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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.
`
`IPR2020-00129
`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 Challenged Claims Unpatentable
`Not Deciding Patent Owner’s Contingent Motion to Amend
`35 U.S.C. § 318(a)
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`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.
`
`IPR2020-00129
`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 Challenged Claims Unpatentable
`Not Deciding Patent Owner’s Contingent Motion to Amend
`35 U.S.C. § 318(a)
`
`PUBLIC VERSION
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`IPR2020-00129
`Patent RE45,380E
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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 25–39 of U.S. Reissue Patent RE45,380E (Ex. 1201, “the
`’380 patent”). Teleflex Innovations S.À.R.L. (“Patent Owner”)1 filed a
`Preliminary Response to the Petition (Paper 8). Upon review of the Petition
`and the Preliminary Response, we instituted an inter partes review of all
`claims and grounds asserted in the Petition (Paper 22)
`Patent Owner subsequently filed a Patent Owner Response (Paper 43,
`“PO Resp.”) (redacted version available at Paper 44), Petitioner filed a
`Reply (Paper 82, “Pet. Reply”) (redacted version available at Paper 83), and
`Patent Owner filed a Sur-Reply (Paper 101, “Sur-Reply”) (redacted version
`available at Paper 102).
`With prior authorization of the Board, Patent Owner filed a
`Consolidated Response Addressing Conception and Reduction to Practice
`(Paper 39), to which Petitioner filed Reply (Paper 78 (redacted version
`available at Paper 79)), Patent Owner filed a Sur-Reply (Paper 96), and
`Petitioner filed a Sur-Sur-Reply (Paper 110).
`Patent Owner also filed a Contingent Motion to Amend (Paper 38,
`“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, respectively. Motion 1. Petitioner
`
`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 [the ’380 patent] to Teleflex Life Sciences Limited.” Paper 7,
`2.
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`filed an opposition (Paper 85) to the Motion, Patent Owner filed a reply
`(Paper 104), and Petitioner filed a sur-reply (Paper 112).
`An oral hearing was held on March 8, 2021, and a transcript of the
`hearing is included in the record. Paper 123 (“Tr.”) (redacted version
`available at Paper 124).
`
`Related Matters
`A.
`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, IPR2020-00130, 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 E), IPR2020-00134 (U.S. Patent No. RE45,760
`E), IPR2020-00135 (U.S. Patent No. RE45,776 E), IPR2020-00136
`(U.S. Patent No. RE45,776 E), IPR2020-00137 (U.S. Patent No. RE47,379
`E), IPR2020-00138 (U.S. Patent No. RE47,379 E).
`B.
`Real Parties-in-Interest
`Petitioner identifies Medtronic, Inc. and Medtronic Vascular, Inc. as
`real parties-in-interest and notes that Medtronic plc is the “ultimate parent of
`both entities.” Pet. 4–5.
`Patent Owner identifies itself and Vascular Solutions LLC, Arrow
`International, Inc., and Teleflex LLC as real parties-in-interest. Paper 7, 2.
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`Patent Owner further notes that “Teleflex Incorporated is the ultimate
`parent” of each of these entities. Id.
`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. 1201, 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 a 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. To
`achieve this result, 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.
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`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 together. 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, both of which are pierced by
`lumen 50 (not labeled in Figure 1). Id. at 7:16–20. 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 8:6–10. According to the ’380
`patent, “[c]oaxial guide catheter 12, with tapered inner catheter 14, provides
`an inner support member for proper translation over guidewire 64.” Id. at
`8:10–14. “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 catheter, which may be advanced to the
`stenosis. Id. at 8:17–18, 8:30–32.
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`Illustrative Claims
`D.
`Independent claim 25 and dependent claims 26 and 27 are illustrative
`of the challenged claims and are reproduced below.
`25. A system comprising:
`means for guiding an interventional device from a
`location outside of a subject, through a main vessel, to
`a location near an ostium of a branch vessel; and
`means for receiving the interventional device from an
`intermediate or distal portion of the means for guiding
`the interventional device to the location near the
`ostium of the branch vessel and guiding the
`interventional device deeper into the branch vessel,
`the means for receiving the interventional device and
`guiding the interventional device deeper into the
`branch vessel including, in a distal to proximal
`direction, a tip portion, a reinforced portion, a side
`opening, and a substantially rigid portion, and having
`a length such that when the distal end of the tip
`portion is extended distally of the distal end of the
`means for guiding the interventional device to the
`location near the ostium of the branch vessel, a
`portion of the proximal end of the substantially rigid
`portion extends proximally of the proximal end of the
`means for guiding the interventional device to the
`location near the ostium of the branch vessel,
`wherein the tip portion, the reinforced portion, the side
`opening, and the substantially rigid portion are
`configured to be passed, at least in part, into a lumen
`of the means for guiding the interventional device to
`the location near the ostium of the branch vessel, and
`the side opening and the substantially rigid portion are
`configured to be more rigid along a length thereof
`than the tip portion.
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`Ex. 1201, 13:43–14:5.
`
`26. The system of claim 25, wherein the side opening
`includes at least one inclined slope.
`
`Id. at 14:6–7.
`
`27. The system of claim 26, wherein the side opening
`includes at least two different inclined slopes.
`
`Id. at 14:8–9.
`
`Prior Art and Asserted Grounds
`E.
`We instituted review of claims 25–39 of the ’380 patent on the
`following grounds (Inst. Dec. 7, 38):
`Claim(s) Challenged
`35 U.S.C. §2
`25–31, 34–37, 39
`102
`27
`103
`27
`103
`27
`103
`32, 33
`103
`38
`103
`
`Reference(s)/Basis
`Ressemann3
`Ressemann
`Ressemann, Kataishi4
`Ressemann, Enger5
`Ressemann, Takahashi6
`Ressemann, Berg7
`
`2 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125
`Stat. 284, 287–88 (2011), amended 35 U.S.C. §§ 102 and 103, effective
`March 16, 2013. Because the effective filing date of the challenged claims
`of the ’380 patent is before this date, the pre-AIA version of these statutes
`apply. See 35 U.S.C. § 100(i)(2); Ex. 1201, code (64).
`3 Ressemann, US 7,604,612 B2, issued October 20, 2009 (Ex. 1208)
`(“Ressemann”).
`4 Kataishi, US 2005/0015073 A1, published January 20, 2005 (Ex. 1225)
`(“Kataishi”).
`5 Enger, US 5,980,486, issued November 9, 1999 (Ex. 1250) (“Enger”).
`6 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) (Ex. 1210) (“Takahashi”).
`7 Berg, US 5,911,715, issued June 15, 1999 (Ex. 1251) (“Berg”).
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`Claim(s) Challenged
`25, 26, 28–30, 32–37, 39
`31
`27
`38
`
`35 U.S.C. §2
`102
`103
`103
`103
`
`Reference(s)/Basis
`
`Itou8
`Itou
`Itou, Kataishi
`Itou, Berg
`
`In support of its arguments, Petitioner relies on the expert declarations
`of Dr. Stephen Jon David Brecker (Exs. 1205, 1806, 1902), Dr. Richard A.
`Hillstead (Exs. 1242, 1905), Mr. Michael Jones (Ex. 1807), and Dr. Paul
`Zalesky (Exs. 1755, 1830, 1919). Patent Owner relies on the declarations of
`Mr. Howard Root (Ex. 2118), Mr. Gregg Sutton (Ex. 2119), Mr. Mark
`Goemer (Ex. 2120), Ms. Amanda O’Neil (Ex. 2121), Mr. Steve Erb
`(Ex. 2122), Mr. Peter T. Keith (Exs. 2124, 2138, 2243), Dr. John J. Graham
`(Ex. 2145), Dr. Lorenzo Azzalini (Ex. 2151), Ms. Heather S. Rosecrans
`(Ex. 2205), and Dr. Craig Thompson (Ex. 2215).
`
`ANALYSIS
`II.
`Legal Standards
`A.
`To prevail in its challenge to claims 25–39 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).
`To anticipate a patent claim under 35 U.S.C. § 102, a single prior art
`reference must “describe every element of the claimed invention, either
`
`8 Itou, US 7,736,355 B2, issued June 15, 2010 (Ex. 1207) (“Itou”).
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`expressly or inherently,” to one of ordinary skill in the art. Advanced
`Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed. Cir. 2000).
`A reference can anticipate a claim even if it does not expressly spell out all
`the limitations arranged or combined as in the claim, if a person of skill in
`the art, reading the reference, would at once envisage the claimed
`arrangement or combination. See Kennametal, Inc. v. Ingersoll Cutting Tool
`Co., 780 F.3d 1376, 1381 (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 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. 13. Alternatively, Petitioner asserts that if
`a person of ordinary skill in the art was “an engineer s/he would have had (a)
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`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 Medtronic’s proposed definition of a
`POSITA.” PO Resp. 7.
`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 these definitions 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, we address the meaning of two terms of
`the ’380 patent: “means for guiding” and “means for receiving . . . and
`guiding.”
`1. Means for Guiding
`Claim 25 requires a “means for guiding an interventional device from
`a location outside of a subject, through a main vessel, to a location near an
`ostium of a branch vessel.” Ex. 1201, 13:44–46. Both parties assert that this
`“means for guiding” should be treated as a means-plus-function claim term
`under 35 U.S.C. § 112 ¶ 6 and that the corresponding structure is a guide
`catheter. Pet. 15–16; PO Resp. 7. We agree and adopt this construction for
`purposes of this decision. Ex. 1201, 3:9–12 (“The present invention is a
`coaxial guide catheter that is deliverable through standard guide
`catheters . . . .”).
`2. Means for Receiving . . . and Guiding
`Claims 25 also requires a
`means for receiving the interventional device from an
`intermediate or distal portion of the means for
`guiding the interventional device to the location near
`the ostium of the branch vessel and guiding the
`interventional device deeper into the branch vessel,
`the means for receiving the interventional device and
`guiding the interventional device deeper into the
`branch vessel including, in a distal to proximal
`direction, a tip portion, a reinforced portion, a side
`opening, and a substantially rigid portion, and having
`a length such that when the distal end of the tip
`portion is extended distally of the distal end of the
`means for guiding the interventional device to the
`location near the ostium of the branch vessel, a
`portion of the proximal end of the substantially rigid
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`portion extends proximally of the proximal end of the
`means for guiding the interventional device to the
`location near the ostium of the branch vessel,
`wherein the tip portion, the reinforced portion, the side
`opening, and the substantially rigid portion are
`configured to be passed, at least in part, into a lumen
`of the means for guiding the interventional device to
`the location near the ostium of the branch vessel, and
`the side opening and the substantially rigid portion are
`configured to be more rigid along a length thereof
`than the tip portion.
`Ex. 1201, 13:47–14:5 (emphases added). The parties dispute whether the
`“means for receiving the interventional device . . . and guiding the
`interventional device deeper into the branch vessel” (“means for receiving . .
`. and guiding”) is a means-plus-function limitation and, if so, what structure
`described in the specification corresponds to this claim limitation. Pet. 16–
`17; PO Resp. 7–16.
`“Section 112, paragraph 6, allows a patentee to express a claim
`limitation by reciting a function to be performed rather than by reciting
`structure or materials for performing that function.” Northrop Grumman
`Corp. v. Intel Corp., 325 F.3d 1346, 1350 (Fed. Cir. 2003). Use of the term
`“means” creates a rebuttable presumption that a claim term is a means-plus-
`function limitation. Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1348
`(Fed. Cir. 2015). This presumption may be rebutted, however, if the claim
`recites sufficient structure for performing the recited functions. TriMed, Inc.
`v. Stryker Corp., 514 F.3d 1256, 1259 (Fed. Cir. 2008); Cross Med. Prods.,
`Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1304 (Fed. Cir.
`2005) (“While the limitation recites the word ‘means,’ thus giving rise to the
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`presumption that § 112, ¶ 6 applies, . . . the claim language is sufficiently
`structural as to take the limitation out of the ambit of § 112, ¶ 6.”).
`The Parties’ Arguments
`a)
`Petitioner contends claim 25 recites the structural components that
`make up the coaxial guide catheter, including “a tip portion, a reinforced
`portion, a side opening, and a substantially rigid portion,” and specifies the
`length (longer than the guide catheter), the size (configured to be passed
`through the lumen of the guide catheter), and the properties of the device
`(having a side opening and substantially rigid portion that are more rigid
`than the tip portion). Pet. 16 (citing Ex. 1201, 13:55–14:5; Ex. 1205 ¶¶ 147–
`149). According to Petitioner, this detailed recitation of structure in claim
`25 describing the “means for receiving . . . and guiding” overcomes the
`presumption that claim 25 is a means-plus-function limitation. Id.
`Patent Owner contends Petitioner has not overcome the presumption
`that the identified claim term is a means-plus-function limitation because the
`“tip portion” and “reinforced portion” of claim 25 are insufficient structure
`to perform the recited function of “guiding an interventional device, received
`from the guide catheter, ‘deeper into the branch vessel.’” PO Resp. 8–10
`(citing Laitram Corp. v. Rexnord, Inc., 939 F.2d 1533, 1536 (Fed. Cir.
`1991); TriMed, 514 F.3d at 1259). Patent Owner reasons that claim 25 does
`not indicate that the “tip portion” or the “reinforced portion” have a lumen,
`and “[w]ithout a lumen, the claimed device is not capable of” guiding an
`interventional device deeper into the branch vessel. Id. at 10 (citing
`Ex. 2138 ¶ 108). Patent Owner contends the absence of a recited lumen for
`the “means for receiving . . . and guiding” is contrasted with the recitation of
`a “lumen” for the “means for guiding” and with the non-means-plus-
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`function independent claims of the ’380 patent (e.g., claim 1), which
`expressly recite that the tip portion has a coaxial lumen. Id. at 10–11 (citing
`Ex. 1201, 10:58–65, 12:17–26, 13:67–14:2; Ex. 2138 ¶ 110).
`Petitioner argues in response that one of ordinary skill in the art
`looking only at the recited limitations of claim 25 would know that the “tip
`portion” and “reinforced portion” form a tubular structure with a lumen for
`at least three reasons. Pet. Reply 1–2. First, it is undisputed that the claimed
`“side opening” has a lumen, and the only reason to have a lumen in a side
`opening is if it extends all the way through the “tip portion” of the device.
`Id. Second, “the specification repeatedly recites that the reinforced portion
`and tip portion form a tubular structure with a lumen” and it was understood
`in the art that the reinforcement used to form the “reinforced portion” is
`intended to keep the lumen in that section from deforming during a
`procedure. Id. at 2–3. Finally, a lumen that extends from the side opening
`all the way through to the “tip portion” of the device “is the only way to
`guide a device into a branch vessel,” one of the stated functions of the
`“means for receiving . . . and guiding.” Id. (citing Ex. 1806 ¶¶ 28–30, 32,
`33).
`Patent Owner argues in response that Petitioner effectively concedes
`that a lumen is required to perform the recited functions, thereby
`demonstrating that claim 25 fails to recite necessary structure for achieving
`the recited functions in their entirety. Sur-Reply 2. Patent Owner contends
`“this should end the inquiry and lead to the conclusion that the means-plus-
`function presumption has not been overcome.” Id. Patent Owner further
`contends that it is inappropriate to consult the specification of the ’380
`patent to determine if sufficient structure is recited in the claims, but even if
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`reference is made to the written description of the ’380 patent there is no
`definitional statement or disavowal to justify reading “lumen” into the terms
`“tip portion” and “reinforced portion.” Id. at 4. Consistent with this
`conclusion, Patent Owner asserts that other claims of the ’380 patent
`expressly recite a “tip portion . . . defining a coaxial lumen,” which is strong
`evidence that the term “lumen” should not be read into claim 25. Id. at 4–5.
`b)
`Analysis
`When a claim uses the term “means” and then recites a function for
`that “means,” the analysis as to whether the claim term is in means-plus-
`function format focuses on whether the claim “recites sufficient structure or
`materials for performing” the recited function. Apex Inc. v. Raritan
`Comput., Inc., 325 F.3d 1364, 1372 (Fed. Cir. 2003). In conducting this
`analysis, we do not merely consider the introductory phrase “means for
`receiving . . . and guiding” in isolation, “but look to the entire passage
`including functions performed by the introductory phrase.” MTD Prods.,
`Inc. v. Iancu, 933 F.3d 1336, 1342 (Fed. Cir. 2019) (noting that “other
`language in the claim ‘might inform the structural character of the
`limitation-in-question or otherwise impart structure’ to the claim term”
`(quoting Williamson, 792 F.3d at 1351)); TI Grp. Automotive Sys. v. VDO N.
`Am., L.L.C., 375 F.3d 1126, 1135 (Fed. Cir. 2004).
`The claim limitation at issue recites not only a “means for receiving
`the interventional device and guiding the interventional device deeper into
`the branch vessel,” but also its structure (“including, in a distal to proximal
`direction, a tip portion, a reinforced portion, a side opening, and a
`substantially rigid portion”), length (“having a length such that when the
`distal end of the tip portion is extended distally of the distal end of the means
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`for guiding . . . a portion of the proximal end of the substantially rigid
`portion extends proximally of the proximal end of the means for guiding”),
`and its configuration with respect to the means for guiding (requiring that
`the “tip portion, the reinforced portion, the side opening, and the
`substantially rigid portion are configured to be passed, at least in part, into a
`lumen of the means for guiding”). This detailed and extensive recitation of
`structure strongly suggests that the claim term is not in means-plus-function
`format. See Cross Med., 424 F.3d at 1304; TI Grp., 375 F.3d at 1135; Cole
`v. Kimberly-Clark Corp., 102 F.3d 524, 531 (Fed. Cir. 1996) (explaining
`that to invoke § 112, ¶ 6, “the alleged means-plus-function claim element
`must not recite a definite structure which performs the described function”).
`As noted by Patent Owner, the structure recited for the “means for
`receiving . . . and guiding” does not expressly include a “lumen,” which both
`parties agree is necessary to achieve the function of guiding the
`interventional device deeper into the branch vessel. PO Resp. 10; Pet.
`Reply 2; Sur-Reply 2. Petitioner persuasively demonstrates, however, that
`the “side opening” recited in the disputed claim phrase has a lumen and that
`the “tip portion” and “reinforced portion” would be understood by one of
`ordinary skill in the art to have a lumen extending through both elements.
`Pet. Reply 1–2. That is, from the structure expressly recited in the claim,
`i.e., a “tip portion,” “reinforced portion,” and “side opening,” and from the
`recited function of the claim limitation, one of ordinary skill in the art would
`understand that the “means for receiving . . . and guiding” contains a lumen.
`Id. at 1–3.
`This conclusion is well supported by the written description of the
`’380 patent, which explains that coaxial guide catheter 12 includes “tip
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`portion 16, reinforced portion 18, and rigid portion 20”; that reinforced
`portion 18 includes a side opening; that reinforced portion 18 and tip
`portion 16 form a tubular structure with a lumen; and that tapered inner
`catheter 14, which extends beyond tip portion 16 when inserted into a
`coronary artery, is removed from the inside of coaxial guide catheter 12.
`Ex. 1201, 3:50–55, 6:53–54 (“Tip portion 16 and reinforced portion 18
`together form a substantially cylindrical structure.”), 8:11–17 (“Tapered
`inner catheter tip 42 provides a distal tapered transition from guidewire 64 to
`coaxial guide catheter 12. Once coaxial guide catheter 12 is in place,
`tapered inner catheter 14 is removed from the inside of coaxial guide
`catheter 12.”), Figs. 1, 3–4, 8 (consistently depicting a lumen extending
`through tip portion 16, reinforced portion 18, and rigid portion 20).9
`Patent Owner’s argument that it is improper to reference the written
`description of the ’380 patent when seeking to determine whether the claim
`recites sufficiently definite structure is foreclosed by the Federal Circuit’s
`decisions in Inventio AG v. Thyssenkrupp Elevator Americas Corporation,
`649 F.3d 1350, 1357 (Fed. Cir. 2011) (overruled on other grounds by
`Williamson, 792 F.3d at 1347) and TI Group, 375 F.3d at 1135. As stated in
`Inventio, “where the claims recite the term ‘means,’ we have considered the
`
`9 As noted by Patent Owner, independent claim 1 explicitly recites a
`“lumen.” Ex. 1201, 10:64–67. The relevant claim language, however,
`serves to further limit the shape and orientation of the lumen, requiring that
`it be “coaxial” and have “a cross-sectional inner diameter through which
`interventional cardiology devices are insertable.” Id. Thus, we do not
`understand the presence of the term “lumen” in claim 1 to imply that a
`lumen is not present in the “tip portion” and “reinforced portion” of claim
`25.
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`written description to inform the analysis of whether the claim recites
`sufficiently definite structure to overcome the presumption that § 112, ¶ 6
`governs the construction of the claim.” Inventio, 649 F.3d at 1357.
`In view of the foregoing, we find that claim 25 recites sufficient
`structure for performing the recited functions of “receiving the interventional
`device . . . and guiding the interventional device deeper into the branch
`vessel.” Accordingly, this limitation of claim 25 is not a means-plus-
`function claim term.
`D. Claims 25–31, 34–37, and 39 in View of Ressemann
`Petitioner contends Ressemann anticipates claims 25–31, 34–37, and
`39 of the ’380 patent. Pet. 19–45.
`1. 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. Figure 1A of Ressemann, reproduced below, illustrates a first
`embodiment of a system for evacuating emboli from a blood vessel:
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`Figure 1A is a cross-sectional view of a partial length evacuation sheath and
`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
`3:16–18, 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, which includes 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 the angled open ends also allows for larger deformable
`particulate matter to pass through the lumen more smoothly.” Id. at 6:58–
`60.
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`Figure 1B of Ressemann is reproduced below:
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`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 1B
`shows inflation lumen 142, which has open proximal end 142a and closed
`distal end 142b (shown in Figure 1A) and is designed to provide fluid to
`inflate balloons on evacuation head 132. Id. at 6:61–64. 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.
`Id. at 12:19–21. In this process, evacuation head 132 is posit
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