Appeal No. 2001-0869 Page 5
Application No. 08/453,347
and dosage frequency is not provided so that the artisan can make and use the
invention with a reasonable expectation of success without an undue amount of
experimentation.” Examiner’s Answer, page 3.
The examiner’s enablement analysis considered several of the Wands
factors. See the Examiner’s Answer, pages 3-8. In particular, the examiner
found that
• the nature of the invention was “within the realm of gene therapy,”
id., page 4;
• “[a]t the time of filing, the art considered gene therapy as
unpredictable without an undue amount of experimentation,” id.;
• contemporaneous references showed that much work remained to
be done before gene therapy would be clinically applicable, id.,
pages 5-6;
• “[t]he specification does not teach routes of delivery, vectors,
promoters, dosage amounts or dosage frequencies which in
combination would guide the artisan to suppress tumor formation,
attract monocytes, treat localized side-effects of malignancy or treat
parasitic infections,” id., page 6; and
• the animal model used in the specification’s examples “is not seen
as being correlatable to [the] claimed invention,” because the model
animals did not have preexisting tumors; id., pages 7-8.
The examiner concluded that “the specification does not provide a sufficient
guidance to overcome the art recognized unpredictabilities and lack of teachings.
Thus, without further guidance from the specification, the claimed methods would
not have been enabled at the time of the instant invention because the skilled
artisan would have needed to engage [in] an undue amount of experimentation.”
Examiner’s Answer, page 8.
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