Ex Parte Davis - Page 10


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

                          Salen, cited by Appellant (Appeal Brief, page 14), shows how Belamarich                               
                  would have been understood by those of skill in the art.  Salen teaches that                                  
                  cholestyramine produces “bile acid malabsorption.”  Page 951, left-hand column.                               
                  That is, cholestyramine interferes with absorption of sterol-containing bile acids in                         
                  the digestive tract, with the result that the bile acids and their component sterols                          
                  are excreted in the stool and eliminated from the patient’s body.                                             
                          Rosenblum teaches that “[w]hen intestinal cholesterol absorption is                                   
                  reduced, by whatever means, less cholesterol is delivered to the liver. . . .  Thus,                          
                  the net effect of inhibiting intestinal cholesterol absorption is a decrease in plasma                        
                  cholesterol levels.”  Column 2, lines 6-12.  Rosenblum also teaches that                                      
                  “[c]ombination therapy of an HMG CoA reductase inhibitor and a bile acid                                      
                  sequestrant [a.k.a. bile acid binding resin] has been demonstrated to be more                                 
                  effective in human hyperlipidemic patients than either agent in monotherapy.”                                 
                  Column 2, lines 17-21.                                                                                        
                          Rosenblum teaches that compounds like ezetimibe “have been found to                                   
                  inhibit the intestinal absorption of cholesterol and to significantly reduce the                              
                  formation of liver cholesteryl esters in animal models.”  Column 20, lines 41-44.8                            
                  Rosenblum teaches that ezetimibe can be administered to reduce serum                                          
                  cholesterol levels either alone (column 3, lines 44-49) or in combination with a                              
                  “cholesterol biosynthesis inhibitor” (column 3, lines 54-67) such as an HMG-CoA                               
                  reductase inhibitor (column 6, lines 37-40)                                                                   
                                                                                                                               
                  8 Appellant does not dispute that Rosenblum’s genus encompasses ezetimibe.  See the Appeal                    
                  Brief, page 11 (“Rosenblum et al. disclose that ezetimibe, optionally in combination with an HMB-             
                  CoA reductase inhibitor . . . , is useful for reducing cholesterol.”).                                        




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