DCT

1:23-cv-07952

Osseo Imaging LLC v. Dentsply Sirona Inc

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-07952, E.D.N.Y., 10/25/2023
  • Venue Allegations: Plaintiff alleges venue is proper in the Eastern District of New York because Defendant Sirona transacts business, has committed acts of patent infringement, and maintains a regular and established place of business within the district, specifically an office in Long Island City.
  • Core Dispute: Plaintiff alleges that Defendant’s 3D dental imaging systems and related software infringe three patents related to creating and using tomographic models with densitometric data for dental and orthopedic applications.
  • Technical Context: The technology at issue involves the application of X-ray densitometry—a method for quantitatively measuring material density—to the dental field to create detailed 3D models of a patient's jaw and teeth for improved diagnosis and treatment planning.
  • Key Procedural History: The complaint alleges a significant history between the parties, including notice letters regarding the patents-in-suit sent to Sirona in October 2009, June 2014, and May 2017. It also notes that Plaintiff Osseo previously litigated the same patents against another company, Planmeca USA, Inc., resulting in an August 2022 jury verdict of infringement and validity, with a damages award of $2.3 million.

Case Timeline

Date Event
1999-12-01 Priority Date for ’301, ’262, and ’374 Patents
2002-04-30 ’301 Patent Issue Date
2003-01-24 ’262 Patent Application Filing Date
2005-09-13 ’262 Patent Issue Date
2009-10-01 Approximate Date Sirona Notified of Alleged Infringement of ’301 and ’262 Patents
2012-09-14 ’374 Patent Application Filing Date
2013-07-30 ’374 Patent Issue Date
2014-06-01 Approximate Date Sirona Notified of Alleged Infringement of all three Patents-in-Suit
2017-05-01 Approximate Date Sirona Sent a Preliminary Infringement Chart for the ’374 Patent
2017-10-25 Alleged Damages Period Begins
2020-08-09 Alleged Damages Period Ends
2022-08-01 Approximate Date of Jury Verdict in Osseo v. Planmeca
2023-10-25 Complaint Filing Date

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

U.S. Patent No. 6,381,301 - "Dental and orthopedic densitometry modeling system and method," issued April 30, 2002

The Invention Explained

  • Problem Addressed: The patent’s background section states that conventional diagnostic procedures, like standard X-rays, are often insufficient for the early detection of dental pathologies such as subsurface caries, certain types of fractures, and early-stage apical abscesses (’301 Patent, col. 1:21-55). It notes that a system for applying medical densitometry technology to dental applications was not previously available (’301 Patent, col. 2:33-38).
  • The Patented Solution: The invention is a system that applies scanning X-ray techniques to generate a "tomographical densitometry model" of a patient's dental or orthopedic structures (’301 Patent, Abstract). The system includes a controller with a microprocessor, an X-ray source and detector, and an output device, all configured to create a model that can be color-coded to represent varying densities, thereby revealing pathologies not easily seen on a standard X-ray (’301 Patent, col. 2:55-62; Fig. 1). The system is also designed to compare a current model to a pre-existing model to monitor changes over time (’301 Patent, col. 6:1-4).
  • Technical Importance: The invention proposed adapting quantitative bone morphology density (BMD) analysis, a technique used medically for diseases like osteoporosis, for use in dentistry, enabling more precise and earlier diagnosis of dental conditions and evaluation of implant success (’301 Patent, col. 2:21-38).

Key Claims at a Glance

  • The complaint asserts independent claims 1 (system) and 10 (method), along with dependent claims 2-8 and 11-19 (Compl. ¶32).
  • Independent Claim 1 recites a system comprising:
    • A controller with a microprocessor, a memory device, and "means for storing a pre-existing tomographical dental/orthopedic densitometry model"
    • An input device
    • A positioning motor responsive to the microprocessor
    • X-ray equipment (source and detector array)
    • "Conversion means" for converting the detector signal for the microprocessor
    • An output device for receiving the tomographical densitometry model

U.S. Patent No. 6,944,262 - "Dental and orthopedic densitometry modeling system and method," issued September 13, 2005

The Invention Explained

  • Problem Addressed: The ’262 Patent builds on the same problems as its parent (’301 Patent) but expands the applications to include forensics, identification, and biometrics (’262 Patent, col. 1:15-18). It addresses the need for a system that can create and compare densitometry models over time to monitor patient health and also compare individual models to broader population data (’262 Patent, col. 7:26-45).
  • The Patented Solution: The patent describes a digital modeling system for creating, storing, and comparing three-dimensional densitometry models specifically "without the use of fiducial markers" (’262 Patent, Abstract; col. 9:8-14). The system comprises a computer, an input device with an energy source and sensor, and imaging and comparison software (’262 Patent, col. 9:1-14). This marker-less approach is intended to simplify the process of aligning and comparing scans taken at different times or from different individuals.
  • Technical Importance: The invention’s focus on operating "without the use of fiducial markers" suggests a move toward a more streamlined clinical workflow, removing the need for physical registration points to align 3D scans, and introduces the concept of using population databases for baseline comparisons (’262 Patent, col. 7:26-36).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and dependent claims 2-6 (Compl. ¶38).
  • Independent Claim 1 recites a system comprising:
    • A computer with a digital memory, an input, and an output
    • A dental or orthopedic input device with an energy source and sensor
    • The computer being configured for "creating, storing and comparing three-dimensional digital densitometry models without the use of fiducial markers"
    • An output device for communicating comparison information
    • Imaging software and a display

Multi-Patent Capsule

  • Patent Identification: U.S. Patent No. 8,498,374, "Dental and orthopedic densitometry modeling system and method," issued July 30, 2013 (Compl. ¶15).
  • Technology Synopsis: The patent addresses the difficulty of detecting dental pathologies like caries and fractures with conventional X-rays (’374 Patent, col. 1:29-52). It proposes a system that creates 3D digital tomographic models of a dental structure using X-ray equipment, a microprocessor, and memory, specifically "without the use of fiducial markers," to provide quantitative density information for improved diagnosis and for comparing models over time (’374 Patent, col. 5:35-51, col. 6:52-58).
  • Asserted Claims: The complaint asserts claims 1-24, which includes independent claims 1 and 13 (Compl. ¶45).
  • Accused Features: The accused features are the Sirona 3D X-Ray Family systems, which allegedly create, store, and compare 3D digital tomographic models of dental structures using cone beam computed tomography, including quantitative density data, without the use of fiducial markers (Compl. ¶¶23-25, 45).

III. The Accused Instrumentality

Product Identification

  • The complaint identifies the "Accused Systems" as a combination of Sirona’s 3D dental imaging hardware, associated software, and a computerized device (Compl. ¶¶23-24). The hardware is the "Sirona 3D X-Ray Family," which includes the Galileos Comfort Plus, Orthophos SL 3D, and Orthophos XG 3D systems (Compl. ¶23). The software includes Galaxis, SIDEXIS XG, and SIDEXIS 4 (Compl. ¶24).

Functionality and Market Context

  • The Accused Systems are alleged to be operable to produce 3D X-ray models of a patient's dental structure using cone beam computed tomography (Compl. ¶24). The complaint alleges these systems generate digital X-ray images that are merged into tomographic models containing "quantitatively calculated bone density values calibrated to the Hounsfield Unit scale" (Compl. ¶24). The Sirona Software allegedly allows a user to observe these bone density values; for example, the SIDEXIS XG software is said to include a "Measuring bone density" function (Compl. ¶25). The SIDEXIS 4 software is alleged to include a "side-by-side function that linked three-dimensional tomographic models of the same patient obtained at different times for comparison" (Compl. ¶24).

IV. Analysis of Infringement Allegations

The complaint references, but does not include, claim chart exhibits. The following tables are constructed based on the narrative allegations in the complaint and the language of the asserted independent claims.

’301 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a) a controller with a microprocessor and a memory device... said controller including means for storing a pre-existing tomographical dental/orthopedic densitometry model; The Accused Systems include a computerized device (e.g., laptop/workstation) with a microprocessor and memory, running Sirona Software that includes a function to link and compare 3D models of the same patient from different times. ¶24 col. 4:10-14
b) an input device connected to the microprocessor; The computerized device includes input devices (e.g., keyboard, mouse) for operating the Sirona Software. ¶24 col. 4:6-9
c) a positioning motor connected to the microprocessor and movable in response to from said microprocessor; The Sirona 3D X-Ray Family hardware, which operates via cone beam computed tomography, includes motors to position the X-ray source and detector around the patient. ¶24 col. 4:17-20
d) X-ray equipment including an X-ray source and a detector array; The Sirona 3D X-Ray Family hardware is a dental imaging system that inherently includes an X-ray source and detector array. ¶23-24 col. 4:20-29
e) conversion means for converting a signal from said detector array, said conversion means being connected to said detector array and to said microprocessor; The Accused Systems generate digital X-ray images, which requires converting the analog signals from the X-ray detector into a digital format for the microprocessor. ¶24 col. 4:30-34
f) an output device connected to said microprocessor and adapted for receiving a tomographical densitometry model from said microprocessor. The computerized device includes an output device (e.g., a display) on which the tomographic models are received, stored, and displayed. ¶24 col. 4:37-41

’262 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a computer including a digital memory storing patient densitometry information, an input and an output; The Accused Systems include a computerized device with memory, input (e.g., keyboard), and output (e.g., display) for storing and managing patient imaging data. ¶24 col. 5:61-6:1
a dental or orthopedic input device including an energy source and an energy sensor... said sensor transferring signals to the computer input; The Sirona 3D X-Ray Family hardware serves as the input device, comprising an X-ray source (energy source) and detector (energy sensor) that transfer signals to the computer. ¶23-24 col. 6:12-23
said signals representing densitometry of the patient's dental or orthopedic structure; The systems generate models with "quantitatively calculated bone density values calibrated to the Hounsfield Unit scale," which are signals representing densitometry. ¶24 col. 5:35-39
said computer creating, storing and comparing three-dimensional digital densitometry models without the use of fiducial markers of patient dental or orthopedic structure; The Sirona Software running on the computer allegedly creates, stores, and compares 3D tomographic models, and the SIDEXIS 4 software provides a side-by-side comparison function. ¶24 col. 9:8-14
an output device connected to said computer output and communicating densitometry model comparison information; The computerized device's display acts as an output device, communicating the models and comparison information to the user. ¶24 col. 5:1-6
imaging software associated with said computer; and a display associated with said output device... The Accused Systems include Sirona Software (e.g., SIDEXIS XG, SIDEXIS 4) and a display on the computerized device. ¶24 col. 6:1-7

No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • Scope Questions: A central question for the ’262 and ’374 patents will be the scope of the negative limitation "without the use of fiducial markers." The parties may dispute what constitutes a "fiducial marker" and whether the Accused Systems employ any form of software-based landmarking or registration that could fall within a potential definition of the term.
    • Technical Questions: For the ’301 patent, a key question may be whether the Accused Systems' alleged capability to compare scans from different times (Compl. ¶24) meets the requirements of the means-plus-function element "means for storing a pre-existing tomographical... model." The analysis will depend on the structures disclosed in the patent for performing this function and their equivalence to the structures in the Accused Systems.

V. Key Claim Terms for Construction

  • The Term: "means for storing a pre-existing tomographical dental/orthopedic densitometry model" (’301 Patent, Claim 1)

  • Context and Importance: This is a means-plus-function limitation under 35 U.S.C. § 112(f). Its construction is critical because infringement requires the accused device to perform the identical function using a structure that is the same as or equivalent to the corresponding structures disclosed in the specification. The dispute will focus on what structures the patent discloses for this function and whether the architecture of the Sirona Software is equivalent.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification states that data input to the system can include "a patient's dental and orthopedic records, including previous tomographical densitometry models" (’301 Patent, col. 4:10-13). This could support an interpretation where the corresponding structure is a general-purpose computer memory (7) and microprocessor (6) configured to access and load prior model data files.
    • Evidence for a Narrower Interpretation: The specification describes a method step of "comparing said patient's current densitometry model to pre-existing densitometry model" (’301 Patent, col. 6:62-64). A defendant may argue this links the function specifically to the comparison algorithm itself, potentially limiting the corresponding structure to the specific implementation shown in the patent's flow chart (Fig. 2), rather than any general-purpose file storage.

  • The Term: "without the use of fiducial markers" (’262 Patent, Claim 1)

  • Context and Importance: This negative limitation is a key differentiator claimed by the ’262 patent. Its meaning will be central to the infringement analysis. Practitioners may focus on this term because the absence of a definition in the patent leaves its scope open to debate, particularly whether it excludes only physical markers placed on a patient or also encompasses software-based reference points used for image registration.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation (i.e., excluding more types of markers): The patent does not define "fiducial markers." A plaintiff might argue that in the context of simplifying 3D model comparison, the term should be broadly construed to mean any artificial reference point—physical or digital—used to align scans, and that the invention's contribution is a system that can align scans based on the anatomical data alone.
    • Evidence for a Narrower Interpretation (i.e., excluding fewer types of markers): A defendant could argue that in the absence of a specific definition, the term should be given its plain and ordinary meaning at the time, which may have referred primarily to physical objects placed on a patient or in a scanner. The lack of any explicit prohibition on software-based registration algorithms in the specification could be cited to support an interpretation that only physical markers are excluded.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all three patents. Inducement is based on allegations that Sirona knowingly caused its customers (dental professionals) to infringe by providing the Accused Systems and intending for them to be used in an infringing manner (Compl. ¶¶34, 41, 47). Contributory infringement is based on allegations that Sirona provided components of the Accused Systems that are a material part of the invention, are not suitable for substantial non-infringing use, and were especially adapted for infringement (Compl. ¶¶35, 42, 48).
  • Willful Infringement: The complaint alleges willful infringement and seeks enhanced damages. The factual basis for this allegation is a series of communications where Plaintiff Osseo allegedly notified Sirona of the patents and its infringement assertions in October 2009, June 2014, and May 2017, long before the suit was filed (Compl. ¶¶27-30, p.11, ¶C).

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

  • A core issue will be one of claim scope and technical operation: Can the term "means for storing a pre-existing... model" in the ’301 patent be construed to read on the Sirona Software's function for comparing scans over time? Further, do the Accused Systems operate "without the use of fiducial markers" as required by the ’262 and ’374 patents, and what is the proper legal construction of that negative limitation?
  • A second central question will concern willfulness and damages: Given the extensive history alleged in the complaint, including multiple pre-suit notices and a prior jury verdict finding the patents valid and infringed by a competitor, the court will have to determine whether Sirona's alleged conduct was objectively reckless. This will be a critical factor in assessing whether to award enhanced damages if infringement is found.
  • A key evidentiary question will be whether the prior litigation against Planmeca has preclusive effect on any issues, or, short of that, how much weight it will carry in the court's and jury's evaluation of issues like validity, infringement, and willfulness in the current case.