throbber
ESTTA Tracking number:
`
`Filing date:
`
`ESTTA1354712
`04/25/2024
`
`Proceeding No.
`
`Filing Party
`
`Other Party
`
`Pending Motion
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`92084707
`
`Defendant
`Overjet Inc.
`
`Plaintiff
`VideaHealth, Inc.
`There is no motion currently pending and no other motion is being filed concur-
`rent with this consent motion.
`
`Attachments
`
`Complaint.pdf(5157953 bytes )
`
`Consent Motion for Suspension in View of Civil Proceeding
`
`The parties are engaged in a civil action which may have a bearing on this proceeding. Accordingly, Overjet
`Inc. hereby requests suspension of this proceeding pending a final determination of the civil action. Trade-
`mark Rule 2.117.
`Overjet Inc. has secured the express consent of all other parties to this proceeding for the suspension re-
`quested herein.
`
`Certificate of Service
`
`The undersigned hereby certifies that a copy of this submission has been served upon all parties, at their ad-
`dress of record by Email on this date.
`Respectfully submitted,
`/s/ Katherine W. Soule
`Katherine W. Soule
`ksoule@sunsteinlaw.com, ssternberg@sunsteinlaw.com
`04/25/2024
`
`

`

`Case 1:24-cv-10446 Document 1 Filed 02/23/24 Page 1 of 49
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`UNITED STATES DISTRICT COURT
`DISTRICT OF MASSACHUSETTS
`
`[Jury Trial Demanded]
`
`Overjet, Inc.,
`
`[Preliminary Injunction Requested]
`
`Plaintiff,
`
`
`
`Case No. ____________________
`
`Defendant.
`
`
`
`
`
`
`COMPLAINT
`
`v.
`
`VideaHealth, Inc.,
`
`
`
`
`
`
`Overjet, Inc., by and through its counsel, Sunstein LLP, brings this Complaint against
`
`VideaHealth, Inc. and alleges as follows:
`
`INTRODUCTION
`
`1.
`
`This action arises out of VideaHealth’s misconduct. Specifically, Overjet brings claims
`
`for trademark infringement, copyright infringement, patent infringement, false advertising, and
`
`unfair competition against VideaHealth. VideaHealth’s actions have caused irreparable damage
`
`to Overjet’s goodwill, reputation, relationships with customers and other business partners, and
`
`resulted in the dilution of Overjet’s intellectual property. If the Court does not stop VideaHealth
`
`soon, Overjet will continue to be irreparably damaged. For these reasons, this Complaint is
`
`accompanied by a motion for a preliminary injunction seeking to prevent VideaHealth from
`
`continuing its infringement, false advertising, and unfair competition during the course of this
`
`litigation. In addition to that preliminary relief, Overjet seeks, among other things, permanent
`
`
`
`1
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`

`

`Case 1:24-cv-10446 Document 1 Filed 02/23/24 Page 2 of 49
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`
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`injunctive relief enjoining VideaHealth from any further infringement, false advertising, and unfair
`
`competition, and/or damages related to rest of VideaHealth’s misconduct.
`
`PARTIES
`
`2.
`
`Overjet, Inc. (“Overjet”) is a corporation incorporated under the laws of Delaware with its
`
`principal place of business at 50 Milk Street, Boston, Massachusetts 02108.
`
`3.
`
`Upon information and belief, VideaHealth, Inc. (“VideaHealth”) is a corporation
`
`incorporated under the laws of Delaware with its principal place of business at 19 Kingston Street,
`
`Floor 3, Boston, Massachusetts 02111.
`
`JURISDICTION AND VENUE
`
`4.
`
`This Court has original subject matter jurisdiction over the federal law claims under 28
`
`U.S.C. § 1331 (federal question), 28 U.S.C. § 1138(a)-(b) (trademark, copyright, patent, and unfair
`
`competition), and 15 U.S.C. § 1121 (Lanham Act).
`
`5.
`
`This Court has supplemental subject matter jurisdiction over the state law and common law
`
`claims under 28 U.S.C. § 1367(a).
`
`6.
`
`This Court has both specific and general personal jurisdiction over Defendant VideaHealth.
`
`Pursuant to due process and the Massachusetts long-arm statute, Mass. Gen. Laws Ch. 223A, § 3,
`
`Defendant VideaHealth is subject to this Court’s specific personal jurisdiction because this cause
`
`of action arises from: (1) VideaHealth’s business transactions in Massachusetts; and (2)
`
`VideaHealth causing tortious injury to Overjet by acts within Massachusetts, specifically by
`
`infringing Overjet’s trademark, copyright, and patent rights through acts in Massachusetts.
`
`Defendant VideaHealth is subject to this Court’s general personal jurisdiction because it has
`
`continuous and systematic general business contacts in Massachusetts and the exercise of
`
`jurisdiction would be reasonable.
`
`
`
`2
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`

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`Case 1:24-cv-10446 Document 1 Filed 02/23/24 Page 3 of 49
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`7.
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`Venue is proper in this district under 28.U.S.C. §§ 1391(b)-(c) and 28 U.S.C. § 1400
`
`because, inter alia, Defendant VideaHealth resides in this jurisdiction and is subject to personal
`
`jurisdiction in Massachusetts, and a substantial part of the events giving rise to the claims in this
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`action arose or occurred in this district.
`
`FACTS AND BACKGROUND
`
`A. Overjet’s Innovative Dental AI Technology
`
`8.
`
`Plaintiff Overjet, Inc. was formed in Delaware on August 24, 2018, with its corporate
`
`headquarters in Boston, Massachusetts.
`
`9.
`
`Overjet is a global leader in dental artificial intelligence (“AI”), helping both payers and
`
`providers improve patient care. By combining deep expertise in dentistry and advanced
`
`engineering, Overjet develops accurate and quantified ways to detect pathologies and integrates
`
`actionable insights into systems and workflows. Overjet uses AI to scan dental radiographic X-
`
`rays and detect dental diseases. Private practices, dental service organization (DSOs), and
`
`insurance companies rely on the accurate information provided by Overjet’s FDA-cleared platform
`
`to drive care and service to patients.
`
`10.
`
`Overjet is the only dental AI company with United States Food and Drug Administration
`
`(FDA) clearance for performing dental detection and segmentation to outline exactly where
`
`pathologies exist.
`
`11.
`
`Overjet’s competitors in the Dental AI space are only FDA-cleared to perform a “bounded
`
`box” approach in connection with dental assessment technology. A bounded box approach is a
`
`“detection” approach that can localize and distinguish between objects within an x-ray image, and
`
`can place a “box” around the area detected, such as an area on a specific tooth where caries were
`
`
`
`3
`
`

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`Case 1:24-cv-10446 Document 1 Filed 02/23/24 Page 4 of 49
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`found. However, the bounded box approach does not detect the exact border and extent of the
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`caries1 on the tooth, unlike Overjet’s “segmentation” approach.
`
`12.
`
`By way of example, in a blog post dated April 5, 2021, VideaHealth describes the three
`
`broad categories of computer vision, a subfield of Machine Learning that focuses on the
`
`understanding and processing of visual data, such as images: (1) “Classification: refers to a type
`
`of labeling where a given x-ray/image is assigned certain concepts. For example, we might ask the
`
`algorithm a specific question such as ‘Is the image quality readable?’ or ‘Are there any caries
`
`present in the image?’” (2) “Detection: is a computer vision technique that deals with localizing
`
`and distinguishing between objects with an x-ray or image”; and (3) “Segmentation: Segmentation
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`models provide the exact outline of the object within an image” (e.g., the exact borders and extent
`
`of caries on a tooth).2
`
`13.
`
`The fact that Overjet is the only dental AI company with software cleared by the FDA for
`
`segmentation gives it a competitive advantage. Overjet advertises this advantage to consumers on
`
`its website, press releases, social media, and presentations. Its unique abilities and approach
`
`contribute to Overjet’s success in the marketplace.
`
`
`
`
`1 “Caries” refers to “a progressive destruction of bone or tooth,” such as a cavity. See
`https://www.merriam-webster.com/dictionary/caries#:~:text=caries-
`,noun,especially%20%3A%20tooth%20decay.
`2 https://www.videa.ai/blog-posts/ai-101-for-the-dental-industry. Image available at Appendix A,
`p. 1.
`
`
`
`4
`
`

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`Case 1:24-cv-10446 Document 1 Filed 02/23/24 Page 5 of 49
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`
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`14.
`
`Overjet has invested substantial resources creating and improving various iterations of its
`
`software since its inception. In early 2021, Overjet came up with a unique naming convention for
`
`its software products: “Overjet [X] Assist.” For example, Overjet named various iterations of its
`
`product “Overjet Dental Assist,” “Overjet Caries Assist,” “Overjet Calculus Assist,” “Overjet
`
`Periapical Radiolucency Assist,” and “Overjet Charting Assist” (collectively, the “Overjet
`
`Software”).3 This naming convention is not a standard way of describing AI software in the dental
`
`industry and was originated by Overjet to brand identify its product line.
`
`15.
`
` On January 25, 2021, Overjet applied for 510(k) Premarket clearance of its “Overjet
`
`Dental Assist” product (FDA 510(k) No. K210187), which was cleared by the FDA on May 19,
`
`2021. As described in the 510(k) Clearance Summary, the Overjet Dental Assist product is a
`
`radiological semi-automated image processing software intended to aid dental professionals in the
`
`measurements of mesial and distal bone levels associated with each tooth from bitewing and
`
`periapical radiographs.4 The application to the FDA and the FDA Clearance Summary describe
`
`the trade name of the product as “Overjet Dental Assist.” The identified patient population is
`
`anyone over the age of 21 receiving dental care, meaning potentially most adults in the United
`
`States.
`
`16.
`
`On August 10, 2021, Overjet applied for 510(k) Premarket clearance of its Overjet Caries
`
`Assist (“Caries Assist”) product (FDA 510(k) No. K212519), which was cleared by the FDA on
`
`May 10, 2022, which allows segmentation of caries on bitewing radiographs.5 Specifically, Caries
`
`Assist is a radiological concurrent read computer-assisted detection software intended to aid in the
`
`detection and segmentation of caries on bitewing radiographs and periapical radiographs. The
`
`
`3 See, e.g., https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm.
`4 See https://www.accessdata.fda.gov/cdrh_docs/pdf21/K210187.pdf.
`5 See https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212519.pdf.
`
`
`
`5
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`

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`Case 1:24-cv-10446 Document 1 Filed 02/23/24 Page 6 of 49
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`device provides additional information for the clinician to use in their diagnosis of a tooth surface
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`suspected of being carious. In this submission, the Caries Assist software was indicated for use on
`
`patients at least 18 years of age, meaning potentially any adult in the United States.
`
`17.
`
`On September 12, 2022, Overjet applied for 510(k) Premarket clearance of another version
`
`of Caries Assist, which allows segmentation of caries on periapical radiographs, in addition to
`
`bitewing radiographs (FDA 510(k) No. K222746). On March 27, 2023, the FDA cleared the
`
`improved Caries Assist, which expanded the age range and image type and improved model
`
`accuracy for caries.6 In this approval, the FDA cleared the Caries Assist software for use on
`
`patients 12 years and older, meaning potentially any pediatric patient aged 12-17 and any adults
`
`in the United States.
`
`18.
`
`On March 31, 2022, Overjet applied for 510(k) Premarket clearance of its “Overjet
`
`Calculus Assist” product (FDA 510(k) No. K220928), which was cleared on December 16, 2022.7
`
`Overjet Calculus Assist is a radiological automated concurrent-read computer-assisted detection
`
`software intended to aid in the detection of interproximal calculus deposits on both bitewing and
`
`periapical radiographs. The Overjet Calculus Assist software is indicated for use on patients
`
`18 years of age or older, meaning potentially any adult in the United States.
`
`19.
`
`On June 9, 2023, Overjet applied for 510(k) Premarket clearance of its “Overjet Periapical
`
`Radiolucency Assist” product (FDA 510(k) No. K231678), which was cleared on September 21,
`
`2023.8 Overjet Periapical Radiolucency (PARL) Assist is a radiological, automated, concurrent
`
`read computer-assisted detection software intended to aid in the detection of periapical
`
`radiolucencies on permanent teeth captured on periapical radiographs. The Overjet Periapical
`
`
`6 See https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222746.
`7 See https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220928.pdf.
`8 See https://www.accessdata.fda.gov/cdrh_docs/pdf23/K231678.pdf.
`
`
`
`6
`
`

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`Case 1:24-cv-10446 Document 1 Filed 02/23/24 Page 7 of 49
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`Radiolucency Assist software is indicated for use on patients 12 years of age or older, meaning
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`potentially any pediatric patient aged 12-17 and any adult in the United States.
`
`20.
`
`21.
`
`On February 23, 2024, Overjet received FDA clearance for its Overjet Charting Assist.”
`
`Overjet’s software operates in three layers – a Network Layer, a Decision Layer, and a
`
`Presentation Layer. Images are pulled in from a clinic/dental office, and the Machine Learning
`
`model creates predictions in the Decision Layer, and the results are pushed back to the dashboard,
`
`which are in the Presentation Layer. The Machine Learning System within the Decision Layer
`
`processes bitewing radiographs and annotates with various findings such as suspected carious
`
`lesions, including by providing a segmentation mask for each tooth number.
`
`B. Overjet’s U.S. Federal Registration and Use of the DENTAL ASSIST mark
`
`22.
`
`Since at least as early as May 2021, Overjet has marketed and sold its software services for
`
`use by dentists and hygienists to detect and measure dental disease in connection with the
`
`DENTAL ASSIST trademark (the “DENTAL ASSIST Mark”) to customers in the United States,
`
`including, without limitation to dental practices and DSOs, including customers in Massachusetts.
`
`23.
`
`Overjet promotes its software services in connection with the DENTAL ASSIST Mark
`
`across the United States through its website, www.overjet.ai, social media, YouTube, print and
`
`digital marketing materials, presentations and lectures to customers and potential customers, and
`
`through its active participation at industry conferences.
`
`24.
`
`Overjet has invested a substantial amount of time, money, and effort to advertise and
`
`promote its software services in connection with the DENTAL ASSIST Mark in the United States.
`
`25.
`
`Overjet owns a United States federal trademark registration for the mark DENTAL
`
`ASSIST (Reg. No. 7,124,822) in connection with “Software as a medical device service (SAAS)
`
`services featuring software used by dentists and hygienists to detect and measure dental disease”
`
`
`
`7
`
`

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`Case 1:24-cv-10446 Document 1 Filed 02/23/24 Page 8 of 49
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`
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`in International Class 44. Overjet applied to register this mark on April 22, 2022, and it was
`
`registered on August 1, 2023, with a first use date of May 2021.
`
`26.
`
`27.
`
`A true and correct copy of Registration No. 7,124,822 is attached as Exhibit A hereto.
`
`Through Overjet’s significant promotional activities and media attention, its DENTAL
`
`ASSIST Mark embodies extensive goodwill and industry recognition.
`
`C. Overjet’s distinctive Anatomical Structures Visualization Tool and related copyright
`protection
`
`
`28.
`
`Throughout its history, Overjet has created several design iterations of its software to help
`
`users visualize the detection and segmentation of various findings on dental radiographic images.
`
`Overjet carefully selects and arranges the visualizations in its software outputs as part of its
`
`branding efforts.
`
`29.
`
`In the fall of 2023, Overjet launched its “Anatomical Structures Visualization Tool” of
`
`Overjet Caries Assist, which presented unique color schemes, shapes, and designs to highlight
`
`various findings on the dental radiographic images.
`
`30.
`
`Using creative authorship, each of the findings that is generated by the code to annotate
`
`dental radiographic images is represented by a unique color and shape. By way of example, as
`
`shown in the image below, each tooth is segmented.9 The white represents enamel. The purple
`
`represents the pulp of each tooth. The bright green line with a dot on either end provides
`
`measurements of bone levels relevant to the evaluation of periodontal disease. The reddish
`
`represents areas of decay. Overjet made the artistic choice to fill in the areas of decay with specific
`
`translucencies.
`
`
`9 https://www.overjet.ai/product/clinical-intelligence-platform/. See Appendix A, p. 2.
`
`
`
`8
`
`

`

`Case 1:24-cv-10446 Document 1 Filed 02/23/24 Page 9 of 49
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`31.
`
`Overjet introduced its new Anatomical Structures Visualization Tool in written and video-
`
`recorded materials presented to one of its customers, Heartland Dental, a top DSO, on November
`
`
`
`15, 2023.
`
`32.
`
`A representative image of the Anatomical Structures Visualization Tool that was shared
`
`with Heartland is shown below on the right, next to an image of a radiograph without Overjet’s
`
`annotations10.
`
`
`
`
`10 See Appendix A, p. 3.
`
`
`
`9
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`
`
`

`

`Case 1:24-cv-10446 Document 1 Filed 02/23/24 Page 10 of 49
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`33. With the Anatomical Structures Visualization Tool, the Overjet Software highlights the
`
`enamel and dental pulp with vibrant colors that contrast with the gray scale on the radiograph.
`
`Users can toggle these visualizations on and off with a dashboard slider or keyboard shortcuts.
`
`These visualizations can help with patient assessment, diagnosis, and treatment planning.
`
`34.
`
`Overjet touts the Anatomical Structures Visualization Tool to customers and potential
`
`customers as a tremendous aid in patient education when it comes to explaining dental anatomy,
`
`disease detection, and disease progression on radiographs, as well as the proximity to vital
`
`structures such as the pulp. Highlighting enamel and pulp allows for a richer understanding of the
`
`nature and severity of disease progression and a visual that matches dentists’ quantified AI finding.
`
`35.
`
`Overjet chose the design and colors for the output intentionally as an effort to brand its
`
`product. For example, Overjet selected the purple color to represent the pulp because it
`
`complements Overjet’s purple brand colors and serves as a brand identifier.
`
`36.
`
`The design and appearance of Overjet’s product, including the specific colors used for
`
`segmentation of the output images identify the Overjet product to consumers since at least as early
`
`as August 2023.
`
`37.
`
`The combination of design elements is creative, distinctive, and non-functional, and the
`
`specific combination of design elements is not required for use of Overjet’s services and software
`
`or as a diagnostic necessity.
`
`38.
`
`Overjet’s unique design interface and unique choice of colors and arrangement is well
`
`known to the relevant consumers through consistent use by Overjet and promotion by Overjet.
`
`Overjet has an established place as a leader in the dental AI market, and Overjet’s design is
`
`associated with the high-quality products and services that Overjet is known for in the market,
`
`including its FDA-cleared capability for segmentation.
`
`
`
`10
`
`

`

`Case 1:24-cv-10446 Document 1 Filed 02/23/24 Page 11 of 49
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`
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`39.
`
`Overjet, Inc. is the owner of U.S. Copyright Registration Number TX 9-344-133 for its
`
`computer program titled “Overjet Code 2022,” which was first published on April 26, 2022. The
`
`copyright registration for “computer program” covers the copyrightable expression in the program
`
`code and the copyrightable expression in screen displays that the program code generates.
`
`40.
`
`A true and correct copy of U.S. Copyright Registration Number TX 9-344-133 is attached
`
`as Exhibit B hereto.
`
`41.
`
`U.S. Copyright Registration Number TX 9-344-133 has not expired and is in full force and
`
`effect.
`
`42.
`
`Overjet, Inc. is the owner of U.S. Copyright Registration Number TX 9-344-155 for its
`
`computer program titled “Overjet Code 2023,” which was first published on September 21, 2023
`
`(together with Copyright Registration No. TX 9-344-133, the “Copyrighted Works”). The
`
`copyright registration for “computer program” covers the copyrightable expression in the program
`
`code and the copyrightable expression in screen displays that the program code generates.
`
`43.
`
`A true and correct copy of U.S. Copyright Registration Number TX 9-344-155 is attached
`
`as Exhibit C hereto.
`
`44.
`
`U.S. Copyright Registration Number TX 9-344-155 has not expired and is in full force and
`
`effect.
`
`45.
`
`An example of the screen displays generated by Overjet’s copyrighted computer programs
`
`is shown below11.
`
`
`11 See Appendix A, pp. 2.
`
`
`
`11
`
`

`

`Case 1:24-cv-10446 Document 1 Filed 02/23/24 Page 12 of 49
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`
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`46.
`
`The image above can be viewed by the public on Overjet’s website, www.overjet.ai.
`
`
`
`D. Overjet’s Patented Technology
`
`47.
`
`On October 26, 2021, the United States Patent and Trademark Office duly and lawfully
`
`issued to Overjet U.S. Patent No. 11,158,046 (the “’046 Patent”) entitled “Estimating
`
`Measurements of Craniofacial Structures in Dental Radiography.”
`
`48.
`
`A true and correct copy of the ’046 Patent is attached hereto as Exhibit D and incorporated
`
`by reference.
`
`49.
`
`The ’046 Patent discloses a novel system and method for providing segmentation and
`
`measurements of dental radiographic images.
`
`50.
`
`The claims of the ’046 Patent recite one or more inventive concepts that produce a more
`
`accurate approximation of absolute and relative measurements of oral structures featured within a
`
`radiographic image.
`
`51.
`
`The ’046 Patent teaches a technological solution in the form of novel, unconventional
`
`computer technology.
`
`
`
`12
`
`

`

`Case 1:24-cv-10446 Document 1 Filed 02/23/24 Page 13 of 49
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`
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`52.
`
`Accordingly, each claim of the ’046 Patent recites a combination of elements sufficient to
`
`ensure that the claim in practice amounts to significantly more than a patent on an ineligible
`
`concept.
`
`53.
`
`Representative Claim 10 of the ’046 Patent is reproduced below for convenience:
`
`10. A method for providing a calibrated measurement of an oral structure in a dental
`radiograph image comprising:
`
`receiving a dental radiographic Image that includes the oral structure;
`
`selecting a segmenter and an object detector;
`
`predicting masks and points of the oral structure using the segmenter and the object
`detector;
`
`providing image metadata comprising the masks and points and the dental
`radiographic image to a selector;
`
`selecting by the selector at least one measurement method of a set of measurement
`methods according to the dental radiographic image and the image metadata;
`
`calculating a sensor pixel to mm (millimeter) ratio using the measurement method;
`and
`
`calculating a calibrated measurement of the oral structure using the sensor pixel to
`mm ratio and the image metadata.
`
`The ’046 Patent has not expired and is in full force and effect.
`
`54.
`
`E. VideaHealth’s Software Products and FDA Clearance
`
`55.
`
`Upon information and belief, VideaHealth, Inc. (“VideaHealth”) was formed in Delaware
`
`on August 24, 2018, with its corporate headquarters in Boston, Massachusetts.
`
`56.
`
`VideaHealth is a dental artificial intelligence company that offers dental providers dental
`
`AI technology. VideaHealth uses AI to scan X-rays and detect dental diseases.
`
`57.
`
`VideaHealth is a direct competitor of Overjet.
`
`
`
`13
`
`

`

`Case 1:24-cv-10446 Document 1 Filed 02/23/24 Page 14 of 49
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`
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`58.
`
`VideaHealth and Overjet compete for the same customers and market their products in the
`
`same forums, including at trade shows and dental conferences.
`
`59.
`
`VideaHealth adopted a naming convention for its software products identical to Overjet’s
`
`product naming convention, namely “Videa Caries Assist,” “Videa Perio Assist,” and “Videa
`
`Dental Assist,” in a direct attempt to copy and/or trade off the good will associated with Overjet’s
`
`products.
`
`60.
`
`On December 6, 2021, VideaHealth filed a 510(k) application with the FDA (K213795)
`
`for Videa Caries Assist, which was cleared on April 21, 2022.12
`
`61.
`
`The VideaHealth FDA 510(k) application for “Videa Caries Assist” was filed four months
`
`after Overjet’s FDA 510(k) application for “Overjet Caries Assist,” which was filed on August 10,
`
`2021.
`
`62.
`
`Videa Caries Assist was cleared by the FDA as a “computer-assisted detection (CADe)
`
`device that analyzes intraoral radiographs to identify and localize carious lesions.” As stated in the
`
`FDA 510(k) Clearance Summary, “[p]rovided proper authentication and a bitewing image, the
`
`device returns a set of bounding boxes representing the carious lesions detected.” 13
`
`63.
`
`VideaHealth’s Caries Assist software is only FDA-cleared for the “bounding box”
`
`approach and not for segmentation.
`
`64.
`
`A representative image of VideaHealth’s bounded box approach is shown below, as seen
`
`on VideaHealth’s website.14
`
`
`12 See https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213795.pdf.
`13 See https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213795.pdf .
`14 See https://www.videa.ai/. See Appendix A, p. 4.
`
`
`
`14
`
`

`

`Case 1:24-cv-10446 Document 1 Filed 02/23/24 Page 15 of 49
`
`
`
`
`
`65.
`
`On October 26, 2022, VideaHealth filed a 510(k) application with the FDA (K223296) for
`
`Videa Perio Assist, which was cleared on February 6, 2023. As stated in the 510(k) Summary,
`
`“Videa Perio Assist (VPA) software is a cloud-based AI-powered medical device for the automatic
`
`measurement of tooth interproximal alveolar bone level in dental radiographs. The device itself is
`
`available as an API (Application Programming Interface) behind a firewalled network. The device
`
`returns 1) a series of points with connecting lines measuring the mesial and distal alveolar bone
`
`levels associated with each tooth 2) this distance expressed in millimeters and/or as a percentage
`
`of the root length.”15
`
`66.
`
`On August 8, 2023, VideaHealth filed a 510(k) application with the FDA (K232384)
`
`seeking clearance of the VIDEA DENTAL ASSIST device. The FDA granted 510(k) clearance on
`
`December 15, 2023, and the FDA clearance summary became available in January 2024.16
`
`67.
`
`The VideaHealth FDA 510(k) application for “Videa Dental Assist” was filed over two
`
`years after Overjet’s FDA 510(k) application for “Overjet Dental Assist” was cleared in May 2021.
`
`
`15 See https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223296.pdf.
`16 See https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232384.pdf.
`
`
`
`15
`
`

`

`Case 1:24-cv-10446 Document 1 Filed 02/23/24 Page 16 of 49
`
`
`
`68.
`
`The VideaHealth FDA 510(k) application for “Videa Dental Assist” was filed after Overjet
`
`obtained a Federal U.S. Trademark registration for DENTAL ASSIST on August 1, 2023 (Reg.
`
`No. 7,124,822).
`
`69.
`
`As stated in the 510(k) Clearance summary, “Videa Dental Assist (VDA) software is a
`
`cloud-based AI-powered medical device for the automatic detection of the features listed in the
`
`Indications For Use statement in dental radiographs. The device itself is available as a service via
`
`an API (Application Programming Interface) behind a firewalled network. Provided proper
`
`authentication and an eligible bitewing, periapical or panoramic image, the device returns a set of
`
`bounding boxes representing the suspect dental finding, historical treatment or normal anatomy
`
`detected.”17
`
`70.
`
`VideaHealth’s Dental Assist software is only cleared by the FDA for the “bounding box”
`
`approach and not for segmentation.
`
`71.
`
`Historically, VideaHealth used “bounding boxes” to indicate a suspect dental finding,
`
`historical treatment, or normal anatomy detected, as shown below.18
`
`
`17 See https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232384.pdf.
`18 See https://www.videa.ai/. See Appendix A, p. 4.
`
`
`
`16
`
`

`

`Case 1:24-cv-10446 Document 1 Filed 02/23/24 Page 17 of 49
`
`
`
`
`
`F. VideaHealth’s Infringing Use of Overjet’s DENTAL ASSIST trademark
`
`72.
`
`Upon information and belief, following the 510(k) clearance for “Videa Dental Assist,”
`
`beginning at least as early as January 4, 2024, VideaHealth started marketing its software as
`
`VIDEA DENTAL ASSIST. For example, on the home page of its website, www.videa.ai,
`
`VideaHealth advertises “30+ new FDA-cleared dental detections on VideaAI. Meet Videa Dental
`
`Assist,” as shown below. The page links to a video available on YouTube titled, “Introducing
`
`Videa Dental Assist on VideaAI.”19
`
`
`19 www.videa.ai.
`
`
`
`17
`
`
`
`

`

`Case 1:24-cv-10446 Document 1 Filed 02/23/24 Page 18 of 49
`
`
`
`
`
`73.
`
`In a blog post dated January 4, 2024, available on VideaHealth’s website, VideaHealth
`
`announced the FDA clearance for the VIDEA DENTAL ASSIST product, which VideaHealth
`
`advertises as “the largest FDA clearance in dental AI and the first in pediatric dental AI.”20 The
`
`blog post references the VIDEA DENTAL ASSIST mark several times and provides a link to the
`
`same YouTube video described above titled, “Introducing Videa Dental Assist on VideaAI.”
`
`74.
`
`VideaHealth has also referenced VIDEA DENTAL ASSIST in posts on its LinkedIn
`
`page.21
`
`75.
`
`VideaHealth has been using the VIDEA DENTAL ASSIST mark in connection with
`
`images that copy the exact design, look, and feel of the Overjet Software, including Overjet’s
`
`proprietary Anatomical Structures Visualization Tool.
`
`76.
`
`For example, “VIDEA DENTAL ASSIST” is displayed in a video on VideaHealth’s
`
`YouTube page along with the below images.22
`
`
`
`
`20 https://www.videa.ai/blog-posts/videahealth-achieves-landmark-fda-clearance-for-30-dental-
`conditions-heres-what-you-need-to-know.
`21 See, e.g., https://www.linkedin.com/posts/videahealth_dentalai-videahealth-dsos-activity-
`7148315009926791169-UPhu?utm_source=share&utm_medium=member_desktop.
`22 See, e.g., https://www.videa.ai/;
`https://www.youtube.com/watch?v=rgkRwPpR42U&t=70s. See Appendix A, p. 5.
`
`
`
`18
`
`

`

`Case 1:24-cv-10446 Document 1 Filed 02/23/24 Page 19 of 49
`
`
`
`77.
`
`Use of the VIDEA DENTAL ASSIST mark in connection with these images improperly
`
`causes a likelihood of confusion with Overjet’s own DENTAL ASSIST mark and software.
`
`78.
`
`Registration of Overjet’s DENTAL ASSIST trademark on the Principal Register provided
`
`constructive notice to VideaHealth of Overjet’s trademark rights in the DENTAL ASSIST mark.
`
`79.
`
`It is common practice within the competitive dental AI industry to monitor the release of
`
`products by competitors. Upon information and belief, VideaHealth knew or should have known
`
`about Overjet’s DENTAL ASSIST software product.
`
`80.
`
`Use of the VIDEA DENTAL ASSIST mark in connection with dental AI software,
`
`especially in connection with the infringing images above, demonstrates VideaHealth’s intentional
`
`and willful infringement of Overjet’s intellectual property and efforts to mislead consumers, and
`
`trade off of Overjet’s hard-earned goodwill and reputation, and copy Overjet’s innovative
`
`technology and unique aesthetic designs.
`
`81.
`
`VideaHealth offers its VIDEA DENTAL ASSIST software as a medical device service for
`
`use by dentists and hygienists to detect and measure dental disease. VideaHealth’s services are
`
`legally identical to the services with which Overjet registered its DENTAL ASSIST trademark.
`
`82.
`
`The dental AI services promoted and sold in connection with the VIDEA DENTAL
`
`ASSIST Mark are identical or highly similar to Overjet’s services promoted and sold in connection
`
`with Overjet’s registered DENTAL ASSIST trademark, as set forth in the paragraphs above.
`
`83.
`
`VideaHealth uses and displays the VIDEA DENTAL ASSIST mark on its website,
`
`promotional materials, industry conferences, and social media to market and promote its new
`
`software within the dental industry.
`
`
`
`19
`
`

`

`Case 1:24-cv-10446 Document 1 Filed 02/23/24 Page 20 of 49
`
`
`
`84.
`
`VideaHealth markets and sells its dental AI software under the VIDEA DENTAL ASSIST
`
`mark in the same geographic regions that Overjet markets and sells its DENTAL ASSIST software,
`
`including, among other geographic locations, in the Commonwealth of Massachusetts.
`
`85.
`
`As a result of VideaHealth’s

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