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UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC. and MEDTRONIC VASCULAR, INC.,
`Petitioners,
`
`v.
`
`TELEFLEX LIFE SCIENCES LIMITED,
`Patent Owner
`
`IPR2020-01343
`Patent RE46,116 E
`
`PETITIONERS MEDTRONIC, INC. AND MEDTRONIC VASCULAR,
`INC.’S NOTICE OF APPEAL UNDER 37 C.F.R. § 90.2(a)
`
`
`
`
`
`
`
`
`

`

`Pursuant to 35 U.S.C. §§ 141-144, 319, and 37 C.F.R.§ 90.2(a), notice is
`
`hereby given that Petitioners Medtronic, Inc. and Medtronic Vascular, Inc.
`
`(“Medtronic”) appeal to the United States Court of Appeals for the Federal Circuit
`
`from the Final Written Decision (“Final Written Decision”) (Paper No. 85, dated
`
`February 23, 2022) entered by the United States Patent and Trademark Office,
`
`Patent Trial and Appeal Board (“Board”) in IPR2020-01343, and from all
`
`underlying orders, decisions, rulings, and opinions. A copy of the Final Written
`
`Decision is attached hereto as Exhibit A.
`
`In accordance with 37 C.F.R. § 90.2(a)(3)(ii), Medtronic further indicates
`
`that the issues on appeal may include, but are not limited to, whether the Board
`
`erred in determining that claims 25-40, 42, and 44-48 of U.S. Patent Number
`
`RE46,116 were not shown to be unpatentable under 35 U.S.C. § 103, any findings
`
`supporting or related to the Board’s determination, and all other issues decided
`
`adversely to Medtronic in any order, decision, ruling, and/or opinion, including but
`
`not limited to the Board’s failure to properly consider evidence of record, the
`
`Board’s legal errors in undertaking the obviousness analysis, and the Board’s
`
`findings that conflict with the evidence of record and are not supported by
`
`substantial evidence.
`
`Simultaneous with this submission, a copy of this Notice of Appeal is being
`
`filed through the Patent Trial and Appeal Board End to End (“PTAB E2E”)
`
`1
`
`

`

`System. In addition, a copy of the Notice of Appeal, along with the required
`
`docketing fee, is being filed with the Clerk of Court for the United States Court of
`
`Appeals for the Federal Circuit.
`
`
`
`Dated: April 22, 2022
`
`Respectfully submitted,
`
`
`
`
`
`
`
`
`
`
`
`
`/s/ Cyrus A. Morton
`Cyrus A. Morton
`ROBINS KAPLAN LLP
`800 LaSalle Avenue, Suite 2800
`Minneapolis, MN 55402
`(612) 349-8500
`Attorney for Petitioners
`
`
`
`2
`
`

`

`CERTIFICATE OF SERVICE
`
`I hereby certify that on this April 22, 2022, a copy of Petitioners Medtronic,
`
`Inc. and Medtronic Vascular, Inc.’s Notice of Appeal Under 37 C.F.R. § 90.2(a)
`
`was served in its entirety by electronic mail on Patent Owner’s counsel at the
`
`following addresses included in Patent Owner’s Mandatory Notices:
`
`J. Derek Vandenburgh, Reg. No. 32,179
`dvandenburgh@carlsoncaspers.com
`
`Dennis C. Bremer, Reg. No. 40,528
`dbremer@carlsoncaspers.com
`
`Joseph W. Winkels
`jwinkels@carlsoncaspers.com
`
`Peter M. Kohlhepp
`pkohlhepp@carlsoncaspers.com
`
`Tara C. Norgard
`tnorgard@carlsoncaspers.com
`
`Megan E. Christner, Reg. No. 78,979
`mchristner@carlsoncaspers.com
`
`Shelleaha L. Jonas
`sjonas@carlsoncaspers.com
`
`
`Dated: April 22, 2022
`
`
`
`
`
`Respectfully submitted,
`/s/ Cyrus A. Morton
`Cyrus A. Morton
`Reg. No. 44,954
`Attorney for Petitioners
`
`
`
`3
`
`

`

`
`
`
`Exhibit A
`Exhibit A
`
`

`

`Trials@uspto.gov
`571-272-7822
`
`Paper 85
`Entered: February 23, 2022
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC. AND MEDTRONIC VASCULAR,INC.,
`Petitioner,
`
`V.
`
`TELEFLEX LIFE SCIENCES LIMITED,
`Patent Owner.
`
`IPR2020-01343
`Patent RE46,116 E
`
`  ÿÿ
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`
`JUDGMENT
`Final Written Decision
`Determining Some Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`
`Before SHERIDAN K. SNEDDEN, JAMES A. TARTAL,and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`Opinion for the Board filed by Administrative Patent Judge TARTAL.
`
`Opinion Concurring by Administrative Patent Judge PAULRAJ.
`
`ORDER
`Denying Petitioner’s Motion to Exclude
`37 CER. $ 42.64(c)
`
`ÿ
`
`

`

`IPR2020-01343
`Patent RE46,116 E
`
`Wehavejurisdiction to conductthis inter partes review
`
`under 35 U.S.C. § 6. This Final Written Decision is issued pursuant
`
`to 35 U.S.C. § 318(a) (2018) and 37 C.F.R. § 42.73 (2019). Medtronic,Inc.
`
`and Medtronic Vascular,Inc. (“Petitioner”)! contends that claims 25-40, 42,
`
`44-48, 52, and 53 (“the Challenged Claims”) of U.S. Patent No. RE46,116 E
`
`(Ex. 1001, “the ’116 patent’) are unpatentable. For the reasons discussed
`
`below, we determine that Petitioner has shown by a preponderance of the
`
`evidencethat each of claims 52 and 53 of the ’116 patent is unpatentable,
`
`but has not shown by a preponderance of the evidencethat any of claims 25—
`
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`' Petitioner identifies as real parties-in-interest Medtronic, Inc. and
`Medtronic Vascular, Inc., and states, “Medtronic plc is the ultimate parent of
`Medtronic Inc.” Pet. 5.
`? Patent Owneridentifies as real parties-in-interest Teleflex Life Sciences
`Limited; Teleflex Medical Devices $.A.R.L.; Vascular Solutions LLC;
`Arrow International, Inc., and Teleflex LLC. Paper 4, 2. Patent Owneralso
`states “Teleflex Incorporated is the ultimate parent of the entities listed
`above.” Id.
`3 Prior to institution, Patent Ownerfiled a Preliminary Responsedirected
`primarily to whether discretionary denial of the Petition was warranted, not
`to the merits of Petitioner’s unpatentability contentions. See Paper 7.
`
`40, 42, and 44-48 of the ’116 patent is unpatentable.
`
`I.
`
`INTRODUCTION
`
`A. Summary ofProcedural History
`
`Petitioner filed a Petition pursuant to 35 U.S.C. §§ 311-319
`
`requesting an inter partes review of the Challenged Claims. Paper 1
`
`(“Pet.”). We instituted an inter partes review of the Challenged Claims on
`
`all grounds of unpatentability asserted in the Petition. Paper 9 (“Inst. Dec.”).
`
`Teleflex Life Sciences Limited (“Patent Owner”)’ filed a Patent Owner
`
`Response.’ Paper 21 (“PO Resp.”) (underseal), 22 (redacted, publicly
`
`2
`
`

`

`IPR2020-01343
`Patent RE46,116 E
`
`accessible). Petitioner filed a Reply to the Patent Owner Response.
`
`Paper 46 (“Pet. Reply’’) (underseal), 47 (redacted, publicly accessible).
`
`Patent Ownerfiled a Sur-reply in support of the Patent Owner Response.
`
`Paper 59 (“PO Sur-reply”).
`
`grounds in IPR2020-01344. Pet. 6; Paper 4, 3. The parties identify the ’116
`
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`Following oral argument, we entered a transcript of the hearing in
`
`the record. Paper 84 (“Tr.”). Petitioner bears the burden of proving
`
`unpatentability of each claim it has challenged by a preponderance ofthe
`
`evidence, and the burden of persuasion nevershifts to Patent Owner.
`
`See 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d); Dynamic Drinkware, LLC v.
`
`Nat'l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015).
`
`B. Related Proceedings
`
`Petitioner challenges claims 25—55 of the ’116 patent under separate
`
`patent as a subject of: (1) Vascular Solutions LLC, et al. v. Medtronic, Inc.,
`
`et al., No. 19-cv-01760 (D. Minn.), and (2) OXMedical, LLC v. Vascular
`
`Solutions, LLC, No. 17-cv-01969 (D. Minn.). Pet. 5—6; Paper 4, 2. Patent
`
`Ownerstates that both of these district court proceedings are currently
`
`stayed. Paper 4, 2. The parties further state that the ’116 patentis a reissue
`
`of the ’850 patent and that the ’850 patent was a subject of: (1) Vascular
`
`Solutions, Inc. v. Boston Scientific Corp., No. 13-cv-01172 (D. Minn.),
`
`and (2) Boston Scientific Corp. v. Vascular Solutions, Inc., IPR2014-00762,
`
`IPR2014-00763 (PTAB, terminated). Pet. 6; Paper 4, 2-3.
`
`Additionally, Petitioner filed petitions challenging patents related to
`
`the ’116 patent in the following proceedings: IPR2020-00126 and IPR2020-
`
`00127 (Patent 8,048,032 B2); IPR2020-00128, IPR2020-00129, IPR2020-
`
`00130, and IPR2020-00131 (Patent RE45,380 E); IPR2020-00132,
`
`IPR2020-00133, and IPR2020-00134 (Patent RE45,760 E); IPR2020-00135
`
`

`

`IPR2020-01343
`Patent RE46,116 E
`
`and IPR2020-00136 (Patent RE45,776 E); IPR2020-00137 and IPR2020-
`
`00138 (Patent RE47,379 E); and IPR2020-01341 and IPR2020-01342
`
`(Patent 8,142,413 B2). Institution of inter partes review was denied in
`
`IPR2020-00131 and IPR2020-00133.
`
`C. The ’116 Patent
`
`The ’116 patent, titled “Coaxial Guide Catheter for Interventional
`
`Cardiology Procedures,” issued August 23, 2016, from Application
`
`No. 14/195,435, filed March 3, 2014. Ex. 1001, codes (21), (22), (45), (54).
`
`The *116 patent is a reissue of U.S. Patent No. 8,292,850 (“the ’850 patent”)
`
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`from Application No. 13/359,059 filed on January 26, 2012, which
`
`the ’116 patent states is a continuation of an application filed on
`
`November 1, 2013 (issued as U.S. Patent No. RE45,380), which is an
`
`application for the reissue of U.S. Patent No. 8,292,850, whichis a division
`
`of an application filed on June 28, 2010 (issued as U.S. Patent
`
`No. 8,142,413), which is a division of an application filed on May 3, 2006
`
`(Application No. 11/416,629 (“the ’629 application”), issued as U.S. Patent
`
`No. 8,048,032). Jd. codes (60), (64). The ’116 patent is directed to
`
`“methods and apparatus for increasing backup support for catheters inserted
`
`into the coronary arteries from the aorta.” Jd. at 1:38-40.
`
`The ’116 patent explains, as background,that in “[i]nterventional
`
`cardiology procedures,” guidewiresor other instruments, such as balloon
`
`catheters and stents, are often inserted through guide catheters into coronary
`
`arteries that branch off from the aorta. Jd. at 1:44—-50. In coronary artery
`
`disease, “the coronary arteries may be narrowed or occluded by
`
`atherosclerotic plaques or other lesions” in a phenomenon known as
`
`stenosis. Jd. at 1:50-54. In treating the stenosis, “‘a guide catheter is
`
`inserted through the aorta and into the ostium of the coronary artery,”
`
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`IPR2020-01343
`Patent RE46,116 E
`
`The ’116 patent purports to resolve issues identified with the prior
`
`procedures by using “a coaxial guide catheter that is deliverable through
`
`standard guide catheters by utilizing a guidewire rail segment to permit
`
`delivery without blocking use of the guide catheter.” Jd. at 3:20-23.
`
`According to the ’116 patent, the coaxial guide catheter “preferably includes
`
`a tapered inner catheter that runs over a standard 0.014 inch coronary
`
`guidewire to allow atraumatic placement within the coronary artery,” and
`
`this feature allows removal of the tapered inner catheter after the coaxial
`
`guide catheteris in place. /d. at 3:23-28.
`
`Figures 1 and 2, reproduced below, show a coaxial guide catheter and
`
`a tapered inner catheter in accordance with the invention described in
`
`the ’116 patent:
`
`Fig. 1
`10
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`Fig. 2
`
`Figure | is a schematic depiction of the coaxial guide catheter and tapered
`
`inner catheter separately, and Figure 2 depicts those two elements assembled
`
`together. /d. at 5:51-56; Figs. 1 and 2. As shown above,“coaxial guide
`
`catheter assembly 10” includes coaxial guide catheter 12 and tapered inner
`
`catheter 14. Jd. at 6:42-44. Coaxial guide catheter 12 includestip
`
`

`

`IPR2020-01343
`Patent RE46,116 E
`
`portion 16, reinforced portion 18, and rigid portion 20. Jd. at 6:45—46.
`
`Tapered inner catheter 14 “includes tapered inner catheter tip 42.” Jd.
`
`at 7:26—27. Tapered inner catheter tip 42 includes tapered portion 46 at a
`
`distal end thereof, and straight portion 48. /d. at 7:30-31. Both tapered
`
`portion 46 andstraight portion 48 are pierced by lumen 50 (not labeled in
`
`figures above). Jd. at 7:31—32. “Tapered inner catheter 14 may also include
`
`clip 54 at a proximal end thereofto releasably join tapered inner catheter 14
`
`to coaxial guide catheter 12.” Jd. at 7:35—37. “The tapered inner catheter
`
`provides a gradualtransition from the standard 0.014 inch diameter
`
`guidewire to the diameter of the coaxial guide catheter whichis typically
`
`five to eight French.” /d. at 3:28-31. The coaxial guide catheter is made in
`
`at least three sizes corresponding to sizes commonly usedin interventional
`
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`cardiology procedures. /d. at 3:39-42.
`
`Figure 4, reproduced below, showsa coaxial guide catheter in
`
`accordance with the invention described in the ’116 patent:
`
`Figure 4 is a sectional view of the coaxial guide catheter with tip portion 16
`
`depicted on the left side of the figure (rather than on the right side as shown
`
`in Figures 1 and 2). Jd. at 5:60; Fig. 4. As shown above, coaxial guide
`
`catheter 12 has rigid portion 20 that “includesfirst full circumference
`
`portion 34, hemicylindrical portion 36, arcuate portion 38, and second full
`
`ÿ
`
`

`

`IPR2020-01343
`Patent RE46,116 E
`
`circumferenceportion 40” (second full circumference portion 40 is shown in
`
`Figure 3). Jd. at 7:7—10.
`
`In operation, a guide catheter and a guidewire are used along with the
`
`coaxial guide catheter and the tapered inner catheter. Ex. 1001, 8:20—22.
`
`Figure 8, reproduced below, showsthe operation of the coaxial guide
`
`catheter assembly in accordance with the invention described in the ’116
`
`   ÿ
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`The presence of coaxial guide catheter 12 within guide catheter 56 “provides
`
`Figure 8 is a schematic view of a guide catheter and a guide wire in use with
`
`the coaxial guide catheter assembly within the aortic arch and coronary
`
`artery. Id. at 6:5—-8; Fig. 8. First, guidewire 64 is inserted and passed
`
`through aortic arch 58 into ostium 60 of coronary artery 62. Jd. at 7:65—66.
`
`Guide catheter 56 is then passed over guidewire 64 until the distal end of
`
`guide catheter 56 is seated in ostium 60. Jd. at 8:4—6. Next, coaxial guide
`
`catheter 12 with tapered inner catheter 14 is passed through guide
`
`catheter 56 and over guidewire 64 into coronary artery 62. Id. at 8:22—24.
`
`

`

`IPR2020-01343
`Patent RE46,116 E
`
`stiffer back up support than guide catheter 56 alone.” Jd. at 8:38-40. “Once
`
`the coaxial guide catheter-tapered inner catheter combination has been
`
`inserted sufficiently into the ostium of the coronary artery to achieve deep
`
`seating the tapered inner catheter may be removed.” /d. at 4:58-62; see also
`
`id. at 8:30-32. Thereafter, coaxial guide catheter 12 can “accept a treatment
`
`catheter such as a stent or a balloon catheter.” Jd. at 8:33-34. “[T]he
`
`presence of the coaxial guide catheter provides additional backup support to
`
`makeit less likely that the coaxial guide catheter guide catheter combination
`
`will be dislodged from the ostium of the coronary artery while directing the
`
`coronary therapeutic device past a tough lesion.” Jd. at 5:2-6. “[T]he
`
`invention is deliverable through an existing hemostatic valve arrangement on
`
`a guide catheter without preventing injections through existing Y adapters.”
`
`Id. at 5:42-44.
`
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`25. A method, comprising:
`advancinga distal end of a guide catheter having a lumen through
`a main blood vessel to an ostium of a coronary artery;
`advancinga distal end of a guide extension catheter through, and
`beyond the distal end of,
`the guide catheter,
`including
`advancing a distal end portion of a tubular structure of the
`guide extension catheter beyond the distal end of the guide
`catheter while a segment defining a side opening ofthe guide
`extension catheter remains within the guide catheter the side
`
`D. Illustrative Claim ofthe ’116 Patent
`
`Petitioner challenges claims 25—40, 42, 44-48, 52, and 53 of
`
`the ’116 patent. Pet. 1. Claims 25 and 52 are independent method claims.
`
`Ex. 1001, 13:62—14:25, 17:10-18:10. Claims 26—40, 42, and 44-48 depend
`
`from claim 25 and claim 53 depends from claim 52. /d. at 14:26—15:41,
`
`15:47-S0, 18:11-14. Claim 25 is illustrative of the claimed subject matter
`
`and is reproduced below.
`
`

`

`IPR2020-01343
`Patent RE46,116 E
`
`Id. at 13:62-14:25.
`
`E. References and Testimony
`
`Petitioner’s contentionsrely, in part, on testimony from Dr. Brecker,
`
`Dr. Hillstead, and Mr. Jones. Dr. Breckerstates that he has been an
`
`interventional cardiologist for over twenty-four years, that he has been Chief
`
`of Cardiology at St. Georges University Hospitals London since 2015, and
`
`opening extending for a distance along a longitudinal axis of
`the guide extension catheter and accessible from a longitudinal
`side defined transverse to the longitudinal axis, the tubular
`structure having a cross-sectional inner diameter that is not
`more than one French size smaller than a cross-sectional inner
`diameter of the lumen of the guide catheter;
`maintaining the distal end portion of the tubular structure of the
`guide extension catheter in position beyond the distal end of
`the guide catheter; and
`while maintaining the distal end of the guide extension catheter
`positioned beyond the distal end of the guide catheter
`advancinga balloon catheter or stent at least partially through
`the guide catheter and the guide extension catheter and into the
`coronary artery, including advancing the balloon catheter or
`stent through a hemostatic valve associated with a proximal
`end of the guide catheter, along a substantially rigid segment
`of the guide extension catheter, through the side opening, and
`through the tubular structure.
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