DCT
1:10-cv-10951
Smith & Nephew Inc v. Interlace Medical Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Smith & Nephew, Inc. (Delaware)
- Defendant: Interlace Medical, Inc. (Delaware)
- Plaintiff’s Counsel: Nixon Peabody LLP
- Case Identification: 1:10-cv-10951, D. Mass., 06/09/2010
- Venue Allegations: Venue is asserted based on Defendant Interlace Medical, Inc.'s principal place of business being located within the District of Massachusetts.
- Core Dispute: Plaintiff alleges that Defendant’s MyoSure Tissue Removal Device infringes a patent related to reciprocating rotary surgical instruments.
- Technical Context: The technology concerns powered surgical instruments designed to efficiently cut and remove semi-rigid biological tissue, such as uterine fibroids or polyps, during minimally invasive procedures.
- Key Procedural History: The complaint alleges that Defendant’s Chief Technology Officer, Ronald Adams, was formerly employed by Plaintiff and was "integrally involved" with the commercialization of the technology embodied in the patent-in-suit. It further alleges that Defendant had pre-suit knowledge of the patent, citing Defendant’s own patent application filings which identified the patent-in-suit.
Case Timeline
| Date | Event |
|---|---|
| 2001-10-26 | '459 Patent Priority Date (Application Filing) |
| Late 2006 | Interlace Medical, Inc. was founded |
| 2007-06-05 | '459 Patent Issue Date |
| 2009-10-01 | Interlace receives 510K clearance for MyoSure System (approx. date) |
| 2010-06-09 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,226,459 - "Reciprocating Rotary Arthroscopic Surgical Instrument"
- Patent Identification: U.S. Patent No. 7,226,459, "Reciprocating Rotary Arthroscopic Surgical Instrument," issued June 5, 2007 (the "'459 Patent").
The Invention Explained
- Problem Addressed: The patent's background section describes how conventional arthroscopic surgical instruments, such as rotary shears, had difficulty cutting semi-rigid tissue (e.g., meniscus, intrauterine fibroids), often tending to "bounce away from the tissue" instead of initiating a cut (Compl. ¶7; ’459 Patent, col. 2:16-25). This limited their efficiency, particularly when removing large volumes of such tissue.
- The Patented Solution: The invention is a surgical instrument that uses a single, uni-directional rotational input to generate simultaneous rotation and reciprocation (i.e., back-and-forth axial translation) of a cutting member ('459 Patent, Abstract). This is accomplished through a drive mechanism comprising a "helical groove" on a drive member and a stationary "translation piece" (or follower) that rides in the groove, converting the rotation into concurrent linear motion ('459 Patent, col. 2:28-33). This combined motion allows the cutting edge to engage tissue with a "tangential approach," which the patent asserts provides a higher resection rate and shortens procedure length (Compl. ¶8; ’459 Patent, col. 2:25-33).
- Technical Importance: The claimed mechanism intended to provide a more effective and faster method for resecting tough, semi-rigid tissues compared to prior art instruments that relied on simple rotation or simple reciprocation alone (Compl. ¶8; '459 Patent, col. 2:30-33).
Key Claims at a Glance
- The complaint asserts independent claims 1, 25, 27, and 32.
- Independent Claim 1: A surgical instrument comprising:
- a cutting member including an implement for cutting tissue;
- a drive coupled to the cutting member to simultaneously rotate, translate, and reciprocate the cutting member in response to only a rotational force applied to the drive in a single direction;
- wherein the drive includes a drive member with a helical groove and a translation piece disposed in the groove, such that rotary driving of the drive member results in simultaneous reciprocation.
- Independent Claim 32: A surgical instrument comprising:
- a cutting member with an implement for cutting tissue;
- a drive with the same simultaneous motion functionality as in claim 1;
- an outer tubular member that receives the cutting member and includes a cutting window disposed proximate to its tip.
- Subsequent to the filing of this complaint, an inter partes reexamination certificate (US 7,226,459 C1, issued Jan. 25, 2019) cancelled all claims asserted in the complaint, including claims 1, 25, 27, and 32.
III. The Accused Instrumentality
Product Identification
- The MyoSure Tissue Removal Device, which is part of the MyoSure Hysteroscopic Tissue Removal System (Compl. ¶1, ¶16).
Functionality and Market Context
- The MyoSure system is described as a medical device for removing fibroids and polyps (Compl. ¶12). The complaint alleges that the key infringing functionality is that its blade "simultaneously rotates and reciprocates, which enables fast tissue cutting," a description Plaintiff attributes to Defendant’s own promotional materials (Compl. ¶12). The complaint positions the accused product as a direct competitor to Plaintiff's own "Operative Hysteroscopy System business" (Compl. ¶11).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
'459 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A surgical instrument, comprising: a cutting member including an implement for cutting tissue; | The Interlace Device includes a cutting member with an implement for cutting tissue. | ¶20 | col. 5:57-59 |
| and a drive coupled to the cutting member to simultaneously rotate, translate, and reciprocate the cutting member in response to only a rotational force applied to the drive in a single direction and to cut tissue during simultaneous rotation and translation of the cutting member; | The Interlace Device includes a drive that is coupled to the cutting member and causes it to simultaneously rotate, translate, and reciprocate in response to a single-direction rotational force. | ¶20 | col. 5:60-65 |
| wherein the drive member including a helical groove, and the drive includes a translation piece disposed in the groove such that rotary driving of the drive member results in simultaneous reciprocation of the drive member relative to the translation piece. | The drive in the Interlace Device includes a driver member with a helical groove and a translation piece, which achieves simultaneous reciprocation from rotary driving. | ¶20 | col. 6:1-6 |
- Identified Points of Contention:
- Claim Validity: The most significant issue in the case, which arose after the complaint was filed, is the validity of the asserted claims. The subsequent cancellation of claims 1, 25, 27, and 32 in reexamination would be dispositive of the infringement allegations.
- Structural Questions: Assuming the claims were valid, a central dispute would likely focus on the specific mechanism used in the accused device. The infringement analysis would require determining if the MyoSure device's drive contains a structure that meets the "helical groove" and "translation piece" limitations of claim 1, or their equivalents. The complaint's allegations on this point are conclusory and lack technical detail (Compl. ¶20).
- Functional Questions: A potential point of contention could be whether the accused device's drive operates "in response to only a rotational force applied... in a single direction" as required by the claims. The defense could explore whether any other forces or inputs are required to achieve the simultaneous motion in the accused device.
V. Key Claim Terms for Construction
The Term: "translation piece"
- Context and Importance: This term is a critical structural element in the asserted independent claims for converting rotational motion into reciprocation. Infringement hinges on whether the accused device contains a "translation piece" as construed from the patent. Practitioners may focus on this term because the patent discloses a specific embodiment of this piece, raising the question of how broadly the term should be defined.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term itself is generic. The claim language requires only that it be "disposed in the groove" to cause reciprocation from rotation (col. 6:3-6). This may support a construction that covers any component that performs this function within a helical groove.
- Evidence for a Narrower Interpretation: The specification describes the translation piece in detail as including a "follower" with a specific "arched bridge shape" and two "legs" that rest in the helical channels, as well as a separate "sealing cap" (col. 2:58-63; col. 4:36-51). An argument could be made to limit the term to the structures disclosed in these specific embodiments.
The Term: "simultaneously rotate, translate, and reciprocate"
- Context and Importance: This phrase defines the core functionality and alleged novelty of the invention. The dispute would center on whether the accused device's cutting member performs all three types of motion concurrently.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent summary broadly describes the invention's ability to "simultaneously rotate and translate" the cutting member (col. 2:19-22). The term "reciprocate" is defined as a type of translation. This could support an interpretation where any concurrent rotation and back-and-forth axial movement meets the limitation.
- Evidence for a Narrower Interpretation: A defendant might argue that the term requires three distinct, mathematically simultaneous vectors of motion at all times. More plausibly, the term could be limited by the mechanism that produces it, tying the functional language back to the "helical groove" and "translation piece" structure disclosed in the patent.
VI. Other Allegations
- Indirect Infringement: The complaint does not contain specific allegations or counts for indirect infringement (inducement or contributory infringement). The allegations focus on direct infringement by Defendant for "making, using, selling, and/or offering for sale" the accused device (Compl. ¶16).
- Willful Infringement: Willfulness is alleged based on Defendant's alleged pre-suit knowledge of the '459 Patent. The complaint provides two main factual bases: (1) the "intimate knowledge" of the patent and related technology possessed by Defendant's CTO, who was a former employee of Plaintiff; and (2) Defendant's alleged identification of the '459 Patent in invention disclosure statements filed with its own patent applications (Compl. ¶26).
VII. Analyst’s Conclusion: Key Questions for the Case
The analysis of the complaint at the time of its filing suggests several key questions. However, the subsequent reexamination of the '459 patent fundamentally altered the landscape of the dispute.
A threshold question, which was ultimately answered post-filing, is one of claim validity: are the asserted claims valid over the prior art? The USPTO’s cancellation of all asserted claims during reexamination resolved this question in the negative, rendering the infringement allegations moot.
Setting aside the dispositive validity issue, a central evidentiary question would have been one of structural correspondence: does the accused MyoSure device contain a drive mechanism with a "helical groove" and a "translation piece" that operates in the manner required by the claims? The complaint's conclusory allegations would have required substantial discovery to prove a structural match.
Finally, the case presented a significant question of willful infringement based on compelling factual allegations, namely the hiring of a key former employee and the Defendant's own alleged citation to the patent-in-suit. Had the claims survived, this would have posed a substantial risk of enhanced damages.