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Eviscerating Patent-Eligibility of Drug Testing Methods: The Nonsensical Reasoning in the SCOTUS Prometheus Decision*


Written by Eric W. Guttag
Eric W. Guttag IP Law Office
Posted: March 21, 2012 @ 2:20 pm
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Justice Breyer delivered the opinion of a unanimous Court.

Well, Justice Breyer, the writer of the dissenting opinion in Laboratory Corp. v. Metabolite Laboratories, Inc., finally got his wish.  Writing the opinion for a unanimous Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., Breyer ruled that a claimed drug dosage calibration method based on previously unknown “precise correlations between metabolite levels [of administered thiopurine drugs] and likely harm or ineffectiveness” was patent-ineligible under 35 U.S.C. § 101 because it “adds nothing to the laws of nature that is not already present when the steps [of the claimed method] are considered separately.”  While I’m not surprised that Breyer ruled the claimed method patent-ineligible, his reasoning in Mayo Collaborative Services is, in my view, often nonsensical, and is fraught with unfortunate statements that could potentially eviscerate the patent-eligibility of drug testing methods (as well as related medical diagnostic methods) generally under 35 U.S.C. § 101.

Briefly, the claimed method in Mayo Collaborative Services determined (calibrated) the proper dosage of thiopurine drugs to treat both gastrointestinal and non-gastrointestinal autoimmune diseases.  What the claimed method sought to do was optimize therapeutic efficacy while minimizing toxic side effects.  The claimed method had essentially only two steps:  (1) administering a thiopurine drug to a patient; and (2) determining the level of metabolites of the drug in the patient after administration.  The claimed method also concluded with some “wherein clauses” that, if certain drug metabolites were below a certain level, that would indicate a need to increase the amount of the drug administered.  Conversely, if those drug metabolites were above a certain level, that would indicate a need to decrease the amount of the drug administered.  See CAFC: Method for Calibrating Drug Dosage Is Transformative.

The district court granted the alleged infringer’s (Mayo Collaborative Services’) motion for summary judgment of invalidity of this claimed drug dosage calibration method as being patent-ineligible under 35 U.S.C. § 101.  The Federal Circuit reversed the district court’s ruling twice, first before the Supreme Court’s decision in Bilski v. USPTO, then in a second decision after Bilski where the Supreme Court granted certiorari, vacated the first decision, and then remanded for reconsideration in view of the Supreme Court’s decision in Bilski.  The ruling by the Federal Circuit in the second decision essentially repeated the basis for the ruling in the first decision, namely that the claimed drug dosage calibration method was “transformative,” was therefore patent-eligible under 35 U.S.C. § 101, and further concluded that the Supreme Court’s decision in Bilski changed nothing in that respect.

In reversing the second decision by the Federal Circuit, Breyer’s opinion quotes the language of 35 U.S.C. § 101 for the first (and last time).  His opinion then proceeds to state the “implicit exception[s]” to this patent-eligibility provision, namely that “laws of nature, natural phenomena, and abstract ideas” are not patent-eligible.  He also states not much further on that “too broad an interpretation of this exclusionary principle could eviscerate patent law.”  So far, no disagreement with what Breyer’s opinion says.

But then Breyer’s opinion takes a decided turn for the worse.  Breyer refers to the claimed method as “purport[ing] to apply natural laws describing the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that the drug dosage will be ineffective or induce harmful side-effects.”  Breyer then posed the patent-eligibility question for the claimed method thusly:  did the “claimed [methods] transform[] these unpatentable laws of nature into patent-eligible application of those laws.”  He concluded that “they have not done so and that therefore the [methods] are not patentable.”

In finding the claimed method to be patent-ineligible, Breyer’s first characterized the “administering step” as “simply refer[ring] to the relevant audience, namely doctors who treat patients with certain diseases with thiopurine drugs.”  Frankly, the “administering step” is more that as it determines what the metabolite will be for which the levels are being determined.  Second, Breyer characterizes the “wherein clauses” that identify what levels of the metabolite are too little or too much as “simply tell[ing] a doctor about the relevant natural laws, at most adding a suggestion that he should take those laws into account when treating his patient.”  Again, these “wherein clauses” are much more than “tell[ing] a doctor about the relevant natural laws,” and are at the crux of why the claimed method is unique.  Finally, Breyer characterizes the “determining step” as “tell[ing] the doctor to determine the level of the relevant metabolites in the blood, through whatever process the doctor or the laboratory wishes to use.”  True, but without determining what those metabolite levels are, the “wherein clauses” are meaningless.

Breyer summarizes this claimed method analysis by stating:

[T]he claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.  For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities.

This statement is very problematical in at least a couple of respects.  First, the claimed method doesn’t simply “inform a relevant audience about certain laws of nature,” but instead tells that audience whether the levels of a specific metabolite found are too low or too high.  Second, that “any additional steps consist of well understood, routine, conventional activity” is likely true of most drug testing methods.  And while this statement might support the lack of patentability of the claimed method under 35 U.S.C. § 102 or 35 U.S.C. § 103 (as was urged by the U.S. Solicitor General), it is frankly inadequate, without more, to support patent-ineligibility under 35 U.S.C. § 101 of the claimed method as just covering a “law of nature.”

Breyer’s opinion then goes into a discussion of “controlling precedents [that] reinforces our conclusion” that the claimed method was patent-ineligible.  Dominating this discussion is the dichotomy created by the 1978 case of Parker v. Flook (method for adjusting alarm limits in catalytic conversion of hydrocarbons deemed patent-ineligible) on the one hand, and the 1981 case of Diamond v. Diehr (using the Arrhenius equation in claimed rubber molding method deemed patent-eligible) on the other.  Frankly, the discussion of this dichotomy by Breyer isn’t helpful in resolving the patent-eligibility of the claimed drug dosage calibration method.  Flook is based on the logically “flawed” view that a previously undiscovered “algorithm” is somehow part of the “prior art” (a view completely inconsistent with 35 U.S.C. § 103), as well as the nonsensical view that “post-solution activity” that is purely “conventional or obvious” cannot “transform an unpatentable principle into a patentable process” (which is also inconsistent with the concept of the invention “as a whole” expressed in 35 U.S.C. § 103).  By contrast, Diehr (in my opinion) is simply an effort by the Supreme Court to “minimize the damage” caused by the illogical reasoning in Flook that could have made the patenting of any process (or method) problematical under 35 U.S.C. § 101.  Going down the Flook-Diehr dichotomy road just makes the jurisprudential “quagmire” created by the Supreme Court on patent-eligibility issues worse.

Another beef I have with Breyer’s opinion is his overstated “concern that patent law  not inhibit further discovery by improperly tying up the future use of laws of nature.”  But the claimed drug dosage calibration method, which is specific to thiopurine drugs, in no way “[ties] up the future use of laws of nature.”  Indeed, his citation to O’Reilly v. Morse (where Samuel Morse discovered the electrical telegraph but then tried to claim any means for electrical communication) is “overkill” in the extreme with respect to this claimed drug dosage calibration method.
Even later in his opinion, Breyer raises a similar “horror story” by arguing that “the grant of patents that tie up [the use of discoveries, laws of nature, etc.] will inhibit future innovation premised upon them, a danger that becomes acute when a patented process amounts to no more than an instruction to ‘apply the natural law’, or otherwise forecloses more future invention than the underlying discovery could reasonably justify.”  But Breyer presents no data or evidence to support this supposed “horror story.”  Instead Breyer cites two law review articles, the first of which is authored by Lemley et al. and which supposedly “argues that [35 U.S.C.] § 101 reflects this kind of concern.”  So much for actual “facts” to support this supposed “horror story.”  This supposed “horror story” raised by Breyer is also pretty flimsy given that Mayo Collaborative Services didn’t “innovate” the claimed method in the first place (and contrary to what some amici disingenuously suggested, was a “for-profit” competitor of Prometheus, the patentee).

Far more troubling to me is the potential reaction by those researching, developing (and funding) such drug dosage calibration or other drug testing methods if the patent-eligibility bar is perceived as being raised too high by Mayo Collaborative Services.  Two potential reactions are possible, both of which would be a far greater impediment to innovation, as well as increasing the storehouse of scientific and technical knowledge for such drug testing methods.  One is that research, development (and funding) of drug testing methods will simply decrease if the investment in such testing cannot be protected (or is perceived to unprotectable) by patents.  (And without patents, there is no “disclosure to the public” of the drug testing methods being claimed.)  The other is that such research, development (and funding) of drug testing methods will continue to the extent that such methods can be viably protected as “trade secrets.”  And for universities engaged in researching such drug testing methods, and where “trade secrets” are not a viable option, making the patent-eligibility bar too high could be the “death knell” for such university research.

Running throughout Breyer’s opinion is another bothersome theme raised by several of the amici which is completely bogus:  the claimed method is trying to “patent thought.”  See, for example, Breyer’s assertion that the claimed method would “tie up the doctor’s subsequent treatment decision whether that treatment does, or does not, change in light of the inference he has drawn using the correlations.”  The trouble with this assertion is that it doesn’t reflect medical reality or what the claimed method actually covers.  The doctor is very unlikely to be the one determining the level of metabolites.  Instead, that doctor, after administering the drug, would most likely need a separate lab to determine the level of metabolites present in the blood sample supplied by that doctor.  And here’s the real kicker:  whatever the doctor does with (or thinks about) the metabolite levels determined by the lab doesn’t infringe the claimed method.  See also 35 U.S.C. §287(c) which immunizes a medical practitioner (and its related health care entity) from patent infringement for performance by the medical practitioner of a “medical activity.”

Another annoying spot in Breyer’s opinion is his response to the argument by the U.S. Solicitor General that the claimed drug dosage calibration method isn’t a patent-eligibility issue under 35 U.S.C. § 101, but is, instead, a patentability issue under either 35 U.S.C. § 102 or 35 U.S.C. § 103.  In fact, Breyer characterizes the U.S. Solicitor General’s argument as suggesting that 35 U.S.C. §§ 102, 103 & 112 should perform this initial “screening function” in place of 35 U.S.C. § 101.  (I frankly agree that it would be better approach, as do others, including Chief Judge Rader.)  But Breyer responds to this perceived approach by the U.S. Solicitor General as making “the ‘law of nature” exception to [35 U.S.C.] § 101 a dead letter.”  That’s simply not true.  For example, and using the Einstein E = mc2 hypothetical posed by Breyer, a claim to this formula might satisfy 35 U.S.C. §§ 102, 103 & 112, yet still be “flunked” for patent-eligibility under 35 U.S.C. § 101 as covering merely a “law of nature.”

I’m particularly irked by Breyer’s snide remark early in his opinion that Supreme Court precedent “warns us against interpreting patent statutes in ways that make patent eligibility ‘depend simply on the draftman’s art’ without reference to the “principles underlying the prohibition against patents for [natural laws],” once more citing the logically flawed Flook case.  But that remark is a non-sequitur, given that 35 U.S.C. § 112, second paragraph, says that the invention is to be described (and defined) by “one or more claims” at the end of the patent specification.  If the “draftman’s art” cannot be used to turn a patent-ineligible “law of nature” into a patent-eligible application of that “law,” then what, pray tell, can be used?  Breyer’s further comment that such precedent “insist that a process that focuses upon the use of a natural law also contain other elements or a combination of elements” (which he says is sometimes referred as the “inventive concept”) is completely unhelpful.  After all, Breyer later in his opinion says “routine, conventional activity” won’t save a claimed process (or method) that otherwise is deemed to cover just a “law of nature.”

One thing I do agree with in Breyer’s opinion (and which is a major weakness is both Federal Circuit decisions) is that the “administering step” being “transformative” in terms of the drug being converted by the human body into the metabolites is essentially irrelevant to the patent-eligibility question under 35 U.S.C. § 101.  The claimed drug dosage calibration method is also problematical in relying upon a final “determining step” followed by “wherein clauses” that essentially provide the results of that “determining step,” as well as some “what ifs” about what those results mean.  After the Supreme Court’s ruling in Bilski, I was already concerned that such data-gathering “determining steps” might not push such drug testing methods, as well as other related diagnostic methods, into the “patent-eligible zone.”  In fact, in the companion case of Classen Immunotherapies, Inc. v. Biogen Idec, the claimed method which essentially calibrates an immunization schedule for a treatment group (relative to a control group) is now likely to be deemed patent-ineligible, especially in view of the Supreme Court’s ruling in Mayo Collaborative Services.

What Mayo Collaborative Services doesn’t address (at least not directly) is a claimed method that has the following additional step:  based on the metabolite levels in the “wherein clauses” showing either too much or too little thiopurine drug being administered, appropriately adjusting the dosage of thiopurine drug administered to patient.  Admittedly, such a claim might complicate the patent enforcement issue against a “for-profit” testing lab like Mayo Collaborative Services.  (An alternative additional step which indicates that the drug dosage should be appropriately adjusted might avoid this patent enforcement issue.)  But given Breyer’s unfortunate statements in his opinion that “routine, conventional activity” won’t save a claimed method that otherwise is deemed to cover just a “law of nature,” one must wonder whether even this additional “drug dosage adjusting step” would put the claimed method into the “patent-eligible zone.”

*© 2012 Eric W. Guttag.  Posted March 21, 2012 on IPWatchdog.com


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34 comments
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  1. EG-

    Nice article!

    At the end you say: “one must wonder whether even this additional “drug dosage adjusting step” would put the claimed method into the “patent-eligible zone.””

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

    -Gene

  2. “Instead, that doctor, after administering the drug, would most likely need a separate lab to determine the level of metabolites present in the blood sample supplied by that doctor. And here’s the real kicker: whatever the doctor does with (or thinks about) the metabolite levels determined by the lab doesn’t infringe the claimed method. ”

    After determing the metabolite levels (something the lab worker could easily have been doing for years prior to the filing of the application), if the lab worker thinks about the correlation then he/she becomes a literal infringer of Prometheus’ claim. Does it make you uncomfortable that the lab worker becomes a literal infringer of Prometheus’ claim only because the lab worker has learned something new? Should the lab worker quit his/her job to avoid literally infringing the claim? Or should the lab worker have his/her brain erased?

    It seems easy to imagine non-medical diagnostic claims having similar effects on the public, in other settings. I would guess the Supreme Court was thinking about these when they wrote the passage you are criticizing.

  3. Raymond-

    The first rule of commenting here on IPWatchdog is to keep it real. Your suggestion that lab workers would have to quit in order to avoid liability for infringement is absurd on its face.

    In what state can a lab worker administer a drug?

    In what state can a lab worker change dosage?

    Fact and reality matter, and if you want to comment here you have to take facts and reality into account. You ignore the language of the claim because you have an agenda and want to pretend that the claim covers things that it literally does not claim.

    -Gene

  4. Gene –

    I will address each of your remarks in turn.

    “Your suggestion that lab workers would have to quit in order to avoid liability for infringement is absurd on its face.”

    No, it’s not. It’s one of several possibilities for avoiding for avoiding infringement of the claim. Another possibility is to refuse to do make the determination because he/she can not avoid thinking about the meaning of the determination. Another possibility is to perform the test but never look at the result before reporting the result to a third party.

    “In what state can a lab worker administer a drug?”

    The lab worker who determines the metabolite level is a literal infringer of Prometheus’ broadest claim asserted against Mayo, provided only that the lab worker is aware of the correlation taught by Prometheus. The broadest claim does not require adminstration of a dosage by the infringer (claim 1, recited in the decision, was not the broadest claim asserted against Mayo).

    “In what state can a lab worker change dosage?”

    Literal infringement of the claims at issue does not require that any dosage be changed. All that is required is that an actor determine the level of metabolite and think about whether the dosage needs to be changed.

    ” if you want to comment here you have to take facts and reality into account. ”

    I assume the same consideration applies to you. Please take the above facts into account should you choose to reformulate your reply to my earlier comment.

  5. My 3 takeaways:

    1. SCOTUS is unqualified to; and should no longer be; deciding patent cases. The CAFC should be the final arbiter.

    2. 101 continues to be fraught with problems; and should be abolished. 102/103/112 are plenty effective.

    3. A variety of additional claims approaches should have been included. Relatedly (I haven’ checked), I hope they’ve got one or more active continuations.

  6. Gene,

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

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

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

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

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

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

  7. I’m a bit concerned about the conflation of prior art rejections and subject matter edibility.

    What about a process claim of known steps placed in a unique combination that yield “unexpected results.” Aren’t those results (often put into a “wherein” clause) merely be the natural result of the known steps? Wouldn’t this also apply to an apparatus that is a combination of known devices?

    The waters have be muddied by the decision.

  8. Sean,

    Unfortunately, the waters are beyond “muddled” and threaten to “drown” the patent-eligibility of any analytical or diagnostic method. As I noted in my comment above, it’s hard to figure out how any analytical or diagnostic method can survive a patent-eligibility eligibility challenge if you take the nonsensical and illogical reasoning of Breyer’s opinon to the extreme. We can only hope that the Federal Circuit, probably led by Chief Judge Rader, “cabin” this opinion so it doesn’t cause such “collateral damage.” Frankly, the Federal Circuit can “outlast” SCOTUS on this issue, as SCOTUS can’t review every single case involving such a patent-eligibility question.

  9. 1) Heat the stew to 325 Degrees F for 20 minutes
    2) Add a pinch of salt
    3) Taste stew
    4) If stew does not taste salty enough add a tiny bit more salt
    5) Taste stew again
    6) Check stew temperature with thermometer
    7) Repeat steps 2-6 until satisfied

    Does that look a bit like the Prometheus patent?

    That’s the problem with Method Patents. I cannot remember seeing a single one that represented a true advance in the state of the art. To quote Article One of Section Eight of the second United States Constitution:

    To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries

    Where is the progress in the Prometheus patent? It describes things that doctors have been doing for years. My own doctor has modified my drug regime based on effects and tests over the years (I suffer from chronic pain). So why did the Patent Office issue this patent? Any doctor who they asked about this would have told them that this was already standard practice.

    As to the Supreme Court ruling, there’s been a lot of criticism of the way the ruling was made, however it is possible that the Court had a point, at least as far as the relationship between a dosage and its affect on an metabolite in the bloodstream.

    As to how patent law has been built up over the years, there was an equally strong body of law built up over the years which stated that women were property. Sometimes law changes.

    Wayne

  10. Wayne,

    Your post shows many errors in logic and legal understanding.

    You appear to be confused by what is the legal definition of progress and the layman’s definition of progress. For the laymen, progress means refinement and advancement in a linear view.

    That is not the legal definition. In the legal definition, progress is obtained when mutliple paths are created. The newly created path need not be better than existing paths.

    The reason for providing patents for what to a layman must be an absurd result (an “inferior” road) is because innovation is not linear.

    Innovation hops about and cannot be foretold based on linear improvements in the art. It is impossible to tell which of the many roads may be combined with other factors in the future to arrive at an invention that today cannot even be begun to be comprehended.

    To speak intelligibly on this topic, in the legal sense, you must appreciate this difference.

    As to your interjections of the Supreme Court rationale and women as property indicating that law must change, both are inapposite to this discussion. You need to tie whatever point you think you are making logically (and in an appropriate legal sense) to the points being made as to why the Supreme Court decision is a horrible legal piece of work. There is a logic gap from the soundbyte you produced to the actual discussion.

    As to the particular point of “would have told them that this was already standard practice,” had you an inkling of knowledge of patent law, you would have realized that you have just agreed that the 101 argument by the Supremes was bogus because you just argued a 102 argument.

  11. Wayne,
    I don’t think the claims in Prometheus are necessarily patentable, though they should be patent eligible. What you are doing is conflating an obviousness analysis with the question of subject matter eligibility.

    Had the drug recited in the Prometheus claims been novel, it’s method of use would also be novel and certainly advanced the art. However, here, the drug was known and recited in a method of use constrained only by readily ascertainable concentrations of the metabolites in the blood. That sounds like a case for an obviousness analysis to me.

  12. It is notable that the equivalent patent in Europe issued with a distinctly better claim.

    It is, unfortunately, all too easy to say that the trouble could have been avoided by a better drafted claim mentioning, as in Europe, that this is an in vitro test on red blood cells using high pressure liquid chromatography. Such a claim would have been more clearly in the useful arts without giving too much away. But we seem to have a host of 102 and 103 objections used to make a 101 objection, and I join the other commentators in their view that the decision makes no logical sense and is surprising coming, as it does, from a judge with a distinguished academic record.

    The EPO Enlarged Appeal Board take the view that a ROM is a technical article and does not cease to be a technical article when it has non-patentable business method software recorded in it. Their approach has much to commend it and the present decision merely highlights how much better it is

  13. Your post shows many errors in logic and legal understanding.

    You appear to be confused by what is the legal definition of progress and the layman’s definition of progress. For the laymen, progress means refinement and advancement in a linear view.

    That is not the legal definition. In the legal definition, progress is obtained when mutliple paths are created. The newly created path need not be better than existing paths.

    Anon,

    Ah, but in that case the law is unconstitutional.

    Had the drug recited in the Prometheus claims been novel, it’s method of use would also be novel and certainly advanced the art.

    Sean,

    Not true. Take the Internal combustion engine for example. It’s use to drive a carriage instead of horses did not “advance” the art. The engine itself however was an advance in the art over the external combustion engine.

    Wayne

  14. The EPO Enlarged Appeal Board take the view that a ROM is a technical article and does not cease to be a technical article when it has non-patentable business method software recorded in it. Their approach has much to commend it and the present decision merely highlights how much better it is

    Paul,

    By that logic recording it on a piece of paper would make it a technical article too.

    Wayne

  15. Wayne,

    You state “Ah, but in that case the law is unconstitutional.” without explanation.

    Please explain. And keep in mind the understanding as I have provided.

    A word of caution: Gene does not take kindly to those that blindly misrepresent the law without absolutely no foundation.

    If you want to play games with imaginary law, may I suggest Patently-O?

  16. Gene,

    Please edit my last post,

    “misrepresent the law without absolutely no foundation.” should read “misrepresent the law with absolutely no foundation.”

    Thanks,

  17. Anon,

    Sorry. I thought everyone was familiar with the wording of Article 1, Section 8 of your Constitution:

    To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries

    Note that the word Progress is in bold. That’s why your assertion is unconstitutional. The newly created path must be better according to the Constitution, or it can’t be covered by patent.

    I’m a Canadian, and I know your Constitution. Possibly you should read it :)

    Wayne

  18. Wayne,

    Reading without understanding is no better than not reading at all. Please pay attention as I have already explained the proper LEGAL understanding for the word “progress” and I have explained what this means in non-legal jargon-free easy to comprehend plain English.

    Being Canadiam is no excuse for making up your own legal understanding. And please leave the smart-@ss comments to those who at least recognize when to use them. You just compound your foolishness otherwise.

  19. Anon,

    Reading without understanding is no better than not reading at all. Please pay attention as I have already explained the proper LEGAL understanding for the word “progress” and I have explained what this means in non-legal jargon-free easy to comprehend plain English.

    But is your “Legal” meaning what the framers of the Constitution meant? A plain language reading of the Constitution indicates that it probably was not, and that the courts have warped the original framers intent.

    Wayne

  20. the courts have warped the original framers intent

    The courts. Really?

    Your insistence on reading a legal document without understanding that it even is a legal document will end our conversation. With all due respect Wayne, you are clueless and your opinions are meaningless, clearly.

    Come back when you understand the language you are trying to speak.

  21. @ Wayne: Indeed the EPO view is that a pencil and a piece of paper would suffice. The analysis is then conducted on the basis of lack of novelty and/or obviousness, not qualifying subject matter. However, in that analysis non-qualifying features e.g. business method features are disregarded. It is a moot point whether the limits, being pure matters of information, should be disregarded under the analysis used by the EPO Appeal Boards which is now black-letter law. But in the EPO the analysis was clearly specified as being in vitro on a blood sample withdrawn from a patient. There is no way that lack of qualifying subject matter would be available in relation to the claimed subject matter as a whole.

  22. “the decision makes no logical sense and is surprising coming, as it does, from a judge with a distinguished academic record.”

    Paul,

    Breyer may have a “distinguished academic record,” but he’s very typical of the Justices on the Supreme Court: antitrust-driven and essentially “patent hostile.” They also tend to denigrate our area of the law and Breyer did it again here with his derogatory reference in Mayo Collaborative Services to the “draftsman’s art.” I first witnessed Breyer’s nonsense when, in the oral argument in KSR International, which dealt with a car throttle control, he goes off on a “frolic and detour” of his own about dealing wiht raccoons “gnawing” his garage door opener (I’m not making this up, it’s in the oral argument transcript).

    Justice Scalia who is usually considered to be at the opposite end of the politicial spectrum from Breyer is no better and other ways worse. Scalia is mired in a 19th Centuyr concept of what is or should be patent-eligible subject matter. He also made the snide remark in KSR International that patent law was “gobbledygook.”

    From what I’ve seen of Chief Justice Roberts in oral argument transcripts so far, he’s confused and clueless about the difference between patent-eligibility under 35 USC 101 and patentability under 35 USC 102/103.

    So with this antitrust-“patent hostile” mindset (and being technologically-challenged to boot) it’s no wonder we get decisions on patent law from our Supreme Court that are unbalanced and make no logical sense. I’m going to provide to Gene a follow up article to this one that addresses the unprincipled “patent law despotism” we’ve been witnessing lately from the Supreme Court.

  23. Anon,

    The courts. Really?

    Your insistence on reading a legal document without understanding that it even is a legal document will end our conversation. With all due respect Wayne, you are clueless and your opinions are meaningless, clearly.

    Come back when you understand the language you are trying to speak.

    Many of the framers of the Constitution were laymen. Therefore the Constitution should be read by laymen, not lawyers.

    @ Wayne: Indeed the EPO view is that a pencil and a piece of paper would suffice. The analysis is then conducted on the basis of lack of novelty and/or obviousness, not qualifying subject matter. However, in that analysis non-qualifying features e.g. business method features are disregarded. It is a moot point whether the limits, being pure matters of information, should be disregarded under the analysis used by the EPO Appeal Boards which is now black-letter law. But in the EPO the analysis was clearly specified as being in vitro on a blood sample withdrawn from a patient. There is no way that lack of qualifying subject matter would be available in relation to the claimed subject matter as a whole.

    So it is possible that by trying to be fair, they could decide that a written “recipe” could qualify. I’m using the word recipe of course to represent something more complex, and trying to make a point that the media involved does have an impact on the invention.

    If the invention is something that you can carry out in your head, along the lines of 2+2=4, no matter how complex, it isn’t patentable subject matter, because it doesn’t produce a physical product, or is not a physical product.

    The “vulcanizing” process is a good example. The output was a physical product.

    The internal combustion engine is a good example. It is a physical product.

    The Prometheus Patent produces nothing, and is nothing. It says do this, and if this happens do this, rather like a simplified set of instructions for a stereo system, which includes the suggestion that you use a voltmeter to check the system voltage if the you don’t get the right sound, because input can have an impact on the output.

    Wayne

  24. Wayne,

    My comment on the concurrent thread addresses your latest post.

  25. Question for Eric and Gene:
    Is if fair to characterize the Prometheus- Bilksi line of cases as limited to method claims?

    How about an apparatus claim drawn (like a draftsman does, of course!) to a device that receives blood samples, analyzes them, and then generates an output signal indicating that the dosage is too low, about right, or too high, such as by red, yellow and green lights, where the analysis is for the specific metabolite and the concentration levels of the litigated method claims are used to select the output signal?

  26. AC,

    You would hope that this nonsensical reasoning in Breyer’s opinion would be limted to method/process claims. Accordingly, the apparatus claim you suggest should hopefully pass muster under 35 USC 101. If not, the MOT test as providing the “safe harbor” for patent-eligible subject matter is dead letter.

    Method/process claims are the most problematical in terms of the potential for simply covering patent-inelgible “abstract ideas.” But with the “gobbledygook” that Breyer’s opinion expresses, you frankly don’t know how far this nonsense might be pushed, especially in a computerized system which has both hardware (“apparatus”) and softwre (“method”) aspects. That’s how bad Breyer’s opinion is for tryiing to logically, rationally and objectivel determine what is patent-eligible subject matter.

    We would do far better to go back to the now discarded “tangible, concrete and useful result” test of State Street. The TCU test at least tells that if the method (at least the unique aspect thereof) doesn’t achieve a “useful result” (which Prometheus’ claimed method, as written, doesn’t), you’ve likely got a patent-ineligibile “abstract idea.” As I’ve repeatedly said, with Breyer’s nonsensical reasoning I could do just as well using a Ouija board to objectively determine the patent-eligibility of a claimed method or process.

  27. [...] Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc.  See Eviscerating Patent-Eligibility of Drug Testing Methods: The Nonsensical Reasoning in the SCOTUS Pro….  Now that the dust is starting to settle (and hopefully the “verbal vitriol” being thrown is [...]

  28. If not, the MOT test as providing the “safe harbor” for patent-eligible subject matter is dead letter.

    Sorry to burst your bubble, EG, but MOT was never a safe harbor.

    We would do far better to go back to the now discarded “tangible, concrete and useful result” test of State Street.

    Yes, but that would mean that the SC wants something that is “better.” As noted in Bilksi that “better” was scorned.

    On the plus side, who knows what the next Court may hold.

  29. “Many of the framers of the Constitution were laymen. Therefore the Constitution should be read by laymen, not lawyers.”

    Wayne,

    You need to read upon on your history, as well as the law, Wayne. What you’ve said has been a nonsequitur since Chief Justice Marshall said in Marbury v. Madison that our Constitution is the “fundamental law of the land.” Also contrary to what you suggest, many, if not most of the framers of the Constitution were lawyers or at least legally trained, and , for the most part, were not simply “laymen,” but very astute and experienced politicians. That includes James Madison, James Monroe, Alexander Hamilton, John Jay, and William Paterson. You would be hard-pressed to find too many of the framers of the Constitution who didn’t have at least a working knowledge of the law.

  30. Wayne-

    I would be OK with allowing the Constitution be be interpreted by laymen instead of lawyers (particularly those 9 lawyers who wear the black dresses), but that is not the path we have chosen. We have to be consistent in order to be fair and not have the Constitution mean whatever any new generation wants it to mean, which is actually a criticism of the way the Supreme Court interprets the Constitution.

    I guess laymen couldn’t do any worse. I just wish precedent meant something to the Supreme Court.

    -Gene
    (totally flabbergasted… can you tell)

  31. BD,

    OK to “burst my bubble.” With Breyer’s opinion dropping a patent law atomic bomb on us, “bursting bubbles” is the least of my worries.

  32. “fact, in the companion case of Classen Immunotherapies, Inc. v. Biogen Idec, the claimed method which essentially calibrates an immunization schedule for a treatment group (relative to a control group) is now likely to be deemed patent-ineligible, especially in view of the Supreme Court’s ruling in Mayo Collaborative Services.”

    To all,

    I’ve changed my mind on the correctness that statement, after having reviewed again the Federal Circuit remand decision in the Classen Immunotherapies case. In fact, the Classen Immunotherapies remand opinion points the way home to keeping the ruling from Mayo Collaborative Services from exploding into complete nonsense.

    Judge Newman’s opinion (joined by Chief Judge Rader) very astutely points to the “immunization step” in the two patents (the ‘739 patent and the ‘139 patent) for why they made the patent-eligibility grade, while the ‘283 patent did not. These two patents might go down for other reasons (Newman also very carefully noted that the claims of these patents “may not meet the substantive criteria of patentability as set forth in §102, §103, and §112″). But the “law of nature” reasoning from Mayo Collaborative Services is completely inapplicable to these Classen claims. There may yet be some “light” in this currently “dark” patent-eligibility tunnel.

  33. [...] in Breyer’s opinion in Mayo Collaborative Services v. Prometheus Laboratories, Inc.  See Eviscerating Patent-Eligibility of Drug Testing Methods: The Nonsensical Reasoning in the SCOTUS Pro….  See also A Matter of Patent Law Despotism: The Nonsensical Reasoning in the Supreme Court’s [...]

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