Appeal 2007-0582
Application 09/832,069
the amount of mitochondrial DNA damage: the Specification states that
increased mitochondrial DNA damage indicates increased oxidative stress.
The Examiner has not adequately explained why the correlations shown in
the working examples do not allow those skilled in the art to the make type
of qualitative determination (normal range vs. abnormal) that is required to
practice the claimed method.
The Examiner also argues that the effect of a given mutation is
unpredictable: depending on its type and location, a mutation can
completely abolish the function of a gene product or it can have no effect at
all (Answer 5). Because a given mutation can have a range of effects on
mRNA production, protein production, etc., the Examiner concludes that
measuring such “downstream” effects cannot be relied on to measure the
amount of DNA damage (id. at 5-6).
We agree with Appellants that the Examiner’s concern is misplaced.
As Appellants have pointed out,
[w]here there is a population of mitochondria being tested
(which there certainly would be if one were testing a blood
sample or blood products as stated by the claim), there would
necessarily be a vast range of mutations occurring in the
mitochondria, some within coding regions and some outside of
a particular coding region. Nevertheless, the distribution would
be expected to be random and thus demonstrate a readily
identifiable correlation between the amount of damage in any
one gene, as measured by expression of that gene, and the
amount of damage overall.
(Br. 9.) We agree with Appellants’ analysis, and note that it is supported by
the correlations demonstrated in the Specification’s working examples.
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