Ex parte GHIONE et al. - Page 13


                     Appeal No. 1995-3257                                                                                                       
                     Application 08/056,382                                                                                                     



                     Enablement                                                                                                                 
                             All the appealed claims are finally rejected under                                                                 
                     the first paragraph of 35 U.S.C. ' 112 as being drawn to a                                                                 
                     non-enabling disclosure.  Examiner bears the initial                                                                       
                     burden of providing reasons why a supporting disclosure                                                                    
                     does not enable a claim.  In re Marzocchi, 439 F.2d 220,                                                                   
                     223, 169 USPQ 367, 369 (CCPA 1971).  We conclude that                                                                      
                     examiner has not met this burden.                                                                                          
                                                                                     1                                                          
                             After reading examiner's position , it is evident that                                                             



                     examiner focuses exclusively on whether the claims are enabled for preventing alopecia in                                  

                     humans and yet does not question enablement with respect to other treatments.  Of all the                                  

                     claims on appeal (1-3, 6-9, 11-15 and 18-20), only claims 12-15 and 18 are directed to                                     

                     methods of therapy and only one claim, claim 18, is directed to preventing alopecia.  The other                            

                     claims are directed to topical compositions.  We reproduce claims 12-15 and 18:                                            

                             12. A method of cytostatic therapy in animals, comprising topically administering to an                            
                     animal in need of such therapy an anthracycline antibiotic and an antidotal effective amount of                            
                     an anti-anthracycline antibiotic monoclonal antibody produced from a hybridoma deposited at                                
                     ECACC under No. 90011003 on January 12, 1990 in a pharmaceutically acceptable topical                                      
                     carrier.                                                                                                                   

                             13. The method of claim 12 wherein the monoclonal antibody is administered before,                                 
                     during and after administration of the anthracycline antibiotic.                                                           

                             14. The method of claim 13 wherein the monoclonal antibody in the carrier is applied                               

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