Ex parte COPELAND et al. - Page 7




              Appeal No. 94-2742                                                                                           
              Application 07/792,600                                                                                       



              human DNA polymerase alpha.”  Absent such a fact based explanation, the examiner’s                           
              rejection is fatally defective.                                                                              
                     The rejection under 35 U.S.C. § 103 is reversed.                                                      


                           NEW GROUNDS OF REJECTION UNDER 37 CFR § 1.196(b)                                                
                     Under the provisions of 37 CFR § 1.196(b), we make the following new grounds of                       
              rejection.                                                                                                   
              1.  Written description.                                                                                     
                     Claims 1, 3/1, 4/3/1, 5/1, and 6 through 8 are rejected under 35 U.S.C. § 112, first                  
              paragraph, as lacking written description.                                                                   
                     The above identified claims are all directed to either a nucleic acid sequence or a                   
              DNA sequence which is identified in the claim only by function.  As set forth in Univ. of Cal.               
              v. Eli Lilly & Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997), “In                          
              claims to genetic material, however, a generic statement as to [human polymerase "                           
              catalytic polypeptide], without more, is not an adequate written description of the genus                    
              because it does not distinguish the claim genus from others, except by function.  It does not                
              specification define any of the genes that fall within its definition.”                                      





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