Appeal No. 2001-1485
Application No. 08/532,211
followed by removal of the inactivating agents and further
optional processing of the product. (Id., page 5, line 19 – page
6, line 7).
The examiner has additionally found that Mitra teaches the
need to produce virus-free ISG to prevent viral infection in
patients. Mitra also recognizes the historic need to reduce the
ACA to obtain safe ISG. (Id., page 6, lines 8-14).
The examiner has further found that Joy Yang discloses an ISG
with a deliberate virus inactivation step followed by retention of
complement activity. (Id., page 6, line 15 – page 7, line 8).
The examiner thus concludes that it would have been obvious
to one of ordinary skill at the time the invention was made to
modify Tenold to pretreat for viral reduction as taught by
Neurath, Mitra, and Joy Yang to both ensure reduction of viruses
and low ACA. (Id., page 7, lines 6-11). As to the incubation
step of Claim 1(b), the examiner explains that the “antibody
solution [of Tenold] is stored for up to six months under the
defined controlled parameters,” citing Tenold, column 4, line 24 –
column 8, line 54).
The appellant, on the other hand, asserts that there is no
suggestion or motivation to require a step (b) which reduces the
increased ACA level as no one was aware of the “surprising”
increase. Consequently, no one could have expected the increased
ACA level, much less found a way to counter it. (Appeal Brief,
4
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