Trials@uspto.gov
`571-272-7822
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`Paper 14
`Entered: September 22, 2015
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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 IPR2015-00889
`Patent 8,573,209 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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`IPR2015-00889
`Patent 8,573,209 B2
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`I.
`
`INTRODUCTION
`
`A. Background
`Praxair Distribution, Inc. (“Petitioner”) filed a Petition to institute an
`inter partes review of claims 1–7 of U.S. Patent No. 8,573,209 B2 (Ex.
`1001, “the ’209 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 1–7 of the ’209 patent.
`B. Additional Proceedings
`In addition to this proceeding, Petitioner has filed petitions
`challenging the patentability of claims 1–16 of U.S. Patent No. 8,573,210
`B2,1 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
`IPR2015-00891; 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. 15-cv-00170, alleging infringement by
`Petitioner of ten U.S. Patents, including the ’209 patent. Pet. 8.
`C. The ’209 Patent
`The ’209 patent (Ex. 1001), titled “Gas Delivery Device and System,”
`relates generally to a gas delivery device used in a gas delivery system, and a
`
`
`1 The ’210 patent is a continuation-in-part of Appln. No. 13/509,873, that
`issued as the ’209 patent.
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`method for administering therapy gas, such as nitric oxide (NO), to a
`medical patient. Ex. 1001, 1:5–17, 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
`which can also track individual patient usage accurately and simply.” Id. at
`1:29–35.
`The ’209 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 5:53–63. 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 wired, or
`wireless link, by valve transceiver 120, with the control module. Id. at 5:64–
`6:6.
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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.2 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 6:53–61.
`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 which the valve was open
`for an event. Id. at 7:11–19. 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 “during a
`
`2 Timer component is apparently mislabeled as 134, and recited in the
`Specification as reference number 124.
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`pre-determined interval in response to a signal from the control module CPU
`transceiver 220.” Id. at 8:7–8, 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 8:22–38, 9:43–48.
`
`
`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, claims 1, 3, 5, and 6 are independent, and
`from which each of claims 2, 4, and 7 depend respectively. Claim 1
`illustrates the claimed subject matter and is reproduced below:
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`1. A gas delivery device to administer therapy gas from
`
`a gas source, the gas delivery device comprising:
`a valve attachable to the gas source, 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 through the valve to a control module; and
`a circuit including:
`memory to store gas data comprising one or more of gas
`identification,
`gas
`expiration
`date
`and
`gas
`concentration and
`a processor and a transceiver in communication with the
`memory 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 to verify one or more of the correct gas, the
`correct gas concentration and that the gas is not
`expired,
`wherein the valve further comprises a data input in com-
`munication with said memory, to permit a user to
`enter the gas data into the memory.
`E. The Alleged Grounds of Unpatentability
`Petitioner contends that the challenged claims are unpatentable on the
`following specific grounds.3
`References
`
`Bathe ’083,4 Peters ’510,5 FR ’804,6 and the IR
`Standard7
`
`3 Petitioner supports its challenge with a Declaration of Dr. Robert T. Stone,
`Ph.D. (Ex. 1002). See infra.
`4 Ex. 1005, U.S. Patent No. 5,558,083 (Sept. 24, 1996).
`5 Ex. 1004, U.S. Patent No. 7,114,510 B2 (Oct. 3, 2006).
`6 Ex. 1006, FR Pub. No.: 2 917 804 (Dec. 26, 2008).
`7 Ex. 1007, INTERNATIONAL STANDARD, ISO/IEEE 11073-30300 (2004).
`
`Basis Claims
`Challenged
`§ 103 1–7
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`References
`
`Bathe, Peters, FR ’804, the IR Standard, and
`Lebel ’5338
`
`
`Basis Claims
`Challenged
`§ 103 3 and 4
`
`II.
`CLAIM CONSTRUCTION
`Petitioner asserts that “a person of ordinary skill in the art would have
`understood each term of the ’209 Patent to have its plain and ordinary
`meaning, and would have understood that no term requires special
`construction for purposes of this proceeding.” Pet. 10. With the exception
`of the term “input means” 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 any other 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, except for “input means,” which is discussed
`below. 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).
`Independent claim 6 recites “an input means to enter patient
`information into the CPU memory.” Patent Owner proposes that “input
`means” be construed as the structure disclosed in the ’209 patent,
`specifically, “a keyboard integrated with the control module’s display or,
`alternatively, a USB port or other port for the connection of an external
`keyboard or other input mechanism.” Prelim. Resp. 14 (citing Ex. 1001,
`2:61–63, 4:53–57, 11:17–29, FIG. 10.) Our review of the Specification
`
`8 Ex. 1008, U.S. Patent No. 6,811,533 B2 (Nov. 2, 2004).
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`reveals that the structure disclosed for performing the function of “enter[ing
`patient information] into the CPU memory” includes a keyboard integrated
`with a display. Ex. 1001, 11:23–27. The Specification also states that the
`input means includes “a USB port or other port for the connection of an
`external keyboard or other input mechanism.” Id. at 11:25–27. We find
`Petitioner’s proposed construction is reasonable. For purposes of this
`Decision, “input means to enter patient information into the CPU memory”
`includes a keyboard integrated with a display, as shown and described in the
`’209 patent, and alternatively, a USB or other port for connection of an
`external keyboard or other input mechanism, and their equivalents. See id.,
`Fig. 10.
`
`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 also 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. 16–20. Patent Owner asserts that the
`Examiner indicated allowance of claim 1 in part because
`Peters fails to disclose, teach, or fairly suggest a circuit
`including a processor and
`transceiver
`that
`is able
`to
`communicate with the memory to send and receive wireless
`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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`Id. at 19 (citing Ex. 1016 at 254.)
`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 ’209
`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 ’209 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-
`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. 30–31.
`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 ’209 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).
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`B. Claims 1–7 — Alleged obviousness over Bathe, Peters, FR ’804,
`and the IR Standard
`Petitioner asserts that claims 1–7 would have been obvious over
`Bathe, Peters, FR ’804, and the IR Standard. Pet. 12. Petitioner has
`established a reasonable likelihood of prevailing on its assertion that claims
`1–7 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.
`
`With flow and operator input information, a system CPU calculates
`the desired flow to provide the selected NO concentration and, in the
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`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
`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). Inside
`handle 16 are several electronic devices, namely, processor 23, timer 21,
`memory 22 and data port 22’, sensor 28, battery 25, 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.
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`Id. at 5:48–56. 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, 1.9 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
`’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.
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`9 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
`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.
`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
`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
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`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. Discussion – Bathe, Peters, FR ’804, and the IR
`Standard
`To meet the elements recited by independent claim 1 of the ’209
`patent, Petitioner argues that at least Bathe and FR ’804 disclose known gas
`delivery systems and devices including gas source cylinders, valves, a
`control module, and, in Bathe, a CPU and ventilator for administering the
`desired gas to a patient. Pet. 27 (citing Ex. 1005, Abst., 3:43–4:2; Ex. 1006,
`17; Ex. 1002 ¶ 62.)
`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 gas delivery
`system, such as disclosed by Bathe. Pet. 27–28 (citing Ex. 1004, 2:40–42,
`46–49, 52–55.)
`Claim 1 further requires the gas delivery device to include “a circuit,”
`including memory, a processor, and a transceiver for sending, receiving, and
`storing data for controlling the gas delivery system. These elements,
`Petitioner contends, are disclosed by Peters as located between valve handle
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`16 and cap 24 as shown in Peters’ Figures 1, 1A, 2, 2A, and 5. Id. at 29–30
`(citing Ex. 1004, 2:58–61, 3:3–5, 3:40–49, 6:21–25, 6:33–7:15.)
`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 (such as gas identification) 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, along with the
`IR Standard, disclose wireless transceivers for receiving and transmitting
`data with a remote recording device. Id. at 31 (citing 6:33–7:15, Ex. 1007,
`40, Ex. 1002 ¶¶ 105–107.) Petitioner 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 30–32 (citing Ex. 1006, 17–19, 21, Fig. 4.)
`Below, we address Patent Owner’s specific arguments with respect to
`the prior art.
`The prior art does not disclose or suggest all of the
`limitations of independent claims 1, 3, 5, and 6
`Patent Owner focuses initially on Peters, and argues that certain
`limitations recited in the independent claims of the ’209 patent are not found
`in this reference. Prelim. Resp. 28–29. Patent Owner distinguishes Peters’
`circuit contending that it discloses a memory “useful for ‘logging and
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`billing,’ and sends such data to ‘a device that generates reports or invoices.’”
`Id. at 29 (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.
`Patent Owner’s arguments here are directed specifically to Peters,
`whereas the Petitioner relies upon Bathe and FR ’804 as disclosing a control
`module. See Pet. 28. 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 30–31. Patent
`Owner’s arguments are misplaced because the arguments attack Peters in
`isolation, whereas Petitioner’s proposed combination is predicated on a
`combination of the teachings of Bathe, Peters, and FR ’804. See In re Merck
`& Co., 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.10 Prelim. Resp. 28–38. On the record before us, Petitioner
`explains persuasively that one of ordinary skill in the art would desire to
`improve the patient safety aspects of Bathe’s NO delivery system with FR
`
`10 Patent Owner argues that FR ’804 does not disclose delivering gas to a
`patient. Prelim. 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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`’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. 21, 23 (citing Ex. 1002 ¶ 94, 96.) 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 ‘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 state a reason or motivation for a person
`of ordinary skill in the art to have combined, or “repurposed” Peters “smart”
`valve with the other references such as Bathe and FR ’804. Prelim. Resp.
`28. 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 29–31. Patent Owner states that
`Petitioner points to no evidence to show that it would have been
`obvious to repurpose the ’510 Patent’s valve—which is used to
`collect logging and billing information for administrative tasks
`such as generating reports and invoices—to store and transmit
`gas data for use by the ’083 Patent’s control module in
`delivering NO gas to a patient.
`Id. at 31 (citing Nestlé Healthcare, IPR2015-00094, Paper 14, at 7–9.) We
`are not persuaded by this contention because Petitioner explains that gas
`supply identification data is not materially different from the gas information
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`and tracking data explicitly disclosed by Peters as stored in the “smart”
`valve. Pet. 22 (citing Ex. 1002 ¶¶ 98–101.) 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 23–24 (citing Ex. 1002 ¶ 94.)
`Petitioner has shown sufficiently at this point in the proceeding that a
`person of ordinary skill in the art would have the ability and reason to store
`gas supply identification data in Peters’ smart valve 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 improvement is more than the predictable use of
`prior art elements according to their established functions”).11
`Accordingly, on the present record we are persuaded that there is a
`reasonable likelihood that Petitioner will prevail as to the obviousness of
`claim 1 of the ’209 patent over Bathe, Peters, FR ’804, and the IR Standard.
`
`
`11 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. 35–
`38. 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. 29–30; Ex. 1005, 6:5–8. Also,
`we are persuaded that Petitioner’s reasons (i.e., comparisons for safety
`purposes) 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 are essentially the same as discussed with respect to
`FR ’804, and on this record, support the combination of references. See Pet.
`21–24.
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`Independent Claim 5
`Patent Owner points out that claim 5 includes a limitation not
`disclosed by any of the asserted references, namely
`the valve comprises a timer including a calendar timer and an
`event timer, wherein the memory stores the date and time of
`opening and closing of the valve and the duration of time that
`the valve is open and the transceiver communicates the date and
`time of opening and closing of the valve to the CPU transceiver
`for storage in the CPU memory.
`Specifically, Patent Owner argues that Peters “does not disclose
`communicating [calendar and event] information to the CPU of a control
`module that controls gas delivery to a subject.” Prelim. Resp. 40. 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 event information, (id.) such as
`opening and closing of the cylinder valve, would be necessary, Petitioner
`explained that a person of skill in the art would look to improve the
`communication and safety aspects of gas delivery systems by sending
`information from Peters valve directly to Bathe’s CPU to carry out the
`comparison described by FR ’804. Pet. 21– 23, see III.B.5 supra. Similarly,
`Petitioner reasoned that a person of skill in the art would have understood
`that essentially any information from Peters’ memory circuit in addition to
`gas type and concentration, such as opening and closing of the valve, could
`also be sent to the CPU in the control module by the valve circuit
`transceiver. Pet. 44 (citing Ex. 1002 ¶ 113.) Petitioner’s reasoning is
`sufficient.
`
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`Independent Claim 6
`We determined in section II, that “‘input means to enter patient
`information into the CPU memory’ includes a keyboard integrated with a
`display, as shown and described in the ’209 patent, and alternatively, a USB
`or other port for connection of an external keyboard or other input
`mechanism, and their equivalents.” As Petitioner points out, Bathe discloses
`an “input device 58 to select the desired concentration of NO that is to be
`administered to the patient. That input device 58 may be one of a variety of
`devices, such as a keyboard, dial, encoder, touch screen, thumb wheel or the
`like.” Pet. 48–49 (citing Ex. 1005, 6:29–33.)
`We are persuaded for purposes of this Decision that the recited “input
`means” is satisfied by Bathe’s disclosure although it does not show precisely
`a keyboard and screen as depicted for example in Figure 10 of the ’209
`patent. The “input means” is not limited to the exact structure disclosed in
`the ’209 patent, but also encompasses “equivalents.” See 35 U.S.C. § 112, ¶
`6 .
`
`Also for claim 6, Patent Owner reiterates its position that “[g]as type
`is different from gas concentration.” Prelim. Resp. 41–42. For the reasons
`explained above, we find this argument unpersuasive. See supra n.11.
`Patent Owner does not specifically address the limitations of
`independent claim 3, and states only that dependent “claims 2, 4, and 7,
`include all the limitations of claims 1, 3, and 6, respectively, plus others, and
`therefore are not obvious for at least the same reasons that claims 1, 3, and 6
`are not obvious.” Prelim. Resp. 46. For the reasons we set forth above with
`respect to independent claims 1, 5, and 6, and those articulated by Petitioner
`for claims 2, 3, 4, and 7 in the Petition, we are persuaded that there is a
`
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`reasonable likelihood that Petitioner will prevail as to the obviousness of
`claims 2, 3, 4, and 7 over Bathe, Peters, FR ’804, and the IR Standard. See
`Pet. 33–38, 50.
`C. Claims 3 and 4 — Alleged obviousness over Bathe, Peters, FR
`’804, INOMAX label, the IR Standard and Lebel
`1. Overview of Lebel
`Lebel discloses a protocol for an RF telemetry communication system
`for medical devices. Ex. 1008, Abst. More specifically, Lebel te