Appeal No. 1997-0473
Application No. 07/870,985
peptides/proteins/viral particles, thereby marking said viral
peptides/proteins/viral particles for removal and ultimate destruction by
phagocytic cells, e.g., macrophages.
Alternatively, the examiner urges that (Answer, page 4):
the claimed method has been interpreted as though the antibody vaccine is
administered only once. Given such an interpretation, the antibodies being
administered have no capacity of regeneration/replenishment and will
accordingly be eliminated from the individual, leaving the individual with no
protective neutralizing capacity, much less a capacity to “prevent” an HEV
invention. Even if the antibody were to be administered a plurality of times,
the specification fails to provide sufficient guidance as to when, how often,
and how much of the vaccine to administer in order to achieve “prevention”
of HEV infection.
The examiner continues this analysis by noting that (Answer, page 5):
At page 20, third paragraph, of the specification, the antibody is described
as being comprised of “polyclonal antibodies from antisera, prepared for
example, by immunization of a suitable animal, such as a rabbit or goat, with
one of the HEV antigens above.” . . . alternative sources include monoclonal
antibodies produced by hybridoma using “lymphocytes from an immunized
animal, preferably mouse or human” that are immortalized with a suitable
fusion partner . . . A plurality of administrations of the vaccine would clearly
potentiate the immune response of the individual against the foreign
antibody which would only hasten its elimination from the system, leaving the
individual with no means for preventing an HEV infection.
This second proposition was raised in the non-final Office action of April 7, 1995
(Paper No. 28). However, the examiner failed to repeat this portion of the rejection in the
final Office action of September 20, 1995 (Paper No. 31). We would observe, that since
the examiner failed to refer to or repeat this portion of the rejection, the appellants may
have considered this basis of rejection withdrawn. This is evidenced by the failure of the
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