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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________
`
`New World Medical, Inc.,
`Petitioner
`
`v.
`
`MicroSurgical Tech., Inc.,
`Patent Owner
`
`_______________________
`
`Case No. IPR2020-01573
`
`U.S. Patent Nos. 9,107,729
`________________________
`
`PETITIONER’S REPLY TO
`PATENT OWNER’S RESPONSE TO PETITION
`__________________________________________________________________
`
`
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`TABLE OF CONTENTS
`
`I.
`
`INTRODUCTION ............................................................................................... 1
`
`II. MST’S ARGUMENTS ARE UNSUPPORTED ............................................. 2
`
`III. MST MISCHARACTERIZES THE CLAIMED INVENTION ..................... 5
`
`IV. THE CHALLENGED CLAIMS ARE UNPATENTABLE ............................ 8
`
`A. Ground 1: Quintana Anticipates Claims 1-4 and 7-9................................... 8
`
`1. Quintana discloses “creating or removing a strip of TM” ........................ 8
`
`2. Quintana discloses a “dual blade device” ...............................................15
`
`3. Quintana discloses “first and second cutting edges
`contacting the TM” and “concurrently cutting a strip of TM of
`defined width” ...............................................................................................20
`
`4. Quintana discloses a “bend or curve” of at least 30° ..............................21
`
`5. Quintana discloses an “ab interno” procedure ........................................22
`
`B.
`
`Ground 5: Jacobi Anticipates Claims 1-4 and 7-8 .....................................23
`
`1. Jacobi discloses a “dual blade device” ...................................................23
`
`2. Jacobi discloses “concurrent cutting by first and second
`cutting edges of a strip of TM of defined width” ..........................................24
`
`3. Jacobi discloses the claimed “bend or curve” ........................................25
`
`C.
`
`Grounds 2-4 and 6 ......................................................................................26
`
`V.
`
`CONCLUSION ..............................................................................................28
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`
`
`i
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`
`
`Cases
`
`TABLE OF AUTHORITIES
`
`Allied Erecting & Dismantling Co. v. Genesis Attachments, LLC, 825
`F.3d 1373 (Fed. Cir. 2016) ...................................................................................27
`
`Atlas Powder Co. v. Ireco, Inc., 190 F.3d 1342 (Fed. Cir. 1999) ............................15
`
`Biogen Idec, Inc. v. GlaxoSmithKline LLC, 713 F.3d 1090 (Fed. Cir.
`2013) .............................................................................................................. 19, 28
`
`Cordis Corp. v. Medtronic AVE, Inc., 339 F.3d 1352 (Fed. Cir. 2003) .................... 7
`
`In re Gleave, 560 F.3d 1331 (Fed. Cir. 2009) .....................................................5, 28
`
`In re Schreiber, 128 F.3d 1473 (Fed. Cir. 1997) ....................................................... 6
`
`Kaneka Corp. v. Xiamen Kingdomway Grp. Co., 790 F.3d 1298 (Fed.
`Cir. 2015) ..............................................................................................................18
`
`KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007) .................................................26
`
`Meiresonne v. Google, Inc., 849 F.3d 1379 (Fed. Cir. 2017) ..................................27
`
`Regulations
`
`37 C.F.R. §42.51(b)(1)(ii) .......................................................................................... 4
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`
`ii
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`PETITIONER’S UPDATED EXHIBIT LIST
`
`Description
`
`U.S. Patent 9,107,729 (“the ‘729 patent”)
`
`U.S. Patent 9,107,729 File History (‘729 patent file history”)
`
`Exhibit
`No.
`
`1001
`
`1002
`
`1003
`
`Declaration of Dr. Peter Netland (“Decl.”)
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`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 SC and the Human Aqueous
`Outflow System,” Am. J. Ophthalmology 76(6):906-917 (1973)
`(“Johnstone”)
`
`U.S. Patent 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”)
`
`Am. Acad. Of Ophthalmology, Section 8 External Disease and
`Cornea, in BASIC AND CLINICAL SCIENCE COURSE 2001-2002
`(2001) (“AAO Cornea”)
`
`Michael John Hogan, History 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”)
`
`iii
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`
`
`
`
`Exhibit
`No.
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`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`Description
`
`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 2002/0111608 to Baerveldt
`(“Baerveldt”)
`
`U.S. Patent 4,501,274 to Skjaerpe (“Skjaerpe ‘274”)
`
`Microsurgical Technology, Inc. v. New World Medical, Inc., No.
`1:20-cv-00754, Doc. 1 (D. Del. June 4, 2020) (“Complaint”)
`
`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. 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: https://ags.planion.com/Web.User/
`AbstractDet?ACCOUNT=AGS&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”)
`
`
`
`
`iv
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`
`
`Exhibit
`No.
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`1022
`
`1023
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`1024
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`1025
`
`1026
`
`1027
`
`1028
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`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`Description
`
`PROTECTIVE ORDER MATERIAL ATTORNEYS EYES ONLY
`– License Agreement
`
`Reserved
`
`Proposed Protective Order
`
`Redlined Proposed Protective Order
`
`Transcript of Telephonic Hearing Held on Thursday, July 15, 2021
`
`Transcript of Telephonic Hearing Held on Friday, August 13, 2021
`
`Email Correspondence Regarding Dr. Quintana’s Deposition
`
`Joint Correspondence to Dr. Quintana Regarding Deposition
`
`Reply Declaration of Dr. Peter Netland
`
`Netland Experiment 2 Video
`
`Netland Experiment 3 Video
`
`Netland Experiment 4 Video
`
`A. Arora et al., “K-RIM (Corneal Rim) Angle Surgery Training
`Model,” J Glaucoma 28(2):146-49 (Feb. 2019) (“Arora”)
`
` Bernard Becker, M.D. et al., “Symposium: microsurgery of the
`outflow channels. Clinical research.” TRANS AM ACAD
`OPHTHALMOL OTOLARYNGOL. 1972 Mar-Apr;76(2):405-10. PMID:
`4582683 (“Becker”)
`
`William H. Spencer, M.D., “Symposium: microsurgery of the
`outflow channels. Histological evaluation of microsurgical
`glaucoma techniques.” TRANS AM ACAD OPHTHALMOL
`OTOLARYNGOL. 1972 Mar-Apr;76(2):389-397. PMID: 4270305
`(“Spencer”)
`
`
`
`
`v
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`
`
`Exhibit
`No.
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`1037
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`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`Description
`
`Jonathan Herschler, M.D., et al., “Modified Goniotomy for
`Inflammatory Glaucoma: Histologic Evidence for the Mechanism
`of Pressure Reduction.” ARCH OPHTHALMOL. 1980;98(4):684–687
`(“Herschler”)
`
`Harold G. Scheie, M.D., “Stripping of Descemet’s Membrane in
`Cataract Extraction,” TR. AM. OPTH. SOC., vol. 62, 140-152 (1964)
`(“Sheie”)
`
`U.S. Provisional Patent Application No. 60/477,258 (“the ‘258
`application)
`
`Email Correspondence from Dr. Quintana Regarding Deposition
`
`Deposition Transcript of Deposition of Garry Condon, M.D.,
`Tuesday, August 17, 2021
`
`Deposition Transcript of Deposition of Garry Condon, M.D.,
`Tuesday, August 18, 2021
`
`1043
`
`Exhibits to Deposition of Garry Condon, M.D.
`
`vi
`
`
`
`
`
`I.
`
`INTRODUCTION
`
`MST relies on an expert witness who testified that he did not understand
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`anticipation or obviousness, merely “flipped through” the ‘729 patent, and could
`
`not identify whether a claim was an apparatus or method claim. This is nothing
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`more than a poorly veiled attempt to cast attorney argument as expert opinion. But
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`in addition to being nothing more than attorney argument, the Response and
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`declaration proved incorrect on many fronts including a torturous interpretation of
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`the Quintana reference that fell apart during the expert’s deposition. MST’s only
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`other arguments are based on a litigation-induced, contradictory “affidavit” of Dr.
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`Quintana—a fact witness who refuses to be deposed—and is subject to a motion to
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`strike. Couple these together and MST presents no evidence to support its
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`arguments, let alone evidence of patentability.
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`Perhaps most damaging to MST’s arguments, New World’s expert actually
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`performed the procedure disclosed in the Quintana reference as a direct response
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`to the Quintana affidavit. The result of this experimentation: Quintana’s
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`procedure removed strips of trabecular meshwork exactly as described in the
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`reference and explained by New World’s expert in his opening declaration. The
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`untested Quintana affidavit, generated over 35 years after the reference was
`
`drafted, is incorrect. As a result, MST is essentially left with nothing to support its
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`arguments, let alone rebut the positions established by New World. Accordingly,
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`
`
`1
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`
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`this IPR should be granted and all claims of the ‘729 patent should be found
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`unpatentable.
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`II. MST’S ARGUMENTS ARE UNSUPPORTED
`
`MST relies on its expert Dr. Condon and putative fact witness Dr. Quintana
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`to support its Response, but their testimony has proven to be either seriously
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`deficient or untested and thus should be afforded little to no weight or even
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`excluded outright. Consequently, MST’s Response amounts to little more than
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`unsubstantiated attorney argument.
`
`Dr. Condon’s declaration (Ex.2019) opines on prior art, the meaning of
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`claim terms, the application of prior art, and ultimately the patentability of the
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`claims. Dr. Condon’s deposition testimony, however, raises serious questions
`
`about the weight that should be given to these opinions because he could not
`
`answer basic questions about these opinions including:
`
`• he merely “flipped through” the ‘729 patent (Ex.1041, 176:2-4);
`
`• he “didn’t drill down into what the requirements of the ‘729 patent is
`
`[sic]” (id., 214:13-15);
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`• he “would not be comfortable telling [NWM’s counsel] what [is]
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`required in [the ‘729 patent]” (id., 214:21-22);
`
`• “It’s not crystal clear to me” when asked if he has an understanding of
`
`what anticipation is (id., 178:10);
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`
`
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`2
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`
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`
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`• when asked if the prior art must have the “exact verbiage in the patent
`
`claim” in order to anticipate, he “can’t answer that with certainty” (id.,
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`179:22-180:5);
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`• when asked if he has an understanding of what obviousness means, he
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`“would have to say no” and “couldn’t explain it” (Ex.1042, 257:10-
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`14);
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`• his understanding of patent claims included “things that are expected
`
`to be understood by persons of ordinary skill in the art” but that
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`“claim construction is not my background” (Ex.1041, 213:9-17);
`
`• he cannot tell the difference between a device or method claim
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`(Ex.1042, 276:8-12);
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`• “I don’t even know if I’m capable of dissecting that exact piece of
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`information out of the claim” when asked if the claims require a bend
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`at a specific place in the device (id., 257:4-9).
`
`Further calling these opinions into question, Dr. Condon’s declaration claims he
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`“read the prosecution history of the ‘729 Patent” and includes paragraphs
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`discussing certain examiner statements regarding Lee. E.g., Ex.2019, ¶¶56-61,
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`155. But when handed those statements at deposition, he testified he had “not seen
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`this before.” Ex.1042, 239:11-20 (emphasis added). Collectively, this failing on
`
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`
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`3
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`
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`
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`Lee and the above list demonstrates the dubious value of his opinions. His
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`declaration should be given little, if any, weight.1
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`Dr. Quintana’s affidavit (Ex.2020) fares no better and is the subject of a
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`motion to strike. See Paper 34. As explained in NWM’s motion, MST’s failure to
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`make Dr. Quintana available for deposition is not only contrary to the Board’s
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`rules on routine discovery, see 37 C.F.R. §42.51(b)(1)(ii), but also highly
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`prejudicial to NWM. Specifically, Dr. Quintana’s “testimony” contradicts the
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`reference (Ex.1004) and NWM has no chance to challenge these litigation-induced
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`statements made 35 years after the fact.
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`The reference states that TM was “stripped” from SC and that the procedure
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`“achieves a section” of TM. Pet., 47-48; Ex.1004, 3, 4. As explained by Dr.
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`Netland, the reference discloses excising or cutting a “strip of tissue” from the TM.
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`Ex.1003, ¶136. Dr. Quintana’s affidavit, however, attempts to equate the terms
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`“section” and “stripping” with “incising” or “opening” (Ex.2020, ¶¶4-7), despite
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`Quintana (Ex.1004) using each of those terms separately. Dr. Quintana clearly
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`knew how to use “incise” and “open” but chose not to use these terms when
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`describing the effect of his needle in SC or on TM. Thus, strip and section cannot
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`mean incise or open. And although MST’s counsel claimed English is not Dr.
`
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`1 MST may also move to exclude portions of Dr. Condon’s declaration.
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`4
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`
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`Quintana’s primary language, both the reference (Ex.1004) and his recent email
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`refusing to be deposed (Ex.1040) were written in English eliminating any illusion
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`of translation issues. The terms were chosen purposefully.
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`Also, in response to Dr. Quintana’s “affidavit,” Dr. Netland performed
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`experiments to replicate the Quintana procedure (Ex.1004). Dr. Netland’s results,
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`described in Exhibit 1030, show performing Quintana’s procedure results in
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`removing “strips of tissue” from the TM. That MST did not attempt such an
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`experiment is notable. Clearly, Quintana removes strips of TM.
`
`III. MST MISCHARACTERIZES THE CLAIMED INVENTION
`
`The ‘729 patent claims performing a known procedure with known devices.
`
`See Paper 1, 18-21. MST does not dispute that the procedure covered by the
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`claims (i.e., goniectomy) was known. See Ex.1001, 1:35-65. MST only attempts
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`to distinguish the claimed device from a bent needle, but misses the mark.
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`Most of MST’s arguments focus on aspects that are not relevant to
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`patentability. MST argues the claimed device “has a distal end with a blunt
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`protruding tip 24 and a blunt top edge 26 separated by two distinct cutting edges
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`20, 22.” Paper 29 (“Resp.”), 9. Nowhere in the ‘729 patent claims is there a
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`requirement for a “blunt protruding tip,” a “blunt top edge,” or “distinct” cutting
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`edges. Labeling these elements using specific terminology does not make those
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`elements novel. See In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2009)
`
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`
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`5
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`
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`
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`(“reference need not satisfy an ipsissimis verbis test”). MST also erroneously
`
`attempts to distinguish the claims based on intended use. Resp., 10; see In re
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`Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997) (reference “may be directed to an
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`entirely different problem from the one addressed by the inventor”).
`
`MST also blatantly ignores the ‘729 patent’s intrinsic record. MST argues
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`that “[s]imply bending the tube” to create the claimed device’s “bends or curves” is
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`“inconsistent with the ‘729 Patent.” Resp., 10. This not only directly contradicts
`
`the patent, but MST amazingly quotes the patent in the very next line of its
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`response that “the tube 14 may be directly bent to form said curves or bends
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`without the use of angular cut out(s) 30.” Ex.1001, 5:6-14 (emphasis added).
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`And MST’s assertion that the ‘729 patent excludes a device made from a
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`hypodermic needle wholly ignores the provisional (U.S. Provisional 60,477,258)
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`from which the ‘729 patent claims priority. The ‘258 provisional describes a
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`goniectomy device that is simply a “bent surgical needle.” Ex.1039, 12. The
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`“distal sides of tube facets” of the goniectomy device “form the cutting blades,”
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`which are described as “means to separate a strip of meshwork.” Id., 13.
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`6
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`
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`Id. The provisional clearly contemplates that the inventions cover a bent needle,
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`yet MST ignores this.2
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`Finally, MST crafts an argument that needles have a single blade by taking
`
`Dr. Netland out of context. Resp., 9. Dr. Netland’s stated “an unbent needle tip
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`would have acted as a single blade to allow the needle to create a slit-like incision
`
`in the trabecular meshwork.” Ex.1003, ¶94. While MST repeatedly points to this
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`statement as “proof” of a single blade, Dr. Netland was specifically referring to a
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`needle with an unbent tip advanced to the TM at a perpendicular approach. Id. In
`
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`2 MST’s suggestion that the claim language “being formed” limits the claim to a
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`specific method of formation imported from the specification is likewise wrong.
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`E.g., Cordis Corp. v. Medtronic AVE, Inc., 339 F.3d 1352, 1357 (Fed. Cir. 2003)
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`(claim language “formed therein” does not require method of formation).
`
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`
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`7
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`
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`contrast, Dr. Netland explains that advancing the needle with the beveled sides
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`facing in the direction the needle moves—as in Quintana—would allow the
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`beveled sides to act as cutting edges resulting in excision of a strip of TM. Id.
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`And his testing proved just that. See Ex.1030.
`
`IV. THE CHALLENGED CLAIMS ARE UNPATENTABLE
`
`MST’s Response purports to address each of the petition’s six grounds of
`
`but simply repeats the same arguments. NWM addresses MST’s arguments
`
`regarding anticipation by Quintana (Ground 1) and Jacobi (Ground 5) individually
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`and then addresses MST’s arguments regarding the remaining grounds (Grounds 2-
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`4, 6) collectively. Nonetheless, MST fails to show that the claims are patentable.
`
`The Board should respectfully invalidate all Challenged Claims of the ‘729 patent.
`
`A. Ground 1: Quintana Anticipates Claims 1-4 and 7-9
`
`1. Quintana discloses “creating or removing a strip of TM”
`
`MST’s core argument—that Quintana does not disclose “creating or
`
`removing a strip of TM”—ignores Quintana’s explicit teaching and is undercut by
`
`Dr. Netland’s testing results.
`
`Quintana recognized that outflow resistance through the TM was the most
`
`accepted mechanism involved in treating open-angle glaucoma. Ex.1004, 3.
`
`Quintana also recognized that prior treatments to open the TM failed, citing
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`Spencer (Ex.1036) and Becker (Ex.1035). Id. Both references discuss procedures
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`where incisions in the TM eventually closed back up or scarred over, re-blocking
`
`
`
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`8
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`
`
`
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`aqueous outflow. Ex.1036, 2-6; Ex.1035, 2. Per Quintana, one goal was to
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`develop a procedure that “eliminates most of the presumed causes of failure of
`
`previous methods.” Ex.1004, 3 (emphasis added). Despite MST’s assertion that
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`Quintana’s “key concern” was avoiding damage to SC, Resp., 18, Quintana was
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`undoubtably focused on resolving the other “causes of failure” identified in
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`Spencer and Becker—by excising the TM to create larger openings/avoid scarring.
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`Ex.1004, 3.
`
`Quintana states that “the TM is stripped slowly, gently and easily from the
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`canal’s lumen” to “achieves a section” of the TM. Id., 3, 4 (emphasis added). Dr.
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`Condon conceded that Quintana’s procedure could “leav[e] some [TM] on the tip
`
`of the needle” thereby admitting removal of TM. Ex.1041, 82:7-15. Dr. Condon
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`also could not provide any definition for a “strip of tissue” during his deposition.
`
`Id., 212:13-20.
`
`According to MST, Quintana’s use of “section” “mean[s] incising or
`
`opening the TM, not creating and removing a strip of TM.” Resp., 14. Equating
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`“section” with “incising” and “opening” makes little sense because Quintana used
`
`“incise” and “opening” elsewhere in the article to describe different things. See
`
`Ex.1004, 3, 4. Dr. Quintana knew how to use the terms “incise” and “opening” but
`
`chose “section” and “stripping” to describe his results.
`
`
`
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`9
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`
`
`
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`MST also relies on dictionary definitions of “section,” but some of these
`
`definitions support NWM’s arguments. MST only applies a favorable definition
`
`while ignoring the unfavorable ones. Resp., 14. Substituting “cutting” for
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`“section” in Quintana’s statement that the procedure “achieves a section” of TM
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`(i.e., “achieves a cutting” of TM) makes no sense. The alternate definitions of
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`“section” provided in MST’s Response are far more appropriate in the context of
`
`Quintana—for example, “achiev[ing] a thin slice” of TM or “achiev[ing] a
`
`segment or subdivision” of TM make far more sense than MST’s interpretation.
`
`Moreover, Quintana not mentioning microscopic study of TM samples does
`
`not mean the reference was cutting the TM rather than excising. Resp., 15.
`
`Quintana was focused on clinical results, rather than histological study. Ex.2021,
`
`173:9-174:3. Dr. Condon even conceded that studying a TM sample by
`
`microscopic examination as a practicing physician is uncommon. Ex.1041,
`
`125:16-126:2.
`
`Quintana’s statement that studying “the ‘in vivo’ behavior of the sectioned
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`trabecular meshwork” likewise does not support MST’s interpretation. See Resp.,
`
`15-16. Even if “sectioned trabecular meshwork” refers to “TM remaining in the
`
`patient’s eye” as asserted by MST, “sectioned” means the TM left behind after a
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`“section” of TM was excised. Ex.1004, 3, 8. Given Quintana’s desire to eliminate
`
`scarring, it is no surprise Quintana would have suggested studying TM remaining
`
`
`
`
`10
`
`
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`in the eye after excision to confirm it did not close up. Additionally, Quintana’s
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`statement that “the remaining cells can enlarge” strongly implies removal. An
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`incision would not leave anything “remaining” as it merely opens. Id., 8.
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`MST also argues that the “TM was stripped” and “stripping” means “cutting
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`or tearing the TM to move it away from the lumen of Schlemm’s Canal.” Resp.,
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`18. MST’s convoluted definition finds no support in the reference—Quintana
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`never mentions tearing or moving TM away from SC. Merely “moving” the TM
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`away from SC could also result in the TM falling right back into place and closing
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`the opening. MST noticeably provides no such definitions for “stripping.” The
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`reason is simple—the commonly-understood meaning of “stripping” is “removal,”
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`which is directly contrary to MST’s argument. See, e.g., Ex.1037, 2 (A
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`trabeculodialysis procedure, stripping away the nasal trabecular sheets…”)
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`(emphasis added); Ex.1038, 1 (“Stripping of Descemet’s membrane to a lesser
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`degree is not rare. Strips of Descemet’s membrane, which appear as curly tags of
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`transparent tissue, can often be seen…”) (emphasis added). In Quintana,
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`“stripping” means removing TM from SC.
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`MST instead relies on semantics. According to MST, NWM substituted the
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`noun “strips” when Quintana referred to “stripping” and “stripped.” Resp., 18.
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`But Quintana states “the TM is stripped slowly, gently and easily from the canal’s
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`lumen towards the anterior chamber as the needle progresses in the angle.”
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`11
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`
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`
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`Ex.1004, 4 (emphasis added). For the TM to have been stripped “from” the SC
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`“towards” the AC, tissue must have been removed from SC. It is unclear how TM
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`could be stripped “towards” the AC if stripped simply means “incising.”
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`MST’s remaining arguments likewise fail. MST claims that because
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`Quintana coined his procedure a “goniotrabeculotomy,” the procedure necessarily
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`involves incising, not excising, TM. Resp., 16. This does not follow. Quintana
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`was describing a new procedure and MST offers no support that a
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`“goniotrabeculotomy” was a known term of art or is reflective of Quintana’s result.
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`Dr. Condon’s testimony undercuts this—he could not provide a definition for the
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`term “goniectomy” when asked during his deposition, Ex.1041, 15:18-16:20,
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`demonstrating that even commonly understood terms may have varying
`
`interpretations and that a name alone would not definitively indicate anything
`
`about the result. In a similar vein, MST’s criticism of NWM’s use of the phrase
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`“excisional goniotomy” is overblown. Resp., 20. This is a distraction. What
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`matters is Dr. Netland’s analysis of the reference and conclusion that it involves
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`excising tissue. Ex.1003, ¶¶56-61.
`
`
`
`
`12
`
`
`
`
`
`Finally, MST attempts to rewrite the reference. In response to this
`
`reimaging of Quintana,3 Dr. Netland performed the procedure described in the
`
`reference. The result: strips of TM. Dr. Netland describes his experimental
`
`protocol and results in the attached reply declaration (Ex.1030). The Reply
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`Declaration shows that Quintana’s procedure “achieves a section,” i.e., a “strip of
`
`tissue” from the TM, contrary to MST’s arguments:
`
`
`
`
`3 MST did not attempt to test Quintana’s procedure and Dr. Condon testified he
`
`does not know how to replicate the procedure. Ex.1041, 19:2-14.
`
`
`
`
`13
`
`
`
`
`
`
`
`
`
`Id., ¶¶17-26; Ex.1031-1032. Dr. Netland’s experiments establish that Quintana’s
`
`statements regarding “section” and “stripping” refer to creating “strips of tissue”
`
`from the TM, and that performing Quintana’s surgical procedure results in “strips
`
`
`
`
`14
`
`
`
`
`
`of tissue.”4 Id. The Board should reject MST’s arguments and find Quintana
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`anticipates the Challenged Claims.
`
`2. Quintana discloses a “dual blade device”
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`The Board gave the term “dual blade device” its ordinary meaning, noting
`
`that “dual refers to two, and blade, in context, refers to a cutting part.” Dec., 17.
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`Quintana’s needle is a device with two edges that act as cutting parts on opposite
`
`sides of the end of the needle tube. Pet., 37-38. Each edge cuts TM tissue, as
`
`indicated by Quintana’s explicit statements that the needle tip pierces the TM, is
`
`inserted into SC and used to “strip[]” the TM, and “a section of the TM” is
`
`“achieve[d].” Id.; Ex.1004, 3, 4.
`
`MST’s argument that Quintana does not disclose a “dual blade device”
`
`makes little sense in the context of the patent, the provisional, and its expert’s
`
`admissions. The patent discloses a device with cutting edges 20, 22 that are
`
`connected at the end of the cutting tube 14.
`
`
`4 See also Atlas Powder Co. v. Ireco, Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999)
`
`(“if the prior art necessarily functions in accordance with, or includes, the claimed
`
`limitations, it anticipates”).
`
`
`
`
`15
`
`
`
`
`
`Id., Fig. 4; Ex.1039, 12-13. The claimed device is, for all intents and purposes,
`
`
`
`nothing more than a bent needle.
`
`According to MST and Dr. Condon, the tip of Quintana’s needle is a single
`
`bevel with a sharp point and 2 sides. Resp., 21; Ex.2019, ¶22. Both MST and Dr.
`
`Condon assert that “the beveled sides of the Quintana device tip merely act
`
`alongside the sharp point as part of a single blade to allow the tip to create a slit-
`
`like incision in the TM.” Resp., 22; see also id., 25; Ex.2019, ¶23. MST and Dr.
`
`Condon thus admit that the tip of Quintana’s needle has beveled sides that act as
`
`blades to cut the TM.5 Dr. Condon even testified that where the beveled sides may
`
`
`5 NWM did not “admit []” that the bevel of Quintana’s needle is a single cutting
`
`edge. See Resp., 25. MST mischaracterizes Dr. Netland’s declaration regarding an
`
`unbent needle used in a perpendicular approach, unlike Quintana’s bent needle
`
`used in a tangential approach. See supra, §III.
`
`
`
`
`16
`
`
`
`
`
`contact the TM and “assist in creating that tearing away of the trabecular
`
`meshwork from its insertion point.” Ex.1041, 181:7-14.
`
`Dr. Condon further testified that Quintana’s needle has two separate “sides.”
`
`According to Dr. Condon, the “tip” of Quintana’s needle “is the bevel, the sides
`
`and the point,” and the portion between the point and proximal portion of the bevel
`
`are the “sides.” Id., 29:12-17, 32:3-7. Dr. Condon also testified that the “sides”
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`are spaced apart and not touching. Id., 130:16-131:14. And Dr. Condon annotated
`
`Fig.1 of Quintana to identify the needle tip, which included the point, two sides,
`
`and bevel. Id., 26:11-28:20.
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`Ex.1043, 192. Dr. Condon changed his mind about what constitutes the “tip”
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`during his deposition and, as shown above, attempted to scratch out the word “tip”
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`and replace it with “bevel.” Ex.1041, 130:6-15. This is semantics. Dr. Condon’s
`
`
`
`
`
`
`17
`
`
`
`
`
`testimony and annotation of Quintana’s needle demonstrates that Quintana’s
`
`needle has two cutting parts and thus is a “dual blade device.”
`
`MST’s argument that Quintana’s needle is not a “dual blade device” is
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`rooted in the mistaken notion that the claims require “distinct” cutting edges. See
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`Resp., 22, 25, 27. According to MST, “the dual blade device of the Challenged
`
`Claims must have two distinct cutting edges, no more and no less.” Id., 25
`
`(emphasis added). There is nothing in the Institution Decision, the plain and
`
`ordinary meaning, or the intrinsic record that requires a “dual blade device” to
`
`have two “distinct” cutting edges. Even the patented device shown in Fig. 4 of the
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`‘729 patent does not have “separate” or “distinct” cutting edges, as cutting edges
`
`20, 22 are connected via the end of the cutting tube 14. Ex.1001, Fig. 4. MST’s
`
`argument that Quintana’s needle does not have “two distinct cutting edges” relies
`
`on a construction that would eliminate an embodiment, which is improper. E.g.,
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`Kaneka Corp. v. Xiamen Kingdomway Grp. Co., 790 F.3d 1298, 1305 (Fed. Cir.
`
`2015).
`
`MST reading “distinct” into the claims is also inconsistent with the intrinsic
`
`record. Lee was cited during prosecution of the ‘729 patent to disclose a device
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`with a “U-shaped cutting edge (14) which has dual blades corresponding to the U-
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`shape.” Pet., 22-23; Ex.1002, 320. Thus, a device may have “dual blades” even
`
`when it has a single, U-shaped cutting edge. The Examiner’s interpretation was
`
`
`
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`18
`
`
`
`
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`not challenged by applicant during prosecution and thus is disclaimer. See
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`Biogen Idec, Inc. v. GlaxoSmithKline LLC, 713 F.3d 1090, 1096 (Fed. Cir. 2013).
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`To the extent MST advocates defining cutting edges based on sharpness
`
`and/or intent to cut tissue as compared to other portions of the device (e.g., the tip),
`
`the patent provides no way to measure these attributes or how to make such a
`
`comparison. As such, whether Quintana’s beveled sides are cutting edges cannot
`
`be judged based on the sharpness of the tip but on whether the beveled sides are
`
`cutting parts, which MST and Dr. Condon both admit. See Resp., 22, 25; Ex.2019,
`
`¶23.
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`Also, NWM’s “dual blade device” arguments are not “circular.” Resp., 24.
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`Instead, Quintana’s needle is a “dual blade device” based on the needle’s structure.
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`See, e.g., Pet., 37-39; Ex.1003, ¶¶120-22. Similarly, Dr. Netland never testified
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`that Quintana’s needle is a “dual blade device” “based solely on his own assertion
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`that Quintana must have created and removed a strip of TM.” Resp., 22. In the
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`excerpt cited by MST, Dr. Netland testified Quintana “didn’t provide specific
`
`evidence” or “measurements” of quantitative metrics as to the sharpness of the
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`beveled sides of Quintana’s needle. Ex.2022, 297:16-298:1.
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`Finally, MST argues NWM’s arguments are “arbitrary” and inappropriately
`
`define the device by its use. Resp., 26-27. Notably, each of MST’s arguments
`
`apply equally to Quintana and the ‘729 Patent. Like Quintana’s needle, the
`
`
`
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`19
`
`
`
`
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`patented device’s tip “is advanced through the trabecular meshwork and into
`
`Schlemm’s Canal.” Ex.1001, 6:12-19. The patent also does not define precisely
`
`where the patented device’s cutting edges start and stop. The patented device
`
`could have a different number of cutting edges depending on use—just as MST
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`argues regarding Quintana. As such, to the extent the patented device is a “dual
`
`bla
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