Patent Owners’ Demonstratives
`MicroSurgical Technology, Inc.
`The Regents of the University of California
`
`IPR Nos. 2020-01573, 2020-01711, 2021-00017, 2021-00065, 2021-00066
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`1
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`Patent Owner Ex. 2034
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`01573 (’729)
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`00017 (’885)
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`01711 (’155)
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`00065 (’905)
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`00066 (’544)
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`Specification
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`Claim
`Elements
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`same
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`ab interno
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`dual blade
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`ab interno
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`dual blade
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`concurrently cutting
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`ab interno
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`dual blade
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`knife blades
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`ab interno
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`protruding tip
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`tip
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`blunt protruding tip
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`tip
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`tip
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`Quintana
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`Prior Art
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`Quintana + Lee
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`Quintana
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`Jacobi
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`Jacobi
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`blunt top edge
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`Quintana
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`Quintana +Lee
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`Jacobi
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`protector member
`(upwardly sloping incline)
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`foot member
`(angled platform)
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`Quintana
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`Jacobi
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`Quintana
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`Jacobi
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`’729 Patent, -01573
`’885 Patent, -00017
`’155 Patent, -01711
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`Ex. 1001
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`’729 Patent 3:10-17
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`’729 Patent 3:44-50
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`’729 Patent 4:61-67
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`’155 Patent, -01711 Ex. 1001
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`’155 Patent 6:57-63 (Claim 1)
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`’905 Patent, -00065 Ex. 1001
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`’905 Patent 9:2-4
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`’905 Patent 9:9-17
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`’905 Patent 14:21-25 (Claim 1)
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`’544 Patent, -00066 Ex.1001
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`’544 Patent 9:24-27
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`’544 Patent 13:43-45
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`’544 Patent 13:53-58
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`’544 Patent 23:8-11 (Claim 1)
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`Ex. 1004 (Quintana)
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`Ex. 1004 (Quintana)
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`Mc heifer i
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`Implitie
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`Quintana, p. 3 of 9
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`IPR2020-01573 Paper 29 at 1-6, 12-22, 24-39, 42- 45, 48, 54-55; 2020-01711 Paper 17 at 1-7, 20-44, 47-50, 54, 57;
`2021-00017 Paper 17 at 1-5, 10-34, 38; 2021-00065 Paper 18 at 1-4, 11-31; 2021-00066, Paper 17 at 1-3, 5, 12-46.
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`Quintana, p. 3 of 9
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`IPR2020-01573 Paper 29 at 1-6, 12-22, 24-39, 42- 45, 48, 54-55; 2020-01711 Paper 17 at 1-7, 20-44, 47-50, 54, 57;
`2021-00017 Paper 17 at 1-5, 10-34, 38; 2021-00065 Paper 18 at 1-4, 11-31; 2021-00066, Paper 17 at 1-3, 5, 12-46.
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`Quintana, p. 4 of 9
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`IPR2020-01573 Paper 29 at 1-6, 12-22, 24-39, 42- 45, 48, 54-55; 2020-01711 Paper 17 at 1-7, 20-44, 47-50, 54, 57;
`2021-00017 Paper 17 at 1-5, 10-34, 38; 2021-00065 Paper 18 at 1-4, 11-31; 2021-00066, Paper 17 at 1-3, 5, 12-46.
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`Quintana, p. 4 of 9
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`IPR2020-01573 Paper 29 at 1-6, 12-22, 24-39, 42- 45, 48, 54-55; 2020-01711 Paper 17 at 1-7, 20-44, 47-50, 54, 57;
`2021-00017 Paper 17 at 1-5, 10-34, 38; 2021-00065 Paper 18 at 1-4, 11-31; 2021-00066, Paper 17 at 1-3, 5, 12-46.
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`Quintana, p. 5 of 9
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`IPR2020-01573 Paper 29 at 1-6, 12-22, 24-39, 42- 45, 48, 54-55; 2020-01711 Paper 17 at 1-7, 20-44, 47-50, 54, 57;
`2021-00017 Paper 17 at 1-5, 10-34, 38; 2021-00065 Paper 18 at 1-4, 11-31; 2021-00066, Paper 17 at 1-3, 5, 12-46.
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`Quintana, p. 8 of 9
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`IPR2020-01573 Paper 29 at 1-6, 12-22, 24-39, 42- 45, 48, 54-55; 2020-01711 Paper 17 at 1-7, 20-44, 47-50, 54, 57;
`2021-00017 Paper 17 at 1-5, 10-34, 38; 2021-00065 Paper 18 at 1-4, 11-31; 2021-00066, Paper 17 at 1-3, 5, 12-46.
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`NO. 6
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`MICROSURGERY OF SCHLEMM’S CANAL AND THE HUMAN
`rimental procedure,
`.
`AQUEOUS OUTFLOW SYSTEM
`
`
`measurement sul
`Morray A, Jounstons, M.D., AnD W. Morton Grant, M.D.
`of eyes was perfused
`
`
`Boston, Massachisetts
`
`internal cystotome trabeculotomy, by
`One basis for some of the present ap-
`terno probing of Schlemm’s canal wit
`Proaches to microsurgery of Schlemm’s ca-
`
`
`nal is the finding by Grant?? that approxi-
`and metal probes, and by causing th
`
`mately 75% of the resistance of the aqueous
`to rupture from the canal into theant
`
`nal
`sections
`contai:
`
`outflow system could be eliminated in per-
`chamberasin current clinical practic
`
`fuséd enucleated human eyes by providing
`.
`:
`
`tures were excised. W
`% osmium tetroxide,
`an opening from the anterior chamber into
`PROCEDURES AND METHODS
`
`
`
`
`QuantitativetrabeculotomySchlemm’s canal by internal aqueous_perfusi
`
`
`with a cystotome, and that
`in open-angle. made measurements before and after.
`
`
`glaucomatous
`eyes, abnormal
`resistance mental dissections as
`follows. W.
`could be eliminated in the same way. Much
`enucleated normal eyes obtained al
`
`earlier, Barkan*® showed that open-angle
`
`at 4°C in a moist environmentuntil
`
`glaucoma could berelieved in adults by an
`utes prior to perfusion, which was s
`
`
`internal
`trabeculotomy with a goniotomy
`to 48 hours post mortem. After 3
` equal parts of 1
`
`
`
`knife. The effect of the Barkan trabeculot-
`from refrigeration, we placed the:ey
`4% glutaraldehy
`
`omy procedure appears generally not
`to
`silicone rubber mold that enveloped.
`‘phosphate buffer (p
`sed in distilled wate
`
`have been long lasting. The cystotome labo-
`terior Segment to the equator. We
`ratory procedure has not been readily adapt-
`the anterior segment with absorben
`
`in isopentane, and chi
`able to clinical use, but recently Bietti and
`saturated in perfusion fluid, An ope
`itrogen. The frozen
`for three hours und
`Quaranta® have reported clinical successes mm in diameter wastrephined in
`
`d the freeze-dried
`by internal trabeculotomy with another type
`of the cornea to give access to th
`of cutting instrument.
`’
`chambét and the inner angle. Except
`id 40% palladium. A
`stored enucleated
`
`Other procedures have been devised and
`special group of eyes, we regulat
`
`applied clinically with ‘the aim of reducing
`formed a radial iridotomy throug!
`lity generally prepare
`
`ination-of fine deta
`resistance to aqueous outflow by surgery on
` phine opening to preventartificial
`
`Schlemm’s canal,
`in particular ab externo
`of the chamber. For quantitative
`in demonstrating th
`trabeculotomy procedures, but
`their effects
`perfusion, we used Barany’st con:
`features in control :
`
`have not beén evaluated in the same experi-
`sure technique, with a comniercial
`$s alterations resulti
`
`mental manner as those of internal cysto-
`tered, phosphate-buffered balanced
`ion procedures.
`
`tome trabeculotomy.
`-
`tion containing glucose. Weinfuse
`tions and surgical
`Thepresent study was carried out to com-
`lution into the anterior chamber ¢
`
`al cystotome trabecu
`Pare in postmortem enucleated human eyes
`stainlesssteelfitting (previously de:
`in 180 degrees of th
`
`the changes induced in the structure and which sealed the opening in the coi
`ame manner as by
`
`n
`and Grant® T
`function of the trabecular meshwork and
`generally measured steady state fl
`the 5-mm corneal t
`
`Schlemm’s canal aqueous outflow system by maintaining intraocular pressure a
`
`rect visualization w:
`From the Howe Laboratory of Ophthalmology
`TH&butin certain instances at 5,
`of Harvard Medical School, at Massachusetts Eye ™m Hg. The measurements made bel
`
`pe at 25 to 40X mz
`
`and Ear Infirmary, Boston, Massachusetts. Thisstudy was supported by Public Health Service cen-
`
`experimental procedure required+ i
`
`‘a cystotome with th:
`ter grant §-PO1-EY000292,training grant 5-TO1. ately ten minutes of perfusio
`angles to the shaft.
`
`EY-00018, and research grant 5-ROI-EY-00002 what appeared to be a steady stal
`om within the ar
`_ from the National EyeInstitute.
`
`
`manipulation or dissection, we ca’
`the
`trabecular
`h
`
`
`Reprint
`requests to W. Morton
`Grant, M.D.,
`‘ani
`,
`.
`flo
`
`
`’s canal, and passec
`Similar perfusion and monitored flov
`Howe Laboratory of Ophthalmology, 243 Charles
`120 minutes. If the same eye under
`St. Boston, MA:02114.
`ircumferentially, with
`
`906
`ner - New World Medical
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`Ex. 1005,p. 1 of 12
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`Ex. 1005 (Johnstone)
`Ex. 1005 (Johnstone)
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`Complex Cases,
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`Simplified’
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`Johnstone, p. 1 of 12
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`IPR2020-01573 Paper 29 at 37, 45, 55; 2020-01711 Paper 17 at 41-42, 50; 2021-00017 Paper 17 at 31.
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`Johnstone, p. 1 of 12
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`IPR2020-01573 Paper 29 at 37, 45, 55; 2020-01711 Paper 17 at 41-42, 50; 2021-00017 Paper 17 at 31.
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`Johnstone, p. 2 of 12
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`IPR2020-01573 Paper 29 at 37, 45, 55; 2020-01711 Paper 17 at 41-42, 50; 2021-00017 Paper 17 at 31.
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`Johnstone, p. 2 of 12
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`IPR2020-01573 Paper 29 at 37, 45, 55; 2020-01711 Paper 17 at 41-42, 50; 2021-00017 Paper 17 at 31.
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`Johnstone, p. 5 of 12
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`IPR2020-01573 Paper 29 at 37, 45, 55; 2020-01711 Paper 17 at 41-42, 50; 2021-00017 Paper 17 at 31.
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`Johnstone, p. 11 of 12
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`IPR2020-01573 Paper 29 at 37, 45, 55; 2020-01711 Paper 17 at 41-42, 50; 2021-00017 Paper 17 at 31.
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`Ex. 1006 (Lee)
`Ex. 1006 (Lee)
`
`4,900,300
`[11] Patent Number:
`United States Patent 1
`
`[45] Date of Patent: Feb, 13, 1990
`Lee
`SURGICAL INSTRUMENT
`4,689,040
`8/1987 Thompson
`. 604/22
`FOREIGN PATENT DOCUMENTS
`Inventor: David A. Lee, 2868 Nicada Dr., #48,
`2450597 11/1980 France
`w+ 128/757
`Los Angeles, Calif. 90077
`Appl. No. 315,190
`Primary Examiner—C. Fred Rosenbaum
`Assistant Examiner—kathieen A. Daley
`Filed:
`Feb, 24, 1989
`Attorney, Agent, or Firm—DavidSilverstein
`Related U.S. Application Data
`[7]
`ABSTRACT
`Contination of Ser. No. 70,325, Jul. 6, 1987, aban-
`This invention relates to the design and application of a
`doned.
`goniectomy instrument for the purpose of diagnosti-
`we AGLB 17/20
`cally andtherapeutically removingtissuefrom the ante-
`604/22; 606/162;
`tior chamber angle of the eye and for retrieving this
`606/166
`tissue for further examination. The surgical instrument
`Field of Search
`604/22, 27, 28;
`of this invention comprises in combination: a hollow,
`305, 321, 757-758
`,
`tapered, shaft having a cutting edge at one end as an
`References Cited
`integral part
`thereof; a retractable stylet contained
`within the hollow interior of the tapered shaft; and an
`U.S. PATENT DOCUMENTS
`irrigation port running along the outside of the tapered
`3,542,031 11/1970 Taylor
`shaft. This instrumentis useful for excising tissue to
`4,011,869
`3/1977 Seiler,Jr.
`relieve ai obstruction blocking the outflow of aqueous
`4,043,322
`8/1977 Robinson
`humorfrom the eye as well as for providing specimens
`4,210,146
`7/1980
`of the excised tissue for histopathological examination.
`4,220,155
`9/1980
`4,577,629
`3/1986
`4,655,743
`4/1987
`24 Claims, 1 Drawing Sheet
`
`
`
`1 of 11
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`Complex Cases,
`Simplified’
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`Petitioner- New World. Medical
`Ex. 1006, p.
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`Lee, p. 4 of 11
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`IPR2020-01573 Paper 29 at 3-4, 38-44; 2020-01711 Paper 17 at 3-4, 44-50; 2021-00017 Paper 17 at 31, 41;
`2021-00065 Paper 18 at 3, 18, 36, 38; 2021-00066, Paper 17 at 4, 25-26, 37, 47-48.
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`Lee, p. 5 of 11
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`IPR2020-01573 Paper 29 at 3-4, 38-44; 2020-01711 Paper 17 at 3-4, 44-50; 2021-00017 Paper 17 at 31, 41;
`2021-00065 Paper 18 at 3, 18, 36, 38; 2021-00066, Paper 17 at 4, 25-26, 37, 47-48.
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`Lee, p. 5 of 11
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`IPR2020-01573 Paper 29 at 3-4, 38-44; 2020-01711 Paper 17 at 3-4, 44-50; 2021-00017 Paper 17 at 31, 41;
`2021-00065 Paper 18 at 3, 18, 36, 38; 2021-00066, Paper 17 at 4, 25-26, 37, 47-48.
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`Ex. 1007 (Jacobi 1997)
`Ex. 1007 (Jacobi 1997)
`
`Brskiiziineraa of Opftaobmkyy 1397361 202-207
`
`Technique of goniocurettage: a potential
`treatment for advanced chronic open angle
`glaucoma
`
`Philipp © Jacobi, Thora 5 Detkin, Garter K Kriegistein
`
`Ex. 100, p.1 of &
`
`Abstract
`sfe—Tointrodyce a Tewconcept of ante-
`rior charoter ange microsurgery, de-
`signed to scrape pathologically altered
`trabecularmeshevork from the scleralsul-
`ces as a potential treatrrent in primary
`opan angle glaycoma,
`Methods—G onioscopically controled ab
`interne abrasion of the trabecular mesh-
`mainstay of surgioal
`treatment
`to contre
`work was performed on six harman eve
`Souenoen @pucooafilteringsuger & the
`intmccuhr passim (OP) in pomer: open
`banking eves for rerphologieal analysis,
`angle ghecomaTher £ a rowingtendto
`‘Thereafter, four ses sutering from ter-
`petioon swgery eadier
`in the coume of
`Tainal glaucomatous optic terse atrophy
`coma management” However despite
`as
`a result of medically encontrolled
`TherersingsyocessFates,especially with the we
`intvaccular presse were also treated by
`of adjunct antinetabolite, several probleme
`‘gondocmettage’, The Tewk desigred
`remain, such ae hyphaema, flat anterior chan
`instrament reserobles a modified cyclo-
`ter, and variable wound healingresponse to
`diakesis spatula with a bowl-chaped tip,
`conpunetival inadpaktion. In order to wold
`200 pro in diameter, ancl with its edges
`thePittervarious techniques have been ivesti-
`sharpened The treatment zone com-
`gpted that minimise conjunctive dissection to
`prised 45 clock hours of the chamber
`Toprove the success mite of fittation surgery.
`angk cite arference,
`Laser sclerotomy hae recenth:
`become @ viadle
`Beswlee—Microse opic sraroination of the
`alternative 10 conmentional
`coc Foticn
`treatroent tore revealed that in addition
`toa complete disruption ofthe trabecular
`teen reported usingditterent keerspsternsand
`taestovork atcinternal wall of Schlerara’s
`Fae However, eyingsuccess Inter have
`techniques." ” Based on the ecncept ofabnor-
`canal goniccurattags ako caused damage
`mal resistance b ovtiiow ofaquecus amour
`tointyac analicular septa. A splitting along
`the posterior wall of Schlerom’s canal was
`meshworls
`extemo tiabe-
`also noted in ore specitoen, The clinical
`= atest Ofaueievectierictthe Tatecuar
`eae moSeSen ae
`data of goniocurettage also showed some
`poemecmonended a surgical procedure of
`promising results. Mean pretreatment
`choice in juvenile open ange ghecorn, In
`TOP averaged 40.7 (SD &#) ran Hy (range
`TEcent pear, tabecwlotomy har again eceved
`#51 Tam Hg) and was significarely
`TereEIterest amongsonegewoon sur-
`
`(TH0.08) reduced to 18.0 (42) mm He
`wensa 8 first choice surgical teatment of
`(12-2 moro Hg)after 6 raonths, represent-
`open age
`° incding
`ing an absolate decrease in [OP of 22.9
`chnivedSengrecommand catamct surgery*
`mm Hg and a mean decrease in IOP of
`Bwed on tensmisin and scanningeko-
`50¥., Clinically significant hyphaema oc-
`Won Ieoercenopy of trabecwectomny specmmnens
`curred in one ai, camsed by iatrogenic
`serious authors hase suggested that i macet
`trauma to a prominent charnher angle
`once: of chime open angle gauccona the
`sessel, In thite eyes a minor reflex of
`poecy incmeme of outflow resistance Hes in
`blood cccurred at
`the treatment site,
`the cobriform Ryer of the tebecular mnesh-
`However, no Tgpotony, chor cidal effusion,
`woretjecent to theinner well endothelrm of
`flattened anterior chamber, or cxclocdiakr-
`Scheron’s canal.'*? Presumingthat the oyter
`sis were observed inthese patients,
`gers of the traboculr meshwork play the Jey
`Coorcfestoor—Morphological analsis
`of
`woke in the pathology of primary open angle
`treated postmortem eyes
`confirmed
`incbional swepry
`‘| Or
`that goniocwmettage completehr remained
`Teechaical diryption (tebecwotorp) of the
`trberuke meshwork could then be avalid cur-
`the trabecdlar meshwork amd opered
`Schlerom’s canal, ensuring direct ances
`gieal approsch to medically uncontmlled open
`into the amterior charmber, In a small
`ange eawcoma Undortunately, siraple drip
`tom of the tbeculr meshwork with the
`amber of patients over a limited period
`of tite this Tew surgical procedure re-
`tTabeculotongy appmoech or punching sal
`sulted in a clinically significant pressure
`Ide: with the @ switchel NaA¥AG lmer
`Retitioner~ New lllorkd Medical
`
`Departoentof
`Ophthahackay,
`University E
`Har pitdGalbgne,
`Berman
`PowTS Detkin
`OK Koegktin
`‘Seccepandenct be
`FC JacebipJAD, Tei
`Eye Heaptd 28 Cslegne,
`Sblzvenndcst 4,
`iLCologne:Gooner,
`eccepted fox publicadion
`1A Decorate 1996,
`
`and a greater amberof
`patients are war-
`reduction However,Loryopr. tert follow ap
`ratted before this axperinental proce-
`dare is applicable to ayes that would do
`well with comaentional surgery.
`(Bef Olathe) 999361 302-307)
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`Complex Cases,
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`Jacobi 1997, p. 2 of 6
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`IPR2020-01573 Paper 29 at 4-6, 45-55; 2020-01711 Paper 17 at 4-6, 50-60; 2021-00017 Paper 17 at 3-5, 31-43;
`2021-00065 Paper 18 at 3-4, 31-38; 2021-00066, Paper 17 at 4-5, 37, 39-48.
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`2021-00065 Paper 18 at 3-4, 31-38; 2021-00066, Paper 17 at 4-5, 37, 39-48.
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`IPR2020-01573 Paper 29 at 4-6, 45-55; 2020-01711 Paper 17 at 4-6, 50-60; 2021-00017 Paper 17 at 3-5, 31-43;
`2021-00065 Paper 18 at 3-4, 31-38; 2021-00066, Paper 17 at 4-5, 37, 39-48.
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`IPR2020-01573 Paper 29 at 4-6, 45-55; 2020-01711 Paper 17 at 4-6, 50-60; 2021-00017 Paper 17 at 3-5, 31-43;
`2021-00065 Paper 18 at 3-4, 31-38; 2021-00066, Paper 17 at 4-5, 37, 39-48.
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`IPR2020-01573 Paper 29 at 4-6, 45-55; 2020-01711 Paper 17 at 4-6, 50-60; 2021-00017 Paper 17 at 3-5, 31-43;
`2021-00065 Paper 18 at 3-4, 31-38; 2021-00066, Paper 17 at 4-5, 37, 39-48.
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`IPR2020-01573 Paper 29 at 4-6, 45-55; 2020-01711 Paper 17 at 4-6, 50-60; 2021-00017 Paper 17 at 3-5, 31-43;
`2021-00065 Paper 18 at 3-4, 31-38; 2021-00066, Paper 17 at 4-5, 37, 39-48.
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`IPR2020-01573 Paper 29 at 4-6, 45-55; 2020-01711 Paper 17 at 4-6, 50-60; 2021-00017 Paper 17 at 3-5, 31-43;
`2021-00065 Paper 18 at 3-4, 31-38; 2021-00066, Paper 17 at 4-5, 37, 39-48.
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`IPR2020-01573 Paper 29 at 4-6, 45-55; 2020-01711 Paper 17 at 4-6, 50-60; 2021-00017 Paper 17 at 3-5, 31-43;
`2021-00065 Paper 18 at 3-4, 31-38; 2021-00066, Paper 17 at 4-5, 37, 39-48.
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`Ex. 1013 (Jacobi 2000)
`Ex. 1013 (Jacobi 2000)
`
`PHILIPP © JACOBI, THOMAS S. DIETLEIN,
`CUNTER K, KRIEGLSTEIN
`
`antericr chambers, prolonged pos‘-ozerative
`hypoteny andlate endophthalmitis from
`infected filtering, blebs.2?
`Mircosurgery on Schlemm’s canal andthe
`human aqueous outflow system for controlling
`intrancular pressure (IOP) in chronic epen-
`angle glaucomahas beenevolvingover the past
`few decades. Theoretical considerations indicate
`that sroduction of approximately10 to 15
`fistulae, each 1U wm in diameter, betweenthe
`anterior chamber and Schlemm’s canal should
`restore normal outflowfacility in cpen-angle
`glavcoma.* The basis for :nost of the current
`approachesta microsurgery of Schlemm’s canal
`is the finding by Grant? +hatthe largest
`proportion of resistance 4otfiny is located
`within the trabecular meshwork, namely the
`cribriform layer, and can be eliminated by
`incising the trabecular meshwork andentering
`Schlemm’'s canal. If one agreesthatthe site of
`+he pathologicalresistance to aqueous humour
`outflowis this tissze,its partial removal, taking
`+he utmost possitle care not to damage the
`sauroundingchamberangle structares, could be
`a new altemative in antiglaucomatous surgery.
`This sor! of selective non-enetrating trabecular
`surgery would be equivalent to internal
`filtration surgerywithout transscleral drainage
`uf aquevus humuur inte the subscunjanctival
`szace, and wouldthereby reduce the incidence
`af post-operative conrylicationstypically
`associated with filtering procedures.
`Ihis review discusses different ab interno
`trabecular microsurgical techniques‘hat are
`designed to facilitate outflowalongits natural
`pathway. Each new technique is described in
`detail newly develuped instn:mentation is
`discussed, and the presumed mechanisms of
`action are outlined. However, the reader must
`understandthat noneof these new
`microsurgical procedures threatensto replace
`conventional filtering approaches, since theyare
`still in the experimental phase and under
`careful clinical evaluation,and ‘hereis plenty of
`room keft for further refinements and
`developments. We hovethis article will give
`impetus to thy searchfor alternative strategies
`in antiglaucomatoussurgery, and foous
`attention more closely onthe diseased Larget
`structure in chronic open-angle glaucoma:the
`
`Pc. Jacobi
`TS. Diallein
`&.X. Kieglsein
`Univesity Eye Hospital
`Lniva’sity of Colegne
`Cologne, Germany
`Pailipp C. Jacobi, MD G3)
`Department o*
`‘Ophthalmology
`Lrivarsity of Colegne
`JoseprStelamanrstrasse 9
`0-50931 Cologne, Germany
`Ta: +49 221 478 4345
`Fax: +49 221 478 4347
`
`519
`Peticioner - New Werld Medial
`Cx. 1013,
`p.
`1 of 12
`
`trabecular meshwork
`
`Perspectives in
`trabecular surgery
`Abstract
`The aim of trabecular surgery is ta selectively
`combatthe diseased structure central to the
`pathogenesis of chronic open-angle glaucoma,
`therebyreducing potential hazards during and
`after conventional filtering procedures. This,
`overview considers new techniquesin ab
`interno trabecularsurgery. Special emphasis is
`placed on the description of each novel
`technique,its instrumentation, presumed
`mechanism of action and clinical results.
`‘Trabecularaspiration is evaluated as a method
`of clearingintertrabecular spacesof
`extracellular debris in pseudoexfoliation
`glaucoma with or without simultaneous
`cataract surgery or goniocurettage, while laser
`trabecular ablationis discussed forthe
`ireatment of absolule glaucomas. Where
`comealhaze has formed visualisation of the
`anterior chamber angle structures and
`trabecular surgeryis performed with the aid of
`amicroendoscope. Although the results are
`very promisingit should be understood that
`someof these proceduresare still in the
`experimental phase and are undergoing
`carefulclinical evaluation, leaving plenty of
`room for refinements and further
`developments.
`Key words Goniccurettage, Microendascopy,
`‘Trabecular aspiration, Trabecular photoablation
`
`Encrmous progress has been mae in
`understandingthe complexityof the underlying
`causes of chronic operrangle glaucoma.
`However, indissuiable conceptsfor effective
`treatmentare still rare. To date, conventional
`filtering surgery remains the mainstay of
`surgical therapy in the managementof
`glaucoma notcontrolled by medication?
`Unfortunately,treatments involving full-
`thickness filtration are scarcely selective since
`healthy structwaes not primarily involved in the
`disease process are subject to surgical
`intervention. The application of adjunctive
`antinetabulites for inhibition of undesired
`episcleral fibroblastic pro‘iferation dramatically
`increased the suc
`procedures, but had the disadvantage of
`exacerbating serious side-effects, such as flat
`Eye (2000) 14, 515-530 © 2000 Rayal CollegeofOphthalmologists
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`Jacobi 2000, p. 2 of 12
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`IPR2020-01573 Paper 29 at 46, 51, 55; 2020-01711 Paper 17 at 51; 2021-00017 Paper 17 at 35;
`2021-00065 Paper 18 at 32; 2021-00066, Paper 17 at 40-42.
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`Jacobi 2000, p. 2 of 12
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`IPR2020-01573 Paper 29 at 46, 51, 55; 2020-01711 Paper 17 at 51; 2021-00017 Paper 17 at 35;
`2021-00065 Paper 18 at 32; 2021-00066, Paper 17 at 40-42.
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`Jacobi 2000, p. 2 of 12
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`IPR2020-01573 Paper 29 at 46, 51, 55; 2020-01711 Paper 17 at 51; 2021-00017 Paper 17 at 35;
`2021-00065 Paper 18 at 32; 2021-00066, Paper 17 at 40-42.
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`Jacobi 2000, p. 2 of 12
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`IPR2020-01573 Paper 29 at 46, 51, 55; 2020-01711 Paper 17 at 51; 2021-00017 Paper 17 at 35;
`2021-00065 Paper 18 at 32; 2021-00066, Paper 17 at 40-42.
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`Jacobi 2000, p. 2 of 12
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`IPR2020-01573 Paper 29 at 46, 51, 55; 2020-01711 Paper 17 at 51; 2021-00017 Paper 17 at 35;
`2021-00065 Paper 18 at 32; 2021-00066, Paper 17 at 40-42.
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`IPR2020-01573 Paper 29 at 46, 51, 55; 2020-01711 Paper 17 at 51; 2021-00017 Paper 17 at 35;
`2021-00065 Paper 18 at 32; 2021-00066, Paper 17 at 40-42.
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`Jacobi 2000, p. 3 of 12
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`IPR2020-01573 Paper 29 at 46, 51, 55; 2020-01711 Paper 17 at 51; 2021-00017 Paper 17 at 35;
`2021-00065 Paper 18 at 32; 2021-00066, Paper 17 at 40-42.
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`Ex. 1018 (Ferrari)
`Ex. 1018 (Ferrari)
`
`European Journcl af Oprtheimalagy /Vol. 12:2 6, 2002 pp. 401-405
`
`
`Ab-interno trabeculo-canalectomy: surgical
`approach and histological examination
`E. FERRARI, F. BANDELLO’, F. ORTOLA NF, L. PETRELLP, M. MARCHINE, D. PONZIN®
`
`. Department of Ophthalmology. University of Udine
`: Department of Medical and Morphological Research, University of Udine
`+ Veneto Eye Bank Foundation, Venezia-Mestre- Italy
`
`Purrose. To evaluate, on eye bank eyes, a new surgical approach aimedat removing a quadrant of
`the trabecular meshwork (TM), with an ab intemo epproach.
`M=TH9ns. Gonioscopically controiied ab interno removal of the TM was done with a sub-
`retinal forcep on six human bank eyes. Serial histological sections were obtained from the
`treated and untreated part of each globe to assess the effect of the technique on intraoc-
`ular tissues.
`Resu.ts. Under the gonioscope,
`the TM was easily removedin strings of varying length.
`Histological examination showed, unexpeciedly,
`thai this resulted in a well-defined deep
`furrow in the middie of the trabecular region involving both the TM and the inner waff of
`Schiemm's canal. The operation created a direct communication between the anterior cham-
`ber and Schlemm 's canal lumen without any evident damage to the outer cana! wall and
`adjacent ocular structures such asthe iris base and comeal endothelium.
`Conc_usicns. Our small series on human bank eyes showedthat the procedure involves
`both the TM and the inner wall of Schlemm's cana! and is therefore calied ab interno tra-
`heculocanalectomy (AITC). The intraoperative findings and the histological evidence are
`encouraging, and suggest that the procecedure could have potential clinical application.
`(Eur J Ophthalmof 2002; 12: 401-5)
`Key Worns. Ab-interno trabecular surgery, Irido-corneal angle surgery, Glaucoma surgery
`Aovephedt Detaner 16, 2007
`
`Ex. C18, p.° of &
`
`proposed to boost aqueous humoroutflow through
`INTRODUCTION
`the anterior chamber angle (1-3, 813). However, the
`choice remains controversial because of the lack of
`Trabecular meshwork surgery aims to increase the
`convincing evidenceof the superiority of any one ap-
`outflow of aqueous humorthrough its normal pathway
`proach over the others. Theoretically, a therapeutic
`and lowerintraocular pressure (IOP) (1-3). The basis
`option that removes the resistance to aqueous out-
`of
`this approach is
`to relieve the resistance to
`flow as far as possible, without damaging the outer
`aqueous humor outflow within the TM,
`in juxtacana-
`outflow pathways and the surrounding ocular struc-
`licular tissue andthe innerwall of Schlemm’scanal (4-
`tures, suchas thebaseofthe iris and the corneal en-
`7). Manysurgical andlaser techniques have been
`
`SB wichtig Ealtcre, 2302
`1120-6721/401 -06$03.00/0
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`Pettioner - Mew World Medical
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`Ferrari, p. 4 of 5
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`IPR2021-00017 Paper 17 at 33, 42 (citing Ex. 2019 ¶¶ 132, 177).
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`Ex. 2021 (May 27, 2021
`Ex. 2021 (May 27, 2021
`Netland Deposition Transcript)
`Netland Deposition Transcript)
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NEW WORLD MEDICAL.INC.
`Petitioner,Case IPR2021-00065
`U.S. Patent No. 10,123,905
`-Vs-
`MICROSURGICAL TECHNOLOGY,INC.,
`Patent Owner.
`NEW WORLD MEDICAL, INC.,
`Petitioner,Case IPR2020-01573
`-Vs-
`U.S. Patent No. 9,107,729
`MICROSURGICAL TECHNOLOGY,INC.,
`Patent Owner.
`
`VIDEOTAPED DEPOSITION OF PETER NETLAND, MD., Ph.D.
`
`9:14 a.m. to 4:24 p.m.
`May27, 2021
`Charlottesville, Virginia
`
`Job No. 45352/4590692
`REPORTEDBY: Rhonda D. Tuck, RPR, CRR
`
`REPORTEDBY: Rhonda D. Tuck, RPR. CRR Z
`
`OoOoaHUnmewwhoe
`
`1
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`NEW WORLD MEDICAL,INC. ,
`Petitioner,
`Case IPR2020-01711
`U.S. Patent No. 9,358,155
`-Vs-
`MICROSURGICAL TECHNOLOGY,INC.,
`Patent Owner.
`NEW WORLD MEDICAL, INC.,
`Petitioner,
`Case IPR2021-00017
`U.S. Patent No. 9,820,385
`-Vs-
`MICROSURGICAL TECHNOLOGY,INC.,
`Patent Owner.
`NEW WORLD MEDICAL, INC. ,
`Petitioner,
`Case IPR2021-00066
`U.S. Patent No. 9,000,544
`-Vs-
`THE REGENTS OF THE UNIVERSITY OF CALIFORNIA.
`Patent Owner.
`
`
`VIDEOTAPED DEPOSITION OF PETER NETLAND, M_D., Ph.D.
`9:14 a.m. to 4:24 p.m.
`May27, 2021
`Charlottesville, Virginia
`Job No, 45352/4590692
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`Ex. 2021 92:14-22
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`IPR2020-01573 Paper 29 at 31-34; 2020-01711 Paper 17 at 35-38; 2021-00066, Paper 17 at 31-34.
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`Ex. 2021 124:17-21
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`IPR2020-01573 Paper 29 at 21-27; 2020-01711 Paper 17 at 22-28; 2021-00017 Paper 17 at 19-26;
`2021-00065 Paper 18 at 19-23; 2021-00066, Paper 17 at 26-30.
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`Ex. 2021 131:16-19
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`IPR2020-01573 Paper 29 at 35, 37, 54; 2020-01711 Paper 17 at 40-42, 50; 2021-00017 Paper 17 at 31.
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`Ex. 2021 262:3-6
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`IPR2020-01573 Paper 29 at 22, 25; 2020-01711 Paper 17 at 23; 2021-00017 Paper 17 at 20;
`2021-00065 Paper 18 at 20; 2021-00066, Paper 17 at 27.
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`Ex. 2021 262:20-263:11
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`IPR2020-01573 Paper 29 at 25-27; 2020-01711 Paper 17 at 26-27; 2021-00017 Paper 17 at 24-25;
`2021-00065 Paper 18 at 21-22; 2021-00066, Paper 17 at 28-29.
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`
`Ex. 2022 (May 28, 2021
`Ex. 2022 (May 28, 2021
`Netland Deposition Transcript)
`Netland Deposition Transcript)
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`NEW WORLD MEDICAL,INC.,
`Petitioner,Case IPR2021-00065
`-Vs-
`U.S. Patent No. 10,123,905
`MICROSURGICAL TECHNOLOGY,INC.,
`Patent Owner.
`NEW WORLD MEDICAL,INC.,
`Pe