Ex parte JANOFF et al. - Page 7


              Appeal No. 2001-1245                                                                                     
              Application 08/430,661                                                                                   
                     We again remind the examiner that obviousness must be based upon facts not                        
              generalities.  The examiner has not explained what facts appear in Fukushima or                          
              knowledge generally known to one of ordinary skill in the art which would reasonably                     
              lead one to conclude that the sequence of steps described in Fukushima may be altered                    
              to arrive at the subject matter of claim 77 on appeal.                                                   
                     For these reasons, the examiner's rejection as based on Fukushima alone is                        
              reversed.                                                                                                
                     Considering Fukushima in light of Moro or Heyne does not aid the examiner's                       
              case.  From the statement of the rejection, we believe the examiner is under the                         
              impression that Moro and Heyne describe the sequence of steps required by the claim                      
              77 on appeal.  If that is the examiner's position, we do not find that it is supported by                
              either reference.  First, Moro and Heyne are directed to forming liposomes, not drug-                    
              lipid complexes as required by claim 77 on appeal.  Thus, the relevance of these                         
              references in considering the obviousness of the subject matter of claim 77 is subject to                
              question.                                                                                                
                     Turning to Moro, we find that it describes a method for forming liposomes in                      
              which an aqueous solution of the drug is added to a solvent solution of the lipidic                      
              component.  See, e.g., page 1, lines 86-95.  Claim 77 requires preparation of separate                   
              solvent solutions of the lipid and polyene antifungal agent which are subsequently                       
              combined.  Thus, even apart from being directed to a method for forming liposomes, the                   
              method described by Moro is further removed from what is required by claim 77 and in                     
              our view presents no reason, suggestion or motivation to modify the procedure specified                  
              in Fukushima in the manner required by claim 77 on appeal.                                               


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