Ex Parte Coleman et al - Page 10


                  Appeal No.  2005-1422                                                           Page 10                   
                  Application No.  09/997,522                                                                               
                  sequence, SEQ ID NO: 1, … encodes a novel human thrombin receptor homolog                                 
                  (TRH), SEQ ID NO:2.”                                                                                      
                         While claim 12 is drawn, inter alia, to “a naturally occurring human variant                       
                  of the polynucleotide sequence of SEQ ID NO: 1,” appellants’ specification does                           
                  not define the term “naturally occurring human variant” in the context of a TRH                           
                  polypeptide, or a polynucleotide.4  With regard to a polypeptide, appellants’                             
                  specification discloses that a “‘[n]aturally occurring TRH’ [polypeptide] refers to                       
                  TRHs produced by human cells that have not been genetically engineered and                                
                  specifically contemplates various TRHs arising from post-translational                                    
                  modifications of the polypeptide including but not limited to acetylation,                                
                  carboxylation, glycosylation, phosphorylation, lipidation and acylation.”                                 
                  Specification, page 5.  We note that appellants do not define a naturally occurring                       
                  TRH polypeptide as a variant.  Instead, appellants define polypeptide variants as                         
                  “recombinant polypeptide variants.”  See specification, page 5, a “‘[r]ecombinant                         
                  polypeptide variant’ refers to any polypeptide having the activity of the TRH                             
                  polypeptide and differing from naturally occurring TRHs by amino acid insertions,                         
                  deletions, and substitutions created using recombinant DNA techniques.”  On                               
                  reflection, appellants’ specification does not identify, or disclose a naturally                          
                  occurring human variant of a TRH polypeptide.                                                             




                                                                                                                            
                  4 We recognize appellants’ assertion (Brief, page 36) that “variants of SEQ ID NO:1 and SEQ ID            
                  NO:2 are described in the specification at, for example, page 4, lines 30-32; page 5, lines 22-25;        
                  page 5, line 30 to page 6, line 11; page 7, lines 17-23; and page 8, lines 14-29.”  None of these         
                  sections of appellants’ specification, however, provide a description of a “naturally occurring           
                  human variant of the polynucleotide sequence of SEQ ID NO: 1” as required by claim 12, part b.            





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