Ex Parte BREITNER et al - Page 3



                Appeal No. 2003-0865                                                  Page 3                  
                Application No. 09/300,789                                                                    

                                                 Background                                                   
                      The specification discloses “a method of preventing or delaying the onset               
                and progression of Alzheimer’s disease and related neurodegenerative                          
                disorders.  The method involves the administration to individuals at risk of                  
                developing the disease a non-steroidal anti-inflammatory agent and/or a                       
                histamine H2 receptor blocking agent.”  Page 1.  Exemplary nonsteroidal anti-                 
                inflammatory agents include acetylsalicylic acid (aspirin) and ibuprofen.  See                
                pages 9-10.  Exemplary histamine H2 receptor blocking agents include ranitidine               
                (Zantac®).  Page 10.                                                                          
                      The specification theorizes that                                                        
                      both nonsteroidal anti-inflammatory agents and histamine H2                             
                      receptor blocking agents may inhibit the pathogenesitic process of                      
                      Alzheimer’s disease . . . via processes mediated by COX                                 
                      [cyclooxygenase], including excitatory events in the n-methyl-d-                        
                      aspartate (NMDA) pathway. . . .  Under aberrant conditions (eg                          
                      [sic], excessive stimulation), the NMDA pathway can induce                              
                      excitotoxic cell death. . . .  The fact that both nonsteroidal anti-                    
                      inflammatory agents and H2 blockers prevent or delay the onset of                       
                      Alzheimer’s disease may result from the involvement of COX and                          
                      the NMDA pathway in development of the disease.                                         
                Pages 12-13.  Based on this observation, the specification speculates that                    
                “inhibition of Alzheimer’s disease pathogenesis can be expected to be effected                
                using compounds, other than those described above, that similarly impact on the               
                NMDA pathway and thereby protect against neuronal cell death that may                         
                underlie the neurodegeneration of Alzheimer’s disease and related disorders.”                 
                Pages 13-14.                                                                                  






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