Ex parte BROWN - Page 8




              Appeal No. 2000-0643                                                                                        
              Application 08/273,423                                                                                      
              alopecia.”4  The issue, however, is whether the “favorable trend toward hair growth”                        

              attributed to administering all-trans-retinoic acid and a corticosteroid would have been                    

              unexpected.                                                                                                 
                     Appellant’s burden to make adequate rebuttal under these circumstances is                            
              described in In re Freeman, 474 F.2d 1318, 1324, 177 USPQ 139, 143 (CCPA 1973):                             
                     In order for a showing of “unexpected results” to be probative evidence of                           
                     non-obviousness, it falls upon the applicant to at least establish: (1) that there                   
                     actually is a difference between the results obtained through the claimed                            
                     invention and those of the prior art: and (2) that the difference actually                           
                     obtained would not have been expected by one skilled in the art at the time                          
                     of the invention (citations omitted).                                                                
                     To the extent that appellant relies on the results of the two double blind studies to                
              demonstrate a difference between the invention and the prior art, we are not persuaded.                     

              Appellant acknowledges that at least one of the components used in the claimed method                       
              is recognized as promoting hair growth (“[Bazzano] does teach that retinoic acid has utility                
              in promoting hair growth”  Brief, page 8).  Nevertheless, in each of the double blind studies               

              described in the declarations, the effect of administering all-trans-retinoic acid in                       

              combination with a corticosteroid is compared with the effect of administering a placebo.                   
              It cannot be established from these results whether there is any difference between                         

              administering the combination and administering all-trans-retinoic acid alone, much less                    

              whether any difference, if it exists, would have been unexpected.  Having carefully reviewed                


                     4 Declaration of Dr. Jules T. Mitchel, executed September 2, 1995 (page 3,                           
              paragraph 22).                                                                                              
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