SmartGene, Inc. v. Advanced Biological Laboratories SA (D.D.C. 2012)

By James DeGiulio --

In an opinion issued only ten days after the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. ("Prometheus"), the District Court for the District of Columbia is believed to be the first to apply the Prometheus decision to invalidate diagnostic method patents.  In finding the claims-at-issue in two patents held by Advanced Biological Laboratories, SA ("ABL") to be directed to unpatentable subject matter, District Court Judge Beryl A. Howell provides an analysis under Prometheus, but also provides an invalidation analysis applying other tests, including the machine-or-transformation ("MOT") test.  While Prometheus is cited throughout Judge Howell's opinion, that case is treated more as a "guidepost" in applying previous tests, as are other touchstone decisions in Benson, Flook, Diehr, and Bilski.  By comparing and contrasting the claims at issue in these cases, as well as others from the Federal Circuit, Judge Howell provides an early roadmap for § 101 analysis, although at times it is unclear precisely what lends the ABL claims to one case rather than another.  However, what is clear from Prometheus according to Judge Howell is that the Supreme Court has fully endorsed the performing of a "threshold test" by the district court as to patentable subject matter, confirming that a ruling of unpatentable subject matter under § 101 is appropriate, and preferred, in total isolation from the other provisions of the Patent Act.

The dispute between SmartGene and ABL began in 2007 when ABL brought a patent infringement suit against SmartGene in the Eastern District of Texas.  That suit was dismissed for lack of personal jurisdiction in 2008, and within a month, SmartGene responded by filing the instant declaratory judgment suit, requesting a finding of non-infringement, invalidity, and unenforceability as to U.S. Patent Nos. 6,081,786 and 6,188,988.  In February 2009, the suit was stayed pending a series of six reexaminations, but restarted in October 2011, after the parties filed a joint motion to lift the stay.  SmartGene filed a motion for partial summary judgment in December 2011, alleging that the '786 and '988 patents encompassed patent ineligible subject matter under 35 U.S.C. § 101 and Bilksi v. Kappos.  A hearing on the pending motion, as well as claim construction, was held in March.

Both the '786 and '988 patents relate "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," as defined by the patentee.  Both patents are based on the same specification and disclosure, and relate to methods (i.e., processes) and systems for an interactive, computerized program for guiding the selection of therapeutic treatment regimens for a patient based on input provided by a physician.  Claim 1 of the '786 patent is representative of the subject matter at issue:

1.  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.

SmartGene contended that the '786 and '988 patents are directed to patent ineligible subject matter, and thus invalid, because they are directed to abstract ideas and mental processes, and fail the MOT test articulated in Bilski.  ABL responded that the claims at issue are not directed to an abstract idea, and while the MOT test is "not the sole test for patentability," the '786 and '988 patents satisfy that test.  In its opposition motion, ABL summarized the invention as follows:

Element (a) specifies that the physician provide patient information to the computing device which includes prior therapeutic treatment regimen information.  This information is then processed against a first knowledge base that contains different treatment regimens and a second knowledge base of expert rules.  The computing device then generates available treatments along with advisory information for those treatments.  By providing the patient information to the system and allowing interaction with the physician, the Patents describe how therapeutic treatment regimens can be listed with corresponding advisory information.

The patents also contain "system" claims, which ABL sought to have read as means-plus-function claims, in an effort to tie the claimed methods to the disclosed "computing device" structures in the specification.  Following ABL's claim construction, Judge Howell found (in a footnote) that the distinction between the claim type has no bearing on the standard of review for patentable subject matter, citing In re Meyer (CCPA 1982).

The legal standard section of the opinion cites only Supreme Court decisions weighing patentability under § 101, including Diehr, Bilski, Benson, and finally Prometheus.  Judge Howell latches onto the unpatentability of Einstein and Newton's theories, but closes the section with the policy justification that "too broad an interpretation of this exclusionary principle could eviscerate patent law.  For all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas."

Judge Howell takes a stepwise and comprehensive approach to evaluating the patentability of the claims under § 101, with the analysis comprising:  (A) examining § 101 as a "threshold" inquiry into patent validity; (B) reviewing Supreme Court caselaw "guideposts" on the subject of patent subject matter eligibility; (C) examining whether the '786 and '988 patents satisfy the MOT test; (D) determining whether the patents constitute eligible subject matter irrespective of the MOT test; and finally (E) examining the parties' claim construction proposals to inform its § 101 analysis.  According to the District Court, ABL's patent claims fail to show patentable subject matter under all five analyses.

As an initial matter, Judge Howell decided that it was appropriate to rule on the patentability of ABL's claims before first construing the claims.  In reaching this conclusion, Judge Howell noted the cases favoring this approach, including Bilski and CLS Bank v. Alice Corp. Pty. Ltd. (D.D.C. 2011), but also recognized the Federal Circuit's recent hostility toward the application of this "threshold" test in isolation by district courts, as embodied in MySpace and Classen.  Judge Howell found the answer in Prometheus, where the Supreme Court "explicitly rejected" the ability of §§ 102, 103, and 112 to provide any "screening function" with regard to the patentability of subject matter.  As such, she holds that "this Court treats the § 101 subject matter patentability inquiry as the threshold inquiry for patent validity."

Following the lead of Bilski and Prometheus, Judge Howell evaluates the Benson, Flook, and Diehr trilogy of opinions as "guideposts" provided by the Supreme Court in considering exceptions to patent subject matter eligibility under § 101.  After summarizing the relevant holdings from each case, Judge Howell provides her interpretation of the Prometheus Court, which "distilled the guideposts from its earlier section 101 cases" into warnings about "interpreting patent statutes in ways that make patent eligibility 'depend simply on the draftsman's art,'" "upholding patents that claim processes that too broadly preempt the use of a natural law," and the requirement of an "inventive concept" comprising other elements "sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself."

The "mental process" characteristics of the instant claims are determinative of unpatentable subject matter, according to Judge Howell.  She finds that the "patents-in-dispute do no more than describe just such an abstract mental process engaged in routinely, either entirely within a physician's mind, or potentially aided by other resources in the treatment of patients."  Judge Howell contrasts Diehr, stating that these claims "involves no 'transformation of an article' nor a 'step-by-step method for accomplishing such [transformation],'" instead noting similarities with Flook as a mere a recitation of abstract steps.  The District Court is seemingly most persuaded by the analogous case In re Meyer, where claims directed to gathering neurological testing data, imputing it into a computer, and using a formula to evaluate certain neurological functions were found to be an "attempt to patent a mathematical algorithm rather than a process for producing a product as in [Diehr]."  ABL could not distinguish its claims from Meyer, instead stating that the purpose of the invention is to provide a doctor with more information than the physician could have in his or her mind, leading the District Court to find these claims even more abstract than in Meyer, which "at least involved a mathematical algorithm."

The opinion proceeds to evaluate each step of the method in the context of precedent, as was done in Prometheus.  The District Court notes that all of the claim steps are typically conducted as mental steps by a doctor, including "guiding the selection of a therapeutic treatment regimen for a patient" (when a patient describes his/her ailments to the doctor), "providing patient information to a computing device comprising [three knowledge databases]" (documenting the patient's symptoms and medical history in a medical chart, and consulting literature), and "generating in said computing device a ranked listing of available therapeutic treatment regimens" (mentally evaluating the benefits and counter-indicators of each treatment option).  The last step, "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," is interpreted as a doctor generating a treatment plan for a patient.  Thus, the claim was found to add nothing to the process that doctors do not already regularly engage in mentally when evaluating and treating patients.  The District Court finally evaluates claim 1 as a whole, finding the four steps as abstract ideas that are commonly performed by medical professionals in evaluating, considering, and constructing treatment options for a patient presenting a specific medical condition.  Following Prometheus, the claim consists of "well understood, routine, conventional activity already engaged in by the scientific community," and is thus lacking the "inventive concept" required to transform unpatentable abstract ideas into patentable applications.

After finding ABL's claims unpatentable under Prometheus, the District Court confirms the unpatentability of the claims under the MOT test.  Judge Howell addresses the Supreme Court's negative treatment of the MOT test in Prometheus, finding that it was only the "Federal Circuit's application of that test" that was rejected in Prometheus, not the test itself, and it remains a "useful investigative tool."  According to the District Court, to satisfy the MOT test under the Supreme Court's application, the "transformation" itself must require the claimed process.  The transformation in Prometheus, which satisfied the MOT test according to the Federal Circuit, transformed the human body (by thiopurine treatment) and the blood (by analyzing metabolite levels), but neither transformation required the claimed process, and thus was deemed "irrelevant" by the Supreme Court.  ABL's argument that its claims "transform the patient's body" suffer the same fate, and cannot be saved by reciting a generic "computing device."  The ABL "computing device" is not a "particular machine" with any specific programming or algorithms, and in no way limits the claims, leading to the conclusion that it is merely extra-solution activity.  The District Court finds that Federal Circuit case law such as Dealertrack and Cybersource "is clear that allowing a process to become patentable simply because it is computer aided and constitutes a practical application would render the subject-matter eligibility criteria contained in section 101 meaningless."

Finally, Judge Howell looks to the ABL's proposed construction for confirmation of her holdings.  Naturally, as the patentee, ABL seeks to have the claim terms construed as broadly as possible, including no limitations on terms such as "database," "patient information," and "knowledge base."  These constructions, akin to Benson, would yield a claim that was "so abstract and sweeping as to cover both known and unknown uses," and would thus foreclose innovation in this area if found valid.  Since ABL's motions and construction were filed before the Supreme Court's opinion in Prometheus was published, ABL's reliance upon the Federal Circuit's previous opinion could certainly explain the relative ease in which Judge Howell was able to find the claims unpatentable.  ABL became an easy target in its choice of claim constructions and characterizations that were effectively overruled by the Supreme Court, which made Judge Howell's ultimate decision much easier.  The patent community has now had some time to digest the "new" criteria from Prometheus, so it remains to be seen how claim construction arguments will be customized to avoid the pitfalls seen in SmartGene.  Regardless, since Prometheus (at least according to one judge) has granted total discretion to the district court to determine patentable subject matter under § 101, it is likely that challenges to subject matter patentability at the district court level will increase in frequency.

SmartGene, Inc. v. Advanced Biological Laboratories, SA (D.D.C. 2012)
Opinion by District Judge Beryl A. Howell

Comments

[EG]

James,

Nice summary of this case. 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 ruling of patent-ineligibility under 35 USC 101 is definitely supportable.

First, I wouldn't characterize ABL's claims as involving medical diagnostics. Instead, as the preamble says, what this method does is to aid in selection of a treatment regime for a patient based on 3 knowledge bases. In fact, I would view the ABL claims as more analogous to those in Bilski, rather than Mayo Collaborative Services.

Second, the only relevancy I see with regard to Mayo Collaborative Services is that patent-eligibility under 35 USC 101 is to be treated as a “threshold” inquiry for patent validity. (In my view, the ABL claims also present potential issues under 35 USC 112, first and second paragraphs.) While I, like others, have reservations to this approach to determining patent claim validity (including no objective standard provided by SCOTUS as to what is or is not an "abstract idea"), the one clear statement from Mayo Collaborative Services is that this is the approach to be taken from now on.

Third, the statement by Judge Howell that: "The Court may conduct a section 101 analysis before the Court conducts a formal construction of claims" I find very problematical. This statement is based on Ultramercial but Ultramercial found the claims patent-eligible under 35 USC 101 and was also based on patent-eligibility being a "coarse screen," not a "threshold" inquiry. Diehr wasn't overruled by Mayo Collaborative Services and Diehr virtually mandates that you must construe what the claim means to determine patent-eligibility under 35 USC 101. In fact, if you don't construe what the claim means before determining patent-eligibility under 35 USC 101, you not only violate what Diehr says, but you also violate at least the second paragraph of 35 USC 112 that the invention is defined by the claim for validity purposes.

Fourth, Judge Howell relies heavily upon In re Meyer, but the ABL claims are much closer to those in In re Grams (claims held patent-ineligible) which she cites only in passing. She also would have been well-advised to address and rely upon the primary holding in the Classen remand decision and not simply make reference to the "additional views" opinions by Newman and Rader. If I were ABL, I would make mention of that in any appeal they might make to the Federal Circuit as that is probably the only chance (and in my opinion, a slim one at that) they've got to gain reversal on the ruling under 35 USC 101.

Fifth, the two "generating steps" in the ABL claims are essentially equivalent to "data gathering" steps. As such, these "generating steps" in the ABL claims are very problematic now in reaching the patent-eligibility zone because they don't prescribe a particular course of treatment. And as Judge Howell correctly notes, these claims read too much like what a doctor might do without using a computer, bringing the "mental steps" doctrine into play. In fact, these ABL claims are in far more danger of being "preemptive" compared to Prometheus' claimed method in Mayo Collaborative Services. The holding in either In re Grams or with respect to the '283 patent claims which were held to the patent-ineligible in the Classen remand are likely to be difficult for these ABL claims to overcome in any appeal to the Federal Circuit.

[step back]

This comments section is too tight of a spot to explicate on why the SmartGenes decision arises from a judge (B. Howell) who is probably well meaning but suffers from the Technologically-Ignorant-Genes syndrome.

At one point, the court assumes (without supporting evidence) that computers operate just like the human brain operates. This step alone embraces two continents' worth of Technological-Ignorance: (1) How computers operate and (2) How the human brain operates.

What we are seeing from Mayo and its progeny is the extent to which Technological-Ignorance is pandemic within the judicial system. Sigh.

[Morton Tavel]

Pardon me for flogging my own pet (and dead) horse. How ironic it is for Einstein to become a poster child for unpatentability. He who began his career working in the Swiss patent office. If we are to take Einstein and Newton as exemplars of natural law, then how to explain that they are in conflict? Newton's law of universal gravitation is in conflict with Einstein's general relativity. Newton's three laws of motion are also not "natural laws," because they are valid only in inertial coordinate systems, which do not exist "naturally" in nature. I guess I would grant patentability to both Newton and Einstein because their laws are incredibly useful products of the human mind.

Morton Tavel, PhD (Physics)