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Hologic, Inc. v. Minerva Surgical, Inc.

United States District Court, D. Delaware

June 28, 2018

HOLOGIC, INC., AND CYTYC SURGICAL PRODUCTS, LLC,, Plaintiffs,
v.
MINERVA SURGICAL, INC., 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 configured to indicate a dimension.
One or more electrodes:[9] One or more electrical conductors.

(D.I. 227, Memorandum Order at 2-5). In addition, the term “monitoring, ” found in the '183 patent, claims 7, 9, and 11, requires no construction. Id. at 3.

         The parties agree to the following additional facts. (D.I. 367-1, Joint [Proposed] Final Pretrial Order, Ex. 1, Joint Statement of Uncontested Facts). Plaintiff Hologic is a corporation organized and existing under the laws of the State of Delaware with a principal place of business in Marlborough, Massachusetts. Plaintiff Cytyc Surgical Products, LLC (“Cytyc”) is a limited liability company organized and existing under the laws of the Commonwealth of Massachusetts with a principal place of business in Marlborough, Massachusetts. Cytyc is a wholly-owned subsidiary of Hologic. Defendant Minerva is a corporation organized and existing under the laws of the State of Delaware with a principal place of business in Redwood City, California.

         The parties agree the '183 Patent was issued by the United States Patent and Trademark Office (“USPTO”) on March 29, 2005, and expires on November 10, 2020.[10] Russel M. Sampson, Mike O'Hara, Csaba Truckai, and Dean T. Miller are the named inventors of the '183 Patent.

         Csaba Truckai assigned his interest in the '183 Patent to NovaCept on February 9, 2001. In February 2001, Csaba Truckai assigned his interest in U.S. Application No. 09/710, 102, an application to which the '183 Patent claims priority, to NovaCept. Hologic is the owner by assignment of the '183 Patent. Hologic acquired the '183 Patent from Cytyc on January 15, 2016.

         The '348 Patent was issued by the USPTO on August 4, 2015 and expires on November 19, 2018.[11] Cytyc listed Csaba Truckai, Russel Mahlon Sampson, Stephanie Squarcia, Alfonso Lawrence Ramirez, and Estela Hilario as named inventors on the face of the '348 Patent.

         In August 1998, Csaba Truckai assigned his interest in U.S. Application No. 09/103, 072, an application to which the '348 Patent claims priority, to NovaCept. Hologic is the owner by assignment of the '348 Patent. Hologic acquired the '348 Patent from Cytyc on January 15, 2016. In May 2004, Cytyc Corporation (“Cytyc”) acquired NovaCept for $325 million dollars. In 2007, Hologic acquired Cytyc Corporation.

         In 1993, Csaba Truckai co-founded NovaCept, Inc. (“NovaCept”) Csaba Truckai and others at NovaCept developed the NovaSure system. NovaCept received FDA premarket NovaCept assigned to Cytyc its patent rights including continuation applications. Hologic markets and sells the NovaSure system throughout the United States and in interstate commerce.

         Csaba Truckai is a founder of Minerva. Minerva was founded in 2008. Csaba Truckai was involved in the development of the Minerva Endometrial Ablation System (“EAS”). Minerva received FDA premarket approval for commercial distribution of the Minerva EAS on July 27, 2015. Minerva began commercial distribution of the Minerva EAS in August 2015. Minerva markets and sells the Minerva EAS throughout the United States and in interstate commerce. Both the Minerva EAS and the NovaSure system are indicated for use on premenopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete. The Array Opening Indicator of the Minerva EAS contains a Black Indicator Line that can move relative to rows of black dots depending on the degree of expansion of the Plasma Formation Array.

         Hologic alleges that Minerva infringes its patent in the use of the Minerva EAS. It alleges that use of the Minerva EAS, consistent with its instructions for use, practices each and every step of the method claims of the ʼ183 Patent. It asserts that Minerva directly infringes these claims and induces and contributes to the infringement by its customers. It further alleges that Minerva infringes the apparatus claims of the '348 Patent by making, selling and/or offering to sell the Minerva EAS in the United States. Also, Hologic contends that Minerva's infringement of the Patents-in-Suit has been and continues to be willful.

         Minerva denies that it infringes-directly or indirectly (under inducement or contributory infringement)-any of the asserted claims of the Patents-in-Suit and denies that infringement, if any, has been willful. In addition, Minerva asserts an invalidity defense to the asserted claims. With respect to the '183 patent, it argues that all the asserted claims of the Patents-in-Suit are invalid for lack of written description and lack of enablement under 35 U.S.C. § 112.

         II. Minerva's Motion to Dismiss (D.I. 275)

         A. Background

         A threshold issue is Minerva's motion to dismiss. Minerva seeks dismissal of Hologic's claim for infringement of the '183 Patent under Federal Rule of Civil Procedure 12(b)(1) and 12(c). Minerva asserts that the '183 Patent claims “should be dismissed as moot” because “no viable cause of action” remains. Minerva's motion is based on a final written decision of the Patent and Trial Appeals Board (“PTAB”) in an inter partes review under 35 U.S.C. § 318(a) of the '183 patent. Minerva contends the PTAB's decision extinguishes any cause of action Hologic may have had with respect to its asserted '183 patent. Hologic has appealed the Patent Office's decision on the '183 Patent to the Federal Circuit (D.I. 344, Hologic Brief at 9).

         In response, Hologic asserts Minerva is estopped from contending the patent is invalid by the doctrine of assignor estoppel. It argues that Minerva profited from its assignment and subsequent sale of the intellectual property and cannot disclaim the patent's validity. Assignor estoppel is also the subject of one of Hologic's motions for summary judgment and will be discussed below.

         B. Law

         A party may move to dismiss for “lack of subject-matter jurisdiction” under Federal Rule of Civil Procedure 12(b)(1). The federal courts are courts of limited jurisdiction. Kokkonen v. Guardian Life Ins. Co. of Am., 511 U.S. 375, 377 (1994). The court's power to render judgment is circumscribed by the Article III requirement that a live case or controversy exist throughout all stages of litigation, including appellate review. United States v. Huff, 703 F.3d 609, 611 (3d Cir. 2013). This requirement is satisfied when the parties “continue to have a ‘personal stake in the outcome' of the lawsuit.” Id.“When the parties lose their personal stake in the outcome, the case becomes moot and must be dismissed, even if it once was a live controversy at an earlier stage of the proceedings.” Id. Courts lack subject matter jurisdiction over moot claims. See Target Training Int'l, Ltd. v. Extended Disc N. Am., Inc., 645 Fed.Appx. 1018, 1025 (Fed. Cir. 2016) (“a dismissal for mootness is a dismissal for lack of jurisdiction.”). In patent cases, the existence of a case or controversy must be evaluated on a claim-by-claim basis. U.S.C.A. Const. art. III, § 2, cl. 1; see Streck, Inc. v. Research & Diagnostic Sys., Inc., 665 F.3d 1269, 1282 (Fed. Cir. 2012).

         Under Federal Rule of Civil Procedure 12(c), a party may move for judgment on the pleadings “[a]fter pleadings are closed-but early enough not to delay trial.” When evaluating a motion for judgment on the pleadings, the court must consider factual allegations in a complaint in the light most favorable to the non-moving party. Rosenau v. Unifund Corp., 539 F.3d 218, 221 (3d Cir. 2008). The court may consider matters of public record as well as authentic documents upon which the complaint is based if they are attached to the complaint or as an exhibit to the motion. Oshiver v. Levin, Fishbein, Sedran & Berman, 38 F.3d 1380, 1384 n.2 (3d Cir. 1994).

         “When a [patent] claim is cancelled, the patentee loses any cause of action based on that claim, and any pending litigation in which the claims are asserted becomes moot.” Fresenius USA, Inc. v. Baxter Int'l, Inc., 721 F.3d 1330, 1340 (Fed. Cir. 2013). Under 35 U.S.C. § 141(c), “[a] party to an inter partes review or a post-grant review who is dissatisfied with the final written decision of the Patent Trial and Appeal Board” has a right to appeal to the Federal Circuit. See Pers. Audio, LLC v. Elec. Frontier Found., 867 F.3d 1246, 1249 (Fed. Cir. 2017), cert. denied, No. 17-1085, 2018 WL 706268 (U.S. May 14, 2018). The Patent Office cannot cancel claims of patents until after appeal. 35 U.S.C. § 318(b) (for inter partes reviews, after “the time for appeal has expired or any appeal has terminated, ” the Director will “issue and publish a certificate canceling any claim of the patent finally determined to be unpatentable”). The Federal Circuit has held that “a determination of patentability . . . occur[s] only after all appeals have terminated.” Bettcher Indus., Inc. v. Bunzl USA, Inc., 661 F.3d 629, 645 (Fed. Cir. 2011) (explaining that a certificate cancelling patent claims “only happens ‘when the time for appeal has expired or any appeal proceeding has terminated'”).

         C. Discussion

         The court rejects Minerva's argument that the PTAB's final written order on inter partes review renders this action moot. The patent has not been cancelled. The PTAB finding is on appeal and does not have preclusive effect as to this action unless and until the appeal is resolved. Accordingly, the court finds Minerva's motion to dismiss should be denied.

         In light of this disposition, the court need not address Hologic's assignor estoppel argument in connection with the motion to dismiss, but will address the doctrine in Hologic's motion for summary judgment. See infra.

         III. The Parties' Motions to Preclude or to Strike ...


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