The United States District Court for the District of Colombia has recently issued an opinion in Smartgene, Inc., v. Advanced Biological Laboratories (Civil Action No. 08-00642 (BAH) which applies the recently issued Supreme Court opinion Mayo Collaborative Servs. v. Prometheus Labs., 132 S. Ct. 1289 (2012).

The Smartgene opinion arises from patents-in-dispute entitled “Systems, Methods and Computer Program Products for Guiding the Selection of Therapeutic Treatment Regions” and relate “to a system, method, and computer program for guiding the selection of therapeutic treatment regimens and providing advisory information”. In finding the patents invalid subject matter under 35 USC 101 of the Patent Act, the Court methodically discussed each of the steps (a-d) in the claims as follows:

(a) a method for guiding the selection of a therapeutic treatment regimen for a patient with a known disease or medical condition, said method comprising”

–The court said that this language was nothing more than a mental process, and one that is performed in doctors’ offices everyday.

(b) providing patient information to a computing device comprising three knowledge databases.

–The Court saw nothing in this step that is any different than the process a doctor goes through in real time when a doctor evaluates a patient by taking a medical history and obtaining information pertinent to the patient’s condition and documenting the same in a medical chart.

(c) generating in said computing device a ranked listing of available therapeutic treatment regimens for said patient.

–The Court against stated that this step describes what goes on in the mind of a doctor in evaluating and ranking possible treatment options for a patient based upon the benefits and counter-indicators of each option.

(d) 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 viewed this step as corresponding to a doctor generating a treatment plan for a patient.

In summary, the Court stated that the steps (a-d) 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. In the rationalization of its decision, the Court carefully followed language of the Supreme Court in Prometheus. For example, the Court, stated that 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. For these reasons [this Court believes] that the steps are not sufficient to transform unpatentable [abstract ideas] into patentable applications”

As further rationale for invalidating the patents, the Court also stated that the patents failed the “machine-or-transformation” (“MOT) test. While the Supreme Court has held that the MOT test is “not the sole test for deciding whether an invention is a patent-eligible process, the Supreme Court has stated that it is a “useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under section 101″   Under the MOT test, a process claim is patentable if (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.

The Court held that the patents above failed both of these prongs of the MOT because (1) the patents did not include any special programming code, nor did they provide any specific algorithms that the computers would use to perform the database matching or synthesis of expert rules, advisory information, treatment regimens, and patient information. To the extent that the claims referenced a machine at all, they referenced a “general purpose computer” which does not satisfy the machine prong. In order for the addition of a machine to impose a meaningful limit on the scope of a claim, it must play a significant part in permitting the claimed method to be performed, rather than function solely as an obvious mechanisms for permitting a solution to be achieved more quickly. (2) The Court also held that the patents failed to satisfy the “transformation” prong of the MOT test which required that the claimed process must “transform a particular article into a different state or thing”. In the instant case, the Court held that the claims were akin to a manual reorganization of treatment options or manipulation of data and did not involve transformation.

What can the individual inventor take away from the Smartgene decision? As mentioned above, when drafting computer related inventions it appears imperative to include programming code and specific algorithms that the computer uses to perform the process.