Ex Parte YOSHII et al - Page 10


                 Appeal No.  2001-1907                                                       Page 10                    
                 Application No.  08/694,315                                                                            

                 less than 0.2 nm.  As taught by the specification, 0.2nm is the sensitivity of a                       
                 radioimmunoassay method used to determine the amount of histamine                                      
                 remaining after its removal by dialysis.  See Specification, page 10.                                  
                        As acknowledged by the rejection, Yoshii I, Yoshii II, Naiki, Getlik,                           
                 Takashi, while teaching histamine added immunoglobulin, do not teach the                               
                 removal of the histamine after activation of the immunoglobulin.  The examiner                         
                 relies upon McMichael for providing motivation for removing the histamine from                         
                 the histamine/immunoglobulin mixture.  That reliance, however, is misplaced.                           
                        McMichael is drawn to compositions comprising histamine and one or                              
                 more immunogenic substances “specifically immunologically associated with the                          
                 disease state,” wherein “[t]he compositions are administered in small,                                 
                 ‘neutralizing doses.”  McMichael, column 4, lines 27-33.  Immunoglobulin, which                        
                 McMichael teaches is associated with rheumatoid arthritis, is just one example of                      
                 an immunogen that may be used according to the method taught by the patent.                            
                 See id. at column 6, Table.  While admittedly McMichael teaches that only                              
                 minute doses of histamine are required, see id. at column 7, lines 22-27, the                          
                 rejection neglected to read that portion in light of the teaching that the total                       
                 volume of a total dose is also small, i.e., from 0.05 cc to 0.5 cc, see id. at column                  
                 7, lines 4-12.  Thus the reference does not support the conclusion that one                            
                 would have been motivated to remove the histamine because of the small                                 
                 amount of histamine administered, as the volume of the unit dosage is also                             
                 small.                                                                                                 







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