Ex Parte HARLEY - Page 6


            Appeal No. 2001-1263                                                 Page 6                    
            Application No. 08/475,955                                                                        



                   The claims stand rejected as follows:                                                      
                   I.  claims 7 through 9 under 35 U.S.C. § 112, first paragraph, as being non-               
            enabled,                                                                                          
                   II.  claims 1, 2, 5, 10, and 11 under 35 U.S.C. § 112, first paragraph as being            
            non-enabled,                                                                                      
                   III.  claims 7 through 11 under 35 U.S.C. § 112, second paragraph, as being                
            indefinite, and,                                                                                  
                   IV.  claims 1, 2, 5, and 7 through 11 under 35 U.S.C. 112, second paragraph, as            
            being indefinite.                                                                                 
                   We reverse all rejections.                                                                 
                                                DISCUSSION                                                    
            Rejection I                                                                                       
                   As seen, claims 7-9 are directed to compositions which comprise the epitopes of            
            claim 1 with a pharmaceutical carrier for administration to a patient.  Claim 7 requires          
            that the epitopes be in an effective concentration for administration to a patient to             
            neutralize circulating autoantibody while claim 9 requires that the pharmaceutical carrier        
            and concentration of sequences elicit an immune response when administered to a                   
            host.  The examiner’s reasoning in regard to this rejection is summarized at Page 4 of            
            the Answer where the examiner states “appellant has not disclosed how to use the                  
            claimed polypeptides to treat autoimmune patients which are reactive to the La/SSB                
            epitopes.  There is insufficient evidence of the invention with respect to the in vivo            







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