Ex Parte Weers et al - Page 2

                 Appeal 2007-0526                                                                                        
                 Application 10/141,032                                                                                  

                 While some drug formulations use propellants or compressed gas to deliver                               
                 the drug to the patient’s lungs, passively inhaled powders rely on the                                  
                 patient’s own inhalation to provide the energy needed to aerosolize the drug                            
                 formulation (id. at 1-2).  However, “inspiration flow rate can drastically vary                         
                 between individuals. . . .  Variability in inspiratory effort may affect the                            
                 ability of the formulation to be dispersed within a gas stream, the ability to                          
                 deagglomerate a powdered formulation, and/or the ability of the aerosolized                             
                 formulation to adequately reach the deep lung” (id. at 2).                                              
                        “Due to its spreading characteristics on lung epithelia, surfactant has                          
                 been proposed as the ideal carrier for delivery of drugs to the lung, and via                           
                 the lung to the systemic circulation” (id. at 3).   However, the Specification                          
                 discloses that using surfactants such as phospholipids to deliver drugs to the                          
                 lungs can be problematic because fine powders containing them may have                                  
                 poor dispersibility, resulting in difficulties “when attempting to deliver,                             
                 aerosolize, and/or package the powders” (id.).                                                          
                        The Specification discloses “dry powder compositions of                                          
                 phospholipids . . . [that] are efficiently delivered to the deep lung.  The                             
                 phospholipid[s] may be delivered alone . . . or in combination another active                           
                 agent and/or excipient” (id.).  “[A]ctive agents useful in this invention                               
                 include . . . tobramycin . . .” (id. at 5).                                                             
                                                    DISCUSSION                                                           
                 1.  CLAIMS                                                                                              
                        Claims 20-31, 33-39, 42, and 51-59 are pending and on appeal.                                    
                        Appellants separate the claims into two groups for argument, with                                
                 Group I containing claims 20-31, 33-39, and 42, and Group II containing                                 


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