Ex Parte Belder et al - Page 2

             Appeal 2007-0185                                                                                         
             Application 10/305,281                                                                                   
                    1.   A method for reducing LDL cholesterol levels in an mammal which                              
             consists essentially of the administration of 80 mg or 160 mg once per day of                            
             pravastatin, or a pharmaceutically acceptable salt or ester thereof, to a mammal in                      
             need of such treatment.                                                                                  

             Grounds of Rejection                                                                                     
                    1.  Claims 1-9 stand rejected under 35 U.S.C. § 103 over Sherwood.                                
                    2.  Claims 1-9 stand rejected under 35 U.S.C. § 103 over Joshi.                                   

                 References cited                                                                                     
                 Joshi    US 5,030,447   Jul.    9, 1991                                                              
                 Sherwood       GB 2 23 787    Sep. 23, 1992                                                          
                                                                                                                     

                                                   DISCUSSION                                                         

             Obviousness - Sherwood                                                                                   
                    Claims 1-9 stand rejected under 35 U.S.C. § 103 over Sherwood (Answer 4).                         
                    The Examiner contends that Sherwood teaches a method of treating                                  
             hypercholesterolemia comprising the administration of 1-80 mg of LDL-                                    
             cholesterol lowering amounts of HMG-CoA reductase inhibitors, such as                                    
             pravastatin, with Chromium (III) in a single or divided dose.  (Answer 4.)   The                         
             Examiner acknowledges that Sherwood does not expressly teach administering                               
             160 mg of pravastatin, and does not particularly teach a composition containing 80                       
             or 160 mg of pravastatin with chromium (III).  (Id.)  However, the Examiner                              
             concludes that it would have been obvious to one of ordinary skill in the art to                         
             employ the claimed amount of pravastatin in the method and composition of the                            
             invention because it is optimization of a result effective parameter.  (Id.)                             

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