Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`
`Paper 14
`Entered: December 5, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`DR. REDDY’S LABORATORIES, LTD. AND DR. REDDY’S
`LABORATORIES, INC.,
`
`Petitioner,
`v.
`MONOSOL RX, LLC,
`Patent Owner.
`____________
`
`Case IPR2016-01112
`Patent 8,017,150 B2
`____________
`Before ERICA A. FRANKLIN, TINA E. HULSE, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`FRANKLIN, Administrative Patent Judge.
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`571-272-7822
`
`
`
`
`
`
`Paper 14
`Entered: December 5, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`DR. REDDY’S LABORATORIES, LTD. AND DR. REDDY’S
`LABORATORIES, INC.,
`
`Petitioner,
`v.
`MONOSOL RX, LLC,
`Patent Owner.
`____________
`
`Case IPR2016-01112
`Patent 8,017,150 B2
`____________
`Before ERICA A. FRANKLIN, TINA E. HULSE, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`FRANKLIN, Administrative Patent Judge.
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`IPR2016-01112
`Patent 8,017,150 B2
`
`
`INTRODUCTION
`I.
`Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc.
`(collectively, “Petitioner”) filed a Petition to institute an inter partes review
`of claims 1, 3–10, and 12–18 of U.S. Patent No. 8,017,150 B21 (Ex. 1001,
`“the ’150 patent”). Paper 1 (“Pet.”). MonoSol RX, LLC (“Patent Owner”)
`filed a Preliminary Response to the Petition. Paper 10 (“Prelim. Resp.”).
`We have jurisdiction under 35 U.S.C. § 314, which provides that an
`inter partes review may not be instituted “unless . . . there is a reasonable
`likelihood that the petitioner would prevail with respect to at least 1 of the
`claims challenged in the petition.” 35 U.S.C. § 314(a).
`Upon considering the Petition and Preliminary Response, we
`determine that the Petitioner has not demonstrated a reasonable likelihood
`that it would prevail in showing the unpatentability of at least one of the
`challenged claims. Accordingly, we decline to institute an inter partes
`review of any challenged claim.
`A.
`Related Proceedings
`Petitioner and Patent Owner identify a number of district court
`proceedings and that “may affect or be affected by a decision in this
`proceeding.” Pet. 12–13; Paper 4, 2–3. In particular, both parties identify
`Reckitt Benckiser Pharmaceuticals Inc. v. Watson Laboratories, Inc. et al.,
`C.A. No.1:13-CV-01674-RGA (D. Del.) and Reckitt Benckiser
`Pharmaceuticals Inc. v. Par Pharmaceutical, Inc. et al., C.A. No.1:14-CV-
`00422-RGA (D. Del.), wherein each case included MonoSol Rx among the
`
`
`
` 1
`
`
`
`
`
` Issued to Robert K. Yang et al., Sept. 13, 2011.
`2
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`IPR2016-01112
`Patent 8,017,150 B2
`plaintiffs and for which a consolidated trial opinion addressing the ’150
`patent was issued on June 3, 2016. Ex. 2009.
`B.
`The ’150 Patent (Ex. 1001)
`The ’150 patent relates to polyethylene oxide-based film products that
`demonstrate non-self-aggregating uniform heterogeneity. Ex. 1001, Title
`and Abstract. The polyethylene oxide may be blended with cellulosic
`polymers. Id. at 1:34–36. The film may also comprise an active ingredient
`that is evenly distributed throughout the film. Id. at 1:36–38. The
`Specification explains that “[t]he even or uniform distribution is achieved by
`controlling one or more parameters, and particularly the elimination of air
`pockets prior to and during film formation and the use of a drying process
`that reduces aggregation or conglomeration of the components in the film as
`it forms into a solid structure.” Id. at 1:38–43.
`
`
`Illustrative Claim
`C.
`Independent claim 1 of the ’150 patent is illustrative and reproduced
`below:
`1. A mucosally-adhesive water-soluble film product comprising:
`an analgesic opiate pharmaceutical active; and
`at least one water-soluble polymer component consisting of
` polyethylene oxide in combination with a hydrophilic
` cellulosic polymer;
`wherein:
`the water-soluble polymer component comprises greater
` than 75% polyethylene oxide and up to 25% hydrophilic
` cellulosic polymer;
`the polyethylene oxide comprises one or more low molecular
` weight polyethylene oxides and one or more higher
` molecular weight polyethylene oxides, the molecular weight
` of the low molecular weight polyethylene oxide
` being in the range 100,000 to 300,000 and the molecular
`
`
`
`
`3
`
`
`
`Patent Application Publication No. WO 00/42992,
`published Jul. 27, 2000
`
`Schiraldi US Patent No. 4,713,243 issued to Michael T.
`Schiraldi et al., Dec. 15, 1987
`
`Patent Application Publication No. US
`2002/0147201 A1, issued Oct. 10, 2002
`
`Verma US Patent No. 6,322,811 issued to Surendra
`Kumar Verma et al., Nov. 27, 2001
`
`US Patent No. 5,656,296 issued to Sadath U.
`Khan et al, Aug. 12, 1997
`
`Patent Application Publication No. US
`2005/0037055 A1, published Feb. 17, 2005
`
`Chen II
`
`
`Khan
`
`Yang
`
`Ex. 1021
`
`
`Ex. 1004
`
`Ex. 1049
`
`Ex. 1005
`
`Ex. 1046
`
`Ex. 1006
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`IPR2016-01112
`Patent 8,017,150 B2
` weight of the higher molecular weight polyethylene
` oxide being in the range 600,000 to 900,000; and
`the polyethylene oxide of low molecular weight comprises
` about 60% or more in the polymer component.
`
`
`Ex. 1001, 57:37–54; (emphasis added to identify dispositive limitations).
`
`
`The Cited References and Declaration
`D.
`Petitioner relies upon the following references:
`
`Chen
`
`
`Petitioner relies also upon the Declaration of Russell J. Mumper,
`Ph.D. (Ex. 1003).
`The Asserted Grounds of Unpatentability
`E.
`Petitioner challenges the patentability of claims 1, 3–10, and 12–18 of
`the ’150 patent on the following grounds (Pet. 16):
`
`
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`IPR2016-01112
`Patent 8,017,150 B2
`Claim(s) Challenged
`1, 3–10, 12–18
`
`Reference(s)
`Basis
`§ 103 Chen, Schiraldi, and Chen II
`
`1, 4–5, 8, 10, 12–14, and 17
`
`§ 103
`
`Schiraldi and Verma
`
`6–7, 9, 15–16, 18
`
`§ 103
`
`Schiraldi, Verma, and Khan
`
`1, 4–10, and 13–18
`
`§ 103
`
`Yang
`
`
`
`
`
` ANALYSIS
`A. Claim Construction
`In an inter partes review, the Board interprets claim terms in an
`unexpired patent according to the broadest reasonable construction in light
`of the specification of the patent in which they appear. 37 C.F.R.
`§ 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016)
`(affirming applicability of broadest reasonable construction standard to inter
`partes review proceedings). Under that standard, and absent any special
`definitions, we give claim terms their ordinary and customary meaning, as
`would be understood by one of ordinary skill in the art at the time of the
`invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`2007). Any special definitions for claim terms must be set forth with
`reasonable clarity, deliberateness, and precision. In re Paulsen, 30 F.3d
`1475, 1480 (Fed. Cir. 1994).
`Only terms which are in controversy need to be construed, and only to
`the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am.
`Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).
`Petitioner proposes a construction for the claim phrase: “at least one
`water-soluble polymer component consisting of polyethylene oxide in
`combination with a hydrophilic cellulosic polymer; wherein: the water-
`
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`Patent 8,017,150 B2
`soluble polymer component comprises greater than 75% polyethylene oxide
`and up to 25% hydrophilic cellulosic polymer,” recited by independent claim
`1 and the similar claim phrase: “at least one water-soluble polymer
`component consisting of polyethylene oxide in combination with a
`hydrophilic cellulosic polymer; wherein: the water-soluble polymer
`component comprises the hydrophilic cellulosic polymer in a ratio of up to
`about 4:1 with the polyethylene oxide,” recited in independent claim 10.
`Pet. 17–19. According to Petitioner, the term “up to” in each of those claim
`phrases should be construed broadly as “and optionally,” such that the
`water-soluble polymer component may optionally include a hydrophilic
`cellulosic polymer. Id. at 19. Petitioner asserts that proposed construction is
`what Patent Owner proffered in a related district court proceeding. Id.
`Patent Owner correctly notes that Petitioner does not rely on its
`proposed claim construction in the Petition. Prelim. Resp. 7. Nor does
`Petitioner provide any discussion supporting its position that the
`construction that it proposes represents the broadest reasonable construction
`in light of the specification of the patent, other than asserting that it is the
`same construction that was proffered in a district court proceeding. For
`purposes of this decision, we agree with Patent Owner that the plain and
`ordinary meaning of the phrases apply. Id. at 7. In any event, this Decision
`does not turn on the claim phrases for which Petitioner has proposed a
`construction.
`B. Obviousness over Chen, Schiraldi, and Chen II
`Petitioner contends that claims 1, 3–10, 12–18 would have been
`
`obvious over the combination of Chen, Schiraldi, and Chen II. Pet. 30–39.
`Patent Owner disagrees. Prelim. Resp. 10–15.
`
`
`
`
`
`6
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`Patent 8,017,150 B2
`
`Chen
`1.
`Chen discloses a dosage unit comprising a water-soluble hydrocolloid
`and a mucosal surface-coat-forming film that includes an effective dose of
`an active agent. Ex. 1021, 3:30–32. The active ingredient may be
`hydromorphone. Id. at 4:9. Chen describes that “the film may be formed
`using a mixture of two or more types of the same hydrocolloid that differ
`only in molecular weights and/or different degrees of substitution.” Id. at
`13:28–31. Included among the list of synthetic hydrocolloids that may be
`used to form the film are hydroxypropyl cellulose, hydroxypropyl methyl
`cellulose (“HPMC”) (hydrophilic cellulosic polymers) and polyethylene
`oxides. Id. at 14:22–29. Chen’s Example 11 describes the preparation of
`film using dry extrusion techniques. Id. at 27:1. In the example, 77.8 g
`polyethylene oxide (Polyox®WSR N-10) was mixed with additional
`ingredients (estradiol, peppermint, propylene glycol, aspartame, citric acid
`Cremphor EL, and benzoic acid) totaling 22.25 g to form about a 100 g
`blend. Id. at 27:2–5.
`
`Schiraldi
`2.
`Schiraldi discloses a bioadhesive extruded film useful for intra-oral
`controlled-releasing drug delivery. Ex. 1004, 1:7–12. The bioadhesive layer
`contains 40–95% of a thermoplastic cellulose ether and 5–60% of a
`homopolymer of ethylene oxide. Id. at 1:13–14. The film forming polymers
`useful for the invention include water-soluble polymers, i.e., hydroxypropyl
`cellulose and polyethylene oxide homopolymers. Id. at 3:14–16. Schiraldi
`also explains that non-soluble polymers may be incorporated for
`modification of the film’s permeability properties. Id. at 3:21–23. Chen
`states, “[b]y varying the ratios of the above polymers both the solubility and
`
`
`
`
`7
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`IPR2016-01112
`Patent 8,017,150 B2
`the adhesive properties of each layer of film may be controlled.” Id. at
`3:25–27. Chen teaches that “it is possible to custom design the film by
`selecting and blending various polymers.” Id. at 3:30–32. Chen explains
`that the homopolymer of ethylene oxide useful for the invention has a
`relatively high molecular weight, i.e., above 100,000, and preferably above
`3,000,000. Id. at 4:24–27. Chen teaches that the commercially available
`ethylene oxide, Polyox WSR-301, “has a molecular weight of approximately
`4,000,000–5,000,000 and is most preferred for the purposes of the present
`invention.” Id. at 4:27–31.
`
`Chen II
`3.
`Chen II is directed to compositions containing active agents
`complexed with glycyrrhizin so as to increase the solubility and
`bioavailability of the active agents. Ex. 1049 ¶¶ 2, 19.
`4.
`Analysis
`A conclusion that the claimed subject matter is obvious must be
`supported by evidence, as shown by some objective teaching in the prior art
`or by knowledge generally available to one of ordinary skill in the art that
`would have led that individual to combine the relevant teachings of the
`references to arrive at the claimed invention. See In re Fine, 837 F.2d 1071,
`1074 (Fed. Cir. 1988). Obviousness grounds must be supported with
`“articulated reasoning with some underpinning” and not by “mere
`conclusory statements.” See KSR Int’l Co. v. Teleflex Inc., 550 U.S 398, 418
`(2007).
`According to Petitioner, Chen teaches or suggests certain limitations
`shared by independent claims 1 and 10, i.e., a mucosally-adhesive water-
`soluble film product comprising an analgesic opiate pharmaceutical active,
`
`
`
`
`8
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`IPR2016-01112
`Patent 8,017,150 B2
`at least one water-soluble polymer component consisting of polyethylene
`oxide in combination with a hydrophilic cellulosic polymer, wherein the
`water-soluble polymer component comprises greater than 75% polyethylene
`oxide and up to 25% hydrophilic cellulosic polymer (claim 1), wherein the
`water-soluble polymer component comprises the hydrophilic cellulosic
`polymer in a ratio of up to about 4:1 with the polyethylene oxide (claim 10),
`and the polyethylene oxide of low molecular weight comprises about 60% or
`more in the polymer component. Pet. 34–36.
`With regard to the requirement in each of independent claims 1 and 10
`that “the polyethylene oxide comprises one or more low molecular weight
`polyethylene oxides and one or more higher molecular weight polyethylene
`oxides, the molecular weight of the low molecular weight polyethylene
`oxide being in the range 100,000 to 300,000 and the molecular weight of the
`higher molecular weight polyethylene oxide being in the range 600,000 to
`900,000,” i.e., “the polyethylene oxides molecular weights limitation,”
`Petitioner asserts that “[b]oth Chen and Schiraldi teach varying the ratios of
`film polymers to control film properties.” Id. at 35. In particular, Petitioner
`refers to Chen’s teaching that its film “may be formed using a mixture of
`two or more types of the same hydrocolloid that differ only in molecular
`weights and/or different degrees of substitution.” Id. (quoting Ex. 1021,
`3:28–32). Petitioner refers also to Schiraldi’s teaching that “[b]y varying the
`ratios of the above polymers both the solubility and the adhesive properties
`of each layer of film may be controlled.” Id. (quoting Ex. 1004, 3:25–27).
`Petitioner additionally refers to Schiraldi’s teaching that its films may be
`custom-designed by selecting and blending various polymers depending on
`the desired delivery rate, disorder being treated, and area affected by
`
`
`
`
`9
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`IPR2016-01112
`Patent 8,017,150 B2
`administration of the drug. Id. at 32 (citing Ex. 1004, 3:28–32). According
`to Petitioner, those combined teachings would have “motivated a person of
`ordinary skill to test different ratios of polyethylene oxides, and thereby
`arrive at the claimed combination of low and higher molecular weight
`polyethylene oxides.” Id. at 32–33.
`Petitioner relies on Chen II only for additional limitations recited in
`dependent claims 6 and 15, which are unrelated to the polyethylene oxides
`molecular weights limitation of independent claim 1. Pet. 39.
`We find Petitioner’s arguments to be conclusory and unpersuasive. In
`particular, Petitioner has not explained adequately why a person of skill in
`the art at the time of the invention would have had a reason to combine the
`teachings of Chen and Shiraldi. As discussed, supra, Chen describes using a
`mixture of two or more types of the same hydrocolloid that differ only in
`molecular weights and Shiraldi describes selecting and blending various
`polymers. Petitioner has not shown that a person of skill in the art would
`have understood that Shiraldi teaches or suggests selecting various polymers
`based upon high and low molecular weights. Nor has Petitioner established
`that Chen’s teaching to combine two or more types of the same hydrocolloid
`having differing molecular weights involved selecting a mixture of high and
`low molecular weights in the manner claimed. Indeed, neither reference
`provides a teaching or an example of such a practice. The example in Chen
`relied upon by Petitioner includes only a low molecular weight polyethylene
`oxide. Pet. 32 (referring to Chen Example 11 using a polyethylene oxide
`having an average molecular weight of 100,000 Da). In contrast to Chen,
`Schiraldi preferred and exemplified only high molecular weight
`polyethylene, in a range well beyond that recited in the claims for that
`
`
`
`
`10
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`IPR2016-01112
`Patent 8,017,150 B2
`component. That is, Schiraldi describes the ethylene oxide useful for its
`invention as having “a relatively high molecular weight” and preferring
`molecular weights above 3,000,000, whereas the claims recite a molecular
`weight range of 600,000 to 900,000. See Ex. 1004, 4:25–31. Moreover,
`Petitioner has not shown that the cited prior art, alone or in combination,
`taught or suggested a film comprising both low and high molecular weight
`polyethylene oxide in the respective ranges recited by the claims, or with the
`specific percentage of the low molecular weight component required.
`The portions of Dr. Mumper’s declaration cited by Petitioner do not
`provide any further support for Petitioner’s position. We note that Dr.
`Mumper does not explain why the polyethylene oxides molecular weights
`limitation would have been obvious to a person of ordinary skill over the
`combined teachings of the prior art. Instead, Dr. Mumper opines only that
`the skilled artisan “would be highly motivated to vary the amounts of the
`low and high molecular weight polyethylene oxide to achieve the desired
`effects including, but not limited to drug solubility, mucoadhesion and drug
`release rate.” Ex. 1003 ¶ 30. That opinion does not address a skilled
`artisan’s motivation, ability, or reasonable expectation of successfully
`achieving a film comprising the specific ranges and proportion of low and
`high molecular weight polyethylene oxides required by the claims. See In re
`Fine, 837 F.2d at 1074 (a showing of obviousness must be supported by
`evidence, as shown by some objective teaching in the prior art or by
`knowledge generally available to one of ordinary skill in the art that would
`have led that individual to combine the relevant teachings of the references
`to arrive at the claimed invention).
`
`
`
`
`11
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`Patent 8,017,150 B2
`Based on at least those deficiencies, we determine that Petitioner has
`not demonstrated a reasonable likelihood of establishing that it would
`prevail in showing the unpatentability of independent claims 1 and 10, or
`their respective dependent claims, 3–9 and 12–18, over Chen, Schiraldi, and
`Chen II.
`
` C. Obviousness over Schiraldi and Verma
`Petitioner contends that claims 1, 4–5, 8, 10, 12–14, and 17 would
`
`have been obvious over the combination of Schiraldi and Verma. Pet. 39–
`48. Patent Owner disagrees. Prelim. Resp. 15–19.
`1.
`Verma
`Verma is directed to alkylene oxide polymer compositions having
`particular molecular weight distributions making the compositions suitable
`for the manufacture of water-soluble films, e.g., for use in soft gel capsules.
`Ex. 1005, 1:9–13. In particular, the compositions of the invention “can
`replace gelatin in the manufacture of soft shell capsules.” Id. at 5:24–26.
`The compositions may also be used in the manufacture of hard shell
`capsules, which are generally rigid. Id. at 5:31–33. The capsules may be
`used for the oral delivery of pharmaceutically active agents. Id. at 6:16–18.
`Preferably, the alkylene oxide polymers of the invention comprise ethylene
`oxide polymers. Id. at 2:12–13.
`2. Analysis
`Petitioner again relies on Schiraldi for the teachings asserted for the
`challenge over Chen, Schiraldi, and Chen II. Pet. 40. Petitioner asserts that
`Verma teaches using polyethylene oxides of different molecular weight to
`adjust film properties. Id. Petitioner asserts also that Verma discloses films
`containing polymers having differing molecular weights that are flexible and
`
`
`
`
`12
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`IPR2016-01112
`Patent 8,017,150 B2
`disintegrate rapidly in water. Id. According to Petitioner, those teachings
`“would have motivated a person of ordinary skill in the art to make the films
`recited in the challenged claims.” Id. Specifically, Petitioner asserts that
`Verma would have provided a skilled artisan the particular ratios needed to
`control the structural properties of Schiraldi’s film and “the release rate of
`the active ingredient in order to achieve balance between dissolution and
`mucoadhesion.” Id. at 41.
`Patent Owner asserts that Petitioner has not provided a reasonable
`motivation for combining the teachings of Schiraldi and Verma, or explained
`that those teachings could be combined. Prelim. Resp. 16–19. In particular,
`Patent Owner asserts that a person of skill in the art would not have
`combined the references because Verma is not directed to making a
`mucosally-adhesive film or any type of film that comprises a pharmaceutical
`active in the film. Id. at 17. According to Patent Owner, Verma is instead
`directed to making plastic exterior films for capsules that are subsequently
`filled with liquid drugs or granules and intended to be taken orally, i.e.,
`swallowed. Id.
`We agree with Patent Owner. Petitioner’s discussion of Verma
`excludes any mention that Verma is directed to films for use in
`manufacturing soft and hard shell capsules. Petitioner also does not
`reference any teaching or suggestion in Verma demonstrating that its
`disclosure is applicable to mucosally-adhesive water-soluble film products.
`Nor does the Petitioner reference any portion of Dr. Mumper’s declaration
`that squarely addresses that issue. Thus, Petitioner has not provided any
`persuasive argument or evidence that a person of ordinary skill in the art
`preparing a mucosally-adhesive water-soluble film, as disclosed by
`
`
`
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`13
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`Schiraldi, would have had a reason to consider or apply the teachings
`relating to manufacturing films for capsule shells that are intended to be
`administered and to deliver active agents in a completely different manner.
`Further, as Patent Owner has asserted, Petitioner also fails to provide
`evidence that a skilled artisan would have had a reasonable expectation that
`teachings relating to preparing a film used to manufacture capsules intended
`to deliver drugs systemically after being swallowed may be successfully
`applied to a film that delivers drugs by adhering to a wet mucosal surface in
`the oral cavity.
`Accordingly, we determine that Petitioner has not demonstrated a
`reasonable likelihood of establishing that it would prevail in showing the
`unpatentability of independent claims 1 and 10, or their respective dependent
`claims 4–5, 8, 12–14, and 17, over the combination of Schiraldi and Verma.
`D. Obviousness over Schiraldi, Verma, and Khan
`
`Petitioner contends that claims 6–7, 9, 15–16, and 18 would have been
`obvious over the combination of Schiraldi, Verma, and Khan. Pet. 49–50.
`Patent Owner disagrees. Prelim. Resp. 15–19.
`
`For this challenge, Petitioner relies upon the combination of Schiraldi
`and Verma in the same manner discussed supra regarding the challenge of
`independent claims 1 and 10. Petitioner relies on Khan only as providing
`the additional claim elements recited in claims 6–7, 9, 15–16, and 18, e.g.,
`sweeteners or buffers. Consequently, we remain unpersuaded for the same
`reasons discussed regarding the ground involving the combination of
`Schiraldi and Verma.
`Accordingly, we determine that Petitioner has not demonstrated a
`reasonable likelihood of establishing that it would prevail in showing the
`
`
`
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`unpatentability of claims 6–7, 9, 15–16, and 18 over the combination of
`Schiraldi, Verma, and Khan.
`E. Obviousness over Yang
`Petitioner contends that claims 1, 4–10, and 13–18 would have been
`obvious over Yang. Pet. 50–58. Patent Owner disagrees, asserting that
`Yang is not prior art. Prelim. Resp. 19–21. We agree with Patent Owner.
`The parties dispute the priority date of the ’150 patent. That dispute
`revolves around whether the ’150 patent is entitled to the May 28, 2003
`filing date of its provisional application, Application No. 60/473,902 (“the
`’902 application”). Petitioner asserts that the ’902 application did not
`include a disclosure sufficient to show possession of the claim limitation
`reciting “the polyethylene oxide of low molecular weight comprises about
`60% or more in the polymer component.” Pet. 21; Ex. 1001, claims 1 and
`10. According to Petitioner, “[i]t was only the claims of the ’150 patent
`itself, as amended during prosecution, that provided any disclosure of
`compositions containing . . . a polymer component comprising at least 60%
`low molecular weight PEO.” Pet. 21–22. Petitioner, however, does not
`address the following disclosure in the ’902 application stating,
`[f]or instance, certain film properties, such as fast dissolution
`rates and high tear resistance, may be attained by combining
`small amounts of high molecular weight PEOs with larger
`amounts of lower molecular weight PEOs. Desirably, such
`compositions contain about 60% or greater levels of the lower
`molecular weight PEO in the PEO-blend polymer component.
`
`
`Ex. 1011, 29 (emphasis added). Based upon our review, that disclosure in
`the ’902 application provides a written description sufficient to comply with
`35 U.S.C. § 112, ¶ 1 with respect to specific percentage limitation raised by
`Petitioner. Thus, Petitioner has not established that Yang is prior art in view
`
`
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`IPR2016-01112
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`of the May 28, 2003 priority date for the ’150 patent claims. As the Patent
`Owner correctly asserted, the district court found, for a similar reason, that
`the ’150 patent is entitled to a priority date of May 28, 2003, and that Yang,
`therefore, is not prior art. Prelim. Resp. 21 (citing Ex. 2009, 53).
`Accordingly, we determine that Petitioner has not demonstrated a
`reasonable likelihood of establishing that that it would prevail in showing
`the unpatentability of claims 1, 4–10, and 13–18 over Yang.
`
`CONCLUSION
`For the foregoing reasons, we determine that the information
`presented in the Petition does not establish that there is a reasonable
`likelihood that Petitioner would prevail in showing that any of the
`challenged claims are unpatentable.
`IV.
` ORDER
`In consideration of the foregoing, it is hereby ordered that the Petition
`is denied.
`
`
`
`
`
`
`
`
`
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`16
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`FOR PETITIONER:
`
`Jeffery Arnold
`Peter Hagerty
`Leslie-Anne Maxwell
`Andrew Ryan
`CANTOR COLBURN LLP
`jarnold@cantorcolburn.com
`phagerty@cantorcolburn.com
`amaxwell@cantorcolburn.com
`ryan@cantorcolburn.com
`
`
`FOR PATENT OWNER:
`
`Harold Fox
`John Abramic
`STEPTOE & JOHNSON LLP
`hfox@steptoe.com
`jabramic@steptoe.com
`
`
`
`
`
`17
`
`
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