`571-272-7822
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` Paper 11
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` Entered: August 27, 2019
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`NALOX-1 PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`OPIANT PHARMACEUTICALS, INC,
`Patent Owner.
`____________
`
`Case IPR2019-00687
`Patent 9,211,253 B2
`____________
`
`
`
`Before ZHENYU YANG, JACQUELINE T. HARLOW, and
`MICHAEL A. VALEK, Administrative Patent Judges.
`
`VALEK, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
`
`
`
`
`
`
`
`
`
`
`IPR2019-00687
`Patent 9,211,253 B2
`
`
`INTRODUCTION
`I.
`Nalox-1 Pharmaceuticals, LLC (“Petitioner”) filed a Petition
`requesting an inter partes review of claims 1–29 of U.S. Patent 9,211,253
`B2 (Ex. 1001, “the ’253 patent”). Paper 1 (“Pet.”). Opiant Pharmaceuticals,
`Inc. (“Patent Owner”) filed a Preliminary Response. Paper 6 (“Prelim.
`Resp.”). We have authority to determine whether to institute an inter partes
`review under 35 U.S.C. § 314, which provides that an inter partes review
`may not be instituted unless the information presented in the petition “shows
`that there is a reasonable likelihood that the petitioner would prevail with
`respect to at least 1 of the claims challenged in the petition.”
`For the reasons set forth below, upon consideration of the papers filed
`by both parties, we exercise our discretion under 35 U.S.C. § 314 and deny
`institution of inter partes review in this case.
`
`II. BACKGROUND
`
`A. Related Matters
`
`The parties inform us that the ’253 patent is asserted in Adapt Pharma
`Operations Ltd. v. Teva Pharmaceuticals USA, No. 2:16-cv-07721 (D.N.J.)
`and Adapt Pharma Operations Ltd. v. Perrigo UK FINCO Limited
`Partnership, No. 2:18-cv-15287 (D.N.J.). Pet. 6; Paper 5, 2. Petitioner is
`not a party to either of these litigations.
`Petitioner informs us that it is “concurrently filing inter partes review
`petitions on related U.S. Patent Nos. 9,468,747; 9,562,177; 9,629,965; and
`9,775,838, which are listed in The Orange Book [along with the ’253 patent]
`as covering Narcan® nasal spray (naloxone).” Pet. 6. What Petitioner does
`2
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`IPR2019-00687
`Patent 9,211,253 B2
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`not clearly indicate is that it has, in fact, filed three IPR petitions on each of
`these five patents for a total of fifteen petitions.
`Petitioner’s other two petitions on the ’253 patent are docketed as
`IPR2019-00685 and IPR2019-00686. The petitions in those proceedings
`challenge the same claims (claims 1–29) of the same patent under the same
`statutory provision (35 U.S.C. § 103(a)) as the Petition here, but purport to
`focus on a different primary reference. As do the parties, we refer to
`Petitioner’s petitions on the ’253 patent by the name of the primary
`reference asserted in each, e.g., the “Wyse Petition” (IPR2019-00685, Paper
`1) and the “Davies Petition” (IPR2019-00687, Paper 1).
`
`B. The ’253 Patent
`
`The ’253 patent discloses “devices adapted for nasal delivery of a
`pharmaceutical composition to a patient, comprising . . . naloxone and
`pharmaceutically acceptable salts thereof.” Ex. 1001, 6:54–57. The ’253
`patent describes naloxone as “an opioid receptor antagonist that is approved
`for use by injection for the reversal of opioid overdose and for adjunct use in
`the treatment of septic shock.” Id. at 2:9–11. “Since the onset of action of
`naloxone used in opioid overdose cases should be as fast as possible,
`naloxone is thus far mainly administered intravenously or intramuscularly by
`emergency health care personnel.” Id. at 6:4–7. According to the ’253
`patent, it can be difficult to “find access into a vein of the addict’s body for
`administering naloxone intravenously” and the use of a needle to inject it
`carries the “risk of exposure to blood borne pathogens.” Id. at 6:14–23.
`Thus, “[t]he administration of naloxone via injection . . . requires . . . trained
`
`3
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`IPR2019-00687
`Patent 9,211,253 B2
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`medical personnel (for intravenous injection) or a trained carer (for
`intramuscular injection).” Id. at 6:10–23.
`According to the ’253 patent, “it has been suggested that in view of
`the growing opioid overdose crisis in the US, naloxone should be made
`available over-the-counter (OTC), which would require a device, such as a
`nasal spray device, that untrained consumers are able to use safely.” Id. at
`6:33–37. The ’253 patent explains that such devices should be capable of
`delivering a “therapeutically effective dose. . . sufficient to obviate the need
`for the untrained individual to administer either a second dose of opioid
`antagonist or an alternative medical intervention to the patient, and to
`stabilize the patient until professional medical care becomes available.” Id.
`at 6:47–54. The ’253 patent purports to describe devices that meet the need
`for an easy-to-use and effective intranasal dosage form of naloxone. See id.
`
`C. Representative Claim
`
`Claim 1 is the sole independent claim and reproduced below.
`1. A single-use, pre-primed device adapted for nasal
`delivery of a pharmaceutical composition to a patient by one
`actuation of said device into one nostril of said patient, having a
`single reservoir comprising a pharmaceutical composition which
`is an aqueous solution of about 100 μL comprising:
`about 4 mg naloxone hydrochloride or a hydrate thereof;
`between about 0.2 mg and about 1.2 mg of an isotonicity agent;
`between about 0.005 mg and about 0.015 mg of a preservative;
`about 0.2 mg of a stabilizing agent;
`an amount of an acid sufficient to achieve a pH or 3.5–5.5.
`
`
`
`
`
`
`
`
`
`Ex. 1001, 50:36–47. Claim 2 additionally specifies that the “preservative is
`benzalkonium chloride” and the “stabilizing agent is disodium edetate.”
`4
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`IPR2019-00687
`Patent 9,211,253 B2
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`Ex. 1001, 50:50–51. Claims 3–15 and 24–29 depend from claim 2 and are
`likewise limited to those excipients. Claims 1 and 16–23 are not limited to a
`particular preservative or stabilizing agent in the recited pharmaceutical
`composition.
`
`D.
`
`The Asserted Grounds of Unpatentability
`
`Petitioner challenges the patentability of claims 1–29 under 35 U.S.C.
`§ 103(3) on the following grounds (Pet. 3):
`
`Claim(s)
`1–4, 16–24
`28–29
`
`5–7, 10–14
`
`8–9
`
`25–27
`
`References
`Davies1 in view of HPE,2 Bahal,3 and Kushwaha4
`Davies in view of HPE, Bahal, Kushwaha, and
`Wyse5
`Davies in view of HPE, Bahal, Kushwaha, and
`Djupesland6
`Davies in view of HPE, Bahal, Kushwaha,
`Djupesland, and the ’291 patent7
`Davies in view of HPE, Bahal, Kushwaha,
`Djupesland, and Wyse
`
`
`1 PCT Publication WO 00/62757, published October 26, 2000 (Ex. 1009).
`2 Handbook of Pharmaceutical Excipients 56–60, 64–66, 78–81, 220–22,
`242–44, 270–72, 441–45, 517–22, 596–98 (Raymond C. Row et al. eds., 6th
`ed. 2009) (Ex. 1012).
`3 U.S. Patent 5,866,154, issued February 2, 1999 (Ex. 1014).
`4 Swatantra Kushwaha et al., Advances in Nasal Trans-Mucosal Drug
`Delivery, 01(07) J. Applied Pharm. Sci. 21–28 (2011) (Ex. 1013).
`5 U.S. Patent 9,192,570, issued November 24, 2015 (Ex. 1007).
`6 Per Gisle Djupseland, Nasal Drug Delivery Devices: Characteristics and
`Performance in a Clinical Perspective––a Review, 3 Drug. Deliv. & Transl.
`Res. 42–62 (2013) (Ex. 1010).
`7 U.S. Patent 8,198,291, issued June 12, 2012 (Ex. 1015).
`5
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`IPR2019-00687
`Patent 9,211,253 B2
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`
`Claim(s)
`
`15
`
`References
`Davies in view of HPE, Bahal, Kushwaha,
`Djupesland, and Wyse or Wang8 or Wermeling
`20139
`
`
`Petitioner also relies on the Declaration of Maureen Donovan (Ex. 1002) and
`the Declaration of Günther Hochhaus (Ex. 1003).
`
`III. DISCRETIONARY DENIAL
`
`Overview
`1.
`As explained above, Petitioner has concurrently filed three petitions,
`each of which challenges claims 1–29 of the ’253 patent. Patent Owner
`argues that we should exercise discretion to deny institution of the Davies
`Petitition at issue here because it is redundant of the Wyse Petition in
`IPR2019-00685. See Prelim. Resp. 6–8. Patent Owner contends the Davies
`Petition “largely duplicates” the Wyse Petition “merely adding grounds that
`make the same arguments with more-complicated combinations of more
`references.” Id. at 1. Patent Owner points out that “large swaths of text
`[are] word-for-word identical” and that although the present Petition is
`premised on a different primary reference (i.e., Davies) it “relies extensively
`on the Wyse reference that is the principal reference in Case IPR2019-
`
`
`8 Chinese Patent 1,575,795, published February 9, 2005 (certified
`translation) (Ex. 1008).
`9 Daniel P. Wermeling, A Response to the Opioid Overdose Epidemic:
`Naloxone Nasal Spray, 3 Drug. Deliv. & Transl. Res. 63–74 (2013)
`(Ex. 1016).
`
`6
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`IPR2019-00687
`Patent 9,211,253 B2
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`00685.” Id. at 2. According to Patent Owner, the Petition here “adds
`nothing substantive to Case IPR2019-00685.” Id.
`On June 11, 2019, we issued an order requiring Petitioner to provide a
`Notice containing: (1) a ranking of the three Petitions in the order in which
`Petitioner wishes the panel to consider the merits, if the Board uses its
`discretion to institute any of the three petitions, and (2) an explanation of the
`differences between the petitions, why the differences are material, and why
`the Board should exercise its discretion to consider the additional petitions if
`it identifies a petition that satisfies Petitioner’s burden under 35 U.S.C.
`§ 314(a). Paper 7 (“Case Management Order”) at 4. We also gave Patent
`Owner an opportunity to respond. Id.
`
`Petitioner filed its Notice on June 17, 2019. Paper 8 (“Notice”). In
`that Notice, Petitioner requests that we consider the Wyse Petition first.
`Notice 1. Petitioner further asserts that “[d]ue to different statutory bases for
`invalidity, as well as substantive differences in the[] three primary
`references,” we “should institute review for all three Petitions.” Id. In its
`Response to Petitioner’s Notice, Patent Owner continues its argument that
`the present Petition is redundant, urging “if the Board institutes anything, it
`should institute only the Wyse Petition.” Paper 9 (“Resp.”).
`
`For the reasons explained in our decision instituting review in
`IPR2019-00685, we are instituting inter partes review of claims 1–29 on the
`grounds presented in the Wyse Petition. As explained more fully below, we
`
`7
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`IPR2019-00687
`Patent 9,211,253 B2
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`exercise discretion to deny institution of the present Petition under 35 U.S.C.
`§ 314(a) in light of IPR2019-00685.10
`
`2.
`
`35 U.S.C. § 314(a)
`
`Under § 314(a), the Director has discretion to deny institution of an
`inter partes review. Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131,
`2140 (2016) (“[T]he agency’s decision to deny a petition is a matter
`committed to the Patent Office’s discretion.”); SAS Inst. Inc. v. Iancu, 138 S.
`Ct. 1348, 1356 (2018) (“[Section] 314(a) invests the Director with discretion
`on the question whether to institute review . . . .” (emphasis omitted));
`Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016)
`(“[T]he PTO is permitted, but never compelled, to institute an IPR
`proceeding.”).
`Our discretionary determination whether to institute review takes into
`consideration guidance in the Trial Practice Guide Update (July 2019),
`available at https://www.uspto.gov/TrialPracticeGuide3 (referenced in
`Office Patent Trial Practice Guide, July 2019 Update, 84 Fed. Reg. 33,926
`(July 16, 2019)) (“TPG July 2019 Update”). The TPG July 2019 Update
`addresses situations where Petitioner has concurrently filed parallel petitions
`challenging the same patent. The TPG July 2019 Update states:
`Based on the Board’s prior experience, one petition should be
`sufficient to challenge the claims of a patent in most situations.
`Two or more petitions filed against the same patent at or about
`
`10 Because we exercise discretion to deny institution on this basis, we need
`not make a determination regarding the other arguments presented in Patent
`Owner’s Preliminary Response.
`
`8
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`IPR2019-00687
`Patent 9,211,253 B2
`
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`the same time (e.g., before the first preliminary response by the
`patent owner) may place a substantial and unnecessary burden
`on the Board and the patent owner and could raise fairness,
`timing, and efficiency concerns. See 35 U.S.C. § 316(b). In
`addition, multiple petitions by a petitioner are not necessary in
`the vast majority of cases.
`TGP July 2019 Update 26.11 The TGP July 2019 Update acknowledges that
`“there may be circumstances in which more than one petition may be
`necessary, including, for example, when the patent owner has asserted a
`large number of claims in litigation or when there is a dispute about priority
`date requiring arguments under multiple prior art references,” but
`characterizes such circumstances as “rare.” Id.
`In addition to the guidance in the Trial Practice Guide, we are also
`mindful to construe our rules to “secure the just, speedy, and inexpensive
`resolution of every proceeding.” 37 C.F.R. § 42.1(b); Deeper, UAB v.
`Vexilar, Inc., Case IPR2018-01310, slip op. at 42 (PTAB Jan. 24, 2019)
`(Paper 7) (informative).
`
`
`11 This is consistent with the guidance previously provided in the August
`2018 update to the Trial Practice Guide Update (August 2018), available at
`https://go.usa.gov/xU7GP (referenced in Office Patent Trial Practice Guide,
`August 2018 Update, 83 Fed. Reg. 39,989 (August 13, 2018)) (“TGP August
`2018 Update”). The TPG August 2018 Update explains that “[t]here may be
`other reasons besides the ‘follow-on’ petition context where the ‘effect . . .
`on the economy, the integrity of the patent system, the efficient
`administration of the Office, and the ability of the Office to timely complete
`proceedings,’ 35 U.S.C. § 316(b), favors denying a petition,” including
`“other proceedings related to the same patent . . . at the Office.” Id. at 10.
`9
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`IPR2019-00687
`Patent 9,211,253 B2
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`3.
`
`Analysis
`
`4
`
`Wyse, HPE, and
`Djupesland
`5–7, 10–14 Wyse, HPE, and
`Djupesland
`Wyse, HPE, Djupesland,
`and the ’291 patent
`
`8, 9
`
`Petitioner’s arguments in the present proceeding are substantially
`similar to those in the Wyse Petition. The table below provides a claim-by-
`claim comparison of the prior art Petitioner asserts in each proceeding.
`Challenged
`IPR2019-00685
`IPR2019-00687
`Claims
`(Wyse Petition)
`(Davies Petition)
`1–3, 16–24 Wyse and HPE
`Davies, HPE, Bahal, and
`Kushwaha
`Davies, HPE, Bahal, and
`Kushwaha
`Davies, HPE, Bahal,
`Kushwaha, and Djupesland
`Davies, HPE, Bahal,
`Kushwaha, Djupesland, and the
`’291 patent
`Davies, HPE, Bahal,
`Kushwaha, Djupesland, and
`(1) Wyse or (2) Wang +
`Pharmacologist POSA
`knowledge or (3) Wermeling
`2013
`Davies, HPE, Bahal,
`Kushwaha, Djupesland, and
`Wyse
`Davies, HPE, Bahal,
`Kushwaha, and Wyse
`
`15
`
`Wyse, HPE, and
`Djupesland
`
`25–27
`
`Wyse, HPE, and
`Djupesland
`
`28, 29
`
`Wyse and HPE
`
`As can be seen from the table above, the main difference between the
`petitions is that here Petitioner relies on Davies, as opposed to Wyse, as the
`primary reference for its obviousness combinations. More specifically, in
`the Wyse Petition, Petitioner relies on Wyse for its teaching of intranasal
`naloxone formulations in a single-use, pre-primed device, whereas here
`
`10
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`IPR2019-00687
`Patent 9,211,253 B2
`
`Petitioner relies on Davies for the same teaching. Compare Wyse Pet. 24–
`25, 28–34, with Pet. 24, 28–31. In both proceedings, Petitioner relies on
`HPE, Djupesland, and the ’291 patent as secondary references for essentially
`the same disclosure. Compare Pet. 30–31 (HPE), 47–48 (Djupesland), 52
`(’291 patent), with Wyse Pet. 31–33 (HPE), 45–46 (Djupesland), 52–32
`(’291 patent). Moreover, Petitioner relies on the same declarations to
`support its arguments in the Davies Petition that it does in the Wyse Petition.
`
`The additional secondary references asserted in the Davies Petition do
`not substantively distinguish Petitioner’s arguments from those in the Wyse
`Petition. These references relate to limitations that Petitioner contends are
`taught by Wyse, but acknowledges are not taught by Davies. It is apparently
`for this reason that Petitioner decided not to rely on them to supplement the
`teachings of the primary reference in its grounds in the Wyse Petition.
`Indeed, Petitioner has not identified any differences relating to these
`secondary references that it contends materially distinguish its arguments
`here from those in the Wyse Petition. See generally Notice 1–3.
`
`To the contrary, Petitioner’s arguments in the Davies Petition largely
`rely on the teachings in Wyse, just as they do in the Wyse Petition. As
`shown in the table above, several of Petitioner’s grounds in the Davies
`Petition expressly rely on Wyse. Moreover, Petitioner presents essentially
`the same argument concerning the “about 4 mg naloxone” limitation of
`claim 1 in this proceeding that it does in the Wyse Petition. In both
`petitions, Petitioner contends that the primary reference discloses an
`overlapping dosage range and relies on the same evidence, including data
`from Table 4 of Wyse, to argue “[a] POSA . . . would have been motivated
`11
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`IPR2019-00687
`Patent 9,211,253 B2
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`to deliver a naloxone dose of about 4-6 mg.” Compare Pet. 18, 30, with
`Wyse Pet. 18–19, 30–31. Thus, even for those grounds in the Davies
`Petition that do not expressly include Wyse in the stated combination of
`references, Petitioner nevertheless relies on Wyse as evidence for its
`argument that a 4 mg dose would be obvious. Indeed, significant portions of
`the arguments in the present Petition are substantively identical to those
`presented in the Wyse Petition. Compare Pet. 13–22, 30–31, with Wyse Pet.
`13–22, 30–33.
`
`None of the “differences” Petitioner identifies in its Notice warrant
`institution of a second IPR. See Notice 3 (table summarizing alleged
`“differences”). First, Petitioner contends that because Wyse “is prior art
`under § 102(a)(2),” as opposed to § 102(b)(2), there is a need for a second
`IPR to ensure that Wyse cannot “be removed as prior art.” See Notice 1–2.
`However, Patent Owner has stipulated that it “will not dispute that Wyse,
`Davies, and Wang are all prior art.” Resp. 1. Thus, there is no dispute as to
`Wyse’s status as prior art that could justify the burden of instituting a second
`inter partes review to consider what are essentially the same arguments, but
`premised on a different primary reference with an earlier priority date. Cf
`TPG July 2019 Update 26 (noting that a second proceeding may be
`necessary if there “is a dispute about priority date requiring arguments under
`multiple prior art references”).
`We are likewise not persuaded by Petitioner’s argument that a second
`IPR is warranted because the Wyse Petition relies on “the Declaration of Dr.
`Donovan to support the position that a POSA would not have considered
`Wyse to teach away from the use of BAC [i.e., benzalkonium chloride],”
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`Patent 9,211,253 B2
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`whereas the Davies Petition “do[es] not rely [on] Wyse for the teaching of
`BAC, but instead for its other teachings.” Notice 2–3. To the extent
`Petitioner is suggesting that the alleged teaching away in Wyse is not at
`issue here, Petitioner is wrong. Patent Owner raises exactly the same
`teaching away argument in response to the Davies Petition that it does in
`response to the Wyse Petition. Compare Prelim. Resp. 47–52, with
`IPR2019-00685 Prelim. Resp. 49–56. Moreover, Petitioner relies on the
`same testimony from Dr. Donovan in support of the Davies Petition. See
`Pet. 58–59 (citing Dr. Donovan’s testimony in support of Petitioner’s
`argument that a POSA “would not have properly concluded that Wyse
`taught away from using BAC with naloxone”). It makes no difference that
`the grounds in the Davies Petition only rely on Wyse’s “other teachings”
`(Notice 3) because “[a] reference must be considered for everything that it
`teaches,” which here includes Wyse’s statements regarding the use of BAC
`in a naloxone intranasal formulation. See In re Applied Materials, Inc., 692
`F.3d 1289, 1298 (Fed. Cir. 2012). Moreover, Petitioner’s arguments
`regarding the BAC limitation are similar in both petitions and largely rely on
`the same secondary reference (HPE) to support Petitioner’s argument that
`the claimed inclusion of BAC would have been obvious. See Pet. 31; Wyse
`Pet. 32–33.
`None of the other “differences” Petitioner identifies weigh in favor of
`instituting a second inter partes review. See Notice 3 (table). Petitioner
`notes that the disclosures in both Wyse and Davies were cited during
`prosecution of the ’253 patent, but that it was a “[p]ublication version,” as
`opposed to the issued Wyse patent, that was cited there. Id. That
`13
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`IPR2019-00687
`Patent 9,211,253 B2
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`distinction, however, makes no difference to the arguments presented in the
`Wyse and Davies Petitions. This is particularly so given Patent Owner’s
`stipulation that it will not challenge Wyse’s status as prior art. See Resp. 1.
`In addition, Petitioner asserts that Wyse “[a]nticipates” certain limitations
`that Davies does not. Id. If anything, that suggests the grounds premised on
`Wyse as the primary reference present a stronger argument for
`unpatentability than the grounds in the Davies Petition. It does not
`demonstrate a need for a second IPR to consider essentially the same
`arguments, but involving a larger set of references to account for limitations
`that Petitioner acknowledges Davies does not expressly teach.
`In sum, having considered the parties’ arguments and evidence in both
`proceedings, we determine that instituting inter partes review on the Davies
`Petition would result in a second, essentially duplicative proceeding running
`concurrently with the proceeding on the Wyse Petition. Such a proceeding
`“would place a substantial and unnecessary burden on the Board and the
`patent owner and could raise fairness, timing, and efficiency concerns.” See
`TGP July 2019 Update 26. We have considered Petitioner’s preference that
`the Wyse Petition be instituted first and determined that institution on that
`petition is appropriate. Thus, all of the claims of the ’253 patent are subject
`to inter partes review of the Wyse Petition. On the record before us, we do
`not find the differences between the references and arguments in the Davies
`Petition and those in the Wyse Petition to be sufficiently material to
`outweigh the inefficiencies and costs of instituting an additional proceeding
`brought by the same Petitioner on the same claims of the same patent.
`
`14
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`Patent 9,211,253 B2
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`Accordingly, we exercise our discretion to deny instituting review of the
`Davies Petition.
`
`IV. CONCLUSION
`For the foregoing reasons, based on the circumstances of this case, we
`exercise discretion under 35 U.S.C. § 314 and deny the present Petition
`requesting institution of inter partes review of claims 1–29 of the ’253
`patent.
`
`V. ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that the Petition is denied as to all challenged claims of
`the ’253 patent and no trial is instituted.
`
`
`
`
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`IPR2019-00687
`Patent 9,211,253 B2
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`PETITIONER:
`Yelee Y. Kim
`Janine A. Carlan
`Richard Berman
`Bradford Frese
`Christopher Yaen
`ARENT FOX LLP
`yelee.kim@arentfox.com
`janine.carlan@arentfox.com
`richard.berman@arentfox.com
`bradford.frese@arentfox.com
`christopher.yaen@arentfox.com
`
`PATENT OWNER:
`
`Robert F. Green
`Jessica Tyrus Mackay
`GREEN, GRIFFITH & BORG-BREEN LLP
`rgreen@greengriffith.com
`jmackay@greengriffith.com
`
`16
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`