Hologic, Inc. v. Minerva Surgical, Inc.

• Decision Date: 28 June 2018
• Docket Number: 1:15CV1031
• Citation: 325 F.Supp.3d 507
• Parties: HOLOGIC, INC., and Cytyc Surgical Products, LLC, Plaintiffs, v. MINERVA SURGICAL, INC., Defendant.
• Court: U.S. District Court — District of Delaware

325 F.Supp.3d 507

HOLOGIC, INC., and Cytyc Surgical Products, LLC, Plaintiffs,

v.MINERVA SURGICAL, INC., Defendant.

1:15CV1031

United States District Court, D. Delaware.

Signed June 28, 2018

Karen L. Pascale, Pilar Gabrielle Kraman, Young, Conaway, Stargatt & Taylor LLP, Wilmington, DE, Assad Rajani, Arnold & Porter Kaye Scholer LLP, Palo Alto, California, Marc A. Cohn, Matthew M. Wolf Ryan J. Casamiquela, William Young, Jr., for Plaintiffs.

Benjamin J. Schladweiler, Greenberg Traurig, LLP, Wilmington, DE, Vera M. Elson, Christopher D. Mays, Dale R. Bish, Wilson Sonsini Goodrich & Rosati, Palo Alto, California, Edward G. Poplawski, Erik J. Carlson, Neil N. Desai, Olivia M. Kim, Ty W. Callahan, Wilson Sonsini Goodrich & Rosati, Los Angeles, California, Sara L. Rose, for Defendant.

MEMORANDUM OPINION

Joseph F. Bataillon, Senior United States District Judge

This matter is before the court on the following motions: defendant Minerva Surgical, Inc.'s ("Minerva") Motion to Dismiss the '183 Patent and the '989 Patent under Federal Rule of Civil Procedure 12(b)(1) or for judgment on the pleadings under Rule 12(c) (D.I. 275);¹ Minerva's motion for partial summary judgment on: invalidity; non-infringement; no willfulness; and no unfair competition (D.I. 277); and plaintiffs Hologic, Inc.'s and Cytyc Surgical Products, LLC's (collectively "Hologic") motions for summary judgment of no invalidity (D.I. 287); infringement (D.I. 288); and assignor estoppel (D.I. 289).² Minerva also seeks a summary judgment that the doctrine of equivalents does not apply to Minerva's redesign, arguing prosecution history estoppel ("PHE"). (D.I. 278, Brief at 44–47).³

I. FACTS

This is an action for patent infringement and related state-law claims.⁴ Hologic alleges that Minerva infringes U.S. Patent No. 6,872,183 ("the '183 Patent"), titled "System and Method for Detecting Perforations in a Body Cavity," filed May 24, 2004, and issued March 29, 2005, and U.S. Patent No. 9,095,348 ("the '348 Patent"), titled "Moisture Transport System for Contact Electrocoagulation

," filed August 8, 2013, and issued August 4, 2015 (collectively "the Patents-in-Suit"). The asserted patent claims that remain at issue are claims 7, 9, 11, 13, and 14 of the '183 Patent and claim 1 of the '348 Patent.⁵ (D.I. 367, Joint [Proposed] Final Pretrial Order at 13; oral order dated June 15, 2018).

Additional facts are set out in the court's memorandum order on the plaintiff's motion for preliminary injunction (D.I. 127) and need not be repeated here. Briefly, the technology at issue in this litigation involves instruments and procedures for endometrial ablation

, a treatment wherein the lining of the uterus is destroyed in order to treat Menorrhagia, or abnormally heavy menstrual bleeding. In the late 1990s, NovaCept Corporation ("NovaCept") under the direction of Csaba Truckai ("Truckai") and his design team developed the NovaSure system ("NovaSure") in the late–1990s. Prior to an ablation procedure, NovaSure uses computerized monitoring to detect perforations in the uterus, by applying C02 gas to the uterus and measuring any flow of gas out of the uterus. NovaSure employs an application head with a triangular shape designed to conform to the shape of the uterus, which ablates the endometrial lining throughout the cavity in two minutes or less. NovaSure also provides a "moisture transport" function with a vacuum used to remove steam and moisture from the cavity during energy delivery. Minerva has developed and brought to market a new technology for the treatment of abnormal uterine bleeding, the Minerva Endometrial Ablation System

("EAS" or "accused product").

The '348 patent is directed to "an apparatus and method of ablating and/or coagulating tissue, such as that of the uterus or other organ." It uses "an electrode array," which "includes a fluid permeable elastic member preferably formed of a metallized fabric having insulating regions and conductive regions thereon." To use the apparatus, "the electrode array is positioned in contact with tissue to be ablated, ablation energy is delivered through the array to the tissue to cause the tissue to dehydrate, and moisture generated during dehydration is actively or passively drawn into the array and away from the tissue." (D.I. 281–7, Ex. 40, '348 patent, 2:34–45). The specification describes two exemplary embodiments. The first embodiment describes an ablation device comprised generally of three major components—RF applicator head, main body, and handle. (Id. at 4:55–58) The applicator head includes an array of electrodes formed on the surface of an electrode carrying means. (Id. at 4:58–61). "The second embodiment differs from the first embodiment primarily in its electrode pattern and in the mechanism used to deploy the electrode applicator head or array." (Id. 11:53–54). Aspects of the two "exemplary embodiments and their methods of operation may be combined without departing from the scope of the present invention." (Id. at 11:50–58).

Claim 1 of the '348 Patent states:

A device for treating a uterus comprising:

an elongate member having a proximal portion and a distal portion, the elongate member comprising an outer sleeve and an inner sleeve slidably and coaxially disposed within the outer sleeve;

an applicator head coupled to the distal portion, the applicator head defining an interior volume and having a contracted state and an expanded state, the contracted state being configured for transcervical insertion and the expanded state being configured to conform to the shape of the uterus, the applicator head including one or more electrodes for ablating endometrial lining tissue of the uterus;

a handle coupled to the proximal portion of the elongate member, wherein the handle comprises a frame, a proximal grip and a distal grip pivotally attached to one another at a pivot point and operably coupled to the applicator head so that when the proximal grip and the distal grip are moved closer together, the applicator head transitions

from the contracted state to the expanded state;

a deflecting mechanism including flexures disposed within the applicator head, the flexures including first and second internal flexures and first and second external flexures, the first and second external flexures being coupled to the outer sleeve and the first and second internal flexures being coupled to the inner sleeve, wherein the deflecting mechanism is configured so that translating the inner sleeve relative to the frame causes the applicator head to transition from the contracted state to the expanded state; and

an indicator mechanism operably coupled to the inner sleeve, the indicator mechanism configured to indicate a dimension of the uterus.

(Id. at 19:9–42) (emphasis added).

The '183 patent is directed to "a system and method for detecting perforations in a body cavity." (D.I. 281–7, Ex. 39). The system delivers a fluid (either liquid or gas) "into a body cavity to slightly pressurize the cavity. A pressure sensing system monitors the pressure within the cavity for a predetermined test period. If cavity pressure is not substantially sustained during the test period, the physician is alerted." In the preferred form of the system, the perforation detection functionality is provided with an RF [radio frequency] ablation system. ( '183 patent, 1:49–62).

What is claimed in Claim 1 of the '183 Patent is:

1. A method of ablating a uterus, comprising 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.

(Id. at 8:10–14). Asserted Claim 7 recites:

The method of claim 1, further including the step of preventing performance of the treating step until after the monitoring step has been carried out.

(Id. at 8:30–33) Asserted Claim 9 recites:

A method of detecting a perforation in a uterus, comprising the steps of:

passing an inflation medium into the uterus;

monitoring for the presence of a perforation in the uterus using a pressure sensor;

if no perforation is detected during the monitoring step, permitting ablation of the uterus using an ablation device; and

if a perforation is detected during the monitoring step, preventing ablation of the uterus.

(Id. at 8:39–48). Dependent claim 11 recites:

The method of claim 9, further including the step of:

if a perforation is detected during the monitoring step, activating a notification signal alerting t e user to the presence of a perforation in the uterus.

(Id. at 8:54–57). Dependent claim 13 limits claim 9 reciting, "wherein the inflation medium is introduced using the ablation device." (Id. at 8:60–61). Claim 14 states: "The method of claim 9, wherein the ablation device is an RF ablation device." (Id. at 8:63–65).

The specification explains that "a pressure sensing system" is "fluidly coupled to the medical device via [a] pressure detection/signal line" and used to monitor the pressure within the body cavity. Fluid or gas is delivered to the body cavity and the pressure sensing system detects "whether elevated pressure can be maintained above a predetermined threshold level over a predetermined period of time. If it cannot, the user is alerted that there may be a perforation in the organ." (Id. at 2:36–44) The pressure sensor "monitors pressure in the pressure signal line ... and delivers the signal to the microprocessor." (Id. at 5:23–25). The specification explains that during testing "[w]hen the pressure at gauge 84 rises and remains above 50mmHg for 4 seconds", the test is passed.

The court has construed the relevant claims of the Patents-in-Suit as follows:

Pressure sensor:⁶ A device whose input detects, directly or indirectly, a force per unit area and outputs a corresponding electrical signal.

Applicator head:⁷ A distal end portion of an ablation device that applies energy to the uterine tissue.

Indicator mechanism:⁸ A mechanism

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