UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC. and MEDTRONIC VASCULAR, INC.,
`Petitioners,
`
`v.
`
`TELEFLEX INNOVATIONS S.A.R.L.,
`Patent Owner
`
`IPR2020-00135
`Patent RE45,776 E
`
`PETITIONERS MEDTRONIC, INC. AND MEDTRONIC VASCULAR,
`INC.’S NOTICE OF APPEAL UNDER 37 C.F.R. § 90.2(a)
`
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`
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`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC. and MEDTRONIC VASCULAR, INC.,
`Petitioners,
`
`v.
`
`TELEFLEX INNOVATIONS S.A.R.L.,
`Patent Owner
`
`IPR2020-00135
`Patent RE45,776 E
`
`PETITIONERS MEDTRONIC, INC. AND MEDTRONIC VASCULAR,
`INC.’S NOTICE OF APPEAL UNDER 37 C.F.R. § 90.2(a)
`
`
`
`
`
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`
`
`
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`Pursuant to 35 U.S.C. §§ 141-144, 319, and 37 C.F.R.§ 90.2(a), notice is
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`hereby given that Petitioners Medtronic, Inc. and Medtronic Vascular, Inc.
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`(“Medtronic”) appeal to the United States Court of Appeals for the Federal Circuit
`
`from the Final Written Decision (“Final Written Decision”) (Paper No. 126, dated
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`June 7, 2021 (filed under seal); Paper No. 128, dated June 17, 2021 (redacted)), the
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`Order denying Director review of the Final Written Decision (“Order Denying
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`Director Review”) (Paper No. 131, dated August 27, 2021), and the Order denying
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`review by the Precedential Opinion Panel (“Order Denying POP Review”) (Paper
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`132, dated September 8, 2021), all entered by the United States Patent and
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`Trademark Office, Patent Trial and Appeal Board (“Board”) in IPR2020-00135,
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`and from all underlying orders, decisions, rulings, and opinions. Copies of the
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`Final Written Decision, the Order Denying Director Review, and the Order
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`Denying POP Review are attached hereto as Exhibits A1 (filed under seal), A2
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`(redacted), B, and C.
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`In accordance with 37 C.F.R. § 90.2(a)(3)(ii), Medtronic further indicates
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`that the issues on appeal may include, but are not limited to, whether the Board
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`erred in determining that claims 25-27, 29-33, 35-39, 41-49, and 52-56 of U.S.
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`Patent Number RE45,776 were not shown to be unpatentable under 35 U.S.C.
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`§ 102 or § 103, any findings supporting or related to the Board’s determination,
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`and all other issues decided adversely to Medtronic in any order, decision, ruling,
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`1
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`
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`and/or opinion, including but not limited to the Board’s failure to properly consider
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`evidence of record, the Board’s legal errors in undertaking the anticipation and
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`obviousness analyses, and the Board’s findings that conflict with the evidence of
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`record and are not supported by substantial evidence.
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`Simultaneous with this submission, a copy of this Notice of Appeal is being
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`filed through the Patent Trial and Appeal Board End to End (“PTAB E2E”)
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`System. In addition, a copy of the Notice of Appeal, along with the required
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`docketing fee, is being filed with the Clerk of Court for the United States Court of
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`Appeals for the Federal Circuit.
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`
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`Dated: September 27, 2021
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`Respectfully submitted,
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`
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`
`
`/s/ Cyrus A. Morton
`Cyrus A. Morton
`ROBINS KAPLAN LLP
`800 LaSalle Avenue, Suite 2800
`Minneapolis, MN 55402
`(612) 349-8500
`Attorney for Petitioner
`
`
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`2
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`
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`CERTIFICATE OF SERVICE
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`I hereby certify that on this September 27, 2021, a copy of Petitioners
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`Medtronic, Inc. and Medtronic Vascular, Inc.’s Notice of Appeal Under 37 C.F.R.
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`§ 90.2(a) was served in its entirety by electronic mail on Patent Owner’s counsel at
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`the following addresses included in Patent Owner’s Mandatory Notices:
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`J. Derek Vandenburgh, Reg. No. 32,179
`dvandenburgh@carlsoncaspers.com
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`Dennis C. Bremer, Reg. No. 40,528
`dbremer@carlsoncaspers.com
`
`Joseph W. Winkels
`jwinkels@carlsoncaspers.com
`
`Peter M. Kohlhepp
`pkohlhepp@carlsoncaspers.com
`
`Tara C. Norgard
`tnorgard@carlsoncaspers.com
`
`Alexander S. Rinn
`pkohlhepp@carlsoncaspers.com
`
`Megan E. Christner, Reg. No. 78,979
`mchristner@carlsoncaspers.com
`
`Kenneth E. Levitt, Reg. No. 39,747
`levitt.kenneth@dorsey.com
`
`
`Dated: September 27, 2021
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`
`
`
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`Respectfully submitted,
`/s/ Cyrus A. Morton
`Cyrus A. Morton
`Reg. No. 44,954
`Attorney for Petitioners
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`3
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`EXHIBIT A1
`(Redacted in Full)
`in
`(Redacted
`Full)
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`EXHIBIT Al
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`EXHIBIT A2
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`EXHIBIT A2
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`PUBLIC VERSION
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`Trials@uspto.gov
`571-272-7822
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`Paper
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`Date:
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC., and MEDTRONIC VASCULAR, INC.,
`Petitioner,
`v.
`TELEFLEX INNOVATIONS S.À.R.L.,
`Patent Owner.
`
`IPR2020-00135
`Patent RE45,776 E
`
`Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`PAULRAJ, Administrative Patent Judge.
`
`JUDGMENT
`Final Written Decision
`Determining No Challenged Claims Unpatentable
`No Deciding Patent Owner’s Contingent Motion to Amend
`35 U.S.C. § 318(a)
`
`ORDER
`Denying Petitioner’s Motion to Exclude (Paper 110)
`37 C.F.R. § 42.64(c)
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`PUBLIC VERSION
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`INTRODUCTION
`I.
`A. Background and Summary
`This is our Final Written Decision entered pursuant to 35 U.S.C.
`§ 318(a) and 37 C.F.R. § 42.73. For the reasons explained in our analysis
`below, we determine that the primary reference relied upon by Petitioner for
`all its patentability challenges does not qualify as prior art because Patent
`Owner has antedated that reference. Thus, Petitioner has not demonstrated
`that any of the challenged claims are unpatentable in this proceeding.
`On November 14, 2019, Medtronic, Inc. and Medtronic Vascular, Inc.
`(collectively, “Petitioner”) filed a Petition requesting an inter partes review
`of claims 25–27, 29–33, 35–39, 41–49, and 52–56 of U.S. Patent No.
`RE45,776 E (“the ’776 patent,” Ex. 1001). Paper 1 (“Pet.”). Teleflex
`Innovations S.À.R.L. (“Patent Owner”)1 filed a Preliminary Response.
`Papers 8 (confidential version), 9 (redacted version). In our Institution
`Decision, we determined that there was a reasonable likelihood that
`Petitioner would prevail with respect to at least one challenged claim and
`accordingly, instituted an inter partes review pursuant to 35 U.S.C. § 314
`based on all challenges presented in the Petition. Paper 22 (“Institution
`Decision” or “Inst. Dec.”).
`Following institution, Patent Owner filed two post-institution
`responses: (1) a Consolidated Response Addressing Conception and
`Reduction to Practice (Paper 39 (“PO CRTP Response” or “PO CRTP
`
`1 Patent Owner represents that “Teleflex Innovations S.A.R.L. merged into
`Teleflex Medical Devices S.A.R.L,” which subsequently “transferred
`ownership of [the ’776 patent] to Teleflex Life Sciences Limited.” Paper 7,
`2.
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`Resp.”)) and (2) a post-institution Response addressing Petitioner’s
`anticipation and obviousness arguments (Papers 43 (confidential version), 44
`(redacted version) (“PO Resp.”)).
`Petitioner filed a Reply to Patent Owner’s Response Addressing
`Conception and Reduction to Practice (Papers 78 (confidential version), 79
`(redacted version) (“Pet. CRTP Reply”)) and a Reply to Patent Owner’s
`Response (Papers 82 (confidential version), 83 (redacted version)
`(“Reply”)). Patent Owner then filed its post-institution Sur-Reply
`Addressing Conception and Reduction to Practice (Paper 96, “PO CRTP
`Sur-Reply”), and Petitioner filed its post-institution Sur-Reply Addressing
`Conception and Reduction to Practice (Paper 111 (“Pet. CRTP Sur-Sur-
`Reply”)). Patent Owner also filed a post-institution Sur-Reply to
`Petitioner’s Reply to Patent Owner’s Response (Papers 102 (confidential
`version), 103 (redacted version) (“PO Sur-Reply)).
`Patent Owner also filed a Contingent Motion to Amend. Papers 38
`(original), 95 (corrected) (“Motion”).2 The Motion requests that if any of
`claims 27, 33, 37, 42, 43, 45, 47, or 56 is found unpatentable, they should be
`replaced by proposed substitute claims 58–65. Motion 1. Petitioner filed an
`Opposition to the Motion to Amend. Paper 101. Patent Owner filed a Reply
`in Support of the Corrected Motion to Amend (Paper 105), and Petitioner
`filed a Sur-Reply (Paper 113).
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`2 Pursuant to a stipulation by the parties, we authorized the filing of the
`corrected Motion to Amend in order to clarify certain antecedent bases and
`thereby simplify the issues.
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`An oral hearing was held on March 8, 2021, and a transcript of the
`hearing is included in the record. Papers 124 (redacted version) (“Tr.”), 125
`(confidential version).
`
`B. Real Parties-in-Interest
`Petitioner identifies Medtronic, Inc. and Medtronic Vascular, Inc. as
`the real parties-in-interest, and notes that “Medtronic plc is the ultimate
`parent of both entities.” Pet. 5. Patent Owner identifies the real parties-in-
`interest for itself as Teleflex Medical Devices S.À.R.L., Vascular Solutions
`LLC, Arrow International, Inc., Teleflex LLC, and Teleflex Life Sciences
`Limited and notes that “Teleflex Incorporated is the ultimate parent of the
`entities listed above.” Paper 4, 2; Paper 7, 2.
`
`C. Related Matters
`Patent Owner is asserting the ’776 patent against Petitioner in the
`United States District Court for the District of Minnesota in Vascular
`Solutions LLC, et al. v. Medtronic, Inc., et al., No. 19-cv-01760 ((D. Minn.,
`filed July 2, 2019). Pet. 5; Paper 4, 2. The ’776 patent is also the subject of
`a declaratory judgement action filed by another party, QXMedical, LLC v.
`Vascular Solutions, LLC, No. 17-cv-01969 (D. Minn., filed June 8, 2017),
`which was stayed pending our Institution Decision. Paper 19; Paper 20.
`Petitioner further notes that the ’776 patent is a reissue of U.S. Patent No.
`8,292,850 (“’850 patent”), which was the subject of a prior district court
`action and inter partes reviews in IPR2014-00762 and IPR2014-00763 filed
`by a different petitioner. Pet. 5.
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`Petitioner filed another petition challenging the ’776 patent based on
`different prior art, and we instituted inter partes review on that petition on
`June 26, 2020. See IPR2020-00136, Paper 20. We issue our final written
`decision in IPR2020-00136 concurrently with this Decision. In addition,
`Petitioner has filed concurrent petitions challenging other related patents:
`U.S. Patent No. 8,048,032 (IPR2020-00126; IPR2020-00127), RE45,380
`(IPR2020-00128; IPR2020-00129; IPR2020-00130; IPR2020-00131), RE
`45,760 (IPR2020-00132; IPR2020-00133; IPR2020-00134), and RE47,379
`(IPR2020-00137; IPR2020-00138).
`
`D. The ’776 Patent
`The ’776 patent, entitled “Coaxial Guide Catheter for Interventional
`Cardiology Procedures,” issued on October 27, 2015, as a reissue of the ’850
`patent, which itself issued from a non-provisional application filed January
`26, 2012. Ex. 1001, codes (45), (64). It claims priority as a divisional of
`Application No. 11/416,629, filed on May 3, 2006, which issued as U.S.
`Patent No. 8,048,032. Id. at code (60).
`The ’776 patent relates generally to a coaxial guide catheter for use
`with interventional cardiology devices that are insertable into a branch artery
`that branches off from a main artery. Ex. 1001, Abstract. According to the
`’776 patent, interventional cardiology procedures often include inserting
`guidewires or other instruments through catheters into coronary arteries that
`branch off from the aorta. Id. at 1:45–47. In coronary artery disease, the
`coronary arteries may be narrowed or occluded by atherosclerotic plaques or
`other lesions in a phenomenon known as stenosis. Id. at 1:50–55. In
`treating the stenosis, a guide catheter is inserted through the aorta and into
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`the ostium of the coronary artery, sometimes with the aid of a guidewire, and
`is passed beyond the occlusion or stenosis. Id. at 1:59–65. However,
`crossing tough lesions can create enough backward force to dislodge the
`guide catheter from the ostium of the artery being treated, which can make it
`difficult or impossible for the interventional cardiologist to treat certain
`forms of coronary artery disease. Id. at 1:65–67.
`To solve this problem, the ’776 patent describes a coaxial guide
`catheter that is deliverable through standard guidewires by utilizing a
`guidewire rail segment to permit delivery without blocking use of the guide
`catheter. Id. at 3:15–18. The ’776 patent teaches that the coaxial guide
`catheter preferably includes a tapered inner catheter that runs over a standard
`0.014 inch coronary guidewire to allow atraumatic placement within the
`coronary artery, and this feature allows removal of the tapered inner catheter
`after the coaxial guide catheter is in place. Id. at 3:24–27. Figures 1 and 2,
`reproduced below, show a coaxial guide catheter and a tapered inner catheter
`in accordance with the invention described in the ’776 patent:
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`Figure 1 is a schematic depiction of the coaxial guide catheter and tapered
`inner catheter separately, and Figure 2 depicts those two elements assembled
`together. Id. at 5:47–52, Figs. 1, 2. As shown 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 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 (not labeled in
`the figures above). 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. at 7:27–29.
`In operation, the tapered inner catheter is inserted inside and through
`the coaxial guide catheter. Id. at 4:43–44. The coaxial guide catheter/
`tapered inner catheter combination may then be inserted into a blood vessel
`that communicates with the aorta, and advanced until the tapered inner
`catheter is passed into the ostium of a coronary artery over the guidewire.
`Id. at 4:47–54. The tapered inner catheter may be removed once the coaxial
`guide catheter/guide catheter combination has been inserted sufficiently into
`the ostium of the coronary artery to achieve deep seating. Id. at 4:54–57.
`Once the tapered inner catheter is removed, a cardiac treatment device, such
`as a guidewire, balloon, or stent, may be passed through the coaxial guide
`catheter within the guide catheter and into the coronary artery. Id. at 4:61–
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`64. The presence of the coaxial guide catheter provides additional backup
`support to make it 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. Id. at 4:64–
`5:3.
`
`E. Illustrative Claims
`Among the challenged claims, independent claim 25 is representative
`and reproduced below:
`25. A guide extension catheter for use with a guide
`catheter, comprising:
`a substantially rigid segment;
`a tubular structure defining a lumen and positioned distal
`to the substantially rigid segment; and
`a segment defining a partially cylindrical opening
`positioned between a distal end of the substantially rigid segment
`and a proximal end of the tubular structure, the segment defining
`the partially cylindrical opening having an angled proximal end,
`formed from a material more rigid than a material or material
`combination forming the tubular structure, and configured to
`receive one or more
`interventional cardiology devices
`therethrough when positioned within the guide catheter,
`wherein a cross-section of the guide extension catheter at
`the proximal end of the tubular structure defines a single lumen.
`Ex. 1001, 13:36–52 (cl. 25).
`
`F. Prior Art and Asserted Grounds
`We instituted review of claims 25–27, 29–33, 35–39, 41–49, and 52–
`56 of the ’776 patent on the following grounds (Inst. Dec. 7, 39):
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`Claims Challenged
`25–27, 29–33, 35–37,
`41–45, 47–49
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`35 U.S.C. §
`102
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`Reference(s)/Basis
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`39, 46
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`36, 37, 52–56
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`103(a)
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`103(a)
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`32, 36–38, 46, 52–56 103(a)
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`52–56
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`103(a)
`
`Itou3
`Itou, the knowledge of a person
`of ordinary skill in the art
`(“POSITA”)
`Itou, Kataishi,4 the knowledge
`of POSITA
`Itou, Ressemann,5 the
`knowledge of POSITA
`Itou, Enger,6 the knowledge of
`POSITA
`In support of its arguments, Petitioner relies on the expert
`declarations of Dr. Stephen Jon David Brecker (Exs. 1005, 1806, 1904), Dr.
`Richard A. Hillstead (Exs. 1042, 1905), Mr. Michael Jones (Ex. 1807), and
`Dr. Paul Zalesky (Exs. 1755, 1830, 1919). Patent Owner relies on the
`declarations of Ms. Deborah Schmalz (Ex. 2039), Ms. Amy Welch (Ex.
`2044), Mr. Howard Root (Ex. 2118), Mr. Gregg Sutton (Ex. 2119), Mr.
`Mark Goemer (Ex. 2120), Ms. Amanda O’Neil (Ex. 2121), Mr. Steve Erb
`(Ex. 2122), Mr. Peter T. Keith (Exs. 2042, 2123, 2124, 2138, 2243), Dr.
`John J. Graham (Ex. 2145), Dr. Lorenzo Azzalini (Ex. 2151), Ms. Heather S.
`Rosecrans (Ex. 2205), and Dr. Craig Thompson (Ex. 2215).
`
`3 Itou, US 7,736,355 B2, issued June 15, 2010 (Ex. 1007) (“Itou”).
`4 Kataishi, US 2005/0015073 A1, published January 20, 2005 (Ex. 1025)
`(“Kataishi”).
`5 Ressemann, US 7,604,612 B2, issued October 20, 2009 (Ex. 1008)
`(“Ressemann”).
`6 Enger, US 5,980,486, issued November 9, 1999 (Ex. 1050) (“Enger”).
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`ANALYSIS
`II.
`A. Priority Date for the ’776 Patent
`Petitioner argues that “[t]he ’776 patent is subject to the AIA’s first-
`to-file provisions because (1) it contains claims that lack written description,
`and therefore pre-AIA priority, and (2) it claims priority to RE45,380 (‘the
`’380 patent’), which is subject to the AIA first-to-file provisions.” Pet. 12
`(footnote omitted). Petitioner advances this argument to preclude Patent
`Owner from swearing behind the Itou reference based on a showing of prior
`invention, which could otherwise be done for a pre-AIA “first-to-invent”
`application. Id. We are not persuaded by Petitioner’s argument.
`“The effective filing date for a claimed invention in an application for
`reissue or reissued patent shall be determined by deeming the claim to the
`invention to have been contained in the patent for which reissue was
`sought.” 35 U.S.C. § 100(i)(2). As the ’850 patent, the “patent for which
`reissue was sought” in this case, was issued October 23, 2012, and that
`patent claims priority to an application filed May 3, 2006, we are not
`persuaded that the AIA’s first-to-file provisions apply to the ’776 patent.
`Indeed, Petitioner provides no legal support for the proposition that claims in
`a reissue patent are not entitled to an effective filing date as if they appeared
`in the original patent for which reissue was sought.7
`
`7 Petitioner’s priority date argument appears to be a back door attempt to
`have us address whether the ’776 patent satisfies the written description
`requirement of 35 U.S.C. § 112. But this is a question we may not address
`in an IPR. See 35 U.S.C. § 311(b).
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`B. Level of Ordinary Skill in the Art
`We consider the asserted grounds of unpatentability in view of the
`understanding of a person of ordinary skill in the art (POSITA). Petitioner
`provides two alternatives for a person having ordinary skill in the art. First,
`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. 13. 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-deployable devices.” Id.
`Additionally, Petitioner contends that “[e]xtensive experience and technical
`training might substitute for education, and advanced degrees might
`substitute for experience.” Id.
`Patent Owner does not dispute Petitioner’s proposed definition of a
`POSITA. PO Resp. 6.
`Upon review of the parties’ arguments and supporting evidence, we
`adopt Petitioner’s definitions for a POSITA, as they are undisputed 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).
`
`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.
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`282(b).” 37 C.F.R. § 42.100(b) (2019). This standard requires that we
`construe claims “in accordance with the ordinary and customary meaning of
`such claim[s] as understood by one of ordinary skill in the art and the
`prosecution history pertaining to the patent.” Id.
`Petitioner proposes constructions for the claim terms a “concave
`track” and “flexural modulus.” Pet. 15–16. Patent Owner proposes
`constructions for “one or more interventional cardiology devices” (all
`claims) and “the segment defining the angled proximal end of the partially
`cylindrical opening includes at least one inclined region that tapers into a
`non-inclined region.” PO Resp. 7–11.
`Upon review of the parties’ arguments and supporting evidence, we
`determine that no express construction of any claim term is necessary to
`decide the patentability of the claims. See Vivid Techs., Inc. v. Am. Sci. &
`Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that “only those
`terms need to be construed that are in controversy, and only to the extent
`necessary to resolve the controversy”); see also Nidec Motor Corp. v.
`Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017)
`(applying Vivid Techs. in the context of an inter partes review).
`
`D. Status of Itou as Prior Art - Conception and Reduction to Practice
`The dispositive issue in this case is whether Itou, which is relied upon
`for all grounds in the Petition, qualifies as prior art.
`Itou was filed on September 23, 2005, published on March 30, 2006,
`and issued on June 15, 2010. Ex. 1007, codes (22), (45), (65). Petitioner
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`contends Itou is prior art under pre-AIA § 102(e). Pet. 16–18.8 In the
`Conception and Reduction to Practice (“CRTP”) briefing that we separately
`authorized for these proceedings, Patent Owner argues that Itou does not
`qualify as prior art based on research and development related to the claimed
`invention that took place at Vascular Solutions, Inc. (“VSI”), Patent Owner’s
`predecessor-in-interest, starting around early 2005 and continuing through
`the filing of the priority application for the challenged patent. See generally
`PO CRTP Response; PO CRTP Sur-Reply. Petitioner disputes these
`contentions. See generally Pet. CRTP Reply; Pet. CRTP Sur-Sur-Reply.
`In its CRTP Response, Patent Owner identifies the evidence on which
`it relies to antedate Itou, including certain inventor testimony, non-inventor
`testimony, and other documentary evidence. PO CRTP Resp. 2. As to
`inventor testimony, Patent Owner relies on the respective declarations of co-
`inventors Howard Root (Ex. 2118) and Gregg Sutton (Ex. 2119). As to non-
`inventor testimony, Patent Owner relies on the declaration of its expert Peter
`T. Keith (Ex. 2123), the declarations of VSI employees Steven Erb (Ex.
`2122) and Deborah Schmalz (Ex. 2039), and the declarations of employees
`of third-party vendors, Amanda O’Neil (Ex. 2121) and Mark Goemer (Ex.
`2120). As to documentary evidence, Patent Owner relies on nearly 75
`exhibits. These documents include inventor lab notebooks and handwritten
`notes (Exs. 2002, 2004); internal company memoranda, presentations, and
`other similar documents (Exs. 2003, 2005, 2017–2018, 2024, 2025, 2036–
`
`8 In addition to this Petition, Petitioner similarly asserts Itou in the petitions
`in IPR2020-00126, -00128, -00129, -00132, -00134, -00135, and -00137.
`Our analysis regarding the prior art status of Itou is similar for each of these
`proceedings.
`
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`2038, 2040–2041, 2099–2100, 2105, 2109, 2127–2134); invoices, sales
`orders, and certificates of completion from technical equipment vendors
`(Exs. 2006–2011, 2013, 2016, 2020–2021, 2026–2035, 2089–2095, 2097,
`2104, 2106–2108, 2110–2112); a photograph (Ex. 2014); deposition
`transcripts (Exs. 2015, 2116); communications with and documents from
`VSI’s outside patent counsel (Exs. 2019, 2023, 2096, 2098, 2101–2103,
`2117); and engineering drawings (Exs. 2022, 2113–2115).
`We have considered this evidence and other rebuttal evidence offered
`by Petitioner. For the following reasons, we conclude that a preponderance
`of the evidence demonstrates that Patent Owner conceived the subject matter
`recited in the challenged claims before September 23, 2005, the date on
`which Itou is effective as prior art (“critical date”) and either actually
`reduced the invention to practice prior to the critical date or diligently
`worked towards constructive reduction to practice until the priority
`application for the challenged patent was filed on May 3, 2006.
`Accordingly, we conclude that Itou does not qualify as prior art to the
`challenged patent.
`For our analysis, we first set forth the relevant legal standards,
`followed by our fact findings and analysis on conception, actual reduction to
`practice, and diligence towards constructive reduction to practice.
`
`Legal Standards
`1.
`“To antedate (or establish priority) of an invention, a [patent owner]
`must show either an earlier reduction to practice, or an earlier conception
`followed by a diligent reduction to practice.” Purdue Pharma L.P. v.
`Boehringer Ingelheim GMBH, 237 F.3d 1359, 1365 (Fed. Cir. 2001).
`
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`“Conception is the formation, in the mind of the inventor, of a definite and
`permanent idea of the complete and operative invention, as it is thereafter to
`be applied in practice.” Cooper v. Goldfarb, 154 F.3d 1321, 1327 (Fed. Cir.
`1998). “A reduction to practice can be either a constructive reduction to
`practice, which occurs when a patent application is filed, or an actual
`reduction to practice.” Id. “In order to establish an actual reduction to
`practice, the [patent owner] must prove that: (1) [the inventors] constructed
`an embodiment or performed a process that met all the limitations of the
`[claimed invention]; and (2) [the inventors] determined that the invention
`would work for its intended purpose.” Id.
`If a patent owner has not shown actual reduction to practice prior to
`the “critical date” of a reference, the patent owner may nonetheless antedate
`the reference by establishing prior conception and reasonable diligence
`towards the constructive reduction to practice. Purdue Pharma, 237 F.3d at
`1365. “Reasonable diligence must be shown throughout the entire critical
`period, which begins just prior to the competing reference’s effective date
`and ends on the date of the invention’s reduction to practice.” Arctic Cat
`Inc. v. GEP Power Prods., Inc., 919 F.3d 1320, 1331 (2019). However, the
`“diligence need not be perfectly continuous—only reasonably continuous.”
`Id.
`
`To be persuasive, an inventor’s testimony of conception and reduction
`to practice must be corroborated by other independent evidence.
`“Conception must be proved by corroborating evidence which shows that
`the inventor disclosed to others his completed thought expressed in such
`clear terms as to enable those skilled in the art to make the invention.” REG
`Synthetic Fuels, LLC v. Neste Oil Oyj, 841 F.3d 954, 962 (Fed. Cir. 2016)
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`(citations and quotation marks omitted). “However, there is no final single
`formula that must be followed in proving corroboration.” Id. (citations and
`quotation marks omitted); see also Kolcraft Enters., Inc. v. Graco Children’s
`Prods., Inc., 927 F.3d 1320, 1324 (Fed. Cir. 2019); Medichem, S.A. v.
`Rolabo, S.L., 437 F.3d 1157, 1169–70 (Fed. Cir. 2006).
`“In the final analysis, each corroboration case must be decided on its
`own facts with a view to deciding whether the evidence as a whole is
`persuasive.” Berges v. Gottstein, 618 F.2d 771, 776 (CCPA 1980).
`Corroborating evidence may consist of “testimony of a witness, other than
`the inventor,” or “evidence of surrounding facts and circumstances
`independent of information received from the inventor.” Medichem, 437
`F.3d at 1171. “Even the most credible inventor testimony is a fortiori
`required to be corroborated by independent evidence, which may consist of
`documentary evidence as well as the testimony of non-inventors.” Id. at
`1171–72. We assess whether evidence corroborates conception and
`reduction to practice under a “rule of reason” analysis. Cooper, 154 F.3d at
`1330.
`
`In an inter partes review, 35 U.S.C. § 316(e) imposes the ultimate
`burden of persuasion to “prove unpatentability by a preponderance of the
`evidence” onto the petitioner. This burden never shifts to the patent owner.
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378
`(Fed. Cir. 2015). However, when the patent owner attempts to antedate the
`prior art, “[a] second and distinct burden, the burden of production” can shift
`between the petitioner and the patentee. Id. at 1379; see In re Magnum Oil
`Tools Int’l, Ltd., 829 F.3d 1364, 1375–76 (Fed. Cir. 2016). Specifically, the
`patent owner “bears the burden of establishing that its claimed invention is
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`entitled to an earlier priority date than an asserted prior art reference.”
`Magnum Oil Tools, 829 F.3d at 1375–76. Once the patent owner establishes
`it is entitled to an earlier priority date, the burden of production then shifts
`back to the petitioner “to convince the court that [the patent owner] is not
`entitled to the benefit” of the earlier priority date. Dynamic Drinkware, 800
`F.3d at 1379 (citing Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316,
`1328 (Fed. Cir. 2008)).
`
`Conception
`2.
`To show prior conception, Patent Owner relies primarily upon Mr.
`Root’s testimony submitted in support of its CRTP Response. Ex. 2118
`(Root Declaration in support of CRTP).9,10 Mr. Root was the founder and
`Chief Executive Officer of VSI from 1997 to 2017. Id. ¶¶ 1–2. Patent
`Owner also relies upon the testimony of co-inventor Mr. Sutton, who was
`Vice President, Research & Development at VSI from 2004 until mid-2006.
`
`9 Patent Owner previously submitted a declaration by Mr. Root with its
`Preliminary Response (Ex. 2001), but withdrew that declaration in favor of
`Ex. 2118. PO CRTP Resp. 2 n.1.
`10 The testimonial evidence that Patent Owner presents in support of
`conception is largely undisputed. Indeed, during a teleconference addressing
`Patent Owner’s request to present live testimony from Mr. Root in these
`proceedings, Petitioner’s counsel acknowledged that Mr. Root’s testimony
`was not disputed in a manner that would require our credibility assessment.
`See Ex. 1920, 11:10–11 (“And I don’t think we have, you know, directly
`said Mr. Root is lying on this topic.”); id. at 17:17–18 (“We don’t have any
`issue at play here that goes to credibility.”). Accordingly, in view of our
`conclusion that “the credibility of Mr. Root is not in question,” we denied
`Patent Owner’s request to present live testimony from Mr. Root at the oral
`hearing. See Paper 109, 4–5 (distinguishing K-40 Elecs., LLC v. Escort,
`Inc., IPR2013-00203, Paper 34 (PTAB May 21, 2014) (precedential)).
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`Ex. 2119 (Sutton Declaration in support of CRTP). As additional
`documentary corroboration for this inventor testimony, Patent Owner relies
`upon certain pages from Mr. Sutton’s laboratory notebook dated January 4,
`2005 (Ex. 2002), a “market feasibility” memorandum from Mr. Root dated
`February 4, 2005 (Ex. 2003), and some additional handwritten notes and
`drawings from Mr. Root dated February 7, 2005 (Ex. 2004). We first set
`forth
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