Trials@uspto.gov
`571-272-7822
`
`Paper No. 20
`Date: June 26, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.,
`Petitioner,
`v.
`TELEFLEX INNOVATIONS S.À.R.L.,
`Patent Owner.
`
`IPR2020-00134
`Patent RE45,760 E
`
`
`
`
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`SNEDDEN, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`

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`IPR2020-00134
`Patent RE45,760 E
`
`INTRODUCTION
`I.
`Medtronic, Inc. and Medtronic Vascular, Inc. (“Petitioner”) filed a
`Petition for inter partes review of claims 48 and 51–53 of U.S. Patent No.
`RE45,760 E (“the ’760 patent,” Ex. 1601). Paper 1 (“Pet.”). Teleflex
`Medical Devices S.A.R.L. (“Patent Owner”) filed a Preliminary Response.
`Paper 10 (“Prelim. Resp.”). Pursuant to our authorization, Petitioner filed a
`Reply addressing its burden on secondary considerations and reduction to
`practice, and Patent Owner filed a Sur-Reply addressing Petitioner’s burden
`on those issues. Paper 14; Paper 15. Also pursuant to our authorization,
`Petitioner filed another Reply (Paper 17) and Patent Owner filed another
`Sur-Reply (Paper 18) addressing the factors for discretionary denial under
`35 U.S.C. § 314(a).
`To institute an inter partes review, we must determine that the
`information presented in the Petition shows “a reasonable likelihood that the
`petitioner would prevail with respect to at least 1 of the claims challenged in
`the petition.” 35 U.S.C. § 314(a) (2012). The Supreme Court has held that a
`decision to institute under 35 U.S.C. § 314 may not institute on fewer than
`all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct.
`1348, 1359–60 (2018) (“SAS”). After considering the parties’ arguments
`and evidence, we determine that Petitioner has demonstrated a reasonable
`likelihood that it would prevail with respect to at least one of the claims
`challenged in the Petition. Accordingly, an inter partes review of all of the
`claims and all of the grounds presented in the Petition is hereby instituted.
`A. Real Parties in Interest
`Petitioner identifies its real parties-in-interest as Medtronic, Inc. and
`Medtronic Vascular, Inc., and notes that “Medtronic plc is the ultimate
`parent of both entities.” Pet. 5. Patent Owner identifies its real parties-in-
`
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`IPR2020-00134
`Patent RE45,760 E
`interest as Teleflex Medical Devices S.A.R.L.; Vascular Solutions LLC;
`Arrow International, Inc.; and Teleflex LLC. Paper 4, 2. Patent Owner also
`notes that “Teleflex Incorporated is the ultimate parent of the entities listed
`above.”
`B. Related Matters
`The ’760 patent is also at issue in IPR2020-00132 and IPR2020-
`00133. Paper 4, 2–3; Pet. 5. We instituted inter partes review in IPR2020-
`00132 on June 9, 2020. IPR2020-00132, Paper 22.
`The parties indicate that the ’760 patent is the subject of litigation in
`Vascular Solutions LLC, et al. v. Medtronic, Inc., et al. No. 19-cv-01760 (D.
`Minn. filed July 2, 2019) (“Medtronic”) and QXMedical, LLC v. Vascular
`Solutions, LLC, No. 17-cv-01969 (D. Minn., filed June 8, 2017) (“QXM”).
`Pet. 5–6; Paper 4, 2.
`The ’760 patent is a reissue of U.S. Pat. No. 8,292,850 (“the ʼ850
`patent). The ’850 patent was the subject of two previous inter partes
`reviews: IPR2014-00762, filed May 16, 2014 and terminated August 11,
`2014 by way of joint motion to terminate, and IPR2014-00763, filed May
`16, 2014 and terminated August 11, 2014 by way of joint motion to
`terminate. Pet. 6; Paper 4, 2–3. The ’850 patent was also at issue in the U.S.
`District Court for the District of Minnesota in Vascular Solutions, Inc. v.
`Boston Scientific Corp., No. 13-cv-01172 (D. Minn., filed May 16, 2013).
`Id.
`C. The ’760 Patent
`1. Specification
`The subject matter claimed in the ’760 patent is directed to a device
`for use with a standard guide catheter. Ex. 1601, 13:36–17:13. Figures 1
`
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`IPR2020-00134
`Patent RE45,760 E
`and 5 of the ’760 patent, reproduced below, depict a coaxial guide catheter
`and a tapered inner catheter.
`
`Figure 1 of the ’760 patent
`
`
`
`
`Figure 5 of the ’760 patent
`As shown in Figures 1 and 5, above, coaxial guide catheter assembly
`10 includes coaxial guide catheter 12 and tapered inner catheter 14. Id. at
`6:37–39. Coaxial guide catheter 12 generally includes tip portion 16,
`reinforced portion 18, and rigid portion 20. Id. at 6:40–41. Tip portion 16
`generally includes bump tip 22 and marker band 24. Id. at 6:44–45. Bump
`tip 22 includes taper 26 and is relatively flexible. Id. at 6:45–46. Marker
`band 24 is formed of a radiopaque material such as platinum/iridium alloy.
`Id. at 6:49–50. Tapered inner catheter tip 42 includes tapered portion 46 at a
`distal end thereof, and straight portion 48. Id. at 7:22–23. Both tapered
`portion 46 and straight portion 48 are pierced by lumen 50. Id. at 7:23–24.
`Tapered inner catheter 14 may also include clip 54 at a proximal end thereof
`to releasably join tapered inner catheter 14 to coaxial guide catheter 12. Id.
`
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`IPR2020-00134
`Patent RE45,760 E
`at 7:27–29. Thus, tapered inner catheter 14 is keyed to coaxial guide
`catheter 12. Id. at 7:29–30.
`2. Illustrative Claim
`Independent claim 48, reproduced below, is illustrative of the
`challenged claims.
`48. A system, comprising:
`a guide catheter configured to be advanceable through a main
`blood vessel to a position adjacent an ostium of a coronary artery,
`the guide catheter having a lumen extending from a hemostatic valve
`at a proximal end of the guide catheter to a distal end of the guide
`catheter that is adapted to be positioned adjacent the ostium of the
`coronary artery; and
`a guide extension catheter configured to be partially advanceable
`through the guide catheter and into the coronary artery, the guide
`extension catheter having a length such that a distal end of the guide
`extension catheter is extendable through the lumen and beyond the
`distal end of the guide catheter, and a proximal end of the guide
`extension catheter is extendable through the hemostatic valve at the
`proximal end of the guide catheter,
`the guide extension catheter including, in a proximal to distal
`direction, a substantially rigid segment, a segment defining a side
`opening, and a tubular structure defining a lumen coaxial and in
`fluid communication with the lumen of the guide catheter, the lumen
`of the tubular structure having a length that is shorter than the length
`of the lumen of the guide catheter and having a uniform cross-
`sectional inner diameter that is not more than one French size
`smaller than the cross-sectional inner diameter of the lumen of the
`guide catheter, the side opening extending/or a distance along a
`longitudinal axis of the segment defining the side opening and
`accessible from a longitudinal side defined transverse to the
`longitudinal axis, and the side opening and the lumen of the tubular
`structure configured to receive one or more stents or balloon
`catheters when the segment defining the side opening and a
`proximal end portion of the tubular structure are positioned within
`the lumen of the guide catheter and the distal end of the guide
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`IPR2020-00134
`Patent RE45,760 E
`extension catheter extends beyond the distal end of the guide
`catheter;
`wherein the segment defining the side opening comprises a
`portion of the guide extension catheter that is more rigid than a distal
`end portion of the tubular structure.
`Ex. 1601, 15:14–53.
`D. Evidence
`Petitioner relies upon the following prior art references.
`Ex. 1607, T. Itou et al., U.S. Patent No. 7,736,355 B2 (issued June 15,
`2010) (“Itou”).
`Ex. 1608, T. V. Ressemann et al., U.S. Patent No. 7,604,612 B2 (issued Oct.
`20, 2009) (“Ressemann”).
`Petitioner also relies upon the Declarations of Dr. Stephen Brecker
`(Ex. 1605) and Richard A. Hillstead (Ex. 1642) to support its contentions.
`Patent Owner relies upon the Declaration of Peter T. Keith to support
`its contentions. Ex. 2042.
`E. Asserted Grounds of Unpatentability
`Petitioner asserts that claims 48 and 51–53 would have been
`unpatentable on the following grounds.
`
`Ground
`
`Claim(s)
`
`35 U.S.C. §1
`
`References/Basis
`
`1
`
`2
`
`48, 51, 53
`
`48, 51, 53
`
`102(e)
`
`103(a)
`
`Itou
`
`Itou, Ressemann,
`Knowledge of a POSITA
`
`
`1 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
`(2011) (“AIA”), amended 35 U.S.C. §§ 102 and 103. Because the
`challenged claims of the ’760 patent have an effective filing date before the
`effective date of the applicable AIA amendments, we refer to the pre-AIA
`versions of 35 U.S.C. § 103 throughout this Decision.
`
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`IPR2020-00134
`Patent RE45,760 E
`
`Ground
`
`Claim(s)
`
`35 U.S.C. §1
`
`References/Basis
`
`52
`
`103(a)
`
`48, 51–53
`
`103(a)
`
`Itou, Knowledge of a
`POSITA
`
`Ressemann, Takahashi,
`Knowledge of a POSITA
`
`3
`
`4
`
`
`
`II. ANALYSIS
`
`A. 35 U.S.C. § 314
`1. Multiple Petitions
`Petitioner filed three petitions for inter partes review of the
`’760 patent. IPR2020-00132 relies on Itou as the primary reference and is
`directed to claims 25–42, 44, and 47 of the ’760 patent. IPR2020-00133
`relies on Ressemann as the primary reference and is directed to claims 25–
`42, 44, and 47 of the ’760 patent. The current Petition relies primarily on
`the combination of Itou and Ressemann as directed to claims 48 and 51–53
`of the ’760 patent, a distinct set of claims as compared to the petitions filed
`in IPR2020-00132 and IPR2020-00133. Paper 3, 1–2. Petitioner labels
`IPR2020-00132 as “Petition 1,” IPR2020-00133 as “Petition 2,” IPR2020-
`00134 as “Petition 3.” Id.
`As noted above, we instituted review of the ’760 patent in IPR2020-
`00132. IPR2020-00132, Paper 22. In this Decision, we address only
`whether we should exercise our discretion to deny the present Petition, i.e.,
`Petition 3. We will address the parties’ arguments regarding Petition 2 in
`our decision in IPR2020-00133.
`Regarding the present Petition, Petitioner asserts that Petition 3
`combines the Itou- and Ressemann-based grounds for claims 48 and 51–53
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`IPR2020-00134
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`in a third petition, which is necessary given the number and length of the
`challenged claims, and given the complexity of issues presented before us
`here. Paper 3, 3. Patent Owner disagrees. Prelim. Resp. 31–33.
`Having considered the parties’ positions and evidence of record,
`summarized above, we determine that analyzing distinct sets of claims of the
`’760 patent in multiple petitions is reasonable and justified given the number
`and length of the challenged claims, and given the complexity of the
`disputes between the parties requiring resolution.
`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. 26–31. In particular,
`Patent Owner contends that the validity of at least some of the challenged
`claims of the ’760 patent and other related patents is the subject of active
`litigation in two separate district court cases, the QXM case and the
`Medtronic case, which are both currently pending in the District of
`Minnesota. Id.
`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 (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
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`IPR2020-00134
`Patent RE45,760 E
`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 17; Paper 18. 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
`request to stay litigation pending reexamination or IPR.” Paper 17, 2 (citing
`Ex. 1693). Petitioner also points out that the QXM case, involving the ’760
`patent and other patents in the 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. 1694). 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 18, 1. Patent Owner contends that the QXM case
`was stayed only because QXMédical agreed to exit the market and waived
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`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. Prelim. Resp. 10; Paper 17, 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
`proceedings is, on average, over eight months after the originally scheduled
`date. Paper 17, 1 (citing Ex. 1689). 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 either before or only a few months
`after the Board’s institution deadlines and 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
`
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`12, 2018); Fintiv, IPR2020-00019, Paper 15 at 10 (noting trial date of March
`8, 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 18,
`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. 10–1. Although
`we 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 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. 1688, 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 18, 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
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`contentions were served in that case. Paper 17, 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.
`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”). Petitioner contends that Patent
`Owner has only asserted a sub-set of the challenged claims in the district
`court litigation. Paper 17, 2. With respect to Fintiv Factor 4 (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 18, 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. We find
`there is an overlap of issues and parties between the Medtronic case and this
`proceeding. In Fintiv, the Board noted that “if the petition includes the same
`or substantially the same claims, grounds, arguments, and evidence as
`presented in the parallel proceeding, this fact has favored denial.” Fintiv,
`Paper 11 at 13. In this case, however, any concerns about inefficiency and
`the possibility of conflicting decisions are 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.
`Indeed, the overlap may actually favor institution here since the Board’s
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`IPR2020-00134
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`earlier determination on the common patentability issues will either be
`dispositive at to the litigated issues, or at least provide sufficient guidance
`for the district court’s resolution of similar issues. Finally, under Fintiv
`Factor 6, we have taken into account the merits of Petitioner’s challenges, as
`discussed above, 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. Level of Ordinary Skill in the Art
`The person having ordinary skill in the art is a hypothetical person
`who is presumed to be aware of all the relevant prior art. Custom
`Accessories, Inc. v. Jeffrey-Allan Indust., Inc., 807 F.2d 955, 962 (Fed. Cir.
`1986); Kimberly-Clarke Corp. v. Johnson & Johnson, 745 F.2d 1437, 1453
`(Fed. Cir. 1984). Moreover, the prior art itself is generally sufficient to
`demonstrate the level of skill in the art at the time of the invention. See
`Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that
`specific findings regarding ordinary skill level are not required “where the
`prior art itself reflects an appropriate level and a need for testimony is not
`shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755
`F.2d 158, 163 (Fed. Cir. 1985)).
`Petitioner asserts that “[i]f a person of ordinary skill in the art
`(‘POSITA’) was a medical doctor, s/he would have had (a) a medical
`degree; (b) completed a coronary intervention training program, and (c)
`experience working as an interventional cardiologist.” Pet. 15.
`Alternatively, Petitioner asserts that “if a POSITA was an engineer s/he
`would have had (a) an undergraduate degree in engineering, such as
`mechanical or biomedical engineering; and (b) at least three years of
`experience designing medical devices, including catheters or catheter-
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`deployable devices.” Id. Additionally, Petitioner contends that “[e]xtensive
`experience and technical training might substitute for education, and
`advanced degrees might substitute for experience.” Id. Petitioner further
`asserts that “a POSITA with a medical degree may have access to a POSITA
`with an engineering degree, and a one with an engineering degree might
`have access to one with a medical degree.” Id. (citing Ex. 1605 ¶ 31; Ex.
`1642 ¶¶ 18–19).
`Patent Owner indicates that “[f]or purposes of this Preliminary
`Response only, [Patent Owner] does not currently dispute [Petitioner]’s
`proposed definition of a POSITA.” Prelim. Resp. 13.
`For the purposes of this decision, we apply Petitioner’s definition of
`the level of ordinary skill in the art because it is undisputed at this time and
`consistent with the evidence of the record. See Okajima v. Bourdeau, 261
`F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the
`appropriate level of ordinary skill in the art).
`The above definition is provisional and the parties are welcome to
`present further argument on this topic at trial.
`
`C. Claim Construction
`
`We interpret a claim “using the same claim construction standard that
`would be used to construe the claim in a civil action under 35 U.S.C.
`282(b).” 37 C.F.R. § 42.100(b) (2019). Under this standard, we construe
`the claim “in accordance with the ordinary and customary meaning of such
`claim as understood by one of ordinary skill in the art and the prosecution
`history pertaining to the patent.” Id.
`Petitioner proposes constructions for several claim terms, including
`the term “flexural modulus.” Pet. 16–18. Patent Owner responds to
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`Petitioner’s proposed constructions by asserting that “no specific
`construction of claim terms is necessary for the Board to deny the Petition in
`view of the deficiencies [Patent Owner] identifies in this Preliminary
`Response.” Prelim. Resp. 13.
`At this stage of the proceeding, we determine that no express
`construction of any claim term is necessary to determine whether to institute
`inter partes review. See 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.”)).
`
`D. Prior Art Status of Itou (Ex. 1607)
`
`Itou was filed on September 23, 2005, published on March 30, 2006,
`and issued on June 15, 2010. Ex. 1607, codes (22), (45), (65). Petitioner
`contends Itou is therefore prior art under pre-AIA § 102(e). Pet. 18–20.
`Patent Owner argues that Itou does not qualify as prior art based on an
`earlier invention date for the claimed invention of the ’760 patent. Prelim.
`Resp. 22–25. In particular, Patent Owner contends that conception of the
`claimed invention occurred in “late 2004,” and reduction to practice
`occurred “in the spring and summer of 2005.” Id. at 22–23. As support for
`this contention, Patent Owner relies upon the declarations of inventor
`Howard Root (Ex. 2001) and Deborah Schmalz (a former Vice President of
`Regulatory Affairs at Patent Owner’s predecessor-in-interest) (Ex. 2039),
`along with certain notebook pages and other documents (Exs. 2005–2022,
`2024) allegedly showing prior conception and reduction to practice. Patent
`Owner further contends that, despite having much of the evidence related to
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`IPR2020-00134
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`conception and reduction to practice, Petitioner does not address it in the
`Petition. Prelim. Resp. 22–23.
`The burden to show that Itou is prior art to the ’760 patent rests with
`Petitioner. Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d
`1375, 1379 (Fed. Cir. 2015). That said, because Petitioner has presented
`evidence that Itou was filed prior to the filing date of the ’760 patent, thus
`qualifying as § 102(e) prior art, the burden of production shifts to Patent
`Owner to demonstrate that Itou is not prior art, for example, by presenting
`evidence of an earlier conception and reduction to practice. Id. at 1380.
`Although Patent Owner presents multiple pieces of evidence in the
`Preliminary Response in support of this contention, Petitioner has not had an
`opportunity to fully consider and address this evidence in this proceeding.2
`Based on the present record, we determine that genuine issues of material
`fact remain about the alleged invention date, and these factual issues are best
`resolved after the record is more fully developed. See 37 C.F.R. § 42.108(c)
`(stating “a genuine issue of material fact created by [Patent Owner’s]
`
`
`2 As noted by Patent Owner, Petitioner was aware of some of Patent
`Owner’s evidence of conception and reduction to practice before it filed the
`Petition. Prelim. Resp. 24. The district court, however, determined that
`Patent Owner’s evidence was “unimpressive” and insufficient to
`demonstrate, at the preliminary injunction stage, an earlier conception and
`reduction to practice. Ex. 1688, 13–14. Petitioner also notes that Patent
`Owner did not provide detailed contentions regarding conception and
`reduction to practice until less than a week before its Petition was filed, and
`the relevant evidence that was previously produced to Petitioner was marked
`“attorneys eyes only’ in the district court case and thus could not have been
`relied upon in the Petition. Paper 14, 2–5. Given that Patent Owner bears
`the burden of producing evidence to support its antedating contention, we
`determine Petitioner did not have an obligation to preemptively address
`Patent Owner’s evidence in its Petition.
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`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.”).
`E. Petitioner’s Patentability Challenges
`1. Ground 1: Anticipation by Itou
`Petitioner asserts that claims 48, 51, and 53 are anticipated by Itou.
`Pet. 19. For the reasons set forth below, we determine that Petitioner has
`demonstrated a reasonable likelihood that claim 48, 51, and 53 are
`anticipated by Itou.
`a) Summary of Itou (Ex. 1607)
`Itou discloses “an intravascular foreign matter suction assembly”
`designed to suck, sample, and remove “foreign matter such as a thrombus or
`an embolus” from a blood vessel. Ex. 1607, 1:6–9, 1:47–49. This assembly
`includes a guiding catheter and a suction catheter configured to be inserted
`into the lumen of the guiding catheter. Id. at 1:49–65.
`Figure 3 of Itou is reproduced below:
`
`Figure 3 is a cross section of a distal end portion of suction catheter 2. Id. at
`2:61–62. Suction catheter 2 includes distal side tubular portion 24 and
`proximal side wire-like portion 25, formed from a solid metal wire and an
`
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`outer layer such as a polymer coating. Id. at 3:46–50. Tubular portion 24
`has reinforced tubular portion 21 and flexible distal tip 22. Id. at 2:15–51,
`3:50–58. Tubular portion 24 has an outer diameter that allows it to be
`inserted into the lumen of a guide catheter and wire-like portion 25 has a
`sectional area smaller than the sectional area of the tube wall of tubular
`portion 24. Id. at 3:59–63.
`
`Figure 5 of Itou is reproduced below:
`
`
`
`Figure 5 shows the suction assembly “in an assembled state.” Id. at 2:66–
`67. In this state, suction catheter 2 is disposed in the lumen of guiding
`catheter 1. Id. at 5:12–14. The distal end of distal end protective catheter 5
`is inserted into the lumen of suction catheter 2 and guide wire 6 is inserted
`into the lumen of the distal end protective catheter 5. Id. at 5:14–17. The
`proximal ends of suction catheter 2, distal end protective catheter 5, and
`guide wire 6 are “introduced to the outside through main connector portion
`31 of Y-shaped connector 3.” Id. at 5:17–20. A valve is built into main
`connector 31 and “can selectively clamp and fix” guide wire 6 and wire-like
`portions 25 or 55 “to prevent leakage of the blood.” Id. at 5:20–23. In one
`embodiment, the inner diameter of the guiding catheter is 1.8 mm and the
`inner diameter of the suction catheter is 1.5 mm. Id. at 7:55–67 (Table 1).
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`
`A portion of Figure 6 of Itou is reproduced below:
`
`
`Figure 6 illustrates the disclosed apparatus disposed in a coronary
`artery of the heart. Id. at 3:1–3. In Figure 6, guiding catheter 1 is disposed
`in aorta 81 and its distal end “is secured in such a form that it is hooked at an
`ostium 821 of coronary artery 82.” Id. at 5:29–34. Tubular portion 24 of
`suction catheter 2 is inserted into coronary artery 82 and is introduced along
`guide wire 6 to target location 80. Id. at 5:35–38. According to Itou, tubular
`portion 24 of suction catheter 2 has a “sufficient axial length so that the
`proximal end of the tubular portion 24 in an open state may not leap out
`from the distal end of the guiding catheter 1.” Id. at 5:38–41.
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`b) Discussion
`Petitioner contends that Itou teaches each of the limitations of claims
`48, 51, and 53. To support its position, Petitioner directs our attention to the
`foregoing discourses of Itou and provides a detailed claim analysis
`addressing how each element of claims 48, 51, and 53 is disclosed by Itou.
`Pet. 21–45 (citing generally Exs. 1405 and 1442).
`Patent Owner disagrees. Prelim. Resp. 33–40. Claims 48, 51, and 53
`each require, inter alia, a “guide extension catheter” including a “tubular
`structure” where “the side opening and the lumen of the tubular structure
`[are] configured to receive one or more stents or balloon catheters” when the
`side opening and proximal end of the tubular structure are within the guide
`catheter and the distal end of the guide extension catheter extends beyond
`the guide catheter. Ex. 1601, claims 48, 51, 53. Patent Owner contends that
`Petitioner