VISSER et al v. HOFVANDER et al - Page 87




          Interference 103,579                                                        
                    prokaryotic or eukaryotic cell which comprises                    
                    introducing into said cell the DNA construct of                   
                    claim 1.                                                          
               5.   A non-native DNA construct which, when present in a               
                    prokaryotic or eukaryotic cell containing a gene,                 
                    produces an RNA which regulates the function of said              
                    gene, said DNA construct containing the following                 
                    operably linked DNA segments:                                     
                         a.  a transcriptional promoter segment;                      
                         b.  a transcription termination segment; and                 
                         c.  a DNA segment comprising a segment of said               
                         gene, said gene segment located between said                 
                         promoter segment and said termination segment                
                         and being inverted with respect to said promoter             
                         segment and said termination segment, whereby                
                         the RNA produced by transcription of the                     
                         inverted gene segment regulates the function                 
                         of said gene.                                                
               In review of a district court’s findings relative to the               
          level of predictability/unpredictability in the art from about              
          1990 to about 1992, the court stated, Enzo Biochem. Inc. v.                 
          Calgene Inc., 188 F.3d at 1372, 52 USPQ2d at 1136:                          
                    The district court next found that antisense was                  
               a highly unpredictable technology, a finding amply                     
               supported by the record.  See, e.g., Inventor Inouye                   
               Test., J.A. at 349 (analogizing the predictability of                  
               antisense to “drilling for oil”); Calgene Expert                       
               Douglas A. Melton, Ph.D. Dep. J.A. at A26,884 (“[T]his                 
               method is not universally applicable, it hasn’t proven                 
               to be, and that’s why it’s such an interesting area                    
               of research, because scientists don’t understand the                   
               rules.”).  A text on cell biology, which was introduced                
               into evidence at trial by Enzo, made the observation                   
               that:                                                                  

                    It is, however, important to realize that antisense               
                    strategies have not been universally straightforward              
                    or as easy to apply as was initially hoped, nor has               
                    the interpretation of results always been unambiguous,            
                                        -87-                                          





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