Appeal No. 2002-1251 Page 10
Application No. 08/459,340
composition that comprises a nucleozyme and a pharmaceutically acceptable
carrier such as water or saline. This interpretation is consistent with the
specification, which discloses that nucleozymes can be used in applications other
than therapy. See the specification, pages 5-6:
The present invention also pertains to methods of using the
nucleozymes. . . . For example, a nucleozyme may be used as a
ribonuclease, ligase, phosphotransferase, acid phosphatase,
polymerase, or an RNA restriction endonuclease. . . .
The nucleozymes also may be used as therapeutic agents
introduced in vivo due to their resistance to chemical and enzymatic
degradation.
Under the examination procedures laid out in the Manual of Patent
Examining Procedure (MPEP), an applicant need not enable every method of
using a product in order to enable those skilled in the art to make and use the
product itself; enabling a single method of using the product is sufficient. See
MPEP § 2164.01(c) (“If multiple uses for claimed compounds or compositions are
disclosed in the application, then an enablement rejection must include an
explanation, sufficiently supported by the evidence, why the specification fails to
enable each disclosed use.”).1 The examiner has not addressed the alternative,
non-therapeutic methods of using the claimed composition, nor provided any
fact-based analysis of why these methods of using the claimed composition
would have required undue experimentation.
1 “While the MPEP does not have the force of law, it is entitled to judicial notice as an official
interpretation of statutes or regulations as long as it is not in conflict therewith.” Molins PLC v.
Textron, Inc., 48 F.3d 1172, 1180 n.10, 33 USPQ2d 1823, 1828 n.10 (Fed. Cir. 1995). See also
Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1425, 7 USPQ2d 1152, 1154 (Fed. Cir. 1988) (“The MPEP
states that it is a reference work on patent practices and procedures and does not have the force
of law, but it ‘has been held to describe procedures on which the public can rely.’”).
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