UNITED STATES PATENT AND TRADEMARK OFFICE
`
`______________________
`
`
`
`IN THE UNITED STATES PATENT TRIAL AND APPEAL BOARD
`
`______________________
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`
`
`PRAXAIR DISTRIBUTION, INC.
`Petitioner
`
`v.
`
`INO THERAPEUTICS, LLC. d/b/a IKARIA, INC.
`Patent Owner
`
`______________________
`
`CASE IPR: UNASSIGNED
`U.S. PATENT NO. 8,573,209
`______________________
`
`PETITION FOR INTER PARTES REVIEW
`
`
`
`
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box. 1450
`Alexandria, VA 22313-1450
`
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,573,209
`
`Table of Contents
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`THE ’209 PATENT ......................................................................................... 1
`
`A. Overview of the ’209 Patent .................................................................. 1
`
`B.
`
`Summary of the Prosecution of the ’209 Patent ................................... 2
`
`III. BACKGROUND OF THE TECHNOLOGY .................................................. 5
`
`IV. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a)) ................................. 8
`
`V.
`
`PAYMENT OF FEES (37 C.F.R. §§ 42.15 and 42.103) ................................ 8
`
`VI. MANDATORY NOTICES (37 C.F.R. § 42.8) ............................................... 8
`
`A.
`
`B.
`
`C.
`
`Real Parties-In-Interest .......................................................................... 8
`
`Related Matters ...................................................................................... 8
`
`Lead and Backup Counsel (37 C.F.R. § 42.8(b)(3)) and Service
`Information (37 C.F.R. § 42.8(b)(4)) .................................................... 9
`
`VII. PERSON OF ORDINARY SKILL IN THE ART .......................................... 9
`
`VIII. CLAIM CONSTRUCTION .......................................................................... 10
`
`IX. STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFORE (37 C.F.R. § 42.22(a) AND 42.104(b)) .............. 11
`
`A. Ground 1: Claims 1-7 Are Unpatentable Under 35 U.S.C. § 103(a)
`as Obvious Over the ’083 Patent in View of the ’510 Patent, the
`FR ’804 Publication, and the IR Standard .......................................... 12
`
`1.
`
`Overview of the Prior Art ......................................................... 12
`
`2. Motivation to Combine ............................................................. 21
`
`3.
`
`Specific Identification of Challenge ......................................... 27
`
`B.
`
`Ground 2: Claims 3 and 4 are Unpatentable Under 35 U.S.C. §
`103(a) as Obvious Over the ’083 Patent in View of the ’510
`
`i
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,573,209
`
`Patent, the FR ’804 Publication, the IR Standard, and the ’533
`Patent ................................................................................................... 50
`
`1.
`
`Overview of Prior Art ............................................................... 50
`
`2. Motivation to Combine ............................................................. 52
`
`3.
`
`Specific Identification of Challenge ......................................... 54
`
`X.
`
`CONCLUSION .............................................................................................. 56
`
`
`
`ii
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,573,209
`
`List of Exhibits
`
`Ex. 1001 U.S. Patent No. 8,573,209
`
`Ex. 1002 Declaration of Robert T. Stone, Ph.D
`
`Ex. 1003 Curriculum Vitae of Robert T. Stone, Ph.D
`
`Ex. 1004 U.S. Patent No. 7,114,510 (“’510 Patent”), filed May 15, 2003, issued
`
`October 3, 2006
`
`Ex. 1005 U.S. Patent No. 5,558,083 (“’083 Patent”), filed November 22, 1993,
`
`issued September 24, 1996
`
`Ex. 1006
`
`French Patent Publication No. 2 917 804 (“FR ’804 Publication”),
`
`published December 26, 2008
`
`Ex. 1007
`
`ISO/IEEE 11073-30300, “Health informatics -- Point-of-care medical
`
`device communication -- Part 30300: Transport profile -- Infrared
`
`wireless,” ISO, IEEE, published December 15, 2004 (“IR Standard”)
`
`Ex. 1008 U.S. Patent No. 6,811,533 (“’533 Patent”), filed January 22, 2001,
`
`issued November 2, 2004
`
`Ex. 1009 Assignment History of the ’083 Patent
`
`Ex. 1010 Reserved
`
`Ex. 1011 Air Liquide OptiKINOX Brochure, dated 2009
`
`Ex. 1012
`
`“Guidance Document for Premarket Notification Submissions for
`
`Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen
`
`iii
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,573,209
`
`Dioxide Analyzer,” (“FDA Guidance”) document issued January 24,
`
`2000 by the U.S. Department of Health and Human Services, Food
`
`and Drug Administration
`
`Ex. 1013 Reserved
`
`Ex. 1014 Reserved
`
`Ex. 1015 Reserved
`
`Ex. 1016
`
`Prosecution History of U.S. Patent No. 8,573,209
`
`
`
`iv
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,573,209
`
`
`I.
`
`INTRODUCTION
`
`Praxair Distribution, Inc. (“Petitioner” or “Praxair”) hereby petitions for
`
`inter partes review of claims 1-7 of U.S. Patent No. 8,573,209 (“’209 Patent”) (Ex.
`
`1001) under 35 U.S.C. §§ 311–319 and 37 C.F.R. § 42.
`
`II. THE ’209 PATENT
`A. Overview of the ’209 Patent
`The ’209 Patent is listed in the U.S. Food and Drug Administration’s
`
`(“FDA”)
`
`list of Approved Drug Products with Therapeutic Equivalence
`
`Evaluations (commonly referred to as the “Orange Book”) in connection with the
`
`prescription drug product INOMAX®. The patent owner and new drug application
`
`holder INO Therapeutics, LLC d/b/a Ikaria, Inc. (“PO”) is the exclusive U.S.
`
`supplier of iNO. PO filed the application that issued as the ʼ209 Patent twelve
`
`years after it released INOMAX®1 in the market. PO’s original patents covering
`
`iNO expired in 2013, and PO is now trying to use the ʼ209 Patent to impermissibly
`
`extend its patent monopoly on INOMAX® to 2031, 35 years after the original
`
`INOMAX patents issued.2
`
`
`1 INOMAX® is the trade name of patent owner’s inhaled nitric oxide drug (“iNO”)
`
`for treating term and near-term infants with respiratory failure.
`
`2 The ’209 Patent expires on January 6, 2031. Petitioner is concurrently filing
`
`petitions for inter partes review of four other Orange Book listed patents that
`
`1
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,573,209
`
`
`The ʼ209 Patent does not claim inventive methods and systems of using
`
`iNO. (See, e.g., Ex. 1001 at Abstract.) Instead, it claims a compiled gas delivery
`
`system with known components operating according to their known functionality,
`
`and methods of using the same. (See, e.g., Ex. 1001 at 16:22-40; 17:1-34; Ex.
`
`1002 ¶36, 40-60.) Indeed, the valves and control systems claimed by the ’209
`
`Patent largely mirror valves and control systems PO itself patented years before
`
`January 6, 2011, the earliest possible priority date for the ’209 Patent. As detailed
`
`below, claims of the ’209 Patent largely mirror valves and control systems PO
`
`itself patented years before filing the application that issued as the ’209 Patent.
`
`(See generally Ex. 1004, Ex. 1005.)
`
`Summary of the Prosecution of the ’209 Patent
`
`B.
`The application that issued as the ’209 Patent was filed on June 11, 2012
`
`after being filed as a national stage entry of International Application No.
`
`PCT/US2011/020319, which was filed January 6, 2011. (Ex. 1016 at 164.)3 On
`
`June 12, 2012, PO submitted a preliminary amendment to rewrite certain
`
`dependent claims in independent form. (Ex. 1016 at 99-103.)
`____________________
`similarly would extend PO’s monopoly: U.S. Patent Nos. 8,291,904; 8,573,210;
`
`8,776,794; and 8,776,795.
`
`3 Petitioner assumes for purposes of this proceeding only that January 6, 2011 is
`
`the priority date of the ’209 Patent.
`
`2
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,573,209
`
`
`On March 15, 2013, the Examiner issued a non-final office action rejecting
`
`the claims, among other reasons, as invalid over U.S. Patent No. 7,114,510 to
`
`Peters (i.e., the ’510 Patent (Ex. 1004) herein) and for obvious-type double
`
`patenting over the claims of U.S. Patent No. 8,291,904. (Ex. 1016 at 187-200.)
`
`
`
`On May 14, 2013, PO conducted an examiner interview. In addition to
`
`agreeing to minor amendments to correct antecedent basis, PO agreed to an
`
`amendment to the independent claims requiring the following language, which
`
`would allegedly overcome the rejections over the ’510 Patent:
`
`the processor and transceiver in communication with the memory
`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
`
`(Ex. 1016 at 210-13.) Finally PO agreed to file a terminal disclaimer to overcome
`
`the double patenting rejection. (Id.) On June 17, 2013, PO filed a terminal
`
`disclaimer and an amendment to the independent claims pursuant to the discussion
`
`during the interview. (Ex. 1016 at 217-29, 237.) The amendment to claim 2,
`
`reproduced below, is representative:
`
`3
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,573,209
`
`
`(Ex. 1016 at 220.)
`
`
`
`The Examiner issued a notice of allowance on August 19, 2013. (Ex. 1016
`
`at 248-55.) In the notice of allowance, the Examiner provided the following
`
`statement of reasons for allowance:
`
`
`
`The closest prior art of record Peters [the ʼ510 Patent] discloses a
`valve with a smart handle including a memory module, a processor
`and a transceiver. Peters also discloses that the memory is able to
`store gas data comprising gas identification. Peters also discloses that
`the processor and transceiver for communicating gas data to a control
`module. However, 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
`
`4
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,573,209
`
`
`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.
`
`(Ex. 1016 at 254.) PO did not comment on the reasons for allowance, and the ‘209
`
`Patent issued on November 5, 2013. (Ex. 1016 at 274.)
`
`III. BACKGROUND OF THE TECHNOLOGY
`As indicated by PO’s prior art patents incorporated by reference in the ’209
`
`Patent (which are statutory bars under 35 U.S.C. § 102(b)), the assemblies and
`
`systems claimed in the ’209 Patent recite components or sub-systems that were
`
`well known before January 6, 2011.
`
`The ʼ510 Patent is owned by PO and is titled “Valve with Smart Handle.”
`
`(Ex. 1004, Ex. 1001 at 7:26-28.) It discloses a valve including a “smart handle”
`
`containing electronics to track opening and closing of the valve and to
`
`communicate stored data with external devices. (Ex. 1004 at 1:9-15, 6:17-7:15.)
`
`The ’510 Patent demonstrates that well before the filing of the ’209 Patent, it was
`
`known in the art to affix a valve to a gas cylinder (Ex. 1002 ¶ 19), the valve
`
`including a processor, memory and a data port or transceiver for transferring data
`
`from the valve memory to other devices. (Ex. 1004 at 2:58-67.) It was also known
`
`that electronics mounted in the handle of the valve could include “an open/closed
`
`5
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`

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`Petition for Inter Partes Review of U.S. Patent No. 8,573,209
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`sensor 28, a battery 25, [and] a display 26.” (Ex. 1004 at 2:58-61.) Thus, long
`
`before January 6, 2011, it was known to include electronics and circuitry, such as
`
`processors, memory devices, and LCD displays, in handles of valves used to
`
`control delivery of gas to patients. (Ex. 1002 ¶¶ 22-25.)
`
`The ’510 Patent’s smart handle was capable of storing both data about the
`
`gas in the cylinder and data about open and close times of the valve in the valve
`
`memory. (Ex. 1004, 5:44-56, 6:21-27.) This smart handle also included data ports
`
`or transceivers (short for “transmitter/receiver”) in communication with the valve
`
`processors and memory devices. Data could be communicated from the smart
`
`handle via the data port or transceiver to a remote device or computer. (Ex. 1004
`
`at 6:33-55; Ex. 1002 ¶¶ 26, 37-38.) Such data ports or transceivers could
`
`communicate with the remote device via wired (i.e., transmission of electrons via
`
`conductors) or wireless (i.e., radio signals propagated through the air encoding
`
`data) connections. (Ex. 1004 at 6:64-7:4.) The transmitted data could include gas
`
`data about the gas in the cylinder. (Ex. 1004 at 5:45-6:12, Ex. 1002 ¶¶ 27-28, 39.)
`
`Another patent assigned to PO, U.S. Patent No. 5,558,083 (“’083 Patent”),
`
`titled “Nitric Oxide Delivery System,” describes known gas delivery modules for
`
`delivering selectable concentrations of nitric oxide (also referred to as “NO”) to a
`
`patient. (Ex. 1005; Ex. 1002 ¶ 19.) The ’083 Patent, which issued in 1996, teaches
`
`that gas delivery systems could include a central processing unit (“CPU”) that
`
`6
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`

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`Petition for Inter Partes Review of U.S. Patent No. 8,573,209
`
`
`receives and compares signals from two sources. Specifically, the ’083 Patent’s
`
`CPU receives both a user’s desired concentration of NO from an input device as
`
`well as actual gas flow rate from a flow transducer, which it can use to determine
`
`gas concentration. The CPU also generates and transmits output signals which
`
`control delivery of the gas. (Ex. 1005 at 2:30-35.) In other words, in known NO
`
`delivery systems, the CPU compared user inputted data about the desired
`
`concentration of NO with the actual concentration of NO being delivered to the
`
`patient. The system would then generate an alarm and/or close a valve to stop NO
`
`delivery as appropriate. (Ex. 1005 at 5:60-65.)
`
`Known NO delivery systems were also designed to enable two cylinders of
`
`gas to be in fluid communication with the delivery system at the same time. (Ex.
`
`1005 at 8:38-65; Fig. 2.) Thus, CPUs of known NO delivery systems could
`
`simultaneously control delivery of gas from two different sources. (Ex. 1005 at
`
`8:46-49, 8:62-65.)
`
`The ’209 Patent is nothing more than a combination of PO’s own prior NO
`
`delivery system and valve technology. This tactic is a transparent attempt to
`
`extend PO’s expiring patent monopoly. However, a person skilled in the art would
`
`have combined PO’s prior technologies, each operating in their intended way, with
`
`other well-known teachings to result in the claims of the ’209 Patent. Accordingly,
`
`the claims are not patentable and should be canceled.
`
`7
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,573,209
`
`IV. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a))
`Petitioner certifies that (1) the ʼ209 Patent, issued on November 5, 2013, is
`
`available for inter partes review; (2) Petitioner is not barred or estopped from
`
`requesting inter partes review of the ʼ209 Patent on the grounds identified herein;
`
`and (3) Petitioner has not filed a complaint relating to the ʼ209 Patent. This
`
`Petition is filed in accordance with 37 C.F.R. § 42.106(a).
`
`V.
`
`PAYMENT OF FEES (37 C.F.R. §§ 42.15 and 42.103)
`
`In accordance with 37 C.F.R. § 42.15 and § 42.103, Petitioner authorizes the
`
`USPTO to charge the required fees for inter partes review of 7 claims, and any
`
`additional fees, to Deposit Account No. 02–1818.
`
`VI. MANDATORY NOTICES (37 C.F.R. § 42.8)
`A. Real Parties-In-Interest
`Praxair Distribution, Inc., head office at 28 McCandless Ave., Pittsburgh,
`
`PA 15201, and Praxair, Inc., worldwide headquarters at 39 Old Ridgebury Rd.,
`
`Danbury, CT 06810 are the real parties-in-interest.
`
`B. Related Matters
`Petitioner understands that on February 19, 2015, PO filed a complaint in the
`
`District Court for the District of Delaware (Case No. 15-cv-00170) alleging that
`
`Petitioner is infringing ten U.S. Patents, including the ’209 Patent. Petitioner has
`
`not been served with the complaint and has not answered or otherwise pleaded.
`
`U.S. Patent Application Nos. 14/328,150, 14/065,962, 14/6629,742
`
`8
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,573,209
`
`
`(unpublished), and 29/471,765 (unpublished) are currently pending and purport to
`
`claim the benefit of the ultimate priority document of the ’209 Patent.
`
`C. Lead and Backup Counsel (37 C.F.R. § 42.8(b)(3)) and Service
`Information (37 C.F.R. § 42.8(b)(4))
`
`Lead Counsel
`Sanjay K. Murthy
`Reg. No. 45,976
`K&L GATES LLP
`70 W. Madison Street, Suite 3100
`Chicago, IL 60602
`sanjay.murthy@klgates.com
`T: (312) 807-4416
`F: (312) 827-8138
`
`Backup Counsel
`Sara Kerrane
`Reg. No. 62,801
`K&L GATES LLP
`1 Park Plaza, Twelfth Floor
`Irvine, CA 92614
`sara.kerrane@klgates.com
`T: (949) 623-3547
`F: (949) 623-4470
`
`Michael J. Abernathy
`Pro Hac Vice Authorization
`Requested
`K&L GATES LLP
`70 W. Madison Street, Suite 3100
`Chicago, IL 60602
`michael.abernathy@klgates.com
`T: (312) 807-4257
`F: (312) 827-8032
`
`Petitioner consents to electronic service by email.
`
`VII. PERSON OF ORDINARY SKILL IN THE ART
`A person of ordinary skill in the art is a hypothetical person presumed to
`
`know the relevant prior art. Gnosis S.p.A. v. South Alabama Med. Sci. Found.,
`
`IPR2013-00116, Final Written Decision (Paper 68) at 9. Such a person or ordinary
`
`skill is of ordinary creativity, not merely an automaton, and is capable of
`
`combining teachings of the prior art. Id. (citing KSR Int’l Co. v. Teleflex Inc., 550
`
`9
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,573,209
`
`
`U.S. 398, 420-21 (2007). Petitioner submits that a person of ordinary skill in the
`
`art of the ’209 Patent as of January 6, 2011, would have had a bachelor’s degree in
`
`electrical engineering, computer science, computer engineering, or the equivalent,
`
`and would have had at least two years’ experience in biomedical engineering
`
`designing medical gas delivery or monitoring systems. (Ex. 1002 ¶¶ 17-18.)
`
`VIII. CLAIM CONSTRUCTION
`The claims of the ’209 Patent should be given their “broadest reasonable
`
`construction in light of the specification.” 37 C.F.R. § 42.100(b); In re Cuozzo
`
`Speed Tech., LLC, Case No. 14-1301, slip op. at 16, 18-19 (Fed. Cir. Feb. 2, 2015).
`
`While the specification cannot be used to impermissibly narrow the meaning of a
`
`term, a claim term must be construed broadly enough to encompass all meanings
`
`set forth in the specification and the references incorporated therein. See MSM
`
`Investments Co. v. Carolwood Corp., 259 F.3d 1335, 1339-40 (Fed. Cir. 2011).
`
`Here, a person of ordinary skill in the art would have understood each term of the
`
`’209 Patent to have its plain and ordinary meaning, and would have understood
`
`that no term requires special construction for purposes of this proceeding.”4 In this
`
`proceeding, the ’510 Patent and the ’083 Patent are owned by PO. Since the ’209
`
`4 Any contention by PO that claim terms should have a special meaning should be
`
`disregarded unless PO also moves to amend its claims as permitted to expressly
`
`recite that meaning. See 77 Fed. Reg. 48764 at II.B.6 (August 14, 2012).
`
`10
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,573,209
`
`
`Patent incorporates the ’510 Patent and the ’083 Patent by reference, claim terms
`
`of the ’209 Patent that are also used in the ’510 Patent or the ’083 Patent should be
`
`interpreted at least broadly enough to cover the meaning of the terms in the
`
`incorporated patents.
`
`IX. STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFORE (37 C.F.R. § 42.22(a) AND 42.104(b))
`
`Petitioner requests review and cancellation of claims 1-7 of the ’209 Patent
`
`based on the following grounds:
`
`Ground
`1
`
`35 U.S.C. Section
`§ 103
`
`2
`
`§ 103
`
`Relied-On Reference
`The ’083 Patent (Ex. 1005) in view
`of the ’510 Patent (Ex. 1004), the FR
`’804 Publication (Ex. 1006), and the
`IR Standard (Ex. 1007)
`The ’083 Patent (Ex. 1005) in view of
`the ’510 Patent (Ex. 1004), the FR
`’804 Publication (Ex. 1006), the IR
`Standard (Ex. 1007), and the ’533
`Patent (Ex. 1008)
`
`Claims
`1-7
`
`3-4
`
`Per 37 C.F.R. § 42.6(c), copies of the relied-on references are marked as exhibits
`
`filed herewith. Petitioner also provides the declaration of Robert T. Stone, Ph.D
`
`(Ex. 1002) in support of its proposed grounds of unpatentability.5
`
`Claims 1, 3, 5, and 6 are the independent claims of the ’209 Patent. Claim 1
`
`is illustrative, and recites:
`
`5 Dr. Robert T. Stone is an expert in the field of the alleged invention and the prior
`
`art. (See, e.g., Ex. 1002 ¶¶ 1-16; Ex. 1003.)
`
`11
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,573,209
`
`
`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,
`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.
`(Ex. 1001 at 16:22-40.)
`
`A. Ground 1: Claims 1-7 Are Unpatentable Under 35 U.S.C. §
`103(a) as Obvious Over the ’083 Patent in View of the ’510 Patent,
`the FR ’804 Publication, and the IR Standard6
`1. Overview of the Prior Art
`(a) The ’083 Patent
`The ’083 Patent (Ex. 1005) was filed on November 22, 1993 and issued on
`
`
`6 The ’510 Patent and the ’083 Patent are both incorporated by reference in the
`
`’209 Patent. (See Ex. 1001 at 7:26-28, 9:49-52; Ex. 1002 ¶ 35.)
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`12
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`

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`Petition for Inter Partes Review of U.S. Patent No. 8,573,209
`
`
`September 24, 1996. (Ex. 1002 ¶ 30.) The ʼ083 Patent is assigned to PO (Ex.
`
`1009), and its lead inventor (Duncan Bathe) is the same as the lead inventor as the
`
`’209 Patent. The ’083 Patent is prior art under 35 U.S.C. § 102(b).
`
`The ’083 Patent discloses a nitric oxide delivery system in which a series of
`
`valves under control of a CPU control the flow and concentration of NO and
`
`nitrogen given to a patient. (Ex. 1005 at Abstract; 1:20-22.) Commercially
`
`available NO usually has a pressure of approximately 2000 psi and a concentration
`
`between 800 and 2000 ppm. The ’083 Patent teaches a system that can reduce the
`
`pressure of the NO gas and can “precisely meter the amount of the NO and
`
`nitrogen mixture so that the desired concentration of NO is actually administered
`
`to the patient.” (Ex. 1005 at 1:26-31.) The ’083 Patent discloses a NO system that
`
`“includes a flow transducer that senses the flow of gas from the gas delivery
`
`system and uses that information with a selective algorithm to provide an operator
`
`selectable concentration of NO to the patient.” (Ex. 1005 at 2:20-24; Ex. 1002 ¶
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`31.) The system of the ’083 Patent is advantageous because it can modify the gas
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`in the cylinder to a gas that is at the desired pressure and concentration for patient
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`delivery. (Ex. 1005 at 2:13-20.)
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`The ’083 Patent discloses an input device that enables a user to select a
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`desired concentration of NO to be delivered to the patient, and a CPU that can
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`compare desired concentration with actual measured concentration to control
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`delivery of a selected therapy. (Ex. 1005 at 2:30-35, 2:52-67, 6:29-33, 6:40-42;
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`Ex. 1002 ¶ 32.) The CPU also triggers alarms if faults occur during NO delivery.
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`(Ex. 1005 at 3:1-4; Ex. 1002 ¶ 32.) A sensor senses the concentration of NO in the
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`supply cylinder and sends a signal indicative of the sensed NO concentration to the
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`CPU. (Ex. 1005 at 6:5-8, 8:1-12; Ex. 1002 ¶¶ 33-34.) The CPU then determines
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`whether the concentration being delivered is appropriate given the user inputted
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`desired concentration. (Id.) Accordingly, one fault monitored by the CPU of the
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`’083 Patent is a mismatch between the user-entered desired gas concentration and
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`the gas concentration actually being delivered. (Ex. 1005 at 8:10-12.)
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`(b) The ’510 Patent
`The ’510 Patent (Ex. 1004), which is also assigned to PO, was filed as a
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`PCT international application on November 15, 2001 and issued on October 3,
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`2006. (Ex. 1002 ¶ 20.) The ’510 Patent is prior art under 35 U.S.C. § 102(b).
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`The ’510 Patent is directed to a “valve with a smart handle including a
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`memory module to log relevant data.” (Ex. 1004 at Abstract.) The smart handle
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`includes “several electronic devices…including a processor 23, a timer 21, a reset
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`button 27, an open/close sensor 28, a battery 25, a display 26, and an electronic
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`memory device 22.” (Ex. 1004 at 2:58-61.) In the ’510 Patent, the processor 23
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`and the electronic memory device 22 are mounted inside the handle 16 of the valve
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`10. (Ex. 1004 at 2:58-61, 3:3-7.) The handle also includes a port that “can be used
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`to transfer data from the handle’s memory 22 to other devices.” (Ex. 1004 at 2:65-
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`66.) Finally, the handle includes a sensor that senses whether the handle is in an
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`open or closed position; and stores a time-stamped indication of a change in
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`position. (Ex. 1004 at 3:34-58.)
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`The ’510 Patent discloses that initial parameters can be loaded into the
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`memory of the handle. (Ex. 1004 at 5:44-56.) These parameters can include gas
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`data such as “[c]ylinder serial number” and “[g]as lot number.” (Ex. 1004 at 5:44-
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`56.) The ’510 Patent teaches that this gas data is typically loaded into memory by
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`the distributor providing the cylinder. (Ex. 1004 at 5:57-64.) In certain situations,
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`however, users (such as hospital employees) may add “more data into the memory
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`device 22 of the valve 10.” (Ex. 1004 at 6:3-4.) The ’510 Patent gives several
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`examples of “more data,” including “patient identification number” and “treatment
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`number” usable for “record keeping and for billing…” (Ex. 1004 at 6:4-8.)
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`After the appropriate data is loaded into the valve memory, the cylinder and
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`valve of the ’510 Patent are provided to a medical provider for use, and the
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`medical provider connects the outlet port 20 of the valve 10 to a delivery device,
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`such as a ventilator, which “is used to adjust the concentration and flow rate or to
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`mix gases administered to the patient.” (Ex. 1004 at 6:17-21.) The medical
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`provider rotates the handle, which is an actuator that opens and closes the valve, to
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`“provide gas treatments to patients.” (Ex. 1004 at 6:18-22, 6:29-32; Ex. 1002 ¶
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`21.) The sensor in the handle senses each time the handle is turned and logs the
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`date, time and event type of each turning event in valve memory 22. (Ex. 1004 at
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`6:21-25, 6:30-32.) “All of this information may be read or downloaded by the user
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`and/or by the supplier” using appropriate data transfer methods, including
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`transferring of data through a port using a wand reader or other appropriate device.
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`(Ex. 1004 at 6:47-55.)
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`In some embodiments, the handle 16 disclosed in the ’510 Patent includes “a
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`transmitter to transmit the data to a remote recording device at intervals or on
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`command, as desired.” (Ex. 1004 at 7:1-4.) The ’510 Patent also broadly states
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`that “many other methods for transmitting the data from the valve 10 to the main
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`computer could be used.” (Ex. 1004 at 7:14-15.) After transfer of the logged
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`position data to a remote device, software on the remote device can be used “to
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`generate reports, to track treatments, do billings, and to control inventory.” (Ex.
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`1004 at 7:9-12.)
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`(c) The FR ’804 Publication
`The FR ’804 Publication (Ex. 1006) was filed on June 20, 2007 and
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`published on December 26, 2008.7 (Ex. 1002 ¶ 61.) Accordingly, the FR ’804
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`Publication constitutes prior art under 35 U.S.C. § 102(b).
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`7 Ex. 1006 includes the original, French-language version of the FR ’804
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`Publication followed by a certified translation from French to English.
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`The FR ’804 Publication is assigned on its face to L’Air Liquide Societe
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`Anonyme Por L’Etude Et L’Exploitation Des Procedes Georges Claude (“Air
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`Liquide”). (Ex. 1002 ¶ 63.) Air Liquide is a French company that has been
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`involved in manufacturing and selling NO and iNO delivery systems for more than
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`ten years; indeed, at least by 2009, Air Liquide was manufacturing and selling its
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`own iNO delivery systems. (See Ex. 1011.) Accordingly, a person of ordinary
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`skill in the art would understand that the FR ’804 Publication covers a system that
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`can be used to deliver iNO. (Ex. 1002 ¶¶ 63-64.)
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`The FR ’804 Publication discloses several embodiments of a system for
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`verifying that the gas being delivered is the expected gas. (Ex. 1006 at 17; Ex.
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`1002 ¶ 65.) It teaches that gas verification can advantageously improve system
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`safety by ensuring that the desired amount and concentration of gas are being
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`delivered to the patient. (Ex. 1006 at 17; Ex. 1002 ¶¶ 65-66.)
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`To achieve its safety goals, the FR ’804 Publication discloses a control
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`module, identified as numeral 300, that receives data about (a) the specific gas in a
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`cylinder and (b) the gas expected to be supplied to a circuit. (Ex. 1006 at 19.) The
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`control module compares the two pieces of gas data, and in the event the
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`comparison is positive (i.e., the gas in the cylinder matches the gas expected to be
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`delivered), supplies a control signal to open a valve and deliver gas from the
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`cylinder to the fluid circuit. (Ex. 1006 at 18.) If a negative comparison occurs
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`(i.e., the gas in the cylinder does not match the gas expected to be delivered), an
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`audible or visible alarm can be emitted to indicate the mismatch. (Ex. 1006 at 19;
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`Ex. 1002 ¶¶ 66-67.)
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`The FR ’804 Publication discusses the source for the data the control module
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`300 uses to make its comparison. It discloses that the identification data of the gas
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`in the bottle 10 (referred to as “IDb data”) can be stored on an information carrier
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`120 affixed to bottle 10. (Ex. 1006 at 20; Ex. 1002 ¶ 68.) This information carrier
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`can be, for example, a bar code or a radio-frequency identification (“RFID”) tag.
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`(Ex. 1006 at 20-21.) The data from the carrier is read using a sensor 110, which
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`could be a bar code scanner (if the gas data is stored on a bar code) or an RFID
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`reader (if the gas data is stored on an RFID tag). (Ex. 1006 at 20-21.) The sensor
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`110 supplies the gas IDb data read from the carrier 120 to the control module 300
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`for comparison. (Ex. 1006 at 21.)
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`With regard to the expected or intended type of gas (referred to as “IDv”),
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`the FR ’804 Publication discloses that this data is stored in a memory 200
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`associated with the control module 300, and the data is supplied to the control
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`module 300 for comparison with the IDb data read from the carrier on the bottle.
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`(Ex. 1006 at 19.) In the embodiment of Fig. 5 (Ex. 1006 at 14), the memory 200 is
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`in a separate physical device from the control module 300. (Ex. 1006 at 21, Fig. 5;
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`Ex. 1002 ¶ 69.) In this embodiment, a transceiver may be used to read the contents
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`of the memory 200 and to transmit the control signal to the valve. (Ex. 1006 at 21,
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`Fig. 5.)
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`(d) The IR Standard
`The IR Standard (Ex. 1007) is a standard that was publishe