Trials@uspto.gov
`571.272.7822
`
`
` Paper 64
` Date: March 11, 2022
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`NEW WORLD MEDICAL, INC.,
`Petitioner,
`
`v.
`
`MICROSURGICAL TECHNOLOGY, INC.,
`Patent Owner.
`____________
`
`IPR2020-01573
`Patent 9,107,729 B2
`____________
`
`
`
`Before JAMES A. TARTAL, ROBERT A. POLLOCK, and
`RYAN H. FLAX, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`
`
`
`JUDGMENT
`
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`
`
`
`
`
`
`571.272.7822
`
`
` Paper 64
` Date: March 11, 2022
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`NEW WORLD MEDICAL, INC.,
`Petitioner,
`
`v.
`
`MICROSURGICAL TECHNOLOGY, INC.,
`Patent Owner.
`____________
`
`IPR2020-01573
`Patent 9,107,729 B2
`____________
`
`
`
`Before JAMES A. TARTAL, ROBERT A. POLLOCK, and
`RYAN H. FLAX, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`
`
`
`JUDGMENT
`
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`
`
`
`
`
`
`
`IPR2020-01573
`Patent 9,107,729 B2
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`
`MicroSurgical Technology, Inc. (“Patent Owner”) is the owner of
`U.S. Patent 9,107,729 B2 (“the ’729 patent,” Ex. 1001). Paper 29, 1
`(“Response” or “Resp.”). New World Medical, Inc. (“Petitioner”) filed a
`Petition for an inter partes review of claims 1–10 (all claims) of the ’729
`patent. Paper 1 (“Pet.”). Trial was instituted on March 16, 2022. Paper 22
`(“Institution Decision” or “DI”). Patent Owner filed a Response to the
`Petition. Paper 29. Petitioner filed a Reply to Patent Owner’s Response
`(Paper 35, “Reply”) and Patent Owner filed a respective Sur-Reply (Paper
`20, “Sur-Reply”). The parties also each filed respective motions to exclude
`the other’s evidence, which were each denied. Papers 51, 52, and 63. A
`final hearing was held on January 10, 2022, where each party presented oral
`argument. Paper 62 (“Hr’g Tr.”).
`We have authority under 35 U.S.C. § 6. This Final Written Decision
`is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`Petitioner bears the burden of proving the unpatentability of
`challenged claims, and the burden of persuasion never shifts to Patent
`Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375,
`1378 (Fed. Cir. 2015). To prevail, Petitioner must prove unpatentability by
`a preponderance of the evidence. See 35 U.S.C. § 316(e); 37 C.F.R.
`§ 42.1(d) (2019). After considering the parties’ arguments and the evidence,
`we conclude that Petitioner proves by a preponderance of the evidence that
`claims 1–10 of the ’729 patent are unpatentable. 35 U.S.C. § 316(e).
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`INTRODUCTION
`I.
`A. REAL PARTIES-IN-INTEREST
`Petitioner identifies itself, “New World Medical, Inc.,” as a real party-
`in-interest. Pet. ix. Patent Owner also identifies itself, “MicroSurgical
`Technology, Inc.,” as a real party-in-interest. Paper 4; Paper 33.
`RELATED MATTERS
`B.
`Petitioner states:
`Microsurgical Tech., Inc. (“MST” or “Patent Owner”)
`and The Regents of the University of California (collectively
`“Plaintiffs”) filed a complaint asserting infringement of U.S.
`Patent 9,107,729 (“the ‘729 patent”) (Ex.1001) against NWM
`in the U.S. District Court for the District of Delaware (No. 20-
`cv-00754) on June 4, 2020. See Ex.1017. Plaintiffs also
`asserted U.S. Patent 9,358,155 (“the ‘155 patent”), U.S. Patent
`9,820,885 (“the ‘885 patent”), U.S. Patent 9,999,544 (“the ‘544
`patent”), and U.S. Patent 10,123,905 (“the ‘905 patent), against
`NWM in that case. NWM was served with the complaint on
`August 5, 2020.
`Pet. ix. Patent Owner identifies the same case in the District of Delaware as
`a related matter. Paper 4; Paper 33.
`Although neither party identifies them as directly related matters, we
`note the following other inter partes reviews, filed by Petitioner, challenging
`Patent Owner’s patents at issue in the aforementioned district court case:
`IPR2020-01711 regarding U.S. Patent 9,358,155 B2; IPR2021-00017
`regarding U.S. Patent 9,820,885 B2; IPR2021-00065 regarding U.S. Patent
`10,123,905 B2; and IPR2021-00066 regarding U.S. Patent 9,999,544 B2.
`The final hearing consolidated oral arguments for this and each of
`these other inter partes review proceedings. Hr’g Tr. 1, 3:3–12.
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`C.
`
`THE ’729 PATENT
`The ’729 patent issued on August 18, 2015, from U.S. Application
`14/481,754, which was filed on September 9, 2014, and ultimately claims
`priority to U.S. Provisional Application 60/477,258, filed on June 10, 2003.1
`Ex. 1001, codes (45), (21), (22), (60), (62). The ’729 patent’s Abstract
`states:
`Methods and devices for cutting strips of tissue from masses of
`tissue inside or outside of the bodies of human or animal
`subjects. The device generally comprises a) an elongate cutting
`tube that has a distal end and a lumen that opens through an
`opening in the distal end and b) first and second cutting edges
`formed on generally opposite edges of the distal end of the
`cutting tube and separated by a distance D. The device is
`advanced through tissue to cut a strip of tissue of approximate
`width W. Width W is approxima[t]ely equal to distance D.
`Id. at Abstract.
`Regarding the indicated feature of the invention of cutting strips of
`tissue, in its Background of the Invention section, the Specification explains
`that “[t]here are numerous medical and surgical procedures in which it is
`desirable to cut and remove a strip of tissue of controlled width from the
`body of a human or veterinary patient” and that
`[o]ne surgical procedure wherein a strip of tissue of a known
`width is removed from an anatomical location within the body
`of a patient is an ophthalmological procedure used to treat
`glaucoma. This ophthalmological procedure is sometimes
`refer[r]ed to as a goniecto[m]y. In a goniecto[m]y procedure, a
`device that is operative to cut or ablate a strip of tissue of
`approximately 2-10 mm in length and about 50-200 μm in
`width is inserted into the anterior chamber of the eye and used
`
`
`1 Petitioner acknowledges this priority claim to June 10, 2003, and does not
`challenge it as the effective date of the ’729 patent. Pet. 21, 24.
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`to remove a full thickness strip of tissue from the trabecular
`meshwork.
`Id. at 1:18–45. The Specification further states that “there remains a need in
`the art for the development of simple, inexpensive and accurate instruments
`useable to perform the goniectomy procedure.” Id. at 1:66–2:2.
`As meeting this asserted need, the ’729 patent’s Specification
`describes “a needle cutter device 10,” which is illustrated in its Figures 1–4.
`Figure 2 is an exemplary illustration and it is reproduced below:
`
`
`
`Figure 2 shows needle cutter device 10 having cutting tube 14 at an end of
`outer tube 16. Id. at 3:3–43. Cutting tube 14 terminates in an end having
`two cutting edges 20, 22, which are sharp to cut tissue and are positioned on
`opposite sides of cutting tube 14, blunt protruding tip 24, and blunt edge 26.
`Id. Cutting tube 14 has bend 17 of approximately 90 degrees at a location
`proximal to these features.2 Id. The Specification describes that such a
`device is used “[t]o perform a goniectomy procedure.” Id. at 5:19–6:27.
`The result of using such a device to perform a goniectomy is the cutting by
`
`
`2 The bend angle was expressly identified by the inventors during the
`prosecution of the ’729 patent as the angle of degrees from straight.
`Ex. 1002, 331 (Amendment dated May 14, 2015, remarks).
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`edges 20, 22 of a strip of tissue of, e.g., about 2–10 mm, proximate to the
`eye’s trabecular meshwork and Schlemm’s Canal, which is disconnected and
`removed from the patient. Id. at 6:15–27.
`The ’729 patent describes methods of manufacturing (or at least
`aspects thereof) such a cutter device 10. Id. at 4:61–5:14, Figs. 3A–3D. For
`example, the cutting tube 14 can be made of “standard tubing (e.g., stainless
`steel hypodermic tubing).” Id. at 4:61–63. Cutting edges 20, 22 may be
`formed by cutting the distal end of a tube and “if it is desired to have one or
`more bends or curves in the cutting tube 14,” the tubing can either be
`angularly cut, bent, and re-adhered, or “the tube 14 may be directly bent to
`form said curves or bends without the use of angular cut out(s).” Id. at 4:63–
`5:9.
`
`The ’729 patent’s sole independent claim, claim 1, reads as follows:
`1. An ab interno method for forming an opening in
`trabecular meshwork of a patient’s eye, said method comprising
`the steps of:
`obtaining a dual blade device which comprises a) an
`elongate proximal portion sized to be grasped by a hand of a
`human operator and b) an elongate probe extending from the
`proximal portion, wherein the elongate probe comprises i) a
`shaft, ii) a distal protruding tip that extends from a distal end of
`the shaft to form a bend or curve having an angle of at least 30
`degrees, said distal protruding tip being sized to be inserted in
`Schlemm’s Canal and iii) first and second cutting edges located
`at a junction of the shaft and the distal protruding tip, said first
`and second cutting edges being formed at spaced-apart
`locations on the distal end of the shaft, said first and second
`cutting edges being separated by a distance D;
`forming an opening into an anterior chamber of the eye;
`inserting the elongate probe through the opening and into
`the anterior chamber;
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`advancing the elongate probe through the anterior
`chamber, while the anterior chamber is filled with fluid, to an
`operative position where the distal protruding tip is positioned
`within Schlemm’s Canal and the first and second cutting edges
`are contacting the trabecular meshwork; and, thereafter
`causing the distal protruding tip to advance through a
`sector of Schlemm’s Canal with the first and second cutting
`edges concurrently cutting, from the trabecular meshwork, a
`strip of tissue having approximate width W, said approximate
`width W being approximately equal to the distance D between
`the first and second cutting edges.
`Id. at 6:43–7:6. In addition to claim 1, the ’729 patent includes dependent
`claims 2–10, which more specifically define aspects of the claimed method
`and device used therefor. Id. at 7:7–8:18.
`For context as to the ’729 patent’s disclosed and claimed invention,
`Petitioner’s witness, Dr. Peter Netland, in his First Declaration, provides a
`cross-sectional, labeled illustration of a human eye, reproduced below:
`
`
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`Ex. 1003 ¶ 34; see also Ex. 1008, 8–9 (cited by Dr. Netland as the source of
`the figure). The figure above shows and labels anatomical features of a
`human eye, including of note (from top of the figure to bottom, i.e.,
`anatomically anterior to posterior), a cornea defining an anterior chamber
`over an iris and pupil, which themselves define a posterior chamber over a
`lens, a vitreous body making up the great volume of the eye’s interior behind
`the lens, and the retina and optic nerve at the back of the vitreous body. See
`Ex. 1003 ¶¶ 34–39. The sclera (the opaque white part of an eye) and ciliary
`body (a vascular layer) are also shown and labeled as adjacent and
`connected to the lens, and immediately above the ciliary body, adjacent the
`iris and iridocorneal angle, the Canal of Schlemm (Schlemm’s Canal) is
`shown and labeled. Id.
`The ’729 patent’s invention relates to more specific parts of the eye,
`namely, Schlemm’s Canal and trabecular meshwork. Dr. Netland’s First
`Declaration also provides an illustration of these features in higher
`resolution, which we reproduce below:
`
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`Ex. 1003 ¶¶ 40–42; see also Ex. 1011 (cited by Dr. Netland as the source of
`the figure). As Dr. Netland explains, the figure above “shows a cutaway
`view of the layers of the trabecular meshwork and Schlemm’s Canal”
`(Schlemm’s Canal was shown in cross-section in the first figure of the eye
`above, adjacent the iridocorneal angle). Ex. 1003 ¶ 41. As described in the
`above figure itself, three layers of trabecular meshwork (uveal,
`corneoscleral, and juxtacanalicular) are adjacent to and in contact with the
`iris, scleral spur, and ciliary muscle, and in front of Schlemm’s Canal. Id.
`PETITIONER’S ASSERTED GROUNDS FOR UNPATENTABILITY
`D.
`Petitioner asserts several grounds for the unpatentability of claims 1–
`10 of the ’729 patent, as follows:
`
`
`CLAIMS
`CHALLENGED 35 U.S.C. §3
`1–4, 7–9
`102
`
`4–6, 10
`
`103(a)
`
`1–4, 7–9
`
`103(a)
`
`GROUND
`
`1
`
`2
`
`3
`
`REFERENCE(S)/BASIS
`
`Quintana4
`Quintana, Knowledge of a
`Person of Ordinary Skill in the
`Art
`Quintana, Lee5
`
`
`3 The ’729 patent indicates a priority date of June 10, 2003, which is before
`the AIA revisions to 35 U.S.C. §§ 102 and 103 took effect. Therefore, the
`pre-AIA version of Sections 102 and 103 apply.
`4 Manuel Quintana, Gonioscopic Trabeculotomy. First Results in
`DOCUMENTA OPHTHALMOLOGICA PROCEEDINGS SERIES 43, SECOND
`EUROPEAN GLAUCOMA SYMPOSIUM 265–71 (E.L. Greve et al. eds. 1985).
`Ex. 1004 (“Quintana”). Herein, we cite Quintana’s added pagination at the
`lower right corner of the document, as has Petitioner.
`5 U.S. Patent 4,900,300 (issued Feb. 13, 1990). Ex. 1006 (“Lee”).
`
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`GROUND
`
`CLAIMS
`CHALLENGED 35 U.S.C. §3
`
`4
`
`5
`
`6
`
`4–6, 10
`
`103(a)
`
`1–4, 7, 8
`
`102
`
`5, 6, 9, 10
`
`103(a)
`
`REFERENCE(S)/BASIS
`
`Quintana, Lee, Knowledge of a
`Person of Ordinary Skill in the
`Art
`Jacobi6
`Jacobi, Knowledge of a Person
`of Ordinary Skill in the Art
`
`
`See Pet. 4.
`Petitioner’s Grounds 2, 4, and 6, summarized above, each reference
`the knowledge of a person of ordinary skill in the art as a distinguishing
`basis for their being separate grounds. When analyzing whether claims
`would have been obvious and whether it would have been obvious to
`combine or modify prior art, it is always from the perspective of an
`ordinarily skilled artisan and one must consider knowledge generally
`available to one of ordinary skill in the art. See KSR Int’l Co. v. Teleflex
`Inc., 550 U.S. 398, 418 (2007) (one considers “the background knowledge
`possessed by a person having ordinary skill in the art”). The “knowledge of
`a person of ordinary skill in the art” is always a consideration and is not a
`basis for a separate challenge for obviousness. Therefore, we do not
`separately analyze a challenge where such “knowledge” is the only basis for
`it being separately presented, and consider obviousness over the cited prior
`
`
`6 Philipp C. Jacobi et al., Technique of goniocurettage: a potential treatment
`for advanced chronic open angle glaucoma, 81 BRIT. J. OPHTHALMOLOGY
`302–07 (1997). Ex. 1007 (“Jacobi”). Herein, we reference Jacobi’s added
`pagination at the lower right corner of the document, as has Petitioner.
`
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`art from the perspective of the ordinarily skilled artisan. Thus, Grounds 2
`and 4 are subsumed by and merged into Ground 3, as discussed herein.
`In support of the grounds for unpatentability Petitioner submits, inter
`alia, two Declarations of Dr. Peter Netland. Ex. 1003 (“First Netland
`Declaration”); Ex. 1030 (“Second Netland Declaration”). We conclude that
`Dr. Netland is qualified to offer testimony on the knowledge of one of
`ordinary skill in the art at the time of the invention. See Ex. 1003 ¶¶ 1–17,
`26–27, 34–61 (Dr. Netland’s statements as to his background and
`qualifications, definition of the person of ordinary skill in the art, and
`background on the relevant technology).
`In support of its positions, Patent Owner submits the Declaration of
`Dr. Garry P. Condon. Ex. 2019 (“Condon Declaration”). Dr. Condon’s
`testimony was the subject of a motion to exclude by Petitioner (Paper 52,
`“Pet. Mot.”) and, although that motion was denied (Paper 63, “Order”), it
`did highlight certain cross-examination testimony by the witness evidencing
`that his direct testimony is deficient or unreliable on several issues. In
`denying Petitioner’s motion, we “agree[d] with Petitioner’s characterizations
`of Dr. Condon’s testimony on cross-examination and also [found]
`Petitioner’s assertions regarding this testimony and its applicability to
`interpreting Dr. Condon’s direct testimony to be accurate.” Order 12. For
`example, our Order stated:
`Petitioner asserts that on cross-examination by
`deposition, Dr. Condon testified, inter alia, that he had not
`carefully read the challenged patent(s), he was unsure in some
`respects as to what the claims of the challenged patent(s)
`require, did not know the difference between device and
`method claims, did not understand anticipation or obviousness,
`had not seen at least some portions of the challenged patent’s
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`prosecution history, did not understand what a patent file
`history is, did not understand or had not analyzed at least some
`claim language of the challenged patent(s), was not capable of
`interpreting the meaning of at least some claim language, and
`presented internally-conflicting testimony on the proper reading
`of Petitioner’s asserted prior art. Pet. Mot. 3–9 (see citations to
`Exs. 1041–1043 therein). Petitioner asserts that, under FRE
`702 and 37 C.F.R. §§ 42.62, 42.65, Dr. Condon’s direct
`testimony is insufficient regarding his knowledge, basis in facts
`and data, and reliability because the witness does not
`understand the legal concepts of anticipation and obviousness
`to which he testifies, had not considered or analyzed evidence
`he had purported in his direct testimony to have considered and
`analyzed, and does not fully understand the challenged claims.
`Id. at 9–13.
`Id. at 10–11; see also Pet. Mot. 3–9 (and citations therein).
`We “conclude[d] that the better course is to have a complete record of
`the evidence,” and, therefore, denied Petitioner’s Motion, but also explained
`that “to the extent that Dr. Condon’s testimony and Patent Owner’s reliance
`thereon ventures into areas the witness has conceded he either does not
`understand or has inadequately analyzed,” we would accord it “little
`weight,” as distinguished “from that relating to Dr. Condon’s technical
`expertise in, for example, anatomy, eye surgery, and his own reading of
`evidence.” Order 13. Therefore, it is through this lens that we consider
`Dr. Condon’s testimony here.
`We review Petitioner’s asserted prior art below.
`E. QUINTANA
`Quintana was published in 1985. Ex. 1004, 2. Quintana is prior art to
`the claims of the ’729 patent under 35 U.S.C. § 102(b); Patent Owner does
`not argue otherwise. Id.; see generally Resp.
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`Quintana “describe[s] a surgical method of goniotrabeculotomy[,]
`which achieves a section of the trabecular meshwork without damage to the
`external wall of Schlemm’s canal.” Ex. 1004, 3.
`Quintana’s Figure 1 illustrates the use of a bent-tip needle device in
`such a procedure; this figure is reproduced below:
`
`
`
`Id. at 4. According to Quintana, Figure 1 shows a “trabeculotome,” i.e., a
`tool for opening the trabecular meshwork of an eye to treat glaucoma, which
`consists of a 0.4 x 15 mm needle, or insulin-type needle, bent by 20°–30° at
`the tip using a needle-holder, inserted into a syringe filed with “healon” (a
`wetting agent according to Dr. Netland (Ex. 1003 ¶ 92)). Ex. 1004, 3–4.
`Figure 1 shows this device penetrating the anterior chamber of an eye,
`running parallel to Schlemm’s Canal, incising and stripping the trabecular
`meshwork with the tip of the needle, while the convex side of the bent tip is
`pointed towards the external wall so as to not cause damage. Id. at 4.
`
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`Quintana states that the healon can be injected during the process at any time
`and that, after the procedure, the device is withdrawn. Id.
`A photograph of such a procedure occurring is provided by Quintana
`at Figure 2, reproduced below:
`
`
`
`Id. at 5. Figure 2 shows the tip of the afore-discussed needle instrument
`introduced into the Schlemm’s Canal of an eye (see upper right quadrant of
`image, needle’s tip points toward center line of image and needle’s shaft
`extends toward the edge of the image) and the trabecular meshwork being
`“stripped slowly, gently and easily from the canal’s lumen towards the
`anterior chamber as the needle progresses.” Id. at 4. Quintana concludes,
`“our results show that goniotrabeculotomy, although highly successful in the
`first postoperative month, is in the end a partially successful procedure.
`Further studies are necessary to disclose the ‘in vivo’ behavior of the
`sectioned trabecular meshwork.” Id. at 8.
`
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`F.
`
`LEE
`Lee issued as U.S. Patent 4,900,300 on February 13, 1990, from U.S.
`Application 315,190, which was filed February 24, 1989, and claims priority
`to U.S. Application 70,325, which was filed July 6, 1987. Ex. 1006, codes
`[45], [21], [22], [63]. Lee is prior art to the claims of the ’729 patent under
`35 U.S.C. § 102(b); Patent Owner does not argue otherwise. See generally
`Resp.
`
`Lee states:
`This invention relates to the design and application of a
`goniectomy instrument for the purpose of diagnostically and
`therapeutically removing tissue from the anterior chamber angle
`of the eye and for retrieving this tissue for further examination.
`The surgical instrument of this invention comprises in
`combination: a hollow, tapered shaft having a cutting edge at
`one end as an integral part thereof; a retractable stylet contained
`within the hollow interior of the tapered shaft; and an irrigation
`port running along the outside of the tapered shaft. This
`instrument is useful for excising tissue to relieve an obstruction
`blocking the outflow of aqueous humor from the eye as well as
`for providing specimens of the excised tissue for
`histopathological examination.
`Ex. 1006, Abstract.
`Lee shows such an instrument at Figures 1 and 2, which are
`reproduced below:
`
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`“FIG. 1 is a schematic side view of the surgical instrument of th[e]
`invention” and “FIG. 2 is a schematic bottom view of the surgical instrument
`of th[e] invention.” Id. at 3:62–65. Lee states that Figures 1 and 2 show
`“the surgical instrument” having “a more or less cylindrical hollow shaft
`10[,] which is tapered from a larger diameter at the handle end 11 to a
`smaller diameter at the forward cutting end,” which is about 0.5 to 2 mm in
`diameter. Id. at 4:18–27. The tip end’s taper is 5–15 degrees. Id. at 32–33.
`The end of shaft 10 has “a parabolic, bowl-like cavity 12 having a sharpened
`rim[,] which creates a single, more or less U-shaped cutting edge 14 integral
`with the sides of shaft 10.” Id. at 4:38–41; see also id. at 7:34–35 (claim 1
`reciting “rim is sharpened so as to form a cutting blade having side cutting
`edges and a distal tip”). “The cutting edge is softly rounded at its distal end
`and is generally parabolic in shape in order to avoid damage to the outer
`wall of Schlemm’s Canal.” Id. at 4:45–48. “[T]he plane of the tip of cutting
`edge 14 [is] at an acute angle of about 5 to 45 degrees with respect to the
`plane of shaft 10,” but may vary to a greater or smaller angle depending on
`surgical requirements. Id. at 4:49–54. Irrigation port 22 is also shown,
`indicated as functioning to maintain fluid levels in the anterior chamber of
`the eye during a procedure. Id. at 5:6–12. The bottom of cavity 12 includes
`a hole or aperture 16 through which tissue may pass. Id. at 4:56–57.
`Lee states that this device is used “in glaucoma surgery to excise a
`piece of tissue from the anterior chamber angle (trabecular meshwork and
`the inner wall of Schlemm’s Canal) to therapeutically relieve the obstruction
`of the outflow of aqueous humor from the eye and to provide specimens of
`the abnormal tissues excised for histopathological examination.” Id. at
`
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`3:51–57. This process is disclosed to include introducing the instrument into
`the anterior chamber of the eye via a corneal incision, followed by excising
`angle tissue as cutting edge 14 is advanced. Id. at 5:61–6:36. The tissue
`samples are detached and removed from the eye. Id. at 6:37–49.
`Lee provides a drawing of such a procedure at Figure 5, which we
`reproduce below:
`
`
`
`Lee states that “FIG. 5 is a schematic side view of an eyeball with the
`surgical instrument of this invention in place and ready to begin cutting and
`removing a tissue segment from the trabecular meshwork.” Id. at 4:3–6.
`Figure 5 shows an eyeball with cornea 30, iris 32, anterior chamber 34,
`trabecular meshwork 36, and Schwalbe’s line 38, and an instrument having
`shaft 10, handle 11, cutting edge 14, irrigation port 22, and lever 24 in the
`process of surgically removing tissue segment 40. Id. at 5:1–65. More
`specifically, Lee discloses the surgical process includes placing a goiniolens
`over the cornea, forming an incision into the anterior chamber 34 through
`the cornea, introducing the goniectomy instrument into the anterior chamber
`through that incision under constant irrigation to maintain anterior chamber
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`fluid level, using cutting edge 14 to excise the angle tissue 40 for
`approximately one-third of the angle circumference as the cutting edge 14 is
`advanced (the excised tissue is guided through aperture 16 or into hollow
`shaft 10 as cutting edge 14 is advanced), and the excised tissue 40 is
`removed by the instrument when it is withdrawn from the anterior chamber.
`Id. at 6:3–62.
`JACOBI
`G.
`Jacobi was published in 1997. Ex. 1007, 1. Jacobi is prior art to the
`claims of the ’729 patent under 35 U.S.C. § 102(b); Patent Owner does not
`argue otherwise. See generally Resp.
`Jacobi discloses a procedure for a “[g]onioscopically controlled ab
`interno abrasion of the trabecular meshwork” using an “instrument
`resemble[ing] a modified cyclodialysis spatula with a bowl-shaped tip,
`300 μm in diameter, and with its edges sharpened.” Ex. 1007, 1. Jacobi
`calls this device a “gonioscraper,” and shows it at Figure 1, reproduced
`below:
`
`
`
`Id. at 2. Jacobi explains that, as shown in the figure above:
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`The ‘gonioscraper’ consists of a small handle and a slightly
`convex-shaped arm for intraocular use and very much
`resembles a cyclodialysis spatula. However, the tip of the
`instrument is shaped as a tiny bowl with 300 μm diameter and
`with its edges sharpened (Fig 1). In order to abrade clockwise
`and anticlockwise the scoop is angulated vertically at 90
`degrees to the left and right, respectively.
`
`Id.
`
`The device is used “to abrade rather than incise uveal meshwork; this
`novel method, therefore, is termed goniocurettage.” Id. Jacobi explains that
`the gonioscraper is inserted into the anterior chamber of an eye through a
`corneal incision, and then positioned against the trabecular meshwork and
`used to peel off trabecular meshwork by passing the device there-over. Id.
`This results in “strings of trabecular tissue” being removed from the eye. Id.
`A stage of this procedure is shown at Figure 2, reproduced below:
`
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`Id. Figure 2 shows the gonioscraper device inserted into an eye, performing
`the goniocurettage procedure. Id.
`II. DISCUSSION
`A. ORDINARY SKILL IN THE ART
`Petitioner states,
`A [person of ordinary skill in the art] would have: (1) a
`medical degree and at least two years’ experience with treating
`glaucoma and performing glaucoma surgery; or (2) an
`undergraduate or graduate degree in biomedical or mechanical
`engineering and at least five years of work experience in the
`area of ophthalmology, including familiarity with ophthalmic
`anatomy and glaucoma surgery. Ex.1003, ¶27.
`Pet. 23–24 (citing Ex. 1003 ¶ 27). Patent Owner states that it “agrees with
`the Board’s preliminary acceptance in its institution decision of Petitioner’s
`proposed definition of a [person of ordinary skill in the art] for purposes of
`this IPR.” Resp. 11, n.6.
`We accept, as has Patent Owner, Petitioner’s proposed definition of
`the person of ordinary skill in the art, or ordinarily skilled artisan, which
`appears to be consistent with the level of skill in the art reflected in the prior
`art of record and the disclosure of the ’729 patent. 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)).
`CLAIM CONSTRUCTION
`B.
`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
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`claims, district courts and the Board here, by default, 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).
`Should claim terms require express construction, sources for claim
`interpretation include “the words of the claims themselves, the remainder of
`the specification, the prosecution history [i.e., the intrinsic evidence], and
`extrinsic evidence concerning relevant scientific principles, the meaning of
`technical terms, and the state of the art.” Id. at 1314 (quoting Innova/Pure
`Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed.
`Cir. 2004)). “[T]he claims themselves [may] provide substantial guidance as
`to the meaning of particular claim terms.” Id. However, the claims “do not
`stand alone,” but are part of “‘a fully integrated written instrument,’
`consisting principally of a specification that concludes with the claims,” and,
`therefore, the claims are “read in view of the specification.” Id. at 1315
`(quoting Markman v. Westview Instruments, Inc., 52 F.3d 967, 978–79 (Fed.
`Cir. 1995) (en banc)). 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). “[W]e need only construe terms ‘that are in controversy, and
`only to the extent necessary to resolve the controversy . . . .’” Nidec Motor
`Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed.
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`Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d
`795, 803 (Fed. Cir. 1999)).
`Petitioner proposes that the claim language “ab interno,” which is
`recited in the preamble of independent claim 1, should be expressly
`construed as meaning “approaching TM [(trabecular meshwork)] through
`the AC [(anterior chamber)].” Pet. 25. Further, Petitioner proposes that the
`claim language “dual blade device,” which is recited by claim 1, should be
`expressly construed to mean the device “has two edges capable of cutting
`tissue.” Id. at 26.
`Patent Owner states that it “submits that all of the terms in the
`Challenged Claims should be accorded their plain and ordinary meanings to
`a POSA.” Resp. 11 (footnote omitted).
`We decline to expressly adopt any proposed construction of the claim
`language. Vivid Techs., 200 F.3d at 803 (“[O]nly those terms need be
`construed that are in controversy, and only to the extent necessary to resolve
`the controversy.”).
`Based on the evidence of record, the term “ab interno” is a well-
`understood term of art in the ophthalmological field. See, e.g., Ex. 1005, 1;
`Ex. 1013, 1; Ex. 1018, 1; Ex. 1020, 1. The ’729 patent does not expressly
`assign a special meaning to the term “ab interno.” Ex. 1001. As Patent
`Owner states, quoting Petitioner’s witness Dr. Netland, “[p]ersons of
`ordinary skill in the art would have understood the term ‘ab interno’ to
`generally mean from the inside . . . .” Resp. 31 (quoting Ex. 1003 ¶ 74
`(emphasis in original)). We find that the record supports that the person of
`ordinary skill in the art would have understood this term and that it
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