Trials@uspto.gov
`571-272-7822
`
`Paper 29
`Date: June 10, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ETHICON, INC.,
`Petitioner,
`v.
`BOARD OF REGENTS, THE UNIVERSITY OF TEXAS SYSTEM,
`Patent Owner.
`
`IPR2019-00407
`Patent 7,033,603 B2
`
`
`
`
`
`
`
`
`
`Before SUSAN L. C. MITCHELL, AVELYN M. ROSS, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`MITCHELL, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`

`

`IPR2019-00407
`Patent 7,033,603 B2
`
`INTRODUCTION
`I.
`A. Background and Summary
`Ethicon, Inc. (“Petitioner”) filed a Petition (Paper 2, “Pet.”) requesting
`inter partes review of claims 1, 2, 6, 11, 13, and 19 of U.S. Patent No.
`7,033,603 B2 (Ex. 1001, “the ’603 patent”). Pet. 1. The Board of Regents,
`The University of Texas System (“Patent Owner”) did not file a preliminary
`response.
`We have authority to determine whether to institute an inter partes
`review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). The standard for instituting
`an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that
`an inter partes review may not be instituted “unless the Director
`determines . . . there is a reasonable likelihood that the petitioner would
`prevail with respect to at least [one] of the claims challenged in the petition.”
`For the reasons set forth below, upon considering the Petition and
`evidence of record, we determine the information presented in the Petition
`establishes a reasonable likelihood that Petitioner would prevail with respect
`to at least one of the challenged claims. Accordingly, we grant the Petition,
`and institute an inter partes review.
`
`B. Real Parties in Interest
`Petitioner identifies Ethicon, Inc.; Ethicon US, LLC; Ethicon Endo-
`Surgery, Inc.; Ethicon LLC; Ethicon Holding S.A.R.L.; Ethicon PR
`Holdings Unlimited Company; Janssen Pharmaceutical; JNJ Irish
`Investments ULC; JNJ International Investment LLC; OMJ
`Pharmaceuticals, Inc.; Medical Device Business Services, Inc.; Synthes,
`Inc.; DePuy Synthes, Inc.; Johnson & Johnson International; and Johnson &
`Johnson as real-parties-in-interest for this proceeding. Pet. 3. Patent Owner
`
`2
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`

`IPR2019-00407
`Patent 7,033,603 B2
`identifies The Board of Regents, The University of Texas System, a
`real-party-in-interest as the sole owner of the ’603 patent, and
`TissueGen, Inc., a real-party-in-interest as the exclusive licensee of the ’603
`patent. Paper 28, 1 (Patent Owner’s Mandatory Notices).
`
`C. Related Matters
`Petitioner identifies pending parallel district court litigation styled
`Board of Regents, The University of Texas System et al. v. Ethicon, Inc. et
`al., 1:17-cv-01084 (W.D. Tex.), in which Patent Owner and its licensee,
`TissueGen, Inc., asserted the ’603 patent and its parent, U.S. Patent No.
`6,596,296 (“the ’296 patent”) against Petitioner. Pet. 3, Paper 28, 1.
`Petitioner also identifies its co-pending petition, seeking to institute inter
`partes review of the ’296 patent. Pet. 3; IPR2019-00406.
`The ’296 patent is asserted against other defendants in the following
`pending litigations:
`Board of Regents, The University of Texas System et al. v. Boston
`Scientific Corporation, 1:18-cv-00392 (D. Del.);
`Board of Regents, The University of Texas System et al. v.
`Medtronic, Inc. et al., No. 1:17-cv-00942 (W.D. Tex.)
`(dismissed without prejudice on July 19, 2018); and
`Board of Regents v. Boston Scientific Corp., No. 18-1700
`(Fed. Cir.).
`Pet. 3–4; Paper 28, 1. The ’603 patent is also the subject of a separate IPR,
`Medtronic, Inc. v. Board of Regents, the University of Texas System,
`IPR2019-00038, Paper 2 (PTAB), that has been terminated due to
`settlement. Paper 24, 3.
`
`3
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`IPR2019-00407
`Patent 7,033,603 B2
`D. The ’603 Patent
`The ’603 patent, titled “Drug Releasing Biodegradable Fiber for
`Delivery of Therapeutics,” issued on April 25, 2006. 1 Ex. 1001, codes (54),
`(45). The ’603 patent is directed to fiber compositions of gels or hydrogels.
`Id. at Abst. More specifically, the ’603 patent involves the composition of a
`gel or hydrogel loaded biodegradable fibers for delivery of a therapeutic
`agent. Id. at Abst., 1:15–17.
`Generally, the drug delivery composition of the ’603 patent comprises
`“at least one fiber, wherein said fiber comprises a first component and a
`second component, and wherein said first component is a biodegradable
`polymer and said second component is selected from the group consisting of
`a gel and a hydrogel.” Id. at 3:8–13. The ’603 patent further describes
`several variations of the disclosed fiber including where the second
`component is water, where the fiber comprises an emulsion of a gel or
`hydrogel, or where the fiber has a gel or hydrogel and a hollow bore. Id. at
`3:13–26. The ’603 patent also describes a scaffold composition comprising
`one or more fibers with a biodegradable polymer first component and a gel
`or hydrogel second component. Id. at 3:26–31.
`
`
`1 The ’603 patent is a continuation-in-part of U.S. Application No.
`09/632,475, which was filed on August 4, 2000, and is now the ’296 patent.
`Ex. 1001, code (63). The ’603 patent also claims priority to U.S. provisional
`application No. 60/147,827, filed on August 6, 1999. Id. at code (60).
`Although Petitioner asserts that the ’603 patent is entitled to a priority date
`no earlier than May 2, 2003—the priority date of the application that issued
`as the ’603 patent—Petitioner states that resolution of the priority date issue
`“does not bear on this Petition.” Pet. 9, n.1. Because the priority date of the
`challenged claims currently is not at issue in this proceeding, we need not
`make any determination in this regard.
`
`4
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`IPR2019-00407
`Patent 7,033,603 B2
`Some exemplary drawings depicting these various biodegradable
`fibers are Figures 3A–3D shown below.
`
`
`
`
`The ’603 patent describes Figures 3A through 3D depicted above as
`
`follows.
`
`FIG. 3A depicts a bicomponent fiber with a gel or
`hydrogel bore (60) and a wall comprising a hydrophobic
`polymer (20) that comprises a drug (70).
`FIG. 3B depicts a bicomponent fiber with a polymer
`bore (80) surrounded by a gel or hydrogel wall (90).
`FIG. 3C depicts a bicomponent fiber with a polymer
`bore (80) comprising a water emulsion (30) that is surrounded
`by a gel or hydrogel wall (90).
`FIG. 3D depicts a bicomponent fiber with a polymer bore
`(80) comprising a gel or hydrogel emulsion (40) that is
`surrounded by a gel or hydrogel wall (90).
`
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`IPR2019-00407
`Patent 7,033,603 B2
`Ex. 1001, 4:1–11.
`
`The ’603 patent describes the types of drugs to be used in the
`biodegradable fibers to include “synthetic and naturally occurring toxins and
`bioaffecting substances as well as recognized pharmaceuticals.” Id. at 8:30–
`33. The ’603 patent defines the term “drug” to be preferably “any substance
`intended for use in the treatment or prevention of disease.” Id. at 8:28–30.
`
`E. Illustrative Claims
`Petitioner challenges claims 1, 2, 6, 11, 13, and 19. Pet. 1. Of these,
`claims 1 and 19 are independent. Challenged claims 2, 6, and 13 depend
`directly from claim 1, and challenged claim 11 depends from claim 6. See
`Ex. 1001, 35:46–48, 58–59, 36:1–10, 13–14.
`Independent claims 1 and 19 are illustrative and are reproduced
`below.
`
`1. A drug delivery composition comprising at least one
`fiber having a bore and a wall, wherein said fiber comprises a
`first component and a second component, and wherein said first
`component is a biodegradable polymer and said second
`component is selected from the group consisting of a gel and
`hydrogel.
`Ex. 1001, 35:41–45.
`19. A drug delivery composition comprising a fiber,
`wherein said fiber comprises an emulsion consisting essentially
`of a gel or hydrogel.
`Id. at 36:30–33.
`F. Evidence
`Petitioner relies on the following evidence to establish the
`unpatentability of the challenged claims.
`
`6
`
`

`

`Date
`Feb. 16, 1993
`
`Exhibit No.
`1007
`
`Sept. 8, 1995
`
`June 2, 1998
`
`1008
`
`1009
`
`Dec. 7, 2018
`
`1002
`
`IPR2019-00407
`Patent 7,033,603 B2
`Reference or Declaration
`Michael J. Groves, U.S. Patent No.
`5,186,936 (filed Aug. 6, 1990)
`(“Groves”)
`Kamalesh Sirkar et al., WO 95/23598
`(filed Feb. 28, 1995) (“Sirkar”)
`Joseph P. Vacanti and Robert S.
`Langer, U.S. Patent No. 5,759,830
`(filed Feb. 28, 1994) (“Vacanti”)
`Declaration of David J. Mooney,
`Ph.D.
`G. Prior Art and Asserted Grounds
`Petitioner asserts that claims 1, 2, 6, 11, 13, and 19 of the ’603 patent
`are unpatentable on the following grounds:
`Claim(s) Challenged
`35 U.S.C. § Reference(s)/Basis
`102/103
`1, 2, 6, 11, 13, and 19
`(pre-AIA) Groves
`102/103
`Sirkar
`(pre-AIA)
`102/103
`(pre-AIA) Vacanti
`II. ANALYSIS
`
`19
`
`1, 2, 13
`
`A. Legal Standards
`“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) (citing 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”)). This burden of persuasion never
`shifts to the patent owner. See Dynamic Drinkware, LLC v. Nat’l Graphics,
`
`7
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`IPR2019-00407
`Patent 7,033,603 B2
`Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in
`inter partes review).
`To show anticipation under § 102, each and every claim element,
`arranged as in the claim, must be found in a single prior art reference. Net
`MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359 (Fed. Cir. 2008). The prior
`art need not, however, use the same words as the claims in order to find
`anticipation. In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2009). It is also
`permissible to take into account not only the literal teachings of the prior art
`reference, but also the inferences an ordinarily skilled person would draw
`from the reference. Eli Lilly and Co. v. Los Angeles Biomedical Res. Inst. at
`Harbor-UCLA Med. Ctr., 849 F.3d 1073, 1074–75 (Fed. Cir. 2017); In re
`Preda, 401 F.2d 825, 826 (CCPA 1968).
`Turning to obviousness, a claim is unpatentable under 35 U.S.C.
`§ 103(a) if the differences between the subject matter sought to be patented
`and the prior art are such that the subject matter as a whole would have been
`obvious at the time the invention was made to a person having ordinary skill
`in the art to which that subject matter pertains. KSR Int’l Co. v. Teleflex
`Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on
`the basis of underlying factual determinations including: (1) the scope and
`content of the prior art; (2) any differences between the claimed subject
`matter and the prior art; (3) the level of ordinary skill in the art; and
`(4) objective evidence of nonobviousness when presented. Graham v. John
`Deere Co., 383 U.S. 1, 17–18 (1966).
`In analyzing the obviousness of a combination of prior art elements, it
`can be important to identify a reason that would have prompted one of skill
`in the art “to combine . . . known elements in the fashion claimed by the
`patent at issue.” KSR, 550 U.S. at 418. A precise teaching directed to the
`
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`IPR2019-00407
`Patent 7,033,603 B2
`specific subject matter of a challenged claim is not necessary to establish
`obviousness. Id. Rather, “any need or problem known in the field of
`endeavor at the time of invention and addressed by the patent can provide a
`reason for combining the elements in the manner claimed.” Id. at 420.
`Accordingly, a party who petitions the Board for a determination of
`unpatentability based on obviousness must show that “a skilled artisan
`would have been motivated to combine the teachings of the prior art
`references to achieve the claimed invention, and that the skilled artisan
`would have had a reasonable expectation of success in doing so.” In re
`Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016)
`(quotations and citations omitted).
`At this preliminary stage, we determine whether the information
`presented shows a reasonable likelihood that Petitioner would prevail in
`establishing that at least one of the challenged claims would have been
`anticipated by or obvious over the proposed prior art.
`We analyze the challenges presented in the Petition in accordance
`with the above-stated principles.
`
`B. Level of Ordinary Skill in the Art
`We review the grounds of unpatentability in view of the
`understanding of a person of ordinary skill in the art at the time of invention.
`Graham, 383 U.S. at 17. Petitioner contends that a person having ordinary
`skill in the art would have had
`a Ph.D. in chemistry, chemical engineering, materials science,
`or a related field and several years of experience working in the
`fields of the patent, drug delivery and tissue engineering.
`Pet. 18 (citing Ex. 1002 ¶ 34).
`
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`IPR2019-00407
`Patent 7,033,603 B2
`Although the level of ordinary skill proffered by Petitioner appears
`rather high, at this stage of the proceeding, Patent Owner has not contested
`this articulation or offered its own statement of the level of ordinary skill in
`the art. Petitioner does not indicate that the outcome of any arguments made
`in this case would change depending on the level of ordinary skill in the art.
`For purposes of this Decision, and based on the record currently presented,
`we find we do not need an express articulation of the level of ordinary skill
`in the art and rely on the prior art of record that reflects the level of skill in
`the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d
`1350, 1355 (Fed. Cir. 2001). Any final determination pertaining to the level
`of ordinary skill in the art shall be made on the full trial record.
`
`C. Claim Construction
`We construe claims “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 (2019). Therefore, we construe the challenged
`claims under the framework set forth in Phillips v. AWH Corp., 415 F.3d
`1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim
`terms are given their ordinary and customary meaning, as would be
`understood by a person of ordinary skill in the art (“POSA”), at the time of
`the invention, in light of the language of the claims, the specification, and
`the prosecution history of record. Id. Only those terms that are in
`controversy need be construed and only to the extent necessary to resolve
`the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor
`Co. Matal, 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)).
`
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`IPR2019-00407
`Patent 7,033,603 B2
`Petitioner provides constructions for the claim terms “gel,”
`“hydrogel,” and “said fiber comprises an emulsion consisting essentially of a
`gel or hydrogel,” that are consistent with the construction of these terms as
`set forth by the District Court in the parallel litigation in the Western District
`of Texas against Ethicon. See Pet. 13–17; Ex. 1013, 5, 14–17. Petitioner
`contends, however, that none of these terms require express construction to
`resolve whether we should institute an inter partes review. Pet 15 (stating
`that construing “gel” and “hydrogel” is not necessary because each of the
`prior art references, Groves, Sirkar, and Vacanti, disclose a “hydrogel” or
`“gel”), 17 (stating under either the District Court’s claim construction or
`Patent Owner’s construction proffered in the parallel litigation, claim 19,
`requiring “an emulsion consisting essentially of a gel or hydrogel,” is
`unpatentable over Groves or Sirkar).
`Petitioner asserts that the District Court construed the claim terms as
`follows:
`
`• “hydrogel”: “a colloid in which a dispersed phase (colloid) is
`combined with a continuous phase (water) to produce a viscous
`jellylike product”
`• “gel”: “a colloidal system with at least two phases, one of
`which forms a continuous three-dimensional network that acts
`as an elastic solid”
`• “an emulsion consisting essentially of a gel or hydrogel”:
`“an emulsion having only the following material elements: a
`gel or hydrogel”
`Pet. 14 (quoting Ex. 1013, 5, 14–17).
`
`11
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`

`IPR2019-00407
`Patent 7,033,603 B2
`
`Although Petitioner’s arguments do not rest exclusively on the
`construction of these terms, we find it useful to examine the construction of
`these terms here.
`“Gel” and “Hydrogel”
`The District Court relied on an express definition set forth in the ’603
`patent that states that “gel” is defined as “a colloidal system with at least two
`phases, one of which forms a continuous three-dimensional network that acts
`as an elastic solid.” Ex. 1001, 5:36–39. The District Court also relied on an
`express definition of “hydrogel” in the ’603 patent that states that a
`“hydrogel” is “a colloid in which a dispersed phase (colloid) is combined
`with a continuous phase (water) to produce a viscous jellylike product.” Id.
`at 5:39–42. We agree with Petitioner and the District Court that “gel” and
`“hydrogel” should be construed in accordance with the express definitions
`provided in the ’603 patent, but also add to the definitions that precursors are
`also encompassed by the terms “gel” and “hydrogel” as expressly stated in
`the ’603 patent. See Phillips v. AWH Corp., 415 F.3d 1303, 1320–21 (Fed.
`Cir. 2015) (stating that the specification acts as a dictionary when a claim
`term is expressly or impliedly defined); Ex. 1002 ¶¶ 50–51.
`For instance, we note that the ’603 patent also expressly provides that
`the terms “gel” and “hydrogel” include “the formed gel or hydrogel as well
`as the appropriate precursor molecules involved in the formation of gels and
`hydrogels.” Ex. 1001, 9:51–55. Also, dependent claim 12 requires that the
`claimed gel or hydrogel “is a precursor gel or precursor hydrogel,”
`indicating that the requirement of a gel or hydrogel of claim 1, from which
`claim 12 depends, must include precursors. Pet. 8 (citing Ex. 1001, 36:11–
`12; Free Motion Fitness, Inc. v. Cybex Int’l, Inc., 423 F.3d 1343, 1351 (Fed
`Cir. 2005) (applying the claim differentiation doctrine, i.e., the presumption
`
`12
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`

`IPR2019-00407
`Patent 7,033,603 B2
`that each claim in a patent has different scope, to determine that an
`independent claim must have more than one cable when its dependent claim
`is limited to a single cable) (citing Comark Communications, Inc. v. Harris
`Corp., 156 F.3d 1182, 1187 (Fed. Cir. 1998)).
`Based on these express teachings in the Specification of the ’603
`patent, we agree with District Court’s claim construction of the claim terms
`“gel” and “hydrogel,” but also clarify that the ’603 patent also expressly
`defines “gel” and “hydrogel” more broadly to include precursors.
`
`“An Emulsion Consisting Essentially of a Gel or Hydrogel”
`
`The District Court interpreted the claim phrase “an emulsion
`consisting essentially of a gel or hydrogel” in terms of the transitional phrase
`“consisting essentially of” to limit the term to “an emulsion having only the
`following material elements: a gel or hydrogel.” See Ex. 1013, 15–16
`(citing PPG Indus. v. Guardian Indus. Corp., 156 F.3d 1351, 1354 (Fed. Cir.
`1998)). We agree with the District Court that this is a proper interpretation
`of the claim phrase in light of the limiting transitional phrase “consisting
`essentially of.”
`We also agree with the District Court that the terms “gel” and
`“hydrogel,” as used in claim 19, are not limited to “a dispersed gel or
`hydrogel phase,” as asserted by the Patent Owner. The District Court’s
`claim interpretation, however, does not further define the meaning of the
`term “emulsion.” We invite the parties to address further the construction of
`“an emulsion consisting essentially of a gel or hydrogel,” and particularly,
`what is meant by “emulsion” in the claim phrase.
`
` At this stage of the proceeding, we determine that it is not necessary
`to provide an express construction for any other term to resolve whether to
`
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`IPR2019-00407
`Patent 7,033,603 B2
`institute an inter partes review. See Nidec Motor Corp. v. Zhongshan Broad
`Ocean Motor Co. Ltd., 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)
`(“[W]e need only construe terms ‘that are in controversy, and only to the
`extent necessary to resolve the controversy.’”)).
`We encourage the parties to address the construction of these terms in
`subsequent briefing so that we have the benefit of Patent Owner’s views in
`making a final determination concerning claim construction.
`
`D. Alleged Anticipation by or Obviousness over Groves (Ground 1:
`Claims 1, 2, 6, 11, 13, and 19)
`Petitioner contends claims 1, 2, 6, 11, 13, and 19 are unpatentable as
`anticipated by or obvious over Groves. Pet. 1. Petitioner directs us to
`portions of Groves that purportedly disclose all the limitations in the
`challenged claims. Id. at 18–33. Petitioner also relies on the testimony of
`Dr. Mooney to support its arguments. See id.
`
`1. Groves (Ex. 1007)
`Groves describes packing material to treat infections of the teeth and
`gums. Ex. 1007, Abst. Specifically, Groves describes:
`A biocompatible, polymeric carrier material, typically calcium
`al[gi]nate, has dispersed therein an antibiotic ester which
`typically defines at least one ester group of 10 to 18 carbon
`atoms per molecule. The antibiotic ester is present in the
`polymeric carrier in an initial concentration sufficient to allow
`the continuous, controlled release of at least an inhibitory
`concentration of free antibiotic as a hydrolysis product from the
`antibiotic ester.
`Id. Bacterial lipase that is present in a higher concentration of infectious
`bacteria causes the release of higher concentrations of free antibiotic that is
`hydrolyzed from the ester, creating a feedback loop. Id.
`
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`Patent 7,033,603 B2
`Groves further describes that the polymeric carrier for the antibiotic
`may be of any desired shape, preferably being of string or
`fibrous form. The string or fiber used as the polymeric carrier
`material containing an antibiotic ester may be a solid string or
`fiber, or a hollow string or fiber having a lumen. If desired, the
`lumen may contain a relatively large supply of antibiotic ester
`in accordance with this invention or another medicament, or a
`mixture thereof. The inner core of the fiber, (the terms “string”
`and “fiber” being synonymous) may contain a polymeric carrier
`a hydrogel which defines ionic polymer units of one charge,
`positive or negative, and, of course, accompanying simple ions
`of the other charge such as calcium or chloride. The fiber also
`may define an outer coating which comprises a hydrogel which
`defines ionic polymer units of the opposite charge to that of the
`hydrogel of the inner core. The antibiotic ester is substantially
`carried in the inner core, and/or in a lumen defined in the inner
`core, while the outer coating acts as controlled release barrier to
`limit generation of free antibiotic. Thus, by control of the outer
`coating, the antibiotic release rates of the packing material of
`this invention may be controlled to conform to a large variety of
`desirable clinical programs.
`Id. at 3:53–4:9.
`
`2. Analysis
`Claim 1
`Petitioner asserts that Groves teaches “[a] drug delivery composition”
`set forth in the preamble of claim 1. We find, on the record before us and
`for institution, that the preamble calling for “[a] drug delivery composition”
`is limiting because it adds structure to the claimed composition, i.e.,
`requiring a drug, that is not recited elsewhere in the claim. See, e.g.,
`Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257
`(Fed. Cir. 1989). Petitioner points to Groves teaching of a “controlled
`release vehicle for antibiotics” in the form of a “packing material . . . for the
`treatment of infections.” Pet. 24 (citing Ex. 1007, 1:30–32, 45–46, 66–67,
`
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`IPR2019-00407
`Patent 7,033,603 B2
`6:26–56 (claims 1–6)); Ex. 1002 ¶ 71. Petitioner also points to Groves’
`statement that its “packing material” is a “biocompatible, polymeric carrier
`material carrying therein an antibiotic ester.” Id. (citing Ex. 1007, 2:66–3:5,
`6:26–27 (claim 1) (reciting a “packing material for the treatment of
`infections” containing a “metronidazole ester”)).
`We agree with Petitioner that it has shown sufficiently that Groves
`teaches “[a] drug delivery composition” as required by claim 1.
`Petitioner relies on Groves statement that “the polymeric carrier may
`be of any desired shape, preferably being of string or fibrous form,” to show
`that Groves teaches that its drug delivery composition comprises “at least
`one fiber.” Pet. 24 (citing Ex. 1007, 3:53–54; 6:42–56). Groves also
`teaches that these fibers have the required “bore and a wall” and “a first
`component and a second component,” Petitioner asserts, because Groves
`teaches that “[t]he string or fiber used as a polymeric carrier material” may
`have an “inner core” and an “outer coating.” Id. at 25 (citing Ex. 1007, 54–
`4:1); Ex. 1002 ¶ 73. Petitioner also mentions that the ’603 patent uses the
`same terminology as Groves, i.e., “inner core” to refer to its fiber’s bore, and
`“Gel Coated Polymer Fiber” to refer to an example of a hydrogel wall.
`Pet. 25 (citing Ex. 1001, 10:40–41, 13:31–34, 26:25–29 (Example 2 title));
`Ex. 1002 ¶ 74.
`Thus, we agree with Petitioner that it has shown sufficiently that
`Groves teaches a drug delivery composition “comprising at least one fiber
`having a bore and a wall, wherein said fiber comprises a first component and
`a second component.”
`Petitioner points to Groves teaching that the “outer coating” of the
`fiber contains “pectin, chitosan [or] chitin,” to establish that Groves teaches
`that “said first component is a biodegradable polymer.” Pet. 26; Ex. 1002
`
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`IPR2019-00407
`Patent 7,033,603 B2
`¶¶ 76–77. The ’603 patent identifies “chitin” as a biodegradable polymer.
`Pet. 26 (citing Ex. 1001, 9:56–61 (describing pectin, chitosan, and chitin as
`polysaccharides that are a class of naturally derived biodegradable
`polymers), 16:1–29; Ex. 1019, 1141); Ex. 1002 ¶ 77. Petitioner also asserts
`that Groves expressly states that the inner core of its fiber contains “a
`hydrogel,” thus teaching “said second component is selected from the group
`consisting of a gel and a hydrogel.” Pet. 27 (citing Ex. 1001, 6:44–56, 3:60–
`4:12); Ex. 1002 ¶ 78.
`Finally, we agree with Petitioner on this record that it has shown
`sufficiently that Groves teaches “said first component is a biodegradable
`polymer and said second component is selected from the group consisting of
`a gel and a hydrogel,” as further required in challenged claim 1 of the ’603
`patent. Because we find on this record that Petitioner has sufficiently shown
`that each limitation of claim 1 arranged as in the claims is taught by Groves
`as supported by Groves disclosure and Dr. Mooney’s testimony, we
`determine that Petitioner has shown a reasonable likelihood of succeeding in
`showing that claim 1 of the ’603 patent is anticipated by Groves.
`With regard to claim 1, Petitioner further asserts that Patent Owner
`admitted during prosecution of a very similar claim in European prosecution
`that Groves discloses the limitations of claim 1. Pet. 19–22. To distinguish
`Groves, Petitioner asserts, Patent Owner added the limitation “the
`concentration of the gel or the hydrogel varies of as a function of distance
`along the long axis of the fiber,” a limitation that is not in claim 1 here.
`Because we determine independently that Groves teaches all of the
`limitations of claim 1 for purposes of institution, we need not reach this
`additional reason for unpatentability of claim 1 over Groves. We invite the
`parties to address this issue in further briefing.
`
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`IPR2019-00407
`Patent 7,033,603 B2
`Claim 19
`
`Petitioner explains how Groves teaches the limitations of independent
`claim 19, arranged as in the claim, under both the District Court’s claim
`construction, and Patent Owner’s claim construction that it offered in the
`District Court parallel litigation. See Pet. 32–33; Ex. 1002 ¶¶ 94–100.
`Under the District Court’s claim construction, Petitioner shows where
`Groves teaches “a drug delivery composition comprising a fiber,” in which
`the “‘material’ elements of the claimed fiber must be a gel or hydrogel.”
`Pet. 32; Ex. 1002 ¶ 96–97. As we stated in our claim construction analysis,
`however, we question whether this interpretation of claim 19 sufficiently
`takes into account that “said fiber comprises an emulsion consisting
`essentially of a gel or a hydrogel.” See supra Section II.C (emphasis added).
`
`In accordance with Patent Owner’s interpretation of claim 19—an
`emulsion consisting of essentially a dispersed gel or hydrogel phase—
`Figure 11, among other figures, and Example 16 of the ’603 patent appears
`to support Patent Owner’s definition. See Ex. 1001, 32:40–33:21. For
`instance, Figure 11 set forth below is described as depicting “the flow of a
`ther[a]peutic through the walls of an emulsion-loaded fiber.” Id. at 5:1–2
`(emphasis added).
`
`18
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`

`

`IPR2019-00407
`Patent 7,033,603 B2
`
`
`Id. at Figure 11. As can be seen from the description provided on Figure 11,
`the flow of a therapeutic through the walls of an emulsion-loaded fiber is
`described as a “pathway through dispersed phase.” See id. (emphasis
`added).
`
`By the same token, Example 16 describes the “creation of a gel or
`hydrogel core in a biodegradable polymer sheath that contains a dispersed
`aqueous phase.” Id. at 32:41–43 (emphasis added). Example 16 describes
`gel bored fibers that contain therapeutic agents in a dispersed aqueous, gel or
`hydrogel phase within a biodegradable polymer fiber wall. This “dispersed
`aqueous, gel or hydrogel phase” is further defined as “a water-in-oil type
`emulsion.” Id. at 33:4–7. Specifically, Example 16 is explained as follows.
`Once the polymer is dissolved in solvent (A), an aqueous
`solution or a gel or a hydrogel (including precursors) containing
`both the biomolecules(s) of interest and a surfactant is added to
`the polymer solution. . . .
`Using some form of mechanical energy such a
`sonication, vortexing, or shear forces generated by forcing the
`liquid through a small orifice, a water-in-oil type emulsion is
`formed between the aqueous and organic-phases. Depending
`
`19
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`IPR2019-00407
`Patent 7,033,603 B2
`on the volume of aqueous solution relative to the polymer
`solution, emulsification can be accomplished in stages, using
`partial additions of the aqueous phase until the total volume is
`incorporated into the polymer solution. This emulsion must be
`stable for periods far in excess of time required for extrusion to
`insure homogeneity of the emulsion throughout the extrusion
`process. The size of the dispersed aqueous phase droplets is
`primarily dependent on the quality of the surfactant, and the
`total amount of mechanical energy imparted to the system in
`forming the emulsion. The aqueous phase size is an important
`variable in both release kinetics and mechanical properties of
`the fiber. This emulsion is then used as the polymer solution,
`and all other details are the same as explained in example 1.
`Id. at 32:50–33:21.
`We tend to agree with Patent Owner on this record concerning how
`claim 19 should be interpreted. We determine that the use of the term
`“emulsion” in claim 19 has meaning and would require something, such as a
`drug, to be dispersed in the gel or hydrogel to create an emulsion. Petitioner
`asserts that Groves teaches a “polymeric carrier material” containing
`“dispersed” antibiotic ester, and the preparation of fibers with “dispersed”
`drug. Pet. 32–33 (citing Ex. 1007, Abst., 5:16–19). Petitioner further
`provides:
`
`Groves explains that the antibiotic ester is “typically . . .
`distributed throughout the mass of the polymeric carrier”
`([Ex. 1007,] 2:29–37), and describes using a hydrogel as the
`“polymeric carrier” for the drug. Id. at 3:60–65. Further,
`Groves encourages a POSA to tailor its drug-delivery fibers to
`meet clinical needs. Ex. 1007 at 2:63–68 (the fiber carrier “can
`be tailored to an optimum clinical program for the treatment of
`chronic infections”