Trials@uspto.gov
`571.272.7822
`
`
`
`
`
`
`
` Paper 56
`
` Entered: June 18, 2020
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`OCULAR THERAPEUTIX, INC.,
`Petitioner,
`
`v.
`
`MATI THERAPEUTICS, INC.,
`Patent Owner.
`____________
`
`IPR2019-00448
`Patent 9,849,082 B2
`____________
`
`
`
`Before ERICA A. FRANKLIN, GRACE KARAFFA OBERMANN, and
`RYAN H. FLAX, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`
`
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`Denying Patent Owner’s Motion to Strike
`Dismissing-In-Part and Denying-In-Part Patent Owner’s Motion to Exclude
`Denying Petitioner’s Motion to Exclude
`35 U.S.C. § 318(a);37 C.F.R. § 42.64
`
`
`
`
`
`571.272.7822
`
`
`
`
`
`
`
` Paper 56
`
` Entered: June 18, 2020
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`OCULAR THERAPEUTIX, INC.,
`Petitioner,
`
`v.
`
`MATI THERAPEUTICS, INC.,
`Patent Owner.
`____________
`
`IPR2019-00448
`Patent 9,849,082 B2
`____________
`
`
`
`Before ERICA A. FRANKLIN, GRACE KARAFFA OBERMANN, and
`RYAN H. FLAX, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`
`
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`Denying Patent Owner’s Motion to Strike
`Dismissing-In-Part and Denying-In-Part Patent Owner’s Motion to Exclude
`Denying Petitioner’s Motion to Exclude
`35 U.S.C. § 318(a);37 C.F.R. § 42.64
`
`
`
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`INTRODUCTION
`I.
`Mati Therapeutics, Inc. (“Patent Owner”) is the owner of U.S. Patent
`No. 9,849,082 B2 (Ex. 1001, “the ’082 patent”). Paper 5, 2. Ocular
`Therapeutix, Inc. (“Petitioner”) filed a Petition requesting inter partes
`review of claims 1–23 of the ’082 patent. Paper 3 (“Pet.”). We instituted
`trial on June 26, 2019. Paper 8 (“Institution Decision”).
`Patent Owner filed a Response to the Petition. Paper 21 (“PO
`Resp.”). Petitioner subsequently filed a Reply, to which Patent Owner
`responded with a Sur-reply. Papers 30 (“Pet. Reply”), 37 (“PO Sur-reply”).
`A final hearing was held where the parties presented oral argument in
`support of their positions. Paper 54 (“Hr’g 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 1–23 of the ’082
`patent are unpatentable. 35 U.S.C. § 316(e).
`Patent Owner filed a Motion to Strike Petitioner’s Reply and Relied
`Upon Evidence. Paper 36 (“PO Mot. Strike”). Petitioner opposed this
`motion. Paper 39 (“Pet. Opp. PO Mot. Strike”). Petitioner and Patent
`Owner also each separately filed Motions to Exclude certain evidence.
`Paper 43 (“PO Mot. Exclude”); Paper 44 (“Pet. Mot. Exclude”). The parties
`filed respective oppositions and replies thereto. Paper 45 (“PO Opp. Pet.
`Mot. Exclude); Paper 47 (“Pet. Opp. PO Mot. Exclude”); Paper 50 (“PO
`Reply Mot. Exclude”); Paper 51 (“Pet. Reply Mot. Exclude”). We address
`each of these motions in this Decision.
`
`2
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`A.
`
`II. BACKGROUND
`REAL PARTIES-IN-INTEREST
`Petitioner identifies the real party-in-interest as “Ocular Therapeutix,
`Inc.” Pet. 3. Patent Owner identifies the real party-in-interest as “Mati
`Therapeutics, Inc.” Paper 5, 2.
`RELATED MATTERS
`B.
`Petitioner has disclosed:
`Ocular is not aware of any pending litigation related to the
`‘082 Patent nor of any requested reissue, reexamination, or
`review of the ‘082 Patent. Ocular is, however, aware of a co-
`pending IPR petition regarding U.S. Pat. No. 9,463,114
`[IPR2019-00442], also filed by Ocular against the same
`Patentee, Mati. The ‘114 Patent is not related to the ‘082 Patent
`but is directed to similar technology.
`Ocular is aware of one pending continuation application,
`U.S. App. No. 15/852,619, that includes the ’082 Patent among
`its priority claims. A non-final office action issued on August
`28, 2018, rejecting the pending claims based on grounds similar
`to the one that the examiner raised against the ‘082 Patent.[1]
`Pet. 4. Patent Owner identifies the same inter partes review and ’619
`application as Petitioner. Paper 5, 2. Patent Owner also identifies U.S.
`Patent Application No. 16/168,554 as related to the ’082 patent.2 Id.
`THE ’082 PATENT
`C.
`The’082 patent issued December 26, 2017, from U.S. Patent
`Application 15,405,991, which was filed January 13, 2017. Ex. 1001, codes
`(45), (21), (22). The ’082 patent indicates priority through a series of
`
`
`1 US application 15/825,619 issued as patent US 10,383,817 B2 on Aug. 20,
`2019.
`2 US application 16/168,554 issued as patent US 10,300,014 B2 on May 28,
`2019.
`
`3
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`continuation applications to a pair of provisional applications: Provisional
`60/787,775 filed March 31, 2006, and Provisional 60/871,864 filed
`December 26, 2006. Id. codes (63), (60). The parties do not dispute the
`’082 patent’s priority date and each treats March 31, 2006, as the earliest
`effective priority date. See Pet. 5 (“the earliest claimed priority date is
`March 31, 2006”); PO Resp. 51 (“as of March 31, 2006, a POSA with both
`Pritchard and Gillespie in hand would not have been able to make and use a
`claimed drug delivery system without undue experimentation”).
`The ’082 patent indicates its invention relates to “[a]n implant for
`insertion through a punctum and into a canalicular lumen of a patient.”
`Ex. 1001, Abstract. In the parties’ submissions here, such devices are
`interchangeably called punctal or lacrimal plugs, inserts, and implants. See,
`e.g., Pet. 1, 2, 6–7, 15, 17–18, 20–26, 36–51, 54–57, 62–64; PO Resp. 1–14.
`Punctal plugs can be intracanalicular, where they are inserted fully into the
`lacrimal canaliculus below the punctal opening, or they can be inserted into
`the lacrimal canaliculus but still exposed above the punctal opening. PO
`Resp. 5–6.
`
`4
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`The relevant physiology is illustrated in a figure provided in Patent
`Owner’s Response, reproduced below:
`
`
`
`PO Resp. 5 (citing Ex. 2014 ¶¶ 26–27). Patent Owner’s figure above shows
`(and labels) the relevant physiology of the human eye, including two
`openings, called puncta, in the corner of the eye and respectively behind the
`upper and lower eyelids, each of which connects to a respective duct called
`lacrimal canaliculi, which converge and connect with a lacrimal sac, which
`becomes a nasolacrimal duct as it travels down along the nose. See id. at 4–
`5. The puncta and lacrimal canaliculi carry tears away from the eye to the
`nasolacrimal duct of the nose anatomy. Id.
`
`5
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`This physiology is also illustrated and described in the ’082 patent at
`Figure 1-1, as shown below:
`
`
`
`“FIG[]. 1-1 [above] . . . show[s] anatomical tissue structures of an eye 2
`suitable for treatment with implants,” where the upper and lower canaliculus
`are labeled 10 and 12 and each has a punctal opening labeled 11 and 13.
`Ex. 1001, 7:31–65.
`The ’082 patent describes a diversity of embodiments of implants.
`See id. at 7:66–14:39, 16:27–19:25, 20:12–25, Figs. 1A–1G, 2A–2M, 3A,
`3B, 4A, 4B, 9A–9G, 10A–10C, 11, 14A, 14B. One embodiment of an
`implant is shown at Figure 1A, reproduced below:
`
`6
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`
`
`“FIG. 1A shows a top cross sectional view of a sustained release implant to
`treat an optical defect of an eye.” Id. at 5:1–2. Figure 1A shows implant
`100 having drug core 110, which can be a matrix 170 of silicone or the like
`and retains a therapeutic agent, such as Latanoprost oil or Bimatoprost
`particles. Id. at 7:66–8:28. Also shown is sheath body 120, impermeable to
`the therapeutic agent, surrounding core 110, but open at an end to allow
`release of the therapeutic agent. Id. at 8:29–37. Implant 100 also includes
`occlusive element 140 and retention structure 130. Id. at 8:38–52.
`Occlusive element 140 is impermeable to tears and occludes the hollow
`tissue structure therefrom. Id. Retention structure 130 is a component
`intended to retain implant 100 in the hollow tissue structure of the punctum
`of a canaliculus. Id. at 8:33–38.
`
`7
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`Another embodiment is illustrated Figure 1G, reproduced below:
`
`
`
`“FIG. 1G schematically illustrates a sustained release implant comprising a
`flow restricting retention element, a core and a sheath.” Id. at 5:19–21.
`Figure 1G schematically illustrates, in cross-section, implant 180 having
`drug core 182 and sheath 184. Id. at 10:11–17. This embodiment further
`includes exposed (core) convex surface area 182A to increase release of the
`therapeutic agent contained within core 182, and retention structure 186 that
`can include occlusive element 188 that blocks tear flow through the
`canaliculus. Id. at 10:17–27.
`Generally, the ’082 patent describes the use and structure of punctal
`plugs as illustrated above, as follows:
`In many embodiments the tube body is sized to occlude the
`punctum to treat dry eye. In some embodiments, the body may
`be smaller than the punctum such that the swollen hydrogel can
`occlude the punctum. The body can comprises a protrusion
`comprising a flange, rim, wing or the like that is sized to remain
`on the exterior of the punctum while the body is positioned in the
`punctum so as to facilitate removal of the plug body and retention
`structure from the punctum while the hydrogel retention element
`is swollen.
`
`8
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`Id. at 17:51–60.
`The ’082 patent also states, “[i]n many embodiments, the sheath body
`and/or retention structure may have a distinguishing feature, for example a
`distinguishing color, to show placement such that the placement of the
`sheath body and/or retention structure in the canaliculus or other body
`tissue structure can be readily detected by the patient.” Id. at 20:67–21:5
`(emphasis added). Other than the claims, this is the only discussion of color
`in the Specification. See generally id.
`The ’082 patent has 23 claims, of which claims 1, 11, and 18 are
`independent claims. Independent claim 1 is illustrative and is reproduced
`below:
`
`1. A drug delivery system for insertion into a lacrimal
`canaliculus of a patient, comprising:
`a therapeutic agent, a distinguishing color to show
`placement of the system in the lacrimal canaliculus of the patient
`and a body of material to hold the therapeutic agent wherein the
`body of material comprises hydrogel polymers and wherein the
`body of material is a cylindrical rod.
`Id. at 30:20–27. Independent claim 11 is similar to claim 1, except in further
`requiring that the body of material “swells when placed in the lacrimal
`canaliculus.” Id. at 30:51–67. Independent claim 18 is also similar to claim
`1, except in further requiring that the “therapeutic agent [is] selected from an
`anti-glaucoma agent, a corticosteroid[,] an anti-microbial agent, and anti-
`allergy agent[,] or a non-steroidal anti-inflammatory agent.” Id. at 31:8–17.
`
`9
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`D.
`
`PETITIONER’S ASSERTED GROUNDS FOR UNPATENTABILITY
`Petitioner asserts five (5) grounds for unpatentability, one under
`35 U.S.C. § 102 for anticipation and the remaining four under 35 U.S.C.
`§ 103 for obviousness. Pet. 13, 27–69. Petitioner’s grounds are as follows:3
`
`Ground
`
`Claims Challenged
`
`35 U.S.C. §
`
`References/Basis
`
`1–7, 9–16, 18–20, 22–23
`
`102
`
`Pritchard4
`
`1–7, 9–16, 18–20, 22–23
`
`103(a)
`
`Pritchard, Gillespie5
`
`8, 17, 21
`
`103(a)
`
`Pritchard, Gillespie,
`Hellberg6
`
`1–7, 9–16, 18–20, 22–23
`
`103(a)
`
`Pritchard, Handbook7
`
`8, 17, 21
`
`103(a)
`
`Pritchard, Handbook,
`Hellberg
`
`1
`
`2
`
`3
`
`4
`
`5
`
`
`
`3 Because March 31, 2006 is the effective filing date of the ’082 patent, and
`there is no evidence that any claim in the ’082 patent’s application ever had
`an effective filing date on or after March 16, 2013, the changes to Sections
`102 and 103 under the AIA do not apply and the ’082 patent is governed by
`pre-AIA 35 U.S.C. §§ 102 and 103.
`4 US 2005/0197614 A1 (published Sept. 8, 2005) (Ex. 1010, “Pritchard”);
`see also U.S. Provisional Application No. 60/557,368 (filed Mar. 29, 2004)
`(Ex. 1012, “Pritchard ’368 Provisional”) (cited for priority and incorporated
`by reference by Pritchard at paragraphs 1, 44, 46, 47, 59, 82, 101, 105, 116,
`121). The Pritchard ’368 provisional includes page numbering at its bottom
`center and lower left corner; we use the numbering at the latter herein.
`5 US 2002/0169409 A1 (published Nov. 14, 2002) (Ex. 1015, “Gillespie”).
`6 US 6,646,001 B2 (issued Nov. 11, 2003) (Ex. 1017, “Hellberg”).
`7 AMERICAN PHARMA ASSOCIATION, HANDBOOK OF PHARMACEUTICAL
`EXCIPIENTS 146–53 (Arthur H. Kibbe, Ph.D. ed., 3d ed. 2000) (Ex. 1016,
`“Handbook”).
`
`10
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`In support of these grounds for unpatentability, Petitioner submitted, inter
`alia, a Declaration of Reza Dana, M.D.,8 and a Declaration of Anthony M.
`Lowman, Ph.D.9 We discuss the disclosures of the asserted references
`below.
`E. GILLESPIE
`Gillespie is the November 14, 2002, published version of U.S.
`Application 09/852,519, which was filed May 10, 2001.10 Ex. 1015, codes
`(43), (21), (22). Thus, Gillespie is prior art with respect to the ’082 patent
`under 35 U.S.C. § 102. Gillespie indicates its invention relates to:
`An improved punctum plug [that] is more easily visualized when
`positioned within a punctual canal of a recipient. The body of
`the plug features an outwardly exposed surface when properly
`positioned, and a substance causing at least the outwardly
`exposed surface to contrast with surrounding tissue, such that the
`use of the substance causes the plug to be more easily visualized
`than if the substance were not present. The substance, which
`may be disposed on the outwardly exposed surface or within the
`body of the plug, may include a saturated coloration, or may be
`phosphorescent, fluorescent or otherwise operative to reflect or
`re-radiate light to assist in visualization.
`Id. at Abstract, ¶¶ 1, 6.
`Gillespie discloses that the insertion of punctal plugs treats the
`condition “dry eye.” Id. ¶¶ 3–4. Gillespie states that because “the plug is
`extremely small, generally being less than a millimeter in diameter and a
`millimeter or so in length, it is very difficult to see” and “[i]t is the objects of
`this invention to make the punctum plug readably visible or detectable to the
`
`
`8 Ex. 1036 (“Dana Declaration”).
`9 Ex. 1052 (“Lowman Declaration”).
`10 Gillespie’s application issued as US 6,982,090 B2 on January 3, 2006.
`
`11
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`recipient or caregiver, and thereby help the recipient determine that the plug
`remains properly in place.” Id. ¶ 5.
`The visualization of punctal plugs disclosed by Gillespie includes
`providing “a substance causing at least the outwardly exposed surface to
`contrast with surrounding tissue, such that the use of the substance causes
`the plug to be more easily visualized than if the substance were not present.”
`Id. at ¶ 6. However, Gillespie states that “[t]he rest of the plug body [other
`than the substances improving visualization] may be composed of any
`suitable material, including those presently used in the manufacture of such
`devices.” Id. Gillespie teaches that the substance used to make the plugs
`more visible can be a variety of compositions, including “a dye or pigment.”
`Id. ¶¶ 7, 13.
`Gillespie states that, to
`allow[] the presence and position of the plug to be seen by
`another person or by the recipient in the mirror[,] [i]n one
`preferred embodiment, at least the outwardly exposed surface of
`the plug, or the entire plug body, is pigmented to contrast with
`surrounding tissue. For example, unlike existing devices, the
`exposed surface or plug body may be black or a saturated
`fluorescent color to create a more defined visual contrast.
`Id. ¶ 11. Gillespie further states that “[i]n an alternative embodiment, the
`end of the plug or entire body is coated with, or otherwise contains a
`fluorescent dye, phosphor, phosphorescent pigment, reflective beads,
`quantum dots, or other material allowing the plug to be more easily
`visualized with appropriate illumination.” Id. ¶ 12.
`PRITCHARD
`F.
`Pritchard is the September 8, 2005, published version of U.S. Patent
`Application 11/071,985, which was filed March 4, 2005. Ex. 1010, codes
`
`12
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`(43), (21), (22). Therefore, it is 35 U.S.C. § 102 prior art with respect to the
`’082 patent. Pritchard indicates priority to four U.S. Provisional
`Applications: provisional 60/550,132, filed March 4, 2004 (“Pritchard ’132
`provisional”); provisional 60/557,368, filed March 29, 2004 (“Pritchard ’368
`provisional”); provisional 60/564,858, filed April 23, 2004; and provisional
`60/637,569, filed December 20, 2004. Id. at code (60). Pritchard states that
`“each of [these provisionals] are hereby incorporated by reference herein.”
`Id. ¶ 1; see also id. ¶¶ 43–45, 55, 77, 94, 98, 107, 111, 120 (repeatedly citing
`and incorporating these provisionals by reference).
`Pritchard states that its invention relates to “a punctum plug for
`blocking flow of lacrimal fluid in an eye, the plug having an introducible
`portion comprising a dehydrated material hydratable by physiological saline
`to swell from a first diameter to a second diameter,” and is “related to
`occlusive devices, and includes disclosure of nasolacrimal occlusive devices
`such as canalicular plugs placed into the punctal opening of the lacrimal
`duct.” Id. at Abstract, ¶ 2. Pritchard states that its plugs can be used to treat
`a variety of conditions, such as dry eye syndrome, corneal ulcers,
`conjunctivitis, seasonal allergies, and glaucoma, to increase
`retention/enhancement of ocular medications, and to enhance healing and
`comfort after surgery, among many others. Id. ¶¶ 24, 48, claims 44, 77.
`Pritchard states that
`Some punctal plug occlusion devices are meant to be
`inserted below the punctal opening and others possess a rim
`meant to sit atop the punctal opening. Devices of both categories
`can be fabricated using hydrogels and other materials as
`described herein.
`Devices inserted below the punctal opening are referred to
`herein as subpunctal devices. Advantages to this type of device
`
`13
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`include ease of insertion and low cost. Subpunctal devices are
`simple in design, being cylindrical pieces of material . . . .
`Devices made with a rim which rests atop the punctal
`opening provide some advantage in that they can be easily
`visualized and are simple to remove. . . . [T]he topmost parts of
`the plug may be made from materials other than hydrogel.
`Id. ¶¶ 29–31.
`Pritchard illustrates generic punctal plugs intended to have a rim that
`rests atop the punctal opening at its Figures 2A, 2B, and 3A, which are
`reproduced below:
`
`
`
`“FIG. 2A is a plan view, with representative dimensions, of one embodiment
`of a punctal plug in accordance with the present invention,” “FIG. 2B is a
`plan view, with representative dimensions, of a second embodiment of a
`punctal plug,” and Figure 3A shows “the punctal plug embodiment of FIG.
`2B in place in the lower punctal opening.” These figures each show a plug
`member 20, 20′ that has three portions: a tip (or barb) portion 22, 22′; a
`middle (or waist) portion 24, 24′; and a head portion 26, 26′. Id. ¶ 36. The
`
`14
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`head portion 26, 26′ is large enough so it rests on the punctal opening to
`prevent the plug from passing into the canaliculus entirely. Id. ¶ 37.
`Pritchard discloses that its plugs 20, 20′ can be made of HEMA
`hydrophilic polymer, for example, and can store and slowly dispense
`ophthalmic drugs to the eye. Id. ¶ 38. Pritchard states that, in addition to the
`basic structures shown in Figures 2A, 2B, and 3A,
`Other features may be incorporated into a nasolacrimal
`occlusive device, as set forth elsewhere herein. These various
`features may be combined with the various materials and
`methods set forth and referenced herein. For example, the shaft
`further may have a ridge or a collapsible portion. The device, or
`a portion thereof, may further comprise a degradable portion.
`The device, or a portion thereof, may further comprise a
`therapeutic agent.
`Id. ¶ 43. Pritchard identifies that the Pritchard ’132 provisional and the
`Pritchard ’368 provisional (which are expressly incorporated by reference),
`among many other references, teach a variety of materials that may
`advantageously be employed in the construction of a nasolacrimal occlusive
`devices. Id. ¶ 44.
`In addition to HEMA, noted above, Pritchard discloses various forms
`of gellan as a hydratable material for its punctal plugs. Id. ¶¶ 46–47.
`Pritchard discloses that
`Gellan has a long history of clinical use in humans that
`spans 15 years. It has been studied as a drug delivery material
`because of its in situ gelling properties. It has also been studied
`as a time release material for drug delivery for its controllable
`and predictable dissolution properties (as a gel) in contact with
`mucosal membrane (analogous to the punctum) in vivo, and for
`insulin delivery in vivo. And gellan has been studied for both its
`gelling properties and dissolution rate. Several studies have been
`completed dealing with the safety of gellan for use in the eye.
`And more specifically, numerous studies involving gellan as a
`
`15
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`for TIMOLOL
`safe and efficacious delivery vehicle
`(antiglaucomatous medication) have been completed.
`Id. ¶ 48.
`Pritchard further discloses that punctal plugs that incorporate hydrogel
`material swell to achieve a secure fit when used.11 Id. ¶ 51–52. Pritchard
`further states
`This unconstrained hydrogel material may be located at, e.g., the
`bottom or nose of a plug. The top end of a plug, the neck and
`rim, may include a strong, non-swelling material to address the
`issues of cutting strength and dimensional stability. For
`example, a nonswelling plastic may be used to cover the upper
`portion of a polysaccharide plug so that the polysaccharide will
`swell against the plastic but not further expand. The other
`portion of such a plug, however, will be free to swell. A punctum
`plug may be shaped to have a configuration as shown in, e.g.,
`FIGS. 2-3.
`Id. ¶ 52. Furthermore, Pritchard discloses that such swellable hydrogels can
`be anisotropically swellable, meaning they swell in only lateral dimensions,
`such as shown in its Figures 7A and 7B (reproduced below), which depict
`cylinders of hydrogel swelling upon hydration after implantation (the
`cylinders become fatter). Id. ¶¶ 56–58. Pritchard states that, “[r]eferring to
`FIGS. 2A and 2B, for example, plug 20 may be made of an anisotropically
`swellable material” entirely or only partially such that the waist portion 24
`
`
`11 There is no dispute that HEMA and gellan are hydrogels. Ex. 1010 ¶ 54;
`Pet. 41–44 (citing Pritchard’s HEMA and gellan as hydrogels); PO Resp. 20,
`40 (“Gellan gum hydrogel”), 49 (“‘controllably swellable materials’ such as
`hydrogel (e.g., Gellan gum); Ex. 1036 ¶¶ 33 (“HEMA is a well-known
`hydrogel material”), 54 (further discussing Pritchard’s disclosure of
`HEMA); Ex. 2014 ¶ 40 (“The sustainability of the ‘light straw color’ in
`Gellan gum hydrogel, however depends on the media.”).
`
`16
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`could sell while the head portion 26 does not. Id. ¶¶ 62–63. Such devices
`are cylindrical in shape. Id. ¶¶ 65–66.
`Pritchard describes cylindrically shaped plugs where either the entire
`plug can be cylindrical hydrogel or a middle portion can be cylindrical
`hydrogel. Id. ¶¶ 30, 36, 55, 65–66, 73–79, 113–119, 131–140, 152.
`Pritchard illustrates cylindrical-bodied plugs at Figures 2A, 2B, and 3A,
`shown above, and also at Figures 7A and 7B, reproduced below:
`
`
`
`“FIGS. 7A and 7B are diagrams showing a nasolacrimal occlusion device
`that swells after contact with a tear or other physiological fluid.” Id. ¶ 20.
`Figure 7A shows a gellan cylinder’s dimensions before swelling and Figure
`7B shows the gellan cylinder’s dimensions after swelling under conditions
`simulating the lacrimal system (e.g., hydrated in response to tears or
`introduced saline). Id. ¶¶ 159–165.
`Pritchard discloses that its devices can be a variety of colors.
`Pritchard discloses examples where devices made of gellan were a turquoise
`color, which persisted in physical saline. Id. ¶¶ 87, 107. This color was a
`
`17
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`result of making the device chelation-resistant by including cuprous (copper
`(I)) chloride in the gellan material. Id. Pritchard discloses another example
`where a gellan device was brown-green, which persisted in physiological
`saline. Id. ¶ 88. This color also resulted from making the device chelation-
`resistant, but by adding iron (II) or iron (III) ions to the gellan material. Id.
`Pritchard discloses other examples where the device was a light straw color,
`which lasted 2–3 weeks upon exposure to physiological saline. Id. ¶¶ 137–
`140.
`
`Pritchard also discloses that its devices can include functional groups
`that are capable of binding a metal ion. Id. ¶¶ 102–108. Such functional
`groups are described as advantageous because they facilitate catalytic
`oxidation of the material of the punctal plug, which may be used to remove
`the device from the nasolacrimal passage. Id. at 105.
`Pritchard also discloses that
`The gels and other devices set forth herein could contain
`medicaments, therapeutic agents, antimicrobials (e.g., silver),
`bioactive minerals and glasses, radioactive therapeutic materials,
`cytotoxic agents (for tissue ablation), etc. The gel would entrap
`active therapeutic agents at the site where the gel is formed in a
`patient, or could slowly elute therapeutic agents into the patient,
`e.g., into the bloodstream or other tissues.
`Id. ¶ 132. Examples of therapeutic agents disclosed by Pritchard include
`silver and the antimicrobial triclosan; however, Pritchard’s incorporated
`provisionals, particularly the Pritchard ’368 provisional, disclose many other
`therapeutic agents. Ex. 1010 ¶¶ 133, 135, 137–140; Ex. 1012. The ’368
`provisional discloses, for example, therapeutic agents such as steroids and
`corticosteroids (dexamethasone), prostaglandin inhibitors, anti-inflammatory
`agents, beta blockers, steroidal and non-steroidal anti-inflammatory agents,
`
`18
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`prostaglandins, antihistamines, and anti-glaucoma drugs (timolol,
`latanoprost, brimonidine), to name a few. Ex. 1012, 6:4–14:22. The
`Pritchard ’368 provisional states that “[p]ersons of skill in these arts, after
`reading this disclosure, will be able to use a variety of techniques to
`incorporate therapeutic agents into materials described herein.” Id. at 15:1–
`2.
`
`Pritchard concludes by stating that “[a]ll patents, patent applications,
`and publications set forth herein are hereby incorporated by reference
`herein” and “[t]he headings, while placed for general convenience of the
`reader, are not intended to limited the embodiments,” followed by a set of 79
`claims. Ex. 1010 ¶ 166, claims 1–79. In various combinations of elements,
`Pritchard’s claims teach an invention, as discussed above, that is a punctum
`plug of dehydrated material hydratable by physiological saline, e.g., gellan,
`which may have a shaft portion introducible into the punctal opening of a
`patient, may have a head portion, may include a therapeutic agent, e.g., an
`antimicrobial such as silver, may include other metals, e.g., copper or iron,
`and may be used to treat eye conditions, such as dry eye, allergies, or
`trauma. Id. at claims 1–79.
`G. HELLBERG
`Hellberg issued on November 11, 2003, from U.S. Application
`10/059,692, which was filed January 28, 2002. Ex. 1017, codes (45), (21),
`(22). Therefore, Hellberg is prior art with respect to the ’082 patent under
`35 U.S.C. § 102. Hellberg indicates its invention is related to “methods and
`compositions for the treatment of glaucoma and ocular hypertension,
`comprising the administration of a prostaglandin FP receptor agonist and a
`prostaglandin synthesis inhibitor.” Id. at Abstract, 5:40–54.
`
`19
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`Hellberg states that “[p]rostaglandins, which are metabolite
`derivatives of arachidonic acid, have recently been pursued for possible
`efficacy in treating glaucoma and lowering IOP.” Id. at 3:40–42. Hellberg
`teaches that “preferred prostaglandin analogs” for treating glaucoma include
`latanoprost, travoprost, and bimatoprost, which are commercially available.
`Id. at 7:49–60. Hellberg states that “[t]he preferred route of administration
`is topical,” and compounds “can be administered as solutions, suspension, or
`emulsions (dispersions) in an ophthalmically acceptable vehicle,” which is
`“any substance . . . non-reactive with the compounds and suitable for
`administration to a patient[,] . . . suitable for topical application to the
`patient’s eyes.” Id. at 8:11–20; see also id. 8:31–34 (eye drops).
`H. HANDBOOK
`Handbook is a publication by the American Pharmaceutical
`Association and the Pharmaceutical Press and was published in 2000.
`Ex. 1016 (cover page and copyright notice). Therefore, Handbook is prior
`art with respect to the ’082 patent.
`Petitioner’s Exhibit 1016 includes a portion of Handbook directed to
`“Coloring Agents.” Id. at 146. Handbook states:
`The primary purpose of coloring agents is to visually alter the
`appearance of a medicinal product by imparting a definite color
`or shade. This has the advantage to the manufacturer of making
`otherwise
`similar products more distinctive.
` Easier
`differentiation of a product is also of considerable benefit to the
`patient on multiple medication.
`The use of color in medicinal products, in conjunction with other
`factors, such as shape and packing, additionally serves to
`reinforce brand
`image and
`identity.
` This commercial
`distinctiveness also aids in preventing the counterfeiting of
`products.
`
`20
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`Colors used in some preparations can also serve to introduce a
`uniformity of appearance to a product, e.g., a tablet, where an
`ingredient in the formulation has itself a variable appearance
`from batch to batch.
`
`Id.
`
`Handbook further states that “[t]he use of color is occasionally
`associated with topical preparations (especially over the counter remedies)
`and sustained-release granules in transparent hard gelatin capsules.” Id.
`Handbook further states that “[s]ome of the insoluble colors or pigments
`have the additional benefit when used in tablet coatings or gelatin shells of
`providing useful opacity which can aid in the stability of light-sensitive
`active materials in the tablet or capsule formulation.” Id.
`Handbook includes tables of dozens of coloring agents that are
`approved for use by the United States or the European Community, as of
`1997 and 1998, respectively. Id. at 146–50 (Tables I–VIII). Handbook
`discloses that some colors have excellent stability, where others have poor
`stability but are useful for low toxicity, indicates that the incompatibilities
`and method of manufacture of coloring agents was known, and discloses that
`“[c]oloring agents are used in a variety of oral and topical pharmaceutical
`formulations, in addition to their use in cosmetics and food products.” Id. at
`147–48. Handbook acknowledges that there are some concerns over the
`safety of particular coloring agents, but bodies such as the FDA have
`provided review that has resulted in a list of permitted colors that are
`generally regarded as safe. Id. at 148.
`
`21
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`III. DISCUSSION
`A. ORDINARY LEVEL OF SKILL IN THE ART
`In determining the level of skill in the art, we consider the type of
`problems encountered in the art, the prior art solutions to those problems, the
`rapidity with which innovations are made, the sophistication of the
`technology, and the educational level of active workers in the field. Custom
`Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir.
`1986); Orthopedic Equip. Co. v. U.S., 702 F.2d 1005, 1011 (Fed. Cir. 1983).
`Petitioner contends “[t]he person of ordinary skill in the relevant art is
`an ophthalmologist with several years of experience in the design,
`development, and/or study of drug delivery devices and/or ophthalmic
`inserts.” Pet. 26–27 (citing Dana Declaration, Ex. 1036 ¶¶ 23–27).
`Patent Owner states:
`Mati does not dispute Petitioner’s proposed definition of a
`“POSA” (“an ophthalmologist with several years of experience
`in the design, development, and/or study of drug delivery devices
`and/or oph
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
