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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
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`v.
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`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
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`Case IPR2020-01344
`U.S. Patent No. RE46,116
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`PATENT OWNER PRELIMINARY RESPONSE TO PETITION
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`TABLE OF CONTENTS
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`Page
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`INTRODUCTION ........................................................................................... 1
`I.
`BACKGROUND ............................................................................................. 2
`II.
`III. THE BOARD SHOULD DECLINE TO INSTITUTE REVIEW .................. 5
`The Petition Should Be Denied Under 35 U.S.C. § 314(a) ................. 5
`A.
`B.
`The Petition Should Be Denied Because Inter Partes Review Is
`Unconstitutional .................................................................................... 8
`IV. CONCLUSION .............................................................................................. 10
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`
`ii
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`
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`TABLE OF AUTHORITIES
`
`
`Cases
`Apple Inc. v. Fintiv, Inc.,
`IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) .................................................... 5
`Arthrex, Inc. v. Smith & Nephew, Inc.,
` 941 F.3d 1320 (Fed. Cir. 2019).............................................................................8, 9
`Centrip. Networks, Inc. v. Cisco Sys.,
`2:18-cv-94, 2019 U.S. Dist. LEXIS 231215 (E.D. Va. Sep. 15, 2019) ..................... 8
`Cequent Performance Prods. v. Hopkins Mfg. Corp,
`13-cv-15293, 2015 U.S. Dist. LEXIS 153654 (E.D. Mich. Nov. 13, 2015) ............. 8
`Horton, Inc. v. Kit Masters, Inc.,
`08-cv-6291, 2010 U.S. Dist. LEXIS 134369 (D. Minn. Dec. 20, 2010) ................... 8
`Lucia v. SEC,
`138 S. Ct. 2044 (2018) ............................................................................................... 9
`Smith & Nephew, Inc. v. Arthrex, Inc.,
`No. 19-1452, 2020 U.S. LEXIS 4928 (Oct. 13, 2020) ..........................................8, 9
`United States v. Booker,
`543 U.S. 220 (2005) ................................................................................................... 9
`Other Authorities
`35 U.S.C. § 314(a) ..................................................................................................... 5
`35 U.S.C. § 316(b) ..................................................................................................... 5
`
`iii
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`TABLE OF EXHIBITS
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`Exhibit Description
`2001 Defendants’ Responses to Plaintiffs’ First Set of Document Requests,
`Vascular Sols. LLC v. Medtronic, Inc., 19-cv-01760-PJS-TNL (D. Minn.
`Aug. 15, 2019)
`2002 Defendants’ Opposition to Plaintiffs’ Motion for Preliminary Injunction
`(Redacted), Vascular Sols. LLC v. Medtronic, Inc., 19-cv-01760-PJS-
`TNL, Dkt. 104 (D. Minn., Nov. 15, 2019)
`2003 Email dated January 24, 2020, from Derek Vandenburgh to Kurt
`Niederluecke
`2004 Email dated July 3, 2019, from Derek Vandenburgh to Paik Saber and
`Matthew Anderson
`2005 Email dated July 16, 2019, from Lora Friedemann to Joe Winkels and
`Kurt Niederluecke
`2006 Declaration of Alexander Rinn, Vascular Sols. LLC v. Medtronic, Inc.,
`19-cv-01760-PJS-TNL, Dkt. 93 (D. Minn., Oct. 16, 2019)
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`iv
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`I.
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`INTRODUCTION
`U.S. Patent No. RE46,116 (“the ’116 patent”) is one of a family of patents
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`covering an industry-changing medical device called GuideLiner. It is also one of
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`seven patents at issue in a pending lawsuit for infringement filed by Patent Owner
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`against Petitioner. In November of 2019, Petitioner filed thirteen IPR petitions
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`against five of the other patents involved in that lawsuit. Eleven of those IPR
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`petitions were granted,1 and the lawsuit was subsequently stayed based on
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`Petitioner’s representation to the district court that those petitions were statutorily
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`required to be completed by no later than June of 2021.
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`The ’116 patent that is the subject of the present IPR Petition is directed to a
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`different invention than the patents at issue in the eleven currently pending IPRs.
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`The claims of the ’116 patent are directed to methods of using a guide extension
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`catheter to deliver interventional cardiology devices, while the patents at issue in
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`the pending IPRs contain only apparatus and system claims directed to the guide
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`extension catheter itself. As a result, the present Petition presents different
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`patentability issues than those involved in the currently-pending IPRs. Indeed, the
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`’116 patent was specifically added to the district court litigation because the
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`1 The pending IPRs are IPR2020-00126, - 0127, -0128, -0129, -0130, -0132, -
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`0134, -0135, -0136, -0137 and -0138.
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`1
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`method of use limitations further distinguish over the prior art identified by
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`Petitioner in the district court.
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`Instituting the current Petition is an inefficient use of the Board’s resources
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`that will unfairly prejudice Patent Owner. Petitioner inexplicably waited almost
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`nine months after the filing of the other thirteen IPR petitions to file the instant
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`Petition challenging the ’116 patent. Petitioner has elsewhere sought to justify this
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`delay based on the fact that the ’116 patent was not asserted in the litigation at the
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`time it filed the other thirteen IPR petitions. But Petitioner has only itself to blame
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`for that, since it refused to timely identify the prior art it was relying on in the
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`district court litigation. Moreover, even measured from the time the ’116 patent
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`was added to the district court litigation, Petitioner still waited six months to file
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`this IPR Petition. This is unreasonable, particularly given the fact that the present
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`Petition relies on the same art and, largely, the same arguments asserted in its
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`earlier-filed IPRs.
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`Under these unique circumstances, the Board should not devote its limited
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`resources to adjudicating this Petition.
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`II. BACKGROUND
`On July 2, 2019, Patent Owner filed suit against Petitioner for infringement
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`of five patents protecting Patent Owner’s industry-changing GuideLiner guide
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`extension catheter. Vascular Sols. LLC v. Medtronic, Inc., 19-cv-1760, Dkt. 1
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`2
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`(Compl.) (D. Minn. July 2, 2019). Concurrent with filing of the Complaint, Patent
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`Owner sought to file a motion for preliminary injunction to immediately stop sales
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`of Petitioner’s infringing product, called Telescope. Ex-2004; Ex-2005.
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`At Petitioner’s request, the district court permitted expedited discovery to be
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`taken before entertaining the preliminary injunction motion. Patent Owner limited
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`its expedited discovery request to a single targeted document request to produce
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`the prior art Petitioner intended to rely on in response to the preliminary injunction
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`motion. Ex-2001 at 3. Rather than comply with the request, Petitioner produced
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`108 pieces of prior art, without identifying which ones it intended to rely on. Id. at
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`3-4; Ex-2006
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`On October 11, 2019, Patent Owner filed its motion for preliminary
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`injunction and supporting papers. E.g., Vascular Sols. LLC v. Medtronic, Inc., 19-
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`cv-1760, Dkt. 73 (D. Minn. Oct. 11, 2019). At Petitioner’s request, its due date for
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`responding to the preliminary injunction motion was extended to November 15,
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`2019. Petitioner used that extra time to file thirteen IPR petitions challenging the
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`five patents in suit. See IPR2020-00126 (filed Nov. 12, 2019), -00127 (filed Nov.
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`12, 2019), -00128 (filed Nov. 12, 2019), -00129 (filed Nov. 14, 2019), -00130
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`(filed Nov. 12, 2019), -00131 (filed Nov. 14, 2019), -00132 (filed Nov. 13, 2019), -
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`00133 (filed Nov. 13, 2019), -00134 (filed Nov. 14, 2019), -00135 (filed Nov. 14,
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`2019), -00136 (filed Nov. 14, 2019), -00137 (filed Nov. 12, 2019), -00138 (filed
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`3
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`Nov. 12, 2019). Petitioner then relied on those IPRs to argue that it had raised a
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`“substantial question” as to the invalidity of the patents in suit, thereby rendering
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`preliminary injunctive relief inappropriate. Ex-2002 at 38-39. The district court
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`ultimately denied Patent Owner’s preliminary injunction motion.
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`One of the references identified for the first time in the IPR filings was U.S.
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`Patent No. 7,736,355 to Itou (Ex-1407). In its reply brief for a preliminary
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`injunction, Patent Owner argued that Itou was not prior art to the patents in suit
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`because the claimed subject matter was invented before the filing date of Itou.
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`Vascular Sols. LLC v. Medtronic, Inc., 19-cv-1760, Dkt. 184 (D. Minn. Dec. 6,
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`2019). Additionally, Itou is directed to a device used for a totally different purpose
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`(suctioning of thrombi) than the guide extension catheter disclosed in the patents in
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`suit. Therefore, shortly after the preliminary injunction hearing, Patent Owner
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`wrote to Petitioner stating that it planned to add two additional patents (including
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`the ’116 patent) containing claims directed to methods of use. Ex-2003. The
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`motion to amend the complaint was filed on January 31, 2020 and was
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`subsequently granted. Vascular Sols. LLC v. Medtronic, Inc., 19-cv-1760, Dkt.
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`225 (Mot. to Amend Compl.) (D. Minn. Jan. 31, 2020), Dkt. 229 (Order Granting
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`Mot. to Amend Compl.) (Feb. 7, 2020).
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`4
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`Six months later, on July 30-31, 2020, Petitioner filed four IPR petitions
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`against the two method patents, including the present Petition. See IPR2020-1341,
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`-1342, -1343, -1344.
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`III. THE BOARD SHOULD DECLINE TO INSTITUTE REVIEW
`A. The Petition Should Be Denied Under 35 U.S.C. § 314(a)
`Under Section 314(a), the Board may decline to institute an inter partes
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`review when doing so would be an inefficient use of resources. 35 U.S.C.
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`§ 314(a); see also 35 U.S.C. § 316(b). As the Board explained in the precedential
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`Apple v. Fintiv decision, the factors considered for institution under 35 U.S.C.
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`§ 314(a) should be considered as part of a “balanced assessment of all relevant
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`circumstances of the case.” Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 at
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`5 (PTAB Mar. 20, 2020) (precedential) (citing Consolidated Trial Practice Guide
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`November 2019 at 58). The Board also explained that its § 314(a) cases “have
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`sought to balance considerations such as system efficiency, fairness, and patent
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`quality.” Id. The Board further emphasized that, in evaluating the Apple factors, it
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`“takes a holistic view of whether efficiency and integrity of the system are best
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`served by denying or instituting review.” Id. at 6. The unique circumstances of
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`this case counsel in favor of denial.
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`Here, despite admitting knowledge of the ’116 patent since at least February
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`2019 (Vascular Sols. LLC v. Medtronic, Inc., 19-cv-1760, Dkt. 233 at 51-52
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`5
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`(¶ 180) (D. Minn. Feb. 28, 2020)), Petitioner waited almost nine months after filing
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`thirteen IPR petitions (in November 2019) against five other patents in suit to file
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`the instant Petition (on July 31, 2020). This unjustified delay counsels in favor of
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`denial. Id. at 11 (“If . . . the evidence shows that the petitioner did not file the
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`petition expeditiously, . . . or even if the petitioner cannot explain the delay in
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`filing its petition, these facts have favored denial.”). This delay is particularly
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`unjustified where the Petition relies largely on the same art (Kontos, Ressemann,
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`Takahashi, and Kataishi) and arguments as the first tranche of Petitions. See IPRs
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`2020-00127 (Kontos and Takahashi), -00129 (Ressemann, Takahashi, and
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`Kataishi), -00130 (Kontos and Takahashi), -00131 (Kontos, Takahashi, and
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`Kataishi), -0133 (Ressemann, Takahashi, and Kataishi), -00136 (Kontos,
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`Ressemann, Takahashi, and Kataishi), -00138 (Ressemann, Takahashi, and
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`Kataishi).2
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`The fact that the ’116 patent was not added to the district court litigation
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`until after the first tranche of petitions were filed does not alter the analysis for at
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`least two reasons. One, the only reason that the ’116 patent was not added to the
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`2 The Petition’s Grounds 4 and 5 also rely on the Root publication (U.S. Patent
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`Publication 2007/0260219) (Ex-1512), which was not at issue in other petitions
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`and is not prior art.
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`6
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`case until January of 2020 is because Petitioner buried Itou and the other prior art it
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`intended to rely on in its August 2019 discovery response. Had Petitioner
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`complied with its sole discovery obligation, Patent Owner would have added the
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`method patents far sooner than it did. Second, Patent Owner informed Petitioner
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`of its plan to assert the ’116 patent on January 24, 2020. Ex-2003. Thus, even
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`measuring just from that date, Petitioner inexplicably waited over six months to
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`file the current Petition.
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`Additionally, this Petition is merely a “backup” Petition, in the event Itou is
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`found not to be prior art. The inefficiency and unfairness that will result if any of
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`Petitioner’s petitions are instituted are even more pronounced in the context of this
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`additional petition that was filed to give Petitioner another bite at the apple.
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`Indeed, Petitioner made a deliberate choice in its primary petition to rely on a
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`§ 102(e) reference that Petitioner knew was not prior art. See, e.g., IPR2020-
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`00126, Paper 14 (detailing Petitioner’s pre-filing knowledge of Patent Owner’s
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`invention date).
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`Petitioner’s unjustified delay in filing these IPR petitions prejudices Patent
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`Owner. Petitioner has already relied on the present IPR petitions as a basis to seek
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`an unprecedented extension of the one year statutory deadline in the eleven
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`pending IPRs, even though it expressly and repeatedly relied on that one year
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`deadline to convince the district court to stay the litigation. See, e.g., IPR2019-
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`7
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`00126, Paper Nos. 56 and 61. If the present IPR petitions are granted, Petitioner
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`will undoubtedly continue such delay tactics, such as by asking the district court to
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`maintain the stay as to all patents in view of the present Petition.3 Such a result
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`will not serve the efficiency, integrity, and fairness of the system. The Petition,
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`thus, should be denied.
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`B.
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`The Petition Should Be Denied Because Inter Partes Review Is
`Unconstitutional
`The Petition should be denied because the manner in which administrative
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`law judges are appointed is unconstitutional. Arthrex, Inc. v. Smith & Nephew,
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`Inc., 941 F.3d 1320, 1325 (Fed. Cir. 2019), cert. granted, 2020 U.S. LEXIS 4928,
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`4969, 5050 (Oct. 13, 2020) (Nos. 19-1434, 19-1452, 19-1458). The purported
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`remedy imposed by the Arthrex decision—severing and invalidating the AIA
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`3 Such a request should fail, as numerous courts (including the district court
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`handling the pending litigation here) have recognized that lifting of a stay as to one
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`patent should not be delayed by ongoing IPR or reexaminations involving other
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`patents in suit. E.g., Centrip. Networks, Inc. v. Cisco Sys., 2:18cv94, 2019 U.S.
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`Dist. LEXIS 231215, at *9-11 (E.D. Va. Sep. 15, 2019); Cequent Performance
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`Prods. v. Hopkins Mfg. Corp, 13-cv-15293, 2015 U.S. Dist. LEXIS 153654, at *2-
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`4 (E.D. Mich. Nov. 13, 2015); Horton, Inc. v. Kit Masters, Inc., 08-cv-6291, 2010
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`U.S. Dist. LEXIS 134369, at *3 (D. Minn. Dec. 20, 2010).
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`8
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`provisions limiting the USPTO Director’s discretion to remove administrative law
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`judges—is insufficient to remedy the constitutional defect. See id. at 1338–39.
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`Any administrative law judges appointed prior to the law change on October 31,
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`2019, remains unconstitutionally appointed. See Lucia v. SEC, 138 S. Ct. 2044,
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`2055 (2018) (requiring “a new ‘hearing before a properly appointed’ official”). In
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`addition, merely giving the director power to terminate an administrative law judge
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`would not alter any defective final written decision; the Director still lacks the
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`power to unilaterally nullify or reverse a final written decision. See Arthrex, 941
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`F.3d at 1328-32. This is also not a situation where severance is available.
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`Severing a statute is appropriate only if the remainder of the statute is “(1)
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`constitutionally valid, (2) capable of functioning independently, and (3) consistent
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`with Congress’ basic objectives in enacting the statute.” Id. at 1335 (citing United
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`States v. Booker, 543 U.S. 220, 258–59 (2005)). Here, severing the removal
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`protections for APJs provided by the statute would be inconsistent with Congress’s
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`goal of providing IPRs as an adjudicatory-type proceeding presided over by
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`unbiased administrative judges.
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`Since the Board instituted the eleven currently-pending IPRs, the Supreme
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`Court has granted certiorari to decide whether administrative patent judges are
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`principal officers or inferior officers, and, if administrative patent judges are
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`principal officers, whether the Federal Circuit’s proposed “remedy” properly cured
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`9
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`any Appointments Clause defect. Smith & Nephew, Inc. v. Arthrex, Inc., No. 19-
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`1452, 2020 U.S. LEXIS 4928 (Oct. 13, 2020) (granting certiorari in Nos. 19-1434,
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`19-1452, 19-1458 as to “Questions 1 and 2 as set forth in the July 22, 2020
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`Memorandum for the United States”). For at least the reasons set forth above, the
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`Petition should be denied.
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`IV. CONCLUSION
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`For the above reasons, Patent Owner respectfully requests that the Board
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`deny Medtronic’s Petition for Inter Partes Review of the challenged claims of the
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`’116 patent.
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`Dated: November 25, 2020.
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`Respectfully submitted,
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`
`/J. Derek Vandenburgh /
`J. Derek Vandenburgh (Lead Counsel)
`Registration No. 32,179
`Carlson, Caspers, Vandenburgh
` & Lindquist, P.A.
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`Telephone: (612) 436-9600
`Facsimile: (612) 436-9650
`Email:
`DVandenburgh@carlsoncaspers.com
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`Lead Counsel for Patent Owner
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`10
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`CERTIFICATE OF WORD COUNT COMPLIANCE
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`Pursuant to 37 C.F.R. §42.24(d), the undersigned certifies that this Patent
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`Owner Response complies with the type-volume limitation of 37 C.F.R. §42.24(b).
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`The word count application of the word processing program used to prepare this
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`Preliminary Response indicates that it contains 2,140 words, excluding the parts
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`exempted by 37 C.F.R. §42.24.
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`Dated: November 25, 2020
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`Respectfully submitted,
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`/J. Derek Vandenburgh/
`J. Derek Vandenburgh (Lead Counsel for Patent
`Owner)
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`11
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`CERTIFICATION OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e) and the agreement of the parties, the
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`undersigned certifies that on November 25, 2020, a true and correct copy of the
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`foregoing Patent Owner Preliminary Response was served via electronic mail
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`upon the following:
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`Cyrus A. Morton (Reg. No. 44,954)
`Sharon Roberg-Perez (Reg. No. 69,600)
`Christopher A. Pinahs (Reg. No. 76,375)
`Robins Kaplan LLP
`800 LaSalle Avenue, Suite 2800
`Minneapolis, MN 55401
`Phone: 349-8500
`Fax: 612-339-4181
`Email: Cmorton@robinskaplan.com
`Email: Sroberg-perez@robinskaplan.com
`Email: Cpinahs@robinskaplan.com
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`/J. Derek Vandenburgh/
`J. Derek Vandenburgh (Lead Counsel for Patent Owner)
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`12
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