Ex Parte LIPARI et al - Page 4


                  Appeal No.  2004-0482                                                           Page 4                   
                  Application No.  09/216,247                                                                              
                  composition must also include a lipophilic co-surfactant.  Lacy, column 3, lines                         
                  52-55.  Accordingly, as we understand Lacy’s disclosure, Lacy’s composition                              
                  includes four components, (1) a hydrophobic drug, (2) a digestible oil2, (3) a                           
                  hydrophilic surfactant, and (4) a lipophilic surfactant.  See e.g., Lacy, column 3,                      
                  lines 56-67.  In contrast, appellants’ claimed invention includes only (1) a                             
                  hydrophobic drug (a fibrate), and (2) at least one medium chain glycerol ester of                        
                  a fatty acid.  Therefore, as we understand the issue on appeal, the question is                          
                  whether Lacy suggests removing two of the four components of the disclosed                               
                  composition and if so, are the two remaining components (1) a fibrate and (2) a                          
                  at least one medium chain glycerol ester of a fatty acid?                                                
                         We note that Lacy carves out an exception to the use of digestible oils.                          
                  Specifically, Lacy discloses (column 4, lines 1-5), “[i]f the lipophilic surfactant is                   
                  itself a digestible oil, or can serve as the source of lipolytic products, then in a                     
                  modification of the preferred carrier system a separate digestible oil component                         
                  may be omitted….”  In this regard, we note the examiner’s reference (Answer,                             
                  page 4) to “polyglycerol esters of fatty acids” which Lacy characterizes as an                           
                  example of a lipophilic surfactant (see column 5, lines 19-26).  As we understand                        








                                                                                                                           
                  2 We note that Lacy discloses (column 9, lines 20-28), the digestible oil may be capric and/or           
                  caprylic triglyceride oils” including: “Miglyol 810, Miglyol 812, Neobee M5, Neobee 0, Captex 300,       
                  Captex 355 and Captex 8000.”                                                                             





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