one. So I think the courts should stop even *thinking* about the MoT-test. Transformation imho is a process creating value – and patents are always supposed to create value, else they are useless.

    QUESTION: could anyone tell me how (un)usual it is for the SCOTUS to grant certorioari a second time for the same case? Even if the first decision was a one line decision?

  23. Blah, blah, blah, blah…

    I’ll say it one more time, as it bears repeating:

    The invention is wholly inoperative, as claims disclose no specific and substantial utility whatsoever, and are therefore invalid for lack of utility under 101.

    All these posts about 103, 101 s-m eligibility, laws of nature, pre-emption, insignificant post-solution activity, infringing by merely thinking…you guys sound like Congress.

    I’m sorry–I enjoy going back-and-forth with many of you, but this thread is a complete waste of time. You guys went off the rails early, and have ended up in Wonderland.

    And DENNIS, where is that mystery thread?????

  24. David –

    The logic you are applying is inappropriate.

    For example, lets say the disease is cancer and the level test is of sodium nitride and the “drug” is lemon juice and controlling the level of sodium nitride to be withing the recited range with lemon juice curse the cancer.

    Is it obvious now? Of course not.

    This is why the courts have developed the “as a whole” standard and why it is inappropriate to dissect the important bits out of the claim as you have done.

    Anyway, Obviousness is another question. Whats at issue here is does the claim recite a method under 35 USC 100 and 101.

  25. The Mayo Brief (link above) I found very helpful on the distinction between Benson, Flook, on the one hand, and Diehr on the other. See the passage starting at the foot of page 22 and ending at the top of page 24. thank you for the Link Malcolm Mooney. 6 is always on about pre-emption. I wonder if he agrees with that passage of the Brief.

    BTW, MM, I think if the Brief laboured any more than it does the point that mere thinking about it constitutes infringement, SCOTUS would get irritated. I liked the bits about freedom of speech and the impossibility of ridding your memory of an infringing thought, once thunk. Bravo F&R (or whoever wrote this Brief).

  26. The actual claims in question are ridiculous and need to be rejected uner 102/103. However, I agree that 101 should not be used.

  27. “I don’t know if I would say that the ranges recited in Prometheus’ claims are “inherent” but it does show (again) how weird these claims are”

    So those maybe the ranges did not indicate a presence of excess stuff such that a dosage amount would need to be adjusted prior to them teaching that it did? They magically made that range indicate that just by teaching it? Or did it already exist in the prior art, waiting for them to find it and teach us about it?

  28. “We really do no know why the claims in Bilski were abstract. With Steven gone, we might have a working majority that will actually tackle that issue.”

    OMG, are you still this much in denial over the SCOTUS Bilski ruling? The Court was VERY specific why. Bilki’s claims covered both the concept of hedging and the application.

    During oral argument a justice pointed out that if a professor lectured about Bilkis concept it would infringe.

    Personally I do not have a problem with such a broad use of a concept being patentable but the Courts want to draw the line at thinking, speaking and teaching concepts. So Bilski did not get his patent.

    But let us not pretend that other so called business methods that have a clear application of science and technology be it with or without machines and transformations, are not instant 101 statutory subject matter. Thats the law so deal with it Ned and like Stevens, move on.

  29. I answered your dadburn question – I’m cooperating here, I’m cooperating with ya…

    Jerry

  30. “Similarly, in Bilski, the Supremes made the point of saying that you can’t simply point to a transformation or a machine and say “It’s 101 eligible” and walk away satisfied that your job is done. In some instances, more thought will be required.”

    Malcolm Wrong Again!

    The Court Actually upheld the MOT as a test that can be used It simply didn’t let MOT become the sole test and in effect narrow the interpretation of Diehr, which would have made Diehrs concept and application analysis as a test for 101 mute. To drive that point home that Diehr still controls and make it clear to num nums like Malcolm the Court said…

    “Finally, in Diehr, the Court established a limitation on the principles articulated in Benson and Flook.” Bilski page 14 final paragraph.

    BAM!!

    Schools Out For Summer!

  31. “Infringement occurs only after potentially toxic drugs are administered to an ill patient, blood samples are extracted, metabolite levels are measured using sophisticated scientific instruments, and a warning is provided about a possible need to adjust dosage.”

    A couple points about this passage from Prometheus’ brief. First, as DC noted in the original post, you don’t need to adminster a drug to infringe. All you need to do is measure the metabolite in the blood sample and know (i.e., think) about the correlation taught in Prometheus’ specification. Any lab carrying out the tests would directly infringe this claim once they are made aware of Prometheus’ numbers, even if they never see the patient, and even if they have been carrying out the identical test for a decade before the patent was ever filed.

    Also, the business about “sophisticated scientific instruments” is rather pathetic. There are no such instruments recited in the claim. What difference would it make anyway? If blood must taken and “transformed” in order to infringe the method, it shouldn’t matter for 101 purposes if the instrument used are “sophisticated” or not. What matters is that Prometheus didn’t claim the use of any particular instrument. If they had, we might not be here.

  32. Wrong Malcolm. Thats what YOU say, and all the time, but the Court had something far more specific, relevant, and legally binding to say. Let’s review shall we?

    “In determining the eligibility of respondents’ claimed process for patent protection under §101, their claims must be considered as a whole. It is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis. This is particularly true in a process claim because a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made. The “novelty” of any element or steps in a process, or even of the <450 U.S. 189> process itself, is of no relevance in determining whether the subject matter of a claim falls within the §101 categories of possibly patentable subject matter.12″

    BAM! CASE CLOSED!

  33. Did they just not get to the anticipation issue in this case because of the motion for summary judgement for invalidity over 101 that was granted?

    I believe this is correct.

    isn’t this yet another case where we have the applicant’s own specification confirming that all the stuff in the wherein is inherent in the prior art?

    As far as I can tell, there is no dispute that researchers and/or doctors in the prior art looked at the drug and/or metabolite levels in patients and adjusted the dose up or downwards in response to those levels, particularly at the extremes of the ranges cited by Prometheus (i.e., very low and very high levels).

    I don’t know if I would say that the ranges recited in Prometheus’ claims are “inherent” but it does show (again) how weird these claims are. Does one need to remember the range precisely in order to infringe?

  34. MM I am curious about one thing. In this particular case, isn’t the “wherein” inherent? Did they just not get to the anticipation issue in this case because of the motion for summary judgement for invalidity over 101 that was granted?

    I mean, isn’t this yet another case where we have the applicant’s own specification confirming that all the stuff in the wherein is inherent in the prior art?

  35. Oh, good that you found that copy, so much easier to read than the copy I found and then finagled into working on my computer.

  36. “I guess what I find most fascinating about this case is that there is no possible way for Prometheus to win it outright.”

    I know right? It’s one of those cases where there simply is no remedy that a court could give them, maybe they should just toss the case because of that. Lulz.

  37. “Infringement occurs only after potentially toxic drugs
    are administered to an ill patient, blood samples are
    extracted, metabolite levels are measured using
    sophisticated scientific instruments, and a warning is
    provided about a possible need to adjust dosage.”

    Yeah I thought they fought against that claim construction back at the DC.

  38. “The gist of Mayo’s position is
    that a valid patent must direct the doctor to take a
    final, physical step or steps in response to the
    information generated. But (as Mayo well knows)
    modern medicine is far too individualized for that kind
    of patent drafting to be practical or desirable.
    Specifying exactly what a treating physician must do
    with useful diagnostic or treatment information would
    require patents to contain infinitely complex decision
    trees that would likely become obsolete long before the
    patent term expires.”

    In other words, requiring Prom to claim an actual patentable invention under 101 would be the worst thing evar!

  39. Dood where is Prometheus’ brief?

    Mayo’s is ez to find, and hard to view or I would have posted a link to that brief. The file format is some Office 2007 nonsense that doesn’t even open unless you’re a supar genius. At least all the versions I could find where that fcking .docx format after it was zipped into 5 different files.

  40. I guess what I find most fascinating about this case is that there is no possible way for Prometheus to win it outright. At the end of the day, they lose the 101 issue or their claims are anticipated (because if the mental step is allowed to impart novelty, then they would have a patent on mental processes, for practical purposes).

    Unless there’s some stipulation somewhere that I’m unaware of, Prometheus can only “win” outright by forcing a settlement. Here’s hoping Mayo refuses to budge …

  41. Prometheus’ brief is awful and overwrought:

    These patents do not claim correlations between
    metabolite levels and toxicity/efficacy in the abstract,
    but instead apply those relationships in concrete
    physical processes to generate useful treatment
    information for physicians

    As pointed out by Mayo, this is simply false. The correlations recited in the claim are not “applied .. in concrete physical processes.” The useful information” is not generated by Prometheus’s claimed invention. Rather, the correlations themselves (natural facts) are the useful information. They are disclosed in the specification. The only concrete physical processes in Mayo’s claim are old processes which they could not patent if they wanted to. The information generated by those processes also can’t be patented.

    Regarding LabCorp, Prometheus attempts to distinguish:

    The patent there did not involve the
    administration of synthetic (or, indeed, any) drugs as
    part of a course of treatment for a particular disease.

    Except that not all of Prometheus claims recite a step of administering a drug. Oops. And the claims at issue do not recite a step of administering a “course of treatment”. Oops.

    The gist of Mayo’s position is
    that a valid patent must direct the doctor to take a
    final, physical step or steps in response to the
    information generated. But (as Mayo well knows)
    modern medicine is far too individualized for that kind
    of patent drafting to be practical or desirable.
    Specifying exactly what a treating physician must do
    with useful diagnostic or treatment information would
    require patents to contain infinitely complex decision
    trees that would likely become obsolete long before the
    patent term expires.

    BOOO HOO HOO HOOOO HOOOOHOOOOO!!!!!!!!!!!!

    Infringement occurs only after potentially toxic drugs
    are administered to an ill patient, blood samples are
    extracted, metabolite levels are measured using
    sophisticated scientific instruments, and a warning is
    provided about a possible need to adjust dosage.

    Really? Who provides the warning? The test tube?

  42. link to articles.law360.s3.amazonaws.com

    It is well-written although it focuses a bit much on the pre-emption issue and not enough, from my perspective, on the practical preclusion of mental processes. Of course, pre-emption/abstraction/mental process do tend to merge in certain instances, and this appears to be one of them.

    It is amazing, though, that the Federal Circuit managed to bury these facts in their opinion.

    Prometheus’s infringement accusations against
    Mayo researcher Dr. Rokea el-Azhary highlight the
    extraordinary breadth of these patents. Dr. el-
    Azhary is a dermatologist. She gave her dermatological patients a thiopurine drug to try to establish a therapeutic range for skin disorders.

    But because the lab report she received referred
    to the correlation ranges in Prometheus’s
    claims, Prometheus accused her of infringement:
    The Biochemical Genetics Laboratory at
    Mayo Clinic Rochester sent a report of test
    results to Dr. El-Azhary, or someone working
    for Dr. el-Azhary. The test results described
    the “therapeutic range” as “235-400.” …

    Such information informed Dr. el-Azhary, or
    someone working for Dr. el-Azhary (and thus
    “indicated a need”), that the next dose of azathioprene given to the patient should be increased in order to be within the “therapeutic
    range.”

    Prometheus even asserted infringement when Dr. el-Azhary subsequently received reports that did not list the “therapeutic range” the ground that the ranges were still in her memory.

    Dr. el-Azhary testified that she knew the numbers, but because Prometheus’s range was developed from patients with gastrointestinal disorders, it was “irrelevant to [her] study” of metabolite levels in patients with dermatological disorders.

    Under Prometheus’s patents, Dr. el-
    Azhary must stop her dermatological research until
    she rids her memory of the gastrointestinal correlations–regardless of how she ultimately may use any test results-because Prometheus’s patents preempt all possible uses of the correlations. If these claims are allowed to stand, Prometheus can sue anyone who thinks about the claimed correlations when conducting research or treating patients, no matter how they obtain such information–including by reading this petition.

    I would hope that if the Supreme Court decides that if transformative data-gathering steps render a claim 101 compliant, that they at least address what must happen during analysis of the claim for anticipation purposes. This was really the Federal Circuit’s major mistake. Cert likely could have been avoided if the CAFC had merely noted that the subsequent mental step must be ignored for the purpose of determining validity under 102/103.

    One obvious issue left unaddressed in Mayo’s brief is whether a final mental step in any method is fatal to the method’s patent eligibility. What if the method of gathering data is, by itself, novel and patent eligible? Does adding the mental step kill it? Mayo doesn’t say.

  43. “Can one patent a new method of using the information about the natural phenomena to do something useful.

    Why, of course, yes.”

    Quick someone inform the Morse court!

  44. “The remaining open issue from Flook was whether tying the data source to a real world measurement would rendered the claim patentable.

    Obviously, not. The output of the claim is still a number not tied to a use. Diehr was patentable because the output of the mathematics was actually used to do something in the real world.

    I think we are soon to get that view from the Supreme Court.”

    Oh look, Ned has fully backslidden.

  45. Malcolm, I might be wrong, but the Feds are not premising their opinion on the mental step, but on the usefulness of the information. It obviously is useful. The claim is also tied physically to something real through its inputs. That is a given. But still there is a problem with the claim in that it cannot be infringed given that the phenomena is one of nature and the measurement is old. The is something fundamentally wrong with such a claim.

    The remaining open issue from Flook was whether tying the data source to a real world measurement would rendered the claim patentable.

    Obviously, not. The output of the claim is still a number not tied to a use. Diehr was patentable because the output of the mathematics was actually used to do something in the real world.

    I think we are soon to get that view from the Supreme Court.

  46. Can one patent a natural phenomena?

    No.

    Can one patent the dectection of the natural phenomena without limit to anything patentable in the method of detection or limited only to a well known method?

    No.

    Can one patent a new method of using the information about the natural phenomena to do something useful.

    Why, of course, yes.

    Where is the broadest Prometheus claim in this spectrum?

  47. “All the court was saying in Diehr is that you can’t point to a line of unpatentable subject matter in the claim and throw the claim out. You have to actually use your powerful computer brain.”

    ftfy

  48. A book describes a new medical procedure. Can I patent the book limited to the description and make infringers of anyone who reads the book?

    Make, use, sell…

    What if a surgeon uses the medical procedure. Is he infringing the book patent?

    Does a person who sells the book to the surgeon infringe the book patent. If he does, is it direct or contributory?

    We are in an uncharted territory here. The reason we are, in part, is because once upon a time I vote yes to the limitation on medical procedures being infringements. I was wrong and I apologize.

  49. MM said: “How do you determine if any ‘post-solution activity’ has been ‘added’ without dissecting the claim?”

    By considering the claim as a whole in view of what is the idea in the abstract, versus a claimed application of the idea. And remember, it says insignificant post-solution activity, not just post-solution activity.

  50. Address the issue,

    I already did. And then I went further and responded to your mostly incoherent comment, asking you some specific, straightforward questions in an attempt to focus your attention on the 101-related problems that some of “us” have identified with Prometheus’ claims.

    You refused to answer those questions. I’ll repeat one of them for you:

    Do you really believe that you can turn an old and therefore unpatentable method into a patentable method merely by adding a subsequent step of thinking about something “new”?

    Here’s another one for you:

    Do you believe that you can turn a new but ineligible process of “thinking about a number” into statutory subject matter merely by adding an admittedly old and unpatentable step of determining a number?

    These are straightforward “yes” or “no’ questions. Just answer them and we can move on. Otherwise I’ll ignore your incoherent babbling.

  51. Man I just read the petition for Cert and I like what I see. On the whole, they did a pretty good job of explaining the preemption doctrine, though not quite a perfect job. I would have expected a huge company like Mayo to be able to afford more eloquent legal staff, but, no matter.

    On the whole, I’d say they have a pretty good shot.

  52. Um, how many socks do you have in your drawer? I count at least five. Do you hope that your multiple socks help to advance your argument that the patents at issue are perfectly legit? Why not just keep posting under your normal name, Actual Inventor?

  53. Address the issue, which is 35 U.S.C. Sec. 101 — NOT 102, 103 or 112. You can say it’s not “new” but that’s beside the point. You can say it lacks utility because it is not new, but then why not just satisfy yourself that it’s not new (which as I said is beside the point anyway). And you can’t say it is not a “process.” “[A]dministering a drug,” or for that matter determining the level 6-thioguanine in a subject, cannot be performed merely “by thinking certain thoughts.” The wherein clauses recite mental steps, but since when do we not consider “the invention as a whole”? Unless maybe they will overrule Diehr now.

  54. Has the thread mysteriously disappeared?

    Mooney, do you know what happened to it?

    Dennis?

  55. “But the vice in Bilski majority opinion is that they simply “announced” that the claim was abstract, when it was not abstract in any known or understandable sense of that term.”

    Not really, if you read the part that where they talk about why they are holding how they are, they explain that it is because the claim would effectively preempt the abstract idea of hedging that is underlying the claim. The only “vice” is that they did not explicitly tell us what that abstract hedging idea was. But, they’re leaving that to the interested student to cipher out. And it isn’t that hard when you read the spec of that app. Iirc I found what it was and posted it in another thread. I’m not going to go look for it again.

    “The claim required the making of contracts with counter risks. That is actually doing something. It is not abstract. It is action. It is real. It is concrete. It involves contacting real people. Etc., etc., etc.”

    Yes… but Ned, do all implementations of the abstract hedging idea underlying that claim also involve contracts with counter risks, actually doing something, performing an action, doing something real, concrete even, and involve contacting real people? I think yes, yes they do. And that is why there is a problem.

    “If this concrete action is abstract, it should be encombant on the Supreme Court to explain why it is abstract.”

    They did not say or imply that the concrete action is abstract. I’m not sure why you keep bringing this up. I’ve explained to you that the type of issue/rejection we’re dealing with is specifically for situations when “concrete, real, etc.” steps are what are involved in the claim. But you keep backsliding into having that be relevant. THAT IS NOT RELEVANT TO THIS TYPE OF ISSUE NED BECAUSE WE HAVE ALREADY ACKNOWLEDGED THAT THE STEPS ARE CONCRETE ETC. AND THE CLAIM DOES NOT FAIL FOR SIMPLY HAVING RECITED AN ABSTRACTION ITSELF. NOW THE ISSUE IS ABOUT THE ABSTRACT IDEA UNDERLYING THE CONCRETE STEPS.

    “If it is because the actions involve contracts and risk, then the vice is that the concrete actions were directed to a ultility that was not technical and therefor not within the useful arts. But that was the positon of the “dissent.” ”

    That is not why, so put that out of your mind.

    We already know “why” and it is the thing which you regarded as “ridiculous” in your previous post. You need to latch on to that concept that you regard as “ridiculous” because that is the concept that makes these claims get struck down.

    “It is a crying shame that you in the PTO have to deal with this nonsense.”

    Well I agree with that, but mainly because attorneys (and some examiners) like yourself refuse to understand what is going on. It is as if I get you to understand, and then you say “but that is ridiculous!” after having understood, and then in your next post you backslide into your old position which is predicated on your non-understanding. It’s like you grasp the concept one minute but then no sooner than you grasp it you let it fly out of your head for no apparent reason. It’s like I’m trying to teach a 5 year old calculus.

    In any event, whenever you feel like understanding why the surpremes are holding the way they are, simply re-read the paragraph I wrote for you which lead you to understand a position that you regard as ridiculous.

    Please, favorite this thread so that you can refer back.

  56. Ned,

    Your reply to Casual Observer makes his point.

    All of your comments are to a 103 issue – not a 101 issue.

  57. Malcolm,

    Your snideness is out of place.

    I thought people were interested in having issues advanced here. Was I mistaken?

  58. “All uses of an abstract idea.”

    Agreed that is right, as the claim is effectively on the abstract idea.

    But the vice in Bilski majority opinion is that they simply “announced” that the claim was abstract, when it was not abstract in any known or understandable sense of that term.

    The claim required the making of contracts with counter risks. That is actually doing something. It is not abstract. It is action. It is real. It is concrete. It involves contacting real people. Etc., etc., etc.

    If this concrete action is abstract, it should be encombant on the Supreme Court to explain why it is abstract.

    If it is because the actions involve contracts and risk, then the vice is that the concrete actions were directed to a ultility that was not technical and therefor not within the useful arts. But that was the positon of the “dissent.”

    The majority opinion makes no sense whatsoever.

    It is a crying shame that you in the PTO have to deal with this nonsense.

  59. I think what you mean to say is “I wish Malcolm, Ned, and 6 would stop posting on this issue because I don’t agree with them and I only want to read posts from people who agree with me.” Is that about right?

  60. The 80:20 rule is most decidedly not at play here.

    Three individuals making up nearly half of all comments on a hundred-plus thread is a reflection of something – a cacophony of intellectual voidness.

  61. “That is ridiculous.”

    Oh, I agree it is ridiculous. Now that you have recognized that it is ridiculous, take that which you believe to be ridiculous HOLD IT WITH BOTH HANDS, DO NOT LET IT GET AWAY and insert it into your mind in place of your old beliefs. Know that great minds, like Chisum, agree with you that it is absolutely ridiculous but they also acknowledge it is absolutely the law as of today. And it is, undisputably, absolutely ridiculous. But it is ridiculousness in response to ridiculous claims, so meh, can you the USSC? I can’t.

    “Per Benson, the only way one wholly preempts a mathematical algorithms to recite a computer for calculating it and to provide no use for the result.”

    Um, no Ned. You need to go read that again. They didn’t say that “the only way one wholly preempts a (judicial exception) is to recite a computer for calculating it and to provide no use for the result”. Nowhere did they say anything even akin to that. And that is why you’re so confused. Put that out of your mind. And keep it out. Forever. Never let back in.

    “Where in Bilski is there a GP computer?”

    Nowhere? And is it relevant? Nope.

    “Where in Bilski is there no use for the algrorithm?””

    Nowhere? And is it relevant? Nope.

    Bottom line ned, Benson’s overall holding was broader than for just GP comps. It also did not hinge on no use being recited. There is language enough in the decision to confuse you into thinking so, but the bottom line is that the claim preempts all uses of the binary-bcd algorithm. The court makes the statements that are confusing you just to shore up why it is holding how it is. You see, had Benson limited his claim to, for instance, use in the railway industry, or use in the chemical industry, then not all uses would have been preempt, and the court might not have held the claim invalid. (Indeed, that is the situation you find in Flook, where the drafter tried to get around the prohibition in Benson by limiting the claim to a specific sub-field of chem.) That is to say, if you tack a “use” on at the end then your claim might not preempt all uses because you are limiting yourself to the one use. However, as in Bilski, you still have a problem if the use which you claim is the only use to which the judicial excepted material might ever be put.

    “Bilski’s statement about wholly preempting the math in the context of its claim was not comprehensible. It was mere words without substance. It was incantation.”

    No, Bilski’s statement about wholly preempting math was simply the court addressing a dependent claim which involved math on top of the underlying hedging abstract idea. This is all very simple once you put your deeply held beliefs aside and accept what I’m saying. I swear, if you simply accept it then everything will fall into place. Neatly even. Just accept it Ned and watch the pieces fall into place.

    I’m really not even sure why you have such an issue with the preemption doctrine as laid forth by me Ned, it is merely the court’s logical extension of the general prohibition against claiming judicial exceptions laid down by the courts throughout the ages. Literally, all it is is the courts calling drafters out for trying to draft around their prohibition and yet accomplishing with their claims the same thing that the courts just got through banning.

    IN A NUTSHELL-THEY DO NOT WANT YOU TO HAVE A CLAIM TO ALL USES OF AN ABSTRACT IDEA BECAUSE THIS HAS THE SAME PRACTICAL EFFECT AS GIVING YOU A CLAIM TO THE ABSTRACT IDEA ITSELF.

    And don’t make me have to have this conversation for the 20th time ok? HOLD ON TO THAT WHICH I AM TELLING YOU AND DO NOT LET IT GET AWAY FROM YOU.

  62. Any patent that you need to take to the Supreme Court in order to enforce is a major failure on a certain level.

  63. Casual, with processes, the steps have to be performed to infringe. Ancient case law.

    The only steps in the broad claim here are exclusively in the prior art, administer, draw blood, test for metabolites. No other steps are required to be performed.

    Now, clearly the information developed may be useful in a new treatment method. But that is not claimed.

    What the claim actually does is make the old steps infringing because nothing further is required to be done. The claim literally covers only old subject matter.

    Now if this subject matter is patentable it makes practice of the prior art infringement. Even if one of the steps were new, it should still not be patentable as the performance of the steps by others who are not seeking to use the novel treatment method would infringe.

    This is not rocket science.

    The Feds are so off base here that it is remarkable that they not be impeached. They are wrong in the extreme.

  64. 6, you have got to be kidding. That is ridiculous.

    Per Benson, the only way one wholly preempts a mathematical algorithms to recite a computer for calculating it and to provide no use for the result.

    Where in Bilski is there a GP computer? Where in Bilski is there no use for the algrorithm?

    Bilski’s statement about wholly preempting the math in the context of its claim was not comprehensible. It was mere words without substance. It was incantation.

  65. You could argue that there is utility in having one’s mind transformed by a novel fact, but that transformation is due to Prometheus’ publication of their correlation, not from the practice of the steps recited in the claimed method.

    You have to love a patent claim that, in view of the spec, is essentially self-infringing.

    I don’t think we can discount the possibility that it’s scary how well-drafted Prometheus’ patent really is.

  66. All the court was saying in Diehr is that you can’t point to a line of unpatentable subject matter in the claim and throw the claim out. You have to actually use your brain.

    Similarly, in Bilski, the Supremes made the point of saying that you can’t simply point to a transformation or a machine and say “It’s 101 eligible” and walk away satisfied that your job is done. In some instances, more thought will be required.

  67. The Supreme Court seems to want to approach everything as a Section 101 problem. But what bothers us about these claim is that they seem to be simply like titration or other ancient trial-and-error adjustment techniques in physical science.

    How about you spend a few minutes and read the comments upthread before telling “us” what bothers “us” about the claims?

    Make believe these claims are not obvious (even if you think they are).

    Who thinks these claims are not obvious? I haven’t heard anyone say that. They seem very likely to be anticipated, to the extent they are not indefinite.

    ASSUMING that is the case, then why would these nonobvious, plainly transformative process steps, which apply but do not wholly preempt any use of a law of nature concerning the effect of certain dosage concentrations, NOT be patentable subject matter?

    First, whether a “law of nature” is “wholly pre-empted” by these claims is debatable. Second, regardless of whether any law of nature is “wholly pre-empted” or not, the claims prevent people who are merely practicing the prior art from thinking certain thoughts about the results of that practice. Such claims are ineligible for patenting because they effectively are patents on mental processes.

    I don’t see how the Supreme Court can add anything worthwhile over what the Federal Circuit stated here.

    The Federal Circuit’s decisions in both Prometheus cases are some of the most poorly reasoned and shallow-thinking decisions they’ve ever written. See the previous posts on the topic for details.

    Whether it’s “new” is an issue to be determined under 102 and 103.

    Do you really believe that you can turn an old and therefore unpatentable method into a patentable method merely by adding a subsequent step of thinking about something “new”?

    Whether it’s “useful” is a legitimate question under 101, but I think it’s hard to argue that (putting aside that it may be trivial), it is not useful.

    I have no idea what you’re trying to say here. Inventions need to have a credible, substantial utility. The claimed methods at issue in this case achieve exactly NOTHING that wasn’t achieved in the prior art because all of the transformative steps are identical to those in the prior art. You could argue that there is utility in having one’s mind transformed by a novel fact, but that transformation is due to Prometheus’ publication of their correlation, not from the practice of the steps recited in the claimed method.

  68. O rly Ned? How come I’ve explained to you a couple dozen times why, under my reasoning Diehr does not preempt “its” algorithm as well?

    Maybe you could do this one on your own, if I hold your hand a bit. First, what “algorithm” is “Diehr’s algorithm”? When you have the answer, write it down. Now, determine if there are any uses for that algorithm that are not covered by Diehr’s claim. Now determine roughly how many of those not covered uses there are. If you said several hundred to thousand to million to infinite then you are correct and are in agreement with the Diehr court and me.

    Now try the same analysis for the claim in Benson. If you said 0 uses for that algorithm are “not covered” or are outside the scope of his claim then you agree with me and the Benson court and you hopefully start to see w t f the issue is.

  69. “Bilski was worse than useless because it undermined an easy to apply black letter rule, and didn’t replace it with anything.”

    Well I have good news for you, Bilski was actually very good. It was actually you that misunderstood the BFD trilogy (indeed as your summary shows) and led to your being let down with Bilski.

    “Nailing down what is too abstract for patentablility is a hopeless cause for everyone, and only prolongs prosecution. No matter which side of the fence you’re on, Bilski made your life harder.”

    Well, to be sure, you’re right that it makes things harder. But you’re wrong that it was the USSC that made it that way, it was the original drafters of the 1952 act (and probably the guys before them) who made our language of 101.

    They could have smacked this sht down a lot easier than a court would.

    Appropriately assigning blame here will hopefully lead to people approaching the appropriate people to solve the problem.

  70. Look, they must KNOW they made a mess in Bilski. Maybe they meant Bilski to actually rein in patent subject matter, and want to take another shot at it. But I don’t see how they are going to do that here.

    Make believe these claims are not obvious (even if you think they are). ASSUMING that is the case, then why would these nonobvious, plainly transformative process steps, which apply but do not wholly preempt any use of a law of nature concerning the effect of certain dosage concentrations, NOT be patentable subject matter?

    The Supreme Court seems to want to approach everything as a Section 101 problem. But what bothers us about these claim is that they seem to be simply like titration or other ancient trial-and-error adjustment techniques in physical science. But if the claims stand up under 103 analysis, why should 101 come into the picture? It is hard to say that this is not a “process.” Whether it’s “new” is an issue to be determined under 102 and 103. Whether it’s “useful” is a legitimate question under 101, but I think it’s hard to argue that (putting aside that it may be trivial), it is not useful.

    I don’t see how the Supreme Court can add anything worthwhile over what the Federal Circuit stated here.

  71. The hypo assumed that the determination of the presence/absence of the molecule X was old. Just like in Prometheus’ case with the measurement of the metabolite levels. If you come up with a new and nonobvious way to measure the metabolite levels, by all means you ought to get a patent for that. Correlation patents like those in this case, and in LabCorp v. Metabolite and AMP v. USPTO (the Myriad case) are, fundamentally, an attempt to circumvent the problem of old “determination” steps.

  72. The Act conveys a monopoly over the USE of an invention. So if your invention is a drug that, by injection ( or by oral administration) absolutely kills all cancers, are you telling me the method of administration claims (I . e. USE ) are not valid under 101?

  73. “If I make/use/sell a test for predicting excessive flatulence that consists of determining the presence/absence of molecule X, do I infringe the patent? ”

    I would argue that you do, but I would also argue that your claim is anticipated by anyone who has measured molecule X for any reason.

    So YES, “This hypothetical illustrates the idiocy of these correlation patents.”

  74. Dennis–

    Can you help me find the post where Mooney stated the following:

    “**if one is otherwise practicing the prior art**, then a claim that would (if enforced) prevent one from merely thinking about what they are doing or merely thinking about the result of what they did is a claim that can NOT, as a matter of law, ever be enforced against such a person. Such claims should not be granted”

    I’ve tried searching for it but I can’t bring it up, yet I know that it existed.

    Thanks.

  75. More than one hundred comments in a single day and all I see is squabbling along the same old lines and no one listening to anyone else and no issue being progressed.

    Implacable camps talking past one another – a waste of time for everyone.

  76. Malcolm Mooney writes above that he can’t see the distinction Judge Lourie makes, between the claim here and the one in Grams.

    I’m glad he wrote that, because I can’t see the distinction either.

    Can anybody help the three of us, with that issue?

  77. Step a and step b are both old. Everyone has a right to do both.

    There is no step c.

    The claim inherently is old.

    This is a simple case, or at least should be.

    The Feds are way, way out there and need a major rebuke from the Supremes.

  78. If I perform the steps of claim 1 (administer + determine level), but I don’t believe that a level less then 230 pmol per 8×10^8 red blood cells indicates a need to increase the amount of said drug, have I infringed the claim?

    Just to keep the analysis clean, let’s first say that you believe that only a level less than a 210 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug. You measure a level of 220 pmol per 8×10^8 red blood cells. As further evidence of your belief, the drug levels are not increased in that patient. Do you infringe the claim? Great question.

    But what if in spite of the measured metabolite levels you increase the drug levels (based, e.g., on other patient symptoms — such as no change in disease state — indicating that the patient in question would be better served by such increases)? Do you still infringe? If so, what about the earlier measurements of drug levels in the prior art which surely were taken when the drug’s toxicity and effects were first studied? How do they not inherently anticipate under this infringement theory?

    For the record, my understanding of the facts (based on the CAFC’s summary) is that Mayo’s protocols did not rely on the identical threshold values recited in Prometheus’ patents but rather fell within those thresholds (one threshold extends to zero; the other to infinity). I’m happy to be corrected if my recollection is mistaken.

    Prometheus’ claims are truly awful from a variety of angles. But you’d never guess that from the Federal Circuit’s opinion(s) or from reading certain other blogs which seem dedicated to defending these cxrp claims at any cost.

  79. “Good. The Supremes told the Feds to look to Benson, Flook and Diehr on remand and they ignored them. ”

    Exactly, how in this case did the CAFC Ignore the SCOTUS?

    At first glance it appears the ruling is based on Diehr, which cabined Flook and Benson ( Bilksi 14 in case you forgot).

    If it’s true, that the CAFC relied on Diehr, then they did the same thing the SCOTUS did in Bilski and all is right with the world.

  80. Was Research corp that recent decision about the “blue mask”?

    “What I learned from Research Corp. is that if your claims are technical and confuse the Federal Circuit, then they will find your claims not abstract.”

    Precisely.

  81. No, you do not infringe. Lemme give you another example: One person discovers correlation between presence of molecule X and stinky breath, and obtains a patent with a claim that says “A method for predicting stinky breath in a person comprising determining presence of molecule X, wherein presence of molecule X indicates person has stinky breath.” I come along and discover a correlation between presence of molecule X and excessive flatulence. If I make/use/sell a test for predicting excessive flatulence that consists of determining the presence/absence of molecule X, do I infringe the patent? This hypothetical illustrates the idiocy of these correlation patents.

  82. Research Corp. teaches us that if you make up a bunch of tests only to have the Supreme Court strike them down each time without giving any incite then you throw your hands up in the air and give up. J. Rader did exactly that saying that the Fed. Cir. isn’t going to guess what abstract means. Interestingly in Research Corp, the Fed. Cir. failed to actually address Benson in relation to the rasterization algorithm claims.

  83. “We learned from Diehr that the use of mathematical algorithms in useful applications was patentable subject matter.”

    What we actually learned from Diehr is that using a mathematical algorithm in a computer program to move mechanical parts to transform an article to a different state or thing is patentable (curing synthetic rubber in a mold using a computer).

    Note the physical transformation and creation of a physical product in Diehr. Use of mathematical algorithms in useful applications was NOT by itself patentable subject matter. Algorithms running on a computer (i.e. most software) is directed to abstract non-patentable subject matter (see Benson, converting decimal to binary in a computer is a useful application of an algorithm, but was found to be unpatentable under Benson as an abstract idea). See also Flook where if the only difference between the prior art and the invention is the algorithm (as is the case with most software since it runs on a general purpose computer) then it is not patentable.

    Bilski was worse than useless because it undermined an easy to apply black letter rule, and didn’t replace it with anything. No matter how bad you may have thought the MoT test was, at least it was straight forward. Nailing down what is too abstract for patentablility is a hopeless cause for everyone, and only prolongs prosecution. No matter which side of the fence you’re on, Bilski made your life harder.

  84. I’d also like to know what the meaning of life is, but they’re just as likely to explain that as they are to actually give some incite into where the too abstract line is.

  85. “I’m sorry 6, but you seem to forget that what has to be preempted is what we know as laws of nature, natural phonemena, and abstract ideas.”

    Um, no I don’t. Indeed, I explicitly recited for you what I thought may be a relevant abstract idea.

    “Now, just what about Bilski was abstract?”

    For the millionth time Ned, the mathematical algorithm underlying the operation of the machines. Read the FIN DECISION.

  86. I think you will find that true for most all forums. It’s a reflection of the 80:20 rule. 20% of the participants provide 80% of the commentary. Take a look at the edits to any Wikipedia article and you will see the same thing.

  87. Malcolm,

    If I perform the steps of claim 1 (administer + determine level), but I don’t believe that a level less then 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug, have I infringed the claim?

  88. Cy you are waaaaay off base. A scientific or technological application of a process requires a top down thinking protocol and as such has a clear beginning , and end which produces the same objective result.

    So much for your infinite regress quip. Got anything else?

  89. The purpose of 112 second paragraph is to inform the pubic what the inventor regards as his/her invention. Suppose I administer the drug (step a) and determine the level of the drug (step b). But I don’t believe that a level less then 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug.

    Have I infringed? I don’t know. I certainly have performed the steps so by that standard I have infringed. But I haven’t satisfied the wherein clause, so by that analysis I have not. Same actions, different conclusions, claim indefinite.

  90. 6, the controlling case law is Diehr. The ruling is very clear regarding dissection. Its not allowed…period.

    CASE CLOSED

  91. “Anonymous said in reply to Actual Inventor…
    Isn’t there case law that indicates that mere “pre-solution activity” isn’t enough though?”

    Actually the term used is extra solution activity. Still the same analysis applies. After the process is complete you can’t come back and add applications of science, technology, machines, and transformations.

    And once again, anyone ignoring applications of science, technology, machines, and transformations during the process, is illegally dissecting the claims. And that’s the law, no matter what the crazy anti patent crowd dreams up.

  92. In actuality, a transformation necessarily passes the Machine or transformation test, because, as the name self evidently states – you need either a machine or a transformation.

    In “actuality”, the machine or transformation necessarily requires more than just the recitation of any “transformation” in the claim, just as the “machine” test is not satisfied by mere the recitation of any machine.

    You are aware that Les is one of the original patent txxbaggers, no? Les would defend a method of thinking about breakfast while taking a dxmp as satisfying 101 because, hey, the water in the bowl is transformed. And that’s about nuanced as any discussion with Les actually gets. Bilski was a monolithic megaton smackdown of Les’s “everything is patent eligible” pipedream from which he will never, ever recover.

  93. I think the point Malcolm was that your reply was incorrect.

    The comment was: “Here we have a transformation, so the MOT is passed.

    To which you replied: “Incredibly wrong.

    In actuality, a transformation necessarily passes the Machine or transformation test, because, as the name self evidently states – you need either a machine or a transformation.

    What you no doubt wanted to say was that patentability is not dependent on the MOT test (and not what you actually said).

    So in essence, you now have made two errors as you did not actually answer the question “already” since this is Les’s first question on the topic, the toppic being raised the first time as a statement, not a question.

  94. Just since it seems to have been brought up above and since I figured it might be interesting for you guys to know, I will give you the view from “the ground” over at the office on this issue.

    Down in the trenches examiners apply whatever test they feel like. Most SPE’s have their own little test, and it appears most examiners follow their SPE.

    I’ve asked around quite a lot on a few cases, mainly for kicks. The 101 helpdesk guy told me that since there is a machine then it should be good to go, although he noted that this “test” was not so much MOT as his own personal made-up test.

    One SPE told me that I should look for “an excuse” to allow the claim over 101 and pointed out to me what he thought was an excuse in the instant case that was before me.

    My own SPE has backed my take on 101 pretty consistently. Although I do not know what advice he gives to other examiners. He does appear to understand the current USPTO guidelines on the matter as supporting my view (indeed, they appear to have cribbed off of me to write the things).

    One examiner I know can tell when a claim is suspicious but used to be going to just make them recite a computer. He has since recanted after I explained my take on the matter and apparently he will follow it going forward (we’re about to see a lot of cases needing a 101 soon).

    Many other examiners simply want to see a computer recited in the claim and they’ll let it go no matter what. I have not had time to spend with all of them just yet to educate them a bit more fully. Likewise, with B claims, most examiners think they’re actually looking for a method when they’re examining a product claim. When the situation is explained to them, they are of course at a loss for why they do this, because they are just following orders, no doubt from the SPE.

    That’s my ground view of what is up over at the office concerning these types of issues.

  95. Hmmm, that’s funny, because I’ve rejected a few now that pass MOT. And more examiners harken to my call every day.

  96. “Although this is not the exclusive test, post-Bilski, it nevertheless provides important clues to subject matter patentabilty.”

    The only important clue it provides is whether or not the person reviewing the claim should take time out of his day to perform the preemption test.

  97. “I didn’t “just make up” my test. It’s a restatement of very well-settled law. The beauty of “my test” is that every Supreme Court justice and every appelate and district court judge that I am aware of has already “taken to” its underlying principles, with no defections that I’m aware of. ”

    Well I hope you’re right. But I don’t think you are.

    “Every one of the Supremes agrees that mental processes are unpatentable under 101.”

    I can get on board with that but I don’t remember it being explicit in Bilski, I will give you the benefit of the doubt. And that is my position as well, regardless of whether or not the Supremes have yet approved it, and it will be what goes on in my office.

    “If the answer is yes, then at least from the point of view of those already practicing the prior art, the claim effectively is a claim to a new mental process or thought. ”

    I like your thought process on this, to be sure, but it isn’t what has been laid out in caselaw just yet.

    “Unless the Supremes want to carve out a judicial exception that completely sidesteps their earlier precedents (including Bilski), they are stuck with this result.”

    Well I hope you’re right, but to be sure, if they do hold that result it will be an expansion of the already on the books preemption law, not merely them doing the same ol’ same ol’.

    “The alternative is to punt the analysis to anticipation where you perform the same analysis except, instead of finding the claim ineligible under 101, you ignore the mental step (because it is ineligible under 101) and find the claim anticipated. Why this makes such a huge difference to some people, I do not know. ”

    Well, they could just allow the claim to be found valid…

    “Has the Supreme Court ever stated an absolute requirement that 101 eligibilty needs to be determined prior to any analysis of validity under 102 or 103?”

    Not that I know of.

  98. Why would being unobservable make it indefinite? Wouldn’t it just make it difficult, if not impossible, to prove infringement?

  99. What I learned from Research Corp. is that if your claims are technical and confuse the Federal Circuit, then they will find your claims not abstract.

    Of course, that would seem to be improperly applying the “technological arts” test, but …

  100. “Like wise If you adding an application of science, technology, machines, or transformation AFTER the process of the claim is complete then you are adding insignificant post-solution activity.”

    Do tell of a case where this nonsense went on. Because the case that is the foremost authority on this subject did not involve any limitations that took place after the process was done.

  101. Isn’t there case law that indicates that mere “pre-solution activity” isn’t enough though?

  102. and how do I know when it’s ‘complete’?

    You know when you see that little dot at the end of the claim. It’s called a period.

  103. Yes, this yet another problem with Prometheus’ claims. As drafted, the claims cover the situation where the level of drug or metabolite is tested to determine the amount and if there is no drug or only traces detectable, you add more drug. Given that the particular treatment itself and the concept of testing for drug and specified metabolite levels is old (as admitted in the specification), this particular embodiment is as obvious as obvious ever gets in the biotech field.

  104. LOL. Because every claim includes a section saying “this is where the process is completed; the rest is post-solution activity.”.

    Actual Inventor: If you are ignoring an application of science, technology, machines, or transformation BEFORE the process of the claim is complete then you are illegally dissecting the claim.

    Love it. What’s the definition of the “process of the claim” and how do I know when it’s “complete”?

  105. Mark N. The state of a person’ mind is per se unobservable.

    Unfortunately, this is not absolutely true in 2011 and without having checked recently I’m nevertheless confident that the PTO has granted patents on methods of determining the “state” of a person’s mind. There are articles in the news all the time about the ability of scientists to determine, for instance, whether a person is lying or experiencing joy or doing a math problem or listening to a foreign language … based simply on imaging various regions of the brain.

    I’m not saying your point isn’t relevant or worth consideration — it certainly is. But I don’t think it is wise to rest the unpatentability of mental processes entirely on an eroding scientific foundation.

    Acceptance of the statement that “the state of a person’ mind is per se unobservable” would also open up a can of worms (albeit an interesting but somewhat off-topic can) regarding the utility of inventions whose primary credible effect is to transform the state of mind of the practitioner, e.g., to “entertain” the practitioner.

    In this regard, it’s worth nothing that the crucial “transformation of mind” in the Prometheus context does not require practicing the steps in the claimed invention; instead, all that is required is that one read the specification.

  106. Making, using, selling, importing, offering to sell.

    How does one infringe a claim that produces old data from an old method where the information is useful in a new treatment? Who directly infringes?

  107. Looking at all 3 cases together would be helpful in sorting out what’s in the patent-eligible zone and what isn’t when it comes to method claims like these.

    I’m not convinced that’s the case and the Bilski decision is part of the reason that I’m not convinced. The differences between the claims in these cases are significant enough to preclude any attempt to create a “generic” rule that will govern claims with their “shared problems” (assuming there are any).

    In my opinion, the claims in Classen are quite a bit more abstract than those in Mayo/Prometheus, especially in view of In re Gram

    I’m inclined to invite you to explain what you mean but I’m not sure I could stomach it. Nothing personal, either. It’s just that in the grand scheme of “abstraction”, the claims in those cases are not remotely as “abstract” as the claims at issue in Bilski which had little or no relationship to the physical world.

    Whatever “abstract” means, it certainly can not be a synonym for “ridiculously broad”, which seems to me to be the clear problem with Classen.

  108. “You’re using MOT as the test because the Supremes said it’s not the test.”

    I’m not doing anything but reading postings and commenting on them. The Supremes said its a useful test, just not the only test….so…the CAFC used the useful test…and that use in now about to be reviewed…

  109. Of course you’re right. So substitute hypoglycemia for high blood pressure. (I’m a sickie)

  110. So let’s rephrase that a bit:

    ‘determining the level of [something] in said subject having [a disease],
    wherein the level of [the something] less than [some amount] indicates a need to increase the amount of said drug subsequently administered to said subject and
    wherein the level of [the something]greater than [some other amount] indicates a need to decrease the amount of said drug subsequently administered to said subject.’

    Where this has been used for centuries with many many patients having many many different diseases, to adjust the dosage of many many different drugs, herbs, and other medicines.

    If that isn’t a 103, I don’t know what is.

  111. 6: Yes, but that is a test you just made up. Off the top of your head. And I don’t think the courts will take to it.

    I didn’t “just make up” my test. It’s a restatement of very well-settled law. The beauty of “my test” is that every Supreme Court justice and every appelate and district court judge that I am aware of has already “taken to” its underlying principles, with no defections that I’m aware of.

    Read Bilski. Every one of the Supremes agrees that mental processes are unpatentable under 101. All my test does is ask whether granting a particular claim and teaching non-infringers (e.g., those already practicing the prior art or practicing otherwise ineligible subject matter) a “new” fact is enough to turn those non-infringers into infringers. If the answer is yes, then at least from the point of view of those already practicing the prior art, the claim effectively is a claim to a new mental process or thought. Why is that the case? Because there is no difference between their unpatentable (old) actions and their current actions except what they think about when they are performing the acts.

    Let me know if you see a hole in the logic.

    Unless the Supremes want to carve out a judicial exception that completely sidesteps their earlier precedents (including Bilski), they are stuck with this result. The alternative is to punt the analysis to anticipation where you perform the same analysis except, instead of finding the claim ineligible under 101, you ignore the mental step (because it is ineligible under 101) and find the claim anticipated. Why this makes such a huge difference to some people, I do not know.

    Has the Supreme Court ever stated an absolute requirement that 101 eligibilty needs to be determined prior to any analysis of validity under 102 or 103?

  112. Easy, just remember “post solution” means AFTER the process is complete. So there is never dissection of the process claim.

    Indeed. In fact, it’s turtles all the way down, as Bertrand Russell was once told.

  113. here’s why:

    … the “machine-or-transformation test. Although this is not the exclusive test …

    Thanks, that clears things right up. You’re using MOT as the test because the Supremes said it’s not the test.

    In that case, you might care to say something more like “Here we have a transformation, so the MOT is passed. So the claim is probably patent-eligible.

  114. “How do you determine if any “post-solution activity” has been “added” without dissecting the claim?”

    Easy, just remember “post solution” means AFTER the process is complete. So there is never dissection of the process claim.

    If you are ignoring an application of science, technology, machines, or transformation BEFORE the process of the claim is complete then you are illegally dissecting the claim.

    Like wise If you adding an application of science, technology, machines, or transformation AFTER the process of the claim is complete then you are adding insignificant post-solution activity.

  115. Unlike the claims in Grams – which the CAFC found unpatentable “because the tests were just to ‘obtain data'” (Slip Op. at 20) – the claims of the Prometheus patents “require the performing of clinical tests on individuals that were transformative.”

    Take a look at the claims and the specification in Grams and you’ll discover that this alleged “distinction” is pure horseshxt. The tests taught by Grams were no less “transformative” than those in Prometheus’ claims. In both cases, the recited tests have one purpose only: to obtain data.

    I’ve said it before and I’ll say it again: both of the CAFC’s decisions regarding the Prometheus case are shamefully sloppy and dishonest.

  116. “Since Bilski, you can’t even call MOT a “test”. Passing MOT doesn’t save your claim, and failing MOT doesn’t kill your claim. You might as well say the claim passes a spelling test.”

    This is simply wrong. Ask 6. If you pass MOT, there isn’t an examiner in Virginia that will reject you under 101.

  117. here’s why:

    In support of its conclusion, the court reiterated its earlier determination that the treatment methods in Prometheus’s patents satisfy the “machine-or-transformation test. Although this is not the exclusive test, post-Bilski, it nevertheless provides important clues to subject matter patentabilty. In applying the machine-or-transformation framework, the court specifically rejected Mayo’s argument that the disputed claims simply claim natural correlations and the associated data-gathering steps, broadly stating that the asserted claims are “claims to methods of treatment, which are always transformative when one of a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition.” Slip Op. at 17. Even leaving out the administration step does not make the claims unpatentable, as the CAFC also found the “determining” step to be transformative because it involves “[s]ome form of manipulation, such as the high pressure liquid chromatography method specified in several of the asserted dependent claims or some other modification of the substances to be measured, [which] is necessary to extract the metabolites from a bodily sample and determine their concentration.” Id. at 18.

    In reaching this conclusion, however, the court was forced to distinguish its earlier decision In re Grams, 888 F.2d 835 (Fed. Cir. 1989), which similarly claimed a process that involved “(1) performing a clinical test on individuals and (2) based on the data from that test, determining if an abnormality existed and determining possible causes of any abnormality by using an algorithm.” Id. at 20. Unlike the claims in Grams – which the CAFC found unpatentable “because the tests were just to ‘obtain data'” (Slip Op. at 20) – the claims of the Prometheus patents “require the performing of clinical tests on individuals that were transformative.”

  118. Has anyone considered a 112 second paragraph attack on these claims? It seems to me that the “wherein…indicates..” clause reads on the state of a person’s mind. The state of a person’ mind is per se unobservable. Hence the claim is indefinite.

  119. MOT (the transformation leg) is the test being questioned:

    MOT is neither “the test” nor “being questioned”. MOT was questioned in Bilski, and was found wanting. Even though it’s not at all clear why or how.

    Since Bilski, you can’t even call MOT a “test”. Passing MOT doesn’t save your claim, and failing MOT doesn’t kill your claim. You might as well say the claim passes a spelling test.

    The only thing being questioned here is why you think MOT is conclusive as to anything at all.

  120. Malcolm,

    In my opinion, the claims in Classen are quite a bit more abstract than those in Mayo/Prometheus, especially in view of In re Gram, and thus in greater danger of being in the patent-ineligible zone. But the similarities in the patent-eligibility issues in these 3 cases are also more than just “surface.” Looking at all 3 cases together would be helpful in sorting out what’s in the patent-eligible zone and what isn’t when it comes to method claims like these.

  121. Sorry, what?

    MOT (the transformation leg) is the test being questioned:

    “simply because well-known methods used to administer prescription drugs and test blood may involve “transformations” of body chemistry.”

  122. Where is “enough already” when you really need him?

    Hey, you’re the consistent one, log, not me. I’m just the guy who occasionally (but not consistently) points out when you’re being an @ss.

    I don’t even consistently read these comments. In fact, I consistently avoid reading those that include the term “6-thioguanine,” as well as most of those authored by 6.

  123. DC – I sue your doctor for malpractice. Your blood pressure dosage should be adjusted based on your blood pressure, not on the basis of a blood test.

  124. “I don’t understand the question.”

    We know Les, people such as myself have been trying to explain it to your willfully blind arse for awhile now.

  125. “The problem with referring to a pre-emption test is that it leads to quibbling about whether some “use” is truly “pre-empted” ”

    Well usually there is no problem related to this because the patentee is willing to hang himself. And, even if there was, that’s really nothing more than an issue of claim construction, which is a matter of law and the courts can decide however they feel like it.

    “the argument being that if one such substantial use is identified that does not fall within the claim, then there is no “pre-emption”.”

    And that’s why we have Flook there to pick up the slack. But you’d know this if you’d read them. Which I encourage you to do.

    “The point of the pre-emption test, I believe, is to provide a way to demonstrate that the claim impermissibly prevents a patentee to claim the use of an otherwise unpatentable fact (or an unpatentable “abstraction”, if you prefer that term). ”

    Yes, I agree, that is entirely the point. It is amazing that you find fault with this test as it works out quite well. Flook will pickup whatever slack there is. And if it doesn’t pick it up, then ok, maybe they have a patentable claim there.

    “here is a much more powerful, specific and irrefutable test. Instead of asking whether the claim “preempts all uses of the correlation”, the test is to ask whether someone who practices the transforming steps becomes an infringer merely by learning the “new” fact described in the specification (or anywhere else). If the answer is “yes”, the claim is ineligible under 101. The answer is clearly “yes” for Prometheus’ claims.”

    Yes, but that is a test you just made up. Off the top of your head. And I don’t think the courts will take to it.

    “But if Bilski tells us anything, it tells us that 101 determinations are not to be made while wearing handcuffs. There are no “magic words.””

    You are correct about that. And admittedly it is my opinion that the courts should adopt a more strigent test than is currently on the books as the preemption test. What precisely that test should be, meh, idk, that’s why they get paid the big $$$. But it isn’t an issue in this case. There may be some fringe uses of the abstract idea at play in this case, but no matter. The limitations preventing the whole abstract idea being covered are tantamount to field of use limitations in so far as they limit the claim to the field of diagnostics. Not going to cut it imo.

    That is to say, one could simply draft a claim to:

    A method in the field of diagnostics comprising:
    applying the abstract idea I identified above.

    And you’d have a claim that is pretty much the same scope as the one at issue I do believe. And drafting the claim differently doesn’t make a sht bit of a difference.

  126. I’m sorry 6, but you seem to forget that what has to be preempted is what we know as laws of nature, natural phonemena, and abstract ideas.

    Wholly preempting by itself says nothing. The question is always, what is being preempted? Is that “what” a law of nature, a natural phenomenon or an abstract idea?

    Now, just what about Bilski was abstract? And please do not bootstraps by saying that IT is abstract be IT is preempted.

    Such circular reasoning is intollerable.

  127. “Incredibly wrong.”

    Which part of what I said is incredibly wrong 1)even the transformation isn’t absolute necessary (MOT is not the only test) or 2) Here we have a transformation, so the MOT is passed. ?

  128. “We learned from Diehr that the use of mathematical algorithms in useful applications was patentable subject matter”

    Um, no we didn’t “learned” that. Because they did not say that. What they said, Ned, was that a claim to an otherwise statutory invention would not become usstatutory merely because of a mathematical idea (or insert other judicial exception here) being tacked on.

    Go read the decision Ned. For the millionth time. Stop making sht up and just read it.

    “We are left to speculate.”

    Um, no we’re not, if you understand the correct thought process. Unfortunately, you constantly turn away from the correct thought process in favor of ignorance and confusion.

  129. “So?”

    So that’s disallowed. Read Benson. For the millionth time Ned. Go and read Benson. Stop jibber jabberin’ and go read it. Use your eyes, not your mouth or your fingertips.

  130. “I recall that we have discussed this before, and the the Court construed the claim as one skilled in the art, upon reading the claim and the specification, would construe, so as to include more than just a mental step (i.e., issue a report, diagnosis, etc.).”

    Did they really? I had totally forgotten about it if so. I was unaware that the rest of the judges had gotten in on Newman’s claim limitation importation service.

  131. The Supremes have already said: even the transformation isn’t absolute necessary (MOT is not the only test). Here we have a transformation, so the MOT is passed.

    Incredibly wrong.

    The Supremes never said that any claim which includes an identifiable “transformation” was per se eligible for patenting under 101. In large part, their failure to adopt such a position led to their rejection of any definitive test for subject matter eligibility.

  132. Here we have a transformation, so the MOT is passed.

    Which would be great, if MOT were the test.

    And if the transformation were any more meaningful to the claimed invention than a claim to:

    “eating a sandwich; and
    determining a level of 6-thioguanine in a subject etc.”

    Which I’m sure would be infringed by most of the people who would be infringing the actual claim.

  133. I don’t understand the question. The Supremes have already said: even the transformation isn’t absolute necessary (MOT is not the only test). Here we have a transformation, so the MOT is passed. What’s there to argue about, whether :””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 8×10^8 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 8×10^8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.”””

    is abstract?

    Paaaaleeeees

  134. One could also ask whether the party or parties that measure the phenomena are infringers simply by making the measurement.

    Since that cannot be right, there is something fundamentally wrong with the claim.

  135. I don’t think that’s a fair assessment. They said that Diehr’s requirment to consider the claims as a whole prevents a such a rule.

    Diehr was not addressing the issue squarely presented to the CAFC and Diehr’s “requirement” is not nearly so strict as it’s made out to be. Just look at the passage you cited:

    Nonetheless, a scientific principle cannot be made patentable by … adding insignificant post-solution activity. Diehr, 450 U.S. at 191-92.

    How do you determine if any “post-solution activity” has been “added” without dissecting the claim?

  136. would politely suggest that the answer must be that the data must be used, otherwise the claim will literally cover all measurements of the physical phenomina regardless of uses

    Indeed. And to be crystal clear, the “use” of the “determined” information must be a necessary, transforming step. It can’t be an “if X, then Y” step that leaves open the possibility of infringing by doing nothing. I’ll remain agnostic for the moment on the question of whether an “if X, then Y, otherwise Z” (where both Y and Z are transforming steps) suffice (leaning towards “yes”), or whether mere personal communication of a diagnosis based on X would suffice as a transformation.

  137. MM said: “The CAFC completely ducked the issue of whether a claim in which the ONLY new step was a mental step was eligible for patenting.”

    I don’t think that’s a fair assessment. They said that Diehr’s requirment to consider the claims as a whole prevents a such a rule.

    p. 12 – “The Supreme Court has also established that while a law of nature, natural phenomenon, or abstract idea cannot be patented, “an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.” Bilski, 130 S. Ct. at 3230 (quoting Diehr, 450 U.S. at 188). In making this determination, the Court has made clear that a claim must be considered as a whole; it is “inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis.” Id. (quoting Diehr, 450 U.S. at 188). Nonetheless, a scientific principle cannot be made patentable by limiting its use to a particular technological environment or by adding insignificant post-solution activity. Diehr, 450 U.S. at 191-92.”

    p. 21 – “We agree with the district court that the final ‘wherein’ clauses are mental steps and thus not patent-eligible per se. However, although they alone are not patent-eligible, the claims are not simply to the mental steps. A subsequent mental step does not, by itself, negate the transformative nature of prior steps. Thus, when viewed in the proper context, the final step of providing a warning based on the results of the prior steps does not detract from the patentability of Prometheus’s claimed methods as a whole.”

  138. I don’t remember exactly what they said about the final mental step in the first case, either, but I do remember the fudging regarding the term “warning” which wasn’t in the claim. The only necessary person possibly being “warned” in the claim is the person who “determines” the level of metabolite in the blood. Maybe the CAFC thinks that test tubes can speak? Someone was watching too much Muppet Show, perhaps.

  139. Malcolm, yes, the data is useful but not used as in Flook.

    So, the one the questions that the Supremes need to answer is this: If the useful data is tied to a measurement of a physical phenomena, is that enought to satisfy Flook and Benson? Clearly, it does not satisfy Diehr which seemingly required actual use of the data.

    I would politely suggest that the answer must be that the data must be used, otherwise the claim will literally cover all measurements of the physical phenomina regardless of uses. That cannot be right.

  140. unless you want to insist that such claims are merely anticipated as a matter of law

    Yes, I have heard of that before – I think it was in a dissent somewhere…

  141. Actually, I recall we discussed the original Fed Cir decision, where they characterized it as being construed as a “warning.” I don’t recall anytihng in the first decision about it being just a mental step, but the more recent decision apparently says that even the “warning” is a mental step as below, so I have to mea culpa. Sorry about that.

    p. 21 – We agree with the district court that the final “wherein” clauses are mental steps and thus not patent-eligible per se. However, although they alone are not patent-eligible, the claims are not simply to the mental steps. A subsequent mental step does not, by itself, negate the transformative nature of prior steps. Thus, when viewed in the proper context, the final step of providing a warning based on the results of the prior steps does not detract from the patentability of Prometheus’s claimed methods as a whole.

  142. Agreed — the claim is incredibly poorly drafted. To the best of my knowledge, though, the claim construction is not being contested and all parties agree that the last step in the claims at issue is one that can be satisfied merely by thinking.

  143. Actually, Malcolm, it even goes too far to suggest that there’s a “thinking” step after the blood test step.

  144. TINLA recall that we have discussed this before, and the the Court construed the claim as one skilled in the art, upon reading the claim and the specification, would construe, so as to include more than just a mental step (i.e., issue a report, diagnosis, etc.).

    That’s false.

    In my view, this business about the claim reading on doing the test and thinking about the correlation is the typical dishonest anti-patent spin we see again and again in these comments.

    You’re the one doing the spinning, TINLA.

    The last step in the claims at issue is a mental step. That fact is explicitly acknowledged and addressed by the Federal Circuit in both their decisions. They lazily waved it off as a non-issue because of the presence of an earlier transforming step in the claim (i.e., the “determining the level” step), citing earlier case law that the mere presence of mental steps in a claim does not render the claim ineligible for patenting. The CAFC completely ducked the issue of whether a claim in which the ONLY new step was a mental step was eligible for patenting. The answer to that question, of course, is yes, unless you want to insist that such claims are merely anticipated as a matter of law. This makes a difference to some people, for reasons that are unclear.

  145. effectively every use of the abstract idea

    Where is “enough already” when you really need him?

  146. 6, “Because allowing a claim to them was effectively allowing a claim to the abstract hedging idea underlying them?”

    So? Hedging using the new algorithm was the invention. Claims that cover hedging using the new algorithm wholly preempt hedging using the new algorithm by definition. They do not, however, preempt the algorithm for other uses.

    We learned from Diehr that the use of mathematical algorithms in useful applications was patentable subject matter. The Bilski claims appeared to cover a practical implementation of the novel mathematical algorithm. In order to infringe, all the steps had to be performed. Nothing was abstract about these steps. They were physical.

    The question is rather why is the invention unpatentable? In Bilski, that was never really explained. The result was just annouced. We are left to speculate.

    Was it because the steps were not implemented on a machine? If so, say so.

    Was it because the method was directed to a business utility? If so, say so.

    Saying it was abstract in context was, IMHO, bizzare.

  147. Construing the claims so that all the claims are redeemed by a limitation recited in only some of the claims is pretty zany, yeah. No matter what it says in the specification.

  148. So construing the claim terms as one skilled in the art would do upon reading the claims and the specification is “zany” now?

  149. MM said: “The only required step after the blood is tested is that the person testing the blood (or an agent of that person) thinks about what the measured level of metabolites in the blood ‘indicate.'”

    I recall that we have discussed this before, and the the Court construed the claim as one skilled in the art, upon reading the claim and the specification, would construe, so as to include more than just a mental step (i.e., issue a report, diagnosis, etc.). In my view, this business about the claim reading on doing the test and thinking about the correlation is the typical dishonest anti-patent spin we see again and again in these comments.

  150. Upon further analysis, I’m going to retract my earlier unqualified praise of Mayo’s formulation of the issue. Specifically, they write:

    Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve “transformations” of body chemistry.

    The problem with referring to a pre-emption test is that it leads to quibbling about whether some “use” is truly “pre-empted” or not, the argument being that if one such substantial use is identified that does not fall within the claim, then there is no “pre-emption”.

    The point of the pre-emption test, I believe, is to provide a way to demonstrate that the claim impermissibly prevents a patentee to claim the use of an otherwise unpatentable fact (or an unpatentable “abstraction”, if you prefer that term).

    Given a claim such as the one at issue in Prometheus in the form:

    Method of optimizing/determining/learning X, comprising

    1) Old step
    2) Thinking about result of old step in light of “new” fact/abstract concept

    there is a much more powerful, specific and irrefutable test. Instead of asking whether the claim “preempts all uses of the correlation”, the test is to ask whether someone who practices the transforming steps becomes an infringer merely by learning the “new” fact described in the specification (or anywhere else). If the answer is “yes”, the claim is ineligible under 101. The answer is clearly “yes” for Prometheus’ claims.

    To its credit, Mayo appears to recognize this problem when it refers to “well-known” methods in its petition.

    Now we can cue up the sound of the Anti-Dissectionists weeping that this analysis violates some previous Supreme Court “absolute rule” about considering only the “claim as a whole.” But if Bilski tells us anything, it tells us that 101 determinations are not to be made while wearing handcuffs. There are no “magic words.”

  151. Just as a reminder to those who are inclined to forget, the first two steps are old in the art and admitted as such in the specification and the parties do not dispute the fact that the last step is purely mental (or at least encompasses a purely mental process, i.e., merely thinking about the result obtained from the old steps in light of the new and unpatentable facts disclosed in the specification).

    I think that points to the problem… Say the patent is valid, and there’s even an admitted infringer. How do you get an injunction to stop someone from thinking? Rather than a concern about whether an idea is abstract or not, because there’s no good test for that, I think the bigger policy argument is that absent a machine or transformation, we can essentially create a thought-crime.

  152. These kinds of patents enjoyed a long run, but the end is near. There is no wiggling out now on the ground that the issue was not properly fleshed out below. I’m sure there will be one or two justices that just do not get it, but I’m confident that it will be a pretty substantial majority. Mayo is the perfect party for this case, because it actually owns/controls some patents just like this. It wasn’t easy for it to take this position in the case (just call up some folks in Mayo’s licensing office and ask), but it was/is the right one.

  153. if they followed their own (incomprehensible) “reasoning” in Prometheus,

    Or their equally zany reasoning in Research Corp that all the claims are fine as long as the spec describes something patent-eligible.

  154. “This also points out to the Supremes that their decision in Bilski was “unclear.” We really do no know why the claims in Bilski were abstract.”

    Because allowing a claim to them was effectively allowing a claim to the abstract hedging idea underlying them?

  155. There are surface similarities but the claims in Classen are quite different from those in Prometheus. It is certainly strange, though, that the CAFC has not decided Classen yet especially because if they followed their own (incomprehensible) “reasoning” in Prometheus, they would find the claims in Classen eligible under 101 in a nanosecond.

  156. “:”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 8×10^8 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 8×10^8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.””

    Aka: effectively every use of the abstract idea that a level of 6-thioguanine less than about 230 pmol per 8×10^8 red blood cells indicates a need to increase the amount of said drug subsequently administered to a subject and the level of 6-thioguanine greater than about 400 pmol per 8×10^8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

  157. For an anticaption or obviousness rejection rejection, it’s not enough to say that testing blood and adjusting dosage are old.

    There is no “adjusting of the dosage” required by the claims, in spite of Dennis’ attempt to summarize the claims. The only required step after the blood is tested is that the person testing the blood (or an agent of that person) thinks about what the measured level of metabolites in the blood “indicate”.

    Please let’s try to remember these basic facts.

    They are very easy to remember.

  158. Well done, Mayo. They’ve framed the issue accurately and succinctly.

    Dennis writes:

    Thus, most of the claims are centered around three ordered-steps of:

    administering the drug to the subject;
    determining the amount of drug in the subject’s blood; and
    re-calibrating the drug dosage based on step-2.

    A broader claim (claim 46 of the ‘632 patent) eliminates the administering step of claim 1 above.

    Just as a reminder to those who are inclined to forget, the first two steps are old in the art and admitted as such in the specification and the parties do not dispute the fact that the last step is purely mental (or at least encompasses a purely mental process, i.e., merely thinking about the result obtained from the old steps in light of the new and unpatentable facts disclosed in the specification).

  159. I do hope the Federal Circuit rules in the remand of the Classen case, as well as ruling in AMP case, before SCOTUS hears Prometheus. The patent-eligibility issues in each of these cases are intertwined.

  160. Mr. Caracappa, you may have been misled by the oversimplified characterization of the claimed subject matter. The claim actually recites:

    “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 8×10^8 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 8×10^8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.”

    For an anticaption or obviousness rejection rejection, it’s not enough to say that testing blood and adjusting dosage are old. The prior art references must reveal that the recited range for that medication was known or would be obvious in view of one or more prior art ranges for adjusting that medication, and the results must have been predictable and not unexpected. Otherwise, the claim should be allowable under 102 and 103.

  161. But meh, you can say it either way.

    You can say anything in any way – but that has no correlation with legal principles.

    As they say, talk is cheap.

  162. Although, I hasten to add, they should have argued the “abstract idea” of the correlation rather than the ” naturally occurring correlations”. But meh, you can say it either way. I just think that a correlation, in and of itself, is an idea in the mind etc., formed based upon observations of similarities of things which are natural.

  163. Is dat me some reversal of CAFC nonsense I smell in the air? BECAUSE I SURE THINK THAT IT IS! CAN YOU SMELL WHAT THE USSC IS COOKING?

  164. Good. The Supremes told the Feds to look to Benson, Flook and Diehr on remand and they ignored them. The gauntlet thrown, the Supremes will once against cross swords with the uncowed Federal Circuit.

    The claims here are not too different than the claims in Flook. The Flook claims calculated a number that is useful but not used. We have always wondered whether the Flook claims could be saved by working on real data, rather than just by starting with a number. It looks like we might finally have an answer.

    This also points out to the Supremes that their decision in Bilski was “unclear.” We really do no know why the claims in Bilski were abstract. With Steven gone, we might have a working majority that will actually tackle that issue.

  165. I think I would have held it invalid under 102 or 103. I’ve been on blood pressure medicine for years now, and every time the prescription has been renewed, for all those years, I had a blood sample taken and analyzed and the dosage changed on that basis.\

    Giving more of a wet noodle than a body punch, I think there is utility in the method – it’s simply that it’s been used, probably, for centuries.

  166. This case presents not a patentable-subject-matter issue, but a simple utility issue.

    The invention is wholly inoperative, as claims disclose no specific and substantial utility whatsoever, and are therefore invalid for lack of utility under 101.

    This presents an excellent chance for the court to make some sense, in a very economical way.

    “Specific and substantial utility”. Do it!

  167. Could it be that, the more criticism rains down on SCOTUS, the more open it is to taking yet another patent case, trying to rehabilitate its reputation?

    Whatever: I’m mightily impressed by the appetite it is showing these days, for patent cases. And let’s face it, 101 issues are pretty fundamental.

  168. Excellent! As I recall, we had one case where cert was granted, but improvidently, and then this one was remanded. Somebody on the court is obviously itching to address this issue – it looks like the CAFC has given that somebody exactly what he/she was looking for.

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