Trials@uspto.gov
`571-272-7822
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` Paper 54
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`Date: September 14, 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 IPR2015-00888
`Patent 8,776,794 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)
`
`
`
`
`571-272-7822
`
`
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`
`
` Paper 54
`
`
`Date: September 14, 2016
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`PRAXAIR DISTRIBUTION, INC.,
`Petitioner,
`
`v.
`
`INO THERAPEUTICS LLC,
`Patent Owner.
`
`
`
`Case IPR2015-00888
`Patent 8,776,794 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)
`
`
`
`
`
`IPR2015-00888
`Patent 8,776,794 B2
`
`I.
`
`INTRODUCTION
`
`Petitioner, Praxair Distribution, Inc., filed a Petition to institute an
`inter partes review of claims 1–20 of U.S. Patent No. 8,776,794 B2 (Ex.
`1001, “the ’794 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.”). In a September 22,
`2015, Decision, we granted the Petition, instituting trial on all claims on the
`following grounds:
`claims 1–12 and 14–20 as obvious over Bathe (Ex. 1005)1,
`Peters (Ex. 1004)2, Paoli (Ex. 1006)3, and IR Standard (Ex. 1007)4;
`claims 4 and 5 as obvious over Bathe, Peters, Paoli, INOMAX
`label (Ex. 1014)5, IR Standard, and Lebel (Ex. 1008)6; and
`claim 13 as obvious over Bathe, Peters, Paoli, INOMAX label,
`IR Standard, and Durkan (Ex. 1010).7
`Paper 14 (“Inst. Dec.”).
`After institution, Patent Owner filed a Patent Owner Response (Paper
`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 FINAL PRINTED LABELING, CENTER FOR DRUG EVALUATION AND
`RESEARCH, Appl’n. No.: NDA 20845 (2000).
`6 U.S. Patent No. 6,811,533 B2, issued Nov. 2, 2004.
`7 U.S. Patent No. 4,462,398, issued July 31, 1984.
`2
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`Patent 8,776,794 B2
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`Also, Patent Owner filed a Motion to Exclude. See Paper 44; see also Paper
`48 (Petitioner’s Opposition); Paper 49 (Patent Owner’s Reply).
`A hearing for oral arguments was held on May 16, 2016, and a
`transcript of the hearing is included in the record. Paper 53.
`As discussed below, Petitioner has not shown by a preponderance of
`the evidence that any of the challenged claims is unpatentable.
`
`A. The ’794 Patent
`
`The ’794 patent relates to the administration of a therapy gas, such as
`nitric oxide (NO), to a patient. Ex. 1001, 1:50–53. 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 ’794 patent describes a gas delivery system comprising 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 5:62–6:7.
`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, or face mask). Id.
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`Figures 2 and 3 are reproduced below.
`
`
`
`
`Figure 2 shows valve assembly 100 attached to gas source (cylinder) 50 via
`attachment portion 102. Ex. 1001, 6:28–31. 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
`6:28–39. Figure 3 shows the assembly valve partially disassembled, thus
`revealing circuit 150 within the actuator. Id. at 6:32–37.
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`Figure 4 is reproduced below.
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`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 124,8 and open/close sensor 126. Ex. 1001, 6:43–
`56. 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. Id. at 7:7–23. 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 8:44–51.
`
`
`8 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 from, but in
`close proximity to, the valve assembly 100. Id. at 10:38–50. 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 6:10,
`8:27–30. 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 8:44–60, 9:65–
`10:7.
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`B. The Challenged Claims
`
`Petitioner challenges all claims of the ’794 patent, i.e., claims 1–20.
`Claims 1, 7, and 15 are independent. Claim 1 is illustrative and reproduced
`below.
`
`1. A gas delivery device comprising:
`a gas source to provide therapy gas comprising nitric
`oxide;
`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 that delivers the therapy gas
`comprising nitric oxide in an amount effective to treat or
`prevent hypoxic respiratory failure; and
`a circuit including:
`a 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 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 gas identification, the gas concentration and
`that the gas is not expired.
`
`
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`Patent 8,776,794 B2
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`II. ANALYSIS
`
`A. Claim Construction
`
`“A claim in an unexpired patent that will not expire before a final
`written decision is issued 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 has proposed expressly construing any term of the
`challenged claims. Pet. 9–10; PO Resp. 7. We discern no reason to construe
`expressly any term for purposes of this Decision.
`
`B. Petitioner Ground 1
`
`Petitioner asserts that claims 1–12 and 14–20 are unpatentable
`because they would have been obvious over Bathe, Peters, Paoli, INOMAX
`label, and IR Standard. Pet. 10. For the reasons explained below, Petitioner
`has not met its burden of persuasion in proving that any claim is
`unpatentable as asserted.
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`1. Overview of Bathe
`
`Bathe identifies the same first named inventor as the challenged ’794
`patent. Ex. 1005, at [75]. Bathes discloses a “nitric oxide delivery system
`that is useable with various means of administering the NO . . . 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 sensor 26
`and flow transducer 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
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`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,
`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, 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 involving the use of gases administered to patients in medical
`treatments. Ex. 1004, 1:16–17, 1:34–35. The “valve records all the
`treatment information and makes the information readily accessible for use
`in tracking and invoicing.” Id. at 1:35–37.
`
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`Figure 1 of Peters is reproduced below.
`
`
`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 handle are
`several electronic components, namely, processor 23, timer 21, memory 22
`and data port 22', sensor 28, battery 25 and display 26. Id. at 2:58–64.
`Figure 2b is reproduced below.
`Figure 2b is reproduced below.
`
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`Figure 2b shows a block diagram of the electronic components just
`mentioned. 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
`22 to log the event, including date, time, and whether the event was an
`opening or a closing of the valve.” Id. at 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 6:29–32. 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
`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.
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`Figure 1 of Paoli is reproduced below.
`
`
`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. Id. 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 INOMAX Label
`
`The INOMAX label reference is a U.S. Food and Drug
`Administration (FDA) publication approving labeling for Patent Owner’s
`INOmax drug generally used in conjunction with NO therapies for newborns
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`with hypoxic respiratory failure. Ex. 1014, 002. The INOMAX label also
`indicates that the drug was used with ventilators administering NO to
`neonatal patients. Id. at 006. The INOMAX label states the following:
`The nitric oxide delivery systems used in the
`clinical
`trials
`provided
`operator-determined
`concentrations of nitric oxide in the breathing gas,
`and the concentration was constant throughout the
`respiratory cycle . . . . In the ventilated neonate,
`precise monitoring of inspired nitric oxide and NO2
`should be instituted, using a properly calibrated
`analysis device with alarms. This system should be
`calibrated using a precisely defined calibration
`mixture of nitric oxide and nitrogen dioxide, such
`as INOcal™. Sample gas for analysis should be
`drawn before the Y-piece, proximal to the patient.
`Oxygen levels should also be measured.
`Id. The INOMAX label indicates that INOmax is supplied in aluminum
`cylinders. Id.
`
`5. Overview of IR Standard
`
`IR Standard is a protocol promulgated by the Institute of Electrical
`and Electronics Engineers (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
`
`14
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`including an IR transceiver in order to retrofit a previously hard wired cable-
`communicating system. Id. at 39–40.
`
`6. Petitioner Has Not Shown That Claims 1–12 and 14–20 Would
`Have Been Obvious over Bathe, Peters, Paoli, the INOMAX
`label, and IR Standard
`
`Although it may not be anticipated, a claimed invention is nonetheless
`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
`before the effective filing date of the claimed invention to a person having
`ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C.
`§ 103(a).9 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).
`Additionally, secondary considerations such as “commercial success, long
`felt but unsolved needs, failure of others, etc., might be utilized to give light
`to the circumstances surrounding the origin of the subject matter sought to
`be patented. As indicia of obviousness or nonobviousness, these inquiries
`may have relevancy.” Id. at 17–18.
`Independent claim 1 is directed to a “gas delivery device” having “a
`valve attached to [a] gas source.” The recited valve includes a circuit that
`must have the following components:
`
`
`9 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, took
`effect on March 18, 2013. As the application from which the ’794 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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`a 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 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 gas identification, the gas
`concentration and that the gas is not expired.
`Independent claim 7 is directed to a “gas delivery system,” that is of
`similar scope to claim 1. Independent claim 15 is directed to a “method for
`administering a therapy gas to a patient,” using a “gas deliver device”
`configured similarly to the gas delivery device of claim 1.
` Peters discloses a memory within the handle of its smart valve that
`stores 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. Ex. 1004, 5:43–56. The memory
`also stores when and for how long the valve is opened or closed. Id. at
`6:21–25. Paoli discloses a memory for storing the type of a gas in a supply
`cylinder (i.e., IDb data), but the Paoli memory is not part of a circuit in a
`valve that also includes a processor and transceiver in accordance with claim
`1. Ex. 1006, 020–021. Bathe teaches obtaining the NO concentration
`actually being delivered to a ventilator in order to provide feedback for a
`CPU to adjust as needed administration of NO a patient is receiving but does
`not store it in a memory in a circuit in a valve. Ex. 1005, 6:5–20. INOmax
`label teaches the importance of administering precise concentrations of NO
`gas to neonatal patients. Ex. 1014, 006. IR Standard describes wireless
`communication standards in medical devices. Ex. 1007, vi.
`
`16
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`Each of Petitioner’s grounds relies on multiple references. In
`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
`Patent [Bathe], the ’510 Patent [Peters], the FR ’804 Publication [Paoli], the
`INOMAX label, and the IR Standard to predictably result in an improved
`nitric oxide delivery system incorporating the advantageous aspects of each
`reference.” Pet. 20.
`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
`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
`course, of the distortion caused by hindsight bias and must be cautious of
`arguments reliant upon ex post reasoning.”); Cheese Sys. v. Tetra Pak
`Cheese & Powder Sys., 725 F.3d 1341, 1352 (Fed. Cir. 2013) (“Obviousness
`cannot be based on the hindsight combination of components selectively
`culled from the prior art to fit the parameters of the patented invention.”)
`(quotation marks omitted).
`The Petition includes a section titled “Motivation to Combine Prior
`Art” that runs approximately six pages. Pet. 20–27. It is difficult to discern
`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.
`Petitioner offers, in part, the following reasoning:
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`The ’083 Patent [Bathe] teaches a basic NO delivery
`system including a gas cylinder 10, valves 14, 18, 20, and 24, and
`a control CPU 56 for controlling the flow and concentration of
`NO gas. (See, e.g., Ex. 1005 at 6:20–28.) The ’510 Patent
`[Peters] discloses a smart valve and handle 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 valve and handle disclosed in the ’510 Patent to obtain
`both the benefits of the smart handle of the ’510 Patent and the
`delivery system of the ’083 Patent. (Ex. 1002 ¶ 110.)
`Pet. 21. 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
`devices according to their established functions, it can be important to
`identify a reason that would have prompted a person of ordinary skill in the
`relevant field to combine the elements in the way the claimed new invention
`does.” KSR, 550 U.S. at 418. “This is so because inventions in most, if not
`all, instances rely upon building blocks long since uncovered, and claimed
`discoveries almost of necessity will be combinations of what, in some sense,
`is already known.” Id. at 418–19. It is important—indeed, we determine
`that it is required in the context of the challenged claims and the relied-upon
`prior art teachings before us—for Petitioner to identify a reason that would
`have prompted a person of ordinary skill to combine the prior art in the
`fashion claimed by Patent Owner.
`The above block-quoted Petitioner argument cites to declaration
`testimony of Dr. Stone. But, the cited testimony is similarly insufficient. It
`states:
`
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`110. 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 ¶ 110. Dr. Stone’s reasoning is unpersuasive. First, Dr. Stone
`testifies that the smart valve of Peters could be incorporated into Bathe
`without saying why a person of ordinary skill in the art would do so in the
`first instance. Id. He then describes, albeit vaguely, the benefits of making
`the combination. Id.
`In his concluding sentence, Dr. Stone testifies that incorporating the
`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
`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,
`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,
`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
`the introduced smart valve separately would record, as Peters teaches, the
`number and duration of treatments for record-keeping purposes, not for
`controlling gas delivery.
`Relying on the same paragraph 110 of Dr. Stone’s declaration,
`Petitioner offers the following additional reason to combine the prior art:
`Since some of the advantages of the ’510 Patent [Peters]
`involve tracking gas data in the cylinders (e.g., “assign patient
`ID to 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
`gas data could be transmitted to a control module as disclosed in
`the ’083 Patent [Bathe], to control gas therapy. (Ex. 1002 ¶ 100.)
`Pet. 21–22. In its Reply, Petitioner expands on this reasoning, quoting the
`Abstract of Peters as disclosing:
`[R]elevant information, such as cylinder fill date, cylinder
`I.D. number, batch number, and patient name or account number
`may also be logged in the memory module. 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 recordkeeping and control functions.
`Reply 14 (quoting Ex. 1004, Abstract) (Petitioner’s emphasis). Petitioner
`argues that the Peters Abstract’s reference to “control functions” refers, not
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`to inventory control, but rather to controlling the administration of
`therapeutic gas to a patient. Id. at 14–15 (citing Ex. 2020, 124:16–125:6,
`128:23–129:1).
`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
`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.
`
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`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 its memory, processor, and transmitter to
`store gas data to be communicated to the CPU and (2) modify the Bathe
`system to operate based on the gas data from the incorporated smart valve as
`opposed to the NO concentration actually being delivered to a ventilator.
`Petitioner’s proffered reasons for why a person of ordinary skill in the
`art would incorporate additional teachings from Paoli, the INOMAX label,
`and IR Standard into the hypothetical combination do not compensate for the
`lack of a sufficient reason to combine, in the first instance, the relied-upon
`teachings of Bathe and Peters. For example, with respect to Paoli, the
`Petition argues:
`The ’083 Patent [Bathe] discloses a general-purpose CPU
`that can use various stored algorithms to process information it
`receives about the actual and desired concentrations of gas to
`control gas delivery. (Ex. 1005 at 2:52–53; Ex. 1002 ¶ 135.) A
`person of skill in the art would understand that the algorithms
`used could be modified to allow the control CPU of the ’083
`Patent to compare the received data and control gas delivery as
`described, for example, in the FR ’804 Publication [Paoli]. (Ex.
`1002 ¶¶ 73, 111–12, 115–18.) Indeed, the comparison of gas
`data with patient data by the control module 300 of the FR ’804
`
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`Publication can easily be incorporated into the delivery system
`of the ’083 Patent since the CPU of the ’083 Patent is taught to
`compare actual concentration data with desired concentration
`data to control gas delivery. (Ex. 1002 ¶¶ 111, 131, 135.) As
`combined, these known prior art elements yield predictable
`results.
`Pet. 22. In this argument, Petitioner again asserts that Bathe could be
`modified to incorporate a feature of another reference and that such
`modification would yield predictable results. Showing that a combination is
`possible and yields predictable results does not, at least not in the context of
`the present challenge (which relies on teachings from five references),
`demonstrate an adequate reason why a person of ordinary skill would have
`combined the prior art in the fashion claimed by Patent Owner.
`Accordingly, Petitioner has not demonstrated that any of the
`challenged claims is unpatentable over Bathe, Peters, Paoli, the INOMAX
`label, and IR Standard.
`
`C. Petitioner Grounds 2 and 3
`
`Petitioner’s Grounds 2 and 3, challenging claims 4 and 5 further in
`view of Lebel and claim 13 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 combinatio
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