LEE et al v. VOGELSTEIN et al - Page 3




                     Interference 104,066                                                                                                                                              
                     2006, p. 1187, col. 2, lines 4-6.3  However, researchers later observed that p53                                                                                  
                     deletions and mutations were present in numerous human cancers and realized that                                                                                  
                     the wild-type p53 gene is actually a tumor suppressor gene which acts to suppress                                                                                 
                     oncogenesis.  See the ‘220 patent, col. 4, line 66-col. 5, line 2; col. 5, lines 40-49;                                                                           
                     LX2006, p. 1187, col. 1, lines 1-8; col. 2, lines 10-13; LX2010, p. 705, col. 1, para. 1.                                                                         
                     Today, of the approximately 6.5 million cancer cases worldwide, researchers estimate                                                                              
                     that 2.4 million contain a p53 gene mutation.  LX 2006, p. 1187, col. 1, lines 7-9.  Thus,                                                                        
                     the goal of the present invention is to express a wild-type p53 tumor suppressor gene in                                                                          
                     a mammalian cancer cell which lacks said gene function and to inhibit cellular                                                                                    
                     proliferation (i.e., suppress the neoplastic phenotype).  LX 2003, p. 924, cols. 1-3;                                                                             
                     LX 2006, p. 1187, col. 1, lines 1-3.                                                                                                                              
                     II.        The Count                                                                                                                                              
                                The subject matter of the interference is defined by a single count, Count 1,                                                                          
                     which reads as follows:                                                                                                                                           
                                           A method of treating mammalian cancer cells lacking endogenous wild-                                                                        
                                type p53 protein, comprising introducing a wild-type p53 tumor suppressor gene                                                                         
                                encoding said endogenous wild-type p53 protein into said mammalian cancer                                                                              
                                cells, whereby said mammalian cancer cells’ neoplastic phenotype is                                                                                    
                                suppressed.                                                                                                                                            


                                3 Lee’s Principal Brief for final hearing (Paper No. 108) will be referred to as LB.                                                                   
                     The Lee record and exhibits will be referred to as LR and LX, respectively, followed by                                                                           
                     the appropriate page number.                                                                                                                                      
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