Appeal No. 2003-1170 Page 5
Application No. 08/817,192
considered enabled under the patent statutes since the legal requirements of
enablement envision that further experimentation and refinement of the claimed
invention may be necessary before it reaches that stage. In re Brana, supra.
Absent a fact-based explanation from the examiner based upon the correct legal
standard, i.e., one that does not require gene therapy being a “routine practice of
medicine,” we do not find that the examiner has established a prima facie case of
nonenablement.
The second aspect of the examiner’s rejection is based upon an unreasonable
reading of the claims. Claim 50 is directed to a method for preventing or delaying the
onset of coronary artery disease in a human individual having lipoprotein lipase enzyme
in which a serine residue is present at amino acid 291 in the enzyme. Focusing on that
individual patient, it seems reasonable that administering the claimed polynucleotide to
produce a functional lipoprotein lipase enzyme in the individual would reasonably be
expected to prevent or delay the onset of coronary artery disease in that individual to
the extent that individual is at an increased risk of coronary artery disease due to the
presence of the defective gene. We think it is an unreasonable reading of the claims to
require that the result of the claim be that the treated individual be, in effect, guaranteed
to be forever free of coronary artery disease. That reading of the claim is unrealistic.
Treating one factor of a multifactorial condition, as set forth in claim 50, would
reasonably be expected to delay or prevent the onset of the condition.
The examiner’s decision is reversed.
REVERSED
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