Interference No. 103,854
As indicated above, claim 3 of the Wallach patent is directed to a trimer which
comprises three (3) monomers consisting of a soluble form of any tumor necrosis factor
(TNF) receptor (a.k.a., a TBP (tumor necrosis factor binding protein) trimer).
Wallach in effect acknowledges that the claimed trimer would have been prima facie
obvious to one of ordinary skill in the art in view of the multimers described in Smith claim 39
and Wallach claim 1, corresponding to the count. Brief, p. 15, last para.6 Thus, in order to
meet their burden of establishing that the TBP trimer described in claim 3 is patentably
distinct from other members of the genus of multimers encompassed by the claims
corresponding to the count, Wallach urges that an unexpected result is obtained by using the
trimer, as opposed to other species of the referenced genus. To that end, Wallach argues
that at the time the invention was made, one of ordinary skill in the art would have had no
reason to expect that TBP trimers would have “superior properties” to TBP dimers. Brief,
sentence bridging pp. 16-17. According to Wallach, their patent and a publication by Peppel7
“provide evidence which creates the expectation that the TBP trimer is a superior TNF
antagonist to a TBP dimer.” Id., p. 17. For support, Wallach points to the disclosure in their
patent that the TNF receptors (TNF-Rs) exist in aggregated form in cells exposed to TNF. Id.
Wallach contends that from this discovery the inventors realized that “multimers of the
soluble form of TNF-Rs would be more effective than monomers in inhibiting TNF activity at
lower doses, since they can effectively compete with the TNF trimers for the binding sites on
6 Also, at oral hearing on July 25, 2000, counsel for Wallach acknowledged that
because the TBP trimer of claim 3 is a species which falls within the genus of multimers
set forth in Smith claim 39 and Wallach claim 1, the species would have been prima
facie obvious in view of the referenced genus.
7 Peppel et al. (Peppel) “A Tumor Necrosis Factor (TNF) Receptor-IgG Heavy
Chain Chimeric Protein as a Bivalent Antagonist of TNF Activity,” J. Exp. Med., Vol.
174, pp. 1483-89 (1991).
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