Appeal No. 2006-2644 Page 8
Application No. 10/047,945
Appellants also argue that additional data to support the examples cannot
properly be required because “what is presented is human clinical data. The only way
to statistically verify its validity is by providing more human clinical data. And that, in
essence, is a requirement for human clinical trials which is clearly outside the law.” Id.,
pages 8-9.
This argument is also unpersuasive. The evidence needed to show that the
claimed method is enabled can take a variety of forms. For example, in vitro studies
showing that LT-10 inactivates or causes degradation of IgE would provide evidence
that LT-10 can reduce IgE levels in vivo. Animal studies, in an art-recognized animal
model, showing that IgE levels measured in saliva correlate to serum IgE levels would
provide evidence to help show that the specification’s working examples support the
claimed method. Evidence that a four amino acid long fragment of SEQ ID NO:2 has
the same effect (in vitro or in an animal model) as LT-10 would help support the breadth
of the current claims. In short, human clinical trials are not required to show
enablement, and the examiner is not implicitly requiring them.
In summary, the specification provides inadequate evidence to show that any
fragment of SEQ ID NO:2 would have the effect of reducing the level of free serum IgE
if administered to a human. Since the specification does not adequately enable any
embodiment within the scope of the claims, it logically follows that it fails to enable
practice of the full scope of the claims without undue experimentation. The examiner
did not err in omitting a detailed discussion of the Wands factors. We affirm the
rejection under 35 U.S.C. § 112, first paragraph, for lack of enablement.
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