`
`United States Court of Appeals
`for the Federal Circuit
`______________________
`
`MEDTRONIC, INC., MEDTRONIC VASCULAR,
`INC.,
`Appellants
`
`v.
`
`TELEFLEX INNOVATIONS S.À.R.L.,
`Appellee
`______________________
`
`2021-2356, 2021-2358, 2021-2361, 2021-2363, 21-2365
`______________________
`
`Appeals from the United States Patent and Trademark
`Office, Patent Trial and Appeal Board in Nos. IPR2020-
`00126, IPR2020-00128, IPR2020-00132, IPR2020-00135,
`IPR2020-00137.
`
`______________________
`
`Decided: May 24, 2023
`______________________
`
`TASHA JOY BAHAL, Wilmer Cutler Pickering Hale and
`Dorr LLP, Boston, MA, argued for appellants. Also repre-
`sented by MARK CHRISTOPHER FLEMING, HANNAH ELISE
`GELBORT, MADELEINE C. LAUPHEIMER; BRITTANY BLUEITT
`AMADI, JENNIFER L. GRABER, Washington, DC.
`
` J. DEREK VANDENBURGH, Carlson, Caspers, Vanden-
`burgh & Lindquist PA, Minneapolis, MN, argued for appel-
`lee. Also represented by PETER M. KOHLHEPP, TARA
`CATHERINE NORGARD, JOSEPH W. WINKELS.
`
`
`
`Case: 21-2356 Document: 56 Page: 2 Filed: 05/24/2023
`
`2
`
`MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.À.R.L.
`
` ______________________
`
`Before MOORE, Chief Judge, LOURIE and DYK, Circuit
`Judges.
`Opinion for the court filed by Circuit Judge LOURIE.
`Dissenting opinion filed by Circuit Judge DYK.
`LOURIE, Circuit Judge.
`Medtronic, Inc. and Medtronic Vascular, Inc. (collec-
`tively, “Medtronic”) appeal from five final written decisions
`of the United States Patent and Trademark Office Patent
`Trial and Appeal Board (“the Board”) finding that Itou1
`does not qualify as prior art to related U.S. Patents
`8,048,032, RE45,380, RE45,776, RE45,760, and RE47,379
`(collectively, “the challenged patents”) under pre-AIA first-
`to-invent provisions, and Medtronic had therefore not
`shown the challenged claims to be unpatentable. Med-
`tronic, Inc. v. Teleflex Innovations S.À.R.L., IPR2020-
`00126 (P.T.A.B. Jun. 7, 2021) (“Decision”), J.A. 1–75; Med-
`tronic, Inc. v. Teleflex Innovations S.À.R.L., IPR2020-
`00128 (P.T.A.B. Jun. 7, 2021), J.A. 76–150; Medtronic, Inc.
`v. Teleflex Innovations S.ÀR.L., IPR2020-00132 (P.T.A.B.
`Jun. 7, 2021), J.A. 151–222; Medtronic, Inc. v. Teleflex In-
`novations S.À.R.L., IPR2020-00135 (P.T.A.B. Jun. 7, 2021),
`J.A. 223–98; Medtronic, Inc. v. Teleflex Innovations
`S.À.R.L., IPR2020-00137 (P.T.A.B. Jun. 7, 2021), J.A. 299–
`373.2 For the reasons provided below, we affirm.
`
`
`1 U.S. Patent 7,736,355 to Itou et al. (“Itou”).
`2 The five final written decisions in the IPRs consol-
`idated on appeal share similar sections on conception and
`reduction to practice. The decision in Medtronic, Inc. v. Te-
`leflex Innovations S.À.R.L., IPR2020-00126 (P.T.A.B. Jun.
`7, 2021), J.A. 1–75, is representative and cited throughout
`as such.
`
`
`
`Case: 21-2356 Document: 56 Page: 3 Filed: 05/24/2023
`
`MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.À.R.L.
`
`3
`
`BACKGROUND
`The challenged patents, developed by Vascular Solu-
`tions Inc. (“VSI”) but now owned by appellee Teleflex Inno-
`vations S.À.R.L. (“Teleflex”), all descend from a common
`application filed on May 3, 2006 and share a common spec-
`ification. The challenged patents are directed to guide ex-
`tension catheters that use a tapered inner catheter that
`runs over a standard coronary guidewire to reduce the like-
`lihood that a guide catheter will dislodge from the coronary
`artery’s opening (i.e., ostium). See, e.g., ’032 patent, col. 1
`ll. 32–36, col. 2 ll. 53–59.
`According to Teleflex, VSI conceived the claimed inven-
`tion in early 2005 and then worked to develop it under the
`“GuideLiner” name. Teleflex asserts that what was known
`as the “rapid exchange” or “RX” version of the GuideLiner
`practices the challenged patents. Decision, J.A. 17. How-
`ever, in the same time period, VSI also worked on develop-
`ing an “over-the-wire” or “OTW” version of the GuideLiner,
`which was more akin to the prior art guide extension cath-
`eters and does not practice the challenged patents. Id. at
`J.A. 19. Because the over-the-wire GuideLiner was more
`similar to devices already in existence, it had fewer chal-
`lenges to overcome and work on it progressed more rapidly
`than for the rapid exchange device. Id. at J.A. 36. The
`rapid exchange GuideLiner eventually entered the market
`in 2009. Id. at J.A. 61.
`Medtronic filed thirteen petitions for inter partes re-
`view (“IPR”) of the challenged patents, eleven of which
`were instituted and five of which are consolidated in this
`appeal. These five IPR petitions asserted Itou as the pri-
`mary prior art reference under pre-AIA 35 U.S.C. § 102(e)
`(2012). Following institution, Teleflex filed a consolidated
`response addressing conception and reduction to practice,
`asserting that Itou did not qualify as prior art because the
`claimed inventions were (1) conceived prior to Itou’s filing
`date of September 23, 2005 (i.e., the critical date), and (2)
`
`
`
`Case: 21-2356 Document: 56 Page: 4 Filed: 05/24/2023
`
`4
`
`MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.À.R.L.
`
`were (a) actually reduced to practice before the critical date
`or (b) diligently pursued until their constructive reduction
`to practice through their effective filing in May 2006. In
`support of its contentions, Teleflex submitted numerous
`declarations, including from inventors and noninventors,
`as well as nearly 75 documentary exhibits including inven-
`tor lab notebooks, internal company memoranda and
`presentations, invoices and sales orders, photographs, en-
`gineering drawings, and documents from outside patent
`counsel. Decision, J.A. 13.
`The Board found that the evidence demonstrated that
`the claimed inventions were (1) conceived no later than Au-
`gust 2005, i.e., before the critical date, and (2) either (a)
`actually reduced to practice for their intended purpose in
`April and July 2005, prior to the critical date, or (b) dili-
`gently worked on toward constructive reduction to practice
`on May 3, 2006, the challenged patents’ effective filing
`date. Id. at J.A. 34, 61–62, 71. In so doing, the Board found
`that the intended purpose of the claimed inventions was
`providing improved backup support for the guide catheter,
`rejecting Medtronic’s suggestion that the intended pur-
`pose, or additional intended purpose, was providing backup
`support necessary for accessing and crossing tough or
`chronic occlusions. Id. at J.A. 53. The Board therefore de-
`termined that Itou did not qualify as prior art to the chal-
`lenged patents under pre-AIA 35 U.S.C. § 102(e), thereby
`eliminating the challenges presented in the five IPRs rele-
`vant to this appeal. The Board thus concluded that Med-
`tronic had failed to demonstrate that the challenged claims
`were unpatentable.
`Medtronic appealed. We have jurisdiction under
`28 U.S.C. § 1295(a)(4)(A).
`DISCUSSION
`In considering whether or not a reference qualifies as
`prior art under pre-AIA 35 U.S.C. § 102(e), we must con-
`sider whether or not “the invention was described in . . . a
`
`
`
`Case: 21-2356 Document: 56 Page: 5 Filed: 05/24/2023
`
`MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.À.R.L.
`
`5
`
`patent granted on an application for patent by another filed
`in the United States before the invention by the applicant
`for patent.” A patent owner may antedate an asserted
`prior art patent by showing conception of the claimed in-
`vention prior to the critical date and either actual reduc-
`tion to practice prior to the critical date or “reasonably
`continuous diligence” in reducing the invention to practice
`until its effective filing date. See ATI Techs. v. Iancu, 920
`F.3d 1362, 1369 (Fed. Cir. 2019); Tyco Healthcare Grp. v.
`Ethicon Endo-Surgery, Inc., 774 F.3d 968, 975 (Fed. Cir.
`2014). Inventor declarations submitted to antedate a ref-
`erence must be corroborated, and corroboration is governed
`by a “rule of reason” standard. Perfect Surgical Techs., Inc.
`v. Olympus Am., Inc., 841 F.3d 1004, 1007–09 (Fed. Cir.
`2016).
`In an IPR, the petitioner bears the ultimate burden of
`persuasion on invalidity, which never shifts to the patent
`owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375, 1378 (Fed. Cir. 2015). However, when a pa-
`tent owner attempts to antedate an asserted prior art ref-
`erence, the patent owner takes on a temporary burden of
`production. Id. at 1378–79. Once that burden is met, the
`burden shifts back to the petitioner. Id. at 1379.
`We review the Board’s factual findings on reduction to
`practice and diligence for substantial evidence, and its le-
`gal conclusion of priority de novo. E.I. du Pont de Nemours
`& Co. v. Unifrax I LLC, 921 F.3d 1060, 1075 (Fed. Cir.
`2019). Medtronic does not challenge the Board’s findings
`of conception prior to the critical date on appeal, but chal-
`lenges both the Board’s findings on actual reduction to
`practice and reasonable diligence toward constructive re-
`duction to practice. We address each argument in turn.
`I
`To establish actual reduction to practice before the crit-
`ical date, it must have been shown that “(1) [the inventors]
`constructed an embodiment or performed a process that
`
`
`
`Case: 21-2356 Document: 56 Page: 6 Filed: 05/24/2023
`
`6
`
`MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.À.R.L.
`
`met all the limitations of the [claimed invention]; and (2)
`[the inventors] determined that the invention would work
`for its intended purpose.” Cooper v. Goldfarb, 154 F.3d
`1321, 1327 (Fed. Cir. 1998). Medtronic challenges the
`Board’s determinations regarding both of these elements
`on three grounds. First, Medtronic argues that the Board
`erred in identifying the intended purpose of the claimed in-
`ventions. Second, Medtronic argues that, even if the
`Board’s finding of the intended purpose was correct, the
`Board erred in not requiring comparative testing to demon-
`strate that the invention worked for that purpose. Third,
`Medtronic argues that the Board erred in relying solely on
`uncorroborated inventor testimony as evidence of actual
`reduction to practice. We disagree for the reasons provided
`below.
`
`A
` Medtronic argues that the intended purpose should be
`both, as the Board found, providing increased backup sup-
`port as compared with a guide catheter alone and facilitat-
`ing the delivery of interventional devices through tough or
`chronic occlusions. Medtronic faults the Board for relying
`on extrinsic evidence to determine the intended purpose
`when the patents’ specifications and claims are the proper
`source of information. Medtronic further argues that had
`the Board correctly determined the intended purpose, it
`could not have found that Teleflex proved that the proto-
`types functioned for that purpose. Teleflex argues that
`Medtronic waived the argument that the Board erred by
`considering extrinsic evidence in determining the intended
`purpose when it repeatedly urged the Board to consider ex-
`trinsic evidence and failed to point the Board to any intrin-
`sic evidence, and the Board’s determination of the intended
`purpose is correct.
`Similar to claim construction, a determination of an in-
`vention’s intended purposes is a legal issue, reviewed de
`novo. See z4 Techs., Inc. v. Microsoft Corp., 507 F.3d 1340,
`
`
`
`Case: 21-2356 Document: 56 Page: 7 Filed: 05/24/2023
`
`MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.À.R.L.
`
`7
`
`1352 (Fed. Cir. 2007) (affording no deference to district
`court’s reading of patents’ language to “define[] the ‘in-
`tended purpose’ of the invention”). Because we evaluate
`the intended purpose without deference to the Board’s de-
`termination, it is of no consequence whether the Board re-
`lied on extrinsic evidence or whether Medtronic waived the
`argument that doing so would have been in error. Regard-
`less, although the patents themselves are the most im-
`portant and, indeed, most persuasive evidence of the
`patents’ intended purpose, we find it is appropriate to con-
`sider extrinsic evidence, particularly when it does not con-
`tradict the patents themselves. Medtronic cites no case
`showing otherwise.
`We, like the Board, find Medtronic’s proposed intended
`purpose to be overly narrow. See Decision, J.A. 52–53. Alt-
`hough the challenged patents do mention crossing “tough”
`or “chronic” occlusions, we find that to be a specific example
`within a broader general purpose. Indeed, as the Board
`found, the challenged patent specification itself recognizes
`a broader purpose when discussing the field and back-
`ground of the invention. See, e.g., ’032 patent at col. 1 ll. 8–
`11 (“More particularly the present invention relates to
`methods and apparatus for increasing backup support for
`catheters inserted into the coronary arteries from the
`aorta.”), col. 2 ll. 45–49 (“Thus, the interventional cardiol-
`ogy art would benefit from the availability of a system that
`would be deliverable through standard guide catheters for
`providing backup support by providing the ability to effec-
`tively create deep seating in the ostium of the coronary ar-
`tery.”). Although that intrinsic evidence is sufficient, a
`broader purpose than that urged by Medtronic is further
`supported by both expert and inventor testimony. See De-
`cision, J.A. 54–55 (citing J.A. 12012; J.A. 11815–16; J.A.
`11834).
`Moreover, the evidence suggests a broader intended
`purpose than the Board found may even be appropriate.
`The challenged patents are titled “Coaxial Guide Catheter
`
`
`
`Case: 21-2356 Document: 56 Page: 8 Filed: 05/24/2023
`
`8
`
`MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.À.R.L.
`
`for Interventional Cardiology Procedures,” and the claims
`are generally directed to a “device for use with a standard
`guide catheter.” See, e.g., ’032 patent at Title, col. 10 ll. 21;
`see also J.A. 11816 (inventor describing the intended pur-
`pose). The claims do not mandate a purpose beyond per-
`forming the functions of a guide extension catheter. This
`is not an obviousness inquiry. The very title of the patents
`themselves, “Coaxial Guide Catheter for Interventional
`Cardiology Procedures,” describes the purpose of the
`claimed inventions, and it is undisputed that the claim lan-
`guage does not impose a further purpose than this. We
`therefore reject Medtronic’s argument that the intended
`purpose of the claimed invention should be narrower than
`that determined by the Board.
`B
`Medtronic further argues that, even assuming the
`Board’s determined intended purpose is correct, there is no
`evidence that Teleflex’s claimed device compared favorably
`with a guide catheter alone (i.e., worked for the Board’s de-
`termined intended purpose of “providing improved backup
`support for a guide catheter”). Decision, J.A. 53 (emphasis
`added). Teleflex argues that Medtronic forfeited the argu-
`ment that comparative testing was required by not raising
`it before the Board, and, regardless, testing is not required
`to confirm aspects of the invention that would have already
`been known to a person of ordinary skill in the art.
`As an initial matter, we do not find Medtronic’s argu-
`ment on this point to be forfeited. Generally, a federal ap-
`pellate court does not consider issues not raised before the
`lower tribunal. Singleton v. Wulff, 428 U.S. 106, 120
`(1976). The exact phrasing of the argument need not have
`been used below “so long as it can be said that the tribunal
`was ‘fairly put on notice as to the substance of the issue.’”
`Nike Inc. v. Adidas AG, 812 F.3d 1326, 1342 (Fed. Cir.
`2016) (citing Consolidation Coal Co. v. United States, 351
`F.3d 1374, 1378 (Fed. Cir. 2003) (quoting Nelson v. Adams,
`
`
`
`Case: 21-2356 Document: 56 Page: 9 Filed: 05/24/2023
`
`MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.À.R.L.
`
`9
`
`529 U.S. 460, 469 (2000) (“But [issue preservation] does not
`demand the incantation of particular words; rather, it re-
`quires that the lower court be fairly put on notice as to the
`substance of the issue.”))). But even if an issue was not
`presented below, there is no absolute bar to considering
`and deciding the issue on appeal, as forfeiture is a matter
`of discretion. Harris Corp. v. Ericsson Inc., 417 F.3d 1241,
`1251 (Fed. Cir. 2005) (“An appellate court retains case-by-
`case discretion over whether to apply waiver.”).
`Here, Medtronic argued in their Reply that “Teleflex
`cannot prove VSI performed any testing, much less testing
`to confirm intended purpose.” J.A. 24495; see also J.A.
`25042 (“The Board cannot evaluate whether Teleflex’s test-
`ing ‘evidence’ proves that VSI demonstrated that [the in-
`vention] would work for its intended purpose.”). We
`consider these assertions sufficient to preserve Medtronic’s
`argument that comparative testing was required given the
`intended purpose determined by the Board. Although
`Medtronic’s statements before the Board more generally
`addressed the insufficiency of the evidence and corrobora-
`tion of testing, without a specific mention to “comparative”
`testing, they still address the same, general issue: whether
`or not the testing showed the invention worked for its in-
`tended purpose.
`Regardless, we find the testing performed to be suffi-
`cient to show that the claimed invention worked for its in-
`tended purpose as determined by the Board. Sufficiency of
`the testing required to show an invention worked for its
`intended purpose is a question of fact reviewed for substan-
`tial evidence. See z4 Techs., 507 F.3d at 1352 (“[T]he ne-
`cessity and sufficiency of such testing are factual issues.”);
`Scott v. Finney, 34 F.3d 1058, 1061–62 (Fed. Cir. 1994)
`(“[T]he testing requirement depends on the particular facts
`of each case.”). Here, the Board thoroughly reviewed and
`analyzed the evidence of testing in the record, and we de-
`cline to remake or reweigh its factual findings.
`
`
`
`Case: 21-2356 Document: 56 Page: 10 Filed: 05/24/2023
`
`10
`
`MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.À.R.L.
`
`Namely, we find the Board’s conclusion that the
`claimed invention was determined to work for its intended
`purpose was supported by substantial evidence. As the
`Board noted, both inventors Howard Root and Gregg Sut-
`ton testified regarding testing performed on a prototype of
`the claimed invention. Decision, J.A. 44 (citing J.A. 11815,
`11834, 11971, 11982–83). Although these tests did not spe-
`cifically compare the invention prototype with a guide cath-
`eter alone, they enabled the inventors to observe the forces
`exerted on the prototype and the durability of the proto-
`type. Id. The Board determined that these tests, although
`“more qualitative than quantitative,” were sufficient to en-
`able the inventors to confirm that the prototype would
`work for its intended purpose—providing increased backup
`support as compared with a guide catheter alone. Id. We
`agree. The Board’s determined intended purpose did not
`mandate a 1:1 comparison or quantitative assessment to
`show an “increase” or “improvement” in function. Rather,
`it simply requires that an inventor, a skilled artisan, would
`observe the tests and understand that they indicate the
`prototype is more effective than a guide catheter alone.
`And that is the case here. See, e.g., J.A. 12010–12 (expert
`testimony that “actual reduction to practice of the Guide-
`Liner invention would have required little if any testing,”
`and that, to the extent it did, “qualitative testing would
`have been sufficient”).
`Because we find the Board’s finding of actual reduction
`to practice under its determined intended purpose sup-
`ported by substantial evidence, we find the same would be
`true for our suggested, broader, intended purpose of simply
`functioning as a guide extension catheter. Indeed, as coun-
`sel for Appellant conceded at oral argument, “[w]e may not
`need comparative testing if the Board had found a different
`intended purpose.” Oral Arg. at 3:18–22.
`
`
`
`Case: 21-2356 Document: 56 Page: 11 Filed: 05/24/2023
`
`MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.À.R.L.
`
`11
`
`C
`Finally, Medtronic argues that Teleflex’s evidence of
`actual reduction to practice is insufficiently corroborated.
`Inventor testimony may serve as evidence of reduction to
`practice, but it must be corroborated by independent evi-
`dence. Cooper, 154 F.3d at 1330. The sufficiency of such
`corroborating evidence is evaluated under a “rule of rea-
`son,” considering all pertinent evidence. Id. Corroboration
`can come from documentary evidence, noninventor testi-
`mony, or a combination of both. Loral Fairchild Corp. v.
`Matsushita Elec. Indus. Co., 266 F.3d 1358, 1364 (Fed. Cir.
`2001) (“Under the ‘rule of reason,’ the inventor's testimony
`must be sufficiently corroborated by independent evidence,
`but not necessarily documentary evidence.”). Corroborat-
`ing evidence may also be circumstantial. Cooper, 154 F.3d
`at 1330 (“In order to corroborate a reduction to practice, it
`is not necessary to produce an actual over-the-shoulder ob-
`server. Rather, sufficient circumstantial evidence of an in-
`dependent nature
`can
`satisfy
`the
`corroboration
`requirement.”). Nor must every individual aspect of reduc-
`tion to practice be corroborated. E.I. du Pont, 921 F.3d at
`1077. Rather, the corroborative evidence simply needs to
`be sufficient to support the credibility of the inventors’
`story. Id.
`Here, we find the inventors’ testimony of actual reduc-
`tion to practice, including that the invention worked for its
`intended purpose, sufficiently corroborated. Inventors
`Root and Sutton testified regarding the building and test-
`ing of a prototype of the claimed invention. J.A. 11815,
`11834, 11971, 11982–83. As the Board found, that testi-
`mony was supported by both documentary evidence and
`noninventor testimony. Decision, J.A. 36–51. For example,
`Steven Erb, a former Research & Development Technician
`at VSI, testified that he “worked on the early GuideLiner
`prototypes,” including the “first rapid exchange Guide-
`Liner prototypes in early 2005.” J.A. 12000. He confirmed
`that “[t]hese prototypes were then tested, including for
`
`
`
`Case: 21-2356 Document: 56 Page: 12 Filed: 05/24/2023
`
`12
`
`MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.À.R.L.
`
`durability . . . and for functionality,” which informed them
`that “it would work.” J.A. 12001–02. Erb testified that he
`was both personally involved in some of the testing, and
`recalls watching the inventors perform testing on the pro-
`totypes on multiple occasions. Id. Deborah Schmalz, the
`former Vice President of Regulatory and Clinical Affairs at
`VSI, testified that she “specifically recall[ed] that a work-
`ing prototype of the rapid exchange version of GuideLiner
`was created” prior to August 24, 2005. J.A. 9878–79.
`Those findings are further supported by documentary
`evidence. For example, reports and invoices show that VSI
`ordered specialized “hypotubes” for prototypes of the rapid
`exchange GuideLiner in the first half of 2005. See, e.g., De-
`cision, J.A. 37–51; J.A. 9592–97 (project spend report); J.A.
`11468 (invoice and purchase orders); J.A. 11471 (invoice
`and purchase orders). As the Board found, the dimensions
`of that hypotubing are consistent with the dimensions pro-
`vided in the patents themselves and engineering drawings
`specific to the rapid exchange GuideLiner. See, e.g., Deci-
`sion, 38–51; ’032 patent at col. 3 ll. 30–32, 43–46, 55–59,
`col. 7 ll. 19–25; J.A. 11592–93, 11595 (engineering draw-
`ings). Even Medtronic’s expert witness acknowledged that
`it “doesn’t make a lot of sense” for VSI not to have assem-
`bled the purchased parts together once they were ordered
`and received. J.A. 13920 at 208:10–25. And Medtronic con-
`cedes that a benchtop model depicted in a July 2005 sales
`presentation could have been used to test a device like the
`rapid exchange GuideLiner. See J.A. 9725 (photograph);
`Decision, J.A. 58 (citing Medtronic, Inc. v. Teleflex Innova-
`tions S.À.R.L., IPR2020-00126, Conception and Reduction
`to Practice Reply at 17–18); see also J.A. 12011–12 (expert
`testimony regarding bench model testing). That evidence,
`taken together, is, at minimum, circumstantial evidence of
`corroboration.
`Medtronic’s main complaint is that some of the evi-
`dence in the record of corroboration is unclear as to
`whether or not it relates to the over-the-wire GuideLiner
`
`
`
`Case: 21-2356 Document: 56 Page: 13 Filed: 05/24/2023
`
`MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.À.R.L.
`
`13
`
`or the rapid exchange GuideLiner. That is true, and cer-
`tain documents could only be connected to the rapid ex-
`change prototype through inventor testimony, which
`carries little to no weight in the context of corroboration;
`one cannot corroborate oneself, after all. However, when
`viewing the pertinent evidence in its entirety, we still find
`the inventors’ story corroborated. Erb’s and Schmalz’ tes-
`timony, along with that of others and numerous docu-
`ments, specifically mention the rapid exchange GuideLiner
`or can be connected to that version of the device in ways
`independent of the inventors’ testimony.
`For example, Teleflex asserts that a Computer Aided
`Design schematic from August 2005, J.A. 9751–52, corrob-
`orates the inventors’ testimony that they had moved be-
`yond prototyping and testing at that point in time.
`Medtronic challenges the Board’s reliance on inventor
`Root’s testimony to connect that document to the reduction
`to practice of the rapid exchange prototype. Although
`Root’s testimony certainly enunciates that connection, his
`testimony is not required to establish the document’s cor-
`roborative value. The document is labeled “GuideLiner
`Rapid Exchange/Preliminary Design Assumptions/Rev
`X03,” indicating that the drawing is indisputably linked to
`the rapid exchange prototype, not the over-the-wire proto-
`type, and that it is not the first, or even second, version of
`that drawing. See Decision, J.A. 42–43. The part number
`(20-0658) on the drawing is also consistent with those iden-
`tified in certain purchase documents for tubing. Compare
`J.A. 9751–52 with J.A. 9749–50, J.A. 11480–84, and J.A.
`11466–71. Moreover, the “law does not impose an impossi-
`ble standard of ‘independence’ on corroborative evidence by
`requiring that every point of a reduction to practice be cor-
`roborated by evidence having a source totally independent
`of the inventor; indeed, such a standard is the antithesis of
`the rule of reason.” Knorr v. Pearson, 671 F.2d 1368, 1374
`(CCPA 1982). We find the inventors’ testimony regarding
`
`
`
`Case: 21-2356 Document: 56 Page: 14 Filed: 05/24/2023
`
`14
`
`MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.À.R.L.
`
`reduction to practice sufficiently corroborated under the
`rule of reason standard.
`Because we find the Board’s determination of actual re-
`duction prior to the critical date supported by substantial
`evidence, we affirm the Board’s finding that Itou does not
`qualify as prior art to the challenged patents under
`35 U.S.C. § 102(e). Because Itou does not qualify as prior
`art, we likewise affirm the Board’s holding that Medtronic
`did not demonstrate by a preponderance of the evidence
`that the challenged claims of the challenged patents are
`unpatentable.
`
`II
` Medtronic additionally argues that the Board erred in
`finding that there was reasonably continuous diligence in
`reducing the invention to practice during the critical pe-
`riod. Because we agree with the Board that the claimed in-
`vention was actually reduced to practice prior to the critical
`date and affirm the Board’s finding that Itou did not qual-
`ify as prior art on that basis, there is no need to reach the
`issue of whether or not reasonable diligence was exercised.
`CONCLUSION
`We have considered Medtronic’s remaining arguments
`but find them unpersuasive. For the foregoing reasons, the
`decision of the Board is affirmed.
`AFFIRMED
`
`
`
`Case: 21-2356 Document: 56 Page: 15 Filed: 05/24/2023
`
`United States Court of Appeals
`for the Federal Circuit
`______________________
`
`MEDTRONIC, INC., MEDTRONIC VASCULAR,
`INC.,
`Appellants
`
`v.
`
`TELEFLEX INNOVATIONS S.À.R.L.,
`Appellee
`______________________
`
`2021-2356, 2021-2358, 2021-2361, 2021-2363, 2021-2365
`______________________
`
`Appeals from the United States Patent and Trademark
`Office, Patent Trial and Appeal Board in Nos. IPR2020-
`00126, IPR2020-00128, IPR2020-00132, IPR2020-00135,
`IPR2020-00137.
`
`______________________
`
`DYK, Circuit Judge, dissenting.
`Contrary to the majority, I think that Itou1 has been
`shown to be prior art to the patents at issue2 and therefore
`could support a determination of anticipation or obvious-
`ness. This is so because, under the pre-America Invents
`
`
`1 U.S. Patent No. 7,736,355 to Itou et al. (“Itou”).
`2 The challenged patents claim priority to the appli-
`cation that led to U.S. Patent No. 8,048,032 (“’032 patent”),
`filed on May 3, 2006.
`
`
`
`Case: 21-2356 Document: 56 Page: 16 Filed: 05/24/2023
`
`2
`
`MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.À.R.L.
`
`Act (“AIA”) 35 U.S.C. § 102(e), applicable to this case,3 Itou
`has an earlier filing date than that of the ’032 patent, and
`the evidence in this case fails to adequately corroborate in-
`ventor testimony that the rapid exchange (“RX”) Guide-
`Liner invention had been reduced to practice before Itou’s
`filing date of September 23, 2005. I agree with the majority
`that the Board correctly identified the object of the inven-
`tion as “providing increased backup support,”4 Panel Op. 6,
`and that the testimony and corroborating evidence support
`the Board’s finding that prototypes reflecting the invention
`were assembled before the priority date. Panel Op. 12. My
`disagreement lies with respect to the issue of testing. Spe-
`cifically, the evidence does not corroborate that testing of
`the RX GuideLiner prototypes before the critical date had
`shown them to work for their intended purpose.
`I
`“To show reduction to practice, [a patent owner] must
`demonstrate that the invention is ‘suitable for its intended
`
`
`3 The AIA’s first-to-file provisions do not apply to the
`challenged patents, because they apply to patents with an
`effective filing date on or after March 16, 2013. See AIA,
`Pub. L. No. 112-29, § 3(n)(1), 125 Stat. 284, 293 (2011).
`4 The majority confusingly suggests the intended
`purpose of the invention may be even broader than the pur-
`pose identified by the Board and urged by Teleflex. Panel
`Op. 7–8; see also J.A. 52 (noting that Teleflex’s position was
`that the intended purpose of the invention was “to increase
`backup support” (citation omitted)). I do not understand
`the majority to rest its disposition on a purpose broader
`than that found by the Board. And reviewing the Board’s
`decision using a different standard than the Board’s own
`standard would present a problem under Securities & Ex-
`change Commission v. Chenery Corp., 332 U.S. 194, 196
`(1947).
`
`
`
`Case: 21-2356 Document: 56 Page: 17 Filed: 05/24/2023
`
`MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.À.R.L.
`
`3
`
`purpose.’” Scott v. Finney, 34 F.3d 1058, 1061 (Fed. Cir.
`1994) (quoting Steinberg v. Seitz, 517 F.2d 1359, 1363
`(C.C.P.A. 1975)). This case does not involve a situation
`where the invention is “so simple and [its] purpose and ef-
`ficacy so obvious that [its] complete construction is suffi-
`cient to demonstrate workability.” Id. (citation omitted).
`Under such circumstances, testing is required to establish
`a reduction to practice. Id. at 1063 (citation omitted). As
`both the majority and the Board assumed, testing was re-
`quired to establish a reduction to practice here. See Panel
`Op. 9–10; J.A. 57 n.22. “The issue . . . is not whether it
`might be possible to reduce the invention to practice by la-
`boratory testing, but whether the particular tests made by
`[the inventor] were sufficient for that purpose.” Elmore v.
`Schmitt, 278 F.2d 510, 513 (C.C.P.A. 1960). The evidence
`must show that the “tests accurately reproduced the oper-
`ating conditions which would be encountered in any prac-
`tical use of the invention.” Id.
`II
`The testimony of the inventors here never describes
`(1) any specific tests showing the RX GuideLiner proto-
`types would work for their intended purpose of providing
`increased backup support5 or (2) the results of the tests
`
`
`5 The inventors do describe in general terms tests re-
`garding the simple delivery of cardiology devices in bench-
`top cardiac models, and they mention “pull te