Ethicon Endo Surgery Inc v. Covidien Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Ethicon Endo-Surgery, Inc. (Ohio) and Ethicon Endo-Surgery, LLC (Delaware)
  • Defendant: Covidien, Inc. (Delaware) and Tyco Healthcare Group, LP (Delaware)
  • Plaintiff’s Counsel: Frost Brown Todd LLC
• Case Identification: 1:11-cv-00871, S.D. Ohio, 06/13/2012
• Venue Allegations: Venue is based on Defendants’ business contacts within the Southern District of Ohio, including marketing, sales, and specific product demonstrations of the accused device at facilities associated with The Ohio State University and in Cincinnati.
• Core Dispute: Plaintiff alleges that Defendant’s Sonicision™ Cordless Ultrasonic Dissection Device infringes nine of its utility and design patents related to the mechanical construction, electronic control systems, and ornamental design of ultrasonic surgical instruments.
• Technical Context: Ultrasonic surgical instruments use high-frequency mechanical vibrations to simultaneously cut and coagulate biological tissue, representing a significant technology in both open and minimally invasive surgery.
• Key Procedural History: The complaint notes that U.S. Patent No. 5,322,055 underwent reexamination in 1996, resulting in the confirmation of some claims and the amendment or addition of others. The complaint also highlights that in seeking FDA approval for the accused product, Defendant represented to the FDA that its device was "substantially similar" to Plaintiff's commercial ultrasonic products.

Case Timeline

Date	Event
1993-01-27	U.S. Patent No. 5,322,055 Priority Date
1994-06-21	U.S. Patent No. 5,322,055 Issued
1996-XX-XX	U.S. Patent No. 5,322,055 Reexamination
1997-02-28	U.S. Patent No. 5,989,275 Priority Date
1997-04-16	U.S. Patent No. 5,897,569 Priority Date
1997-07-09	U.S. Patent No. 5,938,633 Priority Date
1999-04-27	U.S. Patent No. 5,897,569 Issued
1999-08-17	U.S. Patent No. 5,938,633 Issued
1999-11-23	U.S. Patent No. 5,989,275 Issued
2005-02-24	U.S. Patent No. 8,182,501 Priority Date
2008-10-03	Design Patents Priority Date
2010-06-XX	Defendant submits 510(k) application to FDA for Sonicision
2011-02-24	FDA approves Sonicision for marketing
2011-08-24	Date of Defendant's alleged awareness of '055 patent infringement
2012-04-23	Date of Defendant's alleged awareness of '569, '633, and '275 patent infringement
2012-05-22	U.S. Patent No. 8,182,501 Issued
2012-05-22	Date of Defendant's alleged awareness of '501 patent infringement
2012-06-12	Design Patents D661,801, D661,802, D661,803, D661,804 Issued
2012-06-12	Date of Defendant's alleged awareness of design patent infringement
2012-06-13	Amended Complaint Filed

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

U.S. Patent No. 5,322,055 - "Clamp Coagulator/Cutting System For Ultrasonic Surgical Instruments," issued June 21, 1994

The Invention Explained

• Problem Addressed: The patent's background describes that prior ultrasonic surgical instruments, which required an operator to press a vibrating blade directly against tissue, were not effective on soft or loosely supported tissue because sufficient pressure could not be applied to couple the ultrasonic energy (’055 Patent, col. 1:49-65). Existing clamp designs were described as lacking versatility (’055 Patent, col. 2:5-12).
• The Patented Solution: The invention provides a clamp coagulator accessory for an ultrasonic instrument, featuring a clamp jaw that pivots to press tissue against the vibrating blade. Crucially, the clamping force is applied in a direction "normal to the direction of vibration," which is described as achieving faster coagulation and cutting with less attenuation of the blade's motion (’055 Patent, col. 2:15-24). The design also allows the blade and clamp to be rotated relative to each other to perform different functions (’055 Patent, col. 2:59-68).
• Technical Importance: This clamping mechanism improved the control and efficiency of ultrasonic surgical tools, expanding their applicability to a wider range of tissue types and endoscopic procedures (’055 Patent, col. 2:25-29).

Key Claims at a Glance

• The complaint asserts independent claim 1 and dependent claims 2, 10-14, as well as reexamined claims 42, 45-47, and 50-52 (Compl. ¶58).
• Independent claim 1 includes the following essential elements:
  • An ultrasonic surgical apparatus with a housing, an ultrasonic element, and a surgical blade with an elongated edge that vibrates in a longitudinal direction.
  • A clamp carried by the apparatus in opposition to the blade.
  • The clamp is for "biasing tissue" between the clamp and blade with movement in a direction "substantially normal to the longitudinal direction of vibration."
  • A "means for selectively displacing said clamp toward and away from said blade."

U.S. Patent No. 5,897,569 - "Ultrasonic Generator With Supervisory Control Circuitry," issued April 27, 1999

The Invention Explained

• Problem Addressed: The patent identifies that ultrasonic surgical systems can operate at suboptimal frequencies due to environmental factors like temperature changes or when using longer transmission components. This "loss of resonance" can lead to undesirable oscillatory nodes and inefficient performance (’569 Patent, col. 1:24-35).
• The Patented Solution: The invention is a generator incorporating a "supervisory control circuit" that works alongside a standard phase lock loop feedback system. This supervisory circuit automatically detects a non-resonant condition and, in response, applies an overriding control signal to the system's oscillator to restore resonance. The system can store and use the "most recent resonant frequency condition" as a starting point to reduce the time needed to re-establish resonance (’569 Patent, col. 2:2-16; Abstract).
• Technical Importance: This "smart generator" technology enhances the stability and reliability of ultrasonic instruments by actively managing and correcting for operational deviations, thereby ensuring consistent and effective energy delivery (’569 Patent, col. 2:20-24).

Key Claims at a Glance

• The complaint asserts claims 30, 31, 32, and 33 (Compl. ¶75).
• Independent claim 30 includes the following essential elements:
  • A generator for providing electric signals to a transducer assembly.
  • A phase lock loop generating an output signal having a desired frequency.
  • Detector circuitry to detect a non-resonant condition of the phase lock loop.
  • A processing unit coupled to the detector circuitry to provide an input signal to the phase lock loop of a desired condition.

U.S. Patent No. 5,938,633 - "Ultrasonic Surgical Devices," issued August 17, 1999

• Technology Synopsis: The patent addresses the difficulty of attaching, detaching, and manipulating ultrasonic instruments in a sterile surgical field, particularly the need for torque wrenches (’633 Patent, col. 1:21-32). The invention provides a surgical instrument assembly where the end effector can be rotated relative to the handpiece while the transducer is vibrating, which improves surgical ergonomics and flexibility (’633 Patent, col. 2:3-10).
• Asserted Claims: Independent claim 1 and multiple dependent claims (Compl. ¶92).
• Accused Features: The complaint alleges infringement by the Sonicision device's overall construction, which allows for its components to be assembled and manipulated during surgical procedures (Compl. ¶92).

U.S. Patent No. 5,989,275 - "Damping Ultrasonic Transmission Components," issued November 23, 1999

• Technology Synopsis: The patent is directed at mitigating undesired transverse (side-to-side) vibrations in the long transmission components of ultrasonic devices, which can cause energy loss and excessive heat (’275 Patent, col. 1:20-34). The patented solution is an inner damping member or sheath that surrounds and contacts the transmission component to absorb these unwanted vibrations without the use of a damping fluid (’275 Patent, col. 2:3-12).
• Asserted Claims: Independent claim 1 and multiple dependent claims (Compl. ¶109).
• Accused Features: The internal components of the Sonicision device responsible for managing mechanical vibrations are accused of infringement (Compl. ¶109).

U.S. Patent No. 8,182,501 - "Ultrasonic Surgical Shears and Method For Sealing a Blood Vessel Using Same," issued May 22, 2012

• Technology Synopsis: The invention addresses the need for more effective sealing of blood vessels with ultrasonic shears, particularly vessels larger than 3mm (’501 Patent, col. 1:51-55). The solution is a method and apparatus that applies a specific, higher range of "coaptation pressure" (between 60 and 210 psi) on the blood vessel, which is described as resulting in successful sealing with shorter transection times compared to conventional pressures (’501 Patent, col. 2:25-33).
• Asserted Claims: Method and apparatus claims, including independent claims 1 and 12, are asserted (Compl. ¶¶126, 131).
• Accused Features: The complaint accuses the Sonicision device's functionality, specifically the clamping force and resulting pressure it applies to tissue, of infringing the patented method and apparatus (Compl. ¶¶126, 131).

U.S. Design Patent Nos. D661,801; D661,802; D661,803; and D661,804 - "User Interface for a Surgical Instrument," issued June 12, 2012

• Technology Synopsis: These four design patents protect the ornamental, non-functional appearance of a user interface for a surgical instrument, covering various configurations of the handle, grips, and control surfaces.
• Asserted Claims: Each design patent contains a single claim for the ornamental design as shown in its figures.
• Accused Features: The aesthetic and ornamental design of the Sonicision device's handle and user interface is accused of infringing the designs claimed in these patents (Compl. ¶¶143, 160, 177, 194).

III. The Accused Instrumentality

Product Identification

• The accused instrumentality is the Sonicision™ Cordless Ultrasonic Dissection Device ("Sonicision") (Compl. ¶2).

Functionality and Market Context

• The Sonicision is described as a cordless, energy-based surgical device used to cut and coagulate tissue in a variety of procedures, including general, bariatric, and gynecological surgeries (Compl. ¶36). The device consists of components including a single-use dissector and a reusable generator (Compl. ¶34). The complaint alleges that the Sonicision device is Defendant's first entry into the "$800 million ultrasonic market" and that, in obtaining regulatory approval, Defendant represented to the FDA that its device was "substantially similar" to Plaintiff's own commercial products (Compl. ¶¶30, 36).

IV. Analysis of Infringement Allegations

The complaint does not contain specific claim charts or detailed technical allegations mapping product features to claim limitations. The following summaries are based on the complaint's general allegations of infringement.

5,322,055 Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
a clamp carried by said apparatus in opposition to said blade ... for biasing tissue between the clamp and the blade...	The accused Sonicision device is an ultrasonic dissector that necessarily includes a clamp and blade configuration to grasp and treat tissue.	¶¶2, 58	col. 2:50-58
...for movement in a direction toward the blade and substantially normal to the longitudinal direction of vibration of said blade...	The complaint alleges infringement of claims requiring this functionality, implying the Sonicision clamp applies force perpendicularly to the blade's vibration to effectuate cutting and coagulation.	¶58	col. 2:19-24
...and means for selectively displacing said clamp toward and away from said blade.	The accused Sonicision device, as a surgical instrument, includes a user-operated mechanism to open and close its clamp jaw.	¶¶2, 58	col. 3:6-15

5,897,569 Infringement Allegations

Claim Element (from Independent Claim 30)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
a phase lock loop generating an output signal having a desired frequency;	The reusable generator component of the accused Sonicision device is alleged to contain the claimed control circuitry, including a phase lock loop to maintain the operational frequency of the instrument.	¶¶34, 75	col. 9:8-12
detector circuitry to detect a non-resonant condition of the phase lock loop;	The generator is alleged to contain circuitry that monitors the system and detects when it deviates from a resonant operating state.	¶75	col. 9:56-61
and a processing unit coupled to the detector circuitry to provide an input signal to the phase lock loop of a desired condition.	The generator is alleged to contain a processing unit that actively intervenes upon detection of a non-resonant condition to provide a corrective input signal to restore resonance.	¶75	col. 10:1-12

Identified Points of Contention

• For the ’055 Patent, a central technical question may be whether the accused device's clamp applies force in a direction that is "substantially normal" to the blade's longitudinal vibration, and how the term "substantially" should be construed in this mechanical context.
• For the ’569 Patent, the dispute may focus on the specific architecture of the accused generator's control system. An issue for the court could be whether the Sonicision generator employs distinct "detector circuitry" and a "processing unit" that provides an override signal as claimed, or whether it maintains resonance using a different, potentially non-infringing feedback mechanism.

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

The Term: "substantially normal to the longitudinal direction of vibration" (’055 Patent, Claim 1)

• Context and Importance: This term defines the core functional principle of the ’055 patent's clamping mechanism. The infringement analysis for the asserted claims of the ’055 patent may depend on whether the force vector of the accused device's clamp meets this geometric requirement.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification contrasts the claimed "normal" direction with a "parallel" direction, suggesting that any force direction that is not primarily parallel could be considered "substantially normal" for the purpose of achieving the stated benefit of reduced blade motion attenuation (Compl. ¶5:24-30). The use of the word "substantially" may also support a construction that does not require a perfect 90-degree angle.
  • Evidence for a Narrower Interpretation: The patent figures illustrate a pivoting clamp jaw (e.g., ’055 Patent, Fig. 3). A party could argue that for a pivoting jaw, the force is applied at an angle that changes along the jaw's surface, and that "substantially normal" requires the principal force vector to be perpendicular to the blade, a condition that may not be met by the accused device's specific geometry.

The Term: "detector circuitry to detect a non-resonant condition" (’569 Patent, Claim 30)

• Context and Importance: This term is critical because it may require more than a standard feedback loop that simply maintains resonance. Its construction will determine whether the accused generator must have a specific, discrete circuit block for detecting the loss of resonance, as opposed to an integrated system that inherently corrects for drift.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party might argue that any logic within the generator that senses a deviation from resonance and triggers a corrective action performs the function of "detector circuitry," regardless of its specific implementation as a physically separate component.
  • Evidence for a Narrower Interpretation: The patent's block diagram in Figure 3 explicitly shows a "Lock Detector" (162) as a distinct component that provides an "In-Lock Signal" (164) to a "Controller" (166). This could support an interpretation that the claim requires a specific circuit whose function is to make a binary determination (resonant vs. non-resonant) before a separate "processing unit" takes corrective action (’569 Patent, Fig. 3; col. 9:56-61).

VI. Other Allegations

• Indirect Infringement: The complaint alleges both induced and contributory infringement for all asserted utility patents. The factual basis for inducement is the allegation that Defendants encourage physicians and others to use the Sonicision device during product demonstrations with knowledge of infringement (Compl. ¶¶13, 63, 80). The basis for contributory infringement is the allegation that Defendants provide components of the Sonicision device that are not staple articles of commerce and are known to be used in an infringing manner (Compl. ¶¶64, 81).
• Willful Infringement: Willfulness is alleged for all asserted patents. The complaint alleges that Defendants were aware of the patents-in-suit and of their infringement, yet continued their infringing activities (Compl. ¶¶53-56, 60, 77). The complaint provides specific dates on which Defendants allegedly became aware of each family of patents.

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

• A central issue of claim scope and technical operation will be whether the Sonicision device's clamp applies force "substantially normal" to its blade's vibration. The resolution will depend on both the court's interpretation of "substantially" and factual evidence regarding the accused device's mechanical function.
• A key evidentiary question will be one of circuit architecture: does the accused Sonicision generator contain the specific "detector circuitry" and "processing unit" that perform the claimed override function to restore resonance as required by the ’569 patent, or does it utilize a different, non-infringing control system?
• A third core issue will be one of knowledge and intent. With allegations of willfulness and indirect infringement predicated on "information and belief," the case may turn on what evidence Plaintiff can introduce to establish that Defendant had pre-suit knowledge of the specific patents and acted with objective recklessness or specific intent to induce infringement by others.