Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper 7
`Entered: August 1, 2019
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`AQUESTIVE THERAPEUTICS, INC.,
`Petitioner,
`v.
`NEURELIS, INC.,
`Patent Owner.
`
`
`Case IPR2019-00449
`Patent 9,763,876 B2
`
`
`Before ZHENYU YANG, JON B. TORNQUIST, and
`JAMIE T. WISZ, Administrative Patent Judges.
`
`TORNQUIST, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`Tel: 571-272-7822
`
`Paper 7
`Entered: August 1, 2019
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`AQUESTIVE THERAPEUTICS, INC.,
`Petitioner,
`v.
`NEURELIS, INC.,
`Patent Owner.
`
`
`Case IPR2019-00449
`Patent 9,763,876 B2
`
`
`Before ZHENYU YANG, JON B. TORNQUIST, and
`JAMIE T. WISZ, Administrative Patent Judges.
`
`TORNQUIST, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`
`IPR2019-00449
`Patent 9,763,876 B2
`
`INTRODUCTION
`I.
`Acquestive Therapeutics, Inc. (“Petitioner”) filed a Petition (Paper 2,
`“Pet.”) requesting an inter partes review of claims 8–10, 15, and 30–36 of
`U.S. Patent No. 9,763,876 B2 (Ex. 1001, “the ’876 patent”). Neurelis, Inc.
`(“Patent Owner”)1 filed a Preliminary Response to the Petition (Paper 5,
`“Prelim. Resp.”).
`Under 35 U.S.C. § 314, the Board “may not authorize an inter partes
`review to be instituted unless . . . the information presented in the petition
`. . . and any response . . . shows that there is a reasonable likelihood that the
`petitioner would prevail with respect to at least 1 of the claims challenged in
`the petition.” For the reasons explained below, upon consideration of the
`Petition, Preliminary Response, and the evidence of record, we determine
`that the information presented in the Petition does not show that there is a
`reasonable likelihood that Petitioner would prevail with respect to at least
`one of the claims challenged in the Petition. Accordingly, we do not
`institute an inter partes review.
`
`A. Related Proceedings
`Patent Owner indicates that the ’876 patent is also at issue in
`IPR2019-00450 and IPR2019-00451. Paper 4, 2.
`
`B. The ’876 Patent
`The ’876 patent is directed to nasally administered pharmaceutical
`solutions containing one or more benzodiazepine drugs. Ex. 1001, 9:14–17.
`
`
`1 Patent Owner informs us that subsequent to the filing of the Petition, Hale
`Biopharma Ventures, LLC, the originally named Patent Owner in this case,
`assigned its rights in the ’876 patent to Neurelis, Inc. Paper 4, 2 (citing Reel
`048271; Frame 0304).
`
`2
`
`
`
`
`IPR2019-00449
`Patent 9,763,876 B2
`The ’876 patent explains that solubility challenges associated with
`benzodiazepine drugs previously hindered the development of formulations
`intended for oral, rectal, or parenteral administration. Id. at 1:53–57, 19:12–
`15. It was discovered, however, that vitamin E (which includes tocopherols
`and tocotrienols) is an effective carrier for benzodiazepine drugs, as these
`compounds are soluble, or at least partially soluble, in vitamin E. Id. at
`33:8–13, 33:42–45. The ’876 patent also reports that vitamin E “can have
`the added benefit of either avoiding irritation of sensitive mucosal
`membranes and/or soothing irritated mucosal membranes.” Id. at 33:47–49.
`The ’876 patent discloses that one or more lower alcohols, such as
`ethanol and benzyl alcohol, may be used in the formulation. Id. at 2:57–64,
`33:55–67 (noting that to “avoid the drawbacks of emulsions,” the disclosed
`solutions contain vitamin E and “one or more lower alkyl alcohols”).
`In addition, an alkyl glycoside may be added to the formulation to act as a
`penetration enhancer. Id. at 34:2–9.
`
`C. Illustrative Claims
`Claim 1 is the only independent claim in the ’876 patent, with
`challenged claims 8–10, 15, and 30–36 all depending directly or indirectly
`from claim 1. Claims 1 and 8 are illustrative of the challenged claims and
`are reproduced below:
`
`1. A method of treating a patient with a disorder which is
`treatable with a benzodiazepine drug, comprising:
`administering to one or more nasal mucosal membranes of a
`patient a pharmaceutical solution for nasal administration
`consisting of a benzodiazepine drug, one or more natural or
`synthetic tocopherols or tocotrienols, or any combinations
`thereof, in an amount from about 30% to about 95% (w/w);
`
`3
`
`
`
`
`IPR2019-00449
`Patent 9,763,876 B2
`ethanol and benzyl alcohol in a combined amount from about
`10% to about 70% (w/w); and an alkyl glycoside.
`Ex. 1001, 63:26–34.
`8. The method of claim 1, wherein the solution contains ethanol
`from 1 to 25% (w/v) and benzyl alcohol from 1 to 25% (w/v).
`Id. at 63:59–61.
`D. The Asserted Grounds of Unpatentability
`Petitioner contends claims 8–10, 15, and 30–36 of the ’876 patent are
`unpatentable in view of the following grounds (Pet. 5–6):
`Claims
`Ground
`Reference(s)
`Basis
`1
`Cartt ’865 2
`§ 102 8–10, 15, 30–33
`2
`Cartt ’865 or Cartt ’865 and Ueda3 § 103 8–10, 15, 30–33
`3
`Cartt ’865, Meezan,4 and
`§ 103
`34–36
`Jamieson5
`In support of its obviousness arguments, Petitioner relies on the declaration
`testimony of Dr. Nicholas A. Peppas. Ex. 1041.
`
`II. ANALYSIS
`
`A. Claim Construction
`In this inter partes review, claim terms are construed using the same
`claim construction standard that would be used to construe the claim in a
`civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.100(b). Under this
`claim construction standard, claim terms are given their ordinary and
`customary meaning as would have been understood by one of ordinary skill
`
`
`2 US Pub. No. 2009/0258865 A1, published October 15, 2009 (Ex. 1010).
`3 US 4,657,901, issued April 14, 1987 (Ex. 1019).
`4 US Pub. No. 2006/0046962 A1, published March 2, 2006 (Ex. 1011).
`5 US Pub. No. 2008/0070904 A1, published March 20, 2008 (Ex. 1012).
`4
`
`
`
`
`IPR2019-00449
`Patent 9,763,876 B2
`in the art at the time of the invention. See id.; Phillips v. AWH Corp., 415
`F.3d 1303, 1313 (Fed. Cir. 2005). A patentee may define a claim term in a
`manner that differs from its ordinary and customary meaning; however, any
`special definitions must be set forth in the specification with reasonable
`clarity, deliberateness, and precision. See In re Paulsen, 30 F.3d 1475, 1480
`(Fed. Cir. 1994).
`Petitioner provides proposed constructions for the terms “vitamin E,”
`“bioavailability,” “% (w/w),” and “% (w/v).” Pet. 11–13. Patent Owner
`contends Petitioner’s constructions “are consistent with the use of those
`terms in the specification and claims,” but contends a proper understanding
`of the meaning of “about” in claim 1 is “critical” to understanding the scope
`of the challenged claims. Prelim. Resp. 4–5.
`Upon review of the parties’ arguments and the evidence of record,
`we determine that only the term “about” is in need of construction.
`See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d
`1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g,
`Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be
`construed that are in controversy, and only to the extent necessary to resolve
`the controversy.”)).
`
`“About”
`The ’876 patent provides an express definition of the term “about,”
`which is:
`
`As used herein, the modifier “about” is intended to have
`its regularly recognized meaning of approximately. In some
`embodiments, the term may be more precisely interpreted as
`meaning within a particular percentage of the modified value,
`e.g., “about” may in some embodiments mean ±20%, ±10%,
`±5%, ±2%, or ±1% or less.
`
`5
`
`
`
`
`IPR2019-00449
`Patent 9,763,876 B2
`Ex. 1001, 17:60–65.
`
`Patent Owner contends this definition allows 20% to be added or
`subtracted from a disclosed amount. Thus, according to Patent Owner,
`a disclosure of “about 10%” would include 30% at its upper end and any
`positive value at its lower end (as this range “could not include” negative
`numbers). Prelim. Resp. 12.
`Patent Owner contends its construction is supported by the
`dependency of claim 8 from claim 1. Id. at 13. Claim 1 requires ethanol and
`benzyl alcohol in amounts from about 10% to about 70% of the
`pharmaceutical solution, and dependent claim 8 recites that the solution
`“contains ethanol from 1 to 25% (w/v) and benzyl alcohol from 1 to 25%
`(w/v).” Ex. 1001, 63:33–34, 63:59–61. According to Patent Owner,
`claim 8’s dependency only makes sense if “about 10% to about 70%” in
`claim 1 is understood to require only some positive value at the lower end
`and 90% at the upper end. Prelim. Resp. 13–14.
`
`We are not persuaded by Patent Owner’s arguments. In Patent
`Owner’s example, the value of “about 10%” can be from less than 0.001% at
`the lower end to 30% at the upper end, a change of roughly 99.99% on the
`lower end and 200% on the upper end. On this record, such a construction is
`not reasonable as the term “about” in the ’876 patent still has its “regularly
`recognized meaning of approximately,” and Patent Owner does not explain
`why the ordinary meaning of the term “approximately” would include a
`range of values that are 99.99% lower and 200% higher than the “modified
`value.”
`
`The more reasonable construction of this term is to apply it as written,
`i.e., permitting a range within ±20% of “the modified value.” For example,
`
`6
`
`
`
`
`IPR2019-00449
`Patent 9,763,876 B2
`the phrase “about 10%” has a “modified value” of 10%, and 20% of the
`modified value (10%) is 2%, so the range of “about 10%” would be between
`8% and 12%, not any positive value from 0% to 30%, as asserted by Patent
`Owner.
`
`As noted by Patent Owner, claim 8 allows ethanol and benzyl alcohol
`to be present at levels as low as 1%. There does not appear to be anything
`necessarily impermissible in the dependency of claim 8 from claim 1,
`however, as any selected levels of ethanol and benzyl alcohol still must
`result in a combined value of alcohol of at least about 10%, as recited in
`independent claim 1. Pet. 21 (asserting that claims 8 and 15 are “limited at
`the lower end by independent Claim 1’s minimum of 10% alcohols”).
`
`In view of the foregoing, for purposes of this Decision, we construe
`the term “about” in the ’876 patent to mean “approximately,” and note that
`±20% means within ±20% of the modified value, e.g., ±20% of 10% would
`be a range between 8% and 12%.
`
`B. Effective Filing Date of the Challenged Claims
`The ’876 patent was filed as U.S. Application No. 14/527,613, and is
`a continuation of U.S. Application No. 13/495,942 (“the ’942 application”)
`(issued as U.S. Patent No. 8,895,546), which is in turn a continuation-in-part
`(CIP) of U.S. Application No. 12/413,439 (“the ’439 application”).
`Ex. 1001, (63); Pet. 17. The ’439 application was published on October 15,
`2009 as US Pub. No. 2009/0258865 A1 (“Cartt ’865”). The ’876 patent also
`claims priority to provisional applications 61/040,558 (“the ’558
`provisional”), 61/497,017 (“the ’017 provisional”), and 61/570,110 (“the
`’110 provisional”), filed on March 28, 2008; June 14, 2011; and December
`13, 2011, respectively. Ex. 1001, (60).
`7
`
`
`
`
`IPR2019-00449
`Patent 9,763,876 B2
`Petitioner contends that because claims 8–10, 15, and 30–36 of the
`’876 patent are not entitled to a priority date earlier than the June 14, 2011
`filing date of the ’017 provisional, Cartt ’865 is prior art to the challenged
`claims of the ’876 patent under 35 U.S.C. § 102(b). Pet. 5, 17–19.
`
`A CIP application contains new matter beyond the original disclosure,
`and different claims of a CIP application may receive different effective
`filing dates. See PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299,
`1306 (Fed. Cir. 2008). “In order to gain the benefit of the filing date of an
`earlier application under 35 U.S.C. § 120, each application in the chain
`leading back to the earlier application must comply with the written
`description requirement of 35 U.S.C. § 112.” Lockwood v. Am. Airlines,
`Inc., 107 F.3d 1565, 1571 (Fed. Cir. 1997) (citation omitted). To satisfy the
`written description requirement, the applicant must convey with reasonable
`clarity to those of ordinary skill in the art that, as of the filing date sought, he
`or she was in possession of the claimed invention. Vas-Cath Inc. v.
`Mahurkar, 935 F.2d 1555, 1563–64 (Fed. Cir. 1991). An application does
`not need to disclose the claim language in haec verba, but “[e]ntitlement to a
`filing date does not extend to subject matter which is not disclosed, but
`would be obvious over what is expressly disclosed.” Lockwood, 107 F.3d at
`1571–72.
`
`1. Claims 8–10 and 15
`Claims 8–10 depend directly or indirectly from claim 1 and each
`require—either expressly or through their dependence to claim 8—“ethanol
`from 1 to 25% (w/v) and benzyl alcohol from 1 to 25% (w/v).” Ex. 1001,
`63:59–67. Claim 15 depends from claim 1 and requires “ethanol from 10 to
`22.5% (w/v) and benzyl alcohol from 7.5 to 12.5% (w/v).” Id. at 64:15–17.
`8
`
`
`
`
`IPR2019-00449
`Patent 9,763,876 B2
`Petitioner contends the ranges for ethanol and benzyl alcohol recited
`in claims 8–10 and 15 are not disclosed in either Cartt ’865 or the
`’558 provisional. Petitioner concedes that Cartt ’865 discloses ranges for
`alcohol that are as broad as 5–70%, and specific amounts of total alcohol
`that include 10%, 12.5%, and 25%, but contends Cartt ’865 does not show
`possession of any specific ranges for ethanol and benzyl alcohol in
`combination, or the use of specific amounts of alcohols that are less than
`10%. Pet. 22–23. Thus, according to Petitioner, the limited disclosures of
`Cartt ’865 do not show possession of a specific combination of ethanol and
`benzyl alcohol, much less specific solutions with “ethanol from 1 to 25%
`(w/v) and benzyl alcohol from 1 to 25% (w/v)” or “ethanol from 10 to
`22.5% (w/v) and benzyl alcohol from 7.5 to 12.5% (w/v).” Id. at 22–24.
`In support of its written description argument, Petitioner notes that
`during prosecution of a patent application in the European Patent Office
`(EPO), the Applicants expressly asserted that the pending claims were novel
`over Cartt ’865 because that reference contains “no direct and unambiguous
`mention” of the combination of ethanol and benzyl alcohol in individualized
`form, “let alone in the claimed amounts” of 1–25% (w/v) ethanol and 1–25%
`(w/v) benzyl alcohol. Id. at 24 (citing Ex. 1040, 335); see also
`Ex. 1040, 334 (noting that the requirements of claim 7 had been added into
`pending claim 1).
`Patent Owner contends Petitioner’s arguments are not persuasive
`because they fail to address the full scope of the disclosures in the
`specification, “particularly the guidance on how to understand the term
`about.” Prelim. Resp. 15–16.
`
`9
`
`
`
`
`IPR2019-00449
`Patent 9,763,876 B2
`We are directed to no express disclosure in Cartt ’865 or the
`’558 provisional of using ethanol and benzyl alcohol in the ranges recited in
`claims 8 and 15. Nor are we directed to any disclosure in these applications
`of using an individual alcohol at levels below 5%. Conversely, the ’017 and
`’110 provisional applications, to which the ’942 CIP application claims
`benefit, expressly disclose and claim solutions containing “ethanol (1–25%
`w/v) and benzyl alcohol (1–25% w/v)” and “ethanol (10-22.5% w/v) and
`benzyl alcohol (7.5-12.5% w/v).” Ex. 1005 ¶ 10, claims 10 and 11;
`Ex. 1006 ¶ 9, claims 10 and 11. This evidence, combined with Patent
`Owner’s arguments before the EPO, sufficiently demonstrates that the first
`disclosure of the subject matter of claims 8–10 and 15 was made in the
`’017 and ’110 provisional applications.
`Patent Owner’s argument to the contrary is not persuasive as it relies
`on a claim construction that we do not adopt, i.e., that the modifier “about”
`permits simply adding or subtracting 20% to any recited percentage.
`In view of the foregoing, we determine that Cartt ’865 is § 102(b)
`prior art to challenged claims 8–10 and 15 of the ’876 patent.
`
`2. Claims 30–33
`Claims 30 and 31 require “ethanol from 10 to 25% (w/v) and benzyl
`alcohol from 5 to 15% (w/v),” claim 32 requires “ethanol from 15 to 22.5%
`(w/v) and benzyl alcohol from 7.5 to 12.5% (w/v),” and claim 33 requires
`“ethanol from 17 to 20% (w/v) and benzyl alcohol from 10 to 12% (w/v).”
`Ex. 1001, 64:66–65:17. Petitioner contends there is no express disclosure in
`Cartt ’865 or the ’558 provisional application for these claim limitations
`because these applications fail to disclose the recited ranges for ethanol and
`benzyl alcohol. Pet. 27.
`
`10
`
`
`
`
`IPR2019-00449
`Patent 9,763,876 B2
`Patent Owner contends the prior applications support the recited
`claims in view of the broad meaning of the term “about” in the ’876 patent.
`Prelim. Resp. 21.
`Here, we are directed to no express disclosure in Cartt ’865 or the
`’558 provisional application of using ethanol and benzyl alcohol in any
`particular ratios, much less within the ranges recited in claims 30–33.
`Nor are we provided with any persuasive reasoning as to why one of
`ordinary skill in the art, reading the general disclosures in Cartt ’865, would
`have understood the applicants to be in possession of such solutions.
`Thus, on this record, we determine that Cartt ’865 is § 102(b) prior art to
`challenged claims 30–33 of the ’876 patent.
`
`3. Claims 34–36
`Claims 34–36 depend directly or indirectly from claim 1 and further
`require that the “treatment achieves bioavailability” that is from about 80 to
`125% (claim 34), 90 to 110% (claim 35), and 92.5 to 107.5% (claim 36)
`“of that achieved with the same benzodiazepine administered
`intravenously.” Ex. 1001, 65:18–29.
`Petitioner contends Cartt ’865 and the ’558 provisional application do
`not disclose any bioavailability data, and only generally discuss increasing
`or improving bioavailability. Pet. 28–29. Thus, Petitioner contends these
`applications do not demonstrate possession of the inventions recited in
`claims 34–36 of the ’876 patent. Id. at 29.
`Patent Owner asserts that “since 2008 improved bioavailability has
`been the main point of the invention,” and the bioavailabilities recited in
`claims 34–36 are simply inherent properties of the claimed invention.
`Prelim. Resp. 21–24; see Kennecott Corp. v. Kyocera Int’l, Inc., 835 F.2d
`11
`
`
`
`
`IPR2019-00449
`Patent 9,763,876 B2
`1419, 1423 (Fed. Cir. 1987) (“The disclosure in a subsequent patent
`application of an inherent property of a product does not deprive that
`product of the benefit of an earlier filing date.”).
`The ’876 patent discloses that the solution of Table 11-1 achieved a
`bioavailability that is 96% of that achieved when the same drug is given
`intravenously. Ex. 1001, 62:16–18. The ’876 patent also identifies solutions
`that are “similar” to the solution used in Table 11-1, and discloses that
`“solutions similar to those set forth in Table 11-1 achieve bioavailability that
`is from about 80-125%,” about 90-110%, and about 92.5 to 107.5% of that
`obtained “with the same benzodiazepine administered intravenously.”
`Id. at 62:34–40.
`The solutions that are identified in the ’876 patent as being “similar”
`to the solution of Table 11-1 consist of:
`diazepam (5-15% (w/v)), dodecyl maltoside (0.01-1% (w/v)),
`vitamin E (45-65% (w/v)), ethanol (10-25% (w/v)) and benzyl
`alcohol (5-15% (w/v)); diazepam (9-11% (w/v)), dodecyl
`maltoside (0.1- 0.5% (w/v)), vitamin E (50-60% (w/v)), ethanol
`(15-22.5% (w/v)) and benzyl alcohol (7.5-12.5% (w/v)); or
`diazepam (10% (w/v)), dodecyl maltoside (0.15-0.3% (w/v)),
`vitamin E (50-60% (w/v)), ethanol (17-20% (w/v)) and benzyl
`alcohol (10-12% (w/v)).
`Id. at 62:23–32.
`Apparently recognizing that the solutions identified in the ’876 patent
`as being “similar” to the solution of Table 11-1 are not disclosed in
`Cartt ’865, Patent Owner asserts one of ordinary skill in the art would have
`concluded that “the claimed bioavailability is not limited to just the
`expressly disclosed embodiments,” as Cartt ’865 discloses that “[n]umerous
`variations, changes, and substitutions” are encompassed within the scope of
`the invention. Prelim. Resp. 23 (citing Ex. 1001, 62:24–33, 63:11–22).
`12
`
`
`
`
`IPR2019-00449
`Patent 9,763,876 B2
`Cartt ’865 does not disclose any bioavailability data, or the specific
`species of solutions identified in the ’876 patent as having the claimed
`bioavailabilities. Nor does Patent Owner adequately explain why the
`’876 patent’s broad statements regarding potential “variations, changes, and
`substitutions” to the disclosed embodiments would have indicated to one of
`ordinary skill in the art that the bioavailability data set forth in the
`’876 patent for specific species would apply to Cartt 865’s genus of
`pharmaceutical compositions. Thus, it is not evident that the
`bioavailabilities recited in claims 34–36 are an inherent property of the
`genus recited in claim 1 or generally disclosed in Cartt ’865 (Prelim. Resp.
`23–24), as opposed to the specific species disclosed in the ’876 patent (and
`not in Cartt ’865).
`In view of the foregoing, on this record, we determine that Cartt ’865
`is prior art under 35 U.S.C. § 102(b) to claims 34–36 of the ’876 patent.
`
`C. Alleged Anticipation of Claims 8–10, 15, and 30–33 by Cartt ’865
`Petitioner contends Cartt ’865 anticipates claims 8–10, 15, and 30–33
`of the ’876 patent. Pet. 32–60.
`
`1. Claims 8 and 15
`Petitioner contends claims 8 and 15 are anticipated by
`(1) the solutions of Example 6 of Cartt ’865 in combination with the
`additional teachings of the reference, (2) the disclosure in Cartt ’865 of
`ranges that overlap the claimed ranges for ethanol and benzyl alcohol, and
`(3) the disclosure in Cartt ’865 of specific ranges for co-solvents. Pet. 37–
`48. We address these arguments in turn.
`
`13
`
`
`
`
`IPR2019-00449
`Patent 9,763,876 B2
`a. The Solutions of Example 6
`Table 3-1 of Cartt ’865 is reproduced below:
`
`
`As shown in Table 3-1, the components used in the solutions of Example 3
`are diazepam, vitamin E, and ethanol, which is added to achieve a final
`volume of 1 mL. Ex. 1010 ¶ 199, Table 3-1. Example 6 of Cartt ’865 then
`modifies the solutions of Example 3 by adding a “suitable amount of an
`alkyl glycoside,” which Cartt ’865 reports may be in an amount from “about
`0.05% (w/v) to about 0.5% (w/v), or about 0.125% (w/v) to about 0.5%
`(w/v).” Id. ¶¶ 58, 210.
`
`Applying these disclosures, Petitioner produces the following chart
`depicting the contents of solutions 00 and 02 in Example 6 of Cartt ’865:
`
`14
`
`
`
`
`IPR2019-00449
`Patent 9,763,876 B2
`
`
`
`The chart above shows the amount of diazepam, vitamin E, alkyl glycoside,
`and ethanol in solutions 00 and 02 of Example 6, designated by Petitioner as
`solutions 6-00 and 6-02. Pet. 36.6
`In order to anticipate a claimed invention, a prior art reference “must
`not only disclose all elements of the claim within the four corners of the
`document, but must also disclose those elements ‘arranged as in the claim.’”
`Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008)
`(quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir.
`1983)). An exception to the requirement that each element be “arranged as
`in the claim” in the reference exists when a person of ordinary skill in the art
`reading the reference would “at once envisage” from the express disclosures
`of that reference the claimed arrangement or combination. See Kennametal,
`
`6 In Table 3-1, the amount of ethanol was adjusted to achieve 1 mL.
`Petitioner has taken into account the addition of alkyl glycoside in
`calculating the amount of ethanol in solutions 6-00 and 6-02. Pet. 36 n.3.
`15
`
`
`
`
`IPR2019-00449
`Patent 9,763,876 B2
`Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015);
`Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1343–44 (Fed. Cir.
`2016).
`As shown in the figure above, the solutions of Example 6 do not
`contain benzyl alcohol. Thus, the solutions disclosed in Example 6 do not
`anticipate either claim 1 or claim 8 of the ’876 patent. Petitioner contends,
`however, that Cartt ’865 suggests that ethanol and benzyl alcohol may be
`used together as co-solvents, and modifying the solutions of Example 6
`according to the teachings of Cartt ’865 “leads to solutions that fully
`anticipate” claims 8 and 15 of the ’876 patent. Pet. 37–39. Specifically,
`Petitioner argues that Cartt ’865 teaches that lower alcohols, such as ethanol
`and benzyl alcohol, may be added to benzodiazepine solutions, and contends
`“all potential amounts of the combination of ethanol/benzyl alcohol are
`encompassed by Cartt ’865.” Id. at 41 (citing Blue Calypso, 815 F.3d at
`1344).
`We are not persuaded by Petitioner’s arguments. First, Petitioner does
`not persuasively explain why the disclosure of two alcohols in a list of five
`possible alcoholic co-solvents would expressly disclose to one of ordinary
`skill in the art all possible ratios of ethanol and benzyl alcohol. See Nidec
`Motor Corp. v. Zhongshan Broad Ocean Motor Co., 851 F.3d 1270, 1274
`(Fed. Cir. 2017) (“Kennametal does not stand for the proposition that a
`reference missing a limitation can anticipate a claim if a skilled artisan
`viewing the reference would ‘at one envisage’ the missing limitation.”).
`Second, Petitioner supports the majority of its anticipation arguments
`with citations to Blue Calypso, arguing that case stands for the proposition
`that “a reference may still anticipate if that reference teaches that the
`
`16
`
`
`
`
`IPR2019-00449
`Patent 9,763,876 B2
`disclosed components or functionalities may be combined and one of skill in
`the art would be able to implement the combination.” Pet. 41 (quoting Blue
`Calypso, 815 F.3d at 1344). Blue Calypso does not stand for the proposition
`that an undisclosed value or ratio may be found to be expressly disclosed in
`a reference when only the general components are expressly disclosed.
`Rather, following the holding in Kennametal, Blue Calypso holds that a
`reference may anticipate “if that reference teaches that the disclosed
`components or functionalities may be combined and one of skill in the art
`would be able to implement the combination.” Blue Calypso, 815 F.3d at
`1344 (emphasis added) (citing Kennametal, 780 F.3d at 1381). Here, the
`specific ratios recited in claims 8 and 15 are not disclosed in Cartt ’865.
`Thus, Blue Calypso is not applicable. See Nidec Motor, 851 F.3d at 1274
`(noting that a missing limitation may not be found in the art for purposes of
`anticipation when one of ordinary skill in the art would “at once envisage”
`that limitation upon viewing the reference).
`In view of the foregoing, we determine that Petitioner has not
`persuasively demonstrated that the combined disclosures of the ’876 patent,
`including the disclosures of solutions 6-00 and 6-02 and of using ethanol and
`benzyl alcohol as co-solvents, serve to anticipate claims 8–10 and 15 of the
`’876 patent.
`
`b. The Disclosure of Overlapping Ranges
`Petitioner asserts that Cartt ’865 discloses alcohol ranges of 5–70%,
`10–40%, 10–35%, 10–55%, 10–70%, 12–55%, 12–40%, 12–35%, 15–55%,
`15–40%, 15–35%, 25–40%, and 25–35%, which overlap with, or fully
`encompass, the ranges of ethanol and benzyl alcohol recited in claims 8 and
`15. Pet. 44. Petitioner further asserts that Patent Owner has not
`17
`
`
`
`
`IPR2019-00449
`Patent 9,763,876 B2
`demonstrated that the ratio of ethanol and benzyl alcohol in the formulation
`is critical to the operability of the claimed invention. Id. at 44–45.
`Thus, Petitioner concludes that the ranges disclosed in Cartt ’865 anticipate
`the ranges for ethanol and benzyl alcohol recited in claims 8 and 15. Id.
`We are not persuaded by this argument because Cartt ’865 does not
`expressly disclose an example or embodiment that uses ethanol and benzyl
`alcohol in combination, much less any particular ranges for these alcohols
`in a solution. Id. at 24. Nor is it evident that the addition of any amount of
`benzyl alcohol to the Cartt ’865 solutions identified by Petitioner would
`necessarily have ranges of ethanol and benzyl alcohol that overlap the ranges
`recited in the challenged claims. Thus, Petitioner has not demonstrated that
`the ranges disclosed in Cartt ’865 for alcohol solvents serve to anticipate
`challenged claims 8–10 and 15 of the ’876 patent.
`
`c. The Disclosure of Specific Ranges
`Petitioner contends Cartt ’865 discloses the use of specific amounts of
`alcohol that are “about 10%, 12.5%, 15%, 17.5%, 20%, 22.5%, 25%, 27.5%,
`30%, 32.5%, 35%, 37.5%, 40%, 42.5%, 45%, 47.5%, 50%, 52.5%, and
`55%.” Pet. 47 (citing Ex. 1010 ¶¶ 42, 56). Petitioner further contends that
`because these amounts “apply either to a combination of alcohols or to a
`single alcohol,” “Cartt ’865 anticipates the ranges of alcohols recited” in
`claims 8 and 15. Id. (citing Ex. 1041 ¶¶ 263–264, 357–358).
`Again, Cartt ’865 does not expressly disclose an example or
`embodiment having both ethanol and benzyl alcohol in solution. Nor has
`Petitioner demonstrated sufficiently that the alcohol amounts set forth in
`paragraphs 42 and 56 of Cartt ’865 are for individual amounts of alcoholic
`components within a mixture of multiple alcohols, as opposed to the total
`18
`
`
`
`
`IPR2019-00449
`Patent 9,763,876 B2
`amount of alcohol present in the carrier system. Ex. 1010 ¶¶ 42, 56
`(“In some embodiments, the carrier system comprises one or more alcohols
`or glycols, or any combinations thereof, in an amount from about 10% to
`about 55% (w/w).”). Thus, we do not find Petitioner’s anticipation
`argument persuasive.
`
`2. Claims 9, 10, and 30–33
`Claims 9 and 10 depend, directly or indirectly, from claim 8. Because
`we have found that Petitioner has not demonstrated that claim 8 is
`anticipated, we are also not persuaded that claims 9 and 10 are anticipated
`by Cartt ’865.
`Claims 30–33 each recite specific amounts of ethanol and benzyl
`alcohol. Petitioner repeats the same general arguments for these claims that
`are discussed above for claims 8 and 15. Pet. 56–57. Accordingly, we are
`not persuaded that these claims are anticipated by Cartt ’865.
`
`D. Obviousness of Claims 8–10, 15, and 30–33 over Cartt ’865 or
`Cartt ’865 and Ueda
`Petitioner contends the subject matter of claims 8–10, 15, and 30–33
`would have been obvious over the disclosures of Cartt ’865, as well as the
`combined disclosures of Cartt ’865 and Ueda. Pet. 60–63.
`
`1. Claims 8–10, 15, and 30–33 over Cartt ’865
`Petitioner’s analysis with respect to the alleged obviousness of claims
`8–10, 15, and 30–33 in view of Cartt ’865 spans ten lines of text, relying
`heavily on its anticipation arguments discussed above. Pet. 60–61. Critical
`to its obviousness arguments, Petitioner asserts that “none of the recited
`ranges (either separately or combined) have been shown to have any
`criticality or to result in unexpected effects.” Id. at 57; see id. at 45.
`19
`
`
`
`
`IPR2019-00449
`Patent 9,763,876 B2
`Based on this alleged lack of “unexpected effects,” Petitioner contends the
`disclosed ratios of ethanol and benzyl alcohol recited in the challenged
`claims would have been obvious. Id. at 57.
`In support of its argument, Petitioner directs our attention to an office
`action issued by the EPO addressing nearly identical claims, wherein the
`EPO asserted that “[n]o unexpected effect whatsoever has been
`demonstrated in the application for the selection of the claimed individual
`amounts of ethanol and benzyl alcohol.” Ex. 1040, 297. Petitioner fails to
`address, however, that during subsequent prosecution of this application, the
`applicants asserted to the EPO that “the co-solvent system of 1-25% ethanol
`and 1-25% benzyl alcohol provides an unexpected increase in bioavailability
`over and above the increase in bioavailability from” the alkyl glycoside.
`Id. at 377. And, upon review of Cartt ’865, the recited evidence, and the
`applicant’s unexpected results arguments, the EPO withdrew its pending
`rejection and issued claims that are nearly identical to challenged claims 8,
`15, and 30–33 of the ’876 patent. Compare Ex. 1001, claims 8, 15, 30–33,
`with Ex. 1040, 512–13 (claims 1, 6, 8, 12, and 13); see also Ex. 1040, 520
`(noting that the applicants’ Main Request filed on 02.11.2017 could be
`granted).
`Given that (1) Patent Owner has successfully argued to another
`tribunal that the claimed amounts of ethanol and benzyl alcohol provide
`unexpected results, (2) nearly identical claims to those challenged in the
`Petition were issued by that tribunal over the Cartt ’865 reference, and
`(3) the ’876 patent contains the same disclosures relied upon by the EPO to
`establish unexpected results (compare Ex. 1040, 316 (pointing to Figures 1–
`3 and Table 11-3 in support of its unexpected effects argument), 377–79
`
`20
`
`
`
`
`IPR2019-0044
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
