Ex Parte Davis - Page 2


                   Appeal No. 2006-2368                                                                  Page 2                      
                   Application No. 10/247,032                                                                                        

                   32. A method for reducing vascular c-reactive protein levels in a mammal                                          
                   comprising:                                                                                                       
                           administering a therapeutically effective amount of (1) at least one sterol                               
                   absorption inhibitor or 5α-stanol absorption inhibitor and (2) at least one                                       
                   cholesterol biosynthesis inhibitor to a mammal having a blood level of c-reactive                                 
                   protein of greater than about 0.4 mg/dL.                                                                          
                           The claims are subject to a restriction requirement, and appellants have                                  
                   elected the method as practiced with ezetimbre as the specific sterol adsorption                                  
                   inhibitor, and simvastatin as the cholesterol biosynthesis inhibitor.  See Appeal                                 
                   Brief, pages 2-3.                                                                                                 
                           The examiner relies upon the following references:                                                        
                   Rosenblum et al. (Rosenblum)  5,846,966  Dec. 08, 1998                                                            
                   Yeun et al. (Yeun) “C-reactive protein, oxidative stress, homocysteine, and                                       
                   troponin as inflammatory metabolic predictors of atherosclerosis in ESRD,”                                        
                   Current Opinion in Nephrology and Hypertension, Vol. 9, No. 6, pp.621-30                                          
                   (2000).                                                                                                           
                   Erren et al. (Erren) “Systemic inflammatory parameters in patients with                                           
                   atherosclerosis of the coronary and peripheral arteries,” Arterioscler Thromb                                     
                   Vasc Biol. Vol. 19, No. 10, pp. 2355-63 (1999).                                                                   
                   Gruberg, “Inflammatory markers in acute coronary syndromes: C-reactive protein                                    
                   (CRP) and Chlamydia,” American Heart Association Scientific Sessions (2000).                                      

                           Claims 1-3, 10, 12, 13, 17, 19, 20 and 30-35 stand rejected under                                         
                   35 U.S.C. § 102(b) as being anticipated by Rosenblum as evidenced by Erren.                                       
                   In addition, the claims stand rejected under 35 U.S.C. §103(a) as being obvious                                   
                   over the combination of Rosenblum and Erren or Yuen, or as being obvious over                                     
                   the combination of Rosenblum, Erren or Yuen, and Gruberg.  After careful review                                   
                   of the record and consideration of the issues before us, we affirm the rejection of                               






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