MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED

Patent Trials and Appeals Board

Jul 29, 2020

2020000503 (P.T.A.B. Jul. 29, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/683,444 11/21/2012 James S. Baldassarre 26047-0003009 1026
94169 7590 07/29/2020
Fish & Richardson PC (IKARIA INC.)
P.O.Box 1022
minneapolis, MN 55440
EXAMINER
ARNOLD, ERNST V
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
07/29/2020 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
patdoctc@fr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JAMES S. BALDASSARRE
__________

Appeal 2020-000503
Application 13/683,444
Technology Center 1600
__________

Before FRANCISCO C. PRATS, ULRIKE W. JENKS, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL

Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 3–6, 8–11, and 13–18. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies Mallinckrodt Hospital Products IP
Limited, Mallinckrodt IP Unlimited Company, Mallinckrodt Pharma IP
Trading Designated Activity Company, Mallinckrodt International Finance
SA, and Mallinckrodt Public Limited Company, as Real Parties in Interest.
Appeal Br. 1.
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STATEMENT OF THE CASE
The sole rejection before us for review is the Examiner’s rejection of
claims 1, 3–6, 8–11, and 13–18 under pre-AIA 35 U.S.C. § 102(b) as being
anticipated by INOvent.2 Final Act. 3–7;3 Ans. 3–7.
Appellant’s claim 1 is representative and reads as follows:
1. A system for use in administering inhaled nitric
oxide gas, which system reduces the risk of inducing an
increase in pulmonary capillary wedge pressure (PCWP)
leading to pulmonary edema in neonatal patients who have
hypoxic respiratory failure and are candidates for inhaled nitric
oxide treatment, the system comprising:
a source of pharmaceutically acceptable nitric oxide gas
for inhalation;
a delivery device suitable for delivering nitric oxide gas
from the source to a term or near-term neonate patient; and
instructions for use in operating the system, the
instructions comprising: (i) a description of using the system to
deliver 20 ppm inhaled nitric oxide gas to treat hypoxic
respiratory failure in a term or near-term neonate; (ii) a
contraindication for neonates who are dependent on right to left
shunting of blood; and (iii) a warning that a patient with pre-
existing left ventricular dysfunction may experience increased
PCWP leading to pulmonary edema when treated with inhaled
nitric oxide gas, wherein the warning:
is effective to reduce use of inhaled nitric oxide
gas to treat neonate patients who have hypoxic
respiratory failure and pre-existing left ventricular
dysfunction but who are not dependent on right to left
shunting of blood, and

2 INOvent delivery system Operation and Maintenance Manual (2000).
3 Final Action entered July 13, 2018.
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thereby reduces the risk of occurrence of increased
PCWP leading to pulmonary edema in neonates who
have hypoxic respiratory failure.
Appeal Br. 30.
DISCUSSION
The Examiner’s Prima Facie Case
In rejecting Appellant’s representative claim 1, the Examiner found
that INOvent describes a system having a source of nitric oxide gas for
inhalation, a delivery device suitable for delivering the nitric oxide to a term
or near-term neonate patient, and instructions for operating the device. Ans.
3–4.
The Examiner determined that the preamble of claim 1 recited an
intended use that did not distinguish the system recited in claim 1 from
INOvent’s system. Ans. 4–6. The Examiner also determined that the
instructions recited in representative claim 1 are directed to printed matter,
and therefore are not entitled patentable weight. Id. at 6–7.
Therefore, the Examiner determined, “claims 1, 3–6, 8–11 and 13–18
are anticipated by the reference.” Ans. 7.
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant in
response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
Having carefully considered all of the arguments and evidence
advanced by Appellant and the Examiner, Appellant does not persuade us
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that a preponderance of the evidence fails to support the Examiner’s
determination that INOVent anticipates Appellant’s representative claim 1.
In particular, while we have carefully considered all of Appellant’s extensive
analysis as to the various cases cited by the Examiner and the Manual of
Patent Examining Procedure, Appellant does not persuade us that the
Examiner erred in maintaining the anticipation rejection of claim 1 over
INOvent.
Representative claim 1 recites a system for administering inhaled
nitric oxide gas. Appeal Br. 30. The system of claim 1 includes three
components: (1) a nitric oxide source, (2) a delivery device suitable for
delivering nitric oxide gas from the source to a term or near-term neonate
patient, and (3) instructions for use in operating the system. Id.
Claim 1 recites in its preamble that the system “reduces the risk of
inducing an increase in pulmonary capillary wedge pressure (PCWP) leading
to pulmonary edema in neonatal patients who have hypoxic respiratory
failure and are candidates for inhaled nitric oxide treatment.” Appeal Br. 30.
In addition to this preamble recitation, claim 1 recites that the instructions
regarding the operation of the device are
effective to reduce use of inhaled nitric oxide gas to treat
neonate patients who have hypoxic respiratory failure and pre-
existing left ventricular dysfunction but who are not dependent
on right to left shunting of blood, . . . thereby reduc[ing] the risk
of occurrence of increased PCWP leading to pulmonary edema
in neonates who have hypoxic respiratory failure.
Id.
We agree with the Examiner that the recitations in claim 1 stating that
the claimed system reduces the risk of pulmonary edema in neonates do not
impart any structural features to claimed system. Specifically, the reduction
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in the risk of pulmonary edema recited in claim 1 does not depend on any
structural component of the claimed system. Rather, the reduction in the
risk of pulmonary edema recited in claim 1 depends on not using the system
in patients who are contraindicated in the manner recited in claim 1’s
instructions.
Because the reduction in risk recited in claim 1, thus, depends on the
manner in which the system is used, rather than any structural component of
the system recited in claim 1, we agree with the Examiner that the recitations
in claim 1 as to reducing the risk of pulmonary edema, in both the preamble
and the body of the claim, do not impart any structural features to claimed
system. We also agree with the Examiner that the instructions recited in
representative claim 1 are printed matter, and are not entitled to patentable
weight.
Claim 1 requires the claimed system to include “instructions for . . .
operating the system,” the instructions including the following items:
(i) a description of using the system to deliver 20 ppm
inhaled nitric oxide gas to treat hypoxic respiratory failure in a
term or near-term neonate;
(ii) a contraindication for neonates who are dependent on
right to left shunting of blood; and
(iii) a warning that a patient with pre-existing left
ventricular dysfunction may experience increased PCWP
leading to pulmonary edema when treated with inhaled nitric
oxide gas.
Appeal Br. 30.
As Appellant notes, our reviewing court has relatively recently issued
a decision involving patents related to the application under consideration
herein, involving claims similar to those under consideration herein. See
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Appeal Br. 2 (citing Praxair Distribution, Inc., v. Mallinckrodt Hospital
Products IP LTD., 890 F.3d 1024 (Fed. Cir. 2018); see also Praxair, 890
F.3d at 1031–1035 (finding instructions explaining when nitric oxide in
neonates would be contraindicated to be printed matter lacking patentable
weight).
In Praxair, the court explained that “a claim limitation is directed to
printed matter if it claims the content of information.” 890 F.3d at 1032
(internal quotations omitted).
In the present case, the instructions in representative claim 1 are
instructions for operating the claimed system, including a directive to deliver
20 ppm nitric oxide to the patient, a contraindication as to certain patients,
and a warning as to potential side effects. See Appeal Br. 30. Because
instructions explaining how to operate a system claim the content of the
information, we discern no error in the Examiner’s determination that claim
1’s instructions are printed matter.
In Praxiar, the court also explained that “[c]laim 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.” 890 F.3d at 1031.
Thus, “once it is determined that the limitation is directed to printed
matter, one must then determine if the matter is functionally or structurally
related to the associated physical substrate, and only if the answer is ‘no’ is
the printed matter owed no patentable weight.” In re Distefano, 808 F.3d
845, 851 (Fed. Cir. 2015).
In the present case, Appellant does not persuade us that the
instructions recited in representative claim 1 are functionally or structurally
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related to any associated physical substrate recited in the claim 1. Aside
from the instructions, the only physical components recited in claim are (1) a
nitric oxide source, and (2) a delivery device suitable for delivering nitric
oxide gas from the source to a term or near-term neonate patient. See
Appeal Br. 30.
The instructions recited in claim 1 merely advise a potential operator
regarding a set of desired conditions as to how and when the physical
components of the system should be used. Claim 1’s instructions, however,
do not in any way affect or limit how the physical components of the
claimed system actually function. Nor do claim 1’s instructions affect or
limit the structure of either of the physical components of the claimed
system. Appellant does not persuade us, therefore, that claim 1’s
instructions are functionally or structurally related to the physical
components recited in the claim. See Praxair, 890 F.3d at 1032 (“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.”) (citing AstraZeneca LP v. Apotex, Inc.,
633 F.3d 1042, 1065 (Fed. Cir. 2010)).
Appellant also does not persuade us that, because the contraindication
and warning in the instructions are related to claim 1’s recitations regarding
reducing risk of pulmonary edema, the instructions should be given
patentable weight. See, e.g., Appeal Br. 21–22 (“As was true in [In re]
Gulack, [703 F.2d 1381 (Fed. Cir. 1983)], the content of the instructions
required by present claim 1 closely interrelate with element (2) and serve as
the means by which the ‘purpose’ of claim 1 as described in element (2)
(i.e., reducing the risk) is accomplished.”).
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As noted above, to be accorded patentable weight, the printed matter
must be “functionally or structurally related to the associated physical
substrate.” In re Distefano, 808 F.3d at 851 (emphasis added).
As also noted above, because the risk reduction recited in claim 1
depends on the manner in which the system is used, rather than any claimed
structural component, the recitations in claim 1 as to reducing pulmonary
edema risk, in both the preamble and the body of the claim, do not impart
any structural features to claimed system. Thus, because claim 1’s
recitations as to risk reduction do not impart any structural features to the
physical components, i.e., physical substrates, of the claimed system, the
fact that claim 1’s instructions are closely interrelated with the desired risk
reduction does not persuade us that the instructions should be accorded
patentable weight. In other words, the claim-recited purpose of the
instructions in claim 1 is not a physical substrate that is related to the
claimed instructions.
Indeed, a user could avoid using the physical components of the
claimed system in contraindicated patients based on an orally communicated
warning, rather than claim 1’s instructions, and thereby reduce the risk of
pulmonary edema as recited in claim 1. Appellant does not persuade us,
therefore, that claim 1’s instructions are structurally or functionally related
to the physical components of claim 1, even taking into account claim 1’s
recitations as to reducing the risk of pulmonary edema.
In sum, for the reasons discussed, Appellant does not persuade us that
the instructions in representative claim 1 are entitled to patentable weight.
For the reasons discussed above, moreover, Appellant does not persuade us
that claim 1’s recitations regarding reducing the risk of pulmonary edema
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impart any structural limitations to the other physical components of the
claimed system.
Accordingly, giving claim 1 its broadest reasonable interpretation
consistent with the Specification, claim 1 encompasses a system for
administering inhaled nitric oxide gas, wherein the system includes a nitric
oxide source, and a delivery device suitable for delivering nitric oxide gas
from the source to a term or near-term neonate patient. As the Examiner
found, and Appellant does not dispute, INOvent describes a system that
includes those components. See INOvent Fig. 2-5 (generalized diagram of
nitric oxide (NO) flow from NO-containing cylinder to patient breathing
circuit); id. at Fig. 6-3 (neonatal circuit connection diagram). We note,
moreover, that in accordance with instruction (i) of claim 1, the INOvent
system may be configured to deliver 20 ppm to a term or near-term neonate.
See id. at Table 6-1.
Thus, because INOvent describes a system having all of the features
required by representative claim 1, arranged as in the claim, Appellant does
not persuade us that the Examiner erred in finding that INOvent anticipates
claim 1. We therefore affirm the Examiner’s rejection of claim 1 for
anticipation over INOvent. Claims 3–6, 8–11, and 13–18 were not
separately argued and therefore fall with claim 1. See 37 C.F.R.
41.37(c)(1)(iv); see also Appeal Br. 27 (relying on arguments as to claim 1
in relation to claims 3–6, 8–11, and 13–18).

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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 3–6, 8–
11, 13–18
102(b) INOvent 1, 3–6, 8–
11, 13–18

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED