Trials@uspto.gov
`571-272-7822
`
`Paper No. 20
`Date: June 26, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.,
`Petitioner,
`v.
`TELEFLEX INNOVATIONS S.À.R.L.,
`Patent Owner.
`
`IPR2020-00133
`Patent RE45,760 E
`
`
`
`
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`SNEDDEN, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
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`

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`IPR2020-00133
`Patent RE45,760 E
`
`INTRODUCTION
`I.
`Medtronic, Inc., and Medtronic Vascular, Inc. (“Petitioner”) filed a
`Petition for inter partes review of claims 25–42, 44, and 47 of U.S. Patent
`No. RE45,760 E (“the ’760 patent,” Ex. 1201). Paper 1 (“Pet.”). Teleflex
`Medical Devices S.A.R.L. (“Patent Owner”) filed a Preliminary Response.
`Paper 10 (“Prelim. Resp.”). Pursuant to our authorization, Petitioner filed a
`Reply addressing its burden on secondary considerations and reduction to
`practice, and Patent Owner filed a Sur-Reply addressing Petitioner’s burden
`on those issues. Paper 14; Paper 15. Also pursuant to our authorization,
`Petitioner filed another Reply (Paper 17), and Patent Owner filed another
`Sur-Reply (Paper 18) addressing the factors for discretionary denial under
`35 U.S.C. § 314(a).
`To institute an inter partes review, we must determine that the
`information presented in the Petition shows “a reasonable likelihood that the
`petitioner would prevail with respect to at least 1 of the claims challenged in
`the petition.” 35 U.S.C. § 314(a) (2012). After considering the evidence
`and arguments presented in the Petition and Preliminary Response, we
`determine that Petitioner has not satisfied its burden under § 314. Thus, we
`do not institute an inter partes review.
`A. Real Parties in Interest
`Petitioner identifies its real parties-in-interest as Medtronic, Inc. and
`Medtronic Vascular, Inc., and notes that “Medtronic plc is the ultimate
`parent of both entities.” Pet. 5. Patent Owner identifies its real parties-in-
`interest as Teleflex Medical Devices S.A.R.L.; Vascular Solutions LLC;
`Arrow International, Inc.; and Teleflex LLC. Paper 4, 2. Patent Owner also
`notes that “Teleflex Incorporated is the ultimate parent of the entities listed
`above.”
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`IPR2020-00133
`Patent RE45,760 E
`B. Related Matters
`The ’760 patent is also at issue in IPR2020-00132 and IPR2020-
`00134. Paper 4, 2–3; Pet. 5. We instituted inter partes review in IPR2020-
`00132 on June 8, 2020. IPR2020-00132, Paper 22.
`The parties indicate that the ’760 patent is the subject of litigation in
`Vascular Solutions LLC, et al. v. Medtronic, Inc., et al. No. 19-cv-01760 (D.
`Minn. filed July 2, 2019), and QXMedical, LLC v. Vascular Solutions, LLC,
`No. 17-cv-01969 (D. Minn., filed June 8, 2017). Pet. 5; Paper 4, 2.
`The ’760 patent is a reissue of U.S. Pat. No. 8,292,850 (“the ʼ850
`patent). The ’850 patent was the subject of two previous inter partes
`reviews: IPR2014-00762, filed May 16, 2014, and terminated August 11,
`2014 by way of joint motion to terminate, and IPR2014-00763, filed May
`16, 2014, and terminated August 11, 2014, by way of joint motion to
`terminate. Pet. 5; Paper 4, 2–3. The ’850 patent was also at issue in the U.S.
`District Court for the District of Minnesota in Vascular Solutions, Inc. v.
`Boston Scientific Corp., No. 13-cv-01172 (D. Minn., filed May 16, 2013).
`Id.
`C. The ’760 Patent
`Specification
`1.
`The subject matter claimed in the ’760 patent is directed to a device
`for use with a standard guide catheter. Ex. 1201, 13:36–17:13. Figures 1
`and 5 of the ’760 patent, reproduced below, depict a coaxial guide catheter
`and a tapered inner catheter.
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`IPR2020-00133
`Patent RE45,760 E
`
`Figure 1 of the ’760 patent
`
`
`
`
`Figure 5 of the ’760 patent
`As shown in Figures 1 and 5, above, coaxial guide catheter assembly
`10 includes coaxial guide catheter 12 and tapered inner catheter 14. Id. at
`6:37–39. Coaxial guide catheter 12 generally includes tip portion 16,
`reinforced portion 18, and rigid portion 20. Id. at 6:40–41. Tip portion 16
`generally includes bump tip 22 and marker band 24. Id. at 6:44–45. Bump
`tip 22 includes taper 26 and is relatively flexible. Id. at 6:45–46. Marker
`band 24 is formed of a radiopaque material such as platinum/iridium alloy.
`Id. at 6:49–50. Tapered inner catheter tip 42 includes tapered portion 46 at a
`distal end thereof, and straight portion 48. Id. at 7:22–23. Both tapered
`portion 46 and straight portion 48 are pierced by lumen 50. Id. at 7:23–24.
`Tapered inner catheter 14 may also include clip 54 at a proximal end thereof
`to releasably join tapered inner catheter 14 to coaxial guide catheter 12. Id.
`at 7:27–29. Thus, tapered inner catheter 14 is keyed to coaxial guide
`catheter 12. Id. at 7:29–30.
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`IPR2020-00133
`Patent RE45,760 E
`Illustrative Claim
`2.
`Independent claim 25, reproduced below, is illustrative of the
`challenged claims.
`25. A system, comprising:
`a guide catheter configured to be advanceable through a main
`blood vessel to a position adjacent an ostium of a coronary artery,
`the guide catheter having a lumen extending from a hemostatic valve
`at a proximal end of the guide catheter to a distal end of the guide
`catheter that is adapted to be positioned adjacent the ostium of the
`coronary artery; and
`a guide extension catheter configured to be partially advanceable
`through the guide catheter and into the coronary artery, the guide
`extension catheter having a length such that a distal end of the guide
`extension catheter is extendable through the lumen and beyond the
`distal end of the guide catheter, and a proximal end of the guide
`extension catheter is extendable through the hemostatic valve at the
`proximal end of the guide catheter,
`the guide extension catheter including, in a proximal to distal
`direction, a substantially rigid segment, a segment defining a side
`opening, and a tubular structure defining a lumen coaxial and in
`fluid communication with the lumen of the guide catheter, the lumen
`of the tubular structure having a length that is shorter than the length
`of the lumen of the guide catheter and having a uniform cross-
`sectional inner diameter that is not more than one French size
`smaller than the cross-sectional inner diameter of the lumen of the
`guide catheter, the side opening extending for a distance along a
`longitudinal axis of the segment defining the side opening and
`accessible from a longitudinal side defined transverse to the
`longitudinal axis, and the side opening and the lumen of the tubular
`structure configured to receive one or more stents or balloon
`catheters when the segment defining the side opening and a
`proximal end portion of the tubular structure are positioned within
`the lumen of the guide catheter and the distal end of the guide
`extension catheter extends beyond the distal end of the guide
`catheter;
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`IPR2020-00133
`Patent RE45,760 E
`wherein a material forming the segment defining the side
`opening is more rigid than the tubular structure.
`Ex. 1201, 13:36–14:7 (emphasis added).
`D. Evidence
`Petitioner relies upon the following prior art references.
`Ex. 1208, T. V. Ressemann et al., U.S. Patent No. 7,604,612 B2 (issued Oct.
`20, 2009) (“Ressemann”).
`Ex. 1210, New Method to Increase a Backup Support of a 6 French Guiding
`Coronary Catheter, Catheterization and Cardiovascular Interventions 63:
`452-456 (2004) (“Takahashi”).
`Ex. 1225, Y. Kataishi et al., U.S. Patent Application Publication No.
`2005/0015073 A1 (published Jan. 20, 2005) (“Kataishi”).
`Ex. 1250, C. D. Enger et al., U.S. Patent No. 5,980,486 (issued Nov. 9,
`1999) (“Enger”).
`Petitioner also relies upon the Declarations of Dr. Stephen Brecker
`(Ex. 1205) and Richard A. Hillstead (Ex. 1242) to support its contentions.
`E. Asserted Grounds of Unpatentability
`Petitioner asserts that claims 25–42, 44, and 47 would have been
`unpatentable on the following grounds.
`
`Ground
`
`Claim(s)
`
`35 U.S.C. §1
`
`References/Basis
`
`1
`
`2
`
`25–42, 44, 47
`
`103(a)
`
`32
`
`103(a)
`
`Ressemann, Takahashi,
`Knowledge of a POSITA
`
`Ressemann, Takahashi,
`Kataishi, Knowledge of a
`
`
`1 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
`(2011) (“AIA”), amended 35 U.S.C. §§ 102 and 103. Because the
`challenged claims of the ’760 patent have an effective filing date before the
`effective date of the applicable AIA amendments, we refer to the pre-AIA
`versions of 35 U.S.C. § 103 throughout this Decision.
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`IPR2020-00133
`Patent RE45,760 E
`
`Ground
`
`Claim(s)
`
`35 U.S.C. §1
`
`32
`
`103(a)
`
`3
`
`
`
`References/Basis
`POSITA
`
`Ressemann, Takahashi,
`Enger, Knowledge of a
`POSITA
`
`II. ANALYSIS
`
`A. Claim Construction
`We interpret a claim “using the same claim construction standard that
`would be used to construe the claim in a civil action under 35 U.S.C.
`282(b).” 37 C.F.R. § 42.100(b) (2019). Under this standard, we construe
`the claim “in accordance with the ordinary and customary meaning of such
`claim as understood by one of ordinary skill in the art and the prosecution
`history pertaining to the patent.” Id.
`Petitioner proposes constructions for several claim terms, including
`the terms “concave track” and “flexural modulus.” Pet. 14–16. Patent
`Owner responds to Petitioner’s proposed constructions by asserting that “no
`specific construction of claim terms is necessary for the Board to deny the
`Petition in view of the deficiencies [Patent Owner] identifies” in this
`Preliminary Response.” Prelim. Resp. 14.
`At this stage of the proceeding, we determine that no express
`construction of any claim term is necessary to determine whether to institute
`inter partes review. See Nidec Motor Corp. v. Zhongshan Broad Ocean
`Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe
`terms ‘that are in controversy, and only to the extent necessary to resolve the
`controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200
`F.3d 795, 803 (Fed. Cir. 1999))).
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`IPR2020-00133
`Patent RE45,760 E
`B. Grounds 1–3: Obviousness over the Combination of Ressemann and
`Takahashi
`Each of Petitioner’s asserted obviousness grounds rely on the
`combination of Ressemann, Takahashi, and the knowledge of POSITA.
`Pet. 17–75. For the reasons set forth below, we determine that Petitioner has
`failed to demonstrate that the combination of Ressemann and Takahashi
`disclose the limitation of a “tubular structure defining a lumen coaxial . . .
`with the lumen of the guide catheter” as required by the challenged claims.
`Accordingly, we determine that the Petition fails to show a reasonable
`likelihood that claims 25–42, 44, and 47 would have been obvious.
`a) Summary of the References Relied Upon
`(1) Ressemann (Ex. 1208)
`Ressemann is directed to an apparatus “used to prevent the
`introduction of emboli into the bloodstream during and after surgery
`performed to reduce or remove blockage in blood vessels.” Ex. 1208, 1:13–
`16. Figures 1A and 1B of Ressemann are reproduced below:
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`IPR2020-00133
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`
`Figure 1A is a cross-sectional view of a partial length evacuation sheath. Id.
`at 3:16–18. Figure 1B is a cross-sectional view of the partial length
`evacuation sheath of Figure 1A, taken along line 1B-1B of Figure 1A. Id. at
`3:19–20.
`Figure 1A depicts evacuation sheath assembly 100, which “is sized to
`fit inside a guide catheter” and be advanced “into a blood vessel to treat a
`stenosis.” Id. at 6:18–24, Fig. 5A. Evacuation sheath assembly 100 includes
`a shaft having proximal shaft portion 110, intermediate shaft portion 120,
`and distal shaft portion 130 (not shown in Figure 1A). Id. at 10:30–35.
`Evacuation head 132 includes multi-lumen tube 138 having evacuation
`lumen 140 and inflation lumen 142 and is preferably made of a relatively
`flexible polymer. Id. at 6:35–64. Evacuation lumen 140 is preferably larger
`than inflation lumen 142 and “is designed to allow for the passage of
`interventional devices such as, but not limited to, stent delivery systems and
`angioplasty catheters.” Id. at 6:44–47. Proximal and distal ends of
`evacuation lumen 140 are angled to allow for smoother passage of
`evacuation sheath assembly 100 through a guide catheter and to facilitate
`smoother passage of other therapeutic devices through evacuation
`lumen 140. Id. at 6:52–57. According to Ressemann, “[t]he larger area of
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`IPR2020-00133
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`the angled open ends also allows for larger deformable particulate matter to
`pass through the lumen more smoothly.” Id. at 6:58–60.
`Stiffness transition member 135 is attached to the distal end of
`proximal shaft portion 110, “is located co-axially in the inflation lumen
`142,” and extends to soft tip 144. Id. at 11:30–39. Inflation lumen 142,
`having open proximal end 142a and closed distal end 142b, is designed to
`provide fluid to inflate balloons on evacuation head 132. Id. at 6:61–64.
`In use, a guiding catheter is directed to a blood vessel and then a
`coronary guide wire is advanced to a location just proximal to the distal tip
`of the guiding catheter. Id. at 12:9–14. Evacuation sheath assembly 100 is
`then advanced over the guide wire and positioned within the blood vessel.
`Id. at 12:19–21. In this process, evacuation head 132 is positioned with its
`distal end within the blood vessel while its proximal end remains in the
`guiding catheter. Id. at 12:37–39. Sealing balloons 136 and 134 are then
`inflated to provide a fluid seal between the sealing balloons and the blood
`vessel. Id. at 12:40–45.
`Figure 6D of Ressemann is reproduced below:
`
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`IPR2020-00133
`Patent RE45,760 E
`Figure 6D is a cross-sectional view of the partial length evacuation
`sheath of Figures 1A and 1B deployed within a blood vessel. Id. at 3:59–61.
`Guidewire 170 may be advanced beyond stenosis 180 in blood vessel 150.
`Id. at 13:3–16. A therapeutic device, such as a stent, may then be advanced
`over guide wire 170 and across stenosis 180. Id. at 13:57–60. As indicated
`by arrows 195, blood flow within the blood vessel is directed towards
`evacuation sheath 100. Id. at 13:35–41. According to Ressemann, “[t]his
`retrograde flow will carry any dislodged material out of the patient and into
`a collection chamber.” Id. at 13:43–44.
`Takahashi (Ex. 1210)
`(2)
`Takahashi is a journal article entitled “New Method to Increase a
`Backup Support of a 6 French Guiding Coronary Catheter.” Ex. 1210. It
`bears a copyright date of 2004. Id. at 5. Takahashi discloses a “five-in-six”
`system wherein a 5 French guiding catheter is inserted into a 6 French
`guiding catheter to provide increased backup support. Id. at 452. In this
`system, the 5 French catheter is 120 cm in length, whereas the 6 French
`catheter is 100 cm in length. Id. According to Takahashi, the soft end
`portion of the 5 French catheter “can easily negotiate the tortuous coronary
`artery with minimal damage and then it can be inserted more deeply into the
`artery.” Id.
`b) Discussion
`To support its position, Petitioner directs our attention to the
`foregoing discourses of Ressemann and Takahashi and provides a detailed
`claim analysis addressing how each element of independent claim 25 is
`disclosed by the combination of references. Pet. 17–40 (citing generally
`Exs. 1205 and 1242).
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`In particular, Petitioner directs our attention to the following
`annotated Figure 1A of Ressemann:
`
`
`
`Pet. 25; Ex. 1208, Fig. 1A (color and annotations added by Petitioner). As
`discussed above, Figure 1A is a cross-sectional view of a partial length
`evacuation sheath disclosed by Ressemann. Id. at 3:16–18. With reference
`to the figure above, Petitioner contends that “Ressemann teaches a guide
`catheter 160 that is used with an evacuation sheath assembly 100 sized to fit
`therein.” Pet. 21 (citing Ex. 1208, Abstract, 6:18–24, 28:26–29). Petitioner
`contends that sheath assembly (100) includes proximal shaft (110) and
`intermediate shaft (120) and that “shaft (110) and shaft (120) are sufficiently
`rigid to allow evacuation sheath (100) to be advanced within the guide
`catheter.” Id. at 25 (citing Ex. 1208, Figs. 1A, 6A–F; Ex. 1205 ¶ 164).
`Petitioner further contends as follows:
`Ressemann discloses a segment defining a side opening, shown
`above in a dotted red box. That segment is a portion of
`evacuation head 132. It includes 140a, which is the proximal
`opening to the evacuation lumen 140. [Ex. 1208,] 6:35-60.
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`Because head 132 includes distal shaft 130, id.[] 10:31–35, the
`segment defining a side opening also includes the portion of shaft
`130 that is adjacent 140a.
`Distal to opening 140a is a tubular structure, “multi-lumen
`tube 138,” which defines evacuation lumen 140. Id., 6:35-47.
`The claimed “tubular structure” is the portion of the evacuation
`lumen 140 that is distal to 140a. 9 Ex. 1205, ¶ 164.
`Id. at 25–26 (footnote omitted). Thus, with respect to the requirement for a
`“guide extension catheter” including a “tubular structure defining a lumen
`coaxial . . . with the lumen of the guide catheter,” Petitioner relies on the
`disclosure of Ressemann’s evacuation lumen 140 and contends that “lumen
`(140) is coaxial and in fluid communication with the lumen of the guiding
`catheter (160).” Pet. 26–27 (citing Ex. 1205 ¶ 164).
`Patent Owner contends that Petitioner’s assertion that lumen (140) is
`coaxial and in fluid communication with the lumen of the guiding catheter
`(160) is incorrect. Prelim. Resp. 26 (citing Pet. 26–27; Ex. 1205, ¶ 164). In
`contrast, Patent Owner contends that Ressemann’s evacuation lumen 140 is
`part of a multi-lumen tube consisting of offset lumens. Id. at 26–27. To that
`point, Patent Owner directs our attention to, inter alia, annotated Figure 1B
`and an annotated portion of Figure 6C, both reproduced below. Id. at 27.
`
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`Patent RE45,760 E
`
`
`Ressemann discloses that Figure 6C is a “cross-sectional view[] of the
`partial length evacuation sheath of FIGS. 1A and 1B as employed in a
`method according to one aspect of the present invention.” Ex. 1208, 3:59–
`61. Ressemann discloses that “FIG. 1B is a cross-sectional view of the
`partial length evacuation sheath taken along line 1B-1B of FIG. 1A.” Id. at
`3:19–20 (color and annotations added by Patent Owner).
`According to Patent Owner, “Figures 1B and 6C show that the
`longitudinal axis of Ressemann’s evacuation lumen 140 is offset from that of
`the guide catheter 160.” Prelim. Resp. 27. Thus, according to Patent
`Owner, Ressemann “does not disclose ‘a tubular structure defining a lumen
`coaxial . . . with the lumen of the guide catheter,’ as recited by claim 25.”
`Id. at 27–28.
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`IPR2020-00133
`Patent RE45,760 E
`Having considered the parties positions and evidence of record,
`summarized above, we are persuaded by Patent Owner’s arguments that the
`Petition fails to sufficiently establish that Ressemann discloses “a tubular
`structure defining a lumen coaxial . . . with the lumen of the guide catheter”
`as required recited by claim 25 and dependent claims thereto. In particular,
`we are persuaded that Ressemann discloses that evacuation lumen 140 is
`offset from that of the guide catheter 160, and thus the lumen of the
`evacuation lumen 140 is not disclosed as being coaxial to the lumen of the
`guide catheter 160. The Petition fails to sufficiently account for that
`difference identified by Patent Owner.
`In view of the above, we determine that Petitioner has not established
`a reasonable likelihood of prevailing in demonstrating the unpatentability of
`claims 25–42, 44, and 47 based on the combination of Ressemann and
`Takahashi. Consequently, each of Petitioner’s Grounds 1–3 fail.
`III. CONCLUSION
`Petitioner has failed to establish a reasonable likelihood of prevailing
`in demonstrating that claims 25–42, 44, and 47 would have been obvious
`over the combinations of prior art set forth in the asserted grounds.
`IV. ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that the Petition is denied and no trial is instituted.
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`IPR2020-00133
`Patent RE45,760 E
`For PETITIONER:
`
`Cyrus Morton
`Sharon Roberg-Perez
`Christopher Pinahs
`ROBINS KAPLAN LLP
`Cmorton@RobinsKaplan.com
`Sroberg-perez@robinskaplan.com
`Cpinahs@RobinsKaplan.com
`
`
`For PATENT OWNER:
`
`Derek Vandenburgh
`Dennis Bremer
`CARLSON, CASPERS, VANDENBURGH & LINDQUIST, P.A.
`dvandenburgh@carlsoncaspers.com
`dbremer@carlsoncaspers.com
`
`
`
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