Ex Parte Naito - Page 15




               Appeal No. 2005-0126                                                                                              
               Application No. 09/967,791                                                                                        
               the examiner argues that the art teaches suitable alternatives for the mode of                                    
               administration of said sugar composition.  Answer, p. 7.  I agree.                                                
                      Turning to the applied prior art, I find that Keep discloses that hypertonic agents                        
               are typically “infused for 30 seconds through a major cerebral artery,” but that less                             
               invasive and more convenient intravenous routes are also acceptable.  Keep, col. 5,                               
               lines 42-44 and lines 49-52.  Keep further discloses (col. 6, lines 29-33) that the                               
               invention includes                                                                                                
                      . . . all methods of administering treatment medications along with all methods of                         
                      opening, bypassing or disrupting the blood-brain barrier in combination,                                   
                      simultaneously or in sequence to get the treatment medication in contact with                              
                      nervous tissues.                                                                                           
                      Keep still further discloses that numerous alternative routes of administering                             
               pharmaceutical compositions into the blood stream were known in the art at the time the                           
               application was filed.  See, e.g., Keep, col. 5, line 64- col. 6, line 62.  Keep still further                    
               discloses that the preferred route depends on the condition of the patient.  Id., col. 6,                         
               lines 21-22.  Keep still further discloses a formulation comprising a therapeutic drug                            
               (desired compound for crossing the blood-brain barrier) and mannitol (a sugar                                     
               composition) which may be “isotonic, hypotonic or hypertonic with the blood of the                                
               recipient.”  Keep, e.g., col. 8, lines 59-66; see also, the Brief, p. 14, last para.                              
                      In addition to teaching that a hypertonic sugar composition increases the                                  
               permeability of the blood-brain barrier, Naito discloses that the mode of administration is                       
               immaterial so long as the hypertonic sugar composition and compound of interest                                   


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