Ex Parte Stamler et al - Page 2


               Appeal No. 2006-1565                                                                       Page 2                  
               Application No. 09/757,610                                                                                         

               S-nitrosoglutathione and protein S-nitrosothiols to modulate [nitrosative stress], by                              
               controlling the intracellular levels of low mass NO [(nitric oxide)] donor compounds and                           
               preventing protein nitrosylation from reaching toxic levels” (id., pages 2-3).  “[N]itrosative                     
               stress” refers to “an impetus for NO or NO2 [(nitrogen dioxide)] group attachment to                               
               proteins, nucleic acids or other biological molecules” (id., page 1).                                              
                      According to appellants, “where glutathione-dependent formaldehyde                                          
               dehydrogenase is expressed to protect [pathologically proliferating cells] from nitrosative                        
               stress” (id., page 19), “administering . . . a therapeutically effective amount of an inhibitor                    
               of glutathione-dependent formaldehyde dehydrogenase” (id.) “selectively impos[es]                                  
               nitrosative stress to inhibit proliferation of pathologically proliferating cells” (id., page 22).                 
                                                           The Claims                                                             
                      Claims 8-14, the only claims remaining in the application, stand rejected under 35                          
               U.S.C. § 112, first paragraph, as lacking enablement.  Claims 8-11 and 13 are                                      
               representative of the subject matter on appeal and read as follows:                                                
                      8.  A method for treating a patient afflicted with pathologically proliferating cells,                      
               said method comprising administering to said patient a therapeutically effective amount                            
               of an inhibitor of glutathione-dependent formaldehyde dehydrogenase.                                               
                      9.  The method of Claim 8 where the pathologically proliferating cells comprise                             
               pathologic bacteria or fungus and the patient is afflicted with a bacterial or fungal                              
               infection which is mediated or caused by the pathologic bacteria or fungus and the                                 
               administering kills the pathologic bacteria or fungus or reduces the rate of proliferation of                      
               the pathologic bacteria or fungus by at least 10%.                                                                 
                      10.  The method of Claim 8 where the pathologically proliferating cells are                                 
               pathologically proliferating mammalian cells and the administering kills the pathologically                        
               proliferating mammalian cells or reduces the rate of proliferation of the pathologically                           
               proliferating cells by at least 10%.                                                                               
                      11.  The method of Claim 10 wherein the pathologically proliferating mammalian                              
               cells are cancer cells.                                                                                            





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