Ex Parte Lal et al - Page 8


               Appeal No. 2006-1035                                                                           Page 8                   
               Application No. 09/925,140                                                                                              

                       Appellants also argue that polynucleotides encoding inactive SDHH variants                                      
               could be used “in assays to detect the presence of metabolism disorders or cancer.”                                     
               Appeal Brief, page 5.                                                                                                   
                       This argument is also unpersuasive.  The specification states that                                              
                       Northern analysis shows the expression of SDHH in various libraries, 48%                                        
                       of which are cancerous, 29% are involved in immune response, and 23%                                            
                       are fetal, cell line or proliferating, 22% are from gastrointestinal tissue,                                    
                       16% from immune tissue, 16% from reproductive tissue, and 12% are                                               
                       from cardiovascular tissue.                                                                                     
               Page 15, lines 20-24.  (The “Northern analysis” referred to in the quote is not the                                     
               hybridization assay familiar to those skilled in the art, but an “[a]nalogous computer                                  
               technique[ ] . . . used to search for identical or related molecules in nucleotide                                      
               databases.”  Specification, page 44.)  The specification also states that “SDHH is                                      
               expressed in tissues which are cancerous, proliferating, or involved in immune                                          
               response.  Therefore, SDHH appears to play a role in disorders of metabolism and                                        
               cancer.”  Page 25, lines 16-18.                                                                                         
                       The specification, however, provides no explanation for why expression in                                       
               “tissues which are cancerous, proliferating, or involved in immune response” would                                      
               suggest that SDHH is involved in “disorders of metabolism.”  In addition, the mere fact                                 
               that SDHH is expressed in cancerous cells does not provide a sufficient basis for                                       
               asserting that it “play[s] a role in . . . cancer.”  Cancer cells are simply normal cells that                          
               have lost control over cell division.5  Thus, the vast majority of proteins expressed by a                              
               cancer cell are also expressed by normal cells; the fact that a protein is “expressed in                                

                                                                                                                                      
               5 See, e.g., Watson et al., Recombinant DNA, 2nd edition (1992), page 363 (cancer results when a normal                 
               cell sustains a series of mutations that cause it to grow faster) (copy attached).                                      





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