Divining What Mayo Means: Exploring the SmartGene Case*

Trying to divine what Mayo Collaborative Services v. Prometheus Laboratories, Inc. means for the future in judging the patent-eligibility of claimed methods and processes under 35 U.S.C. § 101 is like using a Ouija board. See The Way Forward from Mayo Collaborative Services is through the Classen Immunotherapies Remand.  The first inkling came 10 days after Mayo Collaborative Services in a motion for partial summary judgment in SmartGene, Inc. v. Advanced Biological Laboratories, SA, a case from the District Court of Columbia. When I first read this case, my initial reaction was “oh no, here comes the collateral damage we feared would come from Mayo Collaborative Services.” But having reflected on this case some more, and especially the claims involved, I think Judge Howell’s ultimate conclusion of patent-ineligibility of the claimed process and system under 35 U.S.C. § 101 is defendable. Even so, the reasoning expressed in Judge Howell’s opinion for reaching that conclusion gives pause for concern about the impact of Mayo Collaborative Services on rendering consistent and objective determinations of patent-eligibility under 35 U.S.C. § 101.

SmartGene was filed as a declaratory judgment action by SmartGene, seeking invalidity, unenforceability, and non-infringement of Advanced Biological Laboratories (ABL’s) U.S. Pat. No. 6,081,786 (the “’786 patent”) and U.S. Pat. No. 6,188,988 (the “’988 patent”). After prolonged litigation (including a stay of proceedings of two and a half years), SmartGene filed a motion for partial summary judgment, asserting that the ‘786 and ‘988 patents were invalid under 35 U.S.C. § 101. Both of these patents related to a system, method, and computer program for guiding the selection of therapeutic treatment regimens for complex disorders by ranking available treatment regimens and providing advisory information.

Claim 1 of the ‘786 patent is representative:

A method for guiding the selection of a therapeutic treatment regimen for a patient with a known disease or medical condition, said method comprising:

(a) providing patient information to a computing device comprising:

a first knowledge base comprising a plurality of different therapeutic treatment regimens for said disease or medical condition;

a second knowledge base comprising a plurality of expert rules for evaluating and selecting a therapeutic treatment regimen for said disease or medical condition;

a third knowledge base comprising advisory information useful for the treatment of a patient with different constituents of said different therapeutic treatment regimens; and

(b) generating in said computing device a ranked listing of available therapeutic treatment regimens for said patient; and

(c) generating in said computing device advisory information for one or more therapeutic treatment regimens in said ranked listing based on said patient information and said expert rules.

Here are my initial observations about Claim 1 from the ‘786 patent. First, I wouldn’t characterize ABL’s claimed method as involving medical diagnostics. Instead, as the preamble of Claim 1 of the ‘786 patent says, what this method supposedly does is aid in selection of a treatment regime for a patient based on three knowledge bases. In fact, I would view the ABL claims as more analogous to those in Bilski v. Kappos (method for managing/hedging risks associated with trading commodities sold at fixed price), rather than those in Mayo Collaborative Services (drug dosage calibration method). (For this reason, I’ve even saved the SmartGene case in my case law folder entitled Business Methods.

Second, in my opinion, Claim 1 of the ‘786 patent may also present potential issues under 35 U.S.C. § 112, first and second paragraphs. I’ve underlined above several terms in the Claim 1 which may be problematical in terms of what those terms mean, as well as the potential scope that those terms cover which may (or may not) be “enabled” by the patent specification. Also, the “interaction” between the three knowledge bases and the two “generating steps” is relatively vague and amorphous. In addition, “preemption” of the O’Reilly v. Morse type (which is really an issue of “enablement” under 35 U.S.C. § 112, first paragraph, not a patent-eligibility issue under 35 U.S.C. § 101 as it is too often characterized) looms fairly large in Claim 1 of the ‘786 patent. In fact, Claim 1 is in far more danger of being “preemptive” compared to Prometheus’ claimed drug dosage calibration method in Mayo Collaborative Services.

Third, the two “generating steps” in Claim 1 of the ‘786 patent are essentially equivalent to “data gathering” steps that have been frowned upon by both Supreme Court and Federal Circuit cases. As such, these “generating steps” in the in Claim 1 of the ‘786 patent are very problematic now in reaching the patent-eligibility zone, especially because they don’t prescribe a particular course of treatment to use. Put differently, it’s unclear exactly what has been “transformed” by this claimed method.

Fourth, as Judge Howell correctly notes, Claim 1 of the ‘786 patent reads too much like what a doctor might do without using a computer. That brings the “mental steps” doctrine clearly into play. In fact, the reference to doing the claimed steps in a “computing device” is the only thing that separates the method in Claim 1 of the ‘786 patent from being done (potentially using pencil and paper) solely by the doctor without any mechanical assistance, including that from a computer.

With my initial observations in mind, let’s now proceed to how Judge Howell evaluated ABL’s claimed method and system under 35 U.S.C. § 101. Judge Howell states that “[t]he determination of whether a claimed invention is invalid for lack of subject matter patentability under 35 U.S.C. § 101 is a ‘threshold inquiry’ and a matter of law,” first citing Bilski, and later stating that Mayo Collaborative Services “clarified that a 35 U.S.C. § 101 subject matter patentability inquiry is the threshold analysis for determining patent validity.” In fact, the only relevancy in Mayo Collaborative Services I see for SmartGene is that patent-eligibility under 35 U.S.C. § 101 is to be treated as the “threshold inquiry” for patent validity. While I, like others (including the U.S. Solicitor General), have reservations about this “threshold inquiry” approach for determining patent claim validity (including no objective standard provided by the Supreme Court as to what is or is not merely a “law of nature,” “natural phenomena,” or an “abstract idea”), the one clear statement from Mayo Collaborative Services is that this “threshold inquiry” approach is the one to use from now on.

Judge Howell also states that: “The Court may conduct a section 101 analysis before the Court conducts a formal construction of claims,” citing the Federal Circuit’s 2011 Ultramercial, LLC v. Hulu decision. I find this statement by Judge Howell to be very problematical, including the fact that Ultramercial found the claims patent-eligible under 35 U.S.C. § 101. More significantly, Ultramercial also treated patent-eligibility under 35 U.S.C. § 101 as being a “coarse screen,” not a “threshold inquiry” as now mandated by Mayo Collaborative Services. In addition, let’s not forget that Diamond v. Diehr wasn’t overruled by Mayo Collaborative Services. As I’ve noted previously, there’s paragraph in Diehr (overlooked by Justice Breyer in Mayo Collaborative Services) that virtually mandates that you must construe what the claim means “as a whole” to determine patent-eligibility under 35 U.S.C. § 101. See Selective Precedent Amnesia: The Nonsensical Reasoning in the Supreme Court’s Mayo Collaborative Services Decision Part 3 In fact, with patent-eligibility now being a “threshold inquiry,” if you don’t construe what the claim means before determining patent-eligibility under 35 U.S.C. § 101, you not only violate what Diehr essentially says you need to do first, but you’re also in conflict with at least the second paragraph of 35 U.S.C. § 112 that the invention is defined by the claim for validity purposes. Fortunately, in spite of this statement, Judge Howell did analyze Claim 1 of the ‘786 patent “as a whole” and in compliance with Diehr.

Judge Howell then reviewed the “trilogy” of Gottschalk v. Benson, Parker v. Flook, and Diehr and characterized these cases as providing “useful ‘guideposts’ when considering exceptions to patent subject matter eligibility under 35 U.S.C. § 101.” That Judge Howell followed this path isn’t surprising, given that Justice Breyer’s opinion in Mayo Collaborative Services also followed this path. Unfortunately, as I’ve explained previously, this “trilogy” path, as well as the “guideposts,” are strewn with many boulders (and inconsistencies), thus creating a jurisprudential “quagmire” that makes patent-eligibility determinations under 35 U.S.C. § 101 even more Ouija board-like. See Eviscerating Patent-Eligibility of Drug Testing Methods: The Nonsensical Reasoning in the SCOTUS Prometheus Decision. Even worse, Judge Howell concludes by saying that the Supreme Court in Mayo Collaborative Services distilled these “guideposts” into “warnings,” including that unfortunate statement about “interpreting patent statutes in ways that make patent eligibility ‘depend simply on the draftsman’s art’ without reference to the ‘principles underlying the prohibition against patents for [natural laws].’” (I frankly wish the judges and Justices would “cease and desist” from endlessly denigrating the “draftman’s art” we patent practitioners employ.)

Judge Howell next analyzes the method of Claim 1 of the ‘786 patent and found it to be essentially a patent-ineligible “abstract idea” and/or “mental step.” In this analysis, Judge Howell relies heavily upon the 1982 CCPA case of In re Meyer and even says that Claim 1 is “analogous to the claim” in the Meyer case (for process and an apparatus process for gathering neurological testing data, imputing it into a computer, and using a formula to infer whether certain neurological elements are functioning). Actually, Claim 1 is much closer to the claims in the 1989 Federal Circuit case of In re Grams (claimed method for diagnosing an abnormal condition in an individual held patent-ineligible) which Judge Howell cites only in passing. Judge Howell would have also have been well-advised to address and perhaps even rely upon the primary holding in the remand decision in Classen Immunotherapies, Inc. v. Biogen IDEC, and not simply make reference to the no longer relevant “additional views” opinions by Judge Newman and Chief Judge Rader. See The Way Forward from Mayo Collaborative Services is through the Classen Immunotherapies Remand. If I were ABL, I would certainly make mention of this omission by Judge Howell to consider the primary holding in the Classen remand decision in any appeal that ABL might make to the Federal Circuit as it is probably the only chance (and in my opinion, a slim one at that) they’ve got to gain reversal on this ruling by Judge Howell under 35 U.S.C. § 101.

Based on my third and fourth observations above about Claim 1 of the ‘786 patent, I’m not surprised that Judge Howell considered this claim to be a patent-ineligible “abstract idea,” as well as involving essentially “mental steps” (once you strip out the “computer device” language). Based on these observations, I’m also not surprised that Claim 1 failed to pass muster under the ill-fated “machine or transformation” (MOT) test, which the Supreme Court pays, at most, lip-service to, including in Mayo Collaborative Services. Under current Federal Circuit precedent, Judge Howell correctly stated that a method which is “computer-aided” like Claim 1 does not necessarily pass the MOT test, citing the 2012 Federal Circuit case of Dealertrack, Inc. v. Huber, as well as the 2011 Federal Circuit case of CyberSource Corp. v. Retail Decisions, Inc.

Again, Judge Howell’s ruling in SmartGene that Claim 1 of the ‘786 patent failed to make the patent-eligibility grade under 35 U.S.C. § 101 doesn’t bother (or surprise) me as much as the path she took to get there. Admittedly, Judge Howell had the unenviable task of being the first to try to render some order out the chaos created by Mayo Collaborative Services (including the less than illuminating “guideposts” in the Benson-Flook-Diehr “trilogy”), as well as trying to reconcile the holdings in Ultramercial, Dealertrack, and CyberSource involving different Federal Circuit panels that don’t approach the patent-eligibility question under 35 U.S.C. § 101 in necessarily the same way. My expectation is that Judge Howell’s ruling under 35 U.S.C. § 101 in the SmartGene case will eventually wend its way up to the Federal Circuit. Meanwhile, the Federal Circuit may provide some clues on how Mayo Collaborative Services will be applied to patent-eligibility issues under 35 U.S.C. § 101 in the remand of the AMP v. USPTO case. See Chakrabarty Controls on Isolated DNA Sequences, not Mayo Until then, I would suggest keeping that Ouija board handy.

*© 2012 Eric W. Guttag. Posted April 13, 2012 on IPWatchdog.com

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21 comments so far.

  • [Avatar for patent litigation]
    patent litigation
    April 20, 2012 11:26 am

    Likely it’s taboo for me to say this on a blog for patent lawyers, but I’m glad the Supreme Court ruled as it did in Prometheus. It will be interesting to see how the Myriad patent litigation fares in light of the high court’s ruling.
    http://www.aminn.org/patent-legislation

  • [Avatar for EG]
    EG
    April 19, 2012 10:56 am

    “What I was saying, and again only for 101 purposes, is that a computer loaded with the stated 3 expert knowledge base systems is a ‘particular’ machine. Therefore the method claim IS TIED to a ‘particular’ machine.”

    Not necessarily disagreeing with you SB that that should have been enough pre-Mayo. But post-Mayo, we’ll need to do more in such claims until we get clearer guidance from the Federal Circuit (I’m not holding my breath that we’ll get any sensible guidance from SCOTUS) on what will pass muster under 35 USC 101. My proposed rewrite of the SmartGene claim was simply a suggestion as how much more we might need to do now. But do keep that Ouija board handy anyway.

  • [Avatar for Blind Dogma]
    Blind Dogma
    April 16, 2012 09:51 pm

    The MOT test is fully met. Period.

    Alas poor Yorick!, MOT is not sufficient.

    Witness the feeding on the gall bladder of Prometheus.

  • [Avatar for step back]
    step back
    April 16, 2012 09:02 pm

    EG,

    A problem with forums like this one is that, the minute you stand up for a claim on 101 grounds, people start assuming that you are behind the claim for all other grounds, 112, 102 and 103.

    Not true.

    I never said that the SmartGene claim was a golden model for all purposes. I have not read the spec or analyzed in detail the legitimate claim constructions for all terms used in the claim.

    What I was saying, and again only for 101 purposes, is that a computer loaded with the stated 3 expert knowledge base systems is a “particular” machine. Therefore the method claim IS TIED to a “particular” machine.

    Also you have a transformation at least because a sorted list is generated that wasn’t there before. If I start with a ball of yarn and then I re-organize the thing into a knitted ski cap, I have “transformed” the thing into a reorganized length of yarn. A sorted list is also a transformed physical thing. The MOT test is fully met. Period.

  • [Avatar for EG]
    EG
    April 16, 2012 05:16 pm

    SB,

    Sorry moved too quickly. A cleaned up version of my rewrite:

    A method comprising the following steps:

    providing an electronic database comprising the [first, second and third knowledge bases];

    electronically generating a ranked listing of available therapeutic treatment regimens for said patient by electronically manipulating one or more of the knowledge bases in the electronic database; and

    electronically generating a set of advisory information for one or more therapeutic treatment regimens in said ranked listing by electronically manipulating the patient information and said expert rules to thereby guide the selection of a therapeutic treatment regimen for a patient with a known disease or medical condition.

  • [Avatar for EG]
    EG
    April 16, 2012 05:13 pm

    SB,

    Another thought I neglected to include is that it might have helped to incorporate the preamble language into the body of the claim. For example, here’s how I might rewrite Claim 1:

    A method comprising the following steps:

    providing an electronic database comprising the [first, second and third knowledge bases;

    a first knowledge base comprising a plurality of different therapeutic treatment regimens for said disease or medical condition;

    a second knowledge base comprising a plurality of expert rules for evaluating and selecting a therapeutic treatment regimen for said disease or medical condition;

    a third knowledge base comprising advisory information useful for the treatment of a patient with different constituents of said different therapeutic treatment regimens;

    electronically generating a ranked listing of available therapeutic treatment regimens for said patient by electronically manipulating one or more of the knowledge bases in the electronic database; and

    electronically generating a set of advisory information for one or more therapeutic treatment regimens in said ranked listing by electronically manipulating the patient information and said expert rules to thereby guide the selection of a therapeutic treatment regimen for a patient with a known disease or medical condition.

    My proposed rewrite may require some more fiddling, but you at least get away from this method being able to be carried out by a doctor in his head as it require electronic manipulattion in at least two steps to get to the end result.

  • [Avatar for EG]
    EG
    April 16, 2012 04:51 pm

    SB,

    I hear you. But if the “knowledge base” containing the “expert rules” isn’t a “database” (like in electronic database), you could again collide with the “mental steps” doctrine. All I’m saying is that if we could have fleshed out Claim 1 of the ‘786 patent some more, including some more specific “interactions” between the “knowledge bases” and the ” generating steps,” recasting those “generating steps” to be less “data gathering”-like and more “manipulating” what was in the “knowledge bases,” and perhaps specifying that these “knowledge bases” were actually “electronic databases” (the “providing step” could be simply a manual input of those bases), the result might have been different. But my Ouija board still needs more cases before we might say that with greater certainty.

  • [Avatar for step back]
    step back
    April 16, 2012 04:38 pm

    EG,

    A “knowledge base” containing “expert rules” is not simply a “database”.

    It is all to tempting and easy to jump to conclusions when one has a little knowledge (the dangerous kind) but not enough to qualify as a true expert in the contested field of endeavor.

    http://en.wikipedia.org/wiki/Expert_system

  • [Avatar for EG]
    EG
    April 16, 2012 09:24 am

    Paul,

    I, like you, am surprised that no relevant prior art was turned up that either anticipated or rendered obvious this claimed method, including the one you mentioned. Do you by chance have the number for that patent?

  • [Avatar for Paul F. Morgan]
    Paul F. Morgan
    April 14, 2012 10:03 am

    Since this seems to be a broad claim to computer database electronically suggested appropriate treatments and/or pharmecuticals for a disease, I’m surprised a 103 search did not turn up at least a patent issued way back in about 1969-1971 to Lockheed Missiles and Space Co. for a development on that subject for the Kaiser Permanenti hospitals system. [A good idea, resisted by doctors for at least that long.] It even had light pen screen display selection system for doctors so that they did not even need to type on any keyboad.

  • [Avatar for Dale B. Halling]
    Dale B. Halling
    April 14, 2012 09:30 am

    EG,

    Yes, I figured that – I have absolutely no skills in that area.

  • [Avatar for EG]
    EG
    April 14, 2012 07:49 am

    Dale,

    SB does have some very good points. And my Ouija board on how patent-eligibility issues will be resolved in view of Mayo Collaborative Services certainly requires some more cases before it might become clearer.

    You technical points on what computers do with data in terms “transformation” is very well taken. The problem is that the courts at this point simply don’t buy it. Dealertrack and CyberSource also have held that simply including a computer in the claimed method won’t necessarily pass the MOT test. That’s why the MOT test is so problematic now.

    Right now, the patent-eligibility world of 35 USC 101 is a mess and SmartGene may be a foreboding of how bad it might get in this “far from perfect” world. Like you, I don’t like what I’m seeing so far, and I’ve got no confidence that Congress will do anything to change this “Alice in Wonderland” world of patent-eligibility until the situation gets critical. So we’ve got to look for Federal Circuit cases that will provide us a way out of the debacle created by Mayo Collaborative Services. And as I’ve said before, the Classen remand is the “horse” I’m currently “riding” to get us to a reliable patent-eligibility zone. In that regard, the remand in AMP v USPTO may tell us much about how good (or bad) this “Alice in Wonderland” world of patent-eligibility coud get.

  • [Avatar for step back]
    step back
    April 13, 2012 09:15 pm

    EG,

    IIRC, Judge Giles Rich spent his life’s career fighting against the “synergy” syndrome, with the 1952 Patent Act being the culmination of that lifes’ work.

    Alas, with our new crop of crafty and SmartGened justices; the “synergy” drone is back into our future, with a “genuinely” thick and “significant” layer of Mayo smeared on top of it. Great Scott!

    http://www.anewbandaday.com/2009/07/great-scott-marty-anbad-time-machine-is.html

    Note: “Synergy” requires something “more” than that which is to be expected by combining known elements for their known effects (see also KSR v. Teleflex)

  • [Avatar for Steve M]
    Steve M
    April 13, 2012 07:28 pm

    Meh … that’s actually an easy one … the smartest Gene is … Gene Quinn, of course!

  • [Avatar for Dale B. Halling]
    Dale B. Halling
    April 13, 2012 06:01 pm

    EG -Step back has some pretty good points to which I would add-
    Inputting data into a computer involves the transformation of the state of various transistors, uses energy to do so, and it is not just storing data-it is using data to give one a ranked list of treatment options. Clearly, the computer is transforming the input data into new information. So, they describe a device that does not exist separate from man, designed to solve an objective problem (namely, the ranking of therapeutic options and advisories based on patient information). Not having read the entire patent, it seems like an invention like this would cut down on human error in treatment paths.

  • [Avatar for EG]
    EG
    April 13, 2012 05:02 pm

    SB,

    Excellent sense of humor! I saw my dad argue two cases before Judge Rich, one when it was the CCPA, one when it was the Federal Circuit. As dad said, Rich was completely fair in asking unfair questions of both sides.

  • [Avatar for Blind Dogma]
    Blind Dogma
    April 13, 2012 05:00 pm

    ‘Drink Brando, It’s got electrolytes’

    Hey. I know I have been busy of late and not posting with my usual vim and vigor, but really, step back, you couldn’t throw me a product plug for my world famous Kool Aid?

  • [Avatar for step back]
    step back
    April 13, 2012 04:50 pm

    EG,

    Thanks.

    I talk to Giles Rich (deceased CCPA judge & author of ’52 Act) via my Ouija board.

    I talk to him all the time.

    Just like Doc Brown in Back to the Future talks to Einstein’s photo:
    ( http://www.hark.com/clips/jjmbnvscjj-1-dot-21-gigawatts )

    The Judge keeps asking me, “What could they (the modern judges) possibly be thinking?”
    My answers to him:
    “Two things, (1) ‘1.2 Jigga-whats’ and (2) ‘Drink Brando, It’s got electrolytes’ “.

  • [Avatar for EG]
    EG
    April 13, 2012 04:17 pm

    SB,

    I also forgot say again: keep that Ouija board handy.

  • [Avatar for EG]
    EG
    April 13, 2012 04:14 pm

    SB,

    Perhaps I am “jumping the gun,” but Claim 1 of the “786 patent is reminiscent to me of Bilski and especially In re Grams, as the “generating steps” are essentially “data gathering” steps. As I also point out, the “interaction” between the 3 knowlege bases and the “generating steps” is tenuous at best; again, where’s the “manipulation” or “transformation” in Claim 1? Howell’s opinion may not be a “model” (I especially don’t like her following the “trilogy” path and “guideposts”), but I also don’t think she “gets it wrong on every level,” especially given the “gobbledygook” she’s got to work with in Mayo Collaborative Services, and the three noted Federal Circuit decisions of Ultramercia, Dealertrack, and CyberSource that are very difficult to reconcile.

    These are “strange times” we live in regarding patent-eligibility under 35 USC 101, and Mayo Collaborative Services has created a “nightmare world” for us. We’ll also have to see how the Federal Circuit handles this SmartGene case on appeal. But I won’t be surprised if Howell’s patent-ineligibility ruling is affirmed on appeal. Claim 1 of the ‘786 patent has too much in common with the claims in Bilski and In re Gram, and the lack of “manipulation” or “transformation” in the claimed method is a “red flag” to me. As I’ve already said, structuring claims like those that survived in the Classen remand are the key to reaching the patent-eligibility zone.

  • [Avatar for step back]
    step back
    April 13, 2012 03:27 pm

    Eric,

    With due respect, I suggest you are jumping the gun and being too hasty in concluding that Judge Howell got the 101 question “right”.

    IIRC, the SmartGenes case has an ugly history including a repeated dragging of the patent owner through one reexamination after the next, apparently to the point where appeal to a court on 102/103 bases was no longer possible.

    Then again, claim 1 is not a model of clarity and an exposition of good claim drafting technique. The computer is pre-loaded with the 3 knowledge bases. Therefore it is not a “general purpose” computer (as if such a thing ever existed in the real world), but rather a “special purpose” computer and the method claim is therefore “tied” to a “special purpose” computer.

    Also by causing a generation within the computer of an ordered list, you are “transforming” the computer into a new state. So the claim clearly meets the MOT test.

    The only thing we have going on here is the treatment of inventors as second class citizens who don’t have rights under the ex-post facto law making prohibitions that apply to everybody else.

    Howell gets it wrong on every level, including giving the inventors fair treatment under traditional notions of justice and fair play.

    Maybe claim 1 fails under 112, but that was not argued to the court. I don’t see how claim 1 can rationally fail under 101. You’ve got tying to a “particular” machine and a physical transformation going on here. What more can you demand of the poor inventor (or more rightly, his patent counsel)?