Ex parte EGIDIO et al. - Page 9




                     Appeal No. 1996-0944                                                                                                                                               
                     Application No. 08/181,259                                                                                                                                         


                                           3.  The method according to claim 1 wherein said vaginal infection consists of                                                               
                                bacterial vaginosis.                                                                                                                                    

                                           4. The method of treatment of a vaginal infection oaccording to claim 1 which                                                                
                                consists of applying by the topical route a pharmaceutically effective amount of                                                                        
                                Rifaximin to a patient in need of said treatment.                                                                                                       

                                           5.  The method according to claim 4 wherein said vaginal infection consists of                                                               
                                bacterial vaginosis.                                                                                                                                    

                                           6.  The method according to claim 4 wherein said topical application is carried                                                              
                                out by means of a vaginal foam.                                                                                                                         

                                           7.  The method according to claim 4 wherein said topical application is carried                                                              
                                out by means of a cream.                                                                                                                                

                                Thus, the claimed pharmaceutical composition is obvious over the pharmaceutical composition                                                             

                     specifically required by the methods of Egidio.                                                                                                                    

                                Appealed claim 24 requires between 50 and 500 mg of rifaximin while claim 1 of Egidio recites                                                           

                     a “therapeutically effective amount” of rifaximin.  In order to determine what constitutes a                                                                       

                     “therapeutically effective amount” of rifaximin, one must consult the specification of Egidio.  In re                                                              

                     Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970) (the  specification of a patent may                                                                     

                     be consulted under these circumstances not as prior art, but “to learn the meaning of terms in a claim”).                                                          

                     Turning to Egidio, col. 2, lines 24-26, we find that as in the present invention a “therapeutically effective                                                      

                     amount of rifaximin, [is] preferably between 50 mg and 500 mg.” Thus, it is apparent that claims 1-7 of                                                            

                     Egidio encompass the pharmaceutical composition of appealed claim 24.                                                                                              


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