Ex Parte Davis - Page 6


                   Appeal No. 2006-2368                                                                  Page 6                      
                   Application No. 10/247,032                                                                                        

                   level of C-reactive protein is inherently present in 50 out of 100 atherosclerosis                                
                   patients.  And as the treatment of a single patient with ezetimbre as the specific                                
                   sterol adsorption inhibitor, and simvastatin as the HMG-CoA reductase inhibitor,                                  
                   wherein the patient has a blood level of CRP greater than about 0.4 mg/dL would                                   
                   anticipate the methods of claims 1 and 32, Rosenblum is deemed to inherently                                      
                   anticipate the subject matter of those claims.                                                                    
                           With respect to treating vascular inflammation (claim 1) or reducing                                      
                   vascular c-reactive protein levels (claim 32), those results would be inherent in                                 
                   the method of Rosenblum, as you are administering the same compounds, i.e.,                                       
                   ezetimbre as the specific sterol adsorption inhibitor, and simvastatin as the HMG-                                
                   CoA reductase inhibitor, to the same group of patients, atherosclerosis patients,                                 
                   more than half of which, as discussed above, have c-reactive protein levels                                       
                   greater than about 0.4 mg/dL.  See Perricone v. Medicis Pharmaceutical Co.,                                       
                   432 F.3d 1368, 1377-78, 77 USPQ2d 1321, 1328 (Fed. Cir. 2005) (noting that                                        
                   the realization of a new benefit of an old process does not render that process                                   
                   patentable); see also Bristol-Myers Squibb Co. v. Ben Venue Laboratories, 246                                     
                   F.3d 1368, 1376, 58 USPQ2d 1508,1514 (Fed. Cir. 2001) (stating in the context                                     
                   of a claimed process that was drawn to the same use comprising the same steps                                     
                   of the prior art, “[n]ewly discovered results of known processes directed to the                                  
                   same purpose are not patentable because such results are inherent.”).                                             
                           Our review of the Rosco case, cited by appellants, does not suggest a                                     
                   different result.  That case involved “cross-view” mirrors, used on school buses,                                 
                                                                                                                                     
                   Vol. 68, pp. 297-303 (2004).                                                                                      





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