Ex Parte Janjikhel et al - Page 4

               Appeal  2007-3734                                                                           
               Application 11/286,137                                                                      

                      We conclude that claim 1 is anticipated by Baker or Newman, and                      
               therefore would have been obvious over the applied references.  Anticipation                
               is the epitome of obviousness.  In re McDaniel, 293 F.3d 1379, 1385-1386                    
               (Fed. Cir. 2002).                                                                           
                      Baker describes “a pharmaceutical composition comprising a                           
               combination of synergistically effective analgesic amounts of oxycodone,                    
               . . . and ibuprofen” (Baker, col. 2, ll. 19-22).  Specifically, Baker describes             
               tablets containing oxycodone hydrochloride and ibuprofen (id. at col. 4,                    
               ll. 20-59).                                                                                 
                      Newman describes “a unitary formulation (or oral dosage form)                        
               containing an effective analgesic amount of (a) oxycodone or a                              
               pharmaceutically acceptable salt thereof and (b) ibuprofen or a                             
               pharmaceutically acceptable salt thereof” (Newman ¶ 8).  Specifically,                      
               Newman describes tablets containing oxycodone hydrochloride and                             
               ibuprofen (id. at ¶¶ 59 and 60).                                                            
                      Neither Baker nor Newman specifically recites that                                   
               14-hydroxycodeinone or a pharmaceutically acceptable salt thereof is                        
               present in their compositions.  However, Chapman states that “[c]urrent                     
               commercially-available oxycodone hydrochloride API [active                                  
               pharmaceutical ingredient], and oxycodone hydrochloride prepared by                         
               known procedures, have a level of 14-hydroxycodeinone of greater than                       
               100 ppm” (Chapman ¶ 13).  Thus, we find that Chapman provides evidence                      
               that the oxycodone hydrochloride-containing tablets described in Baker and                  
               Newman inherently contain 14-hydroxycodeinone.                                              



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