Ex Parte Edwards et al - Page 4




              Appeal No. 2005-0224                                                                                          
              Application No. 08/878,146                                                                                    
                     providers and patients.  Furthermore, it would have been obvious to the                                
                     routineer in the art to have modified the method of Maa by substituting the                            
                     proteins with other active agents by routine experimentation and to                                    
                     broaden the scope of the therapy.                                                                      
                     Appellants argue in response that the examiner has failed to establish a prima                         
              facie case of obviousness.  Brief, page 4.                                                                    
                     Appellants argue that, “Maa does not disclose or suggest the presently claimed                         
              method of delivering an agent to the pulmonary system comprising administering, from                          
              a receptacle, a mass of particles characterized by a 5 mg dose of an agent delivered to                       
              the pulmonary system (present claims 1, 156, 157) in a single, breath activated step                          
              (present claims 1, 156 and 157), ... and/or specifically recited percentages of the                           
              particles having a fine particle fraction of less than 6.8 microns (present claims 156 and                    
              157) and/or 4 microns (present claims 152 and 157) delivered in a single breath                               
              activated step.”  Brief, page 4.   Appellants also argue that Cipolla “discloses that the                     
              current state of the art, at best, can not exceed 5 mg of agent in a single dose.”  Brief,                    
              pages 5-6.                                                                                                    
                     The examiner responds, arguing that Maa discloses respirable fractions of 50                           
              and 70%.  Answer, page 4.  The examiner also points out that appellants state that 50%                        
              delivery of drugs is closely related to the FPF limitation, and that Maa discloses FPF’s of                   
              up to 50% and in table 1 actually discloses respirable fractions of 50 and 70%.  Id.                          


                     We agree with appellants that the examiner has failed to establish a prima facie                       


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