DCT

2:23-cv-02320

Cranial Tech Inc v. Ottobock Se Co KGaA

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:23-cv-02320, C.D. Cal., 04/26/2024
  • Venue Allegations: Plaintiff alleges venue is proper in the Central District of California because Defendants have systematic and continuous contacts with California, regularly transact business in the state, and Defendant Active Life LLC maintains multiple regular and established places of business within the district.
  • Core Dispute: Plaintiff alleges that Defendants' MyCRO Band cranial orthotic helmet and the associated iFab design and manufacturing system infringe five U.S. patents related to the automated design and additive manufacturing of custom cranial remodeling devices.
  • Technical Context: The technology concerns the use of 3D digital imaging and automated software to design and manufacture custom-fitted medical helmets used to treat cranial deformities, such as plagiocephaly ("flat head syndrome"), in infants.
  • Key Procedural History: The complaint states that prior to the lawsuit, the parties engaged in acquisition discussions during which Plaintiff provided Defendants with confidential presentations detailing its proprietary and patented technology. The complaint also notes that in response to a prior motion to dismiss in this case, the Court rejected Defendants' patent eligibility challenge under 35 U.S.C. § 101 against U.S. Patent Nos. 7,242,798 and 7,227,979, finding the patents were not directed to an abstract idea.

Case Timeline

Date Event
2003-03-10 Earliest Priority Date for ’798 and ’979 Patents
2007-06-05 U.S. Patent No. 7,227,979 Issues
2007-07-10 U.S. Patent No. 7,242,798 Issues
2017-03-30 Earliest Priority Date for ’203, ’925, and ’617 Patents
2019-12-01 Plaintiff allegedly provides confidential presentation on its technology to Defendant
2020-09-01 Plaintiff sends updated materials to Defendant
2020-03-31 U.S. Patent No. 10,603,203 Issues
2020-07-28 U.S. Patent No. 10,726,617 Issues
2020-11-24 U.S. Patent No. 10,846,925 Issues
2021-03-01 Accused MyCRO Band receives FDA clearance
2023-03-29 Original Complaint filed
2023-11-02 Court denies Defendants' Motion to Dismiss
2024-03-06 Plaintiff serves detailed infringement claim charts on Defendants
2024-04-26 First Amended Complaint filed

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

U.S. Patent No. 7,242,798 - Automatic Selection of Cranial Remodeling Device Configuration

Issued July 10, 2007. (Compl. ¶53).

The Invention Explained

  • Problem Addressed: The patent describes prior art methods for creating cranial remodeling devices as a multi-step, manual process involving making a plaster cast of an infant's head, manually modifying that cast into a desired shape, and then forming the device over the modified cast. (Compl. ¶54; ’798 Patent, col. 1:45-53). This process is described as being inefficient, uncomfortable for the infant, and susceptible to human error. (Compl. ¶54; ’798 Patent, col. 1:45-53, 2:31-36).
  • The Patented Solution: The invention automates the device design process by first capturing a three-dimensional digital image of the infant's head. (Compl. ¶54; ’798 Patent, Abstract). This digital data is then processed to automatically calculate and provide the necessary "cranial remodeling device information"—such as suspension, corrective forces, and trim lines—needed to fabricate a custom device, thereby eliminating the need for a physical plaster cast and manual modifications. (Compl. ¶54; ’798 Patent, col. 14:4-25).
  • Technical Importance: This digital-to-digital approach was designed to improve the efficiency and accuracy of manufacturing custom cranial orthotics while eliminating the discomfort of the physical casting process for infants. (Compl. ¶54).

Key Claims at a Glance

  • The complaint asserts independent claim 1. (Compl. ¶58).
  • The essential elements of Claim 1 are:
    • A method for producing cranial remodeling devices to correct for cranial shape abnormalities comprising:
    • capturing a three dimensional digital image of a deformed head to produce first digital data; and
    • utilizing said first digital data to automatically provide cranial remodeling device information for use in fabricating a cranial remodeling device for said deformed head.
  • The complaint asserts claims 1-8, 10-17, 19-26, and 28, reserving the right to assert dependent claims. (Compl. ¶57).

U.S. Patent No. 7,227,979 - Automatic Selection of Cranial Remodeling Device Trim Lines

Issued June 5, 2007. (Compl. ¶69).

The Invention Explained

  • Problem Addressed: Similar to the ’798 Patent, this patent addresses the cumbersome and error-prone prior art method of producing cranial helmets via physical plaster casting and subsequent manual modification. (Compl. ¶70; ’979 Patent, col. 1:48-56).
  • The Patented Solution: The invention provides a method that uses a 3D digital image of an infant's head to specifically "automatically calculate the unique trim line information" for the remodeling device. (’979 Patent, Abstract, col. 17:5-12). This automation of trim line determination is intended to replace the manual process of drawing lines on a physical model and then cutting the device, thereby improving process efficiency and accuracy. (Compl. ¶70).
  • Technical Importance: By automating the specific, critical step of defining the device's edges (trim lines), the invention aimed to further reduce manual labor and potential inconsistencies in the manufacturing of custom cranial helmets. (Compl. ¶70).

Key Claims at a Glance

  • The complaint asserts independent claim 1. (Compl. ¶74).
  • The essential elements of Claim 1 are:
    • A method for producing cranial remodeling devices to correct for cranial shape abnormalities comprising:
    • capturing a three dimensional digital image of a deformed head to produce first digital data; and
    • utilizing said first digital data to automatically provide cranial remodeling device trim line information for use in fabricating a cranial remodeling device for said deformed head.
  • The complaint asserts claims 1-6 and 9-13. (Compl. ¶73).

U.S. Patent No. 10,603,203 - Custom Cranial Remodeling Devices Manufactured By Additive Manufacture

Issued March 31, 2020. (Compl. ¶85).

Technology Synopsis

This patent addresses inaccuracies and inefficiencies in traditional manufacturing steps that occur even after a digital design is created, such as vacuum thermo-forming plastic over a model and manually cutting trim lines. (Compl. ¶86; ’203 Patent, col. 1:13-26). The patented solution is a custom cranial remodeling device manufactured via an additive process (e.g., 3D printing), where the device's inner and outer layers, including their final peripheral contour lines, are formed directly from a device data file, eliminating subsequent manual trimming steps. (Compl. ¶86; ’203 Patent, Abstract).

Asserted Claims

Independent claim 1 is asserted. (Compl. ¶89).

Accused Features

The 3D-printed nature of the MyCRO Band product is accused of infringing this patent. (Compl. ¶¶28, 88).

U.S. Patent No. 10,846,925 - Method of Manufacture of Custom Cranial Remodeling Devices By Additive Manufacture

Issued November 24, 2020. (Compl. ¶101).

Technology Synopsis

This patent claims a method for creating a device data file intended for use by a 3D printer. The method involves generating a 3D data file of a head, processing it to a modified shape, and then automatically determining and projecting contour lines to establish the peripheral edges of the device within the data file itself. (’925 Patent, Abstract). This process creates a print-ready file that produces a device with finished edges, obviating the need for post-production trimming. (Compl. ¶102; ’925 Patent, col. 14:19-22).

Asserted Claims

Independent claim 17 is asserted. (Compl. ¶105).

Accused Features

The accused iFab system is alleged to perform the claimed method to create the data files used to manufacture the MyCRO Band. (Compl. ¶¶30, 104).

U.S. Patent No. 10,726,617 - Method of Manufacture of Custom Headwear By Additive Manufacture

Issued July 28, 2020. (Compl. ¶121).

Technology Synopsis

Similar to the ’925 patent, this patent claims a method for creating a device data file for 3D printing custom "headwear." The method involves processing a 3D head scan to automatically determine contour lines and then projecting those lines to establish the final edges for the inner and outer surfaces of the headwear within the device data file. (’617 Patent, Abstract). The goal is to create a digital file that enables additive manufacturing of a finished product without requiring subsequent manual trimming. (Compl. ¶122; ’617 Patent, col. 1:52-55).

Asserted Claims

Independent claim 17 is asserted. (Compl. ¶125).

Accused Features

The accused iFab system is alleged to perform the claimed method to create data files for manufacturing the MyCRO Band. (Compl. ¶¶30, 124).

III. The Accused Instrumentality

Product Identification

The Accused Products are the Ottobock MyCRO Band and the Ottobock iFab system. (Compl. ¶27).

Functionality and Market Context

The MyCRO Band is described as a 3D-printed cranial orthotic helmet used for treating cranial deformities in infants. (Compl. ¶26). The complaint includes a photograph of the accused MyCRO Band helmet. (Compl. p. 10). The iFab system is identified as the hardware and software suite used to design and produce the MyCRO Band. (Compl. ¶29). It allegedly comprises the iFab EasyScan, a 3D scanner that captures digital images of a patient's head, and the iFab Customer Center, a software platform that processes the scan data to "automatically model the desired product for fabrication." (Compl. ¶¶29-30). A screenshot from Ottobock's website shows the iFab EasyScan handheld scanner and describes it as a "tool to start digital workflows." (Compl. p. 11). The complaint alleges that the MyCRO Band is Ottobock's first cranial helmet offered in the United States and characterizes it as a "copycat product" developed using knowledge of Plaintiff's patented technology. (Compl. ¶¶23, 28).

IV. Analysis of Infringement Allegations

The complaint references claim chart exhibits that are not provided with the pleading; therefore, the narrative infringement theories are summarized below.

’798 Patent Infringement Allegations

The complaint alleges that Defendants' iFab system performs the method of claim 1 of the ’798 patent. The "capturing a three dimensional digital image" step is allegedly met by the iFab EasyScan scanner and its associated software. (Compl. ¶¶29, 60). The subsequent step of "utilizing said first digital data to automatically provide cranial remodeling device information" is allegedly met by the iFab Customer Center software, which is said to process the scan data to automatically model the MyCRO Band for fabrication. (Compl. ¶¶30, 61).

’979 Patent Infringement Allegations

The complaint makes similar allegations for claim 1 of the ’979 patent. The iFab EasyScan is alleged to perform the "capturing" step. (Compl. ¶¶29, 76). The iFab Customer Center and its associated software are alleged to perform the step of "utilizing said first digital data to automatically provide cranial remodeling device trim line information," which is then used to fabricate the MyCRO Band. (Compl. ¶¶30, 77).

Identified Points of Contention

  • Scope Questions: A central question for both the ’798 and ’979 patents will be the scope of the term "automatically provide." The dispute may focus on the degree of human intervention involved in the accused iFab system's workflow. The defense may argue that the system is merely a tool requiring significant clinician input to generate the final device "information," while the Plaintiff alleges the system performs this function automatically. (Compl. ¶¶61, 77).
  • Technical Questions: A key factual question will be what specific "information" the iFab system generates. For the ’798 patent, does the system output complete "cranial remodeling device information" (e.g., corrective force vectors, suspension points) as contemplated by the patent, or just a modified 3D model? For the ’979 patent, does the system output final "trim line information," or does it generate proposed lines that require substantial manual refinement by the clinician?

V. Key Claim Terms for Construction

The Term

"automatically provide" (from asserted independent claims of the ’798 and ’979 patents)

Context and Importance

This term is critical to the infringement analysis for the two earliest patents. The patents were granted to overcome a manual, multi-step prior art process. The extent to which the accused iFab system must operate without human intervention to meet the "automatically provide" limitation will likely be a central point of dispute.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: The specification of the ’798 patent states an objective is to produce a device "without any significant human intervention," which may suggest that some non-significant level of human interaction is permissible within the claim scope. (’798 Patent, col. 14:22-24).
  • Evidence for a Narrower Interpretation: The abstract of both patents states that the system "operates on three dimensional digital captured data... to automatically provide" the claimed information, suggesting a process that is machine-driven from input to output. (’798 Patent, Abstract; ’979 Patent, Abstract). The patents' consistent differentiation from the manual prior art may support a construction requiring a high degree of automation.

VI. Other Allegations

Indirect Infringement

The complaint alleges both induced and contributory infringement. Inducement is based on allegations that Ottobock encourages and instructs clinicians and orthotists to use the iFab system to produce the MyCRO Band through marketing materials, manuals, and videos. (Compl. ¶¶63, 79). Contributory infringement is based on allegations that the iFab system is a material part of the patented inventions, is not a staple article of commerce, and is especially made for infringing use. (Compl. ¶¶64, 80).

Willful Infringement

The complaint alleges willful infringement based on both pre-suit and post-suit knowledge. It alleges Defendants gained actual knowledge of the Asserted Patents or their pending applications as early as December 2019 during confidential acquisition diligence. (Compl. ¶¶24, 65). The complaint further states that Defendants admitted in an interrogatory response to having actual knowledge since at least 2020. (Compl. ¶25). Continued infringement after the filing of the lawsuit and after the Court's denial of Defendants' motion to dismiss are also cited as bases for willfulness. (Compl. ¶34).

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

  • A core issue will be one of claim scope and automation: to what extent must the accused iFab system operate without human clinical judgment to "automatically provide" the "information" required by the ’798 and ’979 patents? The case will likely require a detailed factual analysis of the accused system's software workflow compared to the patent claims.
  • A second key issue will be one of pre-suit conduct and intent: what information regarding Plaintiff's patented technology was disclosed to Defendants during acquisition discussions, and does the evidence support the allegation that this information was used as a "blueprint" to develop the accused MyCRO Band and iFab system? The resolution of this question will be central to the claim for willful infringement.
  • A third issue will be one of technical implementation for the additive manufacturing patents: does the accused iFab system, in creating a data file for the 3D-printed MyCRO Band, perform the specific method steps of automatically determining and projecting contour lines to define the device's final periphery, as claimed in the ’925 and ’617 patents?