Ex Parte Janjikhel et al - Page 3

               Appeal  2007-3734                                                                           
               Application 11/286,137                                                                      

               teaching “an analgesic mixture of oxycodone and ibuprofen that has a                        
               synergistic analgesic effect” and for exemplifying “oral tablet compositions                
               having 5 mg of oxycodone HCl and 300 mg of ibuprofen” (Answer 4).  The                      
               Examiner relies on Newman for teaching “a composition for pain relief                       
               comprising oxycodone and ibuprofen for acute pain relief” and for                           
               exemplifying “oral tablet compositions having 400 mg ibuprofen and                          
               5.17 mg of oxycodone hydrochloride” (id. at 5).                                             
                      The Examiner relies on Chiu for teaching “a method for the                           
               preparation of oxycodone,” which “proceeds via synthesis of                                 
               14-hydroxycodeinone and subsequent hydrogenation to form the oxycodone                      
               product” (id.).  The Examiner concludes that it would have been obvious                     
                      to  provide  an  oral  composition  for  pain  relief  comprising                    
                      ibuprofen, oxycodone and 14-hydroxycodeinone, because                                
                      Baker et al. and Newman et al. teach that it is known to provide                     
                      a combination of ibuprofen and oxycodone for the treatment of                        
                      pain, and Chiu et al. teaches that oxycodone is prepared by a                        
                      synthetic pathway that . . . necessarily results in an amount of                     
                      remaining 14-hydroxycodeinoene as a part of the oxycodone                            
                      product.                                                                             
               (Id. at 6.)                                                                                 
                      The Examiner also finds that “the state of the prior art at the time of              
               filing of Appellants[’] application was that 14-hydroxycodeinone was                        
               known to be an impurity present in oxycodone formulations that those of                     
               ordinary skill in the art desired to remove and were finding difficult to do                
               so” (id. at 15).  In support of this position, the Examiner refers to Chapman               
               and Freiha, which are of record and “were published shortly before the filing               
               date of [Appellants’] application” (id.).                                                   


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