Prometheus v. Mayo:

In Prometheus Labs. v. Mayo, the patentee's claim focuses on a method of "optimizing therapeutic efficacy" by first administering a particular drug to a subject and then using the subject's metabolite level to adjust future drug doses. The district court found the claims invalid as lacking patentable subject matter under 35 U.S.C. 101. On appeal Prometheus has asked the Federal Circuit to restore its patent rights. (U.S. Patent No. 6,680,302).

In an amicus brief, the AIPLA has also asked the appellate court to uphold the patent rights. The bar association argues that (1) the requite Bilski transformation can be found in the subject's transformation of the drug into metabolites in the body and (2) that no weight should be given to the dissent from denial of certiorari in LabCorp. Other briefs are expected, including several arguing that the method should not be considered patentable.

Notes:

95 thoughts on “Prometheus v. Mayo:

  1. Lionel:

    Hey, I was just pulling your chain. If you do not know how to support the claim “A box comprising a top wall, a plurality of side walls and a bottom wall, wherein said box is capable of hopping in a circle,” consider this:

    Open the top wall flaps, let a 6 year old boy get in and instruct him to jump around in a circle while holding onto the top flaps. Would this disclosure support the claim and render it patentable? The boy’s actions renders the box “capable” of jumping in a circle. But, it is still just a plain old box, just like the method steps in these Prometheus patents are old method steps.

    Assume that the claim did get issued as is, with let’s say a disclosed supporting battery powered or wind up spring system biasing the box to jump in a circle. Then, would the jumping boy infringe the claim so broadly drafted?

    This is perhaps a not so absurd parody of the conundrums caused by the claim drafting in all of these patents and applications being so crudely axed with Bilski. Just return to writing claims with positive structural limitations supported by the disclosure and expressing what is at least novel.

  2. To me this patent obviously fails the obviousness test (pun intended). If you have (1) a medicine and (2) a way of measuring or determining the concentration of the medicine or metabolic derivatives (or even effects of the drug) in the patients body, it becomes extremely obvious to any doctor that he can adjust dosage of (1) based on (2).

    Doctors do this everyday! It’s pretty much standard procedure. Prescribe a treatment -> evaluate if it is working -> adjust or change treatment.

    If this patent where for a machine that did the adjustment automatically, it would have merit. Otherwise this patent should be immediately rejected with the justification of: WELL… DUUUUUHHHHHH

  3. Joe B.,

    I was addressing 101, not 112. I was not going to write a whole patent application and claims. Of course to overcome 112, the written description needs to describe and enable a claim to such a device. Please try not to read posts in a vacuum.

    Malcolm was implying there was a usefulness requirement to patenting an article. I was merely pointing out he was mistaken. Utility requires no actual usefulness in the electromechanical arts

  4. NAL: “The Office is making up Law as it sees fit”

    If so, then so are applicants “making up law”. Actually what’s happening is that the PTO is interpreting the law as they see fit. Frankly, in the big scheme of things, their interpretation is quite reasonable. So get over it already. Less crxppy patents is better than the alternative. People are still filing away. They are just going to have to get used to filing better claims and better specifications. Some of the deadwood will fall away. Boo hoo.

    “Are you willing to concede”

    And stop being a freak.

  5. “Of course, the issue on appeal is 101 and Bilski. IMHO, overreaching in drafting claims that are “broader than the disclosed invention” like these is what has brought us all to this situation that the CAFC strains to reign in by its ever more tortured 101 analyses.”

    Joe,

    You (among others) are missing the crucial point. The Law already is sufficient to decline a patent to applications that do not meet 102/103/112 requirements. “Bad” patents that do not meet these requirements should not be allowed. If allowed, the re-exam path is available for eliminating the “bad” patent.

    The wielding of, and torturing of 101 has NO PLACE in the arsenal of the Office. There is no acceptable reason for 101 to be (mis)used when the other tools (102/102/112) should be used. NONE. Acceptance of this (mis)use, even for blatently bad patents should not be tolerated by anyone. The ends do not justify the means, especially since the proper means are already available. The Office needs to focus on doing its job right, not making up the law to do its job as it feels like it should be.

    The Office is making up Law as it sees fit and simply not using tools already available. The misapplication of the Law goes hand in hand with the illegal Power Grabs of the Office and is further evidence that the Office is engaged in an agenda that is contrary to their legislated purpose.

    Malcom,

    You have been busy today blogging on many topics, but you have not yet put up to the challenge of David Stein’s post of 6:07 PM Classen v. Biogen on the topic of the printed matter doctrine.

    Are you willing to concede, or do you have anything intelligent to say?

  6. Joe B: “The real invention by the inventors’ own assertions lies in determining the optimal dosage ranges, not determining a concentration in any given patient, and using those ranges to adjust the dosage, if necessary, in any given patient.”

    Joe, nice comment and I’m glad to see you haven’t fallen into the “allow claims or die of Crohn’s disease” baloney tossed around here by the peanut gallery.

    I’d quibble with the quoted passage above, however. As I indicated in an earlier comment where I proposed some alternate claim language, the invention is more like: administering drug to patients, taking a sample from patients at time T, measuring metabolite in patients at time T, administering more drug to patient with metabolite levels above X at time T.

    There are more inventions but I believe that is the proper format. Note that I attempted to avoid recitation of any mental steps. Why set off the alarms?

  7. Lionel,

    If your claim is “A box comprising a top wall, a plurality of side walls and a bottom wall, wherein said box is capable of hopping in a circle,” it should be found non-statutory at least under 112 particularly if you fail to disclose any description of what makes the box hop in a circle. At least the claim should include a means or structure limitation directed to the distinction over the prior art and that is supported by the disclosure. Can you provide a novel structure to make the box hop in a circle?

    Like so many of these “therapy” patents, the `302 patent appears to have been written by the inventors, Seidman et al, as it reads more like medical literature than a patent (save for the unrelenting repetitions contributed perhaps by a patent attorney). And it appears to consciously avoid reciting all the steps of the invention.

    At the outset the patent provides definitions of the claimed compounds:

    “6-Mercaptopurine (6-MP) and azathioprine (AZA), a pro-drug that is non-enzymatically converted to 6-mercaptopurine (6-MP), are 6-MP drugs that can be used as an effective treatment for inflammatory bowel diseases such as Crohn’s disease and ulcerative colitis (Kirschner Gastroenterology 115:813-821 (1998)). 6-MP can be enzymatically converted to various 6-MP metabolites, including 6-methyl-mercaptopurine (6-MMP) and 6-thioguanine (6-TG) and their nucleotides. 6-TG nucleotides are thought to be the active metabolite in mediating many of the effects of 6-MP drug treatment.”

    The following two paragraphs summarize the invention:

    “Previous studies suggested that measurement of 6-MP metabolite levels can be used to predict clinical efficacy and tolerance to azathioprine or 6-MP (Cuffari et al., Gut 39:401-406 (1996a)). However, it was unknown what concentrations of 6-MP metabolites correlated with optimized therapeutic efficacy or with toxicity (Cuffari et al., supra, 1996a). As disclosed herein, levels of 6-MP metabolites such as 6-TG and 6-MMP were determined and correlated with therapeutic efficacy and toxicity associated with 6-MP drug therapy (see Examples I and II).

    The invention is directed to methods of optimizing therapeutic efficacy of 6-MP drug treatment of an immune-mediated GI disorder by monitoring predetermined levels associated with therapeutic efficacy or toxicity and adjusting the 6-MP drug dosage so as to maintain an optimized dose that is efficacious and has reduced toxicity. The methods involve administering a 6-MP drug such as 6-MP or azathioprine to a subject having an immune-mediated GI disorder and determining a level of a 6-MP metabolite in the subject having the immune-mediated GI disorder. The methods of the invention are advantageous in that the dosage of a 6-MP drug can be adjusted to maximize the efficacy of treating an immune-mediated GI disorder such as IBD while minimizing toxicity associated with 6-MP drug treatment.”

    So, the “adjusting” step following the “determining” step is recited as what the invention is directed to, but the step is not expressly claimed. In fact, some of the other independent claims do not even recite the “administering” step.

    As far as I can tell, the admitted prior art of the second paragraph anticipates the claimed step or steps which would have inherently resulted in determined concentrations that would have to fall within the ranges expressed in the “wherein” clause. The real invention by the inventors’ own assertions lies in determining the optimal dosage ranges, not determining a concentration in any given patient, and using those ranges to adjust the dosage, if necessary, in any given patient.

    So, why no separate claims to the steps of discovering the optimal ranges or claims adding the “adjusting” step to the `302 patent claims? The absence of the “adjusting” step may make it easier to prove infringement against an institution like Mayo that may be performing the determining step; but additional dependent claims adding this “adjusting” step could also have been asserted and found infringed through discovery of individual medical records kept at Mayo. Such claims would at least satisfy 112.

    Of course, the issue on appeal is 101 and Bilski. IMHO, overreaching in drafting claims that are “broader than the disclosed invention” like these is what has brought us all to this situation that the CAFC strains to reign in by its ever more tortured 101 analyses.

    By the way, there are seven related Seidmen et al patents and two published applications, some of which do include some claims to “adjusting” the dosage. I wonder which patents are being asserted against Mayo in addition to this one and the status of those patent claims. It looks like this entire family of patents will suffer if the CAFC affirms the district court in this case.

  8. Lionel,

    If your claim is “A box comprising a top wall, a plurality of side walls and a bottom wall, wherein said box is capable of hopping in a circle,” it should be found non-statutory at least under 112 particularly if you fail to disclose any description of what makes the box hop in a circle. At least the claim should include a means or structure limitation directed to the distinction over the prior art and that is supported by the disclosure. Can you provide a novel structure to make the box hop in a circle?

    Like so many of these “therapy” patents, the `302 patent appears to have been written by the inventors, Seidman et al, as it reads more like medical literature than a patent (save for the unrelenting repetitions contributed perhaps by a patent attorney). And it appears to consciously avoid reciting all the steps of the invention.

    At the outset the patent provides definitions of the claimed compounds:

    “6-Mercaptopurine (6-MP) and azathioprine (AZA), a pro-drug that is non-enzymatically converted to 6-mercaptopurine (6-MP), are 6-MP drugs that can be used as an effective treatment for inflammatory bowel diseases such as Crohn’s disease and ulcerative colitis (Kirschner Gastroenterology 115:813-821 (1998)). 6-MP can be enzymatically converted to various 6-MP metabolites, including 6-methyl-mercaptopurine (6-MMP) and 6-thioguanine (6-TG) and their nucleotides. 6-TG nucleotides are thought to be the active metabolite in mediating many of the effects of 6-MP drug treatment.”

    The following two paragraphs summarize the invention:

    “Previous studies suggested that measurement of 6-MP metabolite levels can be used to predict clinical efficacy and tolerance to azathioprine or 6-MP (Cuffari et al., Gut 39:401-406 (1996a)). However, it was unknown what concentrations of 6-MP metabolites correlated with optimized therapeutic efficacy or with toxicity (Cuffari et al., supra, 1996a). As disclosed herein, levels of 6-MP metabolites such as 6-TG and 6-MMP were determined and correlated with therapeutic efficacy and toxicity associated with 6-MP drug therapy (see Examples I and II).

    The invention is directed to methods of optimizing therapeutic efficacy of 6-MP drug treatment of an immune-mediated GI disorder by monitoring predetermined levels associated with therapeutic efficacy or toxicity and adjusting the 6-MP drug dosage so as to maintain an optimized dose that is efficacious and has reduced toxicity. The methods involve administering a 6-MP drug such as 6-MP or azathioprine to a subject having an immune-mediated GI disorder and determining a level of a 6-MP metabolite in the subject having the immune-mediated GI disorder. The methods of the invention are advantageous in that the dosage of a 6-MP drug can be adjusted to maximize the efficacy of treating an immune-mediated GI disorder such as IBD while minimizing toxicity associated with 6-MP drug treatment.”

    So, the “adjusting” step following the “determining” step is recited as what the invention is directed to, but the step is not expressly claimed. In fact, some of the other independent claims do not even recite the “administering” step.

    As far as I can tell, the admitted prior art of the second paragraph anticipates the claimed step or steps which would have inherently resulted in determined concentrations that would have to fall within the ranges expressed in the “wherein” clause. The real invention by the inventors’ own assertions lies in determining the optimal dosage ranges, not determining a concentration in any given patient, and using those ranges to adjust the dosage, if necessary, in any given patient.

    So, why no separate claims to the steps of discovering the optimal ranges or claims adding the “adjusting” step to the `302 patent claims? The absence of the “adjusting” step may make it easier to prove infringement against an institution like Mayo that may be performing the determining step; but additional dependent claims adding this “adjusting” step could also have been asserted and found infringed through discovery of individual medical records kept at Mayo. Such claims would at least satisfy 112.

    Of course, the issue on appeal is 101 and Bilski. IMHO, overreaching in drafting claims that are “broader than the disclosed invention” like these is what has brought us all to this situation that the CAFC strains to reign in by its ever more tortured 101 analyses.

    By the way, there are seven related Seidmen et al patents and two published applications, some of which do include some claims to “adjusting” the dosage. I wonder which patents are being asserted against Mayo in addition to this one and the status of those patent claims. It looks like this entire family of patents will suffer if the CAFC affirms the district court in this case.

  9. Let me clarify my previous statement. There is no actual usefulness component of utility in the electromechanical arts, unlike the biotech/chemical arts. It can be something that no one nowhere would ever use or do, but it would still pass 101. A macrame bathtub would be allowable under 101.

  10. Malcolm,

    You are being confused by the fact that you work on the Bio/chemistry side of things. Utility in the electromechanical-physical word is generally defined by the claim. I can claim a box that hops in a circle. That would totally pass 101. If it’s novel and nonobvious and there are no 112 issues, it’ll pass.

  11. “It’s painfully obvious that a great many issues were ignored during prosecution of this claim. I’m also sure that on the day the claim was allowed, there was much celebrating.”

    Its painfully obvious that you do not know what you’re talking about.

    As for the celebration. There is rarely such drama in patent law. Except in Mooney’s dungeon of patent horrors.

  12. Lionel: “HOWEVER, it is perfectly acceptable under 101, as it should be.”

    Really? What’s the specific, credible, and substantial utility, Lionel?

    “It’s statements like this Mooney that have people calling you ignorant.”

    LOL. Wipe the egg off your face.

  13. Joe: “If this is the patentable invention, then it is not claimed either as structure or as steps and should rightly have been rejected. To me, a threshold 112 issue may have been ignored.”

    It’s painfully obvious that a great many issues were ignored during prosecution of this claim. I’m also sure that on the day the claim was allowed, there was much celebrating.

    I’m also sure that it’s going to be found invalid and, finally, I’m sure that I won’t really care why because the reason is less important than the fact that nobody will have to worry about that patent or others drafted exactly like it ever again.

    But I don’t want folks to think I’m completely heartless. Therefore, I will light a sparkler and hold it aloft in memory of the attorneys who can’t do any better than what we’ve been discussing here lately. Lots of layoffs coming.

  14. Does anyone know why the patent claims were allowed over the prior art? I have not seen the file wrapper. It seems to me that the claim copied by MM only recites two steps: (a) administering … and (b) determining …, step (b) ending at “disorder” as follows:

    A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and (b) determining a level of 6-thioguanine or 6-methyl-mercaptopurine in said subject having said immune-mediated gastrointestinal disorder,

    The remaining “wherein” clause recites no steps or activities, just mental conclusions drawn from the results of step (b). Infringement would be complete at performing the administering and determining steps. So, apart from the 101 issue, why did this claim get allowed in the first place? Had no one ever administered this drug per step (a) or conducted step (b)? If step (a) is prior art, then it would seem logical that the clinical studies supporting approval of the drug (for this treatment or any other treatment) would necessarily have involved performing step (b). But, perhaps no researcher ever did measure the amount in an animal or human subject or publish guidelines for subsequent treatment of the patient.

    If the claim was allowed due to the limitations in the wherein clause, then why did the examiner not insist on positive recitation of the further steps implicit in the wherein clause, i.e., “adjusting up” or “adjusting down” the subsequent dosages for the patient rather than leaving it as follows:

    wherein a level of 6-thioguanine less than about 230 pmol per 8 x 108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein a level of 6-thioguanine greater than about 400 pmol per 8 x 108 red blood cells or a level of 6-methyl-mercaptopurine greater than about 7000 pmol per 8 x 108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

    If this is the patentable invention, then it is not claimed either as structure or as steps and should rightly have been rejected. To me, a threshold 112 issue may have been ignored.

  15. “1. A method for reading a book, comprising

    (1) opening a book, wherein the book includes the phrase “the purple cow ate grass in the empty park”;

    (2) injecting a patient with a therapeuticaly effective amount of insulin;

    (3) turning a page in said book.

    What a terrible tragedy that this claim isn’t patentable. The American people are being deprived of so much innovation that would otherwise never take place.”

    It’s statements like this Mooney that have people calling you ignorant.

    This claim fails under 112 as there is no relationship between some of the steps. HOWEVER, it is perfectly acceptable under 101, as it should be.

    Similarly, the claim in this case should absolutely be allowable under 101.

  16. Ad Astra,

    I agree that there should be a presumption of validity, which is why I would prefer that issued patents be relatively invulnerable to attack by anything but 102 art.

    The problem is that the anti-patent crowd is right in that there exist a few claims in patents that block progress in their specific field.

    However I don’t think that such claims justify making patenting impossible or Examiners scared of issuing patents.

    Instead, I suggest that there be a quick and cheap way to reduce the scope of overbroad claims using indisputable 102 art.

  17. Erez Gur said:
    “I don’t know why, but virtually no one actually uses the current reexamination options.”

    I thought it was because of the effect of collateral estoppel. Typically the third parties most likely to be aware of 102 art are those most likely to become accused infringers.

  18. @Erez Gur
    That’s really the problem – it’s hard to amass the collected experience of patent attorneys everywhere into something objective. I agree that patents on cat exercising and swing methods make this field a lot more fun, but only when it’s understood that such patents won’t be enforced in any meaningful way. I had my cat chase a laser pointer spot prior to hearing about the patent; I really don’t believe that the force of the state now says I can’t.

    Re presumption of validity, I think it’s a good thing. Once I have a patent, I shouldn’t have to worry too much about it being invalidated, unless it’s the sort of patent that I know I shouldn’t have gotten in the first place. That stability is one of the major things that makes a patent valuable.

  19. On a completely different topic…

    I think I have drawn E6k as an examiner..

    I have received a 112, 2nd rejection because I canceled a claim set directed to a subcombination and replaced it with a claim set directed to an apparatus including the subcombo.

    Lol wut? Anyone else seen this nonsense before?

  20. Let me clarify what I meant by “relatively simple and cheap administrative invalidation of patent claims with 102 art.”

    Most patents I’ve seen that interfere with further innovation are based on reasonable inventions having too broad claim scope. I don’t know why, but virtually no one actually uses the current reexamination options.

    Imagine a reexamination system where all one has to do is (anonymously) send in 102 art, explain why it invalidates one or more issued claims for a fee of $200.

    An Examiner could then review the simple rejection (it is 102 after all) and if found correct, the patentee could choose to respond (reopen examination without additional search) or just amend the application to the non-rejected claims (for free, or maybe the publication fee).

    The only weak point is if people use the recent “broadest interpretation of claim terms” rampant in the USPTO.

  21. The presumption of validity is statutory. The clear and convincing burden is a judicial construct, but of LONG standing. At least in the U.S., the basic rule in such a case is to assume that Congress has acquiesced in the clear and convincing burden because Congress is presumed aware of judicial interpretations of statutes and has had literally decades to amend the statute if it wished but has never done so.

    So any change in the presumption of validity and the clear and convincing standard requires Congressional action. (Although the Supreme Court is above the law in a de facto sense and could do pretty much whatever it pleases on this issue, and then assert it’s mandated by the Constitution, blah-blah-blah.)

    Personally, I think the presumption of validity should be left alone. At first blush I used to think the burden should be reduced to preponderance of the evidence, but when I see the swarm of special interests attacking patents from all directions (especially bad “reforms” are the first-to-file screw everybody but the largest corporations proposal, and the proposed changes to the computation of damages), I figure the attackers will probably get more than enough advantage in the next round of “reform.” In fact, the more I think about it, the best we can hope for from Washington is if the government is completely divided and the result is stalemate, because almost any action the U.S. government inflicts on us is evil.

  22. Yes but.

    Beneath the words from Erez Gur is a serious public policy point: whether or not to have a Presumption of Validity? Do you need convincing evidence, or just a preponderance of it, to get an issued claim revoked? If the Presumption is to remain (and I suppose that is sacrosanct), and the mechanisms to get a bad claim revoked are so slow and uncertain, then one would hope that the PTO doesn’t issue obvious claims, that impede rather than Promote the Progress.

  23. “The solution for that is to allow relatively simple and cheap administrative invalidation of patent claims with 102 art.”

    I believe ex partes or inter partes re-exam is what we call that in the U.S.

    It is relatively inexpensive, but its not free and should never be “cheap.” Remember, you get what you pay for.

    Bravo for the refreshing comment re “fun” patents that hurt no one and, in a better world, should wipe the grimace of the faces of the I-take-myself-waaaay-too-seriously and garbage-patents-should-never-be-allowed crowd (like Mooney).

  24. Ad Astra | Jan 26, 2009 at 03:35 PM

    All the evidence is anecdotal and private.

    In my experience it has happened a number of times that an Entrepreneur has decided not to invest in a project because the odds were very low for getting a patent allowed, or that the patent that could be allowed would probably be narrow.

    Admittedly, I experienced one case where an existing patent caused someone to stop developing an excellent (and potentially life-saving) idea, but in that case the existing patent was overly broad. The solution for that is to allow relatively simple and cheap administrative invalidation of patent claims with 102 art.

    A comment about the “joke-telling”, “cat exercising”, “wedding proposal” and “swing” patents. These are fun patents. They do no harm and make any presentation about IP interesting. It is peculiar that people mention these in a serious discussion. There is no need to change patent law to the detriment of real inventions just to make sure that fun patents don’t get allowed.

  25. Troll, I wasn’t making a point about whether it’s “ok” for you to post your tiresome, vitriolic, personal attacks. That’s between you and your deity and Dennis. As far as I am concerned, you are absolutely free to be as tiresome, vitriolic and personally insulting as you want to be. I will not ever send an email to Dennis asking that he ban you, nor am I going to ask commenters to “vote you off the blog”. That would be childish and, as you surely know, would accomplish nothing.

  26. “…either beefing up or paring down the patent system will be”

    How bout neither of the above. All of the puppet master’s garbage is designed to try to create a presumption that some kind of reform is inevitable, which it isn’t.

    And anyway, what is “paring down” the system supposed to mean? Destroying patent rights? Creating socialism? Oh, what a great idea.

    I personally vote NO on socialism. Sorry puppet master.

  27. “tired of all the ad hominems…”

    Dear Ad, from one puppet to another (BTW everyone noticed how the master cleverly tried to come up with a plausibly different “look” – interesting use of “@”)

    “how about a personal troll…whine, whine, whine”

    Of course its OK for me to post my inflammatory anti-patent garbage here day after day. But no one should challenge me, because, heck, they just shouldn’t. It is inconvenient to my agenda.

    Oooops, did I say garbage? I meant doo doo, or was it poo poo, or dog crap? Aw heck, time to smoke some more crack.

  28. Ad “Mostly, I’m just really tired of ad hominems and name-calling.”

    Maybe you need a change of pace. How about a personal troll that slings five or six insults directly at you personally every time you comment here, week in and week out, year after year?

    Let me know if you’re interested in one of those.

  29. @ broje
    I’m glad it’s something people are looking at, at least, even if they aren’t coming up with any concrete answers. It just seems ridiculous to make sky-is-falling claims either way when we don’t know what the results of either beefing up or paring down the patent system will be.

    @ Here’s the thing
    That’s a good point. I wholeheartedly agree that the patent system is a valuable thing (otherwise, why would I be here?). I just don’t necessarily buy that the economy will collapse (more than is already has) if we weaken the patent system or, for that matter, strengthen it.

    Mostly, I’m just really tired of ad hominems and name-calling.

  30. “Let’s look at the claim, shall we?”

    I’m sorry, did Mooney just repost the same garbage post from the previous page?

    I guess he felt that we needed to benefit again from his profound french fry line wisdom. He hopes that, with his help and encouragement (and enough puppets), we can make better choices. What a p0mp0us a$$.

  31. The patent system does many things besides encouraging innovation through disclosure. It leads to efficient allocation of capital.

    If A and B (and maybe C and D) were working on an invention in a key area of technology without patents, then they would both work privately until they thought they had developed a commercially viable product then rush it to market with the idea that he who gets to the market first wins critical market share.

    Whoever gets firmly established first, has a chance to become a “real” monopoly. The loser, loses all of his original investment up to the point of predominance of the winner. This is inefficient. Even if the winner buys the loser it will not be a beauty show, it will be a yard sale.

    If, on the other hand, A and B are filing patents during development, they can each see what the other is up to and make adjustments in their strategy, including developing complimentary technology. The bonus is more efficient allocation of capital and more rapid advancement in the state of the art since the would-be loser can now adapt and potentially benefit from the shift in direction by focusing resources on a more promising technology.

    This is pretty much the way its supposed to work. Whether there are a few opportunists in the mix notwithstanding (Lemelson was an anomaly), for sophisticated technologies, the above system has worked well despite what know-nothing idi0ts like Mooney and his fellow traveler puppets try to tell you.

  32. Ad Astra wrote, “People are yelling back and forth over whether patents are necessary for scientific advance to happen in one field or another, but I’ve always wondered: does anybody have any decent studies, or even good anecdotal examples, to show whether, in real life, decreasing the depth or breadth of patent protection results in a significant downturn in innovation and disclosure? This is all sounding very ideological, and I would love to see some data.”

    The effects of the patent system on rates of innovation are inherently impossible to measure. I struggled with this issue at length while writing my senior seminar paper on the topic some years ago. What seems to be a safe assumption is that, without patents, there is less disclosure of innovation or efforts in that regard. And therein lies the problem.

    The inherent problem is that there is no way to measure the amount of innovation that was not disclosed due to lack of a patent system. Nor would there be any way to measure any amount of innovation that never occurred due to the lack of a patent system luring dreamers into the inventor profession, or motivating business entities to engage in research in order to develop IP to use for defensive purposes. So there is no way to know for certain whether there is any truth to the claims of such motivation.

    It seems ironic that Socrates argued against patents out of fear of too rapid a rate of innovation.

  33. smashmouth, not smashmouth, New Light,

    Reading Alappat is a definite MUST. The ease of passing Bilski with Alappat is amazingly simple and straightforward. Bilski explicitly did not answer the question that Alappat did (remember, Bilski was NOT a software case). As noted on these boards, the critical portion of Alappat (an en banc decision) was NOT overruled by Bilski – there is no need for presumption that this is the Law – it IS the Law.

    The USPTO has ignored this before and has been smacked down. Bilski and the spineless CAFC have bolstered their courage, so they are using Bilski has a sledgehammer. In a morbid sense, I do hope they continue their reckless and wanton disregard inapplying Bilski to everything so that the CAFC and the Supremes realize just how out of control the luddite Office is.

  34. New Light:

    Bilski test as applied by USPTO and Alapppat results don’t make sense. Read In re Alappat, especially the part where the court says that once you load (application) software onto a general purpose computer, you now have a special purpose machine to perform that application.

    If that portion of In re Alappat is presumed to be good law, then software inventions can be crafted that will easily pass the “particular machine” prong of Bilski.

    However, the USPTO is ignoring that, and rejecting pretty much anything reciting a computer, electronics, etc. under 101.

    YMMV, as each Examiner seems to be applying 101/Bilski differently.

  35. People are yelling back and forth over whether patents are necessary for scientific advance to happen in one field or another, but I’ve always wondered: does anybody have any decent studies, or even good anecdotal examples, to show whether, in real life, decreasing the depth or breadth of patent protection results in a significant downturn in innovation and disclosure? This is all sounding very ideological, and I would love to see some data.

  36. along the thoughts of business pursuing without patents…

    “According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), by 2006 the cost of researching and developing a new chemical or biological product had reached on average €1,059 million ($1,318 million).”

    from link to lexology.com

  37. I’ve never been able to reconcile Diehr with Parker v. Flook. It seems to me those cases were practically indistinguishable on their facts, and the only significant difference was that the membership of SCOTUS had changed in the interveneing years.

    I think part of the problem is when SCOTUS (and to a somewhat lesser extent the Fed. Cir.) declines to overrule an earlier case even where it is clearly incompatible with the result the present majority wishes. And so Parker and Diehr are both still “good law.” Sort of like Bielski and Allapat.

    From someone old enough to remember, I think the notion of using (and especially of HOW to implement) automated control systems was a lot more novel in 1980 (or whenever Diehr was filed) than it is now. It shouldn’t be that surprising when, in hindsight, we wonder why the claims in Diehr were held patentable.

  38. “Mooney, isn’t your first post the kind of dissection of the claim into old and new that the Supreme Court rejected in Diehr?”

    It’s not much of a dissection. I’m just taking the claim at face value. The claim purports to be a method for “optimizing” an old therapy by **thinking** a new thought about the inherent results of the old therapy.

    As for Diehr, I don’t believe it applies here. More specifically, Diehr should be limited to its facts and allowed to fade away into obscurity and irrelevance, where it belongs.

  39. “Without patent protection, the effort that goes into developing these tests would not be done.”

    But that’s not true, no matter how many times you repeat the lie.

    For example: you are a company making and selling a drug with a huge market. You want people to buy your drug. You want doctors to prescribe the drug.

    So tell me: other then spending millions on free pens, slick brochures, and sleazy TV and radio ads, how do you encourage doctors to prescribe the drug when your drug “has a very narrow therapeutic range”? Spend a few moments thinking about it before you mouth off about what people will and will not do. Perhaps you are spending too much time with the wrong kind of people.

    “If this test is denied patent protection, similar tests for other drugs will not be developed”

    Oops, there you go again! Old habits die hard, I guess. May I ask: what are these “similar tests” you are referring to? Please try to remember that the issue here is not “the test” but rather the “the patent claim”.

    Here’s one way to claim the discovery at issue here that might actually fly:

    1. A method for treating an immune-mediated gastrointestinal disorder in a population, comprising: (a) administering a drug providing 6-thioguanine to a plurality of subjects having said immune-mediated gastrointestinal disorder; and (b) obtaining a blood sample from each subject; (c) measuring the level of 6-thioguanine in each of said samples; and (d) administering an increased drug dose only to patients with less than about 230 pmol 6-thioguanine per 8 x 108 red blood cells.

    There you are. I needn’t write the other independent claims for you. You can figure it out.

    You could probably re-work my claim for an individual patient, if you wanted. Then you could sue the patient, too.

    You might end up having to do that, of course, because if can test my own blood with a non-patented kit then there is no reason for the kit to be sold with instructions. The patent application **is** the instructions. Here’s how to save your life with that old drug! But watch out because if it looks like you are thinking about how to modify the dose of medication you are taking, we will sue you! Right. That’s good for business.

  40. Let’s look at the claim, shall we?

    1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and (b) determining a level of 6-thioguanine or 6-methyl-mercaptopurine in said subject having said immune-mediated gastrointestinal disorder, wherein a level of 6-thioguanine less than about 230 pmol per 8 x 108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein a level of 6-thioguanine greater than about 400 pmol per 8 x 108 red blood cells or a level of 6-methyl-mercaptopurine greater than about 7000 pmol per 8 x 108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

    The short version is: A method of thinking about whether or not a need exists to administer more drug to a patient, comprising measuring the amount drug in a patient, then thinking that a need to administer more drug to said patient exists, or thinking the opposite.

    “(1) the requite Bilski transformation can be found in the subject’s transformation of the drug into metabolites in the body”

    The administration of this drug and measurement of this drug in the body is an old method.

    The patentee claimed a method of “optimizing” therapy by THINKING about the results of the old method in an allegedly “novel” and “non-obvious” way. These allegedly inventive steps comprise “determining” X, asking oneself whether X is greater than or equal to Y, wherein the answer correlates with an “indicated need.” The claim does not require that any drug be administered after the mental step.

    The only relevant transformation, therefore, is the transformation of old data into an **allegedly** new human thought. And let’s be frank: the bold new concept here is administering more drug if more drug is needed — WOW!!!!

    In fact, a disturbing question arises: what happens if a “need for more drug is indicated” by the claim but no drug is administered because, based on some other criteria, the drug is deemed effective at the current dose? Is it still infringed?

    Therein lies the problem with mental inventions. Who infringes? Who can what someone is thinking after they take a measurement? More importantly, who can say what people in the prior art thought to themselves? The PTO Examiner can’t do it.

    “(2) that no weight should be given to the dissent from denial of certiorari in LabCorp.”

    LOL. No weight? Why not? It’s the most reasoned statement of the law. If if was incorrect, that would be one thing. But it’s not. It’s spot on. Breyer did everyone a big favor.

  41. I thought you would say that, EG. So did the PTO. The Exr wrote under 112 (1) that PHOSITA “would not know how to use the claimed invention” because the claimed invention “is not supported by a credible asserted utility”. Not “credible” because, under 101, you can’t obtain a patent in the USA except on a process, machine, manufacture or composition, and a joke is none of those four. On 112(2) all the Exr could come up with is that “novel ” is subjective (Huh?) and, precisely because it is “subjective”, it is indefinite. It seems to me that, but for 101, the Exr has got nothing that withstands scrutiny. I must be missing something. Sorry for being so dim, and humourless.

  42. Max,

    Not a good example. The “joke claim” (pun intended) you point out could be in trouble under at least 35 USC 112, paragraph 1 (“enablement”), and possibly under paragraph 2. This is the O’Reilly v. Morse case from the 19th century all over again which is cited (incorrectly in my opinion) as a case under 35 USC 101; this case is really based on 35 USC 112, at least paragraph 1 (“enablement”)

  43. Hello all,

    I have a small question about this – There was a case called – Arrhythmia v. Corazonix. In this case, the CAFC had reasoned that although the claims recited a mathematical algorithm, the number obtained is not just an abstraction. Reading the claim in this light and in light of the Bilski opinion, isn’t this claim set too patentable. The algorithm here being to find an optimal range for drug delivery.
    So given the case for Arrhythmia, isn’t this claim set acceptable?

  44. I have a question for you EG. In US pat appln 2006/0259306, priority August 2003, claim 1 reads:

    The process of protecting a novel joke, which comprises filing a patent application defining the novel features of the joke.

    Suppose the claim meets 102, 103 and 112. Should the patent issue? If not, what objection would you have to this claim, if you were examining it?

  45. Mooney, isn’t your first post the kind of dissection of the claim into old and new that the Supreme Court rejected in Diehr? I don’t think there is any requirement that the step involving a patent eligible transformation be itself novel.

  46. As the AIPLA amicus brief correctly points out, the district court opinion here is wrong on so many grounds as to defy description. First, it clearly relies upon Breyer’s dissent which is entitled to minimal, if any, precedential value. Second, it incorrectly characterizes the monitoring of the metabolites of the administrated drug. Third, it espouses a view that would improperly make patent coverage controlled drug treatment almost, if not completely, unavailable. That’s for starters.

    Hopefully, this amicus brief by the AIPLA will alert the Federal Circuit to the need to render some order out of the mischief it has created with Bilski, especially as the nebulous “machine or transformation” test is applied outside the the “business method,” computer program, etc., area. But if the Federal Circuit punts on doing that here, we’re in for period of absolute chaos, including the PTO itself using this sort of nonsense to reject similar drug treatement claims in pending cases.

    Again, patent claims should be judged on the merits primarily under 35 USC 112, 102, and 103, not 35 USC 101. Using 35 USC 101 as the primary screen is a receipe for grafting on “rules of exclusion” that make no logical sense, and are contrary to the express language of 35 USC 101.

  47. I don’t have time to read the 40+ previous posts. Just
    an observation. The claim cited on the PATracer web site
    does not claim natural phenomena at all. It claims administering
    a drug and monitoring the results. If, as stated by Mooney earlier

    “The administration of this drug and measurement of this drug in the body is an old method”

    then this would be a better reason to invalidate the claim. If you invalidate
    this particular claim based on a natural phenomena argument, then
    could you not argue that all drug patents are invalid.

  48. Now to the facts, this claim may be unpatentable under Bilski, but I think it should be patentable in a fair system. The Ebay claims this is not. State Street Bank was one crappy decision that led to all kinds of issues, but lets not take the pendulum back so far that we stop important biz development in order to fix the court’s errors.

  49. Mooney, dead wrong again. I think we should take away all his and his failies prescription drugs, because under his standard they would never have been developed.

    Mooney pretty clearly must believe in immaculate cures, but don’t most people in his bible belt location?

  50. Tieing the rhetoric together, we have (once again) the opportunity taken by both Malcolm and the anti-Malcolm to post non-sequetors to the issue at hand.

    Malcolm, to the general topic of “patents shouldn’t be issued when the topic would be pursued without patents”, it would be nice NOT to hear your arguments on such applied to each and every other post of legal topic. The accompanying legal flame of guardianship then would also be silent and the blog would be more interesting.

    David Stein’s post on another thread (Patently-O Bits and Bytes) at Jan 23, 2009 06:36 PM explains well the underlying movement for more and more patents. The anti-patent crowd simply ignored this post. Mooney would hand waive the desire for patent protection altogether with his “the market would do this anyway” argument, and ignore the fact of the matter (that the patent system does work as intended) as indicated by the increasing use of the system.

    The faulty logic here is more of the “patent system overused – let’s limit patents” patents-are-bad mantra which only supports the reject-reject-reject mantra. These attempts at squelching the use of the system are thinly veiled attacks on the rule of Law. Let’s see more principled debate on the merits and less generalized dogmatic preaching from the Mooney show. This way, the Office can focus on actually doing its job, instead of pushing its agenda of deciding what its job is.

  51. The discussion about why this matters in the real world is important. The idea was expressed that the discovery described in the claim needs to be developed into a product in order to be useful.

    Development in this case would mean figuring out what reagents to use and what kind of platform to put them on, and doing the clinical work to get FDA approval for the test.

    (Interestingly, that test itself might be patentable — does anybody know if the actual diagnotic test has been patented?)

    But turning to “order of the coitus”‘s claim that “it doesn’t take a lot to turn it into a commercial test”… this is just a flat out assertion. If you have to do a clinical trial to show that you have “optimized therapeutic efficacy” so that you can actually market your test, that is indeed “a lot.” And the NIH won’t pay for that with basic research funding. So it will take private money, the providers of which would be very “self interested” to make a profit. “Self interest” is not a bad or distorting thing, as described above — it is the nature of capitalism which the whole patent system undergirds.

    Did I go awry here somehow?

    One has to grant that these kinds of correlative claims are not simple to frame or even justify by some “man on the street”/”common sense” standards. But diagnostics and especially so-called theranostic tests are going to be increasingly important – the FDA seems to be increasingly interested in having companies bringing new drugs to also bring companion diagnostics – better for safey and efficacy is the patient population is well defined. And those diagnostics are going to need some kind of protection. How should – how can – the patent system accommodate that need? That seems to be the relevant question…

  52. With enough puppets, I can change the world!

    Puppet 1: that’s right puppet master;
    Puppet 2: (from outside the USA) that that’s right Puppet 1;

    Real Commentator: WTF?

    Puppet 3: Let’s try to keep on point, I think Puppet 1 and Puppet 2 have a point and will preserve the intellectual integrity of the show.

  53. A view from outside the USA is, of course, worth diddly squat, but I have to say that Mooney’s views are refreshingly in tune with what I perceive as the “good sense” sorely needed at this juncture, to preserve the intellectual integrity of the patent system (I thought to write “common sense” but that might put me in more bad company). I welcome his postings, and I learn something from the deluge of intemperate reaction they provoke. Keep it coming, posters, please, but if you could keep the debate on point that would be even better.

  54. “There are no universities that file patent applications on each every discovery that their researchers make. No university can afford to do that.”

    Incidentally, if the Universities don’t file, the corporate sponsors certainly do. I know how that must irritate you Mooney.

  55. “There are no universities…blah, blah, blah”

    The richest companies in the world don’t file on everything. You have just proved a non-point. My aren’t you talented.

    The “order of the coitus” (how appropriate) is keeping some late hours these days… .

    “I’m doing just fine thank you”

    Just goes to show what the correct does of Thorazine can accomplish.

  56. “You don’t get to patent a previously undiscovered species of plant that you find walking along a path, do you?”

    I want to encourage path discovering. So, yes, patent seems to work here.

    Mooney and his Gorb-ridden puppet show don’t seem to understand how miserable a world with limited patentability is. Trade secret and obfuscation would be liberally applied by corporations to preserve their research. Design-around innovation will become extinct. Information will become seriously scarce, inhibiting the advancement of the arts and sciences.

  57. ASE “And the Universities that they are employed by will ensure that they file on each and every one of these discoveries so as not to miss out on potential commercial opportunities”

    There are no universities that file patent applications on each every discovery that their researchers make. No university can afford to do that. And yet, university research still happens. I can only imagine how that must irritate you.

    “I think Mooney needs all the help he can get”

    I’m doing just fine, thank you.

  58. Let’s try yet another way of explaining why claim 1 of this patent is doodoo: you can practice every step of claim 1 of this patent and accomplish absolutely nothing that is tangibly related to what the claim purports to provide, i.e., “optimized therapeutic efficacy.”

    Does everyone understand why that is so? As with the LabCorp. claim, the application teaches you a fact about the world, then the claim attempts to prevent anyone from **thinking** about that fact in virtually every practical circumstance.

  59. Not lurking, just keeping an eye out. Surprise surprise, another puppet. At least this puppet does not seem like such an angry little troll. But you’re wrong, I think Mooney needs all the help he can get. Your lies aren’t going to change that.

    “Researchers at these places already have plenty of incentives to make these discoveries (they are called publication and tenure), so they will continue to get made with or without patents.”

    And the Universities that they are employed by will ensure that they file on each and every one of these discoveries so as not to miss out on potential commercial opportunities that, last time I checked, are looked upon quite favorably by the University boards.

  60. Long-time lurker. Mooney doesn’t need me to defend him, but he is absolutely correct about this. The discovery of a correlation between a drug’s metabolites and the optimum dosage of the drug is nothing more than a discovery of a natural phenomenon, and this claim seeks to preempt all applications of the discovery. You don’t get to patent a previously undiscovered species of plant that you find walking along a path, do you? This is no different. The argument that this correlation and others like it would not be discovered absent the possibility of patent protection is pure propaganda. Compile a list of the most well-known or commercially successful diagnostic assays, and you will find that the overwhelming majority are based on discoveries made by researchers at universities, government agencies, and/or other non-profit institutions. Take, for example, DNA-based disease diagnostics. Any list of the top ten would have to include Alzheimer’s disease/APOE4, Tay-Sachs disease/HEXA, cystic fibrosis/CFTR, fragile X syndrome/FMR1, and factor V Leiden thrombophilia/F5. Note that every one of these discoveries, as well as the one at issue in in this case, came out of universities, government agencies, and/or other non-profits. Researchers at these places already have plenty of incentives to make these discoveries (they are called publication and tenure), so they will continue to get made with or without patents. And once the initial discovery is made, it doesn’t take a lot to turn it into a commercial test.

  61. “But that’s not true, no matter how many times you repeat the lie.

    For example: you are a company making and selling a drug with a huge market. You want people to buy your drug. You want doctors to prescribe the drug.

    So tell me: other then spending millions on free pens, slick brochures, and sleazy TV and radio ads, how do you encourage doctors to prescribe the drug when your drug “has a very narrow therapeutic range”? Spend a few moments thinking about it before you mouth off about what people will and will not do. Perhaps you are spending too much time with the wrong kind of people.”

    The above is not an answer, it is a smokescreen (actually a question) disguised as an answer.

    I like the part about mouthing off about what people will and will not do and spending time with the wrong people.

    Now Mooney is trying to use peer pressure to convince people that patents are bad.

  62. GP, it really doesn’t matter.

    If you’re correct, then I sincerely hope that the MM persona does not reflect the true views (or wine choices and other strange proclivities for that matter) of the hand behind the puppet.

  63. Like I said: Mooney, you are a total a$$hole.

    And you don’t know a thing about business OR patent law for that matter. And you clearly don’t understand how patents fit into business or R&D. I think I hear your boss calling from the french fry line. I thought you were moving up to the salad bar, because of your deep understanding of the nuances of ranch dressing.

  64. AllSeeingEye, you’re missing the thing right in front of your face.

    MM owns this website. It’s the only explanation for his posts and persona.

  65. “Without patent protection, the effort that goes into developing these tests would not be done.”

    But that’s not true, no matter how many times you repeat the lie.

    For example: you are a company making and selling a drug with a huge market. You want people to buy your drug. You want doctors to prescribe the drug.

    So tell me: other then spending millions on free pens, slick brochures, and sleazy TV and radio ads, how do you encourage doctors to prescribe the drug when your drug “has a very narrow therapeutic range”? Spend a few moments thinking about it before you mouth off about what people will and will not do. Perhaps you are spending too much time with the wrong kind of people.

    “If this test is denied patent protection, similar tests for other drugs will not be developed”

    Oops, there you go again! Old habits die hard, I guess. May I ask: what are these “similar tests” you are referring to? Please try to remember that the issue here is not “the test” but rather the “the patent claim”.

    Here’s one way to claim the discovery at issue here that might actually fly:

    1. A method for treating an immune-mediated gastrointestinal disorder in a population, comprising: (a) administering a drug providing 6-thioguanine to a plurality of subjects having said immune-mediated gastrointestinal disorder; and (b) obtaining a blood sample from each subject; (c) measuring the level of 6-thioguanine in each of said samples; and (d) administering an increased drug dose only to patients with less than about 230 pmol 6-thioguanine per 8 x 108 red blood cells.

    There you are. I needn’t write the other independent claims for you. You can figure it out.

    You could probably re-work my claim for an individual patient, if you wanted. Then you could sue the patient, too.

    You might end up having to do that, of course, because if can test my own blood with a non-patented kit then there is no reason for the kit to be sold with instructions. The patent application **is** the instructions. Here’s how to save your life with that old drug! But watch out because if it looks like you are thinking about how to modify the dose of medication you are taking, we will sue you! Right. That’s good for business.

  66. On a completely unrelated note, the BPAI case, In re Gary Edward Wheeler, mentions an application Serial No. 10/899,352. I absolutely cannot find any reference whatsoever to the application aside from the mention on the front page of the BPAI decision in Wheeler.

    Can anyone explain?

  67. Pope, its not not necessarily about being thin skinned, its just that if someone doesn’t counter the constant idi0tic drum beat, then some poor soul might confuse Mooney’s constant stream of garbage as meaningful.

    But you’re right, the puppet show is a great way to generate hits.

  68. He’ll be allowed to post on Patently O until one of the following things is not true:

    1. He doesn’t own the site.
    or
    2. He can’t generate the page hits he does not by raising the hackles of thin skinned reg numbers.

  69. Mooney, I’m guessing you flunked your science classes, because nothing is as easy as you think.

    I sentence you to 10 years studying water. If at the end of the 10 years, all you have to say is, “Oh, its just water, just a bunch of wet crap” Then your life will be proven to be a frivolous and trivial joke.

    If, at the end of the 10 years, you can show us, with wide eyes, volume on volume of empirical data showing the wonders of the amazing molecule we call H2O, then you will be allowed to post again on Patently-O.

    Until the, please STFU.

  70. “If you read claim 1 in Diehr carefully, you will see that the “transformation” in Diehr is the “transformation” from a closed rubber press to an open rubber press.”

    Um, I don’t think so Mooney, you are such an a$$hole.

  71. Mooney, do you know what this test is for? It’s for determining the effective dose of a medication used for, amongst other things, the long-term treatment of Crohn’s disease, a serious, incurable, chronic condition. The drug in question is a good one, but it has a very narrow therapeutic range. Too little and it is ineffective, too much and it compromises the immune system.

    Fine-tuning the dose is extremely important, but it takes months for the negative effects of an incorrect dosage to become apparent. Without this test, the drug is much, much less useful. Without this test, people with Crohn’s can fall ill, suffer a flare up, or even die while spending years trying to find the right dose. With it, finding the right dose takes only a couple of months.

    Without patent protection, the effort that goes into developing these tests would not be done. It is precisely because so many parts of the test are known in the prior art that protection is necessary: once the ‘magic numbers’ are known, actually performing the diagnostic is easy.

    Well over a million people worldwide suffer from Crohn’s, and tens of thousands rely on this test to keep their dosage within the ideal range–and thus live a normal life.

    If this test is denied patent protection, similar tests for other drugs will not be developed; there would simply be no profit in them. Without those tests, many people will suffer and yes, some will die.

  72. “However, the apparatus isn’t patentable, either because it isn’t a particular machine–no more than a general purpose computer and a floppy disk.”

    Uh, dude, how can you say what is and what is not patentable without seeing the claim? A *specified* (i.e., expressly recited) apparatus identifying the arrangement of the sensors and other parts of the apparatus that yielded unexpected results could certainly be patentable.

    ” it preempts all use of the fundamental principles of curing rubber, which are the natural processes associated with that substance.”

    This silly strawman bashing is just as lame as the “millions of people will die if we don’t allow this claim” bogeyman. Give it a rest already.

  73. Exactly, MM.

    However, the apparatus isn’t patentable, either because it isn’t a particular machine–no more than a general purpose computer and a floppy disk.

    After all, it is the exact same act of using the apparatus and performing the method — and we can’t let clever claim drafters exalt form over substance.

    Besides, it preempts all use of the fundamental principles of curing rubber, which are the natural processes associated with that substance.

  74. This gets interesting. How was curing time arrived at, before the Diehr invention? I thought it was trite law, that “mere” automation isn’t patentable. I thought that Diehr was more then “mere” automation. In Europe, it is common to regard method (X-ing, Y-ing and Z-ing steps) and apparatus (means for X-ing, Y-ing and Z-ing) as two different aspects of a common inventive concept XYZ, in one patent. Often such an XYZ apparatus turns out to be old, even while the XYZ method is new and inventive, so MM’S assertion that the apparatus would be patentable, but not the method, is fun.

  75. “the changes in the Diehr’s rubber are naturally occuring changes for rubber at that temperature, just like those for a drug in the body.”

    If you read claim 1 in Diehr carefully, you will see that the “transformation” in Diehr is the “transformation” from a closed rubber press to an open rubber press. The incredible awesome contribution of Diehr was to use a computer to “automatically” open the press when the rubber finished curing. WOW, MAN!!!!!!!! A POWERFUL COMPUTER BRAIN DOES THE CALCULATIONS AND OPENS THE PRESS, LIKE, TOTALLY AUTOMATICALLY.

    Diehr is a bad joke, a wrongly decided case, and the method claims would never issue now in any event because of KSR.

    The apparatus claims would remain patentable, however, in theory.

  76. I’m wondering if Bilski is incomplete: At present, part (2) states: “it transforms a particular article into a different state or thing”.

    Perhaps some additional limitation such as: “(2) it transforms a particular article into a different state or thing, and the transformed particular article produces a useful result under 35 USC 101.” might be better? This modified Bilski would exclude cases where transformed electrons, photons, or molecules occur, but where the transformation is secondary to the intent of the invention.

  77. “We’re actually now at the point where a method claim that includes the step of injecting a patient with a compound is being questioned as to subject matter?”

    I hope we can move beyond the sort of whining embodied by the above question.

    1. A method for reading a book, comprising

    (1) opening a book, wherein the book includes the phrase “the purple cow ate grass in the empty park”;

    (2) injecting a patient with a therapeuticaly effective amount of insulin;

    (3) turning a page in said book.

    What a terrible tragedy that this claim isn’t patentable. The American people are being deprived of so much innovation that would otherwise never take place.

  78. We’re actually now at the point where a method claim that includes the step of injecting a patient with a compound is being questioned as to subject matter?

    It’s worse than I thought.

  79. And the short version of the Diamond v. Diehr patent is “thinking about the Arrhenius equation and popping the rubber out when it is cured.”

    …unless, of course, you give some weight to a general purpose computer. But you don’t, so it doesn’t matter in the 101 analysis.

    And the changes in the Diehr’s rubber are naturally occuring changes for rubber at that temperature, just like those for a drug in the body.

  80. “People who claim otherwise are invariably self-interested.”

    Or at least know a heckuva lot more about patent law than Mooney ever will. (And have much better paying ways to spend their time)

  81. Let’s also be clear about one additional aspect of this controversy: denying the patentability of claims such as this one will have ZERO impact on the rate at which optimal dosages of a drug for a particular patient are determined by physicians and researchers.

    People who claim otherwise are invariably self-interested. They are also mistaken.

  82. Let’s look at the claim, shall we?

    1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and (b) determining a level of 6-thioguanine or 6-methyl-mercaptopurine in said subject having said immune-mediated gastrointestinal disorder, wherein a level of 6-thioguanine less than about 230 pmol per 8 x 108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein a level of 6-thioguanine greater than about 400 pmol per 8 x 108 red blood cells or a level of 6-methyl-mercaptopurine greater than about 7000 pmol per 8 x 108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

    The short version is: A method of thinking about whether or not a need exists to administer more drug to a patient, comprising measuring the amount drug in a patient, then thinking that a need to administer more drug to said patient exists, or thinking the opposite.

    “(1) the requite Bilski transformation can be found in the subject’s transformation of the drug into metabolites in the body”

    The administration of this drug and measurement of this drug in the body is an old method.

    The patentee claimed a method of “optimizing” therapy by THINKING about the results of the old method in an allegedly “novel” and “non-obvious” way. These allegedly inventive steps comprise “determining” X, asking oneself whether X is greater than or equal to Y, wherein the answer correlates with an “indicated need.” The claim does not require that any drug be administered after the mental step.

    The only relevant transformation, therefore, is the transformation of old data into an **allegedly** new human thought. And let’s be frank: the bold new concept here is administering more drug if more drug is needed — WOW!!!!

    In fact, a disturbing question arises: what happens if a “need for more drug is indicated” by the claim but no drug is administered because, based on some other criteria, the drug is deemed effective at the current dose? Is it still infringed?

    Therein lies the problem with mental inventions. Who infringes? Who can what someone is thinking after they take a measurement? More importantly, who can say what people in the prior art thought to themselves? The PTO Examiner can’t do it.

    “(2) that no weight should be given to the dissent from denial of certiorari in LabCorp.”

    LOL. No weight? Why not? It’s the most reasoned statement of the law. If if was incorrect, that would be one thing. But it’s not. It’s spot on. Breyer did everyone a big favor.

  83. From the AIPLA brief:
    “Obviously, no purely natural phenomenon encompasses the
    transformation of these administered drugs to these resultant metabolites.” Brief at 8.

    “Applying these principles to this case, it is beyond legitimate
    debate that the physical transformation that flows from the use of the drugs in
    the patented processes in this case is not “insignificant” post-solution activity.” Brief at 15.

    I’m not surprised AIPLA would argue for the strongest conceivable patent protection and broadest possible claim scope. It bothers me though that in this case the physical transformation is done entirely by the patient’s body. This sure looks to me that the patentee is broadening the scope of a composition of matter claim by using a method claim that pre-empts a natural phenomenon.

  84. “The bar association argues that at least the transformation of the drug into metabolites in the body and that no weight should be given to the dissent from denial of certiorari in LabCorp.”

    With all due respect, is the above a complete sentence?

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