In Re Kubin

561 F.3d 1351 (2009)

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Nature of the Case

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Facts

This claim is about an invention for the isolation and sequencing of a human gene that encodes a particular domain of a protein. Ps claim DNA molecules (polynucleotides) encoding a protein (polypeptide) known as the Natural Killer Cell Activation Inducing Ligand (NAIL). Ps also claimed the discovery of a binding relationship between NAIL and CD48 (a protein). Ps claimed a genus of isolated polynucleotides encoding a protein that binds CD48 and is at least 80 percent identical to amino acids 22-221 of SEQ ID NO: 2” the disclosed amino acid sequence for the CD48-binding region of NAIL. They disclosed SEQ ID NO: 1, which recited the specific coding sequence of NAIL, and SEQ ID NO: 3, which recited the full NAIL gene. Natural Killer (NK) cells, thought to originate in the bone marrow, are a class of cytotoxic lymphocytes that play a major role in fighting tumors and viruses. NK cells express a number of surface molecules which, when stimulated, can activate cytotoxic mechanisms. NAIL is a specific receptor protein on the cell surface that plays a role in activating the NK cells. The Board rejected Ps' claims as invalid under both §103 and §112. The Board found the genus of nucleic acids of representative claim 73 unsupported by an adequate written description. It found that Ps' Specification would not have shown possession of a sufficient number of sequences falling within their potentially large genus to establish possession of their claimed genus. The Board rejected the claims over the combined teachings of Valiante and Sambrook. Valiante discloses a receptor protein called 'p38' that is found on the surface of human NK cells. Valiante teaches that the p38 receptor is present on virtually all human NK cells and 'can serve as an activation marker for cytotoxic NK cells.' Valiante also discloses and claims a monoclonal antibody specific for p38 called 'mAB C1.7.' The Board found that Valiante's p38 protein is the same protein as NAIL. Valiante teaches that 'the DNA and protein sequences for the receptor p38 may be obtained by resort to conventional methodologies known to one of skill in the art. The DNA sequence encoding the receptor can be obtained by the 'panning' technique of screening a human NK cell library by eukaryotic expression cloning, of which several are known. The Board found as a factual matter that Ps used conventional techniques 'such as those outlined in Sambrook' to isolate and sequence the gene that codes for NAIL. The Board also found that Ps' claimed DNA sequence is 'isolated from a cDNA library . . . using the commercial monoclonal antibody C1.7 . . . disclosed by Valiante.' Because of NAIL's important role in the human immune response, the Board further found that 'one of ordinary skill in the art would have recognized the value of isolating NAIL cDNA, and would have been motivated to apply conventional methodologies, such as those disclosed in Sambrook and utilized in Valiante, to do so.' The Board concluded that appellants' claim was ''the product not of innovation but of ordinary skill and common sense,' leading us to conclude NAIL cDNA is not patentable as it would have been obvious to isolate it.' Ps appealed.