Appeal No. 2001-0759
Application 08/809,186
Forman, [230 USPQ 546, 547 (Bd Pat App Int 1986)]. They include (1) the quantity of
experimentation necessary, (2) the amount of direction or guidance presented, (3) the
presence or absence of working examples, (4) the nature of the invention, (5) the state
of the prior art, (6) the relative skill of those in the art, (7) the predictability or
unpredictability of the art, and (8) the breadth of the claims. (footnote omitted). In re
Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404, (Fed. Cir. 1988). The threshold
step in resolving this issue is to determine whether the examiner has met his burden of
proof by advancing acceptable reasoning inconsistent with enablement.
The examiner finds the claimed invention is broadly directed towards methods of
inhibiting cellular proliferation by contacting cells with Vpr protein, or functional
fragments thereof that are sufficient to inhibit cellular proliferation. The claims
encompass in vitro, in vivo, ex vivo and clinical applications. Answer, page 4.
According to the examiner (Id.) the:
disclosure fails to teach that exogenous Vpr, or functional fragments
thereof, are capable of mediating cellular replicative events in cell types of
different lineages and states of differentiation. Applicants submit ...that
the claimed invention is directed toward a “method of inhibiting cell
proliferation which comprises the step of contacting cells with an amount
of vpr [sic-Vpr] protein sufficient to inhibit replication.” However, the
disclosure fails to provide any experimental evidence adducing that Vpr
displays the claimed biochemical activities.
In particular, the examiner argues that “[m]any immortalized cell lines routinely
used for biochemical investigations already display characteristics of a terminally
differentiated phenotype. However other cell lines may retain phenotypic
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