Ex parte AGNELLO - Page 4




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



              Knight.  We reverse both rejections.  In addition, we raise an issue for the examiner to                 
              consider upon return of the application.                                                                 
                                                    DISCUSSION                                                         
                     The claims on appeal are directed to measurement of circulating human antibodies                  
              to double stranded DNA (dsDNA).  A serum sample is incubated with immobilized                            
              antibodies or F(ab’)2 fragments specific for the Fc region of human IgG to capture and                   
              immobilize IgG present in the sample; the captured, immobilized IgG is incubated with                    
              labeled synthetic dsDNA, forming an immunological complex if antibodies specific for                     
              dsDNA are present; and the amount of dsDNA-specific antibody in the sample is                            
              determined by measuring the amount of bound labeled dsDNA.  Claim 1 recites that the                     
              dsDNA label is digoxigenin, while claim 3 recites that the label is alkaline phosphatase.                
                     Litman discloses a generic immunoassay protocol “employing rigid solid surfaces                   
              which may or may not be separated from the assay medium for measurement, where the                       
              signal may be developed without concern as to the presence of reagents in the solution                   
              affecting the observed signal on the solid surface.”  IgG is listed as one of hundreds of                
              analytes which can be detected by Litman’s assay protocol.  There is no mention of IgG of                
              any particular specificity.  See column 1, lines 41-45 and column 17, line 67.                           





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