Ex Parte LIPARI et al - Page 6


                  Appeal No.  2004-0482                                                           Page 6                   
                  Application No.  09/216,247                                                                              
                  Lacy (column 8, lines 19-23), “with this class of hydrophilic surfactants there is                       
                  no necessity to include any lipophilic surfactant component at all….”                                    
                  Accordingly, Lacy discloses (column 8, lines 24-30):                                                     
                                [I]n a further aspect, the present invention provides a carrier                            
                         system for a hydrophobic drug which comprises:                                                    
                                (a) a digestible oil,                                                                      
                                (b) a transesterification product of polyoxy-ethylene glycol                               
                                    with glycerol esters of capric and/or caprylic acids as                                
                                    hydrophilic surfactant, and                                                            
                                (c) optionally a lipophilic surfactant.                                                    
                  Lacy discloses that Labrasol (glyceryl caprylate/caprate and PEG-8                                       
                  caprylate/caprate) and Softigen 767 (PEG-6 caprylic/capric glycerides) as                                
                  examples of this type of hydrophilic surfactant.  See Lacy, column 8, lines 31-37.                       
                  Since this composition includes (1) a hydrophobic drug, (2) a digestible oil, and                        
                  (3) a hydrophilic surfactant, this embodiment of Lacy’s disclosure also does not                         
                  support the examiner’s position.                                                                         
                         Therefore, while it may be true that Lacy suggests, under certain                                 
                  circumstances, that a digestible oil or a lipophilic surfactant are not necessary,                       
                  and may be removed from Lacy’s composition, for the foregoing reasons we find                            
                  nothing in Lacy to suggest that even if these components were removed they                               
                  would lead to appellants’ claimed invention.  In this regard, we remind the                              
                  examiner that “[t]he Patent Office has the initial duty of supplying the factual                         
                  basis for its rejection.  It may not, because it may doubt that the invention is                         
                  patentable, resort to speculation, unfounded assumptions or hindsight                                    
                  reconstruction to supply deficiencies in its factual basis.” In re Warner, 379 F.2d                      
                  1011, 1017, 154 USPQ 173, 178 (CCPA 1967).  For the foregoing reasons, it is                             






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