Appeal No. 1996-1002
Application 07/988,945
meets this prima facie burden, does the burden shift to applicants to provide suitable
evidence indicating that the specification is enabling in a manner commensurate in
scope with the protection sought by the claims. In re Marzocchi, 439 F.2d 220, 223,
169 USPQ 367, 369 (CCPA 1971) .
Factors appropriate for determining whether undue experimentation is required
to practice the claimed invention throughout its full scope are listed in In re Wands, 858
F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). These factors 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.
The examiner's rejection, reasoning, and evidence presented in support thereof
focus on these factors as they relate to the use of the claimed compositions for
immunosuppressive therapy. (Answer, page 5-7). The examiner begins the analysis by
noting that the specification (Answer , page 5):
provides no exemplification of how to use the claimed compositions for
successful immunosuppression therapy of the various disorders listed in
the specification page 2, and further fails to describe how (sic, to) use the
claimed composition in vitro.
The examiner also discusses the predictability of the use of such materials in
immunosuppression citing confusion in the art as to mechanism of activity as well as
6
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 12 13 Next
Last modified: November 3, 2007