By Kevin E. Noonan —
The Federal Circuit engaged in judicial parsimony last week, in affirming the decision below that the asserted claims of U.S. Patent No. 5,723,283 are invalid for failure to encompass statutory subject matter. The opinion, written by Judge Moore and joined by Judge Newman and District Court Judge Joseph Farnan of the District of Delaware, sitting by designation, reads in its entirety as follows:
The opinion is 69 words. At 89 words, the claim at issue is longer:
The result is also anomalous because the Classen case was widely viewed as foreshadowing how the Federal Circuit will address the issues raised by Laboratory Corp. v. Metabolite Labs., Inc. (LabCorp), and Justice Breyer's criticism of the scope of that claim under a patentability analysis.
The following is the claim at issue in the Labcorp case:
There are parallels between the structure of this claim and the Classen claim. Each recites a preamble directed to identifying a biological phenomenon (a vitamin deficiency in Labcorp, a chronic immune-related disorder related to a acute immunization schedule in Classen), comprising an unambiguous diagnostic/tangible step (assaying a bodily fluid to detect elevated homocysteine levels in Labcorp, immunizing mammals with one or more doses of one or more immunogens, according to an immunization schedule in Classen), followed by an interpreting step (correlating elevated homocysteine with the vitamin deficiency in Labcorp, comparing the incidence, prevalence, frequency or severity of chronic immune-mediated disorders in mammals immunized according to the immunization schedule in Classen).
Now it cannot be the case that all diagnostic claims are per se invalid, suggesting that the claims in both Labcorp and Classen are particularly deficient, in reciting limitations to "correlate" or "compare" results of assays or actions clearly falling within the scope of 35 U.S.C. § 101 as statutory subject matter. It may be (although it is not clear from the reasoning in Bilski) that the Federal Circuit would consider the claim to be patent-eligible if the comparing or correlating steps were "tied to a particular machine or apparatus" (such as a clinical diagnostic computer); it is clear that such claims would be significantly more narrow and less valuable.
What these claims have in common is that they use the results of a tangible step (assaying or immunizing) to provide the raw material, information, used in the second part of each claim. This is the relevance of Bilski, and the only apparent rationale for the court's decision in Classen: what is at issue is whether methods for using, interpreting, or manipulating information, from financial markets or clinical results, can be patented. The informational component bedevils the analysis, because it removes claims like the claims in Labcorp and Classen from the comfort of typical chemical/pharma claims.
But the Federal Circuit's rote application of Bilski to the Classen claims raises the question of whether diagnostic claims should be patentable. That the diagnostic methods in Labcorp and Classen are biological/medical methods should not be dispositive, under the Federal Circuit's "technology-neutral" approach to patent law and the Supreme Court's decision in Diamond v. Chakrabarty. It is thus interesting to speculate on whether the court would come to the same conclusion with regard to claim 1 of U.S. Patent No. 7,464,002:
While we are at a far remove from Sadie Carnot and Lord Rumsford, could it not be said that this claim has the very same problems as the Labcorp and Classen claims, provided the relationships between the thermal transmission rates and thermal conductivity are fundamental properties of thermodynamics? And is this claim, from U.S. Patent No. 7,435,551, patentable under Classen?
The answer to these questions await further developments. The decision is non-precedential, and so the judicial impact is minimal. But as of last week, the Court seems to have decided to address patentable subject matter questions using a mechanical application of the Bilski test, pending eventual Supreme Court review.
Nonprecedential disposition
Panel: Circuit Judges Newman and Moore and District Judge Farnan
Opinion by Circuit Judge Moore
Patent Docs 
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