`
`Trials@uspto.gov
`571-272-7822
`
`Paper
`
`Date:
`
`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.
`
`IPR2020-00134
`Patent RE45,760 E
`
`Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`SNEDDEN, Administrative Patent Judge.
`
`JUDGMENT
`Final Written Decision
`Determining No Challenged Claims Unpatentable
`Not Deciding Patent Owner’s Contingent Motion to Amend
`35 U.S.C. § 318(a)
`
`ORDERS
`Denying Petitioner’s Motion to Exclude (Paper 106)
`37 C.F.R. § 42.64(c)
`
`PUBLIC VERSION
`
`
`
`IPR2020-00134
`Patent RE45,760 E
`
`INTRODUCTION
`I.
`Medtronic, Inc. and Medtronic Vascular, Inc. (“Petitioner”) filed a
`Petition for inter partes review of claims 48 and 51–53 of U.S. Patent No.
`RE45,760 E (“the ’760 patent,” Ex. 1601). Paper 1 (“Pet.”). Teleflex
`Medical Devices S.A.R.L. (“Patent Owner”)1 filed a Preliminary Response.
`Paper 10 (“Prelim. Resp.”). Upon review of the Petition and Preliminary
`Response, we instituted an inter partes review of all claims on all grounds
`asserted in the Petition (Paper 20).
`Patent Owner subsequently filed a Patent Owner Response (Paper 40,
`“PO Resp.”) (redacted version available at Paper 41), Petitioner filed a
`Reply (Paper 79) (redacted version available at Paper 80), and Patent Owner
`filed a Sur-Reply (Paper 98) (redacted version available at Paper 99).
`With prior authorization of the Board, Patent Owner filed a
`Consolidated Response Addressing Conception and Reduction to Practice
`(Paper 36, “PO CRTP Resp.”), to which Petitioner filed a Reply (Paper 75,
`“Pet. CRTP Reply”) (redacted version available at Paper 76), Patent Owner
`filed a Sur-Reply (Paper 93, “PO CRTP Sur-Reply”), and Petitioner filed a
`Sur-Sur-Reply (Paper 107, “Pet. CRTP Sur-Sur-Reply”).
`Patent Owner also filed a Contingent Motion to Amend. Paper 35.2
`The Motion requests that if any of issued claims 37, 38, 39, 48, or 51 of the
`’760 patent are determined to be unpatentable, they should be replaced by
`proposed substitute claims 54–58. Id. at 1. Petitioner filed an Opposition to
`
`1 Patent Owner represents that “Teleflex Innovations S.A.R.L. merged into
`Teleflex Medical Devices S.A.R.L,” which subsequently “transferred
`ownership of U.S. Patent No. RE45,760E to Teleflex Life Sciences
`Limited.” Paper 7, 2.
`2 Patent Owner filed a consolidated motion to amend addressing claims of
`the ’760 patent challenged in both IPR2020-00132 and IPR2020-00134.
` 2
`
`PUBLIC VERSION
`
`
`
`IPR2020-00134
`Patent RE45,760 E
`the Motion to Amend (Paper 82), to which Patent Owner filed a Reply
`(Paper 101), and Petitioner filed a Sur-reply (Paper 109).
`An oral hearing was held on March 8, 2021, and a transcript of the
`hearing is included in the record. Paper 121 (“Tr.”) (redacted version
`available at Paper 120).
`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.” Id.
`B. Related Matters
`The parties indicate that the ’760 patent is the subject of litigation in
`Vascular Solutions LLC v. Medtronic, Inc., No. 19-cv-01760 (D. Minn. filed
`July 2, 2019) (“Medtronic”) and QXMedical, LLC v. Vascular Solutions,
`LLC, No. 17-cv-01969 (D. Minn., filed June 8, 2017) (“QXM”). Pet. 5–6;
`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 a joint motion to terminate, and IPR2014-00763, filed May
`16, 2014 and terminated August 11, 2014 by way of a joint motion to
`terminate. Pet. 6; 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.
`
` 3
`
`PUBLIC VERSION
`
`
`
`IPR2020-00134
`Patent RE45,760 E
`Boston Scientific Corp., No. 13-cv-01172 (D. Minn., filed May 16, 2013).
`Id.
`
`Petitioner also challenged the ’760 patent in IPR2020-00132 and
`IPR2020-00133. Paper 4, 2–3; Pet. 5.
`C. The ’760 Patent
`1. Specification
`The subject matter claimed in the ’760 patent is directed to a device
`for use with a standard guide catheter. Ex. 1601, 13:36–17:13. Figures 1
`and 5 of the ’760 patent, reproduced below, depict a coaxial guide catheter
`and a tapered inner catheter.
`
`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
` 4
`
`PUBLIC VERSION
`
`
`
`IPR2020-00134
`Patent RE45,760 E
`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.
`2. Illustrative Claim
`Independent claim 48, reproduced below, is illustrative of the
`challenged claims.
`48. 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
` 5
`
`PUBLIC VERSION
`
`
`
`IPR2020-00134
`Patent RE45,760 E
`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/or 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;
`wherein the segment defining the side opening comprises a
`portion of the guide extension catheter that is more rigid than a distal
`end portion of the tubular structure.
`Ex. 1601, 15:14–53.
`D. Evidence
`Petitioner relies upon the following prior art references.
`Ex. 1607, T. Itou et al., U.S. Patent No. 7,736,355 B2 (issued
`June 15, 2010) (“Itou”).
`Ex. 1608, T. V. Ressemann et al., U.S. Patent No. 7,604,612 B2
`(issued Oct. 20, 2009) (“Ressemann”).
`Ex. 1610, Saeko Takahashi, et al., New Method to Increase a Backup
`Support of a 6 French Guiding Coronary Catheter, Catheterization
`and Cardiovascular Interventions 63:452–456 (2004) (“Takahashi”).
`In support of its arguments, Petitioner relies on the expert declarations
`of Dr. Stephen Jon David Brecker (Exs. 1005, 1806, 1903), Dr. Richard A.
`Hillstead (Exs. 1642, 1905), Mr. Michael Jones (Ex. 1807), and Dr. Paul
`Zalesky (Exs. 1755, 1830, 1919).
`Patent Owner relies on the declarations of Mr. Peter T. Keith (Ex.
`2042), Ms. Amy Welch (Ex. 2044) (redacted), Ms. Deborah Schmalz
`(Ex. 2039), Mr. Howard Root (Ex. 2118), Mr. Gregg Sutton (Ex. 2119), Mr.
` 6
`
`PUBLIC VERSION
`
`
`
`IPR2020-00134
`Patent RE45,760 E
`Mark Goemer (Ex. 2120), Ms. Amanda O’Neil (Ex. 2121), Mr. Steve Erb
`(Ex. 2122), Mr. Peter T. Keith (Exs. 2042, 2123, 2124, 2138, 2243), Dr.
`John J. Graham (Ex. 2145), Dr. Lorenzo Azzalini (Ex. 2151), Mr. Steve
`Jagodzinkski (Ex. 2152 (redacted), 2153 (confidential)), Ms. Heather S.
`Rosecrans (Ex. 2205), and Dr. Craig Thompson (Ex. 2215).
`E. Asserted Grounds of Unpatentability
`Petitioner asserts that claims 48 and 51–53 would have been
`unpatentable on the following grounds.
`
`Ground
`
`Claim(s)
`
`35 U.S.C. §3
`
`References/Basis
`
`1
`
`2
`
`3
`
`4
`
`48, 51, 53
`
`48, 51, 53
`
`52
`
`48, 51–53
`
`102(e)
`
`103(a)
`
`103(a)
`
`103(a)
`
`Itou
`
`Itou, Ressemann
`
`Itou
`
`Ressemann, Takahashi
`
`ANALYSIS
`II.
`A. Priority Date of the ’760 Patent
`The AIA’s first-to-file provisions apply to patent applications “that
`contain[] or contained at any time a claim to a claimed invention that has an
`effective filing date” on or after March 16, 2013. AIA § 3(n)(1). The
`application for reissue for the ’760 patent was filed March 3, 2014 and
`
`3 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 (March 16, 2013), we refer
`to the pre-AIA versions of 35 U.S.C. §§ 102 and 103 throughout this
`Decision.
`
` 7
`
`PUBLIC VERSION
`
`
`
`IPR2020-00134
`Patent RE45,760 E
`sought reissue of US Patent No. 8,292,850, which issued October 23, 2012
`from an application filed January 26, 2012. Ex. 1001, codes (22), (64).
`Petitioner contends,
`The ’760 patent is subject to the AIA first-to-file provisions
`because (1) it contains claims that lack written description, and
`therefore pre-AIA priority, and (2) it claims priority to RE 45,380
`(“the ’380 patent”), which is subject to the AIA first-to-file
`provisions. Thus, Patent Owner cannot swear behind Itou in this
`proceeding.
`Pet. 14. Petitioner contends that because there is no written description
`support for the subject matter of at least claim 32 of the ’760 patent, the ’760
`patent has an effective filing date after March 16, 2013. Pet. 14. Thus,
`according to Petitioner, the ’760 patent is subject to the AIA’s first-to-file
`provisions, which precludes Patent Owner’s from attempting to swear
`behind Itou’s filing date. Id.
`“The effective filing date for a claimed invention in an application for
`reissue or reissued patent shall be determined by deeming the claim to the
`invention to have been contained in the patent for which reissue was
`sought.” 35 U.S.C. § 100(i)(2) (2018). As the “patent for which reissue was
`sought” in this case was issued October 23, 2012, we are not persuaded that
`AIA’s first-to-file provisions apply to the ’760 patent. Indeed, Petitioner
`provides no legal support for the proposition that a reissue patent may lose
`the filing date of the original patent for which reissue was sought.4
`
`4 To the extent the original patent for which reissue was sought does not
`contain written description support for a reissue claim, that claim may be
`invalid. But this is a question we may not address in an IPR. 35 U.S.C.
`§ 311(b).
`
`8
`
`PUBLIC VERSION
`
`
`
`IPR2020-00134
`Patent RE45,760 E
`B. Level of Ordinary Skill in the Art
`We consider the asserted grounds of unpatentability in view of the
`understanding of a person of ordinary skill in the art (“POSITA”). Petitioner
`provides two alternative definitions of a person of ordinary skill in the art.
`First, Petitioner asserts that if a person of ordinary skill in the art “was a
`medical doctor, s/he would have had (a) a medical degree; (b) completed a
`coronary intervention training program, and (c) experience working as an
`interventional cardiologist.” Pet. 15. Alternatively, Petitioner asserts that if
`a person of ordinary skill in the art was “an engineer s/he would have had (a)
`an undergraduate degree in engineering, such as mechanical or biomedical
`engineering; and (b) at least three years of experience designing medical
`devices, including catheters or catheter-deployable devices.” Id.
`Additionally, Petitioner contends that “[e]xtensive experience and technical
`training might substitute for education, and advanced degrees might
`substitute for experience.” Id.
`Patent Owner “does not dispute Petitioner’s proposed definition of a
`POSITA.” PO Resp. 9.
`Upon review of the parties’ arguments and supporting evidence, we
`adopt Petitioner’s definitions for a person of ordinary skill in the art, which
`allow the ordinarily skilled artisan to be either a medical doctor or an
`engineer, as they are undisputed and consistent with the level of skill
`reflected in the prior art and the written description of the ’760 patent. See
`Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art
`itself can reflect the appropriate level of ordinary skill in the art).
`C. 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.
` 9
`
`PUBLIC VERSION
`
`
`
`IPR2020-00134
`Patent RE45,760 E
`282(b).” 37 C.F.R. § 42.100(b) (2019). This standard requires that we
`construe a 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.
`Upon review of the parties’ arguments and supporting evidence, we
`determine that it is not necessary to construe any claim terms to resolve the
`disputed issues for purposes of this Final Written Decision. See Vivid
`Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)
`(holding that “only those terms need to be construed that are in controversy,
`and only to the extent necessary to resolve the controversy”).
`
`D. Challenges Based on Itou
`
`Petitioner contends: i) claims 48, 51, and 53 are anticipated by Itou
`(Pet. 18–45); ii) claims 48, 51, and 53 would have been obvious over the
`combination of Itou and Ressemann (id. at 45–54); and iii) claim 52 would
`have been obvious over Itou (id. at 54–56).
`Critical to its grounds based on Itou, Petitioner contends Itou is prior
`art under 35 U.S.C. § 102(e). Pet. 19. Patent Owner contends Itou is not
`prior art to the ’760 patent because the invention set forth in the challenged
`claims was conceived and reduced to practice prior to the effective filing
`date of Itou. PO CRTP Resp. 1. The parties filed consolidated briefing to
`address those issues in IPR2020-00126, -00128, -00129, -00132, -
`00134, -00135, and -00137 and present the same arguments and evidence for
`each proceeding. The primary argument raised by Petitioner is that Patent
`Owner’s core conception documents do not disclose the “side opening”
`feature recited in numerous challenged claims. Pet. CRTP Reply 5–7.
`Petitioner does not identify specifically which limitation of the ’760 patent
`
` 10
`
`PUBLIC VERSION
`
`
`
`IPR2020-00134
`Patent RE45,760 E
`claims constitute the “side opening” limitation. However, according to
`Petitioner’s table in its CRTP Sur-Sur-Reply, the side-opening limitation
`appears in the following claims: claims 3 and 4 of the ’032 patent; claims 3,
`4, 36 of the ’380 patent; claims 25, 52, and 53 of the ’776 patent; and claims
`25, 48, 51, and 53 of the ’760 patent. Pet. CRTP Sur-Sur-Reply 14–15.
`Thus, the parties do not present distinct arguments with respect to
`challenged claims 48, 51, 52, and 53 (challenged in this proceeding) versus
`claims 25–42, 44, and 47 (challenged in IPR2020-00132) of the ’760 patent.
`Furthermore, in its consolidated briefs, Patent Owner persuasively
`demonstrates that its evidence of conception and reduction to practice
`applies to challenged claims 48, 51, 52, and 53 of the ’760 patent. Ex. 2118,
`Appx. B (pages 143–158); PO CRTP Resp. 3–29. Accordingly, for the
`reasons set forth in IPR2020-00132, Paper 125, we find that Itou is not prior
`art to claims 48, 51, 52, and 53 of the ’760 patent, and that Petitioner has not
`demonstrated by a preponderance of the evidence that claims 48, 51, 52, and
`53 are unpatentable over the Itou-based grounds.
`E. Obviousness of Claims 48, 51, 52, and 53 over the Combination of
`Ressemann and Takahashi
`Petitioner asserts that claims 48, 51, 52, and 53 are unpatentable under
`35 U.S.C. § 103(a) as obvious over Ressemann and Takahashi. Pet. 56–86.
`For the reasons set forth below, we determine that Petitioner has not
`established by a preponderance of evidence that claims 48, 51, 52, and 53
`would have been obvious over the combination of Ressemann and
`Takahashi.
`
`a) Summary of Ressemann (Ex. 1608)
`Ressemann is directed to an apparatus “used to prevent the
`introduction of emboli into the bloodstream during and after surgery
` 11
`
`PUBLIC VERSION
`
`
`
`IPR2020-00134
`Patent RE45,760 E
`performed to reduce or remove blockage in blood vessels.” Ex. 1608, 1:13–
`16. Figures 1A and 1B of Ressemann, reproduced below, illustrate a first
`embodiment of a “system and method for evacuating emboli, particulate
`matter, and other debris from a blood vessel.” Id. at 5:65–68.
`
`Figure 1A is a cross-sectional view of a partial length evacuation sheath
`assembly 100. Id. at 3:16–18. “Evacuation sheath assembly 100 includes an
`evacuation head and a shaft.” Id. at 6:19–20. “Evacuation head 132
`includes a multi-lumen tube 138.” Id. at 6:35–36. Evacuation sheath
`assembly 100 “is sized to fit inside a guide catheter to advance a distal end
`of the evacuation sheath assembly into a blood vessel to treat a stenosis.” Id.
`at 6:20–24. Evacuation head 132 includes multi-lumen tube 138, which
`preferably is made of a relatively flexible polymer, as well as evacuation
`lumen 140 and inflation lumen 142. Id. at 6:35–64. Evacuation lumen 140
`is preferably larger than inflation lumen 142 and is designed to allow for
`fluid flow and also “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. “The larger area of the
` 12
`
`PUBLIC VERSION
`
`
`
`IPR2020-00134
`Patent RE45,760 E
`angled open ends also allows for larger deformable particulate matter to pass
`through the lumen more smoothly.” Id. at 6:58–60.
` Figure 1B, reproduced below, is a cross-sectional view of the partial
`length evacuation sheath of Figure 1A, taken along line 1B–1B. Id. at 3:19–
`20. Figure 1B shows inflation lumen 142, and a “second and preferably
`smaller lumen of the multi-lumen tube 138.” Id. at 6:61–62.
`
`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. Evacuation sheath assembly 100 has a shaft that
`includes proximal shaft portion 110, intermediate shaft portion 120, and
`distal shaft portion 130 (not shown in Figure 1A). Id. at 10:30–35. 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.
`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,
`and then evacuation head 132 is positioned with its distal end within the
`
` 13
`
`PUBLIC VERSION
`
`
`
`IPR2020-00134
`Patent RE45,760 E
`blood vessel while its proximal end remains in the guiding catheter. Id. at
`12:19–21, 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.
`As shown in Figure 6D, reproduced below, the guidewire may then be
`advanced beyond a stenosis in the blood vessel.
`
`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. As
`shown in Figure 6D, in this configuration, the guide wire 170 may be
`advanced beyond stenosis 180 and then a therapeutic device, such as a stent,
`advanced over guide wire 170 and across stenosis 180. Id. at 13:15–20,
`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.
`
` 14
`
`PUBLIC VERSION
`
`
`
`IPR2020-00134
`Patent RE45,760 E
`Ressemann discloses another embodiment where the “multi-lumen
`tube forming the evacuation head may include three lumens,” illustrated in
`Figures 16A–16J. Id. at 22:29–33. Figure 16A, reproduced below, is side
`view of a full-length evacuation sheath assembly 2100. Id. at 5:21–23.
`
`Figure 16A also shows evacuation head 2132, which includes a multi-lumen
`tube 2138. Id. at 22:32–33. “The evacuation head includes two expandable
`sealing surfaces on a multi-lumen tube.” Id. at 22:40–41. Evacuation sheath
`assembly 2100 that includes a shaft, which includes two sections, a proximal
`shaft portion 2110 and an intermediate shaft portion 2120, each having
`distinct diameters. Id. at 27:22–36. “The proximal shaft portion 2110
`provides fluid communication between an inflation apparatus (see FIG. 16I)
`and the intermediate shaft portion 2120.” Id. at 27:37–38. “The
`intermediate shaft portion 2120 includes a tapered metallic core wire 2135
`inside a polymer tube 2122, as shown in FIG. 16C.” Id. at 27:51–53.
`“[T]he evacuation head 2132 may include a structure to reinforce the
`proximal opening of the multi-lumen tube 2138,” shown in Figure 16A. Id.
`at 24:47–49. Figures 16D and 16J illustrate the structure to reinforce the
`proximal opening of multi-lumen tube 2138. Id. Figure 16D, reproduced
`below, is an enlarged cross-sectional side view of the proximal end of an
`
` 15
`
`PUBLIC VERSION
`
`
`
`IPR2020-00134
`Patent RE45,760 E
`evacuation sheath assembly 2100 and shows the placement of support collar
`2141. Id. at 5:29–31.
`
` Figure 16J, reproduced below, is an isometric view of support collar
`2141 used in evacuation sheath assembly 2100. Id. at 5:46–47.
`
` 16
`
`PUBLIC VERSION
`
`
`
`IPR2020-00134
`Patent RE45,760 E
`Support collar 2141 is positioned about the proximal end of multi-lumen
`tube 2138 and serves to reinforce the proximal opening of evacuation lumen
`2140 “in the presence of deforming forces, particularly torsional stresses that
`may be created unintentionally by rotation of the catheter shaft near its
`proximal end.” Id. at 24:49–55. Support collar 2141 includes cylindrical
`portion 2141 a that fits into the proximal opening of evacuation lumen 2140.
`Id. at 24:55–58. Preferably, support collar 2141 is fabricated from a thin
`walled metallic tube with a series of windows 2141 c that “allow for some
`flexibility and also allow for better adhesion of the encapsulation material
`2133, which covers the support collar 2141, while the cylindrical portion
`2141 a maintains hoop support to the proximal opening of the evacuation
`lumen 2140.” Id. at 25:1–8 (emphasis added).
`Additionally, support collar cylindrical portion 2141 a tapers into tab
`portion 2141 b that extends proximally and in a direction parallel to a
`longitudinal axis of evacuation lumen 2140 to provide a flexibility transition
`between the proximal end of evacuation head 2131 and the shaft of
`evacuation sheath assembly 2100. Id. at 24:58–67. To facilitate attachment
`between evacuation head 2132 and intermediate shaft portion 2120, a distal
`portion of polymer tube 2122 is flared and flattened by heating with an
`appropriately formed mandrel. Id. at 27:59–63. “This flared section is
`overlapped over the walls of the multi-lumen tube 2138, which define the
`core wire lumen 2143 and the inflation lumen 2142, as well as over the tab
`portion 2141 b of the support collar 2141.” Id. at 27:63–67.
`Figure 16E, reproduced below, is a cross-sectional view of the
`evacuation sheath assembly 2100 and shows core wire lumen 2143 and
`inflation lumen 2142. Id. at 5:32–33, 23:41–52.
`
` 17
`
`PUBLIC VERSION
`
`
`
`IPR2020-00134
`Patent RE45,760 E
`
`b) Summary of Takahashi (Ex. 1610)
`Takahashi is a journal article entitled “New Method to Increase a
`Backup Support of a 6 French Guiding Coronary Catheter.” Ex. 1610. 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.
`c) Discussion
`Petitioner contends that claims 48, 51, 52, and 53 are would have been
`obvious over the combination of Ressemann and Takahashi. Pet. 56–86. In
`support of its contention, Petitioner provides a detailed discussion that
`identifies where it contends every limitation of claims 48, 51, 52, and 53 is
`disclosed by the combination of Ressemann and Takahashi. Id.
`
` 18
`
`PUBLIC VERSION
`
`
`
`IPR2020-00134
`Patent RE45,760 E
`Petitioner contends that one of ordinary skill in the art would have
`sought to remove Ressemann’s sealing balloons and inflation lumen and
`replace the inflation lumen with a solid pushrod or wire, to allow Ressemann
`to be used as an extension catheter. Pet. 64–67. Petitioner reasons that
`extension catheters were known in the art, removing the sealing balloons
`would have simplified the manufacturing process, and removal of the sealing
`balloons would decrease the outer diameter of Ressemann’s assembly 100.
`Id. at 65.
`Petitioner contends that reducing the size of the outer diameter of
`assembly 100 would have been advantageous because the device could then
`be used with smaller guide catheters. Id. Petitioner further contends that
`Takahashi expressly discloses that using a child catheter with a lumen “not
`more than one French size smaller” provides better back-up support for the
`guide catheter and assists in deploying an angioplasty catheter across
`chronic total occlusions. Id. (citing Ex. 1610, 452, 454, 456; Ex. 1605
`¶¶ 220–221).
`Ressemann’s invention is directed to occluding blood flow for a
`minimal amount of time to capture particulate matter during a procedure.
`Ex. 1608, 1:13–16, 2:56–61, 8:12–15 (sealing balloons are inflated to “form
`a seal within the blood vessel”), 12:31–53 (sealing balloons facilitate “fluid
`communication between the distal end of the evacuation sheath assembly
`100 and a fluid collection chamber, filter, and vacuum source”), 13:15–
`14:39 (seal formed by inflated balloons allows capturing of “dislodged
`material” in the course of positioning and placing stent 194).
`Petitioner’s extensive proposed modifications to Ressemann’s device require
`removal of the sealing balloons that are critical to Ressemann’s device and
`its intended purpose of withdrawing particulate matter through aspiration.
`In
`
`19
`
`PUBLIC VERSION
`
`
`
`IPR2020-00134
`Patent RE45,760 E
`this case, such an intended-purpose-destroying modification counsels
`strongly against an obviousness determination. See Polaris Indus. v. Arctic
`Cat, Inc., 882 F.3d 1056, 1069 (Fed. Cir. 2018) (finding error in the Board’s
`failure to consider evidence that a proposed combination would result in a
`modification “which would run contrary to one of [the reference’s] stated
`purposes”); Plas-Pak Indus. v. Sulzer Mixpac AG, 600 F. App’x 755, 758-59
`(Fed. Cir. 2015) (finding a proposed modification that would not perform the
`“specific function” “repeatedly recite[d]” throughout the specification not
`obvious).
`Petitioner argues in Reply that embolic protection could be provided
`without aspiration by using a non-occlusive, distal-protection device in
`Ressemann. Pet. Reply 13 (citing Ex. 1806 ¶¶ 107–110; Ex. 1807 ¶ 119).
`Petitioner did not make this argument in the Petition and the extensive
`proposed modifications to Ressemann’s device, including adding a non-
`occlusive, distal-protection device that was not discussed in the Petition,
`suggest that the proposed modifications are improperly based on a hindsight
`desire to recreate the inventions recited in the challenged claims, and not on
`a known need in the art for such a device.
`Accordingly, in view of the above, we determine that Petitioner has
`not established by a preponderance of evidence that claims 48, 51, 52, and
`53 would have been obvious over the combination of Ressemann and
`Takahashi.
`
`III. CONTINGENT MOTION TO AMEND
`Patent Owner’s Motion to Amend requests that if any of issued claims
`37, 38, 39, 48, or 51 of the ’760 patent are determined to be unpatentable,
`the Board substitute those claims with proposed substitute claims 54–58.
`Paper 38, 1.
`
` 20
`
`PUBLIC VERSION
`
`
`
`IPR2020-00134
`Patent RE45,760 E
`Claims 37, 38, and 39 are not challenged in this proceeding. Pet. 7
`(setting forth the asserted grounds). 35 U.S.C. § 316(d) does not permit a
`patent owner to cancel or propose substitute claims for unchallenged claims.
`35 U.S.C. § 316(d)(1)(B) (motion to amend may “[f]or each challenged
`claim, propose a reasonable number of substitute claims”). Thus, we do not
`consider proposed substitute claims 54–56 that correspond to unchallenged
`claims 37, 38, and 39, respectively.5
`Because we do not find challenged claims 48 and 51 unpatentable in
`this proceeding, we do not reach the merits of the Motion to Amend with
`regard to proposed substitute claims 57 and 58 that correspond to challenged
`claims 48 and 51, respectively.
`IV. CONSTITUTIONAL CHALLENGE
`Patent Owner argues that the Petition should be denied because “the
`manner in which administrative law judges are appointed is
`unconstitutional.” PO Resp. 49 (citing Arthrex, Inc. v. Smith & Nephew,
`Inc., 941 F.3d 1320, 1325 (Fed. Cir. 2019)). Patent Owner further argues
`that the remedy in the Arthrex decision “severing certain removal
`protections, is insufficient to cure the constitutional defect, because, e.g., it
`still does not give a properly appointed principle office the power to review
`administrative law judge decisions.” Id. (citing Lucia v. SEC, 138 S. Ct.
`2044, 2055 (2018)). We decline to consider Patent Owner’s constitutional
`argument because the Federal Circuit addressed this issue in
`Arthrex. Arthrex, 941 F.3d at 1328.
`
`5 Patent Owner’s Motion to Amend with respect to claims 37, 38, and 39 is
`addressed in IPR2020-00132, a proceeding in which Petitioner challenges
`claims 37, 38, and 39.
`
` 21
`
`PUBLIC VERSION
`
`
`
`IPR2020-00134
`Patent RE45,760 E
`
`V. MOTION TO EXCLUDE
`Petitioner has moved to exclude Exhibit 202