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