Ex Parte Naito - Page 3




               Appeal No. 2005-0126                                                                                              
               Application No. 09/967,791                                                                                        
               leakage of fluid from the capillaries, leaving transcellular flow from the capillary to the                       
               brain as the only means for fluid and solutes to enter the brain from the bloodstream.”                           
               Id.                                                                                                               
                      “Among the means of transcellular fluid flow available to other organs of the                              
               body, pinocytosis is virtually non-existent in brain capillaries.  Consequently, solutes                          
               may enter the brain in one of two ways.  Facilitated transport, a specialized carrier or                          
               receptor catalyst molecule transports a particular molecule through the endothelial cell                          
               wall into the brain.  In lipid-mediated transport, small lipid molecules dissolve in and                          
               diffuse through the endothelial cell membrane. ”  Specification, pages 1-2.                                       
                      “While these mechanisms permit entry into the brain of essential nutrients, the                            
               existence of the blood-brain barrier effectively prevents other substances, such as                               
               hormones, proteins, certain ions, and drugs from entering the brain.”  Specification,                             
               page 2.                                                                                                           
                      According to the specification, it has been discovered that a hypertonic sugar                             
               composition is effective to promote the entry of a chemical substance, such as a                                  
               nutrient or diagnostic or therapeutic agent, across the blood-brain barrier when the                              
               composition is administered to an animal by other than by gastrointestinal absorption or                          
               intravascular injection.  In particular, the described invention provides for the promotion                       
               of the entry of a nutrient or a diagnostic or therapeutic agent across the blood-brain                            
               barrier by co-administering the agent with a hypertonic sugar composition, which sugar                            
               is administered by a route that permits absorption into the body through the nasal,                               

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