Ex Parte Digan et al - Page 6

                Appeal 2007-1633                                                                             
                Application 09/480,236                                                                       
                In addition to these structural requirements, claim 51 provides the functional               
                requirement that the antibody be at least about 90% as effective on a molar                  
                basis in competing with UCHT-1 for binding to human CD3 antigen.                             
                      The problem is, however, that Appellants’ Specification fails to                       
                provide a disclosure of which residues are required for the antibody to be at                
                least about 90% as effective on a molar basis in competing with UCHT-1 for                   
                binding to human CD3 antigen.  In our opinion, a skilled artisan cannot, as                  
                one can do with a fully described genus, visualize or recognize the identity                 
                of the members of the genus that exhibit this functional property.                           
                      “A written description of an invention involving a chemical genus,                     
                like a description of a chemical species, ‘requires a precise definition, such               
                as by structure, formula, [or] chemical name,’ of the claimed subject matter                 
                sufficient to distinguish it from other materials.”  University of California v.             
                Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1405 (Fed. Cir.                      
                1997 (bracketed material in original).  The claims in Lilly were directed                    
                generically to vertebrate or mammalian insulin cDNAs.  See id. at 1567,                      
                43 USPQ2d at 1405.  The court held that a structural description of a rat                    
                cDNA was not an adequate description of these broader classes of cDNAs.                      
                      The Lilly court explained that                                                         
                      a generic statement such as. . . ‘mammalian insulin cDNA,’                             
                      without more, is not an adequate written description of the                            
                      genus because it does not distinguish the claimed genus from                           
                      others, except by function.  It does not specifically define any                       
                      of the genes that fall within its definition.  It does not define                      
                      any structural features commonly possessed by members of the                           
                      genus that distinguish them from others.  One skilled in the art                       
                      therefore cannot, as one can do with a fully described genus,                          
                      visualize or recognize the identity of the members of the genus.                       


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