The Software IP Report

Therapeutic Treatment Regimen Not Patent Eligible Despite Computer Implementation

By Charles Bieneman

Categories: Patent Eligibility, Software Patents, The Software IP Report

In a decision that was probably made easy by the Supreme Court’s recent Prometheus decision, a D.C. district court has invalidated, as patent ineligible under 35 U.S.C. § 101, patent claims that recite using a computer to recommend a therapeutic treatment regimen.  SmartGene, Inc. v. Advanced Biological Laboratories, SA, No. 08-00642 (D. D.C. March 30, 2012).  The representative claim of the two patents-in-suit, reproduced below, recited providing to a computing system (a) patient information including therapeutic treatment information, (b) expert rules for evaluating therapeutic treatment regimens, and (c) advisory information, and then generating a ranked listing of possible therapeutic treatment regimens as well as advisory information.  Considering method and system claims according to the same standard of patentability, the court held that none of the claims directed to selecting a therapeutic treatment regimen were patent eligible.

The declaratory judgment plaintiff argued that the claims were directed to nothing more than a physician’s mental steps.  The patent owner responded that the claims satisfied the machine-or-transformation test, which it said should be dispositive even though that test was admittedly not the sole test for patent eligibility.

The court first noted that in Prometheus the Supreme Court had settled the debate of MySpace, Inc. v. Graphon Corp. concerning whether Section 101 is a threshold test of validity: it is.  After reviewing applicable precedent, including Gottshalk v. Benson, Parker v. Flook, and Bilski v. Kappos, the court held that the patent claims at issue recited unpatentable abstract ideas.  Following the analytic paradigm established by the Supreme Court in Prometheus, the court examined each step of the representative claim to determine that the steps were either recitations of routine medical practice (selecting a therapeutic treatment regimen) and/or recitations of activity that would occur in the mind of a doctor (ranking therapeutic treatment regimens).  Moreover, looking at the claim as a whole, it recited abstract ideas.  Thus, this court took a cue from Prometheus by deciding that steps that are either very broad or clearly anticipated by the prior art will not be given patentable weight.

For the sake of completeness, the court then determined that the claims did not in fact satisfy the machine-or-transformation test.  A simple reference to a “computing device” or “general purpose computer” did not tie the claims to a “particular machine.”  Any combination of software and hardware could be used to carry out the claims.  Any uses of a computer device were mere post-solution activity, and Prometheus taught that any transformation in the human body incidental to the claims was not enough to render them patent eligible.  These claims did not have the complexity of the claims in the recent Ultramercial decision; the claims there, unlike the claims here, could not be performed strictly as mental steps.  The claims here were more like the claims in the recent Dealertrack decision, which were directed to an abstract idea.

Finally, the court commented that, though claim construction was not necessary, the patent owner’s broad proposed constructions reinforced the patent ineligibility of the claims.  The claim language failed to put any meaningful limits on the claim scope.  A claim so broad as to cover known and unknown uses was not patent eligible.

Claim 1 of U.S. 6,081,786

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.
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