DCT

1:17-cv-01386

Osseo Imaging LLC v. Planmeca USA Inc

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-01386, D. Del., 10/03/2017
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is a Delaware corporation.
  • Core Dispute: Plaintiff alleges that Defendant’s Promax 3D family of dental imaging systems infringes a family of patents related to creating and comparing tomographic densitometry models of dental and orthopedic structures.
  • Technical Context: The technology involves using X-ray based imaging to generate three-dimensional models of a patient's dental structures to measure density, which can be used to diagnose pathologies like caries and fractures and to monitor implants.
  • Key Procedural History: The three patents-in-suit belong to the same family. The complaint notes that U.S. Patent No. 8,498,374 is a continuing application that claims the benefit of U.S. Patent No. 6,944,262 and U.S. Patent No. 6,381,301, suggesting a shared specification and a long-running development and prosecution effort for the underlying technology.

Case Timeline

Date Event
1999-12-01 Earliest Priority Date ('301, '262, '374 Patents)
2002-04-30 '301 Patent Issued
2005-09-13 '262 Patent Issued
2013-07-30 '374 Patent Issued
2017-10-03 Complaint Filed

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

U.S. Patent No. 6,381,301 - "DENTAL AND ORTHOPEDIC DENSITOMETRY MODELING SYSTEM AND METHOD"

  • Patent Identification: 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 describes the limitations of conventional dental diagnostics, noting that tools like explorers and standard X-rays often fail to detect incipient caries (especially subsurface decay), certain types of fractures, and early-stage apical abscesses (’301 Patent, col. 1:21-50).
  • The Patented Solution: The invention proposes a system that applies medical densitometry techniques to dentistry. It uses scanning X-ray equipment, preferably emitting dual-energy beams, to generate a "tomographical densitometry model" of a patient's dental or orthopedic structure (’301 Patent, col. 2:38-61). This digital model, which can be color-coded to show density variations, allows for more sensitive detection of pathologies and can be compared to a patient's prior models to track changes over time (’301 Patent, col. 4:44-55).
  • Technical Importance: The invention sought to bring the quantitative diagnostic power of medical bone densitometry, used for conditions like osteoporosis, into the field of dentistry for earlier and more accurate detection of common dental problems (’301 Patent, col. 2:7-20).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-9, focusing on independent claim 1 (Compl. ¶15).
  • Independent Claim 1 recites a system comprising:
    • a controller with a microprocessor and a memory device, where the controller includes means for storing a pre-existing tomographical model;
    • an input device connected to the microprocessor;
    • a positioning motor connected to the microprocessor;
    • X-ray equipment including an X-ray source and a detector array;
    • conversion means for converting a signal from the detector array; and
    • an output device for receiving the tomographical densitometry model.
  • The complaint reserves the right to assert dependent claims 2-9 (Compl. ¶16).

U.S. Patent No. 6,944,262 - "DENTAL AND ORTHOPEDIC DENSITOMETRY MODELING SYSTEM AND METHOD"

  • Patent Identification: U.S. Patent No. 6,944,262, "DENTAL AND ORTHOPEDIC DENSITOMETRY MODELING SYSTEM AND METHOD," issued September 13, 2005.

The Invention Explained

  • Problem Addressed: Like its parent patent, the ’262 Patent addresses the shortcomings of conventional dental diagnostics in detecting pathologies like decay and fractures (’262 Patent, col. 1:31-46).
  • The Patented Solution: The patent describes a system for creating, storing, and importantly, comparing three-dimensional digital densitometry models "without the use of fiducial markers" (’262 Patent, col. 9:8-11). The system includes a computer, an input device (comprising an energy source and sensor which can be placed internally or externally to the patient), and an output device. By eliminating the need for fiducial markers (physical reference points), the invention aims to streamline the process of comparing a patient's current dental model to previous models to track changes.
  • Technical Importance: The focus on a markerless comparison system represents a step toward a more practical and clinically efficient method for longitudinal monitoring of a patient's dental health using densitometric data (’262 Patent, col. 9:8-11).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-6, focusing on independent claim 1 (Compl. ¶21).
  • Independent Claim 1 recites a digital modeling system comprising:
    • a computer with digital memory for storing patient densitometry information;
    • a dental or orthopedic input device with an energy source and sensor;
    • the computer is configured for creating, storing, and comparing 3D digital densitometry models without the use of fiducial markers;
    • an output device for communicating the model comparison information;
    • imaging software; and
    • a display.
  • The complaint reserves the right to assert dependent claims 2-6 (Compl. ¶22).

U.S. Patent No. 8,498,374 - "DENTAL AND ORTHOPEDIC DENSITOMETRY MODELING SYSTEM AND METHOD"

  • Patent Identification: U.S. Patent No. 8,498,374, "DENTAL AND ORTHOPEDIC DENSITOMETRY MODELING SYSTEM AND METHOD," issued July 30, 2013.
  • Technology Synopsis: Continuing the subject matter of the family, the ’374 Patent describes a system for tomographically modeling a dental structure. The system includes a controller adapted for storing, creating, and comparing 3D digital tomographic models of an object without using fiducial markers, along with a positioning motor and X-ray equipment, to produce models that can be compared against pre-existing patient models or standard models (’374 Patent, Abstract; col. 7:35-50).
  • Asserted Claims: Independent claims 1, 13, and 21 are asserted (Compl. ¶27).
  • Accused Features: The complaint alleges that the Accused Systems infringe by providing the hardware and software to generate, store, and compare 3D tomographic models of a patient's dental structure over time (Compl. ¶¶ 11-12, 27).

III. The Accused Instrumentality

  • Product Identification: The "Accused Systems" are identified as Defendant's "Promax 3D Family Imaging Systems," including the Promax 3Ds/3D, 3Ds/3D Classic, 3D Plus, 3D Mid, and 3D Max models, when used with the accompanying "Romexis" software that includes a 3D imaging module (Compl. ¶11).
  • Functionality and Market Context:
    • The complaint alleges the Accused Systems use cone beam computed tomography (CBCT) to produce three-dimensional X-ray models of a patient's dental and other orthopedic structures (Compl. ¶12).
    • The Romexis software is alleged to enable the system to "capture, process, and store" these 3D models. A central allegation is that the software "includes overlay and side-by-side functions that link three-dimensional models obtained at different times for comparison" (Compl. ¶12).
    • The complaint asserts that Defendant sells and offers for sale these systems throughout the United States via a network of distributors (Compl. ¶13).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint references claim chart exhibits (Exhibits D, E, F) that were not attached to the filed document. The following analysis is based on the narrative allegations of infringement in the complaint.

’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... model The Accused Systems include a controller and microprocessor; the Romexis software stores 3D models from different times, which constitutes storing a "pre-existing" model for later comparison. ¶10, ¶12 col. 4:56-64
b) an input device connected to the microprocessor The Accused Systems are operated via input devices connected to a controller. ¶10 col. 4:6-9
c) a positioning motor connected to the microprocessor... The Accused Systems perform cone beam computed tomography, which requires a positioning motor to move the X-ray equipment around the patient's head. ¶10, ¶12 col. 4:17-20
d) X-ray equipment including an X-ray source and a detector array The Accused Systems are X-ray based imaging systems that use cone beam computed tomography, which requires an X-ray source and detector. ¶12 col. 4:23-26
e) conversion means for converting a signal from said detector array... The Accused Systems capture and process digital 3D models, which requires converting the analog signals from the X-ray detector into digital data. ¶12 col. 4:31-36
f) an output device connected to said microprocessor and adapted for receiving a tomographical densitometry model... The Accused Systems include an output (e.g., a monitor) where the Romexis software displays the captured 3D models for viewing and comparison. ¶12 col. 4:39-44

’262 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a computer creating, storing and comparing three-dimensional digital densitometry models without the use of fiducial markers... The Romexis software allegedly provides "overlay and side-by-side functions that link three-dimensional models obtained at different times for comparison." This is alleged to be a markerless comparison. ¶12 col. 9:8-11
a dental or orthopedic input device including an energy source and an energy sensor... The Promax 3D Imaging Systems function as the input device, using a CBCT X-ray source (energy source) and detector (energy sensor). ¶11, ¶12 col. 6:11-14
an output device... communicating densitometry model comparison information... a display associated with said output device... The overlay and side-by-side comparison views are displayed on a monitor, which communicates the comparison information to the user. ¶12 col. 6:4-10

Identified Points of Contention:

  • Scope Questions: The case may raise the question of whether the term "tomographical densitometry model," as used in the patents, can be interpreted to read on the volumetric data (e.g., Hounsfield units or grayscale values) generated by a modern CBCT system. A defendant could argue the patent term implies a more specific, quantitative density measurement, akin to dual-energy BMD, rather than the general-purpose imaging of the accused devices.
  • Technical Questions: A central question is what evidence the complaint provides that the accused software's "overlay and side-by-side functions" (Compl. ¶12) perform the active step of "comparing" models as required by claim 1 of the ’262 Patent. The analysis may focus on whether this feature is merely a passive viewing tool for manual user inspection or if it involves an automated or semi-automated comparison that aligns with the claimed function of diagnosing changes over time.

V. Key Claim Terms for Construction

  • The Term: "tomographical densitometry model" (’301 Patent, claim 1)

  • Context and Importance: This term defines the core output of the patented invention. The viability of the infringement case hinges on whether the 3D images produced by the accused CBCT systems fall within this definition. Practitioners may focus on this term because the patents' specifications link "densitometry" to specific medical techniques for measuring bone density.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification states the model can be output in various formats, "including a visual image color-coded to depict varying dental and orthopedic structure densities" (’301 Patent, col. 2:58-61). This language could support an interpretation that covers any tomographic image that visually represents density variations.
    • Evidence for a Narrower Interpretation: The background repeatedly references medical "densitometry procedures" for measuring "bone morphology density (BMD)" and the use of "dual-energy X-ray beams" (’301 Patent, col. 2:1-4, col. 5:12-16). This could support a narrower construction limiting the term to models created using specific, quantitative densitometry techniques rather than general-purpose CBCT imaging.
  • The Term: "comparing... models" (’262 Patent, claim 1)

  • Context and Importance: This term is central to the infringement allegation against the Romexis software's "overlay and side-by-side functions" (Compl. ¶12). The definition of "comparing" will determine whether a simple visual display tool meets the claim limitation.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The plain meaning of "comparing" could encompass enabling a user to visually inspect two models side-by-side or overlaid, which is what the complaint alleges the accused software does.
    • Evidence for a Narrower Interpretation: The patent describes using the comparison to monitor "osseointegration" and to distinguish "conditions requiring treatment from normal decalcification/calcification" (’262 Patent, col. 8:11-18). This context suggests "comparing" may imply a more analytical process than passive viewing, potentially requiring software-aided alignment, subtraction, or highlighting of differences.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement for all three patents, asserting that Defendant knowingly causes and intends for its customers, including medical professionals, to directly infringe by using the Accused Systems as claimed (Compl. ¶¶ 17, 23, 29).
  • Willful Infringement: The prayer for relief includes a request for a declaration that Defendant's infringement is willful and justifies enhanced damages under 35 U.S.C. § 284 (Compl., Prayer for Relief ¶D). The body of the complaint alleges Defendant acts "knowingly" in its inducement counts but does not plead specific facts establishing pre-suit knowledge of the patents.

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

  • A core issue will be one of definitional scope: can the term "tomographical densitometry model," rooted in the patents’ disclosure of specific dual-energy bone density measurement techniques, be construed to cover the three-dimensional volumetric data generated by the accused general-purpose cone beam computed tomography (CBCT) systems?
  • A key evidentiary question will be one of functional operation: does the accused Romexis software’s "overlay and side-by-side" viewing feature perform the active step of "comparing" models as required by the claims, or does it merely provide a passive tool for manual user inspection, creating a potential mismatch in technical operation?