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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.
`
`
`_______________
`
`Case IPR2020-00769
`Patent 9,593,066
`_______________
`
`
`Patent Owner Preliminary Response Under
`35 U.S.C. § 313 and 37 C.F.R. § 42.107
`
`
`

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`Case IPR2020-00769
`Patent 9,593,066
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`Patent Owner Preliminary Response
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`TABLE OF CONTENTS
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` 
`
` 
`
` 
`
`C. 
`
`INTRODUCTION ........................................................................................... 1 
`THE ’066 PATENT ......................................................................................... 2 
`  CLAIM CONSTRUCTION ............................................................................ 4 
`A. 
`“Pharmaceutical Product” ..................................................................... 5 
`B. 
`“A Pharmaceutical Composition Comprising Treprostinil or a
`Pharmaceutically Acceptable Salt Thereof” ......................................... 5 
`Additional terms require construction ................................................... 7 
`1. 
`Starting Batch .............................................................................. 7 
`2. 
`Stored, Storing, Storage .............................................................. 8 
`  THE BOARD SHOULD DENY INSTITUTION UNDER § 325(D) ............ 9 
`A. 
`The Advanced Bionics Two-Part Framework ..................................... 10 
`B. 
`Liquidia Relies on the Same Art (Becton Factors (a) & (b)) .............. 12 
`C. 
`Liquidia Relies on the Same Arguments (Becton Factor (d)) ............. 18 
`D. 
`Liquidia Fails to Prove the Examiner Erred in A Manner
`Material to The Patentability of Challenged Claims ........................... 21 
`1. 
`Factor (c) – the examiner thoroughly evaluated the same
`art and substantially the same arguments in a variety of
`permutations .............................................................................. 22 
`Factors (e) & (f) – Liquidia has failed to show an error
`warranting reconsideration ........................................................ 23 
`LIQUIDIA’S ARGUMENTS ARE NOT SUPPORTED BY
`RELIABLE EVIDENCE ............................................................................... 27 
`  LIQUIDIA’S “THREE STRONG BASES FOR INVALIDATION”
`ARE FACTUALLY IRRELEVANT OR INCOMPLETE ........................... 28 
`A.  A Known Synthesis of Treprostinil Is Not the Issue .......................... 29 
`B. 
`Existence of a “Standard Chemical Purification Known in the
`Art” Is Not the Issue ............................................................................ 29 
`
`2. 
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`C. 
`
`The Board’s Findings In the ’393 IPR Do Not Render the ’066
`Claims Obvious ................................................................................... 31 
`  THE GROUNDS SHOULD BE DENIED ON THE MERITS .................... 32 
`A. 
`Scope and Content of the Prior Art ..................................................... 32 
`1. 
`Liquidia Focuses on the Wrong Problem ................................. 32 
`2. 
`Liquidia’s Positions Lack Basis ................................................ 35 
`3. 
`The ’393 Patent and the ’066 Patent Are Not Directed to
`the Same Invention ................................................................... 40 
`Phares and Moriarty are Directed to Different Problems ......... 48 
`4. 
`The Prior Art Does Not Teach Stability ................................... 50 
`5. 
`Liquidia Misidentifies the Person of Ordinary Skill ........................... 54 
`Liquidia Ignores the Differences Between the Claimed
`Invention and Phares ........................................................................... 56 
`1. 
`Ground 1: Phares Did Not Render Claims 1-7 Obvious ........... 56 
`2. 
`Ground 2: Phares Did Not Anticipate Claims 8-10 .................. 58 
`3. 
`Ground 3: Moriarty and Phares Did Not Render
`Claims 1-10 Obvious ................................................................ 61 
`  LIQUIDIA IGNORES OBJECTIVE INDICIA OF OBVIOUSNESS ......... 65 
`  CONCLUSION .............................................................................................. 68 
`
`B. 
`C. 
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`TABLE OF AUTHORITIES
`
`Cases 
`American Hoist & Derrick Co. v. Sowa & Sons, 725 F.2d 1350, 1359 (Fed. Cir.
`
`1984) ............................................................................................................. 13, 26
`
`Graham v. John Deere Co., 383 U.S. 1, 17 (1966) .......................................... 40, 56
`
`Griffin v. Bertina, 285 F.3d 1029, 1033 (Fed. Cir. 2002) .......................................... 6
`
`In re Chudik, 851 F.3d 1365, 1372 (Fed. Cir. 2017) ............................................... 58
`
`In re Cyclobenzaprine Hydrochloride, 676 F.3d 1063 (Fed. Cir. 2012) ................. 65
`
`In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) ................................................... 58
`
`In re Paulsen, 30 F.3d 1475, 1481 (Fed. Cir. 1994) ................................................ 20
`
`In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995) .......................................................... 65
`
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007) ........................................ 29
`
`Monolithic Power Sys., Inc. v. O2 Micro Int'l Ltd., 558 F.3d 1341, 1350 (Fed. Cir.
`
`2009) .................................................................................................................... 24
`
`Personal Web Techs., LLC v. Apple, Inc., 848 F.3d 987, 993 (Fed. Cir. 2017) ...... 30
`
`Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc) ................. 4
`
`Süd-Chemie Inc. v. Multisorb Technologies, 554 F.3d 1001 (Fed. Cir. 2009) ........ 67
`
`Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1363-64 (Fed. Cir.
`
`2008) .................................................................................................................... 28
`
`
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`United States v. Adams, 383 U.S. 39 (1966) ....................................................... 4, 32
`
`Statutes 
`35 U.S.C. § 103(a) ...................................................................................... 14, 42, 58
`
`35 U.S.C. § 312(a)(3) ........................................................................................ 26, 64
`
`35 U.S.C. § 325(d) ................................................................................................... 11
`
`35 U.S.C. §316 ......................................................................................................... 68
`
`35 U.S.C. 314(a) ...................................................................................................... 64
`
`Other Authorities 
`Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte Gmb .......... passim
`
`Hunting Titan, Inc. v. DynaEnergetics Europe GmbH, IPR2018-00600, Paper 67
`
`(2020) (precedential) ............................................................................................ 21
`
`Puma v. Nike, IPR2019-01042, Paper 10 (informative) ............................. 12, 13, 26
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`Stryker Corp. v. KFx Medical, IPR2019-00817, Paper 10, 28-29 (2019) ............... 68
`
`Rules 
`37 C.F.R. §42.100(b) ................................................................................................. 4
`
`37 C.F.R. §42.104(b) ............................................................................................... 64
`
`37 C.F.R. §42.63(b) ................................................................................................. 42
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`LIST OF EXHIBITS
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`Exhibit No
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`Description
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
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`2011
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`2012
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`4818-3909-1139.1
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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)
`
`Office Action, U.S. application Ser. No. 15/423,021 dated Jan. 11,
`2018
`
`Complete Prosecution History of U.S. Patent No. 9,593,066
`
`Intentionally left blank
`
`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)
`
`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,
`537-77
`Comparing IPR2020-00769 EX1002 to the Petition in IPR2020-
`00769
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`Exhibit No
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`Description
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`2013
`
`2014
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`2015
`
`2016
`
`Intentionally left blank
`
`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) (“Polymorph Guidance”)
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`
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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
`
`Petition, filed by Liquidia Technologies, Inc. (“Liquidia”), for inter partes review
`
`of claims 1-10 (“Challenged Claims”) of U.S. Patent No. 9,593,066 (“the ’066
`
`patent”) for two primary reasons.
`
`First, the Board should exercise its discretion under §325(d) to deny
`
`institution because Liquidia relies on the identical art considered in detail during
`
`examination and nearly identical arguments already considered by the examiner.
`
`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.
`
`Second, Liquidia’s arguments ignore different claim limitations and rely on
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`technical inaccuracies in an effort to leverage the cancelation of the claims of the
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`parent patent. Thus, the Petition fails to establish a reasonable likelihood that
`
`Liquidia would prevail and should be denied. While UT has no burden to establish
`
`patentability, the testimony of its expert, Dr. Rodolfo Pinal (Ex. 2002, ¶¶1-314),
`
`and supporting Exs. 2003-2006, 2008-2012, and 2016, as discussed below provide
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`additional evidence against Liquidia’s arguments.
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` THE ’066 PATENT
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`Patent Owner Preliminary Response
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`Each of the claims in the ’066 patent defines a pharmaceutical composition
`
`or process of preparing pharmaceutical products containing treprostinil or a
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`pharmaceutically acceptable salt thereof. Ex. 1001, 12; Ex. 2002, ¶¶46-53.
`
`Treprostinil is the active ingredient in three Food and Drug Administration-
`
`approved drugs: Remodulin® (treprostinil) Injection, Tyvaso® (treprostinil)
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`Inhalation Solution, and Orenitram® (treprostinil) Extended-Release Tablets.
`
`The ’066 patent includes two independent claims. Claim 1 defines a
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`pharmaceutical composition comprising treprostinil or a pharmaceutically
`
`acceptable salt prepared by a defined process from a starting batch of treprostinil
`
`having one or more impurities resulting from prior alkylation of benzindene triol
`
`and hydrolysis steps. Claim 1 has purity requirements relative to the starting batch.
`
`Ex. 2002, ¶¶46, 49, 51. Claims 2-7 depend from claim 1. Ex. 2002, ¶47. Claim 8
`
`defines a process of preparing a pharmaceutical product comprising treprostinil or
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`a pharmaceutically acceptable salt thereof, comprising five steps including:
`
`(1) alkylating, (2) hydrolyzing, (3) forming, (4) storing, and (5) subsequently
`
`preparing the pharmaceutical product. Ex. 2002, ¶¶48-49, 52. Claims 9 and 10
`
`depend from claim 8. Id., ¶53.
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`Patent Owner Preliminary Response
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`Despite Dr. Winkler’s assertion that claim 8 is simply the process of
`
`preparing the pharmaceutical composition of claim 1, Ex. 1002, ¶¶26-27, this
`
`assertion is plainly wrong. Claim 1 defines a pharmaceutical composition prepared
`
`by a process with limitations specifying the impurity of a starting batch, isolation
`
`of a treprostinil salt, and the resulting purer product. By contrast, claim 8 defines a
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`process for preparing a pharmaceutical product with temperature and storage
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`limitations. Ex. 2002, ¶¶48-52. Although the claims have some limitations in
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`common, Liquidia fails to account for key differences, a failing repeated in the
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`obviousness analysis.
`
`Similarly, Dr. Winkler asserts that the challenged claims are “substantially
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`similar” to the claims of the parent patent, U.S. Patent No. 8,497,393 (“’393
`
`patent”), but this assertion is also facially wrong. Ex. 1002, ¶¶36-37; Ex. 2002,
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`¶¶72-83. The ’393 patent presented claims generally directed to the total synthesis
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`of treprostinil and “[a] product comprising” treprostinil. Ex. 1004, 17:52-21:16.
`
`The ’066 patent claims define pharmaceutical compositions and pharmaceutical
`
`products with specific limitations regarding stability, storage, and purity. Ex. 1001,
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`17:51-63; see also id., 18:34-35, 18:38-61 (claims 6 and 8, with limitations related
`
`to API storage), 18:36-37 (claim 7, reciting a “pharmaceutical solution”), 18:38-66
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`(claims 8-10, reciting a “pharmaceutical product”); Ex. 2002, ¶¶74-79.
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`Liquidia fails to identify a ’393 patent claim with limitations like those of
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`challenged claim 1 requiring a pharmaceutical composition comprising a
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`treprostinil active pharmaceutical ingredient (API) that is purer than a starting
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`batch of treprostinil. The person of ordinary skill in the art (“POSA”) would have
`
`understood that the ’066 patent is focused on the production of pharmaceutical
`
`compositions and products on a batch-size scale, not merely synthesizing
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`treprostinil. Ex. 2002, ¶¶87-89, 91, 136-140.
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` CLAIM CONSTRUCTION
`
`Claim construction requires assigning a meaning that the term would have
`
`had to the POSA at the time of the invention (here, December 17, 2007). 37 C.F.R.
`
`§42.100(b); Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en
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`banc); Ex. 2002, ¶¶45, 102-03. A claim must be construed in light of the
`
`specification, including the disclosed purpose of the invention. United States v.
`
`Adams, 383 U.S. 39, 48-49 (1966) (error to interpret claims apart from disclosed
`
`purpose). Though its own expert offers none (see Ex. 1002, ¶35), Liquidia offers
`
`several claim constructions that fail to meet this standard. Pet.18-19; Ex. 2002,
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`¶¶104-105.
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`A. “Pharmaceutical Product”
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`Patent Owner Preliminary Response
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`Liquidia improperly construes “pharmaceutical product” to exclude
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`“pharmaceutical.” Pet.17 (proposing a construction of “chemical composition” for
`
`both “product” and “pharmaceutical product”). Claim 8 is directed to a “process of
`
`preparing a pharmaceutical product….” Yet Liquidia asserts that “pharmaceutical
`
`product” meant “a chemical composition” broadly, without regard to impurities or
`
`other components within the composition or the requisites for a useful
`
`“pharmaceutical” product. Ex. 2002, ¶106; see also Ex. 1005, 16-17 (noting, in
`
`contrast, that the ’393 patent claims did not “disavow the full scope of the term
`
`‘product’). Liquidia offers conclusory statements rather than intrinsic evidence to
`
`avoid applying the plain and ordinary meaning. The POSA would have understood
`
`“pharmaceutical product” to mean a chemical composition suitable for
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`pharmaceutical use. Ex. 2002, ¶¶107-09, citing Ex. 1001, 5:13-17 (defining
`
`“pharmaceutically acceptable”), 5:18-20 (defining “pharmaceutically acceptable
`
`salts”), & Ex. 2004, 133 (defining “drug product”).
`
`B. “A Pharmaceutical Composition Comprising Treprostinil or a
`Pharmaceutically Acceptable Salt Thereof”
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`Liquidia next exploits its overbroad definition of “product” to argue that the
`
`claims include a “compound of treprostinil or a pharmaceutically acceptable salt
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`thereof, and that may also include other non-mentioned substances (including
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`impurities), additives, or carriers, without limitation as to the types or relative
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`amounts thereof.” Pet.18; Ex. 2002, ¶110. Again, Liquidia’s construction ignores
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`the pharmaceutical limitation in “pharmaceutical composition,” effectively
`
`rendering the term meaningless.
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`Although the transitional phrase “comprising” is open, it is not without
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`limitation because the resulting composition must be pharmaceutically acceptable.
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`Ex. 2002, ¶¶110-112. Griffin v. Bertina, 285 F.3d 1029, 1033 (Fed. Cir. 2002)
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`(affirming Board construction requiring steps relate to diagnosis as provided in
`
`preamble). The POSA would have understood the plain and ordinary meaning of
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`“a pharmaceutical composition comprising treprostinil or a pharmaceutically
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`acceptable salt thereof” to be a composition comprising treprostinil or a
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`pharmaceutically acceptable salt thereof that is suitable for pharmaceutical use.
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`Similarly, the use of “comprising” with the process limitations is not
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`“without limitation,” Pet.18, because the claims include further limitations
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`requiring the resulting product be pharmaceutically acceptable. Ex. 2002, ¶¶113-
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`116, citing Ex. 1005, 19 (noting Liquidia’s proposed “without limitation”
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`construction is even broader than that found for a “process comprising” claim
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`limitation in the ’393 IPR under BRI).
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`C. Additional terms require construction
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`1. Starting Batch
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`Claim 1 includes the term “starting batch.” Ex. 1001, 17:51-63 (claim 1); see
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`also id., 17:64-18:37 (claims 2-7). This starting batch is further processed into the
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`pharmaceutical composition of claim 1. Id.; Ex. 2002, ¶117. The term “starting
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`batch” limits claim 1 to a specific material, used in the production of the claimed
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`pharmaceutical composition. Ex. 2002, ¶¶118-119, citing 21 C.F.R. §210.3 (April
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`1, 2007 ed.) (Ex. 2004), 133 (defining an in-process material as “any material
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`fabricated, compounded, blended, or derived by chemical reaction that is produced
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`for, and 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 ’066 patent claims in light of the ’066 patent
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`specification would have understood claim 1’s “starting batch” to be a specific
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`quantity of treprostinil that is intended to have uniform character and quality,
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`within specified limits, and is 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 the starting batch comprises a level of impurities that is higher than the
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`final batch of treprostinil API used in the formulation of the claimed
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`pharmaceutical composition. Ex. 2002, ¶¶121. Neither Phares nor Moriarty teaches
`
`this limitation. Ex. 2002, ¶122.
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`2. Stored, Storing, Storage
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`Dependent claim 6 recites the “pharmaceutical composition of claim 1,
`
`wherein the isolated salt is stored at ambient temperature.” Ex. 1001, 18:35-36.
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`Process claim 8 requires “storing” and “storage” of the produced treprostinil salt.
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`See Ex. 1001, 18:38-61 (claim 8); see also id., 18:62-66 (dependent claims 9-10).
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`The POSA would have understood these terms to require stability of the material
`
`being stored. Ex. 2002, ¶¶123-24. As the ’066 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, 4:57-63.
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`Thus, claims 8-10 require the treprostinil salt to be “stable at ambient
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`temperature,” and claims 6 and 8-10 further require that the material being stored
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`be stable upon storage such that the stored material maintains integrity for a
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`sufficient period of time to be useful for the claimed “pharmaceutical” purposes.
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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 ’066 patent claims in light of the ’066 patent specification would have
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`understood “stored,” “storage,” and “storing” to require that the stored material
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`possesses stability sufficient to allow manufacture and which maintains integrity
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`for a sufficient period of time to be useful for the preparation of a pharmaceutical
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`composition or a pharmaceutical product. Ex. 2002, ¶126.
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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
`
`nearly identical to Liquidia’s—during the ’066 patent’s examination. Indeed,
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`Liquidia leans hard on an IPR against U.S. Patent No. 8,497,393 (IPR2016-00006;
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`hereinafter “’393 IPR”) resulting in cancelation of the parent ’393 patent claims.
`
`Liquidia uses the same art, arguments, and even the same expert expressing the
`
`same opinions. E.g., Pet.19 (“[S]ince the claim limitations of the ’066 patent are
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`substantively similar to the invalidated ’393 patent, the ’066 patent should be
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`similarly declared invalid.”). Yet UT submitted the ’393 IPR art and arguments to
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`the examiner, who considered them yet allowed the ’066 patent in view of the
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`different claim limitations.
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`Liquidia clearly disagrees with the Office’s prior weighing and consideration
`
`of that evidence and argument, but Liquidia fails to identify any error the Office
`
`committed beyond merely disagreeing with the result. Indeed, Liquidia’s
`
`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
`
`arguments. Thus, the Board should exercise its discretion under 35 U.S.C. § 325(d)
`
`to deny institution against the ’066 patent.
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`A. The Advanced Bionics Two-Part Framework
`
`Under Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte
`
`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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`Case IPR2020-00769
`Patent 9,593,066
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`
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`Patent Owner Preliminary Response
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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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`4818-3909-1139.1
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`Case IPR2020-00769
`Patent 9,593,066
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`Patent Owner Preliminary Response
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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 ’066 patent. Ex. 2002, ¶¶57-62, 250. 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. 2006, 6902, considering Ex. 2006,
`Ex. 2006, 7108-13,
`Ex. 1008:
`6911, item B3: IPR2016-00006 petition
`IDS items A50 &
`WO 2005/007081
`A69, respectively
`(Phares)
`Ex. 2006, 12-14, considering Ex. 2006,
`7113, item D5: IPR2016-00006
`Ex. 2006, 6897-
`Ex. 1009:
`institution decision (redacted)
`6901: List of
`Moriarty 2004
`References cited by
`article
`Ex. 2006, 12-14, considering Ex. 2006,
`applicant and
`7113, item D1: IPR2016-00006
`considered by
`petitioner’s reply (redacted)
`examiner
`Ex. 2006, 12-14, considering Ex. 2006,
`6891-
`Ex. 2006,
`7113, item D2: IPR2016-00006,
`93, using Moriarty
`petitioner’s demonstratives
`in a rejection
`Ex. 2006, 3775-81, withdrawing
`rejection over Moriarty and Phares
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`
`
`
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`4818-3909-1139.1
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`Case IPR2020-00769
`Patent 9,593,066
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`
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`Patent Owner Preliminary Response
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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—these very 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 ’066 patent under
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`35 U.S.C. § 103(a)”).
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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 & Derrick Co. v. Sowa & Sons, 725 F.2d
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`1350, 1359 (Fed. Cir. 1984) (examiner presumed to have properly examined). UT
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`even referenced the competing experts’ views of the references in responding to a
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`rejection based on Moriarty and Phares. Ex. 2006, 3788-3794. Thus, the examiner
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`knew of, considered, and even applied the very information from the ’393 IPR that
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`4818-3909-1139.1
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`Case IPR2020-00769
`Patent 9,593,066
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`Patent Owner Preliminary Response
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`Liquidia asserts is dispositive here. Ex. 2002, ¶¶68-83. The purported
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`misunderstanding is simply Liquidia’s disagreement with the examiner’s
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`conclusion.
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`Moreover, the Office also previously considered the same or substantially
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`the same evidence beyond Moriarty and Phares that Liquidia relies on here as
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`shown in Table 2:
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`Ex. 2006, 6911: IDS
`item B3
`Ex. 2006, 6902: List of
`References cited by
`applicant and considered
`
`Table 2 – Additional Evidence Cited in Petition
`Representative Citation Representative Arguments Using
`Reference Considered in File
`History
`Ex. 2006, 6902, considering Ex.
`2006, 6911, item B3: IPR2016-00006
`petition
`Ex. 2006, 12-14, considering Ex.
`2006, 7113, item D5: institution
`decision (redacted)
`Ex. 2006, 12-14, considering Ex.
`2006, 7113, item D1: IPR2016-00006
`petitioner’s reply (redacted)
`Ex. 2006, 12-14, considering Ex.
`2006, 7113, item D2: IPR2016-00006
`petitioner’s demonstratives
`Ex. 2006, 6902, considering Ex.
`2006, 6911, item B3: IPR2016-00006
`petition
`Ex. 2006, 12-14, considering Ex.
`2006, 7113, item D5: institution
`decision (redacted)
`
`Patent issuing from
`parent application
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`14
`
`Liquidia’s
`Evidence
`
`Ex. 1002:
`Winkler
`declaration
`Ex. 1003:
`Winkler CV
`
`Ex. 1004,
`U.S.
`8,497,393
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`
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`4818-3909-1139.1
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`

`Case IPR2020-00769
`Patent 9,593,066
`
`
`
`Patent Owner Preliminary Response
`
`
`Table 2 – Additional Evidence Cited in Petition
`Representative Citation Representative Arguments Using
`Reference Considered in File
`History
`Ex. 2006, 12-14, considering Ex.
`2006, 7113, item D1: IPR2016-00006
`petitioner’s reply (redacted)
`Ex. 2006, 12-14, considering Ex.
`2006, 7113, item D2: IPR2016-00006
`petitioner’s demonstratives
`N/A
`
`decision entered after
`’066 patent issued
`
`Ex. 2006, 7108-13:
`IDS item A31
`Ex. 2006, 6898-6901:
`List of References cited
`by applicant and
`considered by examiner
`
`Ex. 2006, 6911: IDS item
`B6
`Ex. 2006, 6902: List of
`References cited by
`applicant and considered
`by examiner
`
`Ex. 2006, 6902, considering Ex.
`2006, 6911, item B3: IPR2016-00006
`petition
`Ex. 2006, 12-14, considering Ex.
`2006, 7113, item D5: institution
`decision (redacted)
`Ex. 2006, 12-14, considering Ex.
`2006, 7113, item D1: IPR2016-00006
`petitioner’s reply (redacted)
`Ex. 2006, 12-14, considering Ex.
`2006, 7113, item D2: IPR2016-00006
`petitioner’s demonstratives
`Ex. 2006, 6902, considering Ex.
`2006, 6911, item B3: IPR2016-00006
`petition
`Ex. 2006, 12-14, considering Ex.
`2006, 7113, item D5: institution
`decision (redacted)
`15
`
`Liquidia’s
`Evidence
`
`Ex. 1005,
`IPR2016-
`00006 final
`written
`decision
`Ex. 1007,
`U.S.
`6,765,117
`
`Ex. 1010,
`Wiberg
`textbook
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`
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`4818-3909-1139.1
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`

`Case IPR2020-00769
`Patent 9,593,066
`
`
`
`Patent Owner Preliminary Response
`
`
`Table 2 – Additional Evidence Cited in Petition
`Representative Citation Representative Arguments Using
`Reference Considered in File
`History
`Ex. 2006, 12-14, considering Ex.
`2006, 7113, item D1: IPR2016-00006
`petitioner’s reply (redacted)
`Ex. 2006, 12-14, considering Ex.
`2006, 7113, item D2: IPR2016-00006
`petitioner’s demonstratives
`
`Liquidia’s
`Evidence
`
`Ex. 1011,
`Schoffstall
`textbook
`
`Ex. 1012,
`Kawakami
`translation
`
`
`4818-3909-1139.1
`
`Ex. 2006, 3759-61, IDS
`item D28
`Ex. 2006, 12-14: List of
`References cited by
`applicant and considered
`by examiner
`Ex. 2006, 3746-51, 7047-
`52, same excerpt of
`Wiberg as submitted in
`Ex. 1010
`Ex. 2006, 6911, IDS item
`B5
`Ex. 2006, 6902, List of
`References cited by
`applicant and considered
`by examiner
`Ex. 2006, 3759-61, IDS
`item D26
`Ex. 2006, 12-14: List of
`References cited by
`applicant and considered
`by examiner
`Ex. 2006, 3735-39, 7042-
`46, same excerpt of
`Schoffstall as submitted
`in Ex. 1011
`Ex. 2006, 7108-13: IDS