Ex Parte Gormley et al - Page 8



              Appeal No. 2004-0543                                                                  Page 8                
              Application No. 10/010,678                                                                                  
              transdermally administering a 5-α-reductase inhibitor; claim 30 specifies administration                    
              by transdermal skin patch; claim 33 specifies that the 5-α-reductase inhibitor is 17β-(N-                   
              tert-butylcarbamoyl)-4-aza-5α-androst-1-ene-3-one), otherwise known as Afinasteride;@                       
              claim 36 is directed to a skin patch comprising a 5-α-reductase inhibitor.                                  
                     Goldman teaches that androgenic alopecia/male pattern baldness can be treated                        
              topically or systemically with a combination of three agents: a vasodilator; an estradiol;                  
              and 5-α-reductase inhibitor (column 2, lines 42-46; column 6, lines 5-9).  AA highly                        
              preferred inhibitor of . . . 5-α-reductase for use in [Goldman=s] compositions and                          
              methods@ (column 5, lines 43-44), indeed the only 5-α-reductase inhibitor specifically                      
              mentioned, is finasteride (column 5, lines 43-62).  While Aeach agent of the combination                    
              need not be administered in the same manner@ (column 2, lines 65-67), Ain a highly                          
              preferred embodiment the selected agents are administered from a single vehicle in unit                     
              dosage form, including tablet, capsule, and transdermal patches or preparation@                             
              (column 3, lines 7-10).                                                                                     
                     While Goldman does not specifically describe incorporating a 5-α-reductase                           
              inhibitor into a transdermal skin patch and using the patch to treat androgenic alopecia,                   
              he explicitly suggests doing just that.  Moreover, Goldman identifies finasteride as a                      
              Ahighly preferred@ 5-α-reductase inhibitor for this purpose.  It would have been obvious                    
              for one skilled in the art to have treated androgenic alopecia by transdermal                               
              administration of a pharmaceutical preparation, e.g., a transdermal skin patch,                             
              comprising a 5-α-reductase inhibitor, e.g., finasteride, in view of Goldman=s explicit                      
              suggestions.                                                                                                
                                           TIME PERIOD FOR RESPONSE                                                       
                     This decision contains a new ground of rejection pursuant to 37 CFR ' 41.50(b)                       



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