Ex Parte Jegla - Page 8


               Appeal No. 2005-2207                                                              Page 8                         
               Application No. 09/548,933                                                                                       

                      The examiner concedes that “hHAC3 [ ] is structurally related to a voltage-gated                          
               cation channel family of proteins, specifically it is related to the family of                                   
               hyperpolarization-activated channels (HAC)” (Answer, page 4).  The examiner also                                 
               concedes that “[o]ne skilled in the art [would] readily understand[ ] that hyperpolarization-                    
               gated cation channels could certainly be involved in modulation of cellular excitability” (id.,                  
               page 9), and “could be associated with [the] etiology or development of migraine and                             
               epilepsy” (id.).                                                                                                 
                      Nevertheless, the examiner argues that the “asserted utility of [the] HAC3 channel                        
               as a modulator of cell excitability is not specific because it is associated with a general                      
               physiological function of regulating a membrane potential in a cell” (id., page 12,                              
               emphasis ours).  The examiner also argues that the asserted utility is not substantial                           
               because the identification of hHAC3 as “a novel cation channel does not unequivocally                            
               lead to the conclusion that it is directly associated with dysfunctions, disorders or                            
               conditions in which cation channels are known to be involved” (id.).  We disagree with the                       
               examiner’s analysis and conclusions.                                                                             
                      First, the examiner has not explained why modulating cellular excitability or                             
               regulating membrane potential does not “provide a well-defined and particular benefit to                         
               the public.”  See Fisher, 421 F.3d at 1371, 76 USPQ2d at 1230.  The fact that all cells                          
               have a membrane potential, and that there are many classes of channels that modulate                             
               membrane potential and cell excitability, does not mean that identifying modulators of one                       
               particular type of channel (in this case disclosed to be a hyperpolarization-activated,                          
               cyclic nucleotide-gated channel that generates a mixed sodium/potassium Ih pacemaker                             
               current) does not provide a specific, well-defined and particular benefit to the public,                         





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