Ex Parte Heller - Page 4



              Appeal No. 2003-1716                                                                   Page 4                 
              Application No. 09/946,205                                                                                    
                     Pharmaceutically acceptable solid or liquid carriers may be added to                                   
                     enhance or stabilize the composition, or to facilitate preparation of the                              
                     composition.  Liquid carriers include syrup, peanut oil, olive oil, glycerin,                          
                     saline, ethanol, and water.  Solid carriers include starch, lactose, calcium                           
                     sulfate dihydrate, terra alba, magnesium stearate or stearic acid, talc,                               
                     pectin, acacia, agar or gelatin.  The carrier may also include a sustained                             
                     release material such as glyceryl monostearate or glyceryl distearate,                                 
                     alone or with a wax.  The amount of solid carrier varies but, preferably, will                         
                     be between about 20 mg to about 1 g per dosage unit.  The                                              
                     pharmaceutical preparations are made following the conventional                                        
                     techniques of pharmacy involving milling, mixing, granulating, and                                     
                     compressing, when necessary, for tablet forms; or milling, mixing and                                  
                     filling for hard gelatin capsule forms.  [page 7, lines 18-29; emphasis                                
                     added]                                                                                                 
                     On these facts, we agree with the examiner's finding that Lukas-Laskey                                 
              describes the invention recited in claim 1 on appeal, viz., a tablet comprising carvedilol                    
              or a pharmaceutically acceptable salt thereof; hydochloro-thiazide or a pharmaceutically                      
              acceptable salt thereof; and at least one pharmaceutically acceptable additive.                               
              Accordingly, we agree that Lukas-Laskey establishes a prima facie case of anticipation                        
              of claim 1, and that the burden of persuasion shifted to applicant to rebut the prima                         
              facie case.1                                                                                                  
                     Applicant's sole argument on appeal is that Lukas-Laskey constitutes a non-                            
              enabling reference.  As stated in In re Donohue, 766 F.2d 531, 533, 226 USPQ 619,                             
              621 (Fed. Cir. 1985):                                                                                         
                     It is well settled that prior art under 35 U.S.C. § 102 (b) must sufficiently                          
                     describe the claimed invention to have placed the public in possession of                              
                     it.  Accordingly, even if the claimed invention is disclosed in a printed                              
                     publication, that disclosure will not suffice as prior art if it was not                               
                     enabling.  It is not, however, necessary that an invention disclosed in a                              

                     1   For a discussion of "prima facie case of anticipation" and the introduction of                     
              evidence sufficient to rebut a prima facie case, see In re King, 801 F.2d 1324, 1327,                         
              231 USPQ 136, 138 (Fed. Cir. 1986).                                                                           





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