Ex parte WOODLE et al. - Page 6




          Appeal No. 95-4004                                                          
          Application 07/858,171                                                      
               head group.  Included in this class are the phospholipids              
               such as phosphatidylcholine (PC), PE, phosphatidic acid                
               (PA), phosphatidylinositol (PI), and sphingomyelin (SM),               
               where the two hydrocarbon chains are typically between                 
               about 14-22 carbon atoms in length, and have varying                   
               degrees of unsaturation.  Also included in this class                  
               are the glycolipids, such as cerebrosides and gangliosides.            
                    Another vesicle-forming lipid which may be employed is            
               cholesterol and related sterols.  In general, cholesterol              
               may be less tightly anchored to a lipid bilayer membrane,              
               particularly when derivatized with a high molecular weight             
               polymers [sic], such as polyalkylether, and therefore be               
               less effective in promoting liposome evasion of the RES                
               in the bloodstream.                                                    
          The specification’s teaching that cholesterol and related sterols           
          derivatized with polyalkylether are suitable as vesicle-forming             
          lipids for inclusion in liposome compositions containing                    
          therapeutic compounds for use in treating systemic infection                
          localized at a site by intravenous injection is not a teaching or           
          even a suggestion of the method of the claims on appeal.  In                
          short, the examiner clearly erred in finding that cholesterol and           
          related sterols derivatized with polyalkylether are diacyl-chain            
          amphipathic vesicle-forming lipids derivatized with polyethylene            
          glycol having a molecular weight between about 350 and 5,000                
          daltons.  Therefore, we must reverse the examiner’s holding that            
          Claims 1 and 4-7 on appeal are unpatentable under 35 U.S.C. § 103           
          over the teaching of Popescu in view of the teachings of                    
          Radhakrishnan and McGregor.                                                 
                                    Other Issues                                      

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