Appeal No. 2001-1485
Application No. 08/532,211
The Invention
The invention is directed to a method for treating a solution
of antibodies which may have viral activity by a two-step process
of first contacting the solution with a trialkylphosphate and
detergent under conditions which reduce viral activity and
increase anticomplement activity, then incubating the solution
under controlled time, pH, temperature, and ionic strength to
reduce the increased anticomplement activity. (Claim 1).
Discussion
The § 103 Rejection of Claims 1-24 over
Tenold in view of Neurath, Mitra, and Joy Yang
The examiner has found that Tenold teaches the modification
of immune serum globulin (ISG) to reduce anticomplement activity
(ACA) in order that the serum may be administered safely.
(Examiner’s Answer, page 4, lines 15-17). The resulting ISG
product is then maintained at a controlled pH, temperature, ionic
strength, and tonicity so as to generate a monomeric solution of
antibodies with a reduced ACA rendering the solution safe for
intravenous administration (Id., page 5, lines 7-11).
The examiner has also found that Neurath discloses a method
for inactivating infectious virus present in blood or blood
derived solutions (including ISG) while maintaining the activity
of proteins contained in the composition. This is accomplished by
treating the solution with a trialkylphosphate and a detergent
3
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