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 IPR2020-01342
`U.S. Patent No. 8,142,413
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`PATENT OWNER RESPONSE
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`1
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`TABLE OF CONTENTS
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`2.
`
`
`INTRODUCTION ........................................................................................... 1
`I.
`II. BACKGROUND ............................................................................................. 2
`III. THE PERSON OF ORDINARY SKILL IN THE ART ................................. 6
`IV. OVERVIEW OF PETITIONER’S REFERENCES ........................................ 6
`A. Kontos (Ex-1409) .................................................................................. 6
`B. Adams (Ex-1435) .................................................................................. 9
`V. PETITIONER HAS NOT SHOWN THAT THE CHALLENGED
`CLAIMS OF THE ’413 PATENT ARE INVALID AS OBVIOUS ............. 12
`A. ALL GROUNDS: Petitioner Fails to Show that Kontos and/or
`Adams Would be Used in the Manner Required by the Steps of
`the Claimed Methods (All Claims) ..................................................... 12
`1.
`The Claimed Step of Inserting an ICD Must Be Performed
`After the Coaxial Guide Catheter Is Inserted Into the Guide
`Catheter ..................................................................................... 12
`Petitioner Does Not Show Prior Art Methods Performed in
`the Required Sequence .............................................................. 18
`B. GROUND 1: Petitioner Fails to Show that Kontos Discloses
`Particular Claimed Methods of Providing Backup Support
`(Claims 2 and 7) .................................................................................. 21
`C. GROUND 1: Petitioner Fails to Show that Claims 4, 9-12, and 14
`Are Obvious Because It Is Not Obvious to Modify Kontos in View
`of Adams to Create a Proximal Side Opening (Claims 4, 9-12,
`and 14) ................................................................................................. 26
`1. No Motivation or Reasonable Expectation of Success—
`Removing Kontos’s Funnel Portion would Create Problems .. 26
`Petitioner’s Modification Requires Ignoring What Adams
`Actually Teaches ....................................................................... 31
`
`2.
`
`ii
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`

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`3.
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`6.
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`Petitioner’s Alleged Motivations Are Based on Hindsight
`And/or Unsupported by the Evidence ....................................... 34
`D. GROUND 2: Petitioner Fails to Show It Would Be Obvious to
`Modify the Inner Diameter of the Lumen of Kontos’s Tubular
`Structure “to be not more than one French smaller than the cross-
`sectional inner diameter of the guide catheter” ................................... 42
`E. The Objective, Real-World Evidence Shows that Challenged
`Claims 4, 9, and 14 Are Not Obvious ................................................. 47
`1.
`Long-Felt Need ......................................................................... 49
`2. Commercial Success ................................................................. 51
`3.
`Industry Praise ........................................................................... 55
`4.
`Licensing ................................................................................... 57
`5. Copying ..................................................................................... 57
` ........................................ 58
` .............................................. 60
` ..................................................... 60
`There Is Nexus Between the Invention of Claims 4, 9, and
`14 and the Objective Evidence of Nonobviousness ................. 64
`The Petition Should Be Denied Because Inter Partes Review Is
`Unconstitutional .................................................................................. 71
`VI. CONCLUSION .............................................................................................. 71
`CERTIFICATE OF WORD COUNT COMPLIANCE ........................................... 73
`CERTIFICATION OF SERVICE............................................................................ 74
`
`
`F.
`
`iii
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`

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`TABLE OF AUTHORITIES
`
`
`Cases
`Altiris, Inc. v. Symantec Corp.,
`318 F.3d 1363 (Fed. Cir. 2003) ............................................................................ 13
`Apple Inc. v. Samsung Elecs. Co.,
`839 F.3d 1034 (Fed. Cir. 2016) ............................................................................ 64
`Arctic Cat Inc. v. Bombardier Rec. Prods.,
`876 F.3d 1350 (Fed. Cir. 2017) ............................................................................ 30
`Arthrex, Inc. v. Smith & Nephew, Inc.,
`941 F.3d 1320 (Fed. Cir. 2019) ............................................................................ 71
`
`Fox Factory, Inc. v. SRAM, LLC,
`944 F.3d 1366 (Fed. Cir. 2019) ..................................................................... 64, 70
`Gambro Lundia AB v. Baxter Healthcare Corp.,
`110 F.3d 1573 (Fed. Cir. 1997) ............................................................................ 67
`Hytera Communs. Co. v. Motorola Sols., Inc.,
`841 F. App’x 210 (Fed. Cir. 2021) ....................................................................... 17
`Institut Pasteur & Universite Pierre Et Marie Curie v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013) ............................................................... 31, 55, 57
`Intendis GmbH v. Glenmark Pharm., Inc.,
`822 F.3d 1355 (Fed. Cir. 2016) ............................................................................ 64
`Interactive Gift Express, Inc. v. CompuServe Inc.,
`256 F.3d 1323 (Fed. Cir. 2001) ............................................................................ 13
`Intri-Plex Techs. Inc. et al. v. Saint-Gobain Performance Plastics Rencol Ltd.,
`IPR2014-00309, Paper 83 (PTAB Mar. 23, 2015) ............................................... 58
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) ............................................................................ 64
`Lectrosonics, Inc. v. Zaxcom, Inc.,
`IPR2018-01129, Paper 33 (PTAB Jan. 24, 2020) ................................................ 65
`
`iv
`
`

`

`Lucia v. SEC,
`138 S. Ct. 2044 (2018) ......................................................................................... 71
`Mantech Envtl. Corp. v. Hudson Envtl. Servs.,
`152 F.3d 1368 (Fed. Cir. 1998) ............................................................... 16, 17, 18
`Mformation Techs., Inc. v. Research in Motion Ltd.,
`764 F.3d 1392 (Fed. Cir. 2014) ............................................................................ 16
`Transclean Corp. v. Bridgewood Servs.,
`290 F.3d 1364 (Fed. Cir. 2002) ............................................................................ 23
`Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc.,
`699 F.3d 1340 (Fed. Cir. 2012) ............................................................................ 47
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) ......................................................... 49, 51, 57, 65
`Winner Int’l Royalty Corp. v. Wang,
`202 F.3d 1340 (Fed. Cir. 2000) ............................................................................ 41
`Wyers v. Master Lock Co.,
`616 F.3d 1231 (Fed. Cir. 2010) ..................................................................... 57, 58
`
`v
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`

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`I.
`
`INTRODUCTION
`The ’413 patent that is the subject of the present IPR is one of the family of
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`patents covering the industry-changing product called GuideLiner. When Patent
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`Owner’s predecessor, Vascular Solutions, Inc. (“VSI”), introduced GuideLiner in
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`2009, it created a new product category called “guide extension catheters.”
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`GuideLiner’s greatly increased backup support and other advantages enabled
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`physicians to treat coronary stenoses previously considered untreatable.
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`The claims at issue in the present IPR are directed to methods of providing
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`backup support for interventional cardiology devices (“ICDs”) being delivered
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`through guide extension catheters like GuideLiner. Petitioner relies on the Kontos
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`protective catheter as the primary reference for all of its invalidity theories. But
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`there are numerous, fatal problems with Petitioner’s arguments. First, Petitioner’s
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`arguments fail to show fundamental claimed elements, especially since the claimed
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`method steps of the ʼ413 patent must be performed in sequence. Second,
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`Petitioner’s obviousness arguments are pure hindsight, and rely extensively on
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`incorrect arguments that Kontos and Adams are the same kinds of devices as the
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`invention disclosed in the ʼ413 patent. Indeed, one of Petitioner’s experts candidly
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`admits he used the claimed invention as a roadmap for his obviousness analysis,
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`testifying that he was “looking at how to combine the elements to arrive at the
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`claimed invention,” and even that he “was tasked with” proposing combinations
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`1
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`

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`that “are directed at the device that’s claimed in the ’413 and ’116 patents.” Ex-
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`2244, 152:16-21, 161:5-9. Finally, a wealth of objective indicia of nonobvious in
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`the present case belies Petitioner’s invalidity arguments.
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`In view of these overarching issues, and a number of other deficiencies
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`described below, the Petition fails to show that the challenged claims are invalid.
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`II. BACKGROUND
`In 2004, VSI’s founder, Howard Root, recognized a need for a new type of
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`product that would address the backup support problem ICDs encountered when
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`treating complex coronary lesions or tortuous anatomy, while overcoming the
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`drawbacks of the existing options. Ex-2118, ¶¶5-6; Ex-2145, ¶¶41-75; Ex-2151,
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`¶¶4-8; Ex-2215, ¶¶3-19. Mr. Root, along with three coinventors, conceived of,
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`built and successfully tested working prototypes of the GuideLiner invention. Ex-
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`2118, ¶¶5-61. In GuideLiner, Mr. Root and his team invented a rapid-exchange
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`device that could facilitate delivery of the full array of ICDs (including stents) deep
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`into the vasculature by providing improved backup support. GuideLiner succeeded
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`beyond the inventors’ wildest expectations. E.g., Ex-2118, ¶4; Ex-2145, ¶¶ 85-91;
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`Ex-2151, ¶¶9-17; Ex-2215, ¶¶7, 9, 20-29; Ex-2060.
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`The ’413 patent is directed to a method of providing backup support for an
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`ICD using a coaxial guide catheter that is passed through the lumen of a guide
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`catheter, advanced beyond the distal end of the guide catheter, and inserted into a
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`2
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`

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`branch artery to facilitate delivery of stents, balloon angioplasty catheters and other
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`ICDs. Ex-1401 at Abstract, cl. 1. The coaxial guide catheter generally includes,
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`from distal to proximal direction, a soft tip portion, a tubular portion, and a
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`substantially rigid portion that has a rail segment to permit delivery without
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`blocking use of the guide catheter. E.g., id. at 6:16-46 and Figs. 1, 4, 20-22. An
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`important advantage of the design is that it only slightly reduces the available
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`space to deliver ICDs—by no more than “one French size” smaller than the guide
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`catheter in the preferred embodiment. Id. at 3:11-26; Ex-2138, ¶ 93.
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`The method of providing backup support in the ʼ413 patent includes the
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`following steps. First, a standard guide catheter is inserted over a guidewire into a
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`blood vessel until the distal end is positioned in a branch vessel. Ex-1401, 9:51-65.
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`Next, a coaxial guide catheter is inserted through the guide catheter over the guide
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`wire—a flexible tip portion is inserted, followed by a proximal substantially rigid
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`portion. Id. The coaxial guide catheter is then further advanced so that the distal
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`bump tip is inserted past the distal tip of the guide catheter and into the branch
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`vessel. Id. Next, an ICD, such as a stent or balloon catheter, is inserted into and
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`through the guide catheter alongside the substantially rigid portion of the coaxial
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`guide catheter, and then into and through the lumen of the coaxial guide catheter
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`until it reaches a stenosis or blockage. Id., 9:66-10:19. Optionally, a tapered inner
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`catheter may be inserted with the coaxial guide catheter and advanced to the
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`3
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`

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`second vessel, but the tapered inner catheter is removed before inserting an ICD
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`into the coaxial guide catheter. Id., 9:55-66.
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`The ’413 patent has one independent claim, claim 1, which reads as follows,
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`with paragraph identifiers added to facilitate the discussion below:
`
`1.
`
`A method of providing backup support for an interventional
`cardiology device for use in the coronary vasculature, the
`interventional cardiology device being adapted to be passed through a
`standard guide catheter, the standard guide catheter having a
`continuous lumen extending for a predefined length from a proximal
`end at a hemostatic valve to a distal end adapted to be placed in a
`branch artery, the continuous lumen of the guide catheter having a
`circular cross-sectional inner diameter sized such that interventional
`cardiology devices are insertable into and through the lumen, the
`method comprising:
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`1.a.
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`inserting the standard guide catheter into a first artery over a
`guidewire, the standard guide catheter having a distal end;
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`1.b. positioning the distal end of the standard guide catheter in a
`branch artery that branches off from the first artery;
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`1.c.
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`inserting a flexible tip portion of a coaxial guide catheter
`defining a tubular structure having a circular cross-section and a
`length that is shorter than the predefined length of the
`continuous lumen of the standard guide catheter, into the
`continuous lumen of the standard guide catheter, and,
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`4
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`1.d.
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`further inserting a substantially rigid portion that is proximal of,
`operably connected to, and more rigid along a longitudinal axis
`than the flexible tip portion, into the continuous lumen of the
`standard guide catheter, the substantially rigid portion defining
`a rail structure without a lumen and having a maximal cross-
`sectional dimension at a proximal portion that is smaller than
`the cross-sectional outer diameter of the flexible tip portion and
`having a length that, when combined with the length of the
`flexible distal tip portion, defines a total length of the device
`along the longitudinal axis that is longer than the length of the
`continuous lumen of the guide catheter;
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`1.e. advancing a distal portion of the flexible tip portion distally
`beyond the distal end of the standard guide catheter and into the
`second artery such that the distal portion extends into the
`second artery and such that at least a portion of the proximal
`portion of the substantially rigid portion extends proximally
`through the hemostatic valve; and
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`1.f.
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`inserting the interventional cardiology device into and through the
`continuous lumen of the standard guide catheter alongside of the
`substantially rigid portion and advancing the interventional cardiology
`device through and beyond a lumen of the flexible tip portion into
`contact with or past a lesion in the second artery.
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`5
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`

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`III. THE PERSON OF ORDINARY SKILL IN THE ART
`For the purposes of this Response only, Patent Owner applies Petitioner’s
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`proposed definition of a POSITA. Petition, 11-12.1
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`IV. OVERVIEW OF PETITIONER’S REFERENCES
`A. Kontos (Ex-1409)
`Kontos, the primary reference relied on in this Petition, teaches a “support
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`catheter” that has a very different purpose, and uses a different structure, than the
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`invention of the ’413 patent. See Ex-2138, ¶¶120-40. Kontos is specifically
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`designed to “protect[] the fragile balloon” of a PTCA balloon catheter2 during
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`1 Petitioner’s engineering expert, Richard Hillstead, does not meet its definition of
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`a POSITA. Ex-2137, 462:8-13; Ex-1443, 2. Petitioner’s physician expert, Dr.
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`Brecker, has conceded that he doesn’t “have huge experience of using the
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`commercially available guide extensions” and that his practice has been more
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`focused in the structural heart space than complex PCI. Ex-2245, 39:5-7; see also
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`id., 43:6-13, 36:19-21, 27:4-8, 44:17-23, 46:15-20, 67:15-68:13, 69:19-70:8.
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`46:15-20.
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`2 Some portions of Kontos refer to a “PTCA balloon catheter” and others a “PTCA
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`catheter,” but a POSITA would have understood Kontos’s references to “PTCA
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`catheter” to mean a fixed wire balloon catheter. Ex-2138, ¶¶123, 126-27; Ex-2145,
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`¶146; Ex-2137, 287:6-8.
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`6
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`

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`delivery and/or exchanges. E.g. Ex-1409, 5:52-56; Ex-2138, ¶¶122-23; Ex-2145,
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`¶147. Kontos discloses a secondary purpose, where the support catheter itself
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`serves as a temporary stent. Ex-1409, 6:59-7:5; Ex-2138, ¶124; Ex-2145, ¶147.
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`The third disclosed purpose is to facilitate the exchange of fixed wire balloon
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`catheters. Ex-1409, 7:6-22; Ex-2138, ¶¶125-27.
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`To achieve these purposes, Kontos discloses structure consisting of an
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`insertion/manipulation wire 14 embedded in a body 12, as shown (artificially
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`foreshortened) below:
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`
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`Ex-1409, Fig. 1. At the proximal end of the tube, a base portion 18 bulges
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`downwardly to facilitate insertion and attachment of wire 14, while a funnel
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`portion 26 flares upwardly to facilitate the ability to receive a PTCA balloon
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`catheter. The distal end of tube 16 is surrounded by another raised profile section
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`consisting of marker band 30 and soft tip 28:
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`7
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`Id., 3:45-65, 4:5-24; Ex-2138, ¶¶133; Ex-2145, ¶148. The central tube is relatively
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`narrow, with an outer diameter of 0.055 inches (1.4mm) and an inner diameter of
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`0.045 inches (1.14mm). Ex-1409, 4:48-52. The narrow tube is important to
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`Kontos’s disclosed functions: it allows a close fit around the small-diameter PTCA
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`catheter to effectively support it and prevent buckling (Ex-2244, 104:5-10), and it
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`maintains a small diameter exterior profile to allow the support catheter to function
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`as a temporary stent itself and to facilitate exchange of PTCA catheters. Ex-1409,
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`4:61-62, 5:18-24, Fig. 5; Ex-2138, ¶129.
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`Kontos’s asymmetric structure results in a significant gap between the
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`exterior wall of the long central portion of tube 16 and the interior wall of the
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`guide catheter:
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`8
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`

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`Gap
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`
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`Ex-2138, ¶135; Ex-2145, ¶148-49. The gap between the outside of Kontos’s body
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`12 and the inside of the guide catheter does not affect the ability of body 12 to
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`serve its purpose of protecting the delicate PTCA catheter, as the interior of tube
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`16 is still closely fitted around the PTCA catheter. Ex-2138, ¶135; Ex-2145, ¶146.
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`B. Adams (Ex-1435)
`Adams is also unlike the invention of the ’413 patent. Ex-2138, ¶¶141-45.
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`It does not disclose a device for providing backup support or for receiving and
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`guiding ICDs (such as stents and balloon catheters). Id., ¶¶143-45; Ex-2145, ¶192.
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`It also discloses something very different from Kontos. Ex-2145, ¶¶155-
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`161. Adams provides an embolic protection system that uses an expandable mesh
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`guide seal to press against the blood vessel wall to temporarily occlude blood flow
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`during deployment of a distal protection filter. Id. at ¶155. The sole purpose of the
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`guide seal is to temporarily occlude blood flow during deployment of a distal
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`protection filter. Ex-1435, [0011]; Ex-2138, ¶143; Ex-2145, ¶155. Adams
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`emphasizes that occluding blood flow is undesirable, and therefore teaches that the
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`guide seal is preferably deployed only during deployment of the filter and not
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`9
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`

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`during the subsequent delivery of ICDs such as balloons and stents. Ex-1435,
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`[0007], [0064]; Ex-2138, ¶¶144, 238; Ex-2145, ¶157-58.
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`Adams explains, in stepwise fashion, how it provides embolic protection.
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`Ex-1435, Figs. 2A-2F, [0064]. First, the expandable mesh guide seal 20 is
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`advanced to a position at, but not beyond, the distal end of a guide catheter. Then,
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`a delivery catheter 17 containing a distal protection filter is placed inside the mesh
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`guide seal 20:
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`
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`Id., Figs. 2A, 2B, [0064]. Next, the mesh guide seal 20 and the distal protection
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`filter are advanced together partway beyond the distal end of the guide catheter,
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`allowing the protruding portion of the mesh guide seal 20 to expand and seal
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`against the walls of the vessel:
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`10
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`

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`Id., Fig. 2C, [0064]. Then, the distal protection filter 15 is deployed into the blood
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`vessel:
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`Id., Figs. 2D, 2E, [0064]. Finally, with the filter in place, the mesh guide seal 20 is
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`“withdrawn . . . out of the guide catheter,” as it has completed its function:
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`
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`Id., Fig. 1F, [0064]. Once the guide seal has been removed from the guide
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`catheter, a “treatment device” such as a “balloon” or “stent . . . may be
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`advanced . . . to the treatment site.” Id., [0064]; Ex-2138, ¶142.3
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`
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`3 Adams indicates that the guide seal need not be completely withdrawn from the
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`guide catheter. Ex-1435, [0064]. Given that the guide seal has no function to
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`perform other than to block blood flow during delivery of the distal protection net,
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`there would be no reason to keep it in the guide catheter. Ex-2138, ¶238; Ex-2145,
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`¶157.
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`11
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`

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`Adams teaches an “angle” at the proximal end of its mesh guide seal 20 to
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`facilitate “entry of the seal’s proximal end into the distal end of the guide catheter.”
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`Ex-1435, [0066]. Adams does not teach that the angle is intended to facilitate
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`entry of anything, much less ICDs, into the guide seal itself. Ex-2138, ¶145; Ex-
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`2145, ¶¶159-61.
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`Adams does not teach or suggest that the mesh guide seal 20 provides back-
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`up support, nor could it. The mesh guide seal 20 of Adams relies on the expansion
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`of the guide seal to contact the vessel wall to stay in place. Ex-2145, ¶¶156. A
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`POSITA would recognize that it would actually be undesirable, and potentially
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`dangerous, to rely on the pressure of the expanded guide seal against the blood
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`vessel to prevent the guide catheter from moving in response to backout forces. Id.
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`V.
`
`PETITIONER HAS NOT SHOWN THAT THE CHALLENGED
`CLAIMS OF THE ’413 PATENT ARE INVALID AS OBVIOUS
`A. ALL GROUNDS: Petitioner Fails to Show that Kontos and/or
`Adams Would be Used in the Manner Required by the Steps of
`the Claimed Methods (All Claims)
`The Claimed Step of Inserting an ICD Must Be Performed
`1.
`After the Coaxial Guide Catheter Is Inserted Into the Guide
`Catheter
`
`
`Claim element 1.f. requires “inserting the interventional cardiology device
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`into and through the continuous lumen of the standard guide catheter alongside of
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`the substantially rigid portion and advancing the interventional cardiology device
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`through and beyond a lumen of the flexible tip portion into contact with or past a
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`12
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`

`

`lesion in the second artery.” In a footnote, Petitioner argues that this claim element
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`does not “require[] the coaxial guide catheter to be inserted first, followed
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`(separately) by the interventional cardiology device.” Petition, 49, n.15. But that
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`is contrary to the logic of the patent claims, counter to the test set out in the very
`
`case cited by Petitioner, and even counter to the testimony of Petitioner’s own
`
`experts.
`
`Petitioner’s case states a two-part test for determining if the steps of a
`
`method claim must be performed in the order in which they are written.
`
`Interactive Gift Express, Inc. v. CompuServe Inc., 256 F.3d 1323, 1342-43 (Fed.
`
`Cir. 2001); see also Altiris, Inc. v. Symantec Corp., 318 F.3d 1363, 1369-70 (Fed.
`
`Cir. 2003). The first step requires “look[ing] to the claim language to determine if,
`
`as a matter of logic or grammar, they must be performed in the order written.”
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`Altiris, Inc., 318 F.3d 1369-70 (citing Interactive Gift Express, Inc., 256 F.3d at
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`1342-43). If this is not the case, the second step “look[s] to the rest of the
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`specification to determine whether it ‘directly or implicitly requires such a narrow
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`construction.’” Id. In the present case, step one is dispositive, and step two leads
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`to the same conclusion.
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`The overall method recited in claim 1 only makes sense if the recited steps
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`take place in order. Ex-2145, ¶¶102-06. For example, step 1.b. (“positioning the
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`distal end of the standard guide catheter in a branch artery”) cannot logically occur
`
`13
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`

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`until after step 1.a (“inserting the standard guide catheter . . .”). Ex-1401, 10:39-
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`43; Ex-2138, ¶102. Petitioner’s experts, Dr. Hillstead and Dr. Brecker, agree. Ex-
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`2244, 61:24-62:3; Ex-2245, 87:24-88:14. Similarly, steps 1.c.–1.e. relating to
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`inserting various parts of the coaxial guide catheter logically must occur in
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`sequential order. Ex-1401, 10:44-67; Ex-2138, ¶102; Ex-2145, ¶103. Again,
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`Petitioner’s experts both agree. Ex-2244, 61:24-62:3; Ex-2245, 89:21-90:3, 90:13-
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`23. And step 1.e. requires advancing the flexible tip portion of the coaxial guide
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`catheter “beyond the distal end of the standard guide catheter and into the second
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`artery,” meaning that steps 1.c.–1.e. must be performed after steps 1.a. and 1.b.
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`Ex-1401, 10:62-64; Ex-2138, ¶102; Ex-2145, ¶105. Again, Petitioner’s experts
`
`agree. Ex-2244, 61:24-62:3; Ex-2245, 89:21-90:3, 90:17-23.
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`Moreover, step 1.f. itself contains language indicating that insertion of the
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`ICD occurs after insertion of the coaxial guide catheter. As a matter of both
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`grammar and logic, the ICD would not be inserted “into and through” the lumen of
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`the guide catheter “alongside of” the substantially rigid portion of the coaxial guide
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`catheter unless the coaxial guide catheter is already in the guide catheter. Ex-2138,
`
`¶103; Ex-2145, ¶103. Inserting an ICD “alongside of the substantially rigid
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`portion” means that the substantially rigid portion is already in place inside the
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`guide catheter, and when the ICD is inserted into the guide catheter it moves
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`“alongside” the already-positioned substantially rigid portion. Ex-2138, ¶103; Ex-
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`14
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`

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`2145, ¶103. Indeed, Petitioner’s own expert, Dr. Hillstead, agrees that “alongside”
`
`in this context means that the substantially rigid portion is already in place in the
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`guide catheter when the ICD is inserted “alongside” of it. Ex-2244, 63:6-64:1
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`(“Q: . . . the substantially rigid portion is already in the guide catheter when the
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`interventional cardiology device is inserted alongside it; is that right? A: I believe
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`so, following the claim language, yes.”).
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`Similarly, advancing the ICD device “through and beyond” the flexible tip
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`portion of the coaxial catheter “into contact with or past” the lesion strongly
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`suggests that the flexible tip of the coaxial guide catheter is already in the anatomy.
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`Ex-1401, 10:39-11:6; Ex-2138, ¶103; Ex-2145, ¶103. Petitioner’s expert Dr.
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`Hillstead agreed that the language of step 1.f. requires that insertion of the ICD in
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`claim 1 of the ʼ413 patent “ha[s] to take place after the prior steps that are recited
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`in the claim.” Ex-2244, 62:18-24; see also id., 63:13-64:1. 4
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`4 Petitioner’s other expert, Dr. Brecker, equivocated on this point, presumably to
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`preserve his opinion from the related -1341 IPR that Itou anticipates the ʼ413
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`patent. Notably, however, Dr. Brecker does not explain anywhere in his
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`declarations why he believes the steps of claim 1 of the ʼ413 patent need not be
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`read to take place in sequence. E.g. Ex-1405, ¶¶121-35. Dr. Brecker
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`acknowledges that, in the real world, it is actually dangerous to advance an ICD at
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`15
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`

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`Finally, the sequential nature of the method steps is supported by the fact
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`that claim 1 is directed to a “method of providing backup support.” Ex-1401,
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`10:28-38. This backup support is provided by the coaxial guide catheter being
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`inserted into the guide catheter before the ICD is advanced through and beyond it
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`to or past a lesion. Ex-2138, ¶104; Ex-2145, ¶104. Indeed, if one were to insert
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`the ICD into the coaxial guide catheter outside the body and then insert them
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`together into and past the end of the guide catheter, a POSITA would expect more
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`problems with guide catheter back-out, not less. Id.
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`Thus, as a matter of logic and grammar, the entirety of claim 1 requires that
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`step 1.f. (insertion and advancement of the ICD) occur after steps 1.c–1.e.
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`(insertion of the coaxial guide catheter in the guide catheter). This alone is
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`determinative. See, e.g., Mformation Techs., Inc. v. Research in Motion Ltd., 764
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`F.3d 1392, 1399-1400 (Fed. Cir. 2014) (affirming that claims required steps in a
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`particular sequence, including that the substep of establishing a connection take
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`place before transmission); Mantech Envtl. Corp. v. Hudson Envtl. Servs., 152 F.3d
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`the same time as a guide extension catheter. Ex-1405, ¶204 (explaining danger of
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`air embolisms forming if a guide extension catheter were advanced with a loaded
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`interventional device); Ex-2245, 94:8-12, 97:4-19.
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`16
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`

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`1368, 1376 (Fed. Cir. 1998) (holding that “the sequential nature of the claim steps
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`is apparent from the plain meaning of the claim language”).
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`Moreover, even if the Board were to address step two, it leads to the same
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`conclusion. The specification of the ’413 patent emphasizes that backup support is
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`provided by deep seating the coaxial guide catheter prior to inserting the ICD
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`through the coaxial guide catheter and into the artery. Ex-1401, 4:35-44. The
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`specification also describes sequential operation: “a guide catheter 56 is inserted
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`into a major blood vessel . . . [c]oaxial guide catheter 12 . . . is inserted through
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`guide catheter 56 . . . coaxial guide catheter 12 achieves a deep seated position . . .
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`[a]n interventional cardiology treatment device such as a catheter bearing a stent or
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`balloon (not shown) is then inserted through the lumen of coaxial guide catheter
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`12, which remains inside guide catheter 56.” Ex-1401, 9:49-10:3 (emphasis
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`added); Ex-2138, ¶106; Ex-2145, ¶106. Only after the coaxial guide catheter is in
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`place in the anatomy is the ICD “then inserted” through the coaxial guide catheter.
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`Id. Notably, the opposite sequence, i.e. placing the ICD in the guide catheter at the
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`same time as the coaxial guide catheter, is not disclosed as an optional order of
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`operation and is not how a POSITA would perform such a procedure. Ex-2138,
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`¶106; Ex-2145, ¶¶103-06; Hytera Communs. Co. v. Motorola Sols., Inc., 841 F.
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`App’x 210, 219 (Fed. Cir. 2021) (declining to construe claims to deviate from the
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`stated order, because the embodiments were consistent with the plain meaning of
`
`17
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`

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`the claims in the order that was written); Mantech Envtl. Corp., 152 F.3d at 1376
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`(“[T]he sequential nature of the claim steps is apparent from the plain meaning of
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`the claim language and nothing in the written description suggests otherwise.”)
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`2.
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`Petitioner Does Not Show Prior Art Methods Performed in
`the Required Sequence
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`Petitioner makes three arguments allegedly showing that Kontos or Kontos
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`in combination with Adams teaches claim element 1.f. Each of Petitioner’s
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`arguments are deficient and they fail to show the obviousness of the ʼ413 patent.
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`Petitioner first argues that claim 1 does not require the coaxial guide catheter
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`to be inserted first, followed separately by the ICD. Petition, 49, n.15. For the
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`reasons explained above, this starting premise is wrong—even Petitioner’s own
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`experts do not support this argument. §V.A.1, supra.
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`Recognizing the weakness of its first argument, Petitioner next alleges that
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`“Kontos still teaches” element 1.f, even if that claim element is interpreted to
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`require insertion of an ICD after insertion of a coaxial guide catheter. Petition, 49.
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`In support of its argument that Kontos itself still teaches the claimed method,
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`Petitioner cites: 1) paragraphs 201 and 203 of Dr. Brecker’s declaration, and 2) one
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`paragraph from Kontos’s specification. Id. But this evidence does not actually
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`show what Petitioner alleges.
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`The two paragraphs from Dr. Brecker’s declaration cited by Petitioner relate
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`to an alleged combination of Kontos with Adams—not what Kontos alone shows.
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`18
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`Petition, 49 (citing Ex-1405, ¶¶201, 203). Yet Petitioner’s second argument is
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`specifically about what Kontos alone teaches, not what Kontos in combination
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`what Adams teaches. Id. Thus, the citations to Dr. Brecker’s paragraphs 201 and
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`203 are irrelevant to Petitioner’s second argument and should be disregarded.
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`Second, Petitioner cites a paragraph from K