Appeal No. 2006-1879 Page 5
Application No. 10/010,114
Example 11 teaches the expression of lacZ when a plasmid comprising a
β-galactosidase gene complexed to a transfer moiety of the invention is
injected into mouse thigh muscle. . . . Example 12 teaches the finding of
hepatitis B [virus] surface antigen in the blood [of] mice injected i.v. with a
multifunctional molecular complex comprising a plasmid containing a
hepatitis B virus surface antigen gene complexed to a transfer moiety of
the invention.
Id., pages 6-7. The examiner found that these examples did not provide sufficient
guidance, however, because “in neither case does the expression of the delivered gene
result in an alleviation of a symptom of any disease.” Id., page 7.
Appellant argues that “[s]ince the claims do not require a therapeutic effect,
Applicant need not demonstrate such an effect in order to enable the claimed subject
matter.” Appeal Brief, page 4. Appellant argues that he “need[ ] only establish that the
application enable[s] one of ordinary skill in the art to make and use a method for
transfer[ring] nucleic acid compositions to cells . . . without undue experimentation.” Id.
Appellant argues that the references cited by the examiner are not applicable because
they describe different methods of delivering nucleic acids to cells. Id., page 5. Finally,
Appellant relies on a declaration submitted under 37 CFR § 1.132, which is said to
provide additional examples of in vivo transfer of nucleic acids using the claimed
method. See id., pages 7-9
The examiner bears the initial burden of showing that a claimed method is not
enabled. 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.”).
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