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`
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`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 IPR2020-01573
`U.S. Patent No. 9,107,729
`_______________________
`Filed: June 8, 2021
`
`DECLARATION OF GARRY P. CONDON, M.D.
`IN SUPPORT OF PATENT OWNER’S RESPONSE
`
`
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`Patent Owner Ex. 2019-0001
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`

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`TABLE OF CONTENTS
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`I.
`
`Introduction ...................................................................................................... 1
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`II. Qualifications .................................................................................................... 1
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`III. Materials Considered ........................................................................................ 1
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`IV. Legal Standards ................................................................................................ 2
`
`A. Written Description .......................................................................................... 2
`
`B. Definiteness ...................................................................................................... 3
`
`C. Enablement ....................................................................................................... 3
`
`D. Priority .............................................................................................................. 4
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`E. Anticipation and Obviousness .......................................................................... 4
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`F. Claim Construction ........................................................................................... 5
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`G. Person of Ordinary Skill of the Art .................................................................. 6
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`V.
`
`Summary of my opinions ................................................................................. 7
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`VI. Details of my opinions ...................................................................................... 8
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`A. Prior Art ............................................................................................................ 8
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`i. Quintana ........................................................................................................ 9
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`ii. Johnstone ..................................................................................................... 24
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`iii. Lee ............................................................................................................... 26
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`iv. Jacobi and Jacobi 2000 ................................................................................ 30
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`B. The Netland Declaration ................................................................................. 38
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`C. Application of the Prior Art to the ’729 Patent Claims .................................. 46
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`i. Petition Ground 1 (Claims 1-4 and 7-9 are not anticipated by Quintana) .. 46
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`
`
`i
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`ii. Petition Ground 2 (Claims 4-6 and 10 are not obvious over Quintana in
`view of the knowledge in the art) ...................................................................... 58
`
`iii. Petition Ground 3 (Claims 1-4 and 7-9 are not obvious over Quintana in
`view of Lee) ....................................................................................................... 64
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`iv. Petition Ground 4 (Claims 4-6 and 10 are not obvious over Quintana in
`view of Lee and the knowledge in the art) ........................................................ 81
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`v. Petition Ground 5 (Claims 1-4 and 7-8 are not anticipated by Jacobi) ....... 87
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`vi. Petition Ground 6 (Claims 5-6 and 9-10 are not obvious over Jacobi in
`view of the knowledge in the art) ...................................................................... 96
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`D. Conclusion ....................................................................................................102
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`
`
`ii
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`Patent Owner Ex. 2019-0003
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`EXHIBIT LIST
`
`Description
`Exhibit
`Sworn Affidavit of Manuel Quintana, M.D.
`2020
`2023 DORLAND’S MEDICAL DICTIONARY SHORTER EDITION abridged from
`25th ed. (1980) excerpt at 605 (definition of “section”)
`2024 BLACKS MEDICAL DICTIONARY 47th ed. (1992) excerpt at 519
`(definition of “section”)
`
`
`
`
`
`
`iii
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`Patent Owner Ex. 2019-0004
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`IPR2020-01573
`Condon Declaration
`
`I, Garry P. Condon, M.D., hereby declare as follows:
`
`I.
`
`INTRODUCTION
`
`1.
`
`I have been retained by Wiley Rein LLP as an expert witness on
`
`behalf of MicroSurgical Technology, Inc. (“MST”) in support of Patent Owner’s
`
`Response in this Inter Partes Review (“IPR”) of U.S. Patent No. 9,107,729
`
`(Ex. 1001) (“the ’729 Patent”). I am being compensated for my time in connection
`
`with this IPR at a consulting rate of $575 (USD) per hour. My compensation is in
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`no way dependent on the outcome of this matter.
`
`II. QUALIFICATIONS
`
`2.
`
`Attached to this Declaration as Appendix A is my curriculum vitae,
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`which provides a more detailed description of my education, training, and
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`experience in the relevant technology.
`
`III. MATERIALS CONSIDERED
`
`3.
`
`I provide opinions in this declaration based on my education, training,
`
`background, and experience, as well as the documents I have reviewed to date,
`
`including the ’729 Patent and the Petition (including the following documents:
`
`Declaration of Dr. Peter Netland (Ex. 1003) (“the Netland Declaration”); 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) (Ex. 1004) (“Quintana”);
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`Patent Owner Ex. 2019-0005
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`IPR2020-01573
`Condon Declaration
`Page 2
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`M. Johnstone et al., “Microsurgery of Schlemm’s Canal and the Human Aqueous
`
`Outflow System,” Am. J. Ophthalmology 76(6):906-917 (1973) (Ex. 1005)
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`(“Johnstone”); U.S. Patent No. 4,900,300 (Ex. 1006) (“Lee”); Philipp C. Jacobi et
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`al., “Technique of goniocurettage: a potential treatment for advance chronic open
`
`angle glaucoma,” 81 British J. Ophthalmology 302-07 (1997) (Ex. 1007)
`
`(“Jacobi”); Philipp C. Jacobi et al., “Perspectives in trabecular surgery,” Eye
`
`2000;14(Pt 3B)(3b):519-30 (2000) (Ex. 1013) (“Jacobi 2000”); and Sworn
`
`Affidavit of Manuel Quintana, M.D. (Ex. 2020). Those documents, and the other
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`materials cited in this declaration, are listed in Appendix B. I have either read the
`
`materials listed in Appendix B or reviewed summarized data provided by counsel.
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`IV. LEGAL STANDARDS
`
`4.
`
`I am not a lawyer, nor do I have any legal training. In preparing this
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`declaration, I have relied upon the explanation by counsel of certain patent law
`
`concepts, including the legal standard for interpreting claims, as well as those for
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`assessing written description, definiteness, enablement, entitlement of priority,
`
`anticipation, and obviousness.
`
`A. Written Description
`
`5.
`
`I have been informed by counsel that a claim in a granted patent must
`
`be sufficiently supported by the disclosure in the patent’s specification, read in the
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`
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`IPR2020-01573
`Condon Declaration
`Page 3
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`context of what a person of ordinary skill in the art would have known at the time
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`of the claimed invention. I understand that the basic inquiry for written description
`
`is whether the specification provides sufficient information for the person or
`
`ordinary skill to recognize that the named inventors possessed the full scope of the
`
`claimed invention.
`
`B. Definiteness
`
`6.
`
`I have been informed by counsel that, in addition to written
`
`description, a patent specification must also describe the claimed invention so as to
`
`inform a person of ordinary skill in the art of the scope of the claimed invention
`
`with reasonable certainty. A claim may also be indefinite when it contains words
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`or phrases whose meaning is unclear. Conflicting information between the patent
`
`claims and the rest of the patent application, including the figures, may affect that
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`certainty and/or clarity.
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`C. Enablement
`
`7.
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`I have been informed by counsel that, in addition to written
`
`description, a patent specification must also enable a person of ordinary skill in the
`
`art to make and use the full scope of the claimed invention without undue
`
`experimentation as of its effective filing date. I understand that multiple factors
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`should be considered when making this determination. These factors include (1)
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`IPR2020-01573
`Condon Declaration
`Page 4
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`the quantity of experimentation necessary, (2) the amount of direction or guidance
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`presented, (3) the presence or absence of working examples, (4) the nature of the
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`invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7)
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`the predictability or unpredictability of the art, and (8) the breadth of the claims.
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`D. Priority
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`8.
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`I have been informed by counsel that, for the claims of an application
`
`to be entitled to an earlier application’s filing date, the earlier application must
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`provide written description and enablement of the claims, as of the earlier
`
`application’s filing date. I have been informed by counsel that the undisputed and
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`applicable priority date in this IPR is June 10, 2003.
`
`E. Anticipation and Obviousness
`
`9.
`
`I have been informed by counsel that a claim is anticipated when a
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`single prior art reference discloses, either expressly or inherently, each and every
`
`claim element arranged in the order specified by the claim. I also understand that
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`whether a document qualifies as prior art against a claim depends on the effective
`
`filing date to which the claim is entitled. I have been informed that even if a claim
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`is not anticipated, it may be invalid for obviousness where a person having
`
`ordinary skill in the relevant art at the time the alleged invention was made would
`
`have considered the claimed invention as a whole to have been obvious given the
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`IPR2020-01573
`Condon Declaration
`Page 5
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`prior art. I understand that a claim may be obvious in light of one or more prior art
`
`references.
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`F. Claim Construction
`
`10.
`
`I have been informed by counsel that the Patent Trial and Appeal
`
`Board (“PTAB”) applies the same claim construction standard used in district
`
`courts, where the claims are given their ordinary meaning as understood by one
`
`skilled in the art at the time of the invention, informed by the claim language itself,
`
`the specification, and the prosecution history. I also understand that “extrinsic
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`evidence”—i.e., evidence other than the patent and prosecution history, such as
`
`dictionaries and treatises—can be relevant in determining how a skilled artisan
`
`would understand terms of art used in the claims. I have been informed, however,
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`that extrinsic evidence may not be used to contradict the meaning of the claims as
`
`described in the intrinsic evidence—i.e., evidence in the claim language itself, the
`
`specification, and the prosecution history.
`
`11.
`
`I have been informed by counsel that the PTAB, at least as of its
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`March 16, 2021 institution of this IPR, has declined to expressly adopt any
`
`proposed construction of the claim language set forth in the Petition, but instead,
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`assigned the claim language its ordinary meaning as it would have been understood
`
`by a person of ordinary skill in the art (“POSA”). Accordingly, in making the
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`IPR2020-01573
`Condon Declaration
`Page 6
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`findings and reaching the conclusions in this declaration, I too have applied the
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`ordinary meanings of the claim terms as they would have been understood by a
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`POSA. To the extent that the PTAB adopts specific claim constructions regarding
`
`the ’729 Patent claims, I reserve the right to amend my findings and conclusions
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`accordingly.
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`G. Person of Ordinary Skill of the Art
`
`12.
`
`In my opinion, a POSA as of the date of invention would have been at
`
`least (1) a medical degree and at least two years’ experience with treating
`
`glaucoma and performing glaucoma surgery; or (2) an undergraduate or graduate
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`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. For purposes of my Declaration, I do not disagree
`
`with the characterization of a POSA proposed by Petitioner. See Ex. 1003 ¶27.
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`IPR2020-01573
`Condon Declaration
`Page 7
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`V. SUMMARY OF MY OPINIONS
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`13.
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`In my opinion, a POSA would have understood that Quintana does not
`
`disclose each and every element of the ’729 Patent claims, at least because
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`Quintana does not mention or suggest any of the following: (1) the removal of
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`trabecular meshwork (“TM”) tissue; (2) the use of a dual blade device; (3) the
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`cutting of the TM by first and second cutting edges concurrently to create a strip of
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`TM of defined width. Furthermore, in my opinion, a POSA reading Quintana
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`would not necessarily have found it to disclose one or both of: (1) a distal
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`protruding tip that extends from a distal end of the shaft to form a bend or curve
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`having an angle of at least 30 degrees; and (2) an ab interno method for forming an
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`opening in the TM of a patient’s eye.
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`14.
`
`I find numerous statements in the Netland Declaration, Ex. 1003,
`
`about the prior art identified in the Petition to be erroneous, and I find many of Dr.
`
`Netland’s conclusions to be based solely on his own speculation, conjecture, and
`
`hindsight. I address each of these erroneous statements and unfounded conclusions
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`below.
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`15.
`
`In my opinion, not only would a POSA have found Quintana lacking
`
`with respect to elements of the ’729 Patent claims, but a POSA would not have
`
`read Lee, Johnstone and/or Jacobi, or applied the general knowledge in the art, to
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`IPR2020-01573
`Condon Declaration
`Page 8
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`make up for Quintana’s shortfalls in this regard. Similarly, not only would a POSA
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`have found Jacobi lacking with respect to elements of the ’729 Patent claims, but a
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`POSA would not have read Quintana, Johnstone and/or Lee, or applied the general
`
`knowledge in the art, to make up for Jacobi’s shortfalls in this regard. Therefore, I
`
`conclude that a POSA would not have found that any of the prior art identified in
`
`the Petition, alone or in combination, anticipated and/or rendered obvious the
`
`’729 Patent claims according to the applicable legal standards as I understand
`
`them.
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`16. For purposes of this declaration, I do not disagree with the
`
`background of the technology as set forth generally in Sections VII.A.-VII.D.2. of
`
`the Netland Declaration. See Ex. 1003 ¶¶34-55.
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`VI. DETAILS OF MY OPINIONS
`
`A. Prior Art
`
`17.
`
`I have been asked to review the ’729 Patent (Ex. 1001) and its
`
`prosecution history (Ex. 1002), the Netland Declaration (Ex. 1003), the prior art
`
`identified in the Petition (including Exs. 1004-1007, 1013), and the Sworn
`
`Affidavit of Manuel Quintana, M.D. (Ex. 2020). Among other things, I have been
`
`asked to provide my opinion about what a POSA would have known from the prior
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`art available on or before the priority date of June 10, 2003, including the general
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`IPR2020-01573
`Condon Declaration
`Page 9
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`knowledge in the art; to comment on my agreement or disagreement with various
`
`statements in the Netland Declaration; and to compare the prior art to the
`
`’729 Patent claims according to the applicable legal standards as I understand
`
`them.
`
`i. Quintana
`I have reviewed the publication known as Quintana (Ex. 1004).
`
`18.
`
`Quintana is a 7-page journal article containing one of each of a drawing (labeled as
`
`Figure 1), a photograph (labeled as Figure 2), a table (labeled as Table 1), and a
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`graph (labeled as Figure 3). Quintana states that it was published in 1985. Ex. 1004
`
`at 3.
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`19.
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`In my opinion, the most natural reading of Quintana to a POSA would
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`have been the reporting of a new way to move the TM in a patient’s eye away from
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`the lumen of Schlemm’s Canal by following a tangential approach to the TM with
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`a standard hypodermic needle, the tip of which is bent and angled toward the
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`anterior chamber of the eye, so as to avoid injuring the external wall of Schlemm’s
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`Canal. A POSA would have understood that a key concern of Quintana was
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`minimizing the risk of damaging the external wall of Schlemm’s Canal during this
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`procedure. A POSA would have recognized that Quintana did not describe a
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`IPR2020-01573
`Condon Declaration
`Page 10
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`method or device for removing TM for any reason, including tissue biopsy or
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`patient diagnosis or therapy.
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`20. Quintana teaches a POSA how to make a trabeculotome by bending
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`the tip of a standard hypodermic needle (“a 0.4 x 15 mm needle, or an
`
`insuline-type needle; we bend the tip 20-30° with a needle-holder; a factory-made
`
`needle (Morie, France) is even better.”). Ex. 1004 at 3. Quintana does not specify
`
`exactly what is meant by the needle tip, or where at the needle tip, or along what
`
`axis of the needle shaft, the bend is made.
`
`21. Quintana teaches a POSA that the working end of its trabeculotome is
`
`the “tip of the needle.” In this regard, Quintana reads:
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`“The TM is incised with the tip of the needle. From now on, and with
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`the concavity of the tip towards the surgeon, the trabeculotome is
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`progressively introduced in the angle. Only the tip of the instrument is
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`introduced into Schlemm’s canal, and the TM is stripped slowly,
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`gently and easily from the canal’s lumen towards the anterior chamber
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`as the needle progresses in the angle (Fig. 2). Since the convexity of
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`the tip is facing the external wall of the canal, this structure is not
`
`damaged. This is why we bend the tip and we point it towards the
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`anterior chamber.”
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`IPR2020-01573
`Condon Declaration
`Page 11
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`Ex. 1004 at 4 (emphasis in original).
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`In its Figure 2 legend, Quintana also reads: “Goniophotography at operation. The
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`tip of the needle stripping the trabecular meshwork.” Ex. 1004 at 5.
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`22.
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`In my opinion, a POSA would have understood the Quintana
`
`trabeculotome, other than its needle tip bend, to be the same as an unbent standard
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`hypodermic needle, the tip of which has a single bevel with a sharp point and sides.
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`A POSA would have understood that the intended use of a standard hypodermic
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`needle is to penetrate tissue through an incision created by the sharp point at the
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`distal end of the single beveled tip. The drawing labeled as Quintana Figure 1
`
`shows a needle tip consistent with this understanding. Ex. 1004 at 4.
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`23.
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`In my opinion, a POSA would have determined that the beveled sides
`
`of the Quintana trabeculotome, like those of a standard hypodermic needle, may
`
`act alongside the sharp point as part of a single blade to allow the needle to create a
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`slit-like incision in the TM. A POSA reading Quintana would not have found the
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`beveled sides of the Quintana trabeculotome to be otherwise sharp or intended to
`
`cut tissue. A POSA would have read nothing in Quintana to lend support to Dr.
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`Netland’s statement that the beveled sides of the Quintana trabeculotome tip are
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`distinct cutting edges, much less the “first and second cutting edges” described in
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`the ’729 Patent. See Ex. 1003 ¶121.
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`IPR2020-01573
`Condon Declaration
`Page 12
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`24. Dr. Netland’s re-drawing of Quintana Figure 1 to depict the beveled
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`sides of the needle tip of the Quintana trabeculotome as cutting edges has no basis
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`in Quintana. See Ex. 1003 ¶121. A POSA reading Quintana would not have seen
`
`any reference to the beveled sides of the Quintana trabeculotome tip as sharp or
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`any definition of what sharpness might mean in that context. In my opinion, Dr.
`
`Netland’s assertion that Quintana Figure 1 shows cutting edges is wrong and is
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`based solely on his own speculation, conjecture and hindsight.
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`25.
`
`In my opinion, Dr. Netland misreads the ’729 Patent in reaching his
`
`conclusion that the beveled sides of the Quintana trabeculotome tip must be the
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`“first and second cutting edges” described in the ’729 Patent.
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`26.
`
`In at least Paragraphs 85-86 of his declaration, Dr. Netland asserts
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`erroneously that the ’729 Patent “does not specify how sharp the cutting edges
`
`must be”; that “the edges must simply be capable of cutting a strip of tissue”; and
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`that “the patent merely requires that the cutting edges are capable of cutting tissue,
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`regardless of how ‘sharp’ the cutting edges actually are.” Ex. 1003 ¶¶85-86. Dr.
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`Netland refers only to a single sentence from the ’729 Patent as the basis for these
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`mistaken assertions, and states that “[the ’729 Patent] indicates that cutting edges
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`20, 22 are simply ‘sharp and intended to cut tissue.’” Ex. 1003 (quoting Ex. 1001
`
`at 3:16-17).
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`IPR2020-01573
`Condon Declaration
`Page 13
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`27. The actual sentence in the ’729 Patent to which Dr. Netland refers,
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`however, does not say what Dr. Netland says it does. The full context for this
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`statement may be found in the ’729 Patent, which reads:
`
`“[i]n the particular example shown in the drawings, the first and
`
`second cutting edges 20, 22 are located on opposite lateral sides of the
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`distal end of the cutting tube 14 and a blunt, protruding tip 24 is
`
`located on the bottom of the distal end of the cutting tube. Also, a
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`blunt edge 26 is located at the top of the distal end of the cutting tube
`
`14. Thus, only the lateral cutting edges 20, 22 are sharp and intended
`
`to cut tissue.”
`
`Ex. 1001 at 3:10-17 (emphasis added).
`
`In my opinion, a POSA would have understood the ’729 Patent to say that only the
`
`lateral cutting edges 20, 22 of the disclosed device are sharp (as opposed to, for
`
`example, the protruding tip 24 or the top edge 26), and not to say that anything
`
`sharp may constitute a cutting edge, as Dr. Netland wrongly asserts. Accordingly, I
`
`disagree with Dr. Netland that the beveled sides of the Quintana trabeculotome tip
`
`must be the “first and second cutting edges” described in the ’729 Patent.
`
`28. Furthermore, the properly quoted ’729 Patent disclosure precludes
`
`viewing the Quintana trabeculotome as a dual blade device. If the beveled sides of
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`IPR2020-01573
`Condon Declaration
`Page 14
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`the Quintana trabeculotome tip were deemed to be “sharp and intended to cut
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`tissue,” which they are not, then the entire surface of the single bevel (including
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`the sharp point and sides) must also be deemed a single cutting edge. This further
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`militates against Dr. Netland’s characterizations of the beveled sides of the
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`Quintana trabeculotome tip to be two cutting edges or the Quintana trabeculotome
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`to be a dual blade device, as described in the ’729 Patent.
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`29. Quintana never describes its trabeculotome as a device having cutting
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`edges, much less as a dual blade device. The assertions in the Netland Declaration
`
`to the contrary are inconsistent with the plain statements in Quintana, the most
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`natural reading of which to a POSA, in my opinion, would have been simply
`
`disclosing a way to move the TM in a patient’s eye away from the lumen of
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`Schlemm’s Canal by following a tangential approach to the TM using a standard
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`hypodermic needle, the tip of which is bent and angled toward the anterior
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`chamber of the eye, so as to avoid injuring the external wall of Schlemm’s Canal.
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`A POSA would not have understood Quintana to disclose a dual blade device
`
`having two spaced-apart cutting edges that concurrently cut the TM to create
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`and/or remove a strip of TM of defined width equal to the distance between the
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`cutting edges.
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`IPR2020-01573
`Condon Declaration
`Page 15
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`30. Quintana never describes its procedure as involving the removal of
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`TM as set forth in the ’729 Patent. Nor does Quintana even suggest that its
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`trabeculotome would be capable of being used in any way to remove TM.
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`31. The Netland Declaration seizes on the words “section” and
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`“stripping” used in Quintana in an attempt to rationalize that TM must have been
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`removed even though Quintana never actually says so. See, e.g., Ex. 1003 ¶92. I
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`disagree that a POSA would have understood Quintana to refer in any way to the
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`removal of TM.
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`32.
`
`In its Abstract, Quintana describes “a surgical method of
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`goniotrabeculotomy which achieves a section of the trabecular meshwork without
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`damage to the external wall of Schlemm’s canal.” Ex. 1004 at 3 (emphasis added).
`
`In my opinion, a POSA would have understood Quintana’s reference to “section”
`
`in this sentence to mean incising or opening the TM, as opposed to creating or
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`removing a strip of TM.
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`33. Medical dictionaries around the time of Quintana typically referred to
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`alternative meanings for “section.” See, e.g., Ex. 2023 at 605 (defining “section” to
`
`mean “1. an act of cutting. 2. a cut surface. 3. a segment or subdivision of an
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`organ.”); Ex. 2024 at 519 (“(1) A thin slice of a tissue specimen taken for
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`examination under a microscope. (2) The act of cutting in surgery; for example, an
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`abdominal section is done to explore the abdomen.”). Although listed as an
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`alternative definition in these dictionaries, the meaning of “section” as “cutting” is
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`most consistent with other statements in Quintana.
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`34. Quintana only ever refers to “incising” or “opening” the TM.
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`Ex. 1004 at 3 (“Thus, the rational treatment of the trabecular glaucomas should
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`consist in opening the trabecular meshwork (TM).”) (emphasis added); id. at 4
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`(“The TM is incised with the tip of the needle.”) (emphasis added).
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`35. Quintana never mentions creating or removing a strip of TM, much
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`less the study of any TM samples by microscopic examination. In addition, the last
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`sentence in Quintana reads: “Further studies are necessary to disclose the ‘in vivo’
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`behaviour of the sectioned trabecular meshwork.” I note that Dr. Netland does not
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`explain why or how an “in vivo” observation would be relevant if “strips of tissue”
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`from the TM must have been removed in the Quintana procedure, as he asserts. See
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`Ex. 1003 ¶¶97-98. In my opinion, if that were true, a POSA would have expected
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`Quintana’s reference to an in vitro, not in vivo, study – for example, to examine a
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`removed TM “section” under a microscope. Because Quintana instead refers
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`specifically to the study of the in vivo behaviour, the most natural read to a POSA
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`would have been to interpret “sectioned trabecular meshwork” to refer merely to
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`TM that had been incised or opened, not TM from which a strip(s) of tissue had
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`been created or removed.
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`36. Dr. Netland ignores the exclusive and consistent use in Quintana of
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`the terms “goniotrabeculotomy,” “trabeculotomy,” and “goniotomy,” referring to
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`incising, cutting, sectioning, opening, or stripping tissue – all fundamentally
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`different procedures than excising or removing tissue that a POSA would equate
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`instead with “goniotrabeculectomy,” “trabeculectomy,” and “goniectomy,” which
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`are familiar terms of art Quintana apparently chose not to use to describe its
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`procedure. Without any support, Dr. Netland offers only a conclusory statement
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`that “[i]t is my expert opinion that despite using different terminology for the
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`procedure, Quintana discloses a goniectomy procedure for excising and removing
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`trabecular meshwork tissue from the eye.” Ex. 1003 ¶59. In my opinion, Dr.
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`Netland disregards what Quintana actually says and is substituting his own words,
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`and therefore, I disagree with his unsupported statement.
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`37. Dr. Netland refers to bent ab interno needle goniectomy (“BANG”)
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`procedures purportedly published almost 15 years after the priority date of the
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`’729 Patent. See Ex. 1003 ¶¶98-100. I have been informed by counsel that the
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`PTAB may ultimately deem this information irrelevant and/or inadmissible. But to
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`me, this shows Dr. Netland’s own admission that a POSA describing the removal
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`of TM would have used the terms “excise” or “excising” (as did the authors of the
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`BANG videos), rather than “section” or “stripping.” See Ex. 1003 ¶¶98-100.
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`38. Quintana describes a procedure where “[o]nly the tip of the instrument
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`is introduced into Schlemm’s canal, and the TM is stripped slowly, gently and
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`easily from the canal’s lumen towards the anterior chamber as the needle
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`progresses in the angle (Fig. 2).” Quintana’s Figure 2 legend additionally reads:
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`“Goniophotography at operation. The tip of the needle stripping the trabecular
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`meshwork.” In my opinion, a POSA would have understood Quintana’s reference
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`to “stripped” and “stripping” in these sentences to mean simply cutting or tearing
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`the TM to move it away from the lumen of Schlemm’s Canal while avoiding
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`injuring the external wall of Schlemm’s Canal, which was Quintana’s key concern,
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`see Ex. 1004 at 4 (“This is why we bend the tip and we point it towards the anterior
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`chamber.”), and not to mean creating or removing segments or strips of TM, as Dr.
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`Netland asserts, see, e.g., Ex. 1003 ¶98.
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`39. The demonstrative diagrams shown at Paragraph 95 or the purported
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`cartoon rendering of Quintana’s Figure 2 photograph shown at Paragraph 96 of the
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`Netland Declaration do not change the fact that Quintana never mentions or
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`suggests creating or removing a strip(s) of TM. In my opinion, Dr. Netland’s
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`conclusions are wrong and are based solely on his own speculation, conjecture and
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`hindsight.
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`40. While my conclusion that Quintana does not describe creating or
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`removing a strip of TM set forth in the ’729 Patent is based on my own perspective
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`of what a POSA would have understood from a plain reading of Quintana, I note
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`additionally that the author, Dr. Manuel Quintana, has confirmed that neither his
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`work, nor his article reporting that work, ever involved the removal of TM for any
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`reason. See Ex. 2020 ¶¶3-7. Moreover, Dr. Quintana’s sworn statements directly
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`and completely refute Dr. Netland’s assertions about Quintana in this regard. To
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`me, Dr. Quintana’s explanation increases my confidence that Quintana does not
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`describe the removal of TM as set forth in the ’729 Patent.
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`41. Although it is my opinion that a POSA would have understood
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`Quintana not to disclose a dual blade device having spaced-apart first and second
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`cutting edges concurrently cutting the TM to create or remove a strip of TM of
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`defined width equal to the distance between the cutting edges, I will address below
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`several additional points of disagreement with the Netland Declaration.
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`42.
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`In at least Paragraphs 193-194 of his declaration, Dr. Netland asserts
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`that not only must a strip of TM have been created by the Quintana trabeculotome,
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`but that this strip of tissue must have been of a defined width and have resulted
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`from the concurrent cutting of TM by the beveled sides of the Quintana
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`trabeculotome tip that Dr. Netland characterizes as first and second cutting edges.
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`To me, Dr. Netland is engaging in unsubstantiated, circular reasoning that
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`Quintana’s description of “[t]he tip of the needle stripping the trabecular
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`meshwork” must mean that Quintana obtained a strip of TM of certain width
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`necessarily from the concurrent cutting of TM by the beveled sides (and not, for
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`example, the sharp point) of the Quintana trabeculotome tip, that according to Dr.
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`Netland must have been sharp enough to constitute first and second cutting edges
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`merely because there would be no other way to obtain this hypothetical strip of TM
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`of defined width, which Quintana never actually describes.
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`43. Quintana never mentions or suggests removing TM or that its
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`disclosed trabeculotome would be capable of being used in any way to create and
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`remove a strip of TM, much less to create and remove a strip of TM of defined
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`width. Even assuming that the beveled sides of the Quintana trabeculotome tip
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`could be deemed to be “sharp and int