Appeal No. 2006-1608 Page 5
Application No. 09/978,593
Washington Times,6 stating that results in animal models “‘cannot always be
easily replicated in humans.’” Id.
The examiner next cites Kirsi7 for its teaching that “[t]he effect of an
inhibitor is also dependent on the virus, inhibitor concentration and cell line used,”
indicating that an “inhibitor may be effective in one cell line but not in another cell
line for the same virus.” Id. at 6. Finally, the examiner cites Mitsuya8 and
Sandstöm9 as evidence that a drug that showed promise as a treatment of HIV in
vitro, suramin, was not correlated to in vivo efficacy. See id.
The invention that must be enabled to satisfy § 112 is the invention
defined by the claims. See CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333,
1338, 68 USPQ2d 1940, 1944 (Fed. Cir. 2003) (“Title 35 does not require that a
patent disclosure enable one of ordinary skill in the art to make and use a
perfected, commercially viable embodiment absent a claim limitation to that
effect.”). Thus, when the claims are not limited to a method that achieves
therapeutic or clinical efficacy, such efficacy is not required for the claims to be
enabled.
6 Joyce Howard Price, Researchers test ‘smart-bomb’ cancer therapy, Washington Times,
November 16, 2001, at 3.
7 Kirsi et al. (Kirsi), “Broad-Spectrum Antiviral Activity of 2-β-D-Ribofuranosylselenazole-4-
Carboxamide, a New Antiviral Agent,” Antimicrobial Agents and Chemotherapy, Vol. 24, No. 3,
pp. 353-61 (1983).
8 Mitsuya et al. (Mitsuya), “Suramin Protection of T Cells in Vitro Against Infectivity and
Cytopathic Effect of HTLV-III,” Science, Vol. 226, pp. 172-74 (1984).
9 Sandstöm et al. (Sandstöm), “Antiviral Therapy in AIDS Clinical Pharmacological Properties
and Therapeutic Experience to Date,” Drugs, Vol. 34, pp. 372-90 (1987).
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