Ex Parte Lal et al - Page 6


              Appeal No. 2005-0102                                                                 Page 6                
              Application No. 09/840,787                                                                                 

                     Even if this protein is a mitochondrial carrier protein, one of ordinary skill in                   
                     the art would not know which compound is a substrate for the carrier.                               
                     Humans produce many mitochondrial carriers and each mitochondrial                                   
                     carrier is expected to have a specific substrate(s) and function that cannot                        
                     be predicted based on sequence homology alone.  The art teaches that                                
                     there are many mitochondrial carriers that import various metabolites,                              
                     nucleotides, cofactors and compounds which are not synthesized in                                   
                     mitochondria.                                                                                       
              Examiner’s Answer, page 5 (citing Palmieri, “Mitochondrial carrier proteins,” FEBS                         
              Letters, Vol. 346, pp. 48-54 (1994), of record).                                                           
                     The examiner also noted that the specification discloses that HRM-19 is similar                     
              to a protein from C. elegans but concluded that this, too, failed to suggest a patentable                  
              utility, because “[t]he sequence search performed by US PTO shows that SEQ ID                              
              NO:19 has about 35% homology with C. elegans C16C10 that is defined by GenBank                             
              as ‘similar to carrier protein’, i.e. similar to a protein for which the function is not                   
              established.”  Examiner’s Answer, page 5.  The examiner concluded that “a protein of                       
              SEQ ID NO:19 is an uncharacterized protein with no known specific function.”  Id., page                    
              6.                                                                                                         
                     With respect to the specification’s disclosure that polynucleotides encoding SEQ                    
              ID NO:19 can be used to detect the level of expression of the corresponding gene, the                      
              examiner noted that “for a method of detection of a nucleic acid in a sample to be                         
              useful, one must know the biological significance of the polypeptide(s) which is(are)                      
              being detected.  Without this information, the results of the expression profile are                       
              useless because one would not know . . . what significance could be attributed to such                     
              changes in expression profiles.  Without this knowledge, which could not be gleaned                        
              from the instant specification as filed, one of ordinary skill in the art at the time the                  






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