Appeal No. 1997-3019
Application No. 08/404,122
Appellant argues (Brief, page 7) that “[a]djuvants may be tested in vitro and in vivo,”
but “when used as an adjuvant with a vaccine, their administration would be in vivo.” “At
the date of the invention,” however, “only in vitro data were published concerning NAGO
and its behavior and effects in vivo were unexplored.” According to appellant (Brief, page
10), “[t]he generation of a non-specific response by NAGO in vitro does not enhance the
weak specific response elicited by the vaccine or antigen but masks it.” On the other hand
(Brief, page 11), “administration of NAGO in vivo does not provoke the general
proliferation of T cells . . . [r]ather, in vivo, NAGO has the completely opposite effect,” it
“enhances the specific proliferation of T-cells elicited by antigen or vaccine.” This is also
the position advanced in two declarations submitted by Dr. Rhodes under 37 CFR § 1.132
(dated May 22, 1995 and May 16, 1996).
The examiner summarizes (inaccurately, in our view) appellant’s arguments as
follows (Examiner’s Answer, page 7):
The main argument against the secondary references is that they are directed to in
vitro experiments and thus should not be combined with the teaching in the primary
reference which is directed to in vivo experiments.
Nevertheless, the examiner maintains that “it is well known [that] reagents are tested using
more simplistic and readily accessible in vitro studies prior to in vivo applications” and “the
combination of neuraminidase and galactose oxidase (NAGO) was known to be
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