ENGVALL et al. V. DAVID et al. - Page 9




                The bracketed terms, [Ab*Ag], [Ab] and [Ag], represent the equilibrium concentrations in moles27                         
                per liter of the antibody/antigen complex, the antibody and the antigen, respectively.    The “•”28                           
                indicates the mathematical product of the adjacent terms.  The units of affinity are liters/mole.    The29                      
                calculated value of the affinity constant is a characteristic of the specific antibody/antigen reaction,                 
                rather than a characteristic of a particular antibody.30                                                                 
                        As can  be  seen  from  the  above  equation,  the mathematical  maximum  and  minimum                           
                possibilities for affinity are 4 and 0.  Where all antibody and antigen bind to form Ab*Ag and remain                    
                bound (i.e., the binding is so strong that there is no reverse reaction), the concentration of antibody                  
                                                                    31                                                                   
                would be zero giving an affinity constant of 4.  If no reaction takes place, there would be no                           
                                                                                  32, 33                                                 
                concentration of product Ab*Ag, giving an affinity value of 0.                                                           
                        In reality, affinity falls between these two values.   All antibody/antigen reactions have an                    
                affinity constant.  The higher the affinity constant value, the tighter the binding of the antibody and                  
                the antigen and the lower the concentration of the antigen that can be detected.   The subject matter34                                     
                of this interference relates only to antibodies having an affinity constant of about 10  liters/mole and8                                 
                higher.                                                                                                                  
                        Avidity is a concept related to affinity.  Because antibodies have two binding sites, antibodies                 
                are potentially multivalent in the reaction with antigen.  Antigens may also have more than one                          
                antigenic determinant and may also be multivalent.  When such a multivalent antigen combines with                        

                        27                                           23                                                                  
                                A mole is the weight in grams of 6.02 X 10  molecules of a chemical.  CHEM, p. 45.                       
                        28                                                                                                               
                                IMMU, p. 6.6                                                                                             
                        29                                                                                                               
                                         [moles/liter]          =                    1              =   liters/mole                      
                                        [moles/liter][moles/liter]               [moles/liter]                                           
                        30                                                                                                               
                                Throughout this opinion, the use of the word “affinity” means the affinity constant of the relevant      
                antibody/antigen reaction.                                                                                               
                        31                                                                                                               
                                K =    [Ab*Ag] =  4                                                                                      
                                [0]·[0]                                                                                                  
                        32                                                                                                               
                                K =          [0]         = 0                                                                             
                                [Ab][Ag]                                                                                                 
                        33                                                                                                               
                                It is to be recognized that “0" and “4” are theoretical mathematical limits and actually represent “non- 
                reversible reactions.”                                                                                                   
                        34                                                                                                               
                                IMMU, p. 6.6.                                                                                            
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