Trials@uspto.gov
`571-272-7822
`
`Paper 22
`Date: June 8, 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.
`
`IPR2020-00132
`Patent RE45,760 E
`
`
`
`
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and
`CHRISTOPHER PAULRAJ, Administrative Patent Judges.
`SNEDDEN, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`

`

`IPR2020-00132
`Patent RE45,760 E
`
`I.
`
`INTRODUCTION
`
`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. 1001). Paper 1 (“Pet.”). Teleflex
`Medical Devices S.A.R.L. (“Patent Owner”) filed a Preliminary Response.
`Papers 8 (confidential version), 9 (redacted version) (“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 12;
`Paper 14. Also pursuant to our authorization, Petitioner filed another Reply
`(Paper 19) and Patent Owner filed another Sur-Reply (Paper 20) 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). The Supreme Court has held that a
`decision to institute under 35 U.S.C. § 314 may not institute on fewer than
`all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct.
`1348, 1359–60 (2018) (“SAS”). After considering the parties’ arguments
`and evidence, we determine that Petitioner has demonstrated a reasonable
`likelihood that it would prevail with respect to at least one of the claims
`challenged in the Petition. Accordingly, an inter partes review of all of the
`claims and all of the grounds presented in the Petition is hereby instituted.
`
`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
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`IPR2020-00132
`Patent RE45,760 E
`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
`
`Petitioner has filed two separate Petitions for inter partes review of
`the ’760 patent as IPR2020-00133 and IPR2020-00134. The ’760 patent is
`at issue in Vascular Solutions LLC, et al. v. Medtronic, Inc., et al. 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 joint motion to terminate, and
`IPR2014-00763, filed May 16, 2014 and terminated August 11, 2014 by way
`of 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. Boston Scientific Corp., No. 13-cv-01172 (D. Minn., filed
`May 16, 2013). Id.
`Petitioner has filed Petitions for inter partes review of related U.S.
`patents as follows: U.S. Patent No. 8,048,032 (“the ’032 patent”) in
`IPR2020-0126, IPR2020-0127; U.S. Patent No. RE45,380 (“the ’380
`patent”) in IPR2020-00128, IPR2020-00129, IPR2020-00130, and IPR2020-
`00131; U.S. Patent No. RE45,776 (“the ’776 patent”) in IPR2020-00135 and
`
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`IPR2020-00132
`Patent RE45,760 E
`IPR2020-00136; and U.S. Patent No. RE47,379 (“the ’379 patent”) in
`IPR2020-00137 and IPR2020-00138.1
`
`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. 1001, 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
`
`1 In accordance with our Trial Practice Guide, Petitioner provides an
`explanation of material differences and ranking for the multiple petitions
`directed to each challenged patent. Paper 3. Patent Owner responds that
`Petitioner has not justified institution on multiple petitions. Paper 11. Given
`that this is the first petition filed by Petitioner on which we are instituting
`trial for the ’760 patent, we need not and do not address Patent Owner’s
`argument for denial based on multiple petitions.
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`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.
`
`2. Illustrative Claim
`
`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
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`IPR2020-00132
`Patent RE45,760 E
`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/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 a material forming the segment defining the side
`opening is more rigid than the tubular structure.
`Ex. 1001, 13:36–14:7.
`
`3.
`
`Relevant Prosecution History
`
`The ’760 patent issued from U.S. Application Serial No. 14/195,385
`(“the ’385 application,” Ex. 1003). The ’760 patent is a reissue of U.S. Pat.
`No. 8,292,850 (“the ʼ850 patent) (Ex. 1002).
`
`D. Evidence
`
`Petitioner relies upon the following prior art references.
`Ex. 1007, T. Itou et al., U.S. Patent No. 7,736,355 B2 (issued
`June 15, 2010) (“Itou”).
`Ex. 1008, T. V. Ressemann et al., U.S. Patent No. 7,604,612 B2
`(issued Oct. 20, 2009) (“Ressemann”).
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`Ex. 1025, Y. Kataishi et al., U.S. Patent Application Publication
`No. 2005/0015073 A1 (published Jan. 20, 2005) (“Kataishi”).
`Ex. 1050, 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. 1005) and Richard A. Hillstead (Ex. 1042) to support its contentions.
`Petitioner also relies upon the Declarations of Peter T. Keith to
`support its contentions. Ex. 2042.
`
`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. §2
`
`References/Basis
`
`25–31, 33–38,
`41, 42, 44, 47
`
`102(e)
`
`Itou
`
`25, 30, 32, 39, 40 103(a)
`
`32
`
`32
`
`103(a)
`
`103(a)
`
`Itou, Ressemann,
`Knowledge of a POSITA
`
`Itou, Kataishi,
`Knowledge of a POSITA
`
`Itou, Enger, Knowledge
`of a POSITA
`
`1
`
`2
`
`3
`
`4
`
`
`
`
`2 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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`
`II. ANALYSIS
`
`A. Level of Ordinary Skill in the Art
`
`The person having ordinary skill in the art is a hypothetical person
`who is presumed to be aware of all the relevant prior art. Custom
`Accessories, Inc. v. Jeffrey-Allan Indust., Inc., 807 F.2d 955, 962 (Fed. Cir.
`1986); Kimberly-Clarke Corp. v. Johnson & Johnson, 745 F.2d 1437, 1453
`(Fed. Cir. 1984). Moreover, the prior art itself is generally sufficient to
`demonstrate the level of skill in the art at the time of the invention. See
`Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that
`specific findings regarding ordinary skill level are not required “where the
`prior art itself reflects an appropriate level and a need for testimony is not
`shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755
`F.2d 158, 163 (Fed. Cir. 1985)).
`Petitioner asserts that “[i]f a person of ordinary skill in the art
`(‘POSITA’) 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 POSITA 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. Petitioner further
`asserts that “a POSITA with a medical degree may have access to a POSITA
`with an engineering degree, and a one with an engineering degree might
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`Patent RE45,760 E
`have access to one with a medical degree” (citing Ex. 1005 ¶ 31; Ex. 1042
`¶¶ 18–19).
`Patent Owner indicates that “[f]or purposes of this Preliminary
`Response only, [Patent Owner] does not currently dispute [Petitioner]’s
`proposed definition of a POSITA.” Prelim. Resp. 16.
`For the purposes of this decision, we apply Petitioner’s definition of
`the level of ordinary skill in the art because it is undisputed at this time and
`consistent with the evidence of the record. 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).
`The above definition is provisional and the parties are welcome to
`present further argument on this topic at trial.
`
`B. 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. 15–19. 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. 16.
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`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 Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200
`F.3d 295, 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”).
`
`C. Prior Art Status of Itou (Ex. 1007)
`
`Itou was filed on September 23, 2005, published on March 30, 2006,
`and issued on June 15, 2010. Ex. 1007, codes (22), (45), (65). Petitioner
`contends Itou is therefore prior art under pre-AIA § 102(e). Pet. 19–20.
`Patent Owner argues that Itou does not qualify as prior art based on an
`earlier invention date for the claimed invention of the ’032 patent. Prelim.
`Resp. 24–27. In particular, Patent Owner contends that conception of the
`claimed invention occurred in “late 2004,” and reduction to practice
`occurred “in the spring and summer of 2005.” Id. at 24. As support for this
`contention, Patent Owner relies upon the declarations of inventor Howard
`Root (Ex. 2001) and Deborah Schmalz (a former Vice President of
`Regulatory Affairs at Patent Owner’s predecessor-in-interest) (Ex. 2039),
`along with certain notebook pages and other documents (Exs. 2005–2022,
`2024) allegedly showing prior conception and reduction to practice. Patent
`Owner further contends that, despite having much of the evidence related to
`conception and reduction to practice, Petitioner does not address it in the
`Petition. Id. at 24.
`The burden to show that Itou is prior art to the ’032 patent rests with
`Petitioner. Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d
`1375, 1379 (Fed. Cir. 2015). That said, because Petitioner has presented
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`evidence that Itou was filed prior to the filing date of the ’032 patent, thus
`qualifying as § 102(e) prior art, the burden of production shifts to Patent
`Owner to demonstrate that Itou is not prior art, for example, by presenting
`evidence of an earlier conception and reduction to practice. Id. at 1380.
`Although Patent Owner’s presents multiple pieces of evidence in the
`Preliminary Response in support of this contention, Petitioner has not had an
`opportunity to fully consider and address this evidence in this proceeding.3
`Based on the present record, we determine that genuine issues of material
`fact remain about the alleged invention date, and these factual issues are best
`resolved after the record is more fully developed. See 37 C.F.R. § 42.108(c)
`(stating “a genuine issue of material fact created by [Patent Owner’s]
`testimonial evidence will be viewed in the light most favorable to the
`petitioner solely for purposes of deciding whether to institute an inter partes
`review.”).
`
`
`3 As noted by Patent Owner, Petitioner was aware of some of Patent
`Owner’s evidence of conception and reduction to practice before it filed the
`Petition. Prelim. Resp. 24. The district court, however, determined that
`Patent Owner’s evidence was “unimpressive” and insufficient to
`demonstrate, at the preliminary injunction stage, an earlier conception and
`reduction to practice. Ex. 1088, 13–14. Petitioner also notes that Patent
`Owner did not provide detailed contentions regarding conception and
`reduction to practice until less than a week before its Petition was filed, and
`the relevant evidence that was previously produced to Petitioner was marked
`“attorneys eyes only’ in the district court case and thus could not have been
`relied upon in the Petition. Paper 12, 2–5. Given that Patent Owner bears
`the burden of producing evidence to support its antedating contention, we
`determine Petitioner did not have an obligation to preemptively address
`Patent Owner’s evidence in its Petition.
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`D. Petitioner’s Patentability Challenges
`
`1. Ground 1: Anticipation by Itou
`
`Petitioner asserts that claims 25–31, 33–38, 41, 42, 44, and 47 are
`anticipated by Itou. Pet. 19. For the reasons set forth below, we determine
`that Petitioner has demonstrated a reasonable likelihood that claim 25–31,
`33–38, 41, 42, 44, and 47 are anticipated by Itou.
`
`a) Summary of Itou
`
`Itou discloses “an intravascular foreign matter suction assembly”
`designed to suck, sample, and remove “foreign matter such as a thrombus or
`an embolus” from a blood vessel. Ex. 1007, 1:6–9, 1:47–49. This assembly
`includes a guiding catheter and a suction catheter configured to be inserted
`into the lumen of the guiding catheter. Id. at 1:49–65.
`Figure 3 of Itou is reproduced below:
`
`Figure 3 is a cross section of a distal end portion of suction catheter 2. Id. at
`2:61–62. Suction catheter 2 includes distal side tubular portion 24 and
`proximal side wire-like portion 25, formed from a solid metal wire and an
`outer layer such as a polymer coating. Id. at 3:46–50. Tubular portion 24
`has reinforced tubular portion 21 and flexible distal tip 22. Id. at 2:15–51,
`
`
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`3:50–58. Tubular portion 24 has an outer diameter that allows it to be
`inserted into the lumen of a guide catheter and wire-like portion 25 has a
`sectional area smaller than the sectional area of the tube wall of tubular
`portion 24. Id. at 3:59–63.
`
`Figure 5 of Itou is reproduced below:
`
`
`
`Figure 5 shows the suction assembly “in an assembled state.” Id. at 2:66–
`67. In this state, suction catheter 2 is disposed in the lumen of guiding
`catheter 1. Id. at 5:12–14. The distal end of distal end protective catheter 5
`is inserted into the lumen of suction catheter 2 and guide wire 6 is inserted
`into the lumen of the distal end protective catheter 5. Id. at 5:14–17. The
`proximal ends of suction catheter 2, distal end protective catheter 5, and
`guide wire 6 are “introduced to the outside through main connector portion
`31 of Y-shaped connector 3.” Id. at 5:17–20. A valve is built into main
`connector 31 and “can selectively clamp and fix” guide wire 6 and wire-like
`portions 25 or 55 “to prevent leakage of the blood.” Id. at 5:20–23. In one
`embodiment, the inner diameter of the guiding catheter is 1.8 mm and the
`inner diameter of the suction catheter is 1.5 mm. Id. at 7:55–67 (Table 1).
`
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`
`A portion of Figure 6 of Itou is reproduced below:
`
`
`Figure 6 illustrates the disclosed apparatus disposed in a coronary
`artery of the heart. Id. at 3:1–3. In Figure 6, guiding catheter 1 is disposed
`in aorta 81 and its distal end “is secured in such a form that it is hooked at an
`ostium 821 of coronary artery 82.” Id. at 5:29–34. Tubular portion 24 of
`suction catheter 2 is inserted into coronary artery 82 and is introduced along
`guide wire 6 to target location 80. Id. at 5:35–38. According to Itou, tubular
`portion 24 of suction catheter 2 has a “sufficient axial length so that the
`proximal end of the tubular portion 24 in an open state may not leap out
`from the distal end of the guiding catheter 1.” Id. at 5:38–41.
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`b) Discussion
`
`(1)
`
`Independent claim 25
`
`Petitioner contends that Itou teaches each of the limitations of
`independent claim 25. To support its position, Petitioner directs our
`attention to the foregoing discourses of Itou and provides a detailed claim
`analysis addressing how each element of claim 25 is disclosed by Itou.
`Pet. 21–38 (citing Ex. 1005 ¶¶ 167–187). With respect to the requirement
`for a “guide extension catheter” including a “tubular structure” where “the
`side opening and the lumen of the tubular structure [are] configured to
`receive one or more stents or balloon catheters,” Petitioner relies on the
`disclosure of Itou’s suction catheter 2. Id. at 27–38 (citing Ex. 1005 ¶ 170);
`Ex. 1007, 2:12–15, 3:47–50, Fig. 1B, Fig. 3. Additionally, Petitioner
`contends that Itou describes a “distal end protective catheter” that is
`insertable through the suction catheter 2, which may be extended beyond the
`distal end of the guide catheter and into a coronary artery. Pet. 21 (citing
`Ex. 1007, Abstract, 2:29–38; Figs 5, 6; Ex. 1005 ¶¶ 95–98, 146–149; Ex.
`1042 ¶¶ 20–27).
`Patent Owner contends that Itou does not expressly or inherently
`disclose a “guide extension catheter” including a “tubular structure” where
`“the side opening and the lumen of the tubular structure [are] configured to
`receive one or more stents or balloon catheters” when the side opening and
`proximal end of the tubular structure are within the guide catheter and the
`distal end of the guide extension catheter extends beyond the guide catheter.
`Prelim. Resp. 35. In particular, Patent Owner contends that Itou does not
`expressly disclose “that its suction catheter can be used as a guide extension
`catheter, or that its suction catheter has a side opening and lumen configured
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`to receive one or more stents or balloon catheters (which happens in a
`proximal-to-distal direction).” Id. at 35–36. Patent Owner also contends
`that Petition has not established that “Itou’s suction catheter is a guide
`extension catheter or has a side opening and lumen inherently (i.e.
`necessarily) configured to receive one or more stents or balloon catheters.”
`Id. at 36 (citing Ex. 2042 ¶¶ 45, 48).
`Patent Owner further contends that
`[the] Petition focuses solely on Itou’s suction catheter diameter.
`Petition at 35–36. But that alone does not show that Itou’s
`suction catheter is a guide extension catheter or has a side
`opening and lumen inherently (i.e. necessarily) configured to
`receive one or more stents or balloon catheters. Id. at 36 (citing
`Ex. 2042 ¶¶ 45, 48). . . . [The Petition] fails to show that the
`specific suction catheter structure of Itou would necessarily
`allow introduction of stents or balloon catheters. For example,
`Itou explains that its proximal tip 23 is formed by coating the
`inner and outer faces of metal body 231/232 with a “resin.” Ex.
`1007 at 4:27–38; Ex. 2042, ¶ 40. . . . This “resin” is used both to
`bond the proximal tip 23 to the middle body portion 21 by
`“fusion” and to form the inner surface of the proximal end of the
`tube 24 of the suction catheter. Ex. 1007 at 4:36-38; Ex. 2042,
`¶ 40. Itou does not disclose any lubricious coating on the interior
`of its proximal or distal tips. The layer of a material such as
`PTFE with a “sliding property” provided for the middle “body
`portion 21” of Itou’s suction catheter ends abruptly where the
`proximal tip 23 is joined. Ex. 1007 at 3:51-54, Fig. 3; Ex. 2042,
`¶¶ 32, 42.
`Id. at 36–39. Patent Owner further contends that “it was known that heat-
`‘fused’ resins could be sticky or tacky rather than lubricious.” Id. at 39
`(citing Ex. 2042 ¶ 40). Thus, according to Patent Owner, Petitioner has
`failed to establish that the disclosed resin “would necessarily work for
`proximal introduction of stents or balloon catheters.” Id. at 39–40 (citing
`Ex. 2042 ¶¶ 40–41; Ex. 2055, 2).
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`Additionally, Patent Owner contends that Petitioner’s reliance on
`Itou’s protective catheter is misplaced because
`[a] protective catheter is not a stent or balloon catheter—they are
`different devices, with different structure, that serve different
`purposes, and are used differently. Protective catheters, for
`example, are inserted into the suction catheter outside the body.
`E.g., Ex. 1007 at 7:1–15 (explaining that a guide catheter is first
`put in place, and then a “combination” of the suction catheter and
`protective catheter is inserted into the guide catheter). . . .
`Further[more], unlike smooth protective catheters, balloon-
`expandable stents and balloon catheters have irregular exterior
`surfaces (caused by the struts of the stent and the folds of the
`balloon). Ex. 2042, ¶ 47. Thus, stents and balloon catheters are
`far more likely than a protective catheter to be impeded by non-
`lubricious surfaces and hung-up on protrusions, particularly
`when inserted into a reduced-diameter opening within a guide
`catheter.
`Id. at 41–42. Thus, according to Patent Owner, a person of ordinary skill in
`the art would not expect to be able to insert stents or balloon catheters into
`the proximal opening of a suction catheter like Itou when the opening is
`located inside a guide catheter. Id. at 42–43; Ex. 1008, 25:23–29; Ex. 2042
`¶¶ 49–53.
`Having considered the parties positions and evidence of record,
`summarized above, we determine that Petitioner has offered sufficient
`evidence to institute trial. We have considered Patent Owner’s argument
`and evidence in support of its position that Itou does not expressly or
`inherently disclose a “guide extension catheter” including a “tubular
`structure” where “the side opening and the lumen of the tubular structure
`[are] configured to receive one or more stents or balloon catheters,”
`summarized above. However, for purposes of deciding whether to institute
`an inter partes review, we view a genuine issue of material fact in the light
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`most favorable to the petitioner. In this case, Petitioner and Drs. Brecker
`and Hillstead provide a reasoned analysis as to why those elements are
`disclosed by Itou and Patent Owner and Dr. Keith’s counter testimony
`create a genuine issue of fact. 37 C.F.R. § 42.108(c). Thus, for purposes of
`this Decision, we resolve the parties’ dispute in favor of Petitioner. That
`being said, we will evaluate both parties’ arguments once the record is
`developed further during trial.
`Having determined that Petitioner meets the threshold for review of
`claim 25 based on anticipation by Itou, we institute a review as to all of the
`challenged claims and grounds contained in the Petition.
`
`(2) Dependent Claims 26–31, 33–38, 41, 42, 44, and 47
`
`Petitioner also identifies where Itou discloses the limitations of
`dependent claims 26–42, 44, and 47 of the ’760 patent. Pet. 40–48, 54–60.
`In support of these arguments, Petitioner directs our attention to the
`foregoing discourses of Itou and provides a detailed claim analysis
`addressing how each element of claim 25 is disclosed by Itou. Pet. 38–56.
`Patent Owner does not address Petitioner’s specific arguments with
`respect to dependent claims 26–42, 44, and 47.
`Having considered the parties positions and evidence of record, we
`determine that Petitioner has identified sufficiently where Itou discloses
`every limitation of dependent claims 26–42, 44, and 47. Thus, Petitioner has
`demonstrated a reasonable likelihood that these claims are anticipated by
`Itou.
`
`(3) Conclusion
`
`Having considered the parties positions and evidence of record,
`summarized above, we determine that Petitioner has established a reasonable
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`likelihood of prevailing in demonstrating the unpatentability of claims 25–
`31, 33–38, 41, 42, and 44 with respect to Ground 1.
`
`2. Ground 2: Obviousness in view of Itou, Ressemann, and the
`knowledge of POSITA
`
`To the extent not anticipated by Itou, Petitioner contends the subject
`matter of claims 25, 30, 32, 39, and 40 would have been obvious over the
`combined disclosures of Itou and Ressemann, when considered in light of
`the knowledge of one of ordinary skill in the art. Pet. 56–73.
`
`a) Summary of the Ressemann
`
`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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`
`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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`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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`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 guid