Ex Parte LEVY et al - Page 5


                  Appeal No.  2002-1299                                                           Page 5                   
                  Application No.  08/962,740                                                                              
                  the generality of STAT1 involvement in cytokine signaling and to probe the roles                         
                  of STAT1-linked pathways under physiologic settings and during development,                              
                  [Durbin] … disrupted the gene for STAT1 in embryonic stem (ES) cells and in                              
                  mice.”                                                                                                   
                         Therefore, to the extent that appellants would argue that Durbin should be                        
                  limited to the study of Stat1 in vivo we do not agree.  Not only does Durbin                             
                  discuss earlier studies performed with cell lines (page 443), Durbin study                               
                  Stat1-/- ES cells and produce Stat1-/- animals.  We also note Durbin’s discussion                        
                  of the difficulty in maintaining homozygous Stat1-/- animals.  (Durbin, page 445,                        
                  column 2, “no homozygous animal born in this initial colony has survived greater                         
                  than 8 weeks … [however] Stat1-/- animals obtained in … [a pathongen-free]                               
                  colony displayed no symptoms of spontaneous disease.”).   In contrast, the                               
                  examiner points out (Answer, page 5), immortalized cell lines are “an easier                             
                  vehicle to study the interactions of cytokines and Stat1 proteins.  Immortalized                         
                  cell lines can be readily multiplied and grown to run a plethora of assays much                          
                  more quickly than the mouse itself.”  We note that the examiner’s comments are                           
                  supported by Leder.  Leder, column 3, lines 50-60.                                                       
                         In disclosing a method for providing a cell culture from a transgenic non-                        
                  human mammal, Leder state (id.):                                                                         
                         The animals of the invention can also be used as a source of cells                                
                         for cell culture.  Cells from the animals may advantageously exhibit                              
                         desirable properties of both normal and transformed cultured cells;                               
                         i.e., they will be normal or nearly normal morphologically and                                    
                         physiologically, but can, like cells such as NIH 3T3 cells, be                                    
                         cultured for long, and perhaps indefinite, periods of time.  Further,                             
                         where the promoter sequence controlling transcription of the                                      
                         oncogene sequence is inducible, cell growth rate and other culture                                






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