Ex Parte Edwards et al - Page 7




              Appeal No. 2005-0224                                                                                          
              Application No. 08/878,146                                                                                    
                     Upon return of the application to the Examiner, it is recommended that the                             
              Examiner carefully review the disclosure of Cipolla (attached) and determine its                              
              relevance, if any, to the claims of the present application.  It would reasonably appear                      
              that Cipolla, with a publication date of 2000, describes administration of a drug wherein                     
              at least about 50% of the mass of particles stored in the receptacle is delivered to the                      
              pulmonary system of the subject; and at least about 5 milligrams of the agent is                              
              delivered to the pulmonary system of the subject.  In particular, Cipolla describes in                        
              Table 2, page 236, that an “in vivo emitted dose was 51.5% (11.6 mg INS365) for the                           
              AERx® System.”   See also page 234 stating the average emitted dose was                                       
              approximately 50% of the loaded dose.                                                                         
                     The examiner should carefully review Cipolla and enter any appropriate rejection                       
              of the claims, as necessary.                                                                                  


                                                     CONCLUSION                                                             
                     The rejection of claims 1-27, 33-38, 152 and 155 under 35 U.S.C. 103(a)                                
              for obviousness over Maa is reversed.                                                                         
                     The Examiner should review the Cipolla reference of record for its relevance to                        
              the claims of the present application.                                                                        






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