Ex Parte LEE - Page 5


                  Appeal No. 2003-0528                                                            Page 5                   
                  Application No. 09/314,841                                                                               
                  reagent has a shelf life, in the unopened final container, of at least 16 months                         
                  and once opened, of at least 10 days.”  Butler, (column 2, lines 38-42).  Butler                         
                  also discloses the effect of each component of the liquid thromboplastin reagent.                        
                  See (column 5, line 32, to column 9, line 3).  For example, Butler disclose                              
                  (column 5, lines 41-43), “[t]he level of calcium has a minor role in the yield                           
                  obtained, but has a dramatic effect on the normal range and the sensitivity of the                       
                  resulting thromboplastin.  Calcium gluconate provides the necessary calcium for                          
                  the coagulation cascade that results in the formation of a clot.”  Butler’s Table 2                      
                  (column 9) sets forth the preferred final concentrations of all thromboplastin                           
                  reagent components.  According to Butler (column 9, lines 35-40), “[a]s shown in                         
                  Table 2, the components of the final formulation are calcium gluconate, sodium                           
                  citrate, sodium chloride, PEG-1450, bovine serum albumin, sodium propionate                              
                  and RBAP [rabbit brain acetone powder, the thromboplastin source] extract …                              
                  [and] a combination of four antimicrobial compounds.”                                                    
                         Recognizing that Butler discloses that the sensitivity of a thromboplastin                        
                  reagent rests on a number of factors including final reagent composition, and                            
                  that Butler’s “reagent” has a shelf life of at least 16 months, we note that the                         
                  examiner appreciates (Answer, page 4), that Brucato’s reagent differs from the                           















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