UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
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`v.
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`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
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`
`
`Case IPR2020-00134
`Patent RE45,760
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`PATENT OWNER SUR-REPLY TO PETITIONER’S REPLY
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`

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`TABLE OF CONTENTS
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`
`
`I.
`
`INTRODUCTION ........................................................................................... 1
`
`II. Ground 4: Petitioner Fails to Show that Claims 48 and 51-53 Are Obvious in
`View of Ressemann, Takahashi, and the Knowledge of a POSITA ............... 1
`
`A.
`
`Petitioner’s Newly Proposed Construction of “Coaxial” is Improper
`and Unsupported .................................................................................... 1
`
`Page
`
`1.
`
`2.
`
`Petitioner’s attempt to construe the term “coaxial” for the first
`time in its Reply should be rejected ............................................ 2
`
`Petitioner’s proposed construction is untethered from the
`ordinary meaning and should be rejected ................................... 3
`
`i.
`
`ii.
`
`Petitioner’s construction is unsupported by the intrinsic
`evidence ............................................................................ 4
`
`Petitioner’s new construction is unsupported by the
`extrinsic evidence and the opinion offered by Petitioner’s
`expert Dr. Brecker is not credible ..................................... 6
`
`iii. The Board does not need to reach the issue of whether
`the various “tube-in-tube” configurations identified by
`Petitioner meet the coaxial limitation ............................... 9
`
`B.
`
`Ressemann Does Not Disclose a “Tubular Structure Defining a
`Lumen Coaxial … with the Lumen of the Guide Catheter” as
`Required by Claims 48 and 51-53 ...................................................... 10
`
`C. A POSITA Would Not Have Been Motivated to Eliminate the
`Primary Function of Ressemann to Satisfy the “one French size”
`Limitation ............................................................................................ 12
`
`1.
`
`2.
`
`Petitioner cannot assert a new theory at this stage of the
`proceedings ............................................................................... 12
`
`A POSITA would not be motivated to modify Ressemann so
`that it can no longer serve its fundamental purpose as an emboli
`protection device ....................................................................... 14
`
`
`
`ii
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`

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`III. Unrebutted Objective, Real-World Evidence Shows the Non-Obviousness of
`Claims 48, 51, and 53 ................................................................................... 16
`
`A. GuideLiner and Telescope Are Covered By Claims 48, 51 and 53 .... 16
`
`B.
`
`C.
`
`The Combination of Features That Resulted in GuideLiner’s Success
`and Praise Is Not in the Prior Art ........................................................ 17
`
`The Fact that All of GuideLiner’s Competitors Copied its Design
`Confirms Non-Obviousness ................................................................ 19
`
`IV. Non-AIA Patent ............................................................................................. 22
`
`
`
`iii
`
`

`

`Cases
`
`TABLE OF AUTHORITIES
`
`Apple Inc. v. Samsung Elecs. Co.,
`839 F.3d 1034 (Fed. Cir. 2016) ................................................................................ 20
`
`Freebit AS v. Bose Corp.,
`IPR2018-00142, Paper 7 (PTAB May 11, 2018)..................................................... 15
`
`Henny Penny Corp. v. Frymaster LLC,
`938 F.3d 1324 (Fed. Cir. 2019) ................................................................................ 18
`
`Hill-Rom Servs. v. Stryker Corp.,
`755 F.3d 1367 (Fed. Cir. 2014) .................................................................................. 4
`
`In re Gordon,
`733 F.2d 900 (Fed. Cir. 1984) .................................................................................. 15
`
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge, Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) ................................................................................ 13
`
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) ......................................................................... 19, 20
`
`Lectrosonics, Inc. v. Zaxcom, Inc.,
`IPR2018-01129, Paper 33 (PTAB Jan. 24, 2019) ................................................... 18
`
`Personalized Media Commc’ns, LLC v. Apple Inc.,
`952 F.3d 1336 (Fed. Cir. 2020) .................................................................................. 4
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) .................................................................................. 3
`
`Plas-Pak Indus. v. Sulzer Mixpac AG,
`600 F. App’x 755 (Fed. Cir. 2015) .......................................................................... 15
`
`Polaris Indus. v. Arctic Cat, Inc.,
`882 F.3d 1056 (Fed. Cir. 2018) ................................................................................ 15
`
`Raytheon Co. v. Sony Corp.,
`727 F. App’x 662 (Fed. Cir. 2018) .......................................................................... 14
`
`Real Time Data, LLC v. Iancu,
`912 F.3d 1368 (Fed. Cir. 2019) ................................................................................ 10
`
`Redline Detection, LLC v. Star Envirotech, Inc.,
`811 F.3d 435 (Fed. Cir. 2015) .................................................................................... 2
`
`Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc.,
`
`iv
`
`

`

`200 F.3d 795 (Fed. Cir. 1999) .................................................................................. 10
`
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) ................................................................................ 18
`
`Other Authorities
`
`35 U.S.C. § 100(i)(2) ............................................................................................... 21
`
`37 C.F.R. § 42.104(b)(3) ............................................................................................ 2
`
`37 C.R.F. § 42.23(b) ................................................................................................ 13
`
`v
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`

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`I.
`
`INTRODUCTION
`
`Grounds 1-3 should be rejected because Petitioner has failed to prove that
`
`the primary reference, Itou, qualifies as prior art to the ‘760 patent. Paper 36;
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`Paper 93.
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`As for Ground 4, no matter how many times Petitioner calls Ressemann a
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`“guide extension catheter,” it is not. Ressemann is an emboli protection device. It
`
`does not disclose a lumen coaxial with the lumen of the guide catheter it is in, and
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`Petitioner has provided no persuasive motivation to make the fundamental changes
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`that would be required to transform Ressemann into a device with a cross-sectional
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`inner diameter that is not more than one French size smaller than the cross-
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`sectional inner diameter of the lumen of the guide catheter. Moreover, the
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`unrebutted objective evidence presented by Patent Owner (“Teleflex”) confirms
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`the non-obviousness of the invention recited in claims 48 and 51-53. Therefore,
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`Ground 4 should be rejected as well.
`
`II. Ground 4: Petitioner Fails to Show that Claims 48 and 51-53 Are
`Obvious in View of Ressemann, Takahashi, and the Knowledge of a
`POSITA
`
`A.
`
`Petitioner’s Newly Proposed Construction of “Coaxial” is
`Improper and Unsupported
`
`All claims challenged in Ground 4 (claims 48, 51-53) require “a tubular
`
`structure defining a lumen coaxial and in fluid communication with the lumen of
`
`the guide catheter.” As the Board recognized in a parallel Decision Denying
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`1
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`

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`Institution for other claims in the same ’760 patent having the same limitation,
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`Ressemann does not teach a tubular structure with a lumen coaxial with the lumen
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`of the guide catheter. IPR2020-00133, Paper 20, 14-15. Instead, Ressemann
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`teaches a dual-lumen structure that is disclosed as having lumens that are offset
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`from the axis of the guide catheter lumen. Id.; Paper 40 (Patent Owner Response,
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`“POR”), 10-13.
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`Now recognizing this, Petitioner attempts to construe the term “coaxial” for
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`the first time in its Reply. Paper 83 (“Reply”), 2-9. Not only are Petitioner’s
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`efforts too late, they seek to impart a special construction of “coaxial” that is
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`untethered from intrinsic evidence and unsupported by the extrinsic evidence
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`already filed in these proceedings. Petitioner’s tortured construction should be
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`rejected in favor of the term’s plain and ordinary meaning as understood by a
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`POSITA and applied by both the parties and the Board.
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`1.
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`Petitioner’s attempt to construe the term “coaxial” for the
`first time in its Reply should be rejected
`
`In proceedings before the Board, the Petitioner is required to identify and
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`construe any terms requiring construction in its Petition. 37 C.F.R. § 42.104(b)(3);
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`Consolidated Trial Practice Guide (“TPG”), 44-45 (Nov. 2019); see also Redline
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`Detection, LLC v. Star Envirotech, Inc., 811 F.3d 435, 442 (Fed. Cir. 2015).
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`Petitioner did not offer a construction for “coaxial” in its Petition; therefore,
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`Petitioner applied plain and ordinary meaning. Petition, 16-18. The expert
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`2
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`

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`declarations filed with the Petitions confirm Petitioner’s intention. See, e.g.,
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`IPR2020-00130, Ex-1405, ¶171 (Dr. Brecker) (arguing that the Kontos reference’s
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`tube is “coaxial” because it is centered in the guide catheter in Fig. 6A). Both
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`Teleflex and the Board agreed that the plain and ordinary meaning of the term
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`should apply. IPR2020-00133, Paper 20, 14-15; see generally POR.
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`Now, for the first time, Petitioner spends nine pages arguing that “coaxial”
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`requires a special construction. According to these new arguments, “coaxial”
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`means that “the axis of the lumen of the guide extension catheter is aligned in the
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`same direction as the axis of the lumen of the guide catheter.” Reply, 2-9.
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`Petitioner’s attempt to raise a new claim construction argument in its Reply
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`violates inter partes review rules and deprives Teleflex of the opportunity to
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`challenge the construction with expert testimony or other evidence. 37 C.F.R. §
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`42.104(b)(3); TPG, 45 (“The petitioner . . . cannot raise new claim construction
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`issues that were not previously raised in its petition.”).
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`2.
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`Petitioner’s proposed construction is untethered from the
`ordinary meaning and should be rejected
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`Words of a claim are “generally given their ordinary and customary
`
`meaning,” which is “the meaning that the term would have to a person of ordinary
`
`skill in the field at the time of the invention.” Phillips v. AWH Corp., 415 F.3d
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`1303, 1312-13 (Fed. Cir. 2005). Departure from the plain and ordinary meaning of
`
`a claim term is justified in only two instances: 1) where the patentee clearly sets
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`3
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`

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`forth a definition of the disputed claim term other than its plain and ordinary
`
`meaning (lexicography), or 2) where there is an express intent to redefine the term
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`(disavowal). Hill-Rom Servs. v. Stryker Corp., 755 F.3d 1367, 1371 (Fed. Cir.
`
`2014).
`
`By arguing for the construction “axes aligned in the same direction,”
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`Petitioner is essentially trying to construe “coaxial” to mean the same thing as
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`“parallel.” Petitioner identifies nothing in intrinsic or extrinsic evidence that
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`would justify such a radical departure from the plain and ordinary meaning.
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`i.
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`Petitioner’s construction is unsupported by the
`intrinsic evidence
`
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`Even if “coaxial” required construction, the proper meaning of the term
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`should be ascertained from intrinsic evidence. Personalized Media Commc’ns,
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`LLC v. Apple Inc., 952 F.3d 1336, 1340 (Fed. Cir. 2020) (“When construing claim
`
`terms, we first look to, and primarily rely on, the intrinsic evidence, including the
`
`claims themselves, the specification, and the prosecution history of the patent,
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`which is usually dispositive.”). The only piece of intrinsic evidence cited by
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`Petitioner in its entire nine-page argument is column 8, lines 10-16 and Figure 8 of
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`the ’760 patent. Reply, 3-4. This does not support Petitioner’s construction. It
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`says nothing about a “coaxial arrangement” and is simply generically describing
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`how the coaxial guide catheter is placed in the ostium of the coronary artery. Ex-
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`1601, 8:10-22. The lack of intrinsic evidence confirms that there is no support for
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`4
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`

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`the construction Petitioner proposes.
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`Indeed, the ‘760 specification uses “coaxial” consistent with its ordinary
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`meaning. All examples of the “coaxial guide catheter” show a distal tubular
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`portion with a lumen that it is disposed approximately coincident with the axis of
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`the lumen of the guiding catheter. E.g., Ex-1601, Figs. 3, 4, 8, 9:
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`“Coaxial”:
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`Common axis of guide
`extension catheter within
`guide catheter 56
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`From Fig. 9, annotation
`added to highlight
`coaxial arrangement of
`guide extension catheter
`within guide catheter
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` To be clear, Teleflex is not saying that “coaxial” requires mathematical
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`precision. Some clearance is required between the coaxial guide extension catheter
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`and the surrounding guide catheter. E.g., Ex-2240, 128:12-18 (Petitioner’s expert
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`testifying that an inner catheter would need at least approximately 0.002 inch total
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`
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`5
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`

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`clearance). For a “tube-in-tube” arrangement such as that shown in the ’760 patent,
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`such a small (and necessary) clearance gap does not prevent the two lumens from
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`being “coaxial” with one another.
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`In this regard, Petitioner wrongly accuses Teleflex of taking the position that
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`the term “coaxial” required “lumens to be perfectly concentric.” Reply, 2-3.
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`Teleflex said nothing about perfect concentricity. POR, 11-13. Rather, Teleflex
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`and its experts stated that Ressemann is not coaxial because it is configured to have
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`an offset lumen. Id.; see also Ex-2138 (Mr. Keith), ¶¶104-05, 110; Ex-2145 (Dr.
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`Graham), ¶¶127-29. Mr. Keith confirmed that a POSITA would not understand
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`“coaxial” to mean that the lumen of the tubular structure must be perfectly coaxial
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`with the lumen of the surrounding guide catheter at every physical location along
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`the structure and at every point in time. Ex-1764, 90:2-91:18. This is perfectly
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`consistent with the portions of Mr. Keith’s testimony that Petitioner cites. Ex-
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`1805, 119:22-121:1.
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`ii.
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`Petitioner’s new construction is unsupported by the
`extrinsic evidence and the opinion offered by
`Petitioner’s expert Dr. Brecker is not credible
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`To the extent it is necessary to consider extrinsic evidence, there is still no
`
`basis to depart from the plain and ordinary meaning. The Board understood what
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`“coaxial” means, and that Ressemann did not disclose the coaxial limitation.
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`IPR2020-00133, Paper 20 at 13-15. Petitioner’s experts also understood what
`
`6
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`

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`coaxial means. For example, Dr. Zalesky testified that the ordinary meaning of
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`coaxial is that nested catheters share the same axis. Ex-2237, 130:13-22.
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`Similarly, Dr. Brecker’s original declaration argued that Kontos’s tube 16 has a
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`coaxial lumen because it is centered in the guide catheter in Figure 6A (and
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`Teleflex did not dispute that point). IPR2020-00130, Ex-1405, ¶171 (“Indeed, a
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`vertical cross section of Kontos’s Figure 6A show that the tubular structure 16 and
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`guide catheter 38 are coaxial”).
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`Petitioner nonetheless relies on new testimony from Dr. Brecker to support
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`its new construction. E.g. Reply, 4, 9 (citing Ex-1806, ¶¶16-26). But Brecker
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`agreed that the GuideLiner patents do not define the term “coaxial” in any
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`particular manner. Ex-2238, 28:10-14. And the broad definition he offers—that
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`coaxial merely means axes “aligned in the same direction”—is not credible and
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`flatly contradicted by the ordinary use of the term “coaxial” in the context of
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`catheters. First, it is inconsistent with the evidence Petitioner relies on in these
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`IPRs. E.g., Ex-1121, 7:34-43 (describing tube as transitioning from an “‘off-axis’
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`alignment” to being “aligned generally coaxially”); Ex-1609, 8:31-37 (the Kontos
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`reference explaining that its full length embodiment has a “coaxial” tube 116 and
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`lumen 122, unlike the “eccentric” (and “dissimilar”) proximal portion of its first
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`(tube 16) embodiment). Second, it is inconsistent with the way Petitioner itself
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`uses “coaxial.” Dr. Brecker did not disagree that Petitioner’s own patent describes
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`7
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`

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`the side-by-side lumens shown below (similar to Ressemann’s Figure 1B) as a “a
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`non-coaxial arrangement”:
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`
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`Ex-2238, 54:20-24; Ex-2224, Fig. 7 and 7:26-30 (“Fig. 7 . . . illustrates a non-
`
`coaxial arrangement of guidewire lumen 416 and inflation lumen 408”). Third, it
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`is also inconsistent with how Petitioner’s other expert, Dr. Zalesky, understands
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`the term “coaxial.” Ex-2237, 130:3-22.
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`Petitioner purports to support Dr. Brecker’s new opinion by asserting that
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`inventor Mr. Root understood the term “coaxial” to mean a “tube-within-a-tube”
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`configuration. Reply, 5-6. Even viewed in isolation, however, this testimony does
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`not align at all with Petitioner’s construction. And in other testimony, Mr. Root
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`testified that he understood coaxial alignment to additionally require some degree
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`of concentricity. Compare Reply, 5-6 (citing Ex-1714) with Ex-1714, 67:18-23
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`(“Q. [A]re we basically saying that there’s a concentric alignment if we look at the
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`cross section of the flexible tube within the guide catheter? A: Yeah.”), 87:4-7.
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`8
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`

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`
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` Finally, Petitioner asserts yet another alternative construction for “coaxial,”
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`claiming that it means “a catheter-in-a-catheter arrangement that is in line with the
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`coronary ostia.” Reply, 4-5. There is no more support for this deviation from the
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`plain and ordinary meaning than there is for the first one. Although Petitioner
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`appears to argue that this understanding is supported by Teleflex’s own documents,
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`those documents state that the coaxial alignment created by GuideLiner “allows
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`devices to track smoothly into the coronary artery.” Ex-1812, 15 (cited by Reply,
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`5) (emphasis added). Put differently, the coaxial nature of the guide catheter-
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`coaxial guide catheter combination improves the directional alignment of the
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`combination with the coronary ostia. Petitioner cites no evidence supporting an
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`understanding that claimed coaxial limitation is the same as directional alignment
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`with the coronary ostia, and a POSITA would not possess such an understanding.
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`iii. The Board does not need to reach the issue of whether the
`various “tube-in-tube” configurations identified by
`Petitioner meet the coaxial limitation
`
`Petitioner attempts to distract from the myriad problems with its late-
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`breaking and improper claim construction by discussing whether various illustrated
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`single lumen, symmetric “tube-in-tube” configurations, for example 4-in-6 French
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`or 5-in-8 French guide extension catheter within guide catheter configurations,
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`would fall within the scope of the “coaxial” limitation. Reply, 7-9. Petitioner’s
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`illustrations should be taken with a grain of salt. Petitioner’s expert admitted that
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`9
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`

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`the illustrations are not to scale. Ex-2238, 30:2-21. Regardless, however, the
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`Board should ignore Petitioner’s illustrations because Ressemann, the structure at
`
`issue in this IPR, is not the illustrated “tube-in-tube” structure. Rather,
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`Ressemann’s distal evacuation head has multiple offset lumens. E.g. Ex-1608,
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`Figs. 6B-6I. This configuration is different from the tube-in-tube structures Dr.
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`Brecker wants to focus on. The Board need not detour into issues unnecessary to
`
`resolve the present controversy. E.g., Real Time Data, LLC v. Iancu, 912 F.3d
`
`1368, 1375 (Fed. Cir. 2019) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc.,
`
`200 F.3d 795, 803 (Fed. Cir. 1999) (“The Board is required to construe only those
`
`terms . . . that are in controversy, and only to the extent necessary to resolve the
`
`controversy.”)).
`
`B. Ressemann Does Not Disclose a “Tubular Structure Defining a
`Lumen Coaxial . . . with the Lumen of the Guide Catheter” as
`Required by Claims 48 and 51-53
`
`It is undisputed that Ressemann discloses evacuation lumen 140 offset from
`
`the lumen of the guide catheter, as shown in Figures 6B-6I. POR, 11-13. This is
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`particularly apparent from Ressemann’s Figures 6C and 1B:
`
`10
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`

`

`
`
`
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`POR, 12. Petitioner’s expert Dr. Brecker admitted this. Ex-2238, 73:18-23. The
`
`Board’s preliminary ruling was correct: Ressemann does not disclose a tubular
`
`structure having a “tubular structure defining a lumen coaxial . . . with the lumen
`
`of the guide catheter,” as required by claims 48 and 51-53. IPR2020-00133, Paper
`
`20, 14-15.
`
`11
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`

`

`C. A POSITA Would Not Have Been Motivated to Eliminate the
`Primary Function of Ressemann to Satisfy the “one French size”
`Limitation
`
`The Petition conceded that Ressemann does not teach a lumen of a tubular
`
`structure “having a uniform cross-sectional inner diameter that is not more than
`
`one French size smaller than the cross-sectional inner diameter of the lumen of the
`
`guide catheter,” as required by claims 48 and 51-53. Petition, 64. This is not
`
`surprising, as the balloons and inflation lumen in Ressemann’s emboli protection
`
`device limit the size of the evacuation lumen. Recognizing this, the Petition
`
`argued that in view of Takahashi, a POSITA would have been motivated to remove
`
`Ressemann’s sealing balloons to arrive at the one French size limitation of the
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`challenged claims. Petition, 64-67. In response, Teleflex pointed out that
`
`removing Ressemann’s balloons is contrary to Ressemann’s fundamental function
`
`as an “emboli protection device.” POR, 13-21.
`
`In its Reply, Petitioner now seeks to pivot to an entirely new argument: that
`
`a POSITA would not only remove the sealing balloons responsible for the primary
`
`function of Ressemann, but would also be motivated to use an entirely different
`
`type of emboli protection in place of the balloons. Reply, 13. The Board should
`
`reject Petitioner’s new theory.
`
`1.
`
`Petitioner cannot assert a new theory at this stage of the
`proceedings
`
`It is improper to introduce a new obviousness theory at the reply stage.
`
`12
`
`

`

`Intelligent Bio-Sys., Inc. v. Illumina Cambridge, Ltd., 821 F.3d 1359, 1369-70
`
`(Fed. Cir. 2016) (holding that the Board did not err in refusing the reply brief as
`
`improper under 37 C.R.F. § 42.23(b) because petitioner relied on an entirely new
`
`rationale to explain why one of skill in the art would have combined the references
`
`at issue); TPG, 73-74. Petitioner’s experts were clear that Petitioner’s proposed
`
`modifications would eliminate Ressemann’s emboli protection function. Ex-1642
`
`(Dr. Hillstead), ¶¶153-54 (“If a POSITA desired to only use Ressemann for
`
`delivering therapy devices, . . . Ressemann’s design would be simplified to
`
`eliminate the features necessary for evacuating emboli . . . . One feature that
`
`would be removed . . . would be the sealing balloons.”) (emphasis added); Ex-1605
`
`(Brecker), ¶258 (“[B]y the time of the alleged invention of the ʼ760 patent, a
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`POSITA had the motivation to modify the evacuation assembly of Ressemann to
`
`remove the sealing balloons. And that is because catheter 100 could be modified
`
`for use solely as an extension catheter, and not as an aspiration catheter.”)
`
`(emphasis added). And Petitioner’s expert admitted that he was aware of emboli
`
`protection filters when he prepared his declaration in support of the Petition, (Ex-
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`2238, 135:19-23), but he did not include any discussion of these devices in that
`
`declaration. Petitioner cannot now argue that its prior arguments and prior expert
`
`testimony were wrong and deprive Teleflex the opportunity to respond with its
`
`own expert testimony.
`
`13
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`

`

`2.
`
`A POSITA would not be motivated to modify Ressemann so
`that it can no longer serve its fundamental purpose as an
`emboli protection device
`
`Even if the Board were willing to consider Petitioner’s new argument, it
`
`should be rejected. The existence of other types of protection devices does not
`
`change that Ressemann’s device is, fundamentally, an emboli protection device
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`requiring an inflation lumen and use of sealing balloons. Indeed, the title of
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`Ressemann is “Emboli protection Devices and Related Methods of Use.”
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`Petitioner argues that the fact that “the proposed modification impacts
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`Ressemann’s emboli protection function is not determinative of the obviousness
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`inquiry.” Reply, 12. But Petitioner’s proposed modification does not merely
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`“impact” Ressemann’s emboli protection function—it entirely eliminates it. POR,
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`13-18; Ex-2116, 396:21-397:20 (Brecker); Ex-1642 (Hillstead), ¶¶153-54; Ex-
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`2138 (Keith), ¶¶113-114. In this regard, the Raytheon case cited by Petitioner is
`
`inapposite. Raytheon involved a situation where the modifications proposed by the
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`patent challenger affected only two out of six objectives of the prior art reference,
`
`thus merely rendering the device “less efficient” or “less desirable.” Raytheon Co.
`
`v. Sony Corp., 727 F. App’x 662, 667 (Fed. Cir. 2018).
`
`Here, a device that provided emboli protection was not one of several
`
`objectives of the Ressemann patent. It was the objective. Ex-1608, Abstract;
`
`1:13-16; 2:55-61; Ex-2138, ¶¶103-04, 107-08, 113-14. Ressemann does not teach
`
`14
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`

`

`that its evacuation sheath is there to also help guide or deliver stents or balloon
`
`catheters. Rather, it is there only to occlude the blood flow and thereby capture
`
`dislodged particulates. Ex-1008, 13:35-60. The Ressemann evacuation sheath was
`
`disclosed as an obstacle the stent has to traverse through, not a stent delivery
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`device. See id., 17:58-63 (evacuation sheath of full length embodiment “more
`
`fully obstruct[s]” the guide catheter lumen, indicating that all evacuation sheath
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`embodiments obstruct).
`
`Well-established precedent holds that a modification purportedly for
`
`improving a device that would render it inoperable for its intended purpose or
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`fundamentally change its principle of operation is highly unlikely to be obvious.
`
`E.g., In re Gordon, 733 F.2d 900, 902 (Fed. Cir. 1984) (modification that turned
`
`prior art oil strainer upside down not obvious because “would be rendered
`
`inoperable for its intended purpose,” as the strainer relied on gravity for operation);
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`POR, 14 (citing Polaris Indus. v. Arctic Cat, Inc., 882 F.3d 1056, 1069 (Fed. Cir.
`
`2018); Plas-Pak Indus. v. Sulzer Mixpac AG, 600 F. App’x 755, 758-59 (Fed. Cir.
`
`2015); Freebit AS v. Bose Corp., IPR2018-00142, Paper 7 at 37 (PTAB May 11,
`
`2018)). That is exactly what removing Ressemann’s sealing balloons and inflation
`
`lumen would be in this case – a fundamental change that renders Ressemann’s
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`evacuation sheath inoperable for its fundamental purpose.
`
`
`
`
`
`15
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`

`

`III. Unrebutted Objective, Real-World Evidence Shows the Non-
`Obviousness of Claims 48, 51, and 53
`
`Petitioner does not dispute that GuideLiner was an incredibly successful
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`category-creating product, or that the nexus requirement is met. Reply, 16-23.
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`Instead, Petitioner argues that GuideLiner’s remarkable successes should be
`
`disregarded because, it contends, the claimed elements individually were known in
`
`the prior art and it would have been obvious to combine them. Id. at 16-17. But
`
`this ignores the very purpose of objective evidence: to act as a real-world check
`
`against the tendency towards hindsight. The Board should reject Petitioner’s
`
`flawed and unpersuasive attempt to sidestep the compelling objective evidence of
`
`non-obviousness.
`
`A. GuideLiner and Telescope Are Covered By Claims 48, 51 and 53
`
`Petitioner argues that Telescope and GuideLiner do not meet the size
`
`limitation of claims 48, 51 and 53, pointing out that “one French” is
`
`mathematically defined as 0.0131 inches. Reply, 21. But these claims merely
`
`require the lumen of the guide extension catheter be “not more than one French
`
`size smaller” than the lumen of the guide catheter. The ’760 patent specification
`
`expressly states that a one French size difference in inner diameters can be 0.014
`
`inches. Ex-1601, 3:35-51 (for a “5 French in 6 French” configuration, the internal
`
`diameter of a 6 French guide catheter is 0.070”, and the internal diameter of the
`
`guide extension catheter should be “greater than or equal to 0.056 inches”); Ex-
`
`16
`
`

`

`2138, ¶46.
`
`This makes sense because catheters are typically sized by their outer
`
`diameter, while the inner diameter varies depending not just on outer diameter, but
`
`also on wall thickness. Ex-2138, ¶46. Petitioner’s experts agree that when one
`
`was talking about two nested catheters and a one French size difference in inner
`
`diameters, a POSITA would have understood that it was not exactly 0.0131 inches.
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`E.g., Ex-2239, 155:17-156:24 (“you’d have to have some allowance or variation”);
`
`Ex-2137, 371:25-372:9; see also id., 370:14-371:20. This confirms that a POSITA
`
`would not have understood a “one French size” difference for inner catheter
`
`diameters to connote exactly 0.0131 inches.
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`Therefore, both GuideLiner and Telescope meet this limitation. Ex-2138,
`
`¶¶120-121, 162 and Appx B.1
`
`B.
`
`The Combination of Features That Resulted in GuideLiner’s
`Success and Praise Is Not in the Prior Art
`
`Petitioner accuses Teleflex of “confusing commercialization with
`
`invention,” arguing that each of the claimed features resulting in GuideLiner’s
`
`
`1 Even if the Board were to interpret “one French size” to be limited to exactly
`
`0.0131 inches, GuideLiner is covered by these claims under the doctrine of
`
`equivalents. E.g., Ex-2138, pp.121-22. Petitioner has offered no evidence in
`
`rebuttal.
`
`17
`
`

`

`success were contained in Ressemann and Itou. Reply, 16-17. But Petitioner’s
`
`approach of looking at each claimed feature in isolation is legally erroneous.
`
`“[T]he fact that an isolated feature may be present in the prior art may not render
`
`irrelevant objective evidence of non-obviousness of that feature in the claimed
`
`combination.” WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1330-31 (Fed. Cir.
`
`2016); see also Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1333 (Fed.
`
`Cir. 2019); Lectrosonics, Inc. v. Zaxcom, Inc., IPR2018-01129, Paper 33 at 33
`
`(PTAB Jan. 24, 2019) (precedential).
`
`The unrebutted testimony of two Teleflex experts and two cardiologist fact
`
`witnesses establishes that it was the combination of claimed features that led to
`
`GuideLiner’s remarkable success and industry recognition. Ex-2138, ¶¶173-77;
`
`Ex-2145, ¶¶67-71, 76-82, 238-241; Ex-2215, ¶¶20-29; Ex-2151, ¶¶9-17. That
`
`combination of claimed features was not present in the prior art. Itou is not prior
`
`art, and furthermore, was a suction catheter, not a guide extension catheter.
`
`Ressemann is an emboli protection device, not a guide extension catheter, and as
`
`discussed herein, it does not meet either the “coaxial lumen” or “no more than one
`
`French size difference” limitations of claims 48, 51 and 53. And Kontos teaches a
`
`specialized narrow body “support catheter” that, of course, does not have a side
`
`opening. That various individual claimed features may also be present in the prior
`
`art is of no moment because there is not a single prior art reference that teaches all
`
`18
`
`

`

`of the claimed features responsible for GuideLiner’s success. WBIP, 829 F.3d at
`
`1331. Objective evidence is intended for precisely this situation.
`
`C.
`
`The Fact that All of GuideLiner’s Competitors Copied its Design
`Confirms Non-Obviousness
`
`Petitioner does not dispute the substantial similarities Teleflex identifies
`
`between GuideLiner and the competing Guidezilla, Boosting Catheter, and
`
`Telescope GECs. Reply, 20-22. Instead, it attempts to sidestep this evidence by
`
`arguing that competitors’ copycat products “practice the prior art.” Id., 19-20. As
`
`explained supra, Petitioner has not shown that any single prior art reference
`
`discloses all of the claimed features, much less lead to GuideLiner’s enormous
`
`success; for that reason the copycat products do not merely “practice the prior art.”
`
`Petitioner alternatively points to unclaimed, insubstantial differences
`
`between GuideLiner and Petitioner’s own Telescope product to show that
`
`Telescope is not a “replication” of GuideLiner. Reply, 22-23. This argument fails
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`for at least two reason