Ex parte DEL BIANCO et al. - Page 2




          Appeal No. 1996-0756                                 Paper No. 24           
          Application No. 08/027,853                                 Page 2           
          Interferon beta is also written "interferon-$" and "IFN-$".                 
          According to Appellants (Paper No. 14 at 3 to 4, emphasis in                
          original):                                                                  
                    The present invention is not based on the fact                    
               that a particular antiestrogen is useful in the                        
               treatment of breast cancer.  It is not based on the                    
               fact that interferon-$ is useful for the treatment                     
               of breast cancer.  The invention is also not based                     
               on any assertion that it is unexpected to combine                      
               the separate and known antiproliferative effects of                    
               IFN-$ and antiestrogen.  Nevertheless, what is                         
               decidedly not obvious from the references relied on                    
               [by] the Examiner is that the use of these materials                   
               sequentially and with the IFN-$ being administered                     
               first gives rise to a synergistic result.                              
               The only point in contention is whether Appellants'                    
          results are unexpectedly synergistic.  Appellants bear the                  
          burden of showing that their results are unexpected.  E.g., In              
          re Geisler, 116 F.3d 1465, 1469-70, 43 USPQ2d 1362, 1365 (Fed.              
          Cir. 1997).  A result is synergistic if the evidence shows a                
          combined effect greater than the sum of the separate effects.               
          Merck & Co., Inc. v. Biocraft Laboratories Inc., 874 F. 2d                  
          804, 808, 10 USPQ2d 1843, 1847 (Fed. Cir. 1989).  Appellants                
          rely on data described at pages 6 to 8 and illustrated at                   
          Figures 1A, 1B, and 2 of their specification to demonstrate                 
          that sequential administration of IFN-$ and an antiestrogen                 
          yields a result that is unexpected.                                         








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