Ex Parte D et al - Page 9


             Appeal No. 2005-2739                                                          Page 9              
             Application No. 09/966,893                                                                        

                   Sharp discloses TANGO 176, “a family of proteins with homology to lysosomal                 
             protective protein cathepsin A (PPCA)” (Sharp, page 27).  According to Sharp, TANGO               
             176 “nucleic acid molecules, proteins . . . and antibodies . . . can be used in one or more       
             of the following methods: a) screening assays; b) detection assays . . . ; c) predictive          
             medicine (e.g., diagnostic assays, prognostic assays, . . . ); and d) methods of treatment        
             (e.g., therapeutic and prophylactic)” (id., page 76).  Moreover, TANGO 176 proteins may           
             be expressed “in prokaryotic (e.g., E. coli) or eukaryotic cells (e.g., insect cells (using       
             baculovirus expression vectors), yeast cells or mammalian cells) . . . [or] transcribed and       
             translated in vitro, for example using T7 promoter regulatory sequences and T7                    
             polymerase” (id., page 66).                                                                       
                   According to the examiner, Sharp’s description of “TANGO 176 nucleic acids                  
             which encodes PPCA which can be used to treat galactosialidosis[;] . . . methods for              
             production of the disclosed proteins including using insect cells[;] . . . [and]                  
             pharmaceutical compositions of the disclosed nucleic acids and proteins” anticipates              
             the claimed invention (Examiner’s Answer, pages 11-12).                                           
                   Appellants concede that “Sharp does generically mention the production of                   
             proteins in insect cells when providing a [ ] list of the various forms of standard               
             expression vectors and host cells that may be used to produce proteins” (Appeal Brief,            
             page 13), but argue that “Sharp does not specifically teach the production of PPCA                
             (i.e. TANGO 176) in insect cell culture for the purpose of making a pharmaceutical                
             composition” (id.).  In other words, appellants argue that the examiner has combined              
             disparate parts of Sharp’s disclosure to arrive at a pharmaceutical composition                   
             comprising PPCA produced in insect cell culture and a pharmaceutically acceptable                 





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