Appeal No. 2004-2201 Page 6
Application No. 09/788,476
body to certain stimuli, in the instant case the development of HCC or pancreatic
adenocarcinoma.” Example 9 of the Guidelines does not place any restriction as to how
the coding function of the DNA may be claimed. A determination whether a given
nucleic acid is within the scope of the hypothetical claim of Example 9 of the Guidelines
would require expressing the nucleic acid and testing the protein to determine whether it
binds to a dopamine receptor and stimulates adenylate cyclase activity. A
determination whether a given nucleic acid is within the scope of claim 1 would also
require testing, albeit different testing. According to the terms of claim 1, an mRNA
corresponding to the nucleic acid must be differentially or preferentially expressed in
human hepatocellular carcinoma tissue or tissue from pancreatic adenocarcinoma
relative to other tissue in said subject and/or in subjects not diagnosed with this
condition. The examiner states that the functional characteristic recited in claim 1 is
“uncoupled with the structure of the claim genus,” Examiner’s Answer, page 9, but does
not explain why that is significant in determining whether claim 1 complies with the
written description analysis. The training materials are not the end-all of a written
description analysis. The fact that a given claim under review does not fit squarely
within one of the examples does not mean that that claim does not comply with the
written description requirement. Rather than merely pointing out that claim 1 differs
from the hypothetical claim in Example 9 of the Guidelines, an analysis is needed from
the examiner explaining why the function set forth in claim 1 is not an adequate
identifier of the claimed genus of nucleic acids. Instead, all we have is the examiner’s
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