ENGVALL et al. V. DAVID et al. - Page 53




                Hope National Medical Center in June 1978. ER718, ¶ 8.  During her tenure, in July of 1979, Dr.                            
                Ruoslahti moved his laboratory from the City of Hope to the La Jolla Cancer Research Foundation.                           
                Uotila, ER718, ¶ 10.  She continued employment in Dr. Ruoslahti’s laboratory until September, 1980.                        
                Uotila, ER718-19, ¶ 10.  Dr. Uotila was assigned the task of developing monoclonal antibodies to                           
                AFP and to develop immunoassays using the antibodies.  Uotila, ER718, ¶ 8.  She states that she                            
                recorded her experimental work in six notebooks. Uotila, ER725, ¶ 22.  She testified that she entered                      
                data into the notebook “generally” in chronological order.   ER725, ¶ 22.  She also indicated she only                     
                occasionally dated her work.   Uotila, ER725, ¶ 22. Our review of the notebooks shows that the                             
                pages are rarely dated and that the notebook pages are neither signed nor witnessed.                                       
                        It is alleged that Dr. Uotila carried out a one-step, two-site ELISA sandwich assay using two                      
                different monoclonal antibodies to human alphafeto protein.  Engvall Brief, pp. 51-64.  According                          
                to Engvall, Dr. Uotila performed several sandwich immunoassays for human alphafeto protein using                           
                two different monoclonal antibodies.  Engvall Brief, pp. 51-62 and 80-94.  The antibodies used were                        
                designated 50/3, 73/3 and 73/8.  Engvall Brief, p. 59.   Dr. Uotila testified that the raw data for the                    
                first successful sandwich assay is reported at page 0041 of her Notebook V (Exhibits 5 and 5A ) in   63                    
                the upper right hand corner under column 8.  Uotila, ER759, ¶ 83; Uotila, ER760, ¶ 85.  She said that                      
                she used this raw data to plot a dose response curve appearing in red in the center of page 0043D of                       
                Notebook V (Exhibit E5A).  This data was replotted by Dr. Uotila during her redirect examination                           
                as Exhibit E109 and reproduced on page 58 of Engvall’s Brief.                                                              
                        The portions of Engvall’s brief directed to these alleged successful assays (Engvall Brief, pp.                    
                51-68 and 80-94) do not mention the affinity constant of the antibodies used.  Only a part of                              
                Engvall’s Statement of Facts, Section II. F. (Engvall Brief, pp. 64-68), directly discusses the affinity                   
                constants of the antibodies used in the alleged reductions to practice.  Engvall there relies only on                      
                subsequent testing to show that antibodies 50/3, 73/3 and 73/8 had affinity constants for AFP of at                        
                least about 10  liters per mole.  These tests were performed ex parte in 1988, during the pendency8                                                                                                           
                of this interference, to show that antibodies 50/3, 73/3 and 73/8 met the “at about 10  liters per mole”8                                  
                limitation of the count.   Engvall Brief, pp. 64-68.   According to Engvall, samples of antibodies 50/3,                   


                        63                                                                                                                 
                                E5 and E5A appear to be identical but the latter is a color rather than a black and white copy.            
                                                                    50                                                                     





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