Filed on behalf of: INO Therapeutics, LLC
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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 IPR2015-00884
`U.S. Patent No. 8,291,904 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. 8,291,904
`
`
`
`

`
`Case IPR2015-00884
`U.S. Patent No. 8,291, 904
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`
`TABLE OF CONTENTS
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`
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................ 1
`
`RELEVANT FACTUAL AND PROCEDURAL BACKGROUND ............. 3
`
`Page
`
`E.
`
`F.
`
`A. Overview of the Board’s Institution Decision ..................................... 3
`B.
`The ’904 Patent ................................................................................... 4
`C.
`Claim Construction ............................................................................. 6
`D.
`Patent Owner’s Commercial Embodiments of the Inventions of
`the ’904 Patent .................................................................................... 7
`Other NO Delivery Systems Marketed at or Around the Time of
`Inventions of the ’904 Patent Lacked the Inventions of the ’904
`Patent .................................................................................................. 7
`1.
`Petitioner Praxair’s NOMIX System ......................................... 8
`2.
`The Opti Kinox Station from Air Liquide ................................. 8
`The Regulatory Environment Guiding the Work of a POSA
`Developing Medical Devices Like the Claimed Inventions ................. 9
`1.
`Classes of Regulated Devices ................................................. 10
`2.
`The 510(k) Process Is Necessary to Market a Class II
`Device..................................................................................... 10
`The FDA Regulatory Regime Encourages the Use of
`Known Safety Solutions and Discourages Deviation in
`the Absence of an Identifiable and Known Problem ............... 11
`
`3.
`
`III. THE CITED REFERENCES ...................................................................... 12
`
`A.
`B.
`C.
`D.
`
`Bathe (U.S. Patent No. 5,558,083) .................................................... 12
`Peters (U.S. Patent No. 7,114,510) .................................................... 14
`FR ’804 (FR 2,917,804) .................................................................... 16
`IR Standard (ISO/IEEE 11073-30300) .............................................. 17
`
`IV. DR. STONE’S “COMBINABILITY” OPINIONS ARE DEFICIENT
`AS A MATTER OF LAW AND THE BOARD SHOULD
`DISREGARD THEM ................................................................................. 17
`
`A. Dr. Stone Failed to Analyze the Claims ............................................ 18
`B.
`Dr. Stone Did Not Know or Apply the Correct Legal Standards ....... 22
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`Case IPR2015-00884
`U.S. Patent No. 8,291, 904
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`
`C.
`
`Dr. Stone Failed to Consider Objective Indicia of Non-
`Obviousness ...................................................................................... 23
`D. Dr. Stone Improperly Used Hindsight Bias ....................................... 25
`E.
`Given Dr. Stone’s Deficient Declaration, the Petition is
`Insufficient As a Matter of Law ........................................................ 27
`
`V.
`
`THE ASSERTED COMBINATION FAILS TO SATISFY ALL
`LIMITATIONS OF THE CHALLENGED CLAIMS ................................. 29
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`VI. THERE WOULD HAVE BEEN NO MOTIVATION TO COMBINE
`BATHE ’083, PETERS ’510, FR ’804, and THE IR STANDARD ............ 38
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`3.
`
`Petitioner Has Failed to Show That a POSA Was Aware of the
`Problem Addressed by the ’904 Patent Claims .................................. 39
`A POSA Would Not Be Motivated to Combine Bathe And
`Peters ................................................................................................ 42
`A POSA Would Not Be Motivated to Combine Bathe And
`Peters with FR ’804 .......................................................................... 46
`1.
`FR ’804 Does Not Teach Gas Concentration .......................... 47
`2. Mechanical Connection Limitations in NO Delivery
`Systems Eliminate Any Need for FR ’804 .............................. 47
`Replacing the Peters Manual Valve with the Automatic
`Valve of FR ’804 Would Create Substantial Problems ............ 50
`The IR Standard, Lebel, and Durkan Do Not Establish
`Motivation to Combine the Asserted References .............................. 54
`A Generalized Goal of “Improving Safety” Does Not Establish
`a Motivation to Combine Bathe, Peters, FR ’804, and the IR
`Standard ............................................................................................ 55
`1.
`FDA Guidelines Did Not Suggest a Safety Check Was
`Necessary or a “Risk” ............................................................. 56
`The MAUDE Database Provided No Motivation .................... 57
`2.
`3. Minimizing Costs and Development Time Would Have
`Motivated the POSA to Pursue a 510(k) Application .............. 58
`Real World Evidence Regarding NO Delivery Systems
`Show That the Claimed Invention Is Not Obvious .................. 59
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`4.
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`VII. CONCLUSION .......................................................................................... 60
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`Case IPR2015-00884
`U.S. Patent No. 8,573,904
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`I.
`
`INTRODUCTION
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`The Board’s initial determination to institute inter partes review was
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`erroneous because Petitioner’s arguments and evidence fall substantially short of
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`what the law requires to invalidate the claims of the ’904 Patent:
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`• Petitioner’s expert declarant, Dr. Stone did not even attempt to
`examine validity on a claim-by-claim basis (in fact, Dr. Stone
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`testified he performed no analysis of the claims);
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`• Petitioner presented no credible evidence whatsoever of any
`alleged motivation to combine its many asserted prior art
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`references, and ignores entirely the fact that no one in the industry
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`had even perceived of the problem the ’904 Patent solves; and
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`• Petitioner ignores entirely evidence that those of ordinary skill in
`the art (including Petitioner, its expert, and the assignee of the FR
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`’804 reference) developed nitric oxide delivery systems without
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`including the patented features Petitioner now claims, in hindsight,
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`would have been “common sense” to add.
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`First, Petitioner’s expert Dr. Stone failed to examine validity on a claim-by-
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`claim basis. He failed to even identify the differences between any of the asserted
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`prior art references and the claims of the ’904 Patent, or any the differences
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`between the collection of prior art on which he relies and the claims. As part of
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`what he called a “combinability” analysis, Dr. Stone opined without the benefit of
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`any legal framework, and his opinions are therefore insufficient as a matter of law,
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`U.S. Patent No. 8,573,904
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`and leave Petitioner without any meaningful evidence. In this complex field, the
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`absence of any appropriate, substantive expert testimony or proof is alone
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`sufficient to prevent Petitioner from being able to invalidate the ’904 Patent claims.
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`Second, Petitioner and its expert declarant failed to prove that a POSA
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`would have been motivated to combine (and further modify) the prior art to create
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`the claimed inventions. Dr. Stone admits that the efforts of those of skill in the
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`field of medical device design are constrained by the FDA regulatory environment,
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`which encourages the use of known safety solutions and discourages deviation in
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`the absence of a known problem. Here, neither party’s expert saw any evidence
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`that the problem the ’904 Patent addresses was recognized at the time of the
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`invention. Under controlling Federal Circuit law, this failure leaves the Board with
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`no evidentiary basis to conclude that a POSA would have combined the prior art in
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`the manner Petitioner claims.
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`Third, Petitioner and its expert declarant deliberately ignored entirely the
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`evidence of what those of ordinary skill in the art actually did with knowledge of
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`the prior art. Petitioner offered its own NO delivery device shortly before the ’904
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`Patent’s priority date (but after all of the prior art Petitioner relies upon was
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`available), and was not motivated to combine the prior art. Nor was Air Liquide,
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`the assignor of the FR ’804 patent publication that Petitioner asserts would have
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`been readily combined with other asserted prior art to arrive at the claimed
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`inventions. Even Dr. Stone, who did some early development work in the mid-
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`1990’s, did not think to include the inventions of the ’904 Patent into his design.
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`These facts show how real POSAs acted, and prove that Petitioner’s
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`hypothetical prior art analysis relies on impermissible hindsight and makes
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`technological leaps well beyond the skill and motivation of an ordinary designer at
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`the time of the claimed inventions of the ’904 Patent.
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`II. RELEVANT FACTUAL AND PROCEDURAL BACKGROUND
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`A. Overview of the Board’s Institution Decision
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`The Board instituted inter partes review of the ’904 Patent on September 22,
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`2015 on the following grounds: (1) Claims 1-8 and 11-16 as obvious over Bathe,1
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`Peters,2 FR ’804,3 and the IR Standard,4 (2) Claims 3 and 4 as obvious over Bathe,
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`Peters, FR ’804, the IR Standard, and Lebel,5 and (3) Claims 9 and 10 as obvious
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`over Bathe, Peters, FR ’804, the IR Standard, and Durkan. 6
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`1 Ex. 1005, U.S. Patent No. 5,558,083 (Sept. 24, 1996).
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`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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`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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`6 Ex. 1010, U.S. Patent No. 4,462,398 (July 31, 1984).
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`U.S. Patent No. 8,573,904
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`
`B.
`
`The ’904 Patent
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`The ’904 Patent, entitled “Gas Delivery Device and System,” is directed to a
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`gas delivery device, including a valve and a circuit, for use in a gas delivery system
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`for administering therapeutic gas, such as nitric oxide (“NO”), to a patient. (Ex.
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`1001 at 1:14-16, 1:49-56.) The gas delivery system comprises a valve assembly
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`100 attached to a gas source 50, a control module 200 that controls the gas delivery
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`to a patient, and a gas delivery mechanism, such as a ventilator 400. (Id. at 6:4-14,
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`FIG. 1.) The valve assembly comprises a valve and a circuit with a valve memory
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`in communication with a valve processor and a valve transceiver. (Id. at 1:52-56.)
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`The valve memory stores gas data such as the gas composition (e.g., NO), gas
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`concentration, gas expiration date, and other information. (Id. at 7:18-21.) The
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`valve transceiver communicates with a central processing unit (“CPU”) in the
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`control module, for example, via wireless optical line-of-sight signals (such as
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`infrared “IR” signals) that are transmitted between the valve transceiver and a CPU
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`transceiver. (Id. at 1:56-63, 2:25-27, 2:51-62.)
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`The ’904 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 1:21-45.) While known computerized
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`gas delivery devices could track patient and treatment information, they did not
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`communicate with other components of the system (e.g., the valve attached to the
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`gas source) to confirm that the correct concentration of gas was being supplied to
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`the device. (Id. at 1:28-36.) The ’904 Patent discloses and claims this important
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`safety mechanism. (Ex. 2021 ¶¶ 50-54.)
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`The challenged claims are directed to a valve assembly to deliver a gas
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`comprising NO (claims 1-4); and gas delivery system incorporating such a valve
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`assembly (claims 5-10, 16); and a method for administering therapy gas
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`comprising NO using such a valve assembly (claims 11-15). The challenged
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`claims all require at least three key 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 container” that can “open or close…to
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`allow the gas through the valve to the control module” and a “circuit
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`supported within the valve assembly” with a “memory to store gas
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`data comprising gas concentration”; and
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`3. a “processor and transceiver” to communicate, via wireless optical
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`line of sight, the gas concentration data from the memory to the
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`“control module that controls gas delivery to a subject.”
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`(Id. at Cl. 1-16; Ex. 2021 ¶¶ 52-54.) Claim 1 of the ’904 Patent claims:
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`1. A valve assembly to deliver a gas comprising NO from
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`a gas container containing the gas comprising NO, the
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`valve assembly comprising:
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`a valve attachable to the gas container containing the
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`gas comprising NO, the valve including an inlet
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`and an outlet in fluid communication and a valve
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`actuator to open or close the valve to allow the gas
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`comprising NO through the valve to a control
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`module;
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`a circuit supported within the valve assembly and
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`disposed between the actuator and a cap, the
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`circuit including:
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`a valve memory to store gas data comprising gas
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`concentration in the gas container and
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`a valve processor and a valve transceiver in
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`communication with the valve memory to send
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`wireless optical
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`line-of-sight
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`signals
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`to
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`communicate the gas data to the control module
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`that controls gas delivery to a subject; and
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`a data
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`input disposed on
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`the actuator and
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`in
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`communication with said valve memory, to permit
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`a user to enter the gas data into the valve memory.
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`C. Claim Construction
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`Based on Petitioner’s positions, Patent Owner does not presently believe that
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`claim construction is necessary.
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`D.
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`Patent Owner’s Commercial Embodiments of the Inventions of
`the ’904 Patent
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`Over the past two decades, Patent Owner has innovated in the field of
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`treatment and medical devices for delivering therapy gas to patients—in particular
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`NO. Inhaled NO (“iNO”) is a gas used to treat neonates who cannot breathe on
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`their own due to life-threatening cardiovascular conditions. Patent Owner’s iNO
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`product, INOmax®, is approved for such treatment with certain term and near-term
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`neonates. (Ex. 2001 at 1.)
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`Patent Owner’s NO delivery systems deliver pharmaceutical gas comprising
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`NO to provide a constant concentration of NO, as set by the user, to the patient.
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`(Ex. 1005 at Abstract; Ex. 1012 at 3.) Patent Owner’s NO delivery systems also
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`analyze the actual NO concentration that is delivered to the patient to ensure that
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`the delivered NO concentration is within a certain tolerance of the concentration
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`set by the user. (Ex. 1005 at 5:51-56; Ex. 1012 at 3.)
`
`Patent Owner’s current NO delivery systems, INOmax DSIR® NO delivery
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`systems, practice the inventions of the ’904 Patent. (Ex. 2021 ¶ 111.)
`
`E. Other NO Delivery Systems Marketed at or Around the Time of
`Inventions of the ’904 Patent Lacked the Inventions of the ’904
`Patent
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`At or around the time of the inventions claimed in the ’904 Patent, several
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`other NO delivery systems were designed and released to market. None include
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`the innovative safety features of the ’904 Patent, despite being launched after
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`Petitioner’s asserted prior art was known and available. (Ex. 2021 ¶¶ 110-113.)
`
`1.
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`Petitioner Praxair’s NOMIX System
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`Petitioner developed and marketed its own NO delivery system, one it
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`neither disclosed in its Petition or to its expert, Dr. Stone. (Ex. 2020 at 174:15-
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`175:12.) That system, known as NOMIX, was offered by Petitioner for use in
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`Mexico in or around October 2009—just over a year before the filing of the ’904
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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.)
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`The PrinterNOx is “designed to monitor delivered NO used as a
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`therapy . . . .” (Ex. 2027 at 4; Ex. 2021 ¶ 112.) That system uses inline monitoring
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`(Ex. 2027 at 4-5; Ex. 2021 ¶ 112), and does not indicate that it can automatically
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`check concentration, or any other gas data. (Ex. 2021 ¶ 112.)
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`None of the materials for the NOMIX system or the PrinterNOx monitor
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`unit indicate that they are able to automatically check any data regarding the
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`attached cylinder. (Id.) No mention is made of pre-administration safety checks
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`for gas type, gas concentration, or gas expiration, or that the NOMIX system or the
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`PrinterNOx unit can communicate with the cylinder valve. (Id.)
`
`2.
`
`The Opti Kinox Station from Air Liquide
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`U.S. Patent No. 8,573,904
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`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
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`Station. (See Ex. 2017 at 1; Ex. 2021 ¶ 113.) The Opti Kinox Station was on the
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`market as of April 2009 (id), and consists of a cart that can store and transport two
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`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
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`and the monitoring unit is shown or described in the Opti Kinox materials. (Ex.
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`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
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`that gas data is checked by the monitoring unit other than a sensor-based inline
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`sampling of gas concentration. (Id.)
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`Further, the attached valves are traditional manual valve assemblies. (Ex.
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`2017 at 2; Ex. 2021 ¶ 113.) Petitioner’s expert Dr. Stone admitted that the valves
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`are manually operated and he had “no reason to believe that they are automatically
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`controlled.” (Ex. 2020 at 164:4-16.) Dr. Stone also agreed that Air Liquide did
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`not incorporate the teachings of its own FR ’804 patent publication into this
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`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
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`embodying the inventions of the ’904 Patent under the Federal Food, Drug and
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`Cosmetic Act to ensure their safety and effectiveness. (Ex. 2028; Ex. 2021 ¶ 119.)
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`Section 513 of the Food, Drug, and Cosmetic Act specifies a three-class regulatory
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`system for medical devices. (Ex 2029; Ex. 2021 ¶ 120.) The FDA designates NO
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`delivery devices as Class II, subject to significant regulation. (Ex. 2021 ¶ 120.)
`
`1.
`
`Classes of Regulated Devices
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`The FDA assigns each medical device to either Class I, Class II, or Class III.
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`(Ex. 2029; Ex. 2021 ¶ 120.) These classes are based on the level of control
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`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
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`devices are also subject to special controls, including labeling requirements,
`
`performance standards, or postmarket surveillance. (Ex. 2029.) NO delivery
`
`devices are Class II devices. (Ex. 2029; Ex. 2021 ¶¶ 119-121.)
`
`2.
`
`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 at ¶¶ 123-124.) 510(k) submissions
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`include guidance on “the process for determining whether different technological
`
`characteristics raise different questions of safety and effectiveness.” (Ex. 2040.)
`
`To get a Class II medical device approved, one must show that it is
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`“substantially equivalent” to an already-approved device. (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.)
`
`3.
`
`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.) Medical device
`
`engineers are keenly aware of the regulatory issues that determine FDA approval.
`
`(Id. at 18:20-19:19, 108:1-14.)
`
`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
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`will look to see whether there are predicate devices and what process
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`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.
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`Incorporate all of those issues into the very beginning of the
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`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
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`FDA guidance for approved safety features. (Id. at 108:1-14.)
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`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 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.) These facts undermine Petitioner’s claim
`
`that a POSA would have been motivated to combine references for the purpose of
`
`safety to achieve the claimed inventions of the ’904 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
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`system relies on flow rate and concentration data measured at various points
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`downstream from where the NO therapy gas and any additional diluting gas (e.g.,
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`N2 or O2) enter the delivery system, i.e., after the therapy gas exits the gas source
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`through the valve of the gas source and enters the delivery system. (See id. at FIG.
`
`1 (NO sensor 65, gas sensing bench 52).)
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`Bathe does not disclose, teach, or suggest that its delivery system should
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`communicate in any fashion with any component of the gas cylinder’s valve
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`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,
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`processing, sending, or receiving any gas data. (Id. ¶ 66.) To the contrary, Bathe
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`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.7 (Id.)
`
`Patent Owner’s predecessor filed the Bathe application, which has the same
`
`lead inventor as the ’904 Patent. In fact, Bathe is specifically discussed and
`
`incorporated by reference in the ’904 Patent specification, and the Examiner thus
`
`necessarily considered it during prosecution of the ’904 Patent. (Ex. 1001 at 10:1-
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`4.) In particular, the ’904 Patent explains that Bathe describes a method of how a
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`delivery module delivers gas to a ventilator circuit. (Id.) Thus, the ’904 Patent
`
`acknowledges the contribution that Bathe made to the state of the art, and goes on
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`to describe and claim further advances. (Ex. 2021 ¶¶ 65-66.) Bathe teaches away
`
`from the safety mechanism disclosed and claimed in the ’904 Patent, in its
`
`disclosure of a sensor-based approach to detect information about the gas only
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`7 Bathe also discloses merely assuming certain gas information, such as
`
`concentration, rather than sensing or verifying it. (Ex. 2021 ¶ 66.)
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`after it has entered the delivery system. (Id. at 66.)
`
`B.
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`Peters (U.S. Patent No. 7,114,510)
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`Peters discloses a valve that can be used on a gas cylinder for recording and
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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 (Id. at 2:45-46), and
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`senses and records when the cylinder’s actuator is opened and closed and the
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`duration of time the valve is open. (Id. at 3:44-53.) This data is used to generate
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`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 three
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`methods, the purpose of each of which is record keeping and billing—not safety.
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`(Ex. 1004 at 6:36-63; Ex. 2021 ¶¶ 78-79.)
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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. (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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`’904 Patent expressly discloses and discusses Peters. (Ex. 1001 at 7:45-47.)
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`C.
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`FR ’804 (FR 2,917,804)
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`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 automatic valve, such as a controlled
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`solenoid valve or micro-controlled valve, defaulted to open. (Id. at 19-20.)
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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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`an RFID circuit, a bar code or a “gas nano sensor” to sense the type of gas inside
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`the bottle. (Id. at 20-21.) If the control module verifies that the type of gas is
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`correct, it sends an “opening command signal” to automatic valve 20. (Id. at 20.)
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`Accordingly, FR ’804 “prevents opening the valve” when the gas type does not
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`match what is 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” is
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`sufficient to avoid “misguided connections” (i.e., connecting the wrong type of
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`gas). (Id. at 17; Ex. 2021 ¶ 87.) However, FR ’804 states a problem that in certain
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`circumstances—in particular “in factory when filling bottles” and “for a certain
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`number compatible gases or for small bottle sizes” this common practice is
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`insufficient. (Ex. 1006 at 17-18; Ex. 2021 ¶ 87.)
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`The disclosure of FR ’804 concerns the connection system to open and close
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`the valve allowing gas to flow to operating circuit 1. (Ex. 2021 ¶ 86.) It does not
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`address how the gas is used. (Id.) In particular, it does not discuss or describe any
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`medical gas delivery devices, medical gas, patients, or patient safety. (Id. ¶ 97.)
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`Rather, FR ’804 focuses on industrial concerns such as “user safety [as opposed to
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`patient],” “equipment protection,” “connection failure and…damage due to a
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`mismatch between the equipment and the gas used,” and “risk of pollution.” (Id.)
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`In addition, FR ’804 does not teach preventing the automatic valve from
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`opening based on a comparison of gas concentration or expiration date. (Id. ¶ 98.)
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`D.
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`IR Standard (ISO/IEEE 11073-30300)
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`The IR Standard is part of the ISO/IEEE 11073 standards that “enable
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`communication between medical devices and external computer systems.” (Ex.
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`1007 at vi; Ex. 2021 ¶ 99.) The IR Standard does not address why such systems
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`communicate. (Ex. 2021 ¶ 103.)
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`IV. DR. STONE’S “COMBINABILITY” OPINIONS ARE DEFICIENT AS
`A MATTER OF LAW AND THE BOARD SHOULD DISREGARD
`THEM
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`The Board’s institution decision is predicated on Petitioner’s submission of
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`Dr. Stone’s testimony (Pet. at 10), which are flawed for multiple, independent
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`reasons and cannot establish obviousness of any of the claims as a matter of law.8
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`A. Dr. Stone Failed to Analyze the Claims
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`“It is a ‘bedrock principle’ of patent law that the claims of a patent define the
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`invention to which the patentee is entitled the right to exclude.” See, e.g., Phillips
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`v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (quotation omitted).
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`The first step in an obviousness analysis is therefore to identify the “differences
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`between the prior art and the claims….” See KSR Int’l Co. v. Teleflex Inc., 550
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`U.S. 398, 406 (2007) (quotation omitted; emphasis added); see also Dystar
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`Textilfarben GmbH v. C.H. Patrick Co., 464 F.3d 1356, 1372 (Fed. Cir. 2006)
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`(“[W]e must evaluate obviousness on a claim-by-claim basis.”).
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`Dr. S