DCT

1:15-cv-01031

Hologic Inc v. Minerva Surgical Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:15-cv-01031, D. Del., 11/06/2015
  • Venue Allegations: Venue is alleged to be proper as Defendant is subject to personal jurisdiction in the district, and a substantial part of the events giving rise to the claims allegedly occurred there.
  • Core Dispute: Plaintiff alleges that Defendant’s Minerva Endometrial Ablation System infringes three U.S. patents related to systems and methods for endometrial ablation and for detecting uterine perforations.
  • Technical Context: The technology concerns radiofrequency (RF) endometrial ablation, a medical procedure to remove the uterine lining as a treatment for abnormal uterine bleeding.
  • Key Procedural History: A significant post-filing event concerns U.S. Patent No. 6,872,183. An Inter Partes Review (IPR) proceeding (IPR2016-00868) was initiated against the patent, resulting in a certificate issued on February 24, 2020, canceling all claims (1-15). This development presents a substantial challenge to the continued assertion of the ’183 Patent in this litigation.

Case Timeline

Date Event
1998-05-08 Priority Date for ’898 and ’348 Patents
1999-11-10 Priority Date for ’183 Patent
2001-01-01 Plaintiff's NovaSure® system approved for use by the FDA
2005-03-29 U.S. Patent No. 6,872,183 Issued
2015-04-07 U.S. Patent No. 8,998,898 Issued
2015-08-01 Accused Minerva Endometrial Ablation Device commercialized
2015-08-04 U.S. Patent No. 9,095,348 Issued
2015-11-06 Complaint Filed
2016-04-11 Inter Partes Review initiated against ’183 Patent
2020-02-24 U.S. Patent Office issues certificate canceling all claims of ’183 Patent

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

U.S. Patent No. 6,872,183 - “System and Method for Detecting Perforations in a Body Cavity”

The Invention Explained

  • Problem Addressed: The patent addresses the risk of inadvertent injury during medical procedures within a body cavity, such as the uterus. A pre-existing perforation could allow a treatment device, like an ablation tool, to pass through the uterine wall, potentially causing severe harm to adjacent organs like the bowel (’183 Patent, col. 1:35-46).
  • The Patented Solution: The invention is a safety system that verifies the integrity of the body cavity before treatment. It introduces a fluid (e.g., CO2 gas) to slightly pressurize the cavity and then uses a pressure sensor to monitor whether the pressure is maintained over a test period. If the pressure drops, it indicates a likely leak (perforation), and the system can automatically lock out the primary treatment function (such as RF power delivery) to prevent its activation (’183 Patent, Abstract; col. 2:9-19).
  • Technical Importance: This technology provides an integrated safety check to evaluate cavity integrity immediately prior to an invasive and potentially hazardous procedure, reducing the risk of a significant medical complication (’183 Patent, col. 1:41-46).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 9, along with dependent claims 2-7, 11, and 13-15 (Compl. ¶20).
  • Independent Claim 1 requires the steps of:
    • inserting an ablation device into a uterus;
    • flowing an inflation medium into the uterus;
    • monitoring for the presence of a perforation in the uterus using a pressure sensor; and
    • treating the interior of the uterus using the ablation device.
  • The complaint asserts the right to pursue infringement of additional claims not explicitly listed (Compl. ¶20).

U.S. Patent No. 8,998,898 - “Moisture Transport System for Contact Electrocoagulation”

The Invention Explained

  • Problem Addressed: During RF ablation, moisture (liquid and steam) released from the tissue can accumulate at the treatment site. This moisture can create an alternative, low-resistance path for the RF current, causing it to heat the fluid rather than the target tissue. This transforms the procedure into a less predictable and less controllable "passive heating" process, which can lead to unintended thermal damage and inconsistent ablation depths (’898 Patent, col. 2:2-21).
  • The Patented Solution: The invention features an ablation device with an electrode array mounted on a fluid-permeable and/or absorbent material. As the procedure generates moisture, the system actively or passively draws it away from the electrode-tissue interface, for example, through an integrated suction path. This ensures that the RF energy remains focused on desiccating the tissue directly, leading to a more controlled, self-terminating procedure that stops once the tissue's impedance rises sufficiently (’898 Patent, Abstract; col. 2:43-49).
  • Technical Importance: This moisture transport system allows for greater control over the depth of tissue ablation and enhances safety by preventing uncontrolled heating caused by steam and liquid buildup (’898 Patent, col. 2:27-34).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 14, along with dependent claims 2-6, 8, 15, and 16 (Compl. ¶31).
  • Independent Claim 1 requires the steps of:
    • positioning a first electrode within the uterus, which involves extending a tubular member through the cervix and "substantially sealing" the opening around it;
    • delivering ablation energy via electrodes, which causes moisture release from the uterine walls; and
    • removing the released moisture "through a continuously open flow path through the tubular member" during the energy delivery step.
  • The complaint asserts the right to pursue infringement of additional claims not explicitly listed (Compl. ¶31).

U.S. Patent No. 9,095,348 - “Moisture Transport System for Contact Electrocoagulation”

Technology Synopsis

Belonging to the same family as the ’898 Patent, the ’348 Patent focuses on the mechanical structure of an ablation device. It claims an apparatus with an applicator head that uses a system of internal and external flexures to expand and conform to the shape of the uterus. The device also includes an indicator mechanism operably coupled to the deployment mechanism to indicate a dimension of the uterus, such as its width (’348 Patent, Claim 1).

Asserted Claims

The complaint asserts independent claim 1 and dependent claims 3 and 8-10 (Compl. ¶42).

Accused Features

The complaint alleges that the Minerva Endometrial Ablation System is an infringing apparatus due to its "substantially similar designs" (Compl. ¶41-42).

III. The Accused Instrumentality

Product Identification

The Minerva Endometrial Ablation System and its use (Compl. ¶¶13, 20, 31, 42).

Functionality and Market Context

  • The complaint alleges the accused product is an endometrial ablation system for treating abnormal uterine bleeding (Compl. ¶7). It further alleges that the product directly competes with Plaintiffs' own NovaSure® system (Compl. ¶13).
  • The complaint does not provide sufficient detail for analysis of the specific technical operation of the Minerva Endometrial Ablation System. It alleges that the product's operator's manual is available from the FDA website but does not provide the manual or describe its contents (Compl. ¶13).

IV. Analysis of Infringement Allegations

The complaint provides only general allegations of infringement without specific factual support mapping accused product features to claim elements. Therefore, a formal claim chart cannot be constructed based on the pleading. No probative visual evidence provided in complaint. The narrative infringement theory is that the accused Minerva system has a "substantially similar" design and function to Plaintiffs' patented technology (Compl. ¶¶19, 30, 41).

’183 Patent Infringement Allegations

The complaint alleges that making, using, or selling the Minerva system infringes the ’183 Patent (Compl. ¶20). The central question for infringement would be whether the accused system performs a pre-treatment uterine integrity check by flowing a fluid and monitoring pressure as claimed. However, the subsequent cancellation of all claims of the ’183 Patent in an IPR proceeding makes any infringement analysis likely moot, as an invalid patent cannot be infringed.

’898 Patent Infringement Allegations

The complaint alleges that the method of using the Minerva system infringes the ’898 Patent (Compl. ¶31). A primary point of contention will likely be whether the Minerva system performs the claimed step of "removing the released moisture through a continuously open flow path" during the delivery of ablation energy. The evidence will need to show not just that moisture is managed, but that it is removed via a specific pathway structure and contemporaneously with energy delivery, as required by the claim.

V. Key Claim Terms for Construction

Term: "monitoring for the presence of a perforation" (’183 Patent, Claim 1)

  • Context and Importance: This term defines the core safety function of the ’183 Patent. The viability of the infringement claim hinges on whether the accused device performs an action that falls within the scope of this term.
  • Intrinsic Evidence for a Broader Interpretation: A party might argue the term should cover any method of assessing uterine integrity before ablation, not limited to a specific pressure test.
  • Intrinsic Evidence for a Narrower Interpretation: The specification describes a specific process where fluid is delivered to "slightly pressurize the cavity" and a "pressure sensing system monitors the pressure... for a predetermined test period" to see if it is "substantially sustained" (’183 Patent, Abstract). A party would argue that "monitoring" must be construed to include these specific actions of pressurizing and sensing a sustained pressure level over time.

Term: "removing the released moisture through a continuously open flow path" (’898 Patent, Claim 1)

  • Context and Importance: This term is central to distinguishing the invention from prior art that might have incidental moisture management. Practitioners may focus on this term because the dispute will likely turn on whether the accused device’s mechanism for handling steam and liquid meets the structural ("continuously open flow path") and functional ("removing... during the delivering step") requirements.
  • Intrinsic Evidence for a Broader Interpretation: A party could argue this phrase simply requires a passive vent or other pathway that is not actively closed during the procedure, allowing moisture to escape.
  • Intrinsic Evidence for a Narrower Interpretation: The specification emphasizes actively or passively drawing moisture "away from the tissue" and into the device via a "permeable" member to prevent a conductive liquid layer from forming (’898 Patent, Abstract; col. 2:43-49). This suggests the "path" is an engineered channel integrated with the device, and "removing" is a specific function designed to control the ablation physics, not just incidental venting.

VI. Other Allegations

Indirect Infringement

The complaint alleges that Defendant induces infringement by providing "video and print instructions" that direct customers to use the Minerva system in an infringing manner. It also alleges contributory infringement on the basis that the Minerva system is especially made for an infringing use and is not a staple article of commerce (Compl. ¶¶21, 32, 43).

Willful Infringement

Willfulness is alleged for all three patents. For the ’183 and ’898 patents, the complaint alleges knowledge based on the commercial existence of Plaintiffs' NovaSure® product and, at a minimum, knowledge as of the filing of the complaint (Compl. ¶¶18-19, 29-30). A similar allegation is made for the recently issued ’348 patent, establishing a basis for potential post-suit willfulness (Compl. ¶¶40-41).

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

  1. Patent Validity: A threshold issue for the ’183 Patent is its enforceability. Given that all asserted claims were canceled in a post-filing Inter Partes Review, the primary question is whether any cause of action based on this patent can survive.

  2. Claim Scope and Infringement: For the ’898 and ’348 Patents, the case will likely focus on claim construction and technical evidence. A core issue will be one of mechanism and function: does the accused Minerva system operate in a way that meets the specific claim limitations, particularly the requirement for removing moisture via a "continuously open flow path" during ablation, or does it utilize a fundamentally different technical approach?

  3. Evidentiary Sufficiency: As the complaint is sparsely detailed, a key challenge for the plaintiff will be developing sufficient evidence in discovery to prove that the technical operations of the accused Minerva system align with the specific steps and structures required by the asserted claims of the ’898 and ’348 patents.