Ex parte EPSTEIN et al. - Page 10




                 Appeal No. 96-2137                                                                                                                     
                 Application 07/668,920                                                                                                                 



                 intracellular antigens of unspecified necrotic neoplastic tissue but not substantially bind                                            
                 to unspecified living neoplastic tissue.  Reviewing this portion of claim 18 in light of the                                           
                 specification, it is not clear what is meant by the phrase the antibody “does not                                                      
                 substantially bind to living neoplastic tissue.”                                                                                       
                          The most relevant portion of the disclosure of this application which aids in                                                 
                 interpreting this aspect of the claimed invention is Table 1.  However, it is not clear how                                            
                 the data presented in this table are to be interpreted nor how the binding requirements                                                
                 of claim 18 are to be interpreted in light of these data.  As seen from the heading of the                                             
                 table, high counts denote antibody binding.  Appellants do not explain what is meant by                                                
                 high counts.  The table contains negative control values but the specification does not                                                
                 explain how these negative controls were obtained or how they are to be used in                                                        
                 interpreting the count values resulting from the assays using live cells of SU-DHL-2 and                                               
                 A549.  For example, if the negative control value of 552 set forth for the live cells of                                               
                 SU-DHL-2 is to be interpreted as a background control value, all of the monoclonal                                                     
                 antibodies with the exception of 859-4 and 780-3, appear to “substantially bind” rather                                                
                 than “not substantially bind” living neoplastic tissue, i.e., living SU-DHL-2 cells.  The                                              
                 same observation is seen from viewing the data presented for the A549 live cells.                                                      
                 There, all of the monoclonal antibodies appear to “substantially bind” rather than “not                                                
                 substantially bind” living neoplastic tissue, i.e., live A549 cells.                                                                   

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