Ex parte ROIZMAN et al. - Page 5




                  Appeal No. 1996-2639                                                                                                                          
                  Application No. 08/176,320                                                                                                                    


                                                                                                                             4                                  
                  USPQ 71, 76 (CCPA 1979) .  Indeed, in allowing related application no. 07/832,855,  this same                                                 

                  examiner stated in her reasons for allowance that                                                                                             

                                     Applicants have shown that the HSV U 26 open reading frame encodes a                                                       
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                            protease; the biological activity and function of this protein was not previously known in                                          
                            the art.  The newly submitted claims (amendment of 7/3/95) are drawn to an assay to                                                 
                            identify agents that inhibit the HSV protease.  The amendment overcomes the previous                                                
                            art rejections because, in order to assay for an enzyme-inhibiting agent, one would need                                            
                            to know the enzyme exists. This was not known in the art at the time the invention was                                              
                            made.  The claims are thus deemed to be novel and unobvious. [Notice of Allowability,                                               
                            Paper No. 26, mailed July 10, 1995, in application no. 07/832,855, now U.S. Patent                                                  
                            No. 5,478,727, issued Dec. 26, 1995, copy attached to this decision.]                                                               

                  It appears incongruous for the same examiner to allow claims which require “a purified HSV protease                                           
                                                                                    5                                                                           
                  encoded by at least domains II and III of U 26 gene”  because it was not even known that HSV                                                  
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                  possessed a viral protease and to maintain that it would have been obvious to clone a nucleic acid                                            

                  sequence for an enzyme not previously known to exist.  Therefore, although it may have been within                                            

                  ordinary skill in the art to ligate the U 26 open reading frame sequence of McGeoch into a cloning                                            
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                            4Application No. 08/176,320, filed January 3, 1994, is a continuation of application no. 07/705,814, filed May                      
                  24, 1991, now abandoned.  U.S. Patent 5,478,727, issued from application no. 07/832,855 which (a) was a continuation-                         
                  in-part of application no. 07/705,814 and (b) was the same application which was the basis for the withdrawn                                  
                  provisional double patenting rejections noted above.                                                                                          
                            5  Claim 1 in issued U.S. Patent 5,478,787 reads as follows:                                                                        
                                     1.  An assay method to identify a substance capable of inhibiting a herpes virus protease                                  
                            comprising:                                                                                                                         
                            (a) obtaining a purified HSV protease encoded by at least domains II and III of U 26 gene;                                          
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                            (b) adding to said protease a protein substrate containing the cleavage site of said protease under                                 
                            conditions appropriate to effect proteolytic cleavage of said substrate;                                                            
                            (c) adding to said protease a candidate inhibitor substance; and                                                                    
                            (d) determining whether said protein substrate has been cleaved.                                                                    
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