Appeal No. 2005-1442 Page 4
Application No. 09/734,786
[d]ue to the art recognized unpredictability of achieving therapeutic levels
of gene expression following direct or indirect administration of nucleic
acids and the lack of guidance provided by the specification for the
parameters affecting delivery and expression of therapeutic amounts of
DNA into the cells using ex vivo gene transfer into histocultured organs or
tissues, it would require undue experimentation to practice the instant
invention.
Examiner’s Answer, page 10
Appellants argue that the claims are directed to a method of genetically
modifying tissues ex vivo and transplanting the modified tissue into a subject, and
therefore do not require achieving therapeutic levels of gene expression. Appeal Brief,
page 5. Appellants point to the specification’s discussion of prior art techniques and
working examples as guidance to those skilled in the art. Appellants assert that “[t]he
pending claims are fully supported by the ample amount of knowledge available in the
relevant art when the present application was filed and the guidance provided in the
specification.” Id., page 7.
We agree with Appellants that the examiner has not adequately shown that
undue experimentation would have been required to practice the claimed method. The
examiner bears the initial burden of showing that a claimed invention is nonenabled.
See In re Wright, 999 F.2d 1557, 1561-62, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)
(“[T]he PTO bears an initial burden of setting forth a reasonable explanation as to why it
believes that the scope of protection provided by that claim is not adequately enabled
by the description of the invention provided in the specification of the application.”).
“[T]o be enabling, the specification of a patent must teach those skilled in the art
how to make and use the full scope of the claimed invention without ‘undue
experimentation.’” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed.
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