Thursday, December 17, 2015

Judge Newman re-iterates her viewpoints on evidentiary review standards in South Alabama v. Gnosis

The conclusion of the majority

Because substantial evidence supports the Board’s
factual findings, except on the evidence of licensing, and
because we agree with the ultimate conclusion of obviousness,
we affirm the Board’s finding that claims 37, 94–97,
99–100, and 110–111 of the ’915 patent; claim 32 of the
’381 patent; and claim 15 of the ’778 patent are invalid
under 35 U.S.C. § 103.

Judge Newman re-iterated her assertions made in
the companion Merck case:

For the reasons I discussed in Gnosis I, these references
do not fill the gap between the folate compounds
described by Marazza and the uses described by Serfontein,
such that a person of ordinary skill in this field
would have been motivated to combine these references to
treat elevated homocysteine with a reasonable expectation
of success. Ueland provides a description of folate
and homocysteine biochemistry, and shows the biochemical
relationship between homocysteine and L-5-MTHF.
Ueland adds to the scientific investigations that have
been conducted, but Ueland does not suggest that L-5-
MTHF would successfully treat the specified diseases and
overcome the known uncertainties of stability, metabolism,
and bioavailability. Ueland does not suggest that
there would be a likelihood of success in using L-5-MTHF
compositions for the specific purposes discovered and
developed by the South Alabama scientists. The scientific
acclaim and licensing and copying that followed their
work add to the evidence of unobviousness. The PTAB
erred in evaluating and weighing this evidence.
For the reasons discussed in my dissenting opinion in
Gnosis I, obviousness was not established by a preponderance
of the evidence.
From my colleagues’ contrary
ruling, I respectfully dissent.



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