Appeal No. 2001-0562 Page 5
Application No. 08/460,478
the claims are not enabled for any and all means of delivering the
adenovirus to CNS cells in vivo. The standing rejection of [these]
claims … could be overcome by limiting [these] claims … such that
when the adenovirus is administered to central nervous system
cells in vivo, it is done so by stereotactical injection (as in claims 83
and 84).
To support this position, the examiner relies on Friedmann (Answer, page
13) arguing that Friedmann teach:
the CNS is not freely accessible through the general bloodstream
(see Friedmann, page 210, col. 1, para. 2), so it is unclear how one
can infect CNS cells by a systemic route, such as intravenous, oral,
anal, respiratory delivery, since one skilled in the art would not
expect the adenovirus to reach cells of the CNS, at least not in any
effective quantity.
While we note that appellants argue (Reply Brief, page 2) that neither Friedman,
nor the examiner define the phrase “freely accessible,” in our review of
Friedmann, at page 210, column 1, paragraph 2, we are unable to find the
phrase “freely accessible.” Instead, the first sentence of paragraph 2 on page
210, column 1, Friedman states “[i]t is now evident that assessments of the
application of human gene therapy should be extended to neurological
disorders.” In this same paragraph, Friedman states:
Disorders of the CNS … were generally not prominent candidates
for gene therapy in most early discussions … the perceived
physical inaccessibility of the CNS, and physiological barriers to the
introduction of gene transfer vectors through the blood-brain barrier
combined to make gene therapy seem less feasible in the CNS
than in other organs.
In the third paragraph of page 210, column 1, Friedman states “[f]ortunately,
these reservations regarding the feasibility of gene therapy for neurological
disorders are now fading….” Therefore, we agree with appellants’ argument
(Reply Brief, page 3) that “there is no basis in the record to support the
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