Appeal 2007-2864
Application 10/747,798
cavity with an adenoviral vector encoding p53 under control of the CMV
promoter by intramucosal injection in the area of the lesion followed by
topical application of a mouthwash comprising the vector. The record
establishes by a preponderance of the evidence that human papilloma virus
infection is known to be associated with different cancerous and
precancerous conditions, such as the premalignancies of the squamous
epithelium as taught by Clayman. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d
1422, 1427, 7 USPQ2d 1152, 1156 (Fed. Cir. 1988) (explaining the general
evidentiary standard for proceedings before the Office); In re Kollar, 286
F.3d 1326, 1329, 62 USPQ2d 1425, 1427 (Fed. Cir. 2002) (“The PTO bears
the initial burden of demonstrating that the preponderance of the evidence
establishes, prima facie, facts supporting the conclusion that the claimed
invention was on sale within the meaning of § 102(b).”).
As acknowledged in the Specification at page 2, “[m]any proliferative
conditions are known to be associated with papillomaviruses. Examples
include benign lesions such as cutaneous warts and anogenital warts and
premalignant lesions such as epidermodysplasia verruciformis.
Papillomaviruses are also associated with malignant lesions including
carcinomas of the head and neck, cervix, anus, and penis.” El-Deiry teaches
that “HPV infection is well-known to result in cancers of the uterine cervix.
In addition to anogen[it]al cancer, HPV infection may also result in
esophageal squamous cell cancer, laryngeal papilloma, bronchiolo-alveolar
carcinoma, penile carcinoma and bladder carcinoma, among others.” (El-
Deiry, p. 14.) Further, as noted by the rejection, Oda teaches that up to 90%
of oral cancers have been reported as having HPV DNA, and teaches that
about one-half of oral epithelial dysplasias are infected with HPV, and that
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