Appeal No. 1997-4380
Application No. 08/147,878
bears an initial burden of setting forth a reasonable explaination … this includes, of
course, providing sufficient reasons for doubting any assertions in the specification
as to the scope of enablement). On this record, we find no fact based explanation
as to why the examiner doubts the assertions made in the specification, and relied
upon by appellants.
Furthermore, the examiner relies upon Miller, Wagner and Wu-Pong each
published in 1994, and Stull published in 1995, to support his lack of enablement
rejection. We remind the examiner, as set forth in Enzo Biochem, Inc. v. Calgene,
Inc., 188 F.3d 1362, 1371, 52 USPQ2d 1129, 1371 (Fed. Cir. 1999) “[w]hether
claims are sufficiently enabled by a disclosure in a specification is determined as of
the date that the patent application was first filed, see Hybritech, Inc. v. Monoclonal
Antibodies, Inc., 802 F.2d 1367, 1384, 231 USPQ 81, 94 (Fed. Cir. 1986).”
With regard to the examiner’s reference to Baeuerle and related concern
regarding the activation of transcription by NF-RB (Answer, bridging paragraph,
apges 6-7), appellants argue (Brief, page 7) that “[t]he concerns recited in the
Answer are directed to the safety and side effects of the claimed method; they are
best left to the Food & Drug Administration, not the PTO.” We agree with
appellants. See In re Anthony, 414 F.2d 1383, 1395, 162 USPQ 594, 604 (CCPA
1969)("Congress has given the responsibility to the FDA, not to the [PTO], to
determine . . . whether drugs are sufficiently safe").
Accordingly, we vacate the rejection of claims 1, 2, 5, 8 and 15-17 under 35
U.S.C. § 112, first paragraph and we remand the application to allow the examiner
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