Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`Paper: 44
`Date: August 6, 2020
`
`
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`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`AQUESTIVE THERAPEUTICS, INC.,
`Petitioner,
`v.
`NEURELIS, INC.,
`Patent Owner.
`
`
`
`IPR2019-00451
`Patent 9,763,876 B2
`
`
`
`
`Before ZHENYU YANG, JON B. TORNQUIST, and JAMIE T. WISZ,
`Administrative Patent Judges.
`
`WISZ, Administrative Patent Judge.
`
`JUDGMENT
`Final Written Decision
`Determining All Claims Unpatentable
`Denying Petitioner’s Motion to Exclude
`Denying Patent Owner’s Motion to Exclude
`35 U.S.C. § 318(a); 37 C.F.R. § 42.64
`
`
`
`
`
`
`
`Tel: 571-272-7822
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`Paper: 44
`Date: August 6, 2020
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`AQUESTIVE THERAPEUTICS, INC.,
`Petitioner,
`v.
`NEURELIS, INC.,
`Patent Owner.
`
`
`
`IPR2019-00451
`Patent 9,763,876 B2
`
`
`
`
`Before ZHENYU YANG, JON B. TORNQUIST, and JAMIE T. WISZ,
`Administrative Patent Judges.
`
`WISZ, Administrative Patent Judge.
`
`JUDGMENT
`Final Written Decision
`Determining All Claims Unpatentable
`Denying Petitioner’s Motion to Exclude
`Denying Patent Owner’s Motion to Exclude
`35 U.S.C. § 318(a); 37 C.F.R. § 42.64
`
`
`
`
`
`
`
`
`IPR2019-00451
`Patent 9,763,876 B2
`
`I.
`
`INTRODUCTION
`
`A. Background
`Aquestive Therapeutics, Inc. (“Petitioner”) filed a Petition (Paper 3,
`“Pet.”) requesting an inter partes review of claims 1–36 (“the challenged
`claims”) of U.S. Patent No. 9,763,876 B2 (Ex. 1001, “the ’876 patent”).
`Petitioner supported its Petition with the Declaration of Nicholas A. Peppas,
`Sc.D. (Ex. 1041). Neurelis, Inc.1 (“Patent Owner”) filed a Preliminary
`Response (Paper 7, “Prelim. Resp.”). Upon consideration of the Petition, the
`Preliminary Response, and the preliminary evidence of record, we
`determined that Petitioner had demonstrated a reasonable likelihood that it
`would prevail with respect to at least one of the challenged claims of the
`’876 patent (Paper 8, “Institution Decision” or “Inst. Dec.”). Thus, we
`instituted review with respect to all of the challenged claims.
`
`Following institution of trial, Patent Owner filed a Request for
`Rehearing (Paper 10, “Request for Rehearing” or “Req. Reh’g”), which was
`denied (Paper 14, “Decision on Request for Rehearing” or “Dec. on Req.
`Reh’g”), and a request for Precedential Opinion Panel (POP) review
`(Ex. 3001, “POP Request”), which was also denied (Paper 17).
`
`Patent Owner filed a Patent Owner Response (Paper 16, “PO
`Response” or “PO Resp.”) and supported its Response with the Declaration
`of Sveinbjörn Gizurarson, Ph.D. (Ex. 2012). Petitioner filed a Reply (Paper
`
`
`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 6, 2 (citing Reel
`048271; Frame 0304).
`
`2
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`IPR2019-00451
`Patent 9,763,876 B2
`21, “Reply”) with a Declaration of Daniel P. Wermeling, Pharm.D.
`(Ex. 1150). Patent Owner filed a Sur-Reply (Paper 28, “PO Sur-Reply”).
`Petitioner and Patent Owner each separately filed Motions to Exclude
`regarding certain evidence of record (Paper 34, “Pet. MTE”; Paper 35, “PO
`MTE”). We address each of these Motions in this Decision.
`An oral hearing was held on May 14, 2020, and a transcript of the
`hearing is included in the record (Paper 43, “Tr.”).
`
`We have jurisdiction under 35 U.S.C. § 6. After considering the
`parties’ arguments and supporting evidence, we conclude that Petitioner has
`proven by a preponderance of the evidence that claims 1–36 of the ’876
`patent are unpatentable. 35 U.S.C. § 316(e).
`
`B. Real Parties-in-Interest
`Petitioner identifies Aquestive Therapeutics, Inc. (formerly Monosol
`Rx, LLC) as the real party-in-interest. Pet. 1. Patent Owner identifies
`Neurelis, Inc. as the real party-in-interest. Paper 6, 2.
`
`C. Related Proceedings
`The ’876 patent was challenged by Petitioner in IPR2019-00449 and
`IPR2019-00450. Institution of inter partes review in both cases was denied.
`IPR2019-00449, Paper 7; IPR2019-00450, Paper 8.
`Patent Owner also indicates that it filed a tort suit against Petitioner in
`which it cited Petitioner’s IPR petitions “as evidence of a pattern of tortious
`behavior” against Patent Owner. Paper 29, 2 (citing Neurelis, Inc. v.
`Aquestive Therapeutics, Inc., No. 37-00064665-CU-BT-CTL (Super. Ct.
`Cal., San Diego)).
`
`3
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`IPR2019-00451
`Patent 9,763,876 B2
`
`D. The ’876 Patent
`The ’876 patent is directed to nasally administered pharmaceutical
`solutions containing one or more benzodiazepine drugs. Ex. 1001, 9:14–17.
`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. According to the’876 patent, 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. Ex. 1001, 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.
`
`E. Illustrative Claim
`Petitioner challenges claims 1–36 of the ’876 patent. Claim 1, which
`is the only independent claim of the ’876 patent, is illustrative of the
`challenged claims, and is reproduced below:
`
`1. A method of treating a patient with a disorder which is
`treatable with a benzodiazepine drug, comprising:
`
`4
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`IPR2019-00451
`Patent 9,763,876 B2
`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);
`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 (formatting added). Challenged claims 2–36
`depend from claim 1, either directly or indirectly.
`
`F. Instituted Grounds of Unpatentability
`We instituted trial to determine whether claims 1–36 of the ’876
`patent are unpatentable based on the following grounds:
`Claims Challenged
`35 U.S.C. § References/Basis
`1–16, 24–36
`103(a)
`Gwozdz,2 Meezan ’9623
`
`17–23
`
`103(a)
`
`Gwozdz, Meezan ’962, Cartt
`’7844
`
`Inst. Dec. 5.
`
`
`2 PCT Pub. No. WO 2009/120933 A2, published October 1, 2009 (Ex. 1014,
`“Gwozdz”).
`3 U.S. Pub. No. 2006/0046962 A1, published March 2, 2006 (Ex. 1011,
`“Meezan ’962”).
`4 U.S. Pub. No. 2008/0279784 A1, published November 13, 2008 (Ex. 1015,
`“Cartt ’784”).
`
`5
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`Patent 9,763,876 B2
`
`II. ANALYSIS
`We have reviewed the parties’ respective briefs as well as the relevant
`evidence discussed in those papers. For the reasons discussed in detail
`below, we determine that Petitioner has shown by a preponderance of the
`evidence that claims 1–36 of the ’876 patent are unpatentable under 35
`U.S.C. § 103 as having been obvious.
`
`A. Principles of Law
`To prevail in its challenges to the patentability of all claims of the
`’876 patent, Petitioner must demonstrate by a preponderance of the evidence
`that the claims are unpatentable. 35 U.S.C. § 316(e) (2018); 37 C.F.R.
`§ 42.1(d) (2019). “In an [inter partes review], the petitioner has the burden
`from the onset to show with particularity why the patent it challenges is
`unpatentable.” Harmonic Inc. v. Avid. Tech., Inc., 815 F.3d 1356, 1363
`(Fed. Cir. 2016); see also 35 U.S.C. § 312(a)(3) (requiring inter partes
`review petitions to identify “with particularity . . . the evidence that supports
`the grounds for the challenge to each claim”). That burden of persuasion
`never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics,
`Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015); see also In re Magnum Oil Tools
`Int’l, Ltd., 829 F.3d 1364, 1375–78 (Fed. Cir. 2016) (discussing the burden
`of proof in inter partes review).
`Regarding obviousness, the Supreme Court in KSR International Co.
`v. Teleflex Inc., 550 U.S. 398 (2007), reaffirmed the framework for
`determining obviousness as set forth in Graham v. John Deere Co., 383 U.S.
`1 (1966). The KSR Court summarized the four factual inquiries set forth in
`Graham (383 U.S. at 17–18) that are applied in determining whether a claim
`is reasonably likely to be unpatentable as obvious under 35 U.S.C. § 103(a)
`
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`Patent 9,763,876 B2
`as: (1) determining the scope and content of the prior art; (2) ascertaining the
`differences between the prior art and the claims at issue; (3) resolving the
`level of ordinary skill in the pertinent art; and (4) considering objective
`evidence indicating obviousness or non-obviousness. KSR, 550 U.S. at 406.
`“The combination of familiar elements according to known methods
`is likely to be obvious when it does no more than yield predictable results.”
`KSR, 550 U.S. at 416. “[W]hen the question is whether a patent claiming
`the combination of elements of prior art is obvious,” the answer depends on
`“whether the improvement is more than the predictable use of prior art
`elements according to their established functions.” Id. at 417. It is generally
`obvious to those skilled in the art to substitute one known equivalent for
`another. See In re Omeprazole Patent Litigation, 483 F.3d 1364, 1374 (Fed.
`Cir. 2007) (“[T]his court finds no . . . error in [the] conclusion that it would
`have been obvious to one skilled in the art to substitute one ARC [alkaline
`reactive compound] for another.”); see also Wm. Wrigley Jr. Co. v. Cadbury
`Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012) (the combination of
`known elements and substitution of one well known agent for another is
`obvious).
`When there is a range disclosed in the prior art, and the claimed
`invention falls within that range, or the disclosed range overlaps with the
`claimed range, there is a presumption of obviousness. Iron Grip Barbell Co.
`v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004); In re Peterson,
`315 F.3d 1325, 1329 (Fed. Cir. 2003) (“In cases involving overlapping
`ranges, we and our predecessor court have consistently held that even a
`slight overlap in range establishes a prima facie case of obviousness.”); see
`also In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997) (noting that a
`
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`IPR2019-00451
`Patent 9,763,876 B2
`claimed range overlaps with a prior art range if the two ranges share a
`common endpoint (e.g., claim range of 50–100 Å overlaps with prior art
`range of 100–600 Å)). This presumption may be rebutted by showing the
`criticality of the claimed range, that the prior art taught away from the
`claimed range, or that the parameter was not recognized as “result-
`effective.” E.I. DuPont de Nemours & Company v. Synvina C.V., 904 F.3d
`996, 1006 (Fed. Cir. 2018); Iron Grip, 392 F.3d 1322.
`We analyze Petitioner’s asserted grounds of unpatentability in
`accordance with the above-stated principles.
`
`B. Level of Ordinary Skill in the Art
`We consider the asserted grounds of unpatentability in view of the
`understanding of a person of ordinary skill in the art (“POSA” or
`“POSITA”), and thus begin with the level of ordinary skill in the art. The
`level of ordinary skill in the art is “a prism or lens through which . . . the
`Board views the prior art and claimed invention” to prevent hindsight bias.
`Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).
`The parties dispute the level of ordinary skill in the art. Petitioner
`asserts that, as of the earliest priority date, a person of ordinary skill in the
`art would have been:
`a medicinal chemist, pharmaceutical chemist, chemist, or
`biologist involved in the research and development of
`pharmaceutical formulations and/or delivery. The POSITA
`would have at least a bachelor’s degree in chemical, biological,
`or pharmaceutical sciences or a medical degree, and several
`years of experience in the field of transmucosal (including
`intranasal, rectal, vaginal, ocular, lacrimal, nasolacrimal,
`buccal, sublingual, urethral, inhalation, and auricular)
`pharmaceutical formulation development and/or delivery, the
`amount of post-graduate experience depending upon the level
`
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`IPR2019-00451
`Patent 9,763,876 B2
`of formal education. The individual would also have some
`experience in design and testing of formulations for mucosal
`delivery (and particularly in intranasal formulations) of
`systemic-acting drugs.
`Pet. 4. Dr. Peppas also recites this definition in his Declaration. Ex. 1041
`¶ 74.
`In response, Patent Owner disputes certain aspects of Petitioner’s
`
`description of the level of ordinary skill in the art. See PO Resp. 15–17.
`First, Patent Owner, with supporting testimony from Dr. Gizurarson, asserts
`that “the formulation of a benzodiazepine for intranasal administration is a
`difficult and complex science requiring a higher skill set and knowledge than
`a POSA with a bachelor’s degree ‘with several years of experience.’” Id. at
`15 (citing Ex. 2012 ¶¶ 28–29). Specifically, according to Patent Owner and
`Dr. Gizurarson, “the POSA would be working against physiological
`constraints of active ingredient uptake due to the nasal anatomy, as well as
`the very low solubility of benzodiazepines in formulating the pharmaceutical
`composition disclosed in the ’876 patent.” Id. at 15–16 (citing Ex. 2012
`¶¶ 28–29). Therefore, Patent Owner asserts that “a POSA would at least
`have held a Master’s degree with many years of experience, or a Ph.D. or
`Pharm.D[.] degree with several years of experience, or its equivalent
`research experience.” Id. at 16 (citing Ex. 2012 ¶ 29).
`Second, Patent Owner contends that a person of ordinary skill in the
`art would not include a medicinal chemist because “[c]hemists are primarily
`concerned with chemical structures and synthesizing new chemical
`compounds” and it is not clear “what role a medicinal chemist would play in
`the research and development of benzodiazepine pharmaceutical
`formulations for intranasal administration – especially where, as here, the
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`IPR2019-00451
`Patent 9,763,876 B2
`chemical structures were all known.” PO Resp. 16 (citing Ex. 2012 ¶ 30).
`Instead, according to Patent Owner, “a POSA would have had knowledge of
`benzodiazepine structure and function, including solubility issues with
`benzodiazepines in general.” Id. (citing Ex. 2012 ¶ 31). Patent Owner also
`asserts that the “POSA would further have knowledge and practical
`experience working with intranasal formulations, including knowledge of
`the physiology and anatomy of the nasal cavity, with relevant experience in
`developing intranasal formulations.” Id. at 16–17 (citing Ex. 2012 ¶ 31).
`Patent Owner further contends that “[Petitioner] and Dr. Peppas’
`description of a POSA having experience in ‘rectal, vaginal, ocular,
`lacrimal, nasolacrimal, buccal, sublingual, urethral, inhalation, and auricular’
`delivery as ‘related fields’ does not take into consideration the differences in
`formulating an intranasal product and complexities of the intranasal
`pathway.” PO Resp. 17 (citing Ex. 2012 ¶ 32; Ex. 2011, 118:18–120:19).
`Petitioner disagrees with Patent Owner’s definition of a person of
`ordinary skill in the art and contends that such a person would also have
`experience working with “transmembrane” formulations in addition to
`“intranasal” formulations. Reply 12 (citing Ex. 2012 ¶¶ 31, 32; Ex. 11505
`¶¶ 20–22).
`In determining the level of ordinary skill, various factors may be
`considered, including “(1) the educational level of the inventor; (2) type of
`problems encountered in the art; (3) prior art solutions to those problems; (4)
`
`
`5 Throughout the Reply, Petitioner sometimes refers to Ex. 1100 when citing
`to the Declaration of Dr. Wermeling. Because there is no Ex. 1100 in the
`record and because the Declaration of Dr. Wermeling is Ex. 1150, we have
`used Ex. 1150 to indicate Petitioner’s citations to the Wermeling
`Declaration.
`
`10
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`IPR2019-00451
`Patent 9,763,876 B2
`rapidity with which innovations are made; (5) sophistication of the
`technology; and (6) educational level of active workers in the field.” Daiichi
`Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). These
`factors are “merely a guide,” and the weight or significance ascribed to each
`depends on the particular case. Id.
`Based on our consideration of the full record, we find that, overall,
`Patent Owner’s definition is more specifically tailored to the claimed subject
`matter of the ’876 patent. We also find that the factors recited above,
`overall, demonstrate that knowledge of and experience with transmembrane
`formulations, as suggested by Petitioner, would also be relevant. See
`Ex. 1014, 8:32–9:18; Ex. 1011 ¶¶ 9–13. Therefore, we find that such a
`person of ordinary skill in the art would have been a pharmaceutical chemist,
`chemist, or biologist involved in the research and development of
`pharmaceutical formulations and/or delivery. We also find that the person
`of ordinary skill in the art would have at least a Master’s degree with many
`years of experience, or a Ph.D. or Pharm.D. degree with several years of
`experience. In addition, the person of ordinary skill in the art would have
`had knowledge of benzodiazepine structure and function and would further
`have knowledge and practical experience working with intranasal and
`transmembrane formulations, including knowledge of the physiology and
`anatomy of the nasal cavity, with relevant experience in developing
`intranasal and transmembrane formulations.
`Although we agree with and have primarily adopted Patent Owner’s
`definition for an ordinarily skilled artisan in this proceeding, our analysis
`and conclusions herein would not change even under Petitioner’s definition.
`The parties also do not appear to indicate that the outcome would differ
`
`11
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`IPR2019-00451
`Patent 9,763,876 B2
`based on the definition of the person of ordinary skill in the art. See Pet. 4;
`PO Resp. 15–17; Reply 12.
`
`C. Claim Construction
`Having defined the ordinarily skilled artisan, we now turn to 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
`in the art at the time of the invention. See id; Phillips v. AWH Corp., 415
`F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). 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).
`In the Petition, Petitioner provides proposed constructions for the
`terms “vitamin E,” “bioavailability,” “% (w/w),” “% (w/v),” and “about
`56.47% (w/v) vitamin E.” Pet. 11–14. Patent Owner does not propose its
`own construction for these terms.
`In the Patent Owner Response, Patent Owner proposes constructions
`for the terms “consisting of” and “in a combined amount.” PO Resp. 12–15.
`Petitioner disagrees with Patent Owner’s construction of “consisting of” and
`does not provide any comments on the proposed construction of “in a
`combined amount.” Reply 9–11. Furthermore, Petitioner proposes a
`construction for “pharmaceutical solution,” which Patent Owner opposes.
`Reply 11; PO Sur-Reply 4, 18–19.
`
`12
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`IPR2019-00451
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`Upon review of the parties’ arguments and the evidence of record, we
`determine that no terms of the ’876 patent require express construction for
`purposes of this Decision. 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.”)).
`
`D. Priority Claim of the ’876 patent
`The ’876 patent was filed as U.S. Application No. 14/527,613
`(“the ’613 application”) on October 29, 2014. Ex. 1001, codes (21), (22).
`The ’876 patent is a continuation of U.S. Application No. 13/495,942 (“the
`’942 application”) (issued as U.S. Patent No. 8,895,546) (“the ’546 patent”),
`filed on June 13, 2012, which is in turn a continuation-in-part (“CIP”) of
`U.S. Application No. 12/413,439 (“the ’439 application”), filed on March
`27, 2009. Id. at code (63). 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. Id. at
`code (60).
`Petitioner contends that Meezan ’962 qualifies as prior art to the
`claims of the ’876 patent under 35 U.S.C. § 102(b) and that Gwozdz and
`Cartt ’784 qualify as prior art at least under 35 U.S.C. § 102(e)(1). Pet. 6–8.
`Petitioner asserts that Cartt ’784 is prior art based on its May 7, 2008, filing
`date and its November 13, 2008, publication date. Id. at 8. Petitioner also
`contends that Gwozdz qualifies as prior art based on the March 28, 2008,
`filing date of its U.S. Provisional Application No. 61/040,281 (“Gwozdz
`
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`provisional”) (Ex. 1046). Id. at 6. Petitioner has shown that the claims of
`Gwozdz are supported by the Gwozdz provisional, “at least because
`Gwozdz’s claims are literally identical to the claims filed in [the] Gwozdz
`provisional.” Id. (citing Ex. 1014, 14–15; Ex. 1046, 19–20); see Ex. 1014,
`4–10; Ex. 1046, 9–15. Patent Owner does not contest that Gwozdz is
`entitled to this filing date. See PO Resp. 17–23. Therefore, we find that
`Petitioner has satisfied its burden to show that Gwozdz is entitled to the
`filing date of the Gwozdz provisional. See Dynamic Drinkware, 800 F.3d. at
`1381 (holding that “[a] reference patent is only entitled to claim the benefit
`of the filing date of its provisional application if the disclosure of the
`provisional application provides support for the claims in the reference
`patent in compliance with § 112, ¶ 1.”).
`Petitioner asserts that the claims of the ’876 patent are not entitled to
`the priority date of the ’558 provisional and have an effective filing date of
`no earlier than the March 27, 2009 filing date of the ’439 application. Pet.
`18–20. Specifically, Petitioner contends that the ’558 provisional does not
`provide adequate support for the “alkyl glycoside” limitation recited in the
`challenged claims6 because the presence of any alkyl glycoside is not
`disclosed, described, or enabled by the ’558 provisional. Id. at 19–20.
`Petitioner further contends that the ’558 provisional’s “generic disclosure of
`‘surface active agents (especially non-ionic materials)’ . . . does not disclose,
`describe, and/or enable alkyl glycosides in general (or dodecyl maltoside in
`particular).” Id. at 20 (citing Ex. 1008 ¶ 152; Ex. 1041 ¶ 68).
`
`
`6 Claim 1 requires “an alkyl glycoside.” Ex. 1001, 63:34. Since all of the
`remaining claims of the ’876 patent depend, directly or indirectly, from
`Claim 1, they also require the presence of “an alkyl glycoside.”
`
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`Patent Owner argues that Gwozdz and Cartt ’784 are not prior art to
`the challenged claims of the ’876 patent because the claims are properly
`supported by the ’558 provisional, which was filed on March 28, 2008. PO
`Resp. 1, 17–18.
`Patent Owner argues that the ’558 provisional does disclose alkyl
`glycosides as part of the formulation claimed. PO Resp. 10. Specifically,
`Patent Owner points to the following disclosure from the ’558 provisional:
`In some embodiments, the drug delivery system of the
`invention may advantageously comprise an absorption enhancer
`. . . . In some embodiments, enhancing agents that are
`appropriate include . . . acyl glycerols, fatty acids and salts,
`tyloxapol and biological detergents listed in the SIGMA
`Catalog, 1988, page 316-321 (which is incorporated herein by
`reference).
`Id. (quoting Ex. 1008 ¶¶ 150–152 (emphasis added)). Patent Owner
`contends that the excerpt from the 1988 SIGMA catalog (“SIGMA catalog”)
`referenced in the ’558 provisional includes alkyl glycosides such as n-
`Dodecyl β-D-Maltoside, n-Dodecyl β-D-Glucopyranoside, n-Heptyl β-D-
`Glucopyranoside, n-Hexyl β-D-Glucopyranoside, n-Nonyl β-D-
`Glucopyranoside, n-Octyl β-D-Glucopyranoside, and Octyl β-D-
`Thioglucopyranoside, amongst others. Id. at 10–11 (citing Ex. 2006, 319–
`320). Patent Owner, with supporting testimony from Dr. Gizurarson, asserts
`that “a POSA would have recognized and understood that alkyl glycosides
`were disclosed and supported in the ’558 Provisional through this
`incorporation by reference.” Id. at 19 (citing Ex. 2012 ¶ 68).
`Patent Owner also asserts that:
`A POSA would have understood that in the context of
`pharmaceutical formulations, biological detergents would have
`been limited to detergents appropriate for administering to the
`
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`IPR2019-00451
`Patent 9,763,876 B2
`nasal cavity of a human or other animal subject – which, in
`such a case, would have been non-ionic detergents.
`PO Resp. 11 n.5 (citing Ex. 2012 ¶ 70). According to Patent Owner, “of the
`10 non-ionic biological detergents listed on page 316 of the SIGMA catalog,
`9 of them are alkyl glycosides.” Id. at 11 (citing Ex. 2012 ¶ 71). Patent
`Owner also asserts that, of the non-ionic detergents listed on pages 316–321
`of the Sigma catalog, alkyl glycosides “were prominently represented.” Id.
`at 19 (citing Ex. 2012 ¶¶ 71–72).
`
`Petitioner, with supporting testimony from Dr. Wermeling, responds
`that “a POSA would not have understood that the ‘558 provisional was
`providing a written description of alkyl glycosides.” Reply 5 (citing
`Ex. 1150 ¶¶ 171–177). According to Petitioner, paragraphs 150–152 of the
`’558 provisional generically refer to “absorption enhancers” and define the
`term “enhancer” as “any material which acts to increase absorption across
`the mucosa and/or increase bioavailability,” and describe 15 classes falling
`within this broad “absorption enhancer” class. Id. (citing Ex. 1150 ¶¶ 171,
`172). Petitioner also contends that “the recited ‘enhancers’ can include
`mucolytic agents, degradative enzyme inhibitors, ‘compounds which
`increase permeability of the mucosal cell membranes’ [150], only
`identifying lysophospholipids and acyl carnitines as preferred candidates
`[151].” Id. at 5–6 (citing Ex. 1150 ¶¶ 171–173). According to Petitioner,
`paragraph 152 also identifies six additional “enhancer” classes: (i) chelating
`agents, (ii) surface active agents (especially non-ionic materials), (iii) acyl
`glycerols, (iv) fatty acids and salts, (v) tyloxapol and (vi) the biological
`detergents listed on six pages of the SIGMA catalog. Id. at 6 (citing
`Ex. 1150 ¶ 172; Ex. 2006).
`
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`IPR2019-00451
`Patent 9,763,876 B2
`
`Petitioner further asserts that there are approximately 150 different
`compounds on the cited SIGMA catalog pages divided among four discrete
`sub-classes: (i) anionic, (ii) cationic, (iii) zwitterionic (amphoteric) and
`(iv) nonionic (polar). Reply 6 (citing Ex. 2006, 316–321). According to
`Petitioner and Dr. Wermeling, “[w]ithin the ‘non-ionic’ biological detergent
`sub-class are (i) about a dozen alkyl glycoside species and (ii) over eighty
`non-alkyl glycoside species.” Id. (citing Ex. 1150 ¶ 175). Petitioner and
`Dr. Wermeling further contend that “[t]he ‘558 provisional provides
`absolutely no information regarding alkyl glycosides, apart from generally
`listing them among approximately 150 other biological detergents appearing
`in the SIGMA catalog.” Id. (citing Ex. 1150 ¶¶ 175–177). Petitioner and
`Dr. Wermeling conclude:
`In fact, nothing in the ‘558 provisional would reasonably lead a
`POSA to any particular sub-class, let alone specific species
`(compounds) identified in the SIGMA catalog, nor does the
`‘558 provisional suggest that alkyl glycosides might be of
`special interest, or be significant to the claims. Rather, the ‘558
`Provisional directs the POSA to lysophospholipids and acyl
`carnitines; all other enhancers being in a “kitchen sink” listing.
`Id. at 6–7 (citing Ex. 1150 ¶ 176).
`
`1. Analysis of Priority
`“[T]he hallmark of written description is disclosure,” and “the test [for
`satisfaction of the written description requirement] requires an objective
`inquiry into the four corners of the specification from the perspective of a
`person of ordinary skill in the art.” Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The written description
`“must ‘clearly allow persons of ordinary skill in the art to recognize that [the
`inventor] invented what is claimed,’” and “reasonably” convey to those
`
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`IPR2019-00451
`Patent 9,763,876 B2
`skilled in the art “that the inventor had possession of the claimed subject
`matter as of the filing date.” Id. (alteration in original, internal citations
`omitted). Stated another way, “one skilled in the art, reading the original
`disclosure, must immediately discern the limitation at issue in the claims.”
` Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir.
`2000). “Whether a claim satisfies the written description requirement is a
`question of fact.” Nalpropion Pharms., Inc. v. Actavis Labs. Fl, Inc., 934
`F.3d 1344, 1348 (Fed. Cir. 2019) (citing Ariad, 598 F.3d at 1351).
`Furthermore, as the Board explained in Polaris Wireless, Inc. v.
`TruePosition, Inc., IPR2013-00323, Paper 9 (PTAB Nov. 15, 2013), there is
`no presumption of earlier priority where the specifications of the earlier
`applications are not the same. See id. at 29; Power Oasis, Inc. v. T-Mobile
`USA, Inc., 522 F.3d 1299, 1305 (Fed. Cir. 2008). Patent Owner does not
`dispute that the specification of the ’876 patent differs from the specification
`of the ’558 provisional.
`When faced with a prior art challenge to a claim, the burden of
`production—alternatively called the burden of going forward—is on the
`Patent Owner to show that the claim is entitled to a filing date prior to the
`date of the alleged prior art. See Tech. Licensing Corp. v. Videotek, Inc., 545
`F.3d 1316, 1327 (Fed. Cir. 2008). Thus, “Patent Owner must come forward
`with evidence and argument . . . showing why the challenged claim is
`supported by the written description of the priority application.” Nintendo of
`Am. Inc. v. iLife Techs., IPR2015-00106, Paper 12 at 16 (PTAB Apr. 29,
`2015). After considering all the cited evidence of record on this priority
`issue, we find that the evidence favors Petitioner’s position. As explained
`
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`IPR2019-00451
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`below, we find that the challenged claims are not sufficiently supported by
`the written description of the ’558 provisional.
`We do not find that the ’558 provisional’s incorporation by reference
`to six pages of the SIGMA catalog, which includes about 12 alkyl glycosides
`in a list of about 150 biological detergents, is sufficient to provide written
`description support for the claims.7 See Ex. 2006; Ex. 1150 ¶ 175.
`Furthermore, the listing of biological detergents in the SIGMA catalog is
`just a subset of the numerous possible “enhancing agents” that are discussed
`in the ’558 provisional. See Ex. 1008 ¶¶ 150–152; Ex. 1150 ¶¶ 171–177.
`There is nothing in the disclosure of the ’558 provisional that directs one of
`skill in the art to the relatively small number of alkyl glycosides disclosed in
`the SIGMA catalog. See Ex. 1150 ¶ 176; Purdue Pharma, 230 F.3d at
`1326-27 (“[O]ne cannot disclose a forest in the original application and then
`later pick a tree out of the forest and say here is my invention. In order to
`satisfy the written description requirement, the blaze marks directing the
`skilled artisan to that tree must be in the originally filed disclosure.”);
`Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996) (“In the
`absence of such blazemarks, simpl
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