Appeal No. 2006-0735
Reexamination Control No. 90/006,036
therapeutic agent, wherein the localization signal causes the therapeutic agent to be
localized with a viral target in a cellular or viral compartment of the cell” (Brief at 10).
In particular, it is patentee’s position that Hu does not teach that an HIV-1 packaging
signal is tethered to the therapeutic agent. (Brief at 9).
It is the examiner’s position that “all of the constructs [of Hu] inherently contain
an RNA packaging signal between the U5 portion of the LTR and the beginning of Gag.”
(Answer at 6). The examiner notes that Hu teaches that the HIV-1 molecular clone that is
used to make the HIV-1 antisense clone “retains all of the natural HIV-1 structures and
machinery.” The examiner points to Hu’s teaching that “[t]he antisense virus is
infectious and has the same ‘targeting’ or ‘homing’ specificity as the naturally occuring
(wild type) virus” such that it is “able to attach to and enter CD4(+) cells...just at the
natural virus.” According to the examiner, “the ψ sequence located in the HIV-1 genome
functions by guiding the RNA form of the genome carrying the antisense/ribozyme
molecule to the inner surface of the cytoplasmic membrane where virion assembly and
budding take place.” (Answer at 6).
The examiner has convincingly shown that the construct of Hu would inherently
contain the native HIV-1 packaging signal in the absence of evidence to the contrary. In
other words, we agree that the examiner has set forth a prima facie case of anticipation
based on inherency. Thus, it is up to patentee to show that the construct of Hu would not
contain an HIV-1 packaging signal. In re Swinehart, 439 F.2d 210, 212-13, 169 USPQ
226, 229 (CCPA 1971)( stating that once a prima facie case of anticipation based on
inherency has been established, the burden shifts to appellant to “'prove that the subject
matter shown to be in the prior art does not possess the characteristic relied on.").
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