Trials@uspto.gov
`571-272-7822
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Paper 22
`Date: June 8, 2020
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`
`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.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`571-272-7822
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Paper 22
`Date: June 8, 2020
`
`
`
`
`
`
`
`
`
`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.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`IPR2020-00129
`Patent RE45,380
`
`
`INTRODUCTION
`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 RE45,380 (Ex. 1201, “the
`’380 patent”). Teleflex Innovations S.À.R.L. (“Patent Owner”) filed a
`Preliminary Response to the Petition (Paper 8, “Prelim. Resp.”). Pursuant to
`our authorization, Petitioner filed a Reply (Paper 12) addressing its burden
`on secondary considerations and reduction to practice, and Patent Owner
`filed a Sur-Reply (Paper 14) addressing Petitioner’s burden on those issues.
`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).
`We have authority to determine whether to institute an inter partes
`review. 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2019). The standard
`for institution is set forth in 35 U.S.C. § 314(a), which provides that an inter
`partes review may not be instituted “unless the Director determines . . . there
`is a reasonable likelihood that the petitioner would prevail with respect to at
`least 1 of the claims challenged in the petition.”
`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, we institute an inter partes review of all challenged claims and
`all asserted grounds set forth in the Petition. See SAS Inst. Inc. v. Iancu,
`138 S. Ct. 1348, 1355–56 (2018); PGS Geophysical AS v. Iancu, 891 F.3d
`1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-
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`Patent RE45,380
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`or-no institution choice respecting a petition, embracing all challenges
`included in the petition”).
`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.) (“Medtronic case”) and QXMedical, LLC v. Vascular Solutions,
`LLC, No. 17-cv-01969 (D. Minn) (“QXM case”). Pet. 5; Paper 4, 2–3. The
`’380 patent is also at issue in IPR2020-00128, IPR2020-00130, and
`IPR2020-00131. Paper 4, 3; Pet. 5.
`B. The ’380 Patent
`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.” Ex. 1201, 1:31–35.
`“In coronary artery disease the coronary arteries may be narrowed or
`occluded by atherosclerotic plaques or 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,
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`making it difficult or impossible to treat certain forms of coronary artery
`disease. Id. at 1:59–63.
`Figures 1 and 2 of the ’380 patent are reproduced below:
`
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`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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`IPR2020-00129
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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 8:14–17.
`At this point, coaxial guide catheter 12 is ready to accept a treatment
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`catheter such as a stent or balloon catheter which may be advanced to the
`stenosis. Id. at 8:17–18, 8:30–32.
`C. Illustrative Claim
`Independent claim 25 is illustrative of the challenged claims and is
`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
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`IPR2020-00129
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`the side opening and the substantially rigid portion are
`configured to be more rigid along a length thereof
`than the tip portion.
`Ex. 1201, 13:43–14:5.
`D. Prior Art and Asserted Grounds
`Petitioner contends claims 25–39 of the ’380 patent would have been
`unpatentable on the following grounds (Pet. 7–8):
`35
`Reference(s)/Basis
`Claim(s) Challenged
`U.S.C. §
`Ressemann1
`102
`25–31, 34–37, 39
`Ressemann
`103
`27
`Ressemann, Kataishi2
`103
`27
`Ressemann, Enger3
`103
`27
`Ressemann, Takahashi4
`103
`32, 33
`Ressemann, Berg5
`103
`38
`Itou6
`102
`25, 26, 28–30, 32–37, 39
`Itou
`103
`31
`Itou, Kataishi
`103
`27
`Itou, Berg
`103
`38
`Petitioner also relies on the testimony of Dr. Stephen JD Brecker
`(Ex. 1205) and Dr. Richard A. Hillstead (Ex. 1242). Pet. 7 n.2.
`
`
`1 Ressemann, US 7,604,612 B2, issued October 20, 2009 (Ex. 1208)
`(“Ressemann”).
`2 Kataishi, US 2005/0015073 A1, published January 20, 2005 (Ex. 1225)
`(“Kataishi”).
`3 Enger, US 5,980,486, issued November 9, 1999 (Ex. 1250) (“Enger”).
`4 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”).
`5 Berg, US 5,911,715, issued June 15, 1999 (Ex. 1251) (“Berg”).
`6 Itou, US 7,736,355 B2, issued June 15, 2010 (Ex. 1207) (“Itou”).
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`ANALYSIS
`
`A. § 314
`1. Multiple Petitions
`Petitioner filed four petitions for inter partes review of the
`’380 patent. IPR2020-00128 relies on Itou as the primary reference;
`IPR2020-00129—the present proceeding—relies on Ressemann as the
`primary reference; and IPR2020-00130 and IPR2020-00131 rely on Kontos
`as the primary reference. See Paper 3, 1–3. Petitioner labels IPR2020-
`00128 as “Petition 1A,” IPR2020-00129 as “Petition 1B,” IPR2020-00130
`as “Petition 2A,” and IPR2020-00131 as “Petition 2B.” Id. at 1–2.
`Petition 1A is directed to claims 1–4, 6–10, 12–21, and 23 of the ’380
`patent. Id. at 1. Petition 1B is directed to claims 25–39 of the ’380 patent.
`Id. at 1–2. Petition 2A is directed to claims 1–4, 6–9, and 12–21 of the ’380
`patent. Id. at 2. Petition 2B is directed to claims 25–39 of the ’380 patent.
`Petitioner contends two petitions,7 i.e., Petition 1A and Petition 1B,
`are necessary to address the claims of the ’380 patent challenged by
`Petitioner “because of the length, type, and number of claims asserted by
`Patent Owner in district court.” Id. at 4 (emphasis omitted). In particular,
`Petitioner contends the ’380 patent has “42 lengthy claims,” the simple
`recitation of which “takes up over 1,400 word—more than 10% of
`Petitioner[’]s allotted word count.” Id. Petitioner also contends that the
`
`
`7 In this Decision, we address only whether we should exercise our
`discretion to deny the present Petition, i.e., Petition 1B. We will address the
`parties’ arguments regarding Petition 2A in our decision in IPR2020-00130
`and the parties’ arguments regarding Petition 2B in our decision in IPR2020-
`00131.
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`present Petition, Petition 1B, addresses means-plus-function limitations
`“requiring unique arguments.” Id.
`Patent Owner contends Petitioner’s inability to “fit all arguments into
`a single petition is a problem it created itself.” Paper 11, 4. According to
`Patent Owner, “[r]ather than judiciously selecting its strongest arguments,
`[Petitioner] chose, for example, to advance seven grounds against claim 27,
`and three separate grounds against independent claim 25.” Id.
`Claims 25–39 of the ’380 patent, challenged in this Petition, were
`added by reissue and, in contrast to the claims challenged in Petition 1A,
`require analysis of potential means-plus-function claim terms. Ex. 1201,
`13:44–46; Prelim. Resp. 16–21. Given the number and length of the
`challenged claims, and given the unique means-plus-function issues
`presented by the added reissue claims, we agree with Petitioner that
`analyzing claims 1–4, 6–10, 12–21, and 23 and claims 25–39 of the ’380
`patent in two different petitions is reasonable and justified under the
`circumstances.
`Accordingly, we decline to exercise our discretion to deny the Petition
`under § 314(a).
`2. Parallel District Court Cases
`Patent Owner argues that we should exercise our discretion under
`35 U.S.C. § 314(a) to deny institution due to the common issues being
`litigated in parallel district court cases. Prelim. Resp. 25–30. In particular,
`Patent Owner contends that the validity of at least some of the challenged
`claims of the ’380 patent and other related patents is the subject of active
`litigation in two separate district court cases, the QXM case and the
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`Medtronic case, which are both currently pending in the District of
`Minnesota. Id. at 12.
`In NHK Spring Co. v. Intri-Plex Techs., Inc., IPR2018-00752, Paper 8
`(PTAB Sept. 12, 2018) (precedential, designated May 7, 2019) (“NHK”), the
`Board considered the fact that a parallel district court proceeding was
`scheduled to finish before the Board reached a final decision as a factor
`favoring denial of institution. In the more recently designated precedential
`decision Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11, 6 (PTAB Mar.
`20, 2020) (precedential, designated May 5, 2020) (“Fintiv”), the Board set
`forth several other factors to consider under § 314(a) in determining whether
`to institute trial when there is parallel, co-pending litigation concerning the
`same patent: (1) whether a stay of the parallel litigation exists or is likely to
`be granted if a trial proceeding is instituted by the Board; (2) proximity of
`the court’s trial date to the Board’s projected statutory deadline; (3) the
`investment in the parallel proceeding by the court and parties; (4) the extent
`of overlap between issues raised in the petition and in the parallel litigation;
`(5) whether the petitioner and the defendant in the parallel proceeding are
`the same party; and (6) and other circumstances that impact the Board’s
`exercise of discretion, including the merits.
`The parties address the Fintiv factors in supplemental briefing that we
`authorized. Paper 19; Paper 20. We have considered each of these factors
`and conclude that, on balance, the circumstances here do not favor
`discretionary denial under § 314(a).
`As to whether a stay of the parallel litigation exists or is likely to be
`granted (Fintiv Factor 1), Petitioner contends that the presiding district court
`judge in the Medtronic and QXM cases “has granted every post-institution
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`request to stay litigation pending reexamination or IPR.” Paper 19, 2 (citing
`Ex. 1293). Petitioner also points out that the QXM case, involving the ’380
`patent and other patents in this same family, has already been stayed pending
`our institution decisions, and the court indicated that if we institute trial “the
`Court will invite the parties to brief whether the stay should extend through
`the conclusion of the review process.” Id. (citing Ex. 1294). Thus,
`Petitioner contends that the same judge will also entertain Petitioner’s
`motion to stay the Medtronic case in the event of institution. Id. With
`respect to Fintiv Factor 1, Patent Owner contends that Petitioner has not
`sought a stay of the Medtronic litigation, and the Board has previously
`declined to infer how the district court would rule when neither party has
`requested a stay. Paper 20, 1. Patent Owner contends that the QXM case
`was stayed only because QXMedical agreed to exit the market and waived
`its obviousness/anticipation defenses, and that the district court has not
`granted stays involving direct competitors or allegations of irreparable harm.
`Id. Having considered the parties position, we determine that Fintiv Factor
`1 favors institution, especially in view of the fact that a stay has already been
`granted in the related QXM case and the district court’s prior history of
`granting stays pending resolution of related IPRs.
`As to the proximity of the court’s trial dates to our statutory deadlines
`(Fintiv Factor 2), the parties agree that the district court has indicated that
`the Medtronic case must be “Ready for Trial” by August 1, 2021, which
`would be a few weeks after our statutory deadline for a final written decision
`in this proceeding and the related IPRs. PO Resp. 13; Paper 19, 1.
`Petitioner asserts the date for an actual trial will likely be extended even
`further, noting that district court’s final “Ready for Trial” date in patent
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`proceedings is, on average, over eight months after the originally scheduled
`date. Paper 19, 1 (citing Ex. 1289). Petitioner points out that the district
`court already extended the original “Ready for Trial” date by two months in
`the Medtronic case, and that a trial date in the QXM case was finally set for
`February 24, 2020—more than ten months after the original “Ready for
`Trial” set by the court—before that case was stayed pending our institution
`decision. We determine that Fintiv Factor 2 also favors institution,
`especially given that the trials in the district court cases are not scheduled to
`take place until after we issue our final written decisions in these
`proceedings. Notably, in both the NHK and Fintiv cases, the trial dates in
`the parallel litigations were scheduled to occur before the final written
`decision deadlines. See NHK, IPR2018-00752, Paper 8 at 19 (noting trial
`date of March 25, 2019, where Board’s institution decision was issued
`September 12, 2019); Fintiv, IPR2020-00019, Paper 15 at 10 (noting trial
`date of March 18, 2021 where Board’s institution decision was due May 15,
`2021).
`As to the amount of investment by the parties and the court in the
`parallel proceeding (Fintiv Factor 3), Patent Owner contends that the district
`court is already deeply invested and has familiarity with the challenged
`patents in light of the relatively advanced stage of the QXM case. Paper 20,
`1–2. But as noted above, the district court has indicated a preference to wait
`for the Board’s institution decision before proceeding in the QXM case.
`With respect to the Medtronic case, Patent Owner contends that the parties
`have already exchanged infringement contentions, conducted extensive fact
`discovery (set to close September 1, 2020), and addressed the issues in a
`preliminary injunction motion. Id.; see also Prelim. Resp. 13. Although we
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`agree that the parties have invested some time and effort in the related
`litigation, we are not persuaded that those cases are in such an advanced
`stage that would favor of denial of institution. The district court recently
`denied the preliminary injunction motion filed by Patent Owner, noting that
`there are substantial questions with respect to the validity of the asserted
`claims. Ex. 1288, 9–14. However, the district court has not issued a claim
`construction order or any other substantive order. See Fintiv, Paper 11 at 10
`(noting that if “the district court has not issued orders related to the patent at
`issue in the petition, this fact weighs against exercising discretion to deny
`institution under NHK”). We, therefore, determine that resolution of those
`common issues by the Board may be beneficial to the resolution of the
`district court proceedings. Patent Owner also contends that Petitioner
`delayed bringing these challenges. Paper 20, 2. Petitioner, however, points
`out that it filed its IPR petitions roughly four months after the district court
`complaint in the Medtronic case, and before Patent Owner’s infringement
`contentions were served in that case. Paper 19, 2; see Fintiv, Paper 11 at 11
`(noting that “it is often reasonable for a petitioner to wait to file its petition
`until it learns which claims are being asserted against it in the parallel
`proceeding”). We find that Petitioner did not unduly delay filing its IPR
`Petitions and that Factor 3 weighs against discretionary denial.
`We have also considered the remaining Fintiv factors and determine,
`on balance, that they do not outweigh the foregoing factors in favor of
`institution. Fintiv, Paper 11 at 6 (explaining that when various factors weigh
`both in favor and against exercising discretion under § 314(a), we take “a
`holistic view of whether efficiency and integrity of the system are best
`served by denying or instituting review”). With respect to Fintiv Factor 4
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`(overlap of issues), Patent Owner responds that there is complete overlap of
`the issues raised in the parallel proceedings, including the same invalidity
`prior art and arguments raised in the Petitions. Paper 20, 2. With respect to
`Fintiv Factor 5 (whether the same parties are involved), Patent Owner also
`points out that the Petitioner is the defendant in the Medtronic case. Id. In
`contrast to NHK and Fintiv, however, in this case the trial date is after the
`due date for our final written decision and, although there is an overlap of
`issues and parties between the Medtronic case and this proceeding, in this
`case any concerns about inefficiency and the possibility of conflicting
`decisions may be mitigated by the fact that the district court may stay the
`parallel litigation, and thus not reach the merits of Petitioner’s invalidity
`defenses, before we issue our final written decision.
`Finally, under Fintiv Factor 6, we have taken into account the merits
`of Petitioner’s challenges and find that this favors institution.
`In sum, based on our consideration of the foregoing factors, we
`decline to exercise our discretion under § 314(a) to deny institution.
`B. 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 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 agree that this
`“means for guiding” is a means-plus-function claim term and that the
`corresponding structure is a guide catheter. Pet. 15–16; Prelim. Resp. 16.
`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
`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,
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`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” is a means-plus-function
`limitation and, if so, what structure described in the Specification
`corresponds to this claim limitation. Pet. 16–17; Prelim. Resp. 16–21.
`
`“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). A term written
`in means-plus-function form is construed to cover “the corresponding
`structure, materials, or acts described in the specification and equivalents
`thereof” for performing the recited functions. 35 U.S.C. § 112, para. 6.
`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 if
`the claim recites structure sufficient to perform the described functions in
`their entirety. TriMed, Inc. v. Stryker Corp., 514 F.3d 1256, 1259 (Fed. Cir.
`2008). “Sufficient structure exists when the claim language specifies the
`exact structure that performs the functions in question without need to resort
`to other portions of the specification or extrinsic evidence for an adequate
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`understanding of the structure.” Id. at 1259–60; see Inventio AG v.
`ThyssenKrupp Elevator Ams. Corp., 649 F.3d 1350, 1357 (Fed. Cir. 2011)
`(noting that one may still consider the 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”) (overruled on other grounds by Williamson, 792 F.3d at 1339).
`
`Petitioner contends claim 25 recites the basic components of the
`coaxial guide catheter that are described in the specification of the
`’380 patent, including “a tip portion, a reinforced portion, a side opening,
`and a substantially rigid portion.” Pet. 16. Petitioner also contends claim 25
`specifies the length (longer than the guide catheter), the size (configured to
`be passed through the lumen of the guide catheter), and properties of the
`device (having a more rigid side opening and substantially rigid portion than
`the tip portion). Id. (citing Ex. 1201, 13:55–14:5; Ex. 1205 ¶¶ 147–149).
`According to Petitioner, the detailed recitation of structure in claim 25
`describing the “means for receiving” overcomes the presumption that
`claim 25 is a means-plus-function limitation. Id.
`Patent Owner contends the structure recited in claim 25 is not
`sufficient to perform the recited function of receiving an interventional
`device and guiding it deeper into the branch vessel. Prelim. Resp. 17–18. In
`particular, Patent Owner contends claim 25 does not recite a tubular
`structure with a lumen into which an interventional device can be received
`and be guided “deeper into the branch vessel,” which is necessary to achieve
`the recited functions of claim 25. Id. at 17.
`The “means for receiving” in claim 25 must perform two functions.
`First, it must be capable of receiving an interventional device from an
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`intermediate or distal portion of the means for guiding. Second, it must be
`capable of directing this interventional device deeper into the branch vessel.
`As noted by Petitioner, claim 25 provides an extensive recitation of structure
`for the “means for receiving.” Pet. 16. Whether the structures identified in
`claim 25 are sufficient to perform the two recited functions of the means for
`receiving and guiding, however, is a disputed, material issue of fact that is
`addressed by both parties’ experts. See Ex. 1205 ¶¶ 146–149; Ex. 2042 ¶ 21
`(Keith Declaration). Accordingly, this issue is best resolved upon a full trial
`record. See 37 C.F.R. § 42.108(c) (“[A] genuine issue of material fact
`created by such 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.”).
`Because a claim must be construed in order to address questions of
`unpatentability, and in view of the presumption that use of the term “means”
`invokes § 112, ¶ 6, we preliminarily construe “the means for receiving . . .
`and guiding” recited in claim 25 as a means-plus-function claim term.
`Construction of means-plus-function claim terms is a two-step
`processes. Noah Sys., Inc. v. Intuit Inc., 675 F.3d 1302, 1311 (Fed. Cir.
`2012). First, we determine the claimed function. Id. Second, “we identify
`the corresponding structure in the written description of the patent that
`performs the function.” Id.; see Williamson, 792 F.3d at 1351. “Structure
`disclosed in the specification qualifies as ‘corresponding structure’ if the
`intrinsic evidence clearly links or associates that structure to the function
`recited in the claim.” Williamson, 792 F.3d at 1352. In conducting this
`analysis, we may not incorporate structure from the written description
`beyond that which is necessary to perform the claimed function(s). See
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`IPR2020-00129
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`Micro Chemical, Inc. v. Great Plains Chemical Co., 194 F.3d 1250, 1258
`(Fed. Cir. 1999).
`To the extent the “means for receiving . . . and guiding” is construed
`as a means-plus-function claim limitation, Petitioner contends “[t]he
`corresponding structure for the claimed function of receiving and guiding an
`interventional device deeper into a branch vessel is simply a coaxial guide
`catheter.” Pet. 17 (citing Ex. 1205 ¶¶ 144–145). Although Petitioner
`concedes that other structural elements of coaxial guide catheters are
`described in the various embodiments of the ’380 patent, Petitioner contends
`these structures may not be construed as corresponding structure because the
`Specification merely indicates that these structures “may” be used, i.e., that
`they are not necessary to perform the recited functions. Id.
`Patent Owner contends the relevant corresponding structure is a
`“coaxial guide catheter having a tubular portion with a single lumen that is
`circular in cross-section, which is attached and coaxially aligned at its distal
`end to a tip having a lumen with a circular cross-section, and attached at its
`proximal end to a substantially rigid pushrod structure.” Prelim. Resp. 20–
`21 (citing Ex. 1201, 3:9–12, 3:50–55, 6:31–37, 10:1–20; Ex. 2042 ¶ 21).
`Upon review of the claims and the Specification, we agree with both
`parties that the means for receiving and guiding in claim 25 is a coaxial
`guide catheter. On this record, however, we are not persuaded that the
`additional structural limitations for the coaxial guide catheter asserted by
`Patent Owner are necessary to perform the recited functions. In particular,
`Patent Owner does not explain sufficiently why the Specification requires a
`single lumen or a lumen that is circular in cross-section. Nor do the portions
`of the ’380 Specification cited by Patent Owner clearly indicate that these
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`IPR2020-00129
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`
`structural limitations are required to perform the functions set forth in
`claim 25. Thus, insofar as we have preliminarily construed the “means for
`receiving . . . and guiding” in claim 25 as a means-plus-function claim
`limitation, we determine that the corresponding structure for this claim
`limitation would be understood to be a “coaxial guide catheter” and
`equivalents thereof.
`C. 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. Figures 1A and 1B of Ressemann are reproduced below:
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`
`Figure 1A is a cross-sectional view of a partial l
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