Appeal No. 1997-3275
Application No. 07/963,329
vitro, and since the cells are not purified, and the label used in the testing is not specific for
identifying photoreceptor cells, the results observed relate to all viable cells and not just
photoreceptor cells. (Answer, paragraph bridging pages 5-6). The examiner notes that
Example 5 is the exception to this observation and acknowledges that the experiment
appears to be specific for photoreceptor cells. (Answer, page 6). However, the examiner
urges that (id.):
it is unclear how one would conclude that IGF-1 promoted
survival of the photoreceptor cells, since an increase in cell
number at the end of the experiment may be accounted for by
either cell survival, cell proliferation, or both. . . . [t]hus, overall
the results appear to simply demonstrate that IGF-I increases
the number of retinal cells and photoreceptor cells in vitro.
They do not demonstrate an increase in photoreceptor cell
survival.
The examiner concludes that (Answer, page 7):
[t]he quantity of experimentation necessary needed [sic] to
practice the claimed method is undue because the
specification and evidence of record does not support the
assertion that IGF-1 promotes survival per se. . . . Thus, it
would require undue experimentation to determine whether
IGF-1 promotes survival of photoreceptor cells in a mammal.
An examiner may reject claims in a patent application on the basis of an alleged
failure of the applicants to comply with the enablement requirement of 35 U.S.C. § 112 only
if the examiner can establish by a preponderance of the evidence that there is reason to
doubt the objective truth of the statements contained in the specification. In re Marzocchi,
439 F.2d 220, 223-24, 169 USPQ 367, 369-70 (CCPA 1970). Factors appropriate for
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