Ex Parte Liu et al - Page 6


                 Appeal No.  2005-0416                                                         Page 6                  
                 Application No.  09/970,020                                                                           
                        optimal amount of gums/polymers and other adjuvants to produce                                 
                        the right formulation which is free flowing and which can be                                   
                        compressed to a slow release solid dosage unit.  This procedure is                             
                        time intensive and costly.                                                                     
                 Against this backdrop, Baichwal disclose (column 3, line 61 – column 4, line 5),                      
                        [i]t is therefore an object of the present invention to provide a free-                        
                        flowing directly compressible slow release excipient which can be                              
                        used for a wide variety of therapeutically active medicaments. …  It                           
                        is a further object of the present invention to provide a free-flowing                         
                        directly compressible slow release excipient which is relatively                               
                        inexpensive to manufacture due to the lack of coatings and                                     
                        expensive equipment.                                                                           
                 According to the examiner (Answer, page 4), “[o]ne would be motivated to use                          
                 the excipients system of Baichwal for the controlled release portion of the bi-layer                  
                 tablet because[,] … [inter alia, it] is inexpensive to manufacture and can be easily                  
                 compressed into tablets which eliminates the use of expensive manufacturing                           
                 equipment.”  Thus, notwithstanding appellants’ assertions to the contrary (see                        
                 e.g., Brief, pages 4-6; Reply Brief, pages 4-5), Baichwal expressly discloses the                     
                 advantages of using a heteropolysaccharide and polysaccharide gum excipients                          
                 over the use of HPMC.  Accordingly, we are not persuaded by appellants’                               
                 arguments.                                                                                            
                        On reflection, we find no error in the examiner’s finding that the invention                   
                 of appellants’ claim 24 is prima facie obvious over the combination of Gilbert and                    
                 Baichwal.  Accordingly, we affirm the rejection of claim 24 under 35 U.S.C. § 103                     
                 as being unpatentable over Gilbert in view of Baichwal.  As discussed supra                           
                 claims 25-54 fall together with claim 24.                                                             
                        No time period for taking any subsequent action in connection with this                        
                 appeal may be extended under 37 CFR § 1.136(a).                                                       






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