Trials@uspto.gov
`571-272-7822
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` Paper 54
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` Date: September 12, 2016
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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 IPR2015-00884
`Patent 8,291,904 B2
`
`
`
`Before KEN B. BARRETT, MICHAEL J. FITZPATRICK, and
`SCOTT A. DANIELS, Administrative Patent Judges.
`
`
`FITZPATRICK, Administrative Patent Judge.
`
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a)
`
`
`
`
`
`

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`IPR2015-00884
`Patent 8,291,904 B2
`
`I.
`
`INTRODUCTION
`
`Petitioner, Praxair Distribution, Inc., filed a Petition to institute an
`
`inter partes review of claims 1–16 of U.S. Patent No. 8,291,904 B2 (Ex.
`
`1001, “the ’904 patent”) pursuant to 35 U.S.C. § 311(a). Paper 1 (“Pet.”).
`
`Patent Owner, INO Therapeutics LLC, filed a Preliminary Response
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`pursuant to 35 U.S.C. § 313. Paper 9 (“Prelim. Resp.”). In a September 22,
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`2015, Decision, we granted the Petition, instituting trial on all claims on the
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`following grounds:
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`claims 1–8 and 11–16 as obvious over Bathe (Ex. 1005)1, Peters
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`(Ex. 1004)2, Paoli (Ex. 1006)3, and IR Standard (Ex. 1007)4;
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`claims 3 and 4 as obvious over Bathe, Peters, Paoli,
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`IR Standard, and Lebel (Ex. 1008)5; and
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`claims 9 and 10 as obvious over Bathe, Peters, Paoli,
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`IR Standard, and Durkan (Ex. 1010).6
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`Paper 14 (“Inst. Dec.”).
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`After institution, Patent Owner filed a Patent Owner Response (Paper
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`30, “PO Resp.”) to which Petitioner filed a Reply (Paper 40, “Pet. Reply”).
`
`
`
`1 U.S. Patent No. 5,558,083, issued Sept. 24, 1996.
`2 U.S. Patent No. 7,114,510 B2, issued Oct. 3, 2006.
`3 French Patent Application Publication No. 2,917,804, published Dec. 26,
`2008.
`4 ISO/IEEE 11073-30300, “Health informatics -- Point-of-care medical
`device communication -- Part 30300: Transport profile -- Infrared
`wireless,” ISO, IEEE, (Dec. 15, 2004).
`5 U.S. Patent No. 6,811,533 B2, issued Nov. 2, 2004.
`6 U.S. Patent No. 4,462,398, issued July 31, 1984.
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`IPR2015-00884
`Patent 8,291,904 B2
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`Also, Patent Owner filed a Motion to Exclude. See Paper 44; see also Paper
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`48 (Petitioner’s Opposition); Paper 49 (Patent Owner’s Reply).
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`A hearing for oral arguments was held on May 16, 2016, and a
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`transcript of the hearing is included in the record. Paper 53.
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`As discussed below, Petitioner has not shown by a preponderance of
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`the evidence that any of the challenged claims is unpatentable.
`
`A. The ’904 Patent
`
`The ’904 patent relates to the administration of a therapy gas, such as
`
`nitric oxide (NO), to a patient. Ex. 1001, 1:14–16. In a background section,
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`the ’904 patent states that there was a need “to ensure that patient
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`information contained within [a] computerized system matches the gas that
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`is to be delivered” to the patient and “also a need for such an integrated
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`device that does not rely on repeated manual set-ups or connections and
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`which can also track individual patient usage accurately and simply.” Id. at
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`1:40–45.
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`The ’904 patent describes a gas delivery system comprising a valve
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`assembly having a valve and circuit in communication with a control module
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`to control administration of the therapy gas to a patient. Id. at 5:59–6:4.
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`Administration of the therapy gas to the patient is controlled by controlling
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`delivery of the gas from the gas source (i.e., a cylinder to which the valve
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`assembly is mounted) to a medical device for introducing gas to a patient
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`(e.g., a ventilator, nasal cannula, endotracheal tube, or face mask). Id.
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`Figures 2 and 3 are reproduced below.
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`IPR2015-00884
`Patent 8,291,904 B2
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`
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`Figure 2 shows valve assembly 100 attached to gas source (cylinder) 50 via
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`attachment portion 102. Ex. 1001, 6:26–29. The valve assembly includes
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`inlet 104, outlet 106, valve 107, data input 108, and actuator 114 with cap
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`112 mounted thereto, as well as a circuit that is not shown in Figure 2. Id. at
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`6:26–37. Figure 3 shows the assembly valve partially disassembled, thus
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`revealing circuit 150 within the actuator. Id. at 6:30–35.
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`IPR2015-00884
`Patent 8,291,904 B2
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`Figure 4 is reproduced below.
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`
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`Figure 4 shows a block diagram of circuit 150 having valve processor 122,
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`valve memory 134, valve transceiver 120, valve display 132, reset 128,
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`power source 130, timer 124,7 and open/close sensor 126. Ex. 1001, 6:41–
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`54. Gas data, such as gas composition and concentration, can be input to
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`memory 134 in various ways such as programmed by the gas supplier or
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`scanned from a bar code on the gas source. Id. at 7:5–21. The valve
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`assembly is configured to communicate with the control module via wireless
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`optical line-of-sight transmission between the valve transceiver and a CPU
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`transceiver of the control module. Id. at 8:41–48.
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`
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`
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`7 Figure 4 mislabels the timer as 134. It should be labelled 124. Ex. 1001,
`6:45.
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`Patent 8,291,904 B2
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`Figure 9 is reproduced below.
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`
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`Figure 9 shows control module 200 that is physically separate from, but in
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`close proximity to, the valve assembly 100. Ex. 1001, 10:36–48. A
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`depiction of the previously mentioned wireless optical line-of-sight
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`transmission between control module 200 and valve assembly 100 is labeled
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`300. Id. at 6:7, 8:24–27. The control module is ultimately responsible for
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`delivery and regulation of a desired gas to a ventilator and patient, and it
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`requests data from circuit 150 within valve assembly 100 at pre-determined
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`intervals to facilitate the appropriate gas delivery to the patient. Id. at 8:41–
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`57, 9:62–10:4.
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`Patent 8,291,904 B2
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`B. The Challenged Claims
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`Petitioner challenges all claims of the ’904 patent, i.e., claims 1–16.
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`Claim 1 is the sole independent claim. It is illustrative and reproduced
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`below.
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`1. A valve assembly to deliver a gas comprising NO
`from a gas container containing the gas comprising NO, 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 a
`control module;
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`a circuit supported within the valve assembly and
`disposed between the actuator and a cap, the circuit including:
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`a valve memory to store gas data comprising gas
`concentration in the gas container and
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`a valve processor and a valve transceiver in
`communication with the valve memory to send wireless
`optical line-of-sight signals to communicate the gas data
`to the control module that controls gas delivery to a
`subject; and
`
`a data input disposed on the actuator and in
`communication with said valve memory, to permit a user to
`enter the gas data into the valve memory.
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`
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`IPR2015-00884
`Patent 8,291,904 B2
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`II. ANALYSIS
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`A. Claim Construction
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`“A claim in an unexpired patent shall be given its broadest reasonable
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`construction in light of the specification of the patent in which it appears.”
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`37 C.F.R. § 42.100(b). Pursuant to that standard, the claim language should
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`be read in light of the specification, as it would be interpreted by one of
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`ordinary skill in the art. In re Suitco Surface, Inc., 603 F.3d 1255, 1260
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`(Fed. Cir. 2010). Thus, we generally give claim terms their ordinary and
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`customary meaning. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257
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`(Fed. Cir. 2007) (“The ordinary and customary meaning is the meaning that
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`the term would have to a person of ordinary skill in the art in question.”)
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`(internal quotation marks omitted).
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`Neither party has proposed expressly construing any term of the
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`challenged claims. Pet. 8–9; PO Resp. 6. We discern no reason to construe
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`expressly any term for purposes of this Decision.
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`B. Petitioner Ground 1
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`Petitioner asserts that claims 1–8 and 11–16 are unpatentable because
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`they would have been obvious over Bathe, Peters, Paoli, and IR Standard.
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`Pet. 10. For the reasons explained below, Petitioner has not met its burden
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`of persuasion in proving that any claim is unpatentable as asserted.
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`1. Overview of Bathe
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`Bathe identifies the same first named inventor as the challenged ’904
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`patent. Ex. 1005, at [75]. Bathes discloses a “nitric oxide delivery system
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`that is useable with various means of administering the NO . . . such as a
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`IPR2015-00884
`Patent 8,291,904 B2
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`ventilator or with spontaneous ventilation where the NO is introduced by
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`means of a gas proportioning device that provides a continuous flow to the
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`patient.” Id. at 2:14–19.
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`Figure 1 of Bathe is reproduced below.
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`
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`Figure 1 shows a schematic view of the Bathe system having flow sensor 26
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`and flow transducer 46, which determine the flow of gas in the system, and
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`CPU 56 with input device 58, which provides for an operator to select a
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`desired concentration of NO to the patient. With flow and operator input
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`information, the CPU calculates the desired flow to provide the selected NO
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`concentration and, via feedback loop shown above in Figure 1, adjusts the
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`desired gas concentration and flow via signals sent to valves 14, 18, 20, and
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`24. Ex. 1005, 6:5–20. Another input to CPU 56 is the NO concentration in
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`supply cylinder 10. Id. at 6:5–6. Bathe states the following about that input:
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`The NO sensor 65 senses the concentration of NO
`in the supply cylinder 10 so that the user can verify
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`Patent 8,291,904 B2
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`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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`Ex. 1005, 6:6–11. In other words, the CPU knows the gas flow and NO
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`concentration from supply 10, as well as the actual flow of gas administered
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`to the patient from the delivery device by transducer 46 and gas sensing
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`bench 52, and, knowing the desired NO concentration set by the user via
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`input 58, the CPU can adjust valves 14, 18, 20, and 24 to bring the actual gas
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`flow and NO concentration to the patient into accord with the user’s desired
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`input level. Id. at 6:43–53.
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`2. Overview of Peters
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`Peters discloses a valve with a “smart” handle for use with gas
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`cylinders involving the use of gases administered to patients in medical
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`treatments. Ex. 1004, 1:16–17, 1:34–35. The “valve records all the
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`treatment information and makes the information readily accessible for use
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`in tracking and invoicing.” Id. at 1:35–37.
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`Figure 1 of Peters is reproduced below.
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`10
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`Patent 8,291,904 B2
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`
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`Figure 1 illustrates an exploded view of valve 10 having valve body 14
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`supporting valve handle 16 and gas inlet port 18 for connecting to and
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`communicating with a gas cylinder (not shown). Within the handle are
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`several electronic components, namely, processor 23, timer 21, memory 22
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`and data port 22', sensor 28, battery 25 and display 26. Id. at 2:58–64.
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`Figure 2b is reproduced below.
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`Figure 2b shows a block diagram of the electronic components just
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`mentioned. Peters explains that the memory configuration is established by
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`
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`11
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`initial parameters such as the following: born-on date (date when cylinder
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`was filled); cylinder serial number; gas lot number; set the timers (which
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`may include a calendar timer and an event timer); and clear-the-log registers.
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`Id. at 5:43–56.
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`“When the valve handle 16 is turned to open or close the valve, the
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`proximity sensor 28 triggers the processor 23 to instruct the memory device
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`22 to log the event, including date, time, and whether the event was an
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`opening or a closing of the valve.” Id. at 6:21–25. “Thus, as the handle 16
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`is 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 6:29–32. 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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`3. Overview of Paoli
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`Paoli relates to a connection system for a valve to a gas bottle or
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`cylinder. Ex. 1006, 017. 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 019.
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`Figure 1 of Paoli is reproduced below.
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`
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`Figure 1 shows a block diagram illustrative of control module 300 for
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`controlling valve 20. The control module receives input signal IDb, which is
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`the identification of gas type being supplied from the bottle, and compares
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`this with input data IDv, which is the desired type of gas for the procedure
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`that is stored in memory 200. Id. Paoli explains that “the control module
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`300 comprises means 310 for comparing the identification data IDb and IDv
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`and means 320 for transmitting a control signal to the valve 20, capable of
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`emitting a signal for opening the valve in case of a positive comparison.” Id.
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`In another embodiment, Paoli discloses that the type of gas in bottle
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`10 (IDb) can be acquired from information carrier 120, such as an RFID tag
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`on the bottle, which would be read by sensor 110 when the valve is attached
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`to the bottle. Id. at 020.
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`4. Overview of IR Standard
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`IR Standard is a protocol promulgated by the Institute of Electrical
`
`and Electronics Engineers (IEEE) as an international standard for short-
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`range infrared (IR) wireless communication for medical devices used at or
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`near a patient. Ex. 1007, Abstract. IR Standard describes wireless
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`communication standards with a goal of “[f]acilitat[ing] the efficient
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`exchange of vital signs and medical device data, acquired at the point-of-
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`care, in all health care environments.” Id. at vi. IR Standard further
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`explains that such “standards are especially targeted at acute and continuing
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`care devices, such as patient monitors, ventilators, infusion pumps, ECG
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`devices, etc.” Id. IR Standard illustrates an IR communication system
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`including 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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`5. Petitioner Has Not Shown That Claims 1–8 and 11–16 Would
`Have Been Obvious over Bathe, Peters, Paoli, and IR Standard
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`All of the challenged claims are directed to a valve assembly with a
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`circuit having:
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`a valve memory to store gas data comprising gas
`concentration in the gas container and
`
`in
`transceiver
`a valve processor and a valve
`communication with the valve memory to send wireless optical
`line-of-sight signals to communicate the gas data to the control
`module that controls gas delivery to a subject.
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`Peters discloses a memory within the handle of its smart valve but it
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`does not store gas data comprising gas concentration in the container. It
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`stores born-on date (date when cylinder was filled); cylinder serial number;
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`gas lot number; set the timers (which may include a calendar timer and an
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`event timer); and clear-the-log registers. Ex. 1004, 5:43–56. It also stores
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`when and for how long the valve is opened or closed. Id. at 6:21–25. Paoli
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`discloses a memory for storing the type, but not concentration, of a gas in a
`
`supply cylinder (i.e., IDb data). Ex. 1006, 020–021. Bathe teaches
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`obtaining the NO concentration actually being delivered to a ventilator in
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`order to provide feedback for a CPU to adjust as needed administration of
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`NO a patient is receiving. Ex. 1005, 6:5–20. IR Standard describes wireless
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`communication standards in medical devices. Ex. 1007, vi.
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`Although it may not be anticipated, a claimed invention is nonetheless
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`unpatentable “if the differences between the claimed invention and the prior
`
`art are such that the claimed invention as a whole would have been obvious
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`before the effective filing date of the claimed invention to a person having
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`ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C.
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`§ 103(a).8 In assessing obviousness, “the scope and content of the prior art
`
`are to be determined; differences between the prior art and the claims at
`
`issue are to be ascertained; and the level of ordinary skill in the pertinent art
`
`resolved.” Graham v. John Deere Co., 383 U.S. 1, 17 (U.S. 1966).
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`Additionally, secondary considerations such as “commercial success, long
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`felt but unsolved needs, failure of others, etc., might be utilized to give light
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`to the circumstances surrounding the origin of the subject matter sought to
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`be patented. As indicia of obviousness or nonobviousness, these inquiries
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`may have relevancy.” Id. at 17–18.
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`Each of Petitioner’s grounds relies on multiple references. In
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`particular, with respect to Ground 1, the Petition asserts that a “person of
`
`ordinary skill in the art would have been motivated to combine the ’083
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`Patent [Bathe], the ’510 Patent [Peters], the FR ’804 Publication [Paoli], and
`
`
`
`8 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, took
`effect on March 18, 2013. As the application from which the ’904 patent
`issued was filed before that date, our citations to 35 U.S.C. § 103 are to its
`pre-AIA version.
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`the IR Standard to predictably result in an improved nitric oxide delivery
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`system incorporating the advantageous aspects of each reference.” Pet. 19.
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`For example, and with respect to the valve memory limitation, Petitioner
`
`argues Ground 1 as follows:
`
`Claim 1 requires the circuit to include a “valve memory to store
`gas data comprising gas concentration in the gas container.” As
`discussed above, the ’510 Patent [Peters] discloses a valve
`memory 22, disposed between the actuator and the cap. (Ex.
`1004 at 2:58–61, 3:3–5, Ex. 1002 ¶ 23.) The ’510 Patent
`discloses that gas data can be stored in the valve memory to
`indicate information about the gas in the cylinder. (See Ex. 1004
`at 5:43–6:12.) This information can be used for gas therapy.
`(Ex. 1004 at 7:36–47.) The FR ’804 Publication [Paoli] also
`discloses a memory for storing data (i.e., IDb data) about the gas
`in the cylinder. (Ex. 1006 at 20–21.) Finally, the ’083 Patent
`[Bathe] teaches that one of the gas data characteristics that can
`be stored and used to trigger alarms is gas concentration. (Ex.
`1005 at 5:60–6:4.) The ’083 Patent also teaches that the actual
`concentration of the gas in the cylinder can be used to “verify
`that the proper supply is being utilized.” (Ex. 1005 at 6:5–8.)
`Accordingly, the combination of references in this Ground
`discloses that the valve memory can store gas data indicative of
`the concentration of gas in the container, as required by this
`limitation. (Ex. 1002 ¶¶ 101, 107.)
`
`Pet. 28.
`
`A claimed invention, however, “is not proved obvious merely by
`
`demonstrating that each of its elements was, independently, known in the
`
`prior art.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). To
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`prove obviousness, there must have been, at the time of invention, “an
`
`apparent reason to combine the known elements in the fashion claimed by
`
`the patent at issue.” Id. Such reason cannot be provided by the very patent
`
`being challenged as obvious. Id. at 421 (“A factfinder should be aware, of
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`course, of the distortion caused by hindsight bias and must be cautious of
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`arguments reliant upon ex post reasoning.”); Cheese Sys. v. Tetra Pak
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`Cheese & Powder Sys., 725 F.3d 1341, 1352 (Fed. Cir. 2013) (“Obviousness
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`cannot be based on the hindsight combination of components selectively
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`culled from the prior art to fit the parameters of the patented invention.”)
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`(quotation marks omitted).
`
`The Petition includes a section titled “Motivation to Combine Prior
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`Art” that runs approximately five pages. Pet. 19–25. It is difficult to discern
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`precisely what Petitioner’s proffered reasons are for why a person of
`
`ordinary skill in the art would have made a combination that falls within the
`
`scope of the challenged claims.
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`Petitioner offers, in part, the following reasoning:
`
`The ’083 Patent [Bathe] teaches a basic NO delivery system with
`various component parts such as a gas cylinder 10, valves 14, 18,
`20, and 24, and a control CPU 56 for controlling the flow and
`concentration of NO gas delivery to a patient (see Ex. 1005 at
`6:20-28). The ’510 Patent [Peters] discloses an advanced or
`smart handle and valve attached to a gas cylinder for storing and
`transmitting information about the gas to a remote module. A
`person of skill in the art would have known to combine the
`control module disclosed [in] the ’083 Patent with the smart
`handle and valve disclosed in the ’510 Patent to obtain both the
`benefits of the smart handle of the ’510 Patent and the benefits
`of the delivery system of the ’083 Patent. (Ex. 1002 ¶ 100.)
`
`Pet. 20. This proffered reasoning, which proposes combining prior art
`
`teachings merely for the purposes of obtaining the individual benefits of
`
`each, is not persuasive. “Although common sense directs one to look with
`
`care at a patent [] that claims as innovation the combination of two known
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`devices according to their established functions, it can be important to
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`identify a reason that would have prompted a person of ordinary skill in the
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`relevant field to combine the elements in the way the claimed new invention
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`does.” KSR, 550 U.S. at 418. “This is so because inventions in most, if not
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`all, instances rely upon building blocks long since uncovered, and claimed
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`discoveries almost of necessity will be combinations of what, in some sense,
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`is already known.” Id. at 418–19. It is important—indeed, we determine
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`that it is required in the context of the challenged claims and the relied-upon
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`prior art teachings before us—for Petitioner to identify a reason that would
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`have prompted a person of ordinary skill to combine the prior art in the
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`fashion claimed by Patent Owner.
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`The above block-quoted Petitioner argument cites to declaration
`
`testimony of Dr. Stone. But, the cited testimony is similarly insufficient. It
`
`states:
`
`100. The ‘083 Patent [Bathe] teaches a nitric oxide
`delivery system with various components including a gas
`cylinder, several valves and a CPU for controlling therapy, and a
`ventilator for delivering gas to a patient. The ‘510 Patent [Peters]
`teaches a valve assembly for gas delivery that could easily be
`incorporated into the delivery system described in the ‘083
`Patent by installing the ‘510 Patent’s valve on the cylinder of the
`‘083 Patent. When so incorporated, the valve of the ‘510 Patent
`is placed in fluid communication with the fluid circuit of the ‘083
`Patent. The valve from the ‘510 Patent also adds its “smart
`handle” features to the ‘083 Patent’s system, including a
`processor, a transceiver, and a memory device disposed in the
`valve handle. These “smart handle” features provide the same
`benefits described in the ‘510 Patent to the system of the ‘083
`Patent.
`
`Ex. 1002 ¶ 100. Dr. Stone’s reasoning is unpersuasive. First, Dr. Stone
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`testifies that the smart valve of Peters could be incorporated into Bathe
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`without saying why a person of ordinary skill in the art would do so in the
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`first instance. Ex. 1002 ¶ 100. He then describes, albeit vaguely, the
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`benefits of making the combination. Id.
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`In his concluding sentence, Dr. Stone testifies that incorporating the
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`smart valve of Peters into Bathe would provide Bathe with “the same
`
`benefits described in” Peters. Id. Peters describes the benefits of its smart
`
`valve as providing the ability to “record[] the number and duration of the
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`treatments,” to “read or download[]” the recorded information, and to
`
`“generate[] reports to keep a record of the treatments on the patients, for
`
`record keeping, for billing the patients, and for checking the billing [a
`
`healthcare provider] receives from its [therapeutic gas] supplier.” Ex. 1004,
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`6:21–63.
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`Petitioner has not provided an adequate reason to combine the
`
`teachings in the manner Petitioner asserts renders the claims unpatentable.
`
`Even if we were to assume that the described benefits of each reference
`
`provided a reason to combine their teachings—as Dr. Stone’s testimony
`
`implies—the result would not be the combination Petitioner asserts. Rather,
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`the result would be the Bathe NO delivery system remaining controlled by a
`
`CPU that operates based on real time feedback from transducers in which
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`the introduced smart valve would record, as Peters teaches, the number and
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`duration of treatments for record-keeping purposes, not for controlling gas
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`delivery.
`
`Relying on the same paragraph 100 of Dr. Stone’s declaration,
`
`Petitioner offers the following additional reason to combine the prior art:
`
`[S]ince some advantages of the ’510 Patent [Peters] involve
`tracking gas data in the cylinders (e.g., “assign patient ID to
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`cylinders” and “identify and control cylinders for blinded clinical
`trials,” see Ex. 1004 at 7:36-47), a person of skill in the art would
`have understood that the valve memory 22 disclosed in the ’510
`Patent could be used to store gas data, and in turn, that data could
`be transmitted to a control module, as disclosed in the ’083
`Patent, to control gas therapy. (Ex. 1002 ¶ 100.)
`
`Pet. 20–21. In its Reply, Petitioner expands on this reasoning, quoting the
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`Abstract of Peters as disclosing “that data stored in its valve memory can be
`
`used ‘for inventory control, and for other record-keeping and control
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`functions.’” Reply 14 (quoting Ex. 1004, Abstract) (Petitioner’s emphasis).
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`Petitioner argues that this reference to “control functions” refers, not to
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`inventory control, but rather to controlling the administration of therapeutic
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`gas to a patient. Id. at 14–15 (citing Ex. 2020, 124:16–125:6, 128:23–
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`129:1).
`
`We reach a different factual finding. The relevant sentence from the
`
`Abstract reads in entirety as follows: “The log of the events and the
`
`corresponding dates and times may be used to prepare invoices for billing
`
`gas treatments, for inventory control, and for other record-keeping and
`
`control functions.” Ex. 1004, Abstract. By considering the subject of the
`
`sentence—the log of the events and the corresponding dates and times—it
`
`becomes clear that Petitioner’s interpretation that “control functions” refers
`
`to controlling the administration of therapeutic gas to a patient is
`
`unsupportable. Indeed, Peters repeatedly refers to using its smart handle
`
`only for post-treatment uses such as billing and inventory control and the
`
`like. For example, the “Summary” of Peters provides in full:
`
`The present invention provides a valve with a smart handle
`for the gas bottle (or cylinder). This valve records all the
`treatment information and makes the information readily
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`accessible for use in tracking and invoicing. It permits the
`vendor to invoice the user for total treatment time and to provide
`users, such as hospitals or clinics, the information to bill
`individual patients. It also provides both the vendor and the user
`with data which is useful for trend analysis and inventory control.
`
`The valve handle includes sensors for sensing the opening
`and closing of the valve, a timer for timing the duration over
`which the valve is opened, and an electronic memory device
`which records the pertinent information. The information
`recorded by the memory device may include the cylinder fill
`date, the lot batch number, cylinder number, the patient's name,
`the number of times the valve is opened, and the date, time, and
`duration of each opening of the valve, as well as additional
`information, if desired.
`
`The data then can be readily transferred from the memory
`device to a device that generates reports or invoices.
`
`Ex. 1004, 1:34–54; see also id. at 6:56–63 (describing the printing of reports
`
`for billing and inventory purposes); 7:9–15 (describing the generation of
`
`reports “to track treatments, do billings, and to control inventory”). Peters
`
`does not teach using its smart valve for controlling the administration of
`
`therapeutic gas to a patient.
`
`Petitioner’s challenge lacks an adequate reason, 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
`
`gas concentration in the gas container” and (b) its processor and transmitter
`
`“to send 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
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`concentration data, even though the CPU already receives (and uses) flow
`
`and operator input data to provide a desired NO concentration. See Ex.
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`1005, 6:5–20. Accordingly, Petitioner has not demonstrated that any of the
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`challenged claims is unpatentable over Bathe, Peters, Paoli, and IR Standard.
`
`C. Petitioner Grounds 2 and 3
`
`Petitioner’s Grounds 2 and 3, challenging claims 3 and 4 further in
`
`view of Lebel and claims 9 and 10 further in view of Durkan, respectively,
`
`suffer from the same failure as its Ground 1. Accordingly, Petitioner has not
`
`demonstrated that any of the challenged claims is unpatentable over the
`
`asserted combination of references.
`
`III. PATENT OWNER’S MOTION TO EXLCUDE
`
`Patent Owner filed a Motion to Exclude Exhibits 1002 and 2020, i.e.,
`
`Dr. Stone’s declaration and deposition testimony. Paper 44. Because we do
`
`not rely on any of Dr. Stone’s testimony in a manner adverse to Patent
`
`Owner, we dismiss the Motion as moot.
`
`IV. CONCLUSION
`
`Petitioner has not shown by a preponderance of the evidence that any
`
`claim of the ’904 patent is unpatentable.
`
`V. ORDER
`
`Accordingly, it is
`
`ORDERED that claims 1–16 of U.S. Patent No. 8,291,904 B2 are not
`
`unpatentable on the record presented;
`
`FURTHER ORDERED that Patent Owner’s Motion to Exclude is
`
`dismissed as moot; and
`
`FURTHER ORDERED that, because this Decision is final, a party to
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`the proceeding seeking judicial review of the Decision must comply with the
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`notice and service requirements of 37 C.F.R. § 90.2.
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`IPR2015-00884
`Patent 8,291,904 B2
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`Petitioner:
`
`Sanjay Murthy
`Sanjay.murthy@morganlewis.com
`
`Margaux Nair
`Margaux.nair@klgates.com
`
`Maria Doukas
`Maria.doukas@morganlewis.com
`
`Benjamin Weed
`Benjamin.weed.ptab@klgates.com
`
`
`
`Patent Owner:
`
`Bob Steinberg
`Bob.steinberg@lw.com
`
`Daniel Brown
`Daniel.brown@lw.com
`
`David Callahan
`David.callahan@lw.com
`
`Kenneth Schuler
`Kenneth.schuler@lw.com
`
`Marc Zubick
`Marc.zubick@lw.com