The Way Forward from Mayo Collaborative Services is through the Classen Immunotherapies Remand*

Many of us in the patent world (me included) have pounded our heads against the reasoning (not result) expressed in Mayo Collaborative Services v. Prometheus Laboratories, Inc.  See A Matter of Patent Law Despotism: The Nonsensical Reasoning in the Supreme Court’s Mayo Collaborative Services Decision Part 2*.  The reasoning in Mayo Collaborative Services makes no patent law logical sense on numerous grounds, including disregarding an important paragraph in the Supreme Court’s 1981 case of Diamond v. Diehr that is not only binding precedent, but also tells us that Breyer’s opinion repeatedly does what this paragraph from Diehr says not to do in an analysis of method or process claims under 35 U.S.C. § 101.

But the question now becomes what do we do to keep the reasoning in Mayo Collaborative Services from exploding into completely irrational, as well as patent law insane doctrine?  The way forward to patent-eligibility rationality, as well as sanity, is through the remand decision in Classen Immunotherapies, Inc. v. Biogen IDEC.  See CAFC on Patent-Eligibility:  A Firestorm of Opinions in Classen.  Put differently, there may yet be “light” in this currently “dark” patent-eligibility tunnel.

In the interest of full disclosure, in my first article on Mayo Collaborative Services, I had stated that the claimed methods in Classen “[are] now likely to be deemed patent-ineligible, especially in view of the Supreme Court’s ruling in Mayo Collaborative Services.  See Eviscerating Patent-Eligibility of Drug Testing Methods: The Nonsensical Reasoning in the SCOTUS Prometheus Decision*.  Having now reviewed the Classen remand, and especially the claimed methods involved in that case carefully, I’ve completely changed my mind on the correctness of that statement.  The claimed methods which were upheld in the Classen remand are very different from those which went down in Mayo Collaborative Services.  Also, the primary reasoning in the Classen remand for why the claim methods there were deemed patent-eligible under 35 U.S.C. § 101 is very different from that used in the Federal Circuit decision that was reversed in Mayo Collaborative Services.

Judge Newman wrote the majority opinion (joined by Chief Judge Rader) for the Classen remand decision.  Briefly, Classen involved three related patents (the ‘739 patent, the ‘139 patent, and the ‘283 patent) directed generally to a method for essentially evaluating an immunization schedule for a treatment group, relative to a control group.  But where the ‘739 and ‘139 patents differ from the ‘283 patent is in how this immunization schedule calibration method is claimed.

In the ‘283 patent, this immunization schedule method is claimed simply as “immunizing” the mammals in the control group according to the immunization schedule and then “comparing” the “incidence, prevalence, frequency or severity of [the] chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.”  (As my patent attorney brother Mark has astutely observed, how the method is claimed in the ‘283 patent leaves much to be desired because it never says what “end result” is caused by this claimed method).  By contrast, the ‘739 and ‘139 patents start out similarly to the ‘283 patent in defining the claimed method initially as “screening a plurality of immunization schedules” by “identifying” first and second groups of mammals, “immunizing” the first and second groups by different immunization schedules, and then “comparing” the effectiveness of the different immunization schedules.  But where the claimed methods of the ‘739 and ‘139 patents part company with the ‘283 patent is in an additional “immunization” step which is carried out on a “subject” by using the “lower risk” immunization schedule (characterized by the majority opinion as the “optimum schedule”) that resulted from the initial “screening” step.  (Or to use my brother Mark’s words, we now have an “end result” caused by the “immunization” step of the method claimed in the ‘739 and ‘139 patents.)

Fortunately for us, Judge Newman’s majority opinion digs into the language of claims of the three patents.  Judge Newman especially noted the significant difference between what was claimed in the ‘739 and ‘139 patents, versus what was claimed in the ‘283 patent.  As Judge Newman astutely observed, the ‘283 claims of the patent “stand[] in contrast the ’139 and ’739 patent claims, which include the subsequent step of immunization on an optimum schedule.”  With that significant difference in mind, Judge Newman’s opinion ruled that the ’139 and ’739 patent claims passed the “threshold inquiry” for patent-eligibility under 35 U.S.C. §101, while those of the ‘283 patent did not.

In the verbiage of Judge Newman’s opinion for why the ’139 and ’739 patent claims passed the “threshold inquiry,” while those of the ‘283 patent did not, resides the following “kernel of truth”:  “The ‘283 [patent] do not include putting this knowledge [of immunization schedules] to practical use, but are directed to the abstract principle that variation in immunization schedules may have consequences for certain diseases” (emphasis added).  In fact, Judge Newman’s opinion is almost prescient in pointing to the “immunization” step for why the claims in the ‘139 patent and the ‘739 patent made the patent-eligibility grade under, while those of the ’283 patent did not.  (Newman also very carefully noted that these claims in the ’139 and ’739 patents “may not meet the substantive criteria of patentability as set forth in [35 U.S.C.] § 102, § 103, and § 112”).

So why is this reasoning in Judge Newman’s opinion so prescient?  Because it does not rely (at least not primarily) on the now doomed “transformative” step reasoning of the Federal Circuit remand decision that was reversed in Mayo Collaborative Services.  We are also no longer talking strictly about some “abstract idea,” “natural phenomena,” or a “law of nature” (to use the mumbo-jumbo of Mayo Collaborative Services).  Instead, using the words of Newman’s opinion, we’re talking about a “flesh and blood” method that puts the “knowledge” gained into a patent-eligible claim format that causes a real world “practical use.”  That makes the mumbo-jumbo “law of nature” reasoning of Mayo Collaborative Services completely inapplicable (and therefore distinguishable) with respect to the “immunization” step claims of Classen’s ’139 and ’739 patents, and any other method or process claims that are crafted to achieve a “useful result” like these “immunization” step claims.  (Sorry Justice Breyer, the “draftsman’s art” does matter.)

The “additional views’ opinion authored by Chief Judge Rader (also joined by Judge Newman) in the Classen remand is likely now “dead letter” (to also use Justice Breyer’s words with regard to the suggested approach by the U.S. Solicitor General in Mayo Collaborative Services.)  But the primary views and approach expressed in Judge Newman’s opinion about focusing on whether the claimed method or process achieves a real world, “useful result,” point the way forward to rendering any degree of objective and rational “order” out of the confused, conflicting, and illogical mumbo-jumbo reasoning expressed in Mayo Collaborative Services in determining patent-eligibility under 35 U.S.C. § 101.  If you want to refer to this approach as resurrecting the currently discarded “tangible, concrete, and useful result” (TCU) test, so be it.  (And please do remember that 35 U.S.C. § 101 does refer to the need for the invention to be “useful.”)  We could do far better relying upon an objective test like TCU (or whatever you want call Judge Newman’s primary approach in the Classen remand), then trying to divine, like a Ouija board, how to apply the mumbo-jumbo reasoning expressed in Mayo Collaborative Services.

*© 2011 Eric W. Guttag.  Posted March 30, 2012 on IPWatchdog.com

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12 comments so far.

  • [Avatar for EG]
    EG
    April 2, 2012 01:20 pm

    “There is no excuse for the Supreme Court’s ineptitude in construing the claims of Prometheus’s patent.”

    SB,

    You’re “speaking to the choir” so to speak (me included). What I’m trying to do here is provide a way forward that the Federal Circuit can potentially buy into, and essentially minimize the impact Mayo Collaborative Services. At this point, it’s important to tell the Federal Circuit how they can get this Mayo Collaborative Services “genie” back in the bottle so it creates as little “collateral damage” as possible. I recognize that what we’ve got for reasoning (if you can call it that) in Mayo Collaborative Services is atrocious, but if we can give the Federal Circuit a plausible and logical way forward for distinguishing Mayo Collaborative Services, we diminish it’s impact greatly. Or to put it in your terms I’m putting my “emotional rage” in aside, and looking for how to keep this Mayo Collaborative Services decision from turning into a complete patent law debacle.

  • [Avatar for step back]
    step back
    April 2, 2012 12:19 pm

    EG,

    There is no excuse for the Supreme Court’s ineptitude in construing the claims of Prometheus’s patent.

    T o a person actually skilled in the pertinent art, “determining” (in Prome’s Claim 1) cannot rationally and reasonably mean: using only on’e human mental facilities to conjure up, perhaps with aid of animal entrails or a Ouija Board, what the concentration is of a specific metabolite in a specific patient.

    The Supreme Court’s claim construction is wholly unreasonable and demonstrative of their lack of competence in areas of law that intermix with real science. We’ve seen this incompetence rear its ugly head in Benson, then in Bilski, now in Mayo v. Prome and probably soon in Myriad. (Welcome to the Idiocracy. Drink your Brawndo, it’s got electrolytes.)

  • [Avatar for Non Sequitur II]
    Non Sequitur II
    April 2, 2012 12:16 pm

    EG,

    I’m not disagreeing with you, but one thing to keep in mind is why Prometheus was fighting so hard for the claims at issue. There are lots of ways to make those claims patentable, including your suggestion. The problem is that Prometheus needed to cover the “metabolite test” without use of the results. That is why a doctor thinking about the test results with knowledge of the optimal range would have infringed the claim. Assuming that updating a “drug dosage calibration schedule” is sufficient to establish patentability, that would not have reached Prometheus’ intended target.

    I think it would have been relatively easy to draft 101 patentable claims for Prometheus. However, some commentators suggest that almost nothing is patentable after Prometheus. That just isn’t true.

  • [Avatar for EG]
    EG
    April 2, 2012 10:31 am

    To all:

    After thinking through how Prometheus’ claimed method might have been written to pass patent-eligibility muster under 35 USC 101, here’s what I’ve come up with as an initial attempt:

    A method comprising the following steps:

    (a) measuring the level of 6-thioguanine or 6-methylmercaptopurine in a [blood sample] taken from a subject administered a 6-thiopurine drug selected from the group consisting of 6-mercaptopurine, azathiopurine, 6-thioguanine, and 6-methyl-mercaptoriboside, wherein the subject has an immune-mediated gastrointestinal disorder being treated by administration of the 6-thiopurine drug; and

    (b) comparing the level of 6-thioguanine or 6-methylmercaptopurine measured in the [blood sample] to a [drug dosage calibration schedule] for optimizing therapeutic efficacy and reducing toxicity associated with treatment of the subject with the 6-thiopurine drug, wherein a measured level of 6-thioguanine of less than about 230 pmol per 8 x 10 [to the eight power] red blood cells according to the [drug dosage calibration schedule] indicates a need to increase the dosage of the 6-thiopurine drug [by a certain amount] to optimize therapeutic efficacy, and wherein a measured level of 6-thioguanine greater than about 400 pmol per 8 x 10 [to the eight power] red blood cells or a measured level of 6-methylmercaptopurine greater than about 7000 pmol per 8 x 10 [to the eight power] red blood cells according to the [drug dosage calibration schedule] indicates a need to decrease the dosage of the 6-thiopurine drug [by a certain amount] to reduce toxicity.

    The bracketed language in my proposed claim indicates a suggested descriptor (i.e., for “blood sample” or “drug dosage calibration schedule”), an amount of the drug (i.e., “a certain amount”) to be increased or decreased that I can’t currently specify, and denoting the power (i.e., “10 to the eighth”) that the formatting doesn’t allow me to do in this comment. Please note that i’ve moved the preamble langugage to the body of the claim: that’s very important so that this preamble language becomes part of the claimed method (the comparing step) and doesn’t get simply treated as an irrelevant statement of “intended use.” By noting that we’re basing the measurements on a “blood sample,” we’ve taken this measurement out of the theoretical and into the “real world”; the same goes for the “comparing step” which takes the “real world” measured metabolite values, compares them to a predetermined “drug dosage calibration schedule” that tells you, based on the measured metabolites, to increase the drug dosage by a “certain amount” if the metabolite level is below that specified by the “drug dosage calibration schedule” in optimize therapeutic efficacy of the treatment, and to decrease the drug dosage by a “certain amount” if the metabolite level is above that specified by the “drug dosage calibration schedule” in reduce toxicity of the treatment. In other words, the measured metabolite levels are directly tied to the “drug dosage calibration schedule” to achieve a “real world” useful result, namely how to optimize therapeutic efficacy of the drug treatment without causing undesired toxicity (and avoids the potential weakness in the LabCorp v Metabolite claim where the “comparision step” simply leaves you hanging as to what to do with that comparison). If my proposed claim or something similar can’t pass muster in view of Mayo, it’s hard to imagine how such subject matter can be claimed to make the grade under 35 USC 101.

  • [Avatar for EG]
    EG
    April 2, 2012 09:02 am

    To SB and the rest:

    Here are the two claims (one method, one appartus) discussed in Arrythmia:

    A method for analyzing electrocardiograph signals to determine the presence or absence of a predetermined level of high frequency energy in the late QRS signal, comprising the steps of:
    converting a series of QRS signals to time segments, each segment having a digital value equivalent to the analog value of said signals at said time;
    applying a portion of said time segments in reverse time order to high pass filter means;
    determining an arithmetic value of the amplitude of the output of said filter; and
    comparing said value with said predetermined level.

    Apparatus for analyzing electrocardiograph signals to determine the level of high frequency energy in the late QRS signal comprising:
    means for converting X, Y, and Z lead electrocardiographic input signals to digital valued time segments; means for examining said X, Y, and Z digital valued time segments and selecting therefrom
    the QRS waveform portions thereof;
    means for signal averaging a multiplicity of said selected QRS waveforms for each of said X, Y, and
    Z inputs and providing composite, digital X, Y, and Z QRS waveforms;
    high pass filter means;
    means for applying to said filter means, in
    reverse time order, the anterior portion of each said digital X, Y,
    and Z waveform; and
    means for comparing the output of said filter means with a predetermined level [to obtain an indication of the
    presence of a high frequency, low level, energy component in the filter output of said anterior portions].

    You would think (and hope) the Arrhythmia apparatus claim would still pass muster under 35 USC 101. What this apparatus essentially does is essentially manipulate and analyze electronic signals using essentially electronic components (means) for doing so. This apparatus is certainly not executable by using merely “mental steps.” This apparatus certainly achieves a useful resutl (see language that I’ve bracketed).

    The Arrhythmia method claim, as currently written, is a different story. The last two steps in the claimed Arrhythmia method (determining and comparing) are very reminiscient of the method in LabCorp v. Metabolite. In view of Mayo, I doubt that the Arrhythmia method claim, as currently written, would survive a patent-eligibility challenge under 35 USC 101. But if you added the bracketed from the apparatus claim to the “comparing step” of the method claim, you might have a fighting chance that this method would also survive under 35 USC 101 because you’re obtaining a “useful result” in terms of analyzing the electrocardigraphi signal and identfiying the key component of that signal, i.e., the “the
    presence of a high frequency, low level, energy component in the filter output of said anterior portions.”

    My initial thoughts on the patent-eligibility of the subject matter in Arrhythmia in view of Mayo..

  • [Avatar for step back]
    step back
    April 1, 2012 02:19 am

    Arrhythmia Research Technology, Inc. v. Corazonix Corp.

    See this IP WatchDog post:
    http://ipwatchdog.com/2009/04/01/history-of-software-patents-arrhythmia-research/id=2399/

    “directed to the analysis of electrocardiographic signals in order to determine certain characteristics of heart function. In essence, the invention was a monitoring device. “

  • [Avatar for EG]
    EG
    March 31, 2012 12:11 pm

    SB,

    I would hope that something like your suggested (1) and (2) would make the grade. What I was referring to with my statement was that reasoning in Mayo appears to difficulty for analytical and dagnostic methods in general, and not necessarily specific embodiments of such methods.

    The problem we currently have is that Mayo provides us with useless, rudderless guide for evaluating the patent-eligibility of methods and processes. All we know now is that Prometheus’ claimed method didn’t make the grade using reasoning that is absolutely dreadful. What we needed (but got no help on) is what analytical and diagnostic methods could/might make the grade.

    We’re frankly presented with same ambiguous situation that occurred after Bilski. What the Federal Circuit has done (not always clear reasoning) in specific cases is tell us what specific methods will or won’t make the grade; from those we then have to distill out some principles (frequently more than one) for what future method/process claims will (or won’t) make the grade.

    The Classen remand opinion by Newman would at least give us a start in the analytical/diagnostic methods area. We can thin inch forward, case by case, to develop some helpful criteria for determining how analytical/diagnostic methods can be claimed and make the patent-eligibility grade. I won’t be a quick process, but it’ll at least get us moving in the right direction.

    I do remember Arrhythmia, but I don’t exactly recall what the claimed invention was that was involved and what it said. Can you enlighten us?

  • [Avatar for step back]
    step back
    March 30, 2012 07:43 pm

    The trouble with most analytical/diagnostic methods is that they’re most valuable for the numbers/data they generate, and the reasoning in Mayo Collaborative Services is particularly hostile to such number/data generating methods.

    @EG

    Whoha, let’s slow down and step back on that one.

    (1) If I take the probes of a digital voltmeter and apply them to two circuit nodes, the “number” that appears on the voltmeter screen tells me the physical voltage between the two points. It is not a piece of “abstract” information, but rather physical reality. Is the SCt ready to say that a voltmeter, which is physical apparatus, is not patent eligible?

    (2) If I’m a doctor and I take an ultrasound device having a digital readout and aim the ultrasound beam at the patient’s heart (at one of her valves) and the readout gives me Doppler effect data such as the rate (or better yet the acceleration) at which the valve is closing, that is not a piece of “abstract” information, but rather physical reality.
    Does anyone out there still remember the CAFC Arrhythmia case? Is it not still good and valid law?

  • [Avatar for Steve M]
    Steve M
    March 30, 2012 06:17 pm

    “I would hope we could come up with some claim format that would clearly get these analytical/diagnostic methods at least over the patent-eligibility hump under 35 USC 101 . . .”

    Agree EG.

    I vote that such a claim format (in keeping with Jepson & Beauregard claims) be christened:

    Mayo Claims

    Thanks for the great articles and analysis.

    Appreciate all your time and effort.

  • [Avatar for EG]
    EG
    March 30, 2012 04:08 pm

    MBT,

    Thanks for saying I brought up “some good points.” Believe me, after getting over my “emotional rage” (as step back rightly calls it), I looked around for a different “horse” that we (and more importantly, Federal Circuit) might be able to “ride” so that Mayo Collaborative Services doesn’t get spun completely out of control. That happened when I looked at the Classen remand decision, which I had forgotten about, even wondering whether there was remand decision which is why I looked for it on my computer and found it. Until I find a better “horse,” that’s the one I would ride, and one that will also get traction with the Chief Judge. Frankly, the Federal Circuit is in a battle to avoid being completely marginalized on such fundamental patent law issues such as patent-eligibility under 35 USC 101, and I believe that Rader has the will and the desire (he’s expressed it conferences) to keep the Federal Circuit from being little than a “figurehead” on such fundamental patent law issues, a Congress mandated province of the Federal Circuit which I believe the Supreme Court has unnecessarily and relentlessly undermined for reasons I cannot even fathom.

    What’s even worse (and why patent practitioners like me get very “upset”) is that the Supreme Court not only denigrates what we do (calling derisively what we do the “draftsman’s art”), but does so while exhibiting an uninformed and incorrect understanding of what even basic patent claim terminology means (calling “wherein clauses” method steps?). How can you expect the patent bar to respect a decision that doesn’t even get the basics right? What the Supreme Court does in this regard is highly embarrassing and extremely hard to explain to clients who actually know better than the Supreme Court what patents are.

    I really wished I didn’t have to write all this verbiage based on my “emotional rage” I don’t get my jollies from this, but instead sleepless nights trying to figure out “where do we go from here”? I would have much rather seen Breyer go the route I’ve suggested in several comments (the Bilski “abstraction” route) and then either provide some specifical hypothetical claims that make the grade, or perhaps point to some existing patents like the ‘097 patent I keep pointing too. If that had happened, most of the patent bar (including me) would have been “cheering” the Supreme Court for giving us understandable guidance on patent-eligibility, instead of now saddling us with two different precidents that go in diametrically opposed directions on the same patent-eligiblity issue.

    SB,

    You would hope that what you suggested (a machine-implemented step that determines the level of metabolites) would help this analytical method make the patent-eligibility grade. The trouble with most analytical/diagnostic methods is that they’re most valuable for the numbers/data they generate, and the reasoning in Mayo Collaborative Services is particularly hostile to such number/data generating methods. I would hope we could come up with some claim format that would clearly get these analytical/diagnostic methods at least over the patent-eligibility hump under 35 USC 101 and then leave it to 35 USC 102/103 as to whether they make it over the “prior art.” Definitely, thanks for the thoughts, and keeping thinking about what might make the patent-eligibility grade.

  • [Avatar for step back]
    step back
    March 30, 2012 03:12 pm

    EG,

    What do you think of claim drafting revision that says:

    1. A method comprising:
    yah da yah da
    “performing a substantially accurate and machine implemented determination as to what concentration of metabolite X is present in the subject’s bodily fluids”

    I wonder if the courts (and USPTO) can pooh pooh that away as “insignificant” activity?

    It is not a law of nature that one must use machine implemented determination. One could instead use their Ouija Board. They may not get an accurate determination, but the determination via Ouija Board is still a “determining” step if one is allowed to read the word “determining” as broadly and unreasonably as possible while standing in a vacuum.

  • [Avatar for MBT]
    MBT
    March 30, 2012 01:30 pm

    EG – you bring up some good points here – wait, did I say that? 🙂 I do think Classen has some traction for additional law (not sure that would be a good thing or not). I generally agree with Judge Newman, as I think she usually “gets it” with what the patent bar needs to function and what the business community needs in patent protection for their technologies. The biotech community sure has had a lot to chew on lately. However, like the Prometheus claims, we have an action (immunization or administering) couple with … well, not much except a hope of something that should happen – “determining” a drug level, “comparing” immunization levels, etc. All fatally-flawed claims. But alas, the devil is in the details as to how the courts handles them…