Paper 14
`Entered: September 22, 2015
`
`Trials@uspto.gov
`571-272-7822
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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.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
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`IPR2015-00891
`Patent 8,573,210 B2
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`I.
`
`INTRODUCTION
`
`A. Background
`Praxair Distribution, Inc. (“Petitioner”) 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.”). INO Therapeutics LLC, (“Patent
`Owner”) filed a Preliminary Response. Paper 9 (“Prelim. Resp.”).
`We have authority to determine whether to institute an inter partes
`review under 35 U.S.C. § 314 and 37 C.F.R. § 42.4(a). Upon consideration
`of the Petition and the Preliminary Response, we determine that Petitioner
`has established a reasonable likelihood of prevailing on certain claims
`challenged in the Petition. For the reasons expressed below, we institute an
`inter partes review of claims 1–16 of the ’210 patent.
`B. Additional Proceedings
`In addition to this proceeding, Petitioner has filed petitions
`challenging the patentability of claims 1–7 of U.S. Patent No. 8,573,209 B2,
`claims 1–16 of U.S. Patent No. 8,291,904, claims 1–20 of U.S. Patent No.
`8,776,794, and claims 1–20 of U.S. Patent No. 8,776,795. See IPR2015-
`00889; IPR2015-00884; IPR2015-00888; IPR2015-00893. Petitioner states
`that Patent Owner has filed a complaint in the District Court for the District
`of Delaware, case no. 1:15-cv-00170 (GMS) (D. Del.), alleging infringement
`by Petitioner of ten U.S. Patents, including the ’210 patent. Pet. 7.
`C. The ’210 Patent
`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
`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
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`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
`which can also track individual patient usage accurately and simply.” Id. at
`1:40–46.
`The ’210 patent describes a gas delivery device comprised of valve
`assembly 100 having actuator 114, valve 107 and circuit 150 communicating
`with a control module to control administration of the therapy gas to a
`patient. Id. at 5:60–6:5. Administration of therapy gas to the patient is
`regulated by a control module that delivers gas via valve 107 from gas
`source 50 (i.e., a tank to which the valve assembly is mounted) to a medical
`device for introducing gas to a patient (e.g., a ventilator, nasal cannula,
`endotracheal tube, face mask, etc.). Id.
`Figures 2 and 3 are reproduced below.
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`Figure 2 depicts valve assembly 100 and actuator 114 of the gas
`delivery device in communication via valve 107 with gas source 50. Figure
`3 illustrates an exploded view of actuator 114 and valve assembly 100.
` 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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`Figure 4 is a block diagram depicting various components of circuit
`
`150.
`
`Circuit 150 includes inter alia valve processor 122, memory 134,
`valve transceiver 120, power source 130, and valve display.1 Memory 134
`stores the gas data for the particular gas source to which the valve assembly
`is attached. Gas data, such as gas composition and concentrations, can be
`input to memory 134 in various ways such as programmed by the gas
`supplier or scanned from a bar code on the gas source itself. Id. at 7:5–10.
`Valve display 132 allows a user, via window 113 on actuator 114, to view
`information regarding valve operation such as open or close, as monitored
`by open/close sensor 126, and the time duration for which the valve was
`open for an event. Id. at 7:30–38. Valve transceiver 120 communicates
`with the control module that is physically separate, but in relatively close
`proximity to the valve assembly, via an optical wireless line-of-sight signal
`
`
`1 Timer component is apparently mislabeled as 134, and recited in the
`specification as reference number 124.
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`“during a pre-determined interval in response to a signal from the control
`module CPU transceiver 220.” Id. at 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.
`
`
`Figure 9 illustrates gas source 50 and valve assembly 100 in
`communication with control module 200 via optical wireless line-of-sight
`transmission 300.
`D. 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
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`depend directly or indirectly from the delivery device recited in claims 1 and
`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
`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.
`
`E. The Alleged Grounds of Unpatentability
`Petitioner contends that the challenged claims are unpatentable on the
`following specific grounds.2
`
`
`2 Petitioner supports its challenge with a Declaration of Dr. Robert T. Stone,
`Ph.D. (Ex. 1002). See infra.
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`References
`
`Bathe ’083 3, Peters ’5104, 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 provides constructions for any claim terms. Petitioner
`asserts that “a person of ordinary skill in the art would have understood each
`term of each claim of the ’210 Patent to have its plain and ordinary meaning,
`and would have understood that no term requires special construction for
`purposes of this proceeding.” Pet. 9. Patent Owner does not dispute that the
`claim terms are to be given their plain and ordinary meaning. Prelim. Resp.
`13–14. Because there is currently no dispute as to the claim terms, and our
`Decision does not turn on any specific claim interpretation that departs from
`the plain and ordinary meaning, for purposes of this Decision no claim
`construction is necessary. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc.,
`200 F.3d 795, 803 (Fed. Cir. 1999) (only those terms which are in
`controversy need to be construed, and only to the extent necessary to resolve
`the controversy).
`
`3 Ex. 1005, U.S. Patent No. 5,558,083 (Sept. 24, 1996)
`4 Ex. 1004, U.S. Patent No. 7,114,510 (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, INTERNATIONAL STANDARD, ISO/IEEE 11073–30300 (2004)
`8 Ex. 1008, U.S. Patent No. 6,811,533 (Nov. 2, 2004).
`9 Ex. 1010, U.S. Patent No. 4,462,398 (July 31, 1984).
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`III. ANALYSIS
`A. Threshold issue – 325(d)
`Patent Owner argues initially that the Petition should be denied
`because the Peters reference was specifically cited and relied upon by the
`Examiner in rejecting the claims during prosecution and the Bathe reference
`was considered by the Examiner. Prelim. Resp. 17. Patent Owner argues
`that Petitioner’s arguments in support of unpatentability are essentially the
`same as the Examiner’s rationale in rejecting, and subsequently allowing,
`claim 1. Id. at 16–20. Patent Owner asserts that the Examiner indicated
`allowance of claim 1 in part because
`Peters fails to disclose, teach, or fairly suggest the specific
`structure and functional limitation as recited in the claims such
`as claim 1, a circuit including a processor and transceiver that is
`able to communicate with the memory to send and receive
`wireless signals to communicate 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.
`
`Id. at 19 (citing Ex. 1017 at 70–71, 73–74).
`The statute gives the Director discretion to take into account whether,
`and reject a petition because, the same or substantially the same prior art or
`arguments previously were presented to the Office. Id. That Peters and
`Bathe were considered as prior art in the prosecution record of the ’210
`patent is a factor which the Board “may take into account” according to 35
`U.S.C. § 325(d). However, Patent Owner does not show that the examiner
`of the application that became the ’210 patent considered “substantially the
`same . . . arguments,” as Patent Owner presents here, another factor which
`the Board “may take into account” according to 35 U.S.C. § 325(d). For
`example, although Peters may not disclose specifically an optical line-of-
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`sight wireless transceiver for sending and receiving data, Petitioner, here,
`relies upon FR ’804’s optical line-of-sight RFID reader and the IR Standard,
`which were not considered during prosecution, as disclosing a wireless
`transceiver permitting physically separate medical devices to communicate.
`Pet. 30.
`Absent a showing of “substantially the same . . . arguments,” id., and
`considering that Petitioner includes additional evidence not considered by
`the examiner in the underlying prosecution, as well as the declaration of Dr.
`Robert T. Stone, Ph.D. (Ex. 1002), Patent Owner does not show that the
`inter partes review of the ’210 patent would be improper under 35 U.S.C.
`§ 325(d).
`We turn now to Petitioner’s asserted grounds of unpatentability and
`Patent Owner’s arguments in its Preliminary Response to determine whether
`Petitioner has met the threshold standard of 35 U.S.C. § 314(a).
`B. Claims 1–9 and 12–16 — Alleged obviousness over Bathe, Peters,
`FR ’804, INOMAX label, and the IR Standard
`Petitioner asserts that claims 1–9 and 12–16 would have been obvious
`over Bathe, Peters, FR ’804, INOMAX label, and the IR Standard. Pet. 17.
`Petitioner has established a reasonable likelihood of prevailing on its
`assertion that claims 1–9 and 12–16 are obvious for the reasons explained
`below.
`
`1. Overview of Bathe
`Bathe discloses a nitric oxide (NO) delivery system for use with a
`medical ventilation device. Ex. 1005, 1:1–11. As shown in Figure 1,
`reproduced below, Bathe’s system uses flow transducers 26, 46, to
`determine the flow of gas in the system, and input 58 provides for an
`operator to select a desired concentration of NO to the patient.
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`Figure 1 is a depiction of schematic view, partially in block diagram form, of
`apparatus in accordance with an embodiment of Bathe. Id., 3:33–35.
`With flow and operator input information, a system CPU calculates
`the desired flow to provide the selected NO concentration and, in the
`feedback loop shown above in Figure 1, adjusts the desired gas
`concentration and flow via signals sent to valves 14, 18, 20, and 24. Id. at
`6:5–20. Another input to CPU 56 is the NO concentration in supply cylinder
`10. Id. at 6:5–6. Bathe explains that
`[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.
`Id. at 6:6–11. In other words, CPU 56 knows the gas flow and NO
`concentration from supply 10, as well as the actual flow of gas administered
`to the patient from the delivery device by transducer 46 and gas sensing
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`bench 52, and then CPU 56 adjusts valves 14, 18, 20, and 24 to bring the
`actual gas flow and NO concentration to the patient into accordance with the
`user’s desired input level. Id. at 6:43–53.
`2. Overview of Peters
`Peters discloses, as shown in Figure 1 below, valve 10 with “smart”
`handle 16 having a memory module and circuit to log data such as opening
`and closing time for the valve. Ex. 1004, Abst., 2:43–51.
`
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`Figure 1 of Peters illustrates an exploded view of valve 10 having
`valve body 14 supporting valve handle 16 and gas inlet port 18 for
`connecting to and communicating with a gas cylinder (not shown). Id. at,
`1:58–60; 2:43–51. Inside handle 16 are several electronic devices, namely,
`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
`patent explains that memory configuration is established by initial
`parameters such as:
`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)
`Clear the log registers
`Additional area may be available for recording specific notes or
`information relative to a specific treatment or lot.
`
`Id. at 5:43–56. When gas is dispensed through valve 10 during operation,
`sensor 28 tells processor 23 to log the event, including parameters such as
`date, time, and opening or closing of the valve and “[t]hus, as the handle 16
`is rotated to open the valve 10 in order to provide gas treatments to patients,
`the memory device 22 in the handle 16 records the number and duration of
`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
`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.
`3. Overview of 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 safety
`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
`
`
`10 We refer to the top numbered pages of the English translation of FR ’804.
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`’804 as reproduced below, control module 300 communicating with valve 20
`receives input signal IDb, which is the identification of gas type being
`supplied from the bottle 10, and compares this with input data IDv, which is
`the desired type of gas for the procedure that is stored in memory 200. Id. at
`3.
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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
`opening the valve in case of a positive comparison.” Id. at 3.
`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
`module 300 when valve 20 and bottle 10 are connected. Id. at 4, Fig. 2.
`4. Overview of the IR Standard
`The IR Standard is a protocol promulgated by IEEE as an
`international standard for short-range infrared wireless communication for
`medical devices used at or near a patient. Ex. 1007, Abst. 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 health care environments.” Id. at vi. This reference
`further explains that such “standards are especially targeted at acute and
`continuing care devices, such as patient monitors, ventilators, infusion
`pumps, ECG devices, etc.” Id. The IR Standard further illustrates an IR
`communication system including an IR transceiver in order to retrofit a
`previously hard wired cable-communicating system. Id. at 39–40.
`5. Overview of INOMAX Label
`The INOMAX label reference is a U.S. Food and Drug
`Administration (FDA) publication approving labeling for Patent Owner’s
`drug INOmax® generally used in conjunction with NO therapies for
`newborns with hypoxic respository failure. Ex. 1014, 2. The INOMAX
`label also indicates that the drug was used with ventilators administering NO
`to neonatal patients. Id. at 6. The INOMAX label 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,
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`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 INOmax™ is supplied in aluminum
`cylinders. Id.
`
`6. Discussion – Bathe, Peters, FR ’804,
`INOMAX label, and the IR Standard
`To meet the elements recited by independent claim 1 of the ’210
`patent, Petitioner argues that Bathe, FR ’804, and the INOMAX label all
`disclose a gas delivery device, and that Bathe and INOMAX label
`specifically describe a gas source providing NO. Pet. 26 (citing Ex. 1005,
`Abst., 3:43–4:2; Ex. 1006, 17; Ex. 1014, 6). Petitioner also contends that
`Peters discloses delivering inhaled pharmaceutical gas, and FR ’804 teaches
`a gas delivery system for use in a health facility.11 Id. (citing 1004, 1:16–30;
`Ex. 1006, 3).
`Petitioner asserts next that Bathe teaches a “control module,” as
`recited in claim 1, specifically where Bathe discloses a CPU controlling a
`series of valves regulating the NO gas flow from supply 10 to patient. Id.
`Petitioner also points out that the ’210 patent refers to the gas flow control
`portion of the “control module” as “delivery module 260,” and that the ’210
`patent incorporates Bathe by reference.12 Id. (citing Ex. 1001, 9:62–10–4).
`Petitioner argues, in addition, that the FDA approved INOMAX labelling
`“explicitly discloses that its recommended dose of 20 ppm iNO is an amount
`
`
`11 We note that the ’210 patent specification incorporates by reference both
`Bathe and Peters in their entirety. Ex. 1001, 7:45–47, 10:3–4.
`12 Duncan P. Bathe is the lead inventor named in the ’210 patent at issue
`here, as well as the Bathe (’083) reference.
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`effective to treat hypoxic respiratory failure.” Id. at 27 (citing Ex. 1014 , 1,
`4, 6).
`
`Petitioner turns to Peters for a valve assembly including valve body
`14 with an inlet port 18, an outlet port 20 and manually operated handle 16
`(a valve actuator as recited in claim 1) for opening and closing the valve and
`allowing therapy gas to flow from supply cylinder 12 to a medical device.
`Pet. 27–28 (citing Ex. 1004, 2:40–42, 46–49, 52–55). Claim 1 further
`requires “a circuit supported within the valve assembly,” and this element,
`Petitioner contends, is disclosed by Peters as located between valve handle
`16 and cap 24 as shown in Peters’ Figures 1, 1A, 2, 2A, and 5. Id. at 28
`(citing Ex. 1004, 3:3–29).
`Claim 1 further requires that the recited circuit includes “a valve
`memory” for storing particular data. Petitioner argues that Peters discloses a
`circuit with valve memory 22 that stores information about the gas in the
`cylinder to which the valve is attached. Pet. 29 (citing Ex. 1004, 5:43–6:12).
`Petitioner further argues that Peters’ circuit includes a processor in
`communication with the valve memory, and a transceiver to send and
`receive signals and communicate data to an external computer. Id. at 29–30
`(citing Ex. 1004, 2:58–61, 3:40–49, 5:43–6:12, 6:21–25, 6:33–7:15).
`Petitioner further contends that Peters discloses wireless transceivers for
`receiving and transmitting data with a remote recording device. Id. at 31
`(citing 6:13–15, 6:33–7:15). Petitioner then relies on FR ’804 for teaching
`specifically wireless RFID optical line-of-sight data transmission where a
`barcode or carrier 120 on a gas cylinder is scanned to determine IDb (supply
`gas data) for comparison with IDv (user requested gas data) for comparison
`in FR ’804’s control module 300 so as to verify that the proper gas is being
`delivered to a patient. Id. at 30 (citing Ex. 1006, 17–19, 21, Fig. 4).
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`Petitioner argues that Bathe and the INOMAX label further disclose systems
`that enable verification of gas identification. Id. at 31 (citing Ex. 1005, 6:5–
`15; Ex. 1016, 6).
`Based on the generally disclosed wireless communication features
`allegedly disclosed in both FR ’804 and Peters, Petitioner asserts that one of
`ordinary skill in the art of medical device electronic wireless transmission
`would look to the protocols and specific transceivers described in the IR
`standard for communicating data wirelessly to and from Peters’ valve
`memory. Id. at 30–31 (citing Ex. 1002 ¶¶ 117, 121; Ex. 1007, 40).
`Below, we address Patent Owner’s specific arguments with respect to
`the prior art.
`
`The prior art does not disclose or suggest
`one or more of the limitations of claim 1
`Patent Owner focuses initially on Peters, and argues that certain
`limitations recited in claim 1 of the ’210 patent are not found in this
`reference. Prelim. Resp. 26. Patent Owner distinguishes Peters’ circuit
`contending that it discloses a memory “useful for ‘logging and billing,’ and
`sends such data to ‘a device that generates reports or invoices.’” Id. at 27
`(citing Ex. 1004, 1:9–11, 1:52–53). Patent Owner contends specifically that
`Peters does not disclose either a “control module” or “sending “gas data to
`the control module” as recited in claim 1. Id. at 28.
`Patent Owner’s arguments here are directed to Peters, whereas the
`Petitioner relies upon Bathe and FR ’804 as disclosing a control module.
`See Pet. 26. Moreover, Petitioner relies upon FR ’804 for the teaching of
`sending gas data, e.g. gas type data IDb scanned from a carrier or bar code
`on a gas cylinder, to the control module. Id. at 29. Patent Owner’s
`arguments are misplaced because they attack Peters in isolation, whereas
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`Petitioner’s proposed combination is predicated on a combination of the
`teachings of Bathe, Peters, and FR ’804. See In re Merck & Co. Inc., 800
`F.2d 1091, 1097 (Fed. Cir. 1986) (“Non-obviousness cannot be established
`by attacking references individually where the rejection is based upon the
`teachings of a combination of references.”).
`Petitioner does not provide reasoning sufficient
`to support a combination of the prior art
`Patent Owner further argues that Petitioner has failed to identify a
`reason why one of skill in the art would store the IDb supply gas data from
`FR ’804 in the valve memory of Peters before sending to a control module
`such as in Bathe.13 Prelim. Resp. 31–33. On the record before us, Petitioner
`persuasively explains that one of ordinary skill in the art would desire to
`improve the patient safety aspects of Bathe’s NO delivery system with FR
`’804’s gas supply data and delivery data comparison regimen, and “would
`have been motivated to add a smart handle and valve, as disclosed in the
`[Peters] Patent, to the NO delivery system disclosed in the [Bathe] Patent in
`order to allow the user to better link the gas information with patient
`treatments.” Pet. 19, 22 (citing Ex. 1002 ¶ 112). That one of skill in the art
`would look to improve upon the safety and efficacy of a known gas delivery
`system is not a capricious or implausible statement of motivation, but simply
`common sense. See Wyers v. Master Lock, 616 F.3d 1231, 1240 (Fed Cir
`2010) (“Thus, in appropriate cases, the ultimate inference as to the existence
`of a motivation to combine references may boil down to a question of
`
`
`13 Patent Owner argues that FR ’804 does not disclose delivering gas to a
`patient. PO Resp. 30. As with Peters, this argument attacks FR ’804 in
`isolation without considering the teachings of the other references, namely
`Bathe, with which it is combined and, therefore, is also not persuasive.
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`Patent 8,573,210 B2
`‘common sense,’ appropriate for resolution on summary judgment or
`JMOL.”
`Patent Owner also contends that neither the Petition nor the
`Declaration of Dr. Stone adequately states a reason or motivation for a
`person of ordinary skill in the art to have combined Peters “smart” valve
`with the other references such as Bathe and FR ’804. Prelim. Resp. 40–43.
`Specifically, Patent Owner argues that Peters’ valve is used for billing and
`inventory control, not to communicate with a control module controlling gas
`delivery to a patient. Id. at 43. Patent Owner states that Petitioner’s “mere
`assertion that a valve used for one purpose could be used to perform a
`different function is insufficient to support an obviousness finding.” Id.
`citing Nestlé Healthcare, IPR2015-00094, Paper 14, at 7–9 (PTAB May 4,
`2015)). We are not persuaded by this contention because Petitioner explains
`that gas supply identification data is not materially different from the gas
`information and tracking data explicitly disclosed by Peters as stored in the
`“smart” valve. Id. at 20 (citing Ex. 1002 ¶¶ 114–116, 131.) According to
`Petitioner, storing gas identification data in the “smart” valve for eventual
`comparison in a control module with desired gas would predictably improve
`safety and reliability of the gas delivery system. Id. at 22 (citing Ex. 1002 ¶
`136).
`Petitioner has shown, at this point in the proceeding, that a person of
`skill in the art would have the ability and a reason to store gas supply
`identification data in Peters’ memory, and have it transmitted to a control
`module, just as it would with an external computer for the described data
`tracking functions, in the manner asserted by Petitioner. See KSR Int'l Co. v.
`Teleflex, Inc., 550 U.S. 398, 417 (2007) (“a court must ask whether the
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`improvement is more than the predictable use of prior art elements according
`to their established functions”).14
`Upon review of Petitioner’s analysis and the evidence of record and
`having considered all of Patent Owner’s arguments, we determine that
`Petitioner has demonstrated that there is a reasonable likelihood that it would
`prevail as to the obviousness of claim 1 of the ’210 patent in view of Bathe,
`Peters, FR ’804, INOMAX label, and the IR Standard.
`Dependent claims 2–9 and 12–16
`Claims 6, 9, and 12
`Patent Owner alleges with respect to claim 6, and inferentially claims
`9 and 12 that depend directly therefrom, that Petitioner’s reliance upon FR
`’803’s comparison of IDb and IDv gas type data, is not compatible with
`Bathe’s gas concentration data, and does not encompass the comparison of
`gas data and patient information limitations recited in claim 6. Prelim. Resp.
`44–45. Patent Owner specifically argues that “IDv data is not equivalent to
`the ‘input concentration desired to be administered to a patient,’ and IDb
`data is not ‘gas concentration data received from a valve transceiver.’” Id. at
`45. Gas type data (e.g., NO) and gas concentration data (e.g., percentage of
`
`
`14 Patent Owner also asserts several reasons that a person of ordinary skill in
`the art would not store the desired delivery gas concentration to be delivered
`to a patient as described in Bathe, in the valve memory. Prelim. Resp. 33–
`35. Whether or not Patent Owner’s assertions on this point are correct, we
`recognize that Petitioner’s arguments include storage of the supply gas
`concentration in the valve memory. See Pet. 29; Ex. 1005, 6:5–8. Also, we
`are persuaded that Petitioner’s reasons for storing gas information such as
`gas supply concentration data described in Bathe, or the gas supply
`identification data in FR ’804, in the valve memory of Peters is the same as
`discussed with respect to FR ’804, and on this record, supports the
`combination of references. See Pet. 22.
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`NO in a gas), are certainly different as Patent Owner asserts. Id. Patent
`Owner’s argument, however, does not explain why a CPU could not
`compare FR ’803’s gas type data, just like gas concentration data.
`Moreover, claim 6 does not require comparison specifically of either gas
`type or gas concentration with patient information, but recites generally that
`the “CPU compares the patient information . . . and the gas data.”
`Patent Owner does not provide specific arguments with respect to
`claims 9 and 12, instead relying on their relative dependency on claim 6. Id.
`at 44–45. Accordingly, having reviewed Petitioner’s arguments and
`evidence, we are persuaded for purposes of this Decision that Petitioner has
`demonstrated that there is a reasonable likelihood that claims 6, 9, and 12 are
`unpatentable over Bathe, Peters, FR ’804, INOMAX label, and IR Standard.
`Claim 7
`Patent Owner argues that Peters “does not disclose communicating
`[calendar and event] information to the CPU of a control module that
`delivers gas to a patient.” Prelim. Resp. 46–47. This argument, just as
`discussed above with respect to claim 1, attacks Peters in isolation. To the
`extent Patent Owner argues that Bathe offers no teaching or suggestion as to
`why such calendar and