Appeal No. 2001-1485
Application No. 08/532,211
with the Tenold ACA lowering procedure and that the resulting
product did not have an initially acceptable ACA level. This is
in direct contrast to Tenold’s statements that the process
initially provides an acceptable ACA. Confronted with this
anomaly, why would one of ordinary skill in the art then further
incubate the solvent detergent treated ISG having an unacceptable
ACA after the Tenold process?2 On this record we find no reason to
do so.
The six-month data in Tenold only shows that an initial
acceptable ACA level can be maintained upon six months storage.
Importantly, Tenold does not teach that the initially high ACA
level may be lowered merely by storing the ISG for six months.
Assuming the examiner is correct, and that one of skill in the art
would measure ACA after Neurath’s solvent detergent treatment,
that person would presumably discover what the appellants did; the
ISG has a higher ACA level than expected. Why, then would one
skilled in the art know that simply treating the solvent detergent
ISG by way of Tenold would not lower the ACA to an acceptable
level, but rather a significant incubation step would be needed?
Again Tenold only indicates that six months storage maintains, not
lowers, the ACA level.
2 Although not discussed in the Examiner’s Answer or the Brief, we observe that
Mitra teaches a Cohn fractionated ISG, when stored, shows a reduction in the
AIDS virus. (Column 6, lines 42-54 and column 7, line 1 to column 8, line 25).
However, this storage does not occur after a solvent detergent inactivation
step, and does not reveal the effect on the ACA of the ISG solution.
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