BUCHWALD et al v. COLLINS et al v. DRUMM et al v. IANNUZZI et al v. KEREM et al v. RIORDAN et al v. ROMMENS et al v. TSUI - Page 10




                  Interference Nos. 103,882, 103,933, and 104,228                                          Consolidated Judgment                          
                  Gregory v. Tsui et al.                                                                                      Page 10                     
                           47.      The discussion of propagating unstable DNA appears in an earlier part of the                                          
                  specification dealing with trying to obtain clones from genomic DNA, not with splicing partial                                          
                  clones together to make a full-length cDNA.  Moreover, the discussion notes that it was not                                             
                  completely successful (1042 at 20:22-24):                                                                                               
                           Although the region near cosmid cW44 remains to be recovered, the region near                                                  
                           X.6 was successfully rescued with these libraries.                                                                             
                           48.      The Drumm abstract (4006 at item 8) discussed above indicated that low-copy                                           
                  number E. coli vectors were not a solution because aberrant sequences still resulted.  Moreover,                                        
                  the solution finally achieved by the Tsui inventors involved a very different approach: silent                                          
                  mutation of cryptic bacterial promoters in the CFTR cDNA (4005 at 1228).                                                                
                           49.      While we credit Dr. Ray's testimony about what the 609 specification literally                                        
                  discloses and about the techniques available at the time the 609 application was filed, we do not                                       
                  accept his conclusions that one skilled in the art would have appreciated the source of the                                             
                  problem with propagating clones in E. coli.  Indeed, the 609 specification discusses uses for the                                       
                  full-length cDNA without ever explicitly acknowledging any problem existed.  Without an                                                 
                  appreciation of the problem, any discussion of solutions to the problem is speculative at best.                                         
                           50.      Tsui bases its attack on Gregory's benefit on an alleged failure to disclose the best                                 
                  mode for making and using CFTR cDNA.  In particular, Tsui alleges that Gregory knew or                                                  
                  should have known that the cryptic E. coli promoter that Gregory identified in CFTR cDNA is                                             
                  the wrong (inactive) one and that Gregory failed to correct the problem subsequently when filing                                        
                  a continuation-in-part application.                                                                                                     








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