Ex Parte LEE - Page 11


                  Appeal No. 2003-0528                                                           Page 11                   
                  Application No. 09/314,841                                                                               
                  evidence (id.), the examiner concludes “[o]ne skilled in the art would reasonably                        
                  have expected success in using POPC and POPS as the synthetic phospholipids                              
                  in the reagent and methods of B[rucato], B[utler] and S[chwinn] or B[rown],                              
                  B[rucato], B[utler], and S[chwinn]] because H[awkins] teaches that POPS and                              
                  POPS [sic] can be combined with rTF in a method similar to that taught by                                
                  B[rown]….”                                                                                               
                         However, as discussed, supra, the examiner has not provided the                                   
                  evidence necessary to demonstrate that the Brucato, Butler, Brown, or Hawkins                            
                  prothrombin reagents could be modified in a manner that would retain shelf life                          
                  as disclosed by Butler.  Accordingly, we reverse the rejection of claims 12, 13, 41                      
                  and 42 stand rejected under 35 U.S.C. § 103 as being unpatentable over                                   
                  Brucato in view of Butler, Schwinn and Hawkins.  For the same reason, we                                 
                  reverse the rejection of claims 24 and 25 stand rejected under 35 U.S.C. § 103                           
                  as being unpatentable over Brown in view of Brucato, Butler, Schwinn and                                 
                  Hawkins.                                                                                                 
                  Brucato in view of Butler, Schwinn and Prestrelski with or without Brown:                                
                         Brucato, Butler, Brown and Schwinn are relied upon as set forth above.                            
                  The examiner recognizes, however, that Brucato, Butler, Brown and Schwinn do                             
                  not teach reagents dried at a selected temperature and humidity, which are not                           
                  lyophilized.  To make up for this deficiency the examiner relies on Prestrelski.                         
                  According to the examiner (Answer, page 11), Prestrelski teach “air-drying of                            
                  proteins at ambient temperature (about 20 [°]C) at low humidity…..”  The                                 
                  examiner further notes (id.), Prestrelski teach “that excipients such as alanine,                        







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