Ex Parte OHSHIRO - Page 5


                Appeal No. 2002-1360                                                  Page 5                  
                Application No. 09/133,942                                                                    

                3.  In the first working example (pages 8-11), solutions containing varying                   
                concentrations of UTI were prepared and mixed with buffer.  The absorbance of                 
                the mixture was measured, then anti-UTI antibody solution was added and the                   
                absorbance was measured again.  The change in absorbance indicated the UTI                    
                concentration.                                                                                
                      As used in immunology, “agglutination” means “[c]lumping of particulate                 
                antigens, e.g. red cells, bacteria, etc. by reaction with specific antibody which             
                forms bridges between antigenic determinants on contiguous particles.”  See                   
                Herbert,1 page 6.  Precipitation, by contrast, means “the formation of a visible              
                complex on the addition of soluble antibody to soluble antigen.”  Id., page 179.              
                See also Leffell,2 page 120:  “Precipitation and agglutination were the first                 
                methods employed for demonstrating autoantibodies in human sera.                              
                Precipitation of cardiolipin has long served as a method for supporting the                   
                diagnosis of syphilis. . . .  Agglutination reactions are highly sensitive methods for        
                demonstrating antibody.  Indirect, or conditioned, hemagglutination requires that             
                a soluble antigen be attached to a particle, such as a red blood cell or latex.”              
                      The difference between an assay based on precipitation and one based                    
                on agglutination is discussed in detail by Tizard.3  Tizard states that the                   
                difference between precipitation and agglutination is “determined by the physical             
                state of the reactants.  If antibodies combine with soluble antigens in solution              

                                                                                                              
                1 Herbert et al. (eds.), “Dictionary of Immunology,” 3rd edition, Blackwell Scientific Publications
                (1985), copy attached.                                                                        
                2 Leffell et al. (eds.), “Handbook of Human Immunology,” CRC Press (1997), copy attached.     
                3 Tizard, “Immunology: An Introduction,” Saunders College Publishing (1988), copy attached.   





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