CASE 0:19-cv-01760-PJS-TNL Document 16 Filed 08/23/19 Page 1 of 46
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`UNITED STATES DISTRICT COURT
`DISTRICT OF MINNESOTA
`
`
`VASCULAR SOLUTIONS LLC,
`TELEFLEX INNOVATIONS S.À R.L.,
`ARROW INTERNATIONAL, INC., AND
`TELEFLEX LLC,
`
`
`Plaintiffs/Counterclaim Defendants,
`
`Court File No. 0:19-cv-1760 (PJS/TNL)
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`DEFENDANTS’ ANSWER, DEFENSES,
`AND COUNTERCLAIMS TO
`PLAINTIFFS’ COMPLAINT
`
`
`
`v.
`
`
`MEDTRONIC, INC., AND MEDTRONIC
`VASCULAR, INC.,
`
`
`Defendants/Counterclaim Plaintiffs.
`
`
`
`Defendants Medtronic, Inc. and Medtronic Vascular, Inc. (collectively
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`“Medtronic”) hereby answer and otherwise respond as follows to the Complaint of
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`Plaintiffs Vascular Solutions LLC, Teleflex Innovations S.à r.l., Arrow International,
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`Inc., and Teleflex LLC (collectively “Teleflex”). All averments and allegations not
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`expressly admitted herein are denied. The paragraph numbers and headings correspond
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`to those in the Complaint.
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`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
`physicians performing complex vascular procedures.
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`ANSWER: Medtronic lacks knowledge or information sufficient to form a belief
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`as to the truth of the allegations in Paragraph 1, and therefore denies the same.
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`Page 1
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`Teleflex Ex. 2068
`Medtronic v. Teleflex
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`CASE 0:19-cv-01760-PJS-TNL Document 16 Filed 08/23/19 Page 2 of 46
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`2.
`Plaintiff Teleflex S.à r.l. is a Luxembourg corporation affiliated with
`Vascular Solutions LLC. Teleflex S.à r.l. is the owner by assignment of the patents-in-
`suit. Teleflex 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 S.à r.l.
`
`ANSWER: Medtronic lacks knowledge or information sufficient to form a belief
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`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 S.à r.l. Vascular Solutions LLC 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
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`as to the truth of the allegations in Paragraph 3, and therefore denies the same.
`
`4.
`Plaintiff Teleflex LLC employs individuals, as part of a service provider
`relationship with Arrow, that sell products that practice the patents-in-suit. Teleflex LLC
`has entered into a binding asset purchase agreement with Arrow (scheduled to close in
`August 2019) that, among other things, transfers to Teleflex LLC all customer contracts,
`distributor agreements, sales contracts and other commitments and, in August, will be
`paired with a distribution agreement providing to Teleflex LLC the exclusive right to
`offer to sell and sell under the patents-in-suit.
`
`ANSWER: Medtronic lacks knowledge or information sufficient to form a belief
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`as to the truth of the allegations in Paragraph 4, and therefore denies the same. Medtronic
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`denies that Teleflex LLC has standing to assert claims for patent infringement against
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`Medtronic because, according to Teleflex’s own allegations in Paragraph 4, Teleflex LLC
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`did not have rights to offer and sell under the patents-in-suit at the time the Complaint
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`was filed on July 2, 2019.
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`5.
`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 5.
`
`6.
`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.
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`ANSWER: Medtronic admits that Medtronic Vascular, Inc. is a Delaware
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`company with a place of business at 3576 Unocal Place, Fountaingrove A, Santa Rosa,
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`CA 95403. Medtronic also admits that Medtronic Vascular, Inc. is registered to do
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`business in Minnesota with a registered agent address of 2345 Rice Street, Suite 230,
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`Roseville, MN 55113. Medtronic further admits that the Minnesota Secretary of State
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`Business Records Details identify the Chief Executive Officer of Medtronic Vascular as
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`Sean Salmon and list an address for the Chief Executive Officer at 710 Medtronic
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`Parkway, LC300, Minneapolis, MN 55432.
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`JURISDICTION
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`7.
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`This action arises under the Patent Act, 35 U.S.C. § 271 et seq.
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`ANSWER: The allegations in Paragraph 7 state legal conclusions to which no
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`answer is necessary. To the extent an answer is required, Medtronic admits that the
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`Complaint purports to state a cause of action under 35 U.S.C. § 271 et seq.
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`8.
`1338(a).
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`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and
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`ANSWER: The allegations in Paragraph 8 state legal conclusions to which no
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`answer is necessary. To the extent an answer is required, Medtronic admits that the
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`Complaint purports to state a cause of action which would provide this Court with subject
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`matter jurisdiction under 28 U.S.C. §§ 1331 and 1338(a).
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`9.
`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.
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`ANSWER: The allegations in Paragraph 9 state legal conclusions to which no
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`answer is necessary. To the extent an answer is required, Medtronic admits that it is
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`subject to personal jurisdiction in Minnesota based on the claims made in the Complaint.
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`10. Venue is proper in this District under 28 U.S.C. § 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.
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`ANSWER: The allegations in Paragraph 10 state legal conclusions to which no
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`answer is necessary. To the extent an answer is required, Medtronic admits that
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`Medtronic, Inc. is incorporated in and is a resident of Minnesota, and that it transacts
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`business within Minnesota. Medtronic further admits that Medtronic Vascular, Inc. is
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`registered to conduct business in Minnesota, maintains a registered office in Minnesota,
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`and identifies its Chief Executive Officer with an address in Minnesota. Medtronic
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`denies that it has committed acts of infringement in Minnesota or elsewhere. Medtronic
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`does not contest venue in this District.
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`MEDTRONIC’S ALLEGEDLY INFRINGING
`PRODUCTS AND ACTIVITIES
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`11. 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 11.
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`12. 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.
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`ANSWER: Medtronic admits that the Telescope Guide Extension Catheter (the
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`“Telescope™ Catheter”) is available in two sizes. The remainder of Paragraph 12 does
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`not require a response.
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`13. 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
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`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
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`“remarkable success” as a result of its uses and allegedly patented features or otherwise.
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`14. 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.
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`ANSWER: Medtronic admits that Exhibit A to the Complaint is a document that
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`contains information about the Telescope™ Catheter that was believed to be accurate at
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`the time the document was drafted. Medtronic denies Teleflex’s characterization of
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`Exhibit A to the extent it differs from the contents of the exhibit itself.
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`15. 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 Complaint contains
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`instructions for use of the Telescope™ Catheter that were believed to be accurate at the
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`time the instructions were drafted. Medtronic denies Teleflex’s characterization of
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`Exhibit B to the extent it differs from the contents of the exhibit itself. Medtronic denies
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`the remaining allegations in Paragraph 15.
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`16. 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.
`
`ANSWER: Medtronic admits that Exhibit C to the Complaint appears to be a
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`printout from the www.medtronic.com website, printed on July 2, 2019, but lacks
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`sufficient information to admit or deny if Exhibit C was in fact printed from its website
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`on July 2, 2019. Medtronic further admits that the product information for the
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`Telescope™ Catheter in Exhibit C was believed to be accurate at the time the instructions
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`were drafted. Medtronic denies Teleflex’s characterization of Exhibit C to the extent it
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`differs from the contents of the exhibit itself. Medtronic further denies the allegations in
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`Paragraph 16 to the extent they differ from the content available on Medtronic’s website.
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`17. 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-
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`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 Complaint is a press release
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`that includes information regarding the Telescope™ Catheter that was believed to be
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`accurate at the time the press release was drafted. Medtronic denies Teleflex’s
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`characterization of Exhibit D to the extent it differs from the contents of the exhibit itself.
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`Medtronic further denies the allegations in Paragraph 17 to the extent they differ from the
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`content available on Medtronic’s website.
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`18. 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
`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 Complaint includes
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`correspondence from the FDA regarding Medtronic’s 510(k) premarket notification of
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`intent to market the Telescope™ Catheter. Medtronic further admits that Exhibit E
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`includes a summary of Medtronic’s 510(k) premarket notification that was submitted to
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`the FDA that was believed to be accurate at the time the summary was drafted.
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`Medtronic denies Teleflex’s characterization of Exhibit E to the extent it differs from the
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`contents of the exhibit itself.
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`19.
`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.
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`ANSWER: Medtronic admits that, consistent with the requirements for a 510(k)
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`premarket submission, Exhibit E to the Complaint contains the first quoted sentence in
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`Paragraph 19 that “Medtronic’s Telescope™ Guide Extension Catheter is substantially
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`equivalent to the predicate device based on similarities in intended use and technological
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`characteristics.” In the following sentence, Exhibit E referred to the “technological
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`differences” in the Telescope™ Catheter. Medtronic further admits that Exhibit E
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`identifies the “predicate device” as “GuideLiner V3 Catheter.” Medtronic denies
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`Teleflex’s characterization of Exhibit E to the extent it differs from the contents of the
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`exhibit itself.
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`20. Medtronic advertises its coronary guide catheters on its website, including
`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 Complaint appears to be a
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`printout from the www.medtronic.com website that includes information regarding
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`Medtronic’s coronary guide catheter products. Medtronic further admits that the product
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`information in Exhibit F was believed to be accurate at the time it was drafted.
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`Medtronic denies Teleflex’s characterization of Exhibit F to the extent it differs from the
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`contents of the exhibit itself. Medtronic further denies the allegations in Paragraph 20 to
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`the extent they differ from the content available on Medtronic’s website.
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`21.
`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 Complaint. Medtronic denies Teleflex’s characterization of Exhibit A to the extent
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`it differs from the contents of the exhibit itself.
`
`22. 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 Complaint. Medtronic denies Teleflex’s characterization of Exhibits A, B,
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`and E to the extent it differs from the contents of the exhibits themselves.
`
`23. 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,
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`and E to the Complaint. Medtronic denies Teleflex’s characterization of Exhibits A, B,
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`and E to the extent it differs from the contents of the exhibits themselves.
`
`24. 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
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`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
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`and E to the Complaint. Medtronic denies Teleflex’s characterization of Exhibits B and
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`E to the extent it differs from the contents of the exhibits themselves.
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`25. As of at least February 22, 2019, Medtronic was aware that VSI had a
`patent portfolio relating to its GuideLiner catheter.
`
`ANSWER: Medtronic admits that as of February 22, 2019, Medtronic was aware
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`that Teleflex had patents related to guide extension catheter technology.
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`26. 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.
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`27. VSI declined to license its GuideLiner patent portfolio to Medtronic.
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`ANSWER: Medtronic admits that Teleflex and Medtronic did not enter into a
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`license for any guide extension catheter patents.
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`COUNT I
`Alleged Claim for Patent Infringement of U.S. Patent No. 8,048,032
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`28.
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`The allegations of paragraphs 1-27 are re-alleged as if fully set forth herein.
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`ANSWER: Medtronic repeats and re-alleges the foregoing responses as if fully
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`set forth herein.
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`29.
`Teleflex S.à r.l. 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 Complaint appears to be a
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`copy of U.S. Patent No. 8,048,032. Medtronic lacks knowledge or information sufficient
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`to form a belief as to the truth of the remaining allegations in Paragraph 29, and therefore
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`denies the same.
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`30. 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.
`
`ANSWER: Medtronic denies the allegations in Paragraph 30.
`
`31. 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 Complaint is a claim
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`chart, but denies that Exhibit L establishes that Medtronic infringes any valid and
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`enforceable claim of the ’032 patent.
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`32. Medtronic’s Telescope catheter satisfies claim element 11(p), as shown in
`Exhibit L.
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`ANSWER: Medtronic states that the term “satisfies” is vague, such that
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`Medtronic is unable to form a response. To the extent the allegations in Paragraph 32
`
`suggest that the Telescope™ Catheter infringes any valid and enforceable claim of the
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`’032 patent, Medtronic denies them.
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`33. Medtronic’s Telescope catheter satisfies claim element 11(a), as shown in
`Exhibit L.
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`ANSWER: Medtronic states that the term “satisfies” is vague, such that
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`Medtronic is unable to form a response. To the extent the allegations in Paragraph 33
`
`suggest that the Telescope™ Catheter infringes any valid and enforceable claim of the
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`’032 patent, Medtronic denies them.
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`34. Medtronic’s Telescope catheter satisfies claim element 11(b), as shown in
`Exhibit L.
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`ANSWER: Medtronic states that the term “satisfies” is vague, such that
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`Medtronic is unable to form a response. To the extent the allegations in Paragraph 34
`
`suggest that the Telescope™ Catheter infringes any valid and enforceable claim of the
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`’032 patent, Medtronic denies them.
`
`35. 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 35
`
`suggest that the Telescope™ Catheter infringes any valid and enforceable claim of the
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`’032 patent, Medtronic denies them.
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`36. Medtronic’s Telescope catheter satisfies claim element 11(d), as shown in
`Exhibit L.
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`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 36
`
`suggest that the Telescope™ Catheter infringes any valid and enforceable claim of the
`
`’032 patent, Medtronic denies them.
`
`37. 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
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`Medtronic is unable to form a response. To the extent the allegations in Paragraph 37
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`suggest that the Telescope™ Catheter infringes any valid and enforceable claim of the
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`’032 patent, Medtronic denies them.
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`38. Medtronic’s Telescope catheter satisfies claim element 12, as shown in
`Exhibit L.
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`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
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`’032 patent, Medtronic denies them.
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`39. Medtronic’s Telescope catheter satisfies claim element 14, as shown in
`Exhibit L.
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`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
`
`’032 patent, Medtronic denies them.
`
`40. 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
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`that such authorization is required under applicable law.
`
`41. 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 41.
`
`42. 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
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`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
`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
`users and/or customers have used the Telescope catheter in a manner that infringes one or
`more claims of the ’032 patent.
`
`ANSWER: Medtronic admits that the quoted language appears in Exhibits A, B,
`
`and E to the Complaint, but denies Teleflex’s characterizations of those exhibits to the
`
`extent they differ from the content of the exhibits themselves. Medtronic denies the
`
`remaining allegations in Paragraph 42.
`
`43. Upon information and belief, at least as early as February 22, 2019,
`Medtronic had knowledge of the ’032 patent.
`
`ANSWER: Medtronic admits the allegations in Paragraph 43.
`
`44. Medtronic did not develop the Telescope catheter on its own, but instead
`copied VSI’s GuideLiner catheter. Medtronic has willfully infringed and continues to
`willfully infringe the ’032 patent.
`
`ANSWER: Medtronic denies the allegations in Paragraph 44.
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`45. VSI has satisfied the notice or marking provisions of 35 U.S.C. § 287.
`
`ANSWER: Medtronic lacks knowledge or information sufficient to form a belief
`
`as to the truth of the allegations in Paragraph 45, and therefore denies the same.
`
`46. Medtronic’s infringement of the ’032 patent has caused and will continue to
`cause damage to VSI, causing irreparable harm for which there is no adequate remedy at
`law, unless enjoined.
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`ANSWER: Medtronic denies the allegations in Paragraph 46.
`
`COUNT II
`Claim for Patent Infringement of U.S. Patent No. RE45,380
`
`47.
`
`The allegations of paragraphs 1-46 are re-alleged as if fully set forth herein.
`
`ANSWER: Medtronic repeats and re-alleges the foregoing responses as if fully
`
`set forth herein.
`
`48.
`Teleflex S.à r.l. is the owner of United States Patent No. RE45,380 (“’380
`Patent”), which issued on February 17, 2015, a copy of which is attached as Exhibit H.
`
`ANSWER: Medtronic admits that Exhibit H to the Complaint appears to be a
`
`copy of U.S. Patent No. RE45,380. Medtronic lacks knowledge or information sufficient
`
`to form a belief as to the truth of the remaining allegations in Paragraph 48, and therefore
`
`denies the same.
`
`49. Medtronic has infringed and continues to infringe one or more claims of the
`’380 patent, including at least claims 12, 13, and 15, under 35 U.S.C. § 271(a) by making,
`using, offering to sell, selling, and/or importing (directly or through intermediaries), in
`this District and elsewhere in the United States, a system made up of guide extension
`catheters, namely the Telescope catheter, and guide catheters, namely the Medtronic
`Guide Catheters.
`
`ANSWER: Medtronic denies the allegations in Paragraph 49.
`
`50. Attached as Exhibit M is a claim chart showing an example of how
`Medtronic infringes claims 12, 13, and 15 of the ’380 patent.
`
`ANSWER: Medtronic admits that the attached Exhibit M to the Complaint is a
`
`claim chart, but denies that Exhibit M establishes that Medtronic infringes any valid and
`
`enforceable claim of the ’380 patent.
`
`51. Medtronic’s Telescope catheter and/or Medtronic’s Guide Catheters satisfy
`claim element 12(p), as shown in Exhibit M.
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`ANSWER: Medtronic states that the term “satisfy” is vague, such that Medtronic
`
`is unable to form a response. To the extent the allegations in Paragraph 51 suggest that
`
`the Telescope™ Catheter and/or any Medtronic® branded guide catheter infringe any
`
`valid and enforceable claim of the ’380 patent, Medtronic denies them.
`
`52. Medtronic’s Telescope catheter and/or Medtronic’s Guide Catheters satisfy
`claim element 12(a), as shown in Exhibit M.
`
`ANSWER: Medtronic states that