Ex Parte KLINGER et al - Page 2


                Appeal No. 2001-0407                                                  Page 2                  
                Application No. 08/460,215                                                                    

                             contacting said cell with a normal human PKD1 gene or fragments                  
                thereof capable of expressing an amount of polycystin effective to prevent or                 
                reduce cyst formation in said cell.                                                           
                      39. The method of claim 37, wherein said normal human PKD1 gene                         
                comprises an intronless nucleic acid sequence derived from the DNA sequence                   
                of SEQ ID NO:1 or its complement, wherein said intronless nucleic acid                        
                sequence is a cDNA.                                                                           
                      45.    A composition for treating cyst formation associated with APKD,                  
                said composition comprising an isolated human PKD1 gene having the DNA                        
                sequence of SEQ ID NO:1, its complement, or fragments thereof, and a                          
                pharmaceutically acceptable carrier or diluent.                                               

                      The examiner relies on the following references:                                        
                Orkin et al. (Orkin), “Report and Recommendations of the Panel to Assess the                  
                NIH Investment in Research on Gene Therapy,” National Institutes of Health                    
                (1995)                                                                                        
                Cecil Textbook of Medicine, 18th ed., Vol. 2, Wyngaarden et al. (eds.), pp. xxxv              
                and 1039 (1988)                                                                               

                      This merits panel relies on the following reference (of record):                        
                Grabow et al. (Grabow), “Pathophysiology of Adult Polycystic Kidney Disease,”                 
                Adv. Nephrol., Vol. 18, pp. 19-32 (1989)                                                      

                      Claims 37-39 and 45-47 stand rejected under 35 U.S.C. § 112, first                      
                paragraph, as nonenabled.                                                                     
                      Claims 39 and 47 stand rejected under 35 U.S.C. § 112, first paragraph,                 
                as nonenabled and lacking an adequate written description.                                    
                      We affirm in part.                                                                      










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