Appeal No. 2003-0913 5
Application No. 09/277,049
ordinary skill in the art of its scope.” In re Warmerdam, 33 F.3d 1354, 1361, 31 USPQ2d
1754, 1759 (Fed. Cir. 1994). The inquiry is to determine whether the claim sets out and
circumscribes a particular area with a reasonable degree of precision and particularity.
The definiteness of the language employed in a claim must be analyzed not in a vacuum,
but in light of the teachings of the particular application. In re Moore, 439 F.2d 1232, 1235,
169 USPQ 236, 238 (CCPA 1971). Those of ordinary skill in the art would clearly
understand the term, “conventional” in claim 1 are those excipients or carriers that are
usually or customarily added to pharmaceutical agents utilized in oral administration. Our
position is supported by the examples of excipients or carriers found in the specification on
page 9, lines 5 and 6 and Examples 4 through 7.
Based upon the above findings and analysis, the rejection of the examiner under
§ 112, second paragraph is not sustainable.
We turn next to the examiner’s rejection under the first paragraph of 35 U.S.C.
§ 112, on the grounds of lack of enablement. When rejecting a claim under the
enablement requirement of section 112, the PTO bears the initial burden of setting forth
a reasonable explanation as to why it believes the scope of protection provided by the
claimed subject matter is not adequately enabled by the description of the invention
provided in the specification of the application. This includes providing sufficient
reasons for doubting any assertions in the specification as to the scope of enablement.
If this burden is met, the burden then shifts to the appellants to provide suitable proofs
that the specification is enabling. In re Wright, 999 F.2d 1557, 1561-62, 27 USPQ2d
1510, 1513 (Fed. Cir. 1993); In re Marzocchi, 439 F.2d 220, 223-24, 169 USPQ 367,
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