Case 1:20-cv-00754-MN Document 1 Filed 06/04/20 Page 1 of 43 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. _______________
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`DEMAND FOR JURY TRIAL
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`MICROSURGICAL
`TECHNOLOGY, INC. and
`THE REGENTS OF THE UNIVERSITY
`OF CALIFORNIA,
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`
`
`
`
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`v.
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`NEW WORLD MEDICAL, INC.,
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`
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`Defendant.
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`Plaintiffs,
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`
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`
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs MicroSurgical Technology, Inc. (“MST”) and The Regents of the University of
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`California (“Regents”) (collectively, “Plaintiffs”), by and through their attorneys, for their
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`Complaint against defendant New World Medical, Inc. (“Defendant” or “NWM”), allege as
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`follows:
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`NATURE OF ACTION
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`1.
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`This is an action for infringement of Plaintiffs’ United States Patents
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`No. 9,107,729, No. 9,358,155, No. 9,820,885, No. 9,999,544, and No. 10,123,905 under the
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`Patent Act, 35 U.S.C. § 271, based on Defendant’s unauthorized manufacture, use, offer for sale,
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`and/or sale in the United States, and/or importation into the United States, of the Kahook Dual
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`Blade® (“Accused Product(s)” or “KDB”), and/or its acts that induce and/or contribute to use of
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`the Accused Products.
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`PARTIES
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`2.
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`MST is a corporation organized and existing under the laws of the State of
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`Washington, with its principal place of business at 8415 154th Avenue NE, Redmond, WA
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`98052-3863 USA.
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`
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`Petitioner - New World Medical
`Ex. 1017, p. 1 of 236
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`

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`Case 1:20-cv-00754-MN Document 1 Filed 06/04/20 Page 2 of 43 PageID #: 2
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`3.
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`Regents is a California public corporation, authorized and empowered to
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`administer a public trust known as the University of California, pursuant to Article IX, Section 9,
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`subdivisions (a) and (f) of the California Constitution. Its principal place of business is in
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`Oakland, Alameda County, CA USA.
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`4.
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`On information and belief, NWM is a corporation organized and existing under the
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`laws of the State of Delaware, with its principal place of business at 10763 Edison Court, Rancho
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`Cucamonga, CA 91730 USA.
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`JURISDICTION
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`5.
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`This Court has original jurisdiction over the subject matter of this action pursuant
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`to 28 U.S.C. §§ 1331 and 1338(a).
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`6.
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`Personal jurisdiction over Defendant is proper in this District because, on
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`information and belief, Defendant is incorporated under the laws of the State of Delaware.
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`VENUE
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`7.
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`Venue is proper in this District under 28 U.S.C. §§ 1391(b) and 1400(b) because,
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`on information and belief, NWM is incorporated under the laws of the State of Delaware.
`
`FACTS
`
`The Patents-in-Suit
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`8.
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`United States Patent No. 9,107,729 (“the ’729 Patent”), entitled “Methods for
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`Forming an Opening in the Trabecular Meshwork of the Eye of a Patient,” was duly and legally
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`issued by the United States Trademark and Patent Office (“USPTO”) on August 18, 2015. A true
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`and correct copy of the ’729 Patent is attached as Exhibit (“Ex.”) A and is incorporated by
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`reference herein.
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`2
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`Petitioner - New World Medical
`Ex. 1017, p. 2 of 236
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`

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`Case 1:20-cv-00754-MN Document 1 Filed 06/04/20 Page 3 of 43 PageID #: 3
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`9.
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`The ’729 Patent is generally directed towards an ab interno method for forming an
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`opening in trabecular meshwork of a patient’s eye that may be accomplished using a dual blade
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`device to form an opening into an anterior chamber of the eye.
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`10.
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`All rights, title, and interest in the ’729 Patent are assigned to MST, which is the
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`sole owner of the ’729 Patent. The listed inventors of the ’729 Patent originally assigned their
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`rights, title, and interest in the ’729 Patent to NeoMedix Corp. (“NeoMedix”), which MST
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`acquired in 2019. A true and correct copy of the inventors’ assignments to NeoMedix is attached
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`as Ex. B. A true and correct copy of NeoMedix’s assignment to MST is attached as Ex. C.
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`11.
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`United States Patent No. 9,358,155 (“the ’155 Patent”), entitled “Dual Blade
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`Ophthalmologic Surgery Device,” was duly and legally issued by the USPTO on June 7, 2016. A
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`true and correct copy of the ’155 Patent is attached as Ex. D and is incorporated by reference
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`herein.
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`12.
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`The ’155 Patent is generally directed towards a dual blade device useable for
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`performing an ab interno procedure within a human eye to remove a strip of trabecular meshwork
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`tissue.
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`13.
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`All rights, title, and interest in the ’155 Patent are assigned to MST, which is the
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`sole owner of the ’155 Patent. The listed inventors of the ’155 Patent originally assigned their
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`rights, title, and interest in the ’155 Patent to NeoMedix, which MST acquired in 2019. A true and
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`correct copy of the inventors’ assignments to NeoMedix is attached as Ex. B. A true and correct
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`copy of NeoMedix’s assignment to MST is attached as Ex. C.
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`14.
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`United States Patent No. 9,820,885 (“the ’885 Patent”), entitled “Dual Blade
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`Ophthalmologic Surgery Device,” was duly and legally issued by the USPTO on November 21,
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`3
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`Petitioner - New World Medical
`Ex. 1017, p. 3 of 236
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`Case 1:20-cv-00754-MN Document 1 Filed 06/04/20 Page 4 of 43 PageID #: 4
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`2017. A true and correct copy of the ’885 Patent is attached as Ex. E and is incorporated by
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`reference herein.
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`15.
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`The ’885 Patent is generally directed towards a method for cutting a strip of
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`trabecular meshwork tissue within an eye of a subject that may be accomplished using a dual blade
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`device to form an opening into an anterior chamber of the eye.
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`16.
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`All rights, title, and interest in the ’885 Patent are assigned to MST, which is the
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`sole owner of the ’885 Patent. The listed inventors of the ’885 Patent originally assigned their
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`rights, title, and interest in the ’885 Patent to NeoMedix, which MST acquired in 2019. A true and
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`correct copy of the inventors’ assignments to NeoMedix is attached as Ex. B. A true and correct
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`copy of NeoMedix’s assignment to MST is attached as Ex. C.
`
`17.
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`United States Patent No. 9,999,544 (“the ’544 Patent”), entitled “Minimally
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`Invasive Glaucoma Surgical Instrument and Method,” was duly and legally issued by the USPTO
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`on June 19, 2018. A true and correct copy of the ’544 Patent is attached as Ex. F and is incorporated
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`by reference herein.
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`18.
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`The ’544 Patent is generally directed towards a device useable to create an opening
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`in the trabecular meshwork of the eye.
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`19.
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`The listed assignee of the ’544 Patent is Regents. The listed inventors of the ’544
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`Patent assigned their rights, title, and interest in the ’544 Patent to Regents. MST holds an
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`exclusive license from Regents to the ’544 Patent, inter alia, including the exclusive right to make,
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`have made, use, sell, and/or offer to sell and import products, as well as to practice methods,
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`covered by the claims of the ’544 Patent. A true and correct copy of the inventors’ assignments to
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`Regents is attached as Ex. G.
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`4
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`Petitioner - New World Medical
`Ex. 1017, p. 4 of 236
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`

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`20.
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`United States Patent No. 10,123,905 (“the ’905 Patent”), entitled “Devices Useable
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`for Treatment of Glaucoma and Other Surgical Procedures,” was duly and legally issued by the
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`USPTO on November 13, 2018. A true and correct copy of the ’905 Patent is attached as Ex. H
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`and is incorporated by reference herein.
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`21.
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`The ’905 Patent is generally directed towards a device that is insertable into the
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`anterior chamber of an eye and useable to form an opening in the trabecular meshwork of that eye.
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`22.
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`All rights, title, and interest in the ’905 Patent are assigned to MST, which is the
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`sole owner of the ’905 Patent. The listed inventors of the ’905 Patent originally assigned their
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`rights, title, and interest in the ’905 Patent to NeoMedix, which MST acquired in 2019. A true and
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`correct copy of the inventors’ assignments to NeoMedix is attached as Ex. I. A true and correct
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`copy of NeoMedix’s assignment to MST is attached as Ex. C.
`
`23.
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`Collectively, the ’729, ’155, ’885, ’544, and ’905 Patents are referred to herein as
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`the “Asserted Patents” or the “Patents-in-Suit.”
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`Defendant’s Infringing Acts Related To The Accused Products
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`24.
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`On information and belief, Defendant has known of, should have known of, or has
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`been willfully blind to, the Asserted Patents. To the extent Plaintiffs or MST’s predecessor-in-
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`interest, NeoMedix, made or continue to make products that embody the Asserted Patents, they
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`have complied, as applicable, with the patent marking and notice provisions of 35 U.S.C. § 287 by
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`providing constructive and actual notice to Defendant of its infringement.
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`25.
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`Defendant has had actual notice of its infringement of the ’155 and ’729 Patents
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`since at least June 20, 2016. On or around June 20, 2016, NeoMedix’s outside counsel, Robert D.
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`Buyan (“Buyan”) sent a letter to Mateen Ahmed, President and CEO of Defendant, informing
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`Defendant of the ’155 and ’729 Patents and that the unauthorized manufacture, sale, and use of the
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`5
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`Petitioner - New World Medical
`Ex. 1017, p. 5 of 236
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`

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`Case 1:20-cv-00754-MN Document 1 Filed 06/04/20 Page 6 of 43 PageID #: 6
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`KDB, inter alia, infringed these patents. A true and correct copy of the June 20, 2016 Letter is
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`attached as Ex. J. Following the June 20, 2016 letter, Buyan continued to communicate over the
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`course of the next several years with Defendant’s various outside counsel, including Daniel R.
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`Foster (“Foster”), actively engaging in good-faith negotiations regarding Defendant’s infringing
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`conduct but without successful resolution.
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`26.
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`Defendant has had actual notice of its infringement of the ’885 and ’905 Patents
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`since at least December 6, 2018. On or around December 6, 2018, Buyan sent a letter to Foster,
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`informing Defendant of the ’885 and ’905 Patents and that the unauthorized manufacture, use,
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`sale, offer for sale, and/or importation of the KDB, inter alia, infringed these patents. A true and
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`correct copy of the December 6, 2018 Letter is attached as Ex. K.
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`27.
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`Defendant has had actual notice of its infringement of the ’544 Patent since at least
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`February 15, 2019. On or around February 15, 2019, Buyan sent a letter to Defendant’s outside
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`counsel, Christopher D. Bright (“Bright”), informing Defendant of the ’544 Patent and that the
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`unauthorized manufacture, use, sale, offer for sale, and/or importation of the KDB, inter alia,
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`infringed this patent. A true and correct copy of the February 15, 2019 Letter is attached as Ex. L.
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`28.
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`The Accused Products and methods of using the Accused Products (“Accused
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`Methods”) relate to Defendant’s KDB product(s) and its use(s). Defendant’s website and Product
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`Brochure (“PB”) describe the Accused Products as surgical instruments utilized for excisional
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`goniotomy. A true and correct copy of certain portions of the Defendant’s website
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`(https://www.newworldmedical.com/kahook-dual-blade/) is attached as Ex. N. A true and correct
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`copy of the PB is attached as Ex. O. On information and belief, the Accused Products are especially
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`made or adapted for this use, and there is no substantial non-infringing use for the Accused
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`6
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`Petitioner - New World Medical
`Ex. 1017, p. 6 of 236
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`

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`
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`Products. On information and belief, Defendant has been aware that the Accused Products infringe
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`the Asserted Patents and are a material part of the claimed inventions.
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`29.
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`Upon information and belief, Defendant markets the Accused Products through
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`various channels, including its website and the PB.
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`30.
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`Upon information and belief, Defendant engages in the unauthorized manufacture,
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`use, offer for sale, and/or sale in the United States, and/or importation into the United States, of
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`the Accused Products. Based on these acts, Defendant has directly infringed, and/or will directly
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`infringe, the claims of the Asserted Patents that cover the Accused Products and/or Methods.
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`31.
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`Upon information and belief, and pursuant to the regulations of the United States
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`Food and Drug Administration (“FDA”), Defendant includes Instructions for Use (“IFU”) with
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`every Accused Product that is sold. The IFU specifically instructs, directs, and/or requires
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`physicians, healthcare providers, customers, purchasers, and/or users to use the Accused Products
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`in an infringing manner. Specifically, the IFU instructs physicians to use the Accused Products in
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`ophthalmic surgical procedures to manually cut trabecular meshwork in pediatric and adult
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`patients. A true and correct copy of the IFU is attached as Ex. M. Based on these instructions,
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`physicians or other healthcare professionals have directly infringed and/or will directly infringe
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`the claims of the Asserted Patents that cover the Accused Products and/or Methods. Further,
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`Defendant has known or should have known, or was willfully blind to the fact, that its actions
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`would induce others to directly infringe the Asserted Patents. On information and belief, Defendant
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`has been aware that the Accused Products infringe the Asserted Patents, have no substantial
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`non-infringing uses, and are a material part of the claimed inventions. Accordingly, Defendant
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`induces and/or contributes to such infringement.
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`7
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`Petitioner - New World Medical
`Ex. 1017, p. 7 of 236
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`

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`Case 1:20-cv-00754-MN Document 1 Filed 06/04/20 Page 8 of 43 PageID #: 8
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`32.
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`Through the foregoing acts, Defendant directly infringes, and/or induces or
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`contributes to the infringement of, the Asserted Patents. Moreover, Defendant’s ongoing
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`unauthorized manufacture, use, offer for sale, and/or sale in the United States, and/or importation
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`into the United States, of the Accused Products and Methods, with full knowledge of the Asserted
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`Patents, reflects Defendant’s conscious, deliberate disregard of Plaintiffs’ patent rights.
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`33.
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`In Paragraphs 34-38 (including Tables 1-5) below, Plaintiffs provide explanatory
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`examples regarding Defendant’s infringement of the Asserted Patents. These explanations are
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`based on publicly-available information known to Plaintiffs at this time. It is expected that
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`additional information may be learned during discovery. The explanations below, therefore, are
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`not intended to be final or limiting in any way, and Plaintiffs reserve all rights to amend these
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`explanations as the case progresses and as the facts warrant.
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`Infringement of the ’729 Patent
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`34.
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`On information and belief, based on Plaintiffs’ current investigation, Defendant
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`induces others, including customers, purchasers, users, or some combination thereof, to perform,
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`either literally or under the doctrine of equivalents, each and every step of at least claims 1-5 and
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`7-10 of the ’729 Patent and has contributed, and continues to contribute, to the infringement of
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`those claims as follows.
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`Claim
`
`1
`
`Claim Element
`An ab interno method
`for forming an
`opening in trabecular
`meshwork of a
`patient’s eye, said
`method comprising
`the steps of:
`obtaining a dual blade
`device which
`comprises
`
`Table 1 – ’729 Patent
`Claimed Element Present in Accused Product/Method
`
`The Accused Products’ IFU describes that the KDB is a
`dual blade device used by ophthalmic surgeons to carry
`out an ab interno method for forming an opening in
`trabecular meshwork of a patient’s eye. Ex. M at
`Description and Intended Use, Sections 2.4, 2.5.
`
`The Accused Products are obtained by ophthalmic
`surgeons from Defendant. See Ex. N.
`
`
`
`8
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`Petitioner - New World Medical
`Ex. 1017, p. 8 of 236
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`

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`Case 1:20-cv-00754-MN Document 1 Filed 06/04/20 Page 9 of 43 PageID #: 9
`
`Claim
`
`Claim Element
`
`Table 1 – ’729 Patent
`Claimed Element Present in Accused Product/Method
`Panel “a” below shows that the KDB is a dual blade
`device which comprises an elongate proximal portion (A)
`sized to be grasped by a hand of a human operator (i.e.,
`the handle). See Ex. M at Section Description and
`Intended Use (reference letters added).
`
`a) an elongate
`proximal portion sized
`to be grasped by a
`hand of a human
`operator and
`
`b) an elongate probe
`extending from the
`proximal portion,
`wherein the elongate
`probe comprises
`
`
`
`Panel “a” above shows that the elongate probe (B1)
`extends from the proximal portion (A). See Ex. M
`(reference letters added).
`
`Panel “b” below shows that the elongate probe comprises
`i) a shaft (B2). See Ex. M (reference letters added).
`
`i) a shaft
`
`ii) a distal protruding
`tip that extends from
`a distal end of the
`shaft to form a bend
`or curve having an
`angle of at least 30
`
`
`Panel “b” above shows that the elongate probe comprises
`a distal protruding tip (D) that extends from a distal end
`of the shaft (B2) to form a bend or curve (E) having an
`angle of at least 30 degrees, said distal protruding tip (D)
`being sized to be inserted in Schlemm’s Canal. Ex. M at
`Sections 3.2-3.6.
`
`9
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`Petitioner - New World Medical
`Ex. 1017, p. 9 of 236
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`

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`Case 1:20-cv-00754-MN Document 1 Filed 06/04/20 Page 10 of 43 PageID #: 10
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`Claim Element
`degrees, said distal
`protruding tip being
`sized to be inserted
`in Schlemm’s Canal
`and
`iii) first and second
`cutting edges located
`at a junction of the
`shaft and the distal
`protruding tip, said
`first and second
`cutting edges being
`formed at
`spaced-apart locations
`on the distal end of
`the shaft, said first and
`second cutting edges
`being separated by a
`distance D;
`forming an opening
`into an anterior
`chamber of the eye;
`inserting the elongate
`probe through the
`opening and into the
`anterior chamber;
`advancing the
`elongate probe
`through the anterior
`chamber, while the
`anterior chamber is
`filled with fluid, to an
`operative position
`where the distal
`protruding tip is
`positioned within
`Schlemm’s Canal and
`the first and second
`cutting edges are
`contacting the
`trabecular meshwork;
`and, thereafter
`
`Claim
`
`
`
`
`
`Table 1 – ’729 Patent
`Claimed Element Present in Accused Product/Method
`
`Panel “b” above shows that the elongate probe comprises
`first and second cutting edges (C) located at a junction of
`the shaft (B2) and the distal protruding tip (D), said first
`and second cutting edges (C) being formed at spaced
`apart locations on the distal end of the shaft (B2), said
`first and second cutting edges (C) being separated by a
`distance D. See Ex. M (reference letters added).
`
`Defendant instructs surgeons to form an opening into the
`anterior chamber of the eye. Ex. M at Sections 2.4, 2.5,
`3.1.
`Defendant instructs surgeons to insert the elongate probe
`of the Accused Products through the opening and into the
`anterior chamber of the eye. Ex. M at Sections 2.4, 2.6,
`3.1.
`
`Defendant instructs surgeons to advance the Accused
`Products’ elongate probe through the anterior chamber of
`the eye while the anterior chamber is filled with fluid, to
`an operative position where the distal protruding tip (D) is
`positioned within Schlemm’s Canal and the first and
`second cutting edges (C) are contacting the trabecular
`meshwork. Ex. M at Sections 3.1-3.3.
`
`10
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`
`
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`Petitioner - New World Medical
`Ex. 1017, p. 10 of 236
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`

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`Case 1:20-cv-00754-MN Document 1 Filed 06/04/20 Page 11 of 43 PageID #: 11
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`Claim
`
`Claim Element
`
`causing the distal
`protruding tip to
`advance through a
`sector of Schlemm’s
`Canal with the first
`and second cutting
`edges concurrently
`cutting, from the
`trabecular meshwork,
`a strip of tissue having
`approximate width W,
`said approximate
`width W being
`approximately equal
`to the distance D
`between the first and
`second cutting edges.
`
`
`A method according
`to claim 1 further
`comprising the step of
`infusing fluid into the
`anterior chamber
`under controlled
`pressure to keep the
`anterior chamber
`filled with fluid
`during performance of
`the method.
`A method according
`to claim 1 wherein the
`strip of tissue cut from
`the trabecular
`meshwork has a
`length of about 2 to 10
`millimeters.
`
`
`
`
`
`
`
`2
`
`3
`
`
`
`
`
`Table 1 – ’729 Patent
`Claimed Element Present in Accused Product/Method
`Panel “a” above and Panel “c” below (and the instructions
`in Exs. M and N) show that Defendant instructs surgeons
`to advance the distal protruding tip (D) of the Accused
`Products through a sector of Schlemm’s Canal with the
`first and second cutting edges (C) concurrently cutting,
`from the trabecular meshwork, a strip of tissue which has
`an approximate width W which is approximately equal to
`the distance D between the first and second cutting edges
`(C). Ex. M at Sections 3.2, 3.3; see also Ex. N.
`
`
`
`
`
`Defendant instructs surgeons to infuse fluid (e.g.,
`viscoelastic) to keep the anterior chamber filled during
`performance of the method. Ex. M at Section 2.6.
`
`Defendant instructs surgeons to use the Accused Products
`to remove strips of trabecular meshwork tissue which
`covers a range of about 2 to 10 mm in length. Ex. M at
`Section 3.4; see also Ex. O at Intuitive Option.
`
`11
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`Petitioner - New World Medical
`Ex. 1017, p. 11 of 236
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`

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`Case 1:20-cv-00754-MN Document 1 Filed 06/04/20 Page 12 of 43 PageID #: 12
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`Claim
`
`4
`
`5
`
`7
`
`8
`
`Claim Element
`A method according
`to claim 1 further
`comprising the step
`of: removing the strip
`of tissue from the
`patient’s eye.
`A method according
`to claim 4 wherein,
`after the first and
`second cutting edges
`have cut the strip of
`tissue from the
`trabecular meshwork,
`the strip of tissue
`remains connected to
`the trabecular
`meshwork and
`wherein the method
`further comprises the
`step of: disconnecting
`the strip of tissue such
`that it may be
`removed from the eye.
`A method according
`to claim 1 wherein the
`step of forming an
`opening into the
`anterior chamber of
`the eye comprises
`forming an incision
`through a cornea of
`the eye.
`A method according
`to claim 1 wherein the
`method is performed
`under direct
`visualization through
`a lens device
`positioned on an
`anterior aspect of the
`eye.
`
`
`
`
`
`
`
`
`
`
`
`
`
`Table 1 – ’729 Patent
`Claimed Element Present in Accused Product/Method
`
`Defendant instructs surgeons to remove the strip of
`trabecular meshwork tissue from the patient’s eye. Ex. M
`at Sections 3.4, 3.5, 3.6.
`
`Defendant instructs surgeons to use the Accused Products
`in a manner that causes the strip of trabecular meshwork
`tissue to become disconnected so that it may be removed
`from the eye. Ex. M at Sections 3.4, 3.5, 3.6; see also
`Ex. N.
`
`Defendant instructs surgeons to form a corneal incision to
`establish the opening into the anterior chamber of the eye.
`Ex. M at Sections 2.3, 2.4, 2.5.
`
`Defendant instructs surgeons to perform the method of
`Claim 1 under direct visualization through a lens device
`(i.e., a Goniolens) positioned on an anterior aspect of the
`eye. Ex. M at Sections 2.1, 2.2.
`
`12
`
`
`
`
`Petitioner - New World Medical
`Ex. 1017, p. 12 of 236
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`

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`Case 1:20-cv-00754-MN Document 1 Filed 06/04/20 Page 13 of 43 PageID #: 13
`
`Claim
`
`9
`
`10
`
`Claim Element
`A method according
`to claim 1 wherein the
`angle is less than
`approximately 90
`degrees.
`A method according
`to claim 9 wherein the
`angle is approximately
`90 degrees.
`
`
`
`
`
`Table 1 – ’729 Patent
`Claimed Element Present in Accused Product/Method
`
`Panel “b” above shows that the angle (E) of the Accused
`Products must be in the range of 30 degrees to 90 degrees.
`See Ex. M (reference letters added).
`
`Panel “b” above shows that the angle (E) of the Accused
`Products must be in the range of 30 degrees to 90 degrees.
`See Ex. M (reference letters added).
`
`
`
`
`
`Infringement of the ’155 Patent
`
`35.
`
`On information and belief, based on Plaintiffs’ current investigation, Defendant’s
`
`Accused Products embody each and every element of at least claims 1-6 of the ’155 Patent, either
`
`literally or under the doctrine of equivalents, as follows.
`
`Claim
`
`1
`
`Claim Element
`A dual blade device
`useable for
`performing an ab
`interno procedure
`within a human eye to
`remove a strip of
`trabecular meshwork
`tissue, said device
`comprising:
`a handle configured to
`be grasped by an
`operator’s hand;
`
`Table 2 – ’155 Patent
`Claimed Element Present in Accused Product/Method
`
`The Accused Products’ IFU describes that the KBD is a
`dual blade device useable for performing an ab interno
`procedure within a human eye to remove a strip of
`trabecular meshwork tissue. Ex. M at Descriptions and
`Intended Use, Section 3.3.
`
`Panel “a” below shows that the Accused Products have a
`handle (A) configured to be grasped by an operator’s
`hand. See Ex. M (reference letters added).
`
`
`
`13
`
`
`
`
`Petitioner - New World Medical
`Ex. 1017, p. 13 of 236
`
`

`

`Case 1:20-cv-00754-MN Document 1 Filed 06/04/20 Page 14 of 43 PageID #: 14
`
`Claim
`
`Claim Element
`
`Table 2 – ’155 Patent
`Claimed Element Present in Accused Product/Method
`
`an elongate probe
`comprising a shaft
`that extends from the
`handle along a
`longitudinal axis;
`
`a blunt protruding tip
`that extends in a
`lateral direction from
`a distal end of the
`shaft to form a bend
`or curve of
`approximately 30
`degrees to
`approximately 90
`degrees relative to the
`adjacent longitudinal
`axis of the shaft;
`
`
`Panel “b” below shows that the Accused Products have an
`elongate probe (B1) comprising a shaft (B2) that extends
`from the handle along a longitudinal axis. See Ex. M
`(reference letters added).
`
`
`
`Panel “b” above shows that the Accused Products have a
`blunt protruding tip (D) that extends in a lateral direction
`from a distal end of the shaft to form a bend or curve (E)
`of approximately 30 degrees to approximately 90 degrees
`relative to the adjacent longitudinal axis of the shaft. See
`Ex. M (reference letters added).
`
`14
`
`
`
`
`
`
`
`
`Petitioner - New World Medical
`Ex. 1017, p. 14 of 236
`
`

`

`Case 1:20-cv-00754-MN Document 1 Filed 06/04/20 Page 15 of 43 PageID #: 15
`
`Claim
`
`
`
`
`
`Claim Element
`first and second lateral
`cutting edges formed
`at stationary
`side-by-side locations
`on the shaft, said first
`and second lateral
`cutting edges facing in
`the same lateral
`direction as the blunt
`protruding tip and
`being spaced apart
`such that an area
`exists between the
`first and second lateral
`cutting edges; and
`a blunt top edge that
`extends transversely
`from a top end of the
`first lateral cutting
`edge to a top end of
`the second lateral
`cutting edge and
`traverses above the
`area between the first
`and second lateral
`cutting edges;
`the blunt protruding
`tip having a transverse
`width, a top surface, a
`bottom surface and a
`terminal end, the
`transverse width being
`narrowest at the
`terminal end;
`the blunt protruding
`tip being below the
`area between the first
`and second lateral
`cutting edges and
`protruding in the
`lateral direction
`beyond the first and
`second lateral cutting
`edges such that tissue
`
`Table 2 – ’155 Patent
`Claimed Element Present in Accused Product/Method
`
`Panel “b” above shows that the first and second lateral
`cutting edges (C) are formed at stationary side-by-side
`locations on the shaft. Said first and second lateral cutting
`edges (C) are facing in the same lateral direction as the
`blunt protruding tip (D) and spaced apart such that an area
`exists between the first and second lateral cutting edges.
`See Ex. M (reference letters added).
`
`Panel “b” above shows that the blunt top edge (I) extends
`transversely from a top end of the first lateral cutting edge
`(C) to a top end of the second lateral cutting edge (C) and
`traverses above the area between the first and second
`lateral cutting edges (C). See Ex. M (reference letters
`added).
`
`Panel “b” above shows that the blunt protruding tip (D)
`has a transverse width, a top surface (F), a bottom surface
`(G) and a terminal end (H), the transverse width being
`narrowest at the terminal end. See Ex. M (reference letters
`added).
`
`Panel “a” above and Panel “c” below show that the blunt
`protruding tip (D) is below the area between the first and
`second lateral cutting edges and protruding in the lateral
`direction beyond the first and second lateral cutting edges
`such that tissue may pass over the top surface of the blunt
`protruding tip before coming into contact with the first
`and second lateral cutting edges. See Ex. N; see also
`Ex. M (Figures A-C).
`
`15
`
`
`
`
`Petitioner - New World Medical
`Ex. 1017, p. 15 of 236
`
`

`

`Case 1:20-cv-00754-MN Document 1 Filed 06/04/20 Page 16 of 43 PageID #: 16
`
`Table 2 – ’155 Patent
`Claimed Element Present in Accused Product/Method
`
`
`
`Claim
`
`Claim Element
`may pass over the top
`surface of the blunt
`protruding tip before
`coming into contact
`with the first and
`second lateral cutting
`edges;
`
`
`
`Defendant’s website states the width of the distal portion
`of the shaft is 230 microns. Thus, the distal portion of the
`shaft and the blunt protruding tip are sized to pass through
`an incision formed in the eye by a 1.5 mm slit knife. See
`Ex. N; Ex. M Sections 2.4, 2.5, 3.1.
`
`Panel “d” below shows that the blunt protruding tip is
`further sized to fit within Schlemm’s Canal of the human
`eye and, when so positioned, to be advanceable through
`Schlemm’s Canal with trabecular meshwork tissue
`passing over its top surface and into contact with the first
`and second lateral cutting edges. See Ex. N; Ex. M
`(Figures A-C), Sections 3.1, 3.2, 3.3.
`
`a distal portion of the
`shaft and the blunt
`protruding tip being
`sized to pass through
`an incision formed in
`the eye by a 1.5 mm
`slit knife; and
`
`the blunt protruding
`tip being further sized
`to fit within
`Schlemm’s Canal of
`the human eye and,
`when so positioned, to
`be advanceable
`through Schlemm’s
`Canal with trabecular
`meshwork tissue
`passing over its top
`surface and into
`contact with the first
`and second lateral
`cutting edges.
`
`
`
`
`
`16
`
`
`
`
`
`
`Petitioner - New World Medical
`Ex. 1017, p. 16 of 236
`
`

`

`Case 1:20-cv-00754-MN Document 1 Filed 06/04/20 Page 17 of 43 PageID #: 17
`
`Claim
`
`2
`
`3
`
`4
`
`5
`
`Claim Element
`A device according to
`claim 1 wherein the
`first and second
`lateral cutting edges
`are spaced apart by a
`distance D and cut a
`strip of trabecular
`meshwork tissue
`having a width W
`that is substantially
`equal to distance D.
`A device according to
`claim 1 useable for
`cutting a sector of
`trabecular meshwork
`tissue having a length
`of 2 to 10 millimeters.
`
`A device according to
`claim 1 wherein the
`bottom surface of the
`blunt protruding tip
`extends at an angle of
`approximately 90
`degrees relative to the
`adjacent longitudinal
`axis of the shaft.
`
`A system comprising
`a device according to
`claim 1 in
`combination with a
`1.5 mm slit knife for
`forming said incision
`in the human eye.
`
`
`
`
`
`
`
`
`
`
`
`
`
`Table 2 – ’155 Patent
`Claimed Element Present in Accused Product/Method
`
`Panel “d” above shows that the first and second lateral
`cutting edges of the Accused Products are located a
`spaced distance apart and cut a strip of trabecular
`meshwork tissue having a width that is substantially equal
`to the distance between the first and second knife blades.
`See Ex. N. Defendant’s website also explains that “[t]he
`footplate of the blade is designed to fit within Schlemm’s
`canal” within a few microns. Id.
`
`The Accused Products are useable to cut a sector of
`trabecular meshwork tissue having a length of 2 to 10
`millimeters. Ex. M at Section 3.4; see also Ex. O at
`Intuitive Option.
`
`Panels “a” and “b” below show that the bottom surface
`(G) of the blunt protruding tip (D) extends at an angle of
`approximately 90 degrees relative to the adjacent
`longitudinal axis of the shaft. See Ex. M (reference letters
`added).
`
`The Accused Products are inserted into the eye through a
`previously created clear corneal incision formed by a slit
`knife. Ex. M at Sections 2.4, 2.5, 3.1, and product videos
`shown on Defendant’s website (Ex. N).
`
`17
`
`
`
`
`Petitioner - New World Medical
`Ex. 1017, p. 17 of 236
`
`

`

`Case 1:20-cv-00754-MN Document 1 Filed 06/04/20 Page 18 of 43 PageID #: 18
`
`
`
`
`
`Claim
`
`6
`
`Claim Element
`A device according to
`claim 1 wherein the
`device is manually
`operable to remove a
`strip of trabecular
`meshwork tissue.
`
`
`
`Table 2 – ’155 Patent
`Claimed Element Present in Accused Product/Method
`
`The Accused Products are manually operable to remove a
`strip of trabecular meshwork tissue. Ex. M at Description
`and Intended Use, Sections 3.1-3.7.
`
`Infringement of the ’885 Patent
`
`36.
`
`On information and belief, based on Plaintiffs’ current investigation, Defendant
`
`induces others, including cu