Ex parte COLE et al. - Page 9




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


             thought the minor factors were clavulanic acid or penicillin N                                       
             and deacetoxycephalosporin C but, rather, whether clavulanic                                         
             acid is inherently produced in Lilly’s fermentation broth when                                       
             Lilly’s desired products are produced.                                                               
                    Appellants argue, in reliance upon an Elson declaration                                       
             (exhibit 13), that any clavulanic acid formed in Lilly’s                                             
             fermentation broth would not be removed from the ion-exchange                                        
             column used to separate Lilly’s A16886I and A16886II factors                                         
             from the broth unless a sufficient volume of eluant, which is                                        
             not disclosed by Lilly, is used (brief, pages 12-17).                                                
             Appellants further argue, in reliance upon the Hermann                                               
             declaration (exhibit 14), that any clavulanic acid removed                                           
             from the column would be destroyed in the next steps of                                              
             Lilly’s isolation process (brief, page 17).  These arguments                                         
             are not persuasive because they are directed toward the fate                                         
             of the clavulanic acid after the fermentation step.  In so far                                       
             as the § 103 rejection of exemplary claim 42 is concerned, the                                       
             relevant issue is whether clavulanic acid necessarily is                                             
             formed during the fermentation step along with Lilly’s desired                                       
             products.  As pointed out in the prior board decision (exhibit                                       
             10, page 8), appellants’ claim to clavulanic acid does not                                           
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