Appeal No. 1997-3501
Application No. 08/253,232
page 5, lines 26-32. Thus, vWF is not bound to the ion exchanger and is thus separated
from FVIII:C which remains bound on the ion exchange column.
35 U.S.C. § 103
Claims 3, 6, 8-10, 16, 19, 24-25 and 30 stand rejected under 35 U.S.C. § 103 as
obvious over Austen, in view of Mathews, Mitra, Wang, Costello, Scopes and Harris.
It is the examiner’s position that (Answer, Paper No. 33, pages 6-7):
[i]t would have been obvious to one with ordinary skill in the art at the time
Applicants’ invention was made to perform Austen’s anion exchange
procedure in the presence of Mathews’ buffer components because these
are stabilizing components that are of general usefulness in the purification
of proteins, as additionally shown by Wang, and this would insure that the
von Willebrand Factor would not become denatured during the purification
procedure. It would also have been obvious to one with ordinary skill in the
art at the time Applicants’ invention was made to subject Austen’s purified
von Willebrand Factor to the precipitation protocols of Costello and Scopes
because these are procedures that may be used and manipulated to (sic,
so) that the desired protein is purified to the greatest extent possible, which,
for a pharmaceutical preparation is desirable,, (sic) as the more highly
purified a preparation is, the less likely there are to be contaminants present
that would cause undesirable side effects. It would have been obvious to
one with ordinary skill in the art at the time Applicants’ invention was made to
use NaCl as a precipitant in the purification procedure of Austen as modified
by Costello, Mathews, and Scopes, because that is a salt that is known to be
effective for the precipitation of proteins, as shown by Scopes. It would have
been obvious to one with ordinary skill in the art at the time Applicant’s
invention was made to use Mitra’s pasteurization procedure in the presence
of Mitra’s and Wang’s protein stabilizers to inactivate viral or bacterial
contaminants in the von Willebrand Factor preparation suggested by Austen
as modified by Mathews, Costello and Scopes because it is desirable to
have a pharmaceutical preparation that does not contain unwanted materials
such as viruses, and heat treatment will inactivate these undesirable
6
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Next
Last modified: November 3, 2007