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`IN THE UNITED STATES DISTRICT COURT
`FOR THE WESTERN DISTRICT OF WASHINGTON
`NEW WORLD MEDICAL, INC. and THE
`
`REGENTS OF THE UNIVERSITY OF
`Case No.
`COLORADO,
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`COMPLAINT FOR PATENT
`
`INFRINGEMENT
` Plaintiffs,
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`JURY DEMAND
` v.
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`MICROSURGICAL TECHNOLOGY, INC.,
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` Defendant.
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`Plaintiffs New World Medical, Inc. (“NWM”) and The Regents of the University of
`Colorado, a body corporate (“University”) (collectively “Plaintiffs”), by and through their
`attorneys, allege as follows against Defendant Microsurgical Technology, Inc. (“Defendant” or
`“MST”). The allegations herein are made based on personal knowledge as to Plaintiffs with
`respect to their own actions and upon information and belief as to all others. NWM is pursuing
`this action and has the right to join University as a party.
`NATURE OF THE ACTION
`This is a civil action for patent infringement under the Patent Laws of the United
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`States, 35 U.S.C. § 1 et seq. and for such other relief as the Court deems just and proper. Plaintiffs’
`claims are based on Defendant’s infringement of United States Patent No. 10,786,391 (“the ‘391
`patent” or “Asserted Patent”).
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`COMPLAINT FOR PATENT INFRINGEMENT - 1
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`Patent Owner Ex. 2012–0001
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`Case 2:20-cv-01621-BAT Document 1 Filed 11/04/20 Page 2 of 189
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`THE PARTIES
`NWM is a corporation organized and existing under the laws of the State of
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`Delaware, with its principal place of business at 10763 Edison Court, Rancho Cucamonga, CA
`91730.
`University is a body corporate organized under the Colorado Constitution and the
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`laws of the State of Colorado. The office of the Secretary of the Board of Regents of the University
`of Colorado is located at 1800 Grant Street, 8th Floor, Denver, CO 80203.
`On information and belief, MST is a company organized and existing under the
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`laws of the State of Washington, with its principal place of business at 8415 154th Avenue NE,
`Redmond, WA 98052.
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`JURISDICTION AND VENUE
`This civil action arises under the Patent Laws of the United States, Title 35, United
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`States Code. This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1338(a).
`This Court has personal jurisdiction over Defendant at least because Defendant is
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`incorporated under the laws of the State of Washington and has its principal place of business in
`the State of Washington.
`Venue is proper in this District under 28 U.S.C. §§ 1391(b) and 1400(b) because
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`Defendant is incorporated under the laws of the State of Washington and has committed acts of
`infringement and has a regular and established place of business in the State of Washington and in
`this District.
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`A.
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`FACTUAL BACKGROUND
`THE ASSERTED PATENT
`NWM is a leading specialty medical device company that focuses on developing
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`innovative products for alleviating ophthalmic ailments and preserving and enhancing patients’
`vision. NWM supplies products that are used by physicians worldwide, including market-leading
`devices used for treating glaucoma.
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`COMPLAINT FOR PATENT INFRINGEMENT - 2
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`Patent Owner Ex. 2012–0002
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`Case 2:20-cv-01621-BAT Document 1 Filed 11/04/20 Page 3 of 189
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`Glaucoma refers to a group of diseases characterized by optic neuropathy that can
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`lead to irreversible blindness. The disease is one of the leading causes of blindness in the United
`States. Glaucoma can occur in all segments of society, regardless of age, and causes significant
`health and economic consequences in those afflicted with this condition.
`On September 29, 2020, the United States Patent and Trademark Office (“USPTO”)
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`duly and legally issued the ‘391 patent, entitled “Intraocular Device for Dual Incisions,” filed
`November 8, 2019. A true and correct copy of the ‘391 patent is attached hereto as Exhibit A.
`The listed assignee of the ‘391 patent is University. The listed inventor of the ‘391
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`patent assigned the rights, title, and interest in the ‘391 patent to University. The inventor’s
`assignment to University has been recorded with the USPTO at Reel/Frame 051880/0422. NWM
`holds an exclusive license from University to the ‘391 patent.
`The ‘391 patent is generally related to methods for treating glaucoma by excising
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`the trabecular meshwork tissue to form an opening.
`B.
`DEFENDANT’S INFRINGING DEVICES AND CONDUCT
`This patent infringement action arises due to Defendant’s manufacture, use, sale,
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`and offer for sale in the United States, and/or importation into the United States, of the TrabEx™
`and TrabEx+™ devices (“Accused Product(s)” or “TrabEx devices”), and/or its acts that induce
`and/or contribute to use of the Accused Products. Images of the Accused Products from
`Defendant’s website are provided below as Figure 1 (TrabEx™) and Figure 2 (TrabEx+™).
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`COMPLAINT FOR PATENT INFRINGEMENT - 3
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`Patent Owner Ex. 2012–0003
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`Case 2:20-cv-01621-BAT Document 1 Filed 11/04/20 Page 4 of 189
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`Figure 2
`Figure 1
`According to Defendant’s website, Defendant sells the TrabEx™ device. See
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`Exhibit B, available at https://microsurgical.com/products/irrigatinggoniectomydevices/trabex/
`(last visited October 21, 2020). The SKU number of the TrabEx™ device listed on the website is
`600042. Id.
`Defendant’s website indicates that the TrabEx™ device “offers a highly effective
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`solution for excision of the Trabecular Meshwork. It features precision engineered serrated blade
`and a trapezoidal configuration to enable edge to edge removal of the Trabecular Meshwork
`allowing for lasting exposure of collector channels.” Id.
`Defendant’s website further indicates that the TrabEx™ device has a “Serrated
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`Trapezoidal Dual Blade” and a “Footplate.” Id. An image of the TrabEx™ device from
`Defendant’s website is provided below as Figure 3.
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`COMPLAINT FOR PATENT INFRINGEMENT - 4
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`Patent Owner Ex. 2012–0004
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`Case 2:20-cv-01621-BAT Document 1 Filed 11/04/20 Page 5 of 189
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`Figure 3
`According to Defendant’s website, Defendant also sells the TrabEx+™ device. See
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`Exhibit C, available at https://microsurgical.com/products/irrigatinggoniectomydevices/
`trabex-2/ (last visited October 21, 2020). The SKU number of the TrabEx+™ device listed on the
`website is 600021. Id.
`On information and belief, the TrabEx+™ device is the TrabEx™ device with
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`irrigation and aspiration features. Defendant’s website states that “TrabEx+™ in addition to the
`dual-blade technology also incorporates irrigation and aspiration for efficient tissue extraction
`during irrigating goniectomy.” Id. Further, according to Defendant’s website, the TrabEx+™
`device “offers the same superior performance of the TrabEx, enhanced control of the anterior
`chamber, and the ideal angle visualization during surgery.” Id.
`Defendant’s website also lists “Features” of the TrabEx+™ device, including “[t]he
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`Serrated Dual Blade excises a strip of the Trabecular Meshwork” and a “Unique footplate guides
`tip along the contour of Schlemm’s Canal.” Id. Defendant’s website indicates that the TrabEx+™
`device has a “Serrated Trapezoidal Dual Blade” and a “Footplate.” Id. An image of the TrabEx™
`device from Defendant’s website is provided below as Figure 4.
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`COMPLAINT FOR PATENT INFRINGEMENT - 5
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`Case 2:20-cv-01621-BAT Document 1 Filed 11/04/20 Page 6 of 189
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`Figure 4
`Defendant’s website also provides an illustration depicting use of the TrabEx+™
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`device to form an opening in trabecular meshwork tissue of an eye. Id. An annotated version of
`this illustration is provided below as Figure 5.
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`Figure 5
`On information and belief, Defendant markets and sells the Accused Products in
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`the United States. For example, on information and belief, Exhibit D is a product advertisement
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`COMPLAINT FOR PATENT INFRINGEMENT - 6
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`Case 2:20-cv-01621-BAT Document 1 Filed 11/04/20 Page 7 of 189
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`provided by Defendant for the Accused Products. See Exhibit D. According to Exhibit D, the
`Accused Products are “[d]esigned for complete excision of trabecular meshwork.” Id. Further,
`Exhibit D indicates the Accused Products have “[l]aser cut, serrated, and progressively elevated
`blades designed to enable excision of the trabecular meshwork, rather than tearing, of the tissue”
`and the “[t]rapezoidal configuration of the blades promotes maximum width removal of trabecular
`meshwork, and conforms to varying patient anatomy.” Id.
`Similarly, on information and belief, Exhibits E and F are product brochures
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`produced and distributed by Defendant for the TrabEx™ and TrabEx+™ devices, respectively.
`See Exhibit E; Exhibit F. As shown in Exhibits E and F, Defendant instructs users of the Accused
`Products to use the Accused Products in a manner that infringes the ‘391 patent.
`As demonstrated in Exhibit E, Defendant provides instructions to its customers for
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`using the TrabEx™ device. Exhibit E states, inter alia, “TrabEx™ tip pierces, then lifts and
`stretches TM as it is advanced in SC.” See Exhibit E. Exhibit E provides a series of illustrations
`where Defendant instructs its customers to advance the TrabEx™ device, tip first, through the
`trabecular meshwork and into Schlemm’s Canal and to advance the device through Schlemm’s
`Canal to contact and sever trabecular meshwork tissue. Id. These illustrations are provided below
`as Figure 6.
`
`Figure 6
`Similarly, as demonstrated in Exhibit F, Defendant provides instructions to its
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`customers for using the TrabEx+™ device. Exhibit F provides a series of illustrations where
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`COMPLAINT FOR PATENT INFRINGEMENT - 7
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`Case 2:20-cv-01621-BAT Document 1 Filed 11/04/20 Page 8 of 189
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`Defendant instructs its customers to advance the TrabEx+™ device, tip first, through the trabecular
`meshwork and into Schlemm’s Canal and to advance the device through Schlemm’s Canal to
`contact and sever trabecular meshwork tissue. See Exhibit F. These illustrations are provided
`below as Figure 7.
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`Figure 7
`According to Defendant’s website, Defendant acquired the TrabEx™ platform,
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`formerly known
`as
`“Goniotome,”
`in 2019.
` See Exhibit G, available at
`https://microsurgical.com/about-us/ (last visited October 21, 2020). On information and belief,
`Defendant acquired the Goniotome platform from NeoMedix Corporation. On information and
`belief, NeoMedix Corporation is Defendant’s predecessor-in-interest.
`On information and belief, the TrabEx™ device was formerly branded as the
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`Goniotome. See Exhibit E (“*TrabEx™ formerly branded as Goniotome”). On information and
`belief, the TrabEx™ device is substantially identical to the Goniotome device and is used in the
`same manner.
`On information and belief, Instructions for Use (“IFU”) were included with
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`Goniotome devices. Exhibit H is an exemplary version of the IFU for the Goniotome device. See
`Exhibit H. The IFU specifically instructs, directs, and/or requires users to use the Goniotome
`device in ophthalmic surgery procedures to manually cut trabecular meshwork tissue in patients.
`Exhibit H provides a list of “Directions” for using the Goniotome device.
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`According to Exhibit H, Steps 8-10 are performed using the Goniotome as follows: “8. Advance
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`COMPLAINT FOR PATENT INFRINGEMENT - 8
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`Case 2:20-cv-01621-BAT Document 1 Filed 11/04/20 Page 9 of 189
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`the tip toward the TM opposite of the incision site. Establish gonioscopic view of the TM and
`proceed with advancing the tip until it’s [sic] footplate contacts the TM. 9. Pierce the TM with the
`pointed tip [④] so it enters Schlemm’s Canal while avoiding damage to the back wall. 10.
`Advance the tip of the Handpiece along Schlemm’s Canal in the direction you intend to cut TM.
`Keep the smooth footplate [③] moving along Schlemm’s canal while only exerting minimal
`pressure against the back wall of Schlemm’s canal. CAUTION: Maintain both dual blades [⑤]
`perpendicular to the TM during TM excision or only one of the dual blades may cut the TM.” Id.
`Additionally, Defendant provides “MST Online Series Webinars” on its website,
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`which Defendant states that it designed to allow viewers to “Learn more about the latest MST
`technologies from the experts.” See Exhibit I, available at https://microsurgical.com/webinars/
`(last visited October 21, 2020). Dr. Nils Loewen, Dr. Iqbal “Ike” K. Ahmed, and Dr. Brian Francis,
`among others, are presenters who, on information and belief, filmed various webinars for
`Defendant and made available by Defendant on its website. Id. On information and belief, Dr.
`Loewen, Dr. Ahmed, and Dr. Francis have presented on webinars available on Defendant’s website
`at Defendant’s behest and as representatives of Defendant.
`30. Moreover, on information and belief, Dr. Loewen, Dr. Ahmed, and Dr. Francis have
`financial relationships with Defendant and with Defendant’s predecessor-in-interest NeoMedix
`Corporation such that Dr. Loewen, Dr. Ahmed, and Dr. Francis are representatives and affiliates
`of Defendant.
`Additionally, according to Defendant’s website, Dr. Ahmed is a member of
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`Defendant’s staff. See Exhibit J, available at https://microsurgical.com/staff/iqbal-ike-k-ahmed-
`md/ (last visited October 21, 2020).
`In October 2019, Dr. Loewen disclosed in the “Annual Meeting Participant
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`Disclosures” for the American Academy of Ophthalmology annual meeting that he maintained a
`financial relationship with Defendant’s predecessor-in-interest NeoMedix Corporation. See
`Exhibit
`K,
`at
`https://www.aao.org/Assets/95e35db4-fc9d-45a1-8ac5-
`available
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`COMPLAINT FOR PATENT INFRINGEMENT - 9
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`Case 2:20-cv-01621-BAT Document 1 Filed 11/04/20 Page 10 of 189
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`1424670e3151/637116792149100000/aao2019-disclosures-20191204-pdf?inline=1 (last visited
`October 21, 2020).
`In August 2020, Dr. Francis disclosed a “financial agreement or affiliation during
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`the past year” with commercial interests including Defendant’s predecessor-in-interest NeoMedix
`Corporation. See Exhibit L, available at https://www.pathlms.com/mededicus/courses/21960 (last
`visited November 4, 2020). In October 2019, Dr. Francis disclosed in the “Annual Meeting
`Participant Disclosures” for the American Academy of Ophthalmology annual meeting that he
`maintained a financial relationship with Defendant’s predecessor-in-interest NeoMedix
`Corporation. See Exhibit K.
`On information and belief, in a video posted on YouTube entitled “example video
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`TrabEx pseudophakia, angle closure glaucoma NL” dated August 30, 2020, Dr. Loewen provides
`for Defendant’s benefit and at Defendant’s behest instructions for using the Accused Products in
`surgical procedures to cut trabecular meshwork to form an opening in trabecular meshwork tissue
`of patients. See https://www.youtube.com/watch?v=3JWZK_rZUsE&t=34s (last visited October
`21, 2020). He also demonstrates use of the Accused Products for the Defendant’s benefit and at
`its behest. Specifically, as shown in the screenshot from the video below (Figure 8), Dr. Loewen
`instructs users, including Defendant’s customers, to insert the tip of the Accused Products into the
`anterior chamber through an incision in the eye. Id. (minute mark 0:13).
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`Figure 8
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`COMPLAINT FOR PATENT INFRINGEMENT - 10
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`Case 2:20-cv-01621-BAT Document 1 Filed 11/04/20 Page 11 of 189
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`Dr. Loewen then instructs users, including Defendant’s customers, to advance the
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`tip of the Accused Products through the trabecular meshwork and into Schlemm’s Canal and
`demonstrates this exact use, as shown in the screenshot below (Figure 9). Id. (minute mark 0:20).
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`Figure 9
`Dr. Loewen then instructs users, including Defendant’s customers, to advance the
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`tip of the Accused Products through Schlemm’s Canal such that trabecular meshwork tissue
`contacts and is excised by the Accused Products and demonstrates this exact use, as shown in the
`screenshot below (Figure 10). Id. (minute mark 0:25).
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`Figure 10
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`COMPLAINT FOR PATENT INFRINGEMENT - 11
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`Case 2:20-cv-01621-BAT Document 1 Filed 11/04/20 Page 12 of 189
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`Dr. Loewen then instructs users, including Defendant’s customers, to sever or cut
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`a trabecular meshwork strip using the Accused Products and demonstrates this exact use, as shown
`in the screenshot below (Figure 11). Id. (minute mark 0:52).
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`Figure 11
`Dr. Loewen then instructs users, including Defendant’s customers, to excise the
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`other side of the trabecular meshwork using the Accused Products and demonstrates this exact use,
`as shown in the screenshot below (Figure 12). Id. (minute mark 0:56).
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`Figure 12
`Dr. Loewen then instructs users, including Defendant’s customers, to remove the
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`excised trabecular meshwork tissue using the Accused Products and demonstrates this exact use,
`as shown in the screenshot below (Figure 13). Id. (minute mark 1:28).
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`COMPLAINT FOR PATENT INFRINGEMENT - 12
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`Case 2:20-cv-01621-BAT Document 1 Filed 11/04/20 Page 13 of 189
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`Figure 13
`On information and belief, in a video posted on YouTube entitled “Trabectome and
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`Trabexl Ike Ahmed, MD” dated June 29, 2020, Dr. Ahmed provides for Defendant’s benefit and
`at Defendant’s behest instructions for using the Accused Products in surgical procedures to cut
`trabecular meshwork to form an opening in trabecular meshwork tissue of patients. See
`https://www.youtube.com/watch?v=ITGeKAZS5zw (last visited October 21, 2020). According
`to Dr. Ahmed, “the Trabectome and TrabEx are procedures that are designed to remove a strip of
`the inner wall either directly mechanically or with the irrigation. These procedures are designed
`to again use either an ablative procedure using microcautery or using double serrated blades to
`incise the anterior and posterior edge of the trabecular meshwork.” Id. (minute mark 0:01-0:27).
`Further, according to Dr. Ahmed, “TrabEx is a procedure that’s done without irrigation and is
`again dual serrated blade to incise the anterior and posterior wall of the canal.” Id. (minute mark
`0:58-1:07). Dr. Ahmed further states that “TrabEx is using irrigation and aspiration at the same
`time and this creates basically an irrigating goniectomy much like the Trabectome does but in this
`case without using cautery simply using the dual serrated trapezoidal blades.” Id. (minute mark
`1:07-1:22). Dr. Ahmed further provides specific instructions for using a device called the
`Trabectome that is similar to the Accused Products to form an opening in trabecular meshwork
`tissue. Id. (minute mark 1:28-3:37). On information and belief, the Accused Products are used in
`substantially the same manner as instructed by Dr. Ahmed for use of the Trabectome device.
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`COMPLAINT FOR PATENT INFRINGEMENT - 13
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`Case 2:20-cv-01621-BAT Document 1 Filed 11/04/20 Page 14 of 189
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`On information and belief, in a video posted on YouTube entitled “Dr. Francis –
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`Goniotome Introduction 190444” dated May 19, 2018, Dr. Francis provides for Defendant’s
`benefit and at Defendant’s behest instructions for using the Goniotome device in surgical
`procedures to cut trabecular meshwork to form an opening in trabecular meshwork tissue of
`patients. See https://www.youtube.com/watch?v=XoTWagArDjM (last visited October 14, 2020).
`According to Dr. Francis, “the dual blades are used to insert into Schlemm’s Canal through the
`trabecular meshwork, and then lifts and cuts both ends of the trabecular meshwork and inner wall
`of Schlemm’s Canal, thereby removing it.” Id. (minute mark 2:29-2:43). Figure 14 below is a
`screenshot from the video demonstrating use of the Goniotome device to cut trabecular meshwork
`to form an opening in trabecular meshwork tissue of patients.
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`Figure 14
`Defendant directly and indirectly infringes, either literally or under the doctrine of
`42.
`equivalents, at least claims 1 and 13 of the ‘391 patent. In the chart below, Plaintiffs provide
`examples regarding Defendant’s infringement of claims 1 and 13 of the ‘391 patent based on
`publicly-available information known to Plaintiffs at this time. Plaintiffs investigation is ongoing
`and Plaintiffs expect to identify additional information regarding Defendant’s infringement of the
`‘391 patent through further investigation and discovery in this case.
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`COMPLAINT FOR PATENT INFRINGEMENT - 14
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`Case 2:20-cv-01621-BAT Document 1 Filed 11/04/20 Page 15 of 189
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`Claims of the
`‘391 Patent
`
`Examples Demonstrating Infringement of the ‘391 Patent by the
`Accused Products
`
`The Accused Products are used in a method for incising a trabecular
`meshwork to form an opening in trabecular meshwork tissue of an eye
`having a Schlemm's Canal, an anterior chamber and a trabecular
`meshwork, as shown in the exemplary figures below.
`
`Claim 1: A
`method for
`incising a
`trabecular
`meshwork to form
`an opening in
`trabecular
`meshwork tissue
`of an eye having a
`Schlemm's Canal,
`an anterior
`chamber and a
`trabecular
`meshwork, the
`method
`comprising:
`
`
`
`TrabEx™ (see Exhibit E)
`
`
`
`
`
`TrabEx+™ (see Exhibit F)
`
`
`See also, e.g., Exhibit B (TrabEx™ device “offers a highly effective
`solution for excision of the Trabecular Meshwork. It features precision
`engineered serrated blade and a trapezoidal configuration to enable edge
`to edge removal of the Trabecular Meshwork allowing for lasting
`exposure of collector channels.”); Exhibit C (“TrabEx+™ in addition to
`the dual-blade technology also incorporates irrigation and aspiration for
`efficient tissue extraction during irrigating goniectomy.”).
`
`providing a device
`comprising: a
`shaft;
`
`The Accused Products include a tubular shaft as marked in the
`exemplary annotated figures shown below.
`
`
`COMPLAINT FOR PATENT INFRINGEMENT - 15
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`Patent Owner Ex. 2012–0015
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`
`
`Case 2:20-cv-01621-BAT Document 1 Filed 11/04/20 Page 16 of 189
`
`
`
`Claims of the
`‘391 Patent
`
`Examples Demonstrating Infringement of the ‘391 Patent by the
`Accused Products
`
`
` TrabEx™ (see Exhibit B) TrabEx+™ (see Exhibit C)
`
`
`
`The Accused Products include a distal member positioned at a distal end
`of the shaft, the distal member having a forward end and a rearward end
`as marked in the exemplary annotated figures shown below.
`
`
` TrabEx™ (see Exhibit B) TrabEx+™ (see Exhibit C)
`
`
`
`The Accused Products include a tip disposed at the forward end of the
`distal member as marked in the exemplary annotated figures shown
`below.
`
`a distal member
`positioned at a
`distal end of the
`shaft, the distal
`member having a
`forward end and a
`rearward end;
`
`
` a tip
`disposed at the
`forward end of the
`distal member;
`
`
`
`COMPLAINT FOR PATENT INFRINGEMENT - 16
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`Patent Owner Ex. 2012–0016
`
`
`
`Case 2:20-cv-01621-BAT Document 1 Filed 11/04/20 Page 17 of 189
`
`
`
`Claims of the
`‘391 Patent
`
`Examples Demonstrating Infringement of the ‘391 Patent by the
`Accused Products
`
`
` TrabEx™ (see Exhibit B) TrabEx+™ (see Exhibit C)
`
`
`
`The Accused Products include a right edge and a left edge extending
`towards the rearward end from the tip, wherein the right edge and the left
`edge increase in height as they extend rearward as marked in the
`exemplary annotated figures shown below.
`
`
` TrabEx™ (see Exhibit B) TrabEx+™ (see Exhibit C)
`
`
`
`The Accused Products include a gap rearward of the tip and between the
`right edge and the left edge, the gap defining an unoccupied space that is
`not part of a lumen as marked in the exemplary annotated figures shown
`below.
`
` a right
`edge and a left
`edge extending
`towards the
`rearward end from
`the tip, wherein
`the right edge and
`the left edge
`increase in height
`as they extend
`rearward;
`
`a gap rearward of
`the tip and
`between the right
`edge and the left
`edge, the gap
`defining an
`unoccupied space
`that is not part of a
`lumen,
`
`
`COMPLAINT FOR PATENT INFRINGEMENT - 17
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`Patent Owner Ex. 2012–0017
`
`
`
`Case 2:20-cv-01621-BAT Document 1 Filed 11/04/20 Page 18 of 189
`
`
`
`Claims of the
`‘391 Patent
`
`Examples Demonstrating Infringement of the ‘391 Patent by the
`Accused Products
`
`
` TrabEx™ (see Exhibit B) TrabEx+™ (see Exhibit C)
`
`
`
`The Accused Products include portions of the right and left edges that
`are configured to cut trabecular meshwork tissue as the trabecular
`meshwork tissue advances in a rearward direction over the right and left
`edges as marked in the exemplary annotated figures shown below.
`
`
` TrabEx™ (see Exhibit B) TrabEx+™ (see Exhibit C)
`
`
`
`The Accused Products are used by inserting a distal portion of the device
`into the anterior chamber, the distal portion including the distal member;
`advancing the distal member, the tip first, through the trabecular
`meshwork and into the Schlemm's Canal; and advancing the distal
`member, the tip first, through the Schlemm's Canal such that trabecular
`meshwork tissue contacts and is severed by the right and left edges of the
`distal member, as shown in the exemplary figures below.
`
`wherein at least
`portions of the
`right and left
`edges are
`configured to cut
`trabecular
`meshwork tissue
`as the trabecular
`meshwork tissue
`advances in a
`rearward direction
`over the right and
`left edges;
`
`inserting a distal
`portion of the
`device into the
`anterior chamber,
`the distal portion
`including the
`distal member;
`advancing the
`distal member, the
`tip first, through
`the trabecular
`
`
`COMPLAINT FOR PATENT INFRINGEMENT - 18
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`Patent Owner Ex. 2012–0018
`
`
`
`Case 2:20-cv-01621-BAT Document 1 Filed 11/04/20 Page 19 of 189
`
`
`
`Claims of the
`‘391 Patent
`
`Examples Demonstrating Infringement of the ‘391 Patent by the
`Accused Products
`
`meshwork and
`into the Schlemm's
`Canal; and
`advancing the
`distal member, the
`tip first, through
`the Schlemm's
`Canal such that
`trabecular
`meshwork tissue
`contacts and is
`severed by the
`right and left
`edges of the distal
`member.
`
`
`
`TrabEx™ (see Exhibit E)
`
`TrabEx+™ (see Exhibit F)
`
`
`
`
`
`Claim 13: A
`method for
`incising a
`trabecular
`meshwork to form
`an opening in
`trabecular
`meshwork tissue
`of an eye having a
`Schlemm's Canal,
`an anterior
`chamber and a
`trabecular
`meshwork, the
`method
`comprising:
`
`The Accused Products are used in a method for incising a trabecular
`meshwork to form an opening in trabecular meshwork tissue of an eye
`having a Schlemm's Canal, an anterior chamber and a trabecular
`meshwork, as shown in the exemplary figures below.
`
`TrabEx™ (see Exhibit E)
`
`
`
`
`
`
`COMPLAINT FOR PATENT INFRINGEMENT - 19
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`
`Patent Owner Ex. 2012–0019
`
`
`
`Case 2:20-cv-01621-BAT Document 1 Filed 11/04/20 Page 20 of 189
`
`
`
`Claims of the
`‘391 Patent
`
`Examples Demonstrating Infringement of the ‘391 Patent by the
`Accused Products
`
`
`
`TrabEx+™ (see Exhibit F)
`
`
`See also, e.g., Exhibit B (TrabEx™ device “offers a highly effective
`solution for excision of the Trabecular Meshwork. It features precision
`engineered serrated blade and a trapezoidal configuration to enable edge
`to edge removal of the Trabecular Meshwork allowing for lasting
`exposure of collector channels.”); Exhibit C (“TrabEx+™ in addition to
`the dual-blade technology also incorporates irrigation and aspiration for
`efficient tissue extraction during irrigating goniectomy.”).
`
`inserting a distal
`portion of a device
`into the anterior
`chamber,
`
`The Accused Products are used by inserting a distal portion of the device
`into the anterior chamber, as shown in the exemplary figures below.
`
`
`
`TrabEx™ (see Exhibit E)
`
`TrabEx+™ (see Exhibit F)
`
`
`COMPLAINT FOR PATENT INFRINGEMENT - 20
`
`
`
`
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`Patent Owner Ex. 2012–0020
`
`
`
`Case 2:20-cv-01621-BAT Document 1 Filed 11/04/20 Page 21 of 189
`
`
`
`Claims of the
`‘391 Patent
`
`the device
`comprising: a
`shaft;
`
`
`a distal member
`positioned at a
`distal end of the
`shaft, the distal
`member having a
`forward end and a
`rearward end;
`
`Examples Demonstrating Infringement of the ‘391 Patent by the
`Accused Products
`
`The Accused Products include a tubular shaft as marked in the
`exemplary annotated figures shown below.
`
`
` TrabEx™ (see Exhibit B) TrabEx+™ (see Exhibit C)
`
`
`
`The Accused Products include a distal member positioned at a distal end
`of the shaft, the distal member having a forward end and a rearward end
`as marked in the exemplary annotated figures shown below.
`
`
` TrabEx™ (see Exhibit B) TrabEx+™ (see Exhibit C)
`
`
`
`The Accused Products include a tip disposed at the forward end of the
`distal member as marked in the exemplary annotated figures shown
`below.
`
`a tip disposed at
`the forward end of
`the distal member;
`
`
`
`COMPLAINT FOR PATENT INFRINGEMENT - 21
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`Patent Owner Ex. 2012–0021
`
`
`
`Case 2:20-cv-01621-BAT Document 1 Filed 11/04/20 Page 22 of 189
`
`
`
`Claims of the
`‘391 Patent
`
`Examples Demonstrating Infringement of the ‘391 Patent by the
`Accused Products
`
`
` TrabEx™ (see Exhibit B) TrabEx+™ (see Exhibit C)
`
`
`
`The Accused Products include a right edge and a left edge extending
`towards the rearward end from the tip, wherein the right edge and the left
`edge increase in height as they extend rearward, as marked in the
`exemplary annotated figures shown below.
`
`
` TrabEx™ (see Exhibit B) TrabEx+™ (see Exhibit C)
`
`
`
`The Accused Products include a width between the right and left edges
`that increases as they extend rearward, as marked in the exemplary
`annotated figures shown below.
`
`a right edge and a
`left edge
`extending towards
`the rearward end
`from the tip,
`wherein the right
`edge and the left
`edge increase in
`height as they
`extend rearward,
`
`and wherein a
`width between the
`right and left
`edges increases as
`they extend
`rearward;
`
`
`COMPLAINT FOR PATENT INFRINGEMENT - 22
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`
`Patent Owner Ex.