Ex Parte STOUGHTON et al - Page 4


                 Appeal No.  2005-2235                                                           Page 4                   
                 Application No.  09/038,894                                                                              
                         [a]s used herein, cell activation refers to changes in and                                       
                         interactions among circulating white blood cells, including                                      
                         leukocytes, cells lining blood vessels, including endothelial cells,                             
                         and platelets.  These changes are evidenced by increased                                         
                         “stickiness” of cells, changes in shapes of cells, free radical                                  
                         production and release of inflammatory mediators and enzymes.                                    
                         “The test for definiteness is whether one skilled in the art would                               
                 understand the bounds of the claim when read in light of the specification.”                             
                 Miles Laboratories, Inc. v. Shandon, Inc., 997 F.2d 870, 875, 27 USPQ2d                                  
                 1123, 1126 (Fed. Cir. 1993).  We read in light of appellants’ specification,                             
                 we understand the first step of claim 32 to refer to assessing cell activation                           
                 in a subject which is evidenced by increased “stickiness” of cells, changes                              
                 in shapes of cells, free radical production and release of inflammatory                                  
                 mediators and enzymes.  As appellants’ specification explains (page 17),                                 
                 while                                                                                                    
                         [c]ell activation is necessary for normal human immune defense                                   
                         mechanisms, … inappropriate or excessive activation leads to or                                  
                         participates or intensifies many diseases, including, but not limited                            
                         to: arthritis, atherosclerosis, acute cardiovascular incidents,                                  
                         Alzheimer’s Disease, hypertension, diabetes, venous insufficiency,                               
                         autoimmune disease and others.  Cell activation is a major                                       
                         contributor to rejections [sic] processes in organ transplants, and to                           
                         predisposition to poor outcomes in trauma and high[-]risk surgeries.                             
                 Accordingly, as set forth in claim 32, if cell activation is “elevated,” then the                        
                 second step of the method is performed – administering [cell2] activation                                





                                                                                                                          
                 2 Appellants acknowledge the typographical error in the omission of the word “cell” before the           
                 word activation.  Reply Brief, pages 14 and 15.  We encourage the examiner and appellants’ to            
                 work together to correct this oversight.                                                                 





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