Filed on behalf of: INO Therapeutics, LLC
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`
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`
`
`Entered: December 9, 2015
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`
`PRAXAIR DISTRIBUTION, INC.
`Petitioner
`
`v.
`
`INO THERAPEUTICS LLC,
`Patent Owner
`_______________________
`
`
`
`Case IPR2015-00889
`U.S. Patent No. 8,573,209 B2
`_______________________
`
`Before KEN B. BARRETT, MICHAEL J. FITZPATRICK, AND
`SCOTT A. DANIELS, Administrative Patent Judges.
`
`
`
`PATENT OWNER INO THERAPEUTICS LLC’S RESPONSE TO
`PRAXAIR DISTRIBUTION, INC.’S PETITION FOR INTER PARTES
`REVIEW OF U.S. PATENT NO. 8,573,209
`
`
`
`

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`Case IPR2015-00889
`U.S. Patent No. 8,573,209
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`
`
`CONTENTS
`
`TABLE OF CONTENTS
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`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`RELEVANT FACTUAL AND PROCEDURAL BACKGROUND .............. 3
`
`E.
`
`F.
`
`A. Overview of the Board’s Institution Decision ...................................... 3
`B.
`The ’209 Patent ..................................................................................... 4
`C.
`Claim Construction ............................................................................... 7
`D.
`Patent Owner’s Commercial Embodiments of the Inventions of
`the ’209 Patent ....................................................................................... 7
`Other NO Delivery Systems Marketed at or Around the Time of
`Inventions of the ’209 Patent Lacked the Inventions of the ’209
`Patent ..................................................................................................... 8
`1.
`Petitioner Praxair’s NOMIX System .......................................... 8
`2.
`The Opti Kinox Station from Air Liquide .................................. 9
`The Regulatory Environment Guiding the Work of a POSA
`Developing Medical Devices Like the Claimed Inventions ............... 10
`1.
`Classes of Regulated Devices ................................................... 10
`1.
`The 510(k) Process Is Necessary to Market a Class II
`Device ....................................................................................... 11
`The FDA Regulatory Regime Encourages the Use of
`Known Safety Solutions and Discourages Deviation in
`the Absence of an Identifiable and Known Problem ................ 12
`
`2.
`
`III. THE CITED REFERENCES ......................................................................... 13
`
`A.
`B.
`C.
`D.
`
`Bathe (U.S. Patent No. 5,558,083) ...................................................... 13
`Peters (U.S. Patent No. 7,114,510) ..................................................... 14
`FR ’804 (FR 2,917,804) ...................................................................... 17
`IR Standard (ISO/IEEE 11073-30300) ............................................... 19
`
`IV. DR. STONE’S “COMBINABILITY” OPINIONS ARE DEFICIENT
`AS A MATTER OF LAW AND THE BOARD SHOULD
`DISREGARD THEM .................................................................................... 19
`
`A. Dr. Stone Failed to Analyze the Claims .............................................. 20
`B.
`Dr. Stone Did Not Know or Apply the Correct Legal Standards ....... 24
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`Case IPR2015-00889
`U.S. Patent No. 8,573,209
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`C.
`
`Dr. Stone Failed to Consider Objective Indicia of Non-
`Obviousness ......................................................................................... 26
`D. Dr. Stone Improperly Used Hindsight Bias ........................................ 28
`E.
`Given Dr. Stone’s Deficient Declaration, the Petition is
`Insufficient As a Matter of Law .......................................................... 30
`
`V.
`
`THE ASSERTED COMBINATION FAILS TO SATISFY ALL
`LIMITATIONS OF THE CHALLENGED CLAIMS .................................. 32
`
`VI. THERE WOULD HAVE BEEN NO MOTIVATION TO COMBINE
`BATHE ’083, PETERS ’510, FR ’804, and THE IR STANDARD ............. 36
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`2.
`
`Petitioner Has Failed to Show That a POSA Was Aware of the
`Problem Addressed by the ’209 Patent Claims ................................... 38
`A POSA Would Not Be Motivated to Combine Bathe And
`Peters ................................................................................................... 40
`A POSA Would Not Be Motivated to Combine Bathe And
`Peters with FR ’804 ............................................................................. 45
`1. Mechanical Connection Limitations in NO Delivery
`Systems Eliminate Any Need for FR ’804 ............................... 46
`Replacing the Peters Manual Valve with the Automatic
`Valve of FR ’804 Would Create Substantial Problems ............ 48
`The IR Standard and Lebel Do Not Establish Motivation to
`Combine the Asserted References....................................................... 53
`A Generalized Goal of “Improving Safety” Does Not Establish
`a Motivation to Combine Bathe, Peters, FR ’804, and the IR
`Standard ............................................................................................... 54
`1.
`FDA Guidelines Did Not Suggest a Safety Check Was
`Necessary or a “Risk” ............................................................... 55
`The MAUDE Database Provided No Motivation ..................... 56
`2.
`3. Minimizing Costs and Development Time Would Have
`Motivated the POA to Pursue a 510(k) Application ................. 57
`Real World Evidence Regarding NO Delivery Systems
`Show That the Claimed Invention Is Not Obvious ................... 58
`
`4.
`
`VII. CONCLUSION .............................................................................................. 59
`
`
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`Case IPR2015-00889
`U.S. Patent No. 8,573,209
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`I.
`
`INTRODUCTION
`The Board’s initial determination to institute inter partes review was
`
`erroneous because Petitioner’s arguments and evidence fall substantially short of
`
`what the law requires to invalidate the claims of the ’209 Patent:
`
`• Petitioner’s expert declarant, Dr. Stone did not even attempt to
`examine validity on a claim-by-claim basis (in fact, Dr. Stone
`testified he performed no analysis of the claims);
`
`• Petitioner presented no credible evidence whatsoever of any
`alleged motivation to combine its many asserted prior art
`references, and ignores entirely the fact that no one in the industry
`had even perceived of the problem the ’209 Patent solves; and
`
`• Petitioner ignores entirely evidence that those of ordinary skill in
`the art (including Petitioner, its expert, and the assignee of the FR
`’804 reference) developed nitric oxide delivery systems without
`including the patented features Petitioner now claims, in hindsight,
`would have been “common sense” to add.
`
`First, Petitioner’s expert declarant, Dr. Stone, failed to examine validity on a
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`claim-by-claim basis. Indeed, he failed to even identify the differences between
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`any of the asserted prior art references and the claims of the ’209 Patent, or any the
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`differences between the collection of prior art on which he relies and the claims of
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`the ’209 Patent. As part of what he called a “combinability” analysis, Dr. Stone
`
`opined without the benefit of any legal framework. Dr. Stone’s opinions are
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`U.S. Patent No. 8,573,209
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`therefore insufficient as a matter of law, and leave Petitioner without any
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`meaningful expert testimony. In this complicated technological field, the absence
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`of any appropriate, substantive expert testimony or proof is alone sufficient to
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`prevent Petitioner from being able to invalidate the ’209 Patent claims.
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`Second, Petitioner and its expert declarant failed to provide sufficient
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`evidence to establish that a POSA would have been motivated to combine (and in
`
`many instances, further modify) the prior art to create the inventions claimed in the
`
`’209 Patent. Dr. Stone admits that the efforts of those of skill in the field of
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`medical device design are constrained by the FDA regulatory environment, which
`
`encourages the use of known safety solutions and discourages deviation in the
`
`absence of a known problem. Here, neither party’s expert could identify any
`
`evidence that the problem the ’209 Patent addresses was recognized in the field at
`
`the time of the invention. Under controlling Federal Circuit law, this failure alone
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`leaves the Board with no evidentiary basis whatsoever to conclude that a POSA
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`would have combined the prior art in the manner Petitioner claims.
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`Third, Petitioner and its expert declarant deliberately ignored entirely the
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`real world evidence of what those of ordinary skill in the art who were actually
`
`developing NO delivery systems actually did with knowledge of the prior art.
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`Petitioner offered its own NO delivery device shortly before the ’209 Patent’s
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`priority date (but after all of the prior art Petitioner relies upon was available), and
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`was not motivated to combine the prior art to achieve the claimed inventions.
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`Similarly, Air Liquide, the assignor of the FR ’804 patent publication that
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`Petitioner asserts would have been readily combined with other asserted prior art to
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`arrive at the claimed inventions, did no such thing when developing its own
`
`commercial NO delivery system. Even Dr. Stone, who did some initial work on an
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`NO delivery system in the mid-1990s, did not think of incorporating the inventions
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`of the ’209 Patent into his design.
`
`These facts show how real designers acted in the real world, proving that
`
`Petitioner’s hypothetical prior art analysis relies on impermissible hindsight and
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`makes dubious technological leaps that were well beyond the skill and motivation
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`of an ordinary designer at the time of the claimed inventions of the ’209 Patent.
`
`II. RELEVANT FACTUAL AND PROCEDURAL BACKGROUND
`A. Overview of the Board’s Institution Decision
`The Board instituted inter partes review of the ’209 Patent on September 22,
`
`2015 on the following grounds: (1) Claims 1-7 as obvious over Bathe,1 Peters,2 FR
`
`’804,3 and the IR Standard,4 and (2) Claims 3 and 4 as obvious over Bathe, Peters,
`
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`1 Ex. 1005, U.S. Patent No. 5,558,083 (Sept. 24, 1996).
`
`2 Ex. 1004, U.S. Patent No. 7,114,510 B2 (Oct. 3, 2006).
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`3 Ex. 1006, FR Pub. No.: 2 917 804 (Dec. 26, 2008).
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`FR ’804, the IR Standard, and Lebel.5
`
`The ’209 Patent
`
`B.
`The ’209 Patent, entitled “Gas Delivery Device and System,” is directed to a
`
`gas delivery device, including a valve and a circuit, for use in a gas delivery system
`
`for administering therapeutic gas, such as nitric oxide (“NO”), to a patient. (Ex.
`
`1001 at 1:5-7, 1:39-41.) As shown in the ’209 Patent’s FIG. 1, the gas delivery
`
`system comprises a valve assembly 100 attached to a gas source 50, a control
`
`module 200 that controls the gas delivery to a patient, and a gas delivery
`
`mechanism, such as a ventilator 400. (Id. at 5:53-63, FIG. 1.) The valve assembly
`
`comprises a valve and a circuit with a valve memory in communication with a
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`valve processor and a valve transceiver. (Id. at 1:41-45.) The valve memory stores
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`gas data such as the gas composition (e.g., NO), gas concentration, gas expiration
`
`date, and other information. (Id. at 6:66-7:2.) The valve transceiver communicates
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`with a central processing unit (“CPU”) in the control module, for example, via
`
`wireless optical line-of-sight signals (such as infrared “IR” signals) that are
`
`transmitted between the valve transceiver and a CPU transceiver. (Id. at 1:45-52,
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`2:14-15, 2:39-50.)
`
`
`4 Ex. 1007, INTERNATIONAL STANDARD, ISO/IEEE 11073-30300 (2004).
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`5 Ex. 1008, U.S. Patent No. 6,811,533 B2 (Nov. 2, 2004).
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`The ’209 Patent discloses that communication between the valve and CPU
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`transceivers solved previously unrecognized problems with known gas delivery
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`devices at the time of the invention. (Id. at 1:11-35.) In particular, while known
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`computerized gas delivery devices could track patient and treatment information,
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`they did not communicate with other components of the system (e.g., the valve
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`attached to the gas source) to confirm that the correct type and concentration of
`
`unexpired gas was being supplied to the device. (Id. at 1:18-25.) The ’209 Patent
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`discloses and claims this important safety mechanism. (Ex. 2021 ¶¶ 50-54.)
`
`The challenged claims are directed to gas delivery devices to administer a
`
`therapeutic gas (claims 1-4) and gas delivery systems incorporating such a gas
`
`delivery device (claims 5-7). The challenged claims all require at least three key
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`elements (in addition to others):
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`1. a “control module that controls gas delivery to a subject”;
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`2. a “valve attachable to the gas source” that can “open or close . . . to
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`allow the gas through the valve to a control module” and a “circuit”
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`with a “memory to store gas data”; and
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`3. a “processor and transceiver” to communicate, via wireless optical
`
`line of sight, the gas data from the memory to the “control module
`
`that controls gas delivery to a subject” to “verify one or more of the
`
`correct gas, the correct gas concentration, and that the gas is not
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`expired.”
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`(Id. at Cl. 1-7; Ex. 2021 ¶¶ 52-54.) Claim 1 of the ’209 Patent is reproduced
`
`below:
`
`1. A gas delivery device to administer therapy gas from a
`gas source, the gas delivery device comprising:
`
`a valve attachable to the gas source, the valve
`including an
`inlet and an outlet
`in
`fluid
`communication and a valve actuator to open or
`close the valve to allow the gas through the valve
`to a control module; and
`
`a circuit including:
`
`memory to store gas data comprising one or more
`of gas identification, gas expiration date and
`gas concentration and
`
`a processor and a transceiver in communication
`with the memory to send and receive wireless
`optical line-of-sight signals to communicate the
`gas data to the control module that controls gas
`delivery to a subject and to verify one or more
`of the correct gas, the correct gas concentration
`and that the gas is not expired,
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`wherein the valve further comprises a data input in
`communication with said memory, to permit a user
`to enter the gas data into the memory.
`
`C. Claim Construction
`Based on Petitioner’s positions, Patent Owner does not presently believe that
`
`claim construction is necessary.
`
`D.
`
`Patent Owner’s Commercial Embodiments of the Inventions of
`the ’209 Patent
`
`Over the past two decades, Patent Owner and its predecessors have been
`
`pioneers and innovators in the field of treatment and medical devices for delivering
`
`therapy gas to patients—in particular NO. Inhaled NO (“iNO”) is a gas used to
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`treat neonates who cannot breathe on their own due to life-threatening
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`cardiovascular conditions. Patent Owner’s iNO product, INOmax®, is approved
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`for such treatment with certain term and near-term neonates. (Ex. 2001 at 1.)
`
`Patent Owner’s NO delivery systems deliver pharmaceutical gas comprising
`
`NO to provide a constant concentration of NO, as set by the user, to the patient.
`
`(Ex. 1005 at Abstract; Ex. 1012 at 3.) Patent Owner’s NO delivery systems also
`
`analyze the actual NO concentration that is delivered to the patient to ensure that
`
`the delivered NO concentration is within a certain tolerance of the concentration
`
`set by the user. (Ex. 1005 at 5:51-56; Ex. 1012 at 3.)
`
`The current generation of Patent Owner’s NO delivery systems, INOmax
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`DSIR® NO delivery systems, relies on the inventions disclosed and claimed in the
`
`’209 Patent. (Ex. 2021 ¶ 111.)
`
`E. Other NO Delivery Systems Marketed at or Around the Time of
`Inventions of the ’209 Patent Lacked the Inventions of the ’209
`Patent
`
`At or around the time of the inventions claimed in the ’209 Patent, several
`
`other NO delivery systems were designed and released to market. None include
`
`the innovative safety features of the ’209 Patent, despite being launched after
`
`Petitioner’s asserted prior art was known and available. (Ex. 2021 ¶¶ 110-113.)
`
`Petitioner Praxair’s NOMIX System
`
`1.
`Petitioner developed and marketed its own NO delivery system, one it
`
`neither disclosed in its Petition or to its expert, Dr. Stone. (Ex. 2020 at 174:15-
`
`175:12.) That system, known as NOMIX, was offered by Petitioner for use in
`
`Mexico in or around October 2009—just over a year before the filing of the ’209
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`Patent. (Ex. 2025 at 1.) NOMIX was a collection of off-the-shelf components
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`supplied by various vendors, consisting of a pressure regulator, a flowmeter, a
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`PrinterNOx head unit, and a single cylinder of NO gas. (Ex. 2026 at 4.)
`
`The PrinterNOx is “designed to monitor delivered NO used as a
`
`therapy . . . .” (Ex. 2027 at 4; Ex. 2021 ¶ 112.) That system only contemplates
`
`inline monitoring. (Ex. 2027 at 4-5; Ex. 2021 ¶ 112.) There is no indication that
`
`the PrinterNOx is able to automatically check concentration, or any other gas data.
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`(Ex. 2021 ¶ 112.)
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`None of the materials for the NOMIX system or the PrinterNOx monitor
`
`unit indicate that they are able to automatically check any data regarding the
`
`attached cylinder. (Id.) No mention is made of pre-administration safety checks
`
`for gas type, gas concentration, or gas expiration. (Id.) There is no suggestion that
`
`the NOMIX system or the PrinterNOx unit can communicate with the cylinder
`
`valve. (Id.)
`
`The Opti Kinox Station from Air Liquide
`
`2.
`The French company Air Liquide S.A., assignee of the FR ’804 patent on
`
`which Petitioner relies, offers an NO delivery system known as the Opti Kinox
`
`Station. (See Ex. 2017 at 1; Ex. 2021 ¶ 113.) Based on Air Liquide materials, the
`
`Opti Kinox Station was on the market as of April 2009. (Id.) The device consists
`
`of a cart that can store and transport two cylinders of NO gas and an Opti Kinox
`
`monitoring unit. (Ex. 2017 at 2; Ex. 2021 ¶ 113.) No means of communication
`
`between the valves attached to the cylinders and the monitoring unit is shown or
`
`described in the Opti Kinox materials. (Ex. 2021 ¶ 113.) There is no discussion of
`
`wired or wireless (radio frequency or optical) communication capability in the
`
`device, and none of the materials indicate that gas data is checked by the
`
`monitoring unit other than a sensor-based inline sampling of gas concentration.
`
`(Id.)
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`Further, a close review of cylinders and attached valves shows that the
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`attached valves are traditional manual valve assemblies. (Ex. 2017 at 2; Ex. 2021 ¶
`
`113.) Petitioner’s expert Dr. Stone admitted that the valves are manually operated
`
`and he had “no reason to believe that they are automatically controlled.” (Ex. 2020
`
`at 164:4-16.) Dr. Stone also agreed that Air Liquide did not incorporate the
`
`teachings of its own FR ’804 patent publication into this system. (Id. at 164:17-
`
`23.)
`
`F.
`
`The Regulatory Environment Guiding the Work of a POSA
`Developing Medical Devices Like the Claimed Inventions
`
`In the United States, the FDA regulates medical devices like those
`
`embodying the inventions of the ’209 Patent under the Federal Food, Drug and
`
`Cosmetic Act to ensure their safety and effectiveness. (Ex. 2028; Ex. 2021 ¶ 119.)
`
`Section 513 of the Food, Drug, and Cosmetic Act specifies a three-class regulatory
`
`system for medical devices. (Ex. 2029; Ex. 2021 ¶ 120.) The FDA designates NO
`
`delivery devices as the second highest of these three classes, which makes them
`
`subject to significant regulation. (Ex. 2021 ¶ 120.)
`
`Classes of Regulated Devices
`
`1.
`The FDA assigns each medical device to either Class I, Class II, or Class III.
`
`(Ex. 2029; Ex. 2021 ¶ 120.) These classes are based on the level of control
`
`necessary to provide reasonable assurance of the safety and effectiveness of the
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`medical device at issue. (Id.) Class I is the least regulated and includes products
`
`such as bandages, examination gloves, and hand-held surgical instruments. (Ex
`
`2029.) These devices are subject to basic “general controls.” (Ex. 2028.) Class II
`
`devices are subject to general controls as well as certain special controls, including
`
`labeling requirements, performance standards, or postmarket surveillance. (Ex.
`
`2029.) NO delivery devices are Class II devices subject to special controls. (Ex.
`
`2029; Ex. 2021 ¶¶ 119-121.)
`
`1. The 510(k) Process Is Necessary to Market a Class II Device
`The 510(k) application “is a premarket submission made to FDA to
`
`demonstrate that the device to be marketed is at least as safe and effective, that is,
`
`substantially equivalent, to a legally marketed device that is not subject to
`
`premarket approval.” (Ex. 2033; Ex. 2021 ¶¶ 123-124.) 510(k) submissions
`
`include guidance on “the process for determining whether different technological
`
`characteristics raise different questions of safety and effectiveness.” (Ex. 2040.)
`
`The 510(k) process requires a party seeking approval for a Class II medical
`
`device to show that the proposed medical device is “substantially equivalent” to a
`
`device that has already been approved by the FDA. (Id.) The FDA provides
`
`guidance to manufacturers regarding safety features and functionality by
`
`classifying devices based on their intended use. (Ex. 2034; Ex. 2021 ¶ 131.)
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`2.
`
`The FDA Regulatory Regime Encourages the Use of Known
`Safety Solutions and Discourages Deviation in the Absence
`of an Identifiable and Known Problem
`
`Petitioner’s expert, Dr. Robert Stone, admits that the FDA regulatory regime
`
`factors heavily into the way in which medical devices are designed and developed
`
`by those of ordinary skill in the art. (Ex. 2020 at 18:20-19:19.) Unlike those in
`
`many other fields, medical device engineers are keenly aware of the regulatory
`
`issues that determine FDA approval. (Id. at 18:20-19:19, 108:1-14.) Dr. Stone
`
`discussed the impact of regulatory concerns as follows:
`
`Me, as a product designer, typically, as I begin the design process, I'll
`come up with a definition of the problem. How I'd like to solve it, I
`will look to see whether there are predicate devices and what process
`I'm likely to need to follow. I might consult so-called regulatory
`bodies, testing labs, and so forth, to find out what their concepts are.
`Incorporate all of those issues into the very beginning of the
`documentation process before I would actually even begin the design.
`
`(Id. at 20:1-10 (emphasis added).) Dr. Stone admitted that a POSA would look to
`
`FDA guidance for approved safety features. (Id. at 108:1-14.)
`
`NO delivery devices are Class II devices, and Dr. Stone testified that a
`
`POSA would understand that inventing a NO delivery device with a new safety
`
`feature or functionality would mean clearing the additional hurdle of convincing
`
`the FDA that the new feature is at least as safe as what is designated in FDA
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`guidance documents. (Ex. 2020 at 142:10-17.) Thus, a POSA would be highly
`
`motivated to follow the path of the 510(k) application process and would seek to
`
`avoid a design that included unapproved safety features or functionality. (Ex. 2021
`
`¶¶ 122-124.) As discussed in more detail below, these facts—which Petitioner and
`
`Dr. Stone failed to address and consider—undermine Petitioner’s assertions that a
`
`POSA would necessarily have been motivated to combine references for the
`
`purpose of safety to achieve the claimed inventions of the ’209 Patent.
`
`III. THE CITED REFERENCES
`A. Bathe (U.S. Patent No. 5,558,083)
`The Bathe patent discloses an NO delivery system that can be used with a
`
`ventilator to provide gas therapy to a patient. (Ex. 1005 at 2:13-30.) This system
`
`includes a CPU used to monitor and adjust the gas flow. (Id. at 2:31-3:25.) The
`
`system relies on flow rate and concentration data measured at various points
`
`downstream from where the NO therapy gas and any additional diluting gas (e.g.,
`
`N2 or O2) enter the delivery system, i.e., after the therapy gas exits the gas source
`
`through the valve of the gas source and enters the delivery system. (See id. at FIG.
`
`1 (NO sensor 65, gas sensing bench 52).)
`
`Bathe does not disclose, teach, or suggest that its delivery system should
`
`communicate in any fashion with any component of the gas cylinder’s valve
`
`assembly. (Ex. 2021 ¶ 65.) Nor does Bathe disclose a valve assembly attached to
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`a gas source including a memory or any other component capable of storing,
`
`processing, sending, or receiving any gas data. (Id. ¶ 66.) To the contrary, Bathe
`
`teaches a sensor-based approach to obtaining information about the gas entering
`
`the delivery system, and only after the gas has entered the delivery system.6 (Id.)
`
`Patent Owner’s predecessor filed the Bathe application, which has the same
`
`lead inventor as the ’209 Patent. In fact, Bathe is specifically discussed and
`
`incorporated by reference in the ’209 Patent specification, and the Examiner thus
`
`necessarily considered it during prosecution of the ’209 Patent. (Ex. 1001 at 9:49-
`
`52.) In particular, the ’209 Patent explains that Bathe describes a method of how a
`
`delivery module delivers gas to a ventilator circuit. (Id.) Thus, the ’209 Patent
`
`acknowledges the contribution that Bathe made to the state of the art, and goes on
`
`to describe and claim further advances. (Ex. 2021 ¶¶ 65-66.) Bathe teaches away
`
`from the safety mechanism disclosed and claimed in the ’209 Patent, in its
`
`disclosure of a sensor-based approach to detect information about the gas only
`
`after it has entered the delivery system. (Id. ¶ 66.)
`
`Peters (U.S. Patent No. 7,114,510)
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`B.
`Peters discloses a valve that can be used on a gas cylinder for recording and
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`6 Bathe also discloses merely assuming certain gas information, such as
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`concentration, rather than sensing or verifying it. (Ex. 2021 ¶ 66.)
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`storing data useful for preparing billing invoices, inventory control, and other
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`record-keeping functions. (Ex. 1004 at 1:34-42.)
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`The Peters valve must be manually opened or closed by a user (Id. at 2:45-
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`46), and senses and records when the cylinder’s actuator is manually opened and
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`closed and the duration of time the valve is open. (Id. at 3:44-53.) This data is
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`used to generate invoices based on the actual gas usage. (Id. at 1:16-30, 1:52-53.)
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`Peters expressly teaches that the purpose of recording data regarding
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`whether the valve is opened or closed is “to enable logging and billing.” (Id. at
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`1:10-11; Ex. 2021 ¶¶ 67-68.) The stated advantages of Peters are directed to this
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`purpose, such as providing “a convenient way to track and charge for therapy”;
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`ascertaining “actual treatment time” to prevent “error or fraud”; storing the data so
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`that “it is easy to import the data into a spreadsheet or database software.” (Ex.
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`1004 at 7:19-51; Ex. 2021 ¶¶ 67-69, 78-79.) All of the logging and tracking
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`functions supported by the valve are contemplated for later analysis (e.g.,
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`preparing invoices) as opposed to any real-time application, such as a safety check
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`or verification of operating parameters, when the device delivers gas to a patient.
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`(Ex. 2021 ¶ 85.)
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`Although Peters expressly contemplates that the valve will be used in
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`conjunction with “a delivery device, such as a ventilator” (Ex. 1004 at 6:18-19),
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`Peters does not teach, disclose, suggest, or even allude to the valve sending the
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`data stored therein to that delivery device for safety or any other purpose. (Ex.
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`2021 ¶ 85.) Nor does Peters teach, disclose, suggest, or even allude to receiving
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`any information from a delivery device, or describe what the Peters valve would do
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`with any such information. (Id.) Instead, Peters teaches loading data into the
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`Peters valve memory either by (1) the gas distributor who is filling and supplying
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`cylinders using a specialized device (Ex. 1004 at 5:57-6:2), or (2) the hospital
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`using “a hand-held computer or laptop” for the purpose of “record keeping and for
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`billing its patient or other end users.” (Id. at 6:7-9.) With respect to reading or
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`downloading the data from the Peters valve memory, Peters discloses: (1) reading
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`the data using a “PIR-2 reader” so that the data may be “imported into a suitable
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`software program such as a spread sheet program” (id. at 6:36-46); (2)
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`downloading the data directly onto a handheld or laptop computer for the same
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`purpose, i.e., “to generate usage reports or billing reports” (id. at 6:47-55); or (3)
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`sending the data directly to a printer (id. at 6:56-57). (Ex. 2021 ¶ 78.) In each
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`instance, the purpose of reading or downloading the data is record keeping and
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`billing—not safety. (Ex. 1004 at 6:58-63; Ex. 2021 ¶ 79.)
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`Finally, the Peters valve memory does not store gas data, i.e., gas type, gas
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`concentration, or gas expiration date. (Ex. 1004 at 5:47-56; Ex. 2021 ¶ 72.) In
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`particular, the “born on date (date when the cylinder was filled)” (id. at 5:48),
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`stored by the Peters valve is not an expiration date, and one cannot derive the
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`expiration date from a “born on date” because it depends on numerous specific
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`factors, such as storage, temperature, the material in which the gas is stored, and
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`potentially many other factors—all of which may vary from cylinder to cylinder
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`and usage context. (Ex. 2020 at 33:5-35:1; Ex. 2021 ¶ 72.)
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`Peters was also filed by Patent Owner’s predecessor, and like Bathe, the
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`’209 Patent expressly discloses and discusses Peters. (Ex. 1001 at 7:26-28.)
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`During prosecution, the Examiner expressly considered Peters and determined that
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`it did not render the claims of the ’209 Patent obvious, correctly stating in the
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`Notice of Allowance that:
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`Peters fails to disclose, teach, or fairly suggest a circuit including a
`processor and transceiver that is able to communicate with the
`memory to send and receive wireless signals to communicate the gas
`data to the control module that controls gas delivery to a subject and
`to verify one or more of the correct gas, the correct gas concentration
`and that the gas is not expired. Therefore, claims 2-5, 7, 9, and 10
`have been found allowable since any conclusion of obviousness
`would be based upon improper hindsight reasoning using knowledge
`gleaned only from the applicant’s disclosure.
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`(Ex. 1016 at 254.)
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`FR ’804 (FR 2,917,804)
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`C.
`The FR ’804 publication is teaches a “[c]onnection system of a bottle (10) of
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`gas to a valve (20) for supplying an operating circuit (1) with a given type of gas.”
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`(Ex. 1006 at 17; Fig. 1.) Valve 20 is an automatically operated valve, such as a
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`controlled solenoid valve or micro-controlled valve. (Id. at 19.) The default state
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`of the automatic valve is closed. (Id. at 20.)
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`When the bottle 10 is connected to valve 20, “the detector 12 switches the
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`control module 300 from a sleep state to an active state.” (Id.) The control module
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`300 obtains information about the “type of gas” contained in the bottle from one of
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`three potential sources: (1) an RFID circuit on the bottle, (2) a bar code on the
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`bottle, or (3) a “gas nano sensor” to sense the type of gas inside the bottle. (Id. at
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`20-21.) If the control module verifies that the type of gas is correct, it sends an
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`“opening command signal” to automatic valve 20. (Id. at 20.) Accordingly, FR
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`’804 “prevents opening the valve” when the gas type does not match what is
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`expected by control module 300. (Id. at 18.)
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`FR ’804 expressly teaches that “in most cases” the common practice of
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`using “purely mechanical solutions which involve the use of connection types