Ex Parte 5854038 et al - Page 8


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

                   29.  In other words, the examiner argues that Dropulic teaches a localization signal (i.e.,                      
                       the HIV packaging signal)  that inherently would cause the therapeutic agent to be                           
                       localized with the viral target in a “cellular or viral compartment of the cell.”                            
                   30. Unlike Hu, Dropulic does not indicate that the HIV-1 genome contains “all of                                 
                       the natural HIV-1 structures and machinery”  but for the therapeutic portion nor that it                     
                       “has the same ‘targeting’ or ‘homing’ specificity as the naturally occurring (wild                           
                       type) virus.”  (‘See ‘038 at 11:41-45 and 65-67).                                                            
                                                        The 112 rejection                                                           
                   31.  Claims 5 and 11 are dependent claims that require that the localization signal                              
                       comprises “a protein component”.                                                                             
                           Claim 5 depends from claim 1 reproduced supra, while claim 11 depends from                               
                           either claim amended 6 or amended 9.                                                                     
                                                                                                                                   
                   32.  According to the examiner, claims 5 and 11 lack written descriptive support since the                       
                       disclosure “fails to describe the preparation, characterization, and use of a single                         
                       therapeutic agent comprising a proteinaceous signal sequence tethered to a                                   
                       therapeutic nucleic acid” (Answer at 7).                                                                     
                   33. The examiner states that “for purposes of this rejection, the Examiner is                                    
                       interpreting  the  claim  language  to  reasonably  reference  a  nucleic  acid  and                         
                       proteinaceous component that have been chemically linked to one another.”  (Answer                           
                       at 7-8).                                                                                                     
                   34.  According to the examiner, “...the disclosure fails to provide any structural or                            
                       functional guidance pertaining to suitable chemical linkages that can be employed in                         
                       the aforementioned invention” and “fails to provide even one working embodiment                              



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