Appeal No. 1999-2634
Application No. 08/108,606
administered with CTB would provide protection when administered as a
vaccine as taught by Svennerholm et al. [Emphasis added.]
"[P]atentability is determined on the totality of the record, by a preponderance of
evidence with due consideration to persuasiveness of the argument." In re Oetiker,
977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992); In re Piasecki, 745
F.2d 1468, 1471-72, 223 USPQ 785, 787 (Fed. Cir. 1984). Findings of fact and
conclusions of law must be made in accordance with the Administrative Procedure Act,
5 U.S.C. 706 (A), (E) (1994). See, Zurko v. Dickinson, 527 U.S. 150, 158, 119 S.Ct.
1816, 1821, 50 USPQ2d 1930, 1934(1999). In addition upon judicial review, findings of
fact relied upon in making the enablement rejection must be supported by substantial
evidence within the record. See In re Gartside, 203 F.3d 1305,1315, 53 USPQ2d 1769,
1775 (Fed. Cir. 2000).
In the present case, with respect to claims 7-11,16 and 17, we find the examiner
has failed to establish a prima facie case of obviousness. Although the examiner
suggests it would have been obvious to further incubate the formalin-treated bacterial
strains at 4EC in order to prevent contamination of the culture or denaturation of the
bacterial antigens prior to collecting them for use in the vaccine, the examiner has failed
to provide evidence, such as in the form of a patent, reference material or publication to
support this position. Patent examiners, in relying on what they assert to be general
knowledge to negate patentability on the ground of obviousness, must articulate that
knowledge and place it of record, since examiners are presumed to act from the
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