`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`______________________
`
`
`IN THE UNITED STATES PATENT TRIAL AND APPEAL BOARD
`
`______________________
`
`
`PRAXAIR DISTRIBUTION, INC.
`Petitioner
`
`v.
`
`INO THERAPEUTICS, LLC. d/b/a IKARIA, INC.
`Patent Owner
`
`______________________
`
`CASE IPR: UNASSIGNED
`U.S. PATENT NO. 8,291,904
`______________________
`
`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. 8,291,904
`
`Table of Contents
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`THE ’904 PATENT ......................................................................................... 1
`
`A. Overview of the ’904 Patent .................................................................. 1
`
`B.
`
`Summary of the Prosecution of the ’904 Patent ................................... 2
`
`III. BACKGROUND OF THE TECHNOLOGY .................................................. 3
`
`IV. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a)) ................................. 6
`
`V.
`
`PAYMENT OF FEES (37 C.F.R. §§ 42.15 and 42.103) ................................ 6
`
`VI. MANDATORY NOTICES (37 C.F.R. § 42.8) ............................................... 7
`
`A.
`
`B.
`
`C.
`
`Real Parties-In-Interest .......................................................................... 7
`
`Related Matters ...................................................................................... 7
`
`Lead and Backup Counsel (37 C.F.R. § 42.8(b)(3)) and Service
`Information (37 C.F.R. § 42.8(b)(4)) .................................................... 7
`
`VII. PERSON OF ORDINARY SKILL IN THE ART .......................................... 8
`
`VIII. CLAIM CONSTRUCTION ............................................................................ 8
`
`IX. STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFORE (37 C.F.R. § 42.22(a) AND 42.104(b)) ................ 9
`
`A. Ground 1: Claims 1-8 and 11-16 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 ................ 11
`
`1.
`
`Overview of the Prior Art ......................................................... 11
`
`2. Motivation to Combine Prior Art .............................................. 19
`
`3.
`
`Specific Identification of Challenge ......................................... 25
`
`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
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
`
`Patent, the FR ’804 Publication, the IR Standard, and the ’533
`Patent ................................................................................................... 46
`
`1.
`
`Overview of Prior Art ............................................................... 46
`
`2. Motivation to Combine the Prior Art ........................................ 48
`
`3.
`
`Specific Identification of Challenge ......................................... 50
`
`C.
`
`Ground 3: Claims 9 and 10 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, the IR Standard, and the ’398
`Patent ................................................................................................... 52
`
`1.
`
`Overview of Prior Art ............................................................... 52
`
`2. Motivation to Combine Prior Art .............................................. 54
`
`3.
`
`Specific Identification of Challenge ......................................... 57
`
`X.
`
`CONCLUSION .............................................................................................. 60
`
`
`
`ii
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
`
`List of Exhibits
`
`Ex. 1001 U.S. Patent No. 8,291,904 (“’904 Patent”)
`
`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 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 U.S. Patent No. 4,462,398 (“’398 Patent”), filed December 3, 1982,
`
`issued July 31, 1984.
`
`Ex. 1011 Air Liquide OptiKINOX Brochure, dated 2009.
`
`Ex. 1012
`
`“Guidance Document for Premarket Notification Submissions for
`
`iii
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
`
`Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen
`
`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 U.S. Patent No. 4,308,865 (“’865 Patent”), filed October 19, 1979,
`
`issued January 5, 1982.
`
`Ex. 1014 Reserved.
`
`Ex. 1015
`
`Prosecution History of U.S. Patent No. 8,291,904.
`
`
`
`iv
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
`
`I.
`
`INTRODUCTION
`
`Praxair Distribution, Inc. (“Petitioner” or “Praxair”) hereby petitions for
`
`inter partes review of claims 1-16 of U.S. Patent No. 8,291,904 (“’904 Patent”)
`
`(Ex. 1001) under 35 U.S.C. §§ 311–319 and 37 C.F.R. § 42.
`
`II. THE ’904 PATENT
`A. Overview of the ’904 Patent
`The ’904 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®.1 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 ʼ904
`
`Patent twelve years after it released INOMAX® in the market. PO’s original
`
`patents covering iNO expired in 2013, and PO is now trying to use the ʼ904 Patent
`
`to impermissibly extend its patent monopoly on INOMAX® more than 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 ʼ 904 Patent expires on January 6, 2031. Petitioner is concurrently filing
`
`petitions for inter partes review of four other Orange Book listed patents that
`
`1
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
`
`The ʼ904 Patent does not claim inventive methods or 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 16:44-63, 18:18-33; Ex. 1002
`
`¶¶ 35-59, 60.) Indeed, the valves and control systems claimed by the ’904 Patent
`
`largely mirror the valves and control systems PO itself patented years before
`
`January 6, 2011, the earliest possible priority date for the ’904 Patent. (See
`
`generally Ex. 1004, Ex. 1005.)
`
`Summary of the Prosecution of the ’904 Patent
`
`B.
`The application that issued as the ’904 Patent was filed on June 11, 2012,
`
`and claimed priority to International Application No. PCT/US2011/020319, which
`
`was filed on January 6, 2011. (Ex. 1015 at 2, 33.)3
`
`On August 21, 2012, the Examiner issued a pre-interview office action
`
`rejecting the claims as obvious over the prior art. (Ex. 1015 at 89.) On August 29,
`
`2012, PO conducted an examiner interview and agreed to amend the claims
`
`consistent with the interview. (Ex. 1015 at 156-58.) On August 30, 2012, PO
`____________________
`similarly would extend PO’s monopoly: U.S. Patent Nos. 8,573,209; 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 for the ’904 Patent.
`
`2
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
`
`amended claim 1 from its as-filed form as follows:
`
`
`
`(Ex. 1015 at 126.) Applicant also filed a terminal disclaimer over a co-pending
`
`application that issued as U.S. Patent No. 8,573,209 (for which Petitioner is also
`
`requesting inter partes review). (Ex. 1015 at 141, 147.) The Examiner issued an
`
`examiner’s amendment and notice of allowance on September 11, 2012, exactly
`
`three months after the application was filed. (Ex. 1015 at 151-60.) The Examiner
`
`provided reasons for allowance that essentially paraphrased the language of claim
`
`1. (Ex. 1015 at 159.) The ’904 Patent issued on October 23, 2012, just over four
`
`months after it was filed. (Ex. 1015 at 188.)
`
`III. BACKGROUND OF THE TECHNOLOGY
`As indicated by PO’s prior art patents incorporated by reference in the ’904
`
`Patent (which are statutory bars under 35 U.S.C. § 102(b)), the assemblies and
`
`3
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
`
`systems claimed in the ’904 Patent recite components or sub-systems that were
`
`well known before January 6, 2011. (Ex. 1002 ¶ 19.)
`
`U.S. Patent No. 7,114,510 (“’510 Patent”) is owned by PO and is titled
`
`“Valve with Smart Handle.” (Ex. 1004; Ex. 1002 ¶ 20.) 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
`
`’904 Patent, it was known in the art to affix a valve to a gas cylinder, 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; Ex. 1002 ¶ 21.) It
`
`was also known that electronics mounted in the handle of the valve could include
`
`“an open/closed 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
`
`4
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
`
`handle via the data port or transceiver to a remote device or computer. (Ex. 1004
`
`at 6:33-55; Ex. 1002 ¶ 26.) 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; Ex. 1002 ¶ 26.) The transmitted data could include gas data
`
`about the gas in the cylinder. (Ex. 1004 at 5:45-6:12, Ex. 1002 ¶¶ 27-28.)
`
`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, 30.) The ’083 Patent, which issued in 1996,
`
`teaches that gas delivery systems could include a central processing unit (“CPU”)
`
`that 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. (Ex. 1002 ¶¶ 31-33.) The system would generate an alarm and/or close a
`
`valve to stop NO delivery as appropriate. (Ex. 1005 at 5:60-65; Ex. 1002 ¶ 34.)
`
`5
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
`
`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 ’904 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 ’904 Patent. Accordingly,
`
`the claims are not patentable and should be cancelled.
`
`IV. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a))
`Petitioner certifies that (1) the ʼ904 Patent, issued on October 23, 2012 and
`
`is available for inter partes review; (2) Petitioner is not barred or estopped from
`
`requesting inter partes review of the ʼ904 Patent on the grounds identified herein;
`
`and (3) Petitioner has not filed a complaint relating to the ʼ904 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)
`Petitioner authorizes the USPTO to charge the required fees for inter partes
`
`review of 16 claims, and any additional fees, to Deposit Account No. 02–1818.
`
`6
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
`
`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 ’904 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
`
`(unpublished), and 29/471,765 (unpublished) are currently pending and purport to
`
`claim the benefit of the ultimate priority document of the ’904 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
`
`7
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
`
`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 of 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
`
`U.S. 398, 420-21 (2007). Petitioner submits that a person of ordinary skill in the
`
`art of the ’904 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 ’904 Patent should be given their “broadest reasonable
`
`construction in light of the specification” of the ’904 Patent. 37 C.F.R. §
`
`42.100(b); In re Cuozzo Speed Tech., LLC, Case No. 14-1301, slip op. at 16, 18-19
`
`8
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
`
`(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 each claim of the ’904 Patent to have its plain and
`
`ordinary meaning, and would have understood that no term requires special
`
`construction for purposes of this proceeding.4 Further, as discussed above, the
`
`’510 Patent and the ’083 Patent are owned by PO. Since the ’904 Patent
`
`incorporates the ’510 Patent and the ’083 Patent by reference, claim terms of the
`
`’904 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 1-16 of the ’904 Patent
`
`based on the following grounds:
`
`
`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).
`
`9
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
`
`Ground
`1
`
`35 U.S.C. Section
`§ 103
`
`2
`
`3
`
`§ 103
`
`§ 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)
`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 ’398
`Patent (Ex. 1010)
`
`Claims
`1-8, 11-
`16
`
`3-4
`
`9-10
`
`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
`
`Claim 1 is the only independent claim of the ’904 Patent. Claim 1 recites:
`
`A valve assembly to deliver a gas comprising NO from a gas container
`containing the gas comprising NO, the valve assembly comprising:
`a valve attachable to the gas container containing the gas comprising NO,
`the valve including an inlet and an outlet in fluid communication and a valve
`actuator to open or close the valve to allow the gas comprising NO through
`the valve to a control module;
`a circuit supported within the valve assembly and disposed between the
`
`
`5 Dr. Robert T. Stone is an expert in the field of the alleged invention and the prior
`
`art. (See, e.g., Ex. 1002 ¶¶ 1-18; Ex. 1003.)
`
`10
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
`
`actuator and a cap, the circuit including:
`a valve memory to store gas data comprising gas concentration in the
`gas container and
`a valve processor and a valve transceiver in communication with the
`valve memory
`to send wireless optical
`line-of-sight signals
`to
`communicate the gas data to the control module that controls gas delivery
`to a subject; and
`a data input disposed on the actuator and in communication with said
`
`valve memory, to permit a user to enter the gas data into the valve memory.
`
` (Ex. 1001 at 14:28-52.)
`
`A. Ground 1: Claims 1-8 and 11-16 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
`
`September 24, 1996. The ‘083 Patent is assigned to PO (Ex. 1009) and its lead
`
`inventor (Duncan Bathe) is the same as the lead inventor of the ’904 Patent. The
`
`’083 Patent is prior art under 35 U.S.C. § 102(b).
`
`The ’083 Patent discloses a NO delivery system in which a series of valves
`
`
`6 The ’510 Patent and the ’083 Patent are both incorporated by reference in the
`
`’904 Patent, but neither was cited in an Information Disclosure Statement or
`
`considered as prior art during prosecution. (See Ex. 1001 at 7:45-47, 10:1-4.)
`
`11
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
`
`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. (Ex. 1005 at 1:20-26.) 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.) Its NO delivery system
`
`“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.) The ’083
`
`Patent is advantageous because it can modify the gas in the cylinder to a gas at the
`
`desired pressure and concentration for patient delivery. (Ex. 1005 at 2:13-20.)
`
`The ’083 Patent discloses an input device that enables a user to select a
`
`desired concentration of NO to be delivered to the patient, and a CPU that can
`
`compare desired concentration with actual measured concentration to control
`
`delivery of a selected therapy. (Ex. 1005 at 2:30-35, 2:52-67, 6:29-33, 6:40-42.)
`
`The CPU also triggers alarms if faults occur during NO delivery. (Ex. 1005 at 3:1-
`
`4.) A sensor senses the concentration of NO in the supply cylinder and sends a
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`signal indicative of the sensed NO concentration to the CPU. (Ex. 1005 at 6:5-8,
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`8:1-12.) The CPU then determines whether the concentration being delivered is
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`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
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`appropriate given the user inputted desired concentration. (Id.) Accordingly, one
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`fault monitored by the CPU of the ’083 Patent is a mismatch between the user-
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`entered desired gas concentration and the gas concentration actually being
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`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. 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 the
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`valve 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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`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
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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 6:3-8.)
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`After appropriate data is loaded into valve memory, the cylinder and valve
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`of the ’510 Patent are provided to a medical provider for use, and the medical
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`provider connects the outlet port 20 of the valve 10 to a delivery device, such as a
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`ventilator, which “is used to adjust the concentration and flow rate or to mix gases
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`administered to the patient.” (Ex. 1004 at 6:17-21.) The medical provider rotates
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`the handle, which is an actuator that opens and closes the valve, to “provide gas
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`treatments to patients.” (Ex. 1004 at 6:18-22, 6:29-32.) The sensor in the handle
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`senses each time the handle is turned and logs the date, time and event type of each
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`turning event in valve memory 22. (Ex. 1004 at 6:21-25, 6:30-32.) “All of this
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`information may be read or downloaded by the user and/or by the supplier” using
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`appropriate data transfer methods, including transferring of data through a port
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`using a wand reader or other appropriate device. (Ex. 1004 at 6:47-55.)
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`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
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`In at least one embodiment, the handle 16 disclosed in the ’510 Patent
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`includes “a transmitter to transmit the data to a remote recording device at intervals
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`or on command, as desired.” (Ex. 1004 at 7:1-4.) The ’510 Patent also notes that
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`“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 the valve position data is
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`transmitted 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 Accordingly, the FR ’804 Publication
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`constitutes prior art under 35 U.S.C. § 102(b).
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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”). Air Liquide is a French company that has been involved in
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`manufacturing and selling NO and iNO delivery systems for more than ten years;
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`indeed, at least by 2009, Air Liquide was manufacturing and selling its own iNO
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`delivery systems. (See Ex. 1011.) Accordingly, a person of ordinary skill in the
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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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`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
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`art would understand that the FR ’804 Publication covers a system that can be used
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`to deliver iNO. (Ex. 1002 ¶¶ 61-64.)
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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.) It
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`teaches that gas verification can advantageously improve system safety by
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`ensuring that the desired amount and concentration of gas are being delivered to
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`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 300 that receives data about (a) the specific gas in a cylinder and (b) the
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`gas expected to be supplied to a circuit. (Ex. 1006 at 19.) The control module
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`compares the two pieces of gas data and if the information matches (i.e., the gas in
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`the cylinder is what it should be), it supplies a control signal to open the valve and
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`deliver gas from the cylinder to the fluid circuit. (Ex. 1006 at 18; Ex. 1002 ¶¶ 68-
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`69.) If a negative comparison occurs (i.e., the gas in the cylinder is not the gas
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`expected to be delivered), an audible or visible alarm can be emitted to indicate the
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`mismatch. (Ex. 1006 at 19.)
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`The FR ’804 Publication also explains that the gas data the control module
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`300 uses to make its comparison is the gas identification data (referred to as “IDb
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`data”). (Ex. 1006 at 20.) The IDb data can be stored on an information carrier 120
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`affixed to bottle 10. (Id.) This information carrier can be, for example, a bar code
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`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
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`or a radio-frequency identification (“RFID”) tag. (Ex. 1006 at 20-21.) The data
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`from the carrier is read using a sensor 110, which could be a bar code scanner (if
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`the gas data is stored on a bar code) or an RFID reader (if the gas data is stored on
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`an RFID tag). (Ex. 1006 at 20-21.) The sensor 110 supplies the gas IDb data read
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`from the carrier 120 to the control module 300 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, the memory 200 is in a separate
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`physical device from the control module 300. (Ex. 1006 at 21, Fig. 5; Ex. 1002 ¶
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`69.) In this embodiment, a transceiver may read the contents of the memory 200
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`and to transmit the control signal to the valve. (Ex. 1006 at 21, Fig. 5.)
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`(d) The IR Standard
`The IR Standard (Ex. 1007) is a standard that was published by the
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`International Organization for Standardization (“ISO”) and the Institute of
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`Electrical and Electronics Engineer (“IEEE”) on December 15, 2004. (Ex. 1002 ¶¶
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`70-80, 109-114.) It is therefore prior art under 35 U.S.C. § 102(b).
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`The IR Standard “establishes a connection-oriented transport profile and
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`physical layer suitable for medical device communications that use short-range
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`Petition for Inter Partes Review of U.S. Patent No. 8,291,904
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`infrared wireless.” (Ex. 1007 at ii.) This infrared wireless communications
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`protocol is appropriate for medical devices that “require intermittent point-and-
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`shoot connectivity” to another device. (Ex. 1007 at 2.) The IR Standard states that
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`it is appropriate for capture of patient vital signs and device operational data, and
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`that its infrared wireless communication protocol is especially well suited for use
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`in “acute and continuing care devices, such as patient monitors, ventilators,
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`infusion pumps, ECG devices, etc.” (Ex. 1007 at vi; Ex. 1002 ¶ 72.)
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`The IR Standard discloses that a device’s controller communicates in a
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`point-to-point way with a corresponding controller of another device. (Ex. 1007 at
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`10-11; Ex. 1002 ¶ 73.) The IR Standard provides parameters related to the
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`alignment between IR transmitter-receivers (“transceivers”) to