Regents Of University Of California v. Surgical Science North America Corp

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: The Regents of the University of California (California); SonoSim, Inc. (California)
  • Defendant: Surgical Science Sweden AB (Sweden); Surgical Science North America Corporation (Delaware)
  • Plaintiff's Counsel: Cislo & Thomas LLP
• Case Identification: 2:26-cv-06153, C.D. Cal., 08/13/2026
• Venue Allegations: Plaintiffs allege venue is proper in the Central District of California based on exclusive forum-selection clauses in a 2017 Settlement Agreement and a 2021 Nondisclosure Agreement, to which Defendants are allegedly bound as a party or successor-in-interest. Venue is also asserted based on Surgical Science Sweden's status as a foreign entity and its alleged minimum contacts with California.
• Core Dispute: Plaintiffs allege that Defendants' ultrasound simulation and training products infringe five patents related to ultrasound training systems and methods, and further allege that Defendants have breached a prior settlement agreement and misappropriated trade secrets.
• Technical Context: The dispute is in the field of medical simulation technology, specifically systems for training practitioners on how to perform ultrasound procedures.
• Key Procedural History: The complaint outlines a complex history between the parties, beginning with a 2016 lawsuit against Defendants' predecessor (MedaPhor) that resulted in a 2017 Settlement Agreement licensing two of the now-asserted patents. Plaintiffs allege that Defendants, after acquiring MedaPhor's business, began selling new or materially altered products that fall outside the scope of that license. Following pre-suit correspondence where Defendants invoked the 2017 agreement as a defense, Defendants' U.S. subsidiary filed a declaratory judgment action in Ohio, which Plaintiffs contend was a breach of the agreement's dispute resolution and forum-selection clauses.

Case Timeline

Date	Event
2004-11-30	Priority Date for '404 and '983 Patents
2010-01-01	SonoSim Launch Date (approx.)
2012-10-30	'983 Patent Issue Date
2012-12-18	Priority Date for '721 and '709 Patents
2013-07-09	'404 Patent Issue Date
2016-01-01	Prior infringement suit filed against MedaPhor (approx.)
2016-09-28	'944 Patent Filing Date
2017-01-25	2017 Settlement Agreement effective date (approx.)
2018-01-16	'721 Patent Issue Date
2020-01-01	BodyWorks Eve (with COVID-19 module) launch date (approx.)
2021-08-01	Surgical Science acquires Simbionix (approx.)
2021-11-24	Mutual Nondisclosure Agreement (NDA) signed
2021-09-14	'709 Patent Issue Date
2022-01-01	BodyWorks Eve updated to v4.0 (approx. 2022-2023)
2022-05-01	SonoSim allegedly put Surgical Science on notice of '709 patent via Demo Deck (approx.)
2023-01-01	BabyWorks 2.0 launch date (approx.)
2023-01-01	HeartWorks 3D Echo MPR add-on launch date (approx.)
2023-04-18	'944 Patent Issue Date
2025-02-01	Surgical Science acquires Intelligent Ultrasound (approx.)
2026-01-15	Plaintiffs send cease-and-desist letter to Surgical Science
2026-01-23	Surgical Science responds, invoking 2017 Settlement Agreement
2026-01-30	Plaintiffs rebut Surgical Science's non-infringement arguments
2026-02-26	Plaintiffs send letter alleging breach of 2017 Settlement Agreement
2026-03-09	Surgical Science NA files declaratory judgment action in N.D. Ohio
2026-08-13	Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 8,480,404 - "Multimodal Ultrasound Training System"

Issued July 9, 2013

The Invention Explained

• Problem Addressed: The patent describes the high cost and risk to patients associated with traditional "learning by doing" medical training, and notes that existing virtual reality (VR) training systems were often cost-prohibitive and failed to integrate different learning modalities effectively '404 Patent, col. 1:26-2:13
• The Patented Solution: The patent discloses a PC-based training system that provides multimodal education by integrating digital video with 3D anatomical models '404 Patent, abstract A user manipulates a motion-sensing input device simulating an ultrasound probe, and a graphical interface simultaneously displays: (1) the virtual probe's position relative to a 3D anatomical model, and (2) a corresponding digital video. A specific feature is that the digital video comprises both "actual images" recorded from a live subject and "simulated images," which are modified versions of the actual images with certain anatomical layers (e.g., muscle) removed to provide a clearer view of underlying structures '404 Patent, claim 1 '404 Patent, col. 5:58-6:8
• Technical Importance: The invention aimed to make sophisticated, multi-modal ultrasound training more accessible by enabling it on standard computers and combining real patient data with simplified, abstracted views to improve learner comprehension without patient risk '404 Patent, col. 2:14-24

Key Claims at a Glance

• The complaint asserts independent claim 1 Compl. ¶68
• The essential elements of claim 1 include:
  • A medical procedure training system comprising a control device.
  • A graphical interface with a first section for displaying a digital video and a second section for displaying a virtual anatomical model and a 3D ultrasound probe model.
  • The digital video comprising "actual images" (from a live subject, including a muscle layer) and "simulated images" (modified to remove the muscle layer).
  • The images are correlated to the position of the 3D probe model.
  • A user input device with a motion sensor to detect position and pointing direction.
  • The graphical interface displays dynamic images corresponding to the input device's signals and spatial orientation.
  • The system is configured to simulate procedures through system feedback.
• The complaint reserves the right to assert infringement under the doctrine of equivalents and does not waive the right to assert other claims Compl. ¶¶77-78

U.S. Patent No. 8,297,983 - "Multimodal Ultrasound Training System"

Issued Oct. 30, 2012

The Invention Explained

• Problem Addressed: The patent identifies the lack of widespread, efficient, and affordable ultrasound training solutions as a primary barrier to adoption, noting the difficulty of coordinating qualified instructors, trainees, ultrasound machines, and patients with relevant pathologies '983 Patent, col. 2:9-24
• The Patented Solution: The invention proposes a complete, modular ecosystem for creating, validating, and distributing ultrasound training content '983 Patent, abstract It describes a system architecture that includes a "data capture module" for recording real patient data, a "digital asset management module" for storage, a "validation module" for quality control, modules for creating "didactic content", an "integration layer" to combine the validated data and curriculum, and an "internet-based portal" with a "software client" to deliver the final training package to an end-user with a "peripheral probe" '983 Patent, col. 3:11-4:34
• Technical Importance: The patent describes a shift from standalone simulators to a scalable, networked, content-driven platform, enabling the creation and wide distribution of a large library of real-patient training cases '983 Patent, col. 3:1-10

Key Claims at a Glance

• The complaint asserts independent claim 2 Compl. ¶93

• The essential elements of claim 2 include:

  • An ultrasound training system comprising:
  • (a) a "data capture module" for real-time capture of bedside ultrasound images.
  • (b) a "digital asset management module" for storing captured data in relational databases.
  • (c) a "validation module" for multi-step assessment of captured data to produce a validated case volume.
  • (d) "didactic content" including a curriculum.
  • (e) a "media asset production module".
  • (f) an "integration layer" with a GUI to combine validated case volumes and media elements and administer quizzes.
  • (g) an "internet-based portal" with an online storefront.
  • (h) a "software client" to manage downloads from the portal.
  • (i) a "peripheral probe" with a six-degree-of-freedom (6-DOF) sensor and a force detection sensor.

• The complaint reserves the right to assert infringement under the doctrine of equivalents and does not waive the right to assert other claims Compl. ¶¶108-109

• Multi-Patent Capsule: U.S. Patent No. 9,870,721

  • Patent Identification: U.S. Patent No. 9,870,721, "System and Method for Teaching Basic Ultrasound Skills," issued January 16, 2018.
  • Technology Synopsis: The patent addresses the challenge for novices in relating 2D ultrasound slices to 3D anatomy '721 Patent, col. 1:26-34 The disclosed solution is a training system that uses a mock probe to scan simplified, virtual "basic shapes" (e.g., cones, spheres) rather than complex anatomy. By simultaneously displaying the 3D interaction and the resulting 2D cross-section, the system teaches fundamental probe manipulation skills in an abstract, simplified environment '721 Patent, abstract
  • Asserted Claims: Claim 1 Compl. ¶129
  • Accused Features: The complaint accuses Defendants' "ScanTrainer" system and "Sonography Basic Skills Module" of infringing by providing a function for teaching basic ultrasound skills using basic shapes Compl. ¶¶130 Compl. ¶141

• Multi-Patent Capsule: U.S. Patent No. 11,120,709

  • Patent Identification: U.S. Patent No. 11,120,709, "System and Method for Teaching Basic Ultrasound Skills," issued September 14, 2021.
  • Technology Synopsis: As a continuation of the '721 patent, this patent refines the system for teaching basic ultrasound skills using abstract shapes. It specifies that the motion-sensing input device comprises an accelerometer and further details the multi-window display, which includes menus for selecting virtual shapes and probes alongside windows for the 3D simulation and the resulting 2D slice '709 Patent, abstract '709 Patent, claim 1
  • Asserted Claims: Claim 1 Compl. ¶165
  • Accused Features: The "ScanTrainer" system and its associated "Sonography Basic Skills Module" are accused of infringing the method for teaching basic ultrasound skills Compl. ¶¶166 Compl. ¶171

• Multi-Patent Capsule: U.S. Patent No. 11,627,944

  • Patent Identification: U.S. Patent No. 11,627,944, "Ultrasound Case Builder System and Method," issued April 18, 2023.
  • Technology Synopsis: This patent focuses on a system for authoring custom ultrasound simulation cases. It describes a process where a user selects real-patient volumetric data sets (which may be from different patients) from a volume library and assigns them to discrete anatomical regions on a virtual body '944 Patent, abstract The invention enables the creation of composite, customized "virtual patients" for training by assembling discontinuous data sets from a curated library '944 Patent, col. 1:45-2:20
  • Asserted Claims: Claim 1 Compl. ¶194
  • Accused Features: The "BodyWorks Eve" product is accused of infringing by providing a system with over 100 cases derived from real patient scans, allowing users to assign different pathologies (volumetric data sets) to anatomical regions on a virtual body Compl. ¶¶195-199

III. The Accused Instrumentality

Product Identification

• The accused products are a suite of ultrasound simulation and training systems, including BodyWorks Eve, HeartWorks, BabyWorks, ScanTrainer (including ScanTrainer Compact and ScanTrainer Cloud), Needle Trainer, and Ultrasound Mentor (including the Sonography Basic Skills Module) Compl. ¶50

Functionality and Market Context

• The complaint alleges that these products are all built on the same core ultrasound simulation technology but are tailored with additional features for specific applications like cardiac, neonatal, or needle-guided procedure training Compl. ¶53
• A central allegation is that these products are either entirely new or are "materially altered" versions of products previously licensed under a 2017 Settlement Agreement, thereby rendering them unlicensed infringing products Compl. ¶42 Compl. ¶56
• Specifically, the "ScanTrainer" and its "Sonography Basic Skills Module" are alleged to teach basic probe manipulation using abstract shapes Compl. ¶141, while "BodyWorks Eve" is alleged to provide a system for building simulation cases from a library of real-patient volumetric data Compl. ¶¶196-199

IV. Analysis of Infringement Allegations

'404 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
a medical procedure training system for simulating ultrasound... comprising: a control device;	The accused ScanTrainer Compact is an ultrasound training system that employs a laptop computer as a control device.	¶69	col. 3:54-57
a graphical interface connected to the control device providing a plurality of interface sections, wherein a first interface section displays a digital video and a second interface section displays a virtual anatomical model and a three-dimensional ultrasound probe model...	The system provides a graphical interface with multiple sections, one displaying a digital video of an ultrasound scan on a laptop and a second displaying a computer-generated virtual anatomical model and probe on a separate monitor. The screenshot at complaint page 23 shows the system's overall setup.	¶70	col. 3:58-62
wherein the digital video comprises actual images previously recorded by scanning a live subject as well as simulated images, the actual images including a depiction of a muscle layer, the simulated images being modified actual images, the simulated images removing the depiction of the muscle layer from the actual images...	The complaint alleges the digital video includes "actual images" (the main ultrasound scan) that depict a muscle layer, and "simulated images" (guide images below the main scan) that are modified to remove the muscle layer, showing only organs of interest. The screenshot at complaint page 24 depicts the alleged actual and simulated images.	¶¶71-72	col. 4:3-8
where the actual images and simulated images are correlated to a position of the three-dimensional ultrasound probe model relative to the virtual anatomical model;	The complaint alleges the actual and simulated images are correlated to the position of the virtual probe relative to the virtual anatomical model.	¶72	col. 4:8-11
and a user input device connected to the control device, the user input device comprising a motion sensor, the motion sensor detecting a position of the input device and a pointing direction of the input device...	The system includes user input devices, shown to the right of and below the laptop, which allegedly comprise motion sensors to detect position and pointing direction. The screenshot at complaint page 25 (top) depicts the input devices.	¶73	col. 4:12-15
wherein, the graphical interface displays dynamic actual and simulated images corresponding to signals provided by the user input device, the signals corresponding to a spatial orientation...	The graphical interface allegedly displays dynamic images corresponding to the probe's spatial orientation, with the pointing direction shown in yellow on the probe image.	¶¶74-75	col. 4:16-24

• Identified Points of Contention:
  • Scope Questions: A central question will be whether the accused product's use of separate "guide images" Compl. ¶72 meets the claim's specific requirement that the "simulated images" are "modified actual images" from which a "muscle layer" has been removed. The defense may argue that displaying a separate, simplified diagram is technically distinct from modifying the actual source image as claimed.
  • Technical Questions: The infringement theory relies on marketing videos. A key question for the court will be what technical evidence exists to prove that the accused system's "actual images" were "previously recorded by scanning a live subject" and that its "simulated images" are functionally "modified actual images" as the claim requires, rather than just being separate graphical assets.

'983 Patent Infringement Allegations

Claim Element (from Independent Claim 2)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
(a) a data capture module... comprising software... to provide synchronous real-time capture of ultrasound images at a patient's bedside, the ultrasound images being organized in a volumetric format...	Based on information and belief, the ScanTrainer system is alleged to include a data capture module for capturing real-time ultrasound images at a patient's bedside in a volumetric format. The screenshot at complaint page 33 shows a user at a console allegedly performing such a capture.	¶95	col. 3:12-28
(b) a digital asset management module... comprising one or more relational databases receiving and storing information from the data capture module...	Based on information and belief, the system is alleged to include a digital asset management module with databases for storing, archiving, and retrieving the captured case volumes.	¶97	col. 3:36-44
(c) a validation module... providing a multi-step assessment process for the reconstructed ultrasound volume to produce a validated case volume...	Based on information and belief, the system is alleged to include a validation module for managing the upload, storage, and quality assessment of case volumes.	¶98	col. 3:56-65
(d) didactic content, the didactic content comprising a curriculum pertaining to a selected medical topic...	The ScanTrainer system allegedly includes didactic content, such as a curriculum for transabdominal ultrasound education, learning resources, and textbooks. The screenshots at complaint pages 34-35 show menus for learning resources and curriculum topics.	¶99	col. 4:2-5
(f) an integration layer... comprising a graphical user interface... to allow navigation between the media elements and the validated case volume and to administer... interactive quizzes...	The system allegedly includes an integration layer that allows a user to toggle between educational content (teaching videos, textbook) and the case volume to identify structures and make measurements.	¶100	col. 4:7-14
(g) an internet-based portal... comprising an online storefront providing user access to the integrated case volume...	The ScanTrainer system allegedly has an internet-based portal, "ScanTrainer Cloud," which provides "anytime, anywhere" access and includes an online storefront for case volumes. The screenshot at complaint page 39 shows this alleged storefront.	¶¶102-103	col. 4:18-22
(i) a peripheral probe... comprising a mock ultrasound probe... including a six degree of freedom sensor and a force detection sensor...	The system includes a peripheral probe that is visible in the user's hand. A "real-feel scanning experience" is allegedly touted, which Plaintiffs contend implies the presence of a 6-DOF sensor and a force detection sensor.	¶¶105-106	col. 4:27-34

• Identified Points of Contention:
  • Evidentiary Questions: The allegations for several key modules, including the "data capture module" and "validation module", are based entirely on "information and belief" Compl. ¶95 Compl. ¶98 A primary point of contention will be whether Plaintiffs can produce any technical evidence that these modules, as claimed, actually exist and function within the accused systems.
  • Technical Questions: The complaint infers the existence of a "force detection sensor" from the marketing phrase "real-feel scanning experience" Compl. ¶106 The defense will likely challenge this, raising the question of whether this marketing language is sufficient to allege the presence of the specific hardware required by the claim.

V. Key Claim Terms for Construction

For the '404 Patent

• The Term: "simulated images being modified actual images, the simulated images removing the depiction of the muscle layer from the actual images"
• Context and Importance: This term is at the heart of the infringement allegation against the ScanTrainer Compact. The case may turn on whether the accused product's "guide image" Compl. ¶72 meets this two-part definition, which requires both that the image is a "modified" version of the "actual" image and that the modification involves "removing" the muscle layer.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: Practitioners may argue that the patent's overall goal is to provide simplified abstractions for learning '404 Patent, col. 5:58-6:8 and that any simplified anatomical diagram displayed in conjunction with a real scan, if derived from it, should be considered a "modified actual image."
  • Evidence for a Narrower Interpretation: The claim language is highly specific, requiring not just a simplified image, but one that is a modification of the actual image where the muscle layer is removed. The defense may argue this implies a direct image processing operation on the source data, not merely the display of a separate, pre-rendered graphical diagram, which may be how the accused product operates.

For the '983 Patent

• The Term: "validation module"
• Context and Importance: This module is a key component of the patented content-creation ecosystem, representing a quality control gateway. Plaintiffs allege its presence based on "information and belief" Compl. ¶98 Its construction will be critical because if the accused system lacks a component that performs the claimed validation functions, the infringement claim may fail.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A plaintiff may argue that the term should cover any quality control process, citing the claim's description of the module's general purpose: "to manage the upload, storage, and assessment of the case volumes" and "produce a validated case volume" '983 Patent, claim 2
  • Evidence for a Narrower Interpretation: The claim provides specific functional details, including "providing a multi-step assessment process" that includes "a questionnaire for one or more reviewers" and "informing the one or more reviewers that content is available" '983 Patent, claim 2 The specification further elaborates on this review workflow, including the use of visual metaphors for feedback '983 Patent, col. 7:48-8:11 The defense may argue these specifics constrain the term to a formal, multi-reviewer system, which may not be present in the accused product.

VI. Other Allegations

• Indirect Infringement: The complaint alleges both induced and contributory infringement for all asserted patents. The inducement theory is based on allegations that Defendants provide instructional materials and YouTube videos that guide customers to use the products in an infringing manner Compl. ¶85 Compl. ¶117 Knowledge is alleged to stem from the 2017 Settlement Agreement and pre-suit correspondence, where Defendants allegedly demonstrated their awareness that the products practiced the patents Compl. ¶85 Compl. ¶117
• Willful Infringement: Willfulness is alleged for all patents. The claims are based on alleged pre-suit knowledge from multiple sources: the 2017 Settlement Agreement itself, which resolved prior infringement claims on the '404 and '983 patents Compl. ¶60; a "Patent Portfolio slide" allegedly shown to Defendants during business discussions around May 2022 Compl. ¶61; and a formal cease-and-desist letter sent in January 2026 Compl. ¶86 The complaint argues that Defendants knew the scope of the 2017 license and deliberately released new or materially altered products that fell outside its protections Compl. ¶¶60-61

VII. Analyst's Conclusion: Key Questions for the Case

• A threshold issue will be one of contractual scope: do the accused products, which Plaintiffs allege contain "material alterations" and new features, fall outside the definition of "Covered Products" licensed under the 2017 Settlement Agreement, or are they merely iterative improvements that remain under the license? The resolution of this contract-based question will determine whether the patent infringement claims can proceed for products that evolved from the licensed technology.
• A key evidentiary question will be one of technical proof: can Plaintiffs demonstrate, with evidence beyond marketing materials and screenshots, that the accused products actually perform the specific technical functions required by the claims? The case may turn on whether discovery reveals, for example, a "validation module" with a multi-reviewer workflow as claimed in the '983 patent or a specific image modification process of "removing the depiction of the muscle layer" from actual images as claimed in the '404 patent.
• A central question for damages will revolve around knowledge and willfulness: given the prior litigation and settlement agreement, did Defendants possess an objectively reasonable belief that their new and modified products were covered by the 2017 license? The court's determination of whether Defendants' conduct constituted objective recklessness will be critical to the claim for enhanced damages.