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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
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`LIQUIDIA TECHNOLOGIES, INC.,
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`Petitioner,
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`v.
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`UNITED THERAPEUTICS CORPORATION,
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`Patent Owner.
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`_______________
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`Case IPR2020-00770
`Patent 9,604,901
`_______________
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`Patent Owner Preliminary Response Under
`35 U.S.C. § 313 and 37 C.F.R. § 42.107
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`TABLE OF CONTENTS
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`INTRODUCTION ........................................................................................... 1
`THE ’901 PATENT ......................................................................................... 2
` CLAIM CONSTRUCTION ............................................................................ 6
`A.
`Pharmaceutical Batch ............................................................................ 8
`B.
`“Pharmaceutical Product” ..................................................................... 9
`C.
`Storing, Storage ................................................................................... 10
`D. A salt treprostinil ................................................................................. 11
` THE BOARD SHOULD DENY INSTITUTION UNDER § 325(D) .......... 12
`A.
`The Advanced Bionics Two-Part Framework ..................................... 13
`B.
`Liquidia Relies on the Same Art (Becton Factors (a) & (b)) .............. 14
`C.
`Liquidia Relies on the Same Arguments (Becton Factor (d)) ............. 21
`D.
`Liquidia Fails to Prove the Examiner Erred in A Manner
`Material to The Patentability of Challenged Claims ........................... 23
`1.
`Factor (c) – the examiner thoroughly evaluated the same
`art and substantially the same arguments in a variety of
`permutations .............................................................................. 24
`Factors (e) & (f) – Liquidia has failed to show an error
`warranting reconsideration ........................................................ 25
`LIQUIDIA’S ARGUMENTS ARE NOT SUPPORTED BY
`RELIABLE EVIDENCE ............................................................................... 29
` LIQUIDIA’S “THREE STRONG BASES FOR INVALIDATION”
`ARE FACTUALLY IRRELEVANT OR INCOMPLETE ........................... 30
`A. A Known Synthesis of Treprostinil Is Not the Issue .......................... 31
`B.
`Liquidia Assumes the Inherency It Must Prove .................................. 31
`C.
`The Board’s Findings In the ’393 IPR Do Not Render the ’901
`Claims Obvious ................................................................................... 33
` THE GROUNDS SHOULD BE DENIED ON THE MERITS .................... 34
`A.
`Scope and Content of the Prior Art ..................................................... 34
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`2.
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`1.
`2.
`3.
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`2.
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`B.
`C.
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`Liquidia Focuses on the Wrong Problem ................................. 34
`Liquidia’s Positions Lack Basis ................................................ 37
`The ’393 Patent and the ’901 Patent Are Not Directed to
`the Same Invention ................................................................... 43
`Phares and Moriarty are Directed to Different Problems ......... 50
`4.
`The Prior Art Does Not Teach Stability ................................... 51
`5.
`Liquidia Misidentifies the Person of Ordinary Skill ........................... 55
`Liquidia Ignores the Differences Between the Claimed
`Invention and Phares ........................................................................... 57
`1.
`Ground 1: Phares Alone Did Not Render Claims 1-9
`Obvious ..................................................................................... 57
`Ground 2: Moriarty and Phares Did Not Render
`Claims 1-9 Obvious .................................................................. 61
` LIQUIDIA IGNORES OBJECTIVE INDICIA OF OBVIOUSNESS ......... 69
` CONCLUSION .............................................................................................. 72
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`TABLE OF AUTHORITIES
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`Cases
`American Hoist & Derrick Co. v. Sowa & Sons, 725 F.2d 1350, 1359 (Fed. Cir.
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`1984) ............................................................................................................. 17, 30
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`Biotec Biologische Naturverpackungen v. Biocorp., Inc., 249 F.3d 1341, 1353
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`(Fed. Cir. 2001) .................................................................................................... 67
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`Graham v. John Deere Co., 383 U.S. 1, 17 (1966) .......................................... 45, 59
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`In re Cyclobenzaprine Hydrochloride, 676 F.3d 1063 (Fed. Cir. 2012) ................. 72
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`In re Huston, 308 F.3d 1267, 1279 (Fed. Cir. 2002) ............................................... 23
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`In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995) ............................................. 72, 73, 74
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`KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007) ......................................... 68
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`Monolithic Power Sys., Inc. v. O2 Micro Int'l Ltd., 558 F.3d 1341, 1350 (Fed. Cir.
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`2009) .................................................................................................................... 28
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`Motionless Keyboard Co. v. Microsoft Corp., 486 F.3d 1376, 1385 (Fed. Cir. 2007)
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` .............................................................................................................................. 36
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`Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1577-78 (Fed. Cir. 1987) .... 69
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`Par Pharm., Inc. v. Twi Pharms., Inc., 773 F.3d 1186, 1195 (Fed. Cir. 2014) 34, 40,
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`70
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`Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc) ................. 7
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`Shire Dev., LLC v. Watson Pharm., Inc., 848 F.3d 981, 984 (Fed. Cir. 2017) ....... 70
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`Süd-Chemie Inc. v. Multisorb Technologies, 554 F.3d 1001 (Fed. Cir. 2009) ........ 74
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`Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1363–64 (Fed. Cir.
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`2008) .................................................................................................................... 32
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`United States v. Adams, 383 U.S. 39 (1966) ....................................................... 7, 37
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`Statutes
`35 U.S.C. § 103 ................................................................................................. 44, 59
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`35 U.S.C. § 312(a)(3) ............................................................................................... 28
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`35 U.S.C. § 314(a) ..................................................................................................... 6
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`35 U.S.C. § 325(d) ................................................................................................... 13
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`35 U.S.C. §316 ......................................................................................................... 72
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`35 U.S.C. §316(e) ...................................................................................................... 8
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`Other Authorities
`Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH ....... passim
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`Becton, Dickinson & Co. v. Baxter Int’l, IPR2018-01741, Paper 8, 13-14 (2019) ... 8
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`Dexcowin Global, Inc. v. Aribex, Inc., IPR2016-00436, Paper 12, 5-6 (2016) ......... 5
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`Hunting Titan, Inc. v. DynaEnergetics Europe GmbH, IPR2018-00600, Paper 67
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`(2020) (precedential) ............................................................................................ 24
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`Johns Manville Corp. v. Knauf Insulation, Inc., IPR2018-00827, Paper 9, 10-11
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`(2018) (informative) ............................................................................................. 66
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`Puma v. Nike, IPR2019-01042, Paper 10 (informative) ............................. 14, 16, 29
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`Rules
`37 C.F.R. § 42.104(b)(3) ............................................................................................ 8
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`37 C.F.R. § 42.65(a) ................................................................................................. 67
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`37 C.F.R. §42.100(b) ................................................................................................. 7
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`37 C.F.R. §42.63(b) ................................................................................................. 44
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`LIST OF EXHIBITS
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`Exhibit No
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`Description
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`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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`Intentionally left blank
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`Declaration of Rodolfo Pinal, Ph.D.
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`Curriculum Vitae of Rodolfo Pinal, Ph.D.
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`21 C.F.R. §210.3 (April 1, 2007 edition)
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`Office Action, U.S. application Ser. No. 15/423,021 dated Jan. 11,
`2018
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`Intentionally left blank
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`Complete Prosecution History of U.S. Patent No. 9,604,901
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`Stahl, P. H., & Wermuth, C. G. (Eds.). (2001). Handbook of
`Pharmaceutical Salts (1st ed.). Weinheim, Germany: Wiley-VCH,
`pp. 1-7, 41-81, 135-220, 249-63
`Batra, H., et al., Crystallization Process Development for a Stable
`Polymorph of Treprostinil Diethanolamine (UT-15C) by Seeding,
`Org. Proc. Res. Dev., 13, 242-49 (2009)
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`Wiberg, K., Laboratory Technique in Organic Chemistry (1960),
`pp. 75-119
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`Schoffstall, A. M., et al., Microscale and Miniscale Organic
`Chemistry Laboratory Experiments, 2nd ed. (2004), pp. 22-27,
`537-77
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`2012
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`Intentionally left blank
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`Exhibit No
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`2013
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`2014
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`2015
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`2016
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`Description
`Comparing IPR2020-00770 EX1002 to the Petition in IPR2020-
`00770
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`Intentionally left blank
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`Intentionally left blank
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`U.S. Department of Health and Human Services, Food and Drug
`Administration, Center for Drug Evaluation and Research,
`Guidance for Industry: ANDAs: Pharmaceutical Solid
`Polymorphism, Chemistry, Manufacturing, and Controls
`Information (July 2007) (“Polymorph Guidance”)
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`INTRODUCTION
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`Patent Owner Preliminary Response
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`United Therapeutics Corporation (“UT”) requests that the Board deny the
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`Petition, filed by Liquidia Technologies, Inc. (“Liquidia”), for inter partes review
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`of claims 1-9 (“Challenged Claims”) of U.S. Patent No. 9,604,901 (“the ’901
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`patent”) for two primary reasons.
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`First, the Board should exercise its discretion under §325(d) to deny
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`institution because Liquidia relies on the identical art considered in detail during
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`examination and nearly identical arguments already considered by the examiner.
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`Liquidia offers no explanation of Office error, beyond more disagreement with the
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`Office’s prior reasoning and conclusions regarding this art and arguments.
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`Second, Liquidia’s arguments ignore differences in claim limitations and in
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`the types of claims (product versus method) and rely on technical inaccuracies in
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`an effort to leverage the cancelation of the claims of the parent patent. Thus, the
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`Petition fails to establish a reasonable likelihood that Liquidia would prevail and
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`should be denied. While UT has no burden to establish patentability, the testimony
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`of its expert, Dr. Rodolfo Pinal (Ex. 2002, ¶¶1-314), and supporting
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`exhibits Exs. 2003-2005, 2007-2011, 2013, and 2016, as discussed below provide
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`additional evidence against Liquidia’s arguments.
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` THE ’901 PATENT
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`Patent Owner Preliminary Response
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`Each of the claims in the ’901 patent defines a pharmaceutical batch of
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`treprostinil or a treprostinil salt, a pharmaceutical product prepared from the
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`pharmaceutical batch, a method of preparing the product, or a method of preparing
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`the batch.1 Ex. 1001, 12; Ex. 2002, ¶¶54-56. Treprostinil is the active ingredient in
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`three Food and Drug Administration-approved drugs: Remodulin® (treprostinil)
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`Injection, Tyvaso® (treprostinil) Inhalation Solution, and Orenitram® (treprostinil)
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`Extended-Release Tablets.
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`The ’901 patent includes nine claims. Claims 1 and 2 define a
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`pharmaceutical batch, claims 3-5 define a pharmaceutical product made from the
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`pharmaceutical batch of claim 1, claims 6 and 7 define a method of preparing a
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`pharmaceutical product, and claims 8 and 9 define a method of preparing a
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`pharmaceutical batch.
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`Claim 1 defines a pharmaceutical batch of treprostinil or a treprostinil salt
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`prepared by a defined process starting by alkylating a benzindene triol, then
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`1 Importantly, the ‘393 grandparent patent only contained product claims and no
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`method of making claims.
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`hydrolyzing the product to form a solution, then contacting the solution with a base
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`to form a salt, then isolating the treprostinil salt (and optionally further reacting the
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`salt with an acid to form treprostinil), where the pharmaceutical batch contains at
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`least 2.9 grams of treprostinil or its salt. Ex. 1001, 12; Ex. 2002, ¶54. Claim 2
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`requires that claim 1’s pharmaceutical batch be dried under vacuum. Ex. 1001, 12;
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`Ex. 2002, ¶55. Claims 3-5 define a pharmaceutical product comprising a
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`therapeutically effective amount of treprostinil, a salt of treprostinil, and a
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`diethanolamine treprostinil salt, respectively, from the pharmaceutical batch of
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`claims 1. Ex. 1001, 12.
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`Claims 6 and 7 define a method of preparing a pharmaceutical product from
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`the pharmaceutical batch of claim 1, requiring storing the pharmaceutical batch
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`comprising the treprostinil salt at ambient temperature, then preparing the
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`pharmaceutical product from the pharmaceutical batch after storage (claim 6).
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`Ex. 1001, 12. Claim 7 further requires the treprostinil salt be the diethanolamine
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`salt. Id. Claim 8 defines a method of preparing a pharmaceutical batch as in
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`claim 1 that involves the formation and isolation of a salt of treprostinil. Id.
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`Claim 9 depends further requires the treprostinil salt be the diethanolamine salt. Id.
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`The Petition states “the ’901 patent discloses a process for the preparation of
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`a compound of Formula I (which includes treprostinil)” (Pet.10-11), which is true
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`but incomplete and, in any case, irrelevant to the Challenged Claims. Ex. 2002,
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`¶¶20, 145-54. As explained above, the Challenged Claims define pharmaceutical
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`batches and methods of making them, and pharmaceutical products and methods of
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`making them, including a storage step. A specification may disclose more than one
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`distinct invention, yet Liquidia discusses the wrong invention, ignoring disclosure
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`of batch production and the advantages of the disclosed methods over the previous
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`method, including a better final product using less solvent and labor. Ex. 1001, 10-
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`12. As discussed more below, Liquidia discusses the wrong invention in apparently
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`treating this IPR as though it is merely a replay of a previous IPR (IPR2016-00006;
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`hereinafter “’393 IPR”) on a different patent (U.S. Patent No. 8,497,393;
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`hereinafter “’393 patent”) with claims directed to only certain products. It does not
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`work that way: Liquidia must prove the unpatentability of the Challenged Claims
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`and cannot do so by ignoring and blurring the differences.
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`For example, Liquidia fails to identify a ’393 patent claim with limitations
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`like those in claim 1 requiring a pharmaceutical batch or any method of making
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`claim like claim 6 requiring storage of the batch before preparing the
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`pharmaceutical product. The person of ordinary skill in the art (“POSA”) would
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`have understood that the ’901 patent is focused on industrial production of
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`pharmaceutical batch and products, not merely synthesizing treprostinil. Ex. 2002,
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`¶¶87-88, 90-91, 136-140.
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`Liquidia’s misapprehension of the invention of the Challenged Claims is
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`highlighted by, in addressing claim 6, asserting that “The ’901 patent does not
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`teach storing the resulting treprostinil salt at ambient temperature; it only
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`specifically discloses this for a ‘crude’ salt. ([Ex. 1001] at col. 17:4-8.).” Pet.13,
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`43.2 The disclosure in question states:
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`Additional advantages of this process are: (a) crude treprostinil salts
`can be stored as raw material at ambient temperature and can be
`converted
`to
`treprostinil by simple acidification with diluted
`hydrochloric acid, and (b) the treprostinil salts can be synthesized from
`the solution of treprostinil without isolation.
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`2 Liquidia goes so far as to argue that “the ’901 patent does not sufficiently
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`describe or enable this limitation of claim 6.” Pet.67-68. The Board disfavors
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`attempts to insinuate improper patentability arguments into the limited scope for
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`IPRs. Dexcowin Global, Inc. v. Aribex, Inc., IPR2016-00436, Paper 12, 5-6 (2016)
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`(rejecting an indefiniteness argument).
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`What Liquidia dismisses as irrelevant disclosure is exactly what claim 6 does:
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`prepare a pharmaceutical product (treprostinil) from a stored batch of treprostinil
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`salt from claim 1, which includes impurities in the pharmaceutical batch.3 Because
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`Liquidia fails to identify, much less address, the invention of the Challenged
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`Claims, the Petition fails to prove the unpatentability of any one of these claims.
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`35 U.S.C. § 314(a).
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` CLAIM CONSTRUCTION
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`Claim construction requires assigning a meaning that the term would have
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`had to the POSA at the time of the invention (here, December 17, 2007). 37 C.F.R.
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`§42.100(b); Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en
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`banc); Ex. 2002, ¶¶45, 102-05. A claim must be construed in light of the
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`3 The quoted paragraph begins with the phrase “additional advantages” and forms
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`part of the discussion of advantages established by the batch-scale comparative
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`example 6 (“Comparison of the Former [Moriarty] Process and a Working
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`Example of the Process According to the Present Invention”) between the claimed
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`invention and the “former” Moriarty process, the same prior art process relied upon
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`by Liquidia. Ex. 1001 at col. 15:25 - col. 17:12.
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`specification, including the disclosed purpose of the invention. United States v.
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`Adams, 383 U.S. 39, 48-49 (1966) (error to interpret claims apart from disclosed
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`purpose). Liquidia contends construction is unnecessary and all terms should be
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`given their plain and ordinary meaning in December 2007. Pet.18-19. Yet Liquidia
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`implicitly construes the limitations to equate them to the ’393 patent claims and the
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`prior art, inviting error by using “composition” rather than “pharmaceutical batch”
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`and “pharmaceutical product”, and ascribing little weight to terms like “storage”
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`and “pharmaceutical”. Pet.8-9, 17, 33, 41, 44, 65-66, and 69.
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`Liquidia also mis-identifies all of the Challenged Claims as product-by-
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`process claims. Pet.8, 24. Yet Liquidia fails to explain how method claims 6-9 can
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`be product-by-process claims. Liquidia also fails to identify—much less address—
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`the structural and functional differences that the process imparts to the claimed
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`pharmaceutical batch and pharmaceutical product other than to say they would be
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`inherent because the process is the same. Pet.19; but see 37 C.F.R. § 42.104(b)(3)
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`(requiring express construction); cf. Becton, Dickinson & Co. v. Baxter Int’l,
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`IPR2018-01741, Paper 8, 13-14 (2019) (for means-plus-function cases, the Board
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`usually denies institution if the corresponding structure is not identified); see also
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`35 U.S.C. §316(e) (burden on petitioner). By incompletely construing the claims as
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`only product-by-process limitations, Liquidia seeks to focus attention on the
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`process steps in the ’393 IPR and away from the Challenged Claims here and away
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`from the resulting structural and functional characteristics.
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`A. Pharmaceutical Batch
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`Liquidia discusses the pharmaceutical batch limitation in terms of
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`“compounds” in the prior art rather than “pharmaceutical batches” to blur the
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`differences between the Challenged Claims and the ’393 patent claims. Pet.29-32.
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`Yet claim 1 requires a “pharmaceutical batch,” which is incorporated into claims 2-
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`9 as well. Ex. 1001, 12. This pharmaceutical batch is defined, in part, as
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`“consisting of . . . impurities” resulting from the process by which it is made, and
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`may be stored and then processed into the pharmaceutical products of claims 6
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`and 7. Id.; Ex. 2002, ¶¶54-56. The pharmaceutical industry is tightly regulated, and
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`the POSA (who would have been experienced in drug production, see § VII.B
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`below) would have understood a “pharmaceutical batch” with impurities yet
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`suitable for preparation into a pharmaceutical product in an art-specific way as an
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`in-process material. Ex. 2002, ¶119, citing 21 C.F.R. §210.3 (April 1, 2007 ed.)
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`(Ex. 2004), 133 (defining an in-process material as “any material fabricated,
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`compounded, blended, or derived by chemical reaction that is produced for, and
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`used in, the preparation of the drug product”).
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`FDA defines “batch” in a pharmaceutical-process context as meaning “a
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`specific quantity of a drug or other material that is intended to have uniform
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`character and quality, within specified limits, and is produced according to a single
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`manufacturing order during the same cycle of manufacture.” Ex. 2004, 133 and
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`also 134 (defining the word “lot” to mean “a batch, or a specific identified portion
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`of a batch, having uniform character and quality within specified limits”); Ex.
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`2002, ¶120.
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`The POSA viewing the ’901 patent claims in light of the ’901 patent
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`specification would have understood claim 1’s “pharmaceutical batch” to be a
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`specific quantity of treprostinil (or its salt) that is intended to have uniform
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`character and quality, within specified limits, and is produced according to a single
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`manufacturing order during the same cycle of manufacture, wherein the uniform
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`character and quality is such that it still contains impurities resulting from the
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`method by which it is produced. Ex. 2002, ¶121. Neither Phares nor Moriarty
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`teaches this limitation. Ex. 2002, ¶122.
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`B. “Pharmaceutical Product”
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`Liquidia uses “product” and “pharmaceutical product” interchangeably when
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`referring to the claimed subject matter to blur the differences between the
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`Challenged Claims and the ’393 patent claims. Compare Pet.5 and Pet.51.
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`However, the Challenged Claims themselves distinguish between a “product,”
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`which is an in-process intermediate, and a “pharmaceutical product,” which is not.
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`Ex. 1001, 12, compare “the product of step (a)” in claims 1 and 8 with “a
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`pharmaceutical product” in claim 6. The POSA would have understood
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`“pharmaceutical product” to mean a chemical composition suitable for
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`pharmaceutical use. Ex. 2002, ¶¶105-16.
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`C. Storing, Storage
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`Claims 6 and 7 require “storing a pharmaceutical batch” and “preparing a
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`pharmaceutical product from the pharmaceutical batch after storage.” Ex. 1001, 12.
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`The POSA would have understood these terms to require stability of the material
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`being stored in a batch qauntity in the context of commercial pharmaceutical
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`manfacturing. Ex. 2002, ¶¶123-124. As the ’901 patent specification explains,
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`“stable” compounds are those “which possess stability sufficient to allow
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`manufacture and which maintain the integrity of the compound for a sufficient
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`period of time to be useful for the purposes detailed herein.” Ex. 1001, 5:4-10.
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`Thus, claims 6 and 7 require the treprostinil salt to be “stable at ambient
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`temperature,” further requiring that the material being stored be stable after storage
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`such that the stored material maintains integrity for a sufficient period of time to be
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`useful for the purposes of commercially preparing pharmaceutical product on a
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`large scale, including preparing “treprostinil by simple acidification.” Ex. 1001,
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`12; Ex. 2002, ¶¶125-26.
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`This required stability is formulation-specific and not a trivial matter—
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`especially when working with polymorphic salts. Ex. 2002, ¶126. The POSA
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`viewing the ’901 patent claims in light of the ’901 patent specification would have
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`understood “storing,” and “storage” to require that the stored material possesses
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`stability sufficient to allow manufacture and which maintains integrity for a
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`sufficient period of time to be useful for the preparation of a pharmaceutical
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`product. Ex. 2002, ¶127.
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`D. A salt treprostinil
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`The printed version of claim 4 uses the phrase “a salt treprostinil.” Ex. 1001,
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`12. The corresponding allowed claim (original claim 9) uses the phrase “a salt of
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`treprostinil.” Ex. 2007, 24, 3820. Claim 4 incorporates the limitations of claim 1,
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`which uses the phrase “salt of treprostinil” repeatedly but not “salt treprostinil.”
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`Ex. 1001, 12. The POSA would have immediately appreciated that “a salt
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`treprostinil” is a printing error for “a salt of treprostinil.” Ex. 2002, ¶128.
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` THE BOARD SHOULD DENY INSTITUTION UNDER § 325(d)
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`The Office considered prior art identical to Liquidia’s—and arguments
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`nearly identical to Liquidia’s—during the ’901 patent’s examination. Indeed,
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`Liquidia’s challenge leans hard on the ’393 IPR, which resulted in cancelation of
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`the grandparent ’393 patent claims. Liquidia uses the same art, arguments, and
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`even the same expert expressing the same opinions. E.g., Pet.19 (“[S]ince the claim
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`limitations of the ’901 patent are substantively similar to the invalidated [sic] ’393
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`patent, the ’901 patent should be similarly declared invalid.”). Yet UT submitted
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`the ’393 IPR art and arguments to the examiner, who considered them yet allowed
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`the ’901 patent in view of the different claim limitations.
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`Liquidia clearly disagrees with the Office’s prior weighing and consideration
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`of that evidence and argument, but Liquidia fails to identify any error the Office
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`committed beyond merely disagreeing with the result. Indeed, Liquidia’s
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`arguments assume a false equivalency between the Challenged Claims and the
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`’393 patent claims. The examiner instead carefully considered the evidence and
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`arguments in light of the claim limitations—many of which Liquidia ignores or
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`grossly distorts—and issued the challenged claims over Liquidia’s prior art and
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`arguments. Thus, the Board should exercise its discretion under 35 U.S.C. § 325(d)
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`to deny institution against the ’901 patent.
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`A. The Advanced Bionics Two-Part Framework
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`Under Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte
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`GmbH, the Board applies a two-part framework when evaluating whether to
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`exercise its discretion under § 325(d). IPR2019-01469, Paper 6 (Feb. 13, 2020)
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`(precedential)(hereinafter “Advanced Bionics”). In applying this framework, the
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`Board considers: (1) whether the same or substantially the same art previously was
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`presented to the Patent Office or whether the same or substantially the same
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`arguments previously were presented to the Office; and (2) if either condition of
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`first part of the framework is satisfied, whether the petitioner has demonstrated that
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`the Office erred in a manner material to the patentability of challenged claims. Id.
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`“If a condition in the first part of the framework is satisfied and the petitioner fails
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`to make a showing of material error, the Director generally will exercise discretion
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`not to institute inter partes review.” Id. at 8-9 emphasis added). The Becton,
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`Dickinson factors “provide useful insight into how to apply the framework under
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`35 U.S.C. § 325(d).” Id. at 9-11.
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`Prior consideration of the same or substantially the same prior art or
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`arguments is sufficient for the Office to exercise its discretion to decline review.
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`Id.; §325(d)(written in the disjunctive); Puma v. Nike, IPR2019-01042, Paper 10
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`(informative) (denying institution under § 325(d) where petition relied upon same
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`combination of art that Examiner applied in original prosecution even though
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`petitioner “provide[d] new evidence and argument”) (hereinafter “Puma”). Thus,
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`evaluation of step 2 is appropriate based on sufficiently similar prior art or
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`arguments.
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`“If reasonable minds can disagree regarding the purported treatment of the
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`art or arguments, it cannot be said that the Office erred in a manner material to
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`patentability.” Id. at 9.
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`B. Liquidia Relies on the Same Art (Becton Factors (a) & (b))
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`The Office already considered Liquidia’s prior art during examination of the
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`application that issued as the ’901 patent. Ex. 2002, ¶¶57-59, 288. Liquidia asserts
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`only two references: Moriarty and Phares. Pet.3. The prosecution history explicitly
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`shows these references were considered, as the following table illustrates:
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`Table 1 – Art Relied Upon by Liquidia in the Grounds
`Liquidia’s
`Representative
`Representative Arguments Using
`Reference
`Citation
`Reference Considered in File History
`Ex. 2007, 7255 (anticipation by
`Ex. 2007, 7327-30,
`Ex. 1008:
`Moriarty), 6925-28 (anticipation by
`IDS items A49 &
`WO 2005/007081
`Moriarty; obviousness over Moriarty
`A68, respectively
`(Phares)
`and Phares).
`Ex. 2007, 7270-3:
`Ex. 1009:
`Ex. 2007, 7056, considering Ex. 2007,
`List of References
`Moriarty 2004
`7073, item B3: ’393 IPR petition
`cited by applicant
`article
`and considered by
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`examiner
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`Ex. 2007, 20-22, considering Ex. 2007,
`316, item E4: ’393 IPR institution
`decision (redacted)
`Ex. 2007, 3468, considering Ex. 2007,
`3480, item D1: ’393 IPR petitioner’s
`reply (redacted)
`Ex. 2007, 20-22, considering Ex. 2007,
`315, item E1: ’393 IPR, petitioner’s
`demonstratives
`Ex. 2007, 3808-13 (withdrawing
`rejection over these references)
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`This reliance on the same prior art is enough to meet the first prong under
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`the Advanced Bionics framework. Advanced Bionics at 9; Puma v. Nike, IPR2019-
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`01042, Paper 10 (informative) (denying institution where petition relied upon the
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`art combination applied in original examination even though petitioner “provide[d]
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`new evidence and argument”) (“Puma”).
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`Surprisingly, Liquidia asserts that “[t]his Petition does not present a scenario
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`in which ‘the same or substantially the same prior art or arguments previously were
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`presented to the Office.’” Pet.3. Yet the examiner explicitly applied—then
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`withdrew—the exact same references, as Liquidia admits. Id. at 4 (“the Examiner
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`considered both Moriarty (Ex. 1009) and Phares (Ex. 1008) and relied upon these
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`two prior art references in issuing a rejection of all claims of the ’901 patent under
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`35 U.S.C. § 103(a)”); Ex. 2007, 7255, 6925-28; Ex. 2002, ¶62.
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`Liquidia disparages the examiner’s understanding of these references. Pet.4.
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`Yet these are references that Liquidia states a chemistry sophomore would
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`understand. Id. 36, 64; cf. American Hoist & De