Case 1:20-cv-00925-JFB-SRF Document 120 Filed 03/30/21 Page 1 of 176 PageID #: 6640
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
` C.A. No. 15-1031-JFB-SRF
`
`JURY TRIAL DEMANDED
`
`) ) ) ) ) )
`
`HOLOGIC, INC., a Delaware corporation; and
`CYTYC SURGICAL PRODUCTS, LLC, a
`Massachusetts limited liability company,
`
`Plaintiffs,
`
`v.
`
`)
`)
`)
`)
`)
`)
`)
`
`DECLARATION OF ERIK J. CARLSON IN SUPPORT OF DEFENDANT MINERVA
`SURGICAL, INC.’S SUMMARY JUDGMENT AND DAUBERT MOTIONS
`
`MINERVA SURGICAL, INC., a Delaware
`corporation.
`
` REDACTED - PUBLIC VERSION
`
`Ian R. Liston (#5507)
`WILSON SONSINI GOODRICH & ROSATI, P.C.
`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
`(650) 493-9300
`velson@wsgr.com
`
`Edward G. Poplawski
`Olivia M. Kim
`Erik J. Carlson
`WILSON SONSINI GOODRICH & ROSATI, P.C.
`633 West Fifth Street, 15th Floor
`Los Angeles, CA 90071
`(323) 210-2900
`epoplawski@wsgr.com
`okim@wsgr.com
`ecarlson@wsgr.com
`
`Dated: March 22, 2021
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 120 Filed 03/30/21 Page 2 of 176 PageID #: 6641
`
`I, Erik J. Carlson, the undersigned declare as follows:
`
`1.
`
`I am an attorney at law, duly licensed to practice before all the courts of the State
`
`of California, and I am a associate in the law firm of Wilson Sonsini Goodrich and Rosati, PC,
`
`counsel of record for Defendant Minerva Surgical, Inc. (“Minerva”) in this action. I submit this
`
`declaration in support of (a) Defendant Minerva Surgical, Inc.’s Motion for Partial Summary
`
`Judgment of No Lost Profits; (b) Defendant Minerva Surgical, Inc.’s Motion For Partial
`
`Summary Judgment of No Literal Infringement; (c) Defendant Minerva Surgical, Inc.’s Motion
`
`For Partial Summary Judgment of No Infringement Under the Doctrine of Equivalents; and (d)
`
`Defendant Minerva Surgical, Inc.’s Daubert Motion to Exclude Certain Expert Opinions of: (1)
`
`Karl R. Leinsing and (2) Christopher C. Barry.
`
`2.
`
`True and correct copies of the following documents are attached hereto as
`
`Exhibits 1-29:
`
`Exhibit
`
`Description
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`January 18, 2021 Expert Report of Christopher C. Barry.
`
`Highly Confidential – Filed Under Seal
`
`February 22, 2021 Reply Expert Report of Christopher C. Barry.
`
`Highly Confidential – Filed Under Seal
`
`The transcript of the deposition of Christopher C. Barry taken on February 25,
`2021.
`
`Highly Confidential – Filed Under Seal
`
`Minerva Surgical Sales information (bates labeled MSIDE001633).
`
`Highly Confidential – Filed Under Seal
`
`February 8, 2021 Rebuttal Expert Report of Dr. Robert Tucker, M.D., Ph.D., to Karl
`R. Leinsing, Regarding U.S. Patent No. 9,095,348
`
`Highly Confidential – Filed Under Seal
`
`1
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 120 Filed 03/30/21 Page 3 of 176 PageID #: 6642
`
`Exhibit
`
`Description
`
`6.
`
`7.
`
`8.
`
`9.
`
`January 18, 2021 Expert Report Of Karl R. Leinsing, MSME, PE Regarding
`Infringement of U.S. Patent No. 9,095,348
`
`Highly Confidential – Filed Under Seal
`
`The Transcript of the deposition of Karl R. Leinsing taken on March 5, 2021
`
`Highly Confidential – Filed Under Seal
`
`Image with arrows pointing to “Pivot Point” and “Pivot Surface” (bates labeled
`LEINSINGK_000075)
`
`Highly Confidential – Filed Under Seal
`
`February 22, 2021 Reply Expert Report Of Karl R. Leinsing, MSME, PE Regarding
`Infringement of U.S. Patent No. 9,095,348
`
`Highly Confidential – Filed Under Seal
`
`10.
`
`March 8, 2021 Surreply Expert Report of Dr. Robert Tucker, M.D., Ph.D., to Karl
`R. Leinsing, Regarding U.S. Patent No. 9,095,348
`
`Highly Confidential – Filed Under Seal
`
`11.
`
`Photo of part of a handpiece (bates labeled LEINSINGK_000069)
`
`Highly Confidential – Filed Under Seal
`
`12.
`
`Video of Minerva ES handpiece (bates labeled TUCKER-925_0001)
`
`Highly Confidential – Filed Under Seal
`
`13.
`
`Video of Minerva ES handpiece (bates labeled TUCKER-925_0002)
`
`Highly Confidential – Filed Under Seal
`
`14.
`
`15.
`
`Video of Minerva ES handpiece, Leinsing Dep. Ex. 7 (bates labeled
`LEINSINGK_000001)
`
`Highly Confidential – Filed Under Seal
`
`Video of a portion of a handpiece, Leinsing Dep. Ex. 8 (bates labeled
`LEINSINGK_000007)
`
`Highly Confidential – Filed Under Seal
`
`-2-
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 120 Filed 03/30/21 Page 4 of 176 PageID #: 6643
`
`Exhibit
`
`Description
`
`16.
`
`17.
`
`18.
`
`19.
`
`20.
`
`21.
`
`22.
`
`23.
`
`24.
`
`25.
`
`26.
`
`27.
`
`28.
`
`29.
`
`November 23, 2020 Hologic, Inc. and Cytyc Surgical Products, LLC’s Preliminary
`Infringement Contentions
`
`Highly Confidential – Filed Under Seal
`
`Relevant Excerpts from File History re: U.S. Patent No. 9,095,348 at HOL-
`MIN_145561, HOL-MIN_145792-798, HOL-MIN_145809-820, HOL-
`MIN_145823, HOL-MIN_145864-873, HOL-MIN_145901-909, HOL-
`MIN_145914-915, HOL-MIN_145933
`
`U.S. Patent No. 4,646,740 to Peters et al. (“Peters ’740”)
`
`U.S. Patent No. 9,095,348 (bates labeled MSI00013489-520)
`
`Hologic Complaint for Patent Infringement, from Hologic, Inc. et al. v. Minerva
`Surgical, Inc., Civ. No. 15-1031 (D. Del.), First Action D.I. 1
`
`Joint Claim Construction from Hologic, Inc. et al. v. Minerva Surgical, Inc., Civ.
`No. 15-1031 (D. Del.), First Action D.I. 155
`
`February 8, 2021 Defendant Minerva Surgical, Inc.’s Rule 26(a)(2)(C) Disclosure
`
`Highly Confidential – Filed Under Seal
`
`Relevant Excerpts from June 30, 2017 Expert Report of Karl R. Leinsing, MSME,
`PE Regarding U.S. Patent Nos. 6,872,183, 9,095,348, and 9,247,989 served in
`Hologic, Inc. et al. v. Minerva Surgical, Inc., Civ. No. 15-1031 (D. Del.)
`
`Highly Confidential – Filed Under Seal
`
`Oxford Illustrated American Dictionary (1998) definition of “compound”
`
`U.S. Patent No. 5,353,784 to Nady-Mohamed (“Nady-Mohamed ’784”) (bates
`labeled MSIDE000248-257)
`
`U.S. Patent No. 5,112,329 to Storz (“Storz ’329”) (bates labeled MSIDE001573-
`1578)
`
`U.S. Patent No. 4,574,803 to Storz (“Storz ’803”) (bates labeled MSIDE001559-
`1563)
`
`U.S. Patent 5,769,880 to Truckai et al. (Truckai ’880) (bates labeled
`MSIDE000377-400)
`
`U.S. Patent 4,016,867 to King (“King”) (bates labeled MSIDE000226-230)
`
`-3-
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 120 Filed 03/30/21 Page 5 of 176 PageID #: 6644
`
`I declare under penalty of perjury of the laws of the State of California and the United
`
`States that each of the above statements is true and correct. Executed on March 22, 2021, in
`
`Torrance, California.
`
`/s/ Erik J. Carlson
`Erik J. Carlson
`
`-4-
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 120 Filed 03/30/21 Page 6 of 176 PageID #: 6645
`
`CERTIFICATE OF SERVICE
`
`I, Ian R. Liston, hereby certify that on March 22, 2021, I caused the foregoing
`
`DECLARATION OF ERIK J. CARLSON IN SUPPORT OF DEFENDANT MINERVA
`
`SURGICAL, INC.’S SUMMARY JUDGMENT AND DAUBERT MOTIONS 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
`jhiggins@ycst.com
`
`Counsel for Plaintiffs Hologic, Inc. and
`Cytyc Surgical Products, LLC
`
`Matthew M. Wolf
`Marc A. Cohn
`Jennifer A. Sklenar
`ARNOLD & PORTER KAYE SCHOLER LLP
`601 Massachusetts Avenue, N.W.
`Washington, D.C. 20001-3743
`matthew.wolf@apks.com
`marc.cohn@apks.com
`Jennifer.sklenar@arnoldporter.com
`
`Ryan J. Casamiquela
`ARNOLD & PORTER KAYE SCHOLER LLP
`10th Floor, Three Embarcadero Center
`San Francisco, CA 94111-4024
`ryan.casamiquela@apks.com
`
`Assad Rajani
`ARNOLD &PORTER KAYE SCHOLER LLP
`3000 El Camino Real
`Five Palo Alto Square, Suite 500
`Palo Alto, CA 94306-3807
`assad.rajani@apks.com
`
`Counsel for Plaintiffs Hologic, Inc. and
`Cytyc Surgical Products, LLC
`
` /s/ Ian R. Liston
`Ian R. Liston (#5507)
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 120 Filed 03/30/21 Page 7 of 176 PageID #: 6646
`
`
`
`
`EXHIBITS 1-16
`FILED UNDER SEAL
`
`FILED UNDER SEAL
`
`EXHIBITS 1-16
`
`
`
`
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 120 Filed 03/30/21 Page 8 of 176 PageID #: 6647
`Case 1:20-cv-00925—JFB-SRF Document 120 Filed 03/30/21 Page 8 of 176 PageID #: 6647
`
`
`
`
`
`
`
`
`
`
`
`
`
`EXHIBIT 17
`
`EXHIBIT 17
`
`
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 120 Filed 03/30/21 Page 9 of 176 PageID #: 6648
`
`PTO/AIA/15 (03-13)
`Approved for use through 01/31/2014. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless it displays a valid OMB control number
`13.003011 CON 7
`
`Attorney Docket No.
`
`UTILITY
`PATENT APPLICATION
`TRANSMITTAL
`
`(Only for new non provisional applications under 37 CFR 1.53(b))
`
`Express Mail Label No.
`
`APPLICATION ELEMENTS
`See MPEP chapter 600 concerning utility patent application contents.
`
`ADDRESS TO:
`
`First Named Inventor
`
`Csaba TRUCKAI
`
`Title
`
`A Moisture Transport System for Contact Electrocoagulation
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`ACCOMPANYING APPLICATION PAPERS
`
`10. (cid:9)
`
`Assignment Papers
`(cover sheet & document(s))
`Name of Assignee (cid:9)
`
`
`
`n Power of Attorney
`
`(when there is an assignee)
`
`(If applicable)
`
`(PTO/SB/08 or PTO-1449)
`
`Copies of citations attached
`
`11. n 37 CFR 3.73(c) Statement
`12. n English Translation Document
`13. n Information Disclosure Statement
`14. n Preliminary Amendment
`15. n Return Receipt Postcard
`16. n Certified Copy of Priority Document(s)
`17. n Nonpublication Request
`18. n Other: (cid:9)
`
`(MPEP § 503) (Should be specifically itemized)
`
`(if foreign priority is claimed)
`
`Under 35 U.S.C. 122(b)(2)(B)(i). Applicant must attach form PTO/SB/35
`or equivalent.
`
`
`
`(PTO/SB/17 or equivalent)
`
`See 37 CFR 1.27
`
`1. ri Fee Transmittal Form
`2. ri A• pplicant asserts small entity status.
`3. ri A• pplicant certifies micro entity status. See 37 CFR 1.29.
`4. ri S• pecification (cid:9)
`
`Applicant must attach form PTO/SB/15A or B or equivalent.
`
`[Total Pages 45
`Both the claims and abstract must start on a new page.
`(See MPEP § 608.01(a) for information on the preferred arrangement)
`
`
`
`5. n Drawing(s) (35 U.S.C. 113) (cid:9)
`
`[Total Sheets 18
`
`[Total Pages (cid:9)
`6. Inventor's Oath or Declaration (cid:9)
`(including substitute statements under 37 CFR 1.64 and assignments
`serving as an oath or declaration under 37 CFR 1.63(e))
`
`a. ri Newly executed (original or copy)
`b. n A copy from a prior application (37 CFR 1.63(d))
`7. n Application Data Sheet * See note below.
`
`See 37 CFR 1.76 (PTO/AIA/14 or equivalent)
`
`
`
`
`
`8. (cid:9)
`
`CD-ROM or CD-R
`in duplicate, large table, or Computer Program (Appendix)
`
`Landscape Table on CD
`
`9. Nucleotide and/or Amino Acid Sequence Submission
`(if applicable, items a. - c. are required)
`
`a. n Computer Readable Form (CRF)
`b. pi Specification Sequence Listing on:
`
`i.
`
`CD-ROM or CD-R (2 copies); or
`
`ii.
`
`Paper
`
`c. n Statements verifying identity of above copies
`
`*Note: (1) Benefit claims under 37 CFR 1.78 and foreign priority claim
`under 1.55 must be included in an Application Data Sheet (ADS).
`
`(2) For applications filed under 35 U.S.C. 111, the application m ust contain an ADS specifying the applicant if the applicant is an
`assignee, person to whom the inventor is under an obligati
`n to assign, or person who otherwise shows sufficient proprietary
`interest in the matter. See 37 CFR 1.46(b).
`19. CORRESPO DENCE ADDRESS
`
`n The address associated with Customer Number: 38732
`
`OR n Correspondence address below
`
`Name
`
`Address
`
`City
`
`Country
`r
`Signature
`
`State
`
`Telephone
`
`Zip Code
`
`Email
`
`/Robert P. Smith/
`
`Date
`
`August 8, 2013
`
`Registration No.
`Name
``(Print/Type) Robert P. Smith
`(Attorney/Agent) 48,680
`This collection of 'nformation is required by 37 CFR 1.53(b). The information is required to obtain or retain a benefit by the public which is to file (and by the USPTO
`to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.11 and 1.14. This collection is estimated to take 12 minutes to complete,
`including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case. Any comments on
`the amount of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and
`Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND
`TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`If you need assistance in completing the form, call 1-800-PTO-9199 and select option 2.
`
`HOL-MIN_145561
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 120 Filed 03/30/21 Page 10 of 176 PageID #: 6649
`
`Docket No: 13.003011 CON 7
`(PATENT)
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent Application of:
`Csaba TRUCKAI, et al.
`
`Application No: 13/962,178 (cid:9)
`
`Confirmation No: 4658
`
`Filed: August 8, 2013 (cid:9)
`
`Art Unit: 3739
`
`For: MOISTURE TRANSPORT SYSTEM FOR (cid:9)
`CONTACT ELECTROCOAGULATION
`
`Examiner: Jocelyn D. RAM
`
`SECOND PRELIMINARY AMENDMENT
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Dear Sir:
`
`Prior to examination on the merits, please amend the above identified application as follows:
`
`Amendments to the Specification begin on page 2 of this paper.
`
`Amendments to the Claims are reflected in the listing of claims beginning on page 3 of this
`
`paper.
`
`Remarks begin on page 6 of this paper.
`
`HOL-MIN_145792
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 120 Filed 03/30/21 Page 11 of 176 PageID #: 6650
`
`Application No: 13/962,178
`Amendment Dated: December 9, 2014
`Second Preliminary Amendment
`
`Amendments to the Specification
`
`Docket No: 13.003011 CON 7
`
`Please replace paragraph [0001] with the following amended paragraph:
`
`[0001] This application is a continuation of U.S. application 12/581,506 filed October 19,
`
`2009, now U.S. Patent 8,506,563 which is a continuation of U.S. application 10/959,771 filed
`
`October 6, 2004, now U.S. Patent 7,604,633, which is a divisional of U.S. application 09/103,072
`
`filed June 23, 1998, now U.S. Patent 6,813,520, which is a continuation in part of U.S. application
`
`08/632,516 filed April 12, 1996, now U.S. Patent 5,769,880, and claims the benefit of U.S.
`
`provisional application 60/084,791 filed May 8, 1998.
`
`2
`
`HOL-MIN_145793
`
`(cid:9)
`

`

`Case 1:20-cv-00925-JFB-SRF Document 120 Filed 03/30/21 Page 12 of 176 PageID #: 6651
`
`Application No: 13/962,178
`Amendment Dated: December 9, 2014
`Second Preliminary Amendment
`
`Listing of Claims
`
`1-18. (Canceled)
`
`Docket No: 13.003011 CON 7
`
`19.
`
`(New) 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;
`
`a handle coupled to the proximal portion;
`
`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 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
`
`one of the inner and outer sleeves relative to the other 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.
`
`20.
`
`(New) The device of claim 19 further comprising a transverse ribbon coupled to a distal end
`
`of the first and second external flexures, wherein the transverse ribbon is in a relaxed condition
`
`when the applicator head is in the expanded state.
`
`21.
`
`(New) The device of claim 19 wherein the first internal flexure includes a plurality of
`
`longitudinally spaced apertures.
`
`3
`
`HOL-MIN_145794
`
`(cid:9)
`

`

`Case 1:20-cv-00925-JFB-SRF Document 120 Filed 03/30/21 Page 13 of 176 PageID #: 6652
`
`Application No: 13/962,178
`Amendment Dated: December 9, 2014
`Second Preliminary Amendment
`
`Docket No: 13.003011 CON 7
`
`22.
`
`(New) The device of claim 19 wherein when the device is operably coupled to a generator to
`
`deliver current to the electrodes, the device is configured to electronically transmit the dimension of
`
`the uterus to the generator.
`
`23.
`
`(New) The device of claim 19 wherein the applicator head is configured to expand until
`
`limited by the dimension of the uterus.
`
`24.
`
`(New) The device of claim 19 wherein the indicator mechanism includes a gauge, and
`
`wherein the gauge comprises calibration markings corresponding to a range of uterine widths.
`
`25.
`
`(New) The device of claim 19 wherein the expanded state of the applicator includes a range
`
`of uterine widths that range from about 2.5 cm to about 4.5 cm.
`
`26.
`
`(New) The device of claim 19 wherein the handle comprises a proximal grip and a distal
`
`grip 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.
`
`27.
`
`(New) The device of claim 26 wherein the proximal grip is coupled to the inner sleeve and
`
`the distal grip is coupled to the outer sleeve.
`
`28.
`
`(New) The device of claim 26 further comprising an introducer sheath, wherein the inner
`
`sleeve and the outer sleeve are disposed within the introducer sheath when the applicator head is in
`
`a contracted state, and wherein the distal grip is coupled to the introducer sheath so that proximal
`
`movement of the distal grip causes the introducer sheath to move proximally relative to the
`
`applicator head.
`
`29.
`
`(New) A device for treating a uterus comprising:
`
`an elongate member having a proximal portion and a distal portion;
`
`4
`
`HOL-MIN_145795
`
`(cid:9)
`

`

`Case 1:20-cv-00925-JFB-SRF Document 120 Filed 03/30/21 Page 14 of 176 PageID #: 6653
`
`Application No: 13/962,178
`Amendment Dated: December 9, 2014
`Second Preliminary Amendment
`
`Docket No: 13.003011 CON 7
`
`an applicator head coupled to the distal portion of the elongate member, the applicator head
`
`defined by deformable walls having an expanded state and a contracted state, the expanded state
`
`being configured to conform to the shape of the uterus and the contracted state being configured for
`
`transcervical insertion;
`
`a handle coupled to the proximal portion of the elongate member;
`
`a deflecting mechanism disposed within the applicator head and configured to expand the
`
`applicator head from the contracted state to the expanded state; and
`
`an indicator mechanism operably coupled to the deflecting mechanism, the indicator
`
`mechanism comprising a gauge for displaying a dimension of the uterus.
`
`30.
`
`(New) The device of claim 29 wherein the gauge comprises calibration markings
`
`corresponding to a range of uterine widths.
`
`31.
`
`(New) The device of claim 29 wherein the applicator head is configured to expand until
`
`limited by the dimension of the uterus.
`
`32.
`
`(New) The device of claim 29 wherein the expanded state of the applicator includes a range
`
`of uterine widths that range from about 2.5 cm to about 4.5 cm.
`
`5
`
`HOL-MIN_145796
`
`(cid:9)
`

`

`Case 1:20-cv-00925-JFB-SRF Document 120 Filed 03/30/21 Page 15 of 176 PageID #: 6654
`
`Application No: 13/962,178
`Amendment Dated: December 9, 2014
`Second Preliminary Amendment
`
`Docket No: 13.003011 CON 7
`
`Remarks
`
`In the present amendment, the specification and claims have been amended. Applicant
`
`respectfully submits that no new matter has been introduced by the above amendments, as support
`
`therefore is found throughout the specification, claims and drawings as originally filed. Entry of the
`
`above amendments is respectfully requested.
`
`Amendments to the Specification
`
`The specification has been amended to delete reference to U.S. patent application serial no.
`
`08/632,516, filed April 12, 1996 (now U.S. patent no. 5,769,880) from the chain in the priority
`
`claim. This amendment is intended to cancel the priority claim to the April 12, 1996 date and make
`
`May 8, 1998 the earliest effective priority date for the present application.
`
`Amendments to the Claims
`
`Applicant has canceled claims 1-18 and added new claims 19 through 32.
`
`Conclusion
`
`Applicant believes that no fee is due in conjunction with this amendment. However, in the
`
`event of a fee deficiency, authorization is hereby given to charge any required fees to Deposit
`
`Account No. 50-2855, under Docket No. 13.003011 CON 7 from which the undersigned is
`
`authorized to draw.
`
`6
`
`HOL-MIN_145797
`
`(cid:9)
`

`

`Case 1:20-cv-00925-JFB-SRF Document 120 Filed 03/30/21 Page 16 of 176 PageID #: 6655
`
`Application No: 13/962,178
`Amendment Dated: December 9, 2014
`Second Preliminary Amendment
`
`Docket No: 13.003011 CON 7
`
`Dated: December 9, 2014 (cid:9)
`
`Respectfully submitted,
`
`/Robert P. Smith/
`Robert P. Smith
`Registration No.: 48,680
`Cytyc Corporation
`250 Campus Drive
`Marlborough, Massachusetts 01752
`(508) 263-8491
`(508) 263-2959 (Fax)
`Attorney For Applicant
`
`7
`
`HOL-MIN_145798
`
`(cid:9)
`

`

`Case 1:20-cv-00925-JFB-SRF Document 120 Filed 03/30/21 Page 17 of 176 PageID #: 6656
`
`UNITED STA (cid:9)1ES PA (cid:9)PENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO. (cid:9)
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO. (cid:9)
`
`CONFIRMATION NO.
`
`13/962,178
`
`08/08/2013
`
`Csaba Truckai
`
`13.003011 CON 7
`
`4658
`
`03/06/2015
`7590 (cid:9)
`38732 (cid:9)
`Hologic, Inc./Cytyc Corporation
`CarolAnn Mahoney, Sr. IP Paralegal
`35 Crosby Drive
`Bedford, MA 01730
`
`EXAMINER
`
`RAM, JOCELYN D
`
`ART UNIT
`
`PAPER NUMBER
`
`3739
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`03/06/2015
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`hologicpatentgroup@hologic.com
`
`PTOL-90A (Rev. 04/07)
`
`HOL-MIN_145809
`
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`

`

`Case 1:20-cv-00925-JFB-SRF Document 120 Filed 03/30/21 Page 18 of 176 PageID #: 6657
`Application No.
`Applicant(s)
`13/962,178
`TRUCKAI ET AL.
`
`Office Action Summary
`
`AIA (First Inventor to File)
`Status
`No
`-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`Examiner
`JOCELYN D. RAM
`
`Art Unit
`3739
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`- (cid:9) Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`- If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
`1)Z Responsive to communication(s) filed on 12/9/14.
`q A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on (cid:9)
`2a)1=1 This action is FINAL. (cid:9)
`2b)Z This action is non-final.
`3)0 An election was made by the applicant in response to a restriction requirement set forth during the interview on
`; the restriction requirement and election have been incorporated into this action.
`4)0 Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`
`
`Disposition of Claims*
`5)E1 Claim(s) 19-32 is/are pending in the application.
`5a) Of the above claim(s) (cid:9)
`is/are withdrawn from consideration.
`6)0 Claim(s) (cid:9)
`is/are allowed.
`7)Z Claim(s) 19 and 23-32 is/are rejected.
`8)Z Claim(s) 20-22 is/are objected to.
`9)0 Claim(s) (cid:9)
`are subject to restriction and/or election requirement.
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`
`participating intellectual property office for the corresponding application. For more information, please see
`
`httpliwwwusptagovipatents/init events/pphlindex.jsp or send an inquiry to PPI-lteedback@usptaaov.
`
`Application Papers
`10)Z The specification is objected to by the Examiner.
`11)Z The drawing(s) filed on 10/28/13 is/are: a)E accepted or b)Z objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
`
`Priority under 35 U.S.C. § 119
`12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`b)E1Some** c)1=1 None of the:
`1.0 (cid:9) Certified copies of the priority documents have been received.
`.
`2.0 (cid:9) Certified copies of the priority documents have been received in Application No. (cid:9)
`3.0 (cid:9) Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`** See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1) Z Notice of References Cited (PTO-892)
`
`2) Z Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date 5/15/14.
`
`3) q Interview Summary (PTO-413)
`
`Paper No(s)/Mail Date. (cid:9)
`
`
`
`4) q Other: (cid:9)
`
`
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20150225
`
`HOL-MIN_145810
`
`(cid:9)
`(cid:9)
`

`

`Case 1:20-cv-00925-JFB-SRF Document 120 Filed 03/30/21 Page 19 of 176 PageID #: 6658
`
`Application/Control Number: 13/962,178 (cid:9)
`Art Unit: 3739
`
`Page 2
`
`DETAILED ACTION
`
`Status of the Claims
`
`1.
`
`Below is a complete first action on the merits of claims 19-32. Claims 1-18 have
`
`been cancelled.
`
`Notice of Pre-AIA or AIA Status
`
`2.
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions. In the event the determination of the status of the application as subject to
`
`AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is
`
`incorrect, any correction of the statutory basis for the rejection will not be considered a
`
`new ground of rejection if the prior art relied upon, and the rationale supporting the
`
`rejection, would be the same under either status.
`
`Priority
`
`3.
`
`Applicant's deletion of the priority claim to US Patent Application 08/632,516
`
`(issued as US Patent 5,769,880) is acknowledged. The earliest effective priority date of
`
`the instant application is now May 8, 1998.
`
`Information Disclosure Statement
`
`4.
`
`The information disclosure statement (IDS) submitted on May 15, 2014 was filed
`
`before the mailing date of the first office action. The submission is in compliance with
`
`the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is
`
`being considered by the examiner.
`
`5.
`
`Applicant should note that the large number of references in the attached IDS
`
`have been considered by the examiner in the same manner as other documents in
`
`HOL-MIN_145811
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 120 Filed 03/30/21 Page 20 of 176 PageID #: 6659
`
`Application/Control Number: 13/962,178 (cid:9)
`Art Unit: 3739
`
`Page 3
`
`Office search files are considered by the examiner while conducting a search of the
`
`prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to
`
`point out any particular references in the IDS which they believe may be of particular
`
`relevance to the instant claimed invention in response to this office action.
`
`Drawings
`
`6.
`
`The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4)
`
`because reference characters "19b" and "109b" have both been used to designate
`
`single yarns of spandex. It is suggested that "single yarns of spandex 19b" be changed
`
`to —single yarns of spandex 109b—in paragraph [0113].
`
`7.
`
`Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in
`
`reply to the Office action to avoid abandonment of the application. Any amended
`
`replacement drawing sheet should include all of the figures appearing on the immediate
`
`prior version of the sheet, even if only one figure is being amended. Each drawing sheet
`
`submitted after the filing date of an application must be labeled in the top margin as
`
`either "Replacement Sheet" or "New Sheet" pursuant to 37 CFR 1.121(d). If the
`
`changes are not accepted by the examiner, the applicant will be notified and informed of
`
`any required corrective action in the next Office action. The objection to the drawings
`
`will not be held in abeyance.
`
`Specification
`
`8.
`
`The disclosure is objected to because of the following informalities: paragraph
`
`[0164], line 6, "FIGS. 3BA through 36C" should be changed to —FIGS. 36A through 36C-
`
`HOL-MIN_145812
`
`

`

`Case 1:20-cv-00925-JFB-SRF Document 120 Filed 03/30/21 Page 21 of 176 PageID #: 6660
`
`Application/Control Number: 13/962,178 (cid:9)
`Art Unit: 3739
`
`Page 4
`
`-; and "yoke 168, Which" should be changed to —yoke 168, which—in paragraph [0158],
`
`lines 2-3. Appropriate correction is required.
`
`Claim Rejections - 35 USC § 102
`
`9.
`
`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
`
`form the basis for the rejections under this section made in this Office action:
`
`A person shall be entitled to a patent unless —
`
`(b) the invention was patented or described in a printed publication in this or a foreign country or in
`public use or on sale in this country, more than one year prior to the date of application for patent in
`the United States.
`
`(e) the invention was described in (1) an application for patent, published under section
`122(b), by another filed in the United States before the invention by the applicant for patent or
`(2) a patent granted on an application for patent by another filed in the United States before
`the invention by the applicant for patent, except that an international application filed under
`the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an
`application filed in the United States only if the international application designated the United
`States and was published under Article 21(2) of such treaty in the English language.
`
`10. Claims 29-31 are rejected under 35 U.S.C. 102(b) as being anticipated by US
`
`Patent 4,016,867 ("King"). King discloses a device for treating a uterus comprising: an
`
`elongate member (12, 13) having a proximal portion (rearward portion 13) and a distal
`
`portion (forward stem portion 12); an applicator head (resilient wings 28, 29) coupled to
`
`the distal portion (12) of the elongate member (Fig. 2, see below), the applicator head
`
`defined by deformable walls (wings 28, 29 are resilient) having an expanded state (Fig.
`
`2) and a contracted state (Fig. 1), the expanded state being configured to conform to
`
`the shape of the uterus (col 4, lines 60-65) and the contracted state being configured for
`
`transcervical insertion (col 4, li