`571-272-7822
`
`Paper 85
`Entered: February 23, 2022
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC. AND MEDTRONIC VASCULAR,INC.,
`Petitioner,
`
`Vv.
`
`TELEFLEX LIFE SCIENCES LIMITED,
`Patent Owner.
`
`IPR2020-01343
`Patent RE46,116 E
`
`Before SHERIDAN K. SNEDDEN, JAMES A. TARTAL,and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`Opinion for the Board filed by Administrative Patent Judge TARTAL.
`
`Opinion Concurring by Administrative Patent Judge PAULRAJ.
`
`JUDGMENT
`Final Written Decision
`Determining Some Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`
`ORDER
`Denying Petitioner’s Motion to Exclude
`37 CFR. § 42.64(c)
`
`
`
`IPR2020-01343
`Patent RE46,116 E
`
`Wehavejurisdiction to conductthis inter partes review
`
`under 35 U.S.C. § 6. This Final Written Decision is issued pursuant
`
`to 35 U.S.C. § 318(a) (2018) and 37 C.F.R. § 42.73 (2019). Medtronic,Inc.
`and Medtronic Vascular, Inc. (“Petitioner”)! contends that claims 25-40,42,
`
`4448, 52, and 53 (“the Challenged Claims”) of U.S. Patent No. RE46,116 E
`
`(Ex. 1001, “the,?116 patent”) are unpatentable. For the reasons discussed
`
`below, we determine that Petitioner has shown by a preponderanceofthe
`evidence that each of claims 52 and 53 of the ’116 patentis unpatentable,
`but has not shown by a preponderanceof the evidence that any of claims 25—
`
`40, 42, and 44-48 ofthe ’116 patent is unpatentable.
`
`I.
`
`INTRODUCTION
`
`A. Summary ofProcedural History
`
`Petitionerfiled a Petition pursuant to 35 U.S.C. §§ 311-319
`
`requesting an inter partes review of the Challenged Claims. Paper 1
`
`(“Pet.”). We instituted an inter partes review of the Challenged Claims on
`
`all grounds of unpatentability asserted in the Petition. Paper 9 (“Inst. Dec.”).
`Teleflex Life Sciences Limited (“Patent Owner’)’ filed a Patent Owner
`
`Response.? Paper 21 (“PO Resp.”’) (underseal), 22 (redacted, publicly
`
`' Petitioner identifies as real parties-in-interest Medtronic, Inc. and
`Medtronic Vascular, Inc., and states, “Medtronic plc is the ultimate parent of
`Medtronic Inc.” Pet. 5.
`* Patent Owneridentifies as real parties-in-interest Teleflex Life Sciences
`Limited; Teleflex Medical Devices S.A.R.L.; Vascular Solutions LLC;
`Arrow International, Inc., and Teleflex LLC. Paper 4, 2. Patent Owneralso
`states “Teleflex Incorporated is the ultimate parent ofthe entities listed
`above.” Id.
`3 Priorto institution, Patent Ownerfiled a Preliminary Response directed
`primarily to whether discretionary denial of the Petition was warranted, not
`to the merits of Petitioner’s unpatentability contentions. See Paper7.
`
`2
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`
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`IPR2020-01343
`Patent RE46,116E
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`accessible). Petitioner filed a Reply to the Patent Owner Response.
`
`Paper 46 (“Pet. Reply’) (under seal), 47 (redacted, publicly accessible).
`
`Patent Ownerfiled a Sur-reply in support of the Patent Owner Response.
`
`Paper 59 (“PO Sur-reply”).
`
`Following oral argument, we entered a transcript of the hearing in
`
`the record. Paper 84 (“Tr.”). Petitioner bears the burden of proving
`
`unpatentability of each claim it has challenged by a preponderanceofthe
`
`evidence, and the burden of persuasion never shifts to Patent Owner.
`
`See 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d); Dynamic Drinkware, LICv.
`
`Nat’! Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015).
`
`B. Related Proceedings
`
`Petitioner challenges claims 25—55 ofthe ’116 patent under separate
`
`groundsin IPR2020-01344. Pet. 6; Paper 4, 3: The parties identify the °116
`
`patent as a subject of: (1) Vascular Solutions LLC,et al. v. Medtronic,Inc.,
`
`et al., No. 19-cv-01760 (D. Minn.), and (2) OXMedical, LLC v. Vascular
`
`Solutions, LLC, No. 17-cv-01969 (D. Minn.). Pet. 5—6; Paper 4, 2. Patent
`
`Ownerstates that both of these district court proceedings are currently
`
`stayed. Paper 4, 2. The parties further state that the ’116 patent is a reissue
`
`of the ’850 patent and that the ’850 patent was a subject of: (1) Vascular
`
`Solutions, Inc. v. Boston Scientific Corp., No. 13-cv-01172 (D. Minn.),
`
`and (2) Boston Scientific Corp. v. Vascular Solutions, Inc., IPR2014-00762,
`
`IPR2014-00763 (PTAB,terminated). Pet. 6; Paper 4, 2-3.
`
`Additionally, Petitioner filed petitions challenging patents related to
`
`the 7116 patent in the following proceedings: IPR2020-00126 and IPR2020-
`
`00127 (Patent 8,048,032 B2); IPR2020-00128, IPR2020-00129, IPR2020-
`
`00130, and IPR2020-00131 (Patent RE45,380 E); IPR2020-00132,
`
`IPR2020-00133, and IPR2020-00134 (Patent RE45,760 E); IPR2020-00135
`
`
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`IPR2020-01343
`Patent RE46,116 E
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`and IPR2020-00136 (Patent RE45,776 E); IPR2020-00137 and IPR2020-
`
`00138 (Patent RE47,379 E); and IPR2020-01341 and IPR2020-01342
`
`(Patent 8,142,413 B2). Institution of inter partes review was denied in
`
`IPR2020-00131 and IPR2020-00133.
`
`C. The ’116 Patent
`
`The ’116 patent, titled “(Coaxial Guide Catheter for Interventional
`
`Cardiology Procedures,” issued August 23, 2016, from Application
`
`No. 14/195,435, filed March 3, 2014. Ex. 1001, codes (21), (22), (45), (54).
`
`The ’116 patent is a reissue of U.S. Patent No. 8,292,850 (“the ’850 patent”)
`
`from Application No. 13/359,059 filed on January 26, 2012, which
`
`the ?116 patent states is a continuation of an application filed on
`
`November |, 2013 (issued as U.S. Patent No. RE45,380), which is an
`
`application for the reissue of U.S. Patent No. 8,292,850, whichis a division
`
`of an application filed on June 28, 2010 (issued as U.S. Patent
`
`No. 8,142,413), which is a division of an application filed on May 3, 2006
`
`(Application No. 11/416,629 (‘“the.’629 application”), issued as U.S. Patent
`
`No. 8,048,032). Jd. codes (60), (64). The ’116 patentis directed to
`
`“methods and apparatus for increasing backup support for catheters inserted
`
`into the coronary arteries from the aorta.” Jd. at 1:38-40.
`
`The ’116 patent explains, as background,that in “[i]nterventional
`
`cardiology procedures,” guidewires or other instruments, such as balloon
`
`catheters and stents, are often inserted through guide catheters into coronary
`
`arteries that branch off from the aorta. Jd. at 1:44~50. In coronary artery
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`disease, “the coronary arteries may be narrowed or occluded by
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`atherosclerotic plaques or other lesions” in a phenomenon knownas
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`stenosis. Jd. at 1:50-54. In treating the stenosis, “a guide catheteris
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`inserted through the aorta and into the ostium of the coronary artery,”
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`
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`IPR2020-01343
`Patent RE46,116 E
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`sometimeswith the aid of a guidewire, and is passed beyond the occlusion
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`or stenosis. Jd. at 1:59-65. However, according to the ’116 patent,
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`“[c]rossing tough lesions can create enough backward force to dislodge the
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`guide catheter from the ostium ofthe artery being treated,” which “can make
`
`it difficult or impossible for the interventional cardiologist to treat certain
`
`forms of coronary artery disease.” Id. at 1:66—2:3.
`
`The °116 patent discusses four categories of previous“attempts to
`
`provide support to the guiding catheter to prevent backward dislodgement
`
`from the coronary ostium (referred to as ‘backup support’).” Jd. at 2:4—-7.
`
`One category of guiding catheters “are configured to draw backup support
`
`from engaging the wall of the aortic arch opposing the ostium ofthe
`
`coronary artery that is being accessed.” Jd. at 2:8-11. A second category
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`are “guiding catheters that include a retractable appendage. Jd. at 2:25—26.
`
`‘ A third category are “guide catheters that have a portion that seeks to expand
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`laterally to grip the interior wall of the ostium.” Jd. at 2:36-41. A fourth
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`category, or “technique,” of the prior attempts “includes the placementof a
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`smaller guide catheter within a larger guide catheter in order to provide
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`added support for the crossing oflesions or for the distal delivery of balloons
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`and stents.” Jd. at 2:50-53. The ’116 patent states this fourth technique was
`
`described in Takahashi,* which uses a guide catheter inserted “more deeply
`
`into the ostium of the coronary artery than typically has been done before.”
`
`Id. at 2:53-62. The ’116 patent states that such “deep seating” by this
`
`technique “creates the risk that the relatively stiff, fixed curve, guide catheter
`
`will damage the coronary artery.” Jd. at 2:63-65.
`
`4 Saeko Takahashi,et al., New Method to Increase a Backup Support
`ofa 6 French Guiding Coronary Catheter, 63 CATHETERIZATION AND
`CARDIOVASCULARINTERVENTIONS 452-456 (2004) (Ex. 1010, “Takahashr’”).
`
`5
`
`
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`IPR2020-01343
`Patent RE46,116 E
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`The °116 patent purports to resolve issues identified with the prior
`
`procedures by using “a coaxial guide catheter that is deliverable through
`
`standard guide catheters by utilizing a guidewire rail segment to permit
`
`delivery without blocking use of the guide catheter.” Jd. at 3:20—23.
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`According to the ’116 patent, the coaxial guide catheter “preferably includes
`
`a tapered innercatheter that runs over a standard 0.014 inch coronary
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`guidewire to allow atraumatic placement within the coronary artery,” and
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`this feature allows removal of the tapered inner catheter after the coaxial
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`guide catheter is in place. /d. at 3:23-28.
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`Figures 1 and 2, reproduced below, show a coaxial guide catheter and
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`a tapered inner catheter in accordance with the invention described in
`
`the °116 patent:
`
`Fig. 1
`~10
`
`x
`
`48
`
`4
`
`Fig. 2
`“”
`
`2
`
`a
`
`a27
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`Figure 1 is a schematic depiction of the coaxial guide catheter and tapered
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`inner catheter separately, and Figure 2 depicts those two elements assembled
`
`together. Id. at 5:51—56; Figs. 1 and 2. As shownabove,“coaxial guide
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`catheter assembly 10”includes coaxial guide catheter 12 and tapered inner
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`catheter 14. Jd. at 6:42-44. Coaxial guide catheter 12 includes tip
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`
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`IPR2020-01343
`Patent RE46,116 E
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`portion 16, reinforced portion 18, and rigid portion 20. Jd. at 6:45—46.
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`Tapered inner catheter 14 “includes tapered innercatheter tip 42.” Jd.
`
`at 7:26-27. Tapered innercatheter tip 42 includes tapered portion 46 at a
`distal end thereof, and straight portion 48. Jd. at 7:30-3 1. Both tapered
`portion 46 andstraight portion 48 are pierced by lumen 50 (not labeled in
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`figures above). Jd. at 7:31-32. “Tapered inner catheter 14 may also include
`
`clip 54 at a proximal end thereof to releasably join tapered inner catheter 14
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`to coaxial guide catheter 12.” Jd. at 7:35-37. “The tapered inner catheter
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`provides a gradualtransition from the standard 0.014 inch diameter
`guidewire to the diameterof the coaxial guide catheter whichis typically
`five to eight French.” Jd. at 3:28-31. The coaxial guide catheter is made in
`
`at least three sizes corresponding to sizes commonly usedin interventional
`
`cardiology procedures. Jd. at 3:39-42.
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`Figure 4, reproduced below, showsa coaxial guide catheter in
`
`accordance with the invention described in the ’116 patent:
`
`
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`Figure 4 is a sectional view of the coaxial guide catheter with tip portion 16
`
`depicted on theleft side of the figure (rather than on the right side as shown
`
`in Figures 1 and 2). Jd. at 5:60; Fig. 4. As shown above, coaxial guide
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`catheter 12 has rigid portion 20 that “includesfirst full circumference
`
`portion 34, hemicylindrical portion 36, arcuate portion 38, and secondfull
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`
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`IPR2020-01343
`Patent RE46,116E
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`circumference portion 40” (second full circumference portion 40 is shown in
`
`Figure 3). Jd. at 7:7—-10.
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`In operation, a guide catheter and a guidewire are used along with the
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`coaxial guide catheter and the tapered inner catheter. Ex. 1001, 8:20-22.
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`Figure 8, reproduced below, showsthe operation of the coaxial guide
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`catheter assembly in accordance with the invention describedin the ’116
`
`patent:
`
`Figure 8 is a schematic view of a guide catheter and a guide wire in use with
`
`the coaxial guide catheter assembly within the aortic arch and coronary
`
`artery. Id. at 6:5-8; Fig. 8. First, guidewire 64 is inserted and passed
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`through aortic arch 58 into ostium 60 of coronary artery 62. Id. at 7:65—66.
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`Guide catheter 56 is then passed over guidewire 64 until the distal end of
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`guide catheter 56 is seated in ostium 60. Jd. at 8:4-6. Next, coaxial guide
`catheter 12 with tapered inner catheter 14 is passed through guide
`catheter 56 and over guidewire 64 into coronary artery 62. Id. at 8:22-24.
`
`The presence of coaxial guide catheter 12 within guide catheter 56 “provides
`
`
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`IPR2020-01343
`Patent RE46,116 E
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`stiffer back up support than guide catheter 56 alone.” Jd. at 8:38-40. “Once
`
`the coaxial guide catheter-tapered inner catheter combination has been
`
`inserted sufficiently into the ostium of the coronaryartery to achieve deep
`
`seating the tapered inner catheter may be removed.” Jd. at 4:58-62; see also
`
`id. at 8:30-32. Thereafter, coaxial guide catheter 12 can “accept a treatment
`
`catheter such asa stent or a balloon catheter.” Jd. at 8:33-34. “[T]he
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`presence of the coaxial guide catheter provides additional backup support to
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`makeit less likely that the coaxial guide catheter guide catheter combination
`will be dislodged from the ostium of the coronary artery while directing the
`coronary therapeutic device past a tough lesion.” Jd. at 5:2-6. “[T]he
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`invention is deliverable through an existing hemostatic valve arrangement on
`
`a guide catheter without preventing injections through existing Y adapters.”
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`Id. at 5:42-44.
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`D.Illustrative Claim ofthe ’116 Patent
`
`Petitioner challenges claims 25—40, 42, 44-48, 52, and 53 of
`
`the °116 patent. Pet. 1. Claims 25 and 52 are independent methodclaims.
`
`Ex. 1001, 13:62—-14:25, 17:10-18:10. Claims 26—40, 42, and 44-48 depend
`
`from claim 25 and claim 53 depends from claim 52. Jd. at 14:26—-15:41,
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`15:47-50, 18:11-14. Claim 25is illustrative of the claimed subject matter
`
`and is reproduced below.
`
`25. A method, comprising:
`advancing a distal end of a guide catheter having a lumen through
`a main blood vessel to an ostium of a coronary artery;
`advancing a distal end of a guide extension catheter through, and
`beyond the distal end of,
`the guide catheter,
`including
`advancing a distal end portion of a tubular structure of the
`guide extension catheter beyond the distal end of the guide
`catheter while a segment defining a side opening of the guide
`extension catheter remains within the guide catheter the side
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`
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`IPR2020-01343
`Patent RE46,116 E
`
`opening extending for a distance along a longitudinal axis of
`the guide extension catheter and accessible from a longitudinal
`side defined transverse to the longitudinal axis, the tubular
`structure having a cross-sectional inner diameter that is not
`more than one Frenchsize smaller than a cross-sectional inner
`diameter of the lumen ofthe guide catheter;
`maintaining the distal end portion of the tubular structure of the
`guide extension catheter in position beyond the distal end of
`the guide catheter; and
`while maintaining the distal end of the guide extension catheter
`positioned beyond the distal end of the guide catheter
`advancing a balloon catheter or stent at least partially through
`the guide catheter and the guide extension catheter and into the
`coronary artery, including advancing the balloon catheter or
`stent through a hemostatic valve associated with a proximal
`end of the guide catheter, along a substantially rigid segment
`ofthe guide extension catheter, through the side opening, and
`through the tubular structure.
`
`Id. at 13:62—14:25.
`
`E. References and Testimony
`
`Petitioner’s contentionsrely, in part, on testimony from Dr. Brecker,
`
`Dr. Hillstead, and Mr. Jones. Dr. Brecker states that he has been an
`
`interventional cardiologist for over twenty-four years, that he has been Chief
`
`of Cardiology at St. Georges University Hospitals Londonsince 2015, and
`
`that he is a Professor of Cardiology and Chief of Cardiology Clinical
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`Academic Group at St. George’s University. Ex. 1005 f 4, 5, 7.
`
`Dr. Hillstead states that he is CEO of a medical device development and
`
`entrepreneurship consulting firm, the Chairman of a woundhealing device
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`company, a namedinventor on numerouspatents and pending applications
`
`related to catheter design, and that he has been involvedin the design and
`
`developmentof medical devices for more than thirty years. Ex. 1042 {{ 5,
`
`10, 12. Mr. Jones states that he has worked in contract mechanical
`
`
`
`IPR2020-01343
`Patent RE46,116E
`engineering since 1997 on projects including “prototype designs for
`minimally invasive, surgical, and implantable devices, development and
`
`fabrication for surgical devices, test fixture design and fabrication, and
`
`process validation,” that he previously worked as an engineer on medical
`
`device design, development and manufacturing, including on catheters, and
`
`that he is a named inventor on over 100 patents. Ex. 1807 {| 8-10.
`
`Patent Owner’s argumentsrely, in part, on testimony from Mr. Keith
`
`and Dr. Graham. Mr.Keith states that his work between 1987 and 1996 as
`an engineer at a medical device company focused in the field of
`interventional cardiology and catheter design, that since 1997 he has served
`
`as an independentconsultant for early stage medical device companiesin
`~ product design andintellectual property development, that he co-founded a
`
`medical device company “focused on catheter-based treatments for chronic
`
`sinusitis,” and that he is a namedinventor on over 140 patents. Ex. 2138
`
`¥{ 3-6. Dr. Grahamstates that he is an interventional cardiologist at
`
`St. Michael’s Hospital, an Assistant Professor in the Division of Cardiology
`
`at the University of Toronto, and that he has over twenty years of experience
`
`in interventional cardiology. Ex. 2145 ¥ 1.
`
`Below weprovide a table identifying the references asserted.
`
`References
`
`
`
`
`U.S. Patent No. 7,736,355 B2 (“Itou”)
`
`June 15, 2010
`
`1007
`
`US. Patent No. 7,604,612 B2 (“Ressemann”)|October 20, 2009|1008
`
`
`
`US 2005/0015073 Al (“Kataishi’’) January 20, 2005|1025
`
`
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`IPR2020-01343
`Patent RE46,116 E
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`F.. Asserted Grounds of Unpatentability
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`Petitioner alleges unpatentability of the Challenged Claims on the
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`following grounds:
`
`
`
`
`
`
`r
`
`
`Pet. 8-9.
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`
`
`
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`
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`II. MOTION TO EXCLUDE
`
`The party moving to exclude evidence bears the burden of proving
`
`thatit is entitled to the relief requested—namely, that the material sought to
`
`be excluded is inadmissible under the Federal Rules of Evidence (“FRE”).
`
`See 37 C.F.R. §§ 42.20(c), 42.62(a) (2019). In an inter partes review in
`
`which we both decide admissibility and serve as the fact-finder, we are well-
`positioned to determineand assign appropriate weightto evidence presented,
`and we recognize that a complete record of the evidenceis preferable to
`
`facilitate public access as well as appellate review. See, e.g., Sony Computer
`
`Entm’t Am. LLC v. Game Controller Tech. LLC, IPR2013-00634,
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`Paper 32 at 31 (PTAB Apr. 14, 2015); see also Gnosis S.p.A. v. S. Alabama
`
`Med. Sci. Found., IPR2013-00118, Paper 64 at 43 (PTAB June 20, 2014)
`
`(citing Donnelly GarmentCo. v. NLRB, 123 F.2d 215, 224 (8th Cir. 1941)
`(“Ifthe record on review contains not only all evidence which wasclearly
`admissible, but also all evidence of doubtful admissibility, the court which is
`
`called upon to review the case can usually make an end ofit, whereas if
`
`evidence was excluded whichthat court regards as having been admissible, a
`newtrial or rehearing cannot be avoided.”)).
`
`12
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`
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`IPR2020-01343
`Patent RE46,116E
`
`Petitioner moves to exclude Exhibit 2024, a documenttitled “Product
`
`Requirements: Guideliner Catheter System,” as well as certain portions of
`
`the deposition testimony of Steven Erb (specifically, Ex. 1799, 37:2-7,
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`37:20—38:6, 39:17-40:20). Paper 65 (the “Motion”or “Mot.”); see also
`
`Paper 74 (Petitioner’s reply in support of its motion to exclude). Patent
`
`Owneropposes the Motion. Paper 69 (“Mot. Opp.”).
`
`Petitioner contends that Exhibit 2024 is unreliable on its face and that
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`none of Patent Owner’s witnesses can authenticate the document. Mot. 2-9.
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`Patent Ownerresponds that Exhibit 2024 is authenticated under FRE 901
`
`based on the declaration and/or deposition testimony of Mr. Peterson
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`(Ex. 2252 | 18), Ms. Schmalz (Ex. 2039 {J 6—7), Mr. Root (Ex. 2118 757),
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`and Mr. Sutton (Ex. 2119 4 44). Mot. Opp. 3-8.
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`Documents are authenticated by evidence “sufficient to support a
`finding that the item is what the proponent claims it is.” Fed. R.
`
`Evid. 901(a); see Fox Factory v. SRAM, LLC, IPR2016-01876, Paper 59
`at 63 (PTAB Apr. 2, 2018) (quoting same). “Authenticity is, therefore, not
`
`an especially high hurdle for a party to overcome.” Fox Factory, Paper 59
`
`at 63 (citing United States v. Patterson, 277 F.3d 709, 713 (4th Cir. 2002)).
`
`Wedetermine that Exhibit 2024 has been authenticated under the low
`
`bar required under Federal Rule of Evidence 901 based on the evidence
`
`provided by Petitioner. See Mot. Opp. 2-11.
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`In addition, Petitioner’s
`
`arguments go to the weight of the evidence and notits admissibility.
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`Accordingly, we deny Petitioner’s Motion to Exclude. We note, however,
`
`that even if we were to exclude Exhibit 2024, it would not change the
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`outcomeor our general analysis ofthis case.
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`
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`IPR2020-01343
`Patent RE46,116 E
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`Petitioner also argues that the portions of the testimony of Mr. Erbit
`
`seeks to exclude are prejudicial, citing FRE 403. Mot. 10-15. We find
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`Petitioner fails to show any prejudice. As Patent Owner explains, “[t]he
`
`testimony concerned subjects in Mr. Erb’s declaration and about which
`
`Petitioner had elicited testimony, Petitioner had the opportunity to (and did)
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`re-cross Mr. Erb, and Petitioner had the opportunity to (and did) submit a
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`sur-reply brief.” Mot. Opp. 11-14 (citing, e.g., Ex. 1799, 10:11—12:16,
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`38:24-40:21; Ex. 2122 Ff 17-20; IPR2020-01341, Paper 51, 14-15).
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`Accordingly, we deny Petitioner’s motion to exclude testimony of Mr. Erb.
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`Wenote, however, that even if we were to exclude the testimonyatissue,it
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`would not change the outcomeorour generalanalysis of this case.
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`Il. ANALYSIS OF PATENTABILITY
`
`In our analysis of Petitioner’s unpatentability contentions with respect
`
`to the Challenged Claims, we next addressthe priority date of the °116
`
`patent; applicable principles of law; the level of ordinary skill in the art; the
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`proposed construction of claim terms; the scope and content of the asserted
`
`prior art; and then further analyze Petitioner’s contentions with respect to
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`each alleged ground of unpatentability for purposes of determining whether
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`Petitioner showsby a preponderanceof the evidence the unpatentability of
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`the Challenged Claims.
`
`A. Priority Date ofthe ’116 Patent
`Petitioner argues that “[t]he ’116 patent is subject to the AIA[*]first-
`
`to-file provisions because (1) it contains claims that lack written description,
`
`and therefore pre-AJA priority, and (2)it claims priority to RE 45,380
`
`> Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112—29, 125 Stat.
`284 (2011).
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`
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`IPR2020-01343
`Patent RE46,116E
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`(“the ’380 patent”), which is subject to the AIA first-to-file provisions.”
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`Pet. 12-13. Petitioner contends that because there is no written description
`
`support for the subject matter of at least claim 27 of the *380 patent and
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`claim 45 of the ’?116 patent, the ?116 patent has an effective filing date after
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`March 16, 2013. Jd. at 12-13. Thus, according to Petitioner, the ?116 patent
`
`is subject to the AIA’s first-to-file provisions, which precludes Patent Owner
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`from attempting to swear behind Itou’s filing date. Jd. Patent Ownerargues
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`that the Board previously rejected Petitioner’s arguments concerning
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`the ?380 patent, and that Petitioner’s arguments here likewise fail. PO
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`Resp. 5-9; see also Medtronic Inc. and Medtronic Vascular, Inc., v. Teleflex
`Innovations S.A.R.L., [PR2020-00128, Paper 127 (PTAB June7, 2021).
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`Thefirst-to-file provisions apply to patent applications“that contain[]
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`or contained at any time a claim to a claimedinvention that has an effective
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`filing date” on or after March 16, 2013. AIA § 3(n)(1). The application for
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`reissue for the ’116 patent was filed March 3, 2014, and sought reissue of
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`U.S. Patent No. 8,292,850, which issued October 23, 2012, from an
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`application filed January 26, 2012. Ex. 1001, codes (22), (64). “The
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`effective filing date for a claimed invention in an application for reissue or
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`reissued patent shall be determined by deemingthe claim to the invention to
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`have been contained in the patent for which reissue was sought.” 35 U.S.C.
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`§ 100(i)(2) (2018). As the “patent for which reissue was sought”in this case
`wasissued October 23, 2012, we are not persuaded that the AIA’s first-to-
`file provisions apply to the ’116 patent. Indeed, Petitioner provides no legal
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`support for the proposition that claims in a reissue patent are not entitled to a
`°
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`filing date as if they appearedin the original patent for which reissue was
`sought.®
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`B. Principles ofLaw
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`Underone ground,Petitioner contendsthat claims of the ’116 patent
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`are unpatentable based on anticipation. Pet. 23-31. A claim is anticipated if
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`a single prior art reference either expressly or inherently discloses every
`limitation of the claim. Orion IP, LLC v. Hyundai Motor Am., 605 F.3d 967,
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`975 (Fed. Cir. 2010). “A single prior art reference may anticipate without
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`disclosing a feature of the claimed invention if such feature is necessarily
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`present, or inherent, in that reference.” Allergan, Inc. v. Apotex Inc.,
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`754 F.3d 952, 958 (Fed. Cir. 2014) (citing Schering Corp. v. Geneva
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`Pharm., 339 F.3d 1373, 1377 (Fed. Cir. 2003)).
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`Petitioner contends under two groundsthat claims of the ’116 patent
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`are unpatentable based on obviousness. Pet. 32-80. As set forth in
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`35 U.S.C. § 103(a),
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`[a] patent may notbe obtained. . . if the differences between the
`subject matter sought to be patented and the prior art are such
`that the subject matter as a whole would have been obviousat the
`time the invention was madeto a person havingordinary skill in
`the art to which said subject matter pertains.
`The question of obviousness is resolved on the basis of underlying factual
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`determinations including (1) the scope and contentofthe prior art; (2) any
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`differences between the claimed subject matter and the priorart; (3) the level
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`of ordinary skill in the art; and (4) when in evidence, objective evidence of
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`6 To the extent the original patent for which reissue was sought does not
`contain written description support for a reissue claim, that claim may be
`invalid. But this is a question we may not address in an IPR. 35 U.S.C.
`§ 311(b).
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`nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966).
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`An obviousnessanalysis “need not seek out precise teachings directed to the
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`specific subject matter of the challenged claim, for a court can take account
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`of the inferences and creative steps that a person of ordinary skill in the art
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`would employ.” KSR Int’! Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007);
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`accord In re Translogic Tech., Inc., 504 F.3d 1249, 1259 (Fed. Cir. 2007).
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`However, Petitioner cannotsatisfy its burden of proving obviousness by
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`employing “mere conclusory statements.” In re Magnum Oil Tools
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`Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016). Instead, Petitioner must
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`articulate a reason why a person ofordinary skill in the art would have
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`combinedthe prior art references. In re NuVasive, 842 F.3d 1376, 1382
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`(Fed. Cir. 2016).
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`C. Level of Ordinary Skill in the Art
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`In determining whether an invention would have been obviousat the
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`time it was made, 35 U.S.C. § 103 requires us to resolve the level of
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`ordinary skill in the pertinentart at the time of the invention. Graham,
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`383 U.S. at 17. The person ofordinary skill in the art is a hypothetical
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`person whois presumed to have knowntherelevantart at the time of the
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`invention. In re GPAC,Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). In
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`determining the level of ordinary skill in the art, various factors may be
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`considered, including the “type of problems encountered in theart; priorart
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`solutions to those problems; rapidity with which innovations are made;
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`sophistication of the technology; and educational level of active workersin
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`the field.” Jd.
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`Petitioner contendsthat a person of ordinary skill in the art at the time
`
`of the invention would have beeneither: (1) a medical doctor who would
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`have had “(a) a medical degree; (b) completed a coronary intervention
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`training program, and (c) experience working as an interventional
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`cardiologist;” or (2) an engineer who would have had “(a) an undergraduate
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`degree in engineering, such as mechanical or biomedical engineering;
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`and (b) at least three years of experience designing medical devices,
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`including catheters or catheter-deployable devices.” Pet. 13-14.
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`Additionally, Petitioner contends “{e]xtensive experience andtechnical
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`training might substitute for education, and advanced degrees might
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`substitute for experience.” Jd. at 14. Further, according to Petitioner,
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`a person ofordinary skill in the art “with a medical degree” and a person of
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`ordinary skill in the art “with an engineering degree” may have had access to
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`each other. Jd. (citing Ex. 1005 ¥ 31; Ex. 1042 9 18-19).
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`Patent Owner doesnotdispute Petitioner’s proposed level ofordinary
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`skill. PO Resp. 5. We adopt Petitioner’s proposed level of ordinary skill in
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`the art as it is undisputed and consistent with the level of skill reflected in
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`the prior art and the specification of the °116 patent. See Okajimav.
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`Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific
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`findings regarding ordinary skill level are not required “wheretheprior art
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`itself reflects an appropriate level and a need for testimony is not shown”)
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`(quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158,
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`163 (Fed. Cir. 1985)).
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`Astheir qualifications are undisputed, we also determinethat the
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`parties’ experts are qualified to opine on the issues in this proceeding from
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`the perspective of a person of ordinary skill in the art. Ex. 1042 { 5, 10, 12
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`(Dr. Hillstead’s qualifications);’ Ex. 1807 J] 8-10 (Mr. Jones’s
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`qualifications); Ex. 2138 J 3-6 (Mr. Keith’s qualifications); Ex. 2145 {1
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`(Dr. Graham’s qualifications); see Kyocera Senco Indus. Tools Inc. v. Int'l
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`Trade Comm’n, 22 F.4th 1369, 1376-77 (Fed. Cir. 2022) (“To offer expert
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`testimony from the perspective of a skilled artisan in a patent case ...a
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`witness mustat least have ordinary skill in the art.”’).
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`D. Claim Construction
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`“Tn an inter partes review proceeding, a claim of a patent .
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`.
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`. shall be
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`construed using the same claim construction standard that would be used
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`to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R.
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`§ 42.100(b). That standard “includ[es] construing the claim in accordance
`
`with the ordinary and customary meaning of such claim as understood by
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`one of ordinary skill in the art and the prosecution history pertaining to
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`the patent.” Jd.; see also Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir.
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`2005) (en banc).
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`Petitioner proposes the following constructions: (1) “substantially
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`rigid” as “rigid enough to allow the device to be advanced within the guide
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`catheter,” (2) “side opening” needs no construction and should be given
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`its plain and ordinary meaning,(3) “lumen”as “the cavity of a tube,”
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`and (4) “flexural modulus”as “[a] measureofresistance .
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`.
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`. to bending.”
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`7 Patent Ownerarguesthat Dr. Hillstead does not meet the definition of a
`person of ordinary skill in the art because he lacks a four-year undergraduate
`degree in engineering. PO Resp. 5 n.1 (citing, e.g., Ex. 2137, 462:8-13). As
`noted above, however,it is undisputed that “[e]xtensive experience and
`technical training might substitute for education.” Pet. 14. Patent Owner
`does not address Dr. Hillstead’s significant professional experience, which
`wefind sufficient to show heis qualified to opine on the issuesin this
`proceeding from the perspective of a person of ordinary skill in the art. See
`Ex. 1043 (curriculum vitae of Dr. Hillstead).
`
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`Pet. 14-15 (quoting Ex. 1040, 772) (alterations in original). Patent Owner
`does not dispute at this stage of the proceeding Petitioner’s proposed
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`construction of these terms. See generally PO Resp. In view ofthe issues
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`we address below, we determineit is not necessary to address the express
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`interpretation of any claim term. See Nidec Motor Corp. v. Zhongshan
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`Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017); Vivid
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`Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)
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`(“[O]nly those terms need be construed that are in controversy, and only to
`the extent necessary to resolve the controversy’).
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`E. Scope and Content ofthe Prior Art
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`Petitioner relies on Ressemann,Itou, and Kataishi, each of which we
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`briefly summarize in relevant part below.
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`1.
`
`S