Trials@uspto.gov
`Tel: 571-272-7822
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`Paper 14
`Date: May 6, 2021
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`AYLA PHARMA LLC,
`Petitioner,
`
`v.
`
`NOVARTIS AG,
`Patent Owner.
`
`
`IPR2020-00295
`Patent 9,533,053 B2
`
`
`
`
`Before GRACE KARAFFA OBERMANN, CHRISTOPHER M. KAISER,
`and JAMIE T. WISZ, Administrative Patent Judges.
`
`KAISER, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Petitioner’s Request on Rehearing of
`Decision Denying Institution of Inter Partes Review
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`

`

`IPR2020-00295
`Patent 9,533,053 B2
`
`
`INTRODUCTION
`Ayla Pharma LLC (“Petitioner”) filed a Petition (Paper 1, “Pet.”)
`requesting an inter partes review of claims 1–13 of U.S. Patent
`No. 9,533,053 B2 (Ex. 1002, “the ’053 patent”). Novartis AG (“Patent
`Owner”) filed a Preliminary Response. Paper 7 (“Prelim. Resp.”). With our
`authorization, Petitioner filed a Reply (Paper 10), and Patent Owner filed a
`Sur-Reply (Paper 11). On August 6, 2020, we denied institution of inter
`partes review because Petitioner had not shown a reasonable likelihood that
`it would prevail with respect to at least one challenged claim. Paper 12
`(“Decision” or “Dec.”). Petitioner requests rehearing of the Decision under
`37 C.F.R. § 42.71(d)(2). Paper 13 (“Req. Reh’g”). We have considered
`Petitioner’s Request for Rehearing and, for the reasons set forth below, we
`deny the requested relief.
`
`STANDARD OF REVIEW
`A party requesting rehearing bears the burden of showing that a
`decision should be modified. 37 C.F.R. § 42.71(d). The party must identify
`all matters it believes the Board misapprehended or overlooked, and the
`place where each matter was addressed previously in a motion, an
`opposition, or a reply. Id. When rehearing a decision on petition, we review
`the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of
`discretion occurs when a “decision was based on an erroneous conclusion of
`law or clearly erroneous factual findings, or . . . a clear error of judgment.”
`PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567
`(Fed. Cir. 1988) (citations omitted).
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`IPR2020-00295
`Patent 9,533,053 B2
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`
`DISCUSSION
`Petitioner requests rehearing of our denial of institution, arguing that
`we abused our discretion in three respects. Req. Reh’g 1–15. We consider
`each of Petitioner’s arguments below.
`
`A. Reason to Combine Bhowmick, Castillo, and Yanni
`Each of Petitioner’s asserted grounds of unpatentability relies on the
`obviousness of the challenged claims over a combination of prior-art
`references. Pet. 11–12. The Board explained in the Decision why Petitioner
`had not “shown sufficiently that a person of ordinary skill in the art would
`have had a reason to combine the teachings of Bhowmick, Yanni, and
`Castillo.” Dec. 8–11. Petitioner argues that the Board’s determination
`“misapprehends the law and overlooks the facts set forth in the Petition.”
`Req. Reh’g 1–9.
`
`Incorporation of Castillo into Bhowmick
`1.
`Petitioner argues first that we overlooked its argument that Bhowmick
`incorporates Castillo by reference, making a reason to combine those
`references unnecessary. Id. at 2–5. We find this argument unpersuasive of
`an abuse of discretion for two reasons.
`First, Petitioner argues that it previously presented this argument on
`page 24 of the Petition, but it made no such argument in that location. Id.
`at 4. On the subject of the incorporation by reference of Castillo into
`Bhowmick, the indicated portion of the Petition states that “Bhowmick even
`discusses Castillo and its teachings that PVP improves the stability of
`olopatadine solutions.” Pet. 24. There is no argument that this
`“discuss[ion]” represents an incorporation by reference or that it otherwise
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`IPR2020-00295
`Patent 9,533,053 B2
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`provides a reason to combine the teachings of the two references. 1 Id.
`Accordingly, Petitioner’s argument that Bhowmick incorporates Castillo by
`reference is new, and we need not address it. 37 C.F.R. § 42.71(d).
`Second, even if Petitioner had argued in the Petition that Bhowmick
`incorporated Castillo by reference, we would not be persuaded that this
`argument eliminated the need to propose a reason to combine the teachings
`of the references in a manner that would result in the particular ophthalmic
`solution that is the subject of the challenged claims. Assuming, for the sake
`of argument, that Bhowmick incorporated Castillo sufficiently to make
`Castillo’s disclosure part of Bhowmick (turning the combination of Castillo
`and Bhowmick into something akin to a single reference), that still would
`not dispense with the need to articulate a reason to combine the disparate
`teachings of the references. In re Stepan, 868 F.3d 1342, 1346 n.1 (Fed. Cir.
`2017) (a reason to combine the teachings is needed even in a single-
`reference obviousness ground). Accordingly, the mere fact that Castillo
`might be incorporated into Bhowmick does not obviate the need for a reason
`to combine them.
`
`
`1 Petitioner cites to the declaration of Dr. Paul A. Laskar in IPR2018-01020
`and IPR2018-01021 as providing some explanation of the alleged
`incorporation by reference of Castillo into Bhowmick. Pet. 24 (citing
`Ex. 1014 ¶ 197). But that testimony does no more than repeat the Petition’s
`statement that “Bhowmick even discusses Castillo and its teachings that
`PVP improves the stability of olopatadine solutions.” Compare Pet. 24, with
`Ex. 1014 ¶ 197. Even if Dr. Laskar had argued that Bhowmick’s
`“discuss[ion]” of Castillo amounted to an incorporation of Castillo by
`reference into Bhowmick, Petitioner’s adoption of that argument without
`discussing it in the Petition would amount to an incorporation into the
`Petition by reference, in violation of the Board’s rules. 37 C.F.R.
`§ 42.6(a)(3).
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`Where, as here, each ground advanced in the Petition asserted three or
`more references in combination, we are not persuaded that the Petition
`articulated, with sufficient particularity, any reason with a rational
`underpinning why an ordinarily skilled artisan would have been led to
`combine them in the manner claimed. Thus, we did not abuse our discretion
`by not concluding that Bhowmick incorporated Castillo by reference.
`
`2. Alleged “Substantial Evidence” in the Petition
`Petitioner also argues that the Board “overlooked the substantial
`evidence establishing [a] motivation to combine” Bhowmick, Castillo, and
`Yanni. Req. Reh’g 5–9. In making this argument, Petitioner directs us to
`pages 15, 16, and 18–24 of the Petition as having presented this argument
`previously. Id. None of these pages presents such an argument that we
`overlooked. Pages 15 and 16 describe the teachings of Bhowmick, Yanni,
`and Castillo without explaining why those teachings would have led a
`person of ordinary skill in the art to combine them. Pet. 15–16. Pages 18–
`21 discuss the reasons for a person of ordinary skill in the art to have
`combined the teachings only of Bhowmick and Yanni. Id. at 18–21. Pages
`21–23 discuss the teachings of Castillo, but the only argument offered for
`why a person of ordinary skill in the art would have combined those
`teachings with the teachings of Bhowmick and Yanni is the statement on
`page 23 that the Board discussed in the Decision. Id. at 23 (“A POSA would
`have been motivated to look to Castillo because, like Bhowmick, Castillo
`taught ophthalmic olopatadine solutions for treatment of allergic disorders
`comprising similar excipients.”); see Dec. 10 (discussing this argument).
`Thus, we disagree with Petitioner’s statement in the Rehearing Request that
`“[t]he Petition also explained that because Castillo teaches using
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`IPR2020-00295
`Patent 9,533,053 B2
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`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.” Req. Reh’g 6 (emphases in original).
`Petitioner also argues that the Petition provided another reason to
`combine the teachings of Bhowmick and Castillo: “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.
`(quoting Pet. 24). That argument, at best, is directed toward providing a
`reason to combine the teachings of only Bhowmick and Castillo, not to
`combine the teachings of Bhowmick, Castillo, and Yanni, the combination
`on which Petitioner’s obviousness argument rests. Id. at 5–6 (arguing only
`for the combination of Bhowmick and Castillo); Pet. 23–24 (discussing only
`Bhowmick and Castillo). We noted this issue with Petitioner’s arguments in
`our earlier decision. Dec. 10.
`
`B. Reason to Combine Bhowmick, Castillo, and Schneider
`In the Decision, the Board explained why Petitioner had not shown
`sufficiently that a person of ordinary skill in the art would have had a reason
`to combine the teachings of Schneider, Bhowmick, and Castillo. Id. at 12–
`13. Petitioner argues that our determination “overlooked the record
`evidence establishing motivation . . . to combine the teachings of [these
`references].” Req. Reh’g 9–13.
`Petitioner argues first that the same arguments presented with respect
`to the combination of Bhowmick, Castillo, and Yanni also apply to the
`combination of Bhowmick, Castillo, and Schneider. Id. at 9–10. We find
`these arguments unpersuasive for the reasons discussed above.
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`Next, Petitioner directs us to additional arguments we allegedly
`overlooked for combining the teachings of Bhowmick, Castillo, and
`Schneider. Id. at 9–13 (citing Pet. 40, 45–48, 54–55, 58–59). Page 40 of the
`Petition describes the teachings of Schneider without explaining why those
`teachings would have led a person of ordinary skill in the art to combine
`them with the teachings of Bhowmick and Castillo. Pet. 40. The same is
`true of page 45 of the Petition, which discusses what a person of ordinary
`skill in the art would have understood Schneider to teach, without explaining
`why the person of ordinary skill in the art would have combined those
`teachings with the teachings of Bhowmick and Castillo. Pet. 45.
`Petitioner argues that “the Petition explained that a ‘POSA would
`have been motivated to combine the teachings of Schneider and Castillo’
`and that the ‘desire to solubilize higher olopatadine concentrations and
`achieve long-term stability would have motivated a POSA to include
`excipients such as PEG 400 [as taught in Castillo] into the ophthalmic
`composition.’” Req. Reh’g 11–12 (quoting Pet. 46) (emphasis in Rehearing
`Request). We disagree that we overlooked any such argument for
`combining the teachings of Bhowmick, Castillo, and Schneider. First, the
`argument on page 46 of the Petition is not merely that a “POSA would have
`been motivated to combine the teachings of Schneider and Castillo,” as
`Petitioner quotes it. Id. Instead, it is that “a POSA would have been
`motivated to combine the teachings of Schneider and Castillo, because both
`references teach ophthalmic solutions for treatment of allergic disorders
`comprising olopatadine, reciting similar excipients.” Pet. 46 (emphasis
`added). We discussed this argument in our earlier decision, concluding that
`showing that “references are all directed to the same problem is not, by
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`IPR2020-00295
`Patent 9,533,053 B2
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`itself, a sufficient rationale to combine the references.” Dec. 10, 12–13. We
`are not persuaded of an abuse of discretion by the fact that Petitioner directs
`us to a portion of page 46 that argues that Castillo teaches using PEG 400 in
`its composition. This is an argument about what Castillo teaches, not why a
`person of ordinary skill in the art would have combined that teaching with
`the teachings of Schneider and Bhowmick.
`The same is true for the arguments to which Petitioner directs us on
`pages 47 and 48 of the Petition. Req. Reh’g 12. The discussion of
`cyclodextrins on those pages mostly focuses on the teachings of Bhowmick,
`not the reason to combine those teachings with the teachings of the other
`references. Pet. 48. To the extent a reason to combine the teachings of the
`references is given, it is the same reason discussed and rejected in our earlier
`decision: “a POSA would have been motivated to combine the teachings of
`Schneider and Bhowmick, because both references teach ophthalmic
`solutions for treatment of allergic disorders comprising olopatadine, reciting
`similar excipients.” Id. at 47–48. For the reasons discussed both in that
`decision and above, we do not find this argument for combining the
`teachings of the references persuasive. Dec. 10, 12–13. We understand
`Petitioner disagrees with the Board’s assessment, but simple disagreement is
`not effective to demonstrate an abuse of discretion.
`Petitioner also argues that pages 58 and 59 of the Petition contain an
`argument for combining the teachings of Bhowmick, Castillo, and
`Schneider. Req. Reh’g 13. We disagree. Those pages of the Petition
`discuss the teachings of Bhowmick, Castillo, and Schneider regarding the
`inclusion of benzalkonium chloride, not a reason to combine the teachings of
`those references. Pet. 58–59. Accordingly, we did not overlook any
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`IPR2020-00295
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`argument on these pages regarding a reason to combine the teachings of
`Bhowmick, Castillo, and Schneider.
`Finally, in arguing that we overlooked the argument on pages 54
`and 55 of the Petition, Petitioner again directs us to the argument that the
`references being in the same art provides a reason to combine their
`teachings. Req. Reh’g 13 (quoting Pet. 54–55) (“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.’”).
`This argument is unpersuasive to show an abuse of discretion for reasons
`discussed above. As for Petitioner’s argument that we have taken this
`statement out of context, without considering its interaction with Petitioner’s
`other arguments, we have already discussed why those arguments do not
`show sufficiently that a person of ordinary skill in the art would have had a
`reason to combine the teachings of Bhowmick, Castillo, and Schneider.
`Petitioner does not identify, with sufficient particularity, any argument or
`combination of arguments raised in the Petition that the Board overlooked or
`misapprehended in the Decision.
`
`C. Reason to Combine Hayakawa with Bhowmick, Castillo, and
`Schneider
`Petitioner argues that we overlooked arguments it made with respect
`to combining the teachings of Hayakawa with those of Bhowmick, Castillo,
`and Schneider. Req. Reh’g 13–15. As discussed above, however, Petitioner
`has not persuaded us that we abused our discretion in determining that
`Petitioner failed to demonstrate a reason to combine the teachings of
`Bhowmick, Castillo, and Schneider. In the Petition, Hayakawa is advanced
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`IPR2020-00295
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`only in combination with these other references. Pet. 38–54. Accordingly,
`even if, for the sake of argument, we accept that the Decision overlooked
`arguments for combining the teachings of Hayakawa with those of
`Bhowmick, Castillo, and Schneider, we are not persuaded of error.
`Petitioner has not shown where or how the Petition articulates, with
`sufficient particularity, a reason to combine all four references to achieve an
`ophthalmic solution meeting all the limitations of the challenged claims.
`None of the arguments raised by Petitioner in the Rehearing Request
`adequately addresses that deficiency in the Petition.
`
`CONCLUSION
`For the foregoing reasons, Petitioner has not demonstrated that the
`Board abused its discretion in declining to institute an inter partes review of
`claims 1–13 of the ’053 patent.
`
`
`
`ORDER
`
`It is hereby
`ORDERED that the Request for Rehearing is denied.
`
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`IPR2020-00295
`Patent 9,533,053 B2
`
`PETITIONER:
`Jitendra Malik, Ph.D.
`Alissa M. Pacchioli
`KATTEN MUCHIN ROSENMAN LLP
`jitty.malik@katten.com
`alissa.pacchioli@katten.com
`guylaine.hache@katten.com
`
`
`
`PATENT OWNER:
`Andrew V. Trask
`WILLIAMS & CONNOLLY LLP
`atrask@wc.com
`
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