• 2-1 Classen majority imposes “subject matter patentability” filter in transformation-type claims in striking down a transformation claim in a diagnostic method impliedly as an insignificant or token activity

On August 31, 2011, the Federal Circuit rendered its decision in Classen v. Biogen Idec. which may become the gold standard for making subject matter patentability determinations in cases involving transformative steps; squarely addressing the issue of “insignificant or token activity” (e.g., “insignificant post solution activity”) raised by the Supreme Court in Bilski  but now in connection with subject matter involving transformations.  

In Classen, the Federal Circuit was asked to decide whether three patents on a method for improving an immunization schedule involving method claims directed to identifying a safe vaccine regimen and involving a step of immunizing mammals is patentable subject matter.  The patents before the Court were U.S. Pat. Nos.  6,638,739; 6,420,139; and 5,723,283.

In a 2-1 majority, the Court reversed the lower court in finding the ‘139 and ‘739 patents to contain subject matter patentable under 35 U.S.C. 101 while affirming the lower court finding that the ‘283 patent is not patentable subject matter.  Following an unremarkable analysis of the case under its “functional and palpable test” (“If the specified method is “functional and palpable,” the court stated, the claims are drawn to statutory subject matter.” Slip Op. 17), the Classen court went on to analyze the claims in what may be the real take-away from this decision – namely, the implied replacement of the traditional notion that generally all transformative steps are patentable subject matter with a “subject matter patentability filter” through which all transformation steps in a claim must pass. Slip Op. 19  In Classen, claims of one of the three patents before the court, the ‘283 patent, failed to pass the “subject matter patentability filter” impliedly because they amounted to an insignificant or token activity.  Id.  As the court explained, “[t]he “immunizing” in the ’283 patent refers [only] to the gathering of published data, while the immunizing of the ’139 and ’739 patent claims is the physical implementation of the mental step claimed in the ’283 patent.”  Id.

The different treatment given by the Court to the two sets of patents turned on how the immunization step was construed by the Court.  In the ‘139 and ‘739 patents the recitation occurred after a screening step was performed to derive an immunization schedule for use in the immunization step and in the ‘283 the immunization step was recited before a comparing step to generate data for use in the comparison step.  While facially both sets of patents recited “immunization steps” that were transformative, the court opined that the “immunizing step” of the ‘283 patent failed to pass through the “subject matter patentability filter”   Slip Op. 19, 20.  A transformation for data gathering purposes to develop a body of knowledge as was recited in the ‘283 is not patentable the court held while a transformation that “puts this knowledge to practical use” as was recited in the ‘139 and ‘739 patents comports with 35 U.S.C. 101. Slip Op. 21  As explained by the court, “The principles applied in Prometheus support the patent eligibility of the Classen claims that include such transformative steps, but are not relevant to claims that require no more than referring to known information but do not include immunization in light of that information.” Slip Op. 22

In her dissent, Judge Moore found disfavor with the court’s use of the “functional and palpable” test pointedly questioning: “How do we determine whether any given method or claim is “functional” or “palpable?”  Dissent 12.  In our Juhasz Blog on Research Tech, we too posed the same question.  There we said that this “functional and pulpable” standard in defining whether a claim preempts a fundamental idea (“palpable” is defined by Merriam-Webster dictionary to mean “capable of being touched or felt”) provides little guidance on determining the preemption issue and is reminiscent of the phrase made famous by Justice Potter Stewart in the obscenity case of Jacobellis v. Ohio that “I know it when I see it”. 

The Classen court provides further useful insight as to what the “functional and palpable test” means when it predicated its analysis under the test using phrases like “specific, tangible application” (Slip Op. 18) and “concrete, physical step (Slip Op. 20).   In her dissent, again critical of such reasoning, Judge Moore pointedly questioned: “Is this a return to the rejected notions of “useful, concrete, and tangible?”  We too find the Court’s use of  “concrete, physical step” and the “specific, tangible application” type of analytical framework in its analysis to be eerily reminiscent of the “useful, concrete, and tangible result” test that the court used in deciding State Street and AT&T, a decision that the dicta of the Supreme Court in Bilski made clear that “nothing in today’s opinion should be read as endorsing interpretations of §101 that the Court of Appeals for the Federal Circuit has used in the past. See, e.g., State Street, 149 F. 3d, at 1373; AT&T Corp., 172 F. 3d, at 1357.”  For more go to Juhasz Burge PC Blog on State Street Bank and AT&T Lessons.

The Classen decision showcases the continuing struggle of the Court to define the boundary line beyond which a claim preempts a fundamental principle.  The problem, as the Court explained is that “[t[he Court in Bilski v. Kappos did not define “abstract,” and Justice Stevens observed in concurrence that “[t]he Court, in sum, never provides a satisfying account of what constitutes an unpatentable abstract idea,” 130 S. Ct. at 3236.”  Slip. Op. 16.  The solution in the eyes of the Federal Circuit is the “functional and palpable” test which provides that definition. Slip Op. 17.

Still, Classen is likely to become the gold standard for making subject matter patentability determinations in cases involving transformative steps; squarely addressing the issue of “insignificant or token activity” (e.g., “insignificant post solution activity”) raised by the Supreme Court in Bilski  but now in connection with subject matter involving transformations. Classen impliedly may have signaled the end to the general presumptive patentability of transformation claims.  Transformative steps that are mere data gathering steps may now be treated no differently than a general computer is treated in a software patent, that is, as an insignificant post-solution activity.  Classen also points to the wisdom of the Supreme Court in striking down the Federal Circuit’s “machine-or-transformation” test as the exclusive test for determining subject matter patentability.  The transformative step that was deemed to be unpatentable subject matter under Classen could likely have been found to be patentable subject matter under the MOT test. 

In reforming the treatment of transformation steps, Classen is likely to have a big impact on diagnostic methods and chemical process patents by extension. Classen Immuno v. Biogen Idec is a must read for practitioners dealing with Bilski issues.  For a more comprehensive discussion of Classen Immuno v. Biogen Idec and take-aways including suggested tips for use in drafting diagnostic and chemical method claims, go to the September 2011 Juhasz Burge PC Advisory.

The Juhasz Burge PC Firm can help you to better understand the effect of Classen Immuno v. Biogen Idec on your biotechnology, diagnostic, and chemical patents.  For more information regarding these cases and advice on how these decisions may affect your patents, please contact The Juhasz Burge PC Firm. Your patents may be your most important asset. To help you protect your patents contact Juhasz Burge PC, the firm committed to Guiding Your Patent Beyond The Horizon℠.