Appeal No. 2006-0735
Reexamination Control No. 90/006,036
Written Description
The written description requirement of 35 U.S.C. § 112 [¶1] is separate from the
its enablement requirement. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563, 19
USPQ2d 1111, 1116-17 (Fed. Cir. 1991). Adequate written description must be
determined from the disclosure considered as a whole. Reiffin v. Microsoft Corp., 214
F.3d 1342, 1346, 54 USPQ2d 1915, 1917 (Fed. Cir. 2000). To fulfill the written
description requirement, a patent specification must describe an invention in sufficient
detail that one skilled in the art can clearly conclude that the inventor invented the subject
matter claimed. Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1566, 43
USPQ2d 1398, 1404 (Fed. Cir. 1997); Lockwood v. American Airlines, 107 F.3d 1565,
1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). The knowledge of one skilled in the art
must be considered. Bilstad v. Wakalopulos, 386 F.3d 1116, 1126, 72 USPQ2d 1785,
1792 (Fed. Cir. 2004).
Claims 5 and 11, which depend from claims that were amended during
prosecution, have been rejected by the examiner for insufficient written description.
Claim 5 depends from amendment claim 1 and claim 11 depends from amended claim 6
or amended claim 9. The claims requiring that the localization signal comprise “a
protein component”. According to the examiner, however, the disclosure “fails to
describe the preparation, characterization, and use of a single therapeutic agent
comprising a proteinaceous signal sequence tethered to a therapeutic nucleic acid.”
(Answer at 7). The examiner states that “...the disclosure fails to provide any structural
or functional guidance pertaining to suitable chemical linkages that can be employed in
the aforementioned [at claims 5 and 11] invention” and “fails to provide even one
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