Appeal No. 2001-1485
Application No. 08/532,211
Tenold discloses a method for reducing ACA in ISG to the
point that the ISG is suitable for IV administration. This is
accomplished by solubilizing an ISG to yield a solution with a
certain protein concentration. The pH and ionic strength of the
solution is adjusted to the point where the monomer content of the
ISG is greater than about 90% and the actual and latent ACA is
such that the ISG product is IV injectable. (Tenold, column 4,
lines 30-41). The examiner states that Tenold differs from the
instant claims in that the starting material is not pre-treated to
inactivate infectious agents (Examiner’s Answer, page 5, lines 16-
18). The appellant urges that Tenold already has a low ACA and
consequently cannot reduce ACA. (Appeal Brief, page 5, lines 3-6).
Tenold also discloses storing the solutions at an ionic
strength of 0.001, a pH of 4.2, at room temperature, and for a
six-month period of time. (Tenold, column 9, lines 12-21). The
specification reveals that the incubation is conducted at an ionic
strength of 0.001, a pH of 4.25, at 20-27°C (room temperature), at
not less than 21 days (Specification, page 9, lines 4-12). Thus,
Tenold would appear to disclose the values required by step (b) to
obtain the desired ACA goal.
Viewed alone, the relied upon teachings of the applied prior
art may perhaps be said to support a conclusion of prima facie
obviousness.
However, the specification establishes the following:
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