Divining What Mayo Means: Exploring the SmartGene Case*
|Written by Eric W. Guttag
Eric W. Guttag IP Law Office
Posted: April 13, 2012 @ 1:47 pm
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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