Ex parte KAMBOJ et al.; Ex parte FOLDES et al. - Page 13

                  Appeal No.  1999-2200                                                                                         
                  Application No.  08/896,063                                                                                   
                          because Birnbaumer teaches that, as was appreciated in the art,                                       
                          receptor agonists or antagonists which are candidate human                                            
                          therapeutics should be assayed with human receptor systems.  The                                      
                          artisan would reasonably have expected a human homolog having                                         
                          structural and functional properties similar to GluR5-2 to exist                                      
                          because Puckett teaches that a gene family similar to the GluR gene                                   
                          family in rat will be present in humans; moreover, Puckett exemplifies                                
                          one clone which exhibits “extreme conservation” of sequence                                           
                          compared to the most closely related rat cDNA.  The artisan would                                     
                          reasonably have expected the properties of the human GluR5 gene                                       
                          product to be qualitatively the same as those observed for the rat                                    
                          receptor, including the ability to bind to and respond to kainate, as                                 
                          evidenced by Sommer [‘92].  The artisan would also have expected,                                     
                          however, that although qualitatively similar, such properties would                                   
                          likely not be identical because Birnbaumer teaches, as was known in                                   
                          the art, that species-specific variations in the quantitative                                         
                          pharmacological properties are to be expected when comparing                                          
                          homologous gene products.  The artisan would have expected to find                                    
                          one or two cDNAs homologous to the rat GluR5-2 in a human cDNA                                        
                          library because of the recognized diploid nature of the human                                         
                          genome: the copies of the gene inherited from different parents could                                 
                          be identical or different.  The artisan would have expected that each of                              
                          the two alleles would be closely related to the rat cDNA.  The routineer                              
                          would have entertained a reasonable expectation of success in                                         
                          isolating and identifying the desired clone(s) because of Heinemann,                                  
                          Bettler [‘90], and Sommer [‘92] describe several characteristic                                       
                          properties of the receptor (sequence, tissue distribution, functional                                 
                          response in Xenopus and HEK cells, etc.).  The practice of the assays                                 
                          disclosed by Heinemann would necessarily involve the assessment of                                    
                          binding between the candidate (ant)agonists and the receptor protein                                  
                          or would alternatively have involved the measurement of phenomena                                     
                          (e.g., potentiation of electrophysiological properties) which the artisan                             
                          would have expected to correlate with such binding.  The claimed                                      
                          invention would have been prima facie obvious as a whole at the time                                  
                          it was made.                                                                                          
                          While the claims on appeal are drawn to “[a] method of assaying” it is                                
                  obviously key to the examiner’s rejection that a cDNA encoding the EAA3a, 3b, 3c                              
                  or 3d receptor must be first successfully isolated.  Once isolated the cDNA is used                           
                  to engineer a cell to express the receptor, and then the claimed method can be                                


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