Case 1:20-cv-00925-JFB-SRF Document 109 Filed 03/29/21 Page 1 of 26 PageID #: 6222
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`HOLOGIC, INC., a Delaware corporation; and
`CYTYC SURGICAL PRODUCTS, LLC, a
`Massachusetts limited liability company,
`Plaintiffs,
`
`v.
`MINERVA SURGICAL, INC., a Delaware
`corporation,
`
`Defendant.
`
`C.A. No. 20-925-JFB-SRF
`
`REDACTED - PUBLIC VERSION
`
`OPENING BRIEF IN SUPPORT OF PLAINTIFFS’ MOTION FOR
`SUMMARY JUDGMENT OF INFRINGEMENT
`
`Of Counsel:
`Matthew M. Wolf
`Marc A. Cohn
`Jennifer A. Sklenar*
`ARNOLD & PORTER KAYE SCHOLER LLP
`601 Massachusetts Ave., NW
`Washington, DC 20001-3743
`Telephone: (202) 942-5000
`matthew.wolf@arnoldporter.com
`marc.cohn@arnoldporter.com
`jennifer.sklenar@arnoldporter.com
`
`* Admitted in NY and CA only; practice
`limited to matters before federal courts and
`federal agencies.
`
`Ryan J. Casamiquela
`ARNOLD & PORTER KAYE SCHOLER LLP
`Three Embarcadero Center
`San Francisco, CA 94111-4024
`Telephone: (415) 471-3100
`ryan.casamiquela@arnoldporter.com
`
`Assad H. Rajani
`ARNOLD & PORTER KAYE SCHOLER LLP
`Five Palo Alto Square
`3000 El Camino Real, Suite 500
`Palo Alto, CA 94306
`Telephone: (650) 319-4500
`assad.rajani@arnoldporter.com
`
`YOUNG CONAWAY STARGATT & TAYLOR LLP
`Karen L. Pascale (#2903) [kpascale@ycst.com]
`Pilar G. Kraman (#5199) [pkraman@ycst.com]
`Rodney Square
`1000 North King Street
`Wilmington, DE 19801
`Telephone: (302) 571-6600
`
`Attorneys for Plaintiffs Hologic, Inc.
` and Cytyc Surgical Products, LLC
`
`March 22, 2021
`Redacted version: March 29,2021
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 109 Filed 03/29/21 Page 2 of 26 PageID #: 6223
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`III.
`
`IV.
`
`INTRODUCTION............................................................................................................. 1
`
`NATURE AND STAGE OF THE PROCEEDINGS ..................................................... 2 
`
`SUMMARY OF THE ARGUMENT .............................................................................. 3 
`
`STATEMENT OF FACTS ............................................................................................... 4 
`
`A.
`
`B.
`
`Minerva’s New Pivot Design In The First Action And Its Concealment
`Of Commercial Activities ..................................................................................... 4 
`
`Minerva’s New Pivot Device Is Just Like Its Original Device With
`One Meaningless Change To The Handle’s Grips ............................................. 6 
`
`V.
`
`ARGUMENT ..................................................................................................................... 8 
`
`A.
`
`B.
`
`Legal Standard ...................................................................................................... 8 
`
`The Court Should Grant Summary Judgment Of Literal
`Infringement .......................................................................................................... 8 
`
`1.
`
`’348 Patent Claim 1 ................................................................................... 8 
`
`a.
`
`b.
`
`Minerva’s New Pivot Device Has Grips That Are
`“Pivotally Attached To One Another At A Pivot
`Point” ................................................................................. 9 
`
`Minerva’s New Pivot Device Has The
`Remaining, Undisputed Limitations Of Claim 1 ......... 10 
`
`2.
`
`Dependent Claims 3, 8, And 12 .............................................................. 11 
`
`C.
`
`Alternatively, The Court Should Grant Summary Judgment Of
`Infringement Under The Doctrine Of Equivalents (DOE) ............................. 12 
`
`1.
`
`2.
`
`No Reasonable Juror Could Find Non-Infringement Under
`The DOE .................................................................................................. 12 
`
`Minerva Cannot Avoid Application Of The DOE ............................... 14 
`
`a.
`
`b.
`
`Minerva Already Lost On Prosecution History
`Estoppel ............................................................................ 14 
`
`The Legal Doctrine Of Claim Vitiation Does Not
`Apply ................................................................................ 16 
`
`i
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 109 Filed 03/29/21 Page 3 of 26 PageID #: 6224
`
`c.
`
`The Legal Doctrine Of Ensnarement Does Not
`Apply ................................................................................ 17 
`
`D.
`
`The Court Should Grant Summary Judgment That Minerva’s Sales
`Do Not Fall Within The FDA Safe Harbor (Fifth Affirmative Defense) ....... 19 
`
`VI.
`
`CONCLUSION ............................................................................................................... 20 
`
`ii
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 109 Filed 03/29/21 Page 4 of 26 PageID #: 6225
`
`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Cases
`
`Abraxis Bioscience, Inc. v. Mayne Pharma (USA) Inc.,
`467 F.3d 1370 (Fed. Cir. 2006)................................................................................................12
`
`Abtox, Inc. v. Exitron Corp.,
`122 F.3d 1019 (Fed. Cir. 1997)................................................................................................20
`
`Bio-Rad Laby’s v. 10X Genomics Inc.,
`967 F.3d 1353 (Fed. Cir. 2020)..........................................................................................16, 17
`
`Centricut, LLC v. Esab Grp., Inc.,
`390 F.3d 1361 (Fed. Cir. 2004)..................................................................................................8
`
`Cordis Corp. v. Medtronic Ave, Inc.,
`511 F.3d 1157 (Fed. Cir. 2008)................................................................................................16
`
`DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009)......................................................................................8, 17, 18
`
`Eli Lilly & Co. v. Medtronic, Inc.,
`496 U.S. 661 (1990) .................................................................................................................20
`
`Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd.,
`535 U.S. 722 (2002) .................................................................................................................16
`
`Gart v. Logitech, Inc.,
`254 F.3d 1334 (Fed. Cir. 2001)..................................................................................................8
`
`Hologic, Inc. v. Minerva Surgical, Inc.,
`957 F.3d 1256 (Fed. Cir. 2020)..............................................................................................5, 6
`
`Intendis GMBH v. Glenmark Pharm. Inc., USA,
`822 F.3d 1355 (Fed. Cir. 2016)..........................................................................................17, 18
`
`Jean Alexander Cosmetics, Inc. v. L’Oreal USA, Inc.,
`458 F.3d 244 (3d Cir. 2006).....................................................................................................15
`
`LifeNet Health v. LifeCell Corp.,
`837 F.3d 1316 (Fed. Cir. 2016)..................................................................................................8
`
`Momenta Pharm., Inc. v. Teva Pharm. USA Inc.,
`809 F.3d 610 (Fed. Cir. 2015)..................................................................................................20
`
`iii
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 109 Filed 03/29/21 Page 5 of 26 PageID #: 6226
`
`Siemens Mobility, Inc. v. Westinghouse Air Brake Techs. Corp.,
`No. CV 16-284-LPS, 2019 WL 3240521 (D. Del. July 18, 2019) ..........................................18
`
`Soverain Software LLC v. Victoria’s Secret Direct Brand Mgmt., LLC,
`778 F.3d 1311 (Fed. Cir. 2015)................................................................................................14
`
`UCB, Inc. v. Watson Lab’ys Inc.,
`927 F.3d 1272 (Fed. Cir. 2019)..............................................................................13, 14, 17, 19
`
`Warner-Jenkinson Co. v. Hilton Davis Chem. Co.,
`520 U.S. 17 (1997) .....................................................................................................................8
`
`Statutes
`
`35 U.S.C. § 271(e) .....................................................................................................................4, 20
`
`Rules
`
`Fed. R. Civ. P. 56(a) ........................................................................................................................8
`
`iv
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 109 Filed 03/29/21 Page 6 of 26 PageID #: 6227
`
`Plaintiffs Hologic, Inc., and Cytyc Surgical Products, LLC (collectively, “Hologic”)
`
`respectfully request summary judgment of infringement of claims 1, 3, 8, and 12 of U.S. Patent
`
`No. 9,095,348 (the “’348 Patent”) against defendant Minerva Surgical, Inc. (“Minerva”).
`
`I.
`
`INTRODUCTION
`
`On June 28, 2018, this Court granted summary judgment that Minerva’s original
`
`Endometrial Ablation System (“EAS”) infringed claim 1 of the ’348 Patent (the “original
`
`device”). At the time, Minerva had developed a “prototype” of a purported re-design that it
`
`contended was a non-infringing alternative. The Court agreed with Hologic that it should
`
`decline to decide whether that prototype also infringed because, as Hologic argued based on
`
`Minerva’s representations, “the product is not being marketed.” (D.I. 407 at 29.)
`
`On the very day of the Court’s ruling, however, Minerva began to market and sell the re-
`
`designed product, but it did not tell the Court (or Hologic) despite Minerva’s duty of candor. As
`
`a result, the jury trial in July 2018 focused on the original, infringing device. It was not until
`
`post-trial briefing months later that Minerva first revealed that it had been selling its re-design
`
`since the day of the Court’s Order. Minerva’s concealment meant that Hologic had to file the
`
`present lawsuit to recover damages that should have been awarded in the first case.
`
`Minerva’s “re-design” is one in name only. Minerva made a single, insignificant change
`
`to the device’s handle in an attempt to avoid the ’348 Patent’s requirement that two “grips” are
`
`“pivotally attached to one another at a pivot point.” It is undisputed that the re-designed grips
`
`still pivot. In fact, Minerva’s own patent counsel labeled the prototype with the moniker “New
`
`Pivot,” and Minerva’s technical expert admitted at deposition that “there is rotation” of the
`
`grips.1 Thus, the New Pivot Device literally infringed.
`
`1 The Court adopted the parties’ agreed construction of “pivot point” as “a point of attachment
`between two members about which the members hinge or rotate.” (F.A., D.I. 155 at 3.)
`
`1
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 109 Filed 03/29/21 Page 7 of 26 PageID #: 6228
`
`Alternatively, there was infringement under the doctrine of equivalents. Minerva’s
`
`design change was so insignificant that it
`
`—Minerva
`
`. Indeed,
`
`, Minerva never mentioned the change in its marketing, and it did not alter the price.
`
`And,
`
`Minerva simply
`
`; instead,
`
`.
`
`The Court found that Minerva’s original product infringed and, in effect, that Minerva
`
`was competing against Hologic with its own technology—technology and intellectual property
`
`rights that Hologic paid $325 million to acquire from the same people who, years later, went on
`
`to found Minerva and to infringe some of those very patent rights. The Court should not permit
`
`Minerva to circumvent its prior ruling by concealing an insubstantial design change. Summary
`
`judgment of infringement should be granted.
`
`II.
`
`NATURE AND STAGE OF THE PROCEEDINGS
`
`Hologic filed a complaint in this Court against Minerva in November 2015 for
`
`infringement of several patents, including the ’348 Patent (Case No. 15-1031-JFB-SRF, the
`
`“First Action” or “F.A.”). Hologic brought the present lawsuit in July 2020 because Minerva
`
`concealed its commercialization of the accused re-design product from Hologic and the Court in
`
`order to avoid being held accountable in the First Action for its additional infringement.
`
`In view of these facts, the Court expedited fact and expert discovery in this case. (See
`
`D.I. 20, ¶ 2.) It adopted the Court’s “previous claim construction ruling and the parties’ previous
`
`agreement (First Action, D.I. 227; D.I. 155), and the Federal Circuit’s ruling relating thereto
`
`(First Action, D.I. 635-1)” as its claim construction decision here. (Id., ¶ 9.) Fact and expert
`
`discovery are already complete, and a five-day trial is scheduled for August 23, 2021. (Id., ¶ 16.)
`
`2
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 109 Filed 03/29/21 Page 8 of 26 PageID #: 6229
`
`III.
`
`SUMMARY OF THE ARGUMENT
`
`1.
`
`Hologic asserts claims 1, 3, 8, and 12 of the ’348 Patent against Minerva’s re-
`
`designed product, which its own opinion counsel called the “New Pivot” device. Minerva
`
`concedes that the New Pivot Device satisfies every limitation of claim 1 except for “a proximal
`
`grip and a distal grip pivotally attached to one another at a pivot point.” The Court should grant
`
`summary judgment of literal infringement because the undisputed evidence shows that the two
`
`grips of the New Pivot Device’s handle are attached to and rotate (pivot) relative to one another.
`
`2.
`
`The Court should alternatively grant summary judgment under the doctrine of
`
`equivalents (“DOE”). There is no genuine factual dispute that the New Pivot Device’s handle
`
`performs substantially the same function in substantially the same way to achieve substantially
`
`the same result as the claimed handle, and any differences are insubstantial. Minerva did not
`
`even
`
`, and the
`
`, much less substantial ones. Minerva told
`
`. And, Minerva never
`
`included the design change in any of its marketing.
`
`3.
`
`The Court should also grant summary judgment of infringement of claims 3, 8,
`
`and 12, which depend from claim 1. Minerva does not dispute that it meets the limitations of
`
`claims 3 and 12. As to claim 8’s requirement of “an adjustable locking mechanism configured to
`
`limit a degree of expansion of the applicator head,” the undisputed evidence shows that the New
`
`Pivot Device’s “PFA length setting feature” limits how much the applicator head is expanded.
`
`4.
`
`Minerva’s argument that prosecution history estoppel (“PHE”) bars the DOE
`
`should be rejected because the Court has already found that PHE does not apply. The identical
`
`issue (i.e., whether PHE bars equivalents) was litigated and adjudicated in the First Action. The
`
`Court found “no clear and unmistakable surrender of all equivalents to the pivot point limitation”
`
`3
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 109 Filed 03/29/21 Page 9 of 26 PageID #: 6230
`
`and that the claim amendment was nothing “more than tangential to patentability.” (F.A.,
`
`D.I. 407 at 29.) Minerva had a full opportunity to litigate this issue in the First Action: it lost.
`
`The Court should rule that Minerva cannot re-litigate the issue here due to issue preclusion.
`
`5.
`
`Finally, the Court should grant summary judgment that the safe harbor of
`
`35 U.S.C. § 271(e) does not apply to Minerva’s sales of the New Pivot Device, because it is
`
`undisputed that these accused sales were commercial and not reasonably related to the
`
`development and submission of information to obtain FDA approval.
`
`IV.
`
`STATEMENT OF FACTS
`
`A.
`
`Minerva’s New Pivot Design In The First Action And Its Concealment Of
`Commercial Activities
`
`Hologic filed the First Action on November 6, 2015, asserting, inter alia, that Minerva’s
`
`original EAS infringed the ’348 Patent. (F.A., D.I. 1.) During that action, in 2016, Minerva
`
`began developing its New Pivot Device. (D.I. 10, ¶ 36.) To support its damages case, Minerva
`
`produced prototypes of the New Pivot Device as a purported non-infringing design alternative.
`
`(Id., ¶¶ 43, 45; D.I. 13 at 4, 9-10; D.I. 28 at 2.) Hologic argued that the design would still
`
`infringe, and both parties’ technical experts addressed that issue in their reports.
`
`Minerva moved for summary judgment that PHE barred Hologic from arguing that the
`
`New Pivot Device infringed under the DOE. (F.A., D.I. 278 at 44-46; see also D.I. 10, ¶ 43.)
`
`On June 28, 2018, the Court denied Minerva’s motion, finding “no clear and unmistakable
`
`surrender of all equivalents” and explaining that it was “not convinced that the added detail is
`
`more than tangential to patentability.” (F.A., D.I. 407 at 29.) The Court, however, did not
`
`“address whether Minerva’s ‘new’ handle design would infringe Hologic’s ’348 Patent”
`
`because—as Hologic argued based on Minerva’s representations—that “product is not being
`
`marketed.” (Id.) The Court also found that Minerva’s original EAS device infringed and that
`
`4
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 109 Filed 03/29/21 Page 10 of 26 PageID #: 6231
`
`
`
`Minerva’s invalidity defenses under § 112 were meritless. (Id. at 24-26, 32-34.) Thus, the only
`
`issues for trial were willfulness and damages. (See F.A., D.I. 408 at 2.)
`
`At trial, Hologic’s technical expert, Karl Leinsing, demonstrated to the jury how the New
`
`Pivot design infringed claim 1 of the ’348 Patent and was, therefore, not a design-around for
`
`damages purposes. (F.A., D.I. 509 at 931:11-936:10.) Without disclosing that the New Pivot
`
`Device was already commercialized, Minerva requested to withdraw its reliance on the New
`
`Pivot design. (F.A., D.I. 511 at 1502:15-1503:22.) Hologic agreed based on Minerva’s prior and
`
`continued representations that the New Pivot Device was not being marketed. Little did Hologic
`
`(or the Court) know that Minerva had actually been commercializing it for weeks.
`
`During post-trial briefing in Fall 2018, Minerva disclosed for the first time that it began
`
`shipping its re-design on June 28, 2018—before trial and, ironically, on the same day the Court
`
`declined to decide summary judgment because the device was “not being marketed.” (F.A.,
`
`D.I. 407 at 29; F.A., D.I. 549 at 9.) Hologic then sought to include New Pivot Device sales in
`
`the supplemental damages award, because the minor design change was insignificant and did not
`
`impact infringement. (F.A., D.I. 620 at 1-2.) The Court did not include these sales in its
`
`supplemental damages award (see F.A., D.I. 621 at 1), and the Federal Circuit affirmed because
`
`“Hologic did not accuse [the New Pivot Device] of infringement,” Hologic, Inc. v. Minerva
`
`Surgical, Inc., 957 F.3d 1256, 1272 (Fed. Cir. 2020). Hologic had not done so (and could not do
`
`so) because Minerva had concealed its commercialization of the New Pivot Device during trial.
`
`Minerva did not appeal the Court’s finding of infringement of claim 1 of the ’348 Patent.
`
`Instead, Minerva challenged the Court’s constructions of “applicator head” and “indicator
`
`mechanism,” and argued that its original EAS did not infringe under the proper constructions.
`
`See id. at 1269. The Federal Circuit affirmed the Court’s grant of summary judgment of
`
`
`
`5
`
`

`

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`Case 1:20-cv-00925-JFB-SRF Document 109 Filed 03/29/21 Page 11 of 26 PageID #: 6232
`
`infringement, fmding no error in the Court’s constructions. Id. at 1269—70.
`
`Hologic initiated this action on July 8. 2020. as a continuation of the First Action to
`
`recover damages for Minerva’s infringing sales of the New Pivot Device. (D.I. 1.)
`
`B.
`
`Minerva’s New Pivot Device Is Just Like Its Original Device With One
`
`Meaningless Change To The Handle’s Grips
`
`The ’348 Patent is directed to a sophisticated device for the treatment of abnormal uterine
`
`bleeding. (Ex. 1 at 19:9—42.)2 The device applies energy to a woman’s uterus to ablate, or burn.
`
`the inner lining of her uterus in a controlled manner. (Id. at 1:25—31.) The only difference
`
`between Minerva’s original, infringing device and its New Pivot Device has nothing to do with
`
`this energy delivery, but instead involves only the handle’s grips and how they are attached.
`
`Claim 1 recites a handle with two grips that are “pivotally attached to one another at a pivot
`
`point.” such that when the grips are squeezed. the applicator head is deployed. (Id. at 19:22-29.)
`
`The handles of Minerva’s original. infringing device and of Hologic’s NovaSure device,
`
`both of which embodied the ’348 Patent, have the claimed pivotal attachment as shown below:
`
`
`
`Infringing Minerva Device And Hologic ’s NovaSure:
`grips “pivotally attached . . . at a pivot point” (red arrows show pivoting motion)
`
`(Exs. 2—3 (annotations added).) In the New Pivot Device. Minerva changed how the grips were
`
`attached to one another injnst one way:—
`
`2 The Exhibits herein are attached to the accompanying Declaration of Marc A. Cohn.
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 109 Filed 03/29/21 Page 12 of 26 PageID #: 6233
`
`
`
`, as shown below:
`
`Minerva’s accused New Pivot Device:
`grips “pivotally attached … at a pivot point” (red arrow shows pivoting motion)
`(Ex. 4 (annotations added).)
`
`The addition of a
`
` to an otherwise still-pivoting handle does not
`
`negate infringement. Indeed, Minerva’s own patent counsel
`
`
`
`(Ex. 5, ¶ 45; Ex. 6 at 218:20-219:1.) Dr. Tucker, Minerva’s technical expert, admitted that
`
`“
`
`25:18-21 (“
`
`. (Ex. 7 at 183:21-184:10; see also id. at
`
`”), 151:25-152:15 (“
`
`
`
`”), 182:20-21 (“
`
`”).) Thus, there can
`
`be no colorable dispute that the grips are still “pivotally attached to one another at a pivot point”
`
`under the Court’s construction requiring the grips to “hinge or rotate.” (F.A., D.I. 155 at 3.)
`
`The record also shows absolutely no real-world significance to Minerva’s tiny change.
`
`First, Minerva did not even
`
`. (Ex. 8 at 95:19-96:24; see also
`
`id. at 100:23-101:5.) In a medical device case, this is striking, because these devices are used
`
`inside the uterus of living, breathing women. If the change had any significance, then Minerva
`
`would have
`
`. Second, relatedly,
`
`
`
`Ex. 12 at 72:15-73:14, 74:2-6.) Third, Minerva did not alter any of its marketing materials to
`
`. (See Ex. 9 at 163; see also Ex. 10; Ex. 11 at 176:21-177:2;
`
`
`
`7
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 109 Filed 03/29/21 Page 13 of 26 PageID #: 6234
`
`show the design change. (Ex. 8 at 125:9-24; Ex. 11 at 185:2-11.) Fourth, Minerva was not even
`
`. (Ex. 13 at 202-03, 212-13.)
`
`V.
`
`ARGUMENT
`
`A.
`
`Legal Standard
`
`A court shall grant summary judgment when “the movant shows that there is no genuine
`
`dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed.
`
`R. Civ. P. 56(a). “An infringement issue is properly decided upon summary judgment when no
`
`reasonable jury could find that every limitation recited in the properly construed claim . . . is not
`
`found in the accused device either literally or under the doctrine of equivalents.” Gart v.
`
`Logitech, Inc., 254 F.3d 1334, 1339 (Fed. Cir. 2001).3
`
`Literal infringement “requires that each and every limitation set forth in a claim appear in
`
`an accused product.” LifeNet Health v. LifeCell Corp., 837 F.3d 1316, 1325 (Fed. Cir. 2016). A
`
`product that does not literally infringe may still infringe under the DOE if the differences
`
`between a limitation of the asserted claim and an element of the accused product are
`
`insubstantial. See Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 24 (1997).
`
`Minerva asserts three legal limits on the DOE: PHE, vitiation, and ensnarement. Whether any
`
`of these apply is a legal question for the Court and suitable for summary judgment. See id. at 39
`
`n.8; DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1324 (Fed. Cir. 2009).
`
`B.
`
`The Court Should Grant Summary Judgment Of Literal Infringement
`
`1.
`
`’348 Patent Claim 1
`
`Minerva concedes that its New Pivot Device has all the elements of claim 1 except “a
`
`3 “The patentee has the burden of proving infringement by a preponderance of the evidence.”
`Centricut, LLC v. Esab Grp., Inc., 390 F.3d 1361, 1367 (Fed. Cir. 2004).
`
`8
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 109 Filed 03/29/21 Page 14 of 26 PageID #: 6235
`
`
`
`proximal grip and a distal grip pivotally attached to one another at a pivot point.” (D.I. 28 at 2-4;
`
`Ex. 14 at 7-8; Ex. 7 at 31:17-33:5; see also Ex. 15, ¶¶ 95 (citing Ex. 16), 96 (citing Ex. 17 at 2),
`
`112 (citing Ex. 18 at 52913, 52915-15; Ex. 19; Ex. 20).) Even as to this element, there are still
`
`points of agreement.4 For instance, Minerva does not dispute that the New Pivot Device includes
`
`proximal and distal grips that are attached to one another. (See D.I. 10, ¶ 37; Ex. 7 at 34:14-35:3;
`
`Ex. 11 at 98:23-100:20; see also Ex. 15, ¶ 97 (citing Ex. 22; Ex. 23 at 6).) Minerva disputes only
`
`whether the grips of the New Pivot Device are attached “at a pivot point.” (Ex. 14 at 7; Ex. 7 at
`
`31:17-33:5.)5 No reasonable juror could find that this element is not met.
`
`a.
`
`Minerva’s New Pivot Device Has Grips That Are “Pivotally
`Attached To One Another At A Pivot Point”
`
`The Court adopted the parties’ agreed construction of “pivot point” as “a point of
`
`attachment between two members about which the members hinge or rotate.” (F.A., D.I. 155 at
`
`3.) Minerva’s New Pivot Device satisfies the “pivot point” limitation literally. The New Pivot
`
`Device’s rear (proximal) grip has two plastic tabs at its base that nest within the front (distal)
`
`grip and attach the grips together. (Ex. 23 at 6; Ex. 26 at 8; Ex. 13 at 215; see also Ex. 15, ¶ 66
`
`(citing Ex. 23 at 6; Ex. 26 at 8; Ex. 13 at 215).) As the grips are squeezed,
`
`
`
` according to Minerva’s expert. (Ex. 17 at 2-3; Ex. 13 at
`
`215; Ex. 57, ¶ 39; Ex. 7 at 40:21-41:4; see also Ex. 15, ¶ 65 (citing Ex. 17 at 2).) After
`
`
`
`
`
`. As a result, the grips rotate towards one another, as shown below:
`
`
`4 It is undisputed that Minerva made, sold, and/or offered to sell the New Pivot Device in the
`United States between June 28, 2018 and November 19, 2018. (See D.I. 10, ¶ 52; Ex. 21 at 7;
`Ex. 8 at 90:23-91:5, 93:7-94:1, 109:25-110:7.)
`5 Minerva does not dispute that the New Pivot prototype in the First Action is materially the
`same as the commercial New Pivot Device. (D.I. 28 at 2, 4; D.I. 24 at 4; D.I. 26 at 1-2; see also
`Ex. 24 at 71:14-24; Ex. 25, ¶ 163.)
`
`
`
`9
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 109 Filed 03/29/21 Page 15 of 26 PageID #: 6236
`
`
`
`(Exs. 27-28 (annotations added): see also Exs. 29-32; Ex. 15, 11 98 (citing Exs. 29-32).)
`
`Hologic’s expert. Mr. Leinsing. determined that the grips—
`
`—.6 (Ex- 15. ‘H 98-) This is—
`
`- seen in the grips ofiMinerva ’s original, infringing device.
`
`(See id. . 11 99.)
`
`Minerva’s expert. Dr. Tucker. admitted that—
`
`-in what is likely willful blindness—Minerva did not ask him to conduct
`
`his own 111easurements of the angle of rotation. Dr. Tucker thus cannot dispute Mr. Leinsing’s
`
`measru‘ements. (Ex. 7 at 183:21-185124: see also id. at 25: 18-21. 151125-152215. 182:20-21.)
`
`In any event. the extent of rotation is irrelevant. All the Court’s claim construction
`
`requires is that the grips “hinge or rotate” about a point of attachment. and this is not disputed.
`
`Thus. the New Pivot Device literally infringed, and the Court should grant Hologic’s Motion.
`
`b.
`
`Minerva’s New Pivot Device Has The Remaining, Undisputed
`Limitations Of Claim 1
`
`To meet its burden of proof. Hologic provides the following evidence. but Minerva does
`
`not dispute that the New Pivot Device embodied all of the remaining limitations of claim 1:
`
`6
`
`(Ex. 15.1198.)
`
`10
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 109 Filed 03/29/21 Page 16 of 26 PageID #: 6237
`Case 1:20-cv-00925-JFB-SRF Document 109 Filed 03/29/21 Page 16 of 26 PageID #: 6237
`
`
`
`’348 Patent
`
`Evidence/Sn art
`
`
`
`“A device for treating a
`uterus comprising”
`Ex. 1 at 19:9
`
`“an elongate member .
`(Ex. 1 at 19:10-13)
`
`. .”
`
`“an applicator head .
`(Ex. 1 at 19:14-21)
`
`. .”
`
`DJ. 28 at 2-4; Ex. 14 at 7-8: Ex. 7 at 31:17—33z5; see also
`Ex. 15, 1111 78-79 (citing Ex. 33 at 43124)
`
`DJ. 28 at 2-4; Ex. 14 at 7-8: Ex. 7 at 31:17—33z5; see also
`Ex. 15, 1111 82-86 (citing Ex. 33 at 43150; Ex. 18 at 52912-14;
`Ex. 34 at 43240-41
`
`D1. 28 at 2-4; Ex. 14 at 7-8; Ex. 7 at 31217—3315; see also
`Ex. 15, 1111 87-94 (citing Ex. 33 at 43124-26, 43128; Ex. 18 at
`52912-13, 52926-28; Ex. 35 at 4498, 4509-11; Ex. 37
`
`“a deflecting mechanism .
`(Ex. 1 at 19:30-39)
`
`. .” D1. 28 at 2-4; Ex. 14 at 7-8; Ex. 7 at 31217—3315; see also
`Ex. 15, 1111 113-115 (citing Ex. 34 at 43241; Ex. 18 at 52913;
`Ex. 36; Ex. 37
`
`“an indicator mechanism .
`
`. .” D1. 28 at 2-4; Ex. 14 at 7-8; Ex. 7 at 31217—3315; see also
`
`(Ex. 1 at 19:40-42)
`
`Ex. 15, 1111 116-123 (citing Ex. 33 at 43151; Ex. 38 at 148979-
`80; Ex. 39; Ex. 40 at 90338-39; Exs. 41—44
`
`2.
`
`Dependent Claims 3, 8, And 12
`
`Minerva does not dispute that the New Pivot Device embodied the dependent elements of
`
`claims 3 and 12, as shown below:
`
`’348 Patent
`
`Evidence/Sn ort
`
`
`
`D1. 28 at 2-4; Ex. 14 at 14; Ex. 25, 11 303; see
`Claim 3: “The device of claim 1 wherein
`the first internal flexure includes a plurality also Ex. 15, 1111 124-127 (citing Ex. 34 at 43245;
`of longitudinally spaced apemlres.” (Ex. 1
`Ex. 45)
`at 19:47—48.
`
`Ex. 14 at 14; Ex. 25, 11 303; Ex. 46 at 47117;
`Claim 12: “The device of claim 1 wherein
`the applicator head is configured to expand Ex. 18 at 52927-28; Ex. 47 at 1932, 1938; see
`until limited by the dimension of the
`also Ex. 15, 1111 133-138 (citing Ex. 46 at 47117;
`uterus.” Ex. 1 at 20:48-50.
`Ex. 18 at 52927-28; Ex. 47 at 1932, 1938
`
`Claim 8 recites: “The device of claim 1 further comprising an adjustable locking
`
`mechanism configured to limit a degree of expansion of the applicator head.” (Ex. 1 at 2025-7.)
`
`Minerva disputes this element, but it concedes that the New Pivot Device’s PFA length setting
`
`feature‘—
`
`
`
`
`
`—’ (Ex. 25, 1111 304-305; see also Ex. 14 at 14.) This PFA length setting feature is
`
`shown below:
`
`11
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 109 Filed 03/29/21 Page 17 of 26 PageID #: 6238
`
`
`
`(Exs. 48-49 (annotations added); see also Ex. 15, ¶¶ 130-132; Ex. 50, ¶ 71.)
`
`Minerva’s documents confirm that the PFA length setting feature limits the degree to
`
`which the PFA extends into the uterus (i.e., a degree of expansion) based on the predetermined
`
`uterine length. (Ex. 33 at 43149; Ex. 18 at 52915; see also Ex. 15, ¶¶ 128-132 (citing Ex. 33 at
`
`43149; Ex. 18 at 52915; Ex. 49; Ex. 51).) Thus, the New Pivot Device embodied this additional
`
`limitation, and no reasonable jury could find otherwise.
`
`C.
`
`Alternatively, The Court Should Grant Summary Judgment Of Infringement
`Under The Doctrine Of Equivalents (DOE)
`
`Even if the Court does not find literal infringement, the New Pivot Device satisfied the
`
`“pivot point” limitation under the DOE.
`
`1.
`
`No Reasonable Juror Could Find Non-Infringement Under The DOE
`
`Any differences between the New Pivot Device’s handle and the claimed handle would
`
`be utterly insubstantial. The function-way-result test is a guide, as shown in the below table:7
`
`
`7 “An accused device that ‘performs substantially the same function in substantially the same
`way to obtain the same result’ as the patented invention may infringe under [the DOE].” Abraxis
`Bioscience, Inc. v. Mayne Pharma (USA) Inc., 467 F.3d 1370, 1379 (Fed. Cir. 2006).
`
`
`
`12
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 109 Filed 03/29/21 Page 18 of 26 PageID #: 6239
`Case 1:20-cv-OO925-JFB-SRF Document 109 Filed 03/29/21 Page 18 of 26 PageID #: 6239
`
`Claimed Handle
`
`New Pivot Device
`
`Function
`
`Expanding and contracting the
`applicator head with a handle
`
`Expanding and contracting the PFA with the
`handle. (Ex. 33 at 43125, 43128, 43150: Ex. 18
`at 52913, 52915-16, 52940.)
`
`
`
`Actuating a handle with grips
`that rotate relative to one another
`
`Expansion and contraction of the
`applicator head
`
`When the handle is squeezed by a user, the
`grips rotate approximately 6° relative to one
`another. (Ex. 15, 1] 98.)
`
`Expansion and contraction of the PFA. (Ex. 33
`at 43125, 43128, 43150; Ex. 18 at 52913,
`
`52915—16, 52940.)
`
`Minerva’s marketing to customers, customer testing, and representations to the FDA all
`
`support a finding that any differences between the claimed handle and the New Pivot Device’s
`
`handle are insubstantial.8 Minerva did not_ it
`
`was—
`
`—- (EX- 9 at 163(‘—
`
`— -
`
`.”); Ex. 8 at 95:19-96:24; see also id. at 100:23-101:5.)—
`
`— Minerva confirmed that they‘—
`
`—’ of the Minerva handpiece. (See Ex. 9 at 163; see also Ex. 10 (‘-
`
`—);
`
`Ex. 11 at 176:21-177z2; Ex. 12 at 72:15-73:14, 742-6.) The design change was so minor that
`
`Minerva did not market it to customers and—
`
`_ (Ex.