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When “Good Enough” Is Good Enough For Finding Obviousness – Patent & More Breaking News

Mondaq Share
Written by enews

Holding:

In Cornell Research Foundation, Inc. v. Vidal, No.
2020-2334, 2022 WL 1634223 (Fed. Cir. May 24, 2022)
(non-precedential), the Court of Appeals for the Federal Circuit
affirmed the final written decision of the Patent Trial and Appeal
Board’s decision finding the challenged claims in six inter
partes review proceedings unpatentable as anticipated or
obvious.12, The Federal Circuit held that
substantial evidence supported the Board’s determination that
the claims were obvious.

Background:

The patents at issue are related to phytase enzymes, which are
incorporated into livestock feed and aid animals in absorbing
phosphates. Phytase enzymes are typically produced by taking a
phytase gene from one organism and incorporating the gene into a
host cell that expresses the phytase protein. U.S. Patent No.
8,993,300 (“the ‘300 patent”) claims a heterologous
method of producing phytase. Id. at *2-*3. The ‘300
patent uses a phytase gene derived from the Escherichia
coli
bacteria species and a fungal host. Claim 1 and dependent
claims 10-12 of the ‘300 patent were representative for the
purposes of this appeal.

1. A method of producing a phytase
in fungal cells, the method comprising:

Football Highlights

providing a polynucleotide encoding
an Escherichia coli phytase;

expressing the polynucleotide in the
fungal cells; and

isolating the expressed
Escherichia coli phytase wherein the Escherichia
coli
phytase catalyzes the release of phosphate from
phytate.

10. The method of claim 1 wherein
the Escherichia coli phytase has an optimum activity at a
temperature range of 57 degrees C. to 65 degrees C.

11. The method of claim 1 wherein
the Escherichia coli phytase retains at least 40% of its
activity after heating the phytase for 15 minutes at 80 degrees
C.

12. The method of claim 1 wherein
the Escherichia coli phytase retains at least 60% of its
activity after heating the phytase for 15 minutes at 60 degrees
C.

Claim 1 recited a heterologous method of producing phytase, and
dependent claims 10-12 added “thermostability
limitations” to the phytases produced by the heterologous
method described in independent claim 1. Id. at *3.

Associated British Foods PLC (“ABF”) challenged
Cornell’s claims based on two categories of prior-art
combinations-one involving U.S. Patent No. 5,876,996
(“Kretz”), and the other not involving Kretz. The
Kretz-based challenges applied only to the ‘300 patent;
however, the parties agreed that the Board’s six IPR decisions
“stand and fall” with the Board’s obviousness
analysis of the ‘300 patent. Id. at *4. Thus, the
Federal Circuit focused its discussion on the Board’s Final
Written Decision of the ‘300 patent.

On the Kretz grounds, the Board concluded that (1) Cornell
failed to antedate Kretz, (2) Kretz anticipated some claims, and
(3) the remaining claims were obvious in light of the other
references. Id.

On the non-Kretz grounds, the Board concluded there was a
motivation to combine the cited references and a reasonable
expectation of success in arriving at the claimed method, and the
thermostability dependent claims of the ‘300 patent were
obvious due to inherency. Id.

Federal Circuit:

The Federal Circuit affirmed the Board’s finding that there
was a motivation to combine and a reasonable expectation of success
for the non-Kretz combinations. ABF’s expert testified that
P. pastoris yeast, a type of fungus, produced a high yield
of heterologous protein that reduced industrial cost-an important
factor when producing livestock feed for large scale productions.
Id. The Board found this expert testimony persuasive in
finding a motivation-to-combine the E. coli phytase gene
in a fungal cell. Id. Cornell argued the Board’s
motivation-to-combine conclusion was contrary to ABF’s expert
testimony that one of the references taught away from using
bacterial phytase in animal feed. Id. at *7. Cornell
further argued the prior art suggested it would be more
advantageous to pair bacterial phytase with a bacterial host rather
than with a fungal host. However, the Federal Circuit ultimately
concluded that a motivation to combine does not need to be
“the best option, only that it be a suitable option.”
Id. (citing Final Written Decision, at
81-82).

Regarding the Board’s reasonable-expectation-of-success
finding, Cornell presented expert testimony that a skilled artisan
would have “had no reason to expect ‘that expressing the
E. coli phytase in a fungal host would have produced an
active enzyme’ due to increased glycosylation.”
Id. (citing Appellant’s Br. 33 (quoting J.A.
4084-89)). However, ABF’s expert provided numerous examples of
systems that produced bacterial enzymes in yeast hosts.
Id. at *7-*8. Thus, the Federal Circuit held that
“Board was free to weigh ABF’s expert testimony more
heavily [than Cornell’s expert testimony], and that’s what
it did.” Id. at *7.

The Federal Circuit also found substantial evidence supported
the Board’s finding that the thermostability limitations of the
‘300 patent’s dependent claims were inherent results of the
combined teachings of the cited references. Id. at *8. The
Board cited to both parties’ expert testimony, the ‘300
patent, and the prosecution history to support this conclusion.
Id. Even Cornell’s expert testified that
“express[ing] the same enzyme in the same host under the same
conditions” produces “inherent results,” like
thermostability characteristics. Id. Cornell asserted it
was impermissible for the Board to cite no data outside of the
‘300 patent to support its inherency finding. However, the
Federal Circuit held the ‘300 patent’s disclosure provided
data consistent with the thermostability limitations of claims
10-12 and Cornell did not argue that the conditions of the cited
references differed from those described in the ‘300 patent.
Id. at *9.

Thus, the Federal Circuit affirmed the Board’s findings that
all challenged claims of Cornell’s patents were unpatentable as
anticipated or obvious.

Take-aways:

The Federal Circuit made it clear in this case that when
examining a motivation-to-combine, the best option is not always
needed or even necessary to come out on top. Instead, a
“suitable option” is enough to create a winning case.

Further, the Federal Circuit emphasized that while each side may
have an expert that presents evidence to support its case, the
Board has the discretion to weigh one expert’s testimony more
heavily than another when making its decision. If, when exercising
its discretion, the Board is reasonable in weighing one
expert’s testimony over another expert’s testimony, that is
enough to constitute substantial evidence to support the
Board’s determination.

Finally, this case offers a reminder for patent owners when
facing inherency arguments. Overcoming inherency requires showing
that the prior art does not “inevitably” or
“invariably” result in the claimed invention.
Glaxo Inc. v. Novopharm Ltd., 52 F.3d
1043 (Fed. Cir. 1995). This burden rests on the patent owner and
may require careful and detailed analysis and arguments.

Footnotes

1 IPR2019-00577, IPR2019-00578, IPR2019-00579,
IPR2019-00580, IPR2019-00581, and IPR2019-00582.

2 The Director of the Board intervened to defend the
Board’s decision after ABF filed a notice of
non-participation.

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