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Case 1:20-cv-00925-JFB-SRF Document 115 Filed 03/29/21 Page 1 of 7 PageID #: 6366
`
`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
`(cid:53)(cid:40)(cid:39)(cid:36)(cid:38)(cid:55)(cid:40)(cid:39)(cid:3)(cid:16)(cid:3)(cid:51)(cid:56)(cid:37)(cid:47)(cid:44)(cid:38)(cid:3)(cid:57)(cid:40)(cid:53)(cid:54)(cid:44)(cid:50)(cid:49)
`
`DECLARATION OF MARC A. COHN IN SUPPORT OF
`PLAINTIFFS’ MOTIONS FOR SUMMARY JUDGMENT
`AND MOTION TO EXCLUDE EXPERT TESTIMONY
`(VOLUME 3 OF 3: EXHIBITS 46 – 78)
`
`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
`(cid:53)(cid:72)(cid:71)(cid:68)(cid:70)(cid:87)(cid:72)(cid:71)(cid:3)(cid:89)(cid:72)(cid:85)(cid:86)(cid:76)(cid:82)(cid:81)(cid:29)(cid:48)(cid:68)(cid:85)(cid:70)(cid:75)(cid:3)(cid:21)(cid:28)(cid:15)(cid:3)(cid:21)(cid:19)(cid:21)(cid:20)
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 115 Filed 03/29/21 Page 2 of 7 PageID #: 6367
`
`
`I, Marc A. Cohn, declare as follows:
`
`1.
`
`I am an attorney at Arnold & Porter Kaye Scholer LLP and am licensed to
`
`practice law in Washington, D.C. I am admitted pro hac vice to this Court and I am counsel for
`
`Plaintiffs Hologic, Inc. and Cytyc Surgical Products, LLC (collectively, “Hologic” or
`
`“Plaintiffs”) in this matter.
`
`2.
`
`I make this declaration in support of Plaintiffs’ Motions for Summary Judgment
`
`of Infringement and No Invalidity, and Plaintiffs’ Motion to Exclude Certain Opinions and
`
`Testimony of Dr. Robert Tucker.
`
`3.
`
`Attached hereto are true and correct copies of the following documents, as
`
`referenced in Plaintiffs’ Opening Briefs in Support of Plaintiffs’ Motions for Summary Judgment
`
`of Infringement and No Invalidity, and Plaintiffs’ Opening Brief in Support of Plaintiffs’ Motion
`
`to Exclude Certain Opinions and Testimony of Dr. Robert Tucker.
`
`Exhibit
`
`Description
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`U.S. Patent No. 9,095,348, MSI00013489-520
`
`[SEALED] Photograph, Minerva EAS, LEINSINGK_000032
`
`[SEALED] Photograph, NovaSure ADVANCED, LEINSING_000209
`
`[SEALED] Photograph, New Pivot Device, LEINSINGK_000043
`
`[SEALED] Rebuttal Expert Report of Burt Magen, dated August 7, 2017
`
`[SEALED] Deposition Transcript of Burt Magen, dated September 12, 2017
`
`[SEALED] Deposition Transcript of Robert Tucker, dated March 11, 2021
`
`[SEALED] Deposition Transcript of David Clapper, dated February 19, 2021
`
`[SEALED] Email from Dave Clapper to Thomas Gries et al. re First New
`Spring Handle Shipments, MSIDE000163-64, dated August 22, 2018
`
`1
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 115 Filed 03/29/21 Page 3 of 7 PageID #: 6368
`
`
`Exhibit
`
`Description
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`[SEALED] Email from Sylvia Park to Dominique Filloux et al. re New spring
`loaded hand pieces, MSIDE000165-66, dated August 1, 2018
`
`[SEALED] Deposition Transcript of Dominique Filloux, dated February 17,
`2021
`
`[SEALED] Deposition Transcript of Eugene Skalnyi, dated February 17, 2021
`
`[SEALED] PMA Annual Report Amendment for the Minerva Endometrial
`Ablation System, PMA No. 140013/R008/A001, MSIDE000194-216, dated
`November 24, 2020
`
`[SEALED] Defendant Minerva Surgical, Inc.’s Second Supplemental
`Responses to Plaintiffs’ First Set of Interrogatories (No. 2), dated December 30,
`2020
`
`[SEALED] Expert Report of Karl R. Leinsing, MSME, PE Regarding
`Infringement of U.S. Patent No. 9,095,348, dated January 18, 2021
`
`[SEALED] Photograph, New Pivot Device, LEINSINGK_000042
`
`[SEALED] Design Drawings; Flat Spring, Handpiece, Part R0253 Rev. A;
`Assembly, Prototype Handles, Part Assy SD Rev. P2; MSIDE000001-03
`
`[SEALED] Minerva PMA Attachment B – Device Design and Description,
`MSI00052901-58, undated
`
`[SEALED] Photograph, New Pivot Device, LEINSINGK_000036
`
`[SEALED] Photograph, New Pivot Device, LEINSINGK_000037
`
`[SEALED] Defendant Minerva Surgical, Inc.’s Responses to Plaintiffs’ First
`Set of Interrogatories (Nos. 1-2), dated December 14, 2020
`
`[SEALED] Design Drawing, Spring Lever, Left, Part R0266 Rev. B,
`MSIDE000004, dated May 17, 2019
`
`[SEALED] Design Drawings, Spring Handle, Left, Part R0268 Rev. A,
`MSIDE000006-07, dated June 14, 2018
`
`[SEALED] Deposition Transcript of Dominique Filloux, dated October 17,
`2017
`
`[SEALED] Rebuttal Expert Report of Dr. Robert Tucker, M.D., Ph.D., to Karl
`R. Leinsing, Regarding U.S. Patent No. 9,095,348, dated February 8, 2021
`
`2
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 115 Filed 03/29/21 Page 4 of 7 PageID #: 6369
`
`
`Exhibit
`
`Description
`
`26
`
`27
`
`28
`
`29
`
`30
`
`31
`
`32
`
`33
`
`34
`
`35
`
`36
`
`37
`
`38
`
`39
`
`40
`
`41
`
`42
`
`43
`
`44
`
`[SEALED] Design Drawings, Spring Handle, Right, Part R0269 Rev. A,
`MSIDE000008-09, dated June 14, 2018
`
`[SEALED] Photograph, New Pivot Device, LEINSINGK_000021
`
`[SEALED] Photograph, New Pivot Device, LEINSINGK_000022
`
`[SEALED] Photograph, New Pivot Device, LEINSINGK_000008
`
`[SEALED] Photograph, New Pivot Device, LEINSINGK_000009
`
`[SEALED] Photograph, New Pivot Device, LEINSINGK_000012
`
`[SEALED] Photograph, New Pivot Device, LEINSINGK_000013
`
`[SEALED] Minerva Surgical Endometrial Ablation System Operator’s Manual,
`L0001 Rev. C, MSI00043122-64, undated
`
`[SEALED] Design Drawings, Frame Assembly, Part R0042 Rev. C,
`MSI00043240-48, dated March 19, 2015
`
`[SEALED] Excerpts of Minerva Surgical Pre-Training Study Manual,
`MSI00004426-553, undated
`
`[SEALED] Video (side view of handle during expansion and contraction of
`working end), HOL-MIN_005893
`
`[SEALED] Photograph, New Pivot Device, LEINSINGK_000044
`
`[SEALED] Shaft with Sheath Assembly Manufacturing Procedure, MP0008
`Rev. J, MSI00148969-83, dated October 27, 2016
`
`[SEALED] Assembly Drawing, Shaft with Sheath Assembly, Part A0005
`Rev. J, MSI00148504, dated November 17, 2016
`
`[SEALED] Excerpts of Minerva Surgical presentation to
`366, dated July 19, 2011
`
`, MSI00090298-
`
`[SEALED] Photograph, New Pivot Device, LEINSINGK_000045
`
`[SEALED] Photograph, New Pivot Device, LEINSINGK_000046
`
`[SEALED] Photograph, New Pivot Device, LEINSINGK_000047
`
`[SEALED] Photograph, New Pivot Device, LEINSINGK_000048
`
`3
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 115 Filed 03/29/21 Page 5 of 7 PageID #: 6370
`
`
`Exhibit
`
`Description
`
`45
`
`46
`
`47
`
`48
`
`49
`
`50
`
`51
`
`52
`
`53
`
`54
`
`55
`
`56
`
`57
`
`58
`
`59
`
`60
`
`[SEALED] Photograph, Minerva Flexures, LEINSING_000077
`
`[SEALED] PMA No. P140013/A004, Response to FDA Major Deficiency
`Letter October 30, 2014 for the Minerva Endometrial Ablation System,
`MSI00047103-39, dated December 30, 2014
`
`[SEALED] Product Specification Gen. 2 Minerva Endometrial Ablation System
`Disposable Handpiece PS0001 Rev. A, MSI00001928-40, dated March 17, 2015
`
`[SEALED] Photograph, New Pivot Device, LEINSINGK_000049
`
`[SEALED] Photograph, New Pivot Device, LEINSINGK_000041
`
`[SEALED] Reply Expert Report of Karl R. Leinsing, MSME, PE Regarding
`Infringement of U.S. Patent No. 9,095,348, dated February 22, 2021
`
`[SEALED] Photograph, New Pivot Device, LEINSINGK_000040
`
`Minerva Surgical, Technology Overview webpage, HOL-MIN-III_000374-76,
`dated August 8, 2018
`
`Minerva Surgical, Technology Overview webpage, HOL-MIN-III_000368-70,
`dated March 6, 2019
`
`Minerva Surgical, Minerva ES webpage, HOL-MIN-III_000635-38, dated
`January 6, 2021
`
`Minerva Surgical, Technology Overview webpage, HOL-MIN-III_000371-73,
`dated May 19, 2018
`
`[SEALED] Expert Report of Karl R. Leinsing, MSME, PE Regarding U.S.
`Patent Nos. 6,872,183, 9,095,348, and 9,247,989, dated June 30, 2017
`
`[SEALED] Surreply Expert Report of Dr. Robert Tucker, M.D., Ph.D., to Karl
`R. Leinsing, Regarding U.S. Patent No. 9,095,348, dated March 8, 2021
`
`Minerva Surgical, Inc. v. Hologic, Inc., No. IPR2016-00680, Paper 8 (PTAB
`Sept. 12, 2016)
`
`Minerva Surgical, Inc. v. Hologic, Inc., No. IPR2016-00685, Paper 8 (PTAB
`Sept. 12, 2016)
`
`Minerva Surgical, Inc. v. Hologic, Inc., No. IPR2016-00680, Paper 10 (PTAB
`Nov. 28, 2016)
`
`4
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 115 Filed 03/29/21 Page 6 of 7 PageID #: 6371
`
`
`Exhibit
`
`Description
`
`61
`
`62
`
`63
`
`64
`
`65
`
`66
`
`67
`
`68
`
`69
`
`70
`
`71
`
`72
`
`73
`
`74
`
`Minerva Surgical, Inc. v. Hologic, Inc., No. IPR2016-00685, Paper 10 (PTAB
`Nov. 28, 2016)
`
`Excerpts of Defendant Minerva Surgical, Inc.’s Initial Invalidity Contentions,
`dated September 30, 2016
`
`[SEALED] Defendant and Counter-Claimant Minerva Surgical, Inc.’s First
`Supplemental Responses to Plaintiffs’ Second Set of Interrogatories (Nos. 7, 9,
`15), dated December 27, 2016
`
`[SEALED] Defendant Minerva Surgical, Inc.’s Supplemental Invalidity
`Contentions, dated April 26, 2017
`
`[SEALED] Defendant Minerva Surgical, Inc.’s Second Supplemental Invalidity
`Contentions, dated May 17, 2017
`
`[SEALED] Deposition Transcript of Burt Magen, dated April 14, 2017
`
`[SEALED] Magen April 14, 2017 Deposition Exhibit 1, Email from Burt
`Magen to Dominique Filloux attaching Opinion Letter, MSI00297325-517,
`dated January 20, 2017
`
`[SEALED] Supplemental Expert Report of Karl R. Leinsing, MSME, PE
`Regarding U.S. Patent Nos. 6,872,183, 9,095,348, and 9,247,989, dated August
`22, 2017
`
`[SEALED] Defendant and Counterclaimant Minerva Surgical, Inc.’s Rule
`26(a)(2)(C) Disclosure, dated August 8, 2017
`
`[SEALED] Defendant and Counter-Claimant Minerva Surgical, Inc.’s Sixth
`Supplemental Responses to Plaintiffs’ Second Set of Interrogatories (Nos. 5, 9,
`11-14), dated June 23, 2017
`
`Transcript of Hearing before the Honorable Sherry R. Fallon, dated February 3,
`2021
`
`[SEALED] Design Drawing, Grip, Rear Right, Part FAB-05067 Rev. 004,
`HOL-MIN-II_075099-103, dated September 12, 2016
`
`[SEALED] Design Drawing, Grip, Left Rear, Part FAB-05068 Rev. 004, HOL-
`MIN-II_075155-59, dated September 12, 2016
`
`[SEALED] Photograph, Minerva EAS, LEINSING_000072
`
`5
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 115 Filed 03/29/21 Page 7 of 7 PageID #: 6372
`
`
`Exhibit
`
`Description
`
`75
`
`76
`
`77
`
`78
`
`[SEALED] Design Drawing, Lever, Left, Part R0020 Rev. C, MSI00149483,
`dated October 24, 2016
`
`[SEALED] Design Drawing, Lever, Right, Part R0021 Rev. C, MSI00149484,
`dated October 24, 2016
`
`[SEALED] Design Drawing, Handle, Left, Part R0022 Rev. C,
`MSI00149485-86, dated October 24, 2016
`
`[SEALED] Design Drawing, Handle, Right, Part R0023 Rev. D,
`MSI00149487-88, dated October 24, 2016
`
`
`
`
`Dated: March 22, 2021
`
` /s/ Marc A. Cohn
`Marc A. Cohn
`
`
`
`
`
`6
`
`

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