Appeal No. 2006-0735
Reexamination Control No. 90/006,036
1 genomes (nucleic acids)” where “two different therapeutic agents, or ribozymes, were
introduced into the nef coding region of the viral genome” which “inherently contains an
RNA packaging/encapsidation signal (Ψ) that localizes the viral genome to the inner
surface of the cytoplasmic cell membrane prior to encapsulation into the virion.”
(Answer at 4).
The patentee argues, inter alia, that contrary to the examiner’s ascertains,
Dropulic does not teach that the modified HIV-1 genome contains an HIV-1 packaging
signal. According to patentee, since Dropulic does not contain an HIV-1 packaging
signal, it also does not teach “the necessary signal to co-package and co-localize a
therapeutic agent with the HIV-1 particle.” (Brief at 15-16).
There is no express teaching of an HIV-1 packaging in Dropulic. However, the
examiner argues that an HIV packaging signal is inherent in the modified HIV-1 genome
disclosed by Dropulic. Unlike Hu, Dropulic does not indicate that the HIV-1 genome
contains “all of the natural HIV-1 structures and machinery” but for the therapeutic
portion nor that it “has the same ‘targeting’ or ‘homing’ specificity as the naturally
occurring (wild type) virus.” (‘See ‘038 at 11:41-45 and 65-67). In contrast to Hu,
Dropulic contains very little information about that portion of the genome that remains
after modification. Thus, we are not convinced that the examiner has shown a sound basis
for believing that the modified HIV genome of Dropulic inherently contains an HIV
packaging signal. See In re Spada, 911 F.2d 705, 708, 15 USPQ2d 1655, 1658 (Fed. Cir.
1990). Since the examiner has not established a prima facie showing of anticipation
based on inherency, we REVERSE the examiner’s rejection of claims 1-4, 6-10, 12, and
13 under 35 U.S.C. § 102(b) as being anticipated by Dropulic.
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