Ex Parte Davis - Page 4


                  Appeal No. 2006-3204                                                               Page 4                     
                  Application No. 10/057,629                                                                                    

                  In re Gorman, 933 F.2d 982, 986, 18 USPQ2d 1885, 1888 (Fed. Cir. 1991).                                       
                  Appellant argues that the examiner has failed to establish a prima facie case of                              
                  obviousness.  See Appeal Brief, page 10.  We agree, and the rejection is                                      
                  reversed.                                                                                                     
                          As noted by appellant, Rosenblum, while teaching that ezetimibe,                                      
                  optionally in combination with an HMG-CoA reductase inhibitor such as                                         
                  simvastatin, may be used for reducing the cholesterol and the risk of                                         
                  atherosclerosis, does not teach or suggest the use ezetimibe in the treatment of                              
                  sitosterolemia.  See id. at 11.                                                                               
                          Belamarich teaches that patients with sitosterolemia “are frequently                                  
                  hypercholesterolemic with elevated levels of low-density lipoprotein (LDL)                                    
                  cholesterol.”  Belamarich, page 977, second column.  While Belamarich teaches                                 
                  that sitosterolemia may be treated with cholestyramine, a bile sequestering resin,                            
                  it does not teach or suggest the use of ezetimibe.                                                            
                          The examiner’s rationale for the combination appears to be that since                                 
                  patients with sitosterolemia are frequently hypercholesterolemic, and Rosenblum                               
                  teaches that ezetimibe optionally in combination with an HMG-CoA reductase                                    
                  inhibitor is used to lower cholesterol, it would have been obvious to the ordinary                            
                  artisan to use ezetimibe optionally in combination with an HMG-CoA reductase                                  
                  inhibitor to treat sitosterolemia.                                                                            
                          We find that the examiner’s reasoning to be flawed, however, as the art                               
                  established that compounds that are used to treat hypercholesterolemia may not                                
                  be useful in the treatment of sitosterolemia.  See Appeal Brief, pages 12-14.                                 




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