In Re Marek Z. Kubin and Raymond G. Goodwin
Friday, April 03, 2009
In this decision, the Federal Circuit provided guidance for determining when a DNA sequence is obvious under KSR.
On appeal from the Board of Patent Appeals and Interferences’ (BPAI) ruling that Kubin’s and Goodwin’s patent was obvious under 35 U.S.C. § 103(a), the Federal Circuit upheld the BPAI’s ruling stating that the use of conventional tools and techniques to isolate and clone DNA sequences that encode known polypeptides is obvious in light of the abundant prior art.
Before addressing the matter at hand, the Federal Circuit commented on the In re Deuel decision, which held that “knowledge of a protein does not give one a conception of a particular DNA encoding it.” Deuel further stated that the obvious to try standard is an inappropriate test for obviousness. Under Deuel, obvious to try did not constitute obviousness. The Federal Circuit states that the obvious to try standard of Deuel has been “unambiguously discredited” by KSR. As KSR held, “the fact that a combination was obvious to try might show that it was obvious under [35 U.S.C.] § 103.” As a result, the Federal Circuit says that the correct standard is expressed in In re O’Farrell which held that “an obviousness finding was appropriate where the prior art contained detailed enabling methodology for practicing the claimed invention.” Kubin and Goodwin claimed DNA molecules for the Natural Killer Cell Activation Inducing Ligand (NAIL) protein. In finding the isolated DNA molecule obvious, the Federal Circuit relied on the Valiante reference’s disclosure of a method for isolating the human NAIL DNA sequence, and the Matthew reference’s disclosure of a mouse protein that activates mouse NR cells and chromosomal mapping, cloning, expression, and molecular characterization of the gene coding for the NAIL protein. Further, Matthew identified a human homologue for the mouse gene. Based on these teachings, the Federal Circuit held that “a protein of interest, a motivation to isolate the gene coding for that protein, and illustrative instructions to use a monoclonal antibody specific to the protein for cloning this gene” would have rendered Kubin’s and Goodwin’s invention obvious to a skilled artisan because of the “reasonable expectation of success” in obtaining Kubin’s and Goodwin’s invention from the cited prior art.