Ex parte AGNELLO - Page 2




                 Appeal No. 95-4481                                                                                                                     
                 Application No. 07/911,667                                                                                                             



                          Claims 1 through 3 are illustrative of the subject matter on appeal and read as                                               
                 follows:                                                                                                                               
                          1.  A method of assaying for antibodies to human double-stranded DNA in a liquid,                                             
                 human-serum specimen, said method comprising the steps of:                                                                             
                          forming a first incubation mixture of said specimen and a solid phase                                                         
                 immunoadsorbent having immobilized thereon animal anti-human IgG antibody including                                                    
                 F(ab')2 fragment specific for IgG Fc;                                                                                                  
                          incubating said first mixture under conditions and for a period of time sufficient for                                        
                 Fc in human IgG in said specimen to become bound by said F(ab')2 fragment in said                                                      
                 animal anti-IgG antibody;                                                                                                              
                          forming a second incubation mixture of said first mixture and digoximenin-labelled                                            
                 synthetic double-stranded DNA under such conditions and for a period of time sufficient to                                             
                 bind to said immunoadsorbent any anti-DNA antibodies which may be present in the                                                       
                 serum so as to form a double-stranded DNA antibody that has substantially no single                                                    
                 stranded or denatured components;                                                                                                      
                          detecting the amount of digoxigenin labelled synthetic double-stranded DNA bound                                              
                 to said immunoadsorbent; and                                                                                                           
                          relating the amount of bound labelled synthetic double-stranded DNA detected to a                                             
                 predetermined quantitative relationship between the amount of labelled double-stranded                                                 
                 DNA and the amount of animal anti-human IgG antibody to determine the amount of human                                                  
                 IgG in said specimen.                                                                                                                  
                          2.  A method of assaying for antibodies to human double-stranded DNA in a human                                               
                 serum specimen, said method comprising the steps of:                                                                                   
                          capturing the anti-double-stranded DNA portion of IgG in said human serum                                                     
                 specimen by the Fc part of a molecule using solid phase immobilized F(ab')2 fragment of                                                
                 anti-human IgG specific for Fc;                                                                                                        



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