throbber
Case 1:20-cv-00925-JFB-SRF Document 10 Filed 08/31/20 Page 1 of 18 PageID #: 68
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
` C.A. No. 20-00925-JFB-SRF
`
`JURY TRIAL DEMANDED
`
`))))))))))))))
`
`
`)
`
`HOLOGIC, INC., a Delaware corporation;
`and CYTYC SURGICAL PRODUCTS,
`LLC, a Massachusetts limited liability
`company,
`
`Plaintiff,
`
`v.
`
`MINERVA SURGICAL, INC., a Delaware
`corporation,
`
`Defendants.
`
`DEFENDANT’S ANSWER TO COMPLAINT
`FOR PATENT INFRINGEMENT
`
`Defendant Minerva Surgical, Inc. (“Minerva”) hereby answers the Complaint for Patent
`
`Infringement filed by Hologic, Inc. (“Hologic”) and Cytyc Surgical Products, LLC (“Cytyc”)
`
`(collectively, “Plaintiffs”), as follows:
`
`NATURE OF THE ACTION1
`
`1.
`
`Minerva admits that the Complaint purports to allege an action for infringement of
`
`U.S. Patent Nos. 9,095,348 (“the ’348 Patent”). Except as expressly admitted herein, Minerva
`
`denies any and all remaining allegations in Paragraph 1 of the Complaint.
`
`1 Minerva reproduces the headings found in the Complaint. The headings do not state any
`allegation against Minerva to which a response is required. To the extent that any allegations are
`included in the headings, Minerva denies such allegations.
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 10 Filed 08/31/20 Page 2 of 18 PageID #: 69
`
`PARTIES
`
`2.
`
`Minerva admits only that, upon information and belief, Hologic is a corporation
`
`organized and existing under the laws of the State of Delaware with a principal place of business
`
`at 250 Campus Drive, Marlborough, Massachusetts, 01752. Minerva is without knowledge or
`
`information sufficient to form a belief as to the truth of the remaining allegations of paragraph 2
`
`of the Complaint, and accordingly denies the same.
`
`3.
`
`Minerva admits only that, upon information and belief, Cytyc is a limited liability
`
`company organized and existing under the laws of the Commonwealth of Massachusetts with a
`
`principal place of business at 250 Campus Drive, Marlborough, Massachusetts, 01752. Minerva is
`
`without knowledge or information sufficient to form a belief as to the truth of the remaining
`
`allegations of paragraph 3 of the Complaint, and accordingly denies the same.
`
`4.
`
`Minerva admits that it is a corporation organized and existing under the laws of the
`
`State of Delaware with a principal place of business at 4255 Burton Dr., Santa Clara, CA 95054.
`
`JURISDICTION AND VENUE
`
`5.
`
`Minerva admits that the Complaint purports to set forth a claim for patent
`
`infringement arising under the Patent Laws of the United States, Title 35 of the United States Code.
`
`Except as expressly admitted, Minerva denies any and all remaining allegations in paragraph 5 of
`
`the Complaint.
`
`6.
`
`Minerva admits that this Court has subject matter jurisdiction pursuant to 28 U.S.C.
`
`§§ 1331 and 1338.
`
`7.
`
`Minerva admits that this Court has personal jurisdiction over Minerva as a
`
`Delaware corporation. Except as expressly admitted, Minerva denies any and all remaining
`
`allegations in paragraph 7 of the Complaint.
`
`-2-
`
`

`

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`
`8.
`
`Minerva admits that venue is proper in this District under § 1391 because Minerva
`
`is a Delaware corporation. Except as expressly admitted, Minerva denies any and all remaining
`
`allegations in paragraph 8 of the Complaint.
`
`BACKGROUND
`
`Overview of Endometrial Ablation
`
`Minerva admits that one treatment for menorrhagia is a transcervical surgical
`
`A.
`
`9.
`
`technique, known as endometrial ablation, in which the lining of the uterus is destroyed to prevent
`
`further bleeding, such as by using heat, sub-zero temperatures, or electrical energy. Minerva
`
`further admits that in the early-1990s, some physicians used endometrial ablation instruments such
`
`as an electrified metal ball (a “roller ball”) or wire loop to burn away the endometrial lining of the
`
`uterus. Minerva is without knowledge or information sufficient to form a belief as to the truth of
`
`the remaining allegations of paragraph 9 of the Complaint, and accordingly denies the same.
`
`B.
`
`10.
`
`The NovaSure System Modernized Endometrial Ablation
`
` Minerva admits that Mr. Csaba Truckai was a founder of Novacept, Inc.
`
`(“Novacept”) and that Novacept developed the NovaSure system. Minerva further admits that Mr.
`
`Truckai served as Novacept’s VP of R&D and as its President for certain times. Minerva is without
`
`knowledge or information sufficient to form a belief as to the truth of the remaining allegations of
`
`paragraph 10 of the Complaint, and accordingly denies the same.
`
`11. Minerva admits the NovaSure device’s applicator treats the entire uterus
`
`simultaneously by contacting the endometrium. Minerva further admits that paragraph 11 of the
`
`Complaint includes a picture of a handpiece labelled NovaSure. Minerva further admits that the
`
`NovaSure device ablates the endometrial lining throughout the cavity and allowed the procedure
`
`to be performed in a physician’s office. Minerva is without knowledge or information sufficient
`
`-3-
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 10 Filed 08/31/20 Page 4 of 18 PageID #: 71
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`to form a belief as to the truth of the remaining allegations of paragraph 11 of the Complaint, and
`
`accordingly denies the same.
`
`12. Minerva is without knowledge or information sufficient to form a belief as to the
`
`truth of the allegations of paragraph 12 of the Complaint, and accordingly denies the same.
`
`C.
`
`The Patent-In-Suit
`
`13. Minerva admits that Plaintiffs purport that the ’348 Patent entitled “Moisture
`
`Transport System for Contact Electrocoagulation,” was issued on August 5, 2015 to Csaba
`
`Truckai, Russel M. Sampson, Stephanie Squarcia, Alfonso L. Ramirez, and Estela Hilario.
`
`Minerva denies that the ’348 Patent was duly and legally issued. Minerva admits that Exhibit A
`
`of the Complaint purports to be a true and correct copy of the ’348 Patent. Minerva admits that
`
`Hologic claims to have received the ’348 Patent by assignment. Minerva is without knowledge or
`
`information sufficient to form a belief as to the truth of the remaining allegations of paragraph 13
`
`of the Complaint, and accordingly denies the same.
`
`14.
`
`15.
`
`D.
`
`Denied.
`
`Denied.
`
`Hologic Paid $325 Million To Buy Novacept And Its Patented Technology
`
`16. Minerva admits that Mr. Truckai executed an agreement titled “Assignment” on
`
`August 1998 that referred to Novacept as “Assignee” and listed U.S. Application No. 09/103,072.
`
`Minerva further admits that Plaintiffs thereafter filed the application leading to the ’348 Patent and
`
`claimed priority to U.S. Application No. 09/103,072. Minerva further admits that the agreement
`
`titled “Assignment” includes the text: “invented certain new and useful improvements as described
`
`and set forth in the below-identified application for United States Letters Patent.” Except as
`
`-4-
`
`

`

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`expressly admitted herein, Minerva denies any and all remaining allegations in Paragraph 16 of
`
`the Complaint.
`
`17. Minerva admits that Cytyc acquired Novacept for $325 million. Minerva further
`
`admits that the NovaSure system was one of Novacept’s offerings. Minerva admits that Cytyc
`
`claims it received Novacept’s intellectual property by assignment and claims it received the right
`
`to continue patent prosecution. Except as expressly admitted herein, Minerva denies any and all
`
`remaining allegations in Paragraph 17 of the Complaint.
`
`18. Minerva is without knowledge or information sufficient to form a belief as to the
`
`truth of the allegations of paragraph 18 of the Complaint, and accordingly denies the same.
`
`E.
`
`Hologic’s Subsequent Development And Investment In NovaSure
`
`19. Minerva is without knowledge or information sufficient to form a belief as to the
`
`truth of the allegations of paragraph 19 of the Complaint, and accordingly denies the same.
`
`20. Minerva is without knowledge or information sufficient to form a belief as to the
`
`truth of the allegations of paragraph 20 of the Complaint, and accordingly denies the same.
`
`F.
`
`Mr. Truckai Founded Minerva To Compete Directly With Hologic’s
`NovaSure System With An Infringing Product
`
`21. Minerva admits that Mr. Truckai founded Minerva in 2008. Except as expressly
`
`admitted, Minerva denies any and all remaining allegations in paragraph 21 of the Complaint.
`
`22. Minerva admits that Mr. Truckai was one of the people involved with the
`
`development of Generation 1 of the Minerva Endometrial Ablation System (“EAS”). Except as
`
`expressly admitted, Minerva denies any and all remaining allegations in paragraph 22 of the
`
`Complaint.
`
`23. Minerva admits that Mr. Truckai was one of the people involved with portions of
`
`the research, development, testing, clinical testing, and regulatory process related to Generation 1
`
`-5-
`
`

`

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`
`of Minerva’s EAS. Minerva further admits that Mr. Truckai received feedback from physicians
`
`and directed engineers manufacturing prototypes that preceded Generation 1 of the Minerva EAS.
`
`Minerva further admits that Mr. Truckai sent or received emails regarding the physical dimensions
`
`of the Plasma Formation Array (“PFA”) for Generation 1 of the Minerva EAS. Minerva further
`
`admits that Mr. Truckai was one of the people who attended a meeting regarding revising Software
`
`Requirements for Generation 1 of the Minerva EAS. Except as expressly admitted, Minerva denies
`
`any and all remaining allegations in paragraph 23 of the Complaint.
`
`24. Minerva admits that Mr. Truckai sent or received emails regarding Minerva’s
`
`application for an investigational device exemption (IDE) from the FDA, Minerva’s
`
`communications with the FDA, and patient selection for clinical trials. Minerva further admits that
`
`Mr. Truckai was one of the representatives of Minerva during at least one meeting with the FDA.
`
`Except as expressly admitted herein, Minerva denies any and all remaining allegations in
`
`Paragraph 24 of the Complaint.
`
`25. Minerva admits that Mr. Truckai served as Minerva’s President and CEO at its
`
`founding, giving general direction to the company, putting a management team in place, raising
`
`sufficient funds, setting the strategic direction of the company, managing the company, and
`
`executing the company plan. Minerva further admits that all of the foregoing job responsibilities
`
`were related to Generation 1 of the Minerva EAS. Except as expressly admitted, Minerva denies
`
`any and all remaining allegations in paragraph 25 of the Complaint.
`
`26. Minerva admits that from 2008 and at least through 2019, Mr. Truckai served on
`
`Minerva’s Board of Directors. Minerva further admits that Mr. Truckai has a small minority
`
`ownership interest in Minerva. Except as expressly admitted herein, Minerva denies any and all
`
`remaining allegations in Paragraph 26 of the Complaint.
`
`-6-
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 10 Filed 08/31/20 Page 7 of 18 PageID #: 74
`
`G.
`
`The Minerva Endometrial Ablation System (“EAS”)
`
`27. Minerva admits that the Minerva EAS has two main components: a disposable
`
`handpiece and a radio frequency (RF) Controller. Minerva further admits that the distal end of the
`
`disposable handpiece comprises a PFA, which includes an expandable metal frame covered by a
`
`silicone membrane. Minerva further admits that the proximal end of the disposable handpiece
`
`includes a feature that has sometimes been referred to as a PFA Width Indicator. Except as
`
`expressly admitted, Minerva denies any and all remaining allegations in paragraph 27 of the
`
`Complaint.
`
`28. Minerva admits that paragraph 28 appears to include an annotated picture of
`
`Minerva’s EAS showing a callout with the text “PFA width indicator.” Except as expressly
`
`admitted, Minerva denies any and all remaining allegations in paragraph 28 of the Complaint.
`
`26.2 Minerva admits that the handpiece of the Minerva EAS includes a Red Area, a
`
`Green Area, and three rows of dots. Minerva admits that the picture reproduced in this paragraph
`
`26 has a callout with the text “Width Indicator Graduations.” Minerva further admits that
`
`Minerva’s clinical data excludes women with uteri that are smaller than 2.5 cm. Minerva further
`
`admits that one of the reasons the rows of dots were added is because of feedback from physicians.
`
`Except as expressly admitted, Minerva denies any and all remaining allegations in this paragraph
`
`26 of the Complaint.
`
`H.
`
`The Prior Lawsuit And Trial
`
`26.3 Minerva admits that Plaintiffs filed a complaint in this Court against Minerva in
`
`November 2015 alleging infringement of multiple patents including the ’348 Patent (the “First
`
`2 Paragraph 29 is incorrectly numbered paragraph 26 in the Complaint.
`
`3 Paragraph 30 is incorrectly numbered paragraph 26 in the Complaint.
`
`-7-
`
`

`

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`Action”). Except as expressly admitted, Minerva denies any and all remaining allegations in this
`
`paragraph 26 of the Complaint.
`
`29.4 Minerva admits that, before trial, this Court ruled on summary judgment that
`
`“Consistent with the court’s claim construction, the court finds that undisputed evidence in the
`
`record establishes that Minerva has infringed the asserted claims of Hologic’s patents.
`
`Accordingly, the court finds that Hologic’s motion for summary judgment on the issue of
`
`infringement should be granted and Minerva’s corresponding motion should be denied.” Except
`
`as expressly admitted, Minerva denies any and all remaining allegations in paragraph 29 of the
`
`Complaint.
`
`30. Minerva admits that as to the ’348 Patent, the Court found “Hologic’s motion for a
`
`summary judgment of no invalidity should be granted and Minerva’s corresponding motion should
`
`be denied.” Except as expressly admitted, Minerva denies any and all remaining allegations in
`
`paragraph 30 of the Complaint.
`
`31.
`
` Minerva admits that the Court found assignor estoppel applies to Minerva’s
`
`defenses to Hologic’s patent infringement claims in the First Action. Except as expressly admitted,
`
`Minerva denies any and all remaining allegations in paragraph 31 of the Complaint.
`
`32. Minerva admits that following a July 2018 jury trial, the jury awarded lost profits
`
`and reasonable royalty damages to Hologic and Cytyc in the First Action. Except as expressly
`
`admitted, Minerva denies any and all remaining allegations in paragraph 32 of the Complaint.
`
`33. Minerva admits that the Court denied Minerva’s renewed motion for judgment as
`
`a matter of law, Minerva’s motion for a new trial, and Minerva’s motion for an injunction under
`
`the Deceptive Trade Practices Act. Minerva further admits that on June 3, 2019, the Court entered
`
`4 Paragraph 31 is incorrectly numbered paragraph 29 in the Complaint, and paragraph numbering
`continues from there.
`
`-8-
`
`

`

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`judgement against Minerva on Plaintiffs’ claim in the First Action for “infringement of U. S. Patent
`
`No. 9,9095,348 in the amount of $4,787,668.23; plus prejudgment interest in the amount of
`
`$270,533, plus post-judgment interest at the statutory rate of 2.44% under 35 U.S.C. § 1961(a).”
`
`Minerva further admits that the Court entered judgement against Minerva on Plaintiffs’ claim in
`
`the First Action for “infringement of U. S. Patent No. 9,9095,348 in the amount of $1,629,304.08
`
`in supplemental damages for Minerva’s infringing sales from April 1, 2018, through August 13,
`
`2018, plus prejudgment interest on that amount at the prime rate compounded quarterly from the
`
`date of infringement to August 13, 2018, plus post-judgment interest thereafter at the legal rate
`
`under 28 U.S.C. § 1961 until such time as the judgment is paid.” Except as expressly admitted,
`
`Minerva denies any and all remaining allegations in paragraph 33 of the Complaint.
`
`34. Minerva admits that on April 22, 2020, a panel of the Federal Circuit Court of
`
`Appeals concluded that “the district court did not abuse its discretion in applying assignor
`
`estoppel” and affirmed the district court’s grant of summary judgment of no invalidity as to claim
`
`1 of the ’348 Patent. Minerva further admits that the panel held that “[b]ecause the district court
`
`correctly construed the disputed terms in claim 1 of the ’348 patent,” the panel “affirm[ed] the
`
`district court’s grant of summary judgment of infringement.” Except as expressly admitted,
`
`Minerva denies any and all remaining allegations in paragraph 34 of the Complaint.
`
`I.
`
`The Accused “New Pivot” Product
`
`35. Minerva admits that it started shipping its redesigned Minerva EAS handpiece
`
`starting on June 28, 2018. Minerva denies that it concealed the first shipment of that design or that
`
`it did so to avoid having it adjudicated in the First Action. Except as expressly admitted, Minerva
`
`denies any and all remaining allegations in paragraph 35 of the Complaint.
`
`-9-
`
`

`

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`36. Minerva admits that it conceived the modified design in 2016, after Plaintiffs had
`
`commenced the First Action. Minerva further admits it developed prototypes of an EAS handpiece
`
`that incorporated a design change such that the grips of the handpiece are not pivotably attached
`
`at a pivot point. Except as expressly admitted, Minerva denies any and all remaining allegations
`
`in paragraph 36 of the Complaint.
`
`37. Minerva admits that the redesigned Minerva EAS handpiece includes changes to
`
`the proximal and distal grips of the hand piece and the method and design for the attachment of
`
`the grips. Except as expressly admitted, Minerva denies any and all remaining allegations in
`
`paragraph 37 of the Complaint.
`
`38. Minerva admits that as the proximal and distal grips in the redesigned Minerva EAS
`
`handpiece are squeezed together, they slide toward one another, engaging two leaf spring tabs
`
`inside the proximal grip. Except as expressly admitted, Minerva denies any and all remaining
`
`allegations in paragraph 38 of the Complaint.
`
`J.
`
`Infringement Of The ’348 Patent By The Accused “New Pivot” Product
`
`39. Minerva admits that, in the First Action, this Court ruled on summary judgment
`
`that “[c]onsistent with the court’s claim construction, the court finds that undisputed evidence in
`
`the record establishes that Minerva has infringed the asserted claims of Hologic’s patents.
`
`Accordingly, the court finds that Hologic’s motion for summary judgment on the issue of
`
`infringement should be granted and Minerva’s corresponding motion should be denied.” Except
`
`as expressly admitted, Minerva denies any and all remaining allegations in paragraph 39 of the
`
`Complaint.
`
`40.
`
`Denied.
`
`-10-
`
`

`

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`41. Minerva admits that claim 1 of the ’348 Patent recites in part: “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.” Except as expressly
`
`admitted, Minerva denies any and all remaining allegations in paragraph 41 of the Complaint.
`
`42.
`
`Denied.
`
`43. Minerva admits that it argued in the First Action that the redesigned Minerva EAS
`
`handpiece does not infringe the ’348 Patent and therefore it is a non-infringing design option.
`
`Minerva further admits that it moved for summary judgment that the doctrine of equivalents is not
`
`applicable to Minerva’s redesign. Except as expressly admitted, Minerva denies any and all
`
`remaining allegations in paragraph 43 of the Complaint.
`
`K.
`
`Minerva’s Concealment Of Its Commercialization Of The New Pivot Design
`And Its Willful Infringement
`
`44.
`
`Denied.
`
`45. Minerva admits that, in the First Action, it produced in discovery physical protypes
`
`of the redesigned Minerva EAS handpiece and related documents to show that it was a non-
`
`infringing design option as to the asserted ’348 Patent claims. Except as expressly admitted,
`
`Minerva denies any and all remaining allegations in paragraph 45 of the Complaint.
`
`46.
`
`47.
`
`Denied.
`
`Denied.
`
`48. Minerva admits that on June 20, 2018, after the close of discovery, Plaintiffs filed
`
`a letter with the Court requesting documents regarding Minerva’s design-around, prototype
`
`handpiece for the accused product, including communications with the FDA regarding the status
`
`of any application for approval to market the prototype handpiece. Minerva further admits that on
`
`June 22, 2018 it correctly objected to this improper discovery because, at the time, the new design
`
`-11-
`
`

`

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`was not (and could not be) accused by Plaintiffs of infringement, as it was not currently in the
`
`market. Minerva further admits that it started shipping its redesigned Minerva EAS handpiece
`
`starting on June 28, 2018. Minerva denies that any of Minerva’s assertions were misleading or
`
`needed correction. Minerva is without knowledge or information sufficient to form a belief as to
`
`the truth of when Plaintiffs learned Minerva started shipping its redesigned Minerva EAS
`
`handpiece. Except as expressly admitted, Minerva denies any and all remaining allegations in
`
`paragraph 48 of the Complaint.
`
`49. Minerva admits that one or more of its witnesses testified correctly at deposition
`
`that Minerva had not completed verification and validation testing of the redesigned Minerva EAS
`
`handpiece and not a single physician had looked at or tested the redesigned handpiece as of the
`
`date of the deposition(s). Minerva further admits that it correctly confirmed during discovery that
`
`that it had not applied for FDA clearance for this design. Minerva denies that it had any obligation
`
`to provide the supplementation Hologic refers to in paragraph 49. Except as expressly admitted,
`
`Minerva denies any and all remaining allegations in paragraph 49 of the Complaint.
`
`50. Minerva admits the Court ruled on the parties’ summary judgment motions on June
`
`28, 2018. Minerva further admits the Court agreed “with Hologic’s position that a ruling on the
`
`purported handle redesign would be an improper advisory opinion since the product is not being
`
`marketed and is not alleged to be infringing Hologic’s patent.” Minerva further admits that it
`
`started shipping its redesigned Minerva EAS handpiece starting on June 28, 2018. Except as
`
`expressly admitted, Minerva denies any and all remaining allegations in paragraph 50 of the
`
`Complaint.
`
`51. Minerva admits that, at the trial in late-July 2018, it correctly distinguished between
`
`the redesigned Minerva EAS handpiece on one hand and the one Plaintiffs accused of infringement
`
`-12-
`
`

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`in the First Action. Minerva further admits that it started shipping its redesigned Minerva EAS
`
`handpiece starting on June 28, 2018. Minerva admits that Mr. Truckai testified correctly at trial
`
`that he was “not aware of design-around” but Minerva denies that this statement or any other was
`
`misleading. Except as expressly admitted, Minerva denies any and all remaining allegations in
`
`paragraph 51 of the Complaint.
`
`52. Minerva admits it started shipping its redesigned Minerva EAS handpiece starting
`
`on June 28, 2018. Minerva admits the Court ruled on the parties’ summary judgment motions on
`
`June 28, 2018. Minerva further admits the Court agreed “with Hologic’s position that a ruling on
`
`the purported handle redesign would be an improper advisory opinion since the product is not
`
`being marketed and is not alleged to be infringing Hologic’s patent.” Minerva further admits that
`
`on June 22, 2018 it correctly objected to improper discovery regarding the new design because, at
`
`the time, the new design was not (and could not be) accused by Plaintiffs of infringement, as it
`
`was not currently in the market. Except as expressly admitted, Minerva denies any and all
`
`remaining allegations in paragraph 52 of the Complaint.
`
`53.
`
`54.
`
`Denied.
`
`Denied.
`
`COUNT I
`
`(Defendant’s Infringement of the ’348 Patent)
`
`55. Minerva incorporates by reference the above paragraphs of this Answer.
`
`56.
`
`Denied.
`
`57. Minerva admits it has had knowledge the ’348 Patent since at least 2016. Minerva
`
`further admits it had knowledge of the NovaSure system. Except as expressly admitted, Minerva
`
`denies any and all remaining allegations in paragraph 57 of the Complaint.
`
`-13-
`
`

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`58.
`
`59.
`
`60.
`
`61.
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`Denied
`
`Denied.
`
`Denied.
`
`Denied.
`
`PRAYER FOR RELIEF
`
`Minerva denies that Plaintiffs are entitled to the relief requested in paragraph 1.
`
`Minerva denies that Plaintiffs are entitled to the relief requested in paragraph 2.
`
`Minerva denies that Plaintiffs are entitled to the relief requested in paragraph 3.
`
`Minerva denies that Plaintiffs are entitled to the relief requested in paragraph 4.
`
`Minerva denies that Plaintiffs are entitled to the relief requested in paragraph 5.
`
`Minerva denies that Plaintiffs are entitled to the relief requested in paragraph 6.
`
`JURY DEMAND
`
`62.
`
`Plaintiffs demand for a jury trial does not state any allegation against Minerva to
`
`which a response is required. To the extent that any allegations are included in the demand,
`
`Minerva denies such allegations.
`
`AFFIRMATIVE DEFENSES
`
`In addition to the affirmative defenses described below, subject to its responses above,
`
`Minerva respectfully reserves all right to allege affirmative defenses that become known through
`
`the course of discovery.
`
`FIRST AFFIRMATIVE DEFENSE
`(Failure to State Claim)
`
`63.
`
` Plaintiffs Complaint fails to state a claim upon which relief may be granted.
`
`-14-
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 10 Filed 08/31/20 Page 15 of 18 PageID #: 82
`
`SECOND AFFIRMATIVE DEFENSE
`(Noninfringement)
`
`64. Minerva is not infringing and has not infringed, either literally or under the doctrine
`
`of equivalents or in any other way, any valid enforceable claim of the ’348 Patent.
`
`THIRD AFFIRMATIVE DEFENSE
`(Invalidity)
`
`65.
`
`One or more asserted claims of the ’348 Patent are invalid for failing to meet the
`
`conditions for patentability in 35 U.S.C. §§ 101, 102, 103, and/or 112.
`
`FOURTH AFFIRMATIVE DEFENSE
`(Prosecution History Estoppel)
`
`66.
`
`One or more asserted claims of the ’348 Patent are and were limited by amendment,
`
`the prior art, and/or by the statements made during their prosecution before the U.S. Patent and
`
`Trademark Office such that Hologic is now estopped and/or otherwise precluded from maintaining
`
`that such claims of the ’348 Patent are of sufficient scope to cover the accused products either
`
`literally or under the doctrine of equivalents.
`
`FIFTH AFFIRMATIVE DEFENSE
`(Safe Harbor)
`
`67.
`
`There is no infringement—directly, by inducement, contributorily or in any other
`
`way—of any valid claim of the ’348 Patent by Minerva for any allegedly infringing activities
`
`falling within the safe harbor under 35 U.S.C. § 271(e).
`
`SIXTH AFFIRMATIVE DEFENSE
`(Obviousness-Type Double Patenting)
`
`68.
`
`The asserted claims of the ’348 Patent are subject to the doctrine of obviousness-
`
`type double patenting. In order to issue, the asserted claims of the ’348 patent should have been
`
`subject to a terminal disclaimer setting their expiration date as April 12, 2016.
`
`-15-
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 10 Filed 08/31/20 Page 16 of 18 PageID #: 83
`
`SEVENTH AFFIRMATIVE DEFENSE
`(Unclean Hands)
`
`69.
`
`Plaintiffs’ claims are barred by the doctrine of unclean hands, including Plaintiffs
`
`filing this lawsuit in bad faith.
`
`REQUEST FOR RELIEF
`
`WHEREFORE, Minerva respectfully requests that the Court:
`
`A.
`
`B.
`
`C.
`
`Enter judgment in favor of Minerva;
`
`Dismiss all of Plaintiffs’ claims in their entirety with prejudice;
`
`Award Minerva its reasonable costs and fees, including attorneys’ fees under 35
`
`U.S.C. § 285; and
`
`D.
`
`Grant any other relief as the Court may deem appropriate and just under the
`
`circumstances.
`
`-16-
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 10 Filed 08/31/20 Page 17 of 18 PageID #: 84
`
`WILSON SONSINI GOODRICH & ROSATI, P.C.
`
` /s/ Ian R. Liston
`Ian R. Liston (#5507)
`222 Delaware Avenue, Suite 800
`Wilmington, DE 19801
`(302) 304-7600
`iliston@wsgr.com
`
`Counsel for Defendant Minerva Surgical, Inc.
`
`Of Counsel:
`
`Vera M. Elson
`WILSON SONSINI GOODRICH & ROSATI, P.C.
`650 Page Mill Road
`Palo Alto, CA 94304
`Tel: (650) 849-3495
`Fax: (650) 493-6811
`velson@wsgr.com
`
`Olivia M. Kim*
`Erik Carlson*
`WILSON SONSINI GOODRICH & ROSATI, P.C.
`633 West Fifth Street, Suite 1550
`Los Angeles, CA 90071
`(323) 210-2900
`okim@wsgr.com
`ecarlson@wsgr.com
`
`*Applications for admission pro hac vice to
`be submitted
`
`Dated: August 31, 2020
`
`-17-
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 10 Filed 08/31/20 Page 18 of 18 PageID #: 85
`
`CERTIFICATE OF SERVICE
`
`I, Ian R. Liston, hereby certify that on August 31, 2020, I caused the foregoing Defendants’
`
`Answer to Complaint for Patent Infringement to be served via electronic mail upon the following
`
`counsel of record:
`
`Karen L. Pascale
`Pilar G. Kraman
`YOUNG CONAWAY STARGATT & TAYLOR LLP
`Rodney Square
`1000 North King Street
`Wilmington, DE 19801
`kpascale@ycst.com
`pkraman@ycst.com
`
`Counsel for Plaintiffs Hologic, Inc. and
`Cytyc Surgical Products, LLC
`
`Matthew M. Wolf
`Jennifer A. Sklenar
`Marc A. Cohn
`ARNOLD & PORTER LLP
`601 Massachusetts Avenue, N.W.
`Washington, D.C. 20001-3743
`matthew.wolf@arnoldporter.com
`jennifer.sklenar@arnoldporter.com
`marc.cohn@arnoldporter.com
`
`Counsel for Plaintiffs Hologic, Inc.
`and Cytyc Surgical Products, LLC
`
` /s/ Ian R. Liston
`Ian R. Liston (#5507)
`
`

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