Appeal No. 2006-2745 Page 6
Application No. 09/966,119
composition could be administered orally. As the examiner points out, Kent
discloses that the sterilization method can be used to sterilize food, which is
typically consumed orally. Answer, page 7. In addition, we recognize appellants’
assertion (Brief, page 8, emphasis removed), “one may not extrapolate sterilized
IgG to irradiated Cohn II+III suitable for oral administration.” It may be that
appellants are of the opinion that subjecting a Cohn Fraction II + III composition
to irradiation will damage the composition or render it unsuitable for oral
administration. There is, however, no evidence on this record to support such an
assertion. Instead, the evidence of record supports a contrary conclusion. In this
regard, we find that Kent discloses,
there is a need to provide a method of sterilizing products that is
effective in removing biological contaminants while at the same
time having no adverse effect on the product. The present
invention has shown that if the irradiation is delivered at a low dose
rate, then sterilization can be achieved without harming the product.
Kent, column 2, lines 24-29, emphasis added. For the reasons set forth
above, the evidence of record simply does not support this assertion.
We recognize appellants’ assertion (Brief, page 10) that “there had been a
long-felt need for an effective composition for the treatment of immune-mediated
diseases at the time the present invention was filed.” In support of this assertion,
appellants direct attention to page 7, lines 12-15 of their specification which
states, “[i]n view of the unsuccessful and disadvantageous modalities currently
employed to treat those disorders[ ]2, there is a continued need to develop
effective methods and compositions for the treatment of immune-mediated
2 As we understand it, appellants’ reference to “those disorders” refers to multiple sclerosis and
rheumatoid arthritis.
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