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 8

                  Interference Nos. 103,882, 103,933, and 104,228                                          Consolidated Judgment                          
                  Gregory v. Tsui et al.                                                                                       Page 8                     
                           37.      In April 1990, after the 609 application filing date, Tsui inventors indicated that                                   
                  they could not produce cDNA cloning vectors (400710 at 44).                                                                             
                           38.      In October 1990, Tsui co-inventors Collins and Drumm indicated that                                                   
                  conventional cloning methods (including using low copy number vectors) had failed to produce                                            
                  normal, full-length CFTR cDNA, but that small amounts of such cDNA could be produced by                                                 
                  ligation of smaller clones (400611 at item 8).                                                                                          
                           39.      Tsui's opposition does not explain how the 609 application would have directed                                        
                  one skilled in the art to try making the full-length cDNA from smaller clones.                                                          
                           40.      In September 1990, after the filing date of the 609 application, the journal Cell                                     
                  published an article by several Tsui inventors that stated (400512 at 1227-28):                                                         
                           Early attempts to reconstitute a full-length CFTR cDNA from overlapping clones                                                 
                           were uniformly unsuccessful.  The exact cause of these difficulties remains to be                                              
                           defined, but we have data to show that prokaryotic transcription from internal                                                 
                           CFTR cDNA sequences may result in the expression of a protein that is toxic to                                                 
                           bacteria.                                                                                                                      





                           9  (...continued)                                                                                                              
                           • are of interest to an interdisciplinary readership.                                                                          
                           Papers published in Nature have an exceptionally wide impact, both among scientists and frequently                             
                           among the general public.                                                                                                      
                           10  Transcript, L.-C. Tsui et al. in The Identification of the CF (Cystic Fibrosis) Gene at 44 (L.-C. Tsui et al. eds.         
                  1991) (Tsui noting protein expression problems; Tsui and Collins hypothesizing the problem to be cryptic promoters in                   
                  the DNA; and Riordan explaining that related proteins are toxic to bacteria) (transcript apparently made 9-11 April                     
                  1991).                                                                                                                                  
                           11  M. Drumm et al., "The Full-Length CFTR cDNA Is Toxic In Bacterial Hosts" in Pediatric Pulmonology,                         
                  Supp. 5 at 189 (1990) (a report on a conference 3-6 October 1990).                                                                      
                           12  M.L. Drumm et al., "Correction of the Cystic Fibrosis Defect In Vitro by Retrovirus-Mediated Gene                          
                  Transfer", 62 Cell 1227 (21 Sep. 1990).                                                                                                 





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