Friday, May 18, 2018

Praxaire wins at CAFC

The outcome was that Praxaire won its appeal as to claim 9:

Praxair Distribution, Inc. (“Praxair”) appeals from the
inter partes review decision of the United States Patent
and Trademark Office Patent Trial and Appeal Board
(“the Board”) holding claim 9 of U.S. Patent 8,846,112
(the “’112 patent”) not unpatentable as obvious under 35
U.S.C. § 103 (2006).1 Praxair Distrib., Inc. v. Mallinckrodt
Hosp. Prods. IP Ltd., No. IPR2015-00529, 2016 WL
3648375 (P.T.A.B. July 7, 2016) (“Decision”). Mallinckrodt
Hospital Products IP Ltd. (“Mallinckrodt”) crossappeals
from the same decision holding, inter alia, claims
1–8 and 10–11 unpatentable as obvious. Because we
conclude that the Board did not err in its conclusions as to
claims 1–8 and 10–11, but did err with respect to claim 9,
we affirm the Board’s decision in part and reverse it in

Of the review by the CAFC of a PTAB ruling:

Our review of a Board decision is limited. In re Baxter
Int’l, Inc. 678 F.3d 1357, 1361 (Fed. Cir. 2012). We review
the Board’s legal determinations de novo, In re Elsner,
381 F.3d 1125, 1127 (Fed. Cir. 2004), but we review the
Board’s factual findings underlying those determinations
for substantial evidence, In re Gartside, 203 F.3d 1305,
1316 (Fed. Cir. 2000). A finding is supported by substantial
evidence if a reasonable mind might accept the evidence
as adequate to support the finding. Consol. Edison
Co. v. NLRB, 305 U.S. 197, 229 (1938).

As to claim 9:

That does not end the inquiry, however, as we must
still consider whether claim 9 as a whole would have been
obvious to a person of ordinary skill at the time of the
invention. In assessing obviousness, the Board found that
Bernasconi taught that inhaled nitric oxide may lead to
pulmonary edema in patients with LVD, and emphasized
the “need for careful observation and intensive monitoring
during [nitric oxide] inhalation” in patients with LVD.
Decision, 2016 WL 3648375, at *13. Nonetheless, the
Board held that Bernasconi did not render claim 9 obvious
for two reasons, both of which we reject.
First, in addressing the differences between the prior
art and claim 9, the Board found that Bernasconi did not
“teach[] or suggest[] that treatment with [nitric oxide]
should be discontinued in pediatric patients with LVD
that experience pulmonary edema,” as required by
claim 9. Id. at *19. Rather, the Board found Bernasconi
to be “contrary to [its] interpretation of the claim language”
because Bernasconi taught “that [nitric oxide] may
be given to patients with LVD, as long as those patients
are monitored carefully during treatment.” Id. (emphasis
added). The Board’s finding is premised on an incorrect
reading of claim 9, and under the correct reading Bernasconi
is not “contrary to” claim 9. The Board conflated
excluding a patient with LVD from nitric oxide treatment
and discontinuing nitric oxide treatment in a patient with
LVD after that patient experiences a pulmonary edema.
But claim 9 does not permit, let alone require, excluding
patients with LVD from nitric oxide treatment. Instead,
claim 9 recites that nitric oxide be given to patients with
LVD, and be discontinued if a pulmonary edema occurs.
Thus Bernasconi’s teaching that patients with LVD could
be treated with nitric oxide if carefully monitored is not
contrary to the claim language, and the Board erred by
interpreting claim 9 otherwise.
Second, the Board found “compelling” Mallinckrodt’s
evidence of secondary considerations that “patients were
not excluded” from the INOT22 study, despite the known
relationship between nitric oxide treatment and pulmonary
edema for patients with LVD. Decision, 2016 WL
3648375, at *19. The Board found persuasive the inference
that “if it were obvious to a person of ordinary skill
in the art to exclude” such patients from the study, the
researchers conducting the INOT22 study would have
done so. Id. The Board’s secondary considerations analysis
also rested on its “excluding” interpretation of claim 9.
But, because we conclude that claim 9 requires administering
nitric oxide to patients with LVD, Mallinckrodt’s
evidence of secondary considerations regarding the failure
of researchers to exclude such patients from the INOT22
study lacks sufficient nexus to the claim. See Classco, Inc.
v. Apple, Inc., 838 F.3d 1214, 1220 (Fed. Cir. 2016).

In sum, both the Board’s findings regarding the differences
between the prior art and claim 9 and its findings
on secondary considerations depended on an
incorrect interpretation of that claim, and we therefore
hold that they are not supported by substantial evidence.
See In re Smith Int’l, Inc., 871 F.3d 1375, 1384 (Fed. Cir.
We also conclude that remand is unnecessary. The
Board’s uncontested findings regarding Bernasconi render
claim 9 obvious under the proper reading of the claim.


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