Federal Circuit Holds Medical Diagnostic Method Not Patent-Eligible

Patent claims directed to “guiding the selection of a treatment regimen for a patient with a known disease or medical condition” were held not patent-eligible under 35 U.S.C. § 101 by a unanimous Federal Circuit panel.  SmartGene, Inc. v. Advanced Biological Laboratories, S.A., No. 2013-1186 (Jan. 24, 2014).

All claims of U.S. Patent Nos. 6,081,786 and 6,188,988 were held invalid.  Claim 1 of the ’786 patent was representative:

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.

The court first disposed of the patent owner’s argument that the district court erred when it invalidated all claims of both patents-in-suit.  SmartGene had brought a declaratory judgment action of invalidity against all patent claims, which declaratory judgment claims were never narrowed even though the patent owner only counterclaimed for infringement of certain claims.

Turning to the question of patentable subject matter, the court next explained that the district court was correct to hold “that the claim 1 method falls outside the eligibility standards of section 101 as that provision has been construed.”  The claims here were simply directed to a set of mental steps.  The representative claim did “no more than call on a ‘computing device,’ with basic functionality for comparing stored and input data and rules, to do what doctors do routinely.”

After citing supporting precedent, including Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012), CLS Bank Int’l v. Alice Corp. Pty, 717 F.3d 1269 (Fed. Cir. 2013) (en banc), cert. granted, 134 S. Ct. 734 (2013), and Accenture Global Servs., GmbH v. Guidewire Software, Inc., 728 F.3d 1336 (Fed. Cir. 2013), the Court distinguished Ultramercial, Inc. v. Hulu, LLC, 722 F.3d 1335 (Fed. Cir. 2013).  Ultramercial indisputably involved an “abstract idea,” namely “getting a kind of confirmation that a viewer has watched advertising as a precondition to sending the viewer desired programming.”  Nonetheless, “the process at issue in Ultramercial did not involve ‘mere mental steps.’”  Further, Ultramercial considered patent claims that “involved a recitation of specifics of computer networks beyond with the present case involves.”

The opinion was authored by Judge Lourie, who was joined by Judges Dyk and Taranto.

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