The Federal Court in Classen Immunotherapies, Inc., v. Biogen IDEC (Fed. Cir. August 31, 2011) concerns the application of the common-law exclusions from section 101 of “laws of nature, natural phenomena, and abstract ideas” in the post-world of the Myriad and Prometheus cases. This case concerned three patents totalling some 230 claims. The claims of the ‘139 and ‘739 were directed to a method whereby information on immunization schedules and the occurrence of chronic disease is screened and compared and the lower risk schedule identified and then a vaccine is administered based on that schedule. The third ‘283 patent was similar but did not include performing immunizations in accordance with the information learned by the claimed method. This performance of immunizations was key to the Courts decision holding the ‘283 patent invalid while holding the other two patents valid.
In its analysis, the Court noted once again the Diamond v. Diehr, 450 US 175 (1981) decision which stated that “it is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection”.
The Court also noted Bilski v. Kappos (2010) which stated that the “machine-or-transformation test” is not the sole standard of eligibility for patenting. The Bilski Court also reiterated its concern for “barring at the threshold” and encouraged preservation of the legal and practical distinctions between the threshold inquiry of patent-eligiblity, and the substantive conditions of patentability.
The Federal Court also noted the precedent has recognized that the presence of a mental step is not itself fatal to section 101 eligibility, and that the “infinite variety” of mental and physical activity negates application of a rigid rule of ineligbility (p. 15, citing Application of Prater, 415 F2.d 1393, 1402 n.22 (CCPA 1969). The Court in Prater noted that “in ascertaining whether a particular step is “mental” or “physical”, each case must be decided on its own facts, considering all of the surrounding cirumstances, to determine which end of the spectrum that step is nearer. It may well be that the step of “comparing” may be “mental” in one prcoess, yet “physical” in another. In this respect, the Court noted its prior case in Research Corporation 627 F.3d at 868 where the question on appeal was whether the computer conducted method of comparing images was an abstract idea and concluded that the specified method was “functional and palpable” and that the claims recite tangible limitations on performing the specified method of comparing images. The court in Research Corporation explained that the claims must be considered as “a whole” when determining eligibility to seek patentability.
Coming now to the key factor in this case, the Court in Classen Immuno states that the ‘139 and ‘739 patents were directed to a method of lowering the risk of chronic immune-mediated disorder, including the physical step of immunization based on the determiend schedule. These claims, according to the court, were directed to a specific, tangible application and the Court concluded that they traversed the course eligibility filter of 101. The ‘282 patent, on the other hand, did not include the subsequent step of immunization based on an optimum schedule. The claim of the ‘283 patent claims the idea of comparing known immunization results that are, according to the patent, found in the scientific literature, but does not require using this information for immunization purposes. This was key according to the Court, because as in Association for Molecular Pathology v. U.S. Patent 7 Tradmark Office, No. 10-1406 (Fed. Cir. July 29, 2011), methods that simply collect and compare data, without applying the data in a step of the overall method, may fail to traverse the section 101 filter.
This case raises the interesting question of whether including another step in the patent claim which simplies implements the mental step will suffice to meet a section 101 analysis post Prometheus and Myriad (note that the Classen Immuno v. Biogen IDEC case was issued after Bilski but prior to the Supreme Courts’s Prometheus and Myriad decisions).