Appeal No. 2005-2235 Page 9
Application No. 09/038,894
elevated, using [F]uthan,” appellants’ specification does not provide an enabling
disclosure “for any and all activation lowering therapies[,] and any and all
diseases or conditions[,] and any and all methods of assessing cellular
activation[.]” In this regard, the examiner asserts (id.), “[t]he art of biotechnology
is a highly unpredictable art[ ]3 and it would be an undue burden for one of
ordinary skill in the art to test any and all activation lowering therapies and any
and all diseases or conditions and any and all methods of assessing cellular
activation to see if they could perform the claimed processes.” In the examiner’s
opinion (Answer, pages 5-6),
knowing only one activation lowering therapy, one condition to treat
it with and only one type of assay in which to determine if it is
necessary, one of ordinary skill in the art would not know what
other conditions could be treated, what other therapies could be
used or what other assays could be used to determine if such a
method would work. … There is no guidance on which assay would
be useful for which disease/condition.
In response, appellants point out that the therapeutic target and diagnostic
indicator is cell activation. Brief, page 24. In this regard, appellants’ note (id.),
“[n]umerous methods and ways to lower cell activation[ ]4 are provided in the
specification (see, discussion above regarding the claimed subject matter); these
methods range from particular drugs, such as futhan, to lifestyle changes.”
According to appellants (id.),
[p]rior to the instant application … cell activation had not been
identified as a diagnostic or prognostic of disease or treatment
outcome nor as a point of therapeutic intervention. Having
3 According to the examiner (Answer, page 5), “[t]he area of biotechnology is highly unpredictable
since the human body in and of itself is very unpredictable.”
4 Appellants explain (Brief, page 24), “[c]ell activation is a phenomenon that is known to those of
skill in the art as are factors that lead to its elevation and some methods for its decrease.”
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