Trials@uspto.gov
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` Paper 14
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`Date: 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 IPR2015-00884
`Patent 8,291,904 B2
`____________
`
`Before KEN B. BARRETT, MICHAEL J. FITZPATRICK, and
`SCOTT A. DANIELS, Administrative Patent Judges.
`
`FITZPATRICK, Administrative Patent Judge.
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`571-272-7822
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`
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` Paper 14
`
`
`Date: September 22, 2015
`
`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.
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`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
`pursuant to 35 U.S.C. § 313. Paper 9, “Prelim. Resp.”
`We have authority to determine whether to institute an inter partes
`review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a). Upon consideration of the
`Petition and the Preliminary Response, and for the reasons explained below,
`we determine that the information presented shows a reasonable likelihood
`that Petitioner would prevail with respect to all challenged claims. See 35
`U.S.C. § 314(a). Accordingly, we grant the Petition to institute an inter
`partes review.
`
`A. Related Matters
`
`The parties identify INO Therapeutics LLC v. Praxair Distribution,
`Inc., Civil Action No. 1:15-cv-00170 (D. Del.), as a related judicial matter.
`Pet. 7; Paper 6, 2.
`Petitioner asserts that “U.S. Patent Application Nos. 14/328,150,
`14/065,962, 14/[]629,742 (unpublished), and 29/471,765 (unpublished) are
`currently pending and purport to claim the benefit of the ultimate priority
`document of the ’904 Patent.” Pet. 7. In a purported response, Patent
`Owner states that “[c]ontrary to Petitioner’s allegation, there are no pending
`continuing patent applications that claim the benefit of U.S. Patent No.
`8,291,904.” Paper 6, 2. Patent Owner’s statement, however, is not
`responsive to Petitioner’s assertion.
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`B. 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,
`it states that there was a need “to ensure that patient information contained
`within [a] computerized system matches the gas that is to be delivered” 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 1:40–45.
`The ’904 patent describes a gas delivery system comprised of a valve
`assembly having a valve and circuit in communication with a control module
`to control administration of the therapy gas to a patient. Id. at 5:59–6:4.
`Administration of the therapy gas to the patient is controlled by controlling
`delivery of the gas from the gas source (i.e., a cylinder 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 shows valve assembly 100 attached to gas source (cylinder)
`50 via attachment portion 102. Ex. 1001, 6:26–29. The valve assembly
`includes inlet 104, outlet 106, valve 107, data input 108, and actuator 114
`with cap 112 mounted thereto, as well as a circuit that is not shown in Figure
`2. Id. at 6:26–37. Figure 3 shows the assembly valve partially
`disassembled, thus revealing circuit 150 within the actuator. Id. at 6:30–35.
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`Figure 4 is reproduced below.
`
`
`Figure 4 shows a block diagram of circuit 150 having valve processor
`122, valve memory 134, valve transceiver 120, valve display 132, reset 128,
`power source 130, timer 124,1 and open/close sensor 126. Ex. 1001, 6:41–
`54. Gas data, such as gas composition and concentration, 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 7:5–21. The valve
`assembly is configured to communicate with the control module via wireless
`optical line-of-sight transmission between the valve transceiver and a CPU
`transceiver of the control module. Id. at 8:41–48.
`
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`1 Figure 4 mislabels the timer as 134. It should be labelled 124. Ex. 1001,
`6:45.
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`Figure 9 is reproduced below.
`
`
`Figure 9 shows control module 200 that is physically separate, but in
`close proximity to the valve assembly 100. Ex. 1001, 10:36–48. A
`depiction of the previously mentioned wireless optical line-of-sight
`transmission between control module 200 and valve assembly 100 is labeled
`300. Id. at 6:7, 8:24–27. The control module is ultimately responsible for
`delivery and regulation of a desired gas to a ventilator and patient, and it
`requests data from circuit 150 within valve assembly 100 at pre-determined
`intervals to facilitate the appropriate gas delivery to the patient. Id. at 8:41–
`57, 9:62–10:4.
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`C. The Challenged Claims
`
`Petitioner challenges all claims, i.e., claims 1–16. Claim 1 is the sole
`independent claim. It is illustrative and reproduced below.
`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;
`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 gas
`concentration in the gas container and
`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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`D. Asserted Grounds of Unpatentability
`
`Basis
`§ 103(a)6
`
`Claims Challenged
`1–8 and 11–16
`
`Petitioner identifies the following as asserted grounds of
`unpatentability:
`References
`Bathe (Ex. 1005)2, Peters
`(Ex. 1004)3, Paoli (Ex. 1006)4,
`and IR Standard (Ex. 1007)5
`Bathe, Peters, Paoli, IR
`Standard, and Lebel
`(Ex. 1008)7
`Bathe, Peters, Paoli, IR
`Standard, and Durkan
`(Ex. 1010)8
`
`§ 103(a)
`
`3 and 4
`
`§ 103(a)
`
`9 and 10
`
`Pet. 10.
`
`
`2 U.S. Patent No. 5,558,083, issued Sept. 24, 1996.
`3 U.S. Patent No. 7,114,510, issued Oct. 3, 2006.
`4 French Patent Application Publication No. 2,917,804, published Dec. 26,
`2008.
`5 ISO/IEEE 11073-30300, “Health informatics -- Point-of-care medical
`device communication -- Part 30300: Transport profile -- Infrared
`wireless,” ISO, IEEE, (Dec. 15, 2004).
`6 The Leahy-Smith America Invents Act (“AIA”), Pub.L. No. 112-29, took
`effect on March 18, 2013. Because the application from which the ’904
`patent issued was filed before that date, our citations to Title 35 are to its
`pre-AIA version.
`7 U.S. Patent No. 6,811,533 B2, issued Nov. 2, 2004.
`8 U.S. Patent No. 4,462,398, issued July 31, 1984.
`
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`II. ANALYSIS
`
`A. Claim Construction
`
`“A claim in an unexpired patent shall be given its broadest reasonable
`construction in light of the specification of the patent in which it appears.”
`37 C.F.R. § 42.100(b). Pursuant to that standard, the claim language should
`be read in light of the specification, as it would be interpreted by one of
`ordinary skill in the art. In re Suitco Surface, Inc., 603 F.3d 1255, 1260
`(Fed. Cir. 2010). Thus, we generally give claim terms their ordinary and
`customary meaning. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257
`(Fed. Cir. 2007) (“The ordinary and customary meaning is the meaning that
`the term would have to a person of ordinary skill in the art in question.”)
`(internal quotation marks omitted).
`Neither party proposes expressly construing any term of the
`challenged claims. Pet. 8–9; Prelim. Resp. 13. We discern no reason to
`construe expressly any term for purposes of this decision.
`
`B. Petitioner Ground 1
`
`Petitioner asserts that claims 1–8 and 11–16 would have been obvious
`over Bathe, Peters, Paoli, and IR Standard. Pet. 10. For the reasons
`explained below, Petitioner has demonstrated a reasonable likelihood of
`prevailing on that assertion.
`
`1. Overview of Bathe
`
`Bathe identifies the same first named inventor as that of the
`challenged ’904 patent. Ex. 1005, at [75]. Bathes discloses a “nitric oxide
`delivery system that is useable with various means of administering the NO
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`. . . such as a ventilator or with spontaneous ventilation where the NO is
`introduced by means of a gas proportioning device that provides a
`continuous flow to the patient.” Id. at 2:14–19.
`Figure 1 of Bathe is reproduced below.
`
`
`Figure 1 shows a schematic view of the Bathe system having flow
`transducers 26, 46, which determine the flow of gas in the system, and CPU
`56 with input device 58, which provides for an operator to select a desired
`concentration of NO to the patient. With flow and operator input
`information, the CPU calculates the desired flow to provide the selected NO
`concentration and, via feedback loop shown above in Figure 1, adjusts the
`desired gas concentration and flow via signals sent to valves 14, 18, 20, and
`24. Ex. 1005, 6:5–20. Another input to CPU 56 is the NO concentration in
`supply cylinder 10. Id. at 6:5–6. Bathe states the following about that input:
`The 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,
`
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`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.
`Ex. 1005, 6:6–11. In other words, the CPU 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, knowing the desired NO concentration set by the user via
`input 58, the CPU can adjust valves 14, 18, 20, and 24 to bring the actual gas
`flow and NO concentration to the patient into accord with the user’s desired
`input level. Id. at 6:43–53.
`
`2. Overview of Peters
`
`Peters discloses a valve with a “smart” handle for use with gas
`cylinders in medical treatments involving the use of gases administered to
`patients. Ex. 1004, 1:16–17, 34–35.
`Figure 1 of Peters is reproduced below.
`
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`Figure 1 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). Within the handle9 are
`several electronic components, namely, processor 23, timer 21, memory 22
`and data port 22', sensor 28, battery 25 and display 26. Ex. 1004, 2:58–64.
`Figure 2b is reproduced below.
`
`
`Figure 2b shows a block diagram of the electronic components just
`mentioned.10 Peters explains that the memory configuration is established
`by initial parameters such as the following: born on date (date when
`cylinder was filled); cylinder serial number; gas lot number; set the timers
`(which may include a calendar timer and an event timer); and clear the log
`registers. Id. at 5:43–56.
`“When the valve handle 16 is turned to open or close the valve, the
`proximity sensor 28 triggers the processor 23 to instruct the memory device
`
`
`9 The ’904 patent depicts a virtually identical valve handle but refers to it as
`an “actuator.” Ex. 1001, 6:31, Fig. 2, ref. 114.
`10 Figure 2b of Peters is virtually identical to Figure 4 of the ’904 patent,
`except that it lacks a transceiver.
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`22 to log the event, including date, time, and whether the event was an
`opening or a closing of the valve.” Ex. 1004, 6:21–25. “Thus, 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 Paoli
`
`Paoli relates to a connection system for a valve to a gas bottle or
`cylinder. Ex. 1006, 017. 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 019.
`Figure 1 of Paoli is reproduced below.
`
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`Figure 1 shows a block diagram illustrative of control module 300 for
`controlling valve 20. The control module receives input signal IDb, which is
`the identification of gas type being supplied from the bottle, and compares
`this with input data IDv, which is the desired type of gas for the procedure
`that is stored in memory 200. Ex. 1006, 019. Paoli 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, Paoli discloses that the type of gas in bottle
`10 (IDb) can be acquired from information carrier 120, such as an RFID tag
`on the bottle, which would be read by sensor 110 when the valve is attached
`to the bottle. Id. at 020.
`
`4. Overview of IR Standard
`
`IR Standard is a protocol promulgated by IEEE as an international
`standard for short-range infrared (IR) wireless communication for medical
`devices used at or near a patient. Ex. 1007, Abstract. IR Standard describes
`wireless communication standards with a goal of “[f]acilitat[ing] the
`efficient exchange of vital signs and medical device data, acquired at the
`point-of-care, in all health care environments.” Id. at vi. IR Standard 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. IR Standard illustrates an IR communication system
`including an IR transceiver in order to retrofit a previously hard wired cable-
`communicating system. Id. at 39–40.
`
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`5. Petitioner’s Application of the Asserted Art to the Challenged Claims
`
`Petitioner argues that the subject matter of claims 1–8 and 11–16
`would have been obvious over Bathe, Peters, Paoli, and IR Standard. In
`brief, the Petition states that it would have been obvious to a person of
`ordinary skill in the art to use a smart valve (as taught by Peters) to
`communicate data regarding the gas in a supply cylinder (as taught by Paoli)
`and which data would encompass gas concentration (as taught by Bathe), via
`optical line-of-sight transmission (as taught by IR Standard) with a CPU-
`controlled gas delivery system (as taught by Bathe). Id. Pet. 19–24. The
`Petition then explains how the combined teachings meet each limitation of
`the challenged claims. Pet. 24–31 (regarding claim 1); Pet. 31–46
`(regarding the challenged dependent claims).
`a)
`Claim 1
`Claim 1 requires “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.” Petitioner
`directs us to the valve of Peters, which has valve body 14, which “includes a
`threaded inlet port 18 which screws onto the outlet port of the cylinder 12”
`and “also includes an outlet port 20.” Pet. 26 (citing Ex. 1004, 2:46–49).
`Petitioner also notes that the Peters valve includes handle 16, which can be
`turned to open or close the valve to allow the therapy gas to flow through the
`valve and into “a ventilator or other gas dispensing device (not shown).”
`Pet. 26 (citing Ex. 1004, 2:52–55). Patent Owner does not dispute this
`evidence or the assertion that this evidence meets the limitation in question.
`On the present record, we agree that the cited evidence meets this limitation.
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`Claim 1 requires “a circuit supported within the valve assembly and
`disposed between the actuator and a cap.” To meet this limitation, Petitioner
`directs us to the disclosure in Peters of circuit components disposed between
`the “handle 16” (or actuator) and the “cover 24” (or cap). Pet. 27 (citing Ex.
`1004, 2:58–61, Fig. 1, 1A, 2, 2A, and 5). Patent Owner does not dispute this
`evidence or the assertion that this evidence meets the limitation in question.
`On the present record, we agree that the cited evidence meets this limitation.
`Claim 1 requires that the circuit include “a valve memory to store gas
`data comprising gas concentration in the gas container.” Peters specifically
`discloses a memory within the handle of its smart valve. Ex. 1004, 2:58–61.
`Petitioner notes that Peters discloses that gas data can be stored in the valve
`memory to indicate information about the gas in the cylinder and the stored
`information can be used for gas therapy. Pet. 28 (citing Ex. 1004, 5:43–
`6:12, 7:36–47). Petitioner also notes that Paoli discloses a memory for
`storing data about the gas in a supply cylinder (i.e., IDb data). Pet. 28
`(citing Ex. 1006, 020–021).
`Neither Peters nor Paoli disclose storing gas concentration data in its
`respective memory, which omission Patent Owner points out. See Prelim.
`Resp. 19, 20 n.4. But, as Petitioner further notes, a different reference—
`Bathe—discloses a gas delivery system controlled by a CPU that controls
`the concentration of gas being delivered to a patient and teaches that the
`actual concentration of the gas in a supply cylinder can be used to “verify
`that the proper supply is being utilized.” Pet. 11–12 (citing Ex. 1005,
`Abstract); Pet. 28 (citing Ex. 1005, 6:5–8).
`Patent Owner argues that the relied-upon Bathe teachings “are
`irrelevant because they have nothing to do with a valve assembly.” Prelim.
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`Resp. 21. But, that argument addresses Bathe in isolation, whereas
`Petitioner’s ground relies on a combination of references, including Peters,
`which provides the teaching of a smart valve with a memory to which gas
`data can be inputted. Pet. 22–23; 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.”).
`Claim 1 requires that the circuit also include “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.” In addressing this limitation,
`Petitioner directs us to the smart valve of Peters, which includes a processor
`that accesses the valve memory. Pet. 28–29 (citing Ex. 1004, 2:58–61,
`3:40–49, 6:21–25). As noted by Petitioner, Peters also discloses gas data
`entered into the memory by either the cylinder manufacturer or the hospital
`and a transceiver in communication with the memory to send and receive
`signals to communicate the gas data to an external computer for generating
`usage or billing reports. Ex. 1004, 5:57–6:12, 6:33–7:15, Pet. 29. As
`discussed above, Bathe teaches sending, to a CPU that controls a gas
`delivery system, data pertaining to the concentration of a gas in a supply so
`that the CPU can “verify that the proper supply is being utilized.” Ex. 1005,
`6:5–8. Petitioner asserts that a person of ordinary skill in the art, in order to
`communicate gas concentration data from the valve to such a CPU (i.e., the
`asserted control module), would have used an interface disclosed in enabling
`standards, such as those described in IR Standard. Pet. 29.
`
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`Patent Owner argues that Peters does not disclose sending gas data to
`a control module that controls gas delivery to a patient but rather merely
`discloses sending gas data to “an external computer” for “logging and
`billing.” Prelim. Resp. 26. But, that argument addresses Peters in isolation
`instead of the proposed combination. See In re Merck, 800 F.2d at 1097.
`Lastly, claim 1 requires “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.” To meet this limitation, Petitioner directs us to
`the smart valve of Peters, which includes port 22' projecting through handle
`16. Pet. 30. Peters states that gas data can be entered into the valve memory
`via port 22'. Ex. 1004, 5:65–6:12. Indeed, port 22' of Peters looks like the
`data input of the ’904 patent. Compare Ex. 1001, Fig. 3, ref. 108, with Ex.
`1004, Fig. 1, ref. 22'. As discussed above, per Bathe, the inputted gas data
`would include gas concentration data. Patent Owner does not dispute this
`evidence or the assertion that this evidence meets the limitation in question.
`On the present record, we agree that the cited evidence meets this limitation.
`b)
`Dependent Claims 2–8 and 11–16
`For these claims, and their additional limitations, Petitioner directs us
`to relevant teachings from the asserted references and reasons why a person
`of ordinary skill in the art would incorporate those teachings. Pet. 31–46.
`For claims 3, 4, 14, and 15, Patent Owner does not dispute the
`asserted evidence or that the evidence meets the additional limitations in
`question.
`For the remaining dependent claims, Patent Owner attacks a reference
`in isolation instead of the proposed combination. For example, in opposing
`the challenge to claim 2, Patent Owner states the following:
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`Petitioner relies on [Paoli] for its teaching of a bar
`code provided on a bottle of gas. However, the
`only information contained in that bar code is
`identification data IDb regarding the type of gas
`contained in the bottle. Ex. 1006 at 21. Neither
`[Paoli] nor any other cited art teaches or suggests a
`bar code that provides gas concentration, as claim
`2 requires.
`Prelim. Resp. 34–35. Petitioner, however, need not show an express
`teaching in a single limitation of a bar code that provides gas concentration.
`Petitioner instead has relied on a combination of teachings, including Paoli’s
`teaching of a bar code encoding gas data generally and Bathe’s teaching of
`using gas concentration data specifically. Patent Owner’s attacking
`individual references is inapposite. See In re Merck, 800 F.2d at 1097.
`
`6. Reason to Combine
`
`We now turn to Patent Owner’s argument that the Petition fails to
`explain why a person of ordinary skill in the art would have combined the
`prior art teachings as asserted in the Petition. In particular, Patent Owner
`argues that the Petition fails to identify a reason why a person of ordinary
`skill in the art would store supply gas data (as taught by Paoli) in a valve
`memory (as taught by Peters) before sending to a control module such as in
`Bathe. Prelim. Resp. 23. But, the Petition persuasively explains that a
`person of ordinary skill in the art would desire to improve the patient safety
`aspects of Bathe’s NO delivery system with Paoli’s gas supply data and
`delivery data comparison regimen, and “would have added a smart handle
`and valve, as disclosed in the [Peters] Patent, to the NO delivery system
`disclosed in the [Bathe] Patent to allow the user to better link the gas
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`information with patient treatments.” Pet. 21–22 (citing Ex. 1002 ¶ 102).11
`That one of skill would look to improve upon the safety and efficacy of a
`known gas delivery system using a known smart valve from the same field is
`common sense and not inventive. See Wyers v. Master Lock Co., 616 F.3d
`1231, 1240 (Fed. Cir. 2010) (“[T]he 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.”); see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007)
`(“The combination of familiar elements according to known methods is
`likely to be obvious when it does no more than yield predictable results.”).
`Patent Owner also contends that neither the Petition nor the
`declaration of Dr. Stone adequately identifies a reason why a person of
`ordinary skill in the art would have combined a smart valve (as taught by
`Peters) with teachings from the other references such as Bathe and Paoli.
`Prelim. Resp. 33. Specifically, Patent Owner argues that the smart valve of
`Peters is used for billing and inventory control, not to communicate with a
`control module controlling gas delivery to a patient. Id. 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 Nutrition, Inc. v. Steuben Foods, Inc.,
`IPR2015-00094, Paper 14, at 7–9 (PTAB May 4, 2015)). But, the Petition
`includes more than a mere assertion regarding workability. For example, the
`Petition notes that Peters itself teaches that its smart valve can control “‘the
`
`
`11 Exhibit 1002 is a declaration by Robert T. Stone, Ph.D.
`
`20
`
`
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`IPR2015-00884
`Patent 8,291,904 B2
`
`flow of gas from the cylinder 12 to a ventilator or other gas dispensing
`device,’ such as the gas delivery system of the [Bathe] Patent.” Pet. 20
`(quoting Ex. 1004, 2:52–55). Further, Dr. Stone testified that a person of
`ordinary skill in the art would combine a smart valve (as taught by Peters)
`with a gas delivery system (as taught by Bathe) to obtain the known
`beneficial aspects of both references. Ex. 1002 ¶¶ 99–100; see also KSR,
`550 U.S. at 416 (“The combination of familiar elements according to known
`methods is likely to be obvious when it does no more than yield predictable
`results.”). The Petition has presented a sufficient reasoning with rational
`underpinning to support the legal conclusion of obviousness. See In re
`Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).
`For the forgoing reasons, there is a reasonable likelihood that
`Petitioner will prevail in showing that claims 1–8 and 11–16 would have
`been obvious over Bathe, Peters, Paoli, and IR Standard.
`
`C. Petitioner Ground 2
`
`Petitioner asserts that claims 3 and 4 would have been obvious over
`Bathe, Peters, Paoli, IR Standard, and Lebel. Pet. 10. For the reasons
`explained below, Petitioner has demonstrated a reasonable likelihood of
`prevailing on that assertion.
`Lebel discloses a protocol for an RF telemetry communication system
`for medical devices. Ex. 1008, Abstract. More specifically, Lebel teaches
`optimizing power consumption in communication devices for instance
`between a surgically implanted device in a human body, such as an insulin
`pump, and an external control or monitoring device by sending
`communications intermittently to conserve battery power. Id. at 2:18–35.
`
`21
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`IPR2015-00884
`Patent 8,291,904 B2
`
`Lebel states that the time between communications can occur for example
`“no more than 15 seconds apart, more preferably no more than 10 seconds
`apart, and even more preferably no more than 5 seconds apart, and most
`preferably no more than about 2 seconds apart.” Id. at 25:5–9. Lebel further
`explains that power conservation in such medical devices is a balance where
`“desire to minimize power drain in the implantable device is balanced with a
`desire to have the implantable device respond quickly to commands
`transmitted by the external communication device.” Id. at 25:60–63.
`Claim 3 depends from claim 1 and recites that “the valve comprises a
`power source; and the valve transceiver periodically sends the wireless
`optical line-of-sight signals to the control module, wherein the signals are
`interrupted by a duration of time at which no signal is sent.” Claim 4
`depends from claim 3 and adds that “the duration of time at which no signal
`is sent comprises about 10 seconds.” The Petition applies the teachings from
`Lebel relating to power management in battery-operated devices to these
`additional limitations and explains how and why those teachings would be
`incorporated into its proposed combination (i.e., with teachings from Bathe,
`Peters, Paoli, IR Standard as applied in Ground 1). Pet. 46–52.
`Patent Owner’s merits-based arguments against instituting on Ground
`2 are limited to those it raised for Ground 1. Prelim. Resp. 43. We have
`already rejected those arguments above.
`Patent Owner also argues against instituting on Ground 2 as
`“redundant” of Ground 1, which also challenges claims 3 and 4. Id. at 43–
`44 (citing Liberty Mutual Ins. v. Progressive Casualty Ins., CBM2012-
`00003, Paper 7, at 2 (PTAB Oct. 25, 2012) (“Liberty Mutual”)). Liberty
`Mutual provides guidance on asserting multiple challenges (or grounds)
`22
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`IPR2015-00884
`Patent 8,291,904 B2
`
`against the same claims, but we do not find it applicable to the facts here,
`which are that a mere two claims are being challenged under two grounds.
`In contrast, in Liberty Mutual, the petition included four hundred and
`twenty-two grounds of unpatentability, thus averaging twenty-one
`challenges per challenged claim. Liberty Mutual, at 1–2. In Liberty Mutual,
`the panel expressed concern that considering all such grounds would
`jeopardize a just, speedy, and inexpensive resolution of the proceeding. Id.
`at 2 (citing 37 C.F.R. § 42.1(b)). We have no such concern here.
`Additionally, in determining whether to consider multiple grounds
`against the same claim and, if so, which of those grounds, Liberty Mutual
`looked to whether the petition articulated a meaningful distinction in terms
`of relative strengths and weaknesses with respect to application of the
`reference disclosures to one or more claim limitations. Id. at 2. The instant
`Petition, in fact, has articulated a meaningful distinction between Ground 1
`and 2, with respect to specific limitations added by dependent claims 3 and
`4. In that regard, Ground 2 additionally applies Lebel, as it is directly
`related to power conservation in electronic device-to-device communication,
`also in the medical field, and expressly discloses intermittent signal
`propagation as facilitating power conservation.
`“When instituting inter partes review, the Board may authorize the
`review to proceed . . . on all or some of the grounds of unpatentability
`asserted for each claim.” 37 C.F.R. § 42.108(a) (emphasis added). We
`exercise that authority and institute on Ground 2 as well as Ground 1.
`There is a reasonable likelihood that Petitioner will prevail in showing
`that claims 3 and 4 would have been obvious over Bathe, Peters, Paoli, IR
`Standard, and Lebel.
`
`23
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`
`D. Petitioner Ground 3
`
`Petitioner asserts that claims 9 and 10 would have been obvious over
`Bathe, Peters, Paoli, IR Standard, and Durkan. Pet. 10. For the reasons
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