Ignoring Non-Patentable Elements While Judging Novelty

PatentLawPic1046By Dennis Crouch

The Federal Circuit offers some clues to its post-Bilski patentable-subject-matter jurisprudence, but leaves that fight for another day.  Instead, the court held the claims anticipated by explicitly ignoring novel claim elements.

* * * * *

King Pharmaceuticals, Inc. v. Eon Labs, Inc. and Elan Pharmaceuticals, Inc. (Fed. Cir. 2010)

King’s patent claims a method of increasing oral bioavailability of the muscle relaxant metaxalone by putting metaxalone in food eaten by the patient. Claim 21 includes a step of “informing the patient that the administration [of the drug with food] results in an increase [in absorption].  This step likely has two benefits: (1) increasing patient compliance with the drug regimen and (2) taking advantage of any placebo effect that may exist.  The drug metaxalone itself was already a known muscle relaxant well prior to King’s 2001 application date.

Patenting Methods of Treatment: The district court held claim 21 invalid under 35 U.S.C. 101 based on the Federal Circuit’s machine-or-transformation test from Bilski. On appeal, the Federal Circuit rejected the lower court analysis — noting that when examined “as a whole”, the claim requires treatment and “methods of treatments ‘are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition.’” (quoting Prometheus Labs., Inc. v. Mayo Collaborative Serv., 581 F.3d 1336, 1346 (Fed. Cir. 2009), cert. granted and vacated, 78 U.S.L.W. 3254 (U.S. June 29, 2010)).

Although the appellate panel rejected the lower court’s Section 101 analysis, it stopped short of providing any positive position on the patentability of medical treatment methods — presumably saving that battle for the pending remands of Prometheus and Classen

Instead, the appellate court held that a Section 101 decision was not necessary because the claims of interest are anticipated under Section 102.

Ignoring Non-Patentable Elements: Here, the novelty question is interesting because the “informing” step was not specifically identified in the prior art. On appeal, the Federal Circuit held that claiming a step of “informing someone about the existence of an inherent property” of a method cannot render the claim patentable. “[I]n light of our holding that the method of taking metaxalone with food to increase the drug’s bioavailability, as recited in claim 1, is not patentable, it readily follows that claim 21, which recites the same method with the sole additional step of informing the patient about this increase in bioavailability, is not patentable.” 

In its decision, the court ties its case to the precedential foundation of “printed matter” cases that have barred the patentability of known products by the inclusion of printed matter describing the product.

In some ways, this decision may be seen as reviving the suggestion found in the now vacated 2007 In re Comiskey decision. There, the court suggested that, during nonobviousness analysis, any portion of an invention that constitutes nonstatutory subject matter will be considered de facto obvious.

Panel: Judges Bryson, Gajarsa, and Prost. Authored by Judge Gajarsa. 

 

 

Dennis Crouch

About Dennis Crouch

Law Professor at the University of Missouri School of Law. Co-director of the Center for Intellectual Property and Entrepreneurship.

119 thoughts on “Ignoring Non-Patentable Elements While Judging Novelty

  1. All around me are familiar faces
    Worn out places, worn out faces
    Bright and early for their daily races
    Going nowhere, going nowhere

    And I find it kind of funny, I find it kind of sad that today’s science used to be looked at just as Malcolm posts derisively on prayer, crystals and magnets.

  2. I appreciate the fact the court pointed out that “methods of treatment are always transformative…”

    I wonder if that includes homeopathy patents (yes, they do exist) or patents on methods of treating people by praying for them using a novel prayer rug. Or methods of healing with crystals (wouldn’t be surprised) or magnetic bracelets (likewise).

  3. I appreciate the fact the court pointed out that “methods of treatment are always transformative…” Frankly, I think it’s disingenuous when some claim that their methods of treatment are patentable because the body is “transformed” as a result. Such a claim, taken literally, would mean that all medical methods are presumptively patentable, and that is completely ridiculous. Hopefully, this issue will get ironed out in the course of patent litigation soon, whether in Prometheus, Classen, or some other case.

  4. Malcolm, I’m sorry my answers upthread don’t quite nail it down for you. I’ll try again now.

    Back in the 1960’s those who wrote the Strasbourg model patent law (precursor to the EPC)thought it proper to exclude methods of therapy but to permit the patenting of pharmaceuticals. Thus it came to pass, that this is how it was in the EPC from 1973. All a long long time ago.

    But, clever scientists were not slow to invent second uses for known pharmaceuticals. It was thought they should get patent protection commensurate with their valuable contribution to pharmacy. But how, given that methods of therapy are barred?

    Out of this conundrum was born the “second medical use claim” We see it as a claim to a product, purpose-limited, rather than to any process. As you will recall, it started as the “Swiss” form: Use of X in the manufacture of a medicament for treating disease Y.

    Much later, when the EPC was revised in year 2000, things were streamlined, to the extent of removing the need to include the “in the manufacture” words.

    Those inside Europe’s system see these “use” claims as patenting new uses of old drugs (rather than methods of therapy). It takes an outsider (like you?) to see it your way. But, as a pactical matter, European use claims do “work” , and that’s the main thing, I would say.

    This dialogue is fun. Instead of me, the outsider, commenting sceptically on aspects of US patent law, here we have you, the American, commenting adversely on an aspect of European patent law. I like it. I learn from it. More please.

  5. Ned,

    Ya gonna haveta show me a cite that holds that the transformation under a MoT has to be the novel part of a claim, which claim must be looked at as a whole.

    I be pretty sure that one is allowed to have “old” transformations in claims that are, as a whole, patent eligible subject matter.

    Malcolm,

    See what I mean about Maxie being a blimey? It runs through all his postings, not just the ones that are in your backyard.

  6. Is it so strange to have some limit on the patent-eligibility of methods of treatment of the human body by surgery or therapy?

    No, not necessarily. What is strange (for the umpteenth time) is passing a law which prohibits patents on methods of therapy and then allowing applicants to redraft their claims in a transparent fashion to do a complete end-run around the law.

    What is the policy goal of the law against patenting methods of therapeutically administrating drugs, Max? Is that goal being met in Europe?

    Don’t take it personal, buddy.

  7. IANAE – On your first hypothetical, you have to review the requirements for induced/contributory infringement. You can be liable for infringement if you encourage others to use a product in an infringing manner, even if the product per se is not patented.

    My experience with European patents is that you can obtain patents on new uses of known drugs just as easily (or not) as you can in the U.S. You have to phrase the claims differently, but even that is getting easier with recent EP decisions. In Europe, we now can claim : “Old compound X for use in new method Y.”

    Isn’t the “First Amendment” issue a red herring? The First Amendment doesn’t prevent you from enforcing your copyright to keep me from performing a song, why should it be different in the context of patents?

    I walk through some of the “printed matter” cases in my article on this case.

    link to pharmapatentsblog.com

  8. All, interesting line of cases from EPO on patenting new uses of known processes. We all know that new uses of machines, compositions, etc. are patentable as processes. But a new use of a known process? If it is patentable at all, it would have to be patentable as a new process. But, since it is admittedly an old process, it cannot be patentable under US law either under Section 101 or 102 as not new, even though the new “use” may be non obvious.

    Non obviousness cannot trump novelty. There has to be something physically new about the process.

    I think the problem with patenting old processes is apparent when one considers Prometheus. There, the metabolization of the drug in the body was old. The test for metabolites was old. Yet it was asserted that anyone who did only that which was old was an infringer because the of the discovery of the relationship between metabolites and the need to increase or decrease dosages.

    But, add one step — the step of actually increasing or decreasing dosages depending on the test results and, voilla, one has a new process.

    Obviously, the issue can be framed either under 101 or 102; but it seems simpler under 102.

    Now the Feds held that transformations by the body of a drug were per se MOT type transformations. However, such transformations are old in that they are naturally occurring phenomena. Administering a drug for a purpose might be new, but the transformation is inherent and old.

    Discovering something in nature does not entitle one to patent the discovery. But allowing one to use an old test to determine the presence of the natural phenomena seems to me the same as allowing one to patent the natural phenomena. Thus the Feds must be wrong in its reasoning that naturally occurring body transformations per se are transformations within the MOT.

  9. I’m curious Punches. What do you mean when you say that my incompetence is “proven”?

    But never mind. It makes a change, that anybody here is interested in patent law in Europe.

    I too hope that some knowledgeable euro will crawl out of the woodwork to oblige you. You will recall that, upthread, I myself asked for back-up from a pharma patent expert.

    I hope that you and I will both find out soon what is the exact extent of my incompetence.

  10. Dennis–is there any way to recover a post?

    I think my most recent one got caught in the filter.

  11. As Max has both proven and admitted incompetence, and no knowledgeable euro has stepped in, I offer the following comment with the caveat that I have no actual knowledge of EU or UK law on the issue:

    If in fact the communication of public information is restricted (a big assumption), the logic therefor may derive from the same basis as the restriction created in a restraining order on the occupancy and use of public space.

    The information is public, but it is not available for any and all to use at any and all times for any and all purposes.

    Specifically, the same compound would be branded differently, and prescribed to treat only condition B. Evidence of infringement could come from discovery of medical records–I know, difficult at best, but maybe possible for this limited purpose. I don’t know euro evidentiary rules.

    Of course, a problem arises where a patient has original condition A and is already taking the compound as the first branded drug, and then is later diagnosed with condition B. In such a case recovery would become a matter of proof of infringement, which could rest on something like a modified dosage, or subsequent recovery from original condition A. The issues could be ironed out by development of a body of jurisprudence.

    Who gets sued? The one in control–the prescribing doctor and the dispensing pharmacy. I don’t know how the various EU and UK health schemes work, but even where a drug is self-administered, I presume that access thereto is controlled by the prescribing doctor, and likely the dispensing pharmacy. Liability could be joint and several.

    If both the doctor and pharmacy are essentially public servants, the public entity becomes liable.

    Talking out my a$$. Hopefully this will bring somebody who actually knows something out of the woodwork.

  12. Is it so strange to have some limit on the patent-eligibility of methods

    There is. All patents have some limit.

    Haggy, jealousy don’t become you.

  13. “Ya never quite learn that the US is the gold standard”

    There are many things to admire about the USA. This basic attitude is not one of them.

  14. Malcolm as I understand it, the USA baulks at the idea of lawyers enjoining surgeons half way through life-saving operations in theatre. Is it so strange to have some limit on the patent-eligibility of methods of treatment of the human body by surgery or therapy?

    As to your hypothetical, about an infringing act consisting of selling the drug and “separately” giving instructions on its administration, we would need to define “separately”. I don’t know of any European caselaw. Does that surprise you?

    ping, Malcolm’s counsel is that I should not get you excited. I think he’s right on that point.

  15. My motives in blogging here are perhaps different rom those of “domestic” readers. I like to provoke, and to learn from the reactions.

    Haveta LOL ya Maxie – here I thought your motives were to
    one – proselytize,
    two – provoke and
    three – ignore.

    Can’t says as I see ya learnen much, cause ya keep on saying the same things (see number 1 above) Ya never quite learn that the US is the gold standard, and ya always hawk about ways to make it less so.

  16. MD, beruhige dich, or whatever you say in Europe. You are missing the point and you are also exciting ping. Not good.

    If somebody finds out through laborious and expensive research that known medicament X surprisingly cures some hitherto uncurable rare dread disease, shall that person be rewarded for his research with a patent of commensurate scope, or not?

    Sure, in the US we call that a method claim. The only reason we call that a “use” claim in the EP is because for reasons that can not be explained (because they could not be logical) the EP bans methods of treatment but allows patents on compositions limited to the therapeutic use of the composition. As I said, it’s a ridiculously transparent end-around the law. That is what is silly, Max: the end-around the law and the ridiculous transparency of the end-around. Patents on methods of treating humans are perfectly fine with me. Rewriting method claims to comply with the EP’s fake ban on treatment claims is … irritating.

    The far more interesting subject which I was raising upthread is the practical aspects of claims on new uses of old compounds or even new methods of treating people with old compounds. Specifically, the question is: who are you going to sue and what for? The patentee wants the deep pockets.

    The deep pocket is liable if it sells the drug with a label that induces infringement. Is it inducement to sell the drug and, separately, inform the world of public information about how the drug can be used?

  17. Malcolm, you agree with patents on pharmaceuticals, I take it. Why that then?

    So, you agree with drawing a line on patent-eligibility somewhere between that and methods of therapy. So, where exactly are you going to draw that line. If somebody finds out through laborious and expensive research that known medicament X surprisingly cures some hitherto uncurable rare dread disease, shall that person be rewarded for his research with a patent of commensurate scope, or not?

    Second medical use claims are not a joke. I suspect you don’t really think that either.

    But now I’m wondering where you hail from. Perhaps a public policy place in the USA, from which it would be too complicated to admit the usefulness and legitimacy of such claims.

  18. You guys an your intended use limitations.

    The limitation itself is for an actual use. The only thing that’s based on intended use is the infringement litigation, because the guy actually using the product in that way doesn’t have any money.

  19. “Okay, it’s a new use for a drug. But how is that any different from claiming a new use for a screw or an internal combustion engine?”

    You guys an your intended use limitations. Why do you bother with such nonsense? Furthermore, why on earth wouldn’t the court look at your intended use limitation and treat it as such?

  20. They’re just a ridiculously transparent end-around the EP prohibition against patents on methods of treating humans.

    I have a problem with patenting methods of treating humans that involve professional skill, e.g. surgical methods, but why shouldn’t one be able to get a patent on a method of treatment wherein a well-defined chemical can be self-administered in a routine and well-defined manner? How is that really different from claiming the drug itself, when the drug’s only known utility is for medical treatment?

    Okay, it’s a new use for a drug. But how is that any different from claiming a new use for a screw or an internal combustion engine?

  21. You can’t do it under 101, because the use of a drug to treat a condition is clearly statutory subject matter whether or not the advantage is explicitly claimed.

    I think you do it under 101, 102, or under 103. When the sole non-mental step in a method is an admittedly old step, that step can be ignored in a 101 rejection.

    Why not? Why must there be only way to kill methods that try to claim information or the mental uses thereof?

  22. Max, I file “use” claims in the EP all the time. That still doesn’t make them less of a joke. They’re just a ridiculously transparent end-around the EP prohibition against patents on methods of treating humans.

  23. In G2/08 it was EP-A-643965, nicotinic acid compositions, hyperlipidemia and “once a day, prior to sleep”. The successful Applicant was Abbott.

  24. IANAE you need to go to the EPO website and download G_0002/08 “Dosage regime” to see that you might be able to get a European patent even when the only thing that distinguishes the claim from the art is the dosage regime.

    You know what the prefix “G” means, I take it? The EPO’s supreme court, the Enlarged Board of Appeal. On this issue, it has spoken.

    Depending how this thread develops, I might post a link later but, from where I am now, I can’t do that.

  25. Liked your comment on my last para IANAE. LOL.

    You are of course right about kits and such. It is just that, over here in EPO land, chem/bio is one world and Mech/EE quite another.

    Just as individual attorneys at law specialise in one branch of the law, so individual members of that quite other profession, European patent attorney, specialise in the area of their science or engineering background

  26. When the drug has been used to treat something for years, and the innovation is optimization of it’s administration to treat that thing, then you have an obviousness problem, not an anticipation problem.

    But this isn’t even an obvious optimization of a prior art treatment. It’s the exact same treatment as in the prior art.

    However, I would rather see the analysis take place under 101 than 102,

    You can’t do it under 101, because the use of a drug to treat a condition is clearly statutory subject matter whether or not the advantage is explicitly claimed. Patents of that kind are issued all the time. The problem here lies in how much of the claim was already known in the art, which is clearly a 102/103 issue.

  27. A new use for a drug is one thing. If the drug has never been used to treat something before, then the new use patent should be possible.

    When the drug has been used to treat something for years, and the innovation is optimization of it’s administration to treat that thing, then you have an obviousness problem, not an anticipation problem.

    Here, it seems like the Court focused on the new activity being impartation of the knowledge of how to optimize the administration of the drug to patients.

    I think there is a legitimate First Amendment issue regarding human use of words, spoken or written, to impart information in any context (and not a copyrightable expression of that information). But I am not entirely comfortable with the way the Court chose to deny the claim as anticipated.

    If following the statute results in a patent that would prohibit free expression of the information, then the court must do something to prevent the patent from issuing. However, I would rather see the analysis take place under 101 than 102, and the apparent dissection of the claims into novel and non-novel elements for the 102 analysis is particularly troubling.

    I think what we may have here is a preemption issue, not in that all uses of the general principal are preempted, but that at least one Constitutionally protected use of the general principal is preempted.

  28. Max: But as I say, I’m not a pharma drafter. I hesitate to encroach on the territory of specialists.

    The principles of patent law don’t like to stay neatly compartmentalized. As EG pointed out on Gene Quinn’s blog, there’s an overlap between this sort of pharma claim and “kit” claims where the invention is a set of parts plus instructions. Maybe not in places where there’s a specific statutory provision for medical indications, but you can see how the concept carries over.

    Max: My motives in blogging here are perhaps different rom those of “domestic” readers. I like to provoke, and to learn from the reactions.

    Ah, I see. You distinguish your method from the prior art by the “learning” step.

  29. IANAE, sorry, now I see. You had in mind all the time the instant CAFC case, not any thread hypothetical.

    I will think about it and revert. But as I say, I’m not a pharma drafter. I hesitate to encroach on the territory of specialists. Gut reaction though is that it would also be unsustainable here in Europe. I’ll try to give you, later, a concise suggestion why.

    My motives in blogging here are perhaps different rom those of “domestic” readers. I like to provoke, and to learn from the reactions.

  30. But I’m working on the basis that it is a completely different condition.

    Sure, if you discover that ASA in small doses helps in whatever way with heart problems, come get your patent. If you discover that AZT works against HIV, come get your patent. You’ve earned it.

    But what would you do with the facts of King v. Eon? In this case, they claim treating exactly the same condition by administering exactly the same drug in exactly the same way, while informing the consumer about an inherent benefit that relates to the prior art indication.

  31. IANAE, sorry, I don’t understand. You say: Same drug, same form, same dose, same condition.

    But I’m working on the basis that it is a completely different condition.

    How about a daily dose of aspirin, but to manage tendency to blood-clot? Now there’s a case where it might be hard to pursue an infringer. So where’s the great harm in rewarding the inventor with a patent? Like the method of exercising a cat, perhaps?

    As I say, the EPO hands out the patents but leaves to others the job of enforcing them. I still remember the anguished cries from the English judiciary “EPO, have you gone mad? How are we supposed to deal with these use claims, when they come to court. Obviously, they are totally devoid of novelty”.

    Then they changed the EPC, to make absolutely sure such use claims are OK. See upthread. Now the English courts have to do with use claims the best they can. Nary a whimper out of them, these days.

  32. Max,

    On the facts of this case, could one secure a valid European claim for a “second” medical indication?

    Bear in mind that the second indication is also the first indication, and the drug doesn’t actually work any better for the “new” indication than the prior art because it’s the same dosage administered in exactly the same way.

    What would you claim? “C in combination with food, for use in treating D, and by the way it works surprisingly well”?

  33. Good question Punches. Practical problems? We got over them, 20 years ago.

    But I’m the wrong person to ask. We need an elderly English patent litigator to comment now, and give you succour. As I say, use claims are a large part of patent litigation in Europe, these past 20 years. You’ll have difficulty finding somebody who remembers how it was, before use claims came along.

    Thus, I’m finding it quite interesting that, for discerning readers of Patently-O, this is all so new. Must be that Europe is “below the radar”. But, from the amount of pharma litigation that goes on here, I would never have guessed it.

    Suggestion: try Googling “second medical indication” or “second non-medical indication”.

  34. Come on euros, I want to hear from someone other than the euro-booster Max. Someone rational.

    What about the first-order pragmatic questions that inevitably and quickly arise?

  35. Ask patient R whether the one who found out that C will cure Z has added anything useful to the sum of human knowledge.

    Yes, he has added to the sum of human knowledge.

    So did Svante Arrhenius, but (1) he wasn’t actually the first to propose the equation, and (2) he couldn’t have patented it anyway.

    Therefore, I propose that such is not the appropriate test for entitlement to a patent.

    Are the intellectual problems of “use” claims so great that they must be ruled out?

    Not necessarily completely ruled out, but this case is probably the worst of them you’ll ever see. It’s the same drug, taken in the same way, at the same dosage, to treat the same condition. The distinction is that someone wrote on the bottle “by the way, this will work better than you might have expected”, even though it’s no better than the competitor’s identical drug. How does one properly market such an advance? “Try our old-and-improved muscle relaxant”?

  36. Max, forget about the so-called “intellectual problems”.

    What about the practical problems, as pointed out by IANAE and Mooney upthread?

  37. IANAE This “novelty of purpose” stuff is indeed interesting. You are a doctor. Patient R is suffering from rare disease Z. There is no known cure. The state of the art includes medicament C, but being used to treat a completely different disease X.

    Ask patient R whether the one who found out that C will cure Z has added anything useful to the sum of human knowledge.

    When has an inventor done enough to qualify for a patent, the chance to recover his research costs?

    Are the intellectual problems of “use” claims so great that they must be ruled out?

    Is the court up to the task of deciding what is an infringing act? Does it shrink from such difficult tasks?

    And why is it so difficult. If you want to market a new cure for disease Z, you need permission from the FDA don’t you? Is not the patentee in reality watching who asks the FDA? Does he not then seek a quia timet injunction, to rstrrain the party that is petitioning the FDA ?

    Come on, you Euro pharma folks. Help me here.

  38. Has the Exxon fuel additive inventor contributed to the art of ic engines?

    If it’s the same as the prior art additive, and you put it in the same hole in your car, I would say no.

    This is how patent law should work, no?

    Probably. I’m just trying to understand how “how patent law should work” does work.

    It seems there really is a lot of leeway in designing a working patent system once you get around all the litigiousness and rule-lawyering and loophole-exploiting that’s so ingrained in American culture.

    But I still have a problem with “C, for use in treating Z” when the dosage is the same as the prior art indication for treating D. Proving infringement would rest on showing that A revealed (or knew that its customers knew) a fact about the otherwise-lawful product it might have been selling for years already.

  39. IANAE, Articles 52 and 53 of the EPC (make sure you view the current text, the year 2000 version) is Europe’s 101. Here, see Art 53(c).

    Article 54 is our 102. Here, see Art 54(5).

    X should claim:

    1. C, for use in treating Z.

    X’s problem is gathering enough proof of infringement. Start with the packaging of the accused product.

    In Europe, people don’t embark speculatively on a course of patent litigation. The rewards are not big enough. On the contrary, it has to be a big issue to justify going to the last resort, of turning to the courts. People are motivated primarily by a business need to get the other fellow enjoined. In proper cases, an injunction can be granted very quickly, even ex Parte. This is how patent law should work, no?

  40. Posted by: Malcolm Mooney | Aug 03, 2010 at 01:31 PM:

    “ping NAL ripped ya to shreds”

    A rather pathetic attempt to rewrite history, ping. Keep trying.”

    _______

    It’s true. NAL chewed you up and spit you out and chased you across a 100 threads for like six months. If Noise came back today you would go running up the hill with your skirt on and about 20 new alias posters would pop up in the thread within minutes of each other.

  41. Ours is the most wonderful profession in all the world. You think you know how nature works, and then along comes some genius physicist and sees it differently. You think a technical field is mature, and then along comes a genius engineer with a brilliant contribution that starts a frenzy of new developments. You think you’ve got the law of patentable novelty completely sussed, and then along comes some self-confident supreme court judge, and everything starts anew.

    I guess, if you love progress, change and renewal, you’re in the right profession.

  42. Dear Punches, and others, I invite you just to download G_0002/88 from the EPO website and read for youself about “novelty of (non-medical)purpose” and its patentability in Europe. Twenty years ago it kicked up just such a storm as above in this thread. But it’s history now. Patents with use claims, thousands of them, have already reached the end of their 20 year term.

    Has the Exxon fuel additive inventor contributed to the art of ic engines? Is the contribution new, was it obvious, is it useful, is it enabled. OK, we just need to figure out how to claim it. That’s where these “use” claims come in.

    Mental leap required, I’m afraid, to get your heads around these “use” claims.

    Have I been indiscreet? Those US corporations who assiduously and routinely include “use” claims in their European filings probably don’t want anybody else to know about them.

    How about use claims in Asia? Anybody know?

    Malcolm, infringement actions go OK, even in England, despite the early misgivings of the English patent litigation class. Burden of proof lies with the patent owner. Validity (tried by the same judge in the same action) hangs on the preponderance of evidence. Loser pays.

  43. Max gives us a blanket statement and we accept it as true, even though it is not at all nuanced.

    Can some other euro add to this discussion?

  44. and your alter ego is NAL?

    Back to those older dominant women fantasies, eh 6?

    Doncha know – my alter ego is IANAE!

  45. Research Shows Controversial Illness is Real and Treatable

    CHARLESTON, S.C., July 27 /PRNewswire/ — Today, Policyholders of America (POA) released a consensus statement written by treating physicians and researchers in the field on the mechanism and treatment of illness found in people sickened by exposure to water-damaged buildings. This illness has been the subject of heated debate that has resulted in harsh allegations being lobbed at patients by experts hired by industry to cast doubt on the legitimacy of the illness. Today however, so-called “Sick Building Syndrome” is now unveiled to be very real; it’s a chronic inflammatory illness that is easily identified with available lab testing and treatable using FDA-approved medications. The research paper is the first in the field written by physicians with experience treating the illness. Thorough and rigorous, the paper references governmental agency opinions, current published literature and an extensive review of patient data that has made this subject a political and legal hot potato obstructing patient care.

    Nearly six months ago, a distinguished and credentialed panel of medical doctors and researchers, all from outside of POA’s membership, were assembled and charged with developing a consensus statement on the diagnosis and treatment of a growing public health problem across America: illness acquired from water-damaged buildings. The consensus statement was then peer-reviewed by other medical doctors and researchers. The research paper is being released to help physicians and their patients understand the mechanisms, symptoms, diagnosis and treatment protocols available for sickened patients.

    After reviewing hundreds of peer reviewed studies, analyzing hard data from research conducted on thousands of patients, and incorporating published results of treatment of thousands of patients, the authors embarked on this massive assignment with eyes wide open — knowing that if the resulting research did not lessen liability of the powerful stakeholders involved, industry would likely attempt to discredit the findings.

    With the research now concluded, the mysterious illness now has a name: Chronic Inflammatory Response Syndrome or “CIRS”, and when the cause of the illness can be directly linked to a water-damaged building, or (“WDB”), it is called “CIRS-WDB”.

    Says Co-Author, Ritchie Shoemaker, MD, of Pocomoke, Maryland, “This statement builds consensus by debunking false ideas about illness from water-damaged buildings and establishes the basis by which practicing physicians can assess the complex illnesses these patients experience. We don’t have to guess what might be wrong when we have the labs to prove what is abnormal. Patients don’t have to suffer any longer after being given incorrect diagnoses such as allergy, stress or depression.”

    Co-authors included Laura Mark MD from Williamsburg, Virginia; Scott McMahon MD from Roswell, New Mexico; Jack Thrasher PhD of Oakland, California and Carl Grimes HHS, CIEC, President of the Indoor Air Quality Association, from Denver, Colorado.

    The 161-page research paper can be found, in its entirety, at: link to policyholdersofamerica.org

    A layperson’s summary of the research paper follows:

    •CIRS-WDB is a multisystem, multi-symptom illness acquired following exposure to the interior environment of WDB. It exists as a recognizable syndrome that is identifiable and treatable;
    •CIRS-WDB is identified as immunologic in origin, with differential inflammatory responses seen according to (i) genetic susceptibility and (ii) unique aspects of host innate immune responses.
    •CIRS-WDB consistently involves loss of normal control of inflammation and the resulting “inflammation gone wild.”
    •Treatment of human illness that is acquired following exposure to the interior environment of WDB involves a series of steps, each correcting the physiologic problems one by one.
    •CIRS-WDB can be readily identified by current methods of clinical diagnoses. This process of diagnosis is supported by (i) identification of unique subsets (“clusters”) of symptoms found in epidemiologic cohorts of affected patients; (ii) identification of unique groupings of biomarkers, such as genetic markers, neuropeptides, inflammatory markers, and autoimmune findings.
    •Patients with CIRS-WDB are often given incorrect diagnoses such as depression, stress, allergy, fibromyalgia, Post Traumatic Stress Disorder, and somatization. Those conditions, when actually present, will not improve with therapies employed in CIRS-WDB.
    •CIRS-WDB is acquired primarily from inhalation of microbial products that are contaminants found in the complex mixture of WDB.
    •Re-exposure of previously affected patients will bring about immunological host responses that are enhanced in their rapidity of onset and magnitude, such that these patients are “sicker, quicker.”

    Melinda Ballard, POA’s president said, “About 25% of our members have experienced health effects after exposure to toxigenic mold and other organisms in their homes and of those, the vast majority put on the treatment protocol outlined in this paper have reported back to us that their symptoms have either subsided or vanished altogether. While our experience with these members is purely anecdotal, this research paper is not; the findings are irrefutable. Most importantly, the rigorous science in the paper offers hope to so many who are in desperate need of an effective and inexpensive treatment.

    POA is a nonprofit educational organization that, at no charge, helps policyholders receive adequate payment when a property insurance claim is filed. Since it was founded in 2001, more than 2.5 million people have joined, an unfortunate reflection on the manner in which claims are often handled by insurance companies. Its web address is: http://www.policyholdersofamerica.org. POA is a member of ACHEMMIC (the Action Committee on the Health Effects of Mold, Microbes and Indoor Contaminants), a group of scientists, researchers, physicians, indoor air quality experts, environmental engineers, industrial hygienists, structural engineers, teachers and advocates working to advance the understanding of the health effects of mold, microbes and indoor contaminants. ACHEMMIC’s website is http://www.achemmic.com.

  46. “Doctors and mechanics commonly examine the entire “patient” and may identify a number of things wrong, which they may decide to treat all at once or in no particular order. Once you’ve gone for a full checkup and been diagnosed with condition Z, but you’ve also taken drug C for concurrent condition D, wherein drug C inherently also treats condition Z, you are a walking anticipation.”

    True enough, but I doubt the examiner would be privy to any such documentation of this patient’s existance.

  47. You also sound like you’ve been watching fin annoying arse jar jar binks. Maybe because you have a 6 yr old and your alter ego is NAL?

  48. One possible strategy would be to include a step for identifying a car that is particularly in need of freiction reduction based upon some criteria.

    And then presumably you’d have to administer the additive conditionally on the identification.

    Doctors and mechanics commonly examine the entire “patient” and may identify a number of things wrong, which they may decide to treat all at once or in no particular order. Once you’ve gone for a full checkup and been diagnosed with condition Z, but you’ve also taken drug C for concurrent condition D, wherein drug C inherently also treats condition Z, you are a walking anticipation.

  49. Re: claiming the “new” use of the fuel additive.

    My understanding is that a uspto examiner wouldn’t allow the claims to the new use of the prior art method, at least not without some finesse. If the prior art already showed the step of administering the additive to the gasoline and introducing the mixture into the car’s gas tank for different purposes, then claiming “use” of the previously unrecognized friction reduction property won’t save the claim because all the steps that result in this effect were previously being performed, so the firction reduction effect is reasonably denoted as inherent. (I’m somewhat surprised that the EPO would rule differently in this case.)

    That being said, I think there are some claim strategies that could overcome this weakness. One possible strategy would be to include a step for identifying a car that is particularly in need of freiction reduction based upon some criteria. For example,

    A method of minimizing friction in an engine comprising:
    identifying an automobile that has experienced at least one instance of overheating;
    creating a mixture of x parts gasoline with y parts fuel additive;
    introducing the mixture into the fuel tank of the automobile.

    To my limited understanding, the identification step could overcome the prior art in this instance. Although, the identifying step might be too limiting for the inventor’s tastes.

  50. Keep trying.

    Hey Sunshine Malcolm, I aint rewriting anything – me be too lazy. Iza just callin them like I see ’em.

  51. Max: Use claims are useful in pharma, where the intended “use” is abundantly clear from the packaging etc.

    Walk me through this, will you?

    Company A gets patent B to drug C, known to treat condition D. Company A happily sells drug C. Maybe it’s OTC, maybe it’s by prescription. Maybe patent B is expired, maybe not.

    Company X subsequently gets patent Y to the use of drug C for condition Z. Enablement of patent Y is based at least in part on study S by university U, or even by company X, which study is available to the public.

    Is company A prevented by patent Y from:
    1) mentioning the public and true fact that study S shows drug C is useful for treating condition Z?
    2) having its drug placed on the shelf next to the company X drug and indicating that it’s the same drug as the company X brand?
    3) selling its drug to people who have read and have not forgotten the study or marketing materials publicized by company X?
    4) having doctors prescribe drug C for an undisclosed reason to patients having condition Z? What if the patients also have condition D?

    Does this depend on whether drug C is therapeutic in the same dosage for indications D and Z?

    More importantly, what precisely do you claim when indications D and Z have overlapping dosage ranges?

  52. 3. The method of claim 1, wherein said identifying comprises analysis of a photo of said subject.

    4. The method of claim 3, wherein said photo is a photo available on the Internet.

    5. The method of claim 4, further comprising informing said subject of a defect in teeth whiteness by email.

    6. The method of claim 5, further comprising offering said subject a coupon for purchase of a bread or butter by a third party.

    Out of a sincere effort to preclude attempts to patent similar crrp (which I expect to fail, given Kappos apparent love for this crrp), this sort of thing will a significant use for photo-crawling technology. Any photo of an identified person who can be contacted can and will be used to sell something to that person after “analysis” of the photo. Is there a bike in the photo? Hey, buy some bike gear. Acne on the face? Here’s some acne medication. And a coupon for breast enhancement and 1/2 off your next Ann Taylor purse. And some hair dye. And some crrp for your baby. And some Geritol. And next time you go to New York City, check out our cheap flights. Etc., etc.

    No doubt there’s reams of this obvious crrp in the queue already. Or already granted. Bleh.

  53. My contributor is your inducer. We both need a primary infringer first, right?

    That would be anyone who uses the old product, no?

    Remember, we’re talking about an old mixture where one of the components in the mixture has a new effect on the mixture that wasn’t previously appreciated.

    The only difference between the primary infringer before the patent and the primary infringer after the patent is that, in some cases, the primary infringer will know something about the mixture that he/she didn’t know before.

    Mind control. It’s what the printed matter doctrine is all about.

  54. Malcolm: “In the US, the strategy would be to claim the method (since you can’t claim the composition) and then go after inducers of infringement who sell the additive for the express purpose of achieving of the previously unrealized (but inherent) property.”

    Malcolm, a rose by any other name.

    My Use claim is your Method claim.

    My contributor is your inducer. We both need a primary infringer first, right?

    We cannot patent methods of medical treatment here in Europe. Ruled out by our Article 53(c) EPC. But we can patent substances and compositions for use in such methods.

  55. Malcolm,

    It doesn’t hurt me.
    Do you want to feel how it feels?
    Do you want to know, know that it doesn’t hurt me?
    Do you want to hear about the deal that I’m making?

    No big deal to me just how ya “take the doctrine seriously“, but NAL ripped ya to shreds on the issue so many times Iza lost count.

    I do have some of the posts faved – being musically inclined, I specially like the Kate Bush one.

  56. ping what the courts have actually said

    The problem is that the courts don’t take the doctrine seriously and I do. What is the purpose of the doctrine?

  57. I for one do have a problem with people obtaining “new use” patents – especially as in the additive for ic engine fuel example in which the method of use is exactly the same as the prior art use – that smacks of pure inherent properties to me.

  58. Those who tout the additive for its friction-reducing properties need to watch out for Europe’s statutory provisions on “contributory infringement”.

    Use claims are useful in pharma, where the intended “use” is abundantly clear from the packaging etc.

    In other words, a company is prevented from advertising a benefit or use for a product that it was selling prior to the filing of the patent disclosing the previously unappreciated property.

    Totally bogus, as the information about the product’s properties is not owned by anyone. It’s public information in the most legally pristine sense of the term.

  59. Someone find NAL – hey 6, look her up and let her know that Malcolm is talking about the Printed Matter Doctrine (or as I like to call it, the pWinted Matter Doctrine).

    I bet that she would get a kick out of it as she chased Malcolm around with that for what – two years?

    As to Malcolm’s choice wording of “limitations consisting of non-structural information content” I would only like to see Malcolm slide just a little bit closer to what the courts have actually said.

  60. What is the patentable claim to the new “use” for the prior art use of a prior art additive? Do you claim the label, and thereby prevent the competition from making accurate factual statements about the inherent advantage of its prior art formulation?

    Good question. In the US, the strategy would be to claim the method (since you can’t claim the composition) and then go after inducers of infringement who sell the additive for the express purpose of achieving of the previously unrealized (but inherent) property.

    Of course, the question of damages will get interesting. And there certainly is a free speech issue. The patent discussing the new property of the old composition is public. What if the seller of the additive merely posted the patent on its website as a “notice to users of its product regarding newly appreciated benefits of the old mixture”? How in the world could that possibly constitute infringement?

  61. IANAE, since G2/88, so-called “use claims” are “all the rage” in Europe. The EPO sees its duty as to grant patents to people who invent things. THe EPO leaves it to courts in each of its (by now) 38 Member States to decide whether to enforce the clear examined claims it issues. The Brits prophesied doom and disaster if such “use claims” should issue. It hasn’t happened yet.

    Under the EPC you can’t claim the printed label because the framers chose to exclude “the presentation of information” from patent-eligibility. Foresighted, or what?

    Those who tout the additive for its friction-reducing properties need to watch out for Europe’s statutory provisions on “contributory infringement”.

    Use claims are useful in pharma, where the intended “use” is abundantly clear from the packaging etc.

  62. q: If you can claim a new use for an old compound, what if you claimed the old compound with instructions for the new use?

    The printed matter doctrine says that the instructions can’t turn an otherwise invalid claim into a valid claim.

    I hoping that this case represents the Federal Circuit’s attempts to take the printed matter doctrine seriously and apply the logic of the doctrine to claims whose validity depends on the recitation of limitations consisting of non-structural information content and/or the communication of such information.

  63. Can you get a patent covering that valuable, new (or is it?) and certainly not obvious contribution to the technical field, the use of that fuel additive, in fuel, for reducing friction inside the engine?

    Presumably the answer to “can you get a patent?” depends on the answer to “what can you validly claim?”

    Your hypothetical sounds a lot like mine. What is the patentable claim to the new “use” for the prior art use of a prior art additive? Do you claim the label, and thereby prevent the competition from making accurate factual statements about the inherent advantage of its prior art formulation?

  64. Pop quiz: Suppose you discover that eating bread with the usual amount of butter on it whitens your teeth. Pretty unexpected, but also inherent in an activity that’s older than dirt. What’s your patentable claim?

    1. A method for whitening teeth in a subject in need thereof, comprising:

    identifying a subject in need of teeth whitening;

    informing said subject that said subject’s teeth are in need of whitening;

    administering to said subject white bread with butter on it;

    evaluating status of said subject’s teeth whiteness at least once after said administration.

    2. The method of claim 1, wherein said administration is self-administration by said subject.

    3. The method of claim 1, wherein said identifying comprises analysis of a photo of said subject.

    4. The method of claim 3, wherein said photo is a photo available on the Internet.

    5. The method of claim 4, further comprising informing said subject of a defect in teeth whiteness by email.

    6. The method of claim 5, further comprising offering said subject a coupon for purchase of a bread or butter by a third party.

    7. The method of claim 6, further comprising receiving a payment from said third party for each subject identified as in need of teeth whitening.

    Need I go on? If I can get this into one of the lightweight art units, I’m golden.

  65. Ned, you open up the entire field of “novelty of purpose” and “use claims”. Suppose (see EPO Decision G_0002/88) that an additive for ic engine fuel is known, and used to protect that engine against engine corrosion. Then somebody finds out a non-obvious fact, that the same additive, present in the same amounts, is effective to reduce friction inside the engine. Can you get a patent covering that valuable, new (or is it?) and certainly not obvious contribution to the technical field, the use of that fuel additive, in fuel, for reducing friction inside the engine? In Europe, yes.

    As you see from the 1988 date when the EPO Enlarged Board of Appeal decided, the issue arose just as soon as the EPO opened its doors for business in 1978.

  66. If you can claim a new use for an old compound, what if you claimed the old compound with instructions for the new use?

  67. Just visiting: as a doctrinal matter, can a claim be both non obvious and anticipated?

    Back to my earlier post: “claim as whole” applies to obviousness. It does not apply to novelty.

  68. Why not reject based on obviousness?

    Because the content of the printed matter is not necessarily obvious. If the correlation was newly-discovered, it would not have been obvious to indicate the correlation on the label.

    Adding non-obvious printed matter is a cop-out for when you want to turn a discovery into an invention without actually finding a practical use for the discovery.

  69. “How is this a ‘new doctrine”‘? Why is it such a bad decision?”

    The controversy surrounds the use of a 102 rejection where the prior art reference apparently did not teach the printed matter step. Why not reject based on obviousness?

  70. Just a “small” point. I can see how “claim as a whole” applies to obviousness. I do not see how it applies at all to novelty.

  71. We’ve just jumped down the rabbit hole into Bilski in Patentland.

    Bilski, like KSR and eBay before it, is completely not-ridiculous and consistent with everything the patent law is intended to do, once you actually think about it.

    And it would be easily and predictably applicable to future cases had the Supremes waited for a case with more appropriate facts, like Prometheus v. Mayo. Or this one, had the prior art not been so close.

    When the novelty resides in saying “hey, look at this thing I discovered”, 101 should kill your patent. When the novelty resides in saying “hey, keep doing what you’ve been doing, but here’s another good reason for it that I discovered”, 102 should kill it too.

    Pop quiz: Suppose you discover that eating bread with the usual amount of butter on it whitens your teeth. Pretty unexpected, but also inherent in an activity that’s older than dirt. What’s your patentable claim?

  72. “What a terrible opinion. Take the claim as a whole and find the elements. This business of splitting the claim up and then eliminating claim elements is wrong. I wonder if the SCOTUS might not want to smack them again.”

    NWPA,

    I’m with you. Unfortunately, SCOTUS would have to smack down one of their own, namely the recently retired Justice Stevens who opined in Parker v. Flook that a previously unknown algorithm should be treated as “prior art” under 35 USC 103. We’ve just jumped down the rabbit hole into Bilski in Patentland.

  73. Re: “I agree with Dennis and Joe Miller. It seems like an obviousness type ruling would have been both much easier and perhaps more “conservative” (ie. not creating “new” doctrine).”

    Indeed! Just because a decision below is based on 102 there is no reason why the Federal Circuit cannot sustain it on 103 instead, when the only missing claim element in the cited prior art was so obvious and does not make the claim as a whole unobvious. Especially since, as this and other decisions have held, an appelate court can affirm correct decisions even if based on incorrect legal theories.

    But is not this particular case further confused by the legal principle that the discovery of an inherent property of a known compound is not patentable, even if that was unobvious, and not relying on its exceptions, like method of use claims?

  74. suddenly information handling steps don’t get patentable weight.

    I’m sure at some point someone is going to bring up Diehr as an authority for giving information handling steps patentable weight, as long as you end up doing something with the information.

    Wouldn’t have saved this patent, though. Maybe if they’d claimed changing the dosage in response to a patient’s promise to take it with food, or something.

  75. Wow, so now the Fed. Cir. and PTO require a machine in our method claims, confusing the distinction between statutory classes, oh and guess what? It seems that brings in case-law at one time understood as limited to apparatus/machine type claims, and suddenly information handling steps don’t get patentable weight.

  76. The “informing” step could not have been obvious because the inherent property was not known in the prior art.

    Except that there was lots of prior art teaching this very drug in combination with “take with food”. This patent was directed to telling people that taking this drug with food (which was already known to be good) also had another inherent benefit.

    So what’s the invention again? Telling people how great it is to do what they are already doing? That shouldn’t save the claim under 101 or 102.

  77. Joe Miller Said: As I was reading the case, I kept thinking, why not frame this as a one-reference obviousness case? If the only difference between the prior art and the claimed invention is the telling-the-patient limitation, isn’t this the sort of common-sense obviousness defect that KSR was supposed to enable a court to respond to?

    The “informing” step could not have been obvious because the inherent property was not known in the prior art. It can not be obvious to informs someone of something that is unknown. It was only after the discovery of the inherent property that it was obvious to inform the patient of it.

  78. I think we need to be careful not to read this opinion too broadly. I do not see where it stands for a general principle that nonstatutory elements of a claim may be excised for the purposes of novelty/obviousness analysis.

    In fact, it says precisely the opposite (at bottom of p20):

    In such cases, we have recognized that the printed matter is not independently patentable, but have cautioned that the limitation must not be excised from the claim. See id. at 1385 (“[T]he board cannot dissect a claim, excise the printed matter from it, and declare the remaining portion of the mutilated claim to be unpatentable. The claim must be read as a whole.”)

    The decision only appears to stand for a relatively narrow proposition (p. 20):

    The specific question before us is whether an otherwise anticipated method claim becomes patentable because it includes a step of “informing” someone about the existence of an inherent property of that method.

    How is this a “new doctrine”? Why is it such a bad decision?

  79. What a terrible opinion. Take the claim as a whole and find the elements. This business of splitting the claim up and then eliminating claim elements is wrong. I wonder if the SCOTUS might not want to smack them again. Bad Fed. Cir. !!

  80. Ironic?

    Contrary to the Supreme Court’s instructions, the district court ignored the claim as a whole and improperly focused on one limitation, the “informing” limitation, in invalidating the claim under § 101. Such an analysis is improper.

    Yet seems perfectly proper under § 102 as the court isolates and concentrates the analysis on that same one limitation.

  81. Question: suppose somebody comes up with a solution to a classic pure math problem, the “travelling salesperson” problem. Arrange the journey to minimise fuel consumption while getting to visit each of the customers just once.

    Implementation of your “invention” (on the particuler in-car navigation machine that gives the salesperson directions) is trite. Your claim has got past 101 and 102. Should it get past 103? If so, why? Because of the genius it took to solve the math problem, or what?

  82. I agree with Dennis and Joe Miller. It seems like an obviousness type ruling would have been both much easier and perhaps more “conservative” (ie. not creating “new” doctrine). Reading through Dennis’ take on the opinion, though, I also was struck by (superficial?) parallels to themes from recent cases on design patents (like Richardson v. Stanley Works, Inc.): ie. for design patents, should patentability be decided only after first eliminating all functional elements? In a sense, isn’t this the reverse of that? The patentability is to be determined only after first subtracting out any non-functional elements (rather than “as a whole,” for instance). Of course, there is a difference between functional vs. ornamental distinction and a functional vs. non-statutory distinction, but there seems to be overall parallels (moving back from an “as a whole” approach). Its also interesting to note that this type of dissection-based claiming/analysis is quite comment in disputes over copyrights to derivatives of public domain works (adding a frown to Mona Lisa doesn’t give you any rights over the Mona Lisa, but it might over the frown-on-the-Mona-Lisa). Obviously, this is a very different area of law with very different consequences. But it might be interesting, nonetheless, to think about the consequences were this kind of theory (seen more fully in copyright) applied to patent claims.

  83. It makes no sense to have a rule that says “any portion of an invention that constitutes nonstatutory subject matter will be considered de facto obvious.” Just because something is not patentable subject matter does not mean that it is obvious to do. I can, for example, think of many mathematical discoveries and pure mathematical algorithms that could have only been discovered by briliant people. Similarly, I can make my brain do all sorts of nonobvious stuff…not terribly useful stuff, but nonobvious nonetheless. Seems to me the King opinion has the right result, but severely flawed reasoning.

  84. Joe Miller Said: As I was reading the case, I kept thinking, why not frame this as a one-reference obviousness case? If the only difference between the prior art and the claimed invention is the telling-the-patient limitation, isn’t this the sort of common-sense obviousness defect that KSR was supposed to enable a court to respond to?

    DDC: I experienced the same thought process as I read the opinion. I had assumed that the court would simply find the claim obvious because that additional “informing” limitation is a common-sense thing to do (and potentially required as a matter of professional medical ethics). Instead, we have a new doctrine.

  85. I claim:

    1.) Stuff people do that I want to be paid money for.

    2.) Stuff people say that I want to get paid money for.

    3.) The stuff of claims 1 and 2 that people don’t do that I want to get paid for anyway.

    Stand and deliver.

  86. As I was reading the case, I kept thinking, why not frame this as a one-reference obviousness case? If the only difference between the prior art and the claimed invention is the telling-the-patient limitation, isn’t this the sort of common-sense obviousness defect that KSR was supposed to enable a court to respond to?

  87. Thanks TJ — I agree with you that the court used different language, but the printed-matter doctrine is traditionally considered a Section 101 test. But setting that argument aside, I see the two as very comparable because both cases purported to ignore non-patentable elements of asserted during the 102/103 validity analysis.

  88. “The focus seems to be on the mere use of the symbols to express an idea, which is copyrightable, but not patentable.”

    Mhmmm, so we’ve tried to tell you. One can only wonder why those tickets etc. got a pass.

    “lots o relationship talking by them thar judges 6 – and they be talkin bouts structure in the same sentence.”

    O rly? Where? And what of it?

  89. Interesting to note that the “printed matter doctrine” is not confined to the USA, and therefore clearly does not require first amendment rights as a basis. There is a fairly long line of authorities in the English law (followed in Australia, New Zealand, and presumably other common law countries whose patent laws still have ties back to English ancestors). We tend to call it an “exclusion” rather than a “doctrine”. Americans seem to like their doctrines more than we do! :-)

    This is what the Australian Patent Examiner’s manual has to say on the subject (s2.9.2.8). It is lengthy, but it covers a lot of ground and I could not say it any better myself:

    Any presentation of information characterised solely by the content of the information has traditionally been not patentable. In Virginia-Carolina Chemical Corp’s Application [1958] RPC 35, this principle was explained as being that the intellectual or visual content of a paper, film or other medium related to the fine and not the useful arts. The court in Pitman’s Application [1969] RPC 646 took a similar approach, in observing that any matter having a purely intellectual, literary or artistic connotation is not patentable.

    The mere fact that physical apparatus may be involved in the presentation of information will not suffice to avoid the exclusion. Thus the exclusion applies whether a claim is directed to:

    • the presentation of the information per se (for example, by acoustical signals, spoken words or visual display

    • information recorded on a carrier (for example, books characterised by their printed subject matter, gramophone records characterised by the musical piece recorded, an electronic medium characterised by the nucleotide or protein sequence data recorded thereon or magnetic computer tapes characterised by the data or programs recorded). [This does not apply to “functional” information, such as executable computer program code recorded on a carrier, covered elsewhere in the Manual.]

    • processes and apparatus for presenting information (for example, indicators or recorders characterised by the information indicated or recorded.

    The exclusion will not apply if the effect of the presentation of information is to provide a material advantage rather than being of a purely intellectual or visual character.

    For example, in Moore Business Forms Application [1979] AOJP 2521, a claim to a business form having printed transverse bars was allowed because the bars served the material advantage of allowing the form to be printed with more lines of type per inch which would still be as easy to read as prior forms having the usual number of lines of type per inch.

    Other examples include:

    Cooper’s Application (1902) 19 RPC 53 in which one or more spaces was left across the printed page of a newspaper where the paper was to be folded in order to enable the paper to be read when folded and was held to be patentable.

    Fishburn’s Application (1938) 57 RPC 345, in which an arrangement of printing upon a ticket was found to serve a technical purpose in that information was not lost when the ticket was torn.

    Pitman’s Application [1969] RPC 646, in which variations in the visual significance of printed characters in order to assist in voice production by a recording machine or a human reader were held to be patentable. Compare this with Nelson’s Application [1980] RPC 173, relating to a medium carrying an instructional message in three parts: visual, verbal and humorous. This was found to be merely intellectual in nature.

    Rhode’s Application [1973] RPC 243, in which a vehicle speedometer adapted to show “impact speed” was found to be patentable.

    Ciba-Geigy AG (Durr’s) Applications, [1977] RPC 83, in which a claim to a conventional package containing a known product and characterised solely by the instructions on the package for using the product was rejected. Compare this with Organon Laboratories Limited’s Application, [1970] RPC 574, in which a claim was allowed to a package containing pills which were packed in a particular order together with directions for use.

  90. Dennis, I am not sure that, doctrinally, what the court did here is comparable to its suggestion in Comiskey. Comiskey suggested that any element that is unpatentable under section 101 would be excluded from 102 and 103 analysis, which the court backtracked from in Bilski. This decision says that any element that is not “functional” would be excluded from the 102 and 103 analysis. What differs between “functional” and “passes 101” will presumably be ironed out in future cases, but they are definitely not the same thing.

  91. “Malcolm, I think you are right to see no functional relationship in human communications. It’s when the information is fixed in a machine readable medium, such as computer instructions in computer memory, that there is a functional relationship. I have a difficult time thinking of another example.”

    Do you honestly believe encoding non-functional information in a machine readable medium would be treated differently than the non-functional information being spoken?

  92. lots o relationship talking by them thar judges 6 – and they be talkin bouts structure in the same sentence.

    Every. Single. Time.

  93. I got curious and broke open Chisum for a quick review of the origin of the Printed Matter Doctrine. I can’t really find any treatment of it with respect to the First Amendment. The focus seems to be on the mere use of the symbols to express an idea, which is copyrightable, but not patentable. I find it inter sting that one 1926 Federal Circuit Judge wrote that there was a time, say the time of Cadmus, that the alphabet was patentable.

    Most early examples of functional relationships between the printed matter and the substrate involved tickets for riding trains, where there was a perforation and the arrangement of the symbols had a functional relationship to the use of the “manufacture,” which was the ticket, in the business method. So the new arrangement of symbols in that case did not run afoul of the Printed Matter Doctrine.

    Still, the First Amendment was added to the constitution, and thus trumps the Power of Congress to grant Exclusive Rights wherever there is conflict. That is where Fair Use Defense comes in in Copyright law. I’m wondering where the first amendment protections are observed in Patent Law. I thought it was 101. Is there another mechanism in patent law that addresses First Amendment concerns?

  94. ” I think the requirement of a functional relationship is always going to require that the information be at least machine readable. ”

    What about patentable microbe readable? Surely we’ll soon be able to instruct our patenable microbes to go and eat oil by writing out code on a microbe readable medium. Or maybe by a “bat signal” kind of signal in the sky to tell the microbes to eat oil.

    Surely you must think of these as exempt from the PMD.

    On the subject of the first amendment I wonder why my computer doesn’t enjoy first amendment rights such that it would be free to express itself any way it wishes.

  95. The handling by Judge Gajarsa’s opinion of the patent-eligibility issue with regard to Claim 21 is as bizarre as the strained effort by Judge Lourie to shoe-horn the drug dosage calibration method of Prometheus into the “transformative” prong of the MoT test. Garjasa and company obviously wanted to duck the patent-eligibility issue, but how they resolved the invalidity of Claim 21 (“informing” step about inherent property of method doesn’t make an otherwise anticipated method patentable) is as illogical as Stevens saying in Parker v. Flook that an otherwise unknown algorithm is prior art under 35 USC 103. The citation to the In re Ngai case (another illogical expression by the Federal Circuit about handling instructions for use associated with an old compound/drug which describe an otherwise patentable method/process for use of that old compound/drug) makes me cringe. The Federal Circuit needs to address the patent-eligibility issue of methods such as these forthrightly under 35 USC 101 after Bilski v. Kappos, or we’re going to have chaos, much like the Federal Circuit saying MoT test is the exlusive one for determining patent-eligibility of methods/processes.

  96. I agree it would be interesting, but I think the conclusion might be foregone in that, if I remember correctly, the Printed Matter Exception is founded in First Amendment Free Speech principle, and it would naturally extend to oral communications. I think the requirement of a functional relationship is always going to require that the information be at least machine readable. Moreover, if there is ever a case in which a patentee attempts to enforce a Beauregard claim against a defendant for printed words on a page that a computer OCR’s and compiles, I think we may very well find the requirement narrowed to “machine ONLY readable.” But I don’t know for sure.

  97. Hmmm, despite the applicability o some doctrine of claim differentiation I suppose 21 might be said to cover at least one embodiment that is subject to PMD by itself so it appears you may be correct.

    Would be interesting to have had a claim 23 wherein the informing is telling the patient orally.

  98. 1. A method of increasing the oral bioavailability of metaxalone to a patient receiving metaxalone therapy comprising administering to the patient a therapeutically effective amount of metaxalone in a pharmaceutical composition with food.

    21. The method of claim 1, further comprising informing the patient that the administration of a therapeutically effective amount of metaxalone in a pharmaceutical composition with food results in an increase in the maximal plasma concentration (Cmax) and extent of absorption (AUC(last)) of metaxalone compared to administration without food.

    22. The method of claim 1, wherein the metaxalone is from a container with printed labeling advising that administration with food results in an increase in the maximal plasma concentration (Cmax) and extent of absorption (AUC(last)) of metaxalone compared to administration without food.

  99. “the critical question is whether there exists any new and unobvious functional relationship between the printed matter and the substrate”

    Indeed broje, we should never forget one of the most lolable of all proclamations the CAFC has ever made. I look forward to the USSC reviewing that one day. On that day, I will lol most heartily.

    Tell me Broje, how many cases would you estimate that you yourself have riding on the proposition that the USSC will not get around to such a review within the lifetime of those cases?

    “The “informing” in claim 21 of this case is not stated by by oral instructions. ”

    I think it was. One of us will have to read the case again and it isn’t going to be me.

  100. Malcolm, I think you are right to see no functional relationship in human communications. It’s when the information is fixed in a machine readable medium, such as computer instructions in computer memory, that there is a functional relationship. I have a difficult time thinking of another example.

  101. “Printed Matter Doctrine just became the Printed and Spoken Matter Doctrine it appears.”

    I think you are correct to observe that a claim so broad as to read on both printed matter instructions and spoken instructions would run afoul of the printed matter doctrine. The “informing” in claim 21 of this case is not stated by by oral instructions. However, to the extent the claim reads on merely providing written instructions, then the application of the printed matter doctrine seems reasonable and completely in line with the caselaw preexisting this decision. In other words, I don’t see an expansion of the printed matter doctrine here, or any change at all.

  102. new and unobvious functional relationship

    If you could prove that saying Y and doing Z had unexpected results and you disclosed those unexpected results in your application, then you might have something. e.g., a method of levitating, wherein you say “Take me higher, Asmodeus” while rubbing your thumbs and index finger together. And then you actually levitate.

    But is the relationship between a method step(s) and the appreciation or communication of an inherent (but previously unrealized) result of that method step a non-obvious functional relationship? Seems to be stretching the definition of “functional” a bit far …

  103. regarding the MoT test:

    “We therefore understand the Supreme Court to have rejected the exclusive nature of our test, but not necessarily the wisdom behind it.”

  104. Lest we forget:

    703 F.2d 1381, 1385 (Fed. Cir. 1983) (“the critical question is whether there exists any new and unobvious functional relationship between the printed matter and the substrate.”); accord In re Ngai, 367 F.3d 1336 (Fed. Cir. 2004).

  105. Printed Matter Doctrine just became the Printed and Spoken Matter Doctrine it appears.

    Let’s just call it the Information Communication Matter Doctrine and see where it takes us.

  106. On appeal, the Federal Circuit held that claiming a step of “informing someone about the existence of an inherent property” of a method cannot render the claim patentable. “[I]n light of our holding that the method of taking metaxalone with food to increase the drug’s bioavailability, as recited in claim 1, is not patentable, it readily follows that claim 21, which recites the same method with the sole additional step of informing the patient about this increase in bioavailability, is not patentable.”

    Then Prometheus’ claims are invalid under 102 because, after reciting the old step, they require even less, i.e., merely the recognition of a “need.”

    I wonder if they will sua sponte address this issue on remand.

    Anyway, it’s the correct result. Matters not which road is taken as long as at least one of the roads is smoothly paved and accessible by all travellers.

  107. Bring back the principles in In re Comiskey plz. And roll over them with a cement truck so that they stay forever.

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