Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`
`
`
`
`
`
`
`
`
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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 B2
`Issue Date: July 21, 2020
`
`
`
`Title: Treprostinil Administration by Inhalation
`
`
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. Patent No. 10,716,793 B2
`
`

`

`TABLE OF CONTENTS
`
` I. 
`
`C. 
`
`MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(A)(1) ....................... 1 
`A. 
`Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1) ........................... 1 
`B. 
`Related Matters Under 37 C.F.R. § 42.8(b)(2) .................................... 1 
`C. 
`Lead and Back-Up Counsel under 37 C.F.R. § 42.8(b)(3) .................. 2 
`D. 
`Service Information .............................................................................. 2 
`E. 
`Power of Attorney ................................................................................ 3 
`PAYMENT OF FEES - 37 C.F.R. § 42.103 .................................................. 3 
`II. 
`III.  REQUIREMENTS UNDER 37 C.F.R. §§ 42.104 AND 42.108 AND
`CONSIDERATIONS UNDER §§ 314(A) AND 325(D) ............................... 3 
`A.  Grounds for Standing Under 37 C.F.R. § 42.104(a) ............................ 3 
`B. 
`Identification of Challenge Under 37 C.F.R. § 42.104(b) and
`Statement of Precise Relief Requested ................................................ 3 
`Threshold Requirement for Inter Partes Review 37 C.F.R.
`§ 42.108(c) ............................................................................................ 4 
`Considerations under 35 U.S.C. § 314(a) ............................................ 4 
`D. 
`Considerations under 35 U.S.C. § 325(d) ............................................ 6 
`E. 
`IV.  SUMMARY OF THE ’793 PATENT .......................................................... 11 
`A. 
`Brief Description of the ’793 Patent .................................................. 11 
`B. 
`Summary of the Prosecution History of the ’793 Patent ................... 12 
`CLAIM CONSTRUCTION UNDER 37 C.F.R. § 42.104(B)(3) ................. 12 
`V. 
`VI.  OVERVIEW OF THE GROUNDS .............................................................. 13 
`VII.  PERSON OF ORDINARY SKILL IN THE ART ....................................... 13 
`VIII.  TECHNICAL BACKGROUND .................................................................. 14 
`A.  History of Inhalation Therapy ............................................................ 15 
`B. 
`Inhaled Treprostinil and Its Analogues .............................................. 15 
`C.  Well Known Considerations for Inhalation Therapies ...................... 17 
`IX.  OVERVIEW OF THE PRIOR ART ............................................................ 19 
`i
`
`

`

`B. 
`
`TABLE OF CONTENTS
`A. 
`’212 Patent .......................................................................................... 19 
`Voswinckel JESC ............................................................................... 22 
`B. 
`Voswinckel JAHA .............................................................................. 24 
`C. 
`D.  Ghofrani .............................................................................................. 25 
`E. 
`Voswinckel 2006 ................................................................................ 27 
`X.  GROUND 1: CLAIMS 1-8 ARE RENDERED OBVIOUS UNDER
`35 U.S.C. § 103(A) OVER THE ’212 PATENT IN COMBINATION
`WITH VOSWINCKEL JESC AND VOSWINCKEL JAHA ...................... 30 
`A.  Motivation to Combine ’212 Patent with Voswinckel JESC and
`Voswinckel JAHA With a Reasonable Expectation of Success ........ 30 
`The ’212 Patent in combination with Voswinckel JESC and
`Voswinckel JAHA renders obvious claims 1-8 ................................. 35 
`1. 
`Independent Claim 1 ................................................................ 35 
`2. 
`Dependent Claim 2 .................................................................. 41 
`3. 
`Dependent Claim 3 .................................................................. 43 
`4. 
`Dependent Claim 4 .................................................................. 43 
`5. 
`Dependent Claim 5 .................................................................. 44 
`6. 
`Dependent Claim 6 .................................................................. 45 
`7. 
`Dependent Claim 7 .................................................................. 45 
`8. 
`Dependent Claim 8 .................................................................. 45 
`XI.  GROUND 2: CLAIMS 1-8 ARE RENDERED OBVIOUS UNDER
`35 U.S.C. § 103(A) OVER THE ’212 PATENT IN COMBINATION
`WITH VOSWINCKEL JESC ...................................................................... 46 
`A.  Motivation to Combine With a Reasonable Expectation of
`Success ............................................................................................... 46 
`The ’212 Patent in combination with Voswinckel JESC renders
`obvious claims 1-8.............................................................................. 47 
`1. 
`Independent Claim 1 ................................................................ 47 
`
`B. 
`
`ii
`
`

`

`B. 
`
`TABLE OF CONTENTS
`2. 
`Dependent Claims 2-8 .............................................................. 49 
`XII.  GROUND 3: CLAIM 1 IS ANTICIPATED BY GHOFRANI .................... 50 
`A.  Ghofrani Discloses Claim Element 1[a] ............................................ 50 
`B. 
`Ghofrani Discloses Claim Element 1[b] ............................................ 51 
`C. 
`Ghofrani Discloses Element 1[c] ....................................................... 51 
`D.  Ghofrani Discloses Claim Element 1[d] ............................................ 52 
`XIII.  GROUND 4: CLAIMS 1, 3, AND 8 ARE RENDERED OBVIOUS
`UNDER 35 U.S.C. § 103(A) OVER VOSWINCKEL JAHA IN
`COMBINATION WITH GHOFRANI ......................................................... 52 
`A.  Motivation to Combine With A Reasonable Expectation of
`Success ............................................................................................... 52 
`Voswinckel JAHA in combination with Ghofrani renders
`obvious claims 1, 3, and 8 .................................................................. 54 
`1. 
`Independent Claim 1 ................................................................ 54 
`2. 
`Dependent Claim 3 .................................................................. 56 
`3. 
`Dependent Claim 8 .................................................................. 57 
`XIV.  GROUND 5: CLAIMS 1 AND 3 ARE ANTICIPATED BY
`VOSWINCKEL 2006 ................................................................................... 57 
`A. 
`Independent Claim 1 .......................................................................... 57 
`1. 
`Voswinckel 2006 discloses claim element 1[a] ....................... 57 
`2. 
`Voswinckel 2006 discloses claim element 1[b] ....................... 58 
`3. 
`Voswinckel 2006 discloses claim element 1[c] ....................... 58 
`4. 
`Voswinckel 2006 discloses claim element 1[d] ....................... 58 
`Claim 3 ............................................................................................... 59 
`B. 
`XV.  GROUND 6: CLAIMS 2 AND 4-8 ARE OBVIOUS OVER
`VOSWINCKEL 2006 IN COMBINATION WITH THE ’212
`PATENT ....................................................................................................... 59 
`
`iii
`
`

`

`B. 
`
`TABLE OF CONTENTS
`A.  Motivation to Combine With a Reasonable Expectation of
`Success ............................................................................................... 59 
`Voswinckel 2006 in combination with the ’212 Patent renders
`obvious claims 2 and 4-8 .................................................................... 60 
`1. 
`Dependent Claim 2 .................................................................. 60 
`2. 
`Dependent Claim 4 .................................................................. 61 
`3. 
`Dependent Claim 5 .................................................................. 62 
`4. 
`Dependent Claim 6 .................................................................. 63 
`5. 
`Dependent Claim 7 .................................................................. 64 
`6. 
`Dependent Claim 8 .................................................................. 64 
`XVI.  NO SECONDARY CONSIDERATIONS OF NON-OBVIOUSNESS
`EXIST ........................................................................................................... 64 
`XVII. CONCLUSION ............................................................................................. 68 
`
`
`iv
`
`

`

`EXHIBITS
`
`Description of Document
`
`Exhibit
`No.
`1001 U.S. Patent No. 10,716,793 B2 to Olschewski, et al. (“’793 Patent”)
`1002 Declaration of Dr. Nicholas Hill (“Hill Decl.”)
`1003 Curriculum Vitae of Dr. Nicholas Hill
`1004 Declaration of Dr. Igor Gonda (“Gonda Decl.”)
`1005 Curriculum Vitae of Dr. Igor Gonda
`1006 U.S. Patent No. 6,521,212 B1 to Cloutier, et al. (“’212 patent”)
`1007 Voswinckel, R., et al., Abstract 218: “Inhaled treprostinil is a potent
`pulmonary vasodilator in severe pulmonary hypertension,” European
`Heart Journal 25:22 (2004) (“Voswinckel JESC”)
`1008 Robert Voswinckel, Beate Enke, Andre Kreckel, Frank
`Reichenberger, Stefanie Krick, Henning Gall, Tobias Gessier, Thomas
`Schmehl, Markus G. Kohstall, Friedrich Grimminger, Hossein A.
`Ghofrani, Werner Seeger, and Horst Olschewski, Abstract 1414:
`“Inhaled Treprostinil Sodium (TRE) For the Treatment of Pulmonary
`Hypertension,” Abstracts from the 2004 Scientific Sessions of the
`American Heart Association, Circulation, 110(17 Suppl.):III-295
`(October 26, 2004) (“Voswinckel JAHA”)
`1009 Robert Voswinckel, Hossein A. Ghofrani, Friedrich Grimminger, and
`Werner Seeger, “Clinical Observations” on “Inhaled Treprostinil for
`Treatment of Chronic Pulmonary Arterial Hypertension,” “Letters”
`Section of the Annals of Internal Medicine, 144(2):149-50 (January
`2006) (“Voswinckel 2006”)
`1010 Hossein Ardeschir Ghofrani, Robert Voswinckel, et al., Neue
`Therapieoptionen in der Behandlung der pulmonalarteriellen
`Hypertonie, 30(4) HERZ, 30(4):296–302 (June 2005) (“Ghofrani”)
`(Foreign article and English translation attached)
`First Amended Complaint filed in United Therapeutics Corporation
`v. Liquidia Technologies, Inc., Case No. 1:20-cv-00755-RGA (D.
`Del.)
`1012 United Therapeutics Corporation’s Answer to Defendant Liquidia
`Technologies, Inc.’s Counterclaims filed in United Therapeutics
`Corporation v. Liquidia Technologies, Inc., Case No. 1:20-cv-00755-
`RGA (D. Del.)
`1013 United Therapeutics Corporation’s Opening Brief in Support of its
`Motion to Dismiss Defendant’s Counterclaim filed in United
`Therapeutics Corporation v. Liquidia Technologies, Inc., Case No.
`
`1011
`
`v
`
`

`

`Exhibit
`No.
`
`EXHIBITS
`
`Description of Document
`
`1:20-cv-00755-RGA (D. Del.)
`1014 Memorandum Order denying United Therapeutics Corporation’s
`Motion to Dismiss Defendants Counterclaim filed in United
`Therapeutics Corporation v. Liquidia Technologies, Inc., Case No.
`1:20-cv-00755-RGA (D. Del.)
`1015
`10,716,793 Patent Prosecution History
`1016
`10,376,525 Patent Prosecution History (excerpted)
`1017
`9,339,507 Patent Prosecution History (excerpted)
`1018 Remodulin® 2004 Label (authenticated by EX1036, ¶¶56-58)
`1019
`Stein, S.W., et al., “The History of Therapeutic Aerosols: A
`Chronological Review,” Journal of Aerosol Medicine and
`Pulmonary Drug Delivery, 30(1):20-41 (2017) (“Stein”)
`1020 Clark, A.R., “Medical Aerosol Inhalers: Past, Present, and Future,”
`Aerosol Science and Technology, 22:374-91 (1995) (“Clark”)
`1021 Ruan, C.-H., et al., “Prostacyclin Therapy for Pulmonary Arterial
`Hypertension,” Texas Heart Institute Journal, 37(4):391-99 (2010)
`(“Ruan”)
`1022 Walmrath, D., et al., “Direct Comparison of Inhaled Nitric Oxide and
`Aerosolized Prostacyclin in Acute Respiratory Distress Syndrome,”
`American Journal of Respiratory Critical Care Medicine, 153:991-
`96 (1996) (“Walmrath 1996”)
`1023 Olschewski, H., et al., “Inhaled Prostacyclin and Iloprost in Severe
`Pulmonary Hypertension Secondary to Lung Fibrosis,” American
`Journal of Respiratory Critical Care Medicine, 160:600-07 (1999)
`(“Olschewski 1999”)
`1024 Haché, M., et al., “Inhaled epoprostenol (prostacyclin) and
`pulmonary hypertension before cardiac surgery,” Journal of
`Thoracic and Cardiovascular Surgery, 125:642-49 (2003) (“Hache”)
`1025 De Wet, C.J., et al., “Inhaled prostacyclin is safe, effective, and
`affordable in patients with pulmonary hypertension, right heart
`dysfunction, and refractory hypoxemia after cardiothoracic surgery,”
`Journal of Thoracic and Cardiovascular Surgery, 127:1058-67
`(2004) (“De Wet”)
`1026 Denver, J. and Dyche, T., “The Adaptive Aerosol Delivery (AAD)
`Technology: Past, Present, and Future,” Journal of Aerosol Medicine
`and Pulmonary Drug Delivery, 23(1 suppl):S-1-S10 (2010) (“Denver
`
`vi
`
`

`

`Exhibit
`No.
`
`EXHIBITS
`
`Description of Document
`
`and Dyche”)
`1027 U.S. Patent No. 6,242,482 B1 to Shorr, et al. (“Shorr”)
`1028 U.S. Patent Application Publication No. US 2004/0265238 A1 to
`Chaudry (“Chaudry”)
`1029 Ventavis® Label 2004
`1030 Newman, S.P., “Aerosols”, Chapter from Encyclopedia of
`Respiratory Medicine pp. 58-64 (2006) (“Newman”)
`1031 Geller, D.E., “Comparing Clinical Features of the Nebulizer,
`Metered-Dose Inhaler, and Dry Powder Inhaler,” Respiratory Care,
`50(10):1313-21 (2005) (“Geller 2005”)
`1032 Bender, B., et al., “Nonadherence in asthmatic patients: is there a
`solution to the problem?” Annals of Allergy, Asthma & Immunology,
`79:177-86 (1997) (“Bender 1997”)
`1033 Rau, J.L., “Determinants of Patient Adherence to an Aerosol
`Regimen,” Respiratory Care 50(10):1346-56 (2005) (“Rau 2005”)
`1034 Geller, D., et al., “Bolus Inhalation of rhDNase with the AERx
`System in Subjects with Cystic Fibrosis,” Journal of Aerosol
`Medicine, 16(2):175-82 (2003) (“Geller 2003”)
`1035 Chattaraj, S.C., “Treprostinil sodium Pharmacia,” Current Opinion
`in Investigational Drugs, 3(4):582-86 (Apr. 2002), available at
`https://pubmed.ncbi.nlm.nih.gov/12090728/ (“Chattaraj”)
`1036 Declaration of Sylvia Hall-Ellis, Ph.D. (“Hall-Ellis Decl.”)
`1037
`English translation of OptiNeb® User Manual 2005
`1038 Atkins, P.J., “Dry Powder Inhalers: An Overview,” Respiratory
`Care, 50(10):1304-12 (2005) (“Atkins”)
`Frijlink, H.W. and De Boer, A.H., “Dry powder inhalers for
`pulmonary drug delivery,” Expert Opinion on Drug Delivery,
`1(1):67-86 (2004) (“Frijlink and De Boer”)
`1040 Chew N. and Chan H.-K., “Pharmaceutical Dry Powder Aerosol
`Delivery,” KONA, No. 19, pp. 46-56 (2001) (“Chew and Chan”)
`Reserved
`January 27, 2020 Press Release, “Liquidia Submits New Drug
`Application for LIQ861 (Treprostinil) Inhalation Powder to U.S.
`Food And Drug Administration for the Treatment of Pulmonary
`Arterial Hypertension (PAH),” available at
`https://investors.liquidia.com/news-releases/news-release-
`vii
`
`1041
`1042
`
`1039
`
`

`

`Exhibit
`No.
`
`EXHIBITS
`
`Description of Document
`
`1043
`
`details/liquidia-submits-new-drug-application-liq861-treprostinil
`2009 Tyvaso® Label, available at
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022387s
`015lbl.pdf
`1044
`9,358,240 Patent Prosecution History (excerpted)
`1045
`Reserved
`1046 U.S. Patent No. 9,358,240 to Olschewski, et al. (“’240 Patent”)
`1047 Hoeper, M.M., et al., “Long-Term Treatment of Primary Pulmonary
`Hypertension with Aerosolized Iloprost, a Prostacyclin Analogue,” N
`Engl J Med, 342:1866-70 (2000) (“Hoeper”)
`1048 Walmrath, D., et al., “Aerosolised prostacyclin in adult respiratory
`distress syndrome,” Lancet, 342:961-62 (1993) (“Walmrath 1993”)
`1049 April 8, 2020 Press Release, “Liquidia Announces FDA Acceptance
`of New Drug Application for LIQ861 (Treprostinil) Inhalation
`Powder for the Treatment of Pulmonary Arterial Hypertension,”
`available at https://investors.liquidia.com/news-releases/news-
`release-details/liquidia-announces-fda-acceptance-new-drug-
`application-liq861
`Pulmozyme® Label
`Farber, H.W. and Loscalzo, J., “Pulmonary Arterial Hypertension,”
`N Engl J Med, 351:1655-65 (2004) (“Farber and Loscalzo”)
`1052 Rubin, L.J. and Badesch, D.B., “Evaluation and Management of the
`Patient with Pulmonary Arterial Hypertension,” Ann Intern Med.,
`143:282-92 (2005) (“Rubin and Badesch”)
`1053
`Flolan® Label
`1054 Gonda, I., “A semi-empirical model of aerosol deposition in the
`human respiratory tract for mouth inhalation,” J. Pharm.
`Pharmacol., 33:692-96 (1981) (“Gonda 1981”)
`1055 Gonda, I., “Study of the effects of polydispersity of aerosols on
`regional deposition in the respiratory tract,” J. Pharm. Pharmacol.,
`33 (Suppl.) 52P (1981) (“Gonda 1981b”)
`Telko, M.J. and Hickey, A.J., “Dry Powder Inhaler Formulation,”
`Respiratory Care, 50(9):1209-27 (2005) (“Telko and Hickey”)
`1057 October 24, 2005 Press Release, “Aradigm Corporation And United
`Therapeutics Corporation Sign Development and Commercialization
`Agreement Targeting Pulmonary Hypertension,” available at
`viii
`
`1050
`1051
`
`1056
`
`

`

`Exhibit
`No.
`
`EXHIBITS
`
`Description of Document
`
`1058
`
`1060
`
`https://www.biospace.com/article/releases/aradigm-corporation-and-
`united-therapeutics-corporation-sign-development-and-
`commercialization-agreement-targeting-pulmonary-hypertension-/
`Ziegler, J. and Wachtel, H., “Comparison of Cascade Impaction and
`Laser Diffraction for Particle Size Distribution Measurements,”
`Journal of Aerosol Medicine, 18(3):311-24 (2005) (“Ziegler and
`Wachtel”)
`1059 Nauser, T.D., “Pulmonary Hypertension: New Perspectives,” CHF,
`9:155-62 (2003) (“Nauser 2003”)
`Pitcairn, G., et al., “Deposition of Corticosteroid Aerosol in the
`Human Lung by Respimat® Soft Mist™ Inhaler Compared to
`Deposition by Metered Dose Inhaler or by Turbuhaler® Dry Powder
`Inhaler,” Journal of Aerosol Medicine, 18(3):264-72 (2005)
`(“Pitcairn”)
`1061 Dalby, R., et al., “A review of the development of Respimat® Soft
`MistTM Inhaler,” International Journal of Pharmaceutics, 283:1-9
`(2004) (“Dalby”)
`1062 Gessler, T., et al., “Ultrasonic versus jet nebulization of iloprost in
`severe pulmonary hypertension,” Eur Respir J, 17:14-19 (2001)
`(“Gessler”)
`1063
`Reserved
`1064 Dolovich, M.B., et al., “Device Selection and Outcomes of Aerosol
`Therapy: Evidence-Based Guidelines,” CHEST, 127:335-71 (2005)
`(“Dolovich”)
`1065 Olschewski, H., et al., “Inhaled Iloprost for Several Pulmonary
`Hypertension,” N Engl J Med, 347(5):322-29 (2002) (“Olschewski
`2002”)
`1066 AccuNeb® Label
`1067 Anderson, P.J., “History of Aerosol Therapy: Liquid Nebulization to
`MDIs to DPIs,” Respiratory Care, 50(9):1139-49 (2005) (“Anderson
`2005”)
`1068 Vachiéry, J.-L., et al., “Transitioning From IV Epoprostenol to
`Subcutaneous Treprostinil in Pulmonary Arterial Hypertension,”
`CHEST, 121:1561-65 (2002) (“Vachiéry 2002”)
`Zierenberg, B. and Eicher, J., Chapter 78 “The Respimat, a New Soft
`Mist Inahler for Delivering Drugs to The Lungs,” MODIFIED-
`
`1069
`
`ix
`
`

`

`Exhibit
`No.
`
`EXHIBITS
`
`Description of Document
`
`1071
`
`RELEASE DRUG DELIVERY TECHNOLOGY (2002) pp.925-933
`(“Zierenberg”)
`1070 Beasley, R., et al., “Preservatives in Nebulizer Solutions: Risks
`without Benefit,” Pharmacotherapy, 18(1):130-39 (1998)
`(“Beasley”)
`Prober, C.G., et al., “Technical Report: Precautions Regarding the
`Use of Aerosolized Antibiotics,” Pediatrics, 106(6):1-6 (2000)
`(“Prober”)
`1072
`Reserved
`1073 Aradigm Corporation Form 10-Q for the quarterly period ended June
`30, 2009, available at
`https://www.sec.gov/Archives/edgar/data/1013238/00009501230903
`1361/f53244e10vq.htm
`1074 Orenitram® Label, available at
`https://www.orenitram.com/pdf/Orenitram-Prescribing-
`Information.pdf
`1075 November 17, 2008 Press Release, “Eli Lilly and Company Licenses
`U.S. Rights for Tadalafil PAH Indication to United Therapeutics
`Corporation,” available at
`https://www.fiercebiotech.com/biotech/eli-lilly-and-company-
`licenses-u-s-rights-for-tadalafil-pah-indication-to-united
`1076 October 23, 2017 Press Release, “United Therapeutics Announces
`FDA Approval Of Third Generation Nebulizer For The Tyvaso®
`Inhalation System,” available at https://www.prnewswire.com/news-
`releases/united-therapeutics-announces-fda-approval-of-third-
`generation-nebulizer-for-the-tyvaso-inhalation-system-
`300540953.html
`1077 Boyle, M.P., “So Many Drugs, So Little Time. The Future Challenge
`of Cystic Fibrosis Care,” CHEST, 123(1):3-5 (2003) (“Boyle 2003”)
`1078 Azmacort® Label 2003
`1079 Hill, N.S., et al., “Inhaled Therapies for Pulmonary Hypertension,”
`Respiratory Care, 60(6):794-805 (2015) (“Hill 2015”)
`
`x
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`
`This is a petition for Inter Partes Review of claims 1-8 of U.S. Patent No.
`
`10,716,793 B2 (EX1001) (the “’793 Patent”). The ’793 Patent is directed to a
`
`method of treatment of pulmonary hypertension via inhalation of 15 to 90
`
`micrograms of treprostinil in 1 to 3 breaths, through various inhalation devices.
`
`Treprostinil products have been on the market for almost two decades, and the initial,
`
`actually innovative patents have expired. In contrast, the ’793 Patent was issued in
`
`July 2020, over 14 years after the application to which it claims priority. The ’793
`
`Patent is Patent Owner (“PO”) United Therapeutics Corporation’s (“UTC”) latest
`
`attempt to evergreen their way into blocking fair competition, and should be
`
`invalidated based on the numerous prior art references disclosing its claim
`
`limitations before 2006.
`
`I. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(A)(1)
`
`A. Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1)
`
`Petitioner Liquidia Technologies, Inc. (“Liquidia”) is the real party-in-
`
`interest.
`
`B. Related Matters Under 37 C.F.R. § 42.8(b)(2)
`
`UTC has alleged infringement of the ’793 Patent by Liquidia Technologies,
`
`Inc. in United Therapeutics Corporation v. Liquidia Technologies, Inc., 1:20-cv-
`
`00755-RGA, in the United States District Court for the District of Delaware.
`
`
`
`1
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`
`C. Lead and Back-Up Counsel under 37 C.F.R. § 42.8(b)(3)
`
`Petitioner provides the following designation of counsel.
`
`LEAD COUNSEL
`Ivor R. Elrifi (Reg. No. 39,529)
`ielrifi@cooley.com
`zLiquidiaIPR@cooley.com
`zpatdocketing@cooley.com
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue NW,
`Suite 700
`Washington, DC 20004
`Tel: (212) 479-6840
`Fax: (212) 479-6275
`
`
`BACK-UP COUNSEL
`Erik B. Milch (Reg. No. 42887)
`emilch@cooley.com
`zLiquidiaIPR@cooley.com
`zpatdocketing@cooley.com
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue NW,
`Suite 700
`Washington, DC 20004
`Tel: (703) 456-8573
`Fax: (703) 456-8100
`
`Deepa Kannappan
`(pro hac vice to be filed)
`dkannappan@cooley.com
`zLiquidiaIPR@cooley.com
`zpatdocketing@cooley.com
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue NW,
`Suite 700
`Washington, DC 20004
`Tel: (650) 843-5673
`Fax: (650) 849-7400
`
`D.
`
`Service Information
`
`The Petition is being served by FEDERAL EXPRESS to the current
`
`correspondence address for the ’793 Patent, Foley & Lardner LLP, 3000 K Street
`
`N.W., Suite 600, Washington, DC 20007-5109. Petitioner may be served by e-mail
`
`2
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`at the addresses provided above for lead and back-up counsel.
`
`E.
`
`Power of Attorney
`
`Filed concurrently with this petition per 37 C.F.R. § 42.10(b).
`
`II.
`
`PAYMENT OF FEES - 37 C.F.R. § 42.103
`
`This Petition requests review of claims 1-8 of the ’793 Patent (8 claims) and
`
`is accompanied by a payment of $41,500. 37 C.F.R. § 42.15. This Petition meets
`
`the fee requirements of 35 U.S.C. § 312(a)(1). The undersigned further authorizes
`
`the United States Patent and Trademark Office, including the Patent Trial and
`
`Appeal Board, to charge any additional fee that might be due or required to Deposit
`
`Account No. 50-1283.
`
`III. REQUIREMENTS UNDER 37 C.F.R. §§ 42.104 AND 42.108 AND
`CONSIDERATIONS UNDER §§ 314(A) AND 325(D)
`
`A. Grounds for Standing Under 37 C.F.R. § 42.104(a)
`
`Petitioner certifies that the ’793 Patent is eligible for inter partes review, and
`
`Petitioner is not barred or estopped from requesting inter partes review.
`
`B.
`
`Identification of Challenge Under 37 C.F.R. § 42.104(b) and
`Statement of Precise Relief Requested
`
`Petitioner requests the Board institute inter partes review of claims 1-8 of the
`
`’793 Patent based on these grounds:
`
`Ground
`1.
`
`’793 Claim(s)
`1-8
`
`Basis for Challenge
`Obvious over U.S. Patent No. 6,521,212
`(EX1006), Voswinckel JAHA (EX1008), and
`
`3
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`
`2.
`3.
`4.
`
`5.
`6.
`
`1-8
`1
`1, 3, 8
`
`1, 3
`2, 4-8
`
`Voswinckel JESC (EX1007)
`Obvious over ’212 Patent and Voswinckel JESC
`Anticipated by Ghofrani
`Obvious over Voswinckel JAHA and Ghofrani
`(EX1010)
`Anticipated by Voswinckel 2006 (EX1009)
`Obvious over Voswinckel 2006 and ’212 Patent
`
`Sections X to XV of this Petition detail why the challenged claims are invalid.
`
`This Petition is supported by accompanying Declarations of Dr. Nicholas Hill
`
`(EX1002) and Dr. Igor Gonda (EX1004), qualified experts in their fields. See
`
`EX1003; EX1005 (Curriculum Vitae).
`
`C. Threshold Requirement for Inter Partes Review 37 C.F.R.
`§ 42.108(c)
`Inter partes review of claims 1-8 should be instituted because this Petition
`
`establishes a reasonable likelihood that Petitioner will prevail with respect to each
`
`of the challenged claims. 35 U.S.C. § 314(a).
`
`D. Considerations under 35 U.S.C. § 314(a)
`
`Petitioner diligently filed this Petition. PO asserted the ’793 Patent against
`
`Petitioner for the first time on July 22, 2020 (EX1011, 15-17), and identified claims
`
`1, 4, and 6-8 as the asserted claims in infringement contentions served October 16,
`
`2020. This Petition is filed within three months of receiving infringement
`
`contentions and over six months before the one-year bar.
`
`4
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`
`The Board should not discretionarily deny this Petition because UTC filed a
`
`motion in the district court litigation to prevent Petitioner from contesting the
`
`validity of the ’793 Patent under the doctrine of assignor estoppel, based on one of
`
`the inventors, Robert Roscigno, being a former Liquidia employee. EX1013.
`
`Although the district court denied UTC’s original motion (EX1014), UTC indicated
`
`it intends to further pursue its assignor estoppel allegations in district court. See,
`
`e.g., EX1012, 13. Should UTC ultimately prevail on the issue of assignor estoppel
`
`in district court, Petitioner would be foreclosed from raising invalidity of the ’793
`
`Patent in that forum. Under this scenario, this Petition would be Petitioner’s only
`
`available means for challenging validity of the claims, because “assignor estoppel
`
`has no place in IPR proceedings.” Arista Networks, Inc. v. Cisco Sys., Inc., 908 F.3d
`
`792, 804 (Fed. Cir. 2018). Accordingly, the pending district court litigation should
`
`not be a basis for discretionary denial.
`
`Further, the Fintiv factors do not weigh in favor of discretionary denial. First,
`
`this Petition includes claims not at issue in the district court litigation, namely claims
`
`2, 3, and 5—just under half of the total claims challenged in this petition. Second,
`
`the parties have just begun claim construction proceedings in the district court
`
`litigation, have not yet taken any depositions, and have conducted only the initial
`
`minimum required discovery. Third, the merits of this Petition are strong, as
`
`exemplified by the Board’s institution of petitions involving two of the references
`
`5
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`here against similar claims in IPR2017-01621 and IPR2017-01622 (brought by a
`
`different petitioner),1 as well as the fact that this Petition asserts five grounds to
`
`challenge independent claim 1 and at least three different grounds for each of the
`
`seven dependent claims.
`
`Finally, previous IPRs filed on related patents 9,358,240 (IPR2017-01621)
`
`and 9,339,507 (IPR2017-01622) do not warrant discretionary denial. The prior IPRs
`
`were filed by Watson Laboratories, Inc., an unrelated party, prior to PO suing
`
`Petitioner. Alphatec Holdings, Inc. v. Nuvasive, Inc., IPR2019-00361, Paper 19 at
`
`10 (P.T.A.B. July 9, 2019). The prior IPRs were instituted, but terminated before
`
`final decision due to settlement between the parties. Watson Labs., Inc. v. United
`
`Therapeutics, Corp., IPR2017-01621, Paper 64 (P.T.A.B. Aug. 27, 2018); IPR2017-
`
`01622, Paper 64 (P.T.A.B. Aug. 27, 2018).
`
`E. Considerations under 35 U.S.C. § 325(d)
`
`This Petition does not present a scenario in which “the same or substantially
`
`the same prior art or arguments previously were presented to the Office.” 35 U.S.C.
`
`§ 325(d).
`
`
`
`1 There is no evidence that the ’793 Examiner substantively considered the
`
`institution decisions in the prior IPRs.
`
`6
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`
`The art presented in this petition was listed in PO’s Information Disclosure
`
`Statement, but in the absence of additional evidence of “consideration” by the
`
`Examiner, discretionary denial under § 325(d) is not warranted. See Advanced
`
`Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469,
`
`Paper 6 at 7-8 (P.T.A.B Feb. 13, 2020) (precedential) (art in IDS may be considered
`
`“[p]reviously presented”); but see, e.g., Microsoft Corp. v. Parallel Networks
`
`Licensing, LLC, IPR2015-00483, Paper 10 at 15 (P.T.A.B. July 15, 2015) (“[W]hile
`
`[a reference] was listed on a lengthy Information Disclosure Statement initialed by
`
`the Examiner, the reference was not applied against the claims and there is no
`
`evidence that the Examiner considered the particular disclosures cited . . . in the
`
`Petition.”). There is no evidence in the ’793 Prosecution History that the Examiner
`
`substantively considered the art or arguments presented in this Petition. The
`
`Examiner erred in not doing so, and an analysis under the Becton factors confirms
`
`why discretionary denial is not appropriate here.2
`
`
`
`2 The Becton factors are six, non-exclusive factors that are to be considered in the
`
`§ 325(d) analysis: (1) the similarities and material differences between the asserted
`
`art and the prior art involved during examination; (2) the cumulative nature of the
`
`
`
`7
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`
`The Patent Office only issued one substantive rejection during prosecution —
`
`for obviousness-type double patenting over U.S. Patent Nos. 10,376,525; 9,358,240;
`
`and 9,339,507. EX1015, 24-28. Because no prior art was substantively relied on
`
`during examination, under Becton factor 3, the “record of the [Patent] Office’s
`
`previous consideration of the art is . . . silent,” and the threshold for Petitioner to
`
`show the Office erred is lower: Petitioner must simply show the Office
`
`“overlook[ed] something persuasive” under Becton factors 5 and 6. Advanced
`
`Bionics, IPR2019-01469, Paper 6 at 10. As to Becton factor 5, Petitioner details
`
`
`
`asserted art and the prior art evaluated during examination; (3) the extent to which
`
`the asserted art was evaluated during examination; (4) the extent of the overlap
`
`between the arguments made during examination and the manner in which a
`
`petitioner relies on the prior art or a patent owner distinguishes the prior art; (5)
`
`whether a petitioner has pointed out sufficiently how the Office erred in evaluating
`
`the asserted prior art; and (6) the extent to which additional evidence and facts
`
`presented in the petition warrant reconsideration of the prior art or arguments. Trial
`
`Practice Guide Update (July 2019), 29-30 (citing Becton Dickinson & Co. v. B.
`
`Braun Melsungen AG, IPR2017-01586, Paper 8 at 17–18 (P.T.A.B. Dec. 15, 2017)
`
`(informative)).
`
`8
`
`

`

`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`below five persuasive grounds (four based on combinations) that the Examiner
`
`overlooked even though they disclose every element of the claims and are directed
`
`to the same disease (pulmonary hypertension), drug (treprostinil), and mode of
`
`administration (inhalation). As to Becton factor 6, Petitioner provides two expert
`
`declarations, as well as background art not listed in the Information Disclosure
`
`Statement,