Appeal No. 2004-2201 Page 5
Application No. 09/788,476
However, unlike the situation in Example 9 of the Guidelines, the
instantly recited function is not associated with the structural feature of
claimed genera, but associated with human disease status. In the instant
claim 1, the recited function is not dictated by chemical structure of the
claimed genus but dictated by other events i.e. that pancreatic
adenocarcinoma or HCC is developed in a host. In other words, the
expression is not function associated with the structure but a reaction of a
human body to certain stimuli, in the instant case the development of HCC
or pancreatic adenocarcinoma.
In summary, the functional characteristic recited is uncoupled with the
structure of the claimed genus. There is no correlation between the
chemical structure of the claimed genus and the recited function.
Therefore the recited functional language describing the claimed genera
does not adequately describe the common feature of claimed generic
nucleic acid molecule.
Examiner’s Answer, pages 8 and 9.
The analysis of the reasoning set forth in Example 9 of the Guidelines as to why
hypothetical claim 1 of that example complies with the written description requirement is
as follows:
Now turning to the genus analysis, a person of skill in the art would not
expect substantial variation among species encompassed within the scope
of the claims because the highly stringent hybridization conditions set forth
in the claim yield structurally similar DNAs. Thus, a representative
number of species is disclosed, since highly stringent hybridization
conditions in combination with the coding function of DNA and the level of
skill in the art are adequate to determine that applicant was in possession
of the claimed invention.
Guidelines at 36-37.
We disagree with the examiner’s analysis that claim 1 on appeal does not comply
with the written description requirement because the expression of the claimed nucleic
acid is “not function associated with the structure but a reaction of the human
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