Appeal No. 1997-0473
Application No. 07/870,985
block HEV infection of primary human hepatocyte cells in culture. Applicants state that the
composition contains an antibody which is immunoreactive with a peptide containing the
C-terminal 48 amino acids of the capsid protein encoded by the second open reading
frame of the HEV genome.
Discussion
The rejection under 35 U.S.C. § 112, first paragraph
When an issue of enablement is raised under 35 U.S.C. § 112, first paragraph, the
initial burden is on the Patent and Trademark Office to establish reasons why one skilled in
the art would not believe the objective statements of utility and/or enablement in the
specification. In re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA 1971).
In setting forth the basis of the rejection under 35 U.S.C. § 112, first paragraph, it
would reasonably appear that the examiner has premised his conclusion that the
disclosure in support of the presently claimed invention is not enabling on two alternative
propositions. First, the examiner urges that (Answer, page 3):
the claimed method encompasses the prevention of HEV infection. Upon
review of the specification of the subject application, no definition has been
ascribed to the term “infection.” In the absence of such guidance, the term
“infection”, . . . has been interpreted as “the fact or state of being infected,
esp. by the presence in the body of bacteria, protozoans, viruses, or other
parasites” (Webster’s New World dictionary, Third College Edition). Given
such an interpretation, the individual which is to receive the vaccine must not
have HEV enter their body, else they would be infected with the virus.
However, the antibody-comprising vaccine is incapable of such an effect as
the vaccine acts by the binding of the antibodies to epitopes of HEV
3
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 Next
Last modified: November 3, 2007