`Tel: 571-272-7822
`
`Paper 18
`Entered: August 11, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`LIQUIDIA TECHNOLOGIES,INC.,
`Petitioner,
`
`Vv.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
`
`IPR2021-00406
`Patent 10,716,793 B2
`
`Before ERICA A. FRANKLIN, CHRISTOPHER M. KAISER,
`and DAVID COTTA,Administrative Patent Judges.
`
`KAISER, Administrative Patent Judge.
`
`DECISION
`Granting Institution ofInter Partes Review
`35 U.S.C. § 314
`
`
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`IPR2021-00406
`Patent 10,716,793 B2
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`A. Background
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`INTRODUCTION
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`Liquidia Technologies,Inc. (“Petitioner”) filed a Petition (Paper 2,
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`“Pet.”) requesting an inter partes review of claims 1-8 of U.S. Patent
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`No. 10,716,793 B2 (Ex. 1001, “the ’793 patent”). United Therapeutics
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`Corporation (“Patent Owner’) filed a Preliminary Response. Paper 13
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`(“Prelim. Resp.”).
`
`Wehaveauthority to determine whetherto institute an inter partes
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`review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2020). The
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`standard for instituting an inter partes review is set forth in 35 U.S.C.
`
`§ 314(a), which provides that an inter partes review may notbeinstituted
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`unless “there is a reasonable likelihood that the petitioner would prevail with
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`respectto at least 1 of the claims challengedin the petition.”
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`After considering the Petition, the Preliminary Response, and the
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`evidenceof record, we determinethat Petitioner has demonstrated a
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`reasonable likelihood that it would prevail with respect to at least one
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`challenged claim. Accordingly, we institute an inter partes review ofall
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`challenged claimsonall asserted grounds.
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`B. Related Matters
`
`The parties identify United Therapeutics Corporation v. Liquidia
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`Technologies, Inc., 1:20-cv-00755-RGA(D. Del.) (“the District Court
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`proceeding”), as a related matter. Pet. 1; Paper3, 1.
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`C. The Asserted Grounds of Unpatentability
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`Petitioner contends that claims 1-8 of the ’793 patent are unpatentable
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`Claim(s) Challenged|35 U.S.C. §? Reference(s)/Basis
`
`103
`°212 patent,? Voswinckel JESC,*
`Voswinckel JAHA°
`
`based on the following grounds(Pet. 30-68):!
`
`
`
`
`
`
`
`
`
`' Petitioner also relies on declarations from Nicholas Hill, M.D., and Igor
`Gonda, Ph.D. Ex. 1002; Ex. 1004.
`2 The °793 patent claimsa priority date of May 15, 2006, and Petitioner
`“assumesthe relevant priority date ... is May 15, 2006.” Pet. 12; Ex. 1001,
`code (60). Accordingly, patentability is governed by the versions of
`35 U.S.C. §§ 102 and 103 preceding the amendmentsin the Leahy-Smith
`America Invents Act (“AIA”), Pub. L. No. 112-29, 125 Stat. 284 (2011).
`3 US 6,521,212 B1, issued Feb. 18, 2003 (Ex. 1006) (alleged to be priorart
`under 35 U.S.C. §§ 102(a), (b), (e)).
`4 Voswinckel, R., et al., Inhaled treprostinil is a potent pulmonary
`vasodilator in severe pulmonary hypertension, 25 EUROPEAN HEARTJ. 22
`(2004) (Ex. 1007) (alleged to be prior art under 35 U.S.C. § 102(b)).
`> Robert Voswinckel, et al., Inhaled Treprostinil Sodium (TRE) Forthe
`Treatment ofPulmonary Hypertension, in Abstracts from the 2004 Scientific
`Sessions of the American Heart Association, 110 CIRCULATION III-295 (Oct.
`26, 2004) (Ex. 1008) (alleged to be prior art under 35 U.S.C. § 102(b)).
`6 Hossein Ardeschir Ghofrani, et al., Neue Therapieoptionen in der
`Behandlung der pulmonalarteriellen Hypertonie, 30 HERZ 296-302 (June
`2005) (Ex. 1010) (alleged to be prior art under 35 U.S.C. § 102(a)). We rely
`on the English translation that follows the Germanoriginalarticle as part of
`Ex. 1010.
`
`7 Robert Voswinckel,et al., Inhaled Treprostinilfor Treatment ofChronic
`Pulmonary Arterial Hypertension, 144 ANNALS OF INTERNAL MEDICINE
`
`3
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`
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`IPR2021-00406
`Patent 10,716,793 B2
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`Claim(s) Challenged|35 U.S.C. §? Reference(s)/Basis
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`Voswinckel 2006, °212 patent
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`
`
`
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`D. The ’793 Patent
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`The ’793 patent, titled ‘““Treprostinil Administration by Inhalation,”
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`issued on July 21, 2020. Ex. 1001, codes (45), (54). The patent “relates to
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`methodsand kits for therapeutic treatment and, more particularly, to
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`therapeutic methods involving administering treprostinil using a metered
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`dose inhaler andrelated kits.” Jd. at 1:20-23.
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`Treprostinil “is a prostacyclin analogue” that may be usedto treat
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`pulmonary hypertension. Jd. at 5:37-41. According to the ’793 patent, it
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`was previously known to administer treprostinil by intravenous,
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`subcutaneous,or inhalation routes to treat any of several conditions,
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`including pulmonary hypertension. Jd. at 5:42-58.
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`The ’793 patent relates to the administration of treprostinil in high
`
`concentrations over a short inhalation time. Jd. at 16:61-63, 17:44—46. This
`method of administration is described as reducing pulmonary vascular
`|
`resistance and pulmonary artery pressure, as well as increasing cardiac
`
`output. Jd. at 16:32—42,Fig. 10.
`
`E. Illustrative Claim
`
`Claims 1-8 of the ’793 patent are challenged. Claim 1 is independent
`
`andillustrative; it recites:
`
`1. A methodoftreating pulmonary hypertension
`comprising administering by inhalation to a human
`suffering from pulmonary hypertension a
`therapeutically effective single event dose of a
`
`149-50 (January 2006) (Ex. 1009) (alleged to be prior art under 35 U.S.C.
`§ 102(a)).
`
`
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`IPR2021-00406
`Patent 10,716,793 B2
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`formulation comprising treprostinil or a
`pharmaceutically acceptable salt thereof with an
`inhalation device, wherein the therapeutically
`effective single event dose comprises from 15
`microgramsto 90 microgramsoftreprostinil or a
`pharmaceutically acceptable salt thereof delivered
`in 1 to 3 breaths.
`
`Ex. 1001, 18:23-31.
`
`A. Claim Construction
`
`ANALYSIS
`
`In an inter partes review, we construe a claim in an unexpired patent
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`“in accordance with the ordinary and customary meaning of such claim as
`
`understood by oneof ordinary skill in the art and the prosecution history
`
`pertaining to the patent.” 37 C.F.R. § 42.100(b) (2020). “[T]he ordinary
`
`and customary meaning of a claim term is the meaning that the term would
`
`have to a person ofordinary skill in the art in question at the time of the
`
`invention.” Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005)
`
`(en banc). “Importantly, the person of ordinary skill in the art is deemed to
`read the claim term notonly in the context of the particular claim in which
`the disputed term appears, but in the context of the entire patent, including
`
`the specification.” Id.
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`Neither party presents any terms for construction. Pet. 12—13; Prelim.
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`Resp. 1-56. Accordingly, we determine that no express construction of any
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`claim term is necessary in order to decide whetherto institute trial. Nidec
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`Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017
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`(Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d
`
`795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construedthat are in
`
`controversy, and only to the extent necessary to resolve the controversy.”)).
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`B. Discretionary Denial
`Patent Ownerargues that we should exercise discretion to deny
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`institution, either under 35 U.S.C. § 314(a) or under 35 U.S.C. § 325(d).
`
`Prelim. Resp. 9-26. Petitioner disagrees. Pet. 4-11.
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`I=35 US.C. § 314(a) Discretion
`
`Institution of inter partes review is discretionary:
`
`The Director may not authorize an inter partes review to be
`instituted unless the Director determines that the information
`presented in the petition filed under section 311 and any
`response filed under section 313 showsthatthere is a
`reasonable likelihood that the petitioner would prevail with
`respectto at least 1 of the claims challenged in the petition.
`
`35 U.S.C. § 314(a). This language provides the Director with discretion to
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`denyinstitution of a petition. See Cuozzo Speed Techs., LLC v. Lee, 1368.
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`Ct. 2131, 2140 (2016) (“[T]he agency’s decision to deny a petition is a
`
`matter committed to the Patent Office’s discretion.”); Patent Trial and
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`Appeal Board Consolidated Trial Practice Guide (“CTPG”) at 55 (November
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`2019), available at https://www.uspto.gov/TrialPracticeGuideConsolidated.
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`The Director has delegated his authority under § 314(a) to the Board. 37
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`C.F.R. § 42.4(a) (“The Board institutes the trial on behalf of the Director.”).
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`The Leahy-Smith America Invents Act was “designed to establish a
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`moreefficient and streamlined patent system that will improve patent quality
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`and limit unnecessary and counterproductivelitigation costs.” H.R. Rep.
`
`No. 112-98, pt. 1, at 40 (2011), 2011 U.S.C.C.A.N. 67, 69 (reviews were
`
`meantto be “quick and cost effective alternativesto litigation’’); see also
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`S. Rep. No. 110-259, at 20 (2008); CTPG 56. The Board recognized these
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`goals, but also “recognize[d] the potential for abuse of the review process by
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`repeated attacks on patents.” General Plastic Co., Ltd. v. Canon Kabushiki
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`Kaisha, IPR2016-01357, Paper 19, 16-17 (PTAB Sept. 6, 2017)
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`(precedential).
`
`In NHK Spring Co., Ltd. v. Intri-Plex Technologies, Inc., IPR2018-
`
`00752, Paper 8 (PTAB Sept. 12, 2018) (precedential), the Board determined
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`that the advancedstate of a parallel proceeding is an additional factor
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`weighing in favor of denying institution under 35 U.S.C. § 314(a). Jd. at 19—
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`20. In Apple Inc. v. Fintiv, Inc., IPR2020-00019 (“Fintiv”), Paper 11, the
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`Board articulated a list of factors that we consider in determining whetherto
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`exercise discretion to deny institution based on an advancedstage of a
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`parallel proceeding:
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`1. whether the court granted a stay or evidence exists that one
`may be granted if a proceedingis instituted;
`2. proximity of the court’s trial date to the Board’s projected
`statutory deadline for a final written decision;
`3. investment in the parallel proceeding by the court and the
`parties;
`4. overlap betweenissuesraised in the petition andin theparallel
`proceeding;
`5. whether the petitioner and the defendant
`proceeding are the sameparty; and
`6. other circumstances that
`impact
`discretion, including the merits.
`Fintiv, Paper 11, at 5-6. “These factors relate to whetherefficiency,
`
`the Board’s exercise of
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`in the parallel
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`fairness, and the merits support the exercise of authority to deny institution
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`in view ofan earlier trial date in the parallel proceeding.” Jd In evaluating
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`these factors, we take “a holistic view of whether efficiency and integrity of
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`the system are best served by denyingorinstituting review.” Jd. (citing
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`CTPG 58).
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`Patent Ownerhasasserted the ’793 patent against Petitioner in the
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`District Court proceeding. Pet. 1; Paper 3, 1. Given the status of the District
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`Court proceeding, Patent Owner argues that we should exercise discretion
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`under Fintiv to deny institution. Prelim. Resp. 9-26. Wediscuss the Fintiv
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`factors below.
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`a. First Fintiv Factor: Existence or Likelihood of Stay
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`Patent Ownercontendsthat this factor weighs in favor of denial.
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`Prelim. Resp. 13—14. Patent Owner contendsthat Petitioner has not
`
`requested a stay of the District Court proceeding, and there is no reason to
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`believe that a stay would be granted if it were requested. Jd.
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`In support of
`
`this assertion, Patent Ownerarguesthat there are patents at issue in the _
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`District Court proceeding on which the Board has deniedinstitution of inter
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`partes review, leaving the District Court as the only forum in which the
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`invalidity of those patents may be adjudicated. Jd. Petitioner does not
`
`address this Fintiv factor. Pet. 4-6.
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`With regard to the first Fintiv factor, Petitioner has not requested a
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`stay of the District Court proceeding, and if such a request is subsequently
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`made, we decline to speculate on the likelihood of a stay being granted. For
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`these reasons, we determinethat this factor is neutral.
`
`b. Second Fintiv Factor: Proximity of Anticipated Trial
`Date and Statutory Deadline for Final Written
`Decision
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`Patent Ownercontendsthis factor also weighs in favor of denial,
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`because the presently scheduledtrial in the District Court proceeding—a
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`three-daytrial beginning March 28, 2022—will occur roughly four and a
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`half months® before the projected due date for the Board’s Final Written
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`Decision on August 17, 2022. Prelim. Resp. 14-16. Petitioner does not
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`address this factor. Pet. 4-6.
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`Based onthe current trial schedule, there is a relatively high
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`likelihood that the District Court will reach its invalidity determination
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`before we issue our Final Written Decision resolving Petitioner’s
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`unpatentability allegations. Thus, we determine that the second Fintiv factor
`
`weighsin favor of exercising our discretion to deny institution under
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`§ 314(a).
`
`c. Third Fintiv Factor: Investment in Parallel Proceeding
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`Underthis factor, we first consider Petitioner’s timing in filing the
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`Petition. Ifa petitioner, “faced with the prospect of a loomingtrial date,
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`waits until the district court trial has progressed significantly before filing a
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`petition,” that decision “may impose unfair costs to a patent owner.”
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`Fintiv, Paper 11, at 11. On the other hand,“[i]f the evidence showsthat the
`petitionerfiled the petition expeditiously, such as promptly after becoming
`
`awareofthe claims being asserted, this fact has weighed against exercising
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`the authority to deny institution.” Id.
`Petitioner asserts that it filed this Petition “within three months of
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`receiving [Patent Owner’s] infringement contentions.” Pet. 4. Patent Owner
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`arguesthat this three-month delay “can hardly be referred to as
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`§ Patent Ownerdescribes the March 2022trial as scheduled for “six months
`before the Board’s expected statutory deadline.” Prelim. Resp. 15 (emphasis
`in original). The actual time between the conclusion of the scheduled
`District Court trial, i.e., March 30, 2022, and the latest date on which the
`Board’s Final Written Decision could be due is four months and 18 days.
`Accordingly, we analyze this issue based on that anticipated time frame.
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`‘expeditious[]’ or ‘diligent[].’” Prelim. Resp. 18 (quoting Fintiv, Paper 11,
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`11-12 (alterations in original)). Beyond these bare allegations, neither party
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`explains why the facts here suggest either expeditiousness or lack thereof.
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`Pet. 4; Prelim. Resp. 18. We find no unreasonable delay in Petitioner’s
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`filing.
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`Second, weconsider “the amount and type of work already completed
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`in the parallel litigation by the court and the parties at the time of the
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`institution decision.” Fintiv, Paper 11, at 9. “Specifically, if, at the time of
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`the institution decision, the district court has issued substantive orders
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`related to the patentat issue in the petition, this fact favors denial.” Jd. at 9—
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`10.
`
`Petitioner contendsthis factor weighs in favorofinstitution, because
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`“the parties have just begun claim construction proceedingsin the district
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`court litigation, have not yet taken any depositions, and have conducted only
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`the initial minimum required discovery.” Pet. 5. Patent Owner arguesthat
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`this factor weighs against institution because “a claim construction hearing
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`is currently scheduled for June 4, 2021,” and because “the court [likely] will
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`also enter a Claim Construction Order in the case prior to the Board’s
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`decision on institution.” Prelim. Resp. 17. In addition, Patent Ownernotes
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`that the District Court already has entered an order on a substantiveissue,
`
`namely an order denying Patent Owner’s motion to dismiss Petitioner’s
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`invalidity counterclaims due to assignor estoppel. Jd. (citing Ex. 1014).
`
`Although we appreciate that a Markman hearing has been held, we
`
`find no evidencein the record that any substantive determinations on
`
`validity issues have been madein the District Court proceeding. In some
`
`respects, the present circumstancesare similar to those in Sand Revolution
`
`10
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`II, LLC v. Continental Intermodal Group-Trucking LLC, IPR2019-01393,
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`Paper 24 (PTAB June 16, 2020) (informative) (Sand Revolution”), in which,
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`as here, the parties exchanged preliminary infringement and invalidity
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`contentions, and the district court conducted a Markman hearing. Id. at 10.
`
`The Sand Revolution panel found that,“aside from the district court’s
`
`Markman Order, muchofthe district court’s investmentrelates to ancillary
`
`matters untethered to the validity issue itself’ and “much work remains in
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`the district court case as it relates to invalidity: fact discovery is still
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`ongoing, expert reports are not yet due, and substantive motion practice is
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`yet to come.” Jd. at 10-11. One difference between the present case and
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`Sand Revolutionis that neither party here has directed us to the entry of a
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`Markmanorder by the District Court. In fact, as Patent Owner admits, “the
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`parties to the Delaware Litigation are not disputing any claim termsat issue
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`in the ’793 patent,” so even the entry of such an order would not materially
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`advancethe resolution of any invalidity issue related to the ’793 patent.
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`Prelim. Resp. 17. Moreover, here, as in Sand Revolution, much work
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`remains to be donein thedistrict court. Fact discovery will continue until
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`September 17, 2021, and dispositive motions will not be filed until
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`November 2, 2021. Jd. at 11.
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`On balance, given the timeliness of the Petition and the level of
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`investment of time and resourcesin the District Court proceeding, coupled
`
`with the absence of any substantive determinations on validity issues by the
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`court, we find that this factor weighs against exercising our discretion to
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`deny institution under § 314(a).
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`11
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`d. Fourth Fintiv Factor: Overlap Between Issues Raised
`in Petition and in Parallel Proceeding
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`Patent Ownercontendsthis factor favors denial ofinstitution, because
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`“fejach of the asserted claims in the Delaware Litigation is the subject ofthis
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`Petition,” and especially because both proceedings address claim 1 of the
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`°793 patent, the only independent claim. Prelim. Resp. 21. Patent Owner
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`also argues that this factor favors denial of institution because “[t]hree ofthe
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`five references in the Petition are also asserted in Liquidia’s Preliminary
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`Invalidity Contentions in the Delaware Litigation.” Jd. at 21-22. Petitioner
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`arguesthat this factor favors institution because three of the eight claims
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`challenged here are not challenged in the District Court proceeding. Pet. 5.
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`Wenotefirst that neither party cites any evidence in support ofits
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`allegations regarding overlapping issues. Petitioner states that claims are
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`challenged here that are not challenged in the District Court proceeding but
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`cites no support at all for this position. Jd. Patent Owner, meanwhile,cites
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`exhibits that provide the dates of service of the parties’ preliminary
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`infringement and invalidity contentions but does notdirect us to the
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`invalidity contentions themselves. Prelim. Resp. 12 (citing Exs. 2022—
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`2023). In arguing that “[t]here is substantial overlap in theissues relating to
`
`the present matter and the Delaware Litigation,” Patent Ownercites no
`
`sources at all. Jd. at 21-22. Given the lack of evidence supporting either
`
`party’s position, we cannot determine whetherthere is substantial overlap—
`or, indeed, any overlap at all—between the unpatentability issues raised here
`
`and the invalidity issues raised in the District Court proceeding.
`
`If we ignore the lack of evidence and take the parties’ allegations at
`
`face value, there seemsto be at least some overlap betweenthe issues raised
`
`here and the issues raised in the District Court proceeding. But, by Patent
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`12
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`Owner’s own admission, there are claims challenged here that are not
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`challenged in the parallel litigation, and there are prior-art references
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`asserted here that are not asserted in the District Court proceeding. Jd. The
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`overlap is, at most, not total, and it may or may not be substantial.
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`In addition to the arguments regarding the overlap of issues, Petitioner
`
`argues that Patent Ownerhas raised assignor estoppel in the District Court
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`proceeding as a wayto block Petitioner’s assertion of invalidity, which may
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`preclude Petitioner from litigating these issues in any forum other than
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`before the Board. Pet. 5. In response, Patent Ownerstipulates that, if we
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`exercise discretion under § 314(a) to deny institution, Patent Owner will not
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`raise its assignor estoppel arguments in the District Court proceeding.
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`Paper 16, 1-2.
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`Given the lack of evidence supporting either party’s position on the
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`overlap of issues, and given that, even according to the parties’ unsupported
`
`arguments, there may not be substantial overlap of issues, this stipulation
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`does not affect our analysis of the fourth Fintiv factor. There are three
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`possibilities to consider. First, Patent Owner may declineto raise its
`
`assignor estoppel arguments. In that case, Petitioner would continueto press
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`whateverinvalidity arguments it has raised in the District Court proceeding,
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`but we cannot determine on the present record how substantial the overlapis
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`between those arguments and the unpatentability arguments raised here.
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`Evenif the District Court makesits decision before we issue a Final Written
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`Decision, the District Court’s decision will not reach every issue that
`
`Petitioner raises here. Second, Patent Owner maycontinueto press its
`
`assignor estoppel argumentandnotprevail, leaving Petitioner free to raise
`
`the same invalidity arguments. Again, we cannot determine whetherand to
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`13
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`what extent those arguments overlap with Petitioner’s unpatentability
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`arguments. Finally, Patent Owner may prevail onits assignor estoppel
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`argument. In that case, Petitioner would be barred from raising any
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`invalidity arguments in the District Court proceeding, and the District Court
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`would then have no opportunity to rule on invalidity, eliminating any
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`overlap with the present proceeding. Patent Owner’s stipulation eliminates
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`the possibility that Petitioner will not be able to challenge validity before the
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`District Court, but cannot change the fact that the District Court’s decision
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`will not reach every issue that Petitioner raises here.
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`Thus, wefind that there may be someoverlap of issues betweenthis
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`proceeding andthe District Court proceeding, but this overlap (1) is nottotal
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`either in terms of claims challengedor in terms of references asserted, and
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`(2) may or maynot be substantial. Moreover, if we institute, and thus Patent
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`Owner’s stipulation does not take effect, the overlap may disappear
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`altogether, depending on the outcome of Patent Owner’s assignor estoppel
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`argument. Accordingly, we findthat this factor weighs against exercising
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`discretion to denyinstitution.
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`e. Fifth Fintiv Factor: Whether Petitioner and Parallel
`Proceeding Defendant Are Same
`The parties do not dispute that the same parties involvedin the present
`
`proceeding are also involved in the District Court proceeding. Pet. 4-6;
`Prelim. Resp. 23-24. Thus, this factor weighs in favor of exercising our
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`discretion to deny institution under § 314(a).
`
`14
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`f. Sixth Fintiv Factor: Other Circumstances (Including
`Merits)
`Patent Ownerarguesthat this factor favors denying institution,
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`because Petitioner“has not set forth ‘sufficiently strong’ proposed grounds
`
`that would support a grantof institution. Prelim. Resp. 24—25. Petitioner
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`argues to the contrary that “the merits of this Petition are strong,” both
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`because the Board previously instituted review based onearlier petitions
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`challenging related patents, and because the present Petition asserts a
`multiplicity of grounds challenging each claim. Pet, 5-6.
`Weare not persuadedbyeither party’s argument. As discussed
`below, we determinethat Petitioner’s case is strong enough to warrant
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`institution of inter partes review, contradicting the basis of Patent Owner’s
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`argumenton this factor. Petitioner’s argumentthat the present petition is
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`unusually strong because the Board previously instituted review on other
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`petitions suffers from multiple defects. First, a petition that presents
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`arguments strong enoughto institute review is not necessarily a petition that
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`is so strong asto trigger the sixth Fintiv factor. Second, the two petitions on
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`which Petitioner’s argument rests both challenged patents other than the
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`793 patent challenged here. Third, the two petitions in question werefiled
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`by parties other than Petitioner. It is at best unclear why the Board’s
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`determination to institute review on petitions brought by oneparty
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`challenging certain claims in certain patents should mandate a determination
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`that the merits of the present Petition, brought by a different party and
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`challenging different claims of different patents, are so strong as to warrant
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`weighing this factor in Petitioner’s favor. As for Petitioner’s argument that
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`its assertion of multiple grounds to challenge each claim meansthe Petition
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`is strong, we are not persuadedthat the numberofasserted grounds of
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`unpatentability, as opposed to the evidentiary support for and persuasive
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`reasoning behind those grounds,is the proper basis on which to judge the
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`strength of a petition.
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`Because neither party presents a persuasive argument onthe sixth
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`Fintiv factor, we find that this factor is neutral with respect to exercising
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`discretion to deny institution.
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`g. Conclusion
`Becausethe analysis is fact-driven, no single factor is determinative
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`of whether we exercise our discretion to deny institution under 35 U.S.C.
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`§ 314(a).
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`Onthis record, after weighing all of the factors and taking a holistic
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`view, we determine that the facts in this case that weigh against exercising
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`discretion outweigh the facts that favor exercising discretion. Accordingly,
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`we determinethat the circumstances presented weigh against exercising our
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`discretion to deny institution under § 314(a).
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`35 US.C. § 325(d) Discretion
`2.
`Patent Ownerargues that we should exercise our discretion to deny
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`institution under 35 U.S.C. § 325(d). Prelim. Resp. 25—26. Petitioner
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`argues that we should not exercise such discretion. Pet. 6-11.
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`Section 325(d) provides that the Director mayelect not to institute a
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`proceeding if the challenge to the patent is based on matters previously
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`presented to the Office. 35 U.S.C. § 325(d) states, in pertinent part,
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`In determining whetherto institute or order a proceeding under
`this chapter, chapter 30, or chapter 31, the Director may take
`into account whether, and reject the petition or request because,
`the sameor substantially the same prior art or arguments
`previously were presented to the Office.
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`In deciding whether to exercise discretion to deny institution under
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`§ 325(d), we use a two-part framework, determining first “whether the same
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`or substantially the same art previously was presented to the Office or
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`whether the sameor substantially the same arguments previously were
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`presented to the Office,” and second,“if either condition offirst part of the
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`frameworkis satisfied, whether the petitioner has demonstrated that the
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`Office erred in a manner material to the patentability of challenged claims.”
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`Advanced Bionics, LLC v. MED-EL Elektromedizinische Gerdte GmbH,
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`IPR2019-01469, Paper 6, at 8 (PTAB Feb. 13, 2020) (precedential)
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`(“Advanced Bionics’’). To use this framework, we consider the factors set
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`forth in Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-
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`01586, Paper 8, at 17-18 (Dec. 15, 2017) (precedentialas to § IM.C.5,first
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`paragraph) (“Becton, Dickinson”). Specifically, we apply Becton, Dickinson
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`factors (a), (b), and (d) to determine whether the sameor substantially the
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`sameart or arguments previously were presented to the Office, and we apply
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`Becton, Dickinson factors(c), (e), and (f) to determine whetherPetitioner
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`has demonstrated a material error by the Office. Advanced Bionics, at 10.
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`Weconsider the relevant Becton, Dickinson factors below as part of the
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`Advanced Bionics framework.
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`a. Advanced Bionics Step One: Sameor Substantially
`the Same Prior Art or Arguments Previously
`Presented to the Office
`
`In the first step of the Advanced Bionics framework, we determine
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`whetherthe sameor substantially the sameprior art or arguments presented
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`here previously were presented to the Office. We do so by examiningthree
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`of the Becton, Dickinson factors: “(a) the similarities and material
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`differences betweenthe asserted art andthe priorart involved during
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`examination; (b) the cumulative nature of the asserted art and the priorart
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`evaluated during examination;” and “(d) the extent of the overlap between
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`the arguments made during examination and the mannerin which Petitioner
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`relies on the prior art or Patent Ownerdistinguishes the prior art.” Becton,
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`Dickinson, at 17-18; see Advanced Bionics, at 10.
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`Here, Petitioner admits that “[t]he art presented in this petition was
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`listed in [Patent Owner’s] Information Disclosure Statement.” Pet. 7.
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`“Previously presented art includes art .
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`.
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`. provided to the Office by an
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`applicant, such as on an Information Disclosure Statement (IDS), in the
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`prosecution history of the challenged patent.” Advanced Bionics, at 7-8.
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`Accordingly, all of the art asserted against the ’793 patent here previously
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`was presented to the Office.
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`Given this, we evaluate Becton, Dickinson factors (a) and (b) as
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`favoring a finding that the sameor substantially the same prior art presented
`
`here previously was presented to the Office. The art presented hereis not
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`only similar to someart that was before the Office during examination,itis
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`identical, and this identity meansthat there are no material differences
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`betweenthe art presented here and the art previously before the Office.
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`b. Advanced Bionics Step Two: Material Error by the
`Office Shown
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`Becausewefind that the same or substantially the samepriorart
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`presented here previously was presented to the Office, we proceed to the
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`secondstep of the Advanced Bionics framework and determine whether
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`Petitioner has demonstrated a material error by the Office. We do so by
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`examining the three remaining Becton, Dickinson factors: “(c) the extent to
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`whichthe asserted art was evaluated during examination, including whether
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`the prior art was thebasis for rejection;”“(e) whether Petitioner has pointed
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`out sufficiently how the Examinererredin its evaluation of the asserted prior
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`art; and (f) the extent to which additional evidence and facts presented in the
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`Petition warrant reconsideration of the prior art or arguments.” Becton,
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`Dickinson, at 17-18; see Advanced Bionics, at 10.
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`With respectto factor (c), Petitioner argues that “no prior art was
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`substantively relied on during examination,” because the Office “only issued
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`one substantive rejection during prosecution — for obviousness-type double
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`patenting.” Pet. 8 (citing Ex. 1015, 24-28). Patent Owner does not address
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`this factor directly, arguing only that “an analysis of each Becton factoris
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`not necessary here.” Prelim. Resp. 25-26. On the present record, Petitioner
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`appears to be correct: there was only a single substantive rejection, which
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`did not rely on any ofthe prior-art references asserted here. Ex. 1015, 1—
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`208. Becausethe art asserted here was notthe basis for a rejection and was
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`not evaluated substantively at all during examination, Becton, Dickinson
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`factor (c) weighs in favorofa finding that Petitioner has shown material
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`error by the Office.
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`With respectto factors (e) and (f), the present Petition argues for the
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`unpatentability of claims 1-8 on six grounds, using multiple combinations of
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`references. As discussed in detail below, we determine that Petitioner has
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`shown at least a reasonable likelihoodthatit will prevail on its allegation
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`that the challenged claims are unpatentable on at least one of these grounds.
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`In making that determination, we note that several references that were
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`before the Examiner appearonthe present record to disclose elements of the
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`challenged claims. For example, Voswinckel JAHA teachestreating
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`“patients with severe pulmonary hypertension” with “Inhaled Treprostinil
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`Sodium (TRE)” with “3 single breaths” of “TRE solution 600 g/ml,”
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`resulting in “strong pulmonary selective vasodilatory efficacy with a long
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`duration of effect following single acute dosing,” and Voswinckel JESC
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`describes “the acute hemodynamicresponseto inhaled treprostinil”
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`following the administration to patients of nebulized treprostinil solution in
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`concentrations of 16, 32, 48, and 64 g/ml for 6 minute