Tuesday, April 3, 2012

Computer-Implemented Method for Guiding Therapeutic Treatment Ruled Patent Ineligible under Mayo v. Prometheus

On March 30 the United States District Court for the District of Columbia dismissed a lawsuit between Plaintiff SmartGene, Inc., a North Carolina corporation and Defendant Advanced Biological Laboratories, SA, a company with its principal place of business in Luxembourg, after declaring the patents in dispute (U.S. Patent No. 6,081,786 (the “786 patent”) and U.S. Patent No. 6,188,988 B1 (the “988 patent”)) patent ineligible under 35 USC 101. (Click here for decision)

The plaintiff SmartGene brought the suit as a declaratory judgment action, after ABL filed a lawsuit alleging that “Smartgene’s IDNS™ HIV program incorporates at least one technology which infringes at least claim 1 of each [of] the ‘786 and ‘988 Patents.”

The court's analysis focused on Claim 1 of the ‘786 patent as exemplary of the subject matter covered by the patent dispute:

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 district court began by observing that a recent Federal Circuit decision, MySpace, Inc. v. Graphon Corp., had cast doubt upon the use of § 101 subject matter inquiry as a threshold question, and cautioned that lower courts should avoid the “swamp of verbiage that is § 101 by exercising their inherent power to control the processes of litigation, . . . and insist that litigants initially address patent invalidity issues in terms of the conditions of patentability defenses as the statute provides, specifically §§ 102, 103, and 112.” However, the district court concluded that the Supreme Court's recent decision in Mayo v. Prometheus had unambiguously rejected this approach, and firmly established “the § 101 subject matter patentability inquiry as the threshold inquiry for patent validity.
The court's analysis focused on comparing the claims at issue to “Supreme Court caselaw ‘guideposts’ on the subject of patent subject matter eligibility [Benson, Diehr, Flook, Bilski, Prometheus]; and then examining whether the patents-in-dispute [] satisfy the MOT test, and [] constitute eligible subject matter irrespective of the MOT test.”

The court analyzed the claim under the approach used by the Supreme Court in Prometheus, i.e., by determining that the individual steps recited in the claim method are "routine, well understood and conventional." The court concluded that the steps of the claim “describe abstract ideas that are commonly performed by medical professionals in evaluating, considering and constructing treatment options for a patient presenting a specific medical condition. As with the claim examined in Prometheus, these ‘steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.’”

The machine or transformation test played a substantial role in the courts analysis. The court concluded that the claim failed the machine prong of the test because the “generic token reference of a ‘computing device’ in the claims [] does not identify any particular machine or provide any indication of what particular type of machine is to be used,” and because “the computing device referenced in the claims is incidental to the claimed invention and is not used for more than ‘insignificant postsolution activity’”.

Regarding the transformation prong of the test, the court held that “transformation must be central to the purpose of the claimed process” and the “mere manipulation or reorganization of data . . . does not satisfy the transformation prong.” The court concluded “that the defendants’ claims mirror the mental processes that a physician performs, and therefore embody the ‘basic tools of scientific and technological work’ that are free to all men and reserved exclusively to none.’”

Thanks to Docket Navigator for making me aware of this decision.

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Likely it's taboo for me to say this on a blog for patent lawyers, but I'm glad the Supreme Court ruled as it did in Prometheus. It will be interesting to see how the Myriad patent litigation fares in light of the high court's ruling.

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