Appeal No. 1997-3501
Application No. 08/253,232
as a buffer. Examiner’s Answer, page 4. Mathews does not teach isolation, purification or
pasteurization of vWF.
Costello is the only reference of record directly relating to the purification of vWF.
Costello indicates that vWF may be produced by a process including steps of
(i) treating a 3-4% PEG precipitate of a solubilized cryoprecipitate derived from blood with
a solubilizer capable of taking up substantially all of the vWF present in the PEG
precipitate, (ii) adding to the resulting solution of vWF a precipitant which is capable of
preferentially precipitating fibrinogen with regard to the other components in the solution,
(iii) treating the resulting supernatant with an adsorbent capable of adsorbing clotting
factors II, VII, IX and X; (iv) treating the supernatant with a precipitant capable of
precipitating substantially all of the protein present; and (v) solubilizing the precipitate with
a solubilizer capable of taking up substantially all of vWF in the precipitate. Costello, page
1. Costello does not teach pasteurization of vWF or adsorbing only Factor VIII:C to an
anion exchanger while maintaining vWF in solution.
Mitra discloses a process for producing a high purity antihemolitic factor VIII:C
(AHF) concentrate which may be subjected to pasteurization. Mitra describes the
pasteurization process as, “mixing AHF with at least one amino acid selected from glycine,
lysine, arginine and alanine with at least about 30%, preferably from about 54% to
saturation, on weight to volume basis of a compound selected from sugars and reduced
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