`v.
`
`
`MEDTRONIC, INC., and
`MEDTRONIC VASCULAR, INC.,
`
`
`DEFENDANTS’ ANSWER AND
`DEFENSES TO PLAINTIFFS’
`FIRST AMENDED AND
`SUPPLEMENTAL COMPLAINT
`AND SECOND AMENDED
`COUNTERCLAIMS AGAINST
`PLAINTIFFS
`
`CASE 0:19-cv-01760-PJS-TNL Document 233 Filed 02/28/20 Page 1 of 63
`
`
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF MINNESOTA
`
`
`
`
`
`
`Court File No. 0:19-cv-1760 (PJS/TNL)
`
`
`VASCULAR SOLUTIONS LLC,
`TELEFLEX LIFE SCIENCES LIMITED,
`ARROW INTERNATIONAL, INC., and
`TELEFLEX LLC,
`
`
`Plaintiffs/
`Counterclaim Defendants,
`
`Defendants/
`Counterclaim Plaintiffs.
`
`
`
`
`
`Defendants Medtronic, Inc. and Medtronic Vascular, Inc. (collectively
`
`“Medtronic”) hereby answer and otherwise respond as follows to the First Amended and
`
`Supplemental Complaint of Plaintiffs Vascular Solutions LLC, Teleflex Life Sciences
`
`Limited, Arrow International, Inc., and Teleflex LLC (collectively “Teleflex”). All
`
`averments and allegations not expressly admitted herein are denied. The paragraph
`
`numbers and headings correspond to those in the First Amended and Supplemental
`
`Complaint.
`
`PARTIES
`
`1.
`Plaintiff Vascular Solutions LLC is a Minnesota entity with a place of
`business at 6464 Sycamore Court North, Maple Grove, MN 55369. Together with its
`affiliated companies, Vascular Solutions LLC develops and manufactures clinical
`products for use in minimally invasive coronary and peripheral vasculature procedures.
`Vascular Solutions LLC’s innovative products are developed to satisfy the needs of
`
`
`
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`physicians performing complex vascular procedures.
`ANSWER: Medtronic lacks knowledge or information sufficient to form a belief
`
`as to the truth of the allegations in Paragraph 1, and therefore denies the same.
`
`2.
`As of the filing of the original Complaint, Plaintiff Teleflex Innovations
`S.à r.l. was a Luxembourg corporation affiliated with Vascular Solutions LLC and the
`owner of the patents-in-suit. Teleflex Innovations S.à r.l. granted an exclusive license to
`the patents-in-suit to Vascular Solutions LLC to make, use, offer to sell, and sell products
`that are covered by the patents-in-suit along with the right to participate in litigation to
`enforce the patents-in-suit and other rights and obligations as stated in agreements
`between Vascular Solutions LLC and Teleflex Innovations S.à r.l.
`ANSWER: Medtronic lacks knowledge or information sufficient to form a belief
`
`as to the truth of the allegations in Paragraph 2, and therefore denies the same.
`
`3.
`Plaintiff Arrow is a Pennsylvania corporation with a place of business at
`550 East Swedesford Road, Suite 400, Wayne, PA 19087 and is affiliated with Vascular
`Solutions LLC and Teleflex Life Sciences Limited. As of the filing of the original
`Complaint, Vascular Solutions LLC had granted Arrow an exclusive license to offer to
`sell and sell under the patents-in-suit; a right to participate in litigation to enforce the
`patents-in-suit; and other rights and obligations as stated in the agreements between
`Vascular Solutions LLC and Arrow.
`ANSWER: Medtronic lacks knowledge or information sufficient to form a belief
`
`as to the truth of the allegations in Paragraph 3, and therefore denies the same.
`
`4.
`As of the filing of the original Complaint, Plaintiff Teleflex LLC employed
`individuals, as part of a service provider relationship with Arrow, that sell products that
`practice the patents-in-suit. On or about August 5, 2019, Teleflex LLC and Arrow entered
`into an exclusive distribution agreement.
`ANSWER: Medtronic lacks knowledge or information sufficient to form a belief
`
`as to the truth of the allegations in Paragraph 4, and therefore denies the same.
`
`5.
`As a result of a merger conducted on or about September 30, 2019, Teleflex
`Innovations S.à.r.l. merged into and was absorbed by its parent company, Teleflex
`Medical Devices S.à.r.l., a private limited liability company incorporated under the laws
`
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`of the Grand-Duchy of Luxembourg. As a result of this merger, the patents-in-suit
`became the property of Teleflex Medical Devices S.à.r.l. as successor-in-interest to
`Teleflex Innovations S.à.r.l.
`ANSWER: Medtronic lacks knowledge or information sufficient to form a belief
`
`as to the truth of the allegations in Paragraph 5, and therefore denies the same.
`
`6.
`As a result of a subsequent asset transfer conducted on or about December
`30, 2019, the patents-in-suit were transferred from Teleflex Medical Devices S.à.r.l. to
`Teleflex Life Sciences Limited, a limited liability company duly incorporated and validly
`existing under the laws of Malta, having its registered office at 171, Old Bakery Street,
`Valletta VLT 1455, Malta. As a consequence of this asset transfer, the patents-in-suit
`became the property of Teleflex Life Sciences Limited, and Teleflex Life Sciences
`Limited assumed all the rights and obligations of Teleflex Medical Devices S.à.r.l and its
`predecessor-in-interest Teleflex Innovations S.à.r.l., including their right to sue and
`recover for past and future infringements.
`ANSWER: Medtronic lacks knowledge or information sufficient to form a belief
`
`as to the truth of the allegations in Paragraph 6, and therefore denies the same.
`
`7.
`Effective February 3, 2020, the license agreement between Teleflex Life
`Sciences Limited and Vascular Solutions LLC and the license agreement between
`Vascular Solutions LLC and Arrow were terminated by agreement of the parties.
`Vascular Solutions LLC and Arrow maintained their right to sue for infringement
`occurring prior to the effective date of the termination agreement.
`ANSWER: Medtronic lacks knowledge or information sufficient to form a belief
`
`as to the truth of the allegations in Paragraph 7, and therefore denies the same.
`
`8.
`Effective February 3, 2020, Teleflex Life Sciences Limited granted
`Teleflex LLC an exclusive license to make, have made, use, sell, offer for sale, and
`import products that are covered by the patents-in-suit along with the right to participate
`in litigation to enforce the patents-in-suit and other rights and obligations as stated in the
`agreement between Teleflex Life Sciences Limited and Teleflex LLC.
`ANSWER: Medtronic lacks knowledge or information sufficient to form a belief
`
`as to the truth of the allegations in Paragraph 8, and therefore denies the same.
`
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`9.
`Effective February 3, 2020, Teleflex LLC granted Vascular Solutions LLC
`an exclusive license to make and have made products that are covered by the patents-in-
`suit along with the right to participate in litigation to enforce the patents-in-suit and other
`rights and obligations as stated in the agreement between Teleflex LLC and Vascular
`Solutions LLC.
`ANSWER: Medtronic lacks knowledge or information sufficient to form a belief
`
`as to the truth of the allegations in Paragraph 9, and therefore denies the same.
`
`10. Defendant Medtronic, Inc. is a Minnesota corporation with a place of
`business at 710 Medtronic Parkway, Minneapolis, MN 55432.
`ANSWER: Medtronic admits the allegations in Paragraph 10.
`
`11. Defendant Medtronic Vascular, Inc. is a Delaware company with a place of
`business at 3576 Unocal Place, Fountaingrove A, Santa Rosa, CA 95403. Medtronic
`Vascular, Inc. is registered to do business in Minnesota with a registered business address
`of 2345 Rice Street, Suite 230, Roseville, MN 55113. The Minnesota Secretary of State
`Business Record Details identify the Chief Executive Officer of Medtronic Vascular, Inc.
`as Sean Salmon and list an address for the Chief Executive Officer at 710 Medtronic
`Parkway, LC300, Minneapolis, MN 55432.
`ANSWER: Medtronic admits that Medtronic Vascular, Inc. is a Delaware
`
`company with a place of business at 3576 Unocal Place, Fountaingrove A, Santa Rosa,
`
`CA 95403. Medtronic also admits that Medtronic Vascular, Inc. is registered to do
`
`business in Minnesota with a registered agent address of 2345 Rice Street, Suite 230,
`
`Roseville, MN 55113. Medtronic further admits that the Minnesota Secretary of State
`
`Business Records Details identify the Chief Executive Officer of Medtronic Vascular as
`
`Sean Salmon and list an address for the Chief Executive Officer at 710 Medtronic
`
`Parkway, LC300, Minneapolis, MN 55432.
`
`JURISDICTION
`
`12.
`
`This action arises under the Patent Act, 35 U.S.C. § 271 et seq.
`
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`ANSWER: The allegations in Paragraph 12 state legal conclusions to which no
`
`answer is necessary. To the extent an answer is required, Medtronic admits that the First
`
`Amended and Supplemental Complaint purports to state a cause of action under 35
`
`U.S.C. § 271 et seq.
`
`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and
`
`13.
`1338(a).
`ANSWER: The allegations in Paragraph 13 state legal conclusions to which no
`
`answer is necessary. To the extent an answer is required, Medtronic admits that the First
`
`Amended and Supplemental Complaint purports to state a cause of action which would
`
`provide this Court with subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1338(a).
`
`14.
`This Court has personal jurisdiction over Defendants. Medtronic, Inc. is
`incorporated in and is a resident of Minnesota and maintains an office and transacts
`business within Minnesota. Medtronic Vascular, Inc. is registered to conduct business in
`Minnesota, maintains a registered office in Minnesota, and identifies its Chief Executive
`Officer with an address in Minnesota.
`ANSWER: The allegations in Paragraph 14 state legal conclusions to which no
`
`answer is necessary. To the extent an answer is required, Medtronic admits that it is
`
`subject to personal jurisdiction in Minnesota based on the claims made in the First
`
`Amended and Supplemental Complaint.
`
`15. Venue is proper in this District under 28 U.S.C. §[sic] 1391 and 1400(b).
`Medtronic, Inc. is incorporated in and is a resident of Minnesota and maintains an office
`and transacts business within Minnesota. Medtronic Vascular, Inc. is registered to
`conduct business in Minnesota, maintains a registered office in Minnesota, and identifies
`its Chief Executive Officer with an address in Minnesota. Medtronic has committed acts
`of infringement described herein in Minnesota.
`ANSWER: The allegations in Paragraph 15 state legal conclusions to which no
`
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`answer is necessary. To the extent an answer is required, Medtronic admits that
`
`Medtronic, Inc. is incorporated in and is a resident of Minnesota, and that it transacts
`
`business within Minnesota. Medtronic further admits that Medtronic Vascular, Inc. is
`
`registered to conduct business in Minnesota, maintains a registered office in Minnesota,
`
`and identifies its Chief Executive Officer with an address in Minnesota. Medtronic
`
`denies that it has committed acts of infringement in Minnesota or elsewhere. Medtronic
`
`does not contest venue in this District.
`
`MEDTRONIC’S ALLEGEDLY INFRINGING
`PRODUCTS AND ACTIVITIES
`
`16. Medtronic has committed acts of patent infringement by making, using,
`selling, offering for sale, and/or importing into the United States a guide extension
`catheter for interventional cardiology procedures marketed and sold as the Telescope
`Guide Extension Catheter.
`ANSWER: Medtronic denies the allegations in Paragraph 16.
`
`17. Medtronic’s Telescope product is available in two sizes: 6F and 7F. When
`both products are discussed collectively they will be referred to as “Telescope.” If
`referred to separately, they will be referred to as “Telescope 6F” and “Telescope 7F,”
`respectively.
`ANSWER: Medtronic admits that the Telescope Guide Extension Catheter (the
`
`“Telescope™ Catheter”) is available in two sizes. The remainder of Paragraph 17 does
`
`not require a response.
`
`18. Medtronic’s Telescope catheter and its uses are a copy of VSI’s industry-
`leading and bestselling interventional product, the GuideLiner catheter, and its uses, and
`of the patented features of the GuideLiner catheter that resulted in its remarkable success.
`ANSWER: Medtronic denies that the Telescope™ Catheter and its uses are a
`
`copy of GuideLiner, its uses, or allegedly patented features. Medtronic further denies
`
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`that GuideLiner is “industry-leading and bestselling” and that GuideLiner has achieved
`
`“remarkable success” as a result of its uses and allegedly patented features or otherwise.
`
`19. A copy of Medtronic’s in-service slide deck for its Telescope catheter is
`attached as Exhibit A. Medtronic believes and intends that the product information for
`the Telescope catheter in Exhibit A is accurate.
`ANSWER: Medtronic admits that Exhibit A to the First Amended and
`
`Supplemental Complaint is a document that contains information about the Telescope™
`
`Catheter that was believed to be accurate at the time the document was drafted.
`
`Medtronic denies Teleflex’s characterization of Exhibit A to the extent it differs from the
`
`contents of the exhibit itself.
`
`20. A copy of Medtronic’s Instructions for Use for the Telescope catheter is
`attached as Exhibit B. Exhibit B is accessible through https://www.medtronic.com/us-
`en/healthcare-professionals/products/cardiovascular/coronary-catheters/telescope.html,
`which is a link provided on Medtronic’s website https://www.medtronic.com/us
`en/index.html. Medtronic believes and intends that the product information for the
`Telescope catheter in Exhibit B is accurate.
`ANSWER: Medtronic admits that Exhibit B to the First Amended and
`
`Supplemental Complaint contains instructions for use of the Telescope™ Catheter that
`
`were believed to be accurate at the time the instructions were drafted. Medtronic denies
`
`Teleflex’s characterization of Exhibit B to the extent it differs from the contents of the
`
`exhibit itself. Medtronic denies the remaining allegations in Paragraph 20.
`
`21. A copy of Medtronic’s website page for the Telescope catheter is attached
`as Exhibit C. Exhibit C is accessible through https://www.medtronic.com/us-
`en/healthcare-professionals/products/cardiovascular/coronary-catheters/telescope.html,
`which is a link provided on Medtronic’s website https://www.medtronic.com/us-
`en/index.html. Medtronic believes and intends that the product information for the
`Telescope catheter in Exhibit C is accurate.
`
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`ANSWER: Medtronic admits that Exhibit C to the First Amended and
`
`Supplemental Complaint appears to be a printout from the www.medtronic.com website,
`
`printed on July 2, 2019, but lacks sufficient information to admit or deny if Exhibit C was
`
`in fact printed from its website on July 2, 2019. Medtronic further admits that the
`
`product information for the Telescope™ Catheter in Exhibit C was believed to be
`
`accurate at the time the instructions were drafted. Medtronic denies Teleflex’s
`
`characterization of Exhibit C to the extent it differs from the contents of the exhibit itself.
`
`Medtronic further denies the allegations in Paragraph 21 to the extent they differ from the
`
`content available on Medtronic’s website.
`
`22. A copy of a Medtronic press release relating to the Telescope catheter dated
`May 16, 2019 is attached as Exhibit D. Exhibit D is accessible through
`http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-
`newsArticle&ID=2398888, which is a link provided on Medtronic’s website
`https://www.medtronic.com/us-en/index.html. Medtronic believes and intends that the
`product information for the Telescope catheter in Exhibit D is accurate.
`ANSWER: Medtronic admits that Exhibit D to the First Amended and
`
`Supplemental Complaint is a press release that includes information regarding the
`
`Telescope™ Catheter that was believed to be accurate at the time the press release was
`
`drafted. Medtronic denies Teleflex’s characterization of Exhibit D to the extent it differs
`
`from the contents of the exhibit itself. Medtronic further denies the allegations in
`
`Paragraph 22 to the extent they differ from the content available on Medtronic’s website.
`
`23. A copy of a letter from the U.S. Food and Drug Administration (“FDA”) to
`Medtronic concerning Medtronic’s Section 510(k) premarket notification of intent to
`market the Telescope catheter is attached as Exhibit E. Pages 3 through 7 of Exhibit E
`were submitted by or on behalf of Medtronic to the FDA and contain a summary of the
`contents of Medtronic’s Section 510(k) premarket notification of intent to market the
`
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`Telescope catheter. Medtronic believes and intends that the information concerning the
`Telescope catheter and Medtronic’s 510(k) premarket notification of intent to market the
`Telescope catheter are accurate.
`ANSWER: Medtronic admits that Exhibit E to the First Amended and
`
`Supplemental Complaint includes correspondence from the FDA regarding Medtronic’s
`
`510(k) premarket notification of intent to market the Telescope™ Catheter. Medtronic
`
`further admits that Exhibit E includes a summary of Medtronic’s 510(k) premarket
`
`notification that was submitted to the FDA that was believed to be accurate at the time
`
`the summary was drafted. Medtronic denies Teleflex’s characterization of Exhibit E to
`
`the extent it differs from the contents of the exhibit itself.
`
`24.
`Exhibit E states that “Medtronic’s Telescope™ Guide Extension Catheter is
`substantially equivalent to the predicate device based on similarities in intended use and
`technological characteristics.” Ex. E at 5. Exhibit E identifies the substantially
`equivalent predicate device as “GuideLiner V3 Catheter.” Id.
`ANSWER: Medtronic admits that, consistent with the requirements for a 510(k)
`
`premarket submission, Exhibit E to the First Amended and Supplemental Complaint
`
`contains the first quoted sentence in Paragraph 24 that “Medtronic’s Telescope™ Guide
`
`Extension Catheter is substantially equivalent to the predicate device based on
`
`similarities in intended use and technological characteristics.” In the following sentence,
`
`Exhibit E referred to the “technological differences” in the Telescope™ Catheter.
`
`Medtronic further admits that Exhibit E identifies the “predicate device” as “GuideLiner
`
`V3 Catheter.” Medtronic denies Teleflex’s characterization of Exhibit E to the extent it
`
`differs from the contents of the exhibit itself.
`
`25. Medtronic advertises its coronary guide catheters on its website, including
`
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`at least the Launcher Coronary Guide Catheter, the Sherpa NX Active Coronary Guide
`Catheter, and the Sherpa NX Balanced Coronary Guide Catheter (collectively “Medtronic
`Guide Catheters”). Exhibit F is a copy of Medtronic’s website
`https://www.medtronic.com/us-en/healthcare-professionals/products/cardiovascular/
`coronary-catheters/guide.html depicting its coronary guide catheter products. This
`website is accessible via a link provided on Medtronic’s website
`https://www.medtronic.com/us-en/index.html. Medtronic believes and intends that the
`product information for its guide catheters in Exhibit F is accurate.
`ANSWER: Medtronic admits that Exhibit F to the First Amended and
`
`Supplemental Complaint appears to be a printout from the www.medtronic.com website
`
`that includes information regarding Medtronic’s coronary guide catheter products.
`
`Medtronic further admits that the product information in Exhibit F was believed to be
`
`accurate at the time it was drafted. Medtronic denies Teleflex’s characterization of
`
`Exhibit F to the extent it differs from the contents of the exhibit itself. Medtronic further
`
`denies the allegations in Paragraph 25 to the extent they differ from the content available
`
`on Medtronic’s website.
`
`26.
`In connection with its literature regarding the Telescope catheter,
`Medtronic promotes its “legacy of market-leading catheter expertise” and refers to itself
`as a “true market leader . . . [b]ased on guide catheter . . . market share reports and data
`on file at Medtronic.” Ex. A at 23.
`ANSWER: Medtronic admits that the quoted language appears in Exhibit A to
`
`the First Amended and Supplemental Complaint. Medtronic denies Teleflex’s
`
`characterization of Exhibit A to the extent it differs from the contents of the exhibit itself.
`
`27. A guide catheter is required in order to use Medtronic’s Telescope catheter.
`E.g., Ex. A at 39 (“Required GC I.D. (in.) . . .”); Ex. B at 5 (“Other items that are
`required but not provided in the package: Guide catheter . . . .”); Ex. E at 5 (“Telescope™
`Guide Extension Catheter is intended to be used in conjunction with guide catheters . .
`. .”).
`
`ANSWER: Medtronic admits that the quoted language appears in Exhibits A, B,
`
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`and E to the First Amended and Supplemental Complaint. Medtronic denies Teleflex’s
`
`characterization of Exhibits A, B, and E to the extent it differs from the contents of the
`
`exhibits themselves.
`
`28. Medtronic directs its customers and users of the Telescope guide extension
`catheter to use Telescope with a guide catheter. E.g., Ex. A at 39 (“Required GC I.D.
`(in.) . . .”); Ex. B at 4 (“Telescope guide extension catheter is intended to be used in
`conjunction with guide catheters . . . .”) (“The guide extension catheter is designed to act
`as an extension to a traditional guide catheter . . . .”) (“The guide extension catheter is
`delivered through a guide catheter . . . .”), 5 (“Other items that are required but not
`provided in the package: Guide catheter . . . .”); Ex. E at 5 (“Telescope™ Guide
`Extension Catheter is intended to be used in conjunction with guide catheters . . . .”).
`ANSWER: Medtronic admits that the quoted language appears in Exhibits A, B,
`
`and E to the First Amended and Supplemental Complaint. Medtronic denies Teleflex’s
`
`characterization of Exhibits A, B, and E to the extent it differs from the contents of the
`
`exhibits themselves.
`
`29. Medtronic markets its Telescope catheter for the purpose of acting “as an
`extension to a traditional guide catheter and to facilitate the delivery of interventional
`devices into the vasculature.” Ex. B at 4; see also id. (“Telescope guide extension
`catheter is intended to be used in conjunction with guide catheters to access discrete
`regions of the coronary and/or peripheral vasculature, and to facilitate placement of
`interventional devices.”); Ex. E at 5 (“The guide extension catheter is designed to act as
`an extension to a traditional guide catheter . . . .”) (“Telescope™ Guide Extension
`Catheter is intended to be used in conjunction with guide catheters . . . .”).
`ANSWER: Medtronic admits that the quoted language appears in Exhibits B
`
`and E to the First Amended and Supplemental Complaint. Medtronic denies Teleflex’s
`
`characterization of Exhibits B and E to the extent it differs from the contents of the
`
`exhibits themselves.
`
`30. As of at least 2017, Medtronic was aware that VSI had a patent portfolio
`relating to its GuideLiner catheter.
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`ANSWER: Medtronic admits that as of 2017, Medtronic was aware that Teleflex
`
`had patents related to guide extension catheter technology.
`
`31. Medtronic asked to discuss a license to VSI’s GuideLiner patent portfolio.
`ANSWER: Medtronic admits that it engaged in licensing discussions with
`
`Teleflex related to the guide extension catheter patents of which Medtronic was aware.
`
`32. VSI declined to license its GuideLiner patent portfolio to Medtronic.
`ANSWER: Medtronic admits that Teleflex and Medtronic did not enter into a
`
`license for any guide extension catheter patents.
`
`COUNT I
`Alleged Claim for Patent Infringement of U.S. Patent No. 8,048,032
`
`33.
`The allegations of paragraphs 1-32 are re-alleged as if fully set forth herein.
`ANSWER: Medtronic repeats and re-alleges the foregoing responses as if fully
`
`set forth herein.
`
`34.
`Teleflex Life Sciences Limited is the owner of United States Patent No.
`8,048,032 (“’032 patent”), which issued on November 1, 2011, a copy of which is
`attached as Exhibit G.
`ANSWER: Medtronic admits that Exhibit G to the First Amended and
`
`Supplemental Complaint appears to be a copy of U.S. Patent No. 8,048,032. Medtronic
`
`lacks knowledge or information sufficient to form a belief as to the truth of the remaining
`
`allegations in Paragraph 34, and therefore denies the same.
`
`35. Medtronic has infringed and continues to infringe one or more claims of the
`’032 patent, including at least claims 12 and 14, under 35 U.S.C. § 271(a) by making,
`using, offering to sell, selling, and importing (directly or through intermediaries), in this
`District and elsewhere in the United States, guide extension catheters, namely the
`Telescope guide extension catheter.
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`ANSWER: Medtronic denies the allegations in Paragraph 35.
`
`36. Attached as Exhibit L is a claim chart showing an example of how
`Medtronic infringes claims 12 and 14 of the ’032 patent.
`ANSWER: Medtronic admits that the Exhibit L to the First Amended and
`
`Supplemental Complaint is a claim chart, but denies that Exhibit L establishes that
`
`Medtronic infringes any valid and enforceable claim of the ’032 patent.
`
`37. Medtronic’s Telescope catheter satisfies claim element 11(p), as shown in
`Exhibit L.
`ANSWER: Medtronic states that the term “satisfies” is vague, such that
`
`Medtronic is unable to form a response. To the extent the allegations in Paragraph 37
`
`suggest that the Telescope™ Catheter infringes any valid and enforceable claim of the
`
`’032 patent, Medtronic denies them.
`
`38. Medtronic’s Telescope catheter satisfies claim element 11(a), as shown in
`Exhibit L.
`ANSWER: Medtronic states that the term “satisfies” is vague, such that
`
`Medtronic is unable to form a response. To the extent the allegations in Paragraph 38
`
`suggest that the Telescope™ Catheter infringes any valid and enforceable claim of the
`
`’032 patent, Medtronic denies them.
`
`39. Medtronic’s Telescope catheter satisfies claim element 11(b), as shown in
`Exhibit L.
`ANSWER: Medtronic states that the term “satisfies” is vague, such that
`
`Medtronic is unable to form a response. To the extent the allegations in Paragraph 39
`
`suggest that the Telescope™ Catheter infringes any valid and enforceable claim of the
`
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`’032 patent, Medtronic denies them.
`
`40. Medtronic’s Telescope catheter satisfies claim element 11(c), as shown in
`Exhibit L.
`ANSWER: Medtronic states that the term “satisfies” is vague, such that
`
`Medtronic is unable to form a response. To the extent the allegations in Paragraph 40
`
`suggest that the Telescope™ Catheter infringes any valid and enforceable claim of the
`
`’032 patent, Medtronic denies them.
`
`41. Medtronic’s Telescope catheter satisfies claim element 11(d), as shown in
`Exhibit L.
`ANSWER: Medtronic states that the term “satisfies” is vague, such that
`
`Medtronic is unable to form a response. To the extent the allegations in Paragraph 41
`
`suggest that the Telescope™ Catheter infringes any valid and enforceable claim of the
`
`’032 patent, Medtronic denies them.
`
`42. Medtronic’s Telescope catheter satisfies claim element 11(e), as shown in
`Exhibit L.
`ANSWER: Medtronic states that the term “satisfies” is vague, such that
`
`Medtronic is unable to form a response. To the extent the allegations in Paragraph 42
`
`suggest that the Telescope™ Catheter infringes any valid and enforceable claim of the
`
`’032 patent, Medtronic denies them.
`
`43. Medtronic’s Telescope catheter satisfies claim element 12, as shown in
`Exhibit L.
`ANSWER: Medtronic states that the term “satisfies” is vague, such that
`
`Medtronic is unable to form a response. To the extent the allegations in Paragraph 43
`
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`suggest that the Telescope™ Catheter infringes any valid and enforceable claim of the
`
`’032 patent, Medtronic denies them.
`
`44. Medtronic’s Telescope catheter satisfies claim element 14, as shown in
`Exhibit L.
`ANSWER: Medtronic states that the term “satisfies” is vague, such that
`
`Medtronic is unable to form a response. To the extent the allegations in Paragraph 44
`
`suggest that the Telescope™ Catheter infringes any valid and enforceable claim of the
`
`’032 patent, Medtronic denies them.
`
`45. VSI did not give Medtronic authorization or license to make, use, offer to
`sell, sell, or import the Telescope catheter.
`ANSWER: Medtronic admits that Teleflex did not give Medtronic authorization
`
`or license to make, use, offer to sell, sell, or import the Telescope™ Catheter, but denies
`
`that such authorization is required under applicable law.
`
`46. Medtronic also indirectly infringes the ’032 patent, including at least claims
`12 and 14 under at least 35 U.S.C. § 271(b).
`ANSWER: Medtronic denies the allegations in Paragraph 46.
`
`47. Medtronic has induced and continues to induce infringement in this District
`and elsewhere in the United States of one or more claims of the ’032 patent, including at
`least claims 12 and 14, by, among other things, actively and successfully encouraging,
`instructing, enabling, and otherwise causing end users and/or customers to use its
`Telescope catheter in a manner that infringes the ’032 patent. For example, Medtronic’s
`Instructions for Use instruct end users and/or customers to use the Telescope catheter to
`perform interventional cardiology procedures. E.g., Ex. B at 4 (“The guide extension
`catheter is designed to act as an extension to a traditional guide catheter and to facilitate
`the delivery of interventional devices into the vasculature. The guide extension catheter
`is intended to be used within the coronary and/or peripheral vasculature to provide
`support.”). Medtronic’s Instructions for Use, FDA submission, and marketing materials
`indicate that Telescope is specifically designed to be used with a guide catheter and
`require that the Telescope catheter be used along with a guide catheter and hemostatic
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`valve. E.g., Ex. A at 11, 39 (“Required GC I.D. (in.) . . .”); Ex. B at 4 (“Telescope guide
`extension catheter is intended to be used in conjunction with guide catheters . . . .”) (“The
`guide extension catheter is designed to act as an extension to a traditional guide catheter .
`. . .”), 5 (“Other items that are required but not provided in the package: Guide catheter . .
`. Y-adaptor with hemostasis valve”); Ex. E at 5 (“The guide extension catheter is
`designed to act as an extension to a traditional guide catheter . . . .”) (“Telescope™ Guide
`Extension Catheter is intended to be used in conjunction with guide catheters . . . .”). End
`us