Ex parte LIN et al. - Page 6




              Appeal No. 1997-4138                                                                                      
              Application No. 08/384,681                                                                                


              in liquid form comprising an enzyme coupled to a specific second binding partner of the at                
              least one component to be detected."  The examiner acknowledges that (Answer, page 6):                    
                            Fish differs [from the claimed invention] in failing to disclose                            
                            the concentration of the probe (either stock or working                                     
                            solution).                                                                                  
                     The examiner does not allege that the remaining references provide that which is                   
              missing from Fish.  Instead the examiner concludes that (Answer, pages 6-7):                              
                            [i]t would have been a matter of routine optimization well within                           
                            ordinary skill in the art to ascertain an acceptable                                        
                            concentration of probe or sample dilution, such as that                                     
                            specifically claimed, because the particular concentration of                               
                            probe required depends upon the antibody used and the                                       
                            enzyme used, e.g.[,] how avid the antibody is to begin with;                                
                            how active the enzyme preparation is; how much inactivation                                 
                            of the antibody and/or enzyme occurs as a result of the                                     
                            conjugation process; the molar ratio of antibody/enzyme in the                              
                            probe, etc.  These factors can vary widely for different                                    
                            conjugate, particularly when monoclonal antibodies are used.                                
                            Thus, use of a particular concentration of conjugate carries                                
                            little patentable weight, especially where the recited                                      
                            concentration may refer to either a stock solution which can be                             
                            further diluted to form a working solution or to the working                                
                            solution itself.                                                                            

                     What is missing from this analysis and the conclusion reached is any evidence                      
              which would establish that this information was within the knowledge of one of ordinary skill             
              in this art at the time of the invention and which would reasonably support either                        




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