Ex Parte Gordon et al - Page 4

                  Appeal 2007-2516                                                                                         
                  Application 10/302,553                                                                                   
                  3.  “[L]ung surfactant compositions comprise phospholipids and . . . can                                 
                  additionally contain lung surfactant proteins” (Hafner ‘970, col. 3, ll. 42-44).                         
                  4.  The lung surfactant compositions can also contain calcium to set a                                   
                  favorable viscosity (Hafner ‘970, col. 3, ll. 46-48).                                                    
                  5.  Commercially available lung surfactants include “Curosurf® . . . , a                                 
                  highly purified natural surfactant from homogenized pigs’ lungs, Survanta®                               
                  . . . and Alveofact® . . . , both extracts of bovine lungs, and also Exosurf® . .                        
                  . , a synthetic phospholipid with auxiliaries” (Hafner ‘970, col. 3, ll. 48-55).                         
                  6.  Hafner ‘970 describes therapeutic compositions which comprise                                        
                  dipalmitoylphosphatidylcholine, which is a phospholipid (Hafner ‘970, cols.                              
                  4-5, Examples 1-4), or lung surfactant purified from bovine lungs (Hafner’                               
                  970, col. 5, ll. 40-45, Example 5).                                                                      
                  7.  The composition can be a powder (Hafner ‘970, col. 5, ll. 4-6) which is                              
                  administered by inhalation (Hafner ‘970, col. 4, ll. 25-29).                                             
                  8. Using an animal model for ARDS, Hafner ‘970 shows that administration                                 
                  of lung surfactant as powder improves lung function, leading to a desired                                
                  rise in the PaO2 (Hafner ‘970, col. 6, ll. 53-55; cols. 7-8, Tables 1 and 2;                             
                  Answer 5-6).                                                                                             
                  9.  Hafner ‘970 also shows that increasing surfactant dosage results in a rise                           
                  in PaO2.  See Hafner ‘970, Tables 1 and 2, showing the effect of lung                                    
                  surfactant dosages of 25 mg/kg and 100 mg/kg.                                                            
                  Alliance                                                                                                 
                  10.  It is stated in the instant Specification that “[p]articularly preferred                            
                  embodiments of the invention incorporate spray dried, hollow and porous                                  
                  particulate compositions as disclosed in WO 99/16419 [Alliance]”                                         
                  (Specification 7: 17-18).                                                                                

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