Case 6:20-cv-00979-ADA Document 105 Filed 04/26/21 Page 1 of 52
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE WESTERN DISTRICT OF TEXAS
`WACO DIVISION
`
`
`
`
`ALIGN TECHNOLOGY, INC.,
`
`
`
`
`
`Plaintiff and Counterclaim
`Defendant,
`
`
`
`
`3SHAPE A/S and 3SHAPE TRIOS A/S
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`
`
`
`
`
`
`C.A. No. 6:20-cv-00979-ADA
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`JURY TRIAL DEMANDED
`
`v.
`
`
`
`
`
`
`
`Defendants and
`Counterclaimants.
`
`FIRST AMENDED COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiff Align Technology, Inc. (“Align”) demands a trial by jury on all issues so triable and,
`
`for its complaint against Defendants 3Shape A/S and 3Shape Trios A/S (collectively, “3Shape”),
`
`alleges as follows:
`
`1.
`
`Align is a Delaware corporation incorporated in April 1997, with its principal place
`
`THE PARTIES
`
`of business in San Jose, California.
`
`2.
`
`3Shape A/S is a Danish corporation with a principal place of business at Holmens
`
`Kanal 7, 1060 Copenhagen K, Denmark.
`
`3.
`
`3Shape Trios A/S is a Danish corporation with a principal place of business at
`
`Holmens Kanal 7, 1060 Copenhagen K, Denmark.
`
`4.
`
`3Shape makes, uses, sells, and offers for sale in the United States and/or imports
`
`into the United States the TRIOS, TRIOS 3, and TRIOS 4 scanners and software products that
`
`embody systems and/or methods for intraoral scanning for dental applications.
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`Case 6:20-cv-00979-ADA Document 105 Filed 04/26/21 Page 2 of 52
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`JURISDICTION AND VENUE
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`5.
`
`This lawsuit is an action for patent infringement arising under the patent laws of the
`
`United States, Title 35 of the United States Code.
`
`6.
`
`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C. §§
`
`1331 and 1338(a). 
`
`7.
`
`This Court has personal jurisdiction over Defendants in that they have, directly or
`
`through agents and/or intermediaries, committed acts within Texas giving rise to this action and/or
`
`have established minimum contacts with Texas such that the exercise of jurisdiction would not
`
`offend traditional notions of fair play and justice.
`
`8.
`
`On information and belief, Defendants regularly conduct business in Texas, and
`
`purposefully avail themselves of the privileges of conducting business in Texas. In particular, on
`
`information and belief, Defendants, directly and/or through their agents and/or intermediaries,
`
`make, use, import, offer for sale, sell, and/or advertise their products and affiliated services in Texas.
`
`Defendants have placed, and continue to place, infringing products into the stream of commerce,
`
`via an established distribution channel, with the knowledge and/or understanding that such
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`products are sold in the United States including in Texas and specifically including this District.
`
`9.
`
`On information and belief, Defendants have derived substantial revenue from their
`
`infringing activity occurring with the State of Texas and within this District and/or should
`
`reasonably expect their actions to have consequences in Texas. In addition, Defendants have
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`knowingly induced, and continue to knowingly induce, infringement within this District by
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`advertising, marketing, offering for sale and/or selling devices containing infringing functionality
`
`within this District to at least resellers, distributors, customers, dentists, orthodontists, dental and
`
`orthodontic labs, and/or other end users, and by providing instructions, user manuals, advertising
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`Case 6:20-cv-00979-ADA Document 105 Filed 04/26/21 Page 3 of 52
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`and/or marketing materials that facilitate, direct or encourage the use of infringing functionality with
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`knowledge thereof.
`
`10.
`
`Defendants have committed patent infringement in Texas that has led to foreseeable
`
`harm and injury to Align.
`
`11.
`
`Additionally, Defendants are subject to jurisdiction in the United Sates, and
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`specifically in Texas, pursuant to FED. R. CIV. P. 4(k)(2). Defendants have contacts with the United
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`States that include, inter alia, advertising, offering to sell, and/or selling their products and software
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`throughout the United Sates, including Texas and this District.  
`
`12.
`
`Venue is proper pursuant to 28 U.S.C. §§ 1391 and 1400(b) because, as foreign
`
`corporations, 3Shape A/S and 3Shape Trios A/S may be sued in any judicial district. 
`
`BACKGROUND
`
`13.
`
`Align is a global medical device company with industry leading innovative products
`
`such as iTero intraoral scanners and OrthoCAD software that help dental and orthodontic
`
`professionals deliver effective, innovative dental and orthodontic options to their patients. 
`
`14.
`
`Align’s iTero intraoral scanners scan and provide, in conjunction with Align’s
`
`OrthoCAD software, 3D imaging of an intraoral surface, such as the teeth and gums, without drying
`
`and powdering the intraoral surface (as older technology required), resulting in a digital impression.
`
`Align’s iTero intraoral scanners and the software that works in conjunction with the scanners thus
`
`eliminate the need for traditional teeth impressions typically taken with an elastomeric or other
`
`material.
`
`15.
`
`The digital impression captured by Align’s iTero intraoral scanners, when teamed
`
`with Align’s OrthoCAD software, can be used in a variety of dental and orthodontic applications,
`
`such as, for example, modeling the occlusion between the patient’s teeth and processing images that
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`Case 6:20-cv-00979-ADA Document 105 Filed 04/26/21 Page 4 of 52
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`are capable of describing relationships between the various parts of the skeletal, dental and soft
`
`tissue elements of the craniofacial complex.
`
`16.
`
`Align’s iTero intraoral scanner and OrthoCAD digital software constitute a
`
`proprietary system and method for treating, among other things, malocclusion, misalignment,
`
`and/or chipped or missing teeth. Align’s high-precision, high speed intraoral scanner and related
`
`software allow for the creation of a variety of orthodontic and dental devices including, but not
`
`limited to, crowns, bridges, bracket templates, aligners, and implants. Each dental device is custom-
`
`manufactured for each patient using computer-aided design techniques and sophisticated computer
`
`graphic interfaces to communicate with the patient’s dental or orthodontic professional in the
`
`planning and implementation of the customized treatment program.
`
`17.
`
`Align’s iTero intraoral scanner and OrthoCAD software, developed by Align over
`
`many years and at great expense and effort, represent a breakthrough in the manufacturing principle
`
`of “mass customization” and a vast improvement over conventional methods for treating, among
`
`other things, chipped or missing teeth, misalignment of teeth, and malocclusion. Additionally, the
`
`iTero intraoral scanner and OrthoCAD software provide a “chair-side” platform for live viewing of
`
`the digital impression as it is being built on the display screen during scanning, for accessing valuable
`
`digital diagnosis and treatment tools, and for enhancing accuracy of records, treatment efficiency,
`
`and the overall patient experience. The innovations embodied in Align’s iTero intraoral scanner and
`
`OrthoCAD software are protected by numerous United States and foreign patents, including the
`
`patents at issue in this case.
`
`18.
`
`3Shape designs, develops, manufactures, and markets the TRIOS, TRIOS 3, and
`
`TRIOS 4 scanners, as well as the related Dental System software products that include software
`
`modules including, but not limited to, the Implant Studio, Ortho System, Ortho Analyzer, Ortho
`
`Planner, Appliance Designer, and Ortho Control Patent (hereinafter “Dental System software
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`Case 6:20-cv-00979-ADA Document 105 Filed 04/26/21 Page 5 of 52
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`products”). Moreover, 3Shape is involved in the sale and/or importation into the United States of
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`intraoral scanners, digital models, and digital data and Dental System software products for dental
`
`and orthodontic applications including, but not limited to, crowns, bridges, bracket templates,
`
`aligners, and implants. 3Shape’s intraoral scanners, digital and physical models generated from digital
`
`data using 3Shape software, and 3Shape’s software products for dental and orthodontic applications
`
`described above embody and/or use the patented apparatuses, systems, and methods at issue.
`
`19.
`
`3Shape’s TRIOS, TRIOS 3, and TRIOS 4 scanners, as well as 3Shape’s related
`
`Dental System software products (collectively, the Accused Products), directly compete with the
`
`Align’s iTero scanners and OrthoCad software. On information and belief, 3Shape developed, made,
`
`and sold its intraoral scanners and software with the intent to directly compete with Align’s intraoral
`
`scanners and software. Before introducing its products, 3Shape was aware of the structure, design,
`
`and operation of Align’s patented intraoral scanners and software, including but not limited to
`
`intraoral scanners and software developed by Cadent Holdings, Inc. (“Cadent”), which Align
`
`acquired on April 29, 2011. Moreover, 3Shape has previously entered into agreements with Align
`
`that provided 3Shape with significant access to Align’s patented technologies.
`
`20.
`
`On information and belief, 3Shape developed, made, and sold its infringing TRIOS,
`
`TRIOS 3, and TRIOS 4 scanners and related infringing Dental System software products despite
`
`having knowledge of the Align patents at issue (i) based, at a minimum, on its knowledge of the
`
`Align intraoral scanners and software being covered by numerous patents including the patents at
`
`issue through its prior business dealings with Align, including those with Cadent, whereby 3Shape
`
`acquired specific and detailed knowledge from Align regarding the structure, function, operation,
`
`and commercial benefits of the Align products and the patent protection afforded to certain
`
`structures, functions, and operations of the patented Align technology; (ii) by virtue of 3Shape’s
`
`patent prosecution activities wherein Align’s certain of patents at issue and/or family members were
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`Case 6:20-cv-00979-ADA Document 105 Filed 04/26/21 Page 6 of 52
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`cited as prior art, including but not limited to U.S. Patent Nos. 9,101,433, 10,728,519, 10,750,151,
`
`and 10,750,152, or related family members; and/or (iii) by virtue of 3Shape’s U.S. Food and Drug
`
`Administration Section 510(k) premarket notification of intent to market the accused products,
`
`which identifies 3Shape’s accused products as substantially equivalent to Align’s patent-practicing
`
`products. 
`
`THE ASSERTED COLOR SCANNING PATENTS
`
`21.
`
`U.S. Patent No. 9,101,433 (“’433 Patent”), U.S. Patent No. 10,728,519 (“’519
`
`Patent”), U.S. Patent No. 10,750,151 (“’151 Patent”), and U.S. Patent No. 10,750,152 (“’152
`
`Patent”) disclose methods and systems for obtaining a color scan of a patient’s dentition. These
`
`patents are attached as Exhibits 1-4 to this Complaint. 
`
`22.
`
`A common problem in obtaining a three-dimensional color scan of the intraoral
`
`cavity is the difficulty in associating position information obtained using a three-dimensional
`
`scanning method with color information obtained using a two-dimensional scanning method. The
`
`two-dimensional color information and three-dimensional depth information will commonly be
`
`mismatched. Existing methods required covering the intraoral cavity surface with a layer of opaque
`
`material before taking the three-dimensional image, and then removing the layer and manually re-
`
`aligning the camera to capture a two-dimensional color image of the same area. 
`
`23.
`
`The ’433, ’519, ’151, and ’152 patents address this problem by disclosing inventions
`
`that provide relatively simple and effective ways for mapping two-dimensional color information
`
`onto a three-dimensional surface model. Specifically, the inventions provide devices and methods
`
`for obtaining a numerical entity that represents the color and surface topology of an object. This
`
`allows dentists to more easily obtain a color three-dimensional image for use in carrying out
`
`procedures in the dental cavity, such as prosthesis color matching and orthodontics. 
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`Case 6:20-cv-00979-ADA Document 105 Filed 04/26/21 Page 7 of 52
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`24.
`
`The ’519, ’151, and ’152 patents are continuations of the ’433 patent, which has
`
`previously been the subject of an inter partes review filed by (inter alia) 3Shape A/S in the Patent and
`
`Trademark Office. In a Final Written Decision issued on June 6, 2019, the Patent Trial and Appeal
`
`Board upheld as valid claims 12 and 14 of the ’433 patent. 3Shape A/S v. Align Technology Inc., IPR
`
`No. 2019-00163, “Decision, Inter Partes Review,” at 33-42 (June 9, 2020). 
`
`25.
`
`The ’433, ’519, ’151, and ’152 patents are also continuations of U.S. Patent No.
`
`8,363,228 (“’228 Patent”), U.S. Patent No. 8,451,456 (“’456 Patent”), and U.S. Patent No. 8,675,207
`
`(“’207 Patent”), which have previously been the subject of an International Trade Commission
`
`(“ITC”) investigation related to 3Shape’s color scanners. The ’433 patent was also a subject of that
`
`investigation. After an extensive investigation, the ITC confirmed the Initial Decision of the ALJ
`
`and found that 3Shape’s TRIOS 3 and associated Ortho and Dental System software infringed
`
`the ’228 Patent, the ’456 Patent, and the ’207 Patent. In re Certain Color Intraoral Scanners and Related
`
`Hardware and Software, Inv. No. 337-TA-1091, “Commission Opinion,” at 37-44 (Dec. 19, 2020).1
`
`While the recently-issued ’519, ’151, and ’152 patents differ in certain details from the ’228, ’456,
`
`and ’207 patents, the differences in claim language do not meaningfully change the infringement
`
`analysis with respect to 3Shape’s infringing activities. 
`
`26.
`
`The ’433 Patent was issued by the United States Patent and Trademark Office
`
`(“USPTO”) on August 11, 2015. The ’519 Patent was validly issued by the USPTO on July 28, 2020.
`
`The ’151 and ’152 patents were validly issued by the USPTO on August 18, 2020.
`
`27.
`
`The prior art that 3Shape has relied upon in previous challenges to the validity of
`
`the ’433 patent in the USPTO was presented to the USPTO in the prosecution of the ’519, ’151,
`
`
`1 All citations in this Complaint to decisions by the ITC refer to the public versions of the ITC
`opinions. This Complaint does not rely on confidential information contained in the sealed version
`of the opinions.
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`Case 6:20-cv-00979-ADA Document 105 Filed 04/26/21 Page 8 of 52
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`and ’152 patents and is cited on the face of those patents. The USPTO issued the patents over the
`
`prior art cited by 3Shape.
`
`THE ASSERTED SELECTIVE RESCANNING PATENTS
`
`28.
`
`U.S. Patent No. 10,945,609 (“’609 Patent”) and US Patent No. 10,791,936 (“ ’936
`
`Patent”) disclose systems and methods for improving the 3D virtual model of a patient’s teeth by
`
`allowing the user to remove and replace deficient portions of the 3D virtual model. These patents
`
`are attached as Exhibits 5-6 to this Complaint.
`
`29.
`
`A common problem in obtaining accurate 3D virtual models of the intraoral cavity is
`
`that portions of the patient’s teeth may be partially obstructed by agents such as blood, saliva, soft
`
`tissue, or debris. In the presence of such obstructions, the 3D virtual model of the intraoral cavity
`
`may not accurately represent the structure of the patient’s teeth. As a result, various dental or
`
`orthodontic applications that rely on the 3D virtual model (such as crowns or aligners) may not fit
`
`properly.
`
`30.
`
`The ’609 and ’936 patents address this problem by disclosing inventions that allow
`
`the user, after cleaning the patient’s mouth, to digitally erase just the obscured portion of the 3D
`
`virtual model, re-scan that portion of the intraoral cavity, and update the 3D virtual model with the
`
`new, unobscured portion. This improvement allows dentists to more easily obtain an accurate 3D
`
`virtual model of the patient’s teeth, free of any obstructions that might erode the usefulness of the
`
`model.
`
`31.
`
`The ’609 and ’936 patents are both continuations of U.S. Patent No. 9,299,192
`
`(“’192 Patent”), which has previously been the subject of an International Trade Commission
`
`(“ITC”) investigation related to 3Shape’s scanners. After an extensive investigation, the presiding
`
`Administrative Law Judge found that 3Shape’s TRIOS, TRIOS 3, and TRIOS 4 scanners and
`
`associated Dental System software infringed the ’192 Patent. In re Certain Dental and Orthodontic
`
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`Case 6:20-cv-00979-ADA Document 105 Filed 04/26/21 Page 9 of 52
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`Scanners and Software, Inv. No. 337-TA-1144, “Initial Determination on Violation of Section 337 and
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`Recommended Determination on Remedy and Bond,” at 197-217 (April 30, 2020).
`
`32.
`
`The ’936 patent was issued by the USPTO on October 6, 2020. The ’609 patent
`
`issued on March 16, 2021. In the prosecution of these patents, Align presented the USPTO with the
`
`prior art that 3Shape has relied upon in previous challenges to the validity of the ’192 Patent, both in
`
`the ITC proceeding and in a subsequent IPR, as well as the PTAB’s decision in the ’192 Patent IPR.
`
`The USPTO issued the patents over the prior art cited by 3Shape.
`
`THE ASSERTED HOLE-CLOSING TECHNOLOGY PATENT
`
`33.
`
`U.S. Patent No. 10,709,527 (“’527 Patent”) describes and claims systems and
`
`methods for obtaining a 3D virtual model of an intraoral cavity in which a 3D virtual model
`
`generated from a first set of 3D data is missing a portion of the model and a second set of 3D data
`
`for the missing portion is generated and combined with the 3D virtual model. This patent is
`
`attached as Exhibit 7 to this Complaint.
`
`34.
`
`The ’527 Patent overcomes a common problem in obtaining accurate 3D virtual
`
`models of the intraoral cavity, in which portions of the patient’s teeth may be partially obstructed by
`
`soft tissue or foreign matter, causing the 3D model to be incomplete. The ’527 Patent addresses that
`
`problem by collecting a first set of data to generate a 3D virtual model, determining the missing
`
`portion of the model, collecting a second set of data associated with the missing portion, and
`
`combining the second set of data with the model to generate a 3D virtual model with the missing
`
`portion filled in.
`
`35.
`
`The ’527 Patent claims priority to a U.S. patent application filed on February 8, 2006
`
`and a U.S. provisional application filed on July 15, 2005. At that time, the field of intraoral scanning
`
`was in its infancy. The invention of the ’527 patent represented a significant advancement in the art
`
`over methods and systems for creating 3D models that did not determine whether missing portions
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`Case 6:20-cv-00979-ADA Document 105 Filed 04/26/21 Page 10 of 52
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`existed and subsequently generate additional data to create a model that included the missing
`
`portion.
`
`36.
`
`37.
`
`The ’527 Patent was issued by the USPTO on July 14, 2020.
`
`COUNT ONE – INFRINGEMENT OF THE ’433 PATENT
`
`Align incorporates by reference its allegations in Paragraphs 1-36 as if fully restated
`
`in this paragraph.
`
`38.
`
`On August 11, 2015, the USPTO lawfully issued the ’433 Patent, entitled “Method
`
`and Apparatus for Colour Imaging a Three-Dimensional Structure.” Align is the sole owner of
`
`the ’433 Patent and of all rights of recovery thereunder for past and future infringement.
`
`39.
`
`3Shape has directly, literally under 35 U.S.C. § 271(a), and/or equivalently under the
`
`doctrine of equivalents, infringed the ’433 Patent by practicing the patented method in the United
`
`States and by making, using, selling, offering for sale, and/or importing into the United States,
`
`without authority, the Accused Products. The Accused Products meet each and every element of
`
`one or more claims of the ’433 Patent.
`
`40.
`
`By way of illustration only, 3Shape’s TRIOS, TRIOS 3, and TRIOS 4 scanners and
`
`associated Ortho and Dental System software meet each and every element of claim 1 of the ’433
`
`Patent.
`
`41.
`
`The TRIOS, TRIOS 3, and TRIOS 4 scanners, used with associated Dental System
`
`software, provide for a system for determining the surface topology and associated color of at least a
`
`portion of a three-dimensional structure. That system comprises “an apparatus comprising an image
`
`gathering member to generate depth data of the structure portion corresponding to a two-
`
`dimensional reference array substantially orthogonal to a depth direction,” as well as “one or more
`
`processors operably coupled to the apparatus, the one or more processors configured to cause the
`
`system to: [1] receive, from the apparatus, the depth data of the structure portion corresponding to
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`the two-dimensional reference array substantially orthogonal to the depth direction; [2] receive, from
`
`the apparatus, two-dimensional first image data of the structure portion associated with the two-
`
`dimensional reference array; [3] receive, from the apparatus, two-dimensional second image data of
`
`the structure portion associated with the two-dimensional reference array, the second image data
`
`being different from the first image data; [4] generate two-dimensional estimated image data based
`
`on the first image data and the second image data so as to account for when the first image data and
`
`the second image data were generated relative to when the depth data was generated so that the
`
`estimated image data corresponds to when the depth data was generated; and [5] map the estimated
`
`image data to the depth data for the two-dimensional reference array.” ’433 Patent, col. 26 ll. 19-49.
`
`42.
`
`3Shape’s marketing materials illustrate how 3Shape’s TRIOS, TRIOS 3, and TRIOS
`
`4 scanners, in conjunction with the related Dental System software products, satisfy all elements of
`
`claim 1 of the ’433 Patent. By way of example only, the 3Shape marketing video, brochure, and
`
`marketing materials below show that 3Shape’s TRIOS, TRIOS 3, and TRIOS 4 intraoral scanners
`
`and associated software contain the infringing functionality. The TRIOS, TRIOS 3, and TRIOS 4
`
`scanners provide a system that maps two-dimensional color information onto a three-dimensional
`
`surface model to create a three-dimensional color model. On information and belief, the TRIOS,
`
`TRIOS 3, and TRIOS 4 scanners repeatedly generate two-dimensional color information of the
`
`intraoral cavity while collecting three-dimensional depth data and match the color information with
`
`the depth information.
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`Case 6:20-cv-00979-ADA Document 105 Filed 04/26/21 Page 12 of 52
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`(See, e.g., 3Shape TRIOS 3 Video (YouTube, available at:
`
`https://www.youtube.com/watch?v=C5jKnxEyrbU).)
`
`
`
`
`
`
`(See, e.g., 3Shape TRIOS Digital Impression Solution Brochure (Medical Expo website, available at
`
`
`
`https://pdf.medicalexpo.com/pdf/3shape/trios/71366-100299.html).)
`
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`Case 6:20-cv-00979-ADA Document 105 Filed 04/26/21 Page 13 of 52
`Case 6:20-cv-00979-ADA Document 105 Filed 04/26/21 Page 13 of 52
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`SCAN IN
`COLOR
`
`Up to 1000 3Dpictures for true
`geometries
`Combining hundreds or thousands of
`3D pictures to create the final 3D digi-
`tal impression based on real data rather
`than interpolated artificial surfaces.
`
`Scanning has never been easier
`Easily move along the teeth as the
`scanner captures the impression in
`real time. No needto hold the scan-
`
`ner at a specific distance or angle
`for focus.
`
`tei
`
`Autoclaveable tip with anti-mist heater
`Achieve optimal hygiene and meetclini-
`cal
`requirements. The integrated anti-
`mist heater automatically ensures an
`optimal temperature for undistorted and
`
`
`
`(Id.)
`(Id)
`
`
`crystal clear scanning.
`scanning experience
`
`RealColor™ scans with many
`
`clinical advantages
`With TRIOS® color you can scan in
`
`natural colors to clearly distinguish
`
`between teeth, gingiva and restor-
`
`ative materials. Easily identify true
`
`preparation margins and improve
`
`
`
`(Id.)
`(Id)
`
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`Case 6:20-cv-00979-ADA Document 105 Filed 04/26/21 Page 14 of 52
`Case 6:20-cv-00979-ADA Document 105 Filed 04/26/21 Page 14 of 52
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`Complete digital workflows
`
`
`
`
`
`if you’re practicing same day dentistry you're eliminating second visits.
`
`Are there other advantages for patients?
`
`and the
`impressions
`accuracy of digital
`The
`a much better
`fitting
`resulting crowns means
`restoration. The accuracy also cuts down on the
`need for remakes. So patient-visits are quicker and
`they don’t have to come backfor adjustments. Also
`
`So besides patient
`speed and accuracy are huge
`
`comfort, digital
`advantages.
`
`Another interesting benefit when working with 3D digital color impressions is that you now havethe patient’s
`mouth on the big screen. You can show the patient what is going in their mouths.
`
`You don’t know how manydentists have told us about their patients’ reactions to seeing their mouths onscreen
`for the very first time. And how many times the patient has ended up asking to have additional work done.
`Digital impressions are an important tool in helping to gain treatment acceptancefrom patients.
`
`When you factor in the time savings,
`more efficient wav to work
`
`in terms of scanning, design, and production, digital dentistry is just a
`
`-14-
`-14-
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`
`
`
`
`
`(Id.)
`(Id)
`
`

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`Case 6:20-cv-00979-ADA Document 105 Filed 04/26/21 Page 15 of 52
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`(See, e.g., Interview with 3Shape founder, Tais Clausen (3Shape website, available at
`
`https://www.3shape.com/en/news/2015/why-your-patients-love-digital-technology.)
`
`
`
`43.
`
`3Shape has directly infringed the ’433 Patent, including by making, selling, offering
`
`for sale in the United States, and importing into the United States products that contain the system
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`disclosed in the ’433 Patent. Further, 3Shape uses the patented system, and practices the patented
`
`method, as it tests its infringing product prior to marketing and selling the product.
`
`44.
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`Additionally, 3Shape has actively induced infringement of the ’433 Patent under 35
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`U.S.C. § 271(b). 3Shape possesses knowledge of and is aware of the ’433 patent by virtue of, at a
`
`minimum, the filing of the Complaint in Align Technology, Inc. v. 3Shape A/S, Case 1:17-cv-01649-LPS
`
`(D. Del.) (filed on Nov. 14, 2017), and, on information and belief, had prior knowledge of the ’433
`
`patent by virtue of the prior business dealings between 3Shape and Align and other facts described
`
`above. 3Shape induced, with specific intent, infringement of the ’433 Patent by its customers.
`
`3Shape encouraged and facilitated infringing uses of the Accused Products through the creation and
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`dissemination of promotional and marketing materials, instructional materials, product manuals,
`
`and/or technical materials to its customers.
`
`45.
`
`3Shape also has been and is now contributing to the infringement of one or more
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`claims of the ’433 Patent, either literally or under the doctrine of equivalents.
`
`46.
`
`3Shape has actively, knowingly, and intentionally contributed and continues to
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`actively, knowingly, and intentionally contribute to the infringement of the ’433 Patent by selling or
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`offering to sell the TRIOS, TRIOS 3, TRIOS 4, and/or the associated Dental System software
`
`products within the United States and/or by importing the TRIOS, TRIOS 3, TRIOS 4, and/or
`
`associated Dental System software products into the United States, with knowledge that the
`
`infringing technology in the TRIOS, TRIOS 3, TRIOS 4, and/or associated Dental System software
`
`products is especially made and/or especially adapted for use in infringement of the ’433 Patent.
`
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`Case 6:20-cv-00979-ADA Document 105 Filed 04/26/21 Page 16 of 52
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`3Shape has contributed to the infringement by others with knowledge that the infringing technology
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`in the TRIOS, TRIOS 3, TRIOS 4, and/or the associated Dental System software products is a
`
`material part of the patented invention, and with knowledge that the infringing technology in the
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`TRIOS, TRIOS 3, TRIOS 4, and/or the associated Dental System software products is not a staple
`
`article of commerce suitable for substantial non-infringing use, and with knowledge that others
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`including, but not limited to, resellers, distributors, customers, dentists, orthodontists, dental and
`
`orthodontic labs, and/or other end users of the TRIOS, TRIOS 3, TRIOS 4, and/or the associated
`
`Dental System software products and components thereof do not have any substantial non-
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`infringing uses. 3Shape has such knowledge at least because the claimed features of the ’433 Patent
`
`are used by other including, but not limited to, resellers, distributors, customers, dentists,
`
`orthodontists, dental and orthodontic labs, and/or other end users of the TRIOS, TRIOS 3, TRIOS
`
`4, and/or the associated Dental System software products.
`
`47.
`
`3Shape has willfully infringed the ’433 Patent. On information and belief, at least as
`
`of the date upon which it learned of the ’433 Patent (which was no later than November 14, 2017),
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`3Shape has known of the ’433 Patent, and after acquiring that knowledge, 3Shape has continued to
`
`infringe the patent through conduct that 3Shape knew or should have known amounted to
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`infringement of the patent.
`
`48.
`
`49.
`
`3Shape’s acts of infringement have injured Align.
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`3Shape’s wrongful conduct has caused Align to suffer irreparable harm resulting
`
`from the loss of its lawful patent rights to exclude others from making, using, selling, offering to sell
`
`and importing the patented inventions. On information and belief, 3Shape will continue these
`
`infringing acts unless enjoined by this Court.
`
`-16-
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`Case 6:20-cv-00979-ADA Document 105 Filed 04/26/21 Page 17 of 52
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`COUNT TWO – INFRINGEMENT OF THE ’519 PATENT
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`50.
`
`Align incorporates by reference its allegations in Paragraphs 1-49 as if fully restated
`
`in this paragraph.
`
`51.
`
`On July 28, 2020, the USPTO lawfully issued the ’519 Patent, entitled “Method and
`
`Apparatus for Colour Imaging a Three-Dimensional Structure.” Align is the sole owner of the ’519
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`Patent and of all rights of recovery thereunder for past and future infringement.
`
`52.
`
`3Shape has directly, literally under 35 U.S.C. § 271(a), and/or equivalently under the
`
`doctrine of equivalents, infringed the ’519 Patent by practicing the patented method and by making,
`
`using, selling, offering for sale, and/or importing into the United States, without authority, the
`
`Accused Products. The Accused Products meet each and every element of one or more claims of
`
`the ’519 Patent.
`
`53.
`
`By way of illustration only, 3Shape’s TRIOS, TRIOS 3, and TRIOS 4 scanners and
`
`associated Dental System software products meet each and every element of claim 1 of the ’519
`
`Patent.
`
`54.
`
`The TRIOS, TRIOS 3, and TRIOS 4 scanners, used with associated Dental System
`
`software, provides for a system for determining the surface topology and associated color of at least
`
`a portion of a three-dimensional structure. That system comprises “a hand-held device comprising:
`
`[1] a scanning system configured to provide depth data of said portion, the depth data
`
`corresponding to a plurality of data points defined on a plane substantially orthogonal to a depth
`
`direction; [2] an imaging system configured to provide two-dimensional color image data of said
`
`portion associated with said plurality of data points; [3] an illumination unit configured to transmit a
`
`first array of incident light along a path towards the three-dimensional structure; and [4] a detector
`
`configured to measure intensity of each of a plurality of returned light that returns along the path
`
`and from the three-dimensional structure,” as well as “a processor operably coupled to the hand-
`
`-17-
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`

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`Case 6:20-cv-00979-ADA Document 105 Filed 04/26/21 Page 18 of 52
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`held device and configured to associate the depth data with the two-dimensional color image
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`data.” ’519 Patent, col. 26 l. 62 – col. 27 l. 15.
`
`55.
`
`3Shape’s marketing materials illustrate how 3Shape’s TRIOS, TRIOS 3, and TRIOS
`
`4 scanners, in conjunction with the related Dental System software products, satisfy all elements of
`
`claim 1 of the ’519 Patent. By way of example only, the 3Shape marketing video, brochure, and
`
`marketing materials below show that 3Shape’s TRIOS, TRIOS 3, and TRIOS 4 intraoral scanners
`
`and associated software contain the infringing functionality. The TRIOS, TRIOS 3, and TRIOS 4
`
`scanners are handheld devices that generate three-dimensional scans of the intraoral cavity and
`
`associated two-dimensional color images. On information and belief, the TRIOS, TRIOS 3, and
`
`TRIOS 4 scanners generate the data using a light that reflects off the intraoral cavity.
`
`(S