LEMAIRE et al. V. WALLACH et al. - Page 9




              Interference No. 103,625                                                                                   
              contain a written description of specific tumor necrosis factor binding proteins which                     
              includes the end portion, Leu Arg Glu, of the recited sequence in the LeMaire patent                       
              claims.  In addition, Wallach point out that the ‘072 application identifies X  as “probably               
                                                                                           4                             
              Thr” where claims 1-3 of the LeMaire patent require Pro at this position.                                  
              LeMaire claims 1-3                                                                                         
                            LeMaire claims 1-3 read as follows;                                                          
                            1.  (as corrected by Certificate of Correction of November 29, 1994)                         
              A purified and isolated TNF"-binding protein which has a molecular weight of about                         
              42,000 daltons and has at the N terminus the amino acid sequence                                           
              Xaa Thr Pro Tyr Ala Pro Glu Pro Gly Ser Thr Cys Arg Leu Arg Glu                                            
              where Xaa is hydrogen, a phenylalanine residue (Phe) or the amino acid sequences Ala                       
              Phe, Val Ala Phe, Gln Val Ala Phe, Ala Gln Val Ala Phe, Pro Ala Gln Val Ala Phe or Leu                     
              Pro Ala Gln Val Ala Phe.                                                                                   
                            2. A protein as claimed in claim 1 in deglycosylated form.                                   
                            3. A process for the preparation of a protein which has a molecular weight of                
              about 42,000 daltons and has at the N terminus the amino acid sequence                                     
              Xaa Thr Pro Tyr Ala Pro Glu Pro Gly Ser Thr Cys Arg Leu Arg Glu                                            
              where Xaa is hydrogen, a phenylalanine residue (Phe) or the amino acid sequences Ala                       
              Phe, Val Ala Phe, Gln Val Ala Phe, Ala Gln Val Ala Phe, Pro Ala Gln Val Ala Phe or Leu                     
              Pro Ala Gln Val Ala Phe, which comprises concentration of the urine of patients with fever                 
              and subsequent purification of the retentate obtained in this way by ion exchange and                      
              affinity chromatography.                                                                                   
                            While claim 1 recites “[A] purified and isolated TNF"-binding protein, the                   
              claim, in fact, is directed to a genus of eight purified and isolated TNF"-binding proteins                
              having a molecular weight of about 42,000 daltons containing specific N terminus amino                     
              acid sequences.  The eight purified and isolated TNF"-binding proteins have the following                  
              N terminus amino acid sequences:                                                                           


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