In SmartGene, Inc. v. Advanced Biological Labs., S.A., No. 2013-1186 (Fed. Cir., Jan. 24, 2014), the Federal Circuit held that a patent claiming the use of a computer to implement routine mental information-comparison and rule-application processes to select a treatment for a patient fails patent-eligibility because the claims are directed to an abstract idea. The Federal Circuit, in this unpublished opinion, determined that the patent claims no more than the conscious process that doctors can and do perform in their heads. The decision suggests that those seeking to patent computer-aided diagnostic and therapeutic methods, useful in personalized medicine, must identify and claim “something more’” than the use of conventional technologies in a conventional manner to satisfy the evolving patent-eligibility standard.
Systems, Methods and Computer Program for Selection of Therapeutic Treatment Regimens
Defendant Advanced Biological Labs (“ABL”) appealed the grant of summary judgement in favor of plaintiff SmartGene, Inc. (“SmartGene”) that two of ABL’s patents were invalid. See SmartGene, Inc. v. Adv. Biological Labs., 852 F. Supp.2d 42, recons. denied, 915 F.Supp.2d 69 (D.D.C. 2013). SmartGene sought declaratory judgment that it did not infringe two of Advanced Biological Labs (“ABL”) patents, U.S. Patent No. 6,081,786 (the ’786 Patent) and 6,188,988 (the ’988 Patent), directed to methods, systems and computer programs that guide the selection of a treatment regimen for a patient with a known disease or medical condition. Representative claim 1 of the ’786 patent recites:
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.
Claim 1 of the ’988 Patent is nearly identical. Claim 1 recites:
1. A method for guiding the selection of a therapeutic treatment regimen for a patient with a chronic known disease or medical condition, said method comprising:
(a) providing patient information to a computing device, said patient information including prior therapeutic treatment regimen information for said chronic known disease or medical condition, said computer 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 from said patient information and said first knowledge base a 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 for said patient in said listing based on said patient information and said expert rules.
The Federal Circuit noted that other claims in the patents were similar in content but were drafted in the context of “a system” or a “computer program product” rather than method claims. However, because ABL failed to contest in its briefing SmartGene’s assertion that for the purpose of Section 101 analysis, claim 1 of the ’786 Patent was representative, all claims were analyzed by the district court as if they were directed to the method recited in claim 1 of the ’786 Patent. Thus, ABL was estopped from asserting, as it unsuccessfully attempted to do at oral argument, that system claims should be analyzed differently under Section 101 than the representative method claim. Claim 1 was held invalid by the district court for failing to satisfy 35 U.S.C. Section 101 (patent-eligibility) because the claim was directed to an abstract idea. The district court reasoned that claim 1 of the ’786 Patent did no more than describe an abstract mental process routinely performed, either entirely within a physician’s mind, or aided by other resources in the treatment of patients. Because claim 1 was deemed representative of all claims, all claims of the ’986 and ’988 Patents were held invalid.
Computer Aided Methods, Without More, Are Patent-Ineligible
In affirming the district court’s holding that the claims were invalid under Section 101, the Federal Circuit noted that Section 101 patent-eligibility does not embrace a process (here a method) defined simply as using a computer to perform a series of mental steps that a person, aware of each step, can and regularly does perform in their heads, citing CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366 (Fed. Cir. 2011); In re Grams, 888 F.2d 835 (Fed. Cir. 1989); and In re Meyer, 688 F.2d 789 (C.C.P.A. 1982). The court emphasized that Supreme Court decisions note that patent-eligible subject matter does not cover mental processes – associated with, or as part of a category of abstract ideas – or those that merely invoke a computer and its basic functionality for implementing such mental processes, without specifying new physical components or specifying processes defined other than by the mentally performable steps, citing Gottschalk v. Benson, 409 U.S. 63 (1972) and Parker v. Flook, 437 U.S. 584 (1978). The court noted that the claim language placed only broad limitations on a “computer device” and while the claim notes the use of a computer, the steps of the method could be performed without its use.
The Federal Circuit also noted claim elements that could have made the claim patent-eligibile:
1. the use of new machinery to carry out the steps of the claims;
2. the use of new computer hardware; or
3. the use of method steps beyond those that doctors routinely and consciously perform.
Patenting Methods For Personalized Medicine
While much of the prior jurisprudence relating to personalized medicine concern the use of physical criteria such as biomarkers or therapeutic ranges to diagnose disease or monitor therapy, this case is interesting as it relates to another emerging aspect of personalized medicine – computer-aided methods for selecting therapy or matching a patient with clinical trials. Here, the Federal Circuit noted that the mere use of conventional computer hardware will not make a claim patent-eligible, especially when the steps themselves could be performed without the aid of a computer.