IPR2019-00442
`U.S. Patent No. 9,463,114
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`OCULAR THERAPEUTIX, INC.
`Petitioner,
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`
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`v.
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`MATI THERAPEUTICS INC.
`Patent Owner.
`
`
`Case: IPR No. 2019-00442
`Patent No. 9,463,114
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`
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`
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`PATENT OWNER PRELIMINARY RESPONSE
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`U.S. Patent No. 9,463,114
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`OCULAR THERAPEUTIX, INC.
`Petitioner,
`
`
`
`v.
`
`
`
`MATI THERAPEUTICS INC.
`Patent Owner.
`
`
`Case: IPR No. 2019-00442
`Patent No. 9,463,114
`
`
`
`
`
`PATENT OWNER PRELIMINARY RESPONSE
`
`
`
`
`
`
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`
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`IPR2019-00442
`U.S. Patent No. 9,463,114
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`TABLE OF CONTENTS
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`INTRODUCTION .................................................................................. 1
` MATI THERAPEUTICS, INC. ............................................................. 2
` MATI’S ODRICH PATENT (U.S. PATENT NO. 9,463,114).............. 3
`A.
`Technical Background ................................................................ 3
`B.
`The Odrich Patent ....................................................................... 4
` THOROUGH EXAMINATION OF THE ODRICH PATENT ............ 7
` PETITIONER’S PROPOSED LEVEL OF A POSITA IS IMPROPER
` 12
`IS FACIALLY
` PETITIONER’S CLAIM CONSTRUCTION
`UNREASONABLE ............................................................................. 13
`“a medication for treatment of a corneal infection” ....... 13
` LAW ON ANTICIPATION AND OBVIOUSNESS ........................... 14
`A. Anticipation ............................................................................... 14
`B.
`Obviousness .............................................................................. 15
` THE BOARD SHOULD NOT INSTITUTE THE IPR ....................... 17
`A.
`Petitioner Misapplies The Prior Art .......................................... 18
`Schmitt Does Not and Cannot Anticipate ...................... 18
`a.
`Petitioner Improperly Ignores and Effectively
`Reads Out The Key Claim Limitation: “Constant
`Diameter Cylinder” .............................................. 22
`Petitioner Improperly Ignores and Effectively
`Reads Out The Key Claim Limitation: “To Be
`Inserted” ............................................................... 26
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`b.
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`i
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`c.
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`d.
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`B.
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`IPR2019-00442
`U.S. Patent No. 9,463,114
`Petitioner Mischaracterizes Schmitt’s Preplug as a
`Plug ....................................................................... 27
`Petitioner Mischaracterizes Schmitt’s Plug as
`Including an Active Agent ................................... 30
`Petitioner’s Secondary References Do Not Remedy
`Schmitt ............................................................................ 32
`a.
`Higuchi ................................................................. 32
`b.
`PDR ...................................................................... 34
`c.
`Cagle ..................................................................... 35
`Petitioner Fails to Carry its Burden of Proving There is a
`Likelihood that Any Challenged Claim is Unpatentable .......... 35
`Ground 1 – Schmitt Fails to Anticipate Claims 1, 3, 6-8,
`10, and 13 ........................................................................ 35
`Ground 2 – Higuchi Fails to Remedy the Deficiencies in
`Schmitt ............................................................................ 53
`Ground 3 – PDR Fails to Remedy the Deficiencies in
`Schmitt ............................................................................ 56
`Ground 4 – Cagle Fails to Remedy the Deficiencies in
`Schmitt ............................................................................ 58
` CONCLUSION..................................................................................... 60
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`IPR2019-00442
`U.S. Patent No. 9,463,114
`TABLE OF AUTHORITIES
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`Page(s)
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`CASES
`Abbott Labs. v. Sandoz Inc., 544 F.3d 1341, 1352 (Fed. Cir. 2008) ...................... 17
`Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983) ............. 14
`Eli Lilly & Co. v. Teva Pharms. USA, Inc., 619 F.3d 1329, 1336, (Fed. Cir. 2010)15
`Eli Lilly & Co. v. Zenith Goldline Pharms., Inc., 471 F.3d 1369, 1376 (Fed. Cir.
`2006) ................................................................................................................... 15
`Graham v. John Deere Co., 383 U.S. 1, 17, 148 U.S.P.Q. 459, 466-67 (1966) .... 15
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation,
`676 F.3d 1063, 1072-73, (Fed. Cir. 2012) ......................................................... 17
`KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) ........................... 15, 16
`Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1370 (Fed. Cir. 2008)
`……………………...........................…………………….................................14
`Pressure Prods. Med. Supplies, Inc. v. Greatbatch Ltd., 599 F.3d 1308, 1319 (Fed.
`Cir. 2010) ……………...........................……………………...........................17
`Ziegman v. Stephens, IPR2015-01860, Paper 11 (PTAB February 24, 2016)..18, 56
`STATUTES AND RULES
`37 C.F.R. § 42.107 ..................................................................................................... 1
`37 C.F.R. § 42.120 ..................................................................................................... 1
`35 U.S.C. § 314(a) .............................................................................................. 2, 17
`35 U.S.C. § 102 ........................................................................................................ 14
`35 U.S.C. § 325(d) ...................................................................................... 18, 55, 56
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`IPR2019-00442
`U.S. Patent No. 9,463,114
`Pursuant to 37 C.F.R. § 42.107, Patent Owner, Mati Therapeutics Inc.
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`(“Patent Owner” or “Mati”), submits this Preliminary Response to the petition
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`(“Petition” or “Pet.”) for inter partes review (“IPR”) filed by Ocular Therapeutix,
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`Inc. (“Petitioner”) challenging claims 1, 3, 5-8, 10, and 12-14 of U.S. Patent
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`9,463,114 to Odrich et al. (“Odrich Patent”). For the reasons set forth herein, the
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`Petition for IPR should be denied in its entirety.
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`INTRODUCTION
`On its face, Petitioner’s submission fails to provide the Board with the basic
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`evidence and analysis required to institute any IPR. If the Board nonetheless
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`institutes trial on any of the challenged claims, then, pursuant to 37 C.F.R. §
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`42.120, Mati will address, in its patent owner’s response, the numerous substantive
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`errors and shortcomings that underlie each of Petitioner’s arguments and its
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`purported evidence.
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`In
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`this preliminary response, however, Mati addresses fundamental
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`shortcomings of the Petition, including that (i) Petitioner has failed to satisfy its
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`burden by offering a faulty anticipation analysis based on the allegedly anticipatory
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`reference, Schmitt, (ii) Petitioner has failed to satisfy its burden by offering a faulty
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`obviousness analysis and failing to address the Graham factors; (iii) Petitioner
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`improperly relies on an unreasonable claim construction, and without such claim
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`construction, Petitioner’s primary reference, Schmitt, lacks a material limitation in
`1
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`IPR2019-00442
`U.S. Patent No. 9,463,114
`the Odrich Patent’s independent claims; and (iv) Petitioner’s secondary references,
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`Higuchi, PDR, and Cagle, fail to remedy the deficiencies of Schmitt.
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`For these reasons, the Petition fails to show that there is a reasonable
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`likelihood
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`that Petitioner will prevail
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`in proving any challenged claim
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`unpatentable, the Petition should be denied, and no IPR should be instituted under
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`35 U.S.C. § 314(a).
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` MATI THERAPEUTICS, INC.
`Mati originated from a company called Forsight Labs, LLC, which was
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`founded in 2005 and has gone through a number of changes to its name and
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`structure over the years, including QLT Plug Delivery, Inc., 3088922, Inc., QLT
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`Inc., and finally Mati. Mati, led by its former president and CEO was spun out of
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`QLT Inc., and multiple officers from QLT, including the Chief Commercial
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`Officer, Chief Scientific Officer, and Chief Financial Officer, were all part of the
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`newly formed Mati. The Mati team has been actively developing products since
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`2007, including a punctal plug drug delivery system called Evolute®, which is a
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`non-invasive sustained drug delivery platform. Mati expects these products to
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`reach the market as early as 2020.
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`IPR2019-00442
`U.S. Patent No. 9,463,114
` MATI’S ODRICH PATENT (U.S. PATENT NO. 9,463,114)
`A. Technical Background
`Tears provide a protective coating over the front surface of the eyes. As the
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`eye produces new tears, old tears drain away from the eye through two small
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`apertures/holes called the superior and inferior puncta (or the upper and lower
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`puncta). The puncta are located at the inner corner of the eye, at the corners of the
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`upper and lower eyelids near the nose, and are depicted in Netter, Ex. 1024 Netter
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`below. Each punctum is connected to a channel called the lacrimal canaliculus,
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`which carries tears down to the nose.
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`Patients with dry eye syndrome and other ophthalmic conditions sometimes drain
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`their tears through the puncta and lacrimal canaliculi more quickly than their eyes
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`can produce tears. These conditions can be treated by inserting a plug into the
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`IPR2019-00442
`U.S. Patent No. 9,463,114
`punctum to decrease the amount of tears that drain away from the eye and increase
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`the amount of tear fluid available to bathe the front of the eye.
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`B.
`The Odrich Patent
`The inventors of the Odrich Patent1, Steven Odrich and Liane Glazer,
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`invented a punctal plug which can be inserted into the upper and/or lower punctal
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`apertures of the eye and deliver an active agent to the eye. Odrich’s punctal plug
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`delivers the active agent to the eyes and the walls of the canaliculus. Ex. 1001,
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`Odrich Patent, 1:30, 3:18.
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`Claim 1 of the Odrich Patent recites:
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`“A method for administering an active agent to a subject using a
`punctal plug, the method comprising:
`inserting the punctal plug into a punctal aperture of the subject,
`wherein the composition of the punctal plug comprises:
`a) an active agent selected from the group consisting of topical
`prostaglandin; latanoprost; travoprost; bimatoprost; a medication for
`treatment of a corneal
`infection; ciprofloxacin; moxifloxacin;
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`1 The Odrich Patent issued from U.S. Patent Application No. 14/472,844 (“the ’844
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`application”), filed on August 29, 2014. The ’844 application claims the benefit
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`of priority through a number of intervening continuing and/or divisional
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`applications to U.S. Patent Application No. 10/825,047, filed on April 15, 2004.
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`U.S. Patent No. 9,463,114
`gatifloxacin; a systemic medication; a medication for treating
`hypertension; atenolol; nifedipine; hydrochlorothiazide; and a
`medication for treating allergic conjunctivitis, and
`b) a porous or absorbent material, and
`wherein the shape of the punctal plug consists of a constant
`diameter cylinder configured to be inserted into a canalicular puncta
`of the subject.”
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`As discussed below, until the Odrich Patent, there was no punctal plug that
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`disclosed or suggested punctal plugs with the following features, as identified in
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`italics in claim 1 above, and their accompanying benefits:
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` Made of porous or absorbent material such as a hydrophilic polymer;
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` Contains an active agent; and
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` Cylindrical in shape having a constant diameter and configured for insertion
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`into the punctum.
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`Fig. 2 of the Odrich Patent, reproduced below with annotations, illustrates such a
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`punctal plug (the cylindrical punctal plug with a constant diameter highlighted in
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`yellow).
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`U.S. Patent No. 9,463,114
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`(Annotated)
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`Accordingly, Odrich’s cylindrical punctal plugs may be inserted in the
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`punctal aperture to deliver an active agent to the eye and the nasolacrimal system.
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`Ex. 1001, Odrich Patent, 1:30, 3:18. Despite over 200 prior art references
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`considered during examination, no prior art punctal plugs achieved such a benefit.
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`Indeed, the Examiner appreciated the benefits and non-obviousness of Odrich’s
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`invention. In his Reasons for Allowance, the Examiner concluded that:
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`Therefore the insertion of cylindrical drug releasing implant of
`constant diameter for the entire length without a flange or other
`portion of greater diameter into the punctum of a subject is non-
`obvious.
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`U.S. Patent No. 9,463,114
` THOROUGH EXAMINATION OF THE ODRICH PATENT
`Petitioner has cited to numerous references (but has not relied on these
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`references
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`in
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`the Grounds) as showing
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`the evolution of punctal plugs.
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`Additionally, many of the cited references were considered during examination,
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`but were not relied on by the Examiner as being relevant to the claimed invention.
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`As noted by the Petitioner, punctal plugs have been used to treat ophthalmic
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`conditions since the 1960s and have evolved over time into plugs of different
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`shapes comprising different materials. Ex. 1009, Foulds; Ex. 1012, Freeman; Ex.
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`1013, Cohan. While this is true, the art2 has failed to develop a method of
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`delivering active agents having the claimed features including: a cylindrical rod
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`made of porous or absorbent material, containing an active agent that is inserted
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`into the punctum and providing the benefit of delivering the active agent to the eye
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`and the naso-lacrimal system. Nor had the FDA approved any such product having
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`the claimed features prior to Odrich’s filing date. As can be seen from the
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`discussion below, the documents referenced by the Petitioner and considered
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`2 During examination of the application for the Odrich Patent, the Examiner
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`considered over 200 prior art resulting in allowance and issuance of the Odrich
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`Patent. Ex. 1008, ‘844 FH.
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`U.S. Patent No. 9,463,114
`during examination of the application for the Odrich Patent do not provide or
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`suggest a punctal plug with the benefits provided by the claimed invention.
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`Punctal plugs of Freeman (Ex. 1012) (considered during examination) have
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`a large head portion that sits outside the top of the punctum to prevent the entire
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`plug from passing to the nose.
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`The rod-like plug is formed with an oversized tip or barb portion that
`dilates and blockingly projects into the canaliculus, a smaller neck or
`waist portion upon which the punctum sphincter ring tightens, and a
`relatively larger, smooth head portion which rests upon the top of the
`punctal opening and prevents the plug from passing down into the
`canaliculus. Ex. 1012, Freeman, Abstract
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`Figure 3A (reproduced below) provides a clear illustration of the disclosed punctal
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`plugs in Freeman.
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`The large head portion sitting above the punctum means that the plug is vulnerable
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`to patient manipulation and is easily dislocated. See Ex. 1029, Baxter at 2.
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`Furthermore, that large head portion causes unwanted irritation in certain patients
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`by rubbing against the eye and can build up debris and biofilm that harbor
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`microorganisms and cause infection. See id. at 3 and 7. Moreover, Freeman is
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`primarily concerned with delivering drug to the eye, not to the walls of the
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`canaliculus. “This invention relates to a punctum plug for… storing and delivering
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`medication to the eye.” Ex. 1012, Freeman at 1:8-14, see also id. 1:62-66, 2:64-65.
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`For this reason, the drug is contained within the large head portion that sits above
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`the punctum, not within the “middle neck or waist portion” of a smaller diameter.
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`Id. 5:8-14.
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`Similarly, Petitioner references another prior art, Cohan (Ex. 1013)
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`(corresponding PCT considered during examination).3 Unlike Odrich’s punctal
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`plugs, Cohan’s plugs have a portion (the flat disc-like collarette 26 and 40) that sits
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`above the punctal aperture and delivers drug to the eye. “This invention relates to
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`3 During prosecution, Patent Owner cited and the examiner considered the PCT
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`application WO-0062760 corresponding to Cohan (Ex. 1013). Ex. 1008, ‘844
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`FH.
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`U.S. Patent No. 9,463,114
`an ophthalmic insert and method for the sustained release of medication to the eye
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`for treatment of eye disorders.” Ex. 1013, Cohan, 1:12-14. See also id. 1:19-24,
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`2:23-35, 2:46-47, and 2:64-65.
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`Cohan’s plug includes a hollow body made of a medication-impermeable shell for
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`containing a reservoir 34 of the medication, which diffuses out of a pore 42 in the
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`collarette. Id. 4:28-45. Because the collarette sits outside of the punctum, it is
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`vulnerable to patient manipulation and can cause infection and irritation like the
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`Freeman plug. Moreover, because the drug moves out of the pore in the collarette,
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`Cohan’s plug is “designed to store and release medication onto the surface of the
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`eye” (id. 4:25-28), and not to the tissues of the canalicular walls.
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`Thus, while punctal plugs have been used for many years as is evidenced by
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`the thorough examination and consideration of the prior art, no plug had been
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`developed, at the time the Odrich Patent was filed, to deliver an active agent using
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`punctal plugs having a cylindrical rod made of porous or absorbent material,
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`IPR2019-00442
`U.S. Patent No. 9,463,114
`containing an active agent that is inserted into the punctum and provide the benefit
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`of delivering the active agent to the eye and the naso-lacrimal system.
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`Other ways to treat ophthalmic conditions include delivering drug directly to
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`the surface of the eye, such as with eye drops or ointment, or placing an ocular
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`insert under the eyelid between the sclera (the white outer layer of the eyeball) and
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`the palpebral conjunctiva (the inside lining of the eyelid). See Ex. 1005, Higuchi
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`and Ex. 1016, Darougar4. As is depicted in the figure below (Ex. 1024, Netter), the
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`anatomy of the eye between the eyeball and the eyelid has a completely different
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`structure, shape, and size than the punctum. Ocular inserts for placement between
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`the eyeball and the eyelid (e.g., into the so-called “sac” of the eye, or the fornix)
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`can be flat patches with a relatively large surface area (e.g., 4-20 mm in length, 1-
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`12 mm in width, 0.1-2 mm in thickness, see Ex. 1005, Higuchi), while punctal
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`plugs are generally small rods (e.g., 0.3 mm in diameter, see Ex. 1012, Freeman,
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`3:52-55).
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`4 Cited by the Examiner during prosecution of the application for the Odrich
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`Patent. Ex. 1008, ‘844 FH.
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`IPR2019-00442
`U.S. Patent No. 9,463,114
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`Needless to say, eye drops and ocular inserts placed in the “sac” are unsuitable for
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`delivering drug to the canaliculus wall tissue in a concentrated way because they
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`are delivered directly to the eye.
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`Accordingly, before the Odrich Patent, the art failed to teach or suggest a
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`method of delivering active agents using a cylindrical rod made of porous or
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`absorbent material containing an active agent that is inserted into the punctum and
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`provides the benefit of delivering the active agent to the eye and the naso-lacrimal
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`system.
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`PETITIONER’S PROPOSED LEVEL OF A POSITA IS IMPROPER
`Mati disputes Petitioner’s proposed level of skill for the person having
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`ordinary skill in the art (“POSITA”). Pet. at 18. Petitioner proposes that the
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`POSITA is “an ophthalmologist with several years of experience in the design,
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`U.S. Patent No. 9,463,114
`development, or use of drug delivery devices and/or ocular inserts.” Petitioner
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`does not identify or provide a range of number of years that would meet the
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`“several years” criterion. It is unclear whether Petitioner believes 3 years is
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`sufficient experience, or if the POSITA must have 30 years of experience.
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`Moreover, while is it likely that ophthalmologists have experience with the use of
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`drug delivery devices and/or ocular inserts, it is likely that many do not have
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`experience with the design or development of such devices. For these reasons, we
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`propose that a POSITA is a medical doctor specializing in ophthalmology or a
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`person having a doctorate degree in chemistry having at least 5 years of experience
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`in designing and developing drug delivery ocular inserts.
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` PETITIONER’S CLAIM CONSTRUCTION
`UNREASONABLE
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`“a medication for treatment of a corneal infection”
`Petitioner illogically construes the phrase “medication for treatment of a
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`FACIALLY
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`IS
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`corneal infection” to mean “one of a group of medications, including but not
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`limited to antibiotics, that can be used to treat corneal infections.” Pet. at 19-22.
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`The phrase is unambiguous and needs no construction.
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`Petitioner imports limitations from the specification to limit the type of
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`medication to antibiotics for treatment of corneal infections. Petitioner cites to the
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`Odrich Patent’s disclosure of exemplary antibiotics, “ciprofloxacin, moxifloxacin,
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`U.S. Patent No. 9,463,114
`or gatifloxacin” (Ex. 1001, 2:55-57), for its support. Pet. at 19. However,
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`Petitioner confusingly argues for an interpretation that is not limited to such
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`antibiotics.
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`In fact, Petitioner seems to agree that its construction is incomplete, by
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`suggesting a construction that is “not limited to antibiotics.” If the construction is
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`not limited to antibiotics, then there is no need to construe the term at all. The
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`phrase “a medication for treatment of a corneal infection” is clear on its face and
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`should be given its plain and ordinary meaning.
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` LAW ON ANTICIPATION AND OBVIOUSNESS
`A. Anticipation
`It is well settled law that in order to anticipate a claim under 35 U.S.C. §
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`102, a prior art reference must not only disclose all elements of the claim within
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`the four corners of the document, but must also disclose those elements “arranged
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`as in the claim.” Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir.
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`1983). The test is more accurately understood to mean “arranged or combined in
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`the same way as in the claim.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359,
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`1370 (Fed. Cir. 2008). Thus, unless a prior art reference “discloses within the four
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`corners of the document not only all of the limitations claimed but also all of the
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`limitations arranged or combined in the same way as recited in the claim, it cannot
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`U.S. Patent No. 9,463,114
`be said to prove prior invention of the thing claimed and, thus, cannot anticipate
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`under 35 U.S.C. § 102.” Id. at 1371.
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`Moreover, in a case in which the prior art reference merely discloses a genus
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`and the claim at issue recites a species of that genus, the issue of anticipation turns
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`on whether the genus was of such a defined and limited class that one of ordinary
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`skill in the art could “at once envisage” each member of the genus. Eli Lilly & Co.
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`v. Zenith Goldline Pharms., Inc., 471 F.3d 1369, 1376 (Fed. Cir. 2006).
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`B. Obviousness
`The obviousness inquiry involves four factual determinations: (1) the scope
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`and content of the prior art; (2) the differences between the prior art and the
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`claimed invention; (3) the level of ordinary skill in the pertinent art; and (4)
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`additional evidence, which may serve as indicia of obviousness or non-
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`obviousness. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 1742
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`(2007) (affirming the factors of Graham v. John Deere Co., 383 U.S. 1, 17, 148
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`U.S.P.Q. 459, 466-67 (1966)). The obviousness analysis requires a determination
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`of whether “the differences between the subject matter sought to be patented and
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`the prior art are such that the subject matter as a whole would have been obvious at
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`the time the invention was made to a person having ordinary skill in the art.” Eli
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`Lilly & Co. v. Teva Pharms. USA, Inc., 619 F.3d 1329, 1336, (Fed. Cir. 2010).
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`Under KSR, a court must ask whether the improvement is more than the
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`predictable use of prior art elements according to their established functions. KSR
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`Int’l Co., 127 S. Ct. at 1740. Such an inquiry may require a court to look to
`
`“interrelated teachings of multiple patents; the effects of demands known to the
`
`design community or present in the marketplace; and the background knowledge
`
`possessed by a person having ordinary skill in the art.” Id. The Court held that:
`
`In determining whether the subject matter of a patent claim is obvious,
`neither the particular motivation nor the avowed purpose of the
`patentee controls. What matters is the objective reach of the claim. If
`the claim extends to what is obvious, it is invalid under § 103. One of
`the ways in which a patent’s subject matter can be proved obvious is
`by noting that there existed at the time of invention a known problem
`for which there was an obvious solution encompassed by the patent’s
`claims.
`
`Id. When there is a design need or market pressure to solve a problem and there
`
`are a finite number of identified, predictable solutions, a person of ordinary skill
`
`has good reason to pursue the known options within his or her technical grasp. If
`
`this leads to the anticipated success, it is likely the product not of innovation but of
`
`ordinary skill and common sense. Id. at 1742-44.
`
`The Federal Circuit has also held that KSR did not create a presumption that
`
`all experimentation in fields where a background of useful knowledge already
`
`
`
`16
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`
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`IPR2019-00442
`U.S. Patent No. 9,463,114
`exists is “obvious to try” without considering the nature of the science or
`
`technology. Abbott Labs. v. Sandoz Inc., 544 F.3d 1341, 1352 (Fed. Cir. 2008).
`
`Moreover, “[e]vidence of obviousness, especially when that evidence is proffered
`
`in support of an ‘obvious-to-try’ theory, is insufficient unless it indicates that the
`
`possible options skilled artisans would have encountered were ‘finite,’ ‘small,’ or
`
`‘easily traversed,’ and that skilled artisans would have had a reason to select the
`
`route that produced the claimed invention.” In re Cyclobenzaprine Hydrochloride
`
`Extended-Release Capsule Patent Litigation, 676 F.3d 1063, 1072-73, (Fed. Cir.
`
`2012).
`
`Courts have also repeatedly emphasized
`
`that, when conducting an
`
`obviousness analysis, objective indicia of nonobviousness constitute “independent
`
`evidence of nonobviousness.” Pressure Prods. Med. Supplies, Inc. v. Greatbatch
`
`Ltd., 599 F.3d 1308, 1319 (Fed. Cir. 2010).
`
` THE BOARD SHOULD NOT INSTITUTE THE IPR
`An inter partes review may not be instituted unless the information
`
`presented in the petition shows that “there is a reasonable likelihood that the
`
`petitioner would prevail with respect to at least one of the claims challenged in the
`
`petition.” 35 U.S.C. § 314(a). The Petition fails to demonstrate that the claims are
`
`anticipated by Schmitt or that the claims are obvious from Schmitt combined with
`
`any of the secondary references.
`
`
`
`17
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`
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`IPR2019-00442
`U.S. Patent No. 9,463,114
`A.
`Petitioner Misapplies The Prior Art
`
`Schmitt Does Not and Cannot Anticipate
`Schmitt (Ex. 1004), Petitioner’s primary reference for all Grounds, fails. As
`
`an initial matter, a divisional of Schmitt was considered, but not applied during
`
`prosecution of the Odrich Patent.5 Under 35 U.S.C. § 325(d), “the Director may
`
`take into account whether, and reject [a] petition or request because, the same or
`
`substantially the same prior art or arguments previously were presented to the
`
`Office.” When a Petition presents substantially the same art or arguments as those
`
`previously presented to the Office, the board has exercised its discretion under 35
`
`U.S.C. § 325(d) to deny institution of an inter partes review. Ziegman v. Stephens,
`
`IPR2015-01860, Paper 11 (PTAB February 24, 2016). Here, substantially the
`
`same prior art was before the Office, but the Odrich Patent was considered to be
`
`novel and non-obvious in view of substantially the same art.
`
`
`
`5 During examination of the application for the Odrich Patent, Patent Owner cited
`
`and the Examiner considered U.S. Patent No. 5,826,584, which is the divisional
`
`of Schmitt and shares the same specification as Schmitt. Ex. 1008, ‘844 FH at
`
`2015-08-28 List of References Cited by Applicant and Considered by
`
`Examiner, Sheet 3 of 8, dated August 21, 2015.
`
`
`
`18
`
`
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`IPR2019-00442
`U.S. Patent No. 9,463,114
`As the title of Schmitt suggests, Schmitt is to a “cast-in place thermoplastic
`
`channel occluder.” Schmitt describes injecting a flowable thermoplastic polymer
`
`into a channel in a given subject and allowing the polymer to solidify in situ,
`
`thereby occluding or blocking the channel.
`
`The essence of the invention relates to blocking channels within
`things, living mammals or human beings in order to prevent
`movement of a substance into or out of a channel within that host
`using a material that both flows and solidifies within the very narrow
`temperature band defined by (1) the normal temperature of the host
`and (2) the temperature at which thermal damage is done to the walls
`of the channel thereby obtaining beneficial effects.” Ex. 1004,
`Schmitt, 9:35-42, emphasis added.
`
`Schmitt summarizes multiple advantages of injecting a flowable polymer
`
`into a channel and allowing that polymer to solidify in situ. Most of those
`
`advantages center around the “perfect fit” that is achieved between the solidified
`
`plug and the channel wall, by ensuring that the flowable polymer can fill in the
`
`space of the channel:
`
`Another important advantage of the present invention is that because
`the channel occluder is formed in situ against the channel wall, a
`perfect fit is achieved between the plug and the wall thus assuring that
`no passage of any biological fluids or substance will be allowed. Id.,
`5:53-57 (emphasis added).
`
`
`
`19
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`
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`IPR2019-00442
`U.S. Patent No. 9,463,114
`Another important advantage of the present invention is that because
`the channel occluder is formed in situ against the channel wall, a
`perfect fit is achieved between the plug and the normally convoluted
`wall thus assuring that no movement of the plug will occur with time.
`Id., 5:58-62 (emphasis added).
`
`Another important advantage of the invention is that any variation in
`the size of the channel from one subject to another can be
`accommodated because the flowing preplug completely fills the
`lumen of the channel before it solidifies. There is no need to match a
`specific internal diameter with different sized plugs. There will always
`be a perfect fit. Id., 6:5-10 (emphasis added).
`
`Another advantage of the present invention is that the channel
`occluder takes on a shape which conforms with the size and shape of
`the channel being blocked, providing a secure, uniform fit within the
`duct channel without substantial dilation of the duct channel. Id.,
`6:33-38 (emphasis added).
`
`An important advantage of the present invention is that the channel
`occluder can be formed in situ in the lumen of the channel with a
`minimum degree of trauma to the patient. Id., 5:49-51 (emphasis
`added).
`
`Schmitt provides a multitude of reasons for one to form the plug in situ against the
`
`channel wall, the primary reason being to ensure a “perfect fit” with the channel.
`
`
`
`20
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`
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`IPR2019-00442
`U.S. Patent No. 9,463,114
`That perfect fit is beneficial because it ensures that: (1) no fluid passes through the
`
`plug (id., 5:53-57); (2) the plug cannot move (id., 5:58-62); (3) there is no need to
`
`use plugs of different sizes (id., 6:5-10), (4) there is no substantial dilation (id.,
`
`6:33-38), and (5) minimal trauma occurs (id., 5:49-51).
`
`Schmitt describes blocking the canalicular channel to treat dry eye by
`
`blocking the tear ducts to reduce the amount of tears that are drained away, thereby
`
`maintaining a sufficient amount of tears on the surface of the eye. See id., 11:48-
`
`64. While Schmitt refers to composite materials as including a biologically active
`
`substance, Schmitt does not use any material having a biologically active substance
`
`to form a plug within the canalicular channel. In other words, Schmitt does not
`
`teach, disclose, or suggest, using a drug to treat dry eye. According to Schmitt, the
`
`presence of a occluder (with no drug) that completely blocks the canalicular
`
`channel is sufficient to treat dry
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