PUBLIC VERSION
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`Trials@uspto.gov
`571-272-7822
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`Paper
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`Date:
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`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.
`
`IPR2020-00130
`Patent RE45,380
`
`Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`TORNQUIST, Administrative Patent Judge.
`
`JUDGMENT
`Final Written Decision
`Determining Some Claims Unpatentable
`Granting Patent Owner’s Contingent Motion to Amend
`35 U.S.C. § 318(a)
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`INTRODUCTION
`I.
`Medtronic, Inc. and Medtronic Vascular, Inc. (collectively
`“Petitioner”) filed a Petition (Paper 1, “Pet.”) requesting an inter partes
`review of claims 1–4, 6–9, and 12–21 of U.S. Reissue Patent RE45,380
`(Ex. 1401, “the ’380 patent”). Teleflex Innovations S.À.R.L. (“Patent
`Owner”1) filed a Preliminary Response to the Petition (Paper 9). Upon
`review of the Petition and the Preliminary Response, we instituted an inter
`partes review of all claims and grounds set forth in the Petition (Paper 20,
`“Institution Decision” or “Inst. Dec.”).
`Patent Owner subsequently filed a Patent Owner Response (Paper 39,
`“PO Resp.”) (redacted version available at Paper 40), Petitioner filed a
`Reply (Paper 69, “Pet. Reply”) (redacted version available at Paper 70), and
`Patent Owner filed a Sur-Reply (Paper 84, “Sur-Reply”) (redacted version
`available at Paper 85).
`Patent Owner also filed a Contingent Motion to Amend (Paper 35,
`“Motion”) requesting that if either of claims 1 or 12 of the ’380 patent are
`determined to be unpatentable, that the Board substitute those claims with
`proposed substitute claims 43 and 44. Motion 1. Petitioner filed an
`opposition to the Motion (Paper 72, “Pet. MTA Opp.”), Patent Owner filed a
`reply (Paper 87, “PO MTA Reply”), and Petitioner filed a sur-reply (Paper
`93, “Pet. MTA Sur-Reply”).
`
`1 Patent Owner informs us that Teleflex Innovations S.A.R.L has “merged
`into Teleflex Medical Devices S.A.R.L,” who subsequently transferred
`ownership of the ’380 patent to Teleflex Life Sciences Limited. Paper 7, 2.
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`An oral hearing was held on March 8, 2021, and a transcript of the
`hearing is included in the record. Paper 102 (“Tr.”) (redacted version
`available at Paper 101).
`
`A. Related Matters
`The parties indicate that the ’380 patent is the subject of litigation in
`Vascular Solutions LLC, et al. v. Medtronic, Inc., et al., No. 19-cv-01760
`(D. Minn.) and QXMedical, LLC v. Vascular Solutions, LLC, No. 17-cv-
`01969 (D. Minn). Pet. 4–5; Paper 4, 2. The ’380 patent is also at issue in
`IPR2020-00128, IPR2020-00129, and IPR2020-00131 (institution denied).
`Paper 4, 2–3; Pet. 5.
`The following proceedings before the Board also involve the same
`parties and related patents: IPR2020-00126 (U.S. Patent No. 8,048,032 B2),
`IPR2020-00127 (U.S. Patent No. 8,048,032 B2), IPR2020-00132 (U.S.
`Patent No. RE45,760 E1), IPR2020-00134 (U.S. Patent No. RE45,760 E1),
`IPR2020-00135 (U.S. Patent No. RE45,776 E1), IPR2020-00136 (U.S.
`Patent No. RE45,776 E1), IPR2020-00137 (U.S. Patent No. RE47,379 E1),
`IPR2020-00138 (U.S. Patent No. RE47,379 E1).
`B. Real Parties-in-Interest
`Petitioner identifies Medtronic, Inc. and Medtronic Vascular, Inc. as
`the real parties-in-interest and notes that Medtronic plc “is the ultimate
`parent of both” entities. Pet. 4.
`Patent Owner identifies Vascular Solutions LLC, Arrow International,
`Inc. and Teleflex LLC as the real parties-in-interest, and notes that Teleflex
`Incorporated is the ultimate parent of each of these entities. Paper 7, 2.
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`C. The ’380 Patent
`The ’380 Patent is a reissue of U.S. Patent 8,292,850, and claims
`priority as a division of application No. 11/416,629, filed on May 3, 2006,
`now U.S. Patent 8,048,032. Ex. 1401, codes (62), (64). The ’380 patent
`relates to catheters used in interventional cardiology procedures and, in
`particular, to “methods and apparatus for increasing backup support for
`catheters inserted into the coronary arteries from the aorta.” Id. at 1:31–35.
`“In coronary artery disease the coronary arteries may be narrowed or
`occluded by atherosclerotic plaques or other lesions.” Id. at 1:44–46. This
`narrowing is referred to as stenosis. Id. at 1:48–49. To treat this stenosis, “it
`is commonly necessary to pass a guidewire or other instruments through and
`beyond the occlusion or stenosis of the coronary artery.” Id. at 1:49–52. In
`this method, a guide catheter is inserted through the aorta and into the
`ostium of the coronary artery where it is typically seated into the opening or
`ostium of the artery to be treated. Id. at 1:53–57. A guidewire or other
`instrument is then passed through the lumen of the guide catheter and
`inserted into the artery beyond the stenosis. Id. at 1:39–41, 1:57–59.
`Crossing the tough lesions, however, may create enough backwards force to
`dislodge the guide catheter from the ostium of the artery being treated,
`making it difficult or impossible to treat certain forms of coronary artery
`disease. Id. at 1:59–63.
`The system of the ’380 patent utilizes a coaxial guide catheter that
`includes a tapered inner catheter that runs over a standard coronary
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`guidewire to allow atraumatic placement within the coronary artery. Id. at
`3:12–15. Figures 1 and 2 of the ’380 patent are reproduced below:
`
`Figure 1 is a schematic depiction of a coaxial guide catheter and a tapered
`inner catheter and Figure 2 is a schematic depiction of these two elements
`assembled. Id. at 5:40–45. As shown in Figure 1, coaxial guide catheter 12
`includes tip portion 16, reinforced portion 18, and rigid portion 20. Id. at
`6:34–35. Tapered inner catheter 14 includes tapered portion 46 at a distal
`end thereof and straight portion 48. Id. at 7:16–17. Clip 54 releasably joins
`tapered inner catheter 14 to coaxial guide catheter 12. Id. at 7:21–23.
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`Figure 8 of the ’380 patent is reproduced below:
`
`Figure 8 is a schematic view of a guide catheter, a guidewire, a coaxial guide
`catheter, and a tapered inner catheter located in the aortic arch and coronary
`artery. Id. at 5:61–64. In Figure 8, “coaxial guide catheter 12 with tapered
`inner catheter 14 is passed through guide catheter 56 and over guidewire 64
`into coronary artery 62 after the guide catheter 56 has been placed in the
`ostium 60 of coronary artery 62.” Id. at 8:6–8. “Coaxial guide catheter 12,
`with tapered inner catheter 14, provides an inner support member for proper
`translation over guidewire 64.” Id. at 8:11–13. “Once coaxial guide catheter
`12 is in place, tapered inner catheter 14 is removed from the inside of
`coaxial guide catheter 12.” Id. at 8:15–17. At this point, coaxial guide
`catheter 12 is ready to accept a treatment catheter such as a stent or balloon
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`catheter. Id. at 8:18–19. The ’380 patent explains that coaxial guide
`catheter 12 provides additional backup support to resist dislodging of guide
`catheter 56 from ostium 60 when force is applied to guidewire 64 to pass
`through stenotic lesion 66. Id. at 8:15–30.
`D. Illustrative Claims
`Independent claim 1 and dependent claim 3 are illustrative of the
`challenged claims and are reproduced below.
`1. A system for use with interventional cardiology devices
`adapted to be insertable into a branch artery, the system
`comprising:
`a guide catheter having a continuous lumen extending for a
`predefined length from a proximal end at a hemostatic
`valve to a distal end adapted to be placed in the branch
`artery, the continuous lumen of the guide catheter having
`a circular cross-sectional inner diameter sized such that
`interventional cardiology devices are insertable into and
`through the continuous lumen of the guide catheter; and
`a device adapted for use with the guide catheter, including:
`a flexible tip portion defining a tubular structure and
`having a circular cross-section and a length that is
`shorter than the predefined length of the continuous
`lumen of the guide catheter, the tubular structure
`having a cross-sectional outer diameter sized to be
`insertable through the cross-sectional inner diameter
`of the continuous lumen of the guide catheter and
`defining a coaxial lumen having a cross-sectional
`inner diameter through which interventional
`cardiology devices are insertable; and
`a substantially rigid portion proximal of and operably
`connected to, and more rigid along a longitudinal axis
`than the flexible tip portion and defining a rail
`structure without a lumen having a maximal cross-
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`sectional dimension at a proximal portion that is
`smaller than the cross-sectional outer diameter of the
`flexible tip portion and having a length that, when
`combined with the length of the flexible distal tip
`portion, defines a total length of the device along the
`longitudinal axis that is longer than the length of the
`continuous lumen of the guide catheter, such that
`when at least a distal portion of the flexible tip portion
`is extended distally of the distal end of the guide
`catheter, at least a portion of the proximal portion of
`the substantially rigid portion extends proximally
`through the hemostatic valve in common with
`interventional cardiology devices that are insertable
`into the guide catheter;
`wherein the tubular structure includes a flexible cylindrical
`distal tip portion and a flexible cylindrical reinforced
`portion proximal to the flexible cylindrical distal tip
`portion and wherein the flexible cylindrical distal tip
`portion is more flexible than the flexible cylindrical
`reinforced portion.
`Ex. 1401, 10:47–11:24 (limitations added by reissue in italics).
`3. The system of claim 2, wherein the proximal portion of the
`tubular structure further comprises structure defining a
`proximal side opening extending for a distance along the
`longitudinal axis, and accessible from a longitudinal side
`defined transverse to the longitudinal axis, to receive the
`interventional cardiology devices into the coaxial lumen while
`the proximal portion remains within the lumen of the guide
`catheter.
`Id. at 11:33–40.
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`E. Prior Art and Asserted Grounds of Unpatentability
`Petitioner contends claims 1–4, 6–9, and 12–21 of the ’380 patent
`would have been unpatentable on the following grounds (Pet. 7):
`Claims Challenged
`35 U.S.C. §2
`Reference(s)/Basis
`1–4, 6, 7, 9, 12–17, 19, 20
`103
`Kontos3, Adams4
`8, 18
`103
`Kontos, Adams, Takahashi5
`21
`103
`Kontos, Adams, Berg6
`In support of its arguments, Petitioner relies on the expert declarations
`of Dr. Stephen Jon David Brecker (Ex. 1405, 1806, 1902), Dr. Richard A.
`Hillstead (Ex. 1442, 1905), Mr. Michael Jones (Ex. 1807), Dr. Paul Zalesky
`(Ex. 1830, 1919). Patent Owner relies on the declarations of Mr. Peter T.
`Keith (Ex. 2124, 2138, 2243), Dr. John J. Graham (Ex. 2145), Dr. Lorenzo
`Azzalini (Ex. 2151), Mr. Steve Jagodzinkski (Ex. 2152 (redacted), 2153
`(confidential)), Ms. Amy Welch (Ex. 2043 (confidential), 2044 (redacted)),
`and Dr. Craig Thompson (Ex. 2215).
`
`2 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125
`Stat. 284, 287–88 (2011), amended 35 U.S.C. § 103, effective March 16,
`2013. Because the application from which the ’380 patent issued was filed
`before this date, the pre-AIA version of § 103 applies.
`3 Kontos, US 5,439,445, issued August 8, 1995 (Ex. 1409) (“Kontos”).
`4 Adams, US 2004/0010280 A1, published January 15, 2004 (Ex. 1435)
`(“Adams”).
`5 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) (Ex. 1410) (“Takahashi”).
`6 Berg, US 5,911,715, issued June 15, 1999 (Ex. 1451) (“Berg”).
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`ANALYSIS
`II.
`A. Legal Standards
`To prevail in its challenge to claims 1–4, 6–9, and 12–21 of the ’380
`patent, Petitioner has the burden to establish by a preponderance of the
`evidence that the challenged claims are unpatentable. 35 U.S.C. § 316(e)
`(2018); 37 C.F.R. § 42.1(d) (2019). This burden never shifts to Patent
`Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375,
`1378 (Fed. Cir. 2015).
`A claim is unpatentable under 35 U.S.C. § 103 if the differences
`between the claimed subject matter and the prior art are such that the subject
`matter as a whole would have been obvious at the time the invention was
`made to a person having ordinary skill in the art to which said subject matter
`pertains. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The
`question of obviousness is resolved on the basis of underlying factual
`determinations, including (1) the scope and content of the prior art; (2) any
`differences between the claimed subject matter and the prior art; (3) the level
`of ordinary skill in the art; and (4) if in the record, objective evidence of
`nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`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 for a person having 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. 12. Alternatively, Petitioner asserts that if
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`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. Petitioner
`contends that in its proposed definitions, “[e]xtensive experience and
`technical training might substitute for education, and advanced degrees
`might substitute for experience.” Id. at 12–13.
`Patent Owner “does not dispute Medtronic’s proposed definition of a
`POSITA.” PO Resp. 9.
`Upon review of the parties’ arguments and supporting evidence, we
`adopt Petitioner’s definitions of 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 ’380 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
`In this proceeding, the claims of the ’380 patent are construed “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).
`Under that standard, the words of a claim are generally given their “ordinary
`and customary meaning,” which is the meaning the term would have had to
`a person of ordinary skill at the time of the invention, in the context of the
`entire patent including the specification. Phillips v. AWH Corp., 415 F.3d
`1303, 1312–13 (Fed. Cir. 2005) (en banc).
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`For purposes of this decision, only the term “interventional cardiology
`devices” requires construction. See Nidec Motor Corp. v. Zhongshan Broad
`Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid
`Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)
`(“[O]nly those terms need be construed that are in controversy, and only to
`the extent necessary to resolve the controversy.”)).
`“interventional cardiology devices”
`Claims 1 and 12 require a flexible tip portion defining a tubular
`structure with “a coaxial lumen having a cross-sectional inner diameter
`through which interventional cardiology devices are insertable.” Ex. 1401,
`10:58–67, 12:17–28. The ’380 patent expressly defines the term
`“interventional cardiology devices” as follows:
`For the purposes of this application, the term “interventional
`cardiology devices” is to be understood to include but not be
`limited to guidewires, balloon catheters, stents and stent
`catheters.
`Id. at 1:41–44.
`In view of the express definition provided in the ’380 patent and the
`discussion in the ’380 patent of using a guide catheter that is sized to receive
`a guidewire and a stent or balloon, in the Institution Decision, we construed
`claims 1 and 12 to require that the coaxial lumen have a cross-sectional inner
`diameter through which at least two types of interventional cardiology
`devices (including, but not limited to guidewires, balloon catheters, stents,
`and stent catheters) are insertable. Inst. Dec. 10 (citing Ex. 1401, 7:60–64).
`Petitioner contends that claims 1 and 12 require that only one
`interventional cardiology device be insertable through the cross-sectional
`inner diameter of the coaxial lumen. Pet. 31, 60–61. Patent Owner contends
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`claims 1 and 12 require that all four of the enumerated classes of devices
`identified in the definition of “interventional cardiology devices,” i.e.,
`“guidewires, balloon catheters, stents, and stent catheters,” are insertable
`through the cross-sectional inner diameter of the coaxial lumen. PO Resp.
`9–10. Patent Owner reasons that the use of the conjunctive “and,” rather
`than the disjunctive “or,” in the definition indicates that all of the identified
`“interventional cardiology devices” must be insertable through the coaxial
`lumen of the flexible tip portion. Id. at 10. According to Patent Owner, this
`conclusion is consistent with the written description of the ’380 patent
`because the “Summary of the Invention” section notes that the “invention
`has an inner diameter acceptable for delivering standard coronary devices
`after it is placed in the blood vessel,” and guidewires, balloon catheters,
`stents, and stent catheters are four of the most common coronary devices.
`Id. at 11 (citing Ex. 1401, 3:24–27, 5:33–36; Ex. 2145 ¶ 85; Ex. 2138 ¶ 104).
`In its Reply, Petitioner reiterates its position that only one
`interventional cardiology device need be insertable through the coaxial
`lumen of the tip portion, but because resolution of the question of whether
`one or two devices must be insertable into the lumen does not impact the
`outcome in this case, Petitioner asserts that “the Board can adopt its
`preliminary construction of ‘interventional cardiology devices’” in this
`proceeding. Pet. Reply 1–2. Responding to Patent Owner’s arguments,
`Petitioner contends that because the term “standard coronary devices” is
`broader than the specific set of “interventional cardiology devices” identified
`in the written description, the intrinsic record does not support limiting the
`scope of claims 1 and 12 to require that the coaxial lumen of the tip portion
`have a cross-sectional inner diameter through which all four of the
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`“interventional cardiology devices” expressly identified in the ’380 patent
`are insertable. Id. at 2 (citing Ex. 1800, 63:20–64:1).
`As both parties agree, the ’380 patent expressly defines the term
`“interventional cardiology devices” to include, but not be limited to,
`“guidewires, balloon catheters, stents and stent catheters.” We understand
`this definition to mean that “guidewires,” “balloon catheters,” “stents,” and
`“stent catheters,” are each “interventional cardiology devices.” See
`Ex. 1401, 5:2–5 (“This discussion will refer to a guide wire but it is to be
`understood that similar principles apply to other interventional cardiology
`devices including balloon catheters and stent catheters.”). The use of the
`conjunctive “and” in the definition is consistent with this understanding, as
`all the listed devices are “interventional cardiology devices.” See id.
`We further understand that an individual guidewire or stent represents
`an “interventional cardiology device.” Pet. 31 (identifying Kontos’s PTCA
`catheter as an “interventional cardiology device”); PO Resp. 22 (“Thus, the
`PTCA catheter taught by Kontos is one ‘interventional cardiology device,’
`not two.”); Ex. 1401, 4:63–5:2 (describing the forces in play “when a
`physician attempts to direct a guidewire or other interventional cardiology
`device past an occlusive or stenotic lesion in the branch artery”). And
`because a “guidewire” and “balloon catheter” are each an interventional
`cardiology device, as a matter of logic and grammar, to the extent both a
`“guidewire” and a “balloon catheter” are insertable through the cross-
`sectional inner diameter of the coaxial lumen, the lumen is sized to accept
`“interventional cardiology devices.”
` As noted by Patent Owner, the ’380 patent indicates in the
`“Summary of the Invention” section that the “invention has an inner
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`diameter that is appropriate for delivering standard coronary treatment
`devices after it is placed in the blood vessel.” Ex. 1401, 5:33–36; PO Resp.
`11. The same section clarifies, however, that this is only a preference, not a
`requirement. Ex. 1401, 3:24–27 (“In addition, the coaxial guide catheter
`preferably has an inner diameter that is appropriate for delivering standard
`coronary treatment devices after it is placed in the coronary artery.”)
`(emphasis added). In addition, Petitioner persuasively explains why the
`terms “standard coronary treatment devices” and “interventional cardiology
`devices” are not co-extensive in scope. Pet. Reply 2.
`In view of the foregoing, we determine that use of the term
`“interventional cardiology devices” in claims 1 and 12 requires that the
`coaxial lumen of a device has a cross-sectional inner diameter through which
`at least two types of the devices selected from the group that includes, but is
`not limited to, guidewires, balloon catheters, stents and stent catheters, are
`insertable. For example, the cross-sectional diameter of the lumen may be
`sized to receive a guidewire and a stent or a balloon. Ex. 1401, 7:60–64
`(“Once the guidewire 64 is pushed past stenotic lesion 66 or occlusive lesion
`(not shown), a treating catheter including a stent or balloon can be passed
`along the guidewire to stenotic lesion 66 or occlusive lesion (not shown).”).7
`
`7 Although we construe claims 1 and 12 to require that the coaxial lumen of
`the tip portion is sized such that two different types of “interventional
`cardiology devices” are insertable, Petitioner’s construction requiring that
`only one type of device (e.g., “stents”) be insertable through the coaxial
`lumen is not without support. Ex. 1401, 5:2–5 (“This discussion will refer to
`a guide wire but it is to be understood that similar principles apply to other
`interventional cardiology devices including balloon catheters and stent
`catheters.”); Pet. 13, 27–29; Pet. Reply 1. We need not resolve this issue,
`however, because we find that at least two different types of interventional
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`D. Claims 1–4, 6, 7, 9, 12–17, 19, and 20 over Kontos and Adams
`Petitioner contends the subject matter of claims 1–4, 6, 7, 9, 12–17,
`19, and 20 would have been obvious over the combined disclosures of
`Kontos and Adams. Pet. 17–71.
`
`Kontos
`1.
`Kontos is directed to a support catheter assembly for facilitating
`medical procedures and, in particular, to a catheter assembly that has
`“particular utility in facilitating insertion of a PTCA8 balloon into a lesion.”
`Ex. 1409, 1:9–13.
`Figure 1 of Kontos is reproduced below:
`
`Figure 1 is a side plan view of a support catheter, “cut-away in part to show
`in longitudinal cross-section a tubular body having a soft tip and radiopaque
`marker, and a manipulating wire.” Ex. 1409, 2:51–54. As shown in
`Figure 1, support catheter assembly 10 is composed of two major elements,
`body 12 and insertion/manipulation wire 14. Id. at 3:45–46. Body 12,
`“which may be viewed as a mini guide catheter, includes tube 16 having a
`base portion 18 at its proximal end 20.” Id. at 3:47–49. “Tube 16 has a
`
`cardiology devices are insertable through the lumen of Kontos’s stent 10,
`and therefore Kontos teaches this limitation under Petitioner’s construction
`as well.
`8 PTCA stands for “percutaneous transluminal coronary angioplasty.”
`Ex. 1405 ¶ 37.
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`continuous lumen 22 there through from proximal end 20 to distal end 24.”
`Id. at 3:49–50. Body 12 also includes a soft tip 28 disposed at distal end 24
`and funnel portion 26 disposed at proximal end 20. Id. at 3:50–52.
`Insertion/manipulation wire 14 is attached to body 12 at base portion 18. Id.
`at 3:52–53. Support assembly 10 may also include distal marker band 30
`and proximal marker band 32. Id. at 3:53–55.
`Kontos explains that the size and shape of the various elements of
`support assembly 10 “may vary depending on the desired application,” but
`in the embodiment depicted in Figure 1 tube 16 has a 0.055-inch outer
`diameter and lumen 22 has a 0.045-inch inner diameter. Id. at 4:46–50.
`According to Kontos, the sizes used in these embodiments “are generally
`suitable for existing PTCA catheters.” Id. at 4:61–64.
`Figure 5 of Kontos is reproduced below:
`
`Figure 5 is a side schematic view of a support catheter having a PTCA
`catheter disposed therein. Id. at 2:64–66. In this figure, PTCA catheter 40
`and its deflated balloon 48 reside in lumen 22 of support assembly 10. Id. at
`5:2–5.
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`Figures 6A–6C of Kontos are reproduced below:
`
`Figures 6A–6C are cross-sectional views showing three stages in a process
`for guiding a PTCA catheter to a coronary artery lesion. Id. at 2:67–3:2. As
`shown in Figure 6A, the PTCA catheter/support catheter assembly is first
`fed into guide catheter 38 and advanced to the distal end of this catheter by
`exerting axial force on wire 14 and catheter tube 50 simultaneously. Id. at
`5:25–30.
`As shown in Figure 6B, when the PTCA catheter/support catheter
`assembly reaches the distal end of guide catheter 38, “it may be advanced as
`a unit out of the distal end of guide catheter 38 and into coronary ostia 39.”
`Id. at 5:31–35. When extending beyond the distal end of guide catheter 38,
`body 12 functions as a guide catheter extension protecting fragile balloon 48
`and lessening “considerably the tendency of the PTCA catheter 40 to bend,
`buckle or kink.” Id. at 5:52–56. “To help ensure that proximal end 20 does
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`not unintentionally exit from the guide catheter,” guide catheter 38 may be
`provided with “a radially inwardly formed annular ridge 44 for impeding
`further axial movement of funnel 26 beyond the distal end of guide catheter
`38.” Id. at 5:59–6:2.
` As shown in Figure 6C, after body 12 has been positioned adjacent
`the restricted area, PTCA catheter 40 is advanced so that balloon 48 exits
`body 12 and is advanced into the restricted area, e.g., stenosis B. Id. at 6:9–
`13. Balloon 48 is then inflated, as represented by dotted lines 48, “to effect
`a well-known angioplasty procedure.” Id. at 6:13–15. Balloon 48 is then
`deflated and PTCA catheter 40, support catheter assembly 10, and guiding
`catheter 38 may be withdrawn. Id. at 6:15–18.
`Although the Figures depict the use of a PTCA catheter, Kontos
`discloses that, “[o]f course, the device of the present invention may be used
`with almost any type of catheter, including over-the-wire catheters as well as
`catheters with captive guide wires.” Id. at 9:47–50.
`2.
`Adams
`Adams discloses a device and method for treating vascular disease.
`Ex. 1435 ¶ 1. In particular, Adams discloses a device that “includes a distal
`protection device which is deployed to filter or remove embolic debris” and
`a device that “creates a seal to prevent the flow of blood during the treatment
`of vascular disease.” Id. ¶ 11.
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`Figure 1A of Adams is reproduced below:
`
`Figure 1A is a side view in partial cross-section of the device of Adams. Id.
`¶ 28. In this figure, Y connector 7 is attached to the proximal end of guide
`catheter 10 and control wire 5 passes through Y connector 7. Id. ¶¶ 59–60.
`To reduce blood loss, Y connector 7 has hemostasis valve 9 at its proximal
`end. Id. ¶ 60. As shown in Figure 1A, distal end 12 of guide catheter 10
`may be inserted into the ostium “O” of coronary vessel “V,” which has a
`lesion “L.” Id. ¶ 59. Guide seal 20a is then deployed beyond the distal end
`of guide catheter 10. Id.
`Adams explains that in practice, a physician advances a guidewire
`through the femoral artery into the aorta. Id. ¶ 61. “The guide catheter is
`then advanced over the guidewire until the distal tip of the guide catheter is
`in the ostium of the vessel.” Id. The guide seal is then advanced beyond the
`distal tip of the guide catheter and, after some additional steps, an embolic
`protection device of choice may be advanced through the lumen of the guide
`seal and across the lesion to a point distal to the treatment site. Id.
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`Independent Claims 1 and 12
`3.
`Petitioner identifies where it contends every limitation of independent
`claims 1 and 12 is taught or suggested in Kontos and Adams. Pet. 17–43,
`57–66. In particular, Petitioner contends that: (1) guide catheter 38 of
`Kontos serves as a “guide catheter” that is adapted to be placed in a branch
`artery, has a continuous lumen that extends from a proximal end at a
`hemostatic valve to a distal end that is adapted to be placed in a branch
`artery, and has a circular cross-sectional inner diameter sized such that
`interventional cardiology devices are insertable into and through the
`continuous lumen of the guide catheter (id. at 23–29, 57–58); (2) support
`catheter assembly 10, having body 12 and insertion/manipulation wire 14, is
`adapted for use with guide catheter 38 (id. at 29, 58); (3) body 12 of support
`catheter assembly 10 is a flexible tip portion defining a tubular structure
`with a circular cross-section and length that is shorter than the continuous
`lumen of guide catheter 38 (id. at 29–30, 58–60); (4) the cross-sectional
`outer diameter of body 12 is sized to be insertable through the continuous
`lumen of guide catheter 38 (id. at 30–31, 58–60); (5) tube 16 of body 12
`defines a coaxial lumen having a cross sectional inner diameter through
`which interventional cardiology devices (PTCA catheter 40 with balloon 48)
`are insertable (id. at 31, 60–61); (6) the part of tube 16 that is co-extensive
`with receiving hole 34 is a “reinforced portion proximal to the flexible tip
`portion” (id. at 32–33, 38–39, 61–62) (7) insertion/manipulation wire 14
`defines a rail structure without a lumen and constitutes a substantially rigid
`portion that is proximal of and operably connected to the flexible tip portion
`(id. at 32–34, 61–62); (8) insertion/manipulation wire 14 has a smaller cross-
`sectional diameter (0.020 inches) than the outer diameter of tube 16 of
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`Kontos (0.055 inches) (id. at 34); and (9) the combined length of body 12
`and insertion/manipulation wire 14 are such that one of ordinary skill in the
`art would understand the two elements are, in combination, longer than
`guide catheter 38, such that when body 12 is extended distally of the distal
`end of guide catheter 38 at least a portion of proximal portion of
`insertion/manipulation wire 14 extends proximally through the hemostatic
`valve in common with interventional cardiology devices (PTCA catheter 40)
`that are insertable into the guide catheter (id. at 34–35, 62–67).
`To the extent that Kontos does not expressly teach or suggest both a
`support catheter that has a total length (flexible tip and