Ex Parte Naito - Page 6




               Appeal No. 2005-0126                                                                                              
               Application No. 09/967,791                                                                                        
                      The appellant responds, arguing Naito or Keep do not disclose any route of                                 
               administration of a sugar composition to open the blood-brain barrier than oral (Naito) or                        
               intravascular (Keep).  Brief, page 13.                                                                            
                      With respect to Naito, appellant argues that “[t]he oral administration disclosed by                       
               Naito ... is by ingestion, that is by swallowing followed by absorption in the small                              
               intestines.  Thus, the oral administration of Naito is an ‘enteral (i.e. intestinal)                              
               administration.’”  Reply Brief, page 2.  Appellant further argues that the “present                               
               specification, at each instance where it discloses 'oral', refers to absorption through the                       
               oral mucosa, such as occurs when a subject sucks on a lozenge or gargles or chews                                 
               gum.”  Reply Brief, page 2.   Appellant argues claim 10 does not call for oral                                    
               administration, but for administration via one of 6 different mucosal surfaces, one of                            
               which may be the oral mucosa.  Id.                                                                                
                      Appellant argues that, “Keep does not disclose any method of osmotic disruption                            
               of the blood-brain barrier other than by administration of a hypertonic osmotic agent by                          
               an intravascular route, either intra-arterial or intra-venous.”  Id.  Instead Keep describes                      
               alternative modes of administration for only the formulary drug.                                                  
                      In addressing the appellant’s arguments, the examiner submits that “[o]ral                                 
               administration of the hypertonic composition [in Naito] meets the instant requirement of                          
               administration by a route other than enteral administration or intravascular injection (see                       
               claim 10).”  Answer, page 8.                                                                                      



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