Ex Parte HARLEY - Page 7


            Appeal No. 2001-1263                                                 Page 7                    
            Application No. 08/475,955                                                                        

            predictability of the claimed peptides to use Appellant’s invention.”  In support of this         
            rejection, the examiner relies upon Wraith, Tisch, and Kaliyuperumal.                             
                   We have considered the evidence relied upon by the examiner but do not find                
            that it supports a conclusion that claims 7 through 9 are non-enabled.                            
                   Turning to Wraith, the examiner states at page 4 of the Answer that Wraith                 
            teaches “Inhibition of the response restricted by one class II molecule may lead only to          
            the escape to an autoimmune response to a separate epitope restricted by a different              
            class II molecule.” (Page 253, column 1).  However, the entire passage from which the             
            examiner extracted the quote from Wraith reads as follows:                                        
                         Several potential difficulties are apparent in using MHC “blocking: peptides         
                   to treat autoimmune disease.  First, peptides are small and would be expected to           
                   be rapidly cleared from the circulation.  An effective strategy may therefore              
                   require the use of slow-release systems or frequent injection schedules.  Second,          
                   some autoantigens have multiple distinct epitopes that are presented by different          
                   class II molecules of the MHC (Zamvil et al., 1988).  Inhibition of the response           
                   restricted by one class II molecule may lead only to the escape to an                      
                   autoimmune response to a separate epitope restricted by a different class II               
                   molecule.  Third, Ac1-11[3A,4A] may be itself immunogenic in mice.                         
                   Administration of such a peptide could induce a “bystander” Th cell response               
                   that, rather than blocking recognition of a self-peptide, could increase the overall       
                   T cell response to the self-antigen by recruiting cells specific for subdominant           
                   epitopes.  This drawback would be overcome by using I-Au binding peptides of               
                   self-proteins to which the animal would normally be tolerant.                              
            As seen, the examiner has cropped the quote and has not considered the document in                
            its entirety.  At best, the concern expressed by Wraith relied upon by the examiner is            
            “only a potential difficulty.”  What the examiner has ignored on this record is the               
            conclusion of Wraith set forth in the last sentence of the article “[b]ased on these              
            properties we have been able to demonstrate the feasibility of immune intervention in an          








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