Trials@uspto.gov
`571-272-7822
`
`
`
`
`Paper 54
`Entered: September 15, 2016
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`PRAXAIR DISTRIBUTION, INC.,
`Petitioner,
`
`v.
`
`INO THERAPEUTICS, LLC,
`Patent Owner.
`____________
`
`Case IPR2015-00891
`Patent 8,573,210 B2
`
`
`
`Before KEN B. BARRETT, MICHAEL J. FITZPATRICK, and
`SCOTT A. DANIELS, Administrative Patent Judges.
`
`DANIELS, Administrative Patent Judge.
`
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a)
`
`
`

`
`IPR2015-00891
`Patent 8,573,210 B2
`
`Praxair Distribution, Inc. (“Praxair”) filed a Petition to institute an
`
`inter partes review of claims 1–16 of U.S. Patent No. 8,573,210 B2 (Ex.
`
`1001, “the ’210 patent”). Paper 1 (“Pet.”).1 We instituted trial for claims 1–
`
`16 of the ’210 patent on certain grounds of unpatentability asserted in the
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`Petition. Paper 14 (“Decision to Institute” or “Inst. Dec.”). After institution
`
`of trial, Patent Owner, INO Therapeutics, LLC, (“Patent Owner” or “INO”),
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`filed a Patent Owner Response. Paper 30 (“PO Resp.”). Praxair timely filed
`
`a Reply. Paper 40 (“Reply”).
`
`A consolidated hearing for this proceeding as well as IPR2015-00884,
`
`IPR2015-00888, IPR2015-00889, and IPR2015-00893, each involving
`
`Praxair and INO but different patents, was held on May 16, 2016. The
`
`transcript of the consolidated hearing has been entered into the record.
`
`Paper 53. (“Tr.”).
`
`Also before the Board is INO’s Motion to Exclude Evidence (Paper
`
`44), Praxair’s Opposition to the same (Paper 48) and INO’s Reply (Paper
`
`49).
`
`After considering the evidence and arguments of counsel and for the
`
`reasons set forth below, we determine that Praxair has not met its burden of
`
`showing that claims 1–16 of the ’210 patent are unpatentable.
`
`I.
`
`BACKGROUND
`
`A. The ’210 Patent (Ex. 1001)
`
`The ’210 patent (Ex. 1001), titled “Nitric Oxide Delivery Device,”
`
`relates generally to a gas delivery device used in a gas delivery system, and a
`
`method for administering therapy gas, such as nitric oxide (NO), to a
`
`
`1 The ’210 Patent is the subject of litigation captioned INO Therapeutics
`LLC et al v. Praxair Distribution Inc. et al., 1:15-cv-00170-GMS currently
`pending in the District Court for the District of Delaware.
`
`2
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`

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`IPR2015-00891
`Patent 8,573,210 B2
`
`medical patient. Ex. 1001, 1:14–27, Fig. 1. In the Background section, it
`
`states that “[t]here is a need for a gas delivery device that integrates a
`
`computerized system to ensure that patient information contained within the
`
`computerized system matches the gas that is to be delivered by the gas
`
`delivery device” to the patient, and “also a need for such an integrated
`
`device that does not rely on repeated manual set-ups or connections and
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`which can also track individual patient usage accurately and simply.” Id. at
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`1:40–46.
`
`The ’210 patent describes specifically gas delivery system 10
`
`including a supply cylinder of gas, i.e. gas source 50, and valve assembly
`
`100 for connecting gas source 50 to a gas delivery circuit including
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`ventilator 400. Id. at 6:5–15.
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`3
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`

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`IPR2015-00891
`Patent 8,573,210 B2
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`Figure 1 of the ’210 patent, above, is a diagrammatic representation of
`
`gas delivery system 10 for delivering therapeutic gas to a patient.
`
`The ’210 patent is particularly drawn to valve assembly 100 which, by
`
`opening and closing, allows gas to flow from gas source 50, generally a
`
`cylinder containing NO gas for example, to the gas delivery system. Id. at
`
`2:10–20. Figures 2 and 3 are reproduced below depicting valve assembly
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`100 having manual actuator 114, valve 107 and circuit 150 disposed in the
`
`actuator for communicating with a control module to control administration
`
`of the therapy gas to a patient. Id. at 5:60–6:5.
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`
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`4
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`IPR2015-00891
`Patent 8,573,210 B2
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`Figure 2, above, depicts valve assembly 100 and actuator 114 of the
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`gas delivery device in communication via valve 107 with gas source 50.
`
`Figure 3, above, illustrates an exploded view of actuator 114 and circuit 150.
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`Administration of therapy gas to the patient is regulated by a control
`
`module that controls delivery from gas source 50 (i.e., cylinder or tank to
`
`which the valve assembly is mounted) to a medical device for introducing
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`gas to a patient (e.g., a ventilator, nasal cannula, endotracheal tube, face
`
`mask, etc.). Id. Circuit 150 of valve assembly 100, shown diagrammatically
`
`below, is disposed in actuator 114 and communicates, for example via a
`
`wireless link by valve transceiver 120, with the control module. Id. at 6:20–
`
`25.
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`
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`Figure 4 is a block diagram depicting various components of circuit
`
`
`
`150.
`
`Figure 4 depicts various components of circuit 150 including, inter
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`alia, valve processor 122, memory 134, valve transceiver 120, power source
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`5
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`IPR2015-00891
`Patent 8,573,210 B2
`130, and valve display 132.2 Memory 134 stores the gas data for the
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`particular gas source to which the valve assembly is attached. Gas data,
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`such as gas composition and concentrations, can be input to memory 134 in
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`various ways such as programmed by the gas supplier or scanned from a bar
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`code on the gas source itself. Id. at 7:5–10. Valve display 132 allows a
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`user, via window 113 on actuator 114, to view information regarding valve
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`operation such as open or close, as monitored by open/close sensor 126, and
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`the time duration which the valve was open for an event. Id. at 7:30–38.
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`Valve transceiver 120 communicates with the control module that is
`
`physically separate, but in relatively close proximity to the valve assembly,
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`via an optical wireless line-of-sight signal “during a pre-determined interval
`
`in response to a signal from the control module CPU transceiver 220.” Id. at
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`8:24–27, 10:36–48, Figs. 7–9.
`
`Control module 200, shown below in Figure 9, is ultimately
`
`responsible for delivery and regulation of a desired gas to a ventilator and
`
`patient, and requests data from valve assembly circuit 150 at pre-determined
`
`intervals to facilitate the appropriate gas delivery to the patient. Id. at 8:41–
`
`57, 9:62–10:4.
`
`
`2 Timer component is apparently mislabeled as 134, and recited in the
`specification as reference number 124.
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`6
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`

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`IPR2015-00891
`Patent 8,573,210 B2
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`Figure 9 illustrates gas source 50 and valve assembly 100 in
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`communication with control module 200 via a transceiver mounted on cover
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`
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`portion 225.
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`B. Illustrative Claim
`
`Of the challenged claims, claim 1 is independent. Each of dependent
`
`claims 2–11 relate expressly to a nitric oxide delivery device and depend
`
`directly or indirectly from claim 1. Claims 12–16 are method claims that
`
`depend directly or indirectly from the delivery device recited in claims 1 and
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`6. Claim 1 illustrates the claimed subject matter and is reproduced below:
`
`
`
`1. A nitric oxide delivery device comprising:
`a control module to deliver a gas comprising NO to
`a patient in an amount effective to treat or prevent hypoxic
`respiratory failure; and
`
`7
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`

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`IPR2015-00891
`Patent 8,573,210 B2
`
`a valve assembly to deliver the gas comprising NO
`from a gas container containing the gas comprising NO to
`the control module, the valve assembly comprising:
`a valve attachable to the gas container
`containing the gas comprising NO, the valve
`including an
`inlet and an outlet
`in
`fluid
`communication and a valve actuator to open or
`close the valve to allow the gas comprising
`NO through the valve to the control module; and
`a circuit supported within the valve assembly
`and disposed between the actuator and a cap, the
`circuit including:
`a valve memory to store gas data
`comprising one or more of gas identification,
`gas expiration date and gas concentration in
`the gas container and
`a valve processor and a valve
`transceiver in communication with the valve
`memory to send and receive wireless optical
`line-of-sight signals to communicate the gas
`data to the control module and to verify one
`or more of the correct gas, the correct gas
`concentration and that the gas is not expired.
`
`
`C. The Asserted Grounds of Unpatentability
`
`We instituted a trial on Praxair’s challenges to claims 1–16 of the ’210
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`patent as obvious under 35 U.S.C. § 103 over the combination of the
`
`references listed below and as further supported by the Declaration of Dr.
`
`Robert T. Stone (Ex. 1002).
`
`8
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`

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`IPR2015-00891
`Patent 8,573,210 B2
`
`References
`
`Bathe3, Peters4, FR ’8045, INOMAX label6, and
`IR Standard7
`Bathe, Peters, FR ’804, INOMAX label, IR
`Standard, and Lebel ’5338
`Bathe, Peters, FR ’804, INOMAX label, IR
`Standard, and Durkan ’3989
`
`
`Basis Claims
`Challenged
`§ 103 1–9, and 12–16
`
`§ 103 4–5
`
`§ 103 10–11
`
`II.
`
`CLAIM CONSTRUCTION
`
`Neither party proposes express constructions for any term. See Pet.
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`8–9; PO Resp. 7. We maintain our earlier determination that no term
`
`requires express construction. Inst. Dec. 8.
`
`III. OBVIOUSNESS OVER BATHE, PETERS, FR ’804, INOMAX
`LABEL, THE IR STANDARD, AND LEBEL OR DURKAN
`
`Praxair asserts that claims 1–9 and 12–16 would have been obvious
`
`over Bathe, Peters, FR ’804, INOMAX Label and the IR Standard and
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`Bathe, Peters, FR ’804, INOMAX Label, the IR Standard, and either Lebel
`
`or Durkan for claims 4–5 and 10–11 respectively. Pet. 9–10. A patent is
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`invalid for obviousness:
`
`if the differences between the subject matter sought to be
`patented and the prior art are such that the subject matter as a
`whole would have been obvious at the time the invention was
`
`
`3 Ex. 1005, U.S. Patent No. 5,558,083 (Sept. 24, 1996)
`4 Ex. 1004, U.S. Patent No. 7,114,510 B2 (Oct. 3, 2006)
`5 Ex. 1006, FR Pub. No.: 2 917 804 (Dec. 26, 2008)
`6 Ex. 1014, FINAL PRINTED LABELING, CENTER FOR DRUG EVALUATION AND
`RESEARCH, Appl’n. No.: NDA 20845 (2000).
`7 Ex. 1007, Health informatics — Point-of-care medical device
`communication — Part 30300: Transport profile — Infrared wireless,
`ISO/IEEE 11073–30300 (2004)
`8 Ex. 1008, U.S. Patent No. 6,811,533 B2 (Nov. 2, 2004).
`9 Ex. 1010, U.S. Patent No. 4,462,398 (July 31, 1984).
`
`9
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`IPR2015-00891
`Patent 8,573,210 B2
`
`made to a person having ordinary skill in the art to which said
`subject matter pertains.
`
`35 U.S.C. § 103. Obviousness is a question of law based on underlying
`
`factual findings: (1) the scope and content of the prior art; (2) the differences
`
`between the claims and the prior art; (3) the level of ordinary skill in the art;
`
`and (4) objective indicia of nonobviousness. See Graham v. John Deere Co.
`
`of Kansas City, 383 U.S. 1, 17–18 (1966). As the party challenging the
`
`patentability of the claims at issue, Praxair bears the burden of proving
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`obviousness by a preponderance of the evidence. See 35 U.S.C. § 316(e).
`
`We instituted trial on claims 1–16 based on Praxair’s arguments and
`
`accorded some weight initially to the testimony of Dr. Stone with respect to
`
`a motivation to combine based on asserted safety considerations in NO
`
`delivery systems. See Inst. Dec. 18–20. Now, after considering the
`
`evidence and arguments of counsel fully developed on the record before us,
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`for the reasons set forth below, we determine that Praxair has not met its
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`burden of showing that claims 1–16 are unpatentable by a preponderance of
`
`the evidence.
`
`A. Scope and Content of the Prior Art
`
`Praxair relies on the combination of Bathe, Peters, FR ’804, the IR
`
`Standard, the INOMAX Label, and either Lebel or Durkan as obviousness
`
`references. We discuss each reference below.
`
`1.
`
`Bathe
`
`Bathe discloses a nitric oxide (NO) delivery system for use with a
`
`medical ventilation device. Ex. 1005, 1:1–11. Figure 1 of Bathe is
`
`reproduced below.
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`10
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`IPR2015-00891
`Patent 8,573,210 B2
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`
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`Figure 1 is a depiction of schematic view, partially in block diagram form, of
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`apparatus in accordance with an embodiment of Bathe. Id., 3:33–35.
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`Figure 1 shows a schematic view of the Bathe system having flow
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`sensor 26 and flow transducer 46, which determine the flow of gas in the
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`system, and CPU 56 with input device 58, which provides for an operator to
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`select a desired concentration of NO to the patient. Id. at 5:60–6:4. With
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`flow and operator input information, the CPU calculates the desired flow to
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`provide the selected NO concentration and, in the feedback loop shown
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`above in Figure 1, adjusts the desired gas concentration and flow via signals
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`sent to valves 14, 18, 20, and 24. Id. at 6:5–20. Another input to CPU 56 is
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`the NO concentration in supply cylinder 10. Id. at 6:5–6. Bathe explains
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`that
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`[t]he NO sensor 65 senses the concentration of NO in the supply
`cylinder 10 so that the user can verify that the proper supply is
`being utilized or, alternatively, the CPU 56 may use that input to
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`11
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`IPR2015-00891
`Patent 8,573,210 B2
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`adjust the system to adapt for any concentrations of NO in the
`supply within certain limits.
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`Id. at 6:6–11. In other words, CPU 56 knows the NO concentration from
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`supply 10, as well as the actual flow of gas administered to the patient from
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`the delivery device by transducer 46 and gas sensing bench 52, and then
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`knowing the desired NO concentration set by the user via input 58, CPU 56
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`adjusts valves 14, 18, 20, and 24 to bring the actual gas flow and NO
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`concentration to the patient into accordance with the user’s desired input
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`level. Id. at 6:43–53.
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`2.
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`Peters
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`Peters discloses, as shown in Figure 1 below, valve 10 with “smart”
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`handle 16 having a memory module and circuit to log data such as opening
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`and closing time for the valve. Ex. 1004, Abst., 2:43–51.
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`
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`12
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`IPR2015-00891
`Patent 8,573,210 B2
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`
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`Figure 1 of Peters illustrates an exploded view of valve 10 having
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`valve body 14 supporting valve handle 16 and gas inlet port 18 for
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`connecting to and communicating with a gas cylinder (not shown). Id. at
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`1:58–60; 2:43–51. Inside handle 16 are several electronic devices, namely,
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`processor 23, timer 21, memory 22 and data port 22’, sensor 28, battery 25
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`and display 26. Id. at 2:58–64. With respect to the electronics, the ’510
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`patent explains that memory configuration is established by initial
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`parameters such as:
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`Born on date (date when cylinder was filled)[;]
`Cylinder serial number[;]
`Gas lot number[;]
`Set the timers (which may include a calendar timer and an event
`timer) [;] and
`Clear the log registers[.]
`
`Id. at 5:43–53; see also id. at 5:54–56 (“Additional area may be available for
`
`recording specific notes or information relative to a specific treatment or
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`lot.”). When gas is dispensed through valve 10 during operation, sensor 28
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`prompts processor 23 to log the event, including parameters such as date,
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`time, and opening or closing of the valve and “[t]hus, as the handle 16 is
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`rotated to open the valve 10 in order to provide gas treatments to patients,
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`the memory device 22 in the handle 16 records the number and duration of
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`the treatments.” Id. at 6:21–32. Also, Peters teaches that data recorded in
`
`the memory can be downloaded using a wand reader via data port 22’ or
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`handle 16 can “include a transmitter to transmit the data to a remote
`
`recording device at intervals or on command, as desired.” Id. at 6:47– 7:4.
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`13
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`IPR2015-00891
`Patent 8,573,210 B2
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`3.
`
`FR ’804
`
`FR ’804 relates to a connection system for a valve to a gas bottle or
`
`cylinder. Ex. 1006, 1.10 The described connection system includes a
`
`mechanism whereby valve “opening may take place only if the type of gas
`
`contained in the bottle 10 corresponds to the type of gas intended to supply
`
`the circuit 1 used through the valve 20, so as to avoid any risk of error in the
`
`connection of the bottle to the valve.” Id. at 3. Observing Figure 1 of FR
`
`’804 as reproduced below, control module 300 communicating with valve 20
`
`receives input signal IDb, the identification of gas type being supplied from
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`the bottle 10, and compares this with input data IDv, the desired type of gas
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`for the procedure that is stored in memory 200. Id. at 3.
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`
`
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`10 We refer to the top numbered pages of the English translation of FR ’804.
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`14
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`IPR2015-00891
`Patent 8,573,210 B2
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`Figure 1 of FR ’804 is a block diagram illustrative of control module 300 for
`
`controlling valve 20. Once IDb and IDv are input to control module 300, FR
`
`’804 explains that “the control module 300 comprises means 310 for
`
`comparing the identification data IDb and IDv and means 320 for
`
`transmitting a control signal to the valve 20, capable of emitting a signal for
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`opening the valve in case of a positive comparison.” Id. at 3.
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`In another embodiment, FR ’804 also discloses that the type of gas
`
`(IDb) in bottle 10 can be input from information carrier 120, such as an
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`RFID tag on bottle 10, that is read by sensor 110 connected to control
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`module 300 when valve 20 and bottle 10 are connected. Id. at 4, Fig. 2.
`
`4.
`
`The IR Standard
`
`The IR Standard is a protocol promulgated by the Institute of
`
`Electrical and Electronics Engineers (IEEE) as an international standard for
`
`short-range infrared wireless communication for medical devices used at or
`
`near a patient. Ex. 1007, Abstract (ii). The IR Standard purports to describe
`
`wireless communication standards to “[f]acilitate the efficient exchange of
`
`vital signs and medical device data, acquired at the point-of-care, in all
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`health care environments.” Id. at vi. This reference further explains that
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`such “standards are especially targeted at acute and continuing care devices,
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`such as patient monitors, ventilators, infusion pumps, ECG devices, etc.” Id.
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`The IR Standard further illustrates an IR communication system including
`
`an IR transceiver in order to retrofit a previously hard wired cable-
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`communicating system. Id. at 39–40.
`
`5.
`
`INOMAX Label
`
`The INOMAX label reference is a U.S. Food and Drug
`
`Administration (FDA) publication approving labeling for Patent Owner’s
`
`INOmax drug generally used in conjunction with NO therapies for newborns
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`15
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`IPR2015-00891
`Patent 8,573,210 B2
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`with hypoxic respiratory failure. Ex. 1014, 2. The INOMAX label also
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`indicates that the drug was used with ventilators administering NO to
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`neonatal patients. Id. at 6. The INOMAX label provides guidance and
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`monitoring protocols and states that
`
`[t]he nitric oxide delivery systems used in the clinical trials
`provided operator-determined concentrations of nitric oxide in
`the breathing gas, and the concentration was constant throughout
`the respiratory cycle. . . . In the ventilated neonate, precise
`monitoring of inspired nitric oxide and N02 should be instituted,
`using a properly calibrated analysis device with alarms. This
`system should be calibrated using a precisely defined calibration
`mixture of nitric oxide and nitrogen dioxide, such as INOcal™ .
`Sample gas for analysis should be drawn before the Y-piece,
`proximal to the patient. Oxygen levels should also be measured.
`
`Id. The INOMAX label indicates that the INOmax™ drug is supplied in
`
`aluminum cylinders. Id.
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`6.
`
`Lebel
`
`Lebel discloses a protocol for an RF telemetry communication system
`
`for medical devices. Ex. 1008, Abst. More specifically, Lebel teaches
`
`optimizing power consumption in communication devices for instance
`
`between a surgically implanted device in a human body, such as an insulin
`
`pump, and an external control or monitoring device by sending
`
`communications intermittently to conserve battery power. Id. at 2:18–35.
`
`Lebel states that the time between communications can occur for example
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`“no more than 15 seconds apart, more preferably no more than 10 seconds
`
`apart, and even more preferably no more than 5 seconds apart, and most
`
`preferably no more than about 2 seconds apart.” Id. at 25:5–9. Lebel further
`
`explains that power conservation in such medical devices is a balance in
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`which “desire to minimize power drain in the implantable device is balanced
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`with a desire to have the implantable device respond quickly to commands
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`transmitted by the external communication device.” Id. at 25:60–63.
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`7.
`
`Durkan
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`Durkan discloses a gas supply apparatus and method for providing
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`respirating gas to a medical patient. Ex. 1010, 1:6–8. Particularly, Durkan
`
`discloses a gas delivery system having a circuit 100 (Figure 5) including a
`
`visual signal such as an illuminated LED 92 that provides visual
`
`confirmation that a valve is in a position such that a gas pulse is being
`
`supplied. Id. at 11:43–46. When the valve is in a position that gas is not
`
`being supplied, the LED will likewise not be illuminated. Id. at 47–51, Fig.
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`5. Durkan further discloses a dual gas supply for its respiratory system and
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`that the control means disclosed in Figure 5, including alarm circuit 100, can
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`be used with the dual gas supply embodiment to indicate by illuminating
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`LED 92 when both gas supply valves are open and supplying gas to the
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`system. Id. at 7:29–54, 13:57–65, 14:8–12.
`
`B. The Level of Ordinary Skill in the Art
`
`Praxair asserts that a person of ordinary skill in the art would have had
`
`“a bachelor’s degree in electrical engineering, computer science, computer
`
`engineering, or the equivalent, and would have had at least two years’
`
`experience in biomedical engineering designing medical gas delivery or
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`monitoring systems.” Pet. 8 (citing Ex. 1002 ¶¶ 17–18). INO does not
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`expressly dispute the general level of skill in the art proffered by Praxair but
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`adds through its declarant, Mr. Warren P. Heim, that one of skill in the art
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`would “know Food and Drug Administration (FDA) Current Good
`
`Manufacturing Practices.” Ex. 2021 ¶ 107.
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`
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`17
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`IPR2015-00891
`Patent 8,573,210 B2
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`C. Claims 1–16 over Bathe, Peters, FR ’804, the INOMAX Label, the IR
`Standard and either Label or Durkin
`
`1. Whether One of Ordinary Skill in the Art Would Have Combined
`and/or Modified the Prior Art to Achieve the Claimed Invention
`
`INO asserts that Praxair “has failed to meet its burden of proving that
`
`a POSA would have been motivated to combine the cited prior art references
`
`in the precise manner the claims require.” PO Resp. 38. INO argues that (1)
`
`a person of ordinary skill in the art was unaware of the problem solved by
`
`the ’209 patent; (2) a person of ordinary skill in the art would not have
`
`combined Bathe and Peters; (3) a person of ordinary skill in the art would
`
`not have combined Bathe and Peters with FR ’804; and (4) nothing in the IR
`
`Standard, Lebel, Durkan or INOMAX Label cures the improper asserted
`
`combination of Bathe, Peters, and FR ’804. Id. at 39–55.
`
`INO’s first argument is not persuasive because the evidence indicates
`
`that a person of ordinary skill in the art would have been aware that there
`
`was a risk to providing a patient with the incorrect gas or gas concentration.
`
`For example, the ’210 patent states in the Background section that
`
`[g]as delivery devices are often utilized by hospitals to deliver
`the necessary gas to patients in need. It is important when
`administering gas therapy to these patients to verify the correct
`type of gas and the correct concentration are being used. It is
`also important to verify dosage information and administration.
`
`Ex 1001, 1:22–27 (emphasis added). Bathe also discloses in the Background
`
`of the Invention that it was critical to control the concentration of gas to a
`
`patient:
`
`There is, of course, a need for that concentration to be precisely
`metered to the patient since an excess of NO can be harmful to
`the patient.
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`18
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`IPR2015-00891
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`Ex. 1005, 1:37–39. The Federal Drug Administration (“FDA”) also
`
`recognized the problem of administering incorrect gas, for example, FDA
`
`guidance as of January 24, 2000 promulgated
`
`use of a standard gas-specific fitting (as well as the use of nitric
`oxide gas analyzer) will control the risk of incorrect drug
`administration resulting from use of the incorrect compressed
`gas.
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`Ex. 1012, 8, § 3.1.1.i. Based on this evidence, we find that the broad
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`problem of verifying gas concentration was known to those of ordinary skill
`
`in the art. INO cites to Novartis Pharm. Corp. v. Watson Labs., Inc., 611
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`Fed. App’x. 988, 995 (Fed. Cir. 2015) in support of its position. PO Resp.
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`40. Novartis is distinguishable because in that case the patent owner solved
`
`an entirely unknown problem, not a previously solved problem. Novartis,
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`611 Fed. App’x. 988, 997 (The Federal Circuit upholding the district court’s
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`conclusion of non-obviousness, in part, because of the finding that
`
`“rivastigmine was not known to be susceptible to oxidative degradation.”).
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`INO’s argument is more properly stated as: the problem of
`
`verification of supplying the correct gas to a patient had already been
`
`solved. Therefore, as FDA approval could be obtained based on the current
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`state of the art, there was no incentive or motivation to find a different way.
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`PO Resp. 40–41. We are persuaded that such an argument is directed not to
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`a brand new and novel problem solved by INO, but instead, as discussed
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`below, supports INO’s position that Praxair has failed to present persuasive
`
`reasons with rational underpinnings supporting the combination of prior art
`
`references.
`
`After reviewing the record in total, the arguments and evidence
`
`presented by both parties and the prior art itself, we find that Praxair has not
`
`shown a sufficient reason for a person of ordinary skill in the art to have
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`made the proposed combination of Bathe, Peters, FR ’804, the INOMAX
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`Label, and the IR Standard. PO Resp. 36–53. INO points out, correctly, that
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`Praxair has not shown that a person of ordinary skill in the art would have
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`been motivated to combine Peters’s smart valve having a memory for
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`compiling data for billing and invoicing functions, with Bathe. Id.
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`Moreover, we are not persuaded that Praxair’s inability to provide sufficient
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`motivation for combining Peters and Bathe is remedied by the introduction
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`of FR ’804 and the INOMAX Label, particularly given that Bathe already
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`included an in-line sensing unit to sense and verify the gas concentration
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`from the cylinder as mandated by FDA guidance. Id. at 46–47, see also Pet.
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`Reply 11–12.
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`Bathe teaches a gas cylinder supplying NO gas to a gas delivery
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`system and has in-line sensor 65 to detect NO concentration in the delivery
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`system prior to delivery to a patient. Ex. 1005, 6:5–11. Peters’s smart valve
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`with a memory, teaches delivering data such as on/off times for the valve, to
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`a hand-held or laptop computer for compiling usage and billing reports.
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`Ex. 1004, 6:17–57. Praxair argues that motivation to combine the references
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`springs from the contention that Peters’s valve “can control ‘the flow of gas
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`from the cylinder 12 to a ventilator or other gas dispensing device,’ such as
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`the gas delivery system of [Bathe].” Pet. 20 (citing Ex. 1004, 2:52–55).
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`Making a similar assertion, Praxair’s expert Dr. Stone, states that Peters’s
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`“valve assembly for gas delivery [] could easily be incorporated into the
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`delivery system described in [Bathe] by installing [Peters] valve on the
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`cylinder of [Bathe].11 Ex. 1002 ¶ 107. INO correctly points out that this
`
`
`11 For the purpose of consistency in our Decision we have replaced
`Petitioner’s quoted use of “the ’083 patent” with the first named inventor
`“[Bathe],” and similarly replaced “the ’510 patent” with “[Peters].”
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`argument and testimony that Peters’s valve could work on Bathe’s cylinder
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`does not explain why or how a person of skill in the art would combine
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`Bathe and Peters, only that they could. PO Resp. 43–44. That Bathe could
`
`be modified by simply placing Peters’s valve on the cylinder to control gas
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`flow from the cylinder, does not, alone, satisfy the requirements for
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`combining the prior art. See InTouch Techs., Inc. v. VGO Commc’ns, Inc.,
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`751 F.3d 1327, 1352 (Fed. Cir. 2014) (Experts “testimony primarily
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`consisted of conclusory references to her belief that one of ordinary skill in
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`the art could combine these references, not that they would have been
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`motivated to do so.”).
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`Petitioner’s challenge lacks an adequate motivation, not only to
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`incorporate the smart valve of Peters into Bathe, but also to: (1) repurpose
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`the incorporated valve by using (a) its “memory to store gas data comprising
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`one or more of gas identification, gas expiration date and gas concentration”
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`and (b) its processor and transmitter “to send and receive wireless optical
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`line-of-sight signals to communicate the gas data to the control module that
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`controls gas delivery to a subject” and (2) modify the Bathe system, such
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`that its CPU would receive the wirelessly transmitted gas concentration data,
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`even though the CPU already receives (and uses) flow and operator input
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`data to provide a desired NO concentration. See Ex. 1005, 6:5–20.
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`2. Whether the Combination of Prior Art References is Supported by
`Articulated Reasoning and Evidentiary Underpinning
`
`The Supreme Court requires an expansive and flexible approach in
`
`determining whether a patented invention would have been obvious at the
`
`time it was made. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415
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`(2007). The existence of a reason for a person of ordinary skill in the art to
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`modify a prior art reference is a question of fact. See In re Constr. Equip.
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`Co., 665 F.3d 1254, 1255 (Fed. Cir. 2011). In an obviousness analysis, some
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`kind of reason must be shown as to why a person of ordinary skill would
`
`have thought of combining or modifying the prior art to achieve the patented
`
`invention. See Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374
`
`(Fed. Cir. 2008). A reason to combine or modify the prior art may be found
`
`explicitly or implicitly in market forces; design incentives; the “‘interrelated
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`teachings of multiple patents’”; “‘any need or problem known in the field of
`
`endeavor at the time of invention and addressed by the patent’”; and “the
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`background knowledge, creativity, and common sense of the person of
`
`ordinary skill.” Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324,
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`1328–29 (Fed. Cir. 2009) (quoting KSR, 550 U.S. at 418–21).
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`The closest Praxair comes to providing a reason that one of ordinary
`
`skill in the art would have been motivated to combine these references is that
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`doing so allegedly would “allow the user to better link the gas information
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`with patient treatments.” Pet. 22. This assertion however, leaves several
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`unanswered questions in its wake. First, it is unexplained why a direct
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`“link” between the cylinder gas information and patient treatment control
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`module would have been perceived as necessary or better based on any
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`express or even implicit teachings of either Bathe or Peters or the knowledge
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`of a person of ordinary skill. Second, Praxair fails to explain why or a how a
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`person of ordinary skill in the art would have “linked” Peters’s data to
`
`patient treatments, as Peters only communicates certain data, such as valve
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`opening and closing times, to a computer for billing and invoicing purposes,
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`and neither Peters’s communicated data nor computer is used to determine
`
`any physiological aspect of patient treatment. See Ex. 1004 5:43–6:15.
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`(“The hospital or other user, as well as the distributor, may later download
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`the data from the memory device 22 to be used for record keeping and
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`billing.”).
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`Dr. Stone further opines that “[a] person of skill in the art would have
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`read [Bathe] and been motivated to apply subsequent improvements to
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`component parts of that system, such as the improved valve of [Peters].”
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`Ex. 1002 at ¶ 112 (citing Ex. 1005, 6:11–15). Dr. Stone does not, however,
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`point to any persuasive evidence or disclosure in Bathe, or provide sufficient
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`explanation or reasoning to support this statement. See id. In particular, Dr.
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`Stone does not describe what the “improvements” would have been