Filed on behalf of: Mallinckrodt Hosp. Prods. IP Ltd.
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`Entered: June 30, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`
`PRAXAIR DISTRIBUTION, INC. AND NOxBOX LIMITED,
`Petitioner
`
`v.
`
`MALLINCKRODT HOSPITAL PRODUCTS IP LTD.,
`Patent Owner
`_______________________
`
`
`
`Case IPR2016-00779
`U.S. Patent No. 8,293,284
`_______________________
`
`Before STEVEN AMITRANI, Trial Paralegal.
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`
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`PATENT OWNER’S EXHIBIT LIST
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`

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`Case IPR2016-00779
`U.S. Patent No. 8,293,284
`
`
`Pursuant to 37 C.F.R. § 42.63(e), Patent Owner Mallinckrodt Hospital
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`Products IP Ltd. (“Patent Owner”) respectfully submits the following current
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`exhibit list:
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`2002
`2003
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`2004
`2005
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`2006
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`2007
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`2008
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`2009
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`EXHIBIT DESCRIPTION
`2001
`Declaration of Geoffrey L. Rosenthal, M.D., Ph.D. in Support of
`Patent Owner’s Preliminary Response to Praxair’s Petition for Inter
`Partes Review of U.S. Patent No. 8,293,284
`Curriculum Vitae of Geoffrey L. Rosenthal, M.D., Ph.D.
`Google Book Search: “neonatal” “nitric oxide” (“Google Book
`Search 1”)
`INOmax® Label (revised 10/2015) (“Current INOmax® Label”)
`File History for U.S. Patent No. 8,846,112 (“’112 patent file
`history”)
`Duncan J. Macrae et al., Inhaled nitric oxide therapy in neonates
`and children: reaching a European consensus, 30 INTENSIVE CARE
`MED. 372 (2004) (“EU Consensus”)
`File History for U.S. Patent Application No. 12/820,886 (“’866 app.
`file history”)
`Google Book Search: “neonatal respiratory” “nitric oxide”
`(“Google Book Search 2”)
`Google Book Search: “neonatal ventilation” “nitric oxide”
`(“Google Book Search 3”)
`Library of Congress Index for Anne Greenough et al., Neonatal
`Respiratory Disorders (2d ed. 2003)
`National Library of Medicine Index for Anne Greenough et al.,
`Neonatal Respiratory Disorders (2d ed. 2003)
`Harvard University Library Index for Anne Greenough et al.,
`Neonatal Respiratory Disorders (2d ed. 2003)
`OCLC WorldCat Index for Anne Greenough et al., Neonatal
`Respiratory Disorders (2d ed. 2003)
`File History for U.S. Patent Application No. 14/454,373 (“’373 app.
`file history”)
`S&P Capital IQ, Praxair Distribution, Inc. Private Company Profile
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`2010
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`2011
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`2012
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`2013
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`2014
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`2015
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`1
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`

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`2017
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`2018
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`2019
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`2020
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`2021
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`Case IPR2016-00779
`U.S. Patent No. 8,293,284
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`EXHIBIT DESCRIPTION
`Petition for Inter Partes Review of U.S. Patent No. 8,293,284,
`2016
`Praxair Distrib., Inc. v. INO Therapeutics, Inc., No. IPR2015-00524
`(P.T.A.B. Jan. 5, 2015), Paper 1
`Decision Denying Institution of Inter Partes Review, Praxair
`Distrib., Inc. v. INO Therapeutics, Inc., Nos. IPR2015-00522, -
`00524, -00525, -00526 (P.T.A.B. July 29, 2015), Paper 12
`Order on Requests for Oral Argument, Praxair Distrib., Inc. v. INO
`Therapeutics, Inc., No. IPR2015-00529 (P.T.A.B. March 22, 2016),
`Paper 45
`Patent Owner’s Preliminary Response, Praxair Distrib., Inc. v. INO
`Therapeutics, Inc., No. IPR2015-00524 (P.T.A.B. May 4, 2015),
`Paper 8
`Hearing Before the Board, Praxair Distrib., Inc. v. INO
`Therapeutics, Inc., No. IPR2015-00529 (P.T.A.B. Jan. 5, 2016)
`Defendants’ Initial Invalidity Contentions, INO Therapeutics LLC v.
`Praxair Distrib., Inc., No. 15-170-GMS (D. Del. Dec. 15, 2015)
`Definition of Contraindication, MedlinePlus
`Andrew M. Atz et al., Diagnostic and Therapeutic Uses of Inhaled
`Nitric Oxide in Neonatal Ebstein’s Anomaly, 91 AM. J. CARDIOLOGY
`906 (2003) (“Atz 2003”)
`Jesse D. Roberts et al., Inhaled Nitric Oxide in Congenital Heart
`Disease, 87 CIRCULATION 447 (1993) (“Roberts 1993”)
`Milad El-Segaier et al., Nitric oxide in neonatal transposition of the
`great arteries, 94 ACTA PÆDIATRICA 912 (2005) (“El-Segaier
`2005”)
`Aamir S. Shah et al., Nitric Oxide Treatment for Pulmonary
`Hypertension After Neonatal Cardiac Operation, 60 ANN. THORAC.
`SURG. 1791 (1995) (“Shah 1995”)
`Marcus T.R. Roofthooft et al., Persistent Pulmonary Hypertension
`of the Newborn with Transposition of the Great Arteries, 83 ANN.
`THORAC. SURG. 1446 (2007) (“Roofthooft 2007”)
`RESERVED
`Excerpt from Praveen Khilnani, Pediatric and Neonatal Mechanical
`Ventilation (2d ed. 2011) (“Jaypee 2014”)
`Marthur S. Kannan, Nitric Oxide: Biological Role and Clinical
`Uses, 65 INDIAN J. PEDIATRICS 333 (1998) (“Kannan 1998”)
`
`2022
`2023
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`2024
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`2025
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`2026
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`2027
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`2028
`2029
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`2030
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`2
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`

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`2032
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`2033
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`2034
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`2035
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`2036
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`2037
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`2038
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`2039
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`2040
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`Case IPR2016-00779
`U.S. Patent No. 8,293,284
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`EXHIBIT DESCRIPTION
`Excerpt from Praveen Khilnani, Practical Approach to Pediatric
`2031
`Intensive Care (2005) (“Khilnani Textbook”)
`Review of Praveen Khilnani, Practical Approach to Pediatric
`Intensive Care (2005), from www.archdischild.com (“Khilnani
`Book Review”)
`Declaration of Dr. Maurice Beghetti, Praxair Distrib., Inc. v. INO
`Therapeutics, Inc., No. IPR2015-00524 (P.T.A.B. Jan. 5, 2015),
`Exhibit 1002
`Praxair’s Opening Claim Construction Brief Regarding U.S. Patent
`No. 8,846,112, Mallinckrodt Hosp. Prods. IP Ltd. v. Praxair
`Distrib., Inc., No. 15-170-GMS (D. Del. Mar. 17, 2016)
`Praxair’s Responsive Claim Construction Brief Regarding U.S.
`Patent No. 8,846,112, Mallinckrodt Hosp. Prods. IP Ltd. v. Praxair
`Distrib., Inc., No. 15-170-GMS (D. Del. Apr. 14, 2016)
`Evan Loh et al., Cardiovascular Effects of Inhaled Nitric Oxide in
`Patients with Left Ventricular Dysfunction, 90 CIRCULATION 2780
`(1994) (“Loh”)
`David N. Cornfield, Randomized, Controlled Trial of Low-dose
`Inhaled Nitric Oxide in the Treatment of Term and Near-term
`Infants with Respiratory Failure and Pulmonary Hypertension, 104
`PEDIATRICS 1089 (1999) (“Cornfield 1999”)
`W. Butt, Recent Advances in Paediatric Ventilation, 1 Critical Care
`& Resuscitation 85 (1999) (“Butt 1999”)
`Neonatal Inhaled Nitric Oxide Study Group, Inhaled Nitric Oxide in
`Full-Term and Nearly Full-Term Infants with Hypoxic Respiratory
`Failure, 336 NEW ENG. J. MED. 597 (1997) (“Neonatal Group”)
`Reese H. Clark et al., Low-Dose Nitric Oxide Therapy for Persistent
`Pulmonary Hypertension of the Newborn, 342 NEW ENG. J. MED.
`469 (2000) (“Clark 2000”)
`RESERVED
`Gordon Guyatt et al., Users’ Guide to the Medical Literature: A
`Manual for Evidenced-Based Clinical Practice (2d ed. 2008)
`(“Guyatt 2008”)
`Richard Beasley et al., Withdrawal of Fenoterol and the End of the
`New Zealand Asthma Mortality Epidemic, 107 INT. ARCH. ALLERGY
`IMMUNOL. 325 (1995)
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`2041
`2042
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`2043
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`3
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`Case IPR2016-00779
`U.S. Patent No. 8,293,284
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`EXHIBIT DESCRIPTION
`Harvard University Countway Library of Medicine, [HMS] EBM -
`2044
`Evidence-based Medicine, available at
`http://guides.library.harvard.edu/hms/ebm
`AARC Clinical Practice Guideline, reprinted from 39 RESPIRATORY
`CARE 808 (1994)
`David Katerndahl, When Plagiarism Becomes Research, 8 FAMILY
`PRACTICE 382 (1991)
`University of Illinois at Chicago Library Index for Anne Greenough
`et al., Neonatal Respiratory Disorders (2d ed. 2003)
`University of Chicago Library Index for Anne Greenough et al.,
`Neonatal Respiratory Disorders (2d ed. 2003)
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`2045
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`2046
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`2047
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`2048
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`Respectfully submitted,
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`
`
`By: /Robert Steinberg/
`
`Robert Steinberg (Reg. No. 33,144)
`bob.steinberg@lw.com
`Latham & Watkins LLP
`355 South Grand Avenue
`Los Angeles, CA 90071-1560
`213.485.1234; 213.891.8763 (Fax)
`
`Daniel G. Brown (Reg. No. 54,005)
`daniel.brown@lw.com
`Latham & Watkins LLP
`885 Third Avenue
`New York, NY 10022-4834
`212.906.1200; 212.751.4864 (Fax)
`
`Counsel for Patent Owner
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`Dated: June 30, 2016
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`Case IPR2016-00779
`U.S. Patent No. 8,293,284
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 30th day of June,
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`2016, a true and correct copy of the foregoing Patent Owner’s Exhibit List was
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`served by electronic mail on Petitioner’s lead and backup counsel at the following
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`email addresses:
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`sanjay.murthy@morganlewis.com
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`mike.abernathy@morganlewis.com
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`maria.doukas@morganlewis.com
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`margaux.nair.PTAB@klgates.com
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`benjamin.weed.PTAB@klgates.com
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`By: /Robert Steinberg/
`
`Robert Steinberg (Reg. No. 33,144)
`bob.steinberg@lw.com
`Latham & Watkins LLP
`355 South Grand Avenue
`Los Angeles, CA 90071-1560
`213.485.1234; 213.891.8763 (Fax)