Mati Therapeutics, Inc.

Patent Trials and Appeals Board

Jun 18, 2020

IPR2019-00448 (P.T.A.B. Jun. 18, 2020)

Trials@uspto.gov Paper 56
571.272.7822 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

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I. INTRODUCTION
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.
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II. BACKGROUND
A. 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.
B. 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.[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.
C. THE ’082 PATENT
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.
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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.
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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.
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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:
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“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.
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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.
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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.
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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 1–7, 9–16, 18–20, 22–23 102 Pritchard4
2 1–7, 9–16, 18–20, 22–23 103(a) Pritchard, Gillespie5
3 8, 17, 21 103(a) Pritchard, Gillespie, Hellberg6
4 1–7, 9–16, 18–20, 22–23 103(a) Pritchard, Handbook7
5 8, 17, 21 103(a) Pritchard, Handbook, Hellberg

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”).
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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.
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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.
F. PRITCHARD
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
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(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
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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
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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
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safe and efficacious delivery vehicle for TIMOLOL
(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.”).
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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
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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,
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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.
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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.
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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.
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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 ophthalmic inserts,” Pet. at 26-27), to the extent Petitioner
agrees to clarify the definition as follows: an ophthalmologist
with several years of experience in the design, development,
and/or study of drug delivery ophthalmic devices.
PO Resp. 16 (citing Williams Declaration, Ex. 2014 ¶ 20) (emphasis added).
The two proposed definitions (or clarification) of the skilled artisan
are very similar. The scope of Petitioner’s definition encompasses Patent
Owner’s clarification because a skilled artisan experienced in both drug
delivery devices and ophthalmic inserts would necessarily have experience
with drug delivery ophthalmic devices as a subset of such things, thus
making the clarification unnecessary. In addition, Petitioner’s definition is
consistent with the evidence of the ordinary level of skill conveyed by the
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disclosure of the ’082 patent and cited prior art. 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)). Therefore, we agree with and adopt Petitioner’s
proposed definition of the person of ordinary skill in the art set forth above.
However, our decision would not be effected by or change based on which
of the party’s definitions we used herein.
Petitioner cites the Dana Declaration’s paragraphs 23–27 as
supporting the above-discussed definition of a person of ordinary skill in the
art. Pet. 26–27. This portion of Dr. Dana’s Declaration identifies and
discusses the “relevant art” for the invention claimed in the ’082 patent, as
of March 31, 2006, as including hydrogel polymer technology, therapeutic
agent technology, the treatment of ocular conditions, and the use of drug-
delivering implants for such uses. Ex. 1036 ¶¶ 23–27. “The person of
ordinary skill in the art is a hypothetical person who is presumed to know
the relevant prior art,” which, as discussed above in relation to the cited prior
art asserted against the claims and other prior art discussed by the parties and
their witnesses, includes these various, related technologies. In re GPAC
Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). Petitioner makes this point
directly, and by implication in discussing the general knowledge in the prior
art, throughout its Petition and Reply. Pet. 16 (n.2), 17–27; Pet. Reply, 1–2,
8–9, 19–21. The technologies addressed by Dr. Dana as the relevant art,
which would have been known to and a part of the experience of the person
of ordinary skill in the art, are not strictly or narrowly directed to only
ophthalmology. Petitioner further asserts that the person of ordinary skill in
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the art, if (or although) not a chemist, would rely on a chemist, such as an
experienced formulator. Pet. Reply 9–10 (citing Ex. 1052, generally;
Ex. 1043, 12:3–13:1, 36:15–37:1, 167:15–168:7, 224:23–226:2
(Dr. Williams’s deposition testimony on collaboration between
ophthalmologists and chemists)). Thus, we also note that the person of
ordinary skill in the art would not have functioned in isolation in designing
or developing a punctal plug that includes a therapeutic agent, but would
likely have been a part of a multidisciplinary team, including a consulting
chemist, and the skilled artisan’s “experience in the design[] [and]
development” of such drug delivery systems and/or ocular inserts would
have included knowledge of such relevant prior art. See Ex. 1043 (as cited
in Pet. Reply, 9–10) 8:8–13:5, 36:15–37:1 (Dr. Williams testifying that an
ophthalmologist would have worked with a team, including a chemist, to
develop a drug delivery device); Ex. 2014 (as cited in Pet. Reply, 2; PO
Resp. 1, 16, 59) ¶¶ 36, 111 (POSA designers of drug-releasing punctal plugs
would have to account for the physiochemical properties of the selected drug
molecule), Exhibit A (Dr. Williams has a degree in Chemistry); Ex. 1052 (as
cited, generally, in Pet. Reply, 10) ¶¶ 18–23 (Dr. Lowman discussing
interactions between ophthalmologists and chemists in developing drug-
delivering ocular inserts). As described by Dr. Dana, the relevant art to the
’082 patent’s invention included anatomy of the eye, treatment of ocular
conditions, pharmaceuticals and drug delivery, materials science and
polymer chemistry, and ocular inserts like punctal plugs. Ex. 1036 (as cited
in Pet., 6, 9, 17–27) ¶¶ 28–45; see also Ex. 2014 ¶¶ 26–36 (Dr. Williams
testifying to the same or similar technical background relating to the
invention and development of punctal plugs).
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Thus, we find the skilled artisan, i.e., an ophthalmologist with several
years of experience in the design, development, and/or study of drug
delivery devices and/or ophthalmic inserts, would have had access to the
relevant knowledge of, inter alia, a chemist relating to her experience in the
design, development, and/or study of drug delivery devices and/or
ophthalmic inserts, as a part of such experience, as these are the type of
problems or issues encountered in the art by active workers in the field and
would bring such experience and knowledge to bear in developing a punctal
plug as claimed. Custom Accessories, 807 F.2d at 962.
It is from the perspective of such a person of ordinary skill in the art,
as defined above, that we consider and analyze the claims of the ’082 patent,
the prior art, and the issues of patentability discussed below.
B. CLAIM CONSTRUCTION
Based on the filing date of the Petition (Dec. 14, 2018), the Board
interprets claim terms in an inter partes review using the same claim
construction standard that is used to construe claims in a civil action in
federal district court. 37 C.F.R. § 42.100(b) (2019).
In construing claims, district courts give claim terms 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,
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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)).
Any special definition for a claim term must be set forth in the
specification with reasonable clarity, deliberateness, and precision. In re
Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). Without such a special
definition, however, limitations may not be read from the specification into
the claims. In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993).
Other than the claim language addressed below, no claim terms need
be addressed or require express construction. See Vivid Techs., Inc. v. Am.
Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms
need be construed that are in controversy and only to the extent necessary to
resolve the controversy.”).
Distinguishing Color to Show
The claim language “distinguishing color to show” appears in each of
the independent claims, i.e., claims 1, 11, and 18, of the ’082 patent.
Ex. 1001, 30:20–27, 30:51–58, 31:8–17.
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:
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Petitioner’s construction of “distinguishing color to show”
to mean “a color that improves visibility” (Pet. at 10-11) renders
an otherwise unambiguous phrase ambiguous. It is unclear what
“improves” – a term of degree – means. Also, the construction
omits what it means to be “distinguishing.” The phrase, in full
context, “a distinguishing color to show placement of the system
in the lacrimal canaliculus of the patient” as it appears in the
claims, is unambiguous and needs no construction. In other
words, what makes a color “distinguishing” is that it “show[s]
placement of the system in the lacrimal canaliculus of the
patient,” as expressly recited by the claim. EX1001, claim 1.
The claim language is clear.
PO Resp. 25–26 (emphasis added). Patent Owner further asserts that
There is clear support in the specification for this phrase.
Ex. 1001, 20:67-21:5, Pet. at 11. In view of the claim language
and the express teachings of the de Juan [’082 patent’s]
specification, it is clear that “a distinguishing color to show the
placement” must contrast the implant from the surrounding
tissue of the canaliculus. Ex. 1001, 20:67-21:5, claim 1. A
POSA applying the ordinary meaning would fully ascertain
proper claim scope.
Id. at 26.
We found it unnecessary to construe “distinguishing color to show” at
the institution stage of this proceeding because we initially determined this
claim language to be readily understandable on its face to the person of
ordinary skill in the art, within the context of the claims and Specification.
Institution Decision 10–11. To the extent necessary to resolve any
controversy involving that claim language, we further discuss its meaning
here.
Petitioner asserts that ‘“placement . . . in the lacrimal canaliculus’
encompasses the act of placing the system,” meaning moving the punctal
plug into the lacrimal canaliculus, such that Petitioner’s above-noted
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definition regarding improving visibility includes enhanced visibility of the
punctal plug in any circumstance. See, e.g., Pet. Reply 6; Hr’g Tr. 15:13–26
(arguing “placement means the act of placing, the act of inserting
something”); see also Ex. 1036 ¶ 52 (describing a change from clear and
colorless to a light straw color as making the plug easier to see). Patent
Owner, on the other hand, asserts that merely comparing a clear and
colorless device to a device having a color does not establish whether the
color is distinguishing to show placement of the device in the lacrimal
canaliculus because the surrounding tissue must be the context when
considering the color. See, e.g., PO Sur-reply 16–17; Hr’g Tr. 20:18–19
(arguing “in order to be distinguishing, it has to be distinguishing with
respect to the tissue in which it is inserted.”). Therefore, a dispute remains
and clarification is warranted.
We maintain our finding that the claim term “distinguishing color to
show” carries its ordinary meaning as it would have been understood by the
person of ordinary skill in the art. However, in the context of the claim and
in view of the Specification, this claimed color distinguishes “to show
placement of the system in the lacrimal canaliculus of the patient.”
Ex. 1001, 30:22–24. Regarding the coloring of a punctal implant (the
claimed system), the Specification states only that the “distinguishing color[]
. . . show[s] 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 21:2–5 (emphasis added). Thus, the
only “placement” that is described in the Specification is the position of the
implant in the eye, not the act of placing it there, as the only viewer
described as needing to see the implant placement is a patient, who would
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not be a person actively implanting the device, but would only view it once
it was placed in the eye.
Therefore, we agree with Patent Owner’s position, particularly when
considering the claim language within the context of the entire claim and the
relevant description in the Specification. The plain and ordinary meaning of
the full clause “a distinguishing color to show placement of the system in the
lacrimal canaliculus of the patient” is that the color must show the system as
it sits in the lacrimal canaliculus of the patient.
Sheath Body
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
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 [’082 patent] specification, a POSA
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. . . . Accordingly, as the Board agreed, Petitioner’s
proposed construction is unnecessary.” PO Resp. 26–27. Therefore, Patent
Owner argues no construction is necessary. Id.
We find it unnecessary to construe “sheath body,” because this claim
language is readily understandable on its face, within the context of the
claims and Specification, to the person of ordinary skill in the art.
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Other Claim Construction Disputes
The only claim terms the parties expressly assert require consideration
for interpretation are the two addressed above. However, over the course of
opposing the patentability challenge, Patent Owner asserts that the claims
require (1) “intracanalicular placement” of the claimed system (meaning the
device is implanted subpunctally, with no outwardly exposed surface once
placed; applies to all claims), (2) “sustained release of the drug at the desired
therapeutic level for an extended period of time” (applies to all claims),
(3) the claimed distinguishing color be “retained” or “lasting” (applies to all
claims), and (4) that the recited functional groups (applies to claims 9 and
22) “provide the desired solubility of the therapeutic agent in the matrix.”
See PO Resp. 1, 2, 12–14, 19, 20, 40–45, 47, 50, 58. Patent Owner contends
the claims are distinguishable over Petitioner’s prior art based on these
requirements. Id.
Petitioner argues that Patent Owner is attempting to improperly
import the above-identified limitations into the claims. Pet. Reply 1–8.
Petitioner argues that the claims do not require a sustained release at the
desired therapeutic level for an extended period of time because the
limitation is not recited and the Specification describes drug release as
potentially “a relatively short period of time, for example minutes or hours
. . . through days or weeks . . . or longer.” Id. at 3 (citing Ex. 1001, 23:59–
63). Petitioner argues that lasting color is not recited in the claims and
“[n]owhere does the ’082 patent teach that color must endure under all
conditions.” Id. at 3–4 (citing Ex. 1043, 137:21–138:3, 138:21–139:4
(Dr. Williams testifying that the ’082 patent does not teach how to make a
plug with lasting and distinguishing color). Petitioner argues the claims do
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not require placement of the system wholly within the canaliculus, i.e.,
intracanalicular placement. Id. at 5–8. Petitioner argues that “the plain
meaning of [the claim language] ‘placement . . . in the lacrimal canaliculus’
encompasses the act of placing the system, as well as system locations both
wholly within and only partly within the lacrimal canaliculus.” Id. at 6.
Petitioner further argues that the ’082 patent never mentions or suggests
using transillumination to observe the distinguishing color of its plugs and a
patient, who would not use such a technique, would not be able to identify
any device wholly within the canaliculus if transillumination was the
intended means of distinguishing the claimed device. Id. at 7 (citing
Ex. 1001, 20:67–21:5; Ex. 1043, 20:67–21:51, 32:15–18, 34:7–10, 130:7–
131:19, 133:8–9). Petitioner does not discuss Patent Owner’s position on
“functional groups” in its Reply. See generally id.
In response to Petitioner’s arguments, Patent Owner asserts that it
merely argues the invention of the ’082 patent “allows for sustained release
of the drug,” rather than that it must provide it. PO Sur-reply 10 (emphasis
added). Regarding the “lasting” distinguishing color, Patent Owner states
that “the challenged claims do not specifically require the distinguishing
color to be lasting,” but then states that “[a] color that does not last for as
long as the device is in placement cannot be used to show placement, and
thus, would not satisfy the claim limitation.” Id. at 10–12 (citing Ex. 1043,
81:20–82:11). Regarding intracanalicular placement, Patent Owner argues
that the fact that the claims require “1) ‘a cylindrical rod,’ and 2) ‘for
insertion into a lacrimal canaliculus of a patient’” means that the claims
require “an intracanalicular or subpunctal plug, i.e., a plug that is wholly
placed within the canaliculus such that no externally exposed surface
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remains.” Id. at 12–13 (citing Ex. 1001, claim 1, 8:29–33, 9:47–10:3, 10:5–
10, 10:17–27, Figs. 1F, 1G). Countering Petitioner’s argument that the ’082
patent does not describe any way of seeing plugs other than by their
externally exposed parts, Patent Owner argues that the ’082 patent need not
have identified transillumination as a means of detecting its plugs because
such was a conventional, well-known technique and patients with ocular
conditions in need of punctal plugs often seek help from ophthalmologists.
Id. at 15. Patent Owner does not address the issue of functional groups in its
Sur-reply.
Having considered the parties’ arguments on these other claim
construction disputes and the intrinsic record, we conclude that Patent
Owner’s proposed claim interpretations are not supported by the record.
Regarding Patent Owner’s assertion that the claimed invention
requires “intracanalicular placement” of the system, this is not supported by
the claims themselves or the Specification. No claim states or even suggests
that the recited “drug delivery system” must be inserted entirely into a
lacrimal canaliculus, below the puncta. Ex. 1001, 30:20–31:29. Patent
Owner’s argument that the claims recite “a cylindrical rod” and “for
insertion into a lacrimal canaliculus” is not persuasive. Reading the plain
language of the claims, the drug delivery system includes “a hydrogel body
of material,” which “is a cylindrical rod,” and recites that the “system [is] for
insertion into a lacrimal canaliculus.” See, e.g., id. at 30:51–68. The entire
system is not required to be the cylindrical rod, but only some portion
holding the therapeutic agent. Moreover, even were the entire system
cylindrical-rod-shaped, it is not apparent from Patent Owner’s arguments
why this would necessitate that it be placed wholly subpunctally. The
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claims simply do not recite subpunctal insertion or complete insertion or
intracanalicular insertion, or anything hinting that such is required.
Reading the claim language in view of the Specification further
confirms our conclusion. The Specification does not use the terms
“intracanalicular” or “subpunctal,” or any variants thereof. See generally
Ex. 1001. The Specification describes several embodiments of punctal plugs
having complex shapes with only a portion being a cylindrical rod, and
embodiments of punctal plugs intended to have portions remaining exposed
at or above the puncta when implanted. See, e.g., id. at 2:38–41 (the device
may have a flange to retain it near the punctum, the retention structure may
fit partially within the canalicular lumen), 4:1–9 (only a distal end of the
implant is inserted into the punctum, therapeutic agent delivered from a
proximal end of the implant to the tear fluid adjacent the eye), 5:19–22,
5:51–61, 6:42–50, 6:58–7:2, 10:11–27, 12:22–13:15, 17:45–19:25, Figs. 1G,
2I–2K, 9D, 9E, 10A–10C, 11. Nowhere in the claims or Specification are
such embodiments excluded from the invention.
Moreover, the claims require a distinguishing color, which we
concluded above means that the color must show the system as it sits in the
lacrimal canaliculus of the patient. The only mention of such a color in the
Specification is a single sentence, which describes this distinguishing color
as readily detected by the patient. Id. at 20:66–21:5. It makes no sense for
the claim’s scope to at once encompass such ready visual detection by a
patient and then also require that the device to be readily detected is entirely
below the surface of the tissue, hidden from plain view, and requires
technical equipment to detect.
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Again, “while it is true that claims are to be interpreted in light of the
specification . . . , it does not follow that limitations from the specification
may be read into the claims. . . . [T]he claims define the invention.”
Sjolund, 847 F.2d at 1581–82. Here, although there may be embodiments
described in the Specification where a plug is implanted entirely within the
canaliculus, i.e., intracanalicularly, this is neither recited by the claims nor
identified in the Specification as a requirement and, as noted, there are
described embodiments where it does not occur (for example, the
embodiments illustrated at Figs. 1G, 2I, 2K, 9D (Ex. 1001)). Thus, we will
not read a limitation into the claims that is not therein-recited or otherwise
clearly required.
The claims also do not require “sustained release of the drug at the
desired therapeutic level for an extended period of time.” As noted above,
Patent Owner softened its position that this is a claim requirement. PO Sur-
reply 10. No claim recites “sustained release” or that drug release must
reach a “therapeutic level,” although the latter may be implied by certain
claims (e.g., 4, 13, 19) that recite that the drug delivery system is “used to
treat” a condition, such as glaucoma. Ex. 1001, 30:20–31:29. Furthermore,
the Specification does not support that the claims require “sustained release”
of a drug. The Specification states that the “extended period of time” for
drug release of the invention “may mean a relatively short period of time, for
example minutes.” And, the Specification further describes “[i]t is also
within the scope of this invention to modify or adapt the devices to deliver a
high release rate, a low release rate, a bolus release, a burst release, or
combinations thereof.” Id. at 25:66–26:1. Thus, it is apparent that the
claims are not limited to a “sustained release of the drug at the desired
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therapeutic level for an extended period of time,” for more than mere
minutes, if even that long.
The claims also do not require that the recited distinguishing color be
“retained” or “lasting.” There is nothing in the claims themselves that
indicates the system’s color must be retained or last for any period of time.
The Specification describes the invention’s coloring in only a single
sentence, which does not mention how the color is applied, what the color
may be or how it is achieved, and certainly does not indicate that it must last.
Id. at 20:67–21:5. The Specification merely indicates that the
“distinguishing color . . . 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. Contrary to Patent
Owner’s arguments, there is nothing in the intrinsic record indicating that a
plug’s coloring must have some lasting quality. As with the other claim
language discussed above, we will not read such a limitation into the claims.
The claims also do not require that the recited functional groups
(claims 9 and 22) specifically “provide the desired solubility of the
therapeutic agent in the matrix.” Claims 9 and 22 recite that the hydrogel
polymers of the independent claims “comprise functional groups,” but do
not state any structure for such functional groups nor any specific function
for these groups. Ex. 1001, 30:46–47 (claim 9), 31:25–26 (claim 22).
The description of functional groups in the Specification is, “[f]or
example, the core can comprise hydrogel that may promote solubility of
hydrophilic treatment agent. In some embodiments, functional groups can
be added to the polymer to provide the desired solubility of the therapeutic
agent in the matrix. For example, functional groups can be attached to
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silicone polymer.” Id. at 27:26–32. This is neither an explicit nor implicit
definition of the term functional groups, but rather identifies embodiments
of the invention where functional groups provide the desired solubility of the
therapeutic agent in the polymer matrix. See Vitronics Corp. v.
Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) (“The specification
acts as a dictionary when it expressly defines terms used in the claims or
when it defines terms by implication.”).
Patent Owner’s expert, Dr. Williams, testified at deposition that “the
phrase ‘functional group’ [is not] a special technical term” and means “[a]
group with a function,” and does not imply or require any particular
function. Ex. 1043, 40:7–41:8. Dr. Williams more specifically testified that
he agreed that, and the person of ordinary skill in the art would have
understood that, the term “functional group” was not limited to providing a
desired solubility of a therapeutic agent in a matrix nor would have any other
special meaning. Id. at 41:9–42:13; cf. Ex. 2014 ¶ 73 (Dr. Williams stating
that the ’082 patent defines functional groups as groups to provide the
desired solubility of the therapeutic agent in the matrix.).
Thus, although the ’082 patent’s Specification identifies a type of
functional group, which would certainly be within the scope of claims 9 and
22, it does not define the term. And, the claims do not state that the recited
functional groups serve any specific purpose nor state their structure.
Moreover, the term functional groups has no special meaning. Therefore,
we do not interpret the claim term functional groups as asserted by the
Patent Owner, but accord the term its ordinary and customary meaning as it
would have been understood by the person of ordinary skill in the art, which
according to Dr. Williams would be a (chemical) group that provides a
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function. See Ex. 1043, 41:18–42:2. Again, we will not import limitations
from the Specification into the claims. Sjolund, 847 F.2d at 1581–82.
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)).
Microsoft Corp. v. Biscotti, Inc., 878 F.3d 1052, 1068 (Fed. Cir. 2017). 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,
811 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
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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
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.12 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. “[C]ase law
is clear that obviousness cannot be avoided simply by a showing of some
degree of unpredictability in the art so long as there was a reasonable
probability of success.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364
(Fed. Cir. 2007). “Reasonable expectation of success is assessed from the
perspective of the person of ordinary skill in the art.” Life Techs. Inc. v.
Clontech Labs. Inc., 224 F.3d 1320, 1326 (Fed. Cir. 2000).
With these standards in mind, we address the parties’ arguments and
the evidence of record below.

12 No arguments directed to nor evidence of objective indicia of non-
obviousness are of record in this case.
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D. CLAIMS 1–7, 9–16, 18–20, AND 22–23 – OBVIOUSNESS OVER
PRITCHARD AND GILLESPIE (GROUND 2)
Petitioner challenges claims 1–7, 9–16, 18–20, and 22–23 as obvious
over the prior art combination of Pritchard and Gillespie. 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, and identifies how and why Pritchard teaches
every element of the claims. 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). Petitioner’s premise for combining
Pritchard and Gillespie is that, “to the extent that Pritchard’s express and
inherent disclosure of color is somehow deemed an insufficient disclosure of
the “distinguishing color to show” limitation, then Claims 1–7, 9–16, 18–20,
and 22–23 are obvious over Pritchard in view of Gillespie.” Pet. 61. As
discussed below, we conclude claims 1–7, 9–16, 18–20, and 22–23 would
have been obvious over the prior art combination of Pritchard and Gillespie.
Petitioner asserts that the person of ordinary skill in the art would
have been motivated to combine Gillespie’s teachings with Pritchard’s
punctal plugs because Gillespie teaches that it is desirable to “enable a plug
to be more easily visualized following insertion” because, normally, such
plugs are “very difficult to see” because they are “extremely small” and may
be “translucent.” Id. at 61–63 (citing Ex. 1015 ¶¶ 1, 5–7, 11, 13; Ex. 1036
¶¶ 73–77). Petitioner asserts that the person of ordinary skill in the art
would have pigmented Pritchard’s punctal plugs per Gillespie’s teachings to
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make them easier to see, use and locate, thus mitigating “one of the most
common problems of these inserts.” Id. at 63 (citing Ex. 1036 ¶ 78).
Petitioner also asserts that Gillespie evidences that the person of
ordinary skill in the art would have been able to successfully make this
combination and pigment either part or all of the Pritchard plugs because
Gillespie states that, other than the substance used to cause the plug to be
more easily visualized, “the rest of the plug body may be composed of any
suitable material, including those presently used in the manufacture of such
devices.” Id. at 62–63 (citing Ex. 1015 ¶ 6).
We find Petitioner’s positions on motivation for combining Pritchard
and Gillespie, as well as the expectation of successfully doing so, persuasive
and supported by the evidence. Gillespie unambiguously teaches that it is an
advantage to color punctal plugs so that they contrast with the surrounding
tissue once implanted and that such coloring may be added to “any suitable
material, including those presently used in the manufacture of such devices,”
i.e., punctal plugs. Ex. 1015, Abstract, ¶¶ 1–56.
Regarding the expectation of success, Petitioner’s evidence
establishes that adding color to a drug-containing, hydrogel punctal plug
would have been expected to succeed. Punctal plugs had been known and
used as medical devices since the early 1960s. Pet. 15 (citing Ex. 1020;
Ex. 1036 ¶¶ 31, 36). Punctal plugs that hold and deliver medications had
also been well-known for decades preceding the ’082 patent. Id. at 16–19
(citing Ex. 1036 ¶ 32; Ex. 1024; Ex. 1025).13 Petitioner’s expert, Dr. Dana,

13 Although these cited references are not a part of the prior art combinations
cited in the challenges against the ’082 patent’s claims, they are cited by
Petitioner in the Petition and in Petitioner’s expert’s declaration as
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testified that swellable, rod-like hydrogel plugs, like Pritchard’s HEMA and
gellan plugs, had been well-known and commercially successful for decades
prior to the ’082 patent. See Ex. 1036 ¶¶ 32–40 (citing Ex. 1020; Ex. 1022;
Ex. 1023; Ex. 1026; Ex. 1027); see also Pet. 19–21. As of Gillespie’s filing
(May 10, 2001) and publication (November 14, 2002) dates, it was also
well-known that the “Freeman” style of “true punctal plugs” (which
Ex. 1020 (Baxter), Ex. 1022 (Freeman ’750), and Ex. 1023 (Freeman ’063)
confirm were made of hydrogel materials) were available “in all different
shapes, surface profiles, sizes, colors and inserter devices, depending on
your preference and dexterity.” Ex. 1028, 10; see also Pet. 23–24; and
Ex. 1036 ¶¶ 32–45 (discussing the known materials, including colorants, for
ocular inserts, further citing, inter alia, Ex. 1029 (drug-releasing, swellable,
colored capsule for treatment of the eye), Ex. 1030 (ocular inserts of bio-
erodible, swellable, hydrophilic, dexamethasone-containing, colored
material), and Ex. 1031 (colored, bioactive-drug-containing, hydrogel
devices for temporarily occluding a body lumen).
Petitioner’s evidence establishes that the art of punctal plugs, as well
as the use of hydrogels, therapeutic agents, and colorings therein, was
mature as of the ’082 patent. Thus, we are persuaded that the skilled artisan
would have reasonably expected to successfully color the HEMA or gellan
hydrogel, drug-containing, plugs of Pritchard with a colorant, as taught by

evidencing the state of the art and common knowledge (of the skilled
artisan) in the years preceding the ’082 patent’s claims. Genzyme
Therapeutic Prods. Ltd. Partnership v. Biomarin Pharma. Inc., 825 F.3d
1360, 1369 (Fed. Cir. 2016) (citing Ariosa Diagnostics v. Verinata Health,
Inc., 805 F.3d 1359, 1365 (Fed. Cir. 2015) (the Board should, and may be
required to, consider such evidence)).
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Gillespie. Pritchard’s plugs were “suitable material[s]” and, specifically,
materials that were, then, “presently used in the manufacture of” punctal
plugs, as taught by Gillespie. See Ex. 1015 ¶ 6.
Patent Owner presents several arguments alleging reasons why a
person of ordinary skill in the art would not have combined Gillespie and
Pritchard.
Patent Owner first argues that Gillespie is limited to “chemically inert
materials,” e.g., silastic rubber; therefore, it would not have been obvious to
combine its teachings with those of Pritchard directed to hydrogel materials.
PO Resp. 48–50 (citing Ex. 1015 ¶ 5; Ex. 2014 ¶ 89). Patent Owner argues
“Gillespie is completely silent with regards to the use of hydrogel polymers,
or any ‘controllably swellable materials.’” Id. For these reasons, Patent
Owner argues Petitioner failed to show there was an apparent reason to
combine the references and the person of ordinary skill in the art would not
have had a reasonable expectation of success.
This argument is not persuasive because Gillespie is clear that it is not
limited to only chemically inert materials or to silastic rubber. See, e.g., Pet.
62; Pet. Reply 19. Gillespie expressly states that a substance can be
provided to a punctal plug
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 rest of the plug body may be
composed of any suitable material, including those presently
used in the manufacture of such devices.
Ex. 1015 ¶ 6. As of Gillespie’s filing and publication dates, i.e., the date
where a survey of the punctal plug field would be made to ascertain what
materials Gillespie intended to include in such a statement, it was well
known that punctal plugs were made of hydrogel and included coloring
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agents, along with therapeutic agents such as dexamethasone. See, e.g.,
Ex. 1020, 255–56, 264 (disclosing “Freeman” plugs published in 1975 and
plugs of hydrogel); Ex. 1022, Abstract, 1:8–5:15 (Freeman ’750 disclosing,
in 1974, punctal plugs shaped similarly to Pritchard’s, made of HEMA
hydrophilic polymer, impregnated with medication); Ex. 1023, Abstract,
(Freeman ’063 disclosing, in 1992, swellable punctal plugs shaped very
similarly to Pritchard’s, composed of hydrogel material); Ex. 1026, Abstract,
¶¶ 8, 34, 36 (disclosing punctal plugs made of hydrogel); Ex. 1029, Abstract,
2:25–4:61 (disclosing in 1974 ocular implants, colored to facilitate location,
which are made of a gel which swells upon contact with tears); see also Pet.
15–27 (discussing this background of the relevant art). This is all
knowledge the skilled artisan would have brought to bear on the
development of a punctal plug, as claimed in the ’082 patent. Patent
Owner’s own expert, Dr. Williams, testified at his deposition that hydrogel
plugs were known as of Gillespie’s date. Ex. 1043, 197:1–198:16.
Petitioner’s expert witness, Dr. Dana, discussed these well-known
features of punctal plugs and the state of the art in his declaration, which
accompanied and was cited in the Petition. See Pet. 15–26; Ex. 1036 ¶¶ 31–
45. Dr. Dana opined that the skilled artisan would have been motivated to
combine Gillespie’s colorings with Pritchard’s “extremely small” and
“difficult to see” punctal plugs to make them more easily visualized as
contrasting with the surrounding tissue.14 Ex. 1036 ¶¶ 74–78.

14 Patent Owner chose not to depose Dr. Dana during this proceeding;
therefore, his opinions are unrebutted by cross-examination.
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As rebuttal to Patent Owner’s arguments, Petitioner submits a
declaration from its second expert, Dr. Lowman.15 Ex. 1052; see Office
Patent Trial Practice Guide 83 Fed. Reg. 156 (update Aug. 13, 2018).
Dr. Lowman disagrees with Patent Owner’s position and states that Gillespie
is not limited to coloring silastic rubber devices, but confirms that “any
suitable material, including those presently used in the manufacture of”
punctal plugs, such as hydrogel, could be colored per Gillespie’s teachings.

15 Dr. Lowman was provided as, and is here considered, only as a rebuttal
witness. See Pet. Reply. Petitioner proffers Dr. Lowman as a drug delivery
and hydrogel expert. Id. at 4. Dr. Lowman professes to be and we find him
to be an expert in such matters. See Ex. 1052 ¶¶ 1–15; Ex. 1053. Patent
Owner argues Dr. Lowman is not a person of ordinary skill in the art, i.e., is
not an ophthalmologist, but does not contest his knowledge or expertise in
the matters of hydrogels or drug delivery. PO Sur-reply 3–4. Patent Owner
also argues Dr. Lowman’s opinions are proffered by Petitioner to fill gaps in
the challenges made in the Petition. Id. at 5. Whether or not Dr. Lowman is
a person of ordinary skill in the art is immaterial to whether we consider his
opinions on the subjects of his expertise. A person need not be a person of
ordinary skill in the art in order to testify as an expert under Rule 702, but
rather must be “qualified in the pertinent art.” Sundance, Inc. v. DeMonte
Fabricating Ltd., 550 F.3d 1356, 1363–64 (Fed. Cir. 2008). Dr. Lowman’s
opinions in rebuttal concerning hydrogels and drug delivery are relevant
here and are considered as they apply to Patent Owner’s arguments.
Dr. Lowman is a chemist and, as discussed at Section III.A above, the
person of ordinary skill in the art would have consulted such a chemist in
developing a punctal plug. See Ex. 1052 ¶¶ 21–23. There is no requirement
of a perfect match between the expert’s experience and the relevant field.
SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010).
We disagree with Patent Owner’s assertion that Petitioner has “back-filled”
and conclude the evidence set forth by the Petition and the opinions of
Dr. Dana are sufficient for Petitioner to carry its burden of showing the
claims are unpatentable under Grounds 2 and 3.
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Ex. 1052 ¶ 77; see also Pet. Reply 19 (discussing this portion of the
Lowman Declaration). Dr. Lowman further opined that
When Gillespie discloses “the plug body may be composed of
any suitable material, including those presently used in the
manufacture of such devices,” one familiar with the relevant art
would understand that suitable materials include hydrogel
forming materials then used in the manufacture of punctum
plugs. In other words, Gillespie contemplates a punctal plug
made of hydrogel polymers.
Id. In view of the evidence cited and discussed by Dr. Dana and the
Petition, we find Dr. Lowman’s declaration rebuts Patent Owner’s argument
and further supports the conclusion that Gillespie taught or suggested
coloring hydrogel plugs and that coloring would have been expected to be
successful.
Patent Owner further argues that, even were Pritchard and Gillespie
combined, there would have been no reasonable expectation that the color
would be “sufficiently retained.” PO Resp. 50–51. Patent Owner argues
that Pritchard’s light straw color was not retained in its gellan, which calls
into question whether Gillespie’s coloring could be applied. Id. (citing
Ex. 2014 ¶ 93).
As an initial matter, the claims do not require that the recited
“distinguishing color” be lasting or retained for any period of time. See
supra Section III.B regarding Other Claim Construction Disputes.
Therefore, Patent Owner’s argument, on the whole, is not persuasive.
Moreover, the evidence indicates that hydrogel materials such as
gellan can sustain color and that this quality would have been understood by
the person of ordinary skill in the art. Ex. 1043, 116:12–14 (Dr. Williams
testified that “[a] person of ordinary skill in the art would be led to believe
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that certain hydrogels could sustain color.”). Dr. Lowman states in his
declaration that “[a]n experienced formulator,” i.e., a chemist, who would be
consulted by and would have contributed to the knowledge of the person of
ordinary skill in the art, “would have known that hydrogels can be designed
to sustain color until they have degraded.” Ex. 1052 ¶ 58; see also Pet.
Reply, 9–10 (generally citing the Lowman Declaration for this point), 14
(citing this paragraph, specifically). Dr. Lowman states that “Pritchard
discloses exemplary hydrogel devices that certainly maintain their color.”
Id. ¶ 60 (citing Ex. 1010, claim 1, claim 13, ¶¶ 138, 140); see also Pet.
Reply, 4–5 (discussing color retention). Thus, for these reasons, as well,
Patent Owner’s argument is not persuasive.
Patent Owner next argues that Gillespie’s teachings are not applicable
to drug-delivering punctal plugs. PO Resp. 51–55. Patent Owner concedes
that “[i]t was well known that many coloring agents could be used to
visually alter the appearance of a medicinal product,” but argues the
Handbook teaches that there were limitations to such uses because of
possible stability or toxicity issues of some color agents. Id. (citing
Ex. 1016, 22–24; Ex. 2014 ¶ 95). Patent Owner argues Gillespie is simply
not related to drug delivery and that some coloring agents, e.g., fluorescein,
are known to interact with 58 drugs, such as dexamethasone, and methylene
blue interacts with 177 drugs. Id. at 53–54 (citing Ex. 2005; Ex. 2016;
Ex. 2017; Ex. 2014 ¶ 98). Patent Owner argues that Pritchard’s therapeutic
agent silver was known to degrade a range of dyes. Id. at 54–55 (citing
Ex. 2007; Ex. 2008; Ex. 2014 ¶ 99).
Patent Owner, thus, acknowledges that it was well known to color
medicinal products (no more would be required by the claims) and identifies
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that much was known about the potential limitations of using coloring agents
and combining coloring agents with drugs––the interactions of various
colors and drugs, the potential toxicities of certain colors, were understood.
This evidences a level of predictability in such combinations, not
unpredictability. The fact that some colors might not work is not evidence
of unpredictability in the art or that coloring would not work, generally.
“[O]bviousness cannot be avoided simply by a showing of some degree of
unpredictability in the art so long as there was a reasonable probability of
success.” Pfizer, 480 F.3d at 1364. Furthermore, irrefutable evidence in the
form of the Handbook, cited by both parties here, shows that a person of
ordinary skill in the art had at least dozens of coloring agents that were
generally regarded as safe to choose from when pigmenting a punctal plug,
as taught by Gillespie, that included a therapeutic agent, as taught by
Pritchard. See Ex. 1016.
As asserted by Petitioner (see Pet. Reply 21–24), Petitioner’s expert,
Dr. Lowman, points out that the claims merely require the presence of a
distinguishing color, not a “coloring agent,” thus, any specific concerns
about the interactions between coloring agents and therapeutic agents, as
argued by Patent Owner, is not wholly well-founded. Ex. 1052 ¶ 86, 90–93.
However, considering the circumstance where a distinguishing color is
achieved by supplying a coloring agent, for example the dyes or pigments of
Gillespie, Dr. Lowman states that color additives were well known at the
relevant time and routinely considered in combination with medicines. Id.
(citing Ex. 1044; Ex. 1046, 21; Ex. 2014, 73; Ex. 2025, 8); see also Pet.
Reply 4–5, 14, 19–23 (discussing coloring hydrogels and pharmaceuticals in
the prior art as routine and straightforward). Contrary to the opinion of
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Patent Owner’s expert, Dr. Williams, Dr. Lowman explains that formulating
a combination of a well-known drug that has been on the market for some
time and another agent such as a color was straightforward for the person of
ordinary skill in the art because the properties of the drug are known in
greater detail. Ex. 1052 ¶¶ 88, 91–93. Dr. Lowman states that
“[c]ompatibility is not a particular concern in follow-on formulations of
known drugs,” which are encompassed by the disclosure of Pritchard as well
as the ’082 patent and the scope of its claim term “therapeutic agent.” Id.
¶¶ 87, 89. Dr. Lowman indicates that the types of drugs contemplated by
Pritchard, for example, travoprost or dexamethasone (also Timolol), were
such well-understood drugs that would be the subject of such “follow-on”
formulations. Id. ¶¶ 88, 94–96.
Based on the analysis above, we conclude that Pritchard and Gillespie
would have been combined by the person of ordinary skill in the art, as
asserted by Petitioner, because there would have been motivation and a
reasonable expectation of success to do so. Having so concluded, we now
turn to Petitioner’s evidence that this prior art combination teaches or
suggests the limitations of the ’082 patent’s claims.
Claims 1, 11, and 18
As discussed above, Claims 1, 11, and 18 are the independent claims
of the ’082 patent and they are very similar to one another. See supra
Section II.C; see also Ex. 1001, 30:20––27 (claim 1), 30:51–58 (claim 11
has all the limitations of claim 1 and further requires that the claimed body
of material “swells when placed in the lacrimal canaliculus”), 31:8–17
(claim 18 has all the limitations of claim 1 and further requires that the
claimed “therapeutic agent [is] selected from an anti-glaucoma agent, a
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corticosteroid[,] an anti-microbial agent, and anti-allergy agent[,] or a non-
steroidal anti-inflammatory agent”). We will address the differences in these
claims in our analysis below, but both parties have addressed these claims
together in their contentions and arguments. See, e.g., Pet. 28–49, 57–64
(asserting the same, overlapping evidence for each independent claim); PO
Resp. 27–33, 37–41, 44–55 (arguing over common limitations, but not
distinguishing between independent claims). For these reasons, we also
address these claims together.
Claim 1, 11, and 18 each recites as a preamble “[a] drug delivery
system for insertion into a lacrimal canaliculus of a patient.” Ex. 1001,
30:20–21, 30:51–52, 31:8–9. Claims 1 and 18 follow this preamble
language with the open and inclusive transitional term “comprising” and
claim 11 uses the transitional term “consisting essential [sic] of,” however,
neither party asserts there is any difference between these two transitional
terms in view of the scope of the claims and the asserted prior art. CIAS,
Inc. v. Alliance Gaming Corp., 504 F.3d 1356, 1360 (Fed. Cir. 2007) (“In
the patent claim context, the term ‘comprising’ is well understood to mean
‘including but not limited to.’”); PPG Indus. v. Guardian Indus. Corp, 156
F.3d 1351, 1354 (Fed. Cir. 1998) (“By using the term ‘consisting essentially
of,’ the drafter signals that the invention necessarily includes the listed
ingredients and is open to unlisted ingredients that do not materially affect
the basic and novel properties of the invention.”).
Petitioner asserts that Pritchard teaches “[a] drug delivery system for
insertion into a lacrimal canaliculus of a patient” in disclosing canalicular
plugs to be placed into the punctal opening of the lacrimal duct and that such
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plugs can be used to deliver therapeutic agents to the eye.16 Pet. 28–29, 36–
37 (citing Ex. 1010 ¶¶ 2, 13, 14, 35, 37–39, 41, 43, 44, 131–132, Figs. 1, 3,
3A; Ex. 1012, 3; Ex. 1036 ¶ 49).
Addressing the claims’ next common element, Petitioner asserts
Pritchard teaches “a therapeutic agent” in disclosing that its punctal plugs
“may further comprise a therapeutic agent,” as well as disclosing several
specific examples of drugs that may be incorporated into and released by the
punctal plug. Pet. 28–29, 38 (citing Ex. 1010 ¶¶ 38, 43, 131–132, claims 11,
21, 37, 58, 70; Ex. 1012, 3; Ex. 1036 ¶ 50).
Independent claim 18 further defines the commonly claimed
therapeutic agent as “selected from an anti-glaucoma agent, a corticosteroid
an anti-microbial agent, an anti-allergy agent or a non-steroidal anti-
inflammatory agent.” Ex. 1001, 31:10–12. Petitioner asserts Pritchard
teaches this subject matter in disclosing the antimicrobial agents silver and
Triclosan, as well as “anti-glaucoma agents, beta blockers, prostaglandins,
corticosteroids, anti-fungal agents, antibiotics, [and] anti-inflammatories.”
Pet. 33–34, (citing Ex. 1010 ¶¶ 1, 44, 131, 132, 135; Ex. 1012, 5–15;
Ex. 1036 ¶¶ 62–67). The Pritchard ’368 provisional, incorporated by
reference in Pritchard, as cited by the Petitioner and Dr. Dana, specifically
discloses, inter alia, the corticosteroid anti-inflammatory agent
dexamethasone, the non-steroidal anti-inflammatory agent ibuprofen,
prostaglandin PGE1, the antifungal nystatin, the anti-glaucoma agents

16 “Generally, the preamble does not limit the claims.” Allen Eng’g Corp. v.
Bartell Indus., Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). Regardless of
whether the preamble is limiting here, Petitioner shows sufficiently that the
recitation in the preamble is satisfied by the prior art.
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timolol, latanoprost, and brimonidine, and the antibiotic agents triclosan and
cephalexin, each held in gellan hydrogel. Ex. 1012, 5–15.
Addressing the claims’ next common element, Petitioner asserts
Pritchard teaches “a distinguishing color to show placement of the system in
the lacrimal canaliculus of the patient” in disclosing that its hydrogel
material plugs can be a light straw color. Pet. 29, 38–39 (citing Ex. 1010
¶¶ 137–140; Ex. 1036 ¶ 51). Recognizing potential shortcomings in this
position, Petitioner also asserts that “to the extent that Pritchard’s express
and inherent disclosure of color is somehow deemed an insufficient
disclosure of the ‘distinguishing color to show’ limitation, then Claims 1–7,
9–16, 18–20, and 22–23 are obvious over Pritchard in view of Gillespie.”
Id. at 61. Petitioner asserts Gillespie teaches this limitation in disclosing a
punctum plug that is colored to make it more easily visualized after
insertion, that is, more readily visible or detectable to the recipient or
caregiver. Id. at 62 (citing Ex. 1015 ¶¶ 1, 5–7, 11; Ex. 1036 ¶¶ 73–75).
Petitioner asserts that Gillespie teaches that such coloring can be provided
by adding a substance such as fluorescent material, reflective beads,
quantum dots, dye, or pigment, which contrasts with surrounding tissue
when the plug is in place. Id. at 62–63 (citing Ex. 1015 ¶¶ 7, 11; Ex. 1036
¶¶ 76–78). Petitioner asserts that Pritchard and Gillespie would have been
combined by the person of ordinary skill in the art for the reasons set forth
above. Id. at 61–64.
Turning to the next common claim element, “a body of material to
hold the therapeutic agent wherein the body of material comprises hydrogel
polymers,” Petitioner asserts Pritchard discloses numerous hydrogel
polymers, teaches how to make them, discloses they are used as canalicular
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inserts, and discloses the hydrogel holds a therapeutic agent. Pet. 29–30,
39–45 (citing Ex. 1010 ¶¶ 29, 38, 43, 52, 58, 61, 62, 86, 102, 104, 131–132,
139, 152, claims 11, 21, 37, 57, 58, 70, Figs. 2A, 2B, 7A, 7B; Ex. 1012, 3,
45; Ex. 1036 ¶¶ 53–54). Petitioner also asserts Gillespie teaches that punctal
plugs have a body portion, which can be “any suitable material, including
those presently used in the manufacture of such devices.” Id. at 62–63
(citing Ex. 1015 ¶¶ 6, 7, 11).
Petitioner asserts that the next common claim element, “wherein the
body of material is a cylindrical rod,” is taught by Pritchard because it
discloses throughout that its inserts / punctal plugs are preferably cylindrical
in shape, depicts implants that are cylindrical in shape, and have bodies /
middle neck / waist portions that are cylindrical rods. Pet. 30–31, 45–49
(citing Ex. 1010 ¶¶ 30, 36, 55, 65, 66, 75, 77, 79, 119, 138, 140, 152, Figs.
2A, 2B, 7A, 7B; Ex. 1012, 3; Ex. 1036 ¶¶ 56–57).
Independent claim 11 further defines the commonly claimed
cylindrical rod body of material in that it “swells when placed in the lacrimal
canaliculus of the patient.” Ex. 1001, 30:56–58. Petitioner asserts Pritchard
teaches this additional claim element because it “extensively discloses this
phenomenon” and “emphasizes that numerous embodiments of the disclosed
canalicular plugs include ‘swellable devices that expand in volume in
response to lacrimal fluid,’” and in some embodiments they swell
anisotropically. Pet. 31–33, 54–58 (citing Ex. 1010 ¶¶ 8, 20, 22, 51–79,
156–161, Figs. 7A, 7B; Ex. 1036 ¶¶ 58–60).
Considering the claimed invention, as a whole, Dr. Dana opined that
“[t]o a person of ordinary skill in the art, using swellable hydrogel polymers
to construct cylindrical drug-eluting canalicular inserts for treating
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ophthalmic conditions would have been known and understood before the
‘082 Patent.” Ex. 1036 ¶¶ 38–45 (citing as background and common
knowledge Ex. 1026 ¶¶ 14, 15, 34, 41, 45; Ex. 1027, 5:21–35, 7:10–8:32,
9:18–47, 13:60–68; Ex. 1020; Ex. 1025, 6:18–40; Ex. 1028; Ex. 1029, 2:38–
40, 4:4–5; Ex. 1030; Ex. 1031, 4:20–23); see also Pet. 19–26 (citing the
Dana Declaration for the same reason and discussing this same background
of the technical field). Regarding Pritchard’s and Gillespie’s teachings,
Dr. Dana stated, “[i]n my opinion, a person of ordinary skill in the art—who
would, by definition, be familiar with this state of the art—would readily
understand that the claims of the ‘082 Patent were anticipated by Pritchard
or obvious based on Pritchard combined with Gillespie.” Ex. 1036 ¶ 46.
Dr. Dana opines:
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.
Id. ¶¶ 48–60 (citing the portions of Pritchard also cited by Petitioner, noted
above). Dr. Dana further stated that “[t]o the extent that more is needed to
show that the hydrogel canalicular inserts of Pritchard could have a
distinguishing color, then a person of ordinary skill in the art would be
motivated to combine Pritchard with . . . Gillespie.” Id. ¶ 74. Dr. Dana
states that Gillespie teaches “plugs and apparatus which enable a plug to be
more easily visualized following insertion” and “discloses that ‘[b]roadly,
this invention resides in punctum plug configurations which are more easily
visualized, preferably allowing the presence and position of the plug to be
seen by another person or by the recipient in a mirror.” Id. ¶¶ 74–76 (citing
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Ex. 1015 ¶¶ 1, 5, 11, 13). This is essentially the identical teaching of a
“distinguishing color” as made in the Specification of the ’082 patent.
Compare Ex. 1015 ¶ 11, with Ex. 1001, 20:67–21:5. Dr. Dana states that
Gillespie teaches that “the entire plug body[] is pigmented to constra[s]t with
surrounding tissue.” Ex. 1036 ¶ 76 (citing Ex. 1015 ¶ 11). Thus, Dr. Dana
has explained why Pritchard and Gillespie would have been combined by the
skilled artisan and how such a combination would work. See Pet. 61–64
(asserting the aforementioned portions of the Dana Declaration). Gillespie
itself indicates that its coloring would predictably work with hydrogel plugs,
as disclosed by Pritchard. Ex. 1015 ¶ 6.
Taking all of the above-referenced assertions and evidence into
consideration, we find that Petitioner has accounted for each element of
claims 1, 11, and 18, and the inventions claimed therein based on the
teachings and suggestions of Pritchard and Gillespie. As noted above,
Petitioner has likewise established that the person of ordinary skill would
have been motivated to make this prior art combination and would have had
a reasonable expectation of success in doing so.
Except for the claim element directed to “a distinguishing color to
show placement of the system in the lacrimal canaliculus of the patient,”
Patent Owner does not assert that Pritchard fails to teach or suggest any
limitation of claims 1, 11, and 18. See generally PO Resp.; see, e.g., id. at
31 (focusing argument on “distinguishing color to show placement” claim
element). Patent Owner argues that Pritchard discloses “15 separate
embodiments” that variously disclose the claim elements and that Petitioner
has cherry picked features from these embodiments; however, this is an
argument against anticipation by Pritchard and is not applicable to the
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obviousness challenge. See KSR, 550 U.S. at 421 (picking one of a finite
number of known solutions to a known problem is obvious); Merck & Co.
Inc. v. Biocraft Labs. Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (prior art
“disclos[ing] a multitude of effective combinations does not render any
particular formulation less obvious.”); In re Arkley, 455 F.2d at 587 (picking
and choosing from the teachings of a cited reference is entirely proper in the
making of a case for obviousness). Patent Owner expressly agrees with our
reading of Pritchard as the reference was discussed in the Institution
Decision, that is, that Pritchard provides a “‘menu’ embrac[ing] a vast
number of possible permutations and combinations of elements, including
different punctal plug designs/shapes, different modes of administration,
numerous classes of therapeutic agents, unknown and unknowable number
of swellable materials defined by function, and other possible
characteristics.” PO Resp. 29. Even, assuming arguendo, that such a menu
of choices was more picking and choosing than appropriate under an
anticipation analysis, it provides both express disclosure of claim elements
and a reason to combine them when analyzing obviousness.
Patent Owner argues “Petitioner has not made an obviousness
argument with respect to Pritchard, and [has] foreclosed the ability to do so.”
PO Resp. 33. We disagree with Patent Owner. Petitioner’s Ground 2 is
based on obviousness in view of Pritchard and Gillespie and it expressly
incorporates the anticipation rationale for Pritchard. See Pet. 61 (“For the
reasons set forth in Ground 1, Pritchard anticipates Claims 1–7, 9–16, 18–
20, and 22–23. Ocular incorporates by reference the facts and arguments of
Ground 1.”).
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In addition to the arguments that Pritchard and Gillespie would not
have been combined or that such a combination would not have been
reasonably expected to succeed, which have been discussed above as not
persuasive, Patent Owner also argues that Gillespie’s punctal plugs have an
outwardly exposed surface, thus, the combination of Pritchard and Gillespie
does not teach or suggest an intracanalicular drug delivery device that
contains a distinguishing color. PO Resp. 45–48. As discussed above at
Section III.B, the claims do not require an intracanalicular, i.e., wholly
within the lacrimal canaliculus, device. Therefore, this argument is not
persuasive.
For the reasons above, we conclude Petitioner has proven by a
preponderance of the evidence that independent claims 1, 11, and 18 would
have been obvious over Pritchard and Gillespie.
Claim 2
Claim 2 depends from independent claim 1 and further requires “the
system does not comprise a sheath body.” Ex. 1001, 30:28–29. As
discussed above at Section III.B, this claim language is accorded its ordinary
meaning, i.e., a sheath is a cover and a body refers to a distinct mass, hence,
a distinct cover. Although Petitioner’s proposed interpretation of “sheath
body” is more restrictive than the term’s ordinary meaning, it nonetheless
includes a material that covers, which falls within the scope of the ordinary
meaning. See Pet. 12; see also Ex. 1036 ¶ 70.
Petitioner asserts that
Pritchard discloses devices that are simply cylindrical pieces of
hydrogel material that do not have a structure or material layered
over it to prevent release of the therapeutic agent. Id., ¶ 71; see
also Ex. 1010, Pritchard at [0030]. Pritchard further discloses
that hydrogel occlusive devices will achieve a more successful
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fit without an exterior constraint. Ex. 1010, [0052].
Accordingly, Pritchard discloses drug-eluting canalicular inserts
that do not have a sheath body. See Ex. 1036, Dana Decl., ¶¶ 71-
72.
Pet. 34–35; see also id. at 49–51 (citing Ex. 1010 ¶¶ 30, 52, 56–57, 61).
Dr. Dana also opines that Pritchard discloses simple cylindrical pieces of
hydrogel material as devices to release a therapeutic agent, without a
covering and that the “person of ordinary skill in the art would immediately
recognize that Pritchard discloses drug-eluting canalicular inserts that do not
have a sheath body,” as required by claim 2. Ex. 1036 ¶¶ 71–72; see also
Pet. 34–35 (asserting the same).
Patent Owner does not directly contest Petitioner’s assertions or
evidence regarding the unpatentability of claim 2. See generally PO Resp.;
see also Ex. 2014 (Dr. Williams does not discuss the matter).
We conclude Petitioner’s evidence and assertions are sufficiently
persuasive to prove by a preponderance of the evidence that claim 2 would
have been obvious over Pritchard and Gillespie.
Claims 3–8, 12–17, 19–21
Claims 3–8 depend from independent claim 1, claims 12–17 depend
from independent claim 11, and claims 19–21 depend from independent
claim 18. These dependent claims are directed to certain therapeutic agents
being included in the claimed drug delivery system or treatments for which
the claimed system is used. Petitioner asserts that the claimed therapeutic
agents and treatments would have been obvious over Pritchard and Gillespie.
Claims 3 and 12, like independent claim 18 discussed above, further
require that “the therapeutic agent is selected from an anti-glaucoma agent, a
corticosteroid, an anti-microbial agent, an anti-allergy agent or a non-
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steroidal anti-inflammatory agent.” Ex. 1001, 30:30–33, 30:59–62; see also
id. at 31:10–12. Petitioner asserts the same evidence proves claims 3 and 12
to have been obvious over Pritchard and Gillespie as asserted for claim 18’s
respective limitation. Pet. 33–34, 51, 58, 59. Patent Owner does not directly
contest Petitioner’s assertions or evidence regarding the unpatentability of
claim 3 or 12. See generally PO Resp.; see also Ex. 2014 (Dr. Williams
does not discuss the matter).
Pritchard discloses a great variety of therapeutic agents for use in its
hydrogel devices, including, for example the anti-glaucoma medication
Timolol and the anti-microbial agents silver and Triclosan, as well as the
corticosteroid agent dexamethasone, the non-steroidal anti-inflammatory
agent ibuprofen, and anti-allergy agents such as antihistamines. Ex. 1010
¶¶ 48, 131–137; Ex. 1012, 5–15; see also Ex. 1036 ¶¶ 62–67 (Dr. Dana
discussing this evidence); see also Pet. 29, 33–34, 38, 51–53 (asserting
Pritchard discloses such therapeutic agents). We conclude this is sufficient,
and uncontroverted, evidence and Petitioner has proved by a preponderance
of the evidence that claims 3 and 12 would have been obvious over Pritchard
and Gillespie.
Claims 4, 13, and 19 further require that “the system is used to treat
glaucoma, pre and post surgical treatments, dry eye or allergy.” Ex. 1001,
30:34–36, 30:63–65, 31:18–20. Petitioner asserts that Pritchard discloses
treating ocular dryness and dry eye, treating eye trauma from surgery,
treating allergies, and treating glaucoma. Pet. 52, 58–60 (citing Ex. 1010
¶ 24, claims 44, 77; Ex. 1012, 7, 14). Patent Owner does not directly contest
Petitioner’s assertions or evidence regarding the unpatentability of claim 4,
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13, or 19. See generally PO Resp.; see also Ex. 2014 (Dr. Williams does not
discuss the matter).
Pritchard teaches “using the device to treat at least one eye in a patient
having at least one condition chosen from the group consisting of dry eye,
seasonal allergy, and trauma caused by surgical correction.” Ex. 1010, claim
44. Dr. Dana confirms that the person of ordinary skill in the art would have
known Pritchard’s punctal plugs could and would be used to treat such
conditions. Ex. 1036 ¶ 64. Moreover, Gillespie confirms that punctal plugs
are “a long term solution” for treating dry eye. Ex. 1015 ¶¶ 3–6; see also
Pet. Reply 18 (asserting this disclosure of Gillespie). We conclude this is
sufficient, and uncontroverted, evidence and Petitioner has proved by a
preponderance of the evidence that claims 3 and 12 would have been
obvious over Pritchard and Gillespie.
Claims 5, 14, and 20 further require that “the therapeutic agent is
dexamethasone.” Ex. 1001, 30:37–38, 30:66–67, 31:21–22. Petitioner
asserts that Pritchard discloses dexamethasone as a therapeutic agent for use
with its hydrogel punctal plugs. Pet. 52 (citing Ex. 1012, 6). Dr. Dana states
that “[d]examethasone is an anti-inflammatory and can be used to treat pain
and discomfort.” Ex. 1036 ¶ 65; see also Pet. 34 (asserting this evidence
regarding dexamethasone).
Patent Owner argues, “Pritchard and Gillespie do not teach or suggest
an intracanalicular dexamethasone-delivery system that contains hydrogel
polymers and has distinguishing color to show its placement in the
intracanalicular tissue, as claimed in claims 5, 14 and 20. As an initial
matter, Pritchard does not recite dexamethasone.” PO Resp. 56 (citing
Ex. 2014 ¶ 102). Patent Owner argues Pritchard provides the skilled artisan
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no reason to select dexamethasone from the numerous options in the
reference. Id. Patent Owner further argues that, even were dexamethasone
selected by the skilled artisan, there would be no reason to combine it with
Gillespie’s coloring agents because Gillespie is altogether silent on drug
delivery. Id. (citing Ex. 2014 ¶ 103). Patent Owner also argues that
“dexamethasone is known to have adverse interactions with fluorescein, a
widely used coloring agent” and “[n]owhere in Gillespie does it provide any
guidance as to how to pick and choose appropriate coloring agents for
dexamethasone.” Id. at 56 (citing Ex. 2014 ¶ 104; Ex. 2005 (indicating
fluorescein and dexamethasone have moderate interactions); Ex. 2017, 374–
75 (disclosing adverse reactions to intravenous fluorescein angiography,
which was co-administered with intravenous dexamethasone, but not
expressly attributed to their interacting). At its cited portion, Dr. Williams’s
declaration mirrors this contention. Ex. 2014 ¶ 104.
We find Petitioner’s evidence sufficient to meet its burden to show
that the use of dexamethasone in Pritchard’s punctal plugs, colored per the
teachings of Gillespie, would have been obvious. We are not persuaded by
Patent Owner’s arguments.
Contrary to Patent Owner’s argument, Pritchard does disclose
dexamethasone used as a therapeutic. See Pet. Reply 16–17 (citing
Ex. 2014; Ex. 1052; Ex. 1010; Ex. 1012). Pritchard’s ’368 provisional
states:
Materials set forth herein may be associated with
therapeutic agents, including drugs, imaging agents, diagnostic
agents, prophylactic agents, and bioactive agents. A therapeutic
agent may be mixed with a gel precursor that is in solution or
disposed in a solvent, and the gel may be formed. Alternatively,
the therapeutic agent may be introduced after the gel is formed
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or at an intermediate point in the gel formation process. Certain
embodiments include gels that are made in a first solvent and
exposed to a second solvent that contains the therapeutic agent
so as to load the therapeutic agent into the gel.
Ex. 1012, 5–6. Pritchard’s ’368 provisional then goes on to refer to
dexamethasone used as a therapeutic agent. Id. at 6:12, 10:12–21. Stating
that a reference, such as a provisional’s disclosure is “incorporated herein by
this reference,” is sufficiently detailed and particular to plainly incorporate
that reference in its entirety. Paice LLC v. Ford Motor Co., 881 F.3d 894,
907 (Fed. Cir. 2018). Pritchard plainly incorporates all its provisionals by
reference in their entirety. There is no dispute that the Pritchard ’368
provisional is incorporated into Pritchard in its entirety. Hr’g Tr. 42:18–20
(“I want to make very clear for the record that Patent Owner is not arguing
that Pritchard does not incorporate by reference its provisionals. That’s not
the argument.”). Thus, all the provisionals’ disclosures are a part of
Pritchard. Thus, dexamethasone is clearly disclosed as a therapeutic agent in
Pritchard.
In rebuttal, Dr. Lowman confirms that this disclosure in the Pritchard
’368 provisional “discloses the use of dexamethasone as a therapeutic agent
in [Pritchard’s] hydrogel plugs for drug delivery.” Ex. 1052 ¶ 67; see also
Pet. Reply 16 (discussing the same). Dr. Lowman further explained, in
rebuttal of Patent Owner’s argument and Dr. Williams’s testimony, that
incorporating dexamethasone in a gellan device could be achieved in much
the same way Pritchard describes incorporating silver into such a device and
that dexamethasone would not alter the properties of the hydrogel device.
Ex. 1052 ¶ 70 (discussing Ex. 1010 ¶ 139); see also Pet. Reply 16–17
(discussing the same).
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Also, contrary to Patent Owner’s argument, there is evidence as to
why a skilled artisan would have selected dexamethasone as a therapeutic
agent. Pet. 33–34 (discussing motivation to use dexamethasone and other
therapeutic agents to treat ophthalmic conditions, citing Ex. 1036). Dr. Dana
states that “[d]examethasone is an anti-inflammatory and can be used to treat
pain and discomfort,” thus, there would be a reason to select the agent from
among Pritchard’s plethora of choices. Ex. 1036 ¶ 65.
Further, the ’082 patent’s claims make no restrictions as to how to
color a punctal plug body to provide a “distinguishing color.” See, e.g., Pet.
11 (discussing the ’082 patent’s limited disclosure regarding the claimed
color); Pet. Reply, 1 (asserting Patent Owner imports limitations on color
into the claims), 3–4 (“claims, however, simply require ‘a distinguishing
color to show placement”; “the ‘082 Patent has virtually no teaching on
color”), 21 (“Nor did the ‘082 Patent advance the art as to how to include
color in a pharmaceutical formulation.”). The claims do not, for example,
require the use of fluorescein, even if it is a “widely used coloring agent.”
Any means of coloring will do, so long as it is distinguishing. As evidenced
by Pritchard (Ex. 1010 ¶¶ 87, 88, 107, 137–140), Gillespie (Ex. 1015 ¶¶ 6–
13), and Handbook (Ex. 1016, 146–50), there is no shortage of methods of
coloring and coloring agents for the skilled artisan to have chosen from in
medical applications. In rebuttal to Patent Owner’s arguments and
Dr. Williams’s testimony, Dr. Lowman explained that dexamethasone is a
“drug that was generically available, both alone and in combination with
other therapeutic agents, at the relevant time.” Ex. 1052 ¶ 89 (citing
Ex. 1045, 18, 21); see also Pet. Reply 22–23 (discussing this asserted
evidence). Thus, concludes Dr. Lowman, the properties of this therapeutic
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agent would have been well understood at the relevant time and it would be
a mere straightforward formulation to combine dexamethasone with the
punctal plugs disclosed by the Pritchard-Gillespie combination. Ex. 1052
¶ 89. Dr. Lowman further responds to Patent Owner’s argument, stating:
It was within the ability of an experienced formulator at
the relevant time to add color, likely chosen from materials that
are very nearly pharmacotoxicologically inert, to a device for
delivering a well-understood drug without causing adverse
interactions.
An experienced pharmaceutical formulator would have
been able to include color in a pharmaceutical formulation based
on what was known in the art at the relevant time.
Id. ¶¶ 92–93. As noted above, the skilled artisan would have such
experience and knowledge. See supra Section III.A.
For the reasons above, we conclude Petitioner’s evidence is sufficient,
and Petitioner has proved by a preponderance of the evidence, that claims 5,
14, and 20 would have been obvious over Pritchard and Gillespie.
Claims 6 and 15 further require that “the therapeutic agent is an
antibiotic or antifungal agent.” Ex. 1001, 30:39–40, 31:1–2. Petitioner
asserts that Pritchard discloses therapeutic agents, including antibiotics and
antifungal agents. Pet. 52, 59 (citing Ex. 1012, 6, 7, 12–14). Dr. Dana states
the same in his declaration. Ex. 1036 ¶ 66. Patent Owner does not directly
contest Petitioner’s assertions or evidence regarding the unpatentability of
claims 6 or 15. See generally PO Resp.; see also Ex. 2014 (Dr. Williams
does not discuss the matter).
The Pritchard ’368 provisional discloses “a drug or other therapeutic
substance may be associated with the implant, which may serve as a delivery
vehicle for delivery or release of the drug” and that “[t]herapeutic agents
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include . . . antibiotics.” Ex. 1012, 3:19–21, 6:4–6; see also Pet. 52
(disusing this evidence). The Pritchard ’368 provisional also discloses the
therapeutic agent can be an antifungal. Ex. 1012, 12:14; see also Pet. 52.
We conclude this is sufficient, and uncontroverted, evidence and Petitioner
has proved by a preponderance of the evidence that claims 6 and 15 would
have been obvious over Pritchard and Gillespie.
Claims 7 and 16 further require that “the therapeutic agent is a
prostaglandin, a prostaglandin precursor, a beta-blocker, or a prostaglandin
analog.” Ex. 1001, 30:41–43, 31:3–5. Petitioner asserts this is taught by
Pritchard. Pet. 33–34, 53, 59 (citing Ex. 1012, 7, 12; Ex. 1036 ¶¶ 62–67).
Patent Owner does not expressly argue the patentability of claims 7 or 16 or
directly contest Petitioner’s assertions or evidence regarding their
unpatentability. See generally PO Resp.; see also Ex. 2014 (Dr. Williams
does not discuss the matter).
The Pritchard ’368 provisional discloses hydrogel punctal plugs can
include a beta blocker or prostaglandins as a therapeutic agent. Ex. 1012,
7:10, 12:6; see also Pet. 53 (discussing same). Dr. Dana confirms this
disclosure, as it applies to claims 7 and 16. Ex. 1036 ¶ 67; see also Pet. 33–
34. We conclude this is sufficient, and uncontroverted, evidence and
Petitioner has proved by a preponderance of the evidence that claims 7 and
16 would have been obvious over Pritchard and Gillespie.
Claims 9 and 22
Claim 9 depends from independent claim 1 and claim 22 depends
from independent claim 18. Each of claim 9 and 22 requires “the polymers
comprise functional groups.” Ex. 1001, 30:46–47, 31:25–26. We addressed
the meaning of the term “functional groups” above at Section III.B,
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concluding the term should be accorded its ordinary and customary meaning
as it would have been understood by the person of ordinary skill in the art.
Petitioner asserts that Pritchard teaches devices with polymers having
functional groups because Pritchard expressly states that its hydrogel devices
have polymers, which effectively bind metals due to functional groups, and
when the devices have cross-linked first and second polymers, either can
have functional groups. Pet. 33, 54–54 (citing Ex. 1010 ¶¶ 86, 100–105;
Ex. 1036 ¶ 61). Dr. Dana also testified that Pritchard teaches functional
groups with such disclosure, which discloses the claimed subject matter of
claims 9 and 22. Ex. 1036 ¶ 61; see also Pet. 33.
Patent Owner argues Pritchard does not disclose the claimed
“functional groups” because Pritchard does not disclose functional groups
that “provide the desired solubility of the therapeutic agent in the matrix.”
PO Resp. 43. This argument is not persuasive because, as discussed above,
this is not a claim limitation and the claim term “functional groups” is not
interpreted to require providing desired solubility of the therapeutic agent in
the matrix.
We conclude Petitioner’s evidence is sufficient and Petitioner has
proved by a preponderance of the evidence that claims 9 and 22 would have
been obvious over Pritchard and Gillespie.
Claims 10 and 23
Claim 10 depends from independent claim 1 and claim 23 depends
from independent claim 18. Each of claims 10 and 23, like claim 11
discussed above, further requires that “the hydrogel swells when the system
is inserted into the lacrimal canaliculus of a patient.” Ex. 1001, 30:48–50,
31:27–29; see also id. at 30:56–58. Petitioner asserts the same evidence for
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claims 10 and 23 as asserted for the obviousness of claim 11 over Pritchard
and Gillespie. Pet. 31–33, 54–57, 61.
Patent Owner does not expressly argue the patentability of claims 10
or 23, or directly contest Petitioner’s assertions or evidence regarding their
unpatentability. See generally PO Resp.; see also Ex. 2014 (Dr. Williams
does not discuss the matter).
Pritchard extensively teaches hydrogel punctal plugs that swell when
inserted into the lacrimal canaliculus. See e.g., Ex. 1010 ¶ 22; see also Pet.
54–57 (discussing this limitation and Pritchard’s disclosure). Dr. Dana also
discusses this fact, at length. Ex. 1036 ¶¶ 58–60 (citing Ex. 1010 ¶¶ 20, 22,
51–61, Figs. 7A, 7B). We conclude Petitioner’s evidence is sufficient, and
uncontroverted, and Petitioner has proved by a preponderance of the
evidence that claims 10 and 23 would have been obvious over Pritchard and
Gillespie.
Summary for Ground 2
To summarize, for the reasons above, we find that Petitioner has
proven by a preponderance of the evidence the obviousness and
unpatentability of claims 1–7, 9–16, 18–20, and 22–23 over Pritchard and
Gillespie.
E. CLAIMS 8, 17, AND 21 – OBVIOUSNESS OVER PRITCHARD,
GILLESPIE, AND HELLBERG (GROUND 3)
Claims 8, 17, and 21 depend, respectively, from independent claims 1,
11, and 18 and further require that “the therapeutic agent is travoprost.”
Ex. 1001, 30:44–45, 31:6–7.
Petitioner asserts that Hellberg, which discloses treating glaucoma
with travoprost (e.g., topically), would have been obvious to combine with
Pritchard and Gillespie for teaching using travoprost as a therapeutic agent
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to treat glaucoma. Pet. 64–66 (citing Ex. 1017, 5:40–46, 7:56–62, claim 4;
Ex. 1036 ¶ 80). Petitioner asserts that the skilled artisan would have been
motivated to use Hellberg’s travoprost as a glaucoma treating therapeutic
agent and as a substitutable, equivalent alternative for Pritchard’s disclosed
therapeutic agents, e.g., latanoprost and bimatoprost. Id. at 65–66. Dr. Dana
confirms this motivation to use travoprost, as disclosed by Hellberg, in a
punctal plug as taught by the Pritchard-Gillespie combination. Ex. 1036
¶¶ 79–80. Dr. Dana also testified that travoprost was a well-known anti-
glaucoma drug as of Hellberg’s issue date (2003), and was an equivalent
alternative to latanoprost and brimonidine, which are disclosed by Pritchard
as therapeutic agents. Ex. 1036 ¶¶ 80–81 (citing Ex. 1017, 7:56–58;
Ex. 1012, 14–17); see also Pet. 65–66 (asserting the same).
Patent Owner argues that Hellberg cannot cure the deficiencies of
Pritchard and Gillespie. PO Resp. 59 (citing Ex. 2014 ¶¶ 110–111). Patent
Owner also argues that there is no evidence that the skilled artisan would
have selected travoprost individually to treat glaucoma because Hellberg
describes a combination therapy using, e.g., travoprost, and a prostaglandin
synthesis inhibitor. Id. (citing Ex. 1017, Abstract, claim 1; Ex. 2014 ¶ 112).
This argument is not persuasive. First, we do not find any
deficiencies in Pritchard and Gillespie. Dr. Dana’s testimony indicates that
Hellberg teaches travoprost was a known anti-glaucoma drug. Ex. 1036
¶ 81; see also Pet. 66 (citing Dana Declaration). Pritchard discloses that
anti-glaucoma therapeutic agents are used with its gellan-based punctal
plugs. Ex. 1010 ¶ 48; Ex. 1012, 14:15–17; see also Ex. 1036 ¶ 80
(discussing Pritchard’s teaching of anti-glaucoma drugs, e.g., timolol,
latanoprost, and brimonidine); see also Pet. 2–3, 27, 29, 33–34, 51–53, 65–
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66 (discussing Pritchard’s therapeutic agents, including anti-glaucoma
drugs). Whether the skilled artisan would have selected travoprost
individually or in combination with a prostaglandin inhibitor is immaterial
because the claims do not preclude more than one therapeutic agent. Thus,
we conclude the skilled artisan would have selected an anti-glaucoma drug
to incorporate into Pritchard’s devices and that travoprost is such a (well-
known) drug, hence there was motivation to use it, as stated by Dr. Dana.
Patent Owner also argues that the skilled artisan would not have
believed travoprost to be an equivalent alternative to latanoprost or
bimatoprost, which are disclosed by Pritchard, because they have different
potencies. PO Resp. 59 (citing Ex. 2014 ¶ 113). Patent Owner argues that
because travoprost is more potent (marketed in a 0.004% formulation) than
bimatoprost (marketed as a 0.01% or 0.03% formulation), and less potent
than latanoprost (marketed as a 0.005% formulation), it is not
interchangeable for use in a punctal plug. Id. at 59–60 (citing Ex. 2018;
Ex. 2019; Ex. 2020; Ex. 2014 ¶ 113).
As rebuttal to this argument, Dr. Lowman testified that travoprost,
latanoprost, bimatoprost, and unoprostone are “commercially available
alternatives,” as evidenced by the Physicians’ Desk Reference for
Ophthalmic Medicines (PDR-O). Ex. 1052 ¶¶ 100–101 (citing Ex. 1045, 24,
26 (including travoprost in a very short list of glaucoma drugs); see also Pet.
Reply, 24–25 (asserting this evidence). Pritchard discloses that its punctal
plugs’ “therapeutic agents include anti-glaucoma drugs, e.g., timolol,
dorzolamide hydrochloride, latanoprost, and brimonidine (see also: 1998
Physicians’ Desk Reference for Ophthalmology).” Ex. 1012, 14:15–17; see
also Pet. 51 (discussing Pritchard’s disclosure of anti-glaucoma drugs).
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Based on Patent Owner’s evidence on potencies, Pritchard’s disclosed anti-
glaucoma drugs latanoprost and brimonidine have potencies that bracket that
of travoprost, which does not support the contention that the skilled artisan
would have found travoprost’s potency an obstacle to its use, but supports
the skilled artisan would have found travoprost to be interchangeable with at
least one of latanoprost and brimonidine. Dr. Lowman testified that
adjusting the dosage of the drug to the punctal plug means of delivery would
be a matter of routine design work. Ex. 1052 ¶¶ 108–109; see also Pet.
Reply, 26 (addressing this issue).
We conclude that Petitioner has shown by a preponderance of the
evidence that claims 8, 17, and 21 would have been obvious over Pritchard,
Gillespie, and Hellberg. The prior art combination teaches or suggests each
limitation of these claims, there was motivation to make the combination,
and there would have been a reasonable expectation of success.
F. DEFICIENCIES OF GROUND 1, GROUND 4, AND GROUND 5
We conclude that Petitioner’s challenges under Grounds 1, 4, and 5
are not supported by a preponderance of the evidence. We explain why
below.
Under Ground 1, Petitioner challenges claims 1–7, 9–16, 18–20, and
22–23 as anticipated by Pritchard. We have discussed above how Pritchard
discloses each element of claim 1, except for the limitation requiring
“distinguishing color to show placement of the system in the lacrimal
canaliculus of the patient.” See Ex. 1001, 30:22–24. As we discussed in
Section III.B, above, we accord this claim language its ordinary meaning as
it would have been understood by a person of ordinary skill in the art.
However, that ordinary meaning includes the understanding that the color
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must show (distinguish) the system as it sits in the lacrimal canaliculus of
the patient, e.g., a patient must be able to see the plug and distinguish it from
its environment of tissue.
Petitioner asserts that Pritchard’s disclosure of a device with a light
straw color satisfies this limitation. Pet. 29, 38–39 (citing Ex. 1010 ¶¶ 137–
140; Ex. 1036 ¶ 51). Dr. Dana opined that this light straw color was a
distinguishing color because it “improves visibility” of the device and makes
it “easier to see” because it “is not clear or translucent,” but made no
mention as to whether the light straw color would be visible in the context of
the device being implanted in a patient’s eye. Ex. 1036 ¶¶ 51–52.
Patent Owner argues that the light straw color simply making the
device easier to see does not meet the claim limitation of a distinguishing
color that shows placement of the drug delivery system in the lacrimal
canaliculus. PO Resp. 37–38. Patent Owner argues, and this argument is
supported by Dr. Williams’s testimony, that such a color must distinguish
the device from the patient’s surrounding tissue to meet the claim limitation.
Id. at 38 (citing Ex. 2014 ¶ 65). Dr. Williams testified that “the “light straw
color” asserted by Petitioner “is inadequate to distinguish an intracanalicular
punctal plug from the surrounding tissue of the canaliculus.” Ex. 2014 ¶ 65.
Dr. Williams further testified that “[f]or color to be distinguishing, it needs
to be sufficiently saturated with pigmentation that is in contrast to the color
of the skin as well as the canalicular tissue.” Id. ¶ 66. Dr. Williams
concluded that the light straw color relied upon by Petitioner is so close to
the color of skin and canalicular tissue, it is not a distinguishing color. Id.
¶ 67; see also PO Resp. 39 (making this argument).
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Petitioner provided Dr. Lowman’s testimony as a rebuttal to this
argument. Ex. 1052 ¶ 61; see also Pet. Reply, 5–6 (discussing placement as
an act), 15–16 (asserting the Lowman Declaration as support). However,
Dr. Lowman, like Dr. Dana, opined only that the light straw color of
Pritchard’s device was a distinguishable color because it is observable; it is a
color rather than clear and colorless. Id. ¶ 63. Dr. Lowman never indicates
that Pritchard’s light straw color is distinguishable with respect to
surrounding tissue.
For these reasons, we conclude Petitioner failed to establish by a
preponderance of the evidence that Pritchard disclosed each limitation of the
claims. Therefore, Ground 1 of the Petition fails.
Petitioner asserts Ground 4 as an alternative to Ground 2 and, instead
of combining Pritchard with Gillespie, combines Pritchard with Handbook
in contending claims 1–7, 9–16, 18–20, and 22–23 would have been
obvious. Pet. 66–68. Petitioner’s premise for Ground 4 is that Handbook
includes a section disclosing coloring agents as used in medicinal products
to make them distinctive to prevent counterfeiting and to make commercial
products more uniform in appearance. Id. (citing Ex. 1016, 146–53).
Petitioner argues the skilled artisan would have been motivated to color
Pritchard’s devices as taught by Handbook for these reasons. Id. at 67.
We agree with Patent Owner’s argument that the Handbook is silent
on using its coloring agents for devices of the type disclosed by Pritchard.
PO Resp. 62. Handbook is a general disclosure of the applicability of
coloring agents to pharmaceutical products and lists some specific
applications, such as in coated tablets, uncoated tablets, hard and soft gelatin
capsules, liquid oral preparations, oral and topical formulations, and
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cosmetics. See Ex. 1016, 146–53. Although Handbook assuages concerns
over certain adverse effects by explaining that “continuous review, over
many years, by such bodies as the FDA, has resulted in a list of permitted
colors which are generally regarded as free of serious adverse toxicological
effects,” and that coloring agents “associated with adverse effects” relate to
“a relatively small number of people,” we are not persuaded on this record
that such teachings or others of Handbook provide sufficient indication that
Handbook’s teachings relate to the use of its coloring agents to impart color
to an implantable device. Id. at 148.
Further, Handbook’s discussion of using a coloring agent to impart a
distinctive or distinguishing color to a medicinal product is in the context
manufacturing and marketing––to distinguish one product by its color from
another. There is no suggestion in Handbook that such coloring agents are
sufficient or suitable to provide a distinguishing color to show placement of
an implant in an eye structure, as claimed. Insofar as Dr. Dana provides
testimony that a person of skill in the art would have been motivated to
combine the ‘“color’ teachings of the Handbook to make the inserts of
Pritchard easier to see” (Ex. 1036 ¶ 84), we note that discussion does not
explain sufficiently how Handbook teaches or suggests the coloring agents
are suitable for punctum plugs or any implant. Thus, we conclude
Petitioner’s case under Ground 4 lacks sufficient evidence that the skilled
artisan would have motivation to combine Handbook with Pritchard.
Petitioner asserts Ground 5 as an alternative to Ground 3 and, instead
of combining Pritchard and Hellberg with Gillespie, combines Pritchard and
Hellberg with Handbook so as to have rendered claims 8, 17, and 21
obvious. Pet. 68–69. Petitioner’s premise for Ground 5 is essentially the
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same as those for Grounds 3 and 4––that it would have been obvious to use a
colorant in Pritchard’s devices as taught by Handbook, and that it would
have been obvious to use travoprost as the therapeutic agent as taught by
Hellberg, as discussed above. Patent Owner essentially invokes the same
arguments over this Ground 5 as presented for Ground 4. PO Resp. 66. For
the reasons discussed above regarding Ground 4, we find Petitioner has not
established by a preponderance of the evidence that the claims would have
been obvious over Pritchard, Handbook, and Hellberg.
IV. MOTIONS TO STRIKE AND MOTIONS TO EXCLUDE
A. PATENT OWNER’S MOTIONS
Patent Owner’s Motion to Strike Petitioner’s Reply and Relied
Upon Evidence
Patent Owner filed a Motion to Strike Petitioner’s Reply and Relied
Upon Evidence, asserting the Reply and evidence relied upon therein are
directed to “new theories of unpatentability and new evidence for the first
time.” Paper 36 (“PO Mot. Strike”). Patent Owner requests the following
portions of the Reply and evidence be stricken: Pet. Reply, 4–5, 9–10, 13–
14, 16–19, 20–21, 24–26; Ex. 1052 (Lowman Declaration) ¶¶ 46, 49, 50–52,
54, 64, 67–74, 77, 80–81, 83, 84, 100, 103, 106–107, 109–111; Ex. 1011
(Pritchard ’132 provisional); Ex. 1024 (US. 6,196,993 B1 to Cohan);
Ex. 1028 (Scot Morris, Plugs, Drugs and Tears: a Dry Eye Update, Part
Two, OPTOMETRIC MANAGEMENT 36–42, 70 (Oct. 2002)); Ex. 1040 (Chris
T. White, This Just In: Transilluminating the Canaliculus, Review of
Optometry (May 28, 2002)); Ex. 1041 (US 2002/0198453 A1 by Herrick);
Ex. 1042 (ARTHUR H. KIBBE, PH.D., HANDBOOK OF PHARMACEUTICAL
EXCIPIENTS (2000)); Ex. 1044 (US FDA, Color Additives History (2003));
Ex. 1045 (PHYSICIANS’ DESK REFERENCE FOR OPHTHALMIC MEDICINES
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(2004)); Ex. 1047 (Anthony M. Lowman, Biomaterials in Drug Delivery, in
BIOMEDICAL DEVICES AND THEIR APPLICATIONS (D.Shi ed.) 1–31 (2004));
Ex. 1049 (Hiroshi Nishida & Harman M. Risemberg, Silver Nitrate
Ophthalmic Solution and Chemical Conjunctivitis 56(3) Pediatrics 368–73
(1975)); Ex. 1050 (US FDA, Guidance for Industry, FDA Staff, Eye Care
Professionals, and Consumers Decorative, Non-corrective Contact Lenses
(2006)). See id. at Exhibit 1. Petitioner opposed Patent Owner’s Motion to
Strike. Paper 39 (“Pet. Opp. PO Mot. Strike”).
Patent Owner takes issue with the Lowman Declaration (Ex. 1052).
PO Mot. Strike, 2. Patent Owner argues that because Dr. Lowman is a
chemist, not an ophthalmologist, he is not a person of ordinary skill in the art
and his opinions should not be considered. Id. at 2–4. Patent Owner argues
Dr. Lowman’s testimony backfills the Petition with new argument and
advances new theories of unpatentability not made in the Petition. Id.
Patent Owner argues that Dr. Lowman for the first time asserts that the
person of ordinary skill would have consulted a chemist, seeking to change
the definition of the person of ordinary skill in the art. Id. at 3; see also Pet.
Reply 9–10.
Patent Owner argues that the Lowman Declaration introduced new
evidence and a new theory of unpatentability that focuses on the Pritchard
’132 provisional (Ex. 1011) disclosure of the Opaque Herrick Lacrimal Plug
as teaching a visible plug with the claimed distinguishing color. PO Mot.
Strike, 4–5. Similarly, Patent Owner argues that the Lowman Declaration
makes the new assertion that silver is an imaging agent (energy obstructing)
and, so, the silver in Pritchard’s plugs would allow easier transillumination
detection, i.e., visibility. Id. at 5–6.
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Although it is somewhat unclear, Patent Owner argues that
Dr. Lowman’s testimony regarding colored contact lenses in the prior art
evidencing that color could be sustained in hydrogel is a new theory that the
prior art teaches a “distinguishing color,” different from the “light straw
color” of Pritchard’s disclosure. PO Mot. Strike, 6. Patent Owner argues
that this testimony was not responsive to Patent Owner’s argument that
Pritchard did not teach a lasting color. Id.
Patent Owner also argues that Dr. Lowman’s testimony (and citation
to Ex. 1045 and a new portion of Ex. 1028) and the related portions of
Petitioner’s Reply (pages 17–18) on dexamethasone make a new argument
on a motivation to use the drug. Id. at 7.
Patent Owner argues that the Petition never discusses “how to apply
Gillespie’s color to Pritchard,” or “how Gillespie’s color in punctal plugs
made of chemically inert materials could have possibly applied to the drug-
eluting hydrogel device of Pritchard.” Id. at 8. Patent Owner argues that
Dr. Lowman’s testimony that Gillespie contemplated hydrogel materials for
punctal plugs is new and was not responsive to Patent Owner’s arguments.
Id. at 8–9.
Finally, Patent Owner argues that Dr. Lowman’s testimony
concerning a motivation to select travoprost as a therapeutic agent, as recited
in claims 8, 17, and 21, which relied on Ex. 1045 (PDR), is also a new
theory. Id. at 9–10.
Petitioner opposes Patent Owner’s Motion to Strike and argues
Dr. Lowman’s declaration, and its Reply, directly respond to Patent Owner’s
arguments (in the Response) and Dr. Williams’s opinions in his declaration
(Ex. 2014). Pet. Opp. PO Mot. Strike, 1. Petitioner does not dispute that
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Dr. Lowman’s Declaration includes additional testimony and evidence
beyond that of the Petition, but argues it was not required to anticipate the
arguments presented in Patent Owner’s Response (or expert’s testimony).
Id. (citing Idemitsu Kosan Co. v. SFC Co., 870 F.3d 1376, 1381 (Fed. Cir.
2017) (Petitioner is entitled to counter arguments first raised by Patent
Owner; preemptive evidence and arguments by Petitioner are not required).
Petitioner argues that its Reply is not backfilling the Petition, rather, it
corrects Dr. Williams’s testimony’s mischaracterizations of the art and
rehabilitates how a skilled artisan would read Pritchard, Gillespie, and
Hellberg. Id. at 2. Regarding Dr. Lowman’s experience and perspective as
a chemist, Petitioner argues this testimony rebuts Dr. Williams’s opinions on
material chemistry and formulations. Id. at 3. Patent Owner contends
Dr. Lowman testifies as an expert witness regarding pharmaceutics and
collaboration with ophthalmologists, not as a person of ordinary skill in the
art. Id. at 3, n.1.
Regarding Dr. Lowman’s testimony on “distinguishing color” and the
Herrick prior art plugs, and the related portions of the Reply, Petitioner
argues it was Patent Owner that introduced a discussion of Herrick’s plugs
in its Response as evidence to distinguish Pritchard and Gillespie. Id. at 4
(citing PO Resp. 7–8, 38–39 (discussing the transillumination technology
used to visualize Herrick’s drug-free, blue, opaque plugs in use). Petitioner
argues Dr. Lowman’s discussion of Herrick’s technology (Ex. 1040;
Ex. 1041; Ex. 1011) is not creating a new theory, but rebuts Dr. Williams’s
speculation on the prior art and how transillumination works. Id. at 5.
Further, regarding transillumination being a means to identify the claimed
“distinguishing color,” Petitioner argues that Patent Owner understood
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(admitted) that Petitioner’s theory of such a distinguishing color relied on
Pritchard’s examples of light straw colored pugs with suspended silver
particles––Petitioner argues Dr. Lowman’s discussion of energy blocking by
such particles directly rebuts Dr. Williams’s testimony on color and the prior
art. Id. at 6.
Regarding Dr. Lowman’s testimony on colored hydrogel materials,
for example, colored hydrogel contact lenses, and the related Ex. 1050 and
Ex. 1011, Petitioner argues that such evidence rebuts Dr. Williams’s opinion
that Pritchard and Gillespie do not provide the skilled artisan a reasonable
expectation that color could be retained in hydrogel punctal plugs under
physiological conditions. Pet. Opp. PO Mot. Strike, 5–6 (citing PO Resp.
50–51; Ex. 2014 ¶¶ 92–93).
Regarding Dr. Lowman’s testimony on Pritchard’s disclosure of
dexamethasone and selecting dexamethasone as a therapeutic agent,
Petitioner argues this rebuts Dr. Williams’s (and Patent Owner’s) position
that the skilled artisan would not have had a reason to select dexamethasone
because it is so different from silver. Id. at 6–7. Petitioner argues that
Dr. Lowman’s testimony on dexamethasone discusses the Physician’s Desk
Reference because Dr. Williams discussed it, and to explain why, contrary to
Dr. Williams’s position, the skilled artisan would focus on using
dexamethasone (and silver). Id. at 7 (discussing Ex. 1045). Petitioner
argues this testimony illuminates how a skilled artisan would have read
Pritchard, but is not a new unpatentability theory. Id. Petitioner argues that
Dr. Lowman’s testimony, and Petitioner’s Reply, are consistent with the
Petition on anticipation and obviousness challenges to claims 5, 14, and 20.
Id. (citing Pet. 27–49, 52, 57–64, 66–68).
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Regarding Patent Owner’s argument that the Petitioner does not set
forth how Pritchard and Gillespie could be combined, Petitioner first points
out that the challenged exhibits, Ex. 1002, Ex. 1011, and Ex. 1028, were
provided with the Petition and cannot be considered new. Id. at 8.
Petitioner argues that Patent Owner directly challenged the Pritchard-
Gillespie combination by arguing Gillespie taught away from drug-
delivering punctal plugs and that the skilled artisan would have not had a
reasonable expectation of successfully adding color to an intracanalicular
drug delivery device. Id. (citing PO Resp. 53, 55; Ex. 2014 ¶¶ 97, 100).
Petitioner argues Dr. Lowman’s testimony rebuts these arguments by
evidencing color retention in hydrogel material (e.g., Gellan gum), that
Gillespie is not limited to silastic rubber material, and that, to the contrary,
Gillespie is directed to any suitable materials, including those that were
presently used in the manufacturing of punctal plugs, which included
hydrogels as taught by Pritchard. Id. at 8–9.
Regarding Patent Owner’s argument about Dr. Lowman’s testimony
on travoprost, Petitioner argues that Dr. Lowman responds to Patent
Owner’s and Dr. Williams’s assertions that the skilled artisan would have
had no reason to select only travoprost from Hellberg’s disclosure and that
the skilled artisan would have had no reason to expect travoprost to be
suitable for punctal plugs. Id. at 9. Petitioner argues that Dr. Lowman’s
testimony, that the skilled artisan’s choices for a glaucoma treating drug
were limited and travoprost would be at or near the top of the list, is
consistent with Petitioner’s positions in the Petition. Id. (citing Pet. 27–66,
68–69).
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“A reply may only respond to arguments raised in the corresponding
opposition, patent owner preliminary response, or patent owner response.”
37 C.F.R. § 42.23(b) (2019). The Board’s Trial Practice Guide clarifies:
A petitioner may file a reply to a patent owner response, and a
patent owner may file a reply to an opposition to a motion to
amend. 37 C.F.R. § 42.23. Additionally, in response to issues
arising from the Supreme Court’s decision in SAS (138 S. Ct. at
1358), the Board will permit the petitioner, in its reply brief, to
address issues discussed in the institution decision. . . . Petitioner
may not submit new evidence or argument in reply that it could
have presented earlier, e.g. to make out a prima facie case of
unpatentability. A party also may submit rebuttal evidence in
support of its reply. See Belden Inc. v. Berk-Tek LLC, 805 F.3d
1064, 1077–78 (Fed. Cir. 2015). If a party submits a new expert
declaration with its reply, the opposing party may cross-examine
the expert, move to exclude the declaration, and comment on the
declaration and cross-examination in any sur-reply. Id. at
1081−82. . . .
Generally, a reply or sur-reply may only respond to arguments
raised in the preceding brief. 37 C.F.R. § 42.23, except as noted
above. “Respond,” in the context of 37 C.F.R. § 42.23(b), does
not mean proceed in a new direction with a new approach as
compared to the positions taken in a prior filing. While replies
and sur-replies can help crystalize issues for decision, a reply or
sur-reply that raises a new issue or belatedly presents evidence
may not be considered. The Board is not required to attempt to
sort proper from improper portions of the reply or sur-reply.
Examples of indications that a new issue has been raised in a
reply include new evidence necessary to make out a prima facie
case for the patentability or unpatentability of an original or
proposed substitute claim, such as newly raised rationale to
combine the prior art references that was not expressed in the
petition. See Intelligent Bio-Sys., Inc. v. Illumina Cambridge
Ltd., 821 F.3d 1359, 1369–70 (Fed. Cir. 2016) (holding that the
Board did not err in refusing the reply brief as improper under 37
C.F.R. § 42.23(b) because petitioner relied on an entirely new
rationale to explain why one of skill in the art would have
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combined the references at issue). It is also improper for a reply
to present new evidence (including new expert testimony) that
could have been presented in a prior filing, for example newly
cited prior art references intended to “gap-fill” by teaching a
claim element that was not present in the prior art presented with
the petition. See Genzyme Therapeutic Prods. Ltd. v. Biomarin
Pharm. Inc., 825 F.3d 1360, 1365–69 (Fed. Cir. 2016) (proper
for Board to rely on prior art references submitted with
petitioner’s reply to establish the state of the art at the time of the
invention in response to patent owner arguments).
Patent Trial and Appeal Board Consolidated Trial Practice Guide 73–75
(Nov. 2019), https://www.uspto.gov/TrialPracticeGuideConsolidated
(combining the Trial Practice Guide and updates). The Trial Practice Guide
further states that:
In most cases, the Board is capable of identifying new issues or
belatedly presented evidence when weighing the evidence at the
close of trial, and disregarding any new issues or belatedly
presented evidence that exceeds the proper scope of reply or sur-
reply. As such, striking the entirety or a portion of a party’s brief
is an exceptional remedy that the Board expects will be granted
rarely.
Id. at 80.
We conclude that Dr. Lowman’s testimony and the related discussion
in Petitioner’s Reply is responsive to arguments made by Patent Owner in its
Response and opinions expressed by Dr. Williams in his declaration.
Petitioner’s Reply addresses issues raised in Patent Owner’s Response, such
as claim interpretations that would be required by Patent Owner’s arguments
(see, e.g., PO Resp. 1–2), Dr. Williams’s reliance on the prior art (e.g.,
Herrick’s punctal plugs) to explain how intracanalicular plugs have a
distinguishing color (see PO Resp. 7–8, 38–40), whether Pritchard’s silver is
a therapeutic agent, whether hydrogels can be colored, why Pritchard
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discloses using dexamethasone as a therapeutic agent (see, e.g., PO Resp.
34–35), whether color can be applied to hydrogel (see, e.g., PO Resp. 40–
41), why Pritchard and Gillespie were properly combined and what materials
Gillespie taught or suggested could be colored (see PO Resp. 47–57), and
why Hellberg’s travoprost anti-glaucoma drug would have been used in
Pritchard’s punctal plugs (see PO Resp. 59–61). See generally Pet. Reply.
Many of these issues relate to chemistry and pharmaceutical formulations,
which is why Dr. Lowman, a chemist, appropriately testifies as an expert
witness in rebuttal. There is no requirement of a perfect match between the
expert’s experience and the relevant field. SEB, 594 F.3d at 1373. A person
need not be a person of ordinary skill in the art in order to testify as an
expert under Rule 702, but rather must be “qualified in the pertinent art.”
Sundance, 550 F.3d at 1363–64.
Dr. Lowman begins his testimony by stating, “this declaration
focusses on the testimony of Dr. Williams.” Ex. 1052 ¶ 24. Subsequently,
essentially every statement made and position taken by Dr. Lowman in his
declaration is prefaced by the introduction, “I have been asked to consider
Dr. Williams’ opinion” on whatever subject is then discussed, followed by
the reasons Dr. Lowman disagrees (or agrees) with Dr. Williams and
citations to evidence supporting Dr. Lowman’s rationale. See, e.g., id. at
¶¶ 25, 38, 45, 46, 55, 56, 61, 66, 71, 77, 78, 79, 85, 94, 97, 108. Petitioner’s
Reply and Dr. Lowman’s declaration explain the knowledge a skilled artisan
would have already had upon reading Pritchard, Gillespie, and Hellberg as
of March 31, 2006, based on the prior art. See e.g., Pet. Reply 8–10;
Ex. 1052 ¶¶ 18–23, 45, 50–60, 64, 69, 73, 77, 80–82, 84, 86, 89, 92–93, 95–
96, 100, 103, 107–109.
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Our reviewing court has held that it is proper for the Board to consider
prior art evidence, outside of specific prior art combinations cited for an
obviousness challenge, for the purpose of illustrating “the knowledge that
skilled artisans would bring to bear in reading the prior art identified as
producing obviousness.” Genzyme, 825 F.3d at 1368. In fact, not
considering such evidence may constitute error. See Ariosa, 805 F.2d 1359.
Moreover, it is proper for a petitioner to address issues in its reply that are
first raised by a patent owner in its response; counter arguments need not be
preemptively made by a petitioner in its petition. Idemitsu, 870 F.3d at
1381.
To the extent any new evidence is cited by Dr. Lowman or submitted
by Petitioner, Patent Owner had the opportunity to submit rebuttal evidence
in support of its Sur-reply. See Belden, 805 F.3d at 1077–78. Further,
Patent Owner also had the opportunity to, and did, cross-examine
Dr. Lowman at a deposition and addressed Dr. Lowman’s declaration and
deposition testimony in its Sur-reply. See Ex. 2030; PO Sur-reply 3–6, 11–
12, 16–19, 21–22, 24, 26–33.
Furthermore, to the extent that any particular argument asserted in the
Reply (or discussed in Dr. Lowman’s supporting testimony) improperly
introduces a new theory or position on patentability, we are capable of
distinguishing and disregarding such argument. Similar to a district court in
a bench trial, the Board, sitting as a non-jury tribunal with administrative
expertise, is well positioned to determine and assign appropriate weight to
evidence presented, including not relying on it or giving it no weight when
improperly raised in a reply. See, e.g., Donnelly Garment Co. v. NLRB, 123
F.2d 215, 224 (8th Cir. 1941) (“One who is capable of ruling accurately
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upon the admissibility of evidence is equally capable of sifting it accurately
after it has been received . . . .”). As illustrated above in our discussion of
Petitioner’s challenges and Patent Owner’s response to those challenges, we
have not relied upon any theories of unpatentability not presented in the
Petition and our conclusions on obviousness are based on the evidence cited
in the Petition. Thus, in this inter partes review, the better course is to have
a complete record of the evidence to facilitate public access as well as
appellate review.
For the reasons above, we deny Patent Owners’ Motion to Strike.
Patent Owner’s Motion to Exclude Evidence
Patent Owner filed a Motion to Exclude Evidence. Paper 43 (“PO
Mot. Exclude”). Petitioner opposed Patent Owner’s Motion to Exclude
Evidence. Paper 47 (“Pet. Opp. PO Mot. Exclude”). Patent Owner filed a
Reply in support of its Motion to Exclude. Paper 50 (“PO Reply Mot.
Exclude”).
Patent Owner seeks to exclude the following evidence: Ex. 1011
(Pritchard ’132 provisional); Ex. 1013 (Pritchard ’858 provisional); Ex. 1014
(Pritchard ’569 provisional); Ex. 1028 (Morris); Ex. 1032, (Balaram);
Ex. 1035 (PDR re. travoprost); Ex. 1040–1042 (respectively White, Herrick
’453, Handbook - re. history of lacrimal plugs); Ex. 1044 (FDA color
additives history); Ex. 1045 (PDR); Ex. 1047–1050 (respectively, Lowman,
Cayman Chemicals, Nishida, FDA guidance); Ex. 1052 (Lowman
Declaration); Ex. 1053 (Lowman CV).
Patent Owner argues that Ex. 1032, Ex. 1035, Ex. 1042, Ex. 1047, and
Ex. 1048 are inadmissible hearsay under Fed. R. Evid 801–802 and lack
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authentication under Rule 901. The other evidence, Patent Owner argues is
untimely, irrelevant or unduly prejudicial under Fed. R. Evid. 401–403.
As an initial matter, we have not relied on Ex. 1013, Ex. 1014,
Ex. 1032, Ex. 1035, Ex. 1040, Ex. 1041, Ex. 1042, Ex. 1047, Ex. 1048,
Ex. 1049, or Ex. 1050 in our analysis or conclusions on the unpatentability
of the claims, as set forth above. Petitioner has met its burden without such
evidence. Thus, we dismiss the motion to exclude as moot with respect
thereto.
Regarding the other evidence sought to be excluded, we have above
addressed Dr. Lowman’s declaration and the evidence cited therein, and as
cited in the Reply, as not improper. Furthermore, Petitioner’s exhibits up to
Ex. 1037 were submitted with the Petition, thus they are neither late nor
new. We disagree with Patent Owner’s position that the evidence is not
relevant under Fed. R. Evid. 401 because it relates to materials and to
chemistry, as well as to the knowledge of those of ordinary skill in the art
relating to the invention of the ’082 patent’s claims. Furthermore, we also
disagree that this evidence is prejudicial under Fed. R. Evid 403, as the
Panel is capable of weighing whether any evidence is overly confusing,
misleading, or cumulative, for example. Except as proper rebuttal evidence,
we have not relied on any evidence submitted by Petitioner, or any theory of
unpatentability, not presented in the Petition and discussed in the Dana
Declaration.
For the reasons above, we dismiss-in-part and deny-in-part Patent
Owner’s Motion to Exclude.
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B. PETITIONER’S MOTION TO EXCLUDE
Petitioner filed a Motion to Exclude certain evidence of record. Paper
44 (“Pet. Mot. Exclude”). Patent Owner opposed this motion. Paper 45
(“PO Opp. Pet. Mot. Exclude). Petitioner filed a Reply in support of its
Motion to Exclude. Paper 51 (“Pet. Reply Mot. Exclude”).
Petitioner seeks to exclude the declaration of Dr. Williams (Ex. 2014)
because it is not relevant and not reliable, because Dr. Williams does not
offer his own opinions, but merely adopts Patent Owner’s positions, and
because Dr. Williams misunderstood the person of ordinary skill in the art
standard and failed to carefully review Pritchard. Pet. Mot. Exclude, 1.
Dr. Williams’s testimony is relevant because it is directed to the issues
of patentability set forth in the Petition. See generally Ex. 2014.
Petitioner’s further objections go to the weight that should be accorded the
testimony, not its admissibility. The Board has broad discretion to assign
weight to be accorded expert testimony. Yorkey v. Diab, 601 F.3d 1279,
1284 (Fed. Cir. 2010). Petitioner’s objections do not support excluding the
evidence.
For the reasons above, we deny Petitioner’s Motion to Exclude.
V. CONCLUSION
Petitioner has demonstrated by a preponderance of the evidence that
claims 1–23 of the ’082 patent would have been obvious (1) over Pritchard
and Gillespie, and (2) over Pritchard, Gillespie, and Hellberg.
In summary, on Petitioner’s unpatentability challenges:17

17 Should Patent Owner wish to pursue amendment of the challenged claims
in a reissue or reexamination proceeding subsequent to the issuance of this
decision, see the April 2019 Notice Regarding Options for Amendments by
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Patent 9,849,082 B2

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ORDER
Accordingly, it is hereby:
ORDERED that Petitioner has demonstrated by a preponderance of
the evidence that claims 1–23 of the ’082 patent are unpatentable;
FURTHER ORDERED that, because this is a Final Written Decision,
any party to the proceeding seeking judicial review of the decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2; and

Patent Owner Through Reissue or Reexamination During a Pending AIA
Trial Proceeding. See 84 Fed. Reg. 16654 (Apr. 22, 2019). If Patent Owner
chooses to file a reissue application or a request for reexamination of the
challenged patent, Patent Owner has a continuing obligation to notify the
Board in updated mandatory notices. See 37 C.F.R. § 42.8(a)(3), (b)(2).
Claims 35 U.S.C. § References
Claims
Shown
Unpatentable
Claims
Not shown
Unpatentable
1–7, 9–
16, 18–
20, 22, 23
102 Pritchard 1–7, 9–16, 18–20, 22, 23
1–7, 9–
16, 18–
20, 22, 23
103(a) Pritchard, Gillespie
1–7, 9–16, 18–
20, 22, 23
8, 17, 21 103(a)
Pritchard,
Gillespie,
Hellberg
8, 17, 21
1–7, 9–
16, 18–
20, 22, 23
103(a) Pritchard, Handbook
1–7, 9–16,
18–20, 22, 23
8, 17, 21 103(a)
Pritchard,
Handbook,
Hellberg
8, 17, 21
Overall Outcome 1–23
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FURTHER ORDERED that Patent Owner’s Motion to Strike is
denied;
FURTHER ORDERED that Patent Owner’s Motion to Exclude is
dismissed-in-part and denied-in-part; and
FUTHER ORDERED that Petitioner’s Motion to Exclude is denied.

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For PETITIONER:

Kia Freeman
Brian M. Seeve
Thomas Foley
McCARTER & ENGLISH, LLP
kfreeman@mccarter.com
brian.seeve@wilmerhale.com
tfoley@mccarter.com

For PATENT OWNER:

Anita Varma
David Tennant
Grace Wang
Yang Xu
WHITE & CASE LLP
anita.varma@whitecase.com
dtennant@whitecase.com
grace.wang@whitecase.com
yang.xu@whitecase.com