Ex parte TERASAWA et al. - Page 3



                 Appeal No. 1998-2587                                                                                     
                 Application No. 08/451,993                                                                               

                 hexacyclic compounds which “have an excellent antitumor activity and a high                              
                 degree of safety, and are water-soluble.”  Id., page 12.                                                 
                                                       Discussion                                                         
                 1.  The non-enablement rejection.                                                                        
                         The examiner rejected the all of the claims because, in his view, undue                          
                 experimentation would be required to practice the full scope of the claims.  The                         
                 examiner argues, for example, that not all combinations of the R1, R2, and R4                            
                 groups encompassed by claim 1’s generic formula will have the appropriate                                
                 water solubility and lipophilicity to be pharmaceutically useful, and that the                           
                 specification does not enable those skilled in the art to use them in other ways,                        
                 e.g., as prodrugs.  Examiner’s Answer, pages 7 -10, 12, 13-15.  The examiner                             
                 also argues that starting materials are not available to make some of the                                
                 compounds that are encompassed by the generic formula (Answer, pages 10,                                 
                 11-12, 13), and that claims 24 and 25 are not limited to “physiologically                                
                 acceptable” salts and therefore encompass toxic or insoluble salts of the recited                        
                 compounds, which the specification does not teach how to use (Answer, pages                              
                 10-11).                                                                                                  
                         Appellants dispute the potential problems pointed to b y the examiner.                           
                 However, even assuming arguendo that all of the examiner’s critiques have                                
                 merit, we conclude that the examiner has not made out a prima facie case of                              
                 non-enablement.                                                                                          




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