UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NEW WORLD MEDICAL, INC.,
`Petitioner
`v.
`
`MICROSURGICAL TECH., INC.,
`Patent Owner
`
`INTER PARTES REVIEW OF U.S. PATENT NO. 9,107,729
`Case No. IPR2020-01573
`
`EX. 1003 - DECLARATION OF DR. PETER NETLAND
`
`4850-5633-1210, v.1
`
`Petitioner - New World Medical
`Ex. 1003, p. 1 of 269
`
`

`

`Table of Contents
`
`X.
`
`INTRODUCTION ........................................................................................... 3
`I.
`QUALIFICATIONS ........................................................................................ 4
`II.
`III. MATERIALS REVIEWED AND CONSIDERED ........................................ 8
`IV.
`SCOPE OF OPINION ...................................................................................10
`V.
`LEVEL OF ORDINARY SKILL IN THE ART ...........................................11
`VI.
`LEGAL PRINCIPLES ...................................................................................12
`VII. BACKGROUND OF THE TECHNOLOGY ................................................14
`A.
`Eye Anatomy .......................................................................................14
`B.
`Trabecular Meshwork, Schlemm’s Canal, and Aqueous Humor
`Outflow ................................................................................................17
`Glaucoma .............................................................................................19
`C.
`Treatment of Glaucoma .......................................................................23
`D.
`VIII. U.S. PATENT NO. 9,107,729 (“‘729 patent”)..............................................34
`A.
`Overview of the ‘729 Patent ................................................................34
`B.
`Prosecution History of the ‘729 Patent ...............................................38
`IX. CLAIM CONSTRUCTION ..........................................................................41
`A.
`“ab interno” .........................................................................................41
`B.
`“dual blade device” .............................................................................47
`OVERVIEW OF THE PRIOR ART REFERENCES ...................................51
`A.
`Quintana (Ex.1004) .............................................................................51
`B.
`Lee (Ex.1006) ......................................................................................66
`C.
`Jacobi (Ex.1007) ..................................................................................68
`D.
`Johnstone (Ex.1005) ............................................................................72
`SPECIFIC GROUNDS OF CHALLENGE ...................................................74
`A.
`Ground 1: Claims 1-4 and 7-9 Are Anticipated by Quintana (Ex.1004)
` .............................................................................................................74
`Ground 2: Quintana (Ex.1004) in View of the Knowledge of a Person
`of Ordinary Skill in the Art Renders Obvious Claims 4-6 and 10 ......98
`Ground 3: Quintana (Ex.1004) in View of Lee (Ex.1006) Renders
`Obvious Claims 1-4 and 7-9 ..............................................................110
`
`XI.
`
`B.
`
`C.
`
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`Petitioner - New World Medical
`Ex. 1003, p. 2 of 269
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`

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`Declaration of Dr. Peter Netland, MD, PhD.
`
`U.S. Patent No. 9,107,729
`
`D.
`
`Ground 4: Quintana (Ex.1004) in View of Lee (Ex.1006) and the
`Knowledge of a Person of Ordinary Skill in the Art Renders Obvious
`Claims 4-6 and 10..............................................................................134
`Ground 5: Jacobi (Ex.1007) Anticipates Claims 1-4 and 7-8 ..........145
`Ground 6: Jacobi (Ex.1007) in View of the Knowledge of a Person of
`Ordinary Skill in the Art Render Obvious Claims 5-6 and 9-10 ......166
`XII. CONCLUSION ............................................................................................175
`
`E.
`F.
`
`ii
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`4850-5633-1210, v.1
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`Petitioner - New World Medical
`Ex. 1003, p. 3 of 269
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`

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`Declaration of Dr. Peter Netland, MD, PhD
`
`U.S. Patent No. 9,107,729
`
`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.
`
`2.
`
`My opinions are based on my years of education, research, and
`
`experience, as well as my investigation and study of relevant materials. The
`
`materials that I studied for this declaration include all the documents referenced in
`
`this declaration and the exhibits to New World Medical’s Petition for Inter Partes
`
`Review of U.S. Patent No. 9,107,729 (“the ‘729 patent”) (Ex.1001).
`
`3.
`
`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”). 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.
`
`4.
`
`This declaration represents 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.
`
`4850-5633-1210, v.1
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`Petitioner - New World Medical
`Ex. 1003, p. 4 of 269
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`

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`Declaration of Dr. Peter Netland, MD, PhD.
`
`U.S. Patent No. 9,107,729
`
`5.
`
`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. QUALIFICATIONS
`6.
`I am an expert in the field of ophthalmology. I have studied, taught,
`
`practiced, and researched in the field of ophthalmology for over twenty years. I
`
`have summarized in this section my educational background, work experience, and
`
`other relevant qualifications. A true and accurate copy of my curriculum vitae is
`
`attached as Appendix A to this declaration.
`
`7.
`
`I earned my Bachelor of Arts from Princeton University in Princeton,
`
`New Jersey in 1979. I earned my Doctor of Philosophy (“PhD”) in Physiology and
`
`Biophysics from Harvard University Division of Medical Sciences in Boston,
`
`Massachusetts in 1985. In 1987, I earned my Medicinae Doctor (“MD”) from the
`
`University of California School of Medicine in San Francisco, California
`
`(“UCSF”). Following a surgical internship at the UCSF, I completed my residency
`
`in ophthalmology in 1991 at the Massachusetts Eye and Ear Infirmary, which is a
`
`teaching hospital of Harvard Medical School in Boston, Massachusetts. I also
`
`completed a clinical fellowship in glaucoma at the Massachusetts Eye and Ear
`
`Infirmary.
`
`4850-5633-1210, v.1
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`Ex. 1003, p. 5 of 269
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`Declaration of Dr. Peter Netland, MD, PhD.
`
`U.S. Patent No. 9,107,729
`
`8.
`
`After completion of my fellowships, I was appointed Instructor of
`
`Ophthalmology and later promoted to Assistant Professor of Ophthalmology at
`
`Harvard Medical School in Boston, Massachusetts from 1992 to 1996. During this
`
`time, I also served as Associate Director of the Glaucoma Service at Massachusetts
`
`Eye and Ear Infirmary.
`
`9.
`
`I subsequently served as the Consultant and Associate Director for
`
`Glaucoma Services at the King Khaled Eye Specialist Hospital in Riyadh, Saudi
`
`Arabia from 1996 to 1997.
`
`10.
`
`In 1997, I joined the faculty of the University of Tennessee
`
`Department of Ophthalmology at the Health Science Center in Memphis,
`
`Tennessee. From 1997 to 2002, I served as an Associate Professor of
`
`Ophthalmology at the University of Tennessee Health Science Center. I was
`
`awarded tenure in 1999. In 2002, I was promoted to Professor of Ophthalmology
`
`and was also named the Gail S. and Richard D. Siegal Endowed Professor of
`
`Ophthalmology at the University of Tennessee College of Medicine in Memphis,
`
`Tennessee. I held those positions until 2009.
`
`11.
`
`In addition to being an Assistant Professor and Professor at the
`
`University of Tennessee, I also served as the Director of Glaucoma Fellowship
`
`from 1997 to 2009. I was also the Director of Glaucoma Services there for the
`
`same time period. Additionally, from 2003 to 2008, I also served as Vice Chair
`
`4850-5633-1210, v.1
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`5
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`Ex. 1003, p. 6 of 269
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`

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`Declaration of Dr. Peter Netland, MD, PhD.
`
`U.S. Patent No. 9,107,729
`
`and Director of Academic Affairs for the Department of Ophthalmology at the
`
`University of Tennessee Health Science Center.
`
`12.
`
`In 2009, I was appointed the Dupont Guerry, III Professor of
`
`Ophthalmology and Chairman of the Department of Ophthalmology at the
`
`University of Virginia School of Medicine in Charlottesville, Virginia. In 2012, I
`
`became the Vernah Scott Moyston Professor and Chair at the University of
`
`Virginia School of Medicine and still hold that position. I am also an
`
`ophthalmologist affiliated with the University of Virginia Medical Center and
`
`Salem Veterans Affairs Medical Center. My research interest and clinical
`
`specialty is glaucoma. However, my clinical practice includes cataract, glaucoma,
`
`cataract removal, eyelid swelling, and eye care.
`
`13.
`
`I have authored and co-authored over 300 original scientific articles,
`
`book chapters, reviews, and published abstracts. My research interests have
`
`focused primarily on pharmacological effects and surgical techniques in glaucoma.
`
`My publications have covered a wide array of glaucoma-related topics including
`
`screening for glaucoma, evolution of glaucoma, management of glaucoma,
`
`glaucoma filtration devices, glaucoma drainage, effects of therapy on glaucoma,
`
`and therapy of pediatric glaucoma. I have published five textbooks, most recently
`
`the first edition of The Pediatric Glaucomas, published by Elsevier, and the second
`
`edition of Glaucoma Medical Therapy, published by the American Academy of
`
`4850-5633-1210, v.1
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`6
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`Petitioner - New World Medical
`Ex. 1003, p. 7 of 269
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`

`

`Declaration of Dr. Peter Netland, MD, PhD.
`
`U.S. Patent No. 9,107,729
`
`Ophthalmology and Oxford University Press. A complete list of my publications,
`
`presentations, positions, awards, memberships, certifications and licensures is also
`
`contained in my curriculum vitae.
`
`14. My professional affiliations include service in various professional
`
`organizations, such as the American Academy of Ophthalmology (“AAO”) and the
`
`American Board of Ophthalmology (“ABO”). I have served on numerous AAO
`
`Committees, state specialty societies, and subspecialty societies. I was certified by
`
`the ABO in 1992 and have served as an Examiner and Special Associate Examiner
`
`for the ABO. I have been the director of a long-standing AUPO (Association of
`
`University Professors of Ophthalmology) FCC-certified clinical glaucoma
`
`fellowship training program. I was also a Past President of the Memphis Eye
`
`Society and was a Board member and President-Elect of the Tennessee
`
`Ophthalmological Society. I have given numerous international, national, and
`
`regional presentations on clinical and surgical management of glaucoma and
`
`glaucoma research. I served as President of the Albemarle County Medical
`
`Society and I am a delegate to the Medical Society of Virginia. Further, I was
`
`elected to the American Ophthalmological Society (“AOS”) in 2009. I have also
`
`received a number of awards and recognitions, including the Achievement Award
`
`in 2001, the Senior Achievement Award in 2007, and the Life Achievement Honor
`
`Award in 2018 from the AAO. I have also been named to the Best Doctors in
`
`4850-5633-1210, v.1
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`7
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`Petitioner - New World Medical
`Ex. 1003, p. 8 of 269
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`Declaration of Dr. Peter Netland, MD, PhD.
`
`U.S. Patent No. 9,107,729
`
`America List from 2001 to 2020 and America’s Top Ophthalmologists from 2008
`
`to 2020.
`
`15. A complete list of cases in which I have testified at trial, hearing, or
`
`by deposition within the preceding four years is provided in my curriculum vitae.
`
`III. MATERIALS REVIEWED AND CONSIDERED
`16.
`In connection with my work on this matter, I have reviewed and
`
`considered the following documents:
`
`Exhibit No.
`
`Exhibit
`
`1001
`
`U.S. Patent No. 9,107,729 (“the ‘729 patent”)
`
`1002
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`U.S. Patent No. 9,107,729 File History (‘729 patent file
`history”)
`
`Manuel Quintana, Gonioscopic Trabeculotomy. First Results, in
`43 SECOND EUROPEAN GLAUCOMA SYMPOSIUM, DOCUMENTA
`OPHTHALMOLOGICA PROCEEDINGS SERIES 265 (E.L. Greve, W.
`Leydhecker, & C. Raitta ed., 1985) (“Quintana”)
`
`M. Johnstone et al., “Microsurgery of Schlemm’s Canal and the
`Human Aqueous Outflow System,” Am. J. Ophthalmology
`76(6):906-917 (1973) (“Johnstone”)
`
`U.S. Patent No. 4,900,300 to Lee (“Lee”)
`
`Philipp C. Jacobi et al., “Technique of goniocurettage: a
`potential treatment for advance chronic open angle glaucoma,”
`81 BRITISH J. OPHTHALMOLOGY 302-307 (1997) (“Jacobi”)
`
`Richard S. Snell et al., Clinical Anatomy of the Eye, Malden,
`Massachusetts: Blackwell Science, Inc. (2nd ed., 1998) (“Snell”)
`
`4850-5633-1210, v.1
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`8
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`Petitioner - New World Medical
`Ex. 1003, p. 9 of 269
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`

`

`Declaration of Dr. Peter Netland, MD, PhD.
`
`U.S. Patent No. 9,107,729
`
`Exhibit No.
`
`Exhibit
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1018
`
`1019
`
`1020
`
`Am. Acad. Of Ophthalmology, Section 8 External Disease and
`Cornea, in BASIC AND CLINICAL SCIENCE COURSE 2001-2002
`(2001) (“AAO Cornea”)
`
`Michael John Hogan, Histology of the Human Eye: An Atlas
`and Textbook. Philadelphia, Pennsylvania: W. B. Saunders
`Company (1971) (“Hogan”)
`
`M. Bruce Shields, Textbook of Glaucoma, Fourth Edition.
`Baltimore, Maryland: Williams & Wilkins (1998) (“Shields”)
`
`Am. Acad. Of Ophthalmology, Section 10 Glaucoma, in BASIC
`AND CLINICAL SCIENCE COURSE 2000-2001 (2000) (“AAO
`Glaucoma”)
`
`Phillip C. Jacobi et al., “Perspectives in trabecular surgery,” Eye
`2000;14(Pt 3B)(3b):519-530 (2000) (“Jacobi 2000”)
`
`F. Skjaerpe, “Selective Trabeculectomy. A Report of a New
`Surgical Method for Open Angle Glaucoma,” Acta
`Ophthalmologica 61:714-727 (1983) (“Skjaerpe 1983”)
`
`U.S. Patent Application Publication No. 2002/0111608 to
`Baerveldt (“Baerveldt”)
`
`U.S. Patent No. 4,501,274 to Skjaerpe (“Skjaerpe ‘274”)
`
`E. Ferrari et al., “Ab-interno trabeculo-canalectomy: surgical
`approach and histological examination,” European J.
`Ophthalmology 12(5):401-05 (2002) (“Ferrari”)
`
`U.S. Patent App. No. 13/159,356 File History (‘356 application
`file history”)
`
`T. Shute, “A Novel Technique for Ab Interno Trabeculectomy:
`Description of Procedure and Preliminary Results,” Am.
`Glaucoma Society 29th Annual Meeting Poster Abstracts 34-35
`(2019) (available at:
`
`4850-5633-1210, v.1
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`9
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`Petitioner - New World Medical
`Ex. 1003, p. 10 of 269
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`

`

`Declaration of Dr. Peter Netland, MD, PhD.
`
`U.S. Patent No. 9,107,729
`
`Exhibit No.
`
`Exhibit
`
`https://ags.planion.com/Web.User/AbstractDet?ACCOUNT=A
`GS&CONF=AM19&ABSID=12309) (“Shute”)
`
`1021
`
`Arsham Sheybani, Bent Ab-interno Needle Goniectomy
`(BANG), YouTube (Aug. 24, 2017), https://youtu.be/b5QxWts-
`Pxs (“BANG Video”)
`
`17.
`
`I also have relied on my academic and professional experience in
`
`reaching the opinions expressed in this declaration.
`
`IV.
`
`SCOPE OF OPINION
`18.
`I have been asked to provide my opinions regarding whether claims 1-
`
`10 of the ‘729 patent are unpatentable pursuant to the following grounds:
`
`19. Claims 1-4 and 7-9 are anticipated under 35 U.S.C. § 102 by Quintana
`
`(Ex.1004);
`
`20. Claims 4-6 and 10 are rendered obvious under 35 U.S.C. § 103 by
`
`Quintana (Ex.1004) in view of the knowledge of a person of ordinary skill in the
`
`art;
`
`21. Claims 1-4 and 7-9 are rendered obvious under 35 U.S.C. § 103 by
`
`Quintana (Ex.1004) in view of Lee (Ex.1006);
`
`22. Claims 4-6 and 10 are rendered obvious under 35 U.S.C. § 103 by
`
`Quintana (Ex.1004) in view of Lee (Ex.1006) in further view of the knowledge of
`
`a person of ordinary skill in the art;
`
`4850-5633-1210, v.1
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`10
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`Petitioner - New World Medical
`Ex. 1003, p. 11 of 269
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`Declaration of Dr. Peter Netland, MD, PhD.
`
`U.S. Patent No. 9,107,729
`
`23. Claims 1-4 and 7-8 are anticipated under 35 U.S.C. § 102 by Jacobi
`
`(Ex.1007);
`
`24. Claims 5-6 and 9-10 are rendered obvious under 35 U.S.C. § 103 by
`
`Jacobi (Ex.1007) in view of the knowledge of a person of ordinary skill in the art.
`
`25.
`
`This declaration, including the exhibits hereto, sets forth my opinion
`
`on these topics.
`
`V.
`
`LEVEL OF ORDINARY SKILL IN THE ART
`26.
`I have been told by counsel that a “person of ordinary skill in art” is a
`
`hypothetical person to whom an expert in the relevant field could assign a routine
`
`task with reasonable confidence that the task would be successfully carried out. I
`
`have been informed that the level of skill in the art is evidenced by the prior art
`
`references.
`
`27.
`
`The ‘729 patent acknowledges that the prior art teaches surgical
`
`procedures for treating glaucoma including goniectomy procedures and devices for
`
`performing surgical procedures to treat glaucoma. The claimed invention is a
`
`method for forming an opening in the trabecular meshwork of a patient’s eye to
`
`treat glaucoma. Based on my education and experience, I believe that one of skill
`
`in the art would have the following education and experience: (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
`
`4850-5633-1210, v.1
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`11
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`Ex. 1003, p. 12 of 269
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`Declaration of Dr. Peter Netland, MD, PhD.
`
`U.S. Patent No. 9,107,729
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`mechanical engineering and at least five years of work experience in the area of
`
`ophthalmology, including familiarity with ophthalmic anatomy and glaucoma
`
`surgery.
`
`VI. LEGAL PRINCIPLES
`28.
`I am not an attorney and accordingly have not been retained as an
`
`expert in patent law. I have been informed, however, about several principles and
`
`standards of patent law, which I have used in developing my opinions expressed
`
`herein.
`
`29.
`
`It is my understanding that prior art can be defined generally as
`
`evidence that an invention was already publicly known or available before the
`
`effective filing date of a patent or patent application, such as prior patents and/or
`
`publications. It is my understanding that there are two ways in which prior art may
`
`render a patent claim unpatentable. First, the prior art can be shown to “anticipate”
`
`the claim. Second, the prior art can be shown to have made the claim “obvious” to
`
`a person of ordinary skill in the art.
`
`30.
`
`It is my understanding that a patent claim is unpatentable as being
`
`anticipated if all the claim elements are found expressly or inherently within a prior
`
`art reference and arranged as in the claim. It is my understanding that a prior art
`
`disclosure can inherently anticipate claimed subject matter if the disclosure
`
`necessarily functions in accordance with, or includes, the claimed subject matter.
`
`4850-5633-1210, v.1
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`12
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`Petitioner - New World Medical
`Ex. 1003, p. 13 of 269
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`Declaration of Dr. Peter Netland, MD, PhD.
`
`U.S. Patent No. 9,107,729
`
`31.
`
`It is my understanding that a patent claim is unpatentable as being
`
`obvious in view of prior art if the differences between the subject matter sought to
`
`be patented and the prior art are such that the subject matter as a whole would have
`
`been obvious at the time the alleged invention was made to a person of ordinary
`
`skill in the art to which said subject matter pertains. I further understand that an
`
`obviousness analysis takes into consideration factual inquiries such as the level of
`
`ordinary skill in the art, the scope and content of the prior art, and the differences
`
`between the prior art and the patent claim.
`
`32.
`
`I understand that the U.S. Supreme Court has recognized several
`
`rationales for combining references and for modifying a reference as part of an
`
`obviousness analysis. These rationales include combining prior art elements
`
`according to known methods to yield predictable results, simple substitution of a
`
`known element for another to obtain predictable results, a predictable use of prior
`
`art elements in accordance with their established functions, applying a known
`
`technique to improve a known device (or process) and yield predictable results,
`
`and choosing from a finite number of known predictable solutions with a
`
`reasonable expectation of success. It is further my understanding that an
`
`obviousness analysis takes into consideration whether the prior art provides a
`
`teaching, suggestion, or motivation to combine teachings of multiple prior art
`
`references to arrive at the patent claim.
`
`13
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`4850-5633-1210, v.1
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`Ex. 1003, p. 14 of 269
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`Declaration of Dr. Peter Netland, MD, PhD.
`
`U.S. Patent No. 9,107,729
`
`33.
`
`I understand that for the purposes of this proceeding, the priority date
`
`for the ‘729 patent is June 10, 2003. I have therefore analyzed obviousness as of
`
`that date or somewhat before that date.
`
`VII. BACKGROUND OF THE TECHNOLOGY
`A.
`Eye Anatomy
`34.
`The human eye is a sense organ that takes in light and changes it to a
`
`neural signal to provide vision. Ex.1008 (Snell), 8-9, 47. Structurally the eye is
`
`made up of three layers: (1) an outer fibrous layer; (2) a middle vascular layer; and
`
`(3) an inner neural layer. Id., 11. The figure below shows a schematic diagram of
`
`the human eye depicting these layers and the structures that form them.
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`Ex. 1003, p. 15 of 269
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`Declaration of Dr. Peter Netland, MD, PhD.
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`U.S. Patent No. 9,107,729
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`Id., 9.
`
`35.
`
`The outer fibrous layer provides shape and protection to the eye. Id.,
`
`11. This layer consists of the cornea and sclera. Id. The sclera is the opaque
`
`white part of the eye. Id. The cornea is the transparent front that allows light rays
`
`to enter and helps focus light on the retina. Id., 11, 20. As shown in the figure
`
`below, the cornea is divided into “zones”: (1) the central zone; (2) the paracentral
`
`zone; (3) the peripheral zone; and (4) the limbal zone. Ex.1009 (AAO Cornea), 4.
`
`4850-5633-1210, v.1
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`15
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`Petitioner - New World Medical
`Ex. 1003, p. 16 of 269
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`Declaration of Dr. Peter Netland, MD, PhD.
`
`U.S. Patent No. 9,107,729
`
`Id., 9; see also Ex.1008 (Snell), 21.
`
`36.
`
`The limbus, which as shown in the image above is within the limbal
`
`zone of the cornea, is the transition between the cornea and the sclera. Ex.1009
`
`(AAO Cornea), 9; Ex.1008 (Snell), 23.
`
`37.
`
`The vascular layer of the eye, i.e., the uvea, includes the iris, the
`
`ciliary body, and the choroid. Ex.1008 (Snell), 29. The iris, which is the colored
`
`portion of the eye, surrounds the pupil and regulates the amount of light that enters
`
`the eye. Id., 46. The ciliary body produces components of the aqueous humor that
`
`fills several spaces in the eye, and the choroid surrounds and provides nutrients to
`
`the retina. Id., 31-32, 36. The neural layer of the eye consists of the retina, the
`
`light-sensitive inner lining of the back of the eye. Id., 47.
`
`4850-5633-1210, v.1
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`Ex. 1003, p. 17 of 269
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`Declaration of Dr. Peter Netland, MD, PhD.
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`U.S. Patent No. 9,107,729
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`38. Between the layers of the eye are three chambers: (1) the anterior
`
`chamber bounded by the cornea, iris, and lens; (2) the posterior chamber behind
`
`the iris; and (3) the vitreous chamber bounded by the lens and inner retinal layer.
`
`Id., 66-68. The lens is located within the posterior chamber and, like the cornea,
`
`helps to focus images on the retina. Id., 69.
`
`39.
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`The cornea refracts and focuses light and the iris adjusts the size of
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`the pupil to control the amount of light reaching the back of the eye. Id., 20, 46.
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`Behind the pupil, light is further focused by the lens onto the retina. Id., 69.
`
`Through complex biochemical processes, the retina changes this light into a signal
`
`that passes through the optic nerve and on to the brain for processing. Id., 47.
`
`B.
`
`40.
`
`Trabecular Meshwork, Schlemm’s Canal, and Aqueous Humor
`Outflow
`The anterior chamber and posterior chamber are connected through
`
`the pupil and contain a fluid called aqueous humor. Id., 66-68. Aqueous humor
`
`is a clear fluid that nourishes and protects the eye. It provides a continuous stream
`
`into which surrounding tissues can discharge waste products. Ex.1006 (Lee), 1:9-
`
`27.
`
`41. Aqueous humor is produced into the posterior chamber by the ciliary
`
`body and then flows into the anterior chamber via the pupil. Ex.1011 (Shields),
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`27. It drains from the anterior chamber through the trabecular meshwork, a
`
`filterlike tissue between the iris and the cornea, and into Schlemm’s Canal, a
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`collector canal running circularly between the cornea and the iris. Id., 16-17;
`
`Ex.1006 (Lee), 1:9-27. The figure below shows a cutaway view of the layers of
`
`the trabecular meshwork and Schlemm’s Canal.
`
`Ex.1011 (Shields), 18.
`
`42.
`
`From Schlemm’s Canal, the aqueous humor drains through outlets
`
`(sometimes called collector channels) in the eye wall into blood vessels and
`
`eventually back into the circulatory system. Id., 16-17. In healthy eyes, the rate of
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`U.S. Patent No. 9,107,729
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`production of aqueous humor balances the rate of drainage. Id., 7. The figure
`
`below shows an overall schematic of aqueous humor flow of a normal eye from
`
`aqueous production in the ciliary body to aqueous outflow in the trabecular
`
`meshwork/Schlemm’s canal.
`
`Ex.1012 (AAO, Glaucoma), 6.
`
`Glaucoma
`C.
`43. Glaucoma, a form of optic neuropathy, refers to a well-known group
`
`of ocular diseases that are a major cause of irreversible blindness. At the time the
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`U.S. Patent No. 9,107,729
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`‘729 patent was filed, one of the primary risk factors for the development and
`
`progression of glaucoma was known to be elevated intraocular pressure (“IOP”).
`
`Ex.1006 (Lee), 1:9-27; Ex.1012 (AAO, Glaucoma), 6. At that time, it was also
`
`known that “[i]n most cases increased IOP is caused by increased resistance to
`
`aqueous humor outflow” across the trabecular meshwork-Schlemm’s Canal
`
`system. Ex.1012 (AAO, Glaucoma), 6; see also Ex.1004 (Quintana), 3; Ex.1007
`
`(Jacobi), 4; Ex.1006 (Lee), 1:13-27.
`
`44. Generally, there are two forms of glaucoma: open-angle glaucoma and
`
`closed-angle glaucoma. Ex.1012 (AAO, Glaucoma), 7. In open-angle glaucoma,
`
`the trabecular meshwork restricts the aqueous fluid from draining out of the
`
`anterior chamber. Id., 10. The figure below shows an eye with open-angle
`
`glaucoma with resistance to aqueous outflow through the trabecular meshwork-
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`Schlemm’s Canal system.
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`Id.
`
`45. As shown below, in closed-angle glaucoma, the anatomical angle
`
`formed between the iris and cornea (i.e., the “angle”) is narrowed, causing the iris
`
`to block aqueous outflow through the trabecular meshwork. Id.
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`Id.
`
`46. Due to these blockages, the continuous production of aqueous humor
`
`coupled with diminished drainage results in increased pressure in the anterior
`
`chamber. Id., 6; Ex.1011 (Shields), 7. Increased pressure in the anterior chamber
`
`results in increased pressure in the vitreous chamber, thereby placing stress on the
`
`optical nerve, which leads to damage of the nerve fibers and ultimately, vision loss.
`
`Ex.1011 (Shields), 5. Symptoms of glaucoma worsen over time, starting with
`
`peripheral vision loss and progressing to affect the central vision. Id., 4-5. Once
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`part of the visual field is lost, it cannot be restored. Id., 5. While there is currently
`
`no cure for glaucoma, preventative measures can be taken to reduce its effects. Id.
`
`D.
`47.
`
`Treatment of Glaucoma
`Surgical attempts to treat glaucoma date back to at least the mid-
`
`1800’s. Ex.1012 (AAO, Glaucoma), 4-5. As early as the 1860’s, surgical
`
`approaches had been developed that focused on decreasing IOP by creating an
`
`opening between the anterior chamber and the outside of the eye to enhance
`
`outflow, in other words drainage, of intraocular fluid. Id. These early approaches
`
`formed the basis for many additional surgical techniques that were developed over
`
`the next century directed to the same goal: enhancing fluid outflow from the
`
`anterior chamber.
`
`48.
`
`In the late-1950’s and early 1960’s, Grant determined that the largest
`
`portion of resistance to outflow is located at the trabecular meshwork and can be
`
`eliminated by incising the trabecular meshwork and entering Schlemm’s Canal.
`
`Ex.1007 (Jacobi), 4. In particular, Grant demonstrated using an “ab interno”
`
`approach that a 360° incision in the trabecular meshwork can eliminate 75% of the
`
`resistance to aqueous outflow. Ex.1011 (Shields), 23. These findings by Grant led
`
`to the development of many new surgical procedures that, well before 2003,
`
`focused on Schlemm’s Canal and specifically on bypassing, disrupting, incising,
`
`and removing strips of trabecular meshwork tissue.
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`U.S. Patent No. 9,107,729
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`49.
`
`Importantly, surgical procedures for treating glaucoma can be
`
`classified as either “ab interno” or “ab externo.” As explained further below, these
`
`terms are commonly used to describe ophthalmological procedures specifying
`
`whether the tissue on which the procedure is being performed is being approached
`
`from the inside of the eye (“ab interno”) or the outside of the eye (“ab externo”).
`
`In the context of a procedure targeting the trabecular meshwork, for example, an
`
`“ab interno” procedure refers to one in which the trabecular meshwork is
`
`approached from within the eye through the anterior chamber. On the other
`
`hand, an “ab externo” trabecular meshwork procedure is one in which the
`
`trabecular meshwork is approached from the outside of the eye, such as where an
`
`incision is made on the exterior of the eye through the sclera directly into
`
`Schlemm’s Canal to allow for removal of segments or strips of trabecular
`
`meshwork directly through this external incision (rather than through the anterior
`
`chamber).
`
`Trabeculotomy and Trabeculectomy
`1.
`Trabeculotomy, which was first introduced in the early 1960’s, is a
`
`50.
`
`common “ab externo” procedure for incising the trabecular meshwork to establish
`
`direct communication between the anterior chamber and Schlemm’s Canal.
`
`Ex.1011 (Shields), 49.
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`U.S. Patent No. 9,107,729
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`51. Most commonly, trabeculotomy involves creating an incision through
`
`the sclera directly into Schlemm’s Canal and using a surgical instrument to disrupt
`
`the trabecular meshwork overlying the canal. Ex.1012 (AAO, Glaucoma), 51. For
`
`example, a fine wirelike instrument (trabeculotome) is inserted directly into
`
`Schlemm’s Canal from an external incision. Id. As shown in the figure below, by
`
`rotating the trabeculotome into the anterior chamber, the instrument tears a slit-like
`
`opening in the trabecular meshwork. Id., 51-53.
`
`Id., 53.
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`U.S. Patent No. 9,107,729
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`52. A similar surgical technique called trabeculectomy was first described
`
`by Cairns in 1968. Ex.1011 (Shields), 61-63. Rath