Ex Parte Chen - Page 2




                     Appeal No. 2005-0410                                                                                                                                              
                     Application No. 09/902,461                                                                                                                                        


                                21.   A method of treating cardiomyopathy associated with glycogen storage                                                                             
                                disease type II in a human individual having glycogen storage disease type II,                                                                         
                                comprising administering to the individual a therapeutically effective amount of                                                                       
                                human acid " glucosidase periodically at an administration interval, wherein the                                                                       
                                human acid " glucosidase was produced in chinese [sic, Chinese] hamster ovary                                                                          
                                cell cultures.                                                                                                                                         
                                22.   A pharmaceutical composition comprising human acid " glucosidase, wherein                                                                        
                                the human acid " glucosidase was produced in chinese [sic, Chinese] hamster                                                                            
                                ovary cell culture, in a container, the container having a label containing instructions                                                               
                                for administration of the composition for treatment of glycogen storage disease type                                                                   
                                II.                                                                                                                                                    
                                The references relied upon by the examiner are:                                                                                                        
                     Fuller et al. (Fuller), “Isolation and characterisation of a recombinant, precursor form of                                                                       
                     lysosomal acid "-glucosidase.”  Eur. J. Biochem., vol. 234, pp. 903-909, (1995).                                                                                  

                     Bijvoet et al. (Bijvoet), “Recombinant human acid "-glucosidase: high level production in                                                                         
                     mouse milk, biochemical characteristics, correction of enzyme deficiency in GSDII KO                                                                              
                     mice.”  Human Molecular Genetics, vol. 7, pp. 1815-1824, (1998).                                                                                                  
                                The claims stand rejected as follows:                                                                                                                  
                     I.   Claims 1-9 and 11-23 stand rejected under 35 U.S.C. § 112, second paragraph, as                                                                              
                     being indefinite for failing to particularly point out and distinctly claim the subject matter                                                                    
                     which the appellant regards as his invention.                                                                                                                     
                     II.  Claims 1-4, 9, 21 and 23 stand rejected under 35 U.S.C. § 102(b) as being                                                                                    
                     anticipated by Fuller.                                                                                                                                            
                     III.  Claims 1-7, 11-18, 21 and 23 stand rejected under 35 U.S.C. § 102(b) as being                                                                               
                     anticipated by, or in the alternative under 35 U.S.C. § 103(a) as obvious over, Fuller.                                                                           


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