Ex Parte ZIEGELMAIER - Page 9


                   Appeal No. 2001-1654                                                                  Page 9                      
                   Application No. 08/445,584                                                                                        

                           David teaches that a sandwich immunoassay can be conducted by                                             
                   simultaneously incubating an immobilized antibody, the antigen, and a labeled                                     
                   antibody.  See column 4, lines 50-61.  David’s assay comprised only these three                                   
                   components.  See column 8, lines 6-25.  David teaches that simultaneous                                           
                   incubation is possible if both the immobilized antibody and the labeled antibody                                  
                   are monoclonal antibodies, directed to different epitopes of the same antigen.                                    
                   See id.                                                                                                           
                           David does not provide guidance with respect to immunoassays in                                           
                   general, nor does it suggest that all immunoassays can or should be conducted                                     
                   by simultaneously incubating all the components in a single incubation.  In                                       
                   particular, David does not suggest converting Unger’s pretreatment with anti-IgG                                  
                   into a simultaneous incubation of anti-IgG with the other assay components.                                       
                           Schmitz also fails to suggest this limitation of the claimed method.  The                                 
                   examiner cited Schmitz simply to meet the limitation requiring use of a labeled                                   
                   antigen.  See the Examiner’s Answer, page 6 (“It would have been obvious . . . to                                 
                   use the labeled antigen of Schmitz in the assay of Duermeyer.”).  Schmitz does                                    
                   not suggest simultaneous incubation of all the recited reagents.                                                  
                           We therefore conclude that the references cited by the examiner do not                                    
                   teach or suggest all of the limitations of the instant claims.  In particular, the                                
                   references do not suggest the limitation requiring simultaneous incubation of “a                                  
                   substance which inhibits binding of immunoglobulin G to the solid phase and                                       
                   inhibits binding of [the] . . . antigen to immunoglobulin G” with an immobilized                                  
                   anti-IgX antibody, a sample, and an antigen-specific label.                                                       





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