Ex Parte BODMER et al - Page 3


                 Appeal No. 2001-1044                                                         Page 3                    
                 Application No. 08/881,216                                                                             

                        Claims 18-21, 24, and 25 stand rejected under 35 U.S.C. § 103 as                                
                 obvious in view of Birnbaum, Lopez-Berestein, and Janoff.                                              
                        Claim 23 stands rejected under 35 U.S.C. § 103 as obvious in view of                            
                 Birnbaum, Lopez-Berestein, Janoff, and Woodle.                                                         
                        Claim 25 stands rejected under 35 U.S.C. § 103 as obvious in view of                            
                 Birnbaum, Lopez-Berestein, Janoff, and Knight.                                                         
                        Claim 26 stands rejected under 35 U.S.C. § 103 as obvious in view of                            
                 Birnbaum, Lopez-Berestein, Janoff, and Crowe.                                                          
                        We affirm the indefiniteness rejection and the obviousness rejections of all                    
                 claims except claim 23.                                                                                
                                                     Background                                                         
                        Terbinafine, the compound of formula I recited in the claims, is a known                        
                 allylamine anti-mycotic agent.  See the specification, pages 1-2.  Terbinafine is                      
                 highly active when administered topically or orally, but its antifungal activity is                    
                 antagonized by serum.  See id., page 2.                                                                
                        It is thus desirable to find a drug delivery system which can improve                           
                        the bioavailability of [terbinafine] in order to overcome serum                                 
                        binding and/or favourably influence parameters such as                                          
                        pharmacokinetics and tissue distribution and/or reduce side effects                             
                        and toxicity. . . .                                                                             
                        A promising approach meeting the above-mentioned criteria has                                   
                        now been found in the form of liposomes comprising [terbinafine] as                             
                        the active agent.  Thus pharmaceutically acceptable e.g. parenteral                             
                        dosage form for [terbinafine] has been obtained by means of                                     
                        liposomal preparations.                                                                         
                 Id.                                                                                                    







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