Ex Parte Liu et al - Page 5


                 Appeal No.  2005-0416                                                         Page 5                  
                 Application No.  09/970,020                                                                           
                 seek out an alternative to the disclosed HPMC controlled release excipients for                       
                 making a two-part formulation.”                                                                       
                        It is well settled that the suggestion to combine prior art references must                    
                 come from the cited references, not from the application’s disclosure.  See e.g.,                     
                 In re Dow Chemical Co., 837 F.2d 469, 473, 5 USPQ2d 1529, 1531 (Fed. Cir.                             
                 1988).  As we understand appellants’ argument, since Gilbert teaches the use of                       
                 HPMC, there would have been no reason, other than hindsight reconstruction4, to                       
                 modify the teachings of Gilbert to use the sustained release excipients of                            
                 Baichwal.  We disagree.  Baichwal recognizes the disadvantages of using HPMC                          
                 as a slow release matrix for a variety of medicaments.  See e.g., Baichwal,                           
                 column 2, line 34 – column 3, line 45.                                                                
                        Specifically, Baichwal disclose (column 2, lines 34-38), “a great deal of                      
                 attention in the pharmaceutical field has turned to the use of various hydrocolloid                   
                 materials such as hydroxypropylmethyl cellulose in providing a slow release                           
                 matrix for a variety of medicaments.”  Baichwal provides two examples of slow                         
                 release compositions containing HPMC.  See Baichwal’s discussion of the Schor                         
                 and Alderman patents at column 2, line 39 – column 3, line 7.  According to                           
                 Baichwal, (column 3, lines 8-22),                                                                     
                        [t]he carrier bases which provide the slow release profiles in these                           
                        disclosures can only be compressed into a tablet or a solid dosage                             
                        form with the aid of other conventional tableting adjuvants such as                            
                        binders and the like, and therefore contribute only to the slow                                
                        release aspect of the final solid unit dosage form and not to the                              
                        tableting aspects.  In other words, in each of these disclosures it is                         
                        necessary for [sic] to first determine the physical properties of the                          
                        active medicament to be tableted and thereafter proceed through a                              
                        series of trial and error experiments in order to determine the                                
                                                                                                                       
                 4 See Brief, bridging paragraph, pages 6-7; Reply Brief, bridging paragraph, pages 4-5.               





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