Ex Parte Stankov - Page 10

               Appeal 2007-3261                                                                             
               Application 09/854,802                                                                       
               Reply Brief, we affirm the rejection of claims 16-18 and 20-24 for lack of                   
               written description.                                                                         

               Indefiniteness rejection                                                                     
                      Claims 16-18 and 20-24 stand                                                          
                      rejected under 35 U.S.C. 112, second paragraph, as being                              
                      incomplete for omitting essential elements, such omission                             
                      amounting to a gap between the elements. See MPEP §                                   
                      2172.01. The omitted elements are: (2) granulation, (4) addition                      
                      of the retardant excipients, lubricants, volume and gliding                           
                      excipients and (7) application of the melatonin solution under                        
                      pressure on the tablets for the formation of the “cortex”.                            
                      Specification discloses that stages (2), (4) and (7) are essential                    
                      for the preparation of the formulations which are the subject of                      
                      the invention (Pg. 8, lines 27, 28).                                                  
               (Answer 6.)                                                                                  
                      We reverse this rejection.  A specification must conclude with claims                 
               “particularly pointing out and distinctly claiming the subject matter which                  
               the applicant regards as his invention.”  35 U.S.C. § 112, ¶ 2 (2000).  The                  
               purpose of § 112, ¶ 2, is to “reasonably apprise those skilled in the art of the             
               scope of the invention.”  Miles Labs., Inc. v. Shandon, Inc., 997 F.2d 870,                  
               875, 27 USPQ2d 1123, 1126 (Fed. Cir. 1993).  It is the purpose of the                        
               written description, not the claims, to describe how to make and use the                     
               invention. 35 U.S.C. § 112, ¶ 1 (2000).  In this case, the claims are directed               
               to a composition of matter.  It is not necessary under § 112, ¶ 2 to recite the              
               steps for making the composition in the claim; that function is the purpose of               
               the written description.                                                                     



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