Paper _____
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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.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
`
`
`_______________
`
`Case IPR2020-00770
`Patent 9,604,901
`_______________
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`
`PATENT OWNER’S RESPONSE TO PETITION
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`4821-2334-5106.4
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`Case IPR2020-00770
`Patent 9,604,901
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`Patent Owner Response
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`TABLE OF CONTENTS
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` 
`
` 
`
`INTRODUCTION ........................................................................................... 1 
`THE ’901 PATENT IS THE PROPER FOCUS OF THIS
`PROCEEDING ................................................................................................ 2 
`A. 
`The ’901 Patent Claimed Subject Matter .............................................. 2 
`B. 
`The ’393 Patent and the ’901 Patent Claim Different Inventions ......... 4 
`C. 
`Liquidia Ignores the Context and Purpose of the ’901 Patent
`Claims .................................................................................................... 5 
`  CLAIM CONSTRUCTION ............................................................................ 8 
`A. 
`Pharmaceutical Batch ............................................................................ 9 
`B. 
`Pharmaceutical Product ....................................................................... 10 
`C. 
`“[C]ontacting the solution comprising treprostinil from step (b)
`with a base to form a salt of treprostinil” ............................................ 11 
`Storing, Storage ................................................................................... 11 
`A Salt Treprostinil ............................................................................... 12 
`Liquidia’s Implicit Constructions Are Not the Plain and
`Ordinary Meaning ............................................................................... 12 
`Liquidia Ignores the ’901 Patent’s Different Claim Types ................. 14 
`Liquidia Improperly Construes the Instituted Claims as
`“Substantively Similar” to the Claims in the ’393 IPR ....................... 14 
`  THE GROUNDS RELY ON IMPROPER EVIDENCE ............................... 17 
`A. 
`The Winkler Declaration is Not Evidence Under 37 C.F.R. §
`42.63 .................................................................................................... 17 
`Prof. Winkler Failed to Support His Opinion ..................................... 18 
`Prof. Winkler Does Not Understand Inherency in Obviousness ........ 21 
`
`D. 
`E. 
`F. 
`
`G. 
`H. 
`
`B. 
`C. 
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`2. 
`
`3. 
`4. 
`
`THE PERSON OF ORDINARY SKILL MUST HAVE
`APPROPRIATE TRAINING OR SKILL IN PHARMACEUTICAL
`MANUFACTURING .................................................................................... 22 
`  GROUND 1: PHARES FAILS TO RENDER CLAIMS 1-9
`OBVIOUS ...................................................................................................... 27 
`A. 
`Phares Alone Does Not Render Claim 1 Obvious .............................. 29 
`1. 
`Liquidia fails to explain why a POSA would modify
`Phares ........................................................................................ 29 
`Claim 1 requires a pharmaceutical batch consisting of
`treprostinil and impurities ......................................................... 35 
`Phares Does Not Teach Treprostinil Synthesis ........................ 38 
`Phares does not teach a pharmaceutical batch of at least
`2.9 grams ................................................................................... 43 
`Phares does not cite to U.S. Patent No. 4,306,075 for
`selectively alkylating a benzindene triol ................................... 45 
`Eğe, Schoffstall, Wiberg, and Kawakami are irrelevant to
`claim 1, and do not cure any of Phares’s deficiencies .............. 46 
`Phares Alone Does Not Render Claim 2 Obvious .............................. 49 
`B. 
`Phares Alone Does Not Render Claims 3-5 Obvious ......................... 49 
`C. 
`Phares Alone Does Not Render Claims 6 and 7 Obvious ................... 50 
`D. 
`Phares Alone Does Not Render Claims 8 and 9 Obvious ................... 51 
`E. 
`  GROUND 2: MORIARTY AND PHARES FAIL TO RENDER
`CLAIMS 1-9 OBVIOUS ............................................................................... 51 
`A.  UT is Not Precluded from Addressing Motivation to Combine ......... 52 
`B. 
`Phares and Moriarty are Directed to Different Problems ................... 54 
`C.  Moriarty with Phares Does Not Render Claim 1 Obvious.................. 56 
`1.  Moriarty and Phares do not teach the same process steps,
`and there is no motivation to combine these references in
`the way recited in claim 1 ......................................................... 57 
`
`5. 
`
`6. 
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`2. 
`
`A product from Moriarty and Phares does not inherently
`include the same resulting impurities ....................................... 62 
`D.  Moriarty with Phares Does Not Render Claims 6 and 7 Obvious ...... 65 
`  EVIDENCE OF SECONDARY CONSIDERATIONS FURTHER
`ESTABLISHES UNOBVIOUSNESS, WHICH LIQUIDIA
`IGNORES ...................................................................................................... 66 
`  THIS PROCEEDING IS NOT CONSTITUTIONAL .................................. 69 
`CONCLUSION .............................................................................................. 71 
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`TABLE OF AUTHORITIES
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`Cases 
`Arthrex, Inc. v. Smith & Nephew, Inc., 941 F.3d 1320 (Fed. Cir. 2019) ................. 68
`
`B & B Hardware, Inc. v. Hargis Indus., Inc., 135 S. Ct. 1293 (2015) .................... 51
`
`Bicon, Inc. v. Straumann Co., 441 F.3d 945 (Fed. Cir. 2006) ................................. 11
`
`Crown Operations Intern., Ltd. v. Solutia Inc., 289 F.3d 1367 (Fed. Cir. 2002) .... 28
`
`Crown Ops. Int’l v. Solutia, 289 F.3d 1368 (Fed. Cir. 2002) .................................. 62
`
`Environmental Designs, Ltd. v. Union Oil Co., 713 F.2d 693 (Fed. Cir. 1983) ...... 23
`
`Graham v. John Deere Co., 383 U.S. 1 (1966) ....................................................... 48
`
`In re Craig, 411 F.2d 1333 (CCPA 1969) ................................................................. 4
`
`In re Cyclobenzaprine Hydrochloride, 676 F.3d 1063 (Fed. Cir. 2012) ................. 65
`
`In re Newell, 891 F.2d 899 (Fed. Cir. 1989) ............................................................ 62
`
`In re Omeprazole Patent Litigation, 536 F.3d 1361 (Fed. Cir. 2008) ..................... 59
`
`In re Soni, 54 F.3d 7460 (Fed. Cir. 1995) ......................................................... 65, 66
`
`King v. Alston, 75 F.3d 657 (Fed. Cir. 1996) ........................................................... 69
`
`KSR Int’l v. Teleflex Inc., 550 U.S. 398 (2007) ....................................................... 55
`
`Murphy v. NCAA, 138 S. Ct. 1461 (2018) ............................................................... 70
`
`Papst Licensing GMBH & Co. v. Samsung Elecs. Am., Inc., 924 F.3d 1243 (Fed.
`
`Cir. 2019) ............................................................................................................. 53
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`Par Pharm., Inc. v. TWi Pharms., Inc., 773 F.3d 1186 (Fed. Cir. 2014) .. 21, 35, 39,
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`62
`
`PersonalWeb Technologies, LLC v. Apple, Inc., 848 F.3d 987 (Fed. Cir. 2017) .... 52
`
`Süd-Chemie Inc. v. Multisorb Technologies, 554 F.3d 1001 (Fed. Cir. 2009) ........ 67
`
`Unique Concepts, Inc. v. Brown, 939 F.2d 1558 (Fed. Cir. 1991) .......................... 11
`
`United States v. Adams, 383 U.S. 39 (1966) .............................................................. 7
`
`Statutes 
`35 U.S.C. § 103 ........................................................................................................ 50
`
`35 U.S.C. § 25 .......................................................................................................... 17
`
`35 U.S.C. § 312 .......................................................................................................... 4
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`35 U.S.C. § 316 ................................................................................................... 1, 70
`
`Rules 
`37 C.F.R. § 1.68 ....................................................................................................... 18
`
`37 C.F.R. § 25 .......................................................................................................... 18
`
`37 C.F.R. § 42.2 ....................................................................................................... 18
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`37 C.F.R. § 42.53 ..................................................................................................... 18
`
`37 C.F.R. § 42.63 ........................................................................................ 17, 18, 50
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`37 C.F.R. §42.104 ...................................................................................................... 8
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`37 C.F.R. §42.65 ...................................................................................................... 67
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`PTAB Cases 
`ASM IP Holding B.V. v. Kokusai Semiconductor Equipment Corp., IPR2018-
`
`01582, Paper 11 (PTAB 2019) ............................................................................. 17
`
`Bumble Bee Foods v. Kowalski, Case IPR2014-00224, Paper 18 (PTAB 2014) .... 19
`
`Coalition For Affordable Drugs V LLC v. Biogen Int’l. GmbH, IPR2015-01086,
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`Paper 20 (PTAB 2016) ......................................................................................... 20
`
`Coalition for Affordable Drugs VII LLC v. Pozen Inc., IPR2015-01344, Paper 22
`
`(PTAB 2015) ........................................................................................................ 20
`
`FedEx v. Katz, CBM2015-00053, Paper 9 (PTAB 2015) ................................. 19, 33
`
`Intel Corp. v. Alacritech, Inc., IPR2017-01395, Paper 8 (PTAB 2017) .................. 18
`
`International Business Machines Corp. v. Intellectual Ventures II LLC, IPR2015-
`
`01323, Paper 38 (PTAB 2016) ............................................................................. 19
`
`Johns Manville Corp. v. Knauf Insulation, Inc., IPR2018-00827, Paper 9 (PTAB
`
`2018) .................................................................................................................... 64
`
`Samsung Electronics Co. Ltd. v. Rembrandt Wireless Techs., LP, IPR2014-00518,
`
`Paper 47 (PTAB 2015) ......................................................................................... 28
`
`Stryker Corp. v. KFx Medical, IPR2019-00817, Paper 10 (PTAB 2019) ............... 71
`
`TCL Corp. v. Telefonaktiebolaget LM Ericsson, IPR2015-01641, Paper 38 (PTAB
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`2017) .................................................................................................................... 16
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`Tietex International, Ltd. v. Precision Fabrics Group, Inc., IPR2014-01248,
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`Paper 39 (PTAB 2016) .................................................................................. 30, 66
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`Toyota Motor Corp. v. GE Hybrid Techs. LLC, IPR 2019-00009, Paper 7 (PTAB
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`2019) .................................................................................................................... 17
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`EXHIBIT LIST
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`Patent Owner Response
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`Exhibit No
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`Description
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`2001
`
`2002
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`2003
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`2004
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`2006
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`2007
`
`2008
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`2009
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`2010
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`2011
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`2012
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`2013
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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.
`
`21 C.F.R. §210.3 (April 1, 2007 edition)
`
`Intentionally left blank
`
`Complete Prosecution History of U.S. Patent No. 9,604,901
`
`Stahl, P. H., & Wermuth, C. G. (Eds.). (2002). Handbook of
`Pharmaceutical Salts (1st ed.). Weinheim, Germany: Wiley-VCH,
`pp. 1-7, 41-81, 135-220, 259-63
`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)
`
`Wiberg, K., Laboratory Technique in Organic Chemistry (1960),
`pp. 75-119
`
`Schoffstall, A. M., et al., Microscale and Miniscale Organic
`Chemistry Laboratory Experiments, 2nd ed. (2004), pp. 22-27,
`537-59
`
`Intentionally left blank
`
`Comparing IPR2020-00770 Ex.1002 to the Petition in IPR2020-
`00770
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`Exhibit No
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`Patent Owner Response
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`
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`Description
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`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
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`2021
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`2022
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`2023
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`2024
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`2025
`
`Intentionally left blank
`
`Intentionally left blank
`
`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)
`Anderson, Practical Process Research and Development, Second
`Ed., Academic Press, Oxford, UK, 2012
`Gad, Pharmaceutical Manufacturing Handbook, Production and
`Processes, John Wiley & Sons, Hoboken, NJ (2008)
`Levin, Pharmaceutical Process Scale-Up, Taylor & Francis, Boca
`Raton, FL (2006)
`Bennett, Pharmaceutical Production. An Engineering Guide,
`INSTITUTION OF CHEMICAL ENGINEERS (ICHEME), Rugby,
`Warwickshire, UK (2003)
`Qiu, et al., Identification of pharmaceutical impurities, J. LIQUID
`CHROMATOGRAPH. REL. TECHS., 30, 877-935
`Ahuja, et al., Assuring quality of drugs by monitoring impurities,
`ADV. DRUG DELIVERY REV., 59, 3-11 (2007)
`Paul, et al., Design of Reaction Systems for Specialty Organic
`Chemicals, CHEM. ENGINEER. SCI., 43, 1773-82 (1988) (“Paul,”
`EX2023)
`Wadekar, et al., Evaluating Impurities in Drugs (Part I of III),
`PHARM. TECH., 36(2), 46-51 (2012)
`Declaration of Rodolfo Pinal, Ph.D. Supporting Patent Owner
`Response
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`Exhibit No
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`Patent Owner Response
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`Description
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`Winkler Deposition Transcript, December 14, 2020
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`U.S. Patent No. 9,593,066
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`Prosecution History of U.S. Patent Application No. 13/933,623
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`2026
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`2027
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`2028
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`INTRODUCTION
`Liquidia failed to prove claims 1-9 of the ’901 patent (“Instituted Claims”)
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`are unpatentable for at least three fundamental reasons, any one of which is fatal to
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`Liquidia’s case-in-chief. 35 U.S.C. § 316(a).
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`First, Liquidia’s unpatentability grounds cobble together bits of disclosure
`
`guided solely by impermissible hindsight without identifying any legally
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`cognizable motivation. Liquidia relies on Professor Winkler’s unsworn declaration
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`(Ex.1002; “Winkler Declaration”) to support these positions, but Prof. Winkler’s
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`key conclusions are bare opinion unsupported by evidence or explanation. For
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`example, Prof. Winkler’s relies heavily on inherency despite applying the wrong
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`legal standard and not even stating, much less explaining, why a property is
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`inherent. Inherency requires rigorous analysis and is not simply a sleight of hand to
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`dismiss missing claimed elements.
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`Second, Liquidia misapprehends the relevant art, and thus misidentified the
`
`level of ordinary skill, oversimplifying and mischaracterizing the technical issues
`
`facing an ordinarily skilled artisan in pharmaceutical product manufacturing.
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`Specifically, Liquidia assumes that the relevant level of skill is a bench chemist
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`working in an academic laboratory, and not a person that must manufacture on a
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`commercial scale a pharmaceutical product with all the attendant obstacles and
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`concerns. See Paper No. 7, 16 (construing “pharmaceutical product” to mean “a
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`chemical composition manufactured for pharmaceutical use.”).
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`Third, Liquidia ignores objective indicia of nonobviousness, failing to
`
`address the disclosed advantages of the presently claimed invention, including the
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`‘901 patent specification’s supporting data, which is uncontested and rebuts any
`
`suggestion of obviousness. Additionally, claims 6 and 7 are separately patentable
`
`(as the Board acknowledged, Paper 7, 28-30) because they expressly recite the
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`unsuggested advantage of ambient temperature storage stability.
`
` The ’901 Patent is the Proper Focus of This Proceeding
`Throughout its Petition, Liquidia improperly focuses on the ’393 patent
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`claims and related IPR proceeding IPR2016-00006 (“’393 IPR). This is an
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`improper shortcut that does not illuminate the issues and merits of the present
`
`proceeding.
`
`A. The ’901 Patent Claimed Subject Matter
`The ’901 patent has 9 claims. Claim 1, the only independent claim, recites:
`
`1. A pharmaceutical batch consisting of treprostinil or a salt thereof and
`impurities resulting from
`
`(a) alkylating a benzidene triol,
`
`(b) hydrolyzing the product of step (a) to form a solution comprising
`treprostinil,
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`2
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`(c) contacting the solution comprising treprostinil from step (b) with a
`base to form a salt of treprostinil, (d) isolating the salt of treprostinil,
`and (e) optionally reacting the salt of treprostinil with an acid to form
`treprostinil, and
`
`wherein the pharmaceutical batch contains at least 2.9 g of treprostinil
`or its salt.
`
`Ex.1001 (the ’901 patent), 17:24-18:2; see also Ex.2007, 3-6 (correcting claim 1,
`
`which issued reciting “(c) containing the,” to “(c) contacting the”).
`
`Claims 2-5 recite limitations associated with the pharmaceutical batch of
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`claim 1. Ex.1001, 18:3-11.
`
`Claims 6-9 are method claims. Claim 6 recites a method of preparing a
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`pharmaceutical product from the pharmaceutical batch of claim 1, comprising
`
`storing a pharmaceutical batch of a treprostinil salt at ambient temperature and
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`preparing a pharmaceutical product from the pharmaceutical batch after storage.
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`Ex.1001 (the ’901 patent), 18:12-17. Claim 8 recites a method of preparing a
`
`pharmaceutical batch as recited in claim 1, including forming and isolating a
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`treprostinil salt. Id., 18:20-27. Claims 7 and 9 depend from claims 6 and 8,
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`respectively, and recite that the treprostinil salt is treprostinil diethanolamine. Id.,
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`18:18-19, 28-29.
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`B. The ’393 Patent and the ’901 Patent Claim Different Inventions
`Liquidia seeks to leverage a decision in a distinct IPR proceeding as a
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`shortcut in this case. The earlier IPR reviewed ’393 patent claims 1-22. Ex.1002,
`
`¶¶36-37; see also Ex.1004; Ex.1005. Liquidia does not rely on issue preclusion and
`
`for good reason. See infra §VII(A) (explaining why issue preclusion does not
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`apply). The IPR decision on the ’393 patent is not a statutory basis for
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`unpatentability. Cf. 35 U.S.C. § 312(b). Moreover, longstanding precedent bars
`
`preclusion for the patentability of different claims before the Office. In re Craig,
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`411 F.2d 1333, 1335-36 (CCPA 1969) (judicial preclusion doctrines do not apply
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`to Office patentability determinations). Nonetheless, Liquidia contends that “since
`
`the claim limitations of the ’901 patent are substantively similar to the invalidated
`
`’393 patent, the ’901 patent should be similarly declared invalid.” Pet.19.
`
`Yet the ’393 and ’901 patents claim different inventions using different
`
`claim language. Ex.2025, ¶¶39-45; Ex.2002, ¶¶72-83. For example, the Instituted
`
`Claims require a pharmaceutical batch with impurities. Ex.1001, 12. Limitations
`
`drawn to an in-process pharmaceutical batch with impurities do not appear in the
`
`’393 patent claims. Ex.2025, ¶42; Ex.2002, ¶77. Claims 6 and 7 recite a limitation
`
`for pharmaceutical-batch storage at ambient temperature. Ex.1001, 12. As
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`discussed below, this limitation represents an advantage Phares did not teach, and
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`would not have been possible using Moriarty’s commercial process. The ’393
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`patent claims have no such limitations. Because the claims are different, Liquidia
`
`cannot simply rest on the ’393 patent IPR and, instead, must prove the
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`unpatentability of the Instituted Claims, a burden it has not met.
`
`C. Liquidia Ignores the Context and Purpose of the ’901 Patent
`Claims
`The ’901 patent improves upon existing treprostinil synthesis with “an
`
`efficient process to synthesize these compounds on a large scale suitable [sic] for
`
`commercial production.” Ex.1001, 1:66-2:3; Ex.2025, ¶87; Ex.2002, ¶¶130-32,
`
`citing Ex.1001, 6:4-18 (noting that “the purification by column chromatography is
`
`eliminated, thus the required amount of flammable solvents and waste generated
`
`are greatly reduced”); id. (noting that “the product of the process according to the
`
`present invention has a higher purity”); id. (noting that “the present invention
`
`provides for a process that is more economical, safer, faster, greener, easier to
`
`operate”); id., 17:27-29 (“The quality of treprostinil produced according to this
`
`invention is excellent. The purification of benzidine nitrile by column
`
`chromatography is eliminated.”); id., Example 6. The new process is “more
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`economical, safer, faster, greener, easier to operate, and provid[ing] higher purity,”
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`as well as allowing “crude treprostinil salts [to] be stored as raw material at
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`ambient temperature,” which thereafter may be converted to a final treprostinil API
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`through acidification with dilute hydrochloric acid. Ex.2002, ¶135, citing Ex.1001,
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`17:1-12 (noting also that these treprostinil salts may be synthesized from the
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`solution of treprostinil without isolation, and again highlighting how the “process
`
`provides better quality of final product as well as saves significant amount of
`
`solvents and manpower in the purification of intermediates”); id., Example 6
`
`(comparing the previous methods for synthesizing treprostinil with the process
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`disclosed in the patent specification).
`
`The claimed inventions maintain production efficiencies while still
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`delivering an ultra-pure treprostinil active pharmaceutical ingredient (API).
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`Ex.2025, ¶91. The resulting treprostinil API exhibited purity higher than that
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`previously reported in the art, specifically, Moriarty (describing lower purity even
`
`at benchtop scale). The claimed invention provides batch production of treprostinil
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`for use as an active ingredient in a pharmaceutical composition or pharmaceutical
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`product, such as Remodulin® (treprostinil) Injection. Ex.2002, ¶136, citing
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`Ex.1001, [12], [57], 6:4-18, 16:66-17:12.
`
`Unlike the ’393 patent, which presented claims directed to a total synthesis
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`of treprostinil and “[a] product comprising” treprostinil, the ’901 patent defines
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`pharmaceutical batches and pharmaceutical products with specific limitations
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`regarding stability, storage, and purity. Claim 1, parent claim for dependent
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`claims 2-9, defines a pharmaceutical batch “consisting of” treprostinil (or a salt)
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`and impurities resulting from the claimed process steps. Ex.1001, 12. In view of
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`this claim language, the POSA would have understood that the Instituted Claims
`
`focus on the production of pharmaceutical batches and pharmaceutical products, on
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`a batch-size scale. Ex.2025, ¶¶55, 94; Ex.2002, ¶¶137-41, citing Ex.2008, 195
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`(discussing the troublesome phases of manufacturing a crystalline pharmaceutical
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`material that come after the synthesis is completed). Benchtop chemistry or the
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`mere synthesis of treprostinil is a different problem.
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`Liquidia’s silence on the context and purpose of the claimed invention as
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`reflected in the specific claim language—focusing simply on synthesis of
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`treprostinil rather than on making it at a commercially relevant scale, stability and
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`purity—is telling. See Ex.1001, 1:66-2:3, 6:4-18 (present invention provides large-
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`scale synthesis, higher purity); United States v. Adams, 383 U.S. 39, 48-49 (1966)
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`(error to interpret claims apart from disclosed purpose). Liquidia’s improper focus
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`infects its understanding of the scope and content of the art, the differences
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`between the art and the invention, and the level of skill. Indeed, Liquidia ignores
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`entirely the objective indicia of nonobviousness in the record consonant with the
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`stated purpose of the claimed invention. Ex.2002, ¶129. Liquidia has failed to
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`prove obviousness for even one claim.
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` CLAIM CONSTRUCTION
`Petitioners must address any claim terms requiring construction. See
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`37 C.F.R. §42.104(b)(2) (petitioners “must identify . . . [h]ow the challenged claim
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`is to be construed.”). Aside from contending claim construction was unnecessary
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`and all terms should be given their plain and ordinary meaning, Liquidia did not
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`expressly do so. Pet.18-19. Instead, Liquidia implicitly construed certain
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`limitations by equating them to entirely different terms from the ’393 patent claims
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`and the prior art, e.g., by construing “composition” rather than “pharmaceutical
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`batch” and “pharmaceutical product,” and ascribing little weight to terms like
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`“storage” and “pharmaceutical.” Pet.8-9, 17, 33, 41, 44, 65-66, and 69. Liquidia
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`offered no evidence to support these constructions.
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`In its Institution Decision (“Dec.”), the Board construed “pharmaceutical
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`batch,” “pharmaceutical product,” “a salt treprostinil,” and “storage/storing” as UT
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`proposed. Dec., 15-16. These constructions remain correct, and any constructions
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`implicit in Liquidia’s arguments and deviating from these contextually-consistent
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`meanings lack merit.
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`A. Pharmaceutical Batch
`The Decision agreed with (Dec. 16) UT’s “pharmaceutical batch”
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`construction “in part, as ‘consisting of . . . impurities’ resulting from the process by
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`which it is made, and may be stored and then processed into the pharmaceutical
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`products of claims 6 and 7.” POPR, 8 (emphasis added). As Dr. Pinal confirms,
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`“pharmaceutical batch” in claim 1 requires storage stability, while dependent
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`claims 6 and 7 specifically relate to storage stability at ambient temperatures.
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`Ex.2025, ¶78.
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`Liquidia failed to construe “pharmaceutical batch” explicitly, but Prof.
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`Winkler testified that he applied a construction of “pharmaceutical batch” that
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`divorced “pharmaceutical” from “batch”—“plain meaning of batch would simply
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`be an amount of compound.” Ex.2026, 97:10-13. Furthermore, when asked if an
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`individual “engaged in pharmaceutical manufacturing” would use the term batch in
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`the same way he did, Prof. Winkler stated that he “[did]n’t know exactly how that
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`person would be using the term batch.” Ex.2026, 97:6-13.
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`As Dr. Pinal explains, the pharmaceutical industry is tightly regulated, and a
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`relevant POSA must have understood a “pharmaceutical batch” as a specific
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`quantity of treprostinil (or its salt) intended to have uniform character and quality,
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`within specified limits, and produced according to a single manufacturing order
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`during the same cycle of manufacture, wherein the uniform character and quality is
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`such that it still contains impurities resulting from the process by which it is
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`produced. Ex.2025, ¶¶75-79; Ex.2002, ¶121.
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`Just as importantly, given that a pharmaceutical batch is understood as an in-
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`process material, it must meet certain stability criteria in order to be processed into
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`pharmaceutical products. Ex.2025, ¶¶77-78.
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`This plain and ordinary meaning is inconsistent with Prof. Winkler’s
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`understanding of the terminology as “an amount of compound.”
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`B. Pharmaceutical Product
`The Board’s claim construction for a “pharmaceutical product” to mean a
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`chemical composition manufactured for pharmaceutical use is consistent with the
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`plain and ordinary meaning of the term. Dec. 16 (rather than “suitable for” as
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`proposed). Dr. Pinal testifies this modest alteration does not affect his opinions and
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`conclusions. Ex.2025, ¶¶73-74.
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`While Liquidia did not offer a specific construction of “pharmaceutical
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`product,” it did use “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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`Instituted Claims and the ’393 patent claims. Compare Pet.5 and Pet.51. This
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`construction improperly renders “pharmaceutical” meaningless. See Bicon, Inc. v.
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`Straumann Co., 441 F.3d 945, 951 (Fed. Cir. 2006) (explaining that claim
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`language “should not [be] treated as meaningless.”); Unique Concepts, Inc. v.
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`Brown, 939 F.2d 1558, 1562 (Fed. Cir. 1991) (“All the limitations of a claim must
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`be considered meaningful.”).
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`C. “[C]ontacting the solution comprising treprostinil from step (b) with
`a base to form a salt of treprostinil”
`Claim 1 requires “contacting the solution comprising treprostinil from step (b)
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`with a base to form a salt of treprostinil.” The claim’s preamble requires the
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`pharmaceutical batch be one “consisting of” what results from the recited steps.
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`Together, this language means treprostinil is not isolated from the solution formed
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`in step (b) before forming a salt in step (c). Just as in the ‘901 patent’s Example 3
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`(reactor charged with treprostinil solution “35-40 L from the previous step”), claim
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`1 requires the solution in which treprostinil is formed be used directly in the next
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`salt-forming step without isolating treprostinil in between.
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`D. Storing, Storage
`UT’s construction for “storing” and “storage,” which the Decision adopts,
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`specifically requires the stored material possesses stability sufficient to allow
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`manufacture and maintains integrity for a sufficient period of time to be useful for
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`preparing a pharmaceutical product.
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`Again, Liquidia never provided an explicit construction of the claim term.
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`Prof. Winkler, however, asserted that he “use[d] the plain and ordinary meaning of
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`each of the claim terms in [his] declaration. Ex.2026, 70:2-25. Certainly, Prof.
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`Winkler used “stored” as “stable at ambient temperature” improperly to equate
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`relative thermodynamic stabilities of a metastable polymorph (Form A) with a
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`more stable polymorph (Form B). His construction fails to consider overall claim
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`context, which a POSA would have understood to require the stability be sufficient
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`to allow manufacture and maintain integrity for a sufficient period of time to be
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`useful for preparing a pharmaceutical product. Ex.2025, ¶¶206-212.
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`E. A Salt Treprostinil
`The Decision adopted UT’s construction for “a salt treprostinil” as “a salt of
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`treprostinil,” consistent with Dr. Pinal testimony that a POSA would have
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`immediately understood the term in context. Ex.2025, ¶80.
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`F. Liquidia’s Implicit Constructions Are Not the Plain and Ordinary
`Meaning
`Professor Winkler did not provide any explicit constructions. Ex.1002, ¶35.
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`On cross-examination, Prof. Winkler declined to state whether he had been asked
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`to evaluate possible constructions of the ’901 patent claim terms. Ex.2026, 70:2-
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`25. Instead, Prof. Winkler insisted he “use[d] the plain and ordinary meaning of
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`each of the claim terms in [his] declaration.” Ex.2026, 70:17-25.
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`His testimony, however, conflicts with his declaration. Prof. Winkler opines
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`the ‘901 claims are similar to the ‘393 claims because “they disclose the same
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`treprostinil and the identical treprostinil diethanolamine salt.