Ex Parte WEINER et al - Page 9




              Appeal No. 2001-0759                                                                                       
              Application 08/809,186                                                                                     

                     In considering the state of the art, the examiner finds that while Levy teaches                     
              vpr-transfected cells (e.g. rhabdomyosarcomas, which are tumors of muscular origin)                        
              can be induced to undergo differentiation events, it is not readily manifest that cells                    
              contacted with exogenous Vpr will display the same effects.   Answer, page 6.                              
              According to the examiner the “prior art fails to teach or suggest that exogenously                        
              added peptide can induce cellular proliferative events at the extracellular level, or, that                
              Vpr can traverse the cell membrane and enter the cytosolic or nuclear compartments                         
              and prevent cellular proliferative activities.”   Answer, page 7.                                          
                     The appellants respond to the examiner, arguing the examiner has not                                
              established a prima facie case of lack of enablement and has merely made general                           
              statements that the art is unpredictable and has concluded that undue experimentation                      
              would be required for operability.   Brief, page 7.   Further, appellants argue that the                   
              examiner has not articulated reasons why one of skill in the art, at the time the                          
              application was filed, would not have believed that exogenous Vpr protein or fragments                     
              thereof, could be delivered to T cells, B cells or monocytes in vivo and result in cell                    
              growth arrest.   Brief, page 9.                                                                            
                     In support of enablement of the pending claims, the appellants argue that even if                   
              the examiner had proffered sufficient reasoning to shift the burden of proof to                            
              Appellants, the specification discloses the growth inhibitory effect of Vpr protein in both                
              muscle and bone tumor cells in vitro and inhibits cell proliferation.  Brief, page 12.                     


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