Appeal No. 1997-2139
Application No. 08/114,595
In re O'Farrell, 853 F.2d 894, 903-04, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988). Here,
while Muzyczka characterizes the procedures for growing recombinant AAV virus stocks
as "awkward," Muzyczka also states "this does not appear to an insurmountable
technical problem" (p. 122, last para.). Indeed, Muzyczka identifies several methods for
addressing problems in growing AAV stocks. For example, heat inactivation, CsCl
density centrifugation and/or anti-adenovirus neutralizing antibody can be used to
remove adenovirus contamination (Fig. 6, p. 116, last para.). Use of a complementing
plasmid having no homologous sequences between the recombinant genome and the
complementing plasmid is disclosed as producing recombinant virus titers of 104 to 105
with no detectable wild type contamination (citation omitted) (p. 116, first full para.).
Instability seen in plasmids propagated in standard RecA prokaryotic hosts, e.g., can be
solved by propagating AAV vectors in host such as JC8111 (p. 117, para. 1). The fact
that some experimentation is necessary does not preclude enablement; what is
required is that the amount of experimentation “must not be unduly extensive.” Atlas
Powder Co. v. E.I. DuPont De Nemours & Co., 750 F.2d 1569, 1576, 224 USPQ 409,
413 (Fed. Cir. 1984). In this case, Muzyczka provides one of ordinary skill in the art
with specific guidance in constructing and growing an AAV vector containing a nonviral
DNA sequence. Therefore, this argument is not persuasive.
The rejection of claim 49 under § 103 over Muzyczka and Drumm is sustained.
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