Trials@uspto.gov
`571-272-7822
`
`
`
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` Paper 54
` Entered: September 15, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`PRAXAIR DISTRIBUTION, INC.,
`Petitioner,
`
`v.
`
`INO THERAPEUTICS, LLC,
`Patent Owner.
`____________
`
`Case IPR2015-00889
`Patent 8,573,209 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)
`
`
`
`571-272-7822
`
`
`
`
` Paper 54
` Entered: September 15, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`PRAXAIR DISTRIBUTION, INC.,
`Petitioner,
`
`v.
`
`INO THERAPEUTICS, LLC,
`Patent Owner.
`____________
`
`Case IPR2015-00889
`Patent 8,573,209 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)
`
`
`
`
`IPR2015-00889
`Patent 8,573,209 B2
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`
`
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`Praxair Distribution, Inc. (“Praxair”) filed a Petition to institute an
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`inter partes review of claims 1–7 of U.S. Patent No. 8,573,209 B2 (Ex.
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`1001, “the ’209 patent”). Paper 1 (“Pet.”).1 We instituted trial for claims 1–
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`7 of the ’209 patent on certain grounds of unpatentability asserted in the
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`Petition. Paper 14 (“Decision to Institute” or “Inst. Dec.”). After institution
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`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
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`a Reply. Paper 40 (“Reply”).
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`A consolidated hearing for this proceeding as well as IPR2015-00884,
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`IPR2015-00888, IPR2015-00891, and IPR2015-00893, each involving
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`Praxair and INO but different patents, was held on May 16, 2016. The
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`transcript of the consolidated hearing has been entered into the record.
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`Paper 53 (“Tr.”).
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`Also before the Board is INO’s Motion to Exclude Evidence (Paper
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`44), Praxair’s Opposition to the same (Paper 48), and INO’s Reply (Paper
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`49).
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`After considering the evidence and arguments of counsel and for the
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`reasons set forth below, we determine that Praxair has not met its burden of
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`showing that claims 1–7 of the ’209 patent are unpatentable. We dismiss
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`INO’s Motion to Exclude as moot.
`
`
`
`
`1 The ’209 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.
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`2
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`IPR2015-00889
`Patent 8,573,209 B2
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`I. BACKGROUND
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`A. The ’209 Patent (Ex. 1001)
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`The ’209 patent (Ex. 1001), titled “Gas Delivery Device and System,”
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`relates generally to a gas delivery system, and a method for administering
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`therapy gas, such as nitric oxide (NO), to a medical patient. Ex. 1001, (54),
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`1:5–17, Fig. 1. The gas delivery system includes valve assembly 100 having
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`valve 107 shown below in wireless communication with control module 200.
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`Id. at 4:65–67, Fig. 1.
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`Patent 8,573,209 B2
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`Figure 1 of the ’209 patent, above, depicts a diagrammatic
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`representation of a gas delivery system for administering therapy gas from
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`gas source 50 (i.e., a tank to which the valve assembly is mounted) through
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`valve 107 and via control module 200 to a patient. Id. at 5:41–63. In the
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`delivery system, administration of therapy gas to the patient is regulated by
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`control module 200 to a medical device for introducing gas to the patient
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`(e.g., ventilator 400, nasal cannula, endotracheal tube, face mask, etc.). Id.
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`Gas is initially supplied to control module 200 from gas source via valve
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`assembly 100 by opening valve 107.
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`Valve assembly 100 is shown in greater detail in Figures 2 and 3
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`reproduced below.
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`Figure 2 depicts valve assembly 100 and actuator 114, a rotatable
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`knob or handle, for opening and closing valve 107 that is connected between
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`gas source 50 and control module 200. Figure 3 illustrates an exploded view
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`of actuator 114. As best observed in Figure 3 above, the valve assembly
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`includes circuit 150 disposed in actuator 114. Id. at 5:64–66. The circuit
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`communicates with the control module, for example via a wired or wireless
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`link, by valve transceiver 120. Id. at 5:64–6:6.
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`Illustrated by Figure 4 of the ’209 patent, below, is a block diagram of
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`circuit 150.
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`
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`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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`130, and valve display 132.2
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`The primary purpose of circuit 150 and valve processor 122 is not to
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`open or close the valve, but to communicate to control module 200 gas data,
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`specifically gas identification, gas expiration date, and gas concentration.
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`2 In Figure 4, timer component apparently is mislabeled as 134, and recited
`in the specification as reference number 124.
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`5
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`IPR2015-00889
`Patent 8,573,209 B2
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`Id. at 2:11–15. The ’209 patent states that this is important from a safety
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`perspective “to ensure that patient information contained within the
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`computerized system matches the gas that is to be delivered by the gas
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`delivery device.” Id. at 1:30–32. 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 6:53–61. The valve memory may also
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`store valve opening and closing times of the valve using timer 134 and
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`sensor 126. Id. at 2:51–60.
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`Valve display 132 allows a user, via window 113 on actuator 114, to
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`view information regarding valve operation such as open or close, as
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`monitored by open/close sensor 126, and the time duration which the valve
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`was open for an event. Id. at 7:11–19. Valve transceiver 120 communicates
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`with the control module that is physically separate, but in relatively close
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`proximity to the valve assembly, via an optical wireless line-of-sight signal
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`“during a pre-determined interval in response to a signal from the control
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`module CPU transceiver 220.” Id. at 8:7–8, Figs. 7–9.
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`Figure 9 of the ’209 patent, below, depicts control module 200
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`mounted on a cart in close proximity to the valve 100.
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`Patent 8,573,209 B2
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`Figure 9 illustrates gas source 50 and valve assembly 100 in wireless
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`line-of-sight communication 300 with control module 200 via a transceiver
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`
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`mounted on cover portion 225.
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`B. Illustrative Claim
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`Praxair challenges claims 1–7. Claims 1, 3, 5, and 6 are independent,
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`and each of claims 2, 4, and 7 depends from its immediately preceding
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`independent claim. Claim 1 illustrates the claimed subject matter and is
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`reproduced below:
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`1. A gas delivery device to administer therapy gas from
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`a gas source, the gas delivery device comprising:
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`a valve attachable to the gas source, the valve including
`an inlet and an outlet in fluid communication and a
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`7
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`Patent 8,573,209 B2
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`valve actuator to open or close the valve to allow the
`gas through the valve to a control module; and
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`a circuit including:
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`memory to store gas data comprising one or more of gas
`identification, gas expiration date and gas
`concentration and
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`a processor and a transceiver in communication with the
`memory to send and receive wireless optical line-of(cid:173)
`sight signals to communicate the gas data to the
`control module that controls gas delivery to a subject
`and to verify one or more of the correct gas, the
`correct gas concentration and that the gas is not
`expired,
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`wherein the valve further comprises a data input in
`communication with said memory, to permit a user to
`enter the gas data into the memory.
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`C. The Asserted Grounds of Unpatentability
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`We instituted a trial on Praxair’s challenges to claims 1–7 of the ’209
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`patent as obvious under 35 U.S.C. § 103 over the combination of the
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`references listed below and as further supported by the declaration of Dr.
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`Robert T. Stone (Ex. 1002).
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`References
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`Bathe,3 Peters,4 FR ’804,5 and the IR
`Standard6
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`Basis Claims
`Challenged
`§ 103 1–7
`
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`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. 1007, Health informatics — Point-of-care medical device
`communication — Part 30300: Transport profile — Infrared wireless,
`ISO/IEEE 11073-30300 (2004).
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`8
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`References
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`Bathe, Peters, FR ’804, the IR Standard, and
`Lebel7
`
`
`Basis Claims
`Challenged
`§ 103 3 and 4
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`II. CLAIM CONSTRUCTION
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`In our Decision to Institute we determined that “input means to enter
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`patient information into the CPU memory” includes a keyboard integrated
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`with a display, as shown and described in the ’209 patent, and alternatively,
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`a USB or other port for connection of an external keyboard or other input
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`mechanism, and their equivalents. Inst. Dec. 9. Neither party disputes this
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`construction or proposes express constructions for any other term. See Pet.
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`10; PO Resp. 10. We maintain our earlier construction of “input means to
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`enter patient information into the CPU memory” and determine that no other
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`term requires express construction.
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`
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`III. OBVIOUSNESS OVER BATHE, PETERS, FR ’804, AND
`THE IR STANDARD
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`Praxair asserts that claims 1–7 would have been obvious over Bathe,
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`Peters, FR ’804, and the IR Standard. Pet. 12. A patent is invalid for
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`obviousness:
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`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
`made to a person having ordinary skill in the art to which said
`subject matter pertains.
`
`
`7 Ex. 1008, U.S. Patent No. 6,811,533 B2 (Nov. 2, 2004).
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`35 U.S.C. § 103. Obviousness is a question of law based on underlying
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`factual findings: (1) the scope and content of the prior art; (2) the
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`differences between the claims and the prior art; (3) the level of ordinary
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`skill in the art; and (4) objective indicia of nonobviousness. See Graham v.
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`John Deere Co. of Kansas City, 383 U.S. 1, 17–18 (1966). As the party
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`challenging the patentability of the claims at issue, Praxair bears the burden
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`of proving obviousness by a preponderance of the evidence. See 35 U.S.C.
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`§ 316(e).
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`We instituted trial on claims 1–7 based on Praxair’s arguments and
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`accorded some weight initially to the testimony of Dr. Stone with respect to
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`a motivation to combine based on asserted safety considerations in NO
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`delivery systems. See Inst. Dec. 18–20. Now, after considering the
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`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 1–7 are unpatentable by a preponderance of
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`the evidence.
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`A. Scope and Content of the Prior Art
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`Praxair relies on the combination of Bathe, Peters, FR ’804, and the
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`IR Standard as obviousness references. We discuss each reference below.
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`1.
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`Bathe
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`Bathe discloses a nitric oxide (NO) delivery system for use with a
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`medical ventilation device. Ex. 1005, 1:1–11.
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`Figure 1 of Bathe is reproduced below.
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`10
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`Patent 8,573,209 B2
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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 from 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 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 cylinder 10, as well as the actual flow of gas administered to the
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`patient from the delivery device by transducer 46 and gas sensing bench 52,
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`and then knowing the desired NO concentration set by the user via input 58,
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`CPU 56 adjusts valves 14, 18, 20, and 24 to bring the actual gas flow and
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`NO 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 times for the valve. Ex. 1004, Abstract, 2:43–51.
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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). Inside
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`handle 16 are several electronic devices, namely, processor 23, timer 21,
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`memory 22 and data port 22’, sensor 28, battery 25, and display 26. Id. at
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`2:58–64. With respect to the electronics, the ’510 patent explains that
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`memory configuration is established by initial 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[.]
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`Id. at 5:48–53; see also id. at 5:54–56 (“Additional area may be available for
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`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
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`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
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`recording device at intervals or on command, as desired.” Id. at 6:47–7:4.
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`13
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`3.
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`FR ’804
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`FR ’804 relates to a connection system for a valve to a gas bottle or
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`cylinder. Ex. 1006, 1.8 The described connection system includes a
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`mechanism whereby valve “opening may take place only if the type of gas
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`contained in the bottle 10 corresponds to the type of gas intended to supply
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`the circuit 1 used through the valve 20, so as to avoid any risk of error in the
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`connection of the bottle to the valve.” Id. at 3. Observing Figure 1 of FR
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`’804 as reproduced below, control module 300 communicating with valve 20
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`receives input signal IDb, which is the identification of gas type being
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`supplied from the bottle 10, and compares this with input data IDv, which is
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`the desired type of gas for the procedure that is stored in memory 200. Id.
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`8 We refer to the top numbered pages of the English translation of FR ’804.
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`Figure 1 of FR ’804 is a block diagram illustrative of control module 300 for
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`controlling valve 20. Once IDb and IDv are input to control module 300, FR
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`’804 explains that “the control module 300 comprises means 310 for
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`comparing the identification data IDb and IDv and means 320 for
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`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.
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`In another embodiment, FR ’804 also discloses that the type of gas
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`(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.
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`4.
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`The IR Standard
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`The IR Standard is a protocol promulgated by the Institute of
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`Electrical and Electronics Engineers (IEEE) as an international standard for
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`short-range infrared wireless communication for medical devices used at or
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`near a patient. Ex. 1007, Abstract (ii). The IR Standard purports to describe
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`wireless communication standards to “[f]acilitate the efficient exchange of
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`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
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`an IR transceiver in order to retrofit a previously hard wired cable-
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`communicating system. Id. at 39–40.
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`B. The Level of Ordinary Skill in the Art
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`Praxair asserts that a person of ordinary skill in the art would have had
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`“a bachelor’s degree in electrical engineering, computer science, computer
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`engineering, or the equivalent, and would have had at least two years’
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`experience in biomedical engineering designing medical gas delivery or
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`monitoring systems.” Pet. 9–10 (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
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`Manufacturing Practices.” Ex. 2021 ¶ 107.
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`C. Independent claims 1, 3, 5, and 6 over Bathe, Peters, FR ’804 and
`the IR Standard
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`1. Whether One of Ordinary Skill in the Art Would Have Combined
`and/or Modified the Prior Art to Achieve the Claimed Invention
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`Because each of the independent claims at issue includes a similar
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`limitation relating to the valve having a circuit and memory for storage and
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`communication of gas data to the control module and verification of the
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`correct gas, gas concentration, and gas expiration, we address the
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`independent claims together.9
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`INO asserts that Praxair “has failed to meet its burden of proving that
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`a POSA would have been motivated to combine the cited prior art references
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`in the precise manner the claims require.” PO Resp. 37. INO argues that (1)
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`a person of ordinary skill in the art was unaware of the problem solved by
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`the ’209 patent; (2) a person of ordinary skill in the art would not have
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`combined Bathe and Peters; (3) a person of ordinary skill in the art would
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`not have combined Bathe and Peters with FR ’804; and (4) a person of
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`9 Claims 1 and 3 recite that the control module “controls gas delivery to a
`subject,” whereas claims 5 and 6 do not. Ex. 1001, 16:35, 16:58. We do not
`find, and Petitioner does not argue, that the lack of this language in claims 5
`and 6 changes the substantive obviousness analysis of those claims.
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`ordinary skill in the art would not have combined Bathe and Peters, FR ’804
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`and the IR Standard. Id. at 36–59.
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`INO’s first argument is not persuasive because the evidence indicates
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`that a person of ordinary skill in the art would have been aware that there
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`was a risk to providing a patient with the incorrect gas or gas concentration.
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`For example, the ’209 patent states in the Background section that
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`[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.
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`Ex 1001, 1:12–17 (emphasis added). Bathe also discloses in the Background
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`of the Invention that it was critical to control the concentration of gas to a
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`patient:
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`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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`Ex. 1005, 1:37–39. The Federal Drug Administration, (“FDA”), also
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`recognized the problem of administering incorrect gas. For example, FDA
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`guidance as of January 24, 2000 promulgated
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`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
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`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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`38–39. Novartis is distinguishable because in that case the patent owner
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`solved an entirely unknown problem, not a previously solved problem.
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`Novartis, 611 Fed. App’x. at 997 (upholding the district court’s finding of
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`non-obviousness, in part, because “rivastigmine was not known to be
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`susceptible to oxidative degradation”).
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`INO’s argument is more properly stated as: the problem of
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`verification of supplying the correct gas to a patient had already been
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`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. 39. We are persuaded that this argument, articulated properly, is
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`directed not to a brand new and novel problem solved by INO, but instead,
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`as discussed below, supports INO’s position that Praxair has failed to
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`present persuasive reasons with rational underpinning supporting the
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`combination of prior art references.
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`After reviewing the record in total, the arguments and evidence
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`presented by both parties and the prior art itself, we find that Praxair has not
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`shown a sufficient reason for a person of ordinary skill in the art to have
`
`made the proposed combination of Bathe, Peters, FR ’804, and the IR
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`Standard. PO Resp. 36–53. INO points out, correctly, that Praxair has not
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`shown that a person of ordinary skill in the art would have been motivated to
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`combine Peters’s smart valve, having a memory for compiling data for
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`billing and invoicing functions, with Bathe. Id. Moreover, we are not
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`persuaded that Praxair’s inability to provide sufficient motivation for
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`combining Peters and Bathe is remedied by the introduction of FR ’804,
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`particularly given that Bathe already included an in-line sensing unit to sense
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`and verify the gas concentration from the cylinder as required by FDA
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`guidance. Id. at 47.
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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
`
`with a memory, teaches delivering data such as on/off times for the valve, to
`
`a hand-held or laptop computer for compiling usage and billing reports.
`
`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
`
`from the cylinder 12 to a ventilator or other gas dispensing device,’ such as
`
`the gas delivery system of [Bathe].” Pet. 22. Making a similar assertion,
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`Praxair’s expert Dr. Stone, states that Peters’s “valve assembly for gas
`
`delivery [] could easily be incorporated into the delivery system described in
`
`[Bathe] by installing [Peters’s] valve on the cylinder of [Bathe].”10 Ex. 1002
`
`¶ 93. INO correctly points out that this argument and testimony that Peters’
`
`valve could work on Bathe’s cylinder does not explain why or how a person
`
`of skill in the art would combine Bathe and Peters, only that they could. PO
`
`Resp. 42–43. That Bathe could be modified by simply placing Peters’s
`
`valve on the cylinder to control gas flow from the cylinder, does not, alone,
`
`satisfy the requirements for combining the prior art. See InTouch Techs.,
`
`Inc. v. VGO Commc’ns, Inc., 751 F.3d 1327, 1352 (Fed. Cir. 2014) (Expert’s
`
`“testimony primarily consisted of conclusory references to her belief that
`
`one of ordinary skill in the art could combine these references, not that they
`
`would have been motivated to do so.”).
`
`
`10 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].”
`
`19
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`IPR2015-00889
`Patent 8,573,209 B2
`
`
`Petitioner’s challenge lacks an adequate motivation, not only to
`
`incorporate the smart valve of Peters into Bathe, but also to: (1) repurpose
`
`the incorporated valve by using (a) its “memory to store gas data comprising
`
`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
`
`line-of-sight signals to communicate the gas data to the control module that
`
`controls gas delivery to a subject” and (2) modify the Bathe system, such
`
`that its CPU would receive the wirelessly transmitted gas concentration data,
`
`even though the CPU already receives (and uses) flow and operator input
`
`data to provide a desired NO concentration. See Ex. 1005, 6:5–20.
`
`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
`
`(2007). The existence of a reason for a person of ordinary skill in the art
`
`to modify a prior art reference is a question of fact. See In re Constr.
`
`Equip. Co., 665 F.3d 1254, 1255 (Fed. Cir. 2011). In an obviousness
`
`analysis, some 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 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 background knowledge, creativity, and
`
`common sense of the person of ordinary skill. Perfect Web Techs., Inc. v.
`
`20
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`
`
`IPR2015-00889
`Patent 8,573,209 B2
`
`InfoUSA, Inc., 587 F.3d 1324, 1328–29 (Fed. Cir. 2009) (quoting KSR, 550
`
`U.S. at 418–21).
`
`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
`
`doing so allegedly would “allow the user to better link the gas information
`
`with patient treatments.” Pet. 22. This assertion however, leaves several
`
`unanswered questions in its wake. First, it is unexplained why a direct
`
`“link” between the cylinder gas information and patient treatment control
`
`module would have been perceived as necessary or better based on any
`
`express or even implicit teachings of either Bathe or Peters or on the
`
`knowledge of a person of ordinary skill. Second, Praxair fails to explain
`
`why or how a 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 opening and closing times, to a computer for billing and invoicing
`
`purposes, and neither Peters’s communicated data nor computer are used to
`
`determine any physiological aspect of patient treatment. See Ex. 1004,
`
`5:43–6:15 (“The hospital or other user, as well as the distributor, may later
`
`download the data from the memory device 22 to be used for record keeping
`
`and billing.”).
`
`Dr. Stone further opines that “[a] person of skill in the art would have
`
`read [Bathe] and been motivated to apply subsequent improvements to
`
`component parts of that system, such as the improved valve of [Peters].”
`
`Ex. 1002 ¶ 96 (citing Ex. 1005, 6:11–15). Dr. Stone does not, however,
`
`point to any persuasive evidence or disclosure in Bathe, or provide sufficient
`
`explanation or reasoning to support this statement. See id. In particular, Dr.
`
`Stone does not describe what the “improvements” would have been, or
`
`21
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`
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`IPR2015-00889
`Patent 8,573,209 B2
`
`provide sufficient rationale as to why Bathe, which already has a connection
`
`between a supply cylinder and a gas delivery device and teaches verification
`
`of gas concentration from the cylinder by sensor 65 in the delivery system,
`
`would be improved by Peters’s manually actuated valve handle and included
`
`memory to meet the limitations of the independent claims. See Ex. 1005,
`
`6:11–15. We find Dr. Stone’s testimony deficient as to showing any
`
`suggestion in Bathe or otherwise that would have motivated one of skill in
`
`the art to add Peters’s valve and memory to Bathe.
`
`Praxair’s argument also does not persuade us that a person of ordinary
`
`skill in the art would have combined Bathe and Peters “to obtain both the
`
`benefits of the smart handle of [Peters] and the benefits of the delivery
`
`system of [Bathe].” Pet. 22 (citing Ex. 1002 ¶¶ 93, 96). This argument is
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`conclusory because it portrays the motivation in terms of the result, an
`
`unstated “benefit” and relies, again, on the insufficient premise that Peters’s
`
`valve could be incorporated on the cylinder in Bathe. In other words,
`
`Praxair assumes the combination to have occurred structurally and
`
`functionally, i.e., Peters’s valve being placed onto Bathe’s cylinder, and
`
`notes the apparent benefit or improvement to Bathe, but does not provide
`
`any rationale to make the combination in the first instance.
`
`It is reasonable to consider, as we did in our Decision to Institute, that
`
`the motivation and improvement driving the combination of Peters’s valve
`
`to Bathe, could have been related to safety issues, e.g., a pre-use safety
`
`check of the cylinder. Praxair, however, never explains adequately why or
`
`how Peters’s valve, which sends valve opening and closing time for billing
`
`purposes, improves the safety of Bathe’s gas delivery system. From a safety
`
`perspective, Bathe already teaches connecting a gas supply cylinder to a gas
`
`22
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`
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`IPR2015-00889
`Patent 8,573,209 B2
`
`delivery system and that gas concentration is sensed in the delivery system
`
`after leaving the supply cylinder and prior to delivery to a patient. Ex. 1005,
`
`6:5–11. Dr. Stone’s testimony with respect to the safety issue is that
`
`[a] person of skill in the art, with knowledge of [Bathe] and
`looking to expand [Bathe]’s teachings to enable the CPU to
`perform a safety check using the gas data stored in the valve
`memory of [Peters], would have looked to art like the FR ‘804
`Publication for one such safety check.
`
`Ex. 1002 ¶ 131. This statement is not persuasive because it presupposes,
`
`without explaining why, one of skill in the art would have been motivated by
`
`safety concerns to combine Bathe and Peters, and then leaps to FR ’804 to
`
`show such a safety check.
`
`Praxair’s arguments and Dr. Stone’s testimony with respect to
`
`modification of Bathe leaves an analytical gap that does not apprise us of
`
`how or why one of ordinary skill in the art would have modified Bathe with
`
`Peters’s capacity to communicate gas use and billing information to a
`
`separate computer, only that they could. Praxair’s arguments appear to be
`
`based essentially on the theory that, when combined, the references
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`“predictably result in an improved nitric oxide delivery system incorporating
`
`the advantageous aspects of each reference.” Pet. 21 (citing Ex. 1002 ¶¶ 89–
`
`121). In KSR
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