`
`1N THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELA WARE
`
`MICROSURGICAL
`TECHNOLOGY, INC. and
`THE REGENTS OF THE UNIVERSITY
`OF CALIFORNIA,
`
`Pdaint,;fs,
`
`v.
`
`NE W WORLD MEDICAL, INC.,
`
`Defendant.
`
`C.A. No.
`
`DE MAND FOR JURY TRIAL
`
`CO MPLAINT FOR PATENT INFRINGE MENT
`
`Plaintiffs MicroSurgical Technology, Inc. {"MST") and The Regents of the University of
`
`California ("Regents") (collectively, "Plaintiffs"), by and through their attorneys, for their
`
`Complaint against defendant New World Medical, Inc. {"Defendant" or "N WM"}, allege as
`
`follows:
`
`NATURE OF ACTION
`
`1. This is an action for infringement of Plaintiffs' United States Patents
`
`No. 9,107,729, No. 9,358,155, No. 9,820,885, No. 9,999,544, and No. 10,123,905 under the
`
`Patent Act, 3S U.S.C. § 271, based on Defend ant's unauthorized manufacture, use, offer for sale,
`
`and/or sale in the United States, and/or importation into the United States, of the Kahook Dual
`
`Blade® ("Accused Product{s)" or "KDB"), and/or its acts that induce and/or contribute to use of
`
`the Accused Products.
`
`PARTIES
`
`2. MST is a corporation organized and existing under the laws of the State of
`
`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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`Patent Owner Ex. 2004-0001
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`
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`Case 1:20-cv-00754-UNA Document 1 Filed 06/04/20 Page 2 of 43 PagelD #: 2
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`3. 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,
`
`subdivisions (a} and (f} of the California Constitution. Its principal place of business is in
`
`Oakland, Alameda County, CA USA.
`
`4. On information and belief, NWM is a corporation org anized and existing under the
`
`laws of the State of Delaware, with its principal place of business at 107b3 Edison Court, Rancho
`
`Cucamonga, CA 91730 USA.
`
`JURISDICTION
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`5. This Court has original jurisdiction over the subject matter of this action pursu ant
`
`to 28 U.S.C. §§ 1331 and 1338{a).
`
`b. Personal jurisdiction over Defendant is proper in this District because, on
`
`information and belief, Defendant is incorporated under the laws of the State of Delaware.
`
`VENUE
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`7. Venue is proper in this District under 28 U.S.C. §§ 1391(b) and 1400(b} because,
`
`on information and belief, NWM is incorporated under the laws of the State of Delaware.
`
`FACTS
`
`The Patents-in-Suit
`
`8. United States Patent No. 9,107,729 ("the '729 Patent"), entitled "Methods for
`
`Forming an Opening in the Trabecular Meshwork of the Eye of a Patient," was duly and legally
`
`issued by the United States Trademark and Patent Office ("USPTO") on August 18, 2015. A true
`
`and correct copy of the '729 Patent is attached as Exhibit ("Ex.") A and is incorporated by
`
`reference herein.
`
`2
`
`Patent Owner Ex. 2004-0002
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`
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`Case 1:20-cv-00754-UNA Document 1 Filed 06/04/20 Page 3 of 43 PagelD #: 3
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`9. The '729 Patent is generally directed towards an ab interno method for forming an
`
`opening in trabecular meshwork of a patient's eye that may be accomplished using a dual blade
`
`device to form an opening into an anterior chamber of the eye.
`
`10. All rights, title, and interest in the '729 Patent are assigned to MST, which is the
`
`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
`
`acquired in 2019. A true and correct copy of the inventors' assignments to NeoMedix is attached
`
`as Ex. B. A true and correct copy of NeoMedix's assignment to MST is attached as Ex. C.
`
`11. United States Patent No. 9,358,155 {"the '155 Patent"), entitled "Dual Blade
`
`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
`
`herein.
`
`12. The ' 155 Patent is generally directed towards a dual blade device useable for
`
`performing an ab intenno procedure within a human eye to remove a strip of trabecular meshwork
`
`tissue.
`
`13. All rights, title, and interest in the ' 155 Patent are assigned to MST, which is the
`
`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.
`
`14. United States Patent No. 9,820,885 {"the '885 Patent"), entitled "Dual Blade
`
`Ophthalmologic Surgery Device," was duly and legally issued by the USPTO on November 21,
`
`3
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`Patent Owner Ex. 2004-0003
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`
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`Case 1:20-cv-00754-UNA Document 1 Filed 06/04/20 Page 4 of 43 PagelD #: 4
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`2017. A true and correct copy of the '885 Patent is attached as Ex. E and is incorporated by
`
`reference herein.
`
`15. The '885 Patent is generally directed towards a method for cutting a strip of
`
`trabecular meshwork tissue within an eye of a subj ect that may be accomplished using a dual blade
`
`device to form an opening into an anterior chamber of the eye.
`
`16. All rights, title, and interest in the '885 Patent are assigned to MST, which is the
`
`sole owner of the '885 Patent. The listed inventors of the '885 Patent originally assigned their
`
`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
`
`copy of NeoMedix's assignment to MST is attached as Ex. C.
`
`17. United States Patent No. 9,999,544 {"the '544 Patent"), entitled "Minimally
`
`Invasive Glaucoma Surgical Instrument and Method," was duly and legally issued by the USPTO
`
`on June 19, 201$. A true and correct copy of the ' 544 Patent is attached as Ex. F and is incorporated
`
`by reference herein.
`
`18. The '544 Patent is generally directed towards a device useable to create an opening
`
`in the trabecular meshwork of the eye.
`
`19. The listed assignee of the '544 Patent is Regents. The listed inventors of the '544
`
`Patent assigned their rights, title, and interest in the '544 Patent to Regents. MST holds an
`
`exclusive license from Regents to the '544 Patent, inteY cclia, including the exclusive right to make,
`
`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
`
`Regents is attached as Ex. G.
`
`4
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`Patent Owner Ex. 2004—OOfl4
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`Case 1:20-cv-00754-UNA Document 1 Filed 06/04/20 Page 5 of 43 PagelD #: 5
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`20. United States Patent No. 10,123,905 ("the '905 Patent"), entitled "Devices Useable
`
`for Treatment of Glaucoma and Other Surgical Procedures," was duly and legally issued by the
`
`USPTO on November 13, 2018. A true and correct copy of the '905 Patent is attached as Ex. H
`
`and is incorporated by reference herein.
`
`21. 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.
`
`22. All rights, title, and interest in the '905 Patent are assigned to MST, which is the
`
`sole owner of the '905 Patent. The listed inventors of the '905 Patent originally assigned their
`
`rights, title, and interest in the '905 Patent to Neo Medix, 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
`
`copy of Neo Medix's assignment to MST is attached as Ex. C.
`
`23. Collectively, the '729, '155, '885, '544, and '905 Patents are referred to herein as
`
`the "Asserted Patents" or the "Patents-in-Suit."
`
`Defendant's Infrin�in� Acts Related To The Accused Products
`
`24. On information and belief, Defend ant has known of, should have known of, or has
`
`been willfully blind to, the Asserted Patents. To the extent Plaintiffs or MST's predecessor-in-
`
`interest, Neo Medix, 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 Defend ant of its infringement.
`
`25. Defendant has had actual notice of its infringement of the ' 155 and '729 Patents
`
`since at least June 20, 2016. On or around June 20, 2016, NeoMedix's outside counsel, Robert D.
`
`Buyan ("Buy an") sent a letter to Mateen Ahmed, President and CEO of Defendant, informing
`
`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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`Patent Owner Ex. 2004—Oofl5
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`
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`Case 1:20-cv-00754-UNA Document 1 Filed 06/04/20 Page 6 of 43 PagelD #: 6
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`KDB, inter alia, infringed these patents. A true and correct copy of the June 20, 2016 Letter is
`
`attached as Ex. J. Following the June 20, 20161etter, 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.
`
`Foster ("Foster"), actively engaging in good-faith negotiations regarding Defend ant's infringing
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`conduct but without successful resolution.
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`26. 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,
`
`sale, offer for sale, and/or importation of the KDB, inter olio, infringed these patents. A true and
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`correct copy of the December 6, 2018 Letter is attached as Ex. K.
`
`27. Defend ant 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
`
`counsel, Christopher D. Bright ("Bright"), informing Defend ant 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,
`
`infringed this patent. A true and correct copy of the February 15, 2019 Letter is attached as Ex. L.
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`2$. The Accused Products and methods of using the Accused Products ("Accused
`
`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
`
`goniotomy. A true and correct copy of certain portions of the Defendant's website
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`{https://www.newworldmedical.com/kahook-dual-blades 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
`
`b
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`Patent Owner Ex. 2004-0006
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`Case 1:20-cv-00754-UNA Document 1 Filed 06/04/20 Page 7 of 43 PagelD #: 7
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`Products. On information and belief, Defendant has been aware that the Accused Products infringe
`
`the Asserted Patents and are a material part of the claimed inventions.
`
`29. Upon information and belief, Defendant markets the Accused Products through
`
`various channels, including its website and the PB.
`
`30. Upon information and belief, Defendant engages in the unauthorized manufacture,
`
`use, offer for sale, and/or sale in the United States, and/or importation into the United States, of
`
`the Accused Products. Based on these acts, Defend ant has directly infringed, and/or will directly
`
`infringe, the claims of the Asserted Patents that cover the Accused Products and/or Methods.
`
`31. Upon information and belief, and pursuant to the regulations of the United States
`
`Food and Drug Administration ("FDA"), Defendant includes Instructions for Use ("IFU") with
`
`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
`
`patients. A true and correct copy of the IFU is attached as Ex. M. Based on these instructions,
`
`physici ans or other healthcare professionals have directly infringed and/or will directly infringe
`
`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
`
`would induce others to directly infringe the Asserted Patents. On information and belief, Defendant
`
`has been aware that the Accused Products infringe the Asserted Patents, have no substantial
`
`non-infringing uses, and are a material part of the claimed inventions. Accordingly, Defendant
`
`induces and/or contributes to such infringement.
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`7
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`Patent Owner Ex. 2004-0007
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`Case 1:20-cv-00754-UNA Document 1 Filed 06/04/20 Page 8 of 43 PagelD #: 8
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`32. Through the foregoing acts, Defend ant directly infringes, and/or induces or
`
`contributes to the infringement of, the Asserted Patents. Moreover, Defendant's ongoing
`
`unauthorized manufacture, use, offer for sale, and/or sale in the United States, and/or importation
`
`into the United States, of the Accused Products and Methods, with full knowledge of the Asserted
`
`Patents, reflects Defendant's conscious, deliberate disregard of Plaintiffs' patent rights.
`
`33. In Paragraphs 34-38 {including Tables 1-5} below, Plaintiffs provide explanatory
`
`examples regarding Defendant's infringement of the Asserted Patents. These explanations are
`
`based on publicly-available information known to Plaintiffs at this time. It is expected that
`
`additional information may be learned during discovery. The explanations below, therefore, are
`
`not intended to be final or limiting in any way, and Plaintiffs reserve all rights to amend these
`
`expl anations as the case progresses and as the facts warrant.
`
`Infringement of the'729 Patent
`
`34. On information and belief, based on Plaintiffs' current investigation, Defendant
`
`induces others, including customers, purchasers, users, or some combination thereof, to perform,
`
`either literally or under the doctrine of equivalents, each and every step of at least claims 1-5 and
`
`7-10 of the '729 Patent and has contributed, and continues to contribute, to the infringement of
`
`those claims as follows.
`
`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 ProductiMethod
`
`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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`Patent Owner Ex. 2004-0008
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`Case 1:20-cv-00754-UNA Document 1 Filed 06/04/20 Page 9 of 43 PagelD #: 9
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`Claim
`
`Claim Element
`
`Table 1—'729 Patent
`Claimed Element Present in Accused PraductiMethnd
`Panel
`"a"below shows that the KDB is
`a dual blade
`device
`portion (A)
`which comprises an elongate proximal
`sized
`to be grasped by a hand of a hum an
`operator (i.e.,
`handle). See Ex. M at Section Description
`the
`and
`Intended
`Use (reference letters added)
`
`a
`
`a) an elongate
`proximal portion sized
`to be grasped by a
`hand of a hum an
`operator and
`
`b) an elongate probe
`extending from the
`proximal portion,
`wherein the elongate
`probe comprises
`
`� /
`
`Panel "a" above shows that the elongate probe (B 1)
`extends from the proximal portion {A}. See Ex. M
`{reference letters added}.
`
`"b"below shows that the elongate probe
`Panel
`comprises
`i)
`a shaft (B2}. See Ex. M (reference letters
`added).
`b
`
`i} a shaft
`
`©
`
` �� �
`
`© �
`
`G
`
`ii) a distal protruding
`tip that extends from
`a distal end of the
`shaft to farm 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
`
`Patent Owner Ex. 2004-0009
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`
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`Case 1:20-cv-00754-UNA Document 1 Filed 06104120 Page 10 of 43 PagelD #: 10
`
`Table 1— '729 Patent
`Claimed Element Present in Accused PraductiMethnd
`
`1 - • 1
`
` • - 1 � -
`
` • - 1
`
` • •
`
`-
`
` i
`
` 1 - 1
`
` 1 • 1 • ! �
`
` 1
`
`. ! . •
`
` • 1 • 1
`
` 1
`
` 1 / •
`
` 1 . i
`
` 1
`
`1
`
` 1
`
` - -
`
` - - - . 1 1 ' 1
`
`Claim
`
`Claim Element
`degrees, said distal
`protruding tip being
`sized to be inserted
`in Schlemm's Canal
`and
`
`.1 1 - . 1
`
`• - . • - . - 1
`
`• •
`
`1 - 1
`
`! • 1 � !
`
` 1
`
`1
`
` •1 1
`
`• -1
`
`!. - 1 1.
`
` •
`
` •
`
`•
`
` - 1
`
` - 1 •
`
`1.
`
` 1
`
` 1
`
`• 1
`
` • '/ �'
`
`1
`
`•
`
` 1 • . 1 • / - •
`
`� - - 1 .
`
` • - • 1 • •
`
` • 1 - • 1 • -
`
`• .
`
` - •
`
`- •
`
` 1 - •
`
` - - -
`
` •
`
` �
`
`/- •
`
` - -
`
`•
`
` - • • .
`
`� - - 1 .
`
` • - • 1 • 1
`
` - - • 1 • . - 1 • / -
`
`•1 -
`
`� 1
`
` •
`
`- •
`
` 1- /
`
` - -
`
` •
`
` �
`
`•
`
`
`
` !"
`
`.1
`
` •
`
`• •
`
` ! • •
`
`• �
`
` 1 •
`
`. 1 !-
`_ •
`
` - -
` 1 _
`
`- 1
`
` 1 •
`
`�
`
`• 1 -
`
` - ! • •
`
` �
`
` -
`
` -
`
`1•
`
` • - 1
`
` -
`
` 1
`
` 1
`
`1 •
`
` •
`
`1
`
` /
`
`! • 1 � !
`
`/•
`
` • - 1
`
`- 1 1
`
` 1
`
`-
`
` 1 - • 1
`
`• - 1 • -
`
` -
`
`•
`
` �
`
` 1
`
` •
`
`.!"
`
`/
`
`10
`
`Patent Owner Ex. 2004-0010
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`
`
`Case 1:20-cv-00754-UNA Document 1 Filed 06104120 Page 11 of 43 PagelD #: 11
`
`
`
`Claim _
`
`Claim Element
`
`causing the distal
`protruding tip to
`adv ance 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 dist ance 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
`Clafined Element Present in Accused Producti Methnd
`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.
`
`C
`
`� ,,. �.,
`
`�
`
`
`
`..•;.tit..
`�"'��'�"'�•�
`.:t.:.-... .
`� �;•;`,
`� ;,
`' ��" �-'' �' '
`�� =-
`
`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.
`
`Defend ant 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
`
`Patent Owner Ex. 2004-0011
`
`
`
`Case 1:20-cv-00754-UNA Document 1 Filed 06104120 Page 12 of 43 PagelD #: 12
`
`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 maybe
`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 PraductiMethnd
`
`Defend ant 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 maybe removed
`from the eye. Ex. M at Sections 3.4, 3.5, 3.b; see also
`Ex. N.
`
`Defend ant 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
`
`Patent Owner Ex. 2004-0012
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`Case 1:20-cv-00754-UNA Document 1 Filed 06104120 Page 13 of 43 PagelD #: 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 ProductiMethod
`
`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
`inferno 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 ProductiMethod
`
`The Accused Products' IFU describes that the KBD is a
`dual blade device useable for performing an ab inferno
`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
`
`Patent Owner Ex. 2004-0013
`
`
`
`Case 1:20-cv-00754-UNA Document 1 Filed 06104120 Page 14 of 43 PagelD #: 14
`
`Claim
`
`Claim Element
`
`Table 2—'155 Patent
`Claimed Element Present in Accused PraductiMethad
`a
`
`D '�.
`
`l� �
`Panel
`"b"below shows that the Accused
`Products have an
`elongate
`probe (B1) comprising a shaft (B2)
`that extends
`from
`See Ex. M
`the handle along a longitudinal axis.
`letters added}.
`{reference
`b
`
`B2
`
`�
`
`_��
`''"
`
` �' \ 1.,
`
``,
`
`©
`
`© �
`
`G
`
`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
`
`Patent Owner Ex. 2004-0014
`
`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;
`
`
`
`Case 1:20-cv-00754-UNA Document 1 Filed 06104120 Page 15 of 43 PagelD #: 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 PraductiMethnd
`
`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
`
`Patent Owner Ex. 2004-0015
`
`
`
`Case 1:20-cv-00754-UNA Document 1 Filed 06104120 Page 16 of 43 PagelD #: 16
`
`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 .
`
`Table 2-'155 Patent
`Claimed Element Present in Accused Praducti Method
`
`C
`
``' ��'`
`
`�,ti ...,; �.., ,, , ,
`�.... ��ti �. ;C't; ;�.
`
`•� � �
`
`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 hum an 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.
`
`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 nun slit knife. See
`Ex. N; Ex. M Sections 2.4, 2.5, 3.1.
`
`tip is
`Panel
`"d"below shows that the blunt protruding
`further
`sized to fit within Schlemrn's Canal of
`the human
`eye
`and, when so positioned, to be adv anceable
`through
`Schlemm's
`Canal with trabecular meshwork
`tissue
`over its top surface and into contact with
`the first
`Passing
`and second lateral cutting edges. See Ex. N; Ex.
`M
`A-C), Sections 3.1, 3.2, 3.3.
`{Figures
`
`; _, �, �
`
`_� -
`
`�__� �
`
`-�� �
`,,,� �
`� �' � ='==
`��:F�:; �.
`
`v1" � ~'"
`�" r '�
`
`16
`
`Patent Owner Ex. 2004-0016
`
`
`
`Case 1:20-cv-00754-UNA Document 1 Filed 06104120 Page 17 of 43 PagelD #: 17
`
`Table 2—'155 Patent
`Claimed Element Present in Accused PraductiMethnd
`
`Claim Element
`A device according to
`claim 1 wherein the
`panel "d" above shows that the first and second lateral
`first and second
`cutting edges of the Accused Products are located a
`lateral cutting edges spaced distance apart and cut a strip of trabecular
`are spaced apart by a meshwork tissue having a width that is substantially equal
`distance D and cut a to the distance between the first and second knife blades.
`strip of trabecular
`See Ex. N. Defendant's website also explains that "[t]he
`meshwork tissue
`footplate of the blade is designed to fit within Schlemm's
`having a width W
`canal" within a few microns. ld.
`that is substantially
`equal to dist ance D.
`A device according to
`claim 1 useable for
`cutting a sector of
`trabecular meshwork
`tissue having a length
`of 2 to 10 millimeters.
`
`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
`A device according to longitudinal axis of the shaft. See Ex. M (reference letters �
`added).
`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.
`
`Claim
`
`2
`
`3
`
`4
`
`5
`
`a
`
`© �
`p "�
`
`b
`
`;��
`
`_
`�'
`
`p
`1
`
`/ �
` ?t
`
` �
`O
`
`
`
` �"`'
`
`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.
`
`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
`
`Patent Owner Ex. 2004-0017
`
`
`
`Case 1:20-cv-00754-UNA Document 1 Filed 06104120 Page 18 of 43 PagelD #: 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 ProductiMethod
`
`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 customers, purchasers, users, or some combination thereof, to perform,
`
`either literally or under the doctrine of equivalents, each and every step of at least claims 1, 2, 6,
`
`7, and 9-11 of the '885 Patent and has contributed, and continues to contribute, to the
`
`infi-ingement of those claims as follows.
`
`Claim
`
`1
`
`Claim Element
`A method for cutting a
`strip of trabecular
`meshwork tissue
`within an eye of a
`subject, said eye
`having an anterior
`chamber, trabecular
`meshwork tissue and a
`Schlemm's canal, said
`method comprising:
`a) providing or
`obtaining a device
`which comprises:
`
`an elongate probe that
`extends along a
`longitudinal axis;
`
`Table 3 — '885 Patent
`Claimed Element Present in Accused ProductiMethod
`
`The Accused Products' IFU describes that the KBD is a
`dual blade device useable for performing an ab inferno
`procedure within a human eye to remove a strip of
`trabecular meshwork tissue. Ex. M at Description and
`Intended Use, Sections 2.4, 2.5, 3.3; Ex. N.
`
`The Accused Products are obtained by ophthalmic
`surgeons from Defendant. See Ex. N.
`
`Panel "a"below shows that the KDB is a dual blade
`device which comprises an elongate probe {B2) that
`extends along a longitudinal axis. See Ex. M {reference
`letters added}.
`
`18
`
`Patent Owner Ex. 2004-0018
`
`
`
`Case 1:20-cv-00754-UNA Document 1 Filed 061