Ex parte ALEXANDER et al. - Page 7




              Appeal No. 1997-3330                                                                                     
              Application No. 08/271,870                                                                               


                     The examiner has not pointed to factual evidence in the cited references as to how                
              one of ordinary skill in the art would prepare or determine which immunogens can be used                 
              to prepare monoclonal antibodies capable of distinguishing between mycophenolic acid                     
              and mycophenolic esters.                                                                                 
                     Even if it is assumed, for the sake of argument, that one of ordinary skill in the art            
              could prepare monoclonal antibodies from hapten conjugates based on the general                          
              methodologies of Erlanger and Brinkley and use them in conventional assays according to                  
              the disclosure of Rose, one of ordinary skill in the art is not provided with sufficient                 
              information to prepare and obtain monoclonal antibodies with the capability of                           
              distinguishing between mycophenolic acid and mycophenolic ester with a reasonable                        
              expectation of success.                                                                                  
                     Simply put, we find the examiner has not provided the factual support which would                 
              have reasonably suggested modifying the teachings of Nelson to obtain a monoclonal                       
              antibody capable of distinguishing between mycophenolic acid and mycophenolic ester.                     
              The examiner’s inclusion of claims to a kit and to modified cells in the rejection is similarly          
              flawed.                                                                                                  








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