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In re Kubin: Federal Circuit Ignores Principles of Structural Obviousness in Applying 'Obvious to Try' Test

By Warren D. Woessner and Tania A. Shapiro-Barr

On April 3, 2009, a three-judge panel of the Court of Appeals for the Federal Circuit unanimously affirmed the decision that the Board of Patent Appeals had reached in Ex Parte Kubin, 2007 WL 2070495 (B.P.A.I. May 31, 2007), thereby reinforcing and extending the applicability of the “obvious to try” test in biotechnology patent law practice. In furthering the “obvious to try” standard, however, the Federal Circuit also undermined its own precedent regarding biochemical structural obviousness ' namely, that the nucleotide sequence of a previously unknown DNA sequence encoding a known or partially known polypeptide is non-obvious. Thus, In re Kubin, 2009 WL 877646 (Fed. Cir. April 3, 2009), now appears to be the first case in which a defined biochemical structure was found to be obvious despite the fact that the structure was previously unknown and unpredictable.

In Ex Parte Kubin, the Board determined that a DNA sequence encoding a functionally characterized but unisolated receptor protein (the NAIL protein, which is located on the surface of certain types of immune cells) was obvious under 35 U.S.C. ' 103(a). The patent examiner had rejected Kubin's claims as obvious over a combination of prior art teachings disclosing: 1) the functional characteristics of the NAIL protein on cultured cells, 2) a monoclonal antibody that binds to a portion of the NAIL protein, and 3) a prophetic example of how to isolate NAIL DNA and the protein using conventional cloning and sequencing methodologies. Notably absent from the prior art, however, was any teaching or suggestion of either the amino acid sequence (complete or partial), or any working example of a method by which to obtain the amino acid or DNA sequence of the NAIL protein.

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