Ex Parte ETCHEVERRY et al - Page 3

              Appeal No.  2002-0872                                                        Page 3                      
              Application No.  08/470,849                                                                               
              In addition, the examiner finds (Answer, page 5), “[c]laims 20-23 are directed to human                   
              tumor necrosis factor receptor immunoglobulin chimeric protein isolated from the                          
              process of claims 18-19 which results in specific glycosylation properties.”  According to                
              the examiner (id.), “[t]hese glycosylation limitations of molar ratios of sialic acid and N-              
              acetylglucosamine are inherent properties of the glycosylated [sic] of human tumor                        
              necrosis factor receptor immunoglobulin chimeric protein and the protein of Ashkenazi                     
              et al. can reasonably be considered to be same [sic] absent any evidence to the                           
              contrary.”                                                                                                
                     However, as appellants point out (Brief, page 4, emphasis removed), “Ashkenazi                     
              et al. do not disclose the specific culturing conditions used; such as the temperature at                 
              which the cells are grown and/or held in a production phase, the osmolality of the                        
              media, or the sodium butyrate concentrations of the media.”  Appellants emphasize                         
              (Brief, pages 5-6), “that when the cell culture process is altered by the use of separate                 
              growth and production phases, and when alterations are made in the production phase                       
              of cell culture, variation in the oligosaccharide component of an expressed glycoprotein                  
              will result.”  In support of this argument appellants rely on Goochee (U.S. Patent No.                    
              5,510,261), and Tables I-V of their specification.                                                        
                     In response, the examiner argues (Answer, page 6), “no evidnece [sic] has been                     
              presented that the claimed genus of human tumor necrosis factor receptor                                  
              immunoglobulin chimeric protein is glycosylated differently in CHO cells versus the HEK                   
              293 cells.  Furthermore, the claims are directed to product[-]by[-]process or range                       
              limitations of the glycosylation and not a specific species.                                              










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