Ex Parte Coleman et al - Page 19


                  Appeal No.  2005-1422                                                           Page 19                   
                  Application No.  09/997,522                                                                               
                         1. An isolated and purified polynucleotide encoding a thrombin                                     
                                    receptor homolog (TRH) comprising the amino acid sequence of                            
                                    SEQ ID NO: 2.                                                                           
                         3. The polynucleotide of claim 1 comprising a recombinant DNA                                      
                                    molecule whose nucleotide sequence is shown as SEQ ID NO[:]                             
                                    1.                                                                                      
                         Since the specifications of the three patents and the instant specification                        
                  are the same, SEQ ID NOs: 1 and 2 as well as the utilities presented are                                  
                  expected to be the same.  The claims of an issued patent are entitled to a                                
                  presumption of validity.  35 U.S.C. § 282.  This includes a presumption that the                          
                  claims define an invention that meets the requirements of 35 U.S.C. § 101.                                
                  Thus, the examiner in this case must meet a heightened burden of proof, since                             
                  showing that the instant claims lack utility would apparently mean showing that                           
                  claims issued in the ‘870, ‘633, and ‘597 patents also lack utility.                                      
                         On this record, the examiner finds (Supplemental Answer, page 3),                                  
                                [i]t is clear from the instant specification that the claimed                               
                         receptor is what is termed an “orphan receptor” in the art.  The                                   
                         instant application does not disclose the biological role of the                                   
                         protein encoded for by the claimed polynucleotide, or its                                          
                         significance.  Applicants disclose in the specification that this                                  
                         receptor is believed to be a thrombin receptor.  However, the basis                                
                         that the receptor encoded for by the polynucleotide of the present                                 
                         invention is only known to be homologous to thrombin receptors                                     
                         (page 2, lines 21-26 of the specification) is not predictive of a use.                             
                  In support of this rejection the examiner relies on Skolnick, Bork I, Bork II,                            
                  Doerks, Smith, and Brenner, to support his position.  Collectively, these                                 
                  references show two things:  (1) comparing a new protein with existing                                    
                  sequences does not always accurately predict the function of the new protein                              
                  and (2) minor changes in amino acid sequence can result in major changes in a                             







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