`
`
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`OCULAR THERAPEUTIX, INC.
`Petitioner
`
`v.
`
`MATI THERAPEUTICS INC.
`Patent Owner
`
`US Patent No. 9,849,082
`
`Inter Partes Review No. IPR2019-00448
`
`_______________
`
`
`PETITION FOR INTER PARTES REVIEW OF US PATENT NO. 9,849,082
`UNDER 35 USC §§ 311-319 AND CFR § 42.100, et. seq.
`
`
`
` ME1 28528752v.3
`
`

`

`Patent No. 9,849,082
`
`
`
`
`I.
`
`
`
`Attorney Docket No. 129285-00013
`
`TABLE OF CONTENTS
`
`
`
`Page
`
`INTRODUCTION ........................................................................................ 1
`A.
`The Parties .......................................................................................... 1
`B.
`The Challenged ‘082 Patent ................................................................ 2
`C. Mandatory Notices And Certifications ................................................ 3
`1.
`Real Party-in-Interest ................................................................ 3
`2.
`Related Matters ......................................................................... 4
`3.
`Counsel and Service Information .............................................. 4
`4.
`Standing .................................................................................... 5
`II.
`OVERVIEW OF THE ‘082 PATENT AND ITS PROSECUTION .............. 5
`Summary of the ‘082 Patent and Its Claims ........................................ 5
`A.
`The Prosecution of the ‘082 Patent ..................................................... 8
`B.
`III. CLAIM CONSTRUCTION ........................................................................ 10
`A.
`“Distinguishing Color to Show”........................................................ 10
`B.
`“Sheath Body” .................................................................................. 11
`IV. STATUTORY GROUNDS, CHALLENGED CLAIMS, AND PRIOR
`ART ............................................................................................................ 13
`A.
`The Legal Standards for Anticipation and Obviousness .................... 14
`B.
`The Scope And Content of The Prior Art .......................................... 15
`C.
`Level of Ordinary Skill in the Art ..................................................... 26
`THE CHALLENGED CLAIMS ARE UNPATENTABLE ......................... 27
`A. Ground 1: Anticipation of Claims 1-7, 9-16, 18-20, and 22-23
`by Pritchard under §102 ................................................................... 27
`1.
`Limitations Common to All Challenged Claims...................... 28
`(a)
`Claims 1, 11, and 18) .................................................... 28
`
`V.
`
`ME1 28528752v.3
`
`“A drug delivery system for insertion into a
`lacrimal canaliculus of a patient” (Preamble of
`
`i
`
`

`

`Patent No. 9,849,082
`
`
`
`
`
`
`Attorney Docket No. 129285-00013
`
`TABLE OF CONTENTS
`
`
`
`Page
`
`2.
`
`“a distinguishing color to show placement of
`the system in the lacrimal canaliculus of the
`
`“a body of material to hold the therapeutic
`agent wherein the body of material comprises
`
`“wherein the body of material is a cylindrical
`
`“wherein the hydrogel swells when the system
`is inserted into the lacrimal canaliculus of the
`
`“wherein the polymers comprise functional
`
`“a therapeutic agent” ..................................................... 29
`(b)
`(c)
`patient” ......................................................................... 29
`(d)
`hydrogel polymers”....................................................... 29
`(e)
`rod” ............................................................................... 30
`Other Limitations .................................................................... 31
`(a)
`patient” ......................................................................... 31
`(b)
`groups” ......................................................................... 33
`(c)
`specific therapeutic agents ............................................ 33
`(d)
`body” ............................................................................ 34
`B.
`Pritchard in View of Gillespie under §103 ....................................... 61
`C.
`View of Gillespie and Hellberg under §103 ...................................... 64
`D. Ground 4: Claims 1-7, 9-16, 18-20, 22-23 Are Obvious Over
`Pritchard in View of the Handbook under §103 ............................... 66
`E.
`View of the Handbook and Hellberg under §103 .............................. 68
`VI. CONCLUSION .......................................................................................... 70
`ME1 28528752v.3
`
`“wherein the system does not comprise a sheath
`
`Ground 2: Claims 1-7, 9-16, 18-20, 22-23 Are Obvious Over
`
`Ground 3: Claims 8, 17, and 21 Are Obvious Over Pritchard in
`
`Ground 5: Claims 8, 17, and 21 Are Obvious Over Pritchard in
`
`
`
`
`
`ii
`
`

`

`Patent No. 9,849,082
`
`
`
`
`Attorney Docket No. 129285-00013
`
`
`FEDERAL CASES PAGE(S)
`
`TABLE OF AUTHORITIES
`
`Ariosa Diagnostics v. Verinata Health, Inc.,
`805 F.3d 1359 (Fed. Cir. 2015)…………………………………………….17
`
`
`Callaway Golf Co. v. Acushnet Co.,
`
`576 F.3d 1331 (2009)………………………………………………………34
`
`Genzyme Thera. Prods. Ltd. P’ship v. Biomarin Pharm. Inc.,
`
`825 F.3d 1360 (Fed. Cir. 2016)…………………………………………….16
`
`Graham v. John Deere Co. of Kansas City,
`
`383 U.S. 1 (1966)…………………………………………………………..15
`
`Honeywell Int’l, Inc. v. ITT Indus., Inc.,
`
`452 F.3d 1312 (Fed. Cir. 2006)…………………………………………….10
`
`KSR International Co. v. Teleflex Inc.,
`
`550 U.S. 398 (2007)………………………………………………………..15
`
`Phillips v. AWH Corp.,
`
`415 F.3d 1303 (Fed. Cir. 2005)…………………………………………….10
`
`Telemac Celluar Corp. v. Topp Telecom, Inc.,
`
`247 F. 3d 1316 (Fed. Cir. 2001)……………………………………………34
`
`Verdegaal Bros. v. Union Oil Co. of California,
`
`814 F.2d 628 (Fed. Cir. 1987)……………………………………………...15
`
`FEDERAL STATUTES PAGE(S)
`
`35 U.S.C. § 102……………………………...……………………………………14
`
`35 U.S.C. § 103……………………………...……………………………………14
`
`REGULATIONS PAGE(S)
`
` 7
`
`ME1 28528752v.3
`
` C.F.R. § 42.100………...…………………...…………………………………...10
`
`iii
`
`

`

`Patent No. 9,849,082
`
`
`
`
`Attorney Docket No. 129285-00013
`
`TABLE OF AUTHORITIES
`
`
`
`83 FED. REG. 51340…………..……………...……………………………………10
`
`
`
`
`
`
`
`
`
`ME1 28528752v.3
`
`iv
`
`

`

`Patent No. 9,849,082
`
`
`
`
`
`
`Attorney Docket No. 129285-00013
`
`TABLE OF EXHIBITS
`
`Exhibit
`Ex. 1001
`Ex. 1002
`
`Ex. 1003
`
`Ex. 1004
`
`Ex. 1005
`
`Ex. 1006
`
`Ex. 1007
`
`Ex. 1008
`
`Ex. 1009
`
`Ex. 1010
`
`Ex. 1011
`
`Ex. 1012
`
`Ex. 1013
`
`Ex. 1014
`
`Ex. 1015
`
`Ex. 1016
`
`Ex. 1017
`
`Ex. 1018
`
`Ex. 1019
`
`ME1 28528752v.3
`
`Description
`US Patent No. 9,849,082 (the ‘082 Patent)
`US Provisional Application No. 60/787,775, filed March 31, 2006
`(First ‘082 Provisional)
`US Provisional Application No. 60/871,864, filed December 26,
`2006 (Second ‘082 Provisional)
`US Patent Application No. 11/695,454, filed April 2, 2007 (First
`‘082 Non-Provisional)
`US Patent Application No. 15/405,991, filed January 13, 2017
`(‘082 Application)
`Office Action issued on April 6, 2017, in the Prosecution History
`of US Patent No. 9,849,082(the ‘082 File History)
`Amendment and Response submitted on August 7, 2017, in the
`‘082 File History
`Notice of Allowance mailed on August 23, 2017, in the ‘082 File
`History
`Notice of Allowance mailed on September 15, 2017, in the ‘082
`File History
`US Application Publication No. 2005/0197614 to Pritchard et al.,
`published September 8, 2005 (“Pritchard”)
`US Provisional Application No. 60/550,132, filed March 4, 2004
`(the ‘132 Pritchard Provisional)
`US Provisional Application No. 60/557,368, filed March 29, 2004
`(the ‘368 Pritchard Provisional)
`US Provisional Application No. 60/564,858, filed April 23, 2004
`(the ‘858 Pritchard Provisional)
`US Provisional Application No. 60/637,569, filed December 20,
`2004 (the ‘569 Pritchard Provisional)
`US Application Publication No. 2002/0169409 to Gillespie
`(“Gillespie”)
`Handbook of Pharmaceutical Excipients (Arthur H. Kibbe ed. 3d
`ed. 2000) (the “Handbook”)
`US Patent No. 6,646,001 to Hellberg et al., issued November 11,
`2003 (“Hellberg”)
`US Application Publication No. 2006/0020248 to Prescott et al.,
`in the ‘082 File History
`US Application Publication No. 2004/0208910 to Ashton et al., in
`the ‘082 File History
`
`v
`
`

`

`Patent No. 9,849,082
`
`
`
`
`
`
`Attorney Docket No. 129285-00013
`
`TABLE OF EXHIBITS
`
`Exhibit
`Ex. 1020
`
`Ex. 1021
`
`Ex. 1022
`
`Ex. 1023
`
`Ex. 1024
`
`Ex. 1025
`Ex. 1026
`
`Ex. 1027
`
`Ex. 1028
`
`Description
`Baxter et al., Punctal Plugs in the Management of Dry Eyes, 2
`THE OCULAR SURFACE 255-265 (October 2004) (“Baxter”)
`Foulds, Intra-Canalicular Gelatin Implants in the Treatment of
`Conjunctivitis Sicca, 45 BRIT J. OPHTHAL. 625-27 (1961).
`US Patent No. 3,949,750 to Freeman (Freeman ‘750), in the ‘082
`File History
`US Patent No. 5,283,063 to Freeman (Freeman ‘063), in the ‘082
`File History
`US Patent No. 6,196,993 to Cohan et al. (Cohan), in the ‘082 File
`History
`US Patent No. 5,902,598 to Chen et al. (Chen)
`US Application Publication No. 2005/0095269 to Ainpour et al.
`(Ainpour), in the ‘082 File History
`U.S. Pat. No. 4,327,725 to Cortese et al. (Cortese), in the ‘082 File
`History
`Scot Morris, O.D., F.A.A.O., A Lesson in Managing Dry Eye,
`Plugs, Drugs and Tears: A Dry Eye Update, Part Two,
`OPTOMETRIC MANAGEMENT 36-43 (October 2002)
`U.S. Patent No. 3,826,258 to Abraham (“Abraham”)
`Ex. 1029
`U.S. Patent No. 3,993,071 to Higuchi et al. (“Higuchi”)
`Ex. 1030
`U.S. Patent No. 6,152,943 to Sawhney (“Sawhney”)
`Ex. 1031
`Ex. 1032 M. Balaram et al., Efficacy and Tolerability Outcomes after
`Punctal Occlusion with Silicone Plugs in Dry Eye Syndrome, 131
`OPHTHALMOL. 30-36 (2001)
`U.S. Patent No. 9,309,313, entitled “Therapeutic Compositions for
`Treatment of Ocular Inflammatory Disorders”
`US Application Publication No. 2007/0265341, entitled
`“Compositions and Methods for Treating Eye Disorders and
`Conditions”
`Physicians’ Desk Reference (57 ed. 2003)
`Declaration of Reza Dana, M.D., executed December 14, 2018
`Curriculum Vitae of Reza Dana, M.D.
`
`Ex. 1033
`
`Ex. 1034
`
`Ex. 1035
`Ex. 1036
`Ex. 1037
`
`
`
`
`
`ME1 28528752v.3
`
`vi
`
`

`

`
`
`Patent No. 9,849,082
`
`I.
`
`INTRODUCTION
`
`A. The Parties
`
`
`
`Attorney Docket No. 129285-00013
`
`Founded in 2006, Ocular Therapeutix, Inc. (“Ocular” or “Petitioner”) is an
`
`innovative biopharmaceutical company focused on
`
`the development and
`
`commercialization of therapies for various diseases and conditions of the eye.
`
`Ocular is developing the DEXTENZA® drug-eluting intracanalicular insert for
`
`treating post-surgical ocular pain and other ophthalmic conditions. On November
`
`30, 2018, after conducting extensive clinical trials, Ocular received FDA approval
`
`to market DEXTENZA for treating ocular pain following ophthalmic surgery.
`
`Ocular expects to begin marketing DEXTENZA during the first half of 2019.
`
`Mati Therapeutics (“Mati” or “Patentee”) did not invent the technology
`
`claimed in the challenged patent. Instead, years after the alleged invention, Mati
`
`acquired from a third party the rights to the series of applications that resulted in
`
`U.S. Patent No. 9,849,082 (“the ‘082 Patent,” Ex. 1001). Mati has no products on
`
`the market. Nonetheless, aware of the impending FDA approval of the
`
`DEXTENZA insert, Mati sent Ocular a letter accusing the DEXTENZA insert of
`
`infringing the ‘082 Patent and two other patents. This review is necessary to
`
`remove the cloud of Mati’s threats so that Ocular can make this important, FDA-
`
`approved medical advancement available to eye surgery patients.
`
`ME1 28528752v.3
`
`1
`
`

`

`
`
`Patent No. 9,849,082
`
`
`
`Attorney Docket No. 129285-00013
`
`B.
`
`The Challenged ‘082 Patent
`
`
`
`The ‘082 Patent claims a “drug delivery system for insertion into a lacrimal
`
`canaliculus of a patient” that comprise, inter alia, a cylindrical rod-shaped body
`
`made from hydrogel polymers and a therapeutic agent. See, e.g., Ex. 1001, ‘082
`
`Patent, Claims. To overcome the examiner’s prior art rejections, Patentee
`
`amended the claims to add a limitation that these drug delivery systems must also
`
`include “a distinguishing color to show placement of the system in the lacrimal
`
`canaliculus of the patient.” This limitation appears in all of the independent claims
`
`of the ‘082 Patent. Patentee argued that this color limitation—and this limitation
`
`alone—distinguished the cited prior art. But, as described in Section IV.C below,
`
`the prior art included numerous systems, such as punctal plugs and other
`
`canalicular inserts, with a “distinguishing color to show.”
`
`
`
`Moreover, the closest prior art was neither discussed nor applied during
`
`prosecution of the ‘082 Patent. As detailed in Section V.A and the included claim
`
`chart, US Publ. 2005/0197614 to Pritchard et al. (“Pritchard,” Ex. 1010) discloses
`
`lacrimal implants, such as punctal plugs and canalicular inserts, that comprise a
`
`cylindrical rod-shaped body made from hydrogel polymers and a therapeutic agent.
`
`Pritchard further discloses implants that feature color, swell when placed in the
`
`canaliculus, include polymers comprising functional groups, and deliver specific
`
`therapeutic agents to treat various ophthalmic conditions, such as dry eye,
`
`ME1 28528752v.3
`
`2
`
`

`

`
`
`Patent No. 9,849,082
`
`
`
`Attorney Docket No. 129285-00013
`
`glaucoma, and post-surgical discomfort. These elements are, in essence, all of the
`
`limitations of the challenged claims. For example, in the following figures,
`
`Pritchard depicts an embodiment of its hydrogel canalicular inserts—both before
`
`insertion into the canaliculus and swollen as it would be after insertion:
`
`Ex. 1010, Pritchard, FIGS. 7A, 7B. Again, this embodiment is exactly what is
`
`contemplated by the challenged claims. As such, Pritchard anticipates the claims
`
`of the ‘082 patent and, in combination with other prior art, renders them obvious.
`
`
`
`C. Mandatory Notices And Certifications
`
`1.
`
`Real Party-in-Interest
`
`The real party in interest for this petition for inter partes review is Ocular
`
`Therapeutix, Inc., of 15 Crosby Drive, Bedford, MA, 01730.
`
`ME1 28528752v.3
`
`3
`
`

`

`
`
`Patent No. 9,849,082
`
`2.
`
`Related Matters
`
`
`
`Attorney Docket No. 129285-00013
`
`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,
`
`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.
`
`3.
`
`Counsel and Service Information
`
`Lead Counsel
`Kia Freeman, Reg. No. 47,577
`
`kfreeman@mccarter.com
`McCarter English, LLP
`265 Franklin Street
`Boston, MA 02110
`T: 617-449-6500
`
`
`Back-Up Counsel
`Erik Paul Belt (pro hac vice to be filed)
`
`ebelt@mccarter.com
`Brian M. Seeve, Reg. No. 71,721
`
`bseeve@mccarter.com
`Wyley S. Proctor (pro hac vice to be
`filed)
`
`wproctor@mccarter.com
`Thomas R. Fulford, Reg. No. 76,384
`
`tfoley@mccarter.com
`McCarter English, LLP
`265 Franklin Street
`Boston, MA 02110
`T: 617-449-6500
`
`
`
`
`ME1 28528752v.3
`
`4
`
`

`

`
`
`Patent No. 9,849,082
`
`
`
`Attorney Docket No. 129285-00013
`
`
`
`All counsel are attorneys at McCarter & English, LLP, 265 Franklin Street,
`
`Boston, MA
`
`02110. Ocular
`
`consents
`
`to
`
`service
`
`by
`
`email
`
`at
`
`OCLIPR@mccarter.com.
`
`4.
`
`Standing
`
`Pursuant to 37 CFR § 42.104(a), Ocular certifies that the ‘082 Patent is
`
`available for inter partes review and that Ocular is not estopped or barred from
`
`requesting inter partes review of the ‘082 Patent on the grounds in this petition.
`
`II. OVERVIEW OF THE ‘082 PATENT AND ITS PROSECUTION
`
`A.
`
`Summary of the ‘082 Patent and Its Claims
`
`The ‘082 patent was filed on January 13, 2017, and issued on December 26,
`
`2017. The ‘082 patent claims priority back through a series of four continuation
`
`applications to two provisional applications: US Provisional App. Nos. 60/787,775,
`
`dated March 31, 2006 (Ex. 1002), and 60/871,864, dated December 26, 2006 (Ex.
`
`1003). The first non-provisional application was filed on April 2, 2007. Assuming
`
`that Patentee is entitled to the priority of the first provisional--while reserving the
`
`right to challenge priority if Patentee argues that any of the cited references are too
`
`late--then the earliest claimed priority date is March 31, 2006.
`
`The ‘082 Patent is entitled “Nasolacrimal Drainage System Implants for
`
`Drug Delivery.” The nasolacrimal system is associated with the eye. Figure 1-1 of
`
`ME1 28528752v.3
`
`5
`
`

`

`
`
`Patent No. 9,849,082
`
`
`
`Attorney Docket No. 129285-00013
`
`the ‘082 Patent, copied below, illustrates the anatomical tissue structures of a
`
`human eye, including the nasolacrimal system:
`
`
`
`The nasolacrimal system includes upper and lower canaliculi (the two lumens
`
`designated as 10 and 12), a lacrimal sac (14), and a punctum (11 and 13) for each
`
`canaliculus. Tears drain through the canaliculi, into the lacrimal sac, and then out
`
`through the nasal system. See Ex. 1001, ‘082 Patent, 7:30-65. See also Ex. 1036,
`
`Declaration of Reza Dana, M.D., December 14, 2018 (“Dana Decl.”), ¶¶ 28-29.
`
`The ‘082 Patent has 23 claims. Claims 1, 11, and 18 are independent. Each
`
`of the independent claims is directed to “[a] drug delivery system for insertion into
`
`a lacrimal canaliculus of a patient.” While claiming “systems,” the ‘082 patent
`
`generally discloses “implants.” For example, the Abstract discloses “[a]n implant
`
`ME1 28528752v.3
`
`6
`
`

`

`
`
`Patent No. 9,849,082
`
`
`
`Attorney Docket No. 129285-00013
`
`for insertion through a punctum and into a canalicular lumen of a patient.” Ex.
`
`1001, ‘082 Patent, Abstract. See also id., 1:21-24 (“The present invention is
`
`related to implants for use in or near the nasolacrimal drainage system, with
`
`embodiments providing canalicular implants . . .and punctal plugs with drug
`
`delivery capabilities”). For purposes of this discussion, Petitioner refers to such
`
`devices, interchangeably, as “implants” or “inserts.”
`
`Each of the independent claims, broadly speaking, requires (1) a therapeutic
`
`agent, (2) a cylindrical body of hydrogel polymers to hold the therapeutic agent,
`
`and (3) a distinguishing color. For example, Claim 1 recites:
`
`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.
`
`Independent Claim 11 also requires that the hydrogel body swells when placed in
`
`the canaliculus. Independent Claim 18 requires that the therapeutic agent be
`
`selected from “an anti-glaucoma agent, a corticosteroid[,] an anti-microbial agent,
`
`and anti-allergy agent or a non-steroidal anti-inflammatory agent.”
`
`ME1 28528752v.3
`
`7
`
`

`

`
`
`Patent No. 9,849,082
`
`
`
`Attorney Docket No. 129285-00013
`
`Most of the dependent claims recite specific therapeutic agents or ocular
`
`conditions to be treated. Two dependent claims, Claims 9 and 22, recite that the
`
`polymers comprise “functional groups.”
`
`B.
`
`The Prosecution of the ‘082 Patent
`
`During prosecution, the examiner rejected most of the pending claims as
`
`anticipated either by Pub. No. US 2006/0020248, to Prescott et al. (Ex. 1018) or
`
`by Pub. No. US 2004/0208910, to Ashton et al. (Ex. 1019). See Ex. 1006, Office
`
`Action issued on April 6, 2017, in the ‘082 File History, 3-4. The examiner did not
`
`appreciate, and certainly never applied, the closest prior art, namely, Pritchard.
`
`To overcome the examiner’s anticipation rejections, Mati amended the
`
`pending claims to require that the claimed systems include “a distinguishing color
`
`to show placement of the system in the lacrimal canaliculus of the patient.” Ex.
`
`1007, Amendment and Response of August 7, 2017, in the ‘082 File History, 2, 4
`
`(emphasis added). Originally, this “distinguishing color to show” limitation
`
`appeared in only prosecution Claim 12 (which issued as Claim 11) and in two
`
`dependent claims. Ex. 1005, US Patent App. No. 15/405,991 filed January 13,
`
`2017, in the ‘082 File History, 56-58 (Claims).1 In conjunction with these
`
`
`ME1 28528752v.3
`
`1 Although the claimed priority date went back 11 years through four
`
`continuations, this was the first time that Patentee included a “distinguishing color”
`
`8
`
`

`

`
`
`Patent No. 9,849,082
`
`
`
`Attorney Docket No. 129285-00013
`
`amendments, Patentee argued that the newly-added “distinguishing color to show”
`
`limitation alone distinguished the cited prior art:
`
`The subject matter of claims 11 and 25, wherein the drug delivery
`
`system comprises “. . . a distinguishing color to show placement of the
`
`system in the lacrimal canaliculus of the patient” was not included in
`
`the instant art rejections and hence is free of the art. The subject
`
`matter of those claims was incorporated into claims 1 and 19,
`
`respectively. Moreover, claim 12 recites the same language. The
`
`references relied upon by the Office Action do not expressly or
`
`inherently disclose a drug delivery system for insertion into a lacrimal
`
`canaliculus of a patient comprising or consisting essentially of “. . . a
`
`distinguishing color to show placement of the system in the lacrimal
`
`canaliculus of the patient”.
`
`Ex. 1007, Amendment and Response of August 7, 2017, in the ‘082 File History,
`
`8. Based on this argument, the examiner allowed the claims. See Ex. 1008, Notice
`
`of Allowance mailed on August 23, 2017, in the ‘082 File History; Ex. 1009,
`
`Notice of Allowance mailed on September 15, 2017, in the ‘082 File History. See
`
`also Ex. 1036, Dana Decl., ¶ 42.
`
`
`
`As discussed in Section IV.B below, however, a “distinguishing color to
`
`show” ocular implants was long known and used in the field. The examiner,
`
`
`ME1 28528752v.3
`
`limitation in any claims. But there is no indication in the ‘082 application that this
`
`was the first presentation of such claims.
`
`9
`
`

`

`
`
`Patent No. 9,849,082
`
`
`
`Attorney Docket No. 129285-00013
`
`apparently, did not appreciate that “distinguishing color to show” was known in the
`
`prior art.
`
`III. CLAIM CONSTRUCTION
`
`
`
`The claims “shall … be construed using the same claim construction
`
`standard that is used to construe the claim in a civil action in district court” because
`
`this petition was filed after November 13, 2018. See 83 FED. REG. 51340. Thus,
`
`claim terms should be given their ordinary meaning to one of ordinary skill in the
`
`art. See 37 C.F.R. § 42.100; see also Phillips v. AWH Corp., 415 F.3d 1303, 1313
`
`(Fed. Cir. 2005) (en banc). That meaning is always informed by the specification.
`
`Phillips, 415 F.3d at 1315. Indeed, the specification is “usually dispositive; it is
`
`the single best guide to the meaning of a disputed term.” Honeywell Int’l, Inc. v.
`
`ITT Indus., Inc., 452 F.3d 1312, 1318 (Fed. Cir. 2006) (citation omitted). In
`
`addition, the tribunal “should also consider the patent’s prosecution history, if it is
`
`in evidence ….” Phillips, 415 F.3d at 1317.
`
`A.
`
`“Distinguishing Color to Show”
`
`The term “distinguishing color to show” appears in each of the three
`
`independent claims of the ‘082 Patent. But this “distinguishing color to show”
`
`limitation did not appear in any of the original claims of the first non-provisional
`
`application in the claimed chain of priority. See generally Ex. 1004, First ‘082
`
`Non-Provisional Application, claims. Nor was this concept disclosed in the March
`
`ME1 28528752v.3
`
`10
`
`

`

`
`
`Patent No. 9,849,082
`
`
`
`Attorney Docket No. 129285-00013
`
`31, 2006 provisional application. See generally Ex. 1002.
`
`The only teaching of a “distinguishing color to show” in the specification of
`
`the ’082 Patent appears is in just one sentence: “In 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.” Ex. 1001, ‘082 Patent, 20:67-21:5 (emphasis
`
`added). See also Ex. 1036, Dana Decl., ¶ 51.
`
`In 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.” Ex. 1036, Dana Decl., ¶ 51.
`
`B.
`
`“Sheath Body”
`
`The term “sheath body” is recited in Claim 2 of the ‘082 Patent. Claim 2,
`
`which depends from independent Claim 1, recites that “the [drug delivery] system
`
`does not comprise a sheath body.” Ex. 1001, ‘082 Patent, Claim 2.
`
`Here, the specification of the ‘082 Patent describes “sheath body”
`
`throughout the specification (particularly at 20:26-21:9) and make clear what is
`
`meant by the term. For example, the specification states that the sheath body
`
`“comprises appropriate shapes and materials to control migration of the therapeutic
`
`agent from the drug core. The sheath body houses the core and can fit snugly
`
`ME1 28528752v.3
`
`11
`
`

`

`
`
`Patent No. 9,849,082
`
`
`
`Attorney Docket No. 129285-00013
`
`against the core. The sheath body is made from material that is substantially
`
`impermeable to the therapeutic agent so that the rate of migration of the therapeutic
`
`agent may be largely controlled by the exposed surface area of the drug core that is
`
`not covered by the sheath body.” Ex. 1001, ‘082 Patent, 20:27-34. See also id.,
`
`Abstract (the disclosed implants include “a sheath disposed over a portion of the
`
`matrix of material and configured to inhibit the therapeutic agent from being
`
`released from the matrix of material into the canalicular lumen”). See also Ex.
`
`1036, Dana Decl., ¶¶ 68-69.
`
`Thus, 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 therapeutic agent from the covered portion of
`
`the drug core” Ex. 1036, Dana Decl., ¶ 70.
`
`Summary
`proposed construction
`claim term
`“distinguishing color to show” “color that improves visibility”
`
`“sheath body”
`
`
`
`ME1 28528752v.3
`
`“material or structure that is impermeable to the
`therapeutic agent and that covers a portion of a
`drug core
`to prevent migration of
`the
`therapeutic agent from the covered portion of
`the drug core”
`
`12
`
`

`

`
`
`Patent No. 9,849,082
`
`
`
`Attorney Docket No. 129285-00013
`
`IV. STATUTORY GROUNDS, CHALLENGED CLAIMS, AND PRIOR
`ART
`
`Ocular challenges all 23 claims of the ‘082 Patent. Ocular relies on
`
`Pritchard (Ex. 1010) as the sole or primary basis for all of its challenges.
`
`Pritchard anticipates Claims 1-7, 9-16, 18-20, and 22-23. These same claims are
`
`also obvious over Pritchard in view of either of two alternative secondary
`
`references—namely, US Publ. No. 2002/0169409 to Gillespie (“Gillespie,” Ex.
`
`1015) and the 2000 HANDBOOK OF PHARMACEUTICAL EXCIPIENTS (“Handbook,”
`
`Ex. 1016). Additionally, Claims 8, 17, and 21 are obvious over both of the
`
`Pritchard combinations in view of US Patent No. 6,646,001 to Hellberg
`
`(“Hellberg,” Ex. 1017).
`
`Grounds
`
`Claims
`
`1-Anticipated by Pritchard under §102
`
`Claims 1-7, 9-16, 18-20, and 22-23
`
`2-Obvious over Pritchard in view of
`Gillespie under §103
`
`Claims 1-7, 9-16, 18-20, and 22-23
`
`3-Obvious over Pritchard in view of
`Gillespie and Hellberg under §103
`
`Claims 8, 17, and 21
`
`4-Obvious over Pritchard in view of the
`Handbook under §103
`
`Claims 1-7, 9-16, 18-20, and 22-23
`
`5-Obvious over Pritchard in view of the
`Handbook and Hellberg under §103
`
`Claims 8, 17, and 21
`
`
`
`
`
`ME1 28528752v.3
`
`13
`
`

`

`
`
`Patent No. 9,849,082
`
`
`
`Attorney Docket No. 129285-00013
`
`Pritchard was published on September 8, 2005, based on an application filed
`
`on March 5, 2005. See Ex. 1010. Pritchard qualifies as prior art at least because it
`
`was filed and published before the earliest priority date claimed in the ‘082 Patent
`
`(i.e., March 31, 2006).
`
`Gillespie was published on November 14, 2002 (see Ex. 1015), and is thus
`
`prior art at least because it was published more than one year before the earliest
`
`priority date claimed in the ‘082 patent.
`
`The Handbook (3rd ed.) published in 2000. See Ex. 1016. The Handbook is
`
`prior art at least because it published more than one year before the earliest priority
`
`date claimed in the ‘082 patent.
`
`Hellberg issued on November 11, 2003. See Ex. 1017. Hellberg is prior art
`
`at least because it issued more than one year before the earliest priority date
`
`claimed in the ‘082 patent.
`
`A. The Legal Standards for Anticipation and Obviousness
`
`Ocular challenges all claims of the ‘082 patent as anticipated under 35
`
`U.S.C. § 102, obvious under U.S.C. § 103, or both. “A claim is anticipated only if
`
`each and every element as set forth in the claim is found, either expressly or
`
`inherently described, in a single prior art reference.” Verdegaal Bros. v. Union Oil
`
`Co. of California, 814 F.2d 628, 631 (Fed. Cir. 1987). A claim is obvious when
`
`the differences between the claim and the prior art are such that the claim as a
`
`ME1 28528752v.3
`
`14
`
`

`

`
`
`Patent No. 9,849,082
`
`
`
`Attorney Docket No. 129285-00013
`
`whole would have been obvious at the relevant time to a person having ordinary
`
`skill in the art to which claim pertains. KSR International Co. v. Teleflex Inc., 550
`
`U.S. 398, 406 (2007).
`
`In KSR, the Supreme Court confirmed the framework for analyzing
`
`obviousness originally stated in Graham v. John Deere Co. of Kansas City, 383
`
`U.S. 1 (1966). Specifically, “[u]nder §103, the scope and content of the prior art
`
`are to be determined; differences between the prior art and the claims at issue are
`
`to be ascertained; and the level of ordinary skill in the pertinent art resolved.
`
`Against this background the obviousness or nonobviousness of the subject matter
`
`is determined.” KSR, 550 U.S. at 406, quoting Graham, 383 U.S. at 17-18.
`
`B.
`
`The Scope And Content of The Prior Art
`
`
`
`The use of implants to temporarily block tear drainage and thus treat dry eye
`
`has been known since at least the early 1960s. See Ex. 1020, Baxter et al., Punctal
`
`Plugs in the Management of Dry Eyes, 2 THE OCULAR SURFACE at 1(October 2004)
`
`(“Baxter”) (summarizing the history of punctal plugs and state of the art as of
`
`2004); see also Ex. 1036, Dana Decl., ¶ 31. For example, as recounted in Baxter,
`
`in 1961, Dr. Foulds developed and described the first punctal plugs for treating dry
`
`eye. Ex. 1020, Baxter, 1. As depicted in Figures 1 and 2 from the Foulds
`
`reference itself (copied below), these punctal plugs were cylindrical gelatin rods
`
`inserted through puncta to temporarily block the canaliculi:
`
`ME1 28528752v.3
`
`15
`
`

`

`
`
`Patent No. 9,849,082
`
`
`
`Attorney Docket No. 129285-00013
`
`
`
`
`
`
`
`
`
`
`Ex. 1021, Foulds, Intra-Canalicular Gelatin Implants in the Treatment of Kerato-
`
`
`
`Conjunctivitis Sicca, 45 BRIT J. OPHTHAL. 3,4 (1961).2
`
`2 “[T]he Board may consider a prior art reference to show the state of the art at the
`
`time of the invention, regardless of whether tha