`571-272-7822
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` Paper No. 10
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` Entered: October 1, 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 IPR2019-00696
`Patent 9,629,965 B2
`____________
`
`
`Before ERICA A. FRANKLIN, ZHENYU YANG, and
`MICHAEL A. VALEK, Administrative Patent Judges.
`
`
`YANG, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`
`
`
`
`IPR2019-00696
`Patent No. 9,629,965 B2
`
`
`INTRODUCTION
`Nalox-1 Pharmaceuticals, LLC (“Petitioner”) filed a Petition (Paper 1
`(“Pet.”)), seeking an inter partes review of claims 1–30 of U.S. Patent
`No. 9,629,965 B2 (“the ’965 patent,” Ex. 1001). Opiant Pharmaceuticals,
`Inc. (“Patent Owner”) filed a Preliminary Response. Paper 6 (“Prelim.
`Resp.”).
`For the reasons provided below, we exercise our discretion under
`35 U.S.C. § 314 to deny institution of an inter partes review.
`Related Proceedings
`Petitioner challenges claims 1–30 of the ’965 patent in two other
`concurrently filed petitions. In IPR2019-00694, Petitioner relies on Wyse1
`as the primary reference; and in IPR2019-00695, Petitioner relies on Wang2
`as the primary reference.
`The ’965 patent is one of five patents listed in the Orange Book for
`intranasal naloxone sold under the brand name NARCAN. Pet. 1; Paper 8,
`1. Petitioner also filed petitions for inter partes review, challenging the
`other four patents listed. Pet. 6; Paper 4, 1–2.
`According to the parties, Patent Owner asserted all five Orange-Book-
`listed patents in Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals
`USA, Inc., Case 2:16-cv-07721 (D.N.J.) (consolidated, “the Teva Case”),
`and Adapt Pharma Operations Ltd. v. Perrigo UK FINCO Limited
`
`
`1 Wyse et al., U.S. Patent No. 9,192,570 B2, issued November 24, 2015
`(Ex. 1007).
`2 Wang et al., Chinese Patent Publication No. CN 1575795 A, published
`February 9, 2005 (Ex. 1008).
`
`2
`
`
`
`IPR2019-00696
`Patent No. 9,629,965 B2
`
`Partnership, Case 2:18-cv-15287 (D.N.J.). Pet. 6; Paper 4, 2. Petitioner is
`not involved in those actions. Pet. 6.
`Background of Technology and the ’965 Patent
`Opioid overdose is a crisis in the United States. Ex. 1001, 6:46.
`Naloxone is an opioid receptor antagonist that was initially approved for use
`by injection for the reversal of opioid overdose. Id. at 2:15–16. Naloxone
`hydrochloride injection prevents or reverses the effects of opioids,
`“including respiratory depression, sedation and hypotension.” Ex. 1044,3
`1300.
`
`According to the ’965 patent, administering naloxone via injection
`requires trained medical personnel and imposes the risk of exposure to blood
`borne pathogens through needlestick injury. Ex. 1001, 6:17–38. The
`’965 patent discloses that “it ha[d] 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
`6:45–49.
`The ’965 patent acknowledges that nasal administration of naloxone
`was known and used by numerous medical services and health departments.
`Ex. 1001, 2:32–6:16; see also id. at 4:42–45 (“Overdose education and nasal
`naloxone distribution (OEND) programs are community-based interventions
`that educate people at risk for overdose and potential bystanders on how to
`prevent, recognize and respond to an overdose.”). It points out, however,
`
`
`3 Physicians’ Desk Reference 2003, entry for NARCAN (Naloxone
`Hydrochloride Injection, USP).
`
`3
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`IPR2019-00696
`Patent No. 9,629,965 B2
`
`although some studies “reported that the nasal administration of naloxone is
`as effective as the intravenous route in opiate addicts,” others “reported that
`naloxone administered intranasally displays a relative bioavailability of 4%
`only and concluded that the IN [intranasal] absorption is rapid but does not
`maintain measurable concentrations for more than an hour.” Id. at 2:50–58.
`The ’965 patent states
`Thus, there remains a need for durable, easy-to-use, needleless
`devices with storage-stable formulations, that can enable
`untrained individuals to quickly deliver a therapeutically
`effective dose of a rapid-acting opioid antagonist to an opioid
`overdose patient. The therapeutically effective dose should be
`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 6:55–64.
`According to the ’965 patent, its invention relates to devices adapted
`for nasal delivery of “a therapeutically effective amount of an opioid
`antagonist selected from naloxone and pharmaceutically acceptable salts
`thereof, wherein the device is pre-primed, and wherein the therapeutically
`effective amount, is equivalent to about 2 mg to about 12 mg of naloxone
`hydrochloride.” Id. at 6:66–7:5.
`Illustrative Claims
`Among the challenged claims, claims 1 and 20 are independent, and
`are reproduced below:
`intranasal
`for
`formulation
`A
`pharmaceutical
`1.
`administration comprising, in an aqueous solution of not more
`than about 140 μL:
`about 4 mg naloxone hydrochloride;
`about 0.74 mg NaCl;
`about 0.01 mg benzalkonium chloride;
`
`4
`
`
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`IPR2019-00696
`Patent No. 9,629,965 B2
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`
`about 0.2 mg disodium edetate; and
`an amount of hydrochloric acid sufficient to achieve a pH
`of 3.5–5.5.
`20. 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
`comprises per 100 μL of aqueous solution:
`
`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;
`
`between about 0.1 mg and about 0.5 mg of a stabilizing
`agent; and
`
`an amount of acid sufficient to achieve a pH of 3.5–5.5.
`Asserted Grounds of Unpatentability
`Petitioner challenges the patentability of claims 1–30 under 35 U.S.C.
`§ 103 on the following grounds:
`
`Claim(s)
`1, 2, 9–12, 17–23,
`25, 26, 29, 30
`3–5, 14–16
`
`References
`
`Davies,4 HPE,5 Bahal,6 and Kushwaha7
`Davies, HPE, Bahal, Kushwaha, and Wyse
`
`
`4 Davies et al., PCT Publication WO 00/62757, published October 26, 2000
`(Ex. 1009).
`5 Handbook of Pharmaceutical Excipients, 56–60, 64–66, 78–81, 220–22,
`242–44, 270–72, 441–45, 517–22, 596–98 (Rowe et al. eds., 6th ed. 2009)
`(Ex. 1012).
`6 Bahal et al., U.S. Patent No. 5,866,154, issued February 2, 1999
`(Ex. 1014).
`7 Kushwaha et al., Advances in Nasal Trans-Mucosal Drug Delivery, 01(07)
`J. APPLIED PHARM. Sci. 21–28 (2011) (Ex. 1013).
`5
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`IPR2019-00696
`Patent No. 9,629,965 B2
`
`
`Claim(s)
`
`6–8, 13
`24
`27, 28
`
`References
`Davies, HPE, Bahal, Kushwaha, and Wyse or
`Wang and Wermeling 20138
`Davies, Djupesland,9 HPE, Bahal, and Kushwaha
`Davies, Djupesland, HPE, Bahal, Kushwaha, and
`the ’291 patent10
`In support of its patentability challenge, Petitioner relies on the
`Declarations of Maureen D. Donovan, Ph.D. (Ex. 1002) and Günther
`Hochhaus, Ph.D. (Ex. 1003).
`DISCRETIONARY DENIAL
`Overview
`As explained above, Petitioner has concurrently filed three petitions,
`each of which challenges claims 1–30 of the ’965 patent. Patent Owner
`argues that we should exercise discretion to deny institution of the Davies
`Petition at issue here because it is redundant of the Wyse Petition in
`IPR2019-00694. 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
`
`
`8 Wermeling, A Response to the Opioid Overdose Epidemic: Naloxone
`Nasal Spray, 3 DRUG DELIV. & TRANSL. RES. 63–74 (2013) (Ex. 1016).
`9 Djupesland, Nasal Drug Delivery Device: Characteristics and
`Performance in a Clinical Perspective - A Review, 3 DRUG DELIV. &
`TRANSL. RES. 42–62 (2013) (Ex. 1010).
`10 Wermeling, U.S. Patent No. 8,198,291 B2, issued June 12, 2012
`(Ex. 1015).
`
`6
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`IPR2019-00696
`Patent No. 9,629,965 B2
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`on the Wyse reference that is the principal reference in Case
`IPR2019-00694.” Id. at 2. According to Patent Owner, the Petition here
`“adds nothing meaningful to Case IPR2019-00694.” Id.
`On July 31, 2019, we issued an order requiring Petitioner to provide a
`Notice identifying:
`(1) a ranking of the three Petitions in the order in which it wishes
`the panel to consider the merits, if the Board uses its discretion
`to institute any of the Petitions, and (2) a succinct 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, 4. We also gave Patent Owner an opportunity to respond. Id. at 4–
`5.
`Petitioner filed its Notice on August 5, 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, 1 (“Resp.”).
`
`For the reasons explained in our decision instituting review in
`IPR2019-00694, we are instituting inter partes review of claims 1–30 on the
`grounds presented in the Wyse Petition. As explained more fully below, we
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`7
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`IPR2019-00696
`Patent No. 9,629,965 B2
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`exercise discretion to deny institution of the present Petition under 35 U.S.C.
`§ 314 in light of IPR2019-00694.11
`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
`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,
`
`11 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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`IPR2019-00696
`Patent No. 9,629,965 B2
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`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 26.12 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).
`Analysis
`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.
`
`
`
`
`12 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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`IPR2019-00696
`Patent No. 9,629,965 B2
`
`
`IPR2019-00694
`(Wyse Petition)
`
`Wyse and HPE
`
`Wyse and HPE
`
`Challenged
`Claim(s)
`1, 2, 9–12,
`17–22, 25,
`26, 29, 30
`3–5, 14–16
`
`IPR2019-00696
`(Davies Petition)
`Davies, HPE, Bahal, and
`Kushwaha
`Davies, HPE, Bahal, Kushwaha,
`and Wyse
`Davies, HPE, Bahal, Kushwaha,
`and Wyse or Wang and
`Wermeling 2013
`Davies, HPE, Bahal, and
`Wyse, Djupesland,
`Kushwaha
`and HPE
`Davies, Djupesland, HPE, Bahal,
`Wyse, Djupesland,
`and Kushwaha
`and HPE
`Davies, Djupesland, HPE, Bahal,
`Wyse, HPE, and the
`Kushwaha, and the ’291 patent
`’291 patent
`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
`Petitioner relies on Davies for the same teaching. Compare Pet. 41–42, with
`Wyse Pet. 43–44. In both proceedings, Petitioner relies on HPE,
`Djupesland, and the ’291 patent as secondary references for essentially the
`same disclosure. Compare Pet. 31–32 (HPE), 51 (Djupesland), 52–53 (the
`’291 patent), with Wyse Pet. 33–35 (HPE), 47–48 (Djupesland), 49–50 (the
`’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
`
`6–8, 13
`
`Wyse and HPE
`
`23
`
`24
`
`27, 28
`
`10
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`IPR2019-00696
`Patent No. 9,629,965 B2
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`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
`to deliver a naloxone dose of about 4-6 mg.” Compare Pet. 18, with Wyse
`Pet. 20. 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 have been 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, with Wyse Pet. 15–24.
`
`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),” whereas Davies is prior art under § 102(a)(1), “Patent
`
`11
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`IPR2019-00696
`Patent No. 9,629,965 B2
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`Owner may seek to remove Wyse as prior art under an exception under
`§ 102(b)(2), but will be unable to do so for Davies.” See Notice 1–2. Patent
`Owner has stipulated that it will not dispute that both Wyse and Davies are
`prior art. Resp. 1. Thus, there is no dispute as to Wyse’s status as prior art
`that could justify the burden of instituting an additional inter partes review
`to consider what are essentially the same arguments, but premised on a
`different primary reference. 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],”
`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. 47–53, with
`IPR2019-00694 Prelim. Resp. 50–56. Moreover, Petitioner relies on the
`same testimony from Dr. Donovan in support of the Davies Petition. See
`Pet. 54–57 (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 2) because “[a] reference must be considered for everything that it
`
`12
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`IPR2019-00696
`Patent No. 9,629,965 B2
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`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. 19–20,
`31–32; Wyse Pet. 21–22, 33–35.
`None of the other “differences” Petitioner identifies weigh in favor of
`instituting a second inter partes review. See Notice 3 (table). For example,
`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 an
`additional 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 an 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 ’965 patent are subject
`to inter partes review of the Wyse Petition. On the record before us, we do
`
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`IPR2019-00696
`Patent No. 9,629,965 B2
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`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.
`Accordingly, we exercise our discretion to deny instituting review of the
`Davies Petition.
`
`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 1–30 of the
`’965 patent.
`
`ORDER
`
`Accordingly, it is
`ORDERED that Petitioner’s request for an inter partes review of
`claims 1–30 of the ’965 patent is denied and no inter partes review is
`instituted.
`
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`IPR2019-00696
`Patent No. 9,629,965 B2
`
`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
`
`
`
`
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