Appeal 2007-0320
Application 09/945,339
Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1378, 77 USPQ2d 1321,
1327 (Fed. Cir. 2005).
“[T]he Patent Office has the initial burden of coming forward with
some sort of evidence tending to disprove novelty.” See In re Wilder,
429 F.2d 447, 450, 166 USPQ 545, 548 (CCPA 1970). Nevertheless, “when
the PTO shows sound basis for believing that the products of the applicant
and the prior art are the same, the applicant has the burden of showing that
they are not.” In re Spada, 911 F.2d 705, 708, 15 USPQ2d 1655, 1658 (Fed.
Cir. 1990). Similarly, “where the Patent Office has reason to believe that a
functional limitation asserted to be critical for establishing novelty in the
claimed subject matter may, in fact, be an inherent characteristic of the prior
art, it possesses the authority to require the applicant to prove that the
subject matter shown to be in the prior art does not possess the characteristic
relied on.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA
1977). Shifting the burden under these circumstances is reasonable because
of “the PTO’s inability to manufacture products or to obtain and compare
prior art products.” Id. at 1255, 195 USPQ at 433-34.
The issue raised by this appeal, then, is whether the prior art provides
a reasonable basis for shifting the burden to Appellants to establish that
Waller’s mononuclear cells do not retain some ability to proliferate, even if
drastically diminished. However, we find that this issue has not been
developed on the record in a manner susceptible to meaningful review.
On the one hand, we note the Examiner’s assertion that “both Waller
[ ] and the instant Specification use[ ] similar concentrations of cytotoxic
chemotherapeutic drugs to treat mononuclear cells and administer[ ] similar
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