Opinion ID: 209563
Heading Depth: 5
Heading Rank: 1

Heading: Disclosure of Krivan

Text: On appeal, Tzipori argues against this obviousness rejection primarily by praising aspects of his research that do not figure into the claims at issue, such as his research with gnotobiotic 7 piglets and his alleged discovery that SLT-II-producing E. coli only form lesions in the intestines of humans and pigs, not other animals. However, Tzipori's criticism of the prior art for failing to reveal this is, at times, equally applicable to his own claims. For example, he states: Krivan describes animal antibodies to SLTs generally, without identifying or disclosing which SLT is the one that causes HUS in humans. There is 4 L.P. Perara, L.R.M. Marques, A.D. O'Brien, Isolation and Characterization of Monoclonal Antibodies to Shiga-Like Toxin II of Enterohemorrhagic Escherichia coli and Use of the Monoclonal Antibodies in a Colony Enzyme-Linked Immunosorbent Assay, 26(10) J. Clin. Microbio. 2127-2131 (1988). 5 U.S. Patent No. 6,080,400 to Williams et al. 6 Danuta Kozbor & Carlo M. Croce, Human lymphoblastoid Cell Lines as Fusion Partners, in Human Hybridomas and Monoclonal Antibodies 22-27 (Edgar G. Engleman et al., eds. 1985). 7 The parties do not define gnotobiotic, although Tzipori indicates that gnotobiotic piglets do not receive antibodies from their mothers' milk. The Oxford English Dictionary (2d ed. 1989) defines gnotobiotic as Of an organism (esp. a higher animal) or its environment: artificially rendered devoid of bacteria and other organisms which would normally be present as parasites, commensals, symbionts, etc., or having only a few known organisms of this kind present. Precisely what Tzipori means by gnotobiotic in the '958 application, however, is not germane to the outcome of this appeal. 2008-1119 6 no disclosure of the relevant subunits to that specific SLT, nor how those subunits are responsible for the enteric and systemic disease in humans. Krivan discloses that SLT-II existed and that it had subunits. Krivan at 2:14-17; 16:1417; 17:60-62. Krivan discloses purifying SLT-II and using it to make polyclonal bovine antibodies to SLT-II, but does not specify that these antibodies bind specifically to one subunit or the other of SLT-II. Id. at 15:36-43. Krivan did, however, note that a subunit of one or more of the toxins can be used to manufacture antibodies, id. at 8:54-60, which one of ordinary skill in the art would readily understand would produce antibodies specific to that subunit. 8 Tzipori's claim 26 involves antibodies directed to a single subunit of SLT-II. Dependent claims 30 and 33 are limited to antibodies binding the alpha and beta subunits, respectively, of SLT-II. However, as these are, according to Tzipori, the only subunits of SLT-II, his implication that his claims are patentable because they are limited to the subunits responsible for the enteric and systemic disease in humans rings hollow. Tzipori's claims are, as a whole, directed to all parts of SLT-II and no more specific than Krivan's disclosure on this point. Tzipori also asserts that his gnotobiotic pig model is novel and renders his claims patentable over the prior art. In support of this argument, Tzipori offers declarations of several researchers extolling the virtues of the gnotobiotic pig model. It is, however, Tzipori's claims—not his specification—that are the focus of an obviousness inquiry. 8 Additionally, Perera recites that [a]ll the neutralizing MAbs [i.e., monoclonal antibodies] generated in the present study recognized the A subunit of SLT-