`571-272-7822
`
`Paper 7
`Date: July 31, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`GLAXOSMITHKLINE
`CONSUMER HEALTHCARE HOLDINGS (US) LLC,
`Petitioner,
`v.
`CIPLA LTD.,
`Patent Owner.
`
`IPR2020-00368
`Patent 8,163,723 B2
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`
`
`
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`
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`
`
`Before JO-ANNE M. KOKOSKI, ZHENYU YANG, and
`CHRISTOPHER M. KAISER, Administrative Patent Judges.
`YANG, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 325(d)
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`IPR2020-00368
`Patent 8,163,723 B2
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`INTRODUCTION
`GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
`(“Petitioner”) filed a Petition (Paper 1 (“Pet.”)), seeking an inter partes
`review of claims 1–28 of U.S. Patent No. 8,163,723 B2 (Ex. 1002,
`“the ’723 patent”). Cipla Ltd. (“Patent Owner”) filed a Preliminary
`Response. Paper 6 (“Prelim. Resp.”).
`For the reasons provided below, we exercise our discretion under
`35 U.S.C. § 325(d) and deny institution of an inter partes review.
`Related Matters
`According to the parties, the ’723 patent is the subject of Meda
`Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., No. 1:15-cv-
`00785-LPS (D. Del.); Meda Pharmaceuticals Inc. v. Perrigo UK FINCO
`Ltd., No. 1:16-cv-00794-LPS (D. Del.); and Meda Pharmaceuticals, Inc. v.
`Apotex Inc., No. 1:14-cv-01453-LPS (D. Del.). Pet. 56; Paper 5, 1. All three
`cases have been dismissed by stipulation. Pet. 56; Paper 5, 1.
`The parties also identify Argentum Pharmaceuticals LLC v. Cipla
`Ltd., IPR2017-00807 (PTAB) (“the Argentum IPR”) as a related matter.
`Pet. 56; Paper 5, 1. The Argentum IPR challenged the parent of the ’723
`patent, U.S. Patent No. 8,168,620 B2 (Ex. 1001, “the ’620 patent”). There,
`the Board instituted trial but terminated it prior to issuing a final written
`decision. Pet. 56, 58; Paper 5, 1.
`Petitioner concurrently filed three other petitions, challenging patents
`related to the ’723 patent: IPR2020-00369 (challenging the ’620 patent),
`IPR2020-00370 (challenging U.S. Patent No. 9,259,428 B2 (Ex. 1003)), and
`IPR2020-00371 (challenging U.S. Patent No. 9,901,585 B2 (Ex. 1004,
`“the ’585 patent”).
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`IPR2020-00368
`Patent 8,163,723 B2
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`The ’723 Patent
`The ’723 patent discloses and claims pharmaceutical compositions
`comprising azelastine (or its pharmaceutically acceptable salt) and
`fluticasone (or its pharmaceutically acceptable ester) in a dosage form
`suitable for nasal administration. See generally Ex. 1002. It teaches that
`azelastine is an antihistamine useful for treating allergy-related conditions.
`Id. at 1:30–33 (stating “it is known to use the antihistamine azelastine
`(usually as the hydrochloride salt) as a nasal spray against seasonal or
`perennial allergic rhinitis”). It also teaches that it was known in the art to
`treat allergic rhinitis with corticosteroids, “which will suppress nasal and
`ocular inflammatory conditions.” Id. at 1:35–37. The ’723 patent lists
`fluticasone as a corticosteroid “known for nasal use.” Id. at 1:37–38.
`According to the ’723 patent, “[i]t would be highly desirable,
`however, to provide a treatment that combines the effects of anti-histamine
`treatments and steroid treatments, in a pharmaceutically acceptable
`formulation, which is tolerated in situ, without significantly disrupting the
`potency of the constituent pharmaceuticals.” Id. at 1:43–47.
`The ’723 patent states that the inventors found that, “very
`surprisingly, azelastine . . . can advantageously be combined with a
`steroid . . . to provide a stable, very effective combination product or
`formulation” for nasal treatment. Id. at 1:48–57. Such a combination,
`according to the ’723 patent, “can provide, in a single administration or
`dosing regime, the antihistaminic properties of azelastine and the anti-
`inflammatory (and/or other) properties of the steroid, without any significant
`interference between the two, or adverse reaction in situ.” Id. at 1:58–62.
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`The ’723 patent discloses that the pharmaceutical compositions are
`preferably in the form of nasal drops, eye drops, nasal sprays, nasal
`inhalation solutions, aerosols, or insufflation powders. Id. at 2:16–18. Of
`these, the ’723 patent states that a nasal spray is a particularly preferred
`form. Id. at 2:24–26. The ’723 patent also teaches that the formulations may
`contain pharmaceutically acceptable excipients, such as preservatives,
`stabilizers, auxiliary substances, isotonization agents, thickening agents, and
`buffers. Id. at 2:32–3:65.
`
`Illustrative Claim
`Claim 1 is the only independent claim and is reproduced below:
`1. A method for the prophylaxis or treatment in a mammal of
`a condition for which administration of one or more anti-
`histamines and/or one or more steroids is indicated, comprising
`intranasal administration to said mammal of a therapeutically
`effective amount of a pharmaceutical composition comprising
`(a) azelastine, or a pharmaceutically acceptable salt thereof; and
`(b) pharmaceutically acceptable ester of fluticasone.
`The Asserted Grounds of Unpatentability
`Petitioner asserts the following grounds of unpatentability:
`Claims Challenged
`35 U.S.C. §
`References
`1–28
`103(a)
`PDR 1999,1 Segal2
`1–28
`103(a)
`Cramer,3 PDR 1999
`In support of its patentability challenge, Petitioner relies on the
`Declarations of Maureen D. Donovan, Ph.D. (Ex. 1058) and Robert P.
`Schleimer, Ph.D. (Ex. 1062).
`
`
`1 Physicians’ Desk Reference (53rd ed. 1999) (Ex. 1010).
`2 WO 98/48839 A1, published Nov. 5, 1998 (Ex. 1012).
`3 EP 0 780 127 A1, published June 25, 1997 (Ex. 1011).
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`IPR2020-00368
`Patent 8,163,723 B2
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`DISCUSSION
`Patent Owner asks us to exercise our discretion under 35 U.S.C.
`§ 325(d) and deny this Petition. Prelim. Resp. 20–28. Patent Owner argues
`that “[t]he Office has already evaluated—and rejected—Petitioner’s
`arguments.” Id. at 20. According to Patent Owner, Cramer and Segal were
`addressed by the Examiner during prosecution, and while PDR 1999 was not
`previously considered, “its teachings are cumulative of information already
`considered (and rejected) by the Office.” Id. at 21. We find Patent Owner’s
`arguments persuasive.
`Under § 325(d),
`In determining whether to institute or order a proceeding under
`. . . chapter 31, the Director may take into account whether, and
`reject the petition or request because, the same or substantially
`the same prior art or arguments previously were presented to the
`Office.
`In evaluating whether to exercise our discretion under § 325(d), we
`weigh the following non-exclusive factors (“BD factors”):
`(a) the similarities and material differences between the asserted
`art and the prior art involved during examination;
`(b) the cumulative nature of the asserted art and the prior art
`evaluated during examination;
`(c) the extent to which the asserted art was evaluated during
`examination, including whether the prior art was the basis for
`rejection;
`(d) the extent of the overlap between the arguments made during
`examination and the manner in which Petitioner relies on the
`prior art or Patent Owner distinguishes the prior art;
`(e) whether Petitioner has pointed out sufficiently how the
`Examiner erred in its evaluation of the asserted prior art; and
`(f) the extent to which additional evidence and facts presented in
`the Petition warrant reconsideration of prior art or arguments.
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`IPR2020-00368
`Patent 8,163,723 B2
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`Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586,
`Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first
`paragraph).
`Factors (a), (b), and (d) relate to whether the art and arguments
`presented in the petition are the same or substantially the same as those
`previously presented to the Office. Advanced Bionics, LLC v. Med-El
`Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 at 10 (PTAB
`Feb. 13, 2020) (precedential). Factors (c), (e), and (f) “relate to whether the
`petitioner has demonstrated a material error by the Office” in its prior
`consideration of that art or arguments. Id. Only if the same or substantially
`the same art or arguments were previously presented to the Office do we
`then consider whether petitioner has demonstrated error. Id.
`BD Factors (a), (b), and (d)
`We first consider whether Petitioner asserts the same or substantially
`the same prior art or arguments that previously were presented to the Office.
`We conclude that Petitioner does so.
`Cramer
`Petitioner acknowledges that “Cramer was cited by the examiner
`during prosecution.” Pet. 58. Indeed, during the prosecution of the
`parent ’620 patent, the Examiner repeatedly relied on Cramer to reject the
`claims as anticipated or obvious. See Ex. 2001, 497–512, 603–22, 721–42.
`Cramer was also specifically discussed during an Examiner interview. Id. at
`494.
`
`The Examiner found that “Cramer teaches a nasal spray composition
`comprising about 0.001 to about 0.2% concentration of a glucocorticosteroid
`(i.e. beclomethasone, flunisolide, triamcinolone, fluticasone, mometasone,
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`bedusonide and pharmaceutically acceptable salts), 0.01 to about 4%
`concentration of an antihistamine (i.e. azelastine or pharmaceutically
`acceptable sale thereof, and an intranasal carrier).” See, e.g., id. at 732.
`Referring to Example III of Cramer as “disclos[ing] an intranasal
`pharmaceutical composition prepared by combining” azelastine and
`triamcinolone acetonide, a glucocorticoid agent, the Examiner recognized
`that “Cramer does not exemplify a composition comprising azelastine and
`fluticasone.” Id. at 732–33. Nevertheless, the Examiner concluded that “one
`of ordinary skill in the art would have been motivated to make a composition
`comprising azelastine and fluticasone because Cramer suggests that the
`combination of a glucocorticoid (i.e. fluticasone) and antihistamine (i.e.
`azelastine) provide improved relief of symptoms associated with seasonal or
`perennial allergic rhinoconjunctivitis.”4 Id. at 733.
`Petitioner relies on the same teachings of Cramer. For example,
`Petitioner asserts that “Cramer discloses ‘pharmaceutical formulations for
`nasal administration comprising . . . a safe and effective amount of a
`glucocorticoid,’ such as ‘fluticasone,’ and ‘a safe and effective amount of a
`leukotriene inhibiting antihistamine,’ such as ‘azelastine’ or
`‘pharmaceutically acceptable salts thereof.’” Pet. 27 (quoting Ex. 1011,
`2:36–44). Like the Examiner, Petitioner also points to Cramer’s Example III
`for disclosing “an ‘intranasally administered pharmaceutical composition’
`comprising ‘azelastine HCl’ (or azelastine hydrochloride), which is a
`
`
`4 During prosecution of the ’723 patent, the Examiner suggested certain
`amendments to “accord with prior art identified during prosecution of the
`[’620 patent].” Ex. 1006, 3. After the applicant did so, the Examiner allowed
`the claims, stating that “[t]he claims as amended are free of the prior art of
`record.” Id. at 22.
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`pharmaceutically acceptable salt of azelastine, and ‘triamcinolone
`acetonide,’ which is a pharmaceutically acceptable ester of triamcinolone.”
`Id. at 27–28 (quoting Ex. 1011, 6:26–51). Petitioner further refers to
`Example III for disclosing that “substantially similar results are also
`obtained using, in whole or in part, equivalent amounts of other
`glucocorticoid agents such as fluticasone.” Id. at 28 (quoting Ex. 1011,
`6:44–46).
`In sum, Cramer was previously presented to the Office, and Petitioner
`makes the same arguments the Office previously considered regarding
`Cramer.
`
`Segal
`During the prosecution of the ’620 patent, the applicant listed Segal
`on an IDS and the Examiner initialed it. Ex. 2001, 786. Although the
`Examiner did not rely on Segal in any rejections, the Examiner explicitly
`stated that the reference was considered. See Ex. 1008, 36–39.
`Segal was asserted against the ’620 patent claims in the Argentum
`IPR petition. The Examiner, in allowing the claims of the ’585 patent, a
`later-issued patent related to the challenged ’723 patent, stated that “all the
`references cited by the Argentum Petition are of record and have been
`previously evaluated, or disclose information redundant to information of
`record.” Id. at 37. And Petitioner admits that “the Argentum IPR was
`instituted based on the cited prior art and similar arguments” as in this
`Petition. Pet. 58. Accordingly, Segal was previously presented to the Office
`and Petitioner makes the same arguments the Office previously considered
`regarding Segal.
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`PDR 1999
`PDR 1999 was not before the Examiner during prosecution. We agree
`with Patent Owner, however, that the teachings of PDR 1999 do not differ
`“in any material way from the art and arguments already considered and
`overcome during prosecution.” Prelim. Resp. 24.
`PDR 1999 discloses monotherapy nasal spray formulations
`comprising either azelastine hydrochloride or fluticasone propionate.
`Ex. 1010, 1122 (PDR 1999 entry for Flonase, fluticasone propionate nasal
`spray), 3191 (PDR 1999 entry for Astelin, azelastine hydrochloride nasal
`spray). Petitioner relies on PDR 1999 for those teachings, as well as for
`disclosing certain excipients the challenged claims require. See Pet. 4–5,
`28–29.
`As Patent Owner points out, these teachings were already considered
`by the Examiner because “the specification itself recognizes that azelastine
`and fluticasone as monotherapies to treat allergy-related conditions were
`known in the art.” Prelim. Resp. 14 (citing Ex. 1001,5 1:20–30).
`In addition, Patent Owner argues that Cramer, which was considered
`by the Examiner, as well as declarations submitted during prosecution to
`traverse the rejections, described the prior-art practices of using
`antihistamines and corticosteroids as monotherapies. Id. at 14–15. For
`example, Patent Owner points to statements from medical practitioners that
`azelastine alone and fluticasone alone were used to treat seasonal allergic
`rhinitis. Id. at 15 (citing Ex. 2001, 577, 581).
`
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`5 Although Patent Owner cites the specification of the ’620 patent, the ’723
`patent contains the same passages. See Ex. 1002, 1:28–39.
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`Furthermore, the Argentum IPR asserted similar references with
`essentially the same teachings. See Argentum IPR, Paper 11, 6. For example,
`Hettche6 discloses a nasal medicine that contains azelastine or a
`physiologically acceptable salt of azelastine, and each of Phillipps7 and
`Flonase Label8 discloses nasal spray formulations comprising fluticasone
`propionate and other pharmaceutical carriers or excipients. Id. at 14–22. As
`discussed above, in allowing the claims of the ’585 patent, a later-issued
`patent related to the challenged ’723 patent, the Examiner stated that “all the
`references cited by the Argentum Petition are of record and have been
`previously evaluated, or disclose information redundant to information of
`record.” Ex. 1008, 37. And Petitioner admits that “the Argentum IPR was
`instituted based on the cited prior art and similar arguments” as in this
`Petition. Pet. 58.
`Thus, PDR 1999 is cumulative of the art the Examiner considered
`during prosecution and Petitioner makes the same arguments that the Office
`previously considered.
`BD Factors (c), (e), and (f)
`Because we find that the “same or substantially the same prior art or
`arguments previously were presented to the Office,” we turn to whether
`Petitioner demonstrates that the Office erred in a manner material to the
`patentability of the challenged claims. We conclude that Petitioner has failed
`to do so.
`
`
`6 U.S. Patent No. 5,164,194, issued Nov. 17, 1992 (Ex. 1013).
`7 U.S. Patent No. 4,335,121, issued June 15, 1982 (Ex. 1009).
`8 FLONASE® (fluticasone propionate) Nasal Spray, 50 mcg Product
`Information (Dec. 1998) (Ex. 2020).
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` Petitioner does not discuss the factors listed in the Board’s
`precedential decision Becton, Dickinson. Nevertheless, Petitioner asserts
`that, during prosecution, the applicant overcame the rejections over Cramer
`“based solely on alleged objective indicia of nonobviousness, none of which
`demonstrates nonobviousness.” Pet. 58. Petitioner is correct that the
`Examiner allowed the claims of both the challenged ’723 patent and the
`parent ’620 patent after considering objective indicia of nonobviousness.
`Ex. 2001, 195–98; Ex. 1006, 22. Petitioner, however, has not shown
`sufficiently that the Examiner erred in doing so.
`During the prosecution of the ’620 patent, the applicant submitted
`several declarations from inventor Geena Malhotra as evidence supporting
`unexpected stability of the claimed formulation and the inoperability of
`Cramer’s Example III. Ex. 2001, 336–39, 568–70, 698–700. The applicant
`also submitted declarations from Mr. Nikhil Chopra, Joachim Maus, M.D.,
`and Sujeet Rajan, M.D. to support the assertions of commercial success,
`unexpected results, and long-felt need, respectively. Id. at 328–34, 358–64,
`458–62.
`After considering those declarations, the Examiner allowed the
`claims. See id. at 192–99. In the Reasons for Allowability, the Examiner
`discussed in detail the Chopra, Maus, and Rajan declarations. Id. at 195–98.
`The Examiner found “the Chopra Declaration supports that the product of
`the invention has been a commercial success for both the inventors and the
`copiers . . . [and] that the product of the invention has filled a long-felt, but
`unmet need for an improved treatment for allergic rhinitis.” Id. at 196. The
`Examiner found Dr. Rajan’s declaration “also supports that the invention
`fills a long unmet need.” Id. In addition, the Examiner found that “Dr. Maus
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`concludes that the superior results obtained with the combination of nasal
`fluticasone propionate and azelastine HCl would have been unexpected at
`the time of filing of the application. On the basis of this information and
`declaration, the examiner concurs in this conclusion.” Id. at 197 (internal
`citation omitted). Accordingly, the Examiner concluded “the invention [of
`the ’620 patent] is unexpectedly and surprisingly unobvious over, different
`from, and superior to the prior art of record.” Id. at 198.
`Similarly, the Examiner allowed the challenged claims of the ’723
`patent, relying on the applicant’s evidence on objective indicia of
`nonobviousness. Ex. 1006, 22. The Examiner repeats:
`The unobviousness of the method is supported by a proper
`Declaration by Mr. Chopra attesting to commercial success of
`the product, as used in the claimed method. Also, a proper
`Declaration by Dr. Rajan supported that the invention fills a long
`unmet need. A third proper Declaration by Dr. Maus supported
`the notion that contemporary publications found no clinical
`benefit or minimal clinical benefit to a combination of oral
`antihistamine and nasal steroid.
`
`Id.
`
`Petitioner argues that there are no “unexpected results supportive of
`nonobviousness” because, during prosecution, the applicant did not compare
`“the claimed invention to the closest prior art.” Pet. 53. According to
`Petitioner, “the closest prior art is a pharmaceutical nasal formulation
`comprising both azelastine and fluticasone, such as those taught by Cramer
`and Segal.” Id. Thus, Petitioner asserts that the applicant did not show
`unexpected results because it did not present “results comparing the claimed
`invention to a pharmaceutical nasal formulation comprising both azelastine
`and fluticasone . . . or to co-administration of commercially available
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`azelastine hydrochloride nasal spray and fluticasone propionate nasal spray.”
`Id. at 54.
`Assuming, without deciding, that Petitioner is correct that the
`applicant did not compare the claimed invention to the closest prior art,
`Petitioner has not shown sufficiently that the Examiner erred in allowing the
`challenged claims. After all, the Examiner did not allow the claims solely
`based on the applicant’s showing of unexpected results. Rather, the
`Examiner also found persuasive the applicant’s evidence on commercial
`success and long-felt need, including the Chopra and Rajan declarations.
`Ex. 1006, 22.
`Petitioner does not discuss either of these declarations. In fact,
`Petitioner does not even mention commercial success. As to long-felt but
`unmet need, Petitioner’s analysis, in its entirety, reads: Patent Owner “Cipla
`has not shown that the claimed invention satisfied a long-felt but unmet
`need, for at least the reason that Cipla has not shown that any such need that
`was not already satisfied by co-administration of commercially available
`azelastine hydrochloride and fluticasone propionate nasal sprays.”
`Pet. 55–56. This attorney argument, without supporting evidence, is not
`enough to show that the Examiner committed any material error.
`Moreover, Petitioner’s argument is substantially similar to one made
`in the Argentum IPR. Compare Pet. 54, with IPR2017-00807, Paper 2, 55.
`During prosecution of the later-issued, related ’585 patent, the Examiner
`considered that argument made in the Argentum IPR. Ex. 1008, 37 (“With
`regard to the Declaration by Maus, the Argentum Petition asserts that the
`relevant comparator for the inventive formulation is concurrent use of
`fluticasone propionate nasal spray and azelastine nasal spray.”). The
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`Examiner determined that assertion “is not persuasive because at the time of
`the invention, the field as a whole was divided as to whether oral or nasal
`administration of antihistamine was better.” Id. Yet Petitioner does not
`attempt to explain how the Examiner erred in that determination. Nor does
`Petitioner discuss the Maus declaration,9 which the Examiner found
`persuasive. See, e.g., Ex. 1008, 41 (describing the Maus declaration as
`reviewing several studies, including “a non-prior art study which concludes
`that there is no evidence that a combination of intranasal corticosteroids with
`intranasal antihistamines provides any additional therapeutic benefit, in
`comparison with intranasal steroids alone”).
`In sum, the record demonstrates that the Examiner determined the
`claims were unobviousness based on the totality of the evidence. Petitioner
`has not demonstrated a material error by the Office in the prior consideration
`of the same or substantially the same art or arguments presented in the
`Petition.
`
`CONCLUSION
`Weighing the BD factors, we conclude that, on the record presented,
`the circumstances of this case warrant exercise of our discretion to deny
`institution based on § 325(d). The Petition relies on the same and
`substantially the same references, and presents arguments that are
`substantially the same as those the Examiner considered during prosecution.
`
`
`9 Petitioner also argues that a declaration by inventor Geena Malhotra does
`not support nonobviousness. Pet. 54. But, as Petitioner acknowledges, “the
`Examiner did not cite [the Malhotra] declaration in issuing the patents.” Id.
`Thus, we do not find Petitioner’s arguments directed to the Malhotra
`declaration as relevant in determining whether Petitioner shows that the
`Examiner erred in a manner material to patentability.
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`Petitioner has not demonstrated that the Examiner materially erred in that
`consideration. Thus, we exercise our discretion and deny institution of a trial
`under 35 U.S.C. § 325(d).10
`
`ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that the Petition is denied, and no trial is instituted.
`
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`10 Patent Owner argues that we should deny institution for several other
`reasons. Prelim. Resp. 5–11, 29–61. Because we deny the Petition under
`§ 325(d), we do not reach those additional arguments.
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`FOR PETITIONER:
`Charles E. Lipsey
`Trenton A. Ward
`Richard B. Racine
`Joann M. Neth
`Shana K. Cyr
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
`charles.lipsey@finnegan.com
`trenton.ward@finnegan.com
`rich.racine@finnegan.com
`joann.neth@finnegan.com
`shana.cyr@finnegan.com
`
`FOR PATENT OWNER:
`Brandon White
`Emily Greb
`Nathan Kelly
`PERKINS COIE LLP
`White-ptab@perkinscoie.com
`Greb-ptab@perkinscoie.com
`Kelley_nathan-ptab@perkinscoie.com
`
`
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