Ex Parte BANDMAN et al - Page 4



            Appeal No. 2003-1805                                                          Page 4              
            Application No. 09/079,892                                                                        

                   occurring alleles.  The general knowledge in the art concerning alleles                    
                   does not provide any indication of how one allele is representative of                     
                   unknown alleles.  The nature of alleles is such that they are variant                      
                   structures, and in the present state of the art structure of one does not                  
                   provide guidance to the structure of others.  Therefore, many functionally                 
                   unrelated DNAs are encompassed within the scope of these claims.  The                      
                   specification discloses only a single species of the claimed genus (i.e. the               
                   sequence encoding SEQ ID NO:2) which is insufficient to put one of skill                   
                   in the art in possession of the attributes and features of all species within              
                   the claimed genus.  Therefore, one skilled in the art cannot reasonably                    
                   conclude that the applicant had possession of the claimed invention at the                 
                   time the instant application was filed.                                                    
            Examiner’s Answer, paragraph bridging pages 3 and 4.                                              

                   The examiner also                                                                          
                   [F]ully acknowledges appellants’ recitation of the structural limitations of               
                   the polynucleotides of claim 33 parts b) and d)-e).  However, the                          
                   polynucleotides as defined in claim 33 parts b) and d)-e) encompass a                      
                   genus of polynucleotides that encompasses widely variant species, some                     
                   having the same functions as the polypeptide of SEQ ID NO:1, some                          
                   having unknown and distinctly different functions and some possibly                        
                   having no function.  While one of skill in the art, provided the                           
                   polynucleotide sequence of SEQ ID NO:4, may be able to recognize                           
                   variants of SEQ ID NO:4 with nucleotide sequence sharing 90% identity,                     
                   one cannot recognize which of these variants occurs naturally and is thus                  
                   encompassed by the genus of claim 33 part b).  Therefore, the skilled                      
                   artisan would not be able to recognize a member of the claimed genus of                    
                   polynucleotides merely from its structural definition.  This enormous genus                
                   will encompass a wide variety of polynucleotides with their own distinct                   
                   properties.  Because appellants have provided no functional limitation for                 
                   the claimed polynucleotides, the single disclosed polynucleotide of SEQ                         
                   NO:4 is not representative of the entire genus and one of skill in the art                 
                   would not recognize that appellants were in possession of all                              
                   polynucleotides comprising a naturally-occurring polynucleotide having at                  
                   least 90% identity to SEQ ID NO:4 as encompassed by the claims.                            
            Examiner’s Answer, paragraph bridging pages 11 and 12.                                            
                   The Federal Circuit discussed the application of the written description                   
            requirement to inventions in the field of biotechnology in University of California v. Eli        
            Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997), stating                




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