Appeal No. 2006-0148 Page 7
Application No. 09/933,309
experimentation. . . . Normally, if all of the steps of a claimed process are
enabled, the claimed process is enabled.
Id., page 15.
“When rejecting a claim under the enablement requirement of section 112, the
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” In re Wright, 999 F.2d
1557, 1561-62, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
“[E]nablement requires that the specification teach those in the art to make and
use the invention without ‘undue experimentation.’ In re Wands, 858 F.2d 731, 737,
8 USPQ2d 1400, 1404 (Fed. Cir. 1988). That some experimentation may be required is
not fatal; the issue is whether the amount of experimentation required is ‘undue.’”
In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991) (emphasis in
original). “The key word is ‘undue,’ not ‘experimentation.’” In re Angstadt, 537 F.2d
498, 504, 190 USPQ 214, 219 (CCPA 1976).
In this case, the claims are directed to a method comprising three steps:
regenerating an involuted thymus, injecting into the regenerated thymus a sample of the
tissue or organ to be transplanted, and transplanting a tissue or organ. The examiner
has pointed out that “[t]he specification provides no guidance or working examples for
intrathymic injection,” and “[t]he specification fails to teach or disclose working examples
for transplanting an organ or grafting of tissues.” Examiner’s Answer, page 7.
It is unclear from the statement of rejection in the Examiner’s Answer how much
weight the examiner puts on the specification’s lack of working examples of intrathymic
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