Filed on behalf of: INO Therapeutics, LLC
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`Entered: November 5, 2015
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`
`PRAXAIR DISTRIBUTION, INC.
`Petitioner
`
`
`
`v.
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`INO THERAPEUTICS LLC,
`Patent Owner
`_______________________
`
`Case IPR2015-00529
`U.S. Patent No. 8,846,112 B2
`_______________________
`
`Before LORA M. GREEN, TINA E. HULSE, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
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`PATENT OWNER’S UPDATED EXHIBIT LIST
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`Entered: November 5, 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 IPR2015-00529
`U.S. Patent No. 8,846,112 B2
`_______________________
`
`Before LORA M. GREEN, TINA E. HULSE, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`
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`
`
`
`Case IPR2015-00529
`U.S. Patent No. 8,849,112
`
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`Pursuant to 37 C.F.R. § 42.63(e), Patent Owner INO Therapeutics LLC
`
`(“Ikaria”) respectfully submits the following current exhibit list.
`
`EXHIBIT
`2001
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`2002
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`2003
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`2004
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`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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`2010
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`2011
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`DESCRIPTION
`Supplemental Reply filed May 9, 2012, Excerpt from
`prosecution history of U.S. Patent Application No. 12/821,020
`that issued as the ’966 patent
`Non-final office action dated Jan. 31, 2012, Excerpt from
`prosecution history of U.S. Patent Application No. 12/821,020
`that issued as the ’966 patent
`Adatia et al., “Inhaled nitric oxide and hemodynamic evaluation
`of patients with pulmonary hypertension before transplantation,”
`25:1656-64, J. Am. Coll. Cardiol., 1995 (“Adatia”)
`Beghetti et al., “Inhaled nitric oxide can cause severe systemic
`hypotension,” 130:844, J. Pediatr., 1997 (“Beghetti (1997)”)
`Rosales et al., “Adverse hemodynamic effects observed with
`inhaled nitric oxide after surgical repair of total anomalous
`pulmonary venous return,” 20:224-26, Pediatr. Cardiol., 1999
`(“Rosales”)
`Lipshultz, “Ventricular dysfunction clinical research in infants,
`children and adolescents,” 12:1-28, Prog. Pediatr. Cardiol.,
`2000 (“Lipshultz”)
`Stedman’s Medical Dictionary at a Glance, 28th ed., Lippincott
`Williams & Wilkins ©2006, pg. 359 (“Stedman’s 2006”)
`Webster’s II New College Dictionary, Houghton Mifflin
`Company, ©1995, pg. 194 (“Webster 1995”)
`Gidding, “The Importance of Randomized Controlled Trials in
`Pediatric Cardiology,” 298:1214-1216, JAMA., 2007
`(“Gidding”)
`Balaguru et al., “Management of Heart Failure in Children,”
`30:5-30, Curr. Probl. Pediatr., 2000 (“Balaguru”)
`Berger et al., “Clinical features of paediatric pulmonary
`hypertension: a registry study,” 379:537-46, Lancet, 2012
`(“Berger”)
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`1
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`Case IPR2015-00529
`U.S. Patent No. 8,849,112
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`EXHIBIT
`2012
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`2013
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`2014
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`2015
`2016
`2017
`2018
`2019
`2020
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`2021
`2022
`2023
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`2024
`2025
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`2026
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`2027
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`DESCRIPTION
`Rimensberger et al., “Inhaled nitric oxide versus aerosolized
`iloprost in secondary pulmonary hypertension in children with
`congenital heart disease: vasodilator capacity and cellular
`mechanisms”, 103:544-48, Circulation, 2001 (“Rimensberger”)
`Brief on Appeal filed Oct. 4, 2011, Excerpt from prosecution
`history of U.S. Patent Application No. 12/820,866 (“’866
`Appeal Brief”)
`Interview Summary dated Sep. 9, 2010, Excerpt from
`prosecution history of U.S. Patent Application No. 12/821,020
`that issued as the ’966 patent
`Reserved
`Reserved
`Reserved
`Reserved
`Patent Owner’s Updated Power of Attorney
`Declaration of Geoffrey L. Rosenthal, M.D., Ph.D. in Support of
`Patent Owner’s Response to Praxair’s Petition for Inter Partes
`Review of U.S. Patent No. 8,846,112
`Curriculum Vitae of Geoffrey L. Rosenthal
`Deposition of Dr. Maurice Beghetti (dated Oct. 12, 2015)
`INOmax® Label (revised 10/2015) (“Current INOmax®
`Label”)
`Prosecution History of U.S. Patent Application No. 12/820,866
`Sharon Ann Hunt et al., ACC/AHA 2005 Guideline Update for
`the Diagnosis and Management of Chronic Heart Failure in the
`Adult, ACC/AHA Practice Guidelines, AM. COLL. OF
`CARDIOLOGY FOUND. & AM. HEART ASSOC. (2005)
`(“ACC/AHA 2005 Guideline Update”)
`Daphne T. Hsu et al., Heart Failure in Children, Part I:
`History, Etiology, and Pathophysiology, 2 CIRCULATION: HEART
`FAILURE 63 (2009) (“Hsu 2009”)
`Michele Senni et al., Heart Failure With Preserved Systolic
`Function: A Different Natural History?, 38 J. AM. COLL.
`CARDIOLOGY 1277 (2001) (“Senni 2001”)
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`2
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`Case IPR2015-00529
`U.S. Patent No. 8,849,112
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`EXHIBIT
`2028
`
`DESCRIPTION
`Brad G. Angeja et al., Evaluation and Management of Diastolic
`Heart Failure, 107 CIRCULATION 659 (2003) (“Angeja 2003”)
`Michael R. Zile et al., New Concepts in Diastolic Dysfunction
`and Diastolic Heart Failure: Part I – Diagnosis, Prognosis,
`and Measurements of Diastolic Function, 105 CIRCULATION
`1387 (2002) (“Zile 2002 pt. 1”)
`Michael R. Zile et al., New Concepts in Diastolic Dysfunction
`and Diastolic Heart Failure: Part II – Causal Mechanisms and
`Treatment, 105 CIRCULATION 1503 (2002) (“Zile 2002 pt. 2”)
`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”)
`C. S. Hayward et al., Inhaled Nitric Oxide in Cardiac Failure:
`Vascular Versus Ventricular Effects, 27 J. CARDIOVASCULAR
`PHARMACOLOGY 80 (1996) (“Hayward 1996”)
`Niels Kieler-Jensen et al., Inhaled Nitric Oxide in the
`Evaluation of Heart Transplant Candidates with Elevated
`Pulmonary Vascular Resistance, 13 J. HEART & LUNG
`TRANSPLANT 366 (1994) (“Kieler-Jensen 1994”)
`Marc J. Semigran et al., Hemodynamic Effects of Inhaled Nitric
`Oxide in Heart Failure, 24 J. AM. COLL. CARDIOLOGY 982
`(1994) (“Semigran 1994”)
`Nitroglycerin in 5% Dextrose Injection Label (revised Oct.
`2014) (“Nitroglycerin Label”)
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`2029
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`2030
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`2031
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`2032
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`2033
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`2034
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`2035
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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
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`Dated: November 5, 2015
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`Case IPR2015-00529
`U.S. Patent No. 8,849,112
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`Latham & Watkins LLP
`885 Third Avenue
`New York, NY 10022-4834
`212.906.1200; 212.751.4864 (Fax)
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`Counsel for Patent Owner
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`Case IPR2015-00529
`U.S. Patent No. 8,849,112
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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 5th day of
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`November, 2015, a true and correct copy of the foregoing PATENT OWNER’S
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`UPDATED EXHIBIT LIST was served by electronic mail on Petitioner’s lead
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`and backup counsel at the following email addresses:
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`sanjay.murthy@klgates.com
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`sara.kerrane@klgates.com
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`michael.abernathy@klgates.com
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`margaux.nair@klgates.com
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`maria.doukas@klgates.com
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`By: /Robert Steinberg/
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`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)
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