DCT

1:00-cv-10769

McCue PLC v. Massachusetts Insti

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:00-cv-10769, D. Mass., 04/20/2000
  • Venue Allegations: Venue is alleged as proper in the District of Massachusetts under 28 U.S.C. §1391(b) and (c), as Defendants reside in the district.
  • Core Dispute: This is a declaratory judgment action in which Plaintiff, a manufacturer of medical devices, seeks a court ruling that its product does not infringe Defendants' patents and that the patents are invalid, following an infringement lawsuit filed by Defendants against Plaintiff's U.S. distributor.
  • Technical Context: The dispute centers on ultrasound technology used for the non-invasive, in-vivo diagnosis of bone conditions, particularly osteoporosis, by analyzing the propagation of sound waves through bone.
  • Key Procedural History: The complaint notes that Defendants MIT and Hologic previously filed a lawsuit in the same district against Norland Medical Systems, Inc., Plaintiff's exclusive U.S. distributor, alleging that the sale of Plaintiff's product infringes the patents-in-suit. Plaintiff states it has an agreement to indemnify its distributor, Norland, creating the basis for the current declaratory judgment action.

Case Timeline

Date Event
1986-06-03 U.S. Patent No. 4,913,157 Priority Date
1990-04-03 U.S. Patent No. 4,913,157 Issue Date
1995-06-07 U.S. Patent No. 5,755,228 Priority Date
1998-05-26 U.S. Patent No. 5,755,228 Issue Date
2000-04-20 Complaint Filing Date

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

U.S. Patent No. 4,913,157 - Ultrasound Method and Apparatus for Evaluating, In Vivo, Bone Conditions, Issued Apr. 3, 1990

The Invention Explained

  • Problem Addressed: The patent describes a need for diagnostic methods to determine bone conditions like osteoporosis that are non-invasive, accurate, sensitive, and widely available, noting that prior art techniques such as X-rays, Computer Aided Tomography (CAT scans), and Neutron Activation Analysis involved exposure to radiation, were expensive, or were not generally available for early diagnosis (’157 Patent, col. 2:34-40, col. 2:51-65).
  • The Patented Solution: The invention proposes a method and system for analyzing bone by launching an ultrasonic signal with at least two distinguishable frequency components through a bony member (e.g., the patella). The system then analyzes how the transmission characteristics of the signal—such as the transit times of the different frequency components or the signal's gain and phase—are altered by passing through the bone, and compares this information to a database to assess the bone's condition ('157 Patent, Abstract; col. 4:33-51).
  • Technical Importance: This approach provided a method for evaluating bone density and structure that avoided ionizing radiation, suggesting the possibility of safer, more frequent, and more accessible screening for degenerative bone diseases ('157 Patent, col. 4:15-25).

Key Claims at a Glance

  • The complaint does not specify which claims will be at issue. Independent claim 1 is a representative method claim.
  • Independent Claim 1 requires the steps of:
    • launching into a patient an ultrasound signal having at least one component above a first predetermined frequency and at least one component below a second predetermined frequency
    • monitoring the resulting ultrasound spectrum at a second position
    • extracting a time-domain high frequency signal and a time-domain low frequency signal from the monitored spectrum
    • comparing the high frequency signal to the low frequency signal to indicate the bone's condition

U.S. Patent No. 5,755,228 - Equipment and Method for Calibration and Quality Assurance of an Ultrasound Bone Analysis Apparatus, Issued May 26, 1998

The Invention Explained

  • Problem Addressed: The patent notes that the precision and reliability of ultrasound bone scanners are of “substantial importance,” but performing calibration and quality assurance can be difficult. Reference media like water are inconvenient, and other existing “phantoms” (substitute test materials) did not adequately mimic the acoustic properties of human bone and tissue, complicating accurate calibration (’228 Patent, col. 1:21-35, col. 1:60-64).
  • The Patented Solution: The invention discloses various phantoms with specific, defined acoustic properties designed to calibrate and test ultrasound bone analysis equipment. These include a phantom with a “substantially flat” attenuation-versus-frequency profile for establishing a baseline, a phantom that mimics the attenuation properties of a human foot, and a phantom with a temperature-independent speed of sound (SOS) for stable calibration ('228 Patent, Abstract; col. 2:41-65).
  • Technical Importance: The use of standardized phantoms with known, tissue-like properties allows for reliable calibration and quality assurance, aiming to ensure that diagnostic measurements are accurate and consistent across different machines and over time ('228 Patent, col. 1:16-20).

Key Claims at a Glance

  • The complaint does not specify which claims will be at issue. Independent claims 1, 13, and 22 cover different embodiments of the invention.
  • Independent Claim 1 covers a phantom comprising a plug with specific features, including an “attenuation-versus-frequency profile that is substantially flat” and a “sound impedance that approximates that of soft human tissue.”
  • Independent Claim 13 covers a phantom comprising a block of material that has an attenuation profile that “approximates that of a human foot.”
  • Independent Claim 22 covers a phantom comprising a housing and a mixture of ethyl alcohol and water that has a “predetermined SOS that is substantially temperature-independent.”

III. The Accused Instrumentality

Product Identification

The C.U.B.A. Clinical (Contact Ultrasound Bone Analyzer) system (Compl. ¶10).

Functionality and Market Context

The complaint identifies the C.U.B.A. Clinical system as a device used for ultrasound bone analysis (Compl. ¶10). The complaint does not provide sufficient detail for analysis of the product's specific technical functionality or operation. The device is manufactured by Plaintiff McCue and distributed in the United States exclusively by Norland Medical Systems, Inc. (Compl. ¶¶11, 12). Defendants have alleged in a separate lawsuit that this device infringes the patents-in-suit (Compl. ¶¶9, 10).

IV. Analysis of Infringement Allegations

This declaratory judgment complaint seeks a ruling of non-infringement and does not contain affirmative infringement allegations or claim charts. The asserted basis for the dispute is a separate infringement lawsuit filed by Defendants against Plaintiff's distributor concerning the C.U.B.A. Clinical system (Compl. ¶9). The complaint does not specify which patent claims were asserted in that action or provide any theory of how the product allegedly infringes.

No probative visual evidence provided in complaint.

Identified Points of Contention

  • For the ’157 Patent:
    • Scope Question: A central dispute may concern whether the analytical method employed by the C.U.B.A. Clinical system falls within the scope of the patent's claims, such as “comparing the time-domain high frequency signal to the time-domain low frequency signal” (Claim 1). The interpretation of “comparing” and the specific signal processing steps required will be critical.
    • Technical Question: A key factual question will be whether the ultrasound signal generated and processed by the accused device meets the specific multi-component frequency and time-domain characteristics recited in the claims.
  • For the ’228 Patent:
    • Scope Question: Infringement of the '228 patent, which is directed to calibration phantoms and methods, raises the question of whether the calibration tools and procedures sold with or used to maintain the C.U.B.A. Clinical system constitute a “phantom” as defined by the claims (e.g., possessing a “substantially flat” attenuation profile or approximating a “human foot”).
    • Technical Question: The case may turn on evidence of the physical composition, acoustic properties, and intended use of any reference materials employed for the calibration and quality assurance of the C.U.B.A. Clinical system.

V. Key Claim Terms for Construction

Term from the ’157 Patent: "comparing the time-domain high frequency signal to the time-domain low frequency signal" (Claim 1)

  • Context and Importance: This phrase defines the core analytical step of the claimed method. The breadth of “comparing” will likely be a significant point of contention, determining whether a wide range of analytical algorithms infringe or if the claim is limited to the specific techniques disclosed.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification suggests various ways to evaluate the relationship between signal components, including analyzing a “ratio of the first arrival times,” generating “a function of the power spectra,” or evaluating a “gain function” (col. 17:21-34; col. 6:5-12). This language may support an interpretation that covers any mathematical or functional comparison between the two signal types.
    • Evidence for a Narrower Interpretation: The patent's detailed description and figures prominently feature a specific process involving a Fourier transform followed by two separate inverse transforms to generate the high and low frequency signals for evaluation (col. 17:59-col. 18:8; FIG. 9). A party may argue that “comparing” should be construed in light of this specific embodiment, limiting the claim to that particular analytical pathway.

Term from the ’228 Patent: "a phantom" (Claims 1, 13, 22)

  • Context and Importance: The definition of “phantom” is central to the '228 patent. Whether any calibration objects used with the accused C.U.B.A. Clinical system meet this definition will be a dispositive issue for infringement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The background section introduces a phantom simply as a “substitute medium” for performing calibration and quality assurance ('228 Patent, col. 1:33-35). This could support a broad definition covering any object used as a reference standard.
    • Evidence for a Narrower Interpretation: The claims themselves explicitly define the “phantom” by reciting specific, limiting physical characteristics. For example, Claim 1 requires an “attenuation-versus-frequency profile that is substantially flat,” and Claim 13 requires an attenuation profile that “approximates that of a human foot.” This suggests that the term is not generic but is instead defined by the specific functional and physical properties recited in each claim.

VI. Other Allegations

  • Indirect Infringement: The complaint seeks a declaratory judgment that Plaintiff McCue “has not actively induced any others to infringe any valid claim” of the patents-in-suit (Compl. ¶17). The complaint does not, however, allege any specific facts regarding inducement.
  • Willful Infringement: The complaint makes no mention of willful infringement. However, in its prayer for relief, Plaintiff requests a finding that the action is “exceptional under 35 U.S.C. §285” and an award of attorneys' fees (Compl. p. 4, ¶E). This suggests Plaintiff may intend to argue that the infringement allegations made against its distributor were baseless or pursued in bad faith.

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

  1. A primary issue for the ’157 patent will be one of methodological scope: Does the signal processing algorithm of the C.U.B.A. Clinical system perform the function of “comparing” high and low frequency time-domain signals as that term is construed from the patent, or does it utilize a technically distinct and non-infringing analytical approach?
  2. The dispute over the ’228 patent will likely center on a question of definitional scope: Do the materials and methods used for the calibration and quality assurance of the accused system meet the specific physical and acoustic properties required to be considered a “phantom” under the patent's claims, or are they standard reference tools that fall outside the claimed invention?
  3. An underlying legal question is one of controversy and standing: Does the infringement suit filed by Defendants against Plaintiff's distributor, coupled with the indemnification agreement, create a sufficient “actual controversy” between the manufacturer (McCue) and the patentees (MIT/Hologic) to sustain this declaratory judgment action?