UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`AYLA PHARMA LLC,
`Petitioner
`
`v .
`
`NOVARTIS AG,
`Patent Owner.
`
`U.S. Patent No. 9,533,053 to Gamache et al.
`Issue Date: January 3, 2017
`Title: High Concentration Olopatadine Ophthalmic Composition
`
`Inter Partes Review No.: IPR2020-00295
`
`PETITIONER’S REQUEST FOR REHEARING
`UNDER 37 CFR § 42.71
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`TABLE OF CONTENTS
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`Page
`
`I.
`
`II.
`
`INTRODUCTION ....................................................................................... 1
`
`LEGAL STANDARD .................................................................................. 1
`
`III. ARGUMENT .............................................................................................. 1
`
`A.
`
`B.
`
`C.
`
`The Board Overlooked and Misapprehended the Standard and
`the Substantial Evidence for Motivation to Combine
`Bhowmick, Castillo and Yanni (Ground 1) ........................................ 1
`
`The Board Overlooked and Misapprehended the Standard and
`the Substantial Evidence for Motivation to Combine
`Bhowmick, Castillo and Schneider (Grounds 2 and 3) ....................... 9
`
`The Board Overlooked and Misapprehended the Standard and
`the Substantial Evidence for Motivation to Combine
`Bhowmick, Castillo, Schneider and Hayakama (Ground 2) ............. 13
`
`IV. CONCLUSION ......................................................................................... 15
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`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Cases
`
`Advanced Display v. Kent State Univ.,
`212 F.3d 1272 (Fed. Cir. 2000)..............................................................................................2, 3
`
`DyStar Textilfarben GmbH & Co. Deutschland KG v. C. H. Patrick Co.,
`464 F. 3d 1356 (2006) ......................................................................................................7, 9, 12
`
`Husky Injection Molding Sys. v. Athena Auto. Ltd.,
`838 F.3d 1236 (Fed. Cir. 2016)......................................................................................2, 3, 4, 5
`
`In re Fulton,
`391 F.3d 1195 (Fed. Cir. 2004)....................................................................................7, 8, 9, 12
`
`In re Peterson,
`315 F.3d 1325 (Fed. Cir. 2003)................................................................................................14
`
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004)................................................................................................11
`
`Ortho-McNeil Pharm. Inc. v. Kali Labs. Inc.,
`482 F. Supp. 2d 478 (D.N.J. 2007), vacated on other grounds, 344 F. App’x
`595 (Fed. Cir. 2009) ...................................................................................................................5
`
`Palo Alto Networks, Inc. v. Juniper Networks, Inc.,
`IPR2013-00369, Paper 39 (P.T.A.B. Feb. 14, 2014) .................................................................1
`
`Pfizer, Inc. v. Apotex, Inc.
`480 F.3d 1348 (Fed. Cir. 2007)................................................................................................12
`
`Realtime Data, LLC v. Iancu,
`912 F.3d 1368 (Fed. Cir. 2019)..................................................................................................5
`
`Ruiz v. A.B. Chance Co.,
`357 F.3d 1270 (Fed. Cir. 2004)..................................................................................................7
`
`S. Clay Prods., Inc. v. United Catalysts, Inc.,
`43 F. App’x 379 (Fed. Cir. 2002) ..............................................................................................4
`
`Regulations
`
`37 C.F.R. § 42.71(c).........................................................................................................................1
`
`37 C.F.R. § 42.71(d) ........................................................................................................................1
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`I.
`
`INTRODUCTION
`
`In response to the Decision Denying Institution of Inter Partes Review of
`
`U.S. Patent No. 9,533,053 (Paper 12) (hereinafter “Decision” or “Dec.”), pursuant
`
`to 37 C.F.R. § 42.71(c) and (d), Ayla Pharma LLC (“Petitioner”) hereby
`
`respectfully requests that the PTAB reconsider institution on Grounds 1, 2 and 3.
`
`II.
`
`LEGAL STANDARD
`
`Pursuant to 37 C.F.R. § 42.71(d), a party may request rehearing of a decision
`
`by the Board whether to institute a trial. “The request must specifically identify all
`
`matters the party believes the Board misapprehended or overlooked, and the place
`
`where each matter was previously addressed in a motion, an opposition, or a
`
`reply.” Id. The Board will review the previous decision for an abuse of discretion.
`
`37 C.F.R. § 42.71(c). “An abuse of discretion may be indicated if a decision is
`
`based on an erroneous interpretation of law, if a factual finding is not supported by
`
`substantial evidence, or if the decision represents an unreasonable judgment in
`
`weighing the relevant factors.” Palo Alto Networks, Inc. v. Juniper Networks, Inc.,
`
`IPR2013-00369, Paper 39, 2-3 (P.T.A.B. Feb. 14, 2014) (citing Star Fruits S.N.C.
`
`v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005)).
`
`III. ARGUMENT
`
`A.
`
`The Board Overlooked and Misapprehended the Standard and
`the Substantial Evidence for Motivation to Combine Bhowmick,
`Castillo and Yanni (Ground 1)
`
`The Board’s conclusion that the Petition did not “sufficiently show[] a
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`reason to combine the teachings of Bhowmick, Yanni and Castillo” misapprehends
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`the law and overlooks the facts set forth in the Petition. Dec., 11. Specifically,
`
`Petitioner respectfully submits that the Board: (1) misapprehended precedent by
`
`requiring a heightened standard of motivation to combine Bhowmick with Castillo
`
`despite the incorporation of Castillo in Bhowmick, and (2) overlooked the
`
`substantial evidence in the record that a person of ordinary skill in the art
`
`(“POSA”) would have been motivated to combine the references.
`
`As a matter of law, any material incorporated by reference “is effectively
`
`part of the host document as if it were explicitly contained therein.” Advanced
`
`Display v. Kent State Univ., 212 F.3d 1272, 1282 (Fed. Cir. 2000) (addressing
`
`what material in addition to a host document constitutes a single document for
`
`purposes of an anticipation analysis). A host document incorporates material if it
`
`“identif[ies] with detailed particularity what specific material it incorporates and
`
`clearly indicate[s] where that material is found in the various documents.” Id.
`
`Whether the host document describes the material with sufficient particularity is
`
`determined from a POSA’s point of view. Id., 1283. “The incorporation standard
`
`relies only on the reasonably skilled artisan and his or her ability to deduce from
`
`language, however imprecise, what a host document aims to incorporate.” Husky
`
`Injection Molding Sys. v. Athena Auto. Ltd., 838 F.3d 1236, 1248 (Fed. Cir. 2016).
`
`In Husky, the Federal Circuit evaluated whether a textual reference in the
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`Glaesener prior art to “pineapple and toothed ring mechanism described in [Choi]”
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`is of sufficient particularity to incorporate the described subject matter. Id. The
`
`Federal Circuit concluded that the PTAB erred in determining that Glaesener does
`
`not incorporate Choi because a reasonably skilled artisan would appreciate
`
`Glaesener’s reference of “pineapple and toothed-ring” to describe, with sufficient
`
`particularity, the referenced disclosure in Choi. Id. The Federal Circuit
`
`emphasized that “[t]o find otherwise would be to undervalue the knowledge of a
`
`skilled artisan.” Id. (vacating and remanding “for the Board to evaluate
`
`anticipation in light of Glaesener/Choi.”).
`
`The Board first erred by failing to apply this legal standard to Bhowmick
`
`with Castillo, and overlooked the substantial evidence that showed Castillo is
`
`“effectively part of [Bhowmick] as if it were explicitly contained therein.”
`
`Advanced Display, 212 F.3d at 1282. Notably, Bhowmick states, in relevant part:
`
`United States Patent No. 6,995,186 (Alcon Inc., 2006, the ’186
`
`patent)
`
`[Castillo] discloses
`
`topically administrable
`
`solution
`
`composition for treating allergic or inflammatory disorders of the eye
`
`and nose comprising olopatadine and a polymeric ingredient consisting
`
`essentially of polyvinylpyrrolidone [PVP] or polystyrene sulfonic acid
`
`in an amount sufficient to enhance the physical stability of the
`
`solution …
`
`EX1003, 2:7-12 (emphasis added). Bhowmick also sought to “overcome the
`
`physical stability problems associated with [prior art] olopatadine aqueous
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`solutions” by “tr[ying] various ingredients,” including PVP K-30. Id., 2:18-21; S.
`
`Clay Prods., Inc. v. United Catalysts, Inc., 43 F. App’x 379, 383–84 (Fed. Cir.
`
`2002) (finding incorporation notwithstanding the host patent’s criticism of the
`
`incorporated patent’s invention).
`
`The Petition expressly noted that “Bhowmick even discusses Castillo and its
`
`teachings that PVP improves the stability of olopatadine solutions.” Pet., 24. The
`
`Petition also explained that a “skilled artisan would have known that the inclusion
`
`of PVP would allow for higher solution loading of olopatadine, and would have
`
`been motivated to add PVP.” Id. These arguments and substantial evidence were
`
`further supported by Dr. Dyar (and Dr. Laskar). EX1042, ¶¶ 13-14; EX1014, ¶197.
`
`Like Husky, the host document (Bhowmick) provided a textual reference to
`
`subject matter (the use of PVP with olopatadine to enhance physical stability) in a
`
`second reference (Castillo). 838 F.3d at 1248. In this regard, the textual reference
`
`to using PVP with olopatadine in Castillo is akin to the “pineapple and toothed ring
`
`mechanism” described in Choi, which the Federal Circuit concluded was described
`
`with sufficient particularity to incorporate the described subject matter. Id.
`
`Moreover, like Husky, the disclosure of Castillo in Bhowmick was
`
`understood and appreciated by a POSA for “the inclusion of PVP” to improve
`
`stability and solubility. Id.; EX1014, ¶ 197; see also EX1003, 2:18-21 (Bhowmick
`
`trying PVP K-30 “to overcome physical stability problems”). Thus, this express
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`teaching of Castillo’s use of PVP with olopatadine is of sufficient particularity to
`
`incorporate Castillo’s described subject matter in Bhowmick as if it were explicitly
`
`contained therein. Indeed, “[t]o find otherwise would be to undervalue the
`
`knowledge of a skilled artisan.” Husky, 838 F.3d at 1248.
`
`Given the incorporation of Castillo in Bhowmick, no further motivation to
`
`combine these two references was required. Ortho-McNeil Pharm. Inc. v. Kali
`
`Labs. Inc., 482 F. Supp. 2d 478, 520 (D.N.J. 2007), vacated on other grounds, 344
`
`F. App’x 595 (Fed. Cir. 2009). Yet the Board looked beyond the prior art’s
`
`express disclosures, requiring Petitioner to provide a further showing of a
`
`motivation to combine them. Neither the Patent Owner nor the Board cited law
`
`that would require Petitioner to show separate motivation to do something that was
`
`already done in the cited prior art. Realtime Data, LLC v. Iancu, 912 F.3d 1368,
`
`1374 (Fed. Cir. 2019) (“the motivation to combine was premised on the rationale a
`
`person having ordinary skill in the art would have had to turn to Nelson after
`
`reading O’Brien . . . .”) (internal quotations omitted).
`
`Even if a further motivation was required, the Board overlooked the
`
`substantial evidence establishing such motivation to combine. As explained in the
`
`Petition, Bhowmick teaches the use of cyclodextrins to increase “stability, thereby
`
`preventing olopatadine from precipitating and/or crystallizing out of the solution.”
`
`Pet., 15. Similarly, the Petition explained that “Castillo teaches the inclusion of
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`polyvinylpyrrolidone (PVP) in the olopatadine compositions in order to ‘enhance’
`
`stability.” Id., 16. The Board itself acknowledged these express teachings in
`
`Bhowmick and Castillo. Dec., 7-8. In view of such teachings, the Petition noted
`
`that a “skilled artisan would have known that the inclusion of PVP would allow for
`
`higher solution loading of olopatadine, and would have been motivated to add
`
`PVP.” Id., 24; EX1014, ¶¶86, 197, 201 (“[O]phthalmic excipients like
`
`cyclodextrins, PEG and PVP allow for higher solution loading concentration of
`
`olopatadine”).1 Thus, as set forth in the Petition and supporting declarations, the
`
`improvement in stability and higher solution loading of olopatadine solutions
`
`provides the basis for why a POSA would have had a reason to combine the
`
`teachings of the references.
`
`The Petition also explained that because Castillo teaches using polyethylene
`
`glycol (PEG) 400 to enhance stability and increase solution loading of
`
`olopatadine, a POSA would yet have had another reason to combine the teachings.
`
`Pet., 21-23. The Decision overlooked these express arguments and substantial
`
`1 The same argument was raised in the Argentum petition. EX1021 at p. 030-31.
`
`Reference to the Argentum IPR proceeding is not intended as an exercise in
`
`archaeology with the record (Dec., 9); rather, it is raised to notify the Board of its
`
`previous conclusions for judicial consistency.
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`evidence, and instead focused on a statement in the Petition directed to the nature
`
`of the problem addressed in both references to conclude that the argument falls
`
`short. Dec., 10. However, even the Board’s conclusion on this issue is not
`
`reconcilable with precedent. See In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir.
`
`2004) (the “source of the teaching, suggestion, or motivation may be ‘the nature of
`
`the problem’”); Ruiz v. A.B. Chance Co., 357 F.3d 1270, 1276 (Fed. Cir. 2004);
`
`DyStar Textilfarben GmbH & Co. Deutschland KG v. C. H. Patrick Co., 464 F.3d
`
`1356, 1367 (2006).2
`
`The Board also misapprehended the record evidence establishing motivation
`
`to combine Bhowmick/Castillo with Yanni. As explained in the Petition, Yanni
`
`discloses “ophthalmic anti-allergic compositions comprising olopatadine up to 1
`
`w/v%.” Pet., 16. The Petition further explained that Yanni “teaches that
`
`olopatadine efficacy increases with increasing concentration, with 1 w/v% having
`
`a longer-lasting effect.” Id. (citing Table 3, 397; EX1014, ¶ 61) (emphasis added).
`
`Then, in the context of mapping the Bhowmick/Castillo combination to the
`
`elements of Claim 1, Petitioner noted that Bhowmick called for a “therapeutically
`
`2 Substantial evidence for motivation to combine Bhowmick and Castillo in order
`
`to preserve and buffer was also disclosed in the Petition and supporting
`
`declaration. Pet. 14-15 & 31-32; EX1014, ¶¶ 70, 90, 121, 180 & 202-203.
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`effective amount” (Pet., 18-19) and explained that a “skilled artisan would have
`
`been aware of Yanni, which would have taught olopatadine concentrations higher
`
`than those disclosed in Bhowmick” and that “would have resulted in a clinical
`
`benefit.” Pet., 19. Specifically, the “teachings of Yanni would have taught the
`
`desirability of raising the olopatadine concentrations”, particularly since the
`
`“1 wt% olopatadine was superior to 0.1 wt%” by providing 96% inhibition while
`
`the 0.1 wt% only provided 33% inhibition. Pet., 20 (emphasis added).
`
`Additionally, based on the desirability and superiority reasons of Yanni’s
`
`higher olopatadine concentrations, the Petition explained that a “POSA would have
`
`been motivated to utilize higher concentrations of olopatadine in solution than
`
`those reported in Bhowmick, based on Yanni’s teachings that higher
`
`concentrations of olopatadine exhibited superior reductions in symptoms of
`
`allergic conjunctivitis compared to lower concentrations and provided
`
`significantly longer durations of action than lower concentrations of olopatadine.”
`
`Pet., 21 (emphasis added). These arguments and substantial evidence establishing
`
`a reason to combine the references was further supported by Drs. Laskar and Dyar.
`
`See EX1014, ¶¶ 183-187; EX1042, ¶¶ 13-14.
`
`As emphasized in In re Fulton, “[t]he question is whether there is something
`
`in the prior art as a whole to suggest the desirability, and thus the obviousness, of
`
`making the combination, not whether there is something in the prior art as a whole
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`to suggest that the combination is the most desirable combination available.” 391
`
`F.3d at 1200 (emphasis in original). Here, Petitioner showed that the
`
`Bhowmick/Castillo combination was more than just desirable to try with Yanni.
`
`Petitioner showed that it would achieve long-term stability, superior inhibition
`
`and increased efficacy. As such, like In re Fulton, the desire to solubilize the
`
`higher olopatadine concentrations of Yanni to achieve long-term stability, superior
`
`inhibition and increased efficacy, would have motivated a POSA to combine it
`
`with Bhowmick/Castillo. Pet., 21.
`
`Thus, the Board erred in this inquiry by failing to consider the entirety of the
`
`record and imposing too high of a standard of motivation to combine. For the
`
`foregoing reasons, Petitioner respectfully requests reconsideration by the Board
`
`and institution of Ground 1 for claims 1-13 of the ’053 Patent. Dystar, 464 F.3d at
`
`1368 (“Because the desire to enhance commercial opportunities by improving a
`
`product or process is universal—and even common-sensical—we have held that
`
`there exists in these situations a motivation to combine prior art references even
`
`absent any hint of suggestion in the references themselves.”).
`
`B.
`
`The Board Overlooked and Misapprehended the Standard and
`the Substantial Evidence for Motivation to Combine Bhowmick,
`Castillo and Schneider (Grounds 2 and 3)
`
`The Board also overlooked the record evidence establishing motivation, and
`
`reasonable expectation of success, to combine the teachings of Bhowmick, Castillo
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`and Schneider. Dec., 13. As discussed above with respect to Ground 1, Federal
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`Circuit precedent and substantial evidence supports the express incorporation of
`
`Castillo in Bhowmick. See supra III.A. Moreover, substantial evidence in the
`
`record explicitly set forth why a POSA would be motivated to combine these two
`
`references and the PTAB overlooked these arguments and supporting evidence. Id.
`
`In addition to the arguments and substantial evidence on incorporation of
`
`Castillo in Bhowmick and motivation to combine them, the Board misapprehended
`
`the record on motivation to combine Bhowmick/Castillo with Schneider. As set
`
`forth in the Petition, Schneider discloses “solutions that include olopatadine that
`
`are useful in treating allergic conjunctivitis” and explicitly provides for
`
`concentrations of olopatadine “of about 0.05% … 0.60% w/v, or higher.” Pet., 40,
`
`55 (citing EX1006, [0003], [0045] and [0050]) (emphasis in original).
`
`The Petition also noted that Schneider “explains that it is desirable to include
`
`‘compounds’ that enhance solubility, which can allow for increased concentrations
`
`of olopatadine.” Id. at 40 (citing EX1006, [0008]) (emphasis added). The
`
`compositions of Schneider are disclosed as optionally including one or more
`
`polymers as lubricants or viscosity agents. Id. (citing EX1006 [0052]). The Petition
`
`further provides exemplary agents that “include HPMC, PEG, and PVP.” Id.
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`Moreover, as set forth in the Petition, “Schneider further teaches that the
`
`olopatadine-containing solutions desirably comprise a variety of other components,
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`such as tonicity agents (e.g., mannitol), preservatives (e.g., benzalkonium
`
`chloride), chelating agents, buffering agents (e.g., borates), surfactants, and
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`antioxidants.” Id. (emphasis added). Id. For example, “polyols such as mannitol,
`
`sorbitol, propylene glycol, or glycerol are tonicity agents that may be added in
`
`amounts sufficient to provide a solution with an osmolality of 250-350 mOsm.” Id.
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`(citing EX1006, [0053]; EX1014, ¶ 64).
`
`These arguments and substantial evidence were further supported by
`
`Drs. Laskar and Dyar. See EX1014, ¶¶ 63-64; EX1042, ¶¶ 13-14. Moreover, the
`
`Board itself acknowledged such express teachings in Schneider. Dec., 11. In view
`
`of such teachings, the Petition identified at least five reasons for why a POSA
`
`would be motivated to combine Bhowmick/Castillo with Schneider, but the Board
`
`only addressed one in its Decision while overlooking critical factual evidence.
`
`First, the Petition noted that Bhowmick and Schneider have overlapping
`
`ranges for the concentrations of olopatadine. Pet. at 55; EX1006, [0045] (“about
`
`0.05% … 0.60% w/v, or higher”); EX1003, 3:18-19 (“therapeutically effective
`
`amount” with no particular upper limit; Table 1 (0.665 w/v%)); EX1014, ¶ 192.
`
`Such overlapping ranges establish a prima facie case of obviousness. Iron Grip
`
`Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004).
`
`Second, the Petition explained that a “POSA would have been motivated to
`
`combine the teachings of Schneider and Castillo” and that the “desire to solubilize
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`higher olopatadine concentrations and achieve long-term stability would have
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`motivated a POSA to include excipients such as PEG 400 [as taught in Castillo]
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`into the ophthalmic composition”. Pet., 46 (emphasis added); see also EX1014,
`
`¶¶ 219-223. Dr. Laskar further explained that those skilled in the art would look to
`
`using combinations of solubilizers, as taught in Schneider, to enhance the
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`solubility of olopatadine. See EX1014, ¶¶ 219-220; Pet., 45; Dystar, 464 F.3d at
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`1368.
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`Third, the Petition also explained that Bhowmick taught olopatadine
`
`solutions were “prone to precipitation and crystallization” and that the “inclusion
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`of cyclodextrins increased solubility.” Pet. at 47-48 (emphasis added). Thus, as
`
`with Castillo’s PEG 400, the inclusion of Bhowmick’s cyclodextrins to a
`
`combination of other solubilizers would also enhance solubility and “would have
`
`been obvious.” Pet., 47. Moreover, a “POSA would have been motivated to
`
`combine the teachings of Schneider and Bhowmick because both references teach
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`ophthalmic solutions for treatment of allergic disorders comprising olopatadine,
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`reciting similar excipients.” Id.; Pfizer, Inc. v. Apotex, Inc. 480 F.3d 1348, 1361-62
`
`(Fed. Cir. 2007) (rejecting patentee’s argument that there was no motivation and
`
`explaining that such motivation “may be found in any number of sources,
`
`including common knowledge, the prior art as a whole, or the nature of the
`
`problem itself.”) (emphasis added); In re Fulton, 391 F.3d at 1200 (same).
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`Fourth, the Petition further explains that combining Bhowmick, Castillo, and
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`Schneider for their teaching of benzalkonium chloride (BAC) would preserve the
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`ophthalmic compositions, and combining Schneider and Bhowmick for their
`
`teaching of hydroxypropyl methylcellulose (HPMC) would enhance both solubility
`
`and stability. Pet. at 58-59.
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`Finally, the Petition also explained that a “skilled artisan would have been
`
`motivated to combine the teachings of Schneider, Bhowmick and Castillo because
`
`they all teach olopatadine solutions for treatment of allergic disorders using similar
`
`excipients.” Pet., 54-55. Although the Board observed that this statement “speaks
`
`only to whether the teachings of the references could be combined, not why a
`
`person of ordinary skill in the art would have combined them” (Dec., 13), it
`
`incorrectly analyzed the statement in isolation and out of context. Indeed, the
`
`Board overlooked the previously stated potential clinical benefits of increased
`
`concentrations of olopatadine with other similar excipients, as taught in Schneider,
`
`and as applied to Bhowmick and/or Castillo, including (i) solubility, (ii) stability,
`
`(iii) tonicity, (iv) buffering, and (iii) preservation—all of which provide a reason
`
`for why a POSA would combine the references. Thus, the Board’s decision
`
`contradicts the substantial evidence of record.
`
`C.
`
`The Board Overlooked and Misapprehended the Standard and
`the Substantial Evidence for Motivation to Combine Bhowmick,
`Castillo, Schneider and Hayakama (Ground 2)
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`The Board also overlooked and misapprehended the substantial evidence
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`supporting the motivation to combine Bhowmick, Castillo and Schneider (which
`
`were discussed above) with Hayakama. Dec., 13. Notably, the Petition set forth at
`
`least three reasons for why a POSA would be motivated to combine the references,
`
`none of which were addressed by the Board in its Decision.
`
`First, not only do Bhowmick and Schneider have overlapping ranges for the
`
`concentrations of olopatadine (Pet., 55), as discussed above, but also the Petition
`
`noted that Schneider and Hayakawa overlap as well. Pet., 51; EX1006, [0045]
`
`(“about 0.05% … 0.60% w/v, or higher”); EX1007, 6:44 (“0.0001 to 5 w/v%”).
`
`These overlapping ranges establish a prima facie case of obviousness. In re
`
`Peterson, 315 F.3d 1325, 1329–30 (Fed. Cir. 2003). Moreover, in the context of
`
`mapping the Bhowmick/Castillo/Schneider combination to the elements of Claim 1
`
`and in view of the overlapping ranges, the Petition explained that a “POSA would
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`have been motivated to increase the amount of olopatadine beyond those taught in
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`Schneider —‘0.60% w/v, or higher’—based on Hayakawa’s teaching that
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`olopatadine exhibited inhibitory effects on human conjunctival mast cells, and its
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`teachings of the benefits of including higher concentrations of olopatadine.” Pet.,
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`44 (emphasis added); EX1014, ¶ 218.
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`Second, also in the context of mapping the Bhowmick/Castillo/Schneider
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`combination to the elements of Claim 1, the Petition emphasized that a “POSA
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`would have appreciated that the higher concentrations olopatadine reported by
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`Hayakawa would provide superior inhibitory effects” and “exhibited prophylactic
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`effects as well as therapeutic effects” which “would have further encouraged a
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`POSA to use higher concentrations of olopatadine.” Pet., 44 (emphasis added);
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`EX1014, ¶ 146.
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`Finally, the Petition expressly stated that the inclusion of excipients such as
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`PEG and PVP (as taught by Schneider and Castillo) and cyclodextrin (as taught by
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`Bhowmick) with the higher concentrations of olopatadine (as taught by Hayakawa)
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`“would allow for stability and higher solution loading for olopatadine” with
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`“reasonable expectation of success.” Pet., 44, 48-49 (emphasis added). The Board
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`erred in this inquiry by not considering these arguments and substantial evidence.
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`Petitioner respectfully requests reconsideration by the Board and institution of
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`Ground 2 for claims 1-13 of the ’053 Patent.
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`IV. CONCLUSION
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`Although Petitioner recognizes that its burden on this Request is high, and
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`the rehearing of institution decisions is rare, Petitioner respectfully submits that it
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`has met its burden here, and institution granted based on Petitioner’s Grounds 1-3.
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`Date: September 3, 2020
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`
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`/Jitendra Malik/
`Jitendra Malik, Ph.D. (Reg. No. 55823)
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`Lead Counsel for Petitioner
`Ayla Pharma LLC
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`CERTIFICATION OF SERVICE
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`Pursuant to 37 C.F.R. §§ 42.6(e), 42.8(b)(4), and 42.105, the undersigned
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`certifies that on September 3, 2020, a complete copy of the foregoing
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`PETITIONER’S REQUEST FOR REHEARING UNDER 37 CFR § 42.71 was
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`served via email on the Patent Owner counsel as per below:
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`atrask@wc.com
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`scott.chapple@novartis.com
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`peter.waibel@novartis.com
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`Respectfully submitted,
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`KATTEN MUCHIN ROSENMAN LLP
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`By: /Jitendra Malik/
`Jitendra Malik, Ph.D.
`Reg. No. 55,823
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