NICHOLS et al. V. TABAKOFF et al. - Page 24


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               Interference No. 104,522 Paper108                                                                                           
               Nichols v. Tabakoff Page 24                                                                                                 

               Ill." No additional analytical data, e.g., NMR, mass spectral data, etc. have been                                          

               offered for sample 94B-27-1. Further, the NIH did not determine the chemical structure                                      

               or any other physical property of sample 94B-27-1. Thus, none of Exs 2035, 2037 (Ex                                         

               C), 2059 or D, alone or in combination, independently corroborate Nichols' alleged                                          

               synthesis of (NN-diethyl)-4-ureido-5,7-dichloro-2-carboxy-quinoline ethyl ester.                                            

               Moreover, neither Exs 2059 or D, alone or in combination, are sufficient to show that                                       

               sample 94B-27-1 would work for its intended purpose, especially given that the TTE test                                     

               is "new" and neither the test procedure nor the significance of its results have been                                       

               explained.                                                                                                                  

                       Therefore, Nichols fails to meet its burden of proving that the July 1, 1994                                        

               experiment resulted in an actual reduction to practice of an embodiment within the                                          

               scope of the Count, i.e., that the theoretically expected product was obtained and would                                    

               work for its intended purpose.                                                                                              

                                        d. the July 13, 1994 synthesis                                                                     

               54. Dr. Nichols testified that                                                                                              

                       [o]n July 13, 1994, ... I utilized triphosgene 1CO(OCCl3)21 to attach the                                           
                       carbonyl group [CO] to the 4-amino group of 4-tosylamino-5,7-dichloro-2                                             
                       carboxy-quinoline ethyl ester and diphenylamine [NH(diphenyl)21 to attach                                           
                       the secondary amine [NJ to the carbonyl group [CO]. Previously filed as                                             
                       Exhibit 2024 are copies of pages 94B-25 and 94B-32 from my Lab Book                                                 
                       documenting this experiment. I labeled a sample from this experiment                                                
                       94B-32-111.                                                                                                         

                       I sent a sample of 94B-32-1 11 for mass spectral analysis. On August 10,                                            
                       1994, a fast atom bombardment (FAB) mass spectrum was performed in                                                  
                       the Analytical Chemistry Center of the University of Texas Medical School                                           
                       in Houston on 94B-32-111. A copy of a spectrum data sheet generated                                                 
                       from the FAB spectrum of 94B-32-111 and the declaration of William E.                                               
                       Seifert, Assistant Director of the Analytical Chemistry Center in August                                            








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