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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`LIQUIDIA TECHNOLOGIES, Inc.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
`
`
`IPR2021-00406
`U.S. Patent No. 10,716,793
`
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`
`
`IPR2021-00406
`U.S. Patent No. 10,716,793 B2
`
`Patent Owner’s Updated Exhibit List
`
`
`EXHIBIT LIST
`
`Exhibit
`EX2001
`EX2002
`EX2003
`EX2004
`EX2005
`EX2006
`EX2007
`EX2008
`
`EX2009
`EX2010
`
`EX2011
`
`EX2012
`
`EX2013
`
`EX2014
`
`EX2015
`
`Description
`Declaration of Dr. Aaron Waxman
`Dr. Waxman’s curriculum vitae
`Declaration of Dr. Werner Seeger
`Declaration of Dr. Hossein A. Ghofrani
`Declaration of Dr. Frank Reichenberger
`Declaration of Dr. Friedrich Grimminger
`Tyvaso Orange Book listing
`Hill, N., 2005, Therapeutic Options for the Treatment of
`Pulmonary Hypertension, Medscape Pulmonary Medicine 9(2).
`Substantive Submission filed in 12/591,200 (Mar. 9, 2015)
`United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-1 (public
`docket).
`United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-11 (public
`docket).
`United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-16 (public
`docket).
`United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), unnumbered
`docket entry dated 7/30/2020
`United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-20 (public
`docket)(excerpted).
`United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-29 (public
`docket).
`
`
`
`1
`
`
`
`IPR2021-00406
`U.S. Patent No. 10,716,793 B2
`
`Patent Owner’s Updated Exhibit List
`
`
`
`Description
`United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-45 (public
`docket).
`United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-21 (public
`docket).
`United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-41 (public
`docket).
`United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-49 (public
`docket).
`United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-68 (public
`docket).
`United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-71 (public
`docket).
`United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-40 (public
`docket).
`United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-47 (public
`docket).
`United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-75 (public
`docket).
`United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-80 (public
`docket).
`
`Exhibit
`EX2016
`
`EX2017
`
`EX2018
`
`EX2019
`
`EX2020
`
`EX2021
`
`EX2022
`
`EX2023
`
`EX2024
`
`EX2025
`
`
`
`2
`
`
`
`IPR2021-00406
`U.S. Patent No. 10,716,793 B2
`
`Patent Owner’s Updated Exhibit List
`
`
`
`Description
`United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-81 (public
`docket).
`United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-92 (public
`docket).
`United Therapeutics Corporation v. Liquidia Technologies, Inc.,
`Case No. 1:20-cv-00755-RGA-JLH (D. Del.), ECF-74 (public
`docket).
`Hess et al., 2007, A guide to aerosol delivery devices for
`respiratory therapists. American Association for Respiratory
`Care
`Dennis JH, 2002, Standardization issues: in vitro assessment of
`nebulizer performance. Respir. Care. 47(12):1455-1458
`Hess et al., 1996, Medication nebulizer performance. Effects of
`diluent volume, nebulizer flow, and nebulizer brand. Chest,
`110(2):498-505
`Rubin BK et al., 2008 Treatment Delivery Systems (in Clinical
`Asthma), available at
`https://www.sciencedirect.com/topics/medicine-anddentistry/
`nebulizer
`Gardenhire, D.S. et al., 2017, A Guide to Aerosol Delivery
`Devices for Respiratory Therapists (4th Ed.) American
`Association for Respiratory Care
`Tyvaso® Label 2021
`Bourge et al., Cardiovascular Therapeutics, 31:38-44 (2013)
`McLaughlin et al., Efficacy and safety of treprostinil: an
`epoprostenol analog for primary pulmonary hypertension, J.
`Cardiovascular Pharmacology, 41:293-299 (2003)
`Springer website (from fn 13 of Hall-Ellis Decl)
`(Intentionally Left Blank)
`Springer website (from fn 14 of Hall-Ellis Decl)
`
`Exhibit
`EX2026
`
`EX2027
`
`EX2028
`
`EX2029
`
`EX2030
`
`EX2031
`
`EX2032
`
`EX2033
`
`EX2034
`EX2035
`EX2036
`
`EX2037
`EX2038
`EX2039
`
`
`
`3
`
`
`
`IPR2021-00406
`U.S. Patent No. 10,716,793 B2
`
`Patent Owner’s Updated Exhibit List
`
`
`
`Description
`University of Wisconsin–Madison Library Catalog Search for
`holdings of Circulation: the journal of the American Heart
`Association
`Declaration of Ms. Pilar Wyman
`Ms. Pilar Wyman’s curriculum vitae
`Deposition Transcript of Sylvia Hall-Ellis, Ph. D.
`American Heart Association Listing of Circulation Supplements
`Chemical Abstracts Plus Search Results Transcript
`Ovid Search Results for “Voswinckel”
`PubMed Search Results for “Voswinckel”
`Compilation Showing Search Results for Descriptor Terms
`Oxford Academic Listing of European Heart Journal
`Supplements
`Simonneau et al., Updated Clinical Classification of Pulmonary
`Hypertension., J Am. College of Cardiol, 62(25)D34-D42 at
`D34-D35 (2013)
`Sitbon and Noordegraaf, Epoprostenol and pulmonary arterial
`hypertension: 20 years of clinical experience, Eur. Respir Rev.
`26:160055 (2017)
`Second Declaration of Dr. Aaron Waxman
`Declaration of Dr. Jason McConville
`Dr. McConville’s curriculum vitae
`Deposition of Dr. Nicholas Hill
`Deposition of Igor Gonda, Ph. D.
`Vital Signs (Body Temperature, Pulse Rate, Respiration Rate,
`Blood Pressure), Johns Hopkins Medicine, available at
`https://www.hopkinsmedicine.org/health/conditions-and-
`diseases/vital-signs-body-temperature-pulse-rate-respiration-
`rate-blood-pressure
`Pharmacokinetics of Inhaled Drugs, available at
`https://media.lanecc.edu/users/
`
`Exhibit
`EX2040
`
`EX2041
`EX2042
`EX2043
`EX2044
`EX2045
`EX2046
`EX2047
`EX2048
`EX2049
`
`EX2050
`
`EX2051
`
`EX2052
`EX2053
`EX2054
`EX2055
`EX2056
`EX2057
`
`EX2058
`
`
`
`4
`
`
`
`IPR2021-00406
`U.S. Patent No. 10,716,793 B2
`
`Patent Owner’s Updated Exhibit List
`
`
`
`Description
`driscolln/RT127/Softchalk/Pharmcology_SFTCHLK_Lesson/
`Pharmacology_lesson10.html
`(Intentionally Left Blank)
`Waxman et al., Inhaled Treprostinil in Pulmonary Hypertension
`Due to Interstitial Lung Disease, N. Eng. J. Med. 384:325-334
`(2021)
`Watson Labs., Inc. v. United Therapeutics Inc., IPR2017-01622,
`Declaration of Dr. Robert Roscigno (EX2048)
`Watson Labs., Inc. v. United Therapeutics Inc., IPR2017-01622,
`(EX2049)
`Watson Labs., Inc. v. United Therapeutics Inc., IPR2017-01622,
`(EX2050)
`Watson Labs., Inc. v. United Therapeutics Inc., IPR2017-01622,
`(EX2051)
`Declaration of Dr. Werner Seeger regarding Application No.
`11/748,205
`Watson Labs., Inc. v. United Therapeutics Inc., IPR2017-01621
`Declaration of Dr. Werner Seeger (EX2020)
`Watson Labs., Inc. v. United Therapeutics Inc., IPR2017-
`01621/-01622 Declaration of Dr. Hossein A. Ghofrani
`(EX2026)
`Watson Labs., Inc. v. United Therapeutics Inc., IPR2017-
`01621/-01622 Declaration of Dr. Frank Reichenberger
`(EX2027)
`Watson Labs., Inc. v. United Therapeutics Inc., IPR2017-
`01621/-01622 Declaration of Dr. Friedich Grimminger
`(EX2028)
`Watson Labs., Inc. v. United Therapeutics Inc., IPR2017-01621
`Declaration of Dr. Werner Seeger (EX2097)
`Watson Labs., Inc. v. United Therapeutics Inc., IPR2017-01621
`Second Declaration of Dr. Werner Seeger (EX2098)
`
`Exhibit
`
`EX2059
`EX2060
`
`EX2061
`
`EX2062
`
`EX2063
`
`EX2064
`
`EX2065
`
`EX2066
`
`EX2067
`
`EX2068
`
`EX2069
`
`EX2070
`
`EX2071
`
`
`
`5
`
`
`
`IPR2021-00406
`U.S. Patent No. 10,716,793 B2
`
`Patent Owner’s Updated Exhibit List
`
`
`
`Description
`Watson Labs., Inc. v. United Therapeutics Inc., IPR2017-01621
`(EX2101)
`Watson Labs., Inc. v. United Therapeutics Inc., IPR2017-01621
`(EX2102)
`Watson Labs., Inc. v. United Therapeutics Inc., IPR2017-
`01621/-01622 Second Declaration of Dr. Hossein A. Ghofrani
`(EX2099)
`Le Brun et al., A review of the technical aspects of drug
`nebulization, Pharmacy World & Science, 22(3):75-81 (2000)
`Kendrick, et al., Selecting and Using Nebuliser Equipment,
`Thorax, 52 (Suppl 2):S92-S101 (1997)
`Rau et al., Performance Comparison of Nebulizer Designs:
`Constant-Output, Breath-Enhanced, and Dosimetric,
`Respiratory Care, 49(2):174-179 (2004)
`Rau, The Inhalation of Drugs: Advantages and Problems,
`Respiratory Care, 50(3):367-382 (2005)
`Hess et al., Medication Nebulizer Performance, Laboratory and
`Animal Investigations, 110(2):498-505 (1996)
`FDA Guidance 2002
`Newman et al., Efficient Delivery to the Lungs of Flunisolide
`Aerosol from a New Portable Hand-Held Multidose Nebulizer,
`1996 85(9) J. Pharm Sciences 960 (1996)
`Dubus et al., Aerosol Deposition in Neonatal Ventilation,
`PEDIATRIC RESEARCH, 58(1):10-15 (2005)
`Treprostinil, PubChem, available at
`https://pubchem.ncbi.nlm.nih.gov/compound/Treprostinil
`Roscigno et al., 2020 Pharmacokinetics and tolerability of
`LIQ861, a novel dry-powder formulation of treprostinil.
`Pulmonary Circulation, 10(4):1-9 (2020)
`Roscigno et al., Comparative bioavailability of inhaled
`treprostinil administered as LIQ861 and Tyvaso® in healthy
`subjects, Vascular Pharmacology 138:106840 (2021)
`
`Exhibit
`EX2072
`
`EX2073
`
`EX2074
`
`EX2075
`
`EX2076
`
`EX2077
`
`EX2078
`
`EX2079
`
`EX2080
`EX2081
`
`EX2082
`
`EX2083
`
`EX2084
`
`EX2085
`
`
`
`6
`
`
`
`IPR2021-00406
`U.S. Patent No. 10,716,793 B2
`
`Patent Owner’s Updated Exhibit List
`
`
`
`Description
`Declaration of Dr. Roham T. Zamanian regarding Application
`No. 12/591,200
`Sandifer et al., Potent Effects of aerosol compared with
`intravenous Treprostinil on the pulmonary circulation, J. Appl.
`Physiol. 99:2363-2368 (2005)
`U.S. Patent Publication No. 2012/0177693 (Cipolla et al.)
`Liquidia SEC Form 10-K (2020)
`Preston et al., Safety and efficacy of transition from inhaled
`treprostinil to parenteral treprostinil in selected patients with
`pulmonary arterial hypertension. Pulm Cir. 4(3):456-461 (2014)
`Expert Report of Dr. Igor Gonda (D. Del) (excerpts)
`Biography of Mandy H. Kim
`Declaration of Mandy H. Kim
`
`Exhibit
`EX2086
`
`EX2087
`
`EX2088
`EX2089
`EX2090
`
`EX2091
`EX2092
`EX2093
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Dated: January 6, 2022
`FOLEY & LARDNER LLP
`3000 K St., NW
`
`
`Washington Harbour
`Washington, DC 20007
`Telephone: (202) 672-5569
`Facsimile: (202) 672-5399
`
`
`
`
`
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`
`
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`
`
`Respectfully submitted,
`
`By /Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
`
`
`
`
`
`
`
`
`
`7
`
`
`
`IPR2021-00406
`U.S. Patent No. 10,716,793 B2
`
`
`
`Patent Owner’s Updated Exhibit List
`
`
`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that a copy of the foregoing Patent Owner’s
`
`Updated Exhibit List was served on counsel of record for Petitioner on January 6,
`
`2022 by delivering a copy via email to the counsel of record for the Petitioner at the
`
`following addresses:
`
`
`
`zLiquidiaIPR@cooley.com
`ielrifi@cooley.com
`emilch@cooley.com
`dkannappan@cooley.com
`ssukduang@cooley.com
`
`
`
`Dated: January 6, 2022
`FOLEY & LARDNER LLP
`3000 K St., NW
`
`
`Washington Harbour
`Washington, DC 20007
`Telephone: (202) 672-5569
`Facsimile: (202) 672-5399
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`By /Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
`
`4874-0492-8264.1
`
`8
`
`
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