Appeal No. 2003-1170 Page 3
Application No. 08/817,192
There are two main aspects to the examiner’s enablement rejection. First, the
examiner considers gene therapy in and of itself to be a highly unpredictable art. See,
e.g., Examiner’s Answer, page 5 (“Gene therapy has been and remains a highly
unpredictable and undeveloped art.”). The second aspect involves the claim language
which states that the claimed method is for “preventing or delaying the onset of
coronary artery disease.” The examiner observes that coronary artery disease can be
attributed to a wide variety of causes or contributing factors and that “it is highly unlikely
that a defect in lipoprotein lipase function would be the sole causative factor in the
human individuals carrying such a defect.” Examiner’s Answer, pages 6-7.
Turning to the first aspect of the examiner’s rejection, we find that the examiner’s
focus on gene therapy in general is misplaced. It appears that the examiner believes
that in order for the claimed invention to be enabled that one of skill in the art must be
convinced that the claimed method will result in a therapeutic effect. The examiner
explains:
Orkin and Galton were provided as evidence that the specific therapy
claimed would be unlikely to achieve the therapeutic effect required by the
preamble, that coronary artery disease be either prevented or its onset be
delayed. Even normal individuals may develop coronary artery disease
from a variety of environmental factors or genetic factors other than LPL
deficiency. Orkin and Verma show that it is unlikely that the claimed
methods would be able to restore the lipoprotein lipase of the recited
individual to normal levels, particularly since prior experience with gene
therapy protocols indicated that achieving insufficient expression and lack
of persistent expression from the vector were significant problems, and
thus far unattained. At best, the claimed therapy would only result in
reducing the severity of the deficiency, and the treated individual would
still be prone to the same contributing factors as normal individuals.
Examiner’s Answer, page 9, first full paragraph.
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