Ex parte DAVIS et al. - Page 4




          Appeal No. 95-4692                                                          
          Application 08/141,316                                                      


          therefrom, or an enzyme having the structure of enzyme derived              
          from said microorganisms, which is capable of catalyzing the                
          hydroxylation of the referenced compound.  However, when the                
          referenced compound is compactin, the claimed method excludes               
          the use of microorganisms selected from genera Nocardia,                    
          Amycolata and Streptomyces.                                                 
                                          I.                                          
               The examiner argues that the appellants have not                       
          demonstrated that the claimed hydroxylation reaction can be                 
          performed with an enzyme, nor have the appellants isolated and              
          characterized any enzyme.  Answer, p. 3.  The examiner further              
          argues that:                                                                
                    The specification does not contain any evidence                   
                    that the process can indeed be performed by an                    
                    individual enzyme in a cell free system.                          
                    Applicant has [sic, applicants have] apparently                   
                    isolated no enzyme which will accomplish the                      
                    claimed process and in fact has [sic, have]                       
                    really not even shown that the process is mono-                   
                    enzymatic in nature and not in fact cell                          
                    dependent, hence there is no reasonable                           
                    expectation that the process is in fact                           
                    enzymatic.  Therefore without any                                 
                    characterization of the enzymatic reaction or                     
                    enzyme itself, applicant has [sic, applicants                     
                    have] not enabled claims drawn to the use of an                   
                    enzyme as it would require undue experimentation                  
                    by one of ordinary skill in the art at the time                   

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