Appeal 2007-1032
Application 10/062,920
Jere W. McBride et al., Molecular Cloning of the Gene for a
Conserved Major Immunoreactive 28-Kilodalton Protein of Ehrlichia canis:
a Potential Serodiagnostic Antigen, 6 Clin. Diag. Lab. 392-99 (May 1999).
Norio Ohashi et al., Immunodominant Major Outer Membrane
Proteins of Ehrlichia chaffeensis Are Encoded by a Polymorphic Multigene
Family, 66 Infect. Immun. 132-39 (Jan. 1998).
3. ENABLEMENT
Claims 17, 19, and 20 stand rejected under 35 U.S.C. § 112, first
paragraph, as nonenabled on the basis that “undue experimentation would be
required to practice a method of inhibiting E. canis infection” (Answer 4).
The Examiner reasons that the claims encompass processes in which
administration of the E. canis protein results in inhibition of subsequent
infection by the organism (id. at 4-6). The Examiner states that the
Specification “provides general guidance that a 28 kDa protein would be
administered to a subject but does not provide any guidance with any
specifics as to how much of the protein should be administered or how many
times the protein should be administered in order to be effective” (id. at 6).
The Examiner notes that the Specification “does not have any examples of a
method of inducing an immune response to E. canis to inhibit infection”
(id.).
The Examiner urges that while “[s]everal of the proteins used in the
method claims were known at the time of the invention” the art “do[es] not
teach or suggest that any of the proteins disclosed therein could be used
successfully in a method of treating E. canis” (id. at 7). The Examiner
argues that “determining what 28 kDa proteins of E. canis could be used to
successfully inhibit E. canis infection or to induce an immune response
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