Ex parte ZALIPSKY et al. - Page 5



              Appeal No. 1995-4572                                                                                        
              Application 08/035,443                                                                                      
                     On the other hand, Woodle includes no suggestion to attach the active therapeutic                    
              agent (i.e. drug) to the distal ends of the polyethylene glycol chains, as                                  
              recited and called for in the instant claims.  In Woodle, it is clear that the active therapeutic           
              agent (i.e., drug to be delivered to the bloodstream) is encapsulated inside of the                         
              liposome.  A target ligand is disclosed in Woodle as being attached to the outer surface of                 
              the liposome itself, not the distal ends of the PEG chains.  These ligands are merely                       
              targets to bind the liposome to a specific cell or tissue so as to deliver the drug                         
              encapsulated within.  These ligands are not the therapeutic drugs themselves and are not                    
              attached to the distal ends of the PEG chains, as in the instant invention.  In addition,                   
              Woodle includes no teaching or suggestion that the active therapeutic agent can be                          
              polymyxin B.                                                                                                
                     In our view there is no suggestion to combine the references to Woodle and                           
              Handley since these references fall into the two separate and distinct categories as                        
              discussed above.  In Woodle, the problem to be solved is the rapid clearance of                             
              liposomes from the bloodstream by the reticuloendothelial system (RES).  In Handley, the                    
              problem to be solved is the rapid clearance of polymyxin B from the bloodstream by the                      
              renal system or kidneys.  Therefore, each reference deals with separate and distinct                        
              biological entities being eliminated from the bloodstream by separate and distinct                          
              biological systems.                                                                                         






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