Appeal No. 2001-0545 Page 7
Application No. 08/442,423
Most of the examiner’s arguments directed to the use of a nucleic acid
ligand for bFGF to inhibit angiogenesis rely on the proposition that there is no
evidence that the rat is an art recognized or a correlatable model for the
treatment of diseases and conditions that are affected by angiogenesis. The
evidence of record, however, does not support that proposition. For example,
Hayek states that the rabbit cornea, another rodent model, is a model for the
study of in vivo angiogenesis. Similarly, Grant notes that the rabbit cornea is “an
established angiogenic model.” Grant, page 282, abstract.
Because of the deficiencies noted above, the examiner has not met her
burden of setting forth a prima facie case of non-enablement.
REJECTION UNDER 37 CFR § 1.196(b)
New grounds of rejection are entered against claims 20 and 22 under 35
U.S.C. § 112, first paragraph, on the grounds that the disclosure fails to provide
adequate written description of the claimed subject matter.
Claims 20 and 22 are drawn to methods for inhibiting angiogenesis by
administering a pharmaceutically effective amount of a nucleic acid bFGF ligand.
The disclosure fails to provide adequate written description of the nucleic acid
molecules that are encompassed by the phrase “a nucleic acid bFGF ligand.”
The Court of Appeals for the Federal Circuit, our reviewing court, has
addressed the issue of what constitutes adequate written description for a claim
drawn to a nucleic acid. In Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d
1316, 63 USPQ2d 1602 (Fed. Cir. 2002), the court adopted a portion of the
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