Ex parte COLE et al. - Page 7




                 Appeal No. 98-1591                                                                                                                     
                 Application 08/417,625                                                                                                                 


                 Lilly’s example 17 (exhibit 10, page 18, line 56), six tests                                                                           
                 produced both clavulanic acid and cephamycin C which,                                                                                  
                 appellants indicate, is one of Lilly’s desired products                                                                                
                 (brief, page 9),  whereas in six tests, neither clavulanic4                                                                                                         
                 acid nor cephamycin C was made.   In the remaining three5                                                                              
                 tests, the data are inconclusive.   That is, in experiment 6                                                                           
                 R204 batches 50/4 and 50/8, the imidazole assay and bioassay                                                                           
                 showed no production of clavulanic acid or cephamycin C.  The                                                                          
                 HPLC analysis, however, indicated that cephamycin C, but not                                                                           
                 clavulanic acid, was present.  In experiment R204 batch 50/6,                                                                          
                 no clavulanic acid was detected by use of the imidazole assay,                                                                         
                 whereas clavulanic acid was detected by HPLC and cephamycin C                                                                          
                 was detected by use of both the bioassay and HPLC.  It appears                                                                         
                 that the test results which indicated the presence of                                                                                  
                 cephamycin C in batches 50/4 and 50/8, and the test results                                                                            


                          4Experiment R201, batches 50/6, 50/7 and 50/8; experiment                                                                     
                 R204, batches 50/3, 50/5 and 50/7.  In experiment R204,                                                                                
                 batches 50/5 and 50/7, the imidazole and bioassay both showed                                                                          
                 no clavulanic acid, whereas the HPLC test indicated the                                                                                
                 presence of both clavulanic acid and cephamycin C.                                                                                     
                          5Experiments R202 and R203.                                                                                                   
                          6Experiment R204, batches 50/4, 50/6 and 50/8.                                                                                
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