DCT
3:18-cv-06684
Cochlear Ltd v. Oticon Medical Ab
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Cochlear Ltd. (Australia)
- Defendant: Oticon Medical AB (Sweden); Oticon Medical LLC (New Jersey)
- Plaintiff’s Counsel: Sheppard Mullin Richter & Hampton LLP
- Case Identification: 3:18-cv-06684, D.N.J., 04/13/2018
- Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Oticon Medical LLC has its principal place of business in New Jersey and the accused products have been offered for sale and sold within the district.
- Core Dispute: Plaintiff alleges that Defendant’s Ponto BHX implant, a component of its bone anchored hearing systems, infringes a patent related to the structural design of bone anchor fixtures.
- Technical Context: The lawsuit concerns the field of osseointegrated auditory implants, which transmit sound to a user's inner ear through direct vibration of the skull bone, bypassing the outer and middle ear.
- Key Procedural History: The provided documents indicate that after this complaint was filed, the patent-in-suit was the subject of an Inter Partes Review (IPR) proceeding (IPR2019-00975) before the Patent Trial and Appeal Board (PTAB). In a certificate issued September 2, 2021, the PTAB found the asserted independent Claim 1, among others, to be patentable, a decision that may strengthen the patent's presumption of validity against future invalidity challenges.
Case Timeline
| Date | Event |
|---|---|
| 2007-07-20 | U.S. Patent No. 9,838,807 Priority Date |
| 2017-12-05 | U.S. Patent No. 9,838,807 Issue Date |
| 2018-04-13 | Complaint Filing Date |
| 2019-04-15 | IPR Proceeding (IPR2019-00975) Filed Against '807 Patent |
| 2021-09-02 | IPR Certificate Issued Confirming Patentability of Claim 1 |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,838,807 - Bone Anchor Fixture for a Medical Prosthesis
- Patent Identification: U.S. Patent No. 9,838,807, "Bone Anchor Fixture for a Medical Prosthesis," issued December 5, 2017.
The Invention Explained
- Problem Addressed: The patent addresses the need for a more effective and stable integration between a hearing aid implant screw and a patient's skull bone, particularly for patients with impaired bone quality or where earlier loading of the implant after surgery is desired (’807 Patent, col. 2:61-66).
- The Patented Solution: The invention is a screw-shaped anchoring fixture designed to improve initial stability upon implantation. It achieves this through a specific geometry, including a flange that prevents over-insertion and a main body with features that provide "compression in the radial direction on the skull bone" (’807 Patent, col. 2:12-15). This compressive action is generated by features like a wider-diameter portion of the screw body located near the flange (’807 Patent, col. 6:27-33, Fig. 2).
- Technical Importance: By improving the initial stability of the fixture, the invention aimed to enhance the reliability of the implant and potentially shorten the healing time required before the external hearing aid could be attached and used (’807 Patent, col. 2:65-66).
Key Claims at a Glance
- The complaint asserts independent Claim 1 and alleges infringement of "one or more claims" of the ’807 Patent (Compl. ¶25).
- The essential elements of independent Claim 1 are:
- An anchoring fixture for anchoring a prosthesis to a skull bone comprising:
- a screw thread apparatus including a screw thread having a varying outer diameter;
- a flange configured to function as a stop for the anchoring fixture adapted to rest on top of the bone;
- a circumferential groove located, with respect to a side of the flange, on the anchoring fixture on a threaded side of the anchoring fixture; and
- wherein the anchoring fixture is configured for anchoring a hearing prosthesis component to the skull bone behind an external ear for sound transmission via the skull.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is the "Ponto BHX implant," a component of Oticon's "Ponto" bone anchored hearing systems (Compl. ¶¶17, 21).
Functionality and Market Context
- The Ponto BHX implant is a small titanium implant surgically placed in the skull bone behind a patient's ear (Compl. ¶22). It is designed to provide "greater biomechanical fixation" and serves as the anchor for an abutment and an external sound processor (Compl. ¶¶19-20, 22). The complaint alleges the implant has screw threads, a flange, and a groove, and that it functions to transmit sound vibrations from the processor through the skull to the cochlea, bypassing the outer and middle ear (Compl. ¶¶22, pp. 7-9).
IV. Analysis of Infringement Allegations
'807 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a screw thread apparatus including a screw thread having a varying outer diameter; | The Ponto BHX implant is alleged to have "screw threads with decreasing outer diameter from the portion closer to the abutment interface to the portion that is farthest away." The complaint includes an image of this feature (Compl. p. 7). | ¶22 | col. 6:58-63 |
| a flange configured to function as a stop for the anchoring fixture adapted to rest on top of the bone when the anchoring fixture is implanted into the bone; | The Ponto BHX Implant is alleged to have a flange that serves as a stop. The complaint provides an annotated image labeling the "Flange" on the accused product (Compl. p. 8). | ¶22 | col. 6:17-21 |
| and a circumferential groove located, with respect to a side of the flange, on the anchoring fixture on a threaded side of the anchoring fixture, | The Ponto BHX Implant is alleged to have a "circumferential grove on the threaded side of the flange." The complaint includes a close-up, annotated image identifying the "Groove" (Compl. p. 8). | ¶22 | col. 4:50-54 |
| wherein the anchoring fixture is configured for anchoring a hearing prosthesis component to the skull bone at a location behind an external ear so that sound is transmitted from the hearing prosthesis via the skull bone to the cochlea. | The Ponto BHX Implant is alleged to be used in a bone anchored hearing system to anchor a sound processor to the skull, transmitting sound vibrations to the cochlea. | ¶22 | col. 2:23-35 |
- Identified Points of Contention:
- Scope Questions: The interpretation of "circumferential groove" may be a central dispute. The claim requires the groove to be "on a threaded side of the anchoring fixture." The defense may argue that the accused feature does not meet the specific structural and locational characteristics of the "groove" as described and depicted in the patent's embodiments, raising the question of whether the claim term covers any groove or only one with the specific properties taught in the specification.
- Technical Questions: A technical question is whether the accused implant's "screw threads with decreasing outer diameter" (Compl. p. 7) constitutes the claimed "screw thread apparatus including a screw thread having a varying outer diameter." The infringement analysis may turn on whether the accused structure performs the same function in substantially the same way to achieve the same result as the patented invention, particularly with respect to creating the radial compression described in the '807 Patent specification (col. 2:12-15).
V. Key Claim Terms for Construction
The Term: "circumferential groove"
Context and Importance: This term's construction is critical because direct infringement depends on whether the feature identified on the Ponto BHX implant (Compl. p. 8) meets this limitation. Practitioners may focus on this term because the patent's specification illustrates a specific type of groove that contributes to the invention's compressive function.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself is general. Parties advocating for a broader scope may argue that the term should be given its plain and ordinary meaning, which could encompass any channel or indentation around the circumference of the implant's threaded portion.
- Evidence for a Narrower Interpretation: The specification describes and depicts "circumferential grooves 117" located on a specific, wider "second portion 102C" of the implant body, adjacent to the flange (’807 Patent, Fig. 2; col. 6:49-54). A party could argue that the term should be limited to this disclosed structure, which is distinct from the main screw threads and is taught to be part of the mechanism for creating radial compression.
The Term: "screw thread apparatus including a screw thread having a varying outer diameter"
Context and Importance: This limitation defines the primary anchoring element of the fixture. The dispute will likely center on what structures fall within the scope of the "apparatus" and what constitutes a "varying outer diameter" in the context of the patent.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A plaintiff may argue this term is broad enough to read on any implant screw that is not perfectly cylindrical, such as one with a continuous taper, as this would inherently have a "varying outer diameter."
- Evidence for a Narrower Interpretation: A defendant may argue that the term "apparatus" implies a more complex structure than a simple tapered screw. The specification describes a multi-part body with a "distal tapered apical portion 102A," a "first portion 102B," and a "second portion 102C," which work together to achieve the desired compressive effect (’807 Patent, col. 6:61-65). This could support a narrower construction requiring a combination of features rather than just a simple taper.
VI. Other Allegations
- Indirect Infringement: The complaint does not plead separate counts for indirect infringement. However, the prayer for relief includes a request for an injunction against "contribution to infringement or inducement of infringement" (Compl. p. 10, ¶(b)). The complaint's factual allegations focus on the sale of the infringing implant and do not specify facts to support the knowledge and intent elements required for an indirect infringement claim.
- Willful Infringement: The complaint makes no explicit allegation of willful infringement and pleads no facts to suggest that the defendants had pre-suit knowledge of the ’807 Patent.
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of claim construction: Can the term "circumferential groove," as disclosed in the '807 Patent's specific embodiments, be construed broadly enough to read on the accused feature of the Ponto BHX implant, or is it limited to the specific structure shown in the patent's figures which contributes to radial compression?
- A key evidentiary question will be one of infringement: Assuming the claim terms are construed, does the accused Ponto BHX implant, as a whole, operate in a manner that meets all limitations of Claim 1? Specifically, does its design create the radial compression that is a stated object of the patented invention?
- A significant procedural factor will be the impact of the IPR proceeding: How will the PTAB's decision confirming the patentability of the asserted claim over an invalidity challenge influence the litigation, particularly regarding settlement leverage and the resources the defendant is willing to expend on further invalidity defenses in district court?