`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`LIQUIDIA TECHNOLOGIES, INC.,
`
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`
`Patent Owner.
`
`
`_______________
`
`Case IPR2020-00770
`Patent 9,604,901
`_______________
`
`
`Patent Owner Preliminary Response Under
`35 U.S.C. § 313 and 37 C.F.R. § 42.107
`
`
`
`
`
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`Case IPR2020-00770
`Patent 9,604,901
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`Patent Owner Preliminary Response
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`TABLE OF CONTENTS
`
` 
`
` 
`
` 
`
`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. 
`
`2. 
`
`B. 
`C. 
`
`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
`
`Cases 
`American Hoist & Derrick Co. v. Sowa & Sons, 725 F.2d 1350, 1359 (Fed. Cir.
`
`1984) ............................................................................................................. 17, 30
`
`Biotec Biologische Naturverpackungen v. Biocorp., Inc., 249 F.3d 1341, 1353
`
`(Fed. Cir. 2001) .................................................................................................... 67
`
`Graham v. John Deere Co., 383 U.S. 1, 17 (1966) .......................................... 45, 59
`
`In re Cyclobenzaprine Hydrochloride, 676 F.3d 1063 (Fed. Cir. 2012) ................. 72
`
`In re Huston, 308 F.3d 1267, 1279 (Fed. Cir. 2002) ............................................... 23
`
`In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995) ............................................. 72, 73, 74
`
`KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007) ......................................... 68
`
`Monolithic Power Sys., Inc. v. O2 Micro Int'l Ltd., 558 F.3d 1341, 1350 (Fed. Cir.
`
`2009) .................................................................................................................... 28
`
`Motionless Keyboard Co. v. Microsoft Corp., 486 F.3d 1376, 1385 (Fed. Cir. 2007)
`
` .............................................................................................................................. 36
`
`Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1577-78 (Fed. Cir. 1987) .... 69
`
`Par Pharm., Inc. v. Twi Pharms., Inc., 773 F.3d 1186, 1195 (Fed. Cir. 2014) 34, 40,
`
`70
`
`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
`
`Süd-Chemie Inc. v. Multisorb Technologies, 554 F.3d 1001 (Fed. Cir. 2009) ........ 74
`
`Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1363–64 (Fed. Cir.
`
`2008) .................................................................................................................... 32
`
`United States v. Adams, 383 U.S. 39 (1966) ....................................................... 7, 37
`
`Statutes 
`35 U.S.C. § 103 ................................................................................................. 44, 59
`
`35 U.S.C. § 312(a)(3) ............................................................................................... 28
`
`35 U.S.C. § 314(a) ..................................................................................................... 6
`
`35 U.S.C. § 325(d) ................................................................................................... 13
`
`35 U.S.C. §316 ......................................................................................................... 72
`
`35 U.S.C. §316(e) ...................................................................................................... 8
`
`Other Authorities 
`Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH ....... passim
`
`Becton, Dickinson & Co. v. Baxter Int’l, IPR2018-01741, Paper 8, 13-14 (2019) ... 8
`
`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
`
`(2020) (precedential) ............................................................................................ 24
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`Johns Manville Corp. v. Knauf Insulation, Inc., IPR2018-00827, Paper 9, 10-11
`
`(2018) (informative) ............................................................................................. 66
`
`Puma v. Nike, IPR2019-01042, Paper 10 (informative) ............................. 14, 16, 29
`
`Rules 
`37 C.F.R. § 42.104(b)(3) ............................................................................................ 8
`
`37 C.F.R. § 42.65(a) ................................................................................................. 67
`
`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
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`Intentionally left blank
`
`Declaration of Rodolfo Pinal, Ph.D.
`
`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
`
`Intentionally left blank
`
`Complete Prosecution History of U.S. Patent No. 9,604,901
`
`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
`
`2012
`
`Intentionally left blank
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`
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`Exhibit No
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`2013
`
`2014
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`2015
`
`2016
`
`Description
`Comparing IPR2020-00770 EX1002 to the Petition in IPR2020-
`00770
`
`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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`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 1-9 (“Challenged Claims”) of U.S. Patent No. 9,604,901 (“the ’901
`
`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
`
`Office’s prior reasoning and conclusions regarding this art and arguments.
`
`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
`
`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
`
`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
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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
`
`pharmaceutical batch, a method of preparing the product, or a method of preparing
`
`the batch.1 Ex. 1001, 12; Ex. 2002, ¶¶54-56. Treprostinil is the active ingredient in
`
`three Food and Drug Administration-approved drugs: Remodulin® (treprostinil)
`
`Injection, Tyvaso® (treprostinil) Inhalation Solution, and Orenitram® (treprostinil)
`
`Extended-Release Tablets.
`
`The ’901 patent includes nine claims. Claims 1 and 2 define a
`
`pharmaceutical batch, claims 3-5 define a pharmaceutical product made from the
`
`pharmaceutical batch of claim 1, claims 6 and 7 define a method of preparing a
`
`pharmaceutical product, and claims 8 and 9 define a method of preparing a
`
`pharmaceutical batch.
`
`Claim 1 defines a pharmaceutical batch of treprostinil or a treprostinil salt
`
`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
`
`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
`
`salt with an acid to form treprostinil), where the pharmaceutical batch contains at
`
`least 2.9 grams of treprostinil or its salt. Ex. 1001, 12; Ex. 2002, ¶54. Claim 2
`
`requires that claim 1’s pharmaceutical batch be dried under vacuum. Ex. 1001, 12;
`
`Ex. 2002, ¶55. Claims 3-5 define a pharmaceutical product comprising a
`
`therapeutically effective amount of treprostinil, a salt of treprostinil, and a
`
`diethanolamine treprostinil salt, respectively, from the pharmaceutical batch of
`
`claims 1. Ex. 1001, 12.
`
`Claims 6 and 7 define a method of preparing a pharmaceutical product from
`
`the pharmaceutical batch of claim 1, requiring storing the pharmaceutical batch
`
`comprising the treprostinil salt at ambient temperature, then preparing the
`
`pharmaceutical product from the pharmaceutical batch after storage (claim 6).
`
`Ex. 1001, 12. Claim 7 further requires the treprostinil salt be the diethanolamine
`
`salt. Id. Claim 8 defines a method of preparing a pharmaceutical batch as in
`
`claim 1 that involves the formation and isolation of a salt of treprostinil. Id.
`
`Claim 9 depends further requires the treprostinil salt be the diethanolamine salt. Id.
`
`The Petition states “the ’901 patent discloses a process for the preparation of
`
`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
`
`batches and methods of making them, and pharmaceutical products and methods of
`
`making them, including a storage step. A specification may disclose more than one
`
`distinct invention, yet Liquidia discusses the wrong invention, ignoring disclosure
`
`of batch production and the advantages of the disclosed methods over the previous
`
`method, including a better final product using less solvent and labor. Ex. 1001, 10-
`
`12. As discussed more below, Liquidia discusses the wrong invention in apparently
`
`treating this IPR as though it is merely a replay of a previous IPR (IPR2016-00006;
`
`hereinafter “’393 IPR”) on a different patent (U.S. Patent No. 8,497,393;
`
`hereinafter “’393 patent”) with claims directed to only certain products. It does not
`
`work that way: Liquidia must prove the unpatentability of the Challenged Claims
`
`and cannot do so by ignoring and blurring the differences.
`
`For example, Liquidia fails to identify a ’393 patent claim with limitations
`
`like those in claim 1 requiring a pharmaceutical batch or any method of making
`
`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.
`
`Liquidia’s misapprehension of the invention of the Challenged Claims is
`
`highlighted by, in addressing claim 6, asserting that “The ’901 patent does not
`
`teach storing the resulting treprostinil salt at ambient temperature; it only
`
`specifically discloses this for a ‘crude’ salt. ([Ex. 1001] at col. 17:4-8.).” Pet.13,
`
`43.2 The disclosure in question states:
`
`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
`
`describe or enable this limitation of claim 6.” Pet.67-68. The Board disfavors
`
`attempts to insinuate improper patentability arguments into the limited scope for
`
`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:
`
`prepare a pharmaceutical product (treprostinil) from a stored batch of treprostinil
`
`salt from claim 1, which includes impurities in the pharmaceutical batch.3 Because
`
`Liquidia fails to identify, much less address, the invention of the Challenged
`
`Claims, the Petition fails to prove the unpatentability of any one of these claims.
`
`35 U.S.C. § 314(a).
`
` 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
`
`banc); Ex. 2002, ¶¶45, 102-05. A claim must be construed in light of the
`
`
`
`3 The quoted paragraph begins with the phrase “additional advantages” and forms
`
`part of the discussion of advantages established by the batch-scale comparative
`
`example 6 (“Comparison of the Former [Moriarty] Process and a Working
`
`Example of the Process According to the Present Invention”) between the claimed
`
`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
`
`given their plain and ordinary meaning in December 2007. Pet.18-19. Yet Liquidia
`
`implicitly construes the limitations to equate them to the ’393 patent claims and the
`
`prior art, inviting error by using “composition” rather than “pharmaceutical batch”
`
`and “pharmaceutical product”, and ascribing little weight to terms like “storage”
`
`and “pharmaceutical”. Pet.8-9, 17, 33, 41, 44, 65-66, and 69.
`
`Liquidia also mis-identifies all of the Challenged Claims as product-by-
`
`process claims. Pet.8, 24. Yet Liquidia fails to explain how method claims 6-9 can
`
`be product-by-process claims. Liquidia also fails to identify—much less address—
`
`the structural and functional differences that the process imparts to the claimed
`
`pharmaceutical batch and pharmaceutical product other than to say they would be
`
`inherent because the process is the same. Pet.19; but see 37 C.F.R. § 42.104(b)(3)
`
`(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
`
`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
`
`from the resulting structural and functional characteristics.
`
`A. Pharmaceutical Batch
`
`Liquidia discusses the pharmaceutical batch limitation in terms of
`
`“compounds” in the prior art rather than “pharmaceutical batches” to blur the
`
`differences between the Challenged Claims and the ’393 patent claims. Pet.29-32.
`
`Yet claim 1 requires a “pharmaceutical batch,” which is incorporated into claims 2-
`
`9 as well. Ex. 1001, 12. This pharmaceutical batch is defined, in part, as
`
`“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
`
`and 7. Id.; Ex. 2002, ¶¶54-56. The pharmaceutical industry is tightly regulated, and
`
`the POSA (who would have been experienced in drug production, see § VII.B
`
`below) would have understood a “pharmaceutical batch” with impurities yet
`
`suitable for preparation into a pharmaceutical product in an art-specific way as an
`
`in-process material. Ex. 2002, ¶119, citing 21 C.F.R. §210.3 (April 1, 2007 ed.)
`
`(Ex. 2004), 133 (defining an in-process material as “any material fabricated,
`
`compounded, blended, or derived by chemical reaction that is produced 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
`
`specific quantity of a drug or other material that is intended to have uniform
`
`character and quality, within specified limits, and is produced according to a single
`
`manufacturing order during the same cycle of manufacture.” Ex. 2004, 133 and
`
`also 134 (defining the word “lot” to mean “a batch, or a specific identified portion
`
`of a batch, having uniform character and quality within specified limits”); Ex.
`
`2002, ¶120.
`
`The POSA viewing the ’901 patent claims in light of the ’901 patent
`
`specification would have understood claim 1’s “pharmaceutical batch” to be a
`
`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
`
`method by which it is produced. Ex. 2002, ¶121. Neither Phares nor Moriarty
`
`teaches this limitation. Ex. 2002, ¶122.
`
`B. “Pharmaceutical Product”
`
`Liquidia uses “product” and “pharmaceutical product” interchangeably when
`
`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,”
`
`which is an in-process intermediate, and a “pharmaceutical product,” which is not.
`
`Ex. 1001, 12, compare “the product of step (a)” in claims 1 and 8 with “a
`
`pharmaceutical product” in claim 6. The POSA would have understood
`
`“pharmaceutical product” to mean a chemical composition suitable for
`
`pharmaceutical use. Ex. 2002, ¶¶105-16.
`
`C. Storing, Storage
`
`Claims 6 and 7 require “storing a pharmaceutical batch” and “preparing a
`
`pharmaceutical product from the pharmaceutical batch after storage.” Ex. 1001, 12.
`
`The POSA would have understood these terms to require stability of the material
`
`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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`Case IPR2020-00770
`Patent 9,604,901
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`Patent Owner Preliminary Response
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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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`Case IPR2020-00770
`Patent 9,604,901
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`Patent Owner Preliminary Response
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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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`Case IPR2020-00770
`Patent 9,604,901
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`Patent Owner Preliminary Response
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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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`Case IPR2020-00770
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`Patent Owner Preliminary Response
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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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`Case IPR2020-00770
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`Patent Owner Preliminary Response
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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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`
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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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`Case IPR2020-00770
`Patent 9,604,901
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`Patent Owner Preliminary Response
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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