Ex parte AGNELLO - Page 5




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



                     Pope analyzes various species of IgG to determine “which species of IgG is the                    
              most sensitive and specific antigen for the detection of IgG [rheumatoid factor] by                      
              radioimmunoassay.”  See page 842.                                                                        
                     Emlen discloses an ELISA for the detection of circulating antibodies specific for                 
              dsDNA in which biotinylated dsDNA is immobilized in streptavidin-coated wells, the                       
              immobilized  dsDNA is used to capture antibodies specific for dsDNA, and the captured                    
              antibodies are detected with peroxidase-labeled anti-human IgG antibodies.  The                          
              reference focuses on avoiding the problems of a number of conventional assays for                        
              detection of anti-dsDNA antibodies, most of which rely on immobilized DNA to capture                     
              circulating antibodies, and all of which are “plagued with the problem of purity of dsDNA,               
              as well as problems unique to each assay.”  See the Introduction section, especially the                 
              sentence bridging pages 91 and 92.  Emlen overcomes the problems associated with the                     
              other assays by controlling the purity and antigenicity of the immobilized dsDNA.                        
                     Pollard-Knight discloses a number of non-radioactive substances used to label                     
              nucleic acids in hybridization assays.  The labeling substances include digoxigenin, biotin              
              and alkaline phosphatase.                                                                                
                     The examiner believes that it would have been obvious for one of ordinary skill in                
              the art “to combine the solid phase immunoadsorbent for use in a reversible sandwich                     
              immunoassay as disclosed by Litman et al., combined with a method of purifying IgG via                   

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