Appeal No. 1996-2539
Application 08/150,776
Hitzeman et al. (Hitzeman) 4,803,164 Feb. 7, 1989
Vyas 5,017,558 May 21, 1991
Brown et al. (Brown I), “Determination of the Affinity of Antibodies to Hepatitis B Surface
Antigen in Human Sera,” Journal of Immunological Methods, Vol. 72, pp. 41-48 (1984).
Brown et al. (Brown II), “Affinity of Antibody Responses in Man to Hepatitis B Vaccine
Determined with Synthetic Peptides,” The Lancet, July 28, 1984, pp. 184-187 (1984).
Okamoto et al. (Okamoto), “The Loss of Subtypic Determinants in Alleles d/y or w/r, on
Hepatitis B Surface Antigen,” Molecular Immunology, Vol. 26, No. 2, pp. 197-205 (1989).
Claims 24 and 25 stand rejected under 35 U.S.C. § 112, first paragraph, as lacking
adequate support in the specification as originally filed, i.e., as lacking an adequate written
description. The claims also stand rejected under 35 U.S.C. § 103; as evidence of
obviousness, the examiner relies on Miyanohara, Hitzeman, Brown I, Brown II, Vyas,
Okamoto and “Applicants’ Admission.” We reverse both rejections.
DISCUSSION
Antibodies against Hepatitis B virus surface antigen (HBsAg), or S-protein, elicit
protective immunity against HBV infection, and HBsAg is the immunogenic component of
several hepatitis B vaccines. According to the specification, pages 3 through 7 (citations
omitted):
Several antigenic subtypes of HBV . . . have been recognized. All of these
subtypes (for example ayw, adyw, adw2, adw and adr) share common
(group specific) envelope epitopes, the immune response against which
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