PAPER NO. 8
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_______________________
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`AQUESTIVE THERAPEUTICS, INC.
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`Petitioner
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`v.
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`NEURELIS, INC.
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`Patent Owner
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`_______________________
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`Case: IPR2019-00449
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`U.S. Patent No. 9,763,876
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`______________________
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`PETITIONER’S REQUEST FOR REHEARING
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`PURSUANT TO 37 C.F.R. § 42.71(d)
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_______________________
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`AQUESTIVE THERAPEUTICS, INC.
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`Petitioner
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`v.
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`NEURELIS, INC.
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`Patent Owner
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`_______________________
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`Case: IPR2019-00449
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`U.S. Patent No. 9,763,876
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`______________________
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`PETITIONER’S REQUEST FOR REHEARING
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`PURSUANT TO 37 C.F.R. § 42.71(d)
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`IPR2019-00449
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`U.S. Patent No. 9,763,876
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`TABLE OF CONTENTS
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`TABLE OF AUTHORITIES .................................................................................... ii
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`PRELIMINARY STATEMENT ............................................................................... 1
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`PTAB’S DECISION WITH RESPECT TO CARTT ‘865 IN VIEW OF UEDA .... 3
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`MOTIVATION TO COMBINE CARTT ‘865 AND UEDA .................................... 5
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`PETITIONER’S CARTT ‘865 IN VIEW OF UEDA FOR CLAIM 8...................... 8
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`‘876 Patent Claim 1 is expressly disclosed by Cartt ‘865 in view of Ueda. ......... 8
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`Claim 8 of ‘876 Patent expressly disclosed by Ueda. .........................................10
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`Claim 15 of ‘876 Patent is obvious over Cartt ‘876 in view of Ueda with an
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`unexpected results/criticality/optimization argument. .........................................11
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`DR. PEPPAS’S DECLARATION, POINTED TO IN THE PETITION,
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`CONFIRMS CLAIM 8 DID NOT RELY ON ANY UNEXPECTED
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`RESULTS/CRITICALITY/ OPTIMIZATION ARGUMENTS, WHILE CLAIM
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`15 DID RELY ON THESE ARGUMENTS. ...........................................................13
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`CONCLUSION ........................................................................................................15
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`Cases
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`U.S. Patent No. 9,763,876
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`TABLE OF AUTHORITIES
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`PGS Geophysical AS v. Iancu, 891 F.3d 1354 (Fed. Cir. 2018)
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`SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348 (2018)
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`U.S. Patent No. 9,763,876
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`PRELIMINARY STATEMENT
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`Pursuant to 37 C.F.R. § 42.71(d), Petitioner Aquestive Therapeutics, Inc.
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`respectfully requests rehearing of the Decision Denying Institution of Inter Partes
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`Review of claims 8-10, 15 and 30-36 of U.S. Patent No. 9,763,876 (the ‘876
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`Patent”) entered August 1, 2019 (Paper 7) in IPR2019-00449 (“Decision”).1
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`In the Decision, the Board misapprehended and/or overlooked Petitioner’s
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`“stand-alone” argument that claim 8 is obvious over Cartt ‘865 (Exhibit 1010) in
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`view of Ueda (Exhibit 1019) – an argument that does not include unexpected
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`results/criticality/optimization as its basis. Instead the Board appeared to conflate
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`this argument with Petitioner’s arguments regarding obviousness over Cartt ‘865 in
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`view of Ueda for claim 15 (among other claims) – arguments which do have
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`unexpected results/criticality/optimization as their basis. A POSITA would have
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`had ample motivation to expressly combine Cartt ‘865 with Ueda, given their
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`respective teachings. Moreover, their combination expressly disclose all the
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`limitations of claim 8 (as well as claim 1, from which it depends), rendering claim
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`8 unpatentable. The Board, in effect, added a criticality argument to Petitioner’s
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`claim 8 obviousness argument of Cartt ‘865 in view of Ueda, and in so doing,
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`1 August 31st was a Saturday, September 1 and September 2 were a Sunday and
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`Labor Day, respectively, so this request filed September 3rd is timely.
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`never addressed Petitioner’s argument, and thus wrongly denied institution of
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`U.S. Patent No. 9,763,876
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`claim 8 on the basis of “criticality.” Decision, p. 21.
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`Petitioner’s argument in the Petition as to why claim 8 is obvious is
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`straightforward. See Petition, pp. 32-33, 60-63, 74-76. First, Cartt ‘865 in view of
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`Ueda expressly discloses all the limitations of claim 1 of the ‘876 Patent. Ueda
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`provides the express ethanol/benzyl alcohol combination. Second, claim 8 merely
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`adds specified broad ranges to the ethanol/benzyl alcohol combination of claim 1.
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`Claim 8 is therefore obvious over Cartt ‘865 in view of Ueda’s express disclosure
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`of combinations of ethanol and benzyl alcohol in amounts falling directly within
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`the ethanol/benzyl alcohol ranges recited in claim 8. See Petition, pp. 61-63, 74-
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`77, Paper 2 and discussion below. Thus, as discussed further below, Petitioner’s
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`stand-alone obviousness argument in its Petition demonstrates that at least claim 8
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`is obvious over Cartt ‘865 in view of Ueda. Therefore, Petitioner requests that
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`IPR2019-00449 be instituted.
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`Due in part to space limitations, Petitioner is limiting its focus herein to
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`claim 8. Petitioner understands that if the Board decides that Petitioner has
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`demonstrated a reasonable likelihood that at least claim 8 is obvious, then in
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`accordance with SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018) and PGS
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`Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018), the Board will
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`institute on all claims and grounds. However, while Petitioner is only addressing
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`herein claim 8, if the IPR is instituted, Petitioner does not waive and will
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`vigorously pursue the Petition’s remaining claim challenges.
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`PTAB’S DECISION WITH RESPECT TO CARTT ‘865 IN VIEW OF UEDA
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`In its Decision, the Board noted that “Claims 8–10 depend directly or
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`indirectly from claim 1 and each require—either expressly or through their
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`dependence to claim 8— ‘ethanol from 1 to 25% (w/v) and benzyl alcohol from 1
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`to 25% (w/v).’ Ex. 1001, 63:59–67. Claim 15 depends from claim 1 and requires
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`‘ethanol from 10 to 22.5% (w/v) and benzyl alcohol from 7.5 to 12.5% (w/v).’ Id.
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`at 64:15–17.” Decision, p. 8. In deciding that Cartt ‘865 is § 102(b) art to
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`challenged claims 8-10, 15 and 30-33 of the ‘876 Patent, the Board noted that
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`“[w]e are directed to no express disclosure in Cartt ‘865 . . . of using ethanol and
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`benzyl alcohol in the ranges recited in claims 8 and 15.” Decision, p. 10.
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`The Board then went on to consider Petitioner’s arguments that claims 8 and
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`15 were anticipated by Cartt ‘865, finding that Petitioner had failed to demonstrate
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`that the disclosures of Cartt ‘865 regarding ethanol and benzyl alcohol as co-
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`solvents anticipated claims 8-10 and 15 of the ‘876 Patent. Decision, p. 17. The
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`Board also found that Petitioner’s arguments regarding Cartt ‘865’s disclosure of
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`overlapping alcohol ranges and of specific alcohol ranges failed to demonstrate
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`anticipation of the ethanol and benzyl alcohol limitations of claims 8-10 and 15.
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`Decision, pp. 18, 19.
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`Next, the Board considered the obviousness of claims 8 and 15, inter alia,
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`over Cartt ‘865 alone. The Board noted that Petitioner relied on its earlier
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`anticipation arguments and that, significantly, Petitioner was relying on its
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`argument that “none of the recited [ethanol and benzyl alcohol] ranges…have been
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`shown to have any criticality or result in unexpected effects.” Decision, p. 19.
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`However, the Board was not persuaded and held that Petitioner had not
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`demonstrated a reasonable likelihood that claims 8-10 and 15, inter alia, would
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`have been obvious over Cartt ‘865 alone.
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`Then, the Board addressed the obviousness of claims 8 and 15, inter alia,
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`over Cartt ‘865 in view of Ueda. However, in arguing obviousness over Cartt ‘865
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`in view of Ueda, Petitioner never argued “criticality” with respect to claim 1 or
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`claim 8.2 Rather, Petitioner had argued unexpected results/criticality/optimization
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`with respect to claim 15, inter alia. What follows is the complete statement from
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`the Decision on claims 8 and 15 over Cartt ‘865 in view of Ueda.
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`“2. Claims 8–10, 15, and 30–33 over Cartt ’865 and Ueda
`Petitioner’s ground based on Cartt ‘865 and Ueda also relies on a
`perceived lack of criticality in the choice of ranges for ethanol and
`benzyl alcohol. Pet. 62–63 (‘Again, PO has never expressed or argued
`any criticality in its choice of alcohols in general or in the
`ethanol/benzyl alcohol combination
`(in various amounts)
`in
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`2 This is true of claims 30 and 31 as well.
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`particular.’). Accordingly, for the reasons discussed with respect to the
`ground based solely on Cartt ’865, we do not find persuasive
`Petitioner’s arguments with respect to Cartt ’865 and Ueda.”
`Decision, p. 21, Paper 7 (emphasis supplied).
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`Importantly, Petitioner had no need to argue “criticality” with respect
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`to claims 1 or 8, nor did Petitioner so argue. As discussed below, Ueda
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`expressly met the ethanol/benzyl alcohol limitations of claims 1 and 8. See, e.g.
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`Petition, p. 62. On the other hand, as also discussed below, to meet the different
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`ethanol/benzyl alcohol limitations of claim 15, Petitioner argued that a POSITA
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`would have optimized Ueda’s amount of alcohols, noting the absence of any
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`criticality or unexpected results associated with those amounts. This was
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`necessary, as Ueda did not expressly disclose the amounts of ethanol and benzyl
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`alcohol recited in claim 15. See Petition, pp. 62-63.
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`MOTIVATION TO COMBINE CARTT ‘865 AND UEDA
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`A POSITA would have been motivated to combine Cartt ‘865 with Ueda.
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`Cartt ‘865 discloses “one or more alcohols are selected from the group consisting
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`of: ethanol,…benzyl alcohol, any isomers thereof, and any combinations thereof.”
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`Cartt’865, [0023].” Petition, p. 75. Ueda teaches that ethanol and benzyl alcohol is
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`a frequent choice. Id.
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`“Ueda (Exhibit 1019) discloses the combination of benzyl alcohol and
`ethanol which are ‘frequently used, and these alcohols, making up for
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`low solubility of [the active], function to increase absorption and
`penetration’ of Ueda’s invention. Ueda, 3:65-4:1, Exhibit 1019, p.
`0003. As such, Ueda’s disclosure is relevant and useful to a POSITA
`with respect to the use of ethanol/benzyl alcohol to increase intranasal
`absorption and penetration of a drug. See Peppas, Exhibit 1041, ¶322.”3
`Petition, p. 61.
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`Importantly, Ueda discloses examples of its inventive formulations
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`comprising combinations of ethanol and benzyl alcohol in various amounts for the
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`purpose of increasing absorption and penetration of the drug. “Ueda, Table
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`(unnumbered), 6:30-52, Examples 1 and 3 (20% ethanol, 5% benzyl alcohol),
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`Formulation Example 2 (25% ethanol, 10% benzyl alcohol).” Petition, p. 75; see
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`also Ueda, 6:30-52, Exhibit 1019, p. 0004.
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`A POSITA aware of the combined disclosures in Cartt ‘865 and Ueda,
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`would have been motivated to modify Cartt ‘865’s teachings (i.e., to increase the
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`absorption and solubility of its active through the addition of ethanol/benzyl
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`alcohol) using Ueda’s teachings of specific combinations of ethanol and benzyl
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`3 The citation to Dr. Peppas points to his opinion that even though Ueda is a
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`preparation for topical absorption “it is still relevant because it relates to a
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`pharmaceutical solution.” Peppas, ¶ 322, Exhibit 1041, p. 161; see also, id., ¶¶
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`127, 127, 140, 142.
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`alcohol for the same purpose. Such motivation is derived at least from Cartt ‘865’s
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`disclosure to use additional alcoholic ingredients, combined with a POSITA’s
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`desire to maximize efficacy of the alcoholic ingredients (as taught in Ueda). See
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`Petition, pp. 62-63.
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`In the Petition’s section on Cartt ‘865 in view of Ueda (pp. 61-63), Petitioner
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`referenced Peppas Dec. ¶¶ 375-387 (Exhibit 1041), which is a section entitled “A
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`POSITA Would Have Ample Motivation to Combine Cartt ‘865 With Ueda”. At
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`paragraph 376, Peppas confirms the motivation to combine Cartt ‘865 with Ueda.
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`“376. For example, Ueda teaches that ‘an alcohol improves poor
`solubility’. Ueda, 3:27-32, Exhibit 1019, p. 0003. Ueda also makes a
`point of mentioning two specific alcohols: ‘Among others, ethanol and
`benzyl alcohol are frequently used, and these alcohols, making up for
`low solubility of the Compound [I], function to increase absorption and
`penetration of the composition of the present invention.’ Ueda, 3:65-
`4:1, Exhibit 1019, p. 0003. The skilled artisan would therefore
`understand Ueda to be recommending the use of a combination of
`ethanol and benzyl alcohol because it is useful for purposes of
`increasing solubility, increasing absorption, and enhancing penetration.
`Significantly, Ueda also refers to a composition that contains both ethyl
`alcohol and benzyl alcohol as its ‘most preferable composition’ which
`was non-irritative. Ueda, 5:5-13, Exhibit 1019, p. 0004.”
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`Thus, a POSITA would have been motivated to combine the teachings of
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`Cartt ‘865 with Ueda.
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`PETITIONER’S CARTT ‘865 IN VIEW OF UEDA FOR CLAIM 8
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`First, we will discuss claim 1 (from which claims 8 and 15 depend) and its
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`stand-alone obviousness argument. Second, we will discuss claim 8’s stand-alone
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`obviousness argument. Third, to demonstrate the difference in arguments, we will
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`discuss claim 15 and it use of an unexpected results/criticality/optimization
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`obviousness argument.
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`‘876 Patent Claim 1 is expressly disclosed by Cartt ‘865 in view of Ueda.
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`First, as demonstrated in the Petition, Cartt ‘865 in view of Ueda (providing
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`for the combination of ethanol and benzyl alcohol in [1c] below) expressly
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`discloses all the claim limitations of claim 1 of the ‘876 Patent. See Petition, pp.
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`32-33, 61-63, 74-76. Claim 1 of the ‘876 Patent is compared below with the Cartt
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`‘865 and Ueda disclosures from the Petition at pages 32-33, 61-62, and 74-76.
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`Claim 1 ‘876 Patent
`[1a] A method of treating a
`patient with a disorder which
`is treatable with a
`benzodiazepine drug,
`comprising:
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`administering to one or more
`nasal mucosal membranes of
`a patient a pharmaceutical
`solution for nasal
`administration consisting of
`a benzodiazepine drug,
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`Cartt ‘865 and Ueda
`[1a] “A method of treating a patient with a
`disorder which may be treatable with a
`benzodiazepine drug, comprising: (a)
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`“administering to one or more nasal mucosal
`membranes of a patient a pharmaceutical
`composition for nasal administration comprising
`a benzodiazepine drug, [Cartt ‘865, claim 20,
`Exhibit 1010, p. 29.]
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`[1b] one or more natural or
`synthetic tocopherols or
`tocotrienols, or any
`combinations thereof, in an
`amount from about 30% to
`about 95% (w/w);
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`[1c] ethanol and benzyl
`alcohol in a combined
`amount from about 10% to
`about 70% (w/w); and
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`[1d] an alkyl glycoside.
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`[1b] “one or more natural or synthetic
`tocopherols or tocotrienols, or any combinations
`thereof, in an amount from about 30% to about
`95% (w/w), and [Cartt ‘865, claim 20, Exhibit
`1010, p. 29.]
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`[1c] “one or more alcohols or glycols, or any
`combinations thereof, in an amount from about
`10% to about 70% (w/w).” [Cartt ‘865, claim
`20, Exhibit 1010, p. 29.]
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`[1c] “The method of claim 20, wherein the one or
`more alcohols are selected from the group
`consisting of: ethanol, propyl alcohol, butyl
`alcohol, pentanol, benzyl alcohol, any isomers
`thereof, and any combinations thereof.” [Cartt
`‘865, claim 28, Exhibit 1010, p. 30.]
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`[1c] “Among others, ethanol and benzyl
`alcohol are frequently used, and these alcohols,
`making up for low solubility of the Compound
`[I], function to increase absorption and
`penetration of the composition of the present
`invention.” [Ueda, 3:19-3:21, 3:65-4:1, Exhibit
`1019, p. 0003.]
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`[1c] Ueda, Table, 6:30-52, Formulation Examples
`1 and 3 (20% ethanol, 5% benzyl alcohol),
`Formulation Example 2 (25% ethanol, 10%
`benzyl alcohol). Ueda, Exhibit 1019, p. 0004.]
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`[1d] “The composition of claim 20, wherein the
`pharmaceutically-acceptable formulation
`comprises at least about 0.01% (w/w) of an alkyl
`glycoside.” [Cartt ‘865, claim 46, Exhibit 1010,
`p. 30.]
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`Claim 8 of ‘876 Patent expressly disclosed by Ueda.
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`Second, as discussed above, claim 8 merely adds to claim 1 that “the
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`solution contains ethanol from 1 to 25% (w/v) and benzyl alcohol from 1 to 25%
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`(w/v).” See ‘876 Patent, 63:59-67, Exhibit 1001. As demonstrated in the
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`Petition, Ueda expressly discloses the limitation. See pp. 62, 75-76, and below,
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`where claim 8 of the ‘876 Patent is compared with Ueda’s Examples 1-3
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`disclosures of ethanol and benzyl alcohol.
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`Claim 8. The method of claim 1,
`wherein the solution contains
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`ethanol from 1 to 25% (w/v) and
`benzyl alcohol from 1 to 25%
`(w/v).
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`Ueda Examples 1 and 3 disclose
`compositions with
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`20% ethanol and
`5% benzyl alcohol [Exhibit 1019, p.0004.]
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`Ueda Example 2 discloses compositions with
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`25% ethanol and
`10% benzyl alcohol [Exhibit 1019, p.0004.]
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`Thus, the amounts of ethanol and benzyl alcohol in Ueda’s solution
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`examples fall within the ranges recited in claim 8, and Petitioner clearly stated so
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`in the Petition.
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` “Ueda also provides several examples of specific combinations of
`ethanol/benzyl alcohol. Ueda’s Formulation Examples 1 and 3 disclose
`compositions with 20% ethanol and 5% benzyl alcohol. See Ueda,
`Table (unnumbered), Exhibit 1019, p. 0004. These amounts fall within
`the ranges recited in Claim 8 [ethanol from 1 to 25% (w/v) and benzyl
`alcohol from 1 to 25% (w/v)] (and thus in dependent Claims 9-10) and
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`Claims 30-31, thereby rendering obvious the amounts recited in Claims
`8-10 and 30-31. Ueda’s Formulation Example 2 discloses 25% ethanol
`and 10% benzyl alcohol. These amounts fall within the ranges recited
`in Claim 8, thereby again rendering obvious the amount in Claim 8.”
`Petition, p. 62, Paper 2 (emphasis supplied).
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`Ueda’s combinations of ethanol (20%) and benzyl alcohol (5%) fall
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`squarely within the claimed ranges for ethanol (1-25%) and benzyl alcohol
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`(1-25%) of claim 8. Thus, there was no need to argue unexpected
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`results/criticality/ optimization, nor did Petitioner do so. Therefore, it was
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`wrong to deny institution with respect to claim 8.
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`Claim 15 of ‘876 Patent is obvious over Cartt ‘876 in view of Ueda with an
`unexpected results/criticality/optimization argument.
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`Third, we discuss claim 15 by contrast to claim 8, where the
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`unexpected results/criticality/optimization argument was needed for the
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`obviousness analysis of claim 15. This is clear when claim 15 is compared
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`with Ueda’s Examples 1-3 disclosures, see below.
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`Claim 15. The method of
`claim 1, wherein the
`solution comprises
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`ethanol from 10 to
`22.5% (w/v) and
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`benzyl alcohol from 7.5
`to 12.5% (w/v).
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`Ueda Examples 1
`and 3 disclose
`solutions with
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`20% ethanol
`and
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`5% benzyl alcohol
`[Exhibit 1019, p.4.]
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`Ueda Example 2 discloses
`solutions with
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`25% ethanol and
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`10% benzyl alcohol
`[Exhibit 1019, p.4.]
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`As can be seen with respect to ‘876 Patent claim 15 “wherein the
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`solution comprises ethanol from 10 to 22.5% (w/v) and benzyl alcohol from
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`7.5 to 12.5% (w/v)”4, because Ueda’s combined amounts of ethanol and
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`benzyl alcohol do not expressly fall with the claimed ranges, Petitioner
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`argued unexpected results/criticality/optimization. As stated in the Petition:
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`“Formulation Examples 1 and 3’s 20% ethanol falls within the
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`ranges recited in Claims 15, 32, and 33. Further, Formulation
`Example 2’s 10% benzyl alcohol falls within the ranges recited in
`Claims 15, 32, and 33.
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`“Again, PO has never expressed or argued any criticality in its
`choice of alcohols in general or in the ethanol /benzyl alcohol
`combination (in various amounts) in particular. Peppas, Exhibit 1041,
`¶¶60, 260, 264, 380, 384, 386; see also EP FH, Exhibit 1040, p. 0377;
`see also M.P.E.P. § 2144.05(II)(A) (concentration differences generally
`don’t support patentability of subject matter encompassed by prior art,
`absent evidence of criticality).
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`“Therefore, a POSITA aware of the disclosures in Cartt’865
`(e.g., Solution 6-00) and Ueda, could and would have easily optimized
`(through routine experimentation) the amount and type of alcohols
`present in Solution 6-00. See, e.g., Peppas, Exhibit 1041, ¶¶375-387.
`The POSITA would have been motivated to modify Cartt’865’s
`teachings (i.e., to increase the absorption and solubility of its active
`through the addition of ethanol/benzyl alcohol) using Ueda’s teachings
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`4 As well as claim 32 (ethanol (15-22.5%); benzyl alcohol (7.5-12.5%)) and claim
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`33 (ethanol (17-20%); benzyl alcohol (10-12%)).
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`that the preferred combination of enhancers is 20-40% ethanol and 5-
`10% benzyl alcohol. Such motivation is derived at least from
`Cartt’865’s disclosure
`to use additional alcoholic
`ingredients,
`combined with a POSITA’s desire to maximize efficacy of the
`alcoholic ingredients (as taught in Ueda).”
`Petition, pp. 62-63, 78, Paper 2 (emphasis supplied).
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`DR. PEPPAS’S DECLARATION, POINTED TO IN THE PETITION,
`CONFIRMS CLAIM 8 DID NOT RELY ON ANY UNEXPECTED
`RESULTS/CRITICALITY/ OPTIMIZATION ARGUMENTS, WHILE
`CLAIM 15 DID RELY ON THESE ARGUMENTS.
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`Referenced in the Petition’s section on “Cartt ‘865 in view of Ueda” at p.62
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`was, inter alia, ¶¶ 378-380 of Dr. Peppas’s Declaration (Exhibit 1041). These
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`paragraphs confirm the different obviousness arguments made with respect to
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`claims 8 and 15, inter alia. First, Dr. Peppas provides in chart form the
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`ethanol/benzyl alcohol combinations of Ueda’s solutions (¶ 378). Then, Dr.
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`Peppas states that Ueda’s Examples 1-3 all fall expressly within the ethanol/benzyl
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`alcohol ranges of claims 8-10 (¶ 378). Finally, Dr. Peppas states that while
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`Ueda’s examples meet the benzyl alcohol requirements of claim 15, the ethanol
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`amount is slightly higher. Therefore, according to Dr. Peppas a POSITA could use
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`routine experimentation to modify the ethanol amount as there does not appear to
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`be any criticality or unexpected results. See below.
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`“378. Significantly, Ueda teaches specific formulations that include
`combinations of ethanol and benzyl alcohol in the following
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`13
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`IPR2019-00449
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`amounts[fn]:
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`U.S. Patent No. 9,763,876
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`Ethanol
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` Benzyl Alcohol
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`Formulation Example 1
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`Formulation Example 2
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`Formulation Example 3
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`20%
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`25%
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`20%
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`5%
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`10%
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`5%
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`****
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`****
`****
`[fn. See Ueda, Table, Exhibit 1019, p. 0004.]
`“379. Formulation Examples 1-3 therefore all fall within the 1-25%
`range recited in Claim 8 of the ‘876 Patent for each of ethanol and
`benzyl alcohol. Because Claims 9 and 10 of ‘876 Patent depend from
`Claim 8, they each also have the same limitation, which is met by
`Formulation Examples 1-3.
`“380 Formulation Example 2 includes 10% benzyl alcohol, which
`meets the requirement of Claim 15 of the ‘876 Patent. While the
`ethanol in Formulation Example 2 is 25%, which is slightly higher than
`Claim 15’s upper
`limit of 22.5%, a POSITA using routine
`experimentation could modify the amount of ethanol from 25% down
`to, e.g., 22.5% (and even lower) with an expectation of success. In
`particular, and as the EPO has recognized, there does not appear to be
`any criticality or unexpected results based on the specific combinations
`of ethanol and benzyl alcohol. See, e.g., EP FH, Exhibit 1040, pp. 0298,
`0328, and 0365. Therefore, a POSITA would readily recognize that a
`teaching of 25% ethanol could easily be lowered to 22.5% ethanol (and
`even lower) without affecting the overall operation of the combination
`of alcohols.”
`Peppas Dec. ¶¶ 378-380 (Exhibit 1041, emphasis supplied).
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`14
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`IPR2019-00449
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`In the Petition, as confirmed by Dr. Peppas, Petitioner made a stand-alone
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`U.S. Patent No. 9,763,876
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`obviousness argument with respect to claim 8; however, with respect to claim 15,
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`Petitioner relied on an unexpected results/criticality/optimization argument.
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`CONCLUSION
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`
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`The Board misapprehended and/or overlooked Petitioner’s obviousness
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`argument that “Cartt ‘865 in view of Ueda” expressly discloses all the limitations
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`of claims 1 and 8 of the ‘876 Patent and that a POSITA would have been
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`motivated to combine their teachings. Instead, the Board conflated Petitioner’s
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`claim 8 argument, with arguments for other claims, e.g., claim 15, which relied on
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`“Cartt ‘865 in view of Ueda”, albeit where Petitioner relied on unexpected results,
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`criticality or optimization. Absent this conflation of arguments, Petitioner has
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`demonstrated a reasonable likelihood that at least claim 8 is obvious. Therefore,
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`the Board should grant this request for rehearing and institute IPR2019-00449.
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`Dated: September 3, 2019
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`Respectfully submitted,
`
`By: /Daniel A. Scola, Jr./
`Daniel A. Scola, Jr.
`Reg. No. 29,855
`Hoffmann & Baron, LLP
`4 Century Drive
`Parsippany, N.J. 07054
`dscola@hbiplaw.com
`(973) 331-1700
`
`Lead Counsel for Petitioner
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`15
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`IPR2019-00449
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`U.S. Patent No. 9,763,876
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`CERTIFICATE OF SERVICE
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`
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`I hereby certify that on this the 3rd day of September 2019, the foregoing
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`PETITIONER’S REQUEST FOR REHEARING PURSUANT TO 37 C.F.R.
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`§ 42.71(d) was served in its entirety on the following counsel of record by
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`electronic service by email at the email addresses as set forth below in accordance
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`with the consent set forth in Patent Owner’s Mandatory Notices (Paper No. 6, pp.
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`2-3).
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`
` Jeffrey Guise
`Richard Torczon
`Lorelei Westin
`Lee Johnson
`Nathaniel Leachman
`Alina L. Litoshyk
`WILSON SONSINI GOODRICH & ROSATI
`jguise@wsgr.com
`rtorczon@wsgr.com
`lwestin@wsgr.com
`ljohnson@wsgr.com
`nleachman@wsgr.com
`alitoshyk@wsgr.com
`35401.650.palib1@wsgr.com
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`By:
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`/Michael I. Chakansky/
`Michael I. Chakansky (Reg. No. 31,600)
`Hoffmann & Baron, LLP
`6 Campus Drive
`
`Parsippany, N.J. 07054
`mchakansky@hbiplaw.com
`Tel: 973.331.1700
`
`
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`16
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