Ex Parte Edwards et al - Page 2




                       Appeal No. 2005-0224                                                                                                                                                           
                       Application No. 08/878,146                                                                                                                                                     

                       i)         at least about 50% of the mass of particles stored in the receptacle is delivered to                                                                                
                                  the pulmonary system of the subject; and                                                                                                                            
                       ii)        at least about 5 milligrams of the agent is delivered to the pulmonary system of                                                                                    
                                  the subject.                                                                                                                                                        

                                  The prior art references relied upon by the examiner are:                                                                                                           
                       Maa et al. (Maa)                                                      6,284,282                          April, 2001                                                           
                                  Reference cited by appellants and Merits Panel:                                                                                                                     
                       Cipolla, et al. (Cipolla), “Bolus Administration of INS365: studying the feasibility of                                                                                        
                       delivering high dose of drugs using the AERx® Pulmonary Delivery System,” in Byron,                                                                                            
                       PR, Farr, SJ, eds.,  Respiratory Drug Delivery VII, Buffalo Grove, IL, InterPharm Press,                                                                                       
                       pp. 231-239 (May 14-18, 2000).                                                                                                                                                 
                       Grounds of Rejection                                                                                                                                                           
                                  Claims 1-27, 33-38, 152 and 155 stand rejected under 35 U.S.C. 103(a) for                                                                                           
                       obviousness over Maa.                                                                                                                                                          
                                  We reverse this rejection.                                                                                                                                          


                                                                                      DISCUSSION                                                                                                      
                       35 U.S.C. § 103                                                                                                                                                                
                                  Claims 1-27, 33-38, 152 and 155 stand rejected under 35 U.S.C. 103(a)                                                                                               
                       for obviousness over Maa.                                                                                                                                                      
                                  In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden                                                                                    
                       of presenting a prima facie case of obviousness.  See In re Rijckaert, 9 F.3d 1531,                                                                                            
                       1532, 28 USPQ2d 1955, 1956 (Fed. Cir. 1993).   It is well-established that the                                                                                                 
                       conclusion that the claimed subject matter is prima facie obvious must be supported by                                                                                         

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