Court Opinion

ID: 4275521
Source: CourtListenerOpinion
Date Created: 2018-05-16 15:00:36.662118+00
Date Added: 2024-06-11T07:49:18.306976
License: Public Domain

United States Court of Appeals
      for the Federal Circuit
                ______________________

          PRAXAIR DISTRIBUTION, INC.,
                   Appellant

                           v.

MALLINCKRODT HOSPITAL PRODUCTS IP LTD.,
              Cross-Appellant
          ______________________

                 2016-2616, 2016-2656
                ______________________

   Appeals from the United States Patent and Trade-
mark Office, Patent Trial and Appeal Board in No.
IPR2015-00529.
               ______________________

                Decided: May 16, 2018
                ______________________

    WILLIAM R. PETERSON, Morgan, Lewis & Bockius LLP,
Houston, TX, argued for appellant. Also represented by
SANJAY K. MURTHY, MICHAEL J. ABERNATHY, MARIA
DOUKAS, Chicago, IL; JULIE S. GOLDEMBERG, Philadelphia,
PA.

   KENNETH G. SCHULER, Latham & Watkins LLP,
Chicago, IL, argued for cross-appellant. Also represented
by DAVID K. CALLAHAN, MARC NATHAN ZUBICK; GABRIEL
BELL, INGE OSMAN, JONATHAN M. STRANG, Washington,
DC; ROBERT STEINBERG, Los Angeles, CA.
                 ______________________
2        PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.

Before PROST, Chief Judge, NEWMAN and LOURIE, Circuit
                       Judges.
    Opinion for the court filed by Circuit Judge LOURIE.
Opinion filed by Circuit Judge NEWMAN, concurring in the
                         judgment.
LOURIE, Circuit Judge.
    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. Mallinck-
rodt Hosp. Prods. IP Ltd., No. IPR2015-00529, 2016 WL
3648375 (P.T.A.B. July 7, 2016) (“Decision”). Mallinck-
rodt Hospital Products IP Ltd. (“Mallinckrodt”) cross-
appeals 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
part.
                       BACKGROUND
     Mallinckrodt owns the ’112 patent, which is directed
to methods of distributing nitric oxide gas cylinders for
pharmaceutical applications.     Inhaled nitric oxide is
approved by the U.S. Food and Drug Administration
(“FDA”) for treating neonates with hypoxic respiratory
failure, ’112 patent col. 1 ll. 21–25, a condition where
oxygen levels in the blood are too low. Nitric oxide func-

    1    Because the application of the ’112 patent was
filed before March 16, 2013, the pre-Leahy-Smith America
Invents Act version of § 103 applies. See Pub L. No. 112-
29, 125 Stat. 284 (2011); 35 U.S.C. § 103 (2006).
PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.       3

tions to dilate blood vessels in the lungs and can thereby
improve blood oxygenation. Id. col. 3 ll. 34–56. Mallinck-
rodt exclusively supplies inhaled nitric oxide in the Unit-
ed States for pharmaceutical use under the brand name
INOmax®.
    Administering nitric oxide may cause harmful side ef-
fects. For example, the specification of the ’112 patent
describes a clinical study, INOT22, which identified
patients with preexisting left ventricular dysfunction
(“LVD”) as having an increased risk of serious adverse
events (“SAEs”), which include pulmonary edema (“PE”),
when administered nitric oxide. Id. col. 14 ll. 17–25.
Patients with preexisting LVD are characterized by
having a pulmonary capillary wedge pressure (“PCWP”)
greater than 20 mm Hg. Id. col. 1 ll. 56–61. Accordingly,
after identifying the relationship between preexisting
LVD and SAEs in patients administered nitric oxide, the
INOT22 protocol was updated to exclude from the study
patients having PCWP greater than 20 mm Hg. Id. col.
14 ll. 19–21. The specification of the ’112 patent, howev-
er, advises only that “[t]he benefit/risk of using [inhaled
nitric oxide] in patients with clinically significant LVD
should be evaluated on a case by case basis,” id. col. 14 ll.
21–25, and further proposes amending the INOmax
prescribing information to include “a precaution for
patients with LVD,” id. col. 9 ll. 51–53.
    The claims of the ’112 patent generally require sup-
plying a medical provider with a cylinder of nitric oxide
gas and providing the medical provider with certain
prescribing information relating to the harmful side
effects of nitric oxide for certain patients identified in the
INOT22 study. Claim 1 is illustrative and reads as fol-
lows:
    1. A method of providing pharmaceutically ac-
    ceptable nitric oxide gas, the method comprising:
4        PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.

    obtaining a cylinder containing compressed nitric
    oxide gas in the form of a gaseous blend of nitric
    oxide and nitrogen;
    supplying the cylinder containing compressed ni-
    tric oxide gas to a medical provider responsible for
    treating neonates who have hypoxic respiratory
    failure, including some who do not have left ven-
    tricular dysfunction;
    providing to the medical provider (i) information
    that a recommended dose of inhaled nitric oxide
    gas for treatment of neonates with hypoxic respir-
    atory failure is 20 ppm nitric oxide
    and (ii) information that, in patients with pre-
    existing left ventricular dysfunction, inhaled ni-
    tric oxide may increase pulmonary capillary
    wedge pressure (PCWP), leading to pulmonary
    edema, the information of (ii) being sufficient to
    cause a medical provider considering inhaled ni-
    tric oxide treatment for a plurality of neonatal pa-
    tients who (a) are suffering from a condition for
    which inhaled nitric oxide is indicated, and (b)
    have pre-existing left ventricular dysfunction, to
    elect to avoid treating one or more of the plurality
    of patients with inhaled nitric oxide in order to
    avoid putting the one or more patients at risk of
    pulmonary edema.
Id. col. 14 ll. 28–52. We refer to the last two claim limita-
tions of claim 1 collectively as the “providing information”
limitation.
    Certain dependent claims add additional steps direct-
ing what a recipient of the provided information should do
with it. Claim 3 depends from claim 1 and requires
determining that a neonatal patient has preexisting LVD
and then “evaluating the potential benefit of treating the
[neonatal patient] with 20 ppm inhaled nitric oxide vs. the
PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.      5

potential risk that inhaled nitric oxide could cause an
increase in PCWP leading to pulmonary edema” (the
“evaluating” limitation). Id. col. 14 ll. 57–66. Claim 9
depends from independent claim 7. Claim 7 concludes
with a “recommendation that, if pulmonary edema occurs
in a patient who has pre-existing [LVD] and is treated
with inhaled nitric oxide, the treatment with inhaled
nitric oxide should be discontinued” (the “recommenda-
tion” limitation). Id. col. 15 ll. 60–63. Claim 9 then reads:
    9. The method of claim 7, further comprising:
    performing at least one diagnostic process to iden-
    tify a neonatal patient who has hypoxic respirato-
    ry failure and is a candidate for inhaled nitric
    oxide treatment;
    determining prior to treatment with inhaled nitric
    oxide that the neonatal patient has pre-existing
    left ventricular dysfunction;
    treating the neonatal patient with 20 ppm inhaled
    nitric oxide, whereupon the neonatal patient ex-
    periences pulmonary edema; and
    in accordance with the recommendation of [claim
    7], discontinuing the treatment with inhaled nitric
    oxide due to the neonatal patient’s pulmonary
    edema.
Id. col. 16 ll. 2–13 (emphases added).
    Praxair petitioned for inter partes review of claims 1–
19 of the ’112 patent, which the Board instituted. The
Board held that claims 1–8 and 10–19 would have been
obvious over the INOmax Label, 2 Bernasconi, 3 Loh, 4 and

    2   INOmax Final Printed Labeling, NDA 20845,
Center    for   Drug     Evaluation    and     Research,
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20
6        PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.

Goyal. 5 Decision, 2016 WL 3648375, at *22. But the
Board concluded that claim 9 was not unpatentable as
obvious over those same references. Id. at *19.
    The present appeal involves several disputes over the
Board’s claim constructions and obviousness analysis.
The Board found that a person of ordinary skill was at
least a physician with experience treating pediatric heart
and lung disease and administering vasodilators, and
found “that the overall level of skill in the art is high.” Id.
at *4. In construing the claims, the Board applied the
printed matter doctrine. The Board interpreted the
providing information, evaluating, and recommendation
claim limitations to be either printed matter or purely
mental steps not entitled to patentable weight, as those
limitations lacked a functional relationship to the other
claim limitations except in claim 9. Id. at *9–10. For
claim 9, however, the Board interpreted “in accordance
with” to mean “based on, or as a result of” the recommen-
dation to discontinue nitric oxide treatment from claim 7,
thereby establishing a functional relationship to the
recommendation limitation. Id. at *11.
    The Board also construed “pharmaceutically accepta-
ble nitric oxide gas” in the preambles of claims 1 and 7 as

845_INOmax_prntlbl.pdf (Aug. 9, 2000) (“INOmax La-
bel”).
    3   A. Bernasconi & M. Beghetti, Inhaled Nitric Oxide
Applications in Paediatric Practice, 4 Images in Paediat-
ric Cardiology 4 (2002) (“Bernasconi”).
    4   E. Loh et al., Cardiovascular Effects of Inhaled
Nitric Oxide in Patients with Left Ventricular Dysfunc-
tion, 90 Circulation 2780 (1994) (“Loh”).
    5   P. Goyal et al., Efficacy of Nitroglycerin Inhala-
tion in Reducing Pulmonary Arterial Hypertension in
Children with Congenital Heart Disease, 97 British J.
Anaesthesia 208 (2006) (“Goyal”).
PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.       7

“nitric oxide gas that is suitable for pharmaceutical use,”
and rejected Mallinckrodt’s proposed construction of
“pharmaceutically acceptable” that would require consid-
ering information provided in the label of the supplied
product. Id. at *6–7.
    Turning to patentability, the Board found that the
cited prior art collectively taught each limitation of claims
1–8 and 10–19 that did have patentable weight, and that
a person of ordinary skill in the art would have been
motivated to combine the INOmax Label, Bernasconi,
Loh, and Goyal references. Id. at *14–18. The Board
therefore held claims 1–8 and 10–19 unpatentable for
obviousness. Id. However, the Board did not so conclude
with respect to claim 9. The only reference considered by
the Board regarding claim 9 was Bernasconi. Id. at *19.
Bernasconi disclosed administering nitric oxide to new-
borns with hypoxic respiratory failure at the FDA-
recommended dose of 20 ppm. Bernasconi also discussed
several reports of “negative effects of inhaled [nitric oxide]
in patients with [LVD],” including “rapid left heart failure
and pulmonary oedema.” J.A. 249. Accordingly, Bernas-
coni emphasized “the need for careful observation and
intensive monitoring during [nitric oxide] inhalation in
patients with left ventricular failure.” Id.
    The Board found that Bernasconi did not teach or
suggest discontinuing nitric oxide treatment when a
patient with LVD experiences a pulmonary edema, but
rather, “contrary to the claim language,” contemplated
administering nitric oxide to patients with LVD as long as
they were carefully monitored.        Decision, 2016 WL
3648375, at *19. Furthermore, the Board found “compel-
ling” Mallinckrodt’s argument based on secondary consid-
erations, namely that “if it were obvious to a person of
ordinary skill in the art to exclude children with LVD
from treatment with [nitric oxide], the experts in the field
who designed the [INOT22] study would have excluded
those children from the original protocol.” Id. As a result,
8        PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.

the Board held that Praxair did not prove by a preponder-
ance of the evidence that claim 9 was unpatentable as
obvious. Id.
    Praxair timely appealed from the Board’s decision as
to claim 9, and Mallinckrodt cross-appealed from the
same decision as to claims 1–8 and 10–11. We have
jurisdiction under 28 U.S.C. § 1295(a)(4)(A).
                        DISCUSSION
     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 substan-
tial evidence if a reasonable mind might accept the evi-
dence as adequate to support the finding. Consol. Edison
Co. v. NLRB, 305 U.S. 197, 229 (1938).
    Obviousness is a question of law with underlying fac-
tual issues, including the scope and content of the prior
art, differences between the prior art and the claims at
issue, the level of ordinary skill, and relevant evidence of
secondary considerations. Graham v. John Deere Co., 383
U.S. 1, 17–18 (1966). Claim construction is also a ques-
tion of law that may involve underlying factual inquiries.
Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841
(2015). We review the Board’s claim construction based
solely on intrinsic evidence de novo, while we review
subsidiary factual findings regarding extrinsic evidence
for substantial evidence.        HTC Corp. v. Cellular
Commc’ns Equip., LLC, 877 F.3d 1361, 1367 (Fed. Cir.
2017).
                   I. CLAIMS 1–8 AND 10
   Because it underlies the ultimate obviousness issue,
we first address Mallinckrodt’s cross-appeal challenging
PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.    9

the Board’s application of the printed matter doctrine to
claims 1–8 and 10. 6 Mallinckrodt argues that the Board
erred in applying the printed matter doctrine during
claim construction rather than when it assessed patenta-
bility. Mallinckrodt also argues that the Board substan-
tively misapplied the printed matter doctrine by
extending it to encompass mental steps. Furthermore,
Mallinckrodt contends that the Board erred in construing
the term “pharmaceutically acceptable,” and that the
broadest reasonable interpretation of the term supplies a
functional relationship between any claimed printed
matter and the other limitations of the claims of the ’112
patent. Finally, even assuming the Board properly ap-
plied the printed matter doctrine, Mallinckrodt argues
that the Board improperly discounted its evidence of
secondary considerations.
    Praxair responds that, except for claim 9, the Board
correctly applied the printed matter doctrine, including to
mental steps claimed in the ’112 patent. Praxair also
argues that the Board correctly construed “pharmaceuti-
cally acceptable,” and appropriately weighed the evidence
of secondary considerations.
    Claim limitations directed to printed matter are not
entitled to patentable weight unless the printed matter is
functionally related to the substrate on which the printed
matter is applied. E.g., In re DiStefano, 808 F.3d 845, 848
(Fed. Cir. 2015); In re Gulack, 703 F.2d 1381, 1385 (Fed.
Cir. 1983). While early cases developing this doctrine
applied it to claims literally encompassing “printed”
materials, e.g., In re Russell, 48 F.2d 668, 669 (CCPA

    6  The Board addressed claim 11 together with
claims 1–8 and 10 because it erroneously considered
claim 11 as only dependent on claim 7, but claim 11 is
also dependent on claim 9. Thus we address claim 11
together with claim 9 infra.
10       PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.

1931) (claim to phonetically-arranged directory was
printed matter), our cases have not limited the doctrine to
that particular factual context, e.g., King Pharm., Inc. v.
Eon Labs, Inc., 616 F.3d 1267, 1279 (Fed. Cir. 2010)
(holding that a claimed step of informing someone about
an inherent property of a method was printed matter).
Rather, we have held that a claim limitation is directed to
printed matter “if it claims the content of information.”
DiStefano, 808 F.3d at 848.
    Claim limitations directed to the content of infor-
mation and lacking a requisite functional relationship are
not entitled to patentable weight because such infor-
mation is not patent eligible subject matter under 35
U.S.C. § 101. See AstraZeneca LP v. Apotex, Inc., 633
F.3d 1042, 1064 (Fed. Cir. 2010) (“This court has general-
ly found printed matter to fall outside the scope of
§ 101.”); In re Chatfield, 545 F.2d 152, 157 (CCPA 1976)
(“Some inventions, however meritorious, do not constitute
patentable subject matter, e.g., printed matter . . . .”); cf.
Digitech Image Techs., LLC v. Elecs. for Imaging, Inc.,
758 F.3d 1344, 1349–50 (Fed. Cir. 2014) (“Data in its
ethereal, non-physical form is simply information that
does not fall under any of the categories of eligible subject
matter under section 101.”); Guthrie v. Curlett, 10 F.2d
725, 726–27 (2d Cir. 1926) (stating that the plot of a
printed work may be copyrighted but not patented).
While the doctrine’s underlying rationale is in subject
matter eligibility, its application has been in analyzing
other patentability requirements, including novelty under
35 U.S.C. § 102, e.g., King, 616 F.3d at 1279, and nonobvi-
ousness under 35 U.S.C. § 103, e.g., In re Huai-Hung Kao,
639 F.3d 1057, 1072–74 (Fed. Cir. 2011).
    If a claim limitation is directed to printed matter,
then the next step is to ascertain whether the printed
matter is functionally related to its “substrate.” Printed
matter that is functionally related to its substrate is given
patentable weight. DiStefano, 808 F.3d at 850. Likewise,
PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.    11

“[w]here the printed matter is not functionally related to
the substrate, the printed matter will not distinguish the
invention from the prior art in terms of patentability.” In
re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004) (alteration
in original) (internal quotation marks omitted). We have
held that merely adding an instruction sheet or other
informational content to a drug product is not sufficient to
create a functional relationship, even if required by the
FDA for approval. AstraZeneca, 633 F.3d at 1065 (holding
that FDA-required instructions did not create functional
relationship to drug); King, 616 F.3d at 1279 (same for
step of “informing” patient about properties of drug).
Rather, the printed matter must be interrelated with the
rest of the claim. For example, in Ngai, 367 F.3d at 1339,
there was no functional relationship between claimed
instructions and a diagnostic kit, as the instructions “in
no way depend[ed] on the kit, and the kit [did] not depend
on the” instructions. Ngai distinguished Gulack, where
there was a functional relationship between printed digits
on a circular band because “the printed matter and the
circularity of the band were interrelated, so as to produce
a new product useful for educational and recreational
mathematical purposes.” Id. (internal quotation marks
omitted); see also In re Miller, 418 F.2d 1392, 1396 (CCPA
1969) (concluding that there was a functional relationship
between a measuring receptacle and “volumetric indicia
thereon indicating volume in a certain ratio”).
    Applying precedent to this case, we agree with Prax-
air that the Board properly addressed the printed matter
doctrine during claim construction. The Board’s printed
matter analysis here only required analyzing and inter-
preting the meaning of the claim language. That is claim
construction, which is ultimately a legal inquiry. Mark-
man v. Westview Instruments, Inc., 517 U.S. 370, 372
(1996). And to the limited extent the Board considered
extrinsic evidence in weighing competing expert testimo-
12       PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.

ny in arriving at its claim constructions, Mallinckrodt
does not point us to any error by the Board in doing so.
     Mallinckrodt also argues that the Board erred at the
first step of the printed matter analysis by concluding
that claim limitations reciting mental steps were not
entitled to patentable weight. According to Mallinckrodt,
whether claims are directed to mental steps may only be
considered in determining patent eligibility, not obvious-
ness, and thus the Board erred in not giving patentable
weight to the evaluating limitation of claim 3. Cross-
Appellant Br. 27.
    We disagree. Like the information claimed by printed
matter, mental steps or processes are not patent eligible
subject matter. See, e.g., Gottschalk v. Benson, 409 U.S.
63, 67 (1972); Genetic Techs. Ltd. v. Merial L.L.C., 818
F.3d 1369, 1378 (Fed. Cir. 2016); CyberSource Corp. v.
Retail Decisions, Inc., 654 F.3d 1366, 1371 (Fed. Cir.
2011). And while subject matter eligibility underlies the
printed matter doctrine, see AstraZeneca, 633 F.3d at
1064, many of our printed matter cases have arisen in the
context of anticipation or obviousness, see, e.g., DiStefano,
808 F.3d at 848 (anticipation); Kao, 639 F.3d at 1072
(obviousness); King, 616 F.3d at 1278 (anticipation); Ngai,
367 F.3d at 1338 (anticipation); Gulack, 703 F.3d at 1385
(obviousness). The printed matter doctrine thus raises an
issue where the § 101 patent-eligibility inquiry and the
§ 102 and § 103 novelty and nonobviousness inquiries
overlap. Cf. Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 566 U.S. 66, 90 (2012). Because claim limita-
tions directed to mental steps may attempt to capture
informational content, they may be considered printed
matter lacking patentable weight in an obviousness
analysis. Accordingly, a limitation that merely claims
information by incorporating that information into a
mental step will receive patentable weight only if the
limitation is functionally related to the substrate.
PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.     13

   The evaluating limitation in claim 3 is directed to a
mental step that is also printed matter. It requires a
medical provider to weigh:
    the potential benefit of treating the [neonatal pa-
    tient] with 20 ppm inhaled nitric oxide vs. the po-
    tential risk that inhaled nitric oxide could cause
    an increase in PCWP leading to pulmonary edema
    in patients who have pre-existing [LVD], in order
    to arrive at a decision of whether or not to treat
    the [neonatal patient] with inhaled nitric oxide.
’112 patent col. 14 ll. 57–66. This limitation merely
requires a medical provider to think about the infor-
mation claimed in the providing information limitation of
claim 1. But adding an ineligible mental process to
ineligible information still leaves the claim limitation
directed to printed matter. To hold otherwise would make
the printed matter doctrine a dead letter, requiring no
more than a “think about it” step to give patentable
weight to a claim limitation directed to information
content. There is no meaningful distinction between
claim limitations directed to written information in Kao,
Ngai, and AstraZeneca, verbal information in King, and
mentally-processed information here.        An applicant
cannot “continue patenting a product indefinitely provid-
ed that they add a new instruction sheet,” Ngai, 367 F.3d
at 1339, or as we now hold, information together with a
purely mental step.
     Even if the providing information, evaluating, and
recommendation limitations are directed to printed mat-
ter, Mallinckrodt argues that they are functionally related
to the other claim limitations. According to Mallinckrodt,
this is because the term “pharmaceutically acceptable”
incorporates the claimed information into the concrete
step of supplying nitric oxide gas. Cross-Appellant Br.
30–31.
14      PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.

     The preambles of independent claims 1 and 7 both re-
cite a “method of providing pharmaceutically acceptable
nitric oxide gas.” ’112 patent col. 14 ll. 28–29, col. 15
ll. 43–44. Applying the broadest reasonable interpreta-
tion standard, the Board construed “pharmaceutically
acceptable nitric oxide gas” as “nitric oxide gas that is
suitable for pharmaceutical use.” Decision, 2016 WL
3648375, at *4, *7. We agree with the Board that the
ordinary meaning of “pharmaceutically acceptable” here
only refers to the physical condition of the gas, not pre-
scribing information that may accompany it. If the term
“pharmaceutically acceptable” impliedly included the
information regarding the relationship between inhaled
nitric oxide, LVD, and side effects like pulmonary edema,
there would have been no need to explicitly recite that
information later in the claim. And even if “pharmaceuti-
cally acceptable” did include the informational content, it
would only make the claim redundant, not supply a
functional relationship, as “providing” a drug product
together with FDA-required prescribing information does
not suffice to create a functional relationship between the
information and methods of providing and potentially
administering the drug. See AstraZeneca, 633 F.3d at
1065; King, 616 F.3d at 1279. Thus the Board did not err
either in construing “pharmaceutically acceptable” or in
concluding that the term did not create a functional
relationship. Mallinckrodt does not specifically point to
any other source of a functional relationship. Accordingly,
we hold that the printed matter in claims 1–8 and 10
lacks a functional relationship to its substrate.
    Mallinckrodt also argues that in construing “pharma-
ceutically acceptable,” the Board violated Mallinckrodt’s
procedural rights by adopting a claim construction that
neither party proposed. See SAS Inst., Inc. v. Comple-
mentSoft, LLC, 825 F.3d 1341 (Fed. Cir. 2016), rev’d on
other grounds sub nom., SAS Inst. Inc. v. Iancu, 138 S. Ct.
1348 (2018).
PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.   15

     Mallinckrodt’s argument is meritless. The Board did
not “change theories in midstream.” Id. at 1351. It
reasonably declined to construe the generic term “phar-
maceutically acceptable” at institution, then rejected
Mallinckrodt’s further arguments regarding this term in
its final decision. Nor did Praxair, as Mallinckrodt alleg-
es, ever agree that the plain and ordinary meaning of
“pharmaceutically acceptable” included prescribing in-
formation about the product. Rather, the parties litigated
the meaning and relevance of the term “pharmaceutically
acceptable,” and the Board resolved the issue in Praxair’s
favor. Nothing proffered by Mallinckrodt indicates that
the Board violated its procedural rights.
    Mallinckrodt’s final argument regarding claims 1–8
and 10 is that the Board improperly discounted evidence
of secondary considerations. Mallinckrodt contends that
we must weigh secondary considerations of nonobvious-
ness even if the secondary considerations only relate to
printed matter lacking patentable weight. Specifically,
Mallinckrodt argues that the INOT22 study unexpectedly
uncovered the potentially harmful effect of inhaled nitric
oxide on neonates with preexisting LVD.
    While we agree with Mallinckrodt that relevant evi-
dence of secondary considerations must be considered in
an obviousness analysis, see, e.g., Stratoflex, Inc. v.
Aeroquip Corp., 713 F.2d 1530, 1538 (Fed. Cir. 1983), the
evidence submitted here was not relevant to claims 1–8
and 10. The only secondary consideration Mallinckrodt
alleges is based on the information claimed in the provid-
ing information limitation, which we have held lacks any
functional relationship to the non-printed matter limita-
tions in claims 1–8 and 10. That claimed information has
no patentable weight in an obviousness analysis because
printed matter without a functional relationship to a
substrate is not eligible subject matter, see AstraZeneca,
633 F.3d at 1064. Such printed matter cannot be brought
within the ambit of patent eligibility by showing that it
16      PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.

was surprising. No patentable weight means no patenta-
ble weight.
    Because we conclude that the Board did not err in ap-
plying the printed matter doctrine to claims 1–8 and 10,
and Mallinckrodt does not on appeal challenge the
Board’s other findings regarding these claims, we affirm
the Board’s decision holding claims 1–8 and 10 unpatent-
able as obvious.
                   II. CLAIMS 9 AND 11
     Praxair argues in its principal appeal that the Board
erred in holding claim 9 not unpatentable as obvious.
Praxair contends that the Board improperly construed “in
accordance with” in claim 9. Properly construed, Praxair
argues that there is no functional relationship between
the discontinuing step of claim 9 and the recommendation
limitation. And even accepting the Board’s construction,
Praxair argues that claim 9 would have been obvious.
    Mallinckrodt responds that the Board correctly con-
strued “in accordance with,” and that substantial evidence
supports the Board’s findings regarding Bernasconi and
Mallinckrodt’s evidence of secondary considerations.
     We assume that the Board properly construed the
term “in accordance with” as meaning “based on, or as a
result of.” Under this construction, claim 9 requires:
(1) determining that a neonatal patient has preexisting
LVD; (2) treating that neonate with nitric oxide, where-
upon the neonate experiences pulmonary edema;
(3) providing information and a recommendation to the
medical provider to discontinue nitric oxide treatment for
a patient with preexisting LVD who experiences a pulmo-
nary edema; and (4) “based on” the recommendation,
discontinuing nitric oxide treatment due to the pulmonary
edema. See ’112 patent col. 16 ll. 5–13, col. 15 ll. 53–63.
Thus, claim 9 requires a medical provider to take a specif-
ic action, discontinuing treatment, as a result of the
PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.   17

recommendation limitation. Both parties agree that this
suffices to create a functional relationship, and so do we.
By interrelating the claimed information regarding corre-
lations between nitric oxide, LVD, and pulmonary edema
with the concrete step of discontinuing treatment because
of the information, we agree with Mallinckrodt that the
Board did not err in concluding that the printed matter in
claim 9 has a functional relationship to the rest of the
claim and giving the printed matter patentable weight.
     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 obvi-
ous 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 lan-
guage” 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 Bernas-
coni 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
18       PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.

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 pulmo-
nary edema for patients with LVD. Decision, 2016 WL
3648375, at *19. The Board found persuasive the infer-
ence 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 analy-
sis also rested on its “excluding” interpretation of claim 9.
But, because we conclude that claim 9 requires adminis-
tering 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 dif-
ferences between the prior art and claim 9 and its find-
ings 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.
2017).
    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.
The Board found that Bernasconi taught that nitric oxide
treatment may lead to pulmonary edema in patients with
PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.      19

LVD, and emphasized a “need for careful observation and
intensive monitoring during [nitric oxide] inhalation” in
patients with LVD. Decision, 2016 WL 3648375, at *13.
Thus, the only remaining question relevant to this appeal
is whether “careful observation and intensive monitoring”
includes discontinuing nitric oxide treatment when a side
effect that warranted such intensive monitoring actually
occurs.
    It is undisputed that discontinuing a treatment in re-
sponse to a serious side effect was known in the prior art.
See INOmax Label, J.A. 334–35. It is also undisputed
that pulmonary edema is a potentially fatal condition.
See ’112 patent col. 4 ll. 47–57; id. col. 12 l. 62–col. 13 l.
36. And Bernasconi taught that administering “[nitric
oxide] may lead to pulmonary edema in patients with
LVD.” Decision, 2016 WL 3648375, at *13. Based on
these teachings, we conclude that “there is only one
permissible factual finding,” Corning v. Fast Felt Corp.,
873 F.3d 896, 903 (Fed. Cir. 2017), that “careful observa-
tion and intensive monitoring” of patients with LVD
treated with nitric oxide, motivated by the dangerous
possibility of a pulmonary edema known to result from
that treatment, includes or at least suggests to a person of
ordinary skill discontinuing nitric oxide treatment after a
patient with LVD administered nitric oxide suffers a
pulmonary edema. Where the level of ordinary skill in
the art is high, Decision, 2016 WL 3648375, at *4, and the
claim applies a known solution to a known problem, it is
“likely the product not of innovation but of ordinary skill
and common sense.” KSR Int’l Co. v. Teleflex Inc., 550
U.S. 398, 421 (2007). That is the case here. Consequent-
ly, we reverse the Board’s decision holding that claim 9 is
not unpatentable as obvious.
    Finally, claim 11 depends from claim 9. The Board
erroneously indicated that claim 11 depends only from
claim 7, and held claim 11 obvious on that basis. Deci-
sion, 2016 WL 3648375, at *16–17. Given our conclusion
20       PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.

that claim 9 would have been obvious at the time of the
invention, and that Mallinckrodt has not presented any
separate argument regarding claim 11, we conclude that
the Board’s error was harmless.
   We have considered Mallinckrodt’s remaining argu-
ments, but find them unpersuasive.
    The concurrence states that the printed matter doc-
trine is “not relevant to the claimed method of administer-
ing nitric oxide to infants with [LVD].” Concurring Op. at
2. We disagree with the concurrence’s characterization of
the claims. The claims at issue containing printed matter
limitations that we have held lack patentable weight do
not have any additional limitations which recite adminis-
tering nitric oxide to infants and relate functionally to the
printed matter limitations. They do not recite “adjusting
the nitric oxide treatment according[]” to any claimed
information. Concurring Op. at 4. They merely recite
providing a canister of nitric oxide gas to a medical pro-
vider together with information or information coupled to
a purely mental step, with no required adjustment in
treatment. The printed matter doctrine is thus relevant
to the obviousness of claims consisting of nothing but
information or mental processes and functionally unrelat-
ed steps already known in the art.
    Claim 9, on the other hand, does recite an adjustment
in treatment as a result of the claimed information. And
for that claim, we agree with the Board that even the
claim limitation directed to information has patentable
weight, because the claimed adjustment provides a func-
tional relationship to a substrate. Thus, we do not hold
that claim invalid because of the printed matter doctrine,
but because it would have been obvious to a person of
ordinary skill based on the teachings of the prior art.
    Finally, it is our task to review decisions based on the
grounds relied on by the tribunal being reviewed and on
the arguments raised before us. The Board relied on the
PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.     21

printed matter doctrine in its analysis of obviousness, and
Mallinckrodt, in its cross-appeal, spent virtually its entire
brief on the printed matter doctrine. That is what the
majority has reviewed.
                          CONCLUSION
    For the foregoing reasons, we affirm the Board’s deci-
sion with respect to claims 1–8 and 10–11, and reverse
the Board’s decision with respect to claim 9.
  AFFIRMED IN PART AND REVERSED IN PART
                              COSTS
    Costs to Praxair.
  United States Court of Appeals
      for the Federal Circuit
                 ______________________

          PRAXAIR DISTRIBUTION, INC.,
                   Appellant

                            v.

MALLINCKRODT HOSPITAL PRODUCTS IP LTD.,
              Cross-Appellant
          ______________________

                  2016-2616, 2016-2656
                 ______________________

   Appeals from the United States Patent and Trade-
mark Office, Patent Trial and Appeal Board in No.
IPR2015-00529.
               ______________________

NEWMAN, Circuit Judge, concurring in the judgment.
     I concur in the judgment of unpatentability of claims
1–11. However, I respectfully disagree with the court’s
view of the “printed matter doctrine” and its application
to “information” and “mental steps.”
    The “printed matter doctrine” does not apply to un-
printed matter.     My colleagues err in holding that
“[b]ecause claim limitations directed to mental steps may
attempt to capture informational content, they may be
considered printed matter lacking patentable weight in an
obviousness analysis.” Maj. Op. at 12. Mental steps are
mental, not printed. The printed matter doctrine is di-
rected to printed matter, not information and not mental
2        PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.

steps. This “doctrine” is not relevant to the claimed
method of administering nitric oxide to infants with left
ventricular dysfunction. 1 The claimed method warrants
analysis in accordance with the traditional grounds of
sections 102, 103, and 112; not as a newly created catego-
ry within section 101.
    The “printed matter doctrine” arose in response to the
patenting of business forms. See Thomas F. Cotter, A
Burkean Perspective on Patent Eligibility, 22 Berkeley
Tech. L.J. 855 (2007):
    [B]eginning in the mid-nineteenth century, the
    USPTO and the courts began rejecting applica-
    tions claiming purportedly novel types of business
    forms under the “printed matter” doctrine. By
    most accounts, the doctrine was intended to pre-
    serve the boundary between patent and copyright
    law.
Id. at 860 n.15. The principle was elaborated by Kevin
Emerson Collins, Patent Law’s Authorship Screen, 84 U.
Chi. L. Rev. 1603 (2017):
    A book may be a “manufacture” under the plain
    meaning of the word, but it is not the type of
    manufacture that Congress meant to make pa-
    tentable. Much of copyrightable subject matter
    involves the representation of information—
    including books, diagrams, and photographs—and
    it is the printed matter doctrine, operating as part
    of patent eligibility, that keeps innovation in these
    subject matters from infiltrating the patent re-

    1   Praxair Distrib., Inc. v. Mallinckrodt Hosp. Prods.
IP Ltd., IPR2015-00529, 2016 WL 3648375 (P.T.A.B. July
7, 2016) (“Board Op.”); Paper No. 12 (P.T.A.B. July 29,
2015) (“Institution Dec.”).
PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.        3

    gime and upsetting          copyright’s   competition–
    protection balance.
Id. at 1640–41. Precedent relates to printed documents.
See, e.g., In re Russell, 48 F.2d 668, 669 (CCPA 1931)
(“The mere arrangement of printed matter on a sheet or
sheets of paper, in book form or otherwise, does not con-
stitute ‘any new and useful art, machine, manufacture, or
composition of matter,’ or ‘any new and useful improve-
ments thereof,’ as provided in section 4886 of the Revised
Statutes, 35 USCA § 31.”); In re Reeves, 62 F.2d 199, 200
(CCPA 1932) (“It seems to be settled patent law that
invention cannot rest alone in novel printing arrange-
ment, although it may reside in some physical structures
of printed matter.”).
    The Federal Circuit summarized, in In re Lowry, 32
F.3d 1579 (Fed. Cir. 1994):
    The printed matter cases “dealt with claims defin-
    ing as the invention certain novel arrangements of
    printed lines or characters, useful and intelligible
    only to the human mind.”
Id. at 1583 (quoting In re Bernhart, 417 F.2d 1395, 1399
(CCPA 1969)); see generally John F. MacNab, Invention
and Patentability Under the Patent Statutes as Applied to
So-called Printed Matter and Methods or Systems of
Doing Business 4. J. Pat. Off. Soc. 480 (1921) (explaining
that businesses began seeking patent protection after the
Court in Baker v. Seldon, 101 U.S. 99 (1879) established
that authors could no longer receive copyright protection
for “printed matter subjects, such as blank books and
leaves therefor, ruled in different ways forming rows and
columns, headings therefor, spaces for totals, items of
special kinds for bookkeeping adapted for different kinds
of business or purposes of various natures”). None of
these criteria is here present.
4        PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.

    Unprinted matter does not become “printed” if it car-
ries information, nor even if it requires thinking, as my
colleagues hold. The panel majority holds that patent
claims such as these for administering nitric oxide to
neonates with cardiac problems are barred as “printed
matter” because “adding an ineligible mental process to
ineligible information still leaves the claim limitation
directed to printed matter.” Maj. Op. at 13. However,
“printed matter” is not a “mental process,” whatever its
content.
    The creation of a new printed matter doctrine in to-
day’s jurisprudence serves no purpose other than adding
to the uncertainty of patent eligibility. An illustration is
today’s decision, where the majority holds that “infor-
mation”—apparently the information that an infant with
hypoxic respiratory failure who also has preexisting left
ventricular dysfunction is at increased risk for pulmonary
edema, and adjusting the nitric oxide treatment accord-
ingly—violates the printed matter doctrine. This infor-
mation is described in Bernasconi 2 and other cited
references (INOmax Label, 3 Loh, 4 and Goyal 5), and pa-

    2    A. Bernasconi & M. Beghetti, Inhaled Nitric Oxide
Applications in Paediatric Practice, 4 Images in Paediat-
ric Cardiology 4 (2002) (“Bernasconi”).
    3    INOmax Final Printed Labeling, NDA 20845,
Center      for   Drug     Evaluation     and     Research,
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20
845_INOmax_prntlbl.pdf (August 9, 2000) (“INOmax
Label”).
    4    E. Loh et al., Cardiovascular Effects of Inhaled
Nitric Oxide in Patients with Left Ventricular Dysfunc-
tion, 90 Circulation 2780 (1994) (“Loh”).
    5    P. Goyal et al., Efficacy of Nitroglycerin Inhala-
tion in Reducing Pulmonary Arterial Hypertension in
PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.     5

tentability is readily analyzed under the straightforward
procedures of section 103. Review of the cited references
supports finding the challenged claims invalid based on
an obviousness analysis in accord with the law of obvi-
ousness.
    The panel majority converts the patentability analysis
into eligibility under section 101, and states: “[l]ike the
information claimed by printed matter, mental steps or
processes are not patent eligible subject matter.” Maj.
Op. at 12. However, the role of information in patentabil-
ity depends on the novelty and non-obviousness of the
invention as a whole. Neither the inclusion of information
in the patent claim, nor the mental component of the
practice of process steps, negates eligibility under Section
101. The discovery of previously unknown information
may well lead to new and useful technology; and mental
steps often are needed to move through a sequential
process. The conflation of “information” with “mental
steps,” whereby both are designated “printed matter,”
adds neither clarity nor precision to the law.
    The majority admonishes that “mental steps may at-
tempt to capture informational content,” and deems such
attempt inimical to patentability. However, if the “infor-
mational content” is novel and non-obvious, it may well
constitute patentable subject matter. Analysis of all of
the claims herein is readily based on the law of obvious-
ness, for there is extensive precedent on this use of nitric
oxide for neonates. It was known that patients with pre-
existing left ventricular dysfunction are at increased risk
for adverse events from inhaled nitric oxide. It is note-
worthy that Praxair’s petition for inter partes review was
on the ground of obviousness, not printed matter.

Children with Congenital Heart Disease, 97 British J.
Anaesthesia 208 (2006) (“Goyal”).
6        PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.

    The INOmax Label contains information regarding
iNO uses and contraindications, including a recommended
dose of 20 ppm iNO for neonatal patients with hypoxic
respiratory failure and a caution that it “should not be
used in the treatment of neonates known to be dependent
on right-to-left shunting of blood.” See generally INOmax
Label, J.A.331–38; J.A. 335.
    Bernasconi reviews “delivery and monitoring aspects
of inhaled nitric oxide, its potential toxic and side effects
and its applications in several cardiopulmonary disorders
in paediatrics,” Bernasconi Abstract, and states that the
recommended dose for treatment of neonatal hypoxic
respiratory failure is 20 ppm. Bernasconi at 4. Bernas-
coni cautions that iNO may lead to pulmonary edema in
neonatal patients with LVD, and emphasizes “careful
observation and intensive monitoring during NO inhala-
tion in patients with left ventricular failure.” Id. at 3.
    Loh describes the effects of inhalation of nitric oxide
in patients with moderate to severe heart failure due to
LVD. Goyal describes a study of the efficacy of inhaled
nitroglycerin in reducing pulmonary arterial hypertension
in children with congenital heart disease. The prescribing
information and warnings combined with the Bernasconi
teaching of increased risk for developing pulmonary
edema in neonatal patients with LVD, and the need for
physicians to monitor such patients, support an obvious-
ness determination of all of the challenged claims.
    The Board created this unsound new section 101
ground, stating at “institution” that “the information
described in [claim clauses] (i) and (ii) as tantamount to
printed matter.” Institution Dec. at *8–9. The Board
reasoned that although the asserted invention is not
directed to printed matter, claim 5 “expressly provides
that the information ‘appear[s] in prescribing information
supplied to the medical provider with the cylinder con-
taining compressed nitric oxide gas.’” Id. at *9 (alteration
PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.    7

in original); see also Board Op. at *7. The Board then
held that the “providing information” limitation is of “no
patentable weight” because it “lacks a functional relation-
ship to the remaining claim elements,” Board Op. at *8,
and that the “evaluating” limitation is of “no patentable
weight” because it uses purely mental steps. Id. at *10.
The Board then excised the “providing” and “evaluating”
limitations from the claims, and analyzed patentability
based on the remainder of the claims. My colleagues are
in accord.
    However, the form of analysis whereby limitations are
removed from the claim before the claim is analyzed for
patentability, is contrary to the patent statute, which
requires determination of patentability of the claimed
subject matter as a whole. It is improper to pluck limita-
tions out of the claims, as of “no patentable weight,” and
then to review patentability of the remainder. See In re
Gulack, 703 F.2d 1381, 1385 (Fed. Cir. 1983) (“Under
section 103, the board cannot dissect a claim, excise the
printed matter from it, and declare the remaining portion
of the mutilated claim to be unpatentable. The claim must
be read as a whole.”). The Board stated that it afforded
no patentable weight to the “providing information” and
“evaluating” limitations, but gave patentable weight to
the “recommendation” limitation in claim 9. Such piece-
meal analysis does not impart precision to patentability
analysis.
    My colleagues support the Board’s analysis, and add
that the “providing information” limitation is not of
patentable weight because it is “printed matter.” Un-
printed information or mental steps are not “printed
matter.” As stated in Flood v. Coe, 31 F. Supp. 348, 349
(D.D.C. 1940): “The invention here is more than an ar-
rangement of printed matter on a piece of paper.” The
Federal Circuit noted in In re Gulack, 703 F.2d at 1385
n.8 that:
8          PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.

      A “printed matter rejection” under § 103 stands on
      questionable legal and logical footing. Standing
      alone, the description of an element of the inven-
      tion as printed matter tells nothing about the dif-
      ferences between the invention and the prior art
      or about whether that invention was suggested by
      the prior art.
The Gulack court, explaining this doctrine in the early
days of the Federal Circuit, stressed the statutory
      requirement that the claim be viewed as a whole
      in determining obviousness. Graham v. John
      Deere Co., 383 U.S. 1 (1966). The CCPA has con-
      sidered all of the limitations of the claims, includ-
      ing the printed matter limitations, in determining
      whether the invention would have been obvi-
      ous. See In re Royka, 490 F.2d 981 (CCPA
      1974); In re Cavrich, 451 F.2d 1091 (CCPA 1971).
      In Royka, 490 F.2d at 985, the CCPA, notably
      weary of reiterating this point, clearly stated that
      printed matter may well constitute structural lim-
      itations upon which patentability can be predicat-
      ed.
Id.
    Some recent cases on “printed matter” have focused
on the difference between “substrate” and “function,” but
the generalization that unprinted matter is printed
matter if it is “information” or “mental” departs from the
printed matter doctrine. The panel majority errs in
endorsing that “a claim limitation is directed to printed
matter ‘if it claims the content of information,’” Maj. Op.
at 10 (quoting In re Distefano, 808 F.3d 845, 848 (Fed. Cir.
2015)), and that “claim limitations directed to mental
steps may attempt to capture informational content, they
may be considered printed matter lacking patentable
weight in an obviousness analysis.” Maj. Op. at 12. This
PRAXAIR DISTRIB., INC.   v. MALLINCKRODT HOSP. PRODS.     9

is not a sound application of either the printed matter
doctrine or the law of obviousness. 6
    I conclude that the cited references render all of the
claims unpatentable on the ground of obviousness. The
error lies in the analysis in which the court, like the
Board, first applies the “printed matter doctrine” to
remove some limitations from the claim, and then reviews
what is left of the claim. Thus I must, respectfully, dis-
sent from the court’s reasoning.

    6    The panel majority states that our review is lim-
ited to “the arguments raised before us.” Maj. Op. at 20.
I suggest that the appellate role is to assure that the case
is decided on correct law and fact.