CABILLY et al. V. BOSS et al. - Page 18




                   Interference No. 102,572                                                                                                                          

                             (16)  Cabilly testified that he conducted a refolding experiment with the material                                                      

                   from the cotransformed heavy and light chain E. coli cells.  He grew the cotransformants,                                                         

                   lysed them by sonication, solubilized the pellet with guanidine hydrochloride and incubated                                                       
                   this material overnight at room temperature.  He then, dialyzed the reaction mixture against                                                      
                   urea buffer at room temperature followed by dialysis into phosphate buffered saline (PBS).                                                        
                   Cabilly  testified that he performed an assay to detect active anti-CEA antibody.  He                                                             
                   indicated that he found the heavy chain and light chain protein had recombined to yield                                                           
                   antigen binding activity significantly higher than background. Cabilly, ¶ 8 (CR-40).                                                              
                             (17) Mumford, an employee of Genentech, was responsible for microbial                                                                   
                   fermentation optimization of gene products. Mumford, ¶ 2 (CR-35) .  The record shows that                                                         
                   on three occasions between December 13, 1982 to March 25, 1983, he or someone in his                                                              
                   lab received and recorded receipt of labeled microbial samples. Mumford, ¶¶ 5-7  (CR-                                                             

                   36).  Of specific interest is the receipt on February 2, 1983 of W3110/p10  and W3110/p6                 2                      2                 
                   from Heyneker's laboratory. Mumford, ¶ 7.  Mumford recorded:                                                                                      

                             [T]hese two organisms are E. coli strains, which had been co-transformed                                                                
                             with two plasmids for the co-expression of heavy and light chain of an anti-                                                            
                             CEA antibody.  These samples were used to prepare the DMSO stocks                                                                       
                             1246-31 and 1246-32, respectively.  (¶ 7) (CR-36)                                                                                       
                                                                                                                16                                                   
                             (18) Fermentations were run on these two stock solutions.   Thereafter, on                                                              
                   February 14, 1983, Mumford recorded the fermentations in CX-18. Mumford, ¶ 13                                                                     


                             16The Cabilly et al.  brief (page 16) alleges that the fermentations occurred on Feb.                                                   
                   8, 1983.  Rey did not give any specific run dates for these fermentations.  id.                                                                   
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