Trials@uspto.gov
`571.272.7822
`
`
`
`
`
`
`
` Paper No. 8
`
` Filed: June 26, 2019
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`OCULAR THERAPEUTIX, INC.,
`Petitioner,
`
`v.
`
`MATI THERAPEUTICS, INC.,
`Patent Owner.
`____________
`
`Case IPR2019-00448
`Patent 9,849,082 B2
`____________
`
`
`
`Before ERICA A. FRANKLIN, JOHN J. LEE, and RYAN H. FLAX,
`Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`
`
`
`DECISION
`Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`571.272.7822
`
`
`
`
`
`
`
` Paper No. 8
`
` Filed: June 26, 2019
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`OCULAR THERAPEUTIX, INC.,
`Petitioner,
`
`v.
`
`MATI THERAPEUTICS, INC.,
`Patent Owner.
`____________
`
`Case IPR2019-00448
`Patent 9,849,082 B2
`____________
`
`
`
`Before ERICA A. FRANKLIN, JOHN J. LEE, and RYAN H. FLAX,
`Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`
`
`
`DECISION
`Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`
`Mati Therapeutics, Inc. (“Patent Owner”) is the owner of U.S. Patent
`
`No. 9,849,082 B2 to Eugene de Juan, Jr. et al. (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.”).
`
`Patent Owner, in turn, filed a Preliminary Response. Paper 7 (“Prelim.
`
`Resp.”).
`
`Under 37 C.F.R. § 42.4(a), we have authority to determine whether to
`
`institute an inter partes review. We may institute an inter partes review if
`
`the information presented in the petition filed under 35 U.S.C. § 311, and
`
`any response filed under Section 313, shows that there is a reasonable
`
`likelihood that Petitioner would prevail with respect to at least one of the
`
`claims challenged in the petition. 35 U.S.C. § 314. After reviewing the
`
`parties’ submissions, we conclude that Petitioner has demonstrated a
`
`reasonable likelihood that it would prevail in showing at least one claim of
`
`the ’082 patent is unpatentable. Therefore, we institute inter partes review
`
`of all aforementioned claims on all grounds raised in the petition, pursuant to
`
`35 U.S.C. § 314. See SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348, 1359–60
`
`(2018); see also Guidance on the Impact of SAS on AIA Trial Proceedings
`
`(April 26, 2018) (available at https://www.uspto.gov/patents-application-
`
`process/patent-trial-and-appeal-board/trials/guidance-impact-sas-aia-trial).
`
`
`
`
`
`2
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`I.
`
`BACKGROUND
`
`A.
`
`RELATED MATTERS
`
`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.
`
`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. Id.
`
`B.
`
`THE CLAIMED INVENTION
`
`The invention of the ’082 patent 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, canalicular, nasolacrimal, ocular, and ophthamalic – plugs,
`
`inserts, and implants. See, e.g., Pet. 1, 2, 6–7, 15, 17–18, 20–26, 36–51, 54–
`
`57, 62–64; Prelim. Resp. 2–14.
`
`3
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`
`The relevant physiology is illustrated in a figure provided in the
`
`Preliminary Response, reproduced below:
`
`
`
`
`
`Prelim. Resp. 3. Patent Owner’s figure above shows (and labels) the
`
`physiology of the human eye, including a nasolacrimal duct connected to
`
`two openings, called puncta and respectively behind the upper and lower
`
`eyelids, via a lacrimal canaliculi duct that branches from the nasolacrimal
`
`duct toward the puncta. See Prelim. Resp. 3.
`
`4
`
`
`
`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, respectively, and each has a punctal opening labeled
`
`11 and 13, respectively. Ex. 1001, 7:31–65.
`
`5
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`
`An example of an implant for insertion through a punctum and into a
`
`canalicular lumen of a patient is illustrated in the ’082 patent at, for example,
`
`Figure 1G, reproduced below:
`
`
`
`
`
`Figure 1G schematically illustrates, in cross-section, sustained release
`
`implant 180 having core 182 and sheath 184; this embodiment further
`
`includes exposed (core) convex surface area 182A to increase release of the
`
`therapeutic agent contained within the core, and retention structure 186 that
`
`blocks tear flow. Id. at 10:11–27.
`
`The claims of the ’082 patent are generally directed to a generic,
`
`colored, cylindrical, hydrogel-composed version of such a device for treating
`
`certain conditions and/or incorporating certain therapeutic agents.
`
`6
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`
`The ’082 patent has 23 claims, of which claims 1, 11, and 18 are
`
`independent claims. Independent claim 1 is illustrative and 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, but requires that the body
`
`of material “swells when placed in the lacrimal canaliculus.” Id. at 30:51–
`
`67. Independent claim 18 is also similar, but requires 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.
`
`C.
`
`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:
`
`Ground 1: Claims 1–7, 9–16, 18–20, and 22–23 are
`anticipated by Pritchard1 under 35 U.S.C. § 102;
`
`
`1 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).
`
`7
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`
`Ground 2: Claims 1–7, 9–16, 18–20, and 22–23 are
`
`obvious under 35 U.S.C. § 103 over Pritchard and Gillespie;2
`
`Ground 3: Claims 8, 17, and 21 are obvious under
`
`35 U.S.C. § 103 over Pritchard, Gillespie, and Hellberg;3
`
`Ground 4: Claims 1–7, 9–16, 18–20, and 22–23 are
`
`obvious under 35 U.S.C. § 103 over Pritchard and Handbook;4
`and
`
`Ground 5: Claims 8, 17, and 21 are obvious under
`
`35 U.S.C. § 103 over Pritchard, Handbook, and Hellberg.
`
`Id.
`
`In support of these grounds for unpatentability, Petitioner submitted,
`
`inter alia, a Declaration of Reza Dana, M.D.5
`
`II. DISCUSSION
`
`A. ORDINARY LEVEL OF SKILL IN THE ART
`
`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 disputes Petitioner’s definition of the skilled artisan
`
`because it “does not identify or provide a range of number of years that
`
`would meet the ‘several years’ criterion,” and because an ophthalmologist
`
`would be unlikely to have experience in the design or development of
`
`
`2 US 2002/0169409 A1 (published Nov. 14, 2002) (Ex. 1015, “Gillespie”).
`3 US 6,646,001 B2 (issued Nov. 11, 2003) (Ex. 1017, “Hellberg”).
`4 AMERICAN PHARMA ASSOCIATION, HANDBOOK OF PHARMACEUTICAL
`EXCIPIENTS 146–53 (Arthur H. Kibbe, Ph.D. ed., 3d ed. 2000) (Ex. 1016,
`“Handbook”).
`5 Declaration of Reza Dana, M.D. (Ex. 1036, “Dana Declaration”).
`
`8
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`relevant devices. Prelim. Resp. 21–22. Patent Owner, therefore,
`
`“propose[s] that a POSITA [person of ordinary skill in the art] is a medical
`
`doctor specializing in ophthalmology or a person having a doctorate degree
`
`in chemistry having at least 5 years of experience in designing and
`
`developing drug delivery ocular inserts.” Id. at 22.
`
`The two proposed definitions of the skilled artisan are very similar,
`
`except that Patent Owner’s description more broadly encompasses a medical
`
`doctor specializing in ophthalmology or a person having a doctorate degree
`
`in chemistry, and more precisely requires the years of experience to be at
`
`least five, but without clearly specifying whether both identified persons
`
`would have such experience or only the latter.
`
`At this stage of the proceeding, we note that Petitioner’s definition of
`
`the level of ordinary skill in the art is supported by the Dana Declaration.
`
`Therefore, at this stage in the proceeding, we accept and use Petitioner’s
`
`proposed definition of the skilled artisan, taking into account the level of
`
`skill in the art reflected in the prior art of record. See Okajima v. Bourdeau,
`
`261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an
`
`appropriate level” as evidence of the ordinary level of skill in the art)
`
`(quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158,
`
`163 (Fed. Cir. 1985)). Our decision whether to institute, however, does not
`
`turn on which party’s definition is used, and our determinations would be
`
`unchanged if we applied Patent Owner’s definition. Further, we note that
`
`evidence may be presented as the case progresses to support Patent Owner’s
`
`proposed definition, which may influence our determination of this issue.
`
`9
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`
`B.
`
`CLAIM CONSTRUCTION
`
`Based on the filing date of the Petition (Dec. 14, 2018), the Board
`
`interprets claim terms in an inter partes review (“IPR”) using the same claim
`
`construction standard that is used to construe claims in a civil action in
`
`federal district court. See 83 Fed. Reg. 51,340 (Nov. 13, 2018) (to be
`
`codified at 37 C.F.R. pt. 42).
`
`In construing claims, district courts give claims their ordinary and
`
`customary meaning, which is “the meaning that the term would have to a
`
`person of ordinary skill in the art in question at the time of the invention.”
`
`Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc).
`
`Sources for claim interpretation include “the words of the claims themselves,
`
`the remainder of the specification, the prosecution history [i.e., the intrinsic
`
`evidence], and extrinsic evidence concerning relevant scientific principles,
`
`the meaning of technical terms, and the state of the art.” Id. at 1314 (quoting
`
`Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111,
`
`1116 (Fed. Cir. 2004)). “[T]he claims themselves [may] provide substantial
`
`guidance as to the meaning of particular claim terms.” Id. However, the
`
`claims “do not stand alone,” but are part of “‘a fully integrated written
`
`instrument,’ consisting principally of a specification that concludes with the
`
`claims,” and, therefore, the claims are “read in view of the specification.”
`
`Id. at 1315 (quoting Markman v. Westview Instruments, Inc., 52 F.3d 967,
`
`978–79 (Fed. Cir. 1995)).
`
`Petitioner proposes that the claim language “distinguishing color to
`
`show” and “sheath body” require interpretation. Pet. 10–12. Patent Owner
`
`argues they do not. Prelim. Resp. 22–24.
`
`10
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`
`Regarding “distinguishing color to show,” which is recited by every
`
`claim of the ’082 patent, Petitioner contends, “[i]n the context of claim
`
`wording and the specification, a person of ordinary skill in the art would
`
`understand that ‘distinguishing color to show’ means [‘]a color that
`
`improves visibility.’” Pet. 11 (citing Dana Declaration, Ex. 1036 ¶ 51;
`
`Ex. 1001, 20:67–21:5).
`
`In response, Patent Owner states:
`
`The [claimed] phrase, in full context, [is] “a distinguishing color
`to show placement of the system in the lacrimal canaliculus of
`the patient” as it appears in the claims, [and] is unambiguous and
`needs no construction. In other words, what makes a color of the
`system “distinguishing” is that it “show[s] placement of the
`system in the lacrimal canaliculus of the patent,” as expressly
`recited by the claim.
`
`Prelim Resp. 22. Patent Owner contends Petitioner’s proposed interpretation
`
`of the language “renders an unambiguous term ambiguous,” and thus argues
`
`that “[t]he claim language is clear and would be readily understood by the
`
`Board.” Id.
`
`At this stage of the proceedings, and for the purposes of this decision,
`
`we find it unnecessary to construe “distinguishing color to show,” because
`
`this claim language is readily understandable on its face, within the context
`
`of the claims, to a person of ordinary skill in the art.
`
`Regarding “sheath body,” which is recited by claim 2 of the ’082
`
`patent, Petitioner contends “in the context of the specification of the ‘082
`
`patent, a person of ordinary skill in the art would understand ‘sheath body’
`
`to mean a ‘material or structure that is impermeable to the therapeutic agent
`
`and that covers a portion of a drug core to prevent migration of the
`
`11
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`therapeutic agent from the covered portion of the drug core.’” Pet. 12 (citing
`
`Dana Declaration, Ex. 1036 ¶¶ 68–70; Ex. 1001, 20:27–34).
`
`Patent Owner, in response, states, “[i]n view of the claim language
`
`and the express teachings of the de Juan specification, a POSITA applying
`
`the plain and ordinary meaning of the term would fully ascertain proper
`
`claim scope. The claim language is clear and would be readily understood
`
`by the Board.” Prelim. Resp. 24. Therefore, Patent Owner argues no
`
`construction is necessary. Id.
`
`At this stage in the proceedings, and for the purposes of this decision,
`
`we find it unnecessary to construe “sheath body,” because this claim
`
`language is readily understandable on its face, within the context of the
`
`claims, to the person of ordinary skill in the art.
`
`C.
`
`LEGAL STANDARDS FOR ANTICIPATION AND OBVIOUSNESS
`
`Regarding anticipation, our reviewing court has held:
`
`a patent is invalid [or unpatentable] as anticipated if “the
`[claimed] invention was described in” a patent or published
`application “before the invention by” the patentee. 35 U.S.C.
`§ 102(e). In order to anticipate the claimed invention, a prior art
`reference must “disclose all elements of the claim within the four
`corners of the document,” and it must “disclose those elements
`‘arranged as in the claim.’” Net MoneyIN, Inc. v. VeriSign, Inc.,
`545 F.3d 1359, 1369 (Fed. Cir. 2008) (quoting Connell v. Sears,
`Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)).
`“However, a reference can anticipate a claim even if it ‘d[oes]
`not expressly spell out’ all the limitations arranged or combined
`as in the claim, if a person of skill in the art, reading the reference,
`would ‘at once envisage’
`the claimed arrangement or
`combination.” Kennametal, 780 F.3d at 1381 (alteration in
`original) (quoting In re Petering, 301 F.2d 676, 681 (CCPA
`1962)); see also Blue Calypso, LLC v. Groupon, Inc., 815 F.3d
`1331, 1344 (Fed. Cir. 2016) (“[A] reference may still anticipate
`
`12
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`
`if that reference teaches that the disclosed components or
`functionalities may be combined and one of skill in the art would
`be able to implement the combination.” (citing Kennametal, 780
`F.3d at 1383)).
`
`Microsoft Corp. v. Biscotti, Inc., 878 F.3d 1052, 1068 (Fed. Cir. 2017); see
`
`also Net MoneyIN, 545 F.3d at 1371 (to anticipate “a reference [must]
`
`disclose[] within the four corners of the document . . . all of the limitations
`
`claimed [and] also all of the limitations arranged or combined in the same
`
`way as recited in the claim”). Put another way, an anticipating reference
`
`must clearly and unequivocally disclose the claimed subject matter or direct
`
`those skilled in the art to the claimed subject matter without any need for
`
`picking, choosing, and combining various disclosures of the reference not
`
`directly related to each other by its teachings. In re Arkley, 455 F.2d 586,
`
`587–88 (CCPA 1972) (“picking and choosing may be entirely proper in the
`
`making of a 103, obviousness rejection, . . . but it has no place in the making
`
`of a 102, anticipation rejection.”); see also Purdue Pharma L.P. v. Epic
`
`Pharma, LLC, 881 F.3d 1345, 1358–59 (Fed. Cir. 2016) (distinct, but
`
`directly related disclosures of a reference may be combined in an optional,
`
`anticipating embodiment, e.g., a controlled-release pharmaceutical
`
`formulation specifically disclosed as an embodiment with claimed
`
`components directly relates to a disclosed list of therapeutic compounds
`
`useable therewith).
`
`Regarding obviousness, the Supreme Court in KSR International Co.
`
`v. Teleflex Inc., 550 U.S. 398 (2007), reaffirmed the framework for
`
`determining obviousness as set forth in Graham v. John Deere Co., 383 U.S.
`
`1 (1966). The KSR Court summarized the four factual inquiries set forth in
`
`Graham (383 U.S. at 17–18) that are applied in determining whether a claim
`
`13
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`is reasonably likely to be unpatentable as obvious under 35 U.S.C. § 103(a)
`
`as follows: (1) determining the scope and content of the prior art;
`
`(2) ascertaining the differences between the prior art and the claims at issue;
`
`(3) resolving the level of ordinary skill in the pertinent art; and
`
`(4) considering objective evidence indicating obviousness or non-
`
`obviousness. KSR, 550 U.S. at 406. “The combination of familiar elements
`
`according to known methods is likely to be obvious when it does no more
`
`than yield predictable results.” Id. at 416. “[W]hen the question is whether
`
`a patent claiming the combination of elements of prior art is obvious,” the
`
`answer depends on “whether the improvement is more than the predictable
`
`use of prior art elements according to their established functions.” Id. at
`
`417.
`
`With these standards in mind, we address the challenges below.
`
`D. GROUNDS 1 AND 2—CLAIMS 1–7, 9–16, 18–20, AND 22–23
`AS ANTICIPATED BY PRITCHARD OR OBVIOUS OVER
`PRITCHARD AND GILLESPIE
`
`The Parties’ Positions
`
`Petitioner contends, “Pritchard expressly discloses all of the
`
`limitations recited in Claims 1–7, 9–16, 18–20, and 22–23 of the ‘082
`
`Patent.” Pet. 28 (citing Dana Declaration, Ex. 1036 ¶¶ 46–48). Petitioner
`
`identifies Pritchard as directed to the same field as the invention of
`
`independent claims 1, 11, and 18, that is, canalicular inserts. See, e.g., Pet.
`
`27–35 (citing generally Ex. 1010); see also id. at 36–37, 57 (claim chart
`
`citing Ex. 1010 ¶¶ 2, 13, 14, 35, 37–39, 41, 43, 44, 57, 131–132). Further,
`
`Petitioner identifies Pritchard as teaching the claimed therapeutic agent
`
`(including anti-microbials, anti-glaucoma drugs, antihistamines, anti-
`
`14
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`inflammatories, and non-steroidal anti-inflammatories), distinguishing color,
`
`and cylindrical-swellable-body of hydrogel. Id. at 36–49, 51, 54–60 (claim
`
`chart citing Ex. 1010 ¶¶ 1, 2, 8, 13, 14, 20, 22, 29, 30, 35–39, 41, 43, 44, 51–
`
`79, 86, 102, 104, 119, 131–132, 135, 137–140, 152, 156–161, Figures 2A,
`
`2B, 7A, 7B, claims 11, 21, 37, 58, 70; and Ex. 1012, 3, 6, 9–12, 15, 36, 45,
`
`49, 51). It is Petitioner’s position that each element of independent claims 1,
`
`11, and 18, and of dependent claims 2–7, 9, 10, 12–16, 19–20, and 22–23, is
`
`disclosed by Pritchard so that Pritchard anticipates these claims; Petitioner
`
`provides claim charts specifically identifying where and how Pritchard
`
`provides such a disclosure of the claimed drug delivery system for insertion
`
`into a lacrimal canaliculus of a patient, or, put otherwise, a drug-delivering
`
`canalicular plug. See Pet. 36–61.
`
`Petitioner also submits and cites the Dana Declaration as evidence that
`
`Pritchard, read correctly, anticipates the aforementioned claims. See Pet.
`
`28–61; see also Ex. 1036 ¶¶ 48–72. The Dana Declaration states, for
`
`example:
`
`a person of ordinary skill in the art would readily understand that
`Pritchard anticipates Claims 1-7, 9-16, 18-20, and 22-23 of the
`‘082 Patent. Pritchard discloses all of the limitations in these
`claims as arranged in those claims. That is, Pritchard discloses
`hydrogel canalicular inserts that are cylindrical rods, that are
`colored, that swell, that comprise functional groups, and that
`deliver a
`therapeutic agent
`to
`treat various ophthalmic
`conditions, such as dry eye, glaucoma, and post-surgical
`discomfort.
`
`Ex. 1036 ¶ 48.
`
`To the extent the ’082 patent’s claims 1–7, 9–16, 18–20, and 22–23
`
`are not anticipated by Pritchard, most specifically with regard to the claimed
`
`15
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`“distinguishing color” limitation, Petitioner argues (as Ground 2) that the
`
`combination of Pritchard and Gillespie would have rendered these claims
`
`obvious. Pet. 61–64. Petitioner argues that the same teachings of Pritchard
`
`identified as anticipating are likewise applicable under an obviousness
`
`analysis, and further argues that Gillespie teaches that punctum plugs, as
`
`taught by Pritchard, can be colored to be more easily visualized because they
`
`are otherwise difficult to see. Id.; see id. at 63 (quoting Gillespie paragraph
`
`11 that “[i[n [sic] one preferred embodiment, at least the outwardly exposed
`
`surface of the plug, or the entire plug body, is pigmented to contrast with
`
`surrounding tissue” (emphasis Petitioner’s)).
`
`In response to Petitioner’s anticipation arguments, Patent Owner
`
`contends that, in contravention of the legal standard for anticipation set forth
`
`in Net MoneyIN requiring a reference to disclose the claimed subject matter
`
`arranged or combined in the same way as claimed, “Pritchard does not . . .
`
`disclose all the claim elements arranged or combined in the same way as
`
`recited in the claims” because “Pritchard provides 15 separate embodiments
`
`and numerous sub-embodiments illustrating various controllably swellable
`
`materials for use in making the devices” and “Petitioner has cherry picked
`
`from disparate embodiments of Pritchard in an unavailing attempt to piece
`
`the claimed invention together.” Prelim Resp. 29. Patent Owner identifies
`
`Pritchard’s “15 separate embodiments” as:
`
`1) “Gellan, Depolymerized Gellan, and Related Polysaccharides
`for Biomedical Uses” ([0045]-[0050]);
`
`2) “Swellable Materials and Devices” ([0051]-[0055]);
`
`3) “Anisotropically Swelling Materials and Devices” ([0056]-
`[0079]);
`
`16
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`
`4) “Chelation-Resistant Materials and Devices” ([0080]-[0088]);
`
`5) “Controllably Degradable Materials and Devices” ([0089]-
`[0099]);
`
`6) “Triggerable Dissolution of Nasolacrimal Implants” ([0100]-
`[0108]);
`
`7) “Fluidic Occlusive Elements and Materials” ([0109]-[0112]);
`
`8) “Materials of Water-Soluble Polymers Which Gel Under
`Physiological Conditions” ([0113]-[0119]);
`
`9) “Methods of Making Hydrophilic Extrusions, Fibers and
`Monofilaments Incorporating Carboxymethylcellulose” ([0120]-
`[0122]);
`
`10) “Materials of Water-Insoluble Low-Substituted Hydroxy-
`propyl Cellulose” ([0123]-[0130]);
`
`11) “Drug and Therapeutic Agent Delivery” ([0131]-[0140]);
`
`12) “Removal of Hydrogel Occlusive Devices by Changes in
`Tonicity” ([0141]-[0150]);
`
`13) “Additional Embodiments” ([0151]-[0156]);
`
`14) “Swellable Temporary Punctum Plugs” ([0157]-[0158]); and
`
`15) “In Vitro Testing of Gellan, Depolymerized to Varying
`Degrees” ([0159]-[0165]).
`
`Prelim. Resp. 15–16. Patent Owner also contends that these 15 identified
`
`embodiments “further contain numerous sub-embodiments.” Id. at 16.
`
`Patent Owner also argues that “Pritchard does not contemplate
`
`improving the visibility of cylindrical rod-shaped subpunctal devices,” thus
`
`providing another reason the reference does not anticipate. Prelim. Resp.
`
`16–17. Patent Owner argues that the “light straw color” disclosed by
`
`Pritchard would not improve the device’s visibility in the lacrimal
`
`canaliculus, providing a photograph of the human eye’s anatomy to
`
`emphasize the point. Id. at 33–34. On the same issue, Patent Owner
`
`17
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`contends Pritchard’s disclosed color change from translucent to straw
`
`colored is not permanent. Id. at 35.
`
`Turning to the obviousness Ground 2, Patent Owner argues Gillespie
`
`does not cure the above-noted, contended deficiencies in Pritchard. Id. at
`
`36. Patent Owner further argues that the unpredictability of coloring an
`
`implant, such as the device claimed, including the potential stability and
`
`toxicity concerns or adverse effects evidenced by the art, supports the non-
`
`obviousness of the claimed invention. Id. at 37 (citing Handbook, Ex. 1016,
`
`22–24 (noting “widely varying” stability and toxicity properties and that
`
`“[s]ome natural and synthetic organic colors are particularly unstable in
`
`light”)).
`
`Patent Owner also argues Gillespie “does not teach or suggest any
`
`devices that can be used for drug delivery into the canaliculus of a patient in
`
`need thereof,” and that this means Gillespie’s disclosed color additives
`
`would not be suitable for the drug-delivery implants of Pritchard. Prelim.
`
`Resp. 39. Similarly, because Pritchard focuses on controllably swellable
`
`materials for its implants and Gillespie teaches silastic rubber as an implant
`
`material (that is colored), Patent Owner argues there would not have been a
`
`reasonable expectation of success for the skilled artisan in making
`
`Petitioner’s proposed prior art combination, which further supports non-
`
`obviousness. Id. at 41.
`
`Finally, Patent Owner argues that, even if Pritchard and Gillespie
`
`were combined, the combination would still fail to teach the claimed drug-
`
`delivery system. Prelim. Resp. 43. Patent Owner contends “the
`
`combination at best provides a punctal plug with an outwardly exposed
`
`18
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`surface, such as a rim, which is colored. It does not provide a drug delivery
`
`device with a cylindrical rod-shaped body for insertion into the lacrimal
`
`canaliculus that has a distinguishing color to show placement.” Id. at 45.
`
`Analysis
`
`In some respects, the parties’ arguments present us with a reasonably
`
`close question on anticipation because, as Patent Owner observes, the
`
`Pritchard reference does not disclose a single, stand-alone example of a
`
`lacrimal canalicular plug for insertion via a punctal opening having each
`
`element of the ’082 patent’s claims. See, e.g., Microsoft, 878 F.3d. at 1071
`
`(identifying that patent specifications can be written so that it is not a simple
`
`matter to understand the difference between what are intended to be separate
`
`embodiments and what are intended to be directly related elements of an
`
`invention, so as to present a reasonably close question). However, on
`
`balance, at this stage in the proceedings and for the reasons discussed below,
`
`we find Petitioner has carried its burden to show a reasonable likelihood of
`
`anticipation of at least one claim of the ’082 patent.
`
`We conclude, based on the evidence presented by Petitioner at this
`
`stage in the proceedings, that Pritchard discloses the subject matter of claims
`
`1–7, 9–16, 18–20, and 22–23. In particular, Petitioner shows that Pritchard
`
`discloses a punctal plug and describes the remaining claim elements such
`
`that a person of ordinary skill in the art would immediately envisage
`
`selecting them, as if off a menu of directly related options, in the fashion
`
`claimed in the ’082 patent. “[A]n anticipation analysis indisputably allows
`
`for some flexibility.” Microsoft, 878 F.3d at 1069. Pritchard “anticipate[s]
`
`[here] even if it ‘d[oes] not expressly spell out’ all the limitations arranged
`
`19
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`or combined as in the claim[s], [because] a person of skill in the art, reading
`
`the reference, would ‘at once envisage’ the claimed arrangement or
`
`combination.” Id. at 1068; see also Pet. 36–61 (claim charts identifying
`
`where and how Pritchard discloses the claimed subject matter); Ex. 1036
`
`¶¶ 48–72 (Dana Declaration discussing how and why Pritchard anticipates).
`
`The various disclosures of elements by Pritchard, at least respective of the
`
`’082 patent’s claimed invention, appear to be “directly related disclosures,”
`
`such that they “may be combined in an optimal anticipating embodiment.”
`
`See In re Arkley, 455 F.2d at 587–88; Purdue Pharma, 881 F.3d at 1358–59.
`
`At this stage, we are not persuaded that the disclosure of Pritchard
`
`includes the 15 separate and unrelated embodiments as argued by Patent
`
`Owner. Analyzing Patent Owner’s contended list of independent Pritchard
`
`embodiments beginning with the first, what Patent Owner identifies as
`
`Pritchard’s embodiment 1, i.e., paragraphs 45–50, is not a separately
`
`described embodiment, but the cited portion of the specification describes
`
`gellan as a polysaccharide material useful in the invention otherwise taught
`
`in Pritchard. See Prelim. Resp. 15; Ex. 1010 ¶¶ 45–50. Nothing in this
`
`portion of Pritchard hints that it should be considered a separate part of the
`
`disclosure not directly related to the rest. Similarly, Pritchard’s paragraphs
`
`51–55, which Patent Owner contends are its embodiments 2 and 3, describe
`
`why hydrogel and gellan materials swell (or swell anisotropically) and how
`
`they can be used in devices as taught throughout Pritchard, for example,
`
`cylindrical hydrogel or polysaccharide plugs that swell after implanting. See
`
`Prelim. Resp. 15; Ex. 1010 ¶¶ 51–79. Again, nothing in this portion of
`
`Pritchard’s disclosure indicates that it should be considered separate and
`
`20
`
`
`
`IPR2019-00448
`Patent 9,849,082 B2
`
`
`independent from the rest of Pritchard’s disclosure; to the contrary, it
`
`suggests that the swellability characteristics described would be useful
`
`generally. The portion of Pritchard that Patent Owner indicates is
`
`embodiment 4 discusses how punctum plugs and other nasolacrimal
`
`occlusive devices can be made of chelation-resistant materials, including
`
`how the otherwise taught hydrogels and gellan can be made so. See Prelim.
`
`Resp. 15; Ex. 1010 ¶¶ 80–88. This disclosure is not segregating this subject
`
`matter from the other-disclosed subject matter in Pritchard.
`
`The portion of Pritchard that Patent Owner identifies as embodiment
`
`11 relates to drug-delivery and teaches that essentially any embodiment of
`
`Pritchard could contain a therapeutic agent and is not describing a separate,
`
`independent, unrelated embodiment. See Prelim. Resp. 15; Ex. 1010
`
`¶¶ 131–140 (“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.”). In fact, this portion of Pritchard expressly invokes
`
`the other portions of the disclosure that Patent Owner contends are
`
`independent, unrelated embodiments (i.e., hydrogel materials, gellan
`
`materials, swellable/anisotropically swellable devices). See Ex. 1010
`
`¶¶ 131–140. Further, this portion of Pritchard also expressly teaches
`
`incorporating drugs into a cylindrical, anisotropically swellable implant, that
`
`is a light straw color (as opposed to clear), which supports that such implant
`
`characteristics are related to o
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
