UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NEW WORLD MEDICAL, INC.,
`Petitioner
`v.
`
`MICROSURGICAL TECHNOLOGY, INC.,
`Patent Owner
`
`Case No. IPR2020-01573
`
`U.S. Patent No. 9,107,729
`
`REPLY DECLARATION OF DR. PETER NETLAND
`
`Petitioner - New World Medical
`Ex. 1030, p. 1 of 19
`New World Medical, Inc. v. MicroSurgical Tech., Inc., IPR2020-01573
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NEW WORLD MEDICAL, INC.,
`Petitioner
`v.
`
`MICROSURGICAL TECHNOLOGY, INC.,
`Patent Owner
`
`Case No. IPR2020-01573
`
`U.S. Patent No. 9,107,729
`
`REPLY DECLARATION OF DR. PETER NETLAND
`
`Petitioner - New World Medical
`Ex. 1030, p. 1 of 19
`New World Medical, Inc. v. MicroSurgical Tech., Inc., IPR2020-01573
`
`
`
`TABLE OF CONTENTS
`
`I.
`II.
`
`INTRODUCTION ........................................................................................... 1
`QUINTANA DISCLOSES CUTTING A “STRIP OF TISSUE”
`FROM THE TRABECULAR MESHWORK ................................................. 2
`A.
`Development of Experimental Protocol ................................................ 5
`B.
`Experimental Protocol .........................................................................10
`C.
`Experimental Results ...........................................................................12
`III. CONCLUSION ..............................................................................................16
`
`ii
`
`Petitioner - New World Medical
`Ex. 1030, p. 2 of 19
`New World Medical, Inc. v. MicroSurgical Tech., Inc., IPR2020-01573
`
`
`
`I.
`
`INTRODUCTION
`1.
`My name is Dr. Peter Netland, MD, PhD, and I have been retained by
`
`counsel for New World Medical, Inc. (“New World Medical”) as an expert witness
`
`in the above-captioned proceeding. I am the Dr. Peter Netland, MD, PhD who
`
`previously submitted a declaration in this proceeding as Exhibit 1003 (“Opening
`
`Declaration”).
`
`2.
`
`I have been asked to provide this Reply Declaration regarding the
`
`validity of claims 1-10 of U.S. Patent No. 9,107,729 (“the ‘729 patent”) (Ex.1001).
`
`Specifically, I have been asked to respond to issues raised by the Patent Owner’s
`
`Response (Paper 29) (“Response”) and the accompanying Declaration of Garry P.
`
`Condon, M.D. in Support of Patent Owner’s Response (Ex.2019) (“Condon
`
`Declaration”) and Sworn Affidavit of Manuel Quintana, M.D. (Ex.2020)
`
`(“Quintana Affidavit”) filed in this proceeding.
`
`3.
`
`My opinions are based on my years of education, research, and
`
`experience, which I summarized in my Opening Declaration (Ex.1003), as well as
`
`my investigation and study of relevant materials. In addition to the information I
`
`identified in my Opening Declaration, I have also considered the Board’s
`
`Institution Decision (Paper 22) (“Institution Decision”), the Patent Owner’s
`
`Response, the Condon Declaration, the Quintana Affidavit, and any other cited
`
`reference in this Reply Declaration.
`
`1
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`Petitioner - New World Medical
`Ex. 1030, p. 3 of 19
`New World Medical, Inc. v. MicroSurgical Tech., Inc., IPR2020-01573
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`
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`4.
`
`I may rely upon these materials, my knowledge and experience,
`
`and/or additional materials to rebut arguments raised by the Patent Owner
`
`MicroSurgical Technologies, Inc. (“MST”), Dr. Condon, and/or Dr. Quintana.
`
`Further, I may also consider additional documents and information in forming any
`
`necessary opinions, including documents that may not yet have been provided to
`
`me.
`
`5.
`
`This declaration and my Opening Declaration represent only those
`
`opinions I have formed to date. I reserve the right to revise, supplement, and/or
`
`amend my opinions stated herein based on new information and on my continuing
`
`analysis of the materials produced in this proceeding.
`
`6.
`
`I am being compensated on a per hour basis for my time spent
`
`working on issues in this case at the rate of $500 per hour. My compensation does
`
`not depend on the outcome of this matter or the opinions I express.
`
`II. QUINTANA DISCLOSES CUTTING A “STRIP OF TISSUE” FROM
`THE TRABECULAR MESHWORK
`7.
`As explained in my Opening Declaration, it is my opinion that the
`
`surgical procedure described in the Quintana reference (Ex.1004) (“Quintana”)
`
`would without question have resulted in cutting “strips of tissue” from the TM.
`
`Ex.1003 (Opening Declaration), ¶98. This is confirmed by Quintana’s explicit
`
`disclosures, including but not limited to Quintana statements that the procedure
`
`“achieves a section of the trabecular meshwork,” “the TM is stripped slowly,
`2
`
`Petitioner - New World Medical
`Ex. 1030, p. 4 of 19
`New World Medical, Inc. v. MicroSurgical Tech., Inc., IPR2020-01573
`
`
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`gently and easily from the canal’s lumen towards the anterior chamber as the
`
`needle progresses in the angle,” “[f]urther studies are necessary to disclose the ‘in
`
`vivo’ behavior of the sectioned trabecular meshwork,” and Figure 2 and caption
`
`that states “[t]he tip of the needle stripping the trabecular meshwork.” Id., ¶¶ 136-
`
`37, 193-94; Ex.1004 (Quintana), 3-5, 8. I understand that Patent Owner, Dr.
`
`Condon, and Dr. Quintana address certain opinions I expressed in my Opening
`
`Declaration regarding the Quintana reference (Ex.1004) and offer contrary
`
`arguments regarding whether the Quintana reference (Ex.1004) discloses cutting a
`
`“strip of tissue” from the TM.
`
`8.
`
`In particular, I understand Patent Owner and Dr. Condon assert that
`
`the surgical procedure disclosed in the Quintana reference (Ex.1004) does not
`
`involve the removal of TM. Response, 13; Condon Declaration, ¶30. I further
`
`understand that Dr. Condon asserts that my Opening Declaration “seizes on the
`
`words ‘section’ and ‘stripping’ used in Quintana in an attempt to rationalize that
`
`TM must have been removed even though Quintana never actually says so.”
`
`Condon Declaration, ¶31. I understand Dr. Condon asserts that “a POSA would
`
`have understood Quintana’s reference to ‘section’ . . . to mean incising or opening
`
`the TM, as opposed to creating or removing a strip of TM.” Condon Declaration,
`
`¶32. I further understand Dr. Condon asserts that “a POSA would have understood
`
`Quintana’s reference to ‘stripped’ and ‘stripping’ . . . to mean simply cutting or
`
`3
`
`Petitioner - New World Medical
`Ex. 1030, p. 5 of 19
`New World Medical, Inc. v. MicroSurgical Tech., Inc., IPR2020-01573
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`
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`tearing the TM to move it away from the lumen of Schlemm’s Canal while
`
`avoiding injuring the external wall of Schlemm’s Canal, which was Quintana’s key
`
`concern.” Condon Declaration, ¶38.
`
`9.
`
`I also understand Dr. Quintana has submitted an Affidavit discussing
`
`the Quintana reference (Ex.1004). I understand the Quintana Affidavit purports to
`
`interpret the words “section,” “sectioned,” “stripping,” and “stripped” used in the
`
`Quintana reference (Ex.1004).
`
`10.
`
`I disagree with Patent Owner, Dr. Condon, and Dr. Quintana. As I
`
`indicated in my Opening Declaration, it is my opinion that Quintana’s disclosure of
`
`“stripping” the trabecular meshwork to “achieve[] a section of the trabecular
`
`meshwork” explicitly and unequivocally refers to excising or cutting a “strip of
`
`tissue” from the trabecular meshwork as claimed in the ‘729 patent. Opening
`
`Declaration, ¶¶136-37, 193-94. In my opinion, Patent Owner, Dr. Condon, and Dr.
`
`Quintana’s assertions do not reflect how a person of ordinary skill in the art
`
`(“POSA”) would have interpreted the Quintana reference (Ex.1004) or what the
`
`result of the surgical procedure described in the Quintana reference (Ex.1004)
`
`would have been.
`
`11.
`
`In response to what is, in my opinion, Patent Owner’s, Dr. Condon’s,
`
`and Dr. Quintana’s apparent misinterpretation of the explicit disclosures set forth
`
`in the Quintana reference (Ex.1004), I was asked by counsel for New World
`
`4
`
`Petitioner - New World Medical
`Ex. 1030, p. 6 of 19
`New World Medical, Inc. v. MicroSurgical Tech., Inc., IPR2020-01573
`
`
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`Medical to replicate the surgical procedure described in the Quintana reference
`
`(Ex.1004) to demonstrate that the references explicit teachings (e.g., “section,”
`
`“sectioned,” “stripping,” and “stripped”) refer to excising or cutting a “strip of
`
`tissue” from the TM as set forth in the claims of the ‘729 patent and not merely
`
`“incising” or “opening” the TM as set forth by Patent Owner and Dr. Condon.
`
`12.
`
`I have described below the experimental protocol I used to replicate
`
`the surgical procedure described in Quintana, a record of the experiments
`
`conducted, and my observations/results.
`
`Development of Experimental Protocol
`A.
`13. Based on the Quintana reference (Ex.1004), I arrived at the
`
`experimental protocol described below for reproducing the surgical procedure
`
`described in Quintana (Ex.1004). While I attempted to perform the experiments as
`
`closely as possible to the surgical procedure described in Quintana (Ex.1004), I
`
`note several differences between the surgical procedure described in the Quintana
`
`reference (Ex.1004) and the experimental protocol I developed and followed. As
`
`explained in detail below, I do not believe that these differences affected the
`
`outcome of my experiments or the results I obtained.
`
`14.
`
`The surgical procedure described in the Quintana reference (Ex.1004)
`
`was performed on live patients. For ethical reasons, it is not possible to replicate
`
`the surgical procedure described in the Quintana reference (Ex.1004) in live
`
`5
`
`Petitioner - New World Medical
`Ex. 1030, p. 7 of 19
`New World Medical, Inc. v. MicroSurgical Tech., Inc., IPR2020-01573
`
`
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`patients. Instead, human cadaver corneoscleral rims (“corneal rims”) acquired
`
`from Lions Eye Institute in Tampa, Florida were used. A corneal rim is an excised
`
`portion of the eye of a donor cadaver that is removed from the donor cadaver’s eye
`
`within about 6-8 hours after death. Corneal rims are obtained by excising the
`
`cornea and rim of attached sclera from the donor eye. The “rim” of attached sclera
`
`is typically about 4-5 mm of scleral tissue to minimize damage to the limbus and
`
`underlying structures (i.e., SC and TM). Corneal rims are commonly used and
`
`well-accepted in ophthalmology for simulating and training minimally-invasive
`
`glaucoma surgeries (“MIGs”) including accessing the TM and SC. Ex.1034
`
`(Arora), 4. Corneal rims are simple to prepare and teach trainees the variety in
`
`appearance of angle structures and tactile characteristics of SC. Id., 1. Because
`
`corneal rims are obtained from human eyes, corneal rims provide the best, most
`
`realistic model for replicating the surgical procedure described in the Quintana
`
`reference (Ex.1004).
`
`15.
`
`There are several other differences between the surgical procedure
`
`described in the Quintana reference (Ex.1004) and the experimental protocol I
`
`developed and followed that likewise relate to the use of corneal rims. These
`
`differences are described below:
`
` Fixation of Corneal Rim: While Quintana’s surgical procedure was
`
`performed in live patients’ eyes that are attached to the patient’s body, a
`
`6
`
`Petitioner - New World Medical
`Ex. 1030, p. 8 of 19
`New World Medical, Inc. v. MicroSurgical Tech., Inc., IPR2020-01573
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`
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`corneal rim is a detached portion of tissue that needs to be fixed in order to
`
`allow for experiments and training. Additionally, because the cornea tissue
`
`of cadaver corneal rims often becomes cloudy and difficult, if not impossible
`
`to see through, corneal rims are most commonly used by inverting the
`
`corneal rim so that the inner, concave surface of the cornea (as well as the
`
`angle structures including the trabecular meshwork and Schlemm’s Canal)
`
`faces upwards toward the surgeon, allowing the trainee/surgeon to practice
`
`MIGs techniques independent of the tissue’s corneal clarity. See Ex.1034
`
`(Arora), 1-2. As such, using a tissue holder device with a clamp provided by
`
`New World Medical, I clamped the corneal rim in the accepted inverted
`
`fashion to the tissue holder in order to hold the corneal rim in place below an
`
`operating microscope.
`
` Positioning: Quintana (Ex.1004) describes positioning the surgeon “as in
`
`classical goniotomy.” Ex.1004 (Quintana), 3. While I positioned myself on
`
`the temporal side of the corneal rim, I did not perform the experiments in
`
`patients so I did not rotate the patient’s head away or have an assistant
`
`present to hold a vertical recti. Id. For the same reason, I did not have an
`
`assistant present to “rotate the globe clockwise as [I introduced] the
`
`trabeculotome counter-clockwise.” Id., 4. Quintana did this in order to
`
`achieve a 100-120° trabeculotomy. Id. Because I used an inverted corneal
`
`7
`
`Petitioner - New World Medical
`Ex. 1030, p. 9 of 19
`New World Medical, Inc. v. MicroSurgical Tech., Inc., IPR2020-01573
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`
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`rim, I was able to move the needle farther through Schlemm’s Canal to
`
`create a longer trabeculotomy as opposed to rotating the globe and/or
`
`trabeculotome as described in Quintana (Ex.1004). I was able to create a
`
`longer trabeculotomy because I did not have to work around the temple,
`
`nose, or other portions of a patient and was only limited by the relevant
`
`structures of the eye.
`
` Approach: Quintana (Ex.1004) states “[t]he needle penetrates the anterior
`
`chamber at 6 hours (right eye) or 12 hours (left eye) through the scleral side
`
`of the limbus; this is in order to run parallel to Schlemm’s canal. Penetration
`
`at 6 or 12 hour allows a tangential approach [] to the angle; this avoids the
`
`pupillary field and the convexity of the lens.” Ex.1004 (Quintana), 4.
`
`Because corneal rims are excised portions of the eye and are used in an
`
`inverted fashion, it is not necessary or possible to penetrate the anterior
`
`chamber of the eye in the precise manner described in the Quintana
`
`reference (Ex.1004). Instead, because the corneal rim is inverted, direct
`
`access to angle structures is possible from above the corneal rim, which is
`
`either at the scleral side of the limbus or slightly more posterior. To
`
`replicate the procedure described in the Quintana reference (Ex.1004) as
`
`closely as possible, I took care to position the needle in the location that it
`
`would have entered and advanced into a live patient’s eye as described in the
`
`8
`
`Petitioner - New World Medical
`Ex. 1030, p. 10 of 19
`New World Medical, Inc. v. MicroSurgical Tech., Inc., IPR2020-01573
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`
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`Quintana reference (Ex.1004). Additionally, while Quintana describes use
`
`of a goniolens “[o]nce the needle is in the anterior chamber” in order to
`
`visualize the angle, there is no need to use a goniolens to visualize the angle
`
`when using an inverted corneal rim because the angle can be viewed
`
`directly. While this viewing position may provide enhanced visibility of the
`
`TM and SC for a less experienced surgeon, this does not change the
`
`procedure, nor the results achieved.
`
` Fluid: Quintana (Ex.1004) describes using a viscoelastic fluid called Healon
`
`as a wetting agent, to deepen the angle during the procedure, and before
`
`leaving the anterior chamber to avoid loss of aqueous and maintaining a full
`
`chamber. Ex.1004 (Quintana), 4. Because there is no anterior chamber in a
`
`corneal rim (the removed iris forms part of the chamber), the rims have no
`
`aqueous humor in the “chamber.” As such, I injected a similar viscoelastic
`
`fluid into convex portion of the corneal rims in order to eliminate the
`
`“chamber loss” as well as to perform the procedure within fluid (aqueous
`
`humor or viscoelastic fluid) as tissues may behave differently when in air
`
`(gas) versus fluid. I also used forceps at times in order to stretch the corneal
`
`rim tissue to better simulate the more firm tissue that would be in a living
`
`patient’s eye. I also injected another fluid called balanced salt solution
`
`(“BSS”) into the concave portion of the corneal rim to fill the eye with fluid
`
`9
`
`Petitioner - New World Medical
`Ex. 1030, p. 11 of 19
`New World Medical, Inc. v. MicroSurgical Tech., Inc., IPR2020-01573
`
`
`
`to better simulate the eye of a live patient. Last, in some instances, I injected
`
`dye into the angle area of the corneal rims to make it easier to see any tissue
`
`that was excised from the angle.
`
`B.
`16.
`
`Experimental Protocol
`I developed and followed the experimental protocol described below
`
`for reproducing the surgical procedure described in Quintana (Ex.1004).
`
`Materials:
`
` Microscope (Zeiss Lumera 700)
`
` Corneal rims (Lions Eye Institute, Tampa, FL)
`
` Tissue holder device with clamp (New World Medical)
`
` Needles (Exel Int. Hypodermic Needle Model: 27Gx1/2”)
`
` Syringe
`
` Clamp
`
` Forceps
`
` Protractor
`
` Viscoelastic
`
` BSS
`
` Dye (Trypan Blue and Lissamine Green)
`
`10
`
`Petitioner - New World Medical
`Ex. 1030, p. 12 of 19
`New World Medical, Inc. v. MicroSurgical Tech., Inc., IPR2020-01573
`
`
`
`Procedure:
`
` Affix corneal rim to tissue holder device in inverted fashion with
`
`concave side up by sliding corneal rim’s edge under clamp.
`
` Place tissue holder and corneal rim in viewing area of microscope,
`
`affix tissue holder to surface, and focus microscope at appropriate
`
`magnification.
`
` Remove needle from packaging and insert into syringe. Using clamp,
`
`bend needle tip approximately 30° and measure angle to ensure
`
`accuracy using protractor.1
`
` Inject viscoelastic into angle of corneal rim. Inject BSS into concave
`
`portion of corneal rim to fill eye with fluid.
`
` Position needle tip at 6 clock hours overtop corneal rim at shallow
`
`angle both the plane of SC (plane A) to simulate insertion at Scleral
`
`side of limbus as well as a shallow angle to the plane formed at the
`
`1 I understand that Patent Owner and Dr. Condon assert that the Quintana reference
`
`(Ex.1004) does not indicate precisely where the bend is made in Quintana’s needle.
`
`I therefore performed experiments with the bend in two different locations: (1) in
`
`the shaft proximal to the bevel (Experiments 1-3); and (2) within the bevel
`
`(Experiment 4).
`
`11
`
`Petitioner - New World Medical
`Ex. 1030, p. 13 of 19
`New World Medical, Inc. v. MicroSurgical Tech., Inc., IPR2020-01573
`
`
`
`tangent of the outer wall of SC (plane B) (perpendicular to plane A) to
`
`achieve a tangential approach to the TM.
`
` Advance needle tip within concave portion of corneal to simulate
`
`penetrating into the anterior chamber at the scleral side of the limbus
`
`(penetration point).
`
` Advance needle tip toward trabecular meshwork, taking care to
`
`maintain shallow angle and entry at 6 clock hours.
`
` Incise and penetrate the trabecular meshwork with the tip of the
`
`needle.
`
` With concavity of the tip facing surgeon, progressively advance the
`
`needle in the angle.
`
` With tip of needle within the trabecular meshwork, remove a strip of
`
`the trabecular meshwork slowly, gently, and easily from the canal’s
`
`lumen toward the anterior chamber as the needle progress in the angle.
`
`If necessary, stretch corneal rim tissues to better simulate tissue in live
`
`patient’s eye.
`
`C.
`17.
`
`Experimental Results
`The above experimental protocol was performed on four (4) corneal
`
`rims obtained from Lions Eye Institute (Experiments 1-4).
`
`12
`
`Petitioner - New World Medical
`Ex. 1030, p. 14 of 19
`New World Medical, Inc. v. MicroSurgical Tech., Inc., IPR2020-01573
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`
`
`18.
`
`Experiment 1 on the first corneal rim was performed using an older
`
`model microscope that had no video or photo capture capability. While I was not
`
`able to document my results, after performing the protocol described above, I
`
`observed what in my opinion were strips of trabecular meshwork tissue.
`
`19.
`
`Testing on the remaining three corneal rims (Experiments 2-4) was
`
`performed using the Zeiss Lumera 700 microscope with video capture capability. I
`
`am submitting videos documenting portions of my experiments along with this
`
`Reply Declaration (Exhibits 1031-1033). I have also taken screen captures from
`
`these videos and have provided several annotated images below.
`
`Figure 1
`The above image (Figure 1) is a screen capture from a video
`
`20.
`
`submitted as Exhibit 1031 of Experiment 2. In this experiment, I bent the needle in
`
`the shaft proximal to the bevel.
`
`13
`
`Petitioner - New World Medical
`Ex. 1030, p. 15 of 19
`New World Medical, Inc. v. MicroSurgical Tech., Inc., IPR2020-01573
`
`
`
`Figure 2
`The above image (Figure 2) is a screen capture from a video
`
`21.
`
`submitted as Exhibit 1032 of Experiment 3. In this experiment, I bent the needle in
`
`the shaft just above the bevel. The trabecular meshwork tissue has a green color
`
`because I used Lissamine green dye to make the tissue easier to see on camera.
`
`14
`
`Petitioner - New World Medical
`Ex. 1030, p. 16 of 19
`New World Medical, Inc. v. MicroSurgical Tech., Inc., IPR2020-01573
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`
`
`Figure 3
`The above image (Figure 3) is a screen capture from a video
`
`22.
`
`submitted as Exhibit 1033 of Experiment 4. In this experiment, I bent the needle
`
`within the bevel. The trabecular meshwork tissue has a green color because I used
`
`Lissamine green dye to make the tissue easier to see on camera. In Figure 3, the
`
`needle is being held in the microscopic view to show the strip of tissue and bend in
`
`the needle, not to show the surgical approach of the needle.
`
`23. As is shown in the videos and annotated images above, by performing
`
`the experimental protocol described above, I was able to obtain what in my opinion
`
`were strips of trabecular meshwork tissue.
`
`15
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`Petitioner - New World Medical
`Ex. 1030, p. 17 of 19
`New World Medical, Inc. v. MicroSurgical Tech., Inc., IPR2020-01573
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`
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`III. CONCLUSION
`24.
`In summary, following the surgical procedure set forth in the
`
`Quintana reference (Ex.1004), I performed experiments on several corneal rims to
`
`demonstrate that, despite Patent Owner’s, Dr. Condon’s, and Dr. Quintana’s
`
`assertions, the explicit statements in the Quintana reference (Ex.1004) (e.g.,
`
`“section,” “sectioned,” “stripping,” and “stripped”) demonstrates that the
`
`procedure of the Quintana reference yields a “strip of tissue” was cut from the
`
`trabecular meshwork.
`
`25.
`
`The results described above show that performing the surgical
`
`procedure described in the Quintana reference (Ex.1004) results, in most instances,
`
`in obtaining strips of trabecular meshwork tissue.
`
`26.
`
`These results confirm my opinion that the surgical procedure
`
`described in the Quintana reference (Ex.1004) would have result in cutting “strips
`
`of tissue” from the trabecular meshwork, as well as my opinion that Patent Owner,
`
`Dr. Condon, and Dr. Quintana misinterpreted the disclosures of the Quintana
`
`reference (Ex.1004).
`
`16
`
`Petitioner - New World Medical
`Ex. 1030, p. 18 of 19
`New World Medical, Inc. v. MicroSurgical Tech., Inc., IPR2020-01573
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`
`
`27.
`
`I declare under penalty of perjury that the foregoing is true and
`
`correct. I declare that all statements made herein of my knowledge are true, and
`
`that all statements made on information and belief are believed to be true, and that
`
`these statements were made with the knowledge that willful false statements and
`
`the like so made are punishable by fine or imprisonment, or both, under Section
`
`1001 of Title 18 of the United States Code. Executed this 31st day of August,
`
`2021.
`
`Digitally signed by Peter A.
`Peter A. Netland,
`Netland, MD, PhD
`Date: 2021.08.31 17:12:36
`MD, PhD
`-04'00'
`
`Dr. Peter Netland, MD, PhD
`
`17
`
`Petitioner - New World Medical
`Ex. 1030, p. 19 of 19
`New World Medical, Inc. v. MicroSurgical Tech., Inc., IPR2020-01573
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`
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