Ex Parte HOSOKAWA et al - Page 5




              Appeal No. 2002-1358                                                                                         
              Application No. 09/467,903                                                                                   
              35 U.S.C. § 112, first paragraph                                                                             
                     Claims 30-49 stand rejected under 35 U.S.C. § 112, first paragraph for lack of                        
              written description and failing to reasonably convey to one skilled in the relevant art that                 
              the inventor, at the time the application was filed, had possession of the claimed                           
              invention.                                                                                                   
                     The examiner argues (Answer, pages 4-5):                                                              
                            There is no support in the specification as originally filed for the                           
                     recitation of “antibody fragment” in claims 30, 35, 40 or 45.   The scope of                          
                     the term “antibody fragment” encompasses compositions containing                                      
                     fragments not disclosed in the specification (eg. such as Fv or Fd or                                 
                     F(ab)2 ).  There is no written description in the specification as originally                         
                     filed of the claimed conjugate or composition containing said conjugate                               
                     wherein the conjugate contains a “antibody fragment” per se. ...  There is                            
                     also no support in the specification as originally filed for the recitation of                        
                     “F(ab')2“ in claims 34, 39, 44 and 49.  The specification pages 11 and 12,                            
                     discloses the use of Fab’ derived from F(ab')2 for the preparation of the                             
                     claimed invention, but there is no disclosure of the use of F(ab')2 in the                            
                     claimed invention.  The specification merely discloses the use of F(ab')2 to                          
                     prepare Fab’, wherein the Fab’ are then used in the claimed invention. ...                            
                     There is no written description in the specification as originally filed of the                       
                     claimed invention (eg. the claimed invention constitutes new matter).                                 

                     The test for determining compliance with the written description requirement is                       
              whether the disclosure of the application as originally filed reasonably conveys to the                      
              artisan that the inventor had possession at that time of the later claimed subject matter,                   
              rather than the presence or absence of literal support in the specification for the claim                    
              language.  See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111,                           
              1116-17 (Fed. Cir. 1991) and In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089,                               
              1096 (Fed. Cir. 1983).   Furthermore, claim language must be analyzed “not in a                              
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