Ex Parte 5854038 et al - Page 11


                   Appeal No. 2006-0735                                                                                             
                   Reexamination Control No. 90/006,036                                                                             

                                                        The Hu reference                                                            
                           The examiner has rejected claims 1-4, 6-10, 12, and 13 under 35 U.S.C. § 102(e)                          
                   as being anticipated by US Patent 6,107,062 to Hu et al. (Hu).                                                   
                           As we understand it, the examiner’s position is that the HIV-1 molecular clone                           
                   described in Hu anticipates the claim 1 method because the clone:                                                
                           (1) contains a therapeutic agent that is a nucleic acid (i.e., the antisense or                          
                   antisense/ribozyme portion of the genome of the clone),                                                          
                           (2) contains a localization signal (i.e., the HIV-1 packaging signal of the                              
                   clone),                                                                                                          
                   where the two are tethered together within the genome of the clone and where the HIV-1                           
                   packaging signal functions to cause the therapeutic agent to be localized with the HIV-1                         
                   target virus in a cellular of viral compartment of the cell and thereby cause its effect to be                   
                   enhanced.  (Answer at 5-6).                                                                                      
                           The patentee concedes that Hu teaches the delivery of a nucleic acid therapeutic                         
                   agent to a cell within a virus that is “similar to naturally occurring viruses except for                        
                   these [antisense] fragments and [which] enter[s] the host cell in the same manner as the                         
                   naturally occurring viruses.  (Brief at 10).  The patentee does not contest that the                             
                   antisense fragment and the remainder of the HIV genome would be “tethered” to one                                
                   another.                                                                                                         
                           However, according to the patentee, “the Office Action appears to confuse the                            
                   delivery of a therapeutic agent to a cell with the localization of a therapeutic agent with                      
                   its viral target in a cellular or viral compartment of the cell.”  (Brief at 9).  Patentee                       
                   argues that the Hu reference “does not teach or suggest a localization signal tethered to a                      


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