Ex Parte LIPARI et al - Page 5


                  Appeal No.  2004-0482                                                           Page 5                   
                  Application No.  09/216,247                                                                              
                  the Answer, it appears to be the examiner’s position that these polyglycerol                             
                  esters of fatty acids would meet the limitation in appellants’ claim drawn to “at                        
                  least one medium chain glycerol ester of a fatty acid.”  However, as appellants                          
                  point out (Brief, page 5), “[e]ven if one was to accept this characterization of the                     
                  teachings of Lacy, Lacy clearly does not disclose ‘a composition consisting of a                         
                  fibrate dissolved in at least one medium chain glycerol ester of a fatty acid’ as                        
                  required by claim 1.  For the following reasons we agree with appellants.                                
                         According to Lacy (column 6, lines 14-16), these lipophilic surfactants “are                      
                  capable of serving as the digestible oil component in this invention, or serving as                      
                  the source of lipolytic products,” therefore in a modification of Lacy’s preferred                       
                  carrier system a separate digestible oil component may be omitted.  Accordingly,                         
                  such a composition would include (1) a hydrophobic drug, (2) a hydrophilic                               
                  surfactant, and (3) a lipophilic surfactant.  Assuming, arguendo, Lacy’s                                 
                  hydrophobic drug and lipophilic surfactant are within the scope of appellants’                           
                  claimed invention; Lacy’s composition includes an additional component, a                                
                  hydrophilic surfactant, which is specifically excluded from appellants’ claimed                          
                  invention.  Accordingly, this embodiment of Lacy’s disclosure does not support                           
                  the examiner’s position.                                                                                 
                         Lacy also carves out an exception to the use of lipophilic surfactants, we                        
                  note that Lacy discloses (column 8, lines 14-18), this applies to “one class of                          
                  hydrophilic surfactants, namely the transesterification products of                                      
                  polyoxyethylene glycol with glycerol esters of capric and caprylic acids … [which                        
                  do] not substantially inhibit the in vivo lipolysis of digestible oils.”  According to                   







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