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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
`
`IPR2020-01344
`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. 69, dated
`
`February 23, 2022) entered by the United States Patent and Trademark Office,
`
`Patent Trial and Appeal Board (“Board”) in IPR2020-01344, 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 25-55 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”)
`
`System. In addition, a copy of the Notice of Appeal, along with the required
`
`1
`
`

`

`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 69
`Date: 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 SCEINCES LIMITED,
`Patent Owner.
`
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`
`JUDGMENT
`Final Written Decision
`Determining No Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`
`IPR2020-01344
`Patent RE46,116 E
`
`
`
`Before SHERIDAN K. SNEDDEN, JAMES A. TARTAL,and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`SNEDDEN,Administrative Patent Judge.
`
`

`

`unpatentable.
`
`A. Background
`
`Petitioner filed a Petition requesting an inter partes review of
`
`claims 25-55 of the ‘116 patent. Paper 1 (“Pet.’’). Patent Ownerfiled a
`
`Preliminary Response. Paper 7. We determined, based on the information
`
`presented in the Petition and Preliminary Response,that there was a
`
`reasonable likelihood that Petitioner would prevail in showingthatat least
`
`one of the challenged claims was unpatentable overthe cited art. Pursuant
`
`to 35 U.S.C. § 314, the Board instituted trial on February 24, 2021. Paper9.
`
`IPR2020-01344
`Patent RE46,116 E
`
`I.
`
`INTRODUCTION
`
`Wehavejurisdiction under 35 U.S.C. § 6. We issue this Final Written
`
`Decision pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73 in an inter
`
`partes review involving Medtronic, Inc., and Medtronic Vascular,Inc.
`
`(“Petitioner”) and Teleflex Life Sciences Limited (“Patent Owner”).! Based
`
`on the record before us, we concludethat Petitioner has not demonstrated,
`
`by a preponderance ofthe evidence, that claims 25—55 (“the Challenged
`
`Claims’) of U.S. Patent No. RE46,116 E (Ex. 1401, “the ’116 patent’) are
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`' Teleflex Life Sciences Limited (“Teleflex”) filed a notice identifyingitself
`as the owner of U.S. Patent No. 8,142,413 B2. Paper 5, 2. Teleflex further
`explained, “Teleflex Innovations S.A.R.L. merged into Teleflex Medical
`Devices S.A.R.L., and Teleflex Medical Devices S.A.R.L. transferred
`ownership of U.S. Patent No. 8,142,413 to Teleflex Life Sciences Limited.”
`See id. at 2 n.1 (furthering stating that “[t]he assignment documents were
`recorded with the United States Patent & Trademark Office on January 27,
`2020”).
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`Following institution, Patent Ownerfiled a Responseto the Petition
`
`(Paper 21, “PO Resp.”), Petitioner filed a Reply to Patent Owner’s Response
`
`(Paper 37, “Reply”), and Patent Owner filed a Sur-reply (Paper 47).”
`
`On November 18, 2021, the parties presented argumentsat an oral
`
`hearing. The transcript of the hearing has been entered into the record.
`
`Paper 68.
`
`A. The ’116 patent
`
`Il.
`
`BACKGROUND
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`? Redacted versions of the PO Response and Reply are entered as Papers 22
`and 38, respectively.
`
`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. 1401, codes (21), (22), (45), (54).
`
`The ’116 patent is a reissue of U.S. Patent No. 8,292,850 (“the ’850 patent’)
`
`from Application No. 13/359,059 (“the ’059 application”) 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, which is 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 (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,” guidewires or other instruments, such as balloon
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`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 narrowedor occluded by
`
`atherosclerotic plaques or other lesions” in a phenomenon knownas
`
`stenosis. Jd. at 1:50—54. In treating the stenosis, “a guide catheter is
`
`inserted through the aorta and into the ostium ofthe coronary artery,”
`
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`A third category are “guide catheters that have a portion that seeks to expand
`
`sometimes with the aid of a guidewire, and is passed beyond the occlusion
`
`or stenosis. Jd. at 1:59-65. However, “[c]rossing tough lesions can create
`
`enough backward force to dislodge the guide catheter from the ostium ofthe
`
`artery being treated,” which can makeit difficult or impossible for the
`
`interventional cardiologist to treat certain forms of coronary artery disease.
`
`Id. at 1:66—2:3.
`
`The ’116 patent discusses four categories of previous “attempts to
`
`provide support to the guiding catheter to prevent backward dislodgement
`
`from the coronary ostium (referred to as ‘backup support’).” Jd. at 2:4—7.
`
`One category of guiding catheters “are configured to draw backup support
`
`from engaging the wall of the aortic arch opposing the ostium ofthe
`
`coronary artery that is being accessed.” Jd. at 2:8-11. A second category
`
`are “guiding catheters that include a retractable appendage. Jd. at 2:25—26.
`
`laterally to grip the interior wall of the ostium.” Jd. at 2:36-41. A fourth
`
`category, or “technique,” of the prior attempts “includes the placementof a
`
`smaller guide catheter within a larger guide catheter in order to provide
`
`added support for the crossing of lesions or for the distal delivery of balloons
`
`and stents.” Jd. at 2:50-53. The ’116 patent states this fourth technique was
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`described in Takahashi,’ which uses a guide catheter inserted “more deeply
`
`into the ostium of the coronary artery than typically has been done before.”
`
`Id. at 2:53-62. The ’116 patent states that such “deep seating”by this
`
`technique “creates the risk that the relatively stiff, fixed curve, guide catheter
`
`will damage the coronary artery.” Jd. at 2:63—65.
`
`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.” Ex. 1401, 3:20—23.
`
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`3 Saeko Takahashi, et al., New Method to Increase a Backup Support
`ofa 6 French Guiding Coronary Catheter, 63 CATHETERIZATION AND
`CARDIOVASCULAR INTERVENTIONS 452-456 (2004) (Ex. 1410, “Takahashv’’).
`
`Accordingto 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 catheter is in place. Jd. 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:
`
`5
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`
`
`46
`54
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`
`Figure 1 is a schematic depiction of the coaxial guide catheter and tapered
`
`inner catheter separately, and Figure 2 depicts those two elements assembled
`
`together. Jd. 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
`
`portion 16, reinforced portion 18, and rigid portion 20. Id. 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. Jd. 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 mayalso include
`
`clip 54 at a proximalend 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
`
`Fig. 1
`10
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`———}
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`

`IPR2020-01344
`Patent RE46,116 E
`
`at least three sizes corresponding to sizes commonly usedin interventional
`
`cardiology procedures. Jd. at 3:39-42.
`
`Figure 4, reproduced below, showsa coaxial guide catheter in
`
`accordance with the invention described in the ’116 patent:
`
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`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). Ex. 1401, 5:60; Fig. 4. As shown above, coaxial guide
`
`catheter 12 has a rigid portion 20, which “includesfirst full circumference
`
`portion 34, hemicylindrical portion 36, arcuate portion 38, and secondfull
`
`circumference portion 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. 1401, 8:20—22.
`
`Figure 8, reproduced below, showsthe operation of the coaxial guide
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`catheter assembly in accordance with the invention described in the ’116
`
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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. Id. 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.
`
`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.” Jd. at 4:58—62; see also
`
`id. at 8:30-32. Thereafter, coaxial guide catheter 12 can “accept a treatment
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`catheter such as a stent or [a] balloon catheter.” Jd. at 8:33-34. “[T]he
`
`presence of 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.
`
`B. Illustrative Claim
`
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`[25c] including advancinga distal end portion of a tubular
`structure of the guide extension catheter beyondthe distal
`end of the guide catheter while a segment defining a side
`opening ofthe guide extension catheter remains within the
`guide catheter,
`
`Petitioner challenges claims 25—55 of the ’116 patent. Pet. 1.
`
`Claims 25, 51, and 52 are independent. Ex. 1401, 13:62—14:25, 15:51-
`
`16:15, 16:53-18:10. Claims 26—42 and 44-50 depend from claim 25 and
`
`claims 53-55 depend from claim 52. Jd. at 14:62—18:26. Claim 25 is
`
`illustrative of the claimed subject matter and is reproduced below.
`
`25. A method, comprising:
`
`[25a] advancing a distal end of a guide catheter having a
`lumen through a main blood vessel to an ostium of a
`coronary artery;
`
`[25b] advancinga distal end of a guide extension catheter
`through, and beyondthe distal end of, the guide catheter,
`
`[25d] the side opening extending for a distance along a
`longitudinal axis of the guide extension catheter and
`accessible from a longitudinal side defined transverse to
`the longitudinalaxis,
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`[25e] the tubular structure having a cross-sectional inner
`diameterthat is not more than one French size smaller than
`a cross-sectional inner diameter of the lumen ofthe guide
`catheter;
`
`[25f] maintaining the distal end portion of the tubular
`structure of the guide extension catheter in position
`beyondthe distal end of the guide catheter; and
`
`[25g] while maintaining the distal end of the guide
`extension catheter positioned beyondthe distal end of the
`guide catheter advancing a balloon catheterorstent 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.
`
`Id. at 13:62—14:25.
`
`C. Asserted Grounds of Unpatentability
`
`Petitioner asserts that the Challenged Claims are unpatentable based
`
`on the following grounds:
`Claim(s)
`se
`Challenged
`§
`
`Ground
`
`U.S.C.
`
`References/Basis
`
`Kontos,* Ressemann*
`
`Kontos, Ressemann, Takahashi®
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`“Ressemann”’).
`® Takahashi, et al., New Methodto Increase a Backup Support of a 6 French
`Guiding Coronary Catheter, Catheterization and Cardiovascular
`Interventions 63:452-456 (2004) (Ex. 1410) (“Takahashi”).
`
`10
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`
`Ground
`
`Claim(s)
`Challenged
`
`U.S.C.
`
`se
`§
`
`3
`
`4
`
`5
`
`Pet. 8.
`
`References/Basis
`
`Kontos, Ressemann, Takahashi,
`Kataishi’
`
`Root®
`
`Kontos, Ressemann, Takahashi,
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