Ex Parte LI et al - Page 3



              Appeal No. 2003-1020                                                                  Page 3                 
              Application No. 08/859,051                                                                                   
              to limitations not required by any of the claims, we need not discuss those references                       
              further.                                                                                                     
                     Bonte describes a method of promoting hair growth by topical application of                           
              labdane derivatives or plant extracts containing labdanes.  According to the reference,                      
              “activity, which remains weak for certain of these compounds, may be very considerably                       
              potentialized by their incorporation in . . . liposomes” (column 2, lines 37-42).  The                       
              examiner does not assert that the labdanes are antiandrogens, but does note that                             
              Bonte mentions a “generic ‘alpha-reductase inhibitor’ . . . deemed to include [the]                          
              instant inhibitor” (Answer, page 4).  In this regard, we note Bonte’s disclosure from                        
              column 6, line 59 to column 7, line 8:                                                                       
                     According to a variant embodiment, a cosmetic or pharmaceutical,                                      
                     particularly dermatological composition . . . comprises in addition [to                               
                     labdane] at least one other active substance, . . . selected from xanthines,                          
                     vitamins, particularly vitamin B’s, tyrosine or its derivatives, . . . quinine or                     
                     its derivatives, rubefacients . . . , a supernatant of culture of fibroblasts of                      
                     papillae, . . . keratin hydrolysates, oligo-elements such as zinc, selenium,                          
                     copper, 5-"-reductase inhibitors such as: progesterone, cyproterone                                   
                     acetate, Minoxidil, azaleic acid and its derivatives . . . said active                                
                     substance possibly being incorporated at least in part in [ ] hydrated lipidic                        
                     lamelar phases, notably liposomes.                                                                    
                     Rössling describes a method of topically treating androgen-dependent alopecia                         
              with liposome-encapsulated active agents, including anti-androgenic 5-"-reductase                            
              inhibitors.  According to Rössling (column 1, lines 41-58):                                                  
                     [A] therapeutically sufficient and uniform rate of penetration of                                     
                     antiandrogenic active ingredients through the skin [ ] is achieved if the                             
                     ingredients are encapsulated in liposomes.  Thus, it is possible to provide                           
                     topically applicable preparations, which show their action basically on the                           
                     peripheral androgen receptors in the area of application.  As a result,                               
                     systemic side effects are avoided or minimized.  Since the active                                     
                     ingredient is concentrated in the liposomes, it is possible to use small                              
                     amounts of the active ingredient and still achieve a high active ingredient                           
                     amount concentration at the site of action . . . it is believed that much                             
                     higher concentrations of antiandrogen can be achieved in the corium and                               
                     connective tissue of the skin using the pharmaceutical preparations . . .                             



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