`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
`
`v.
`
`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
`
`
`
`
`Case IPR2020-00126
`Case IPR2020-00127
`Patent 8,048,032
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PATENT OWNER’S CONTINGENT MOTION TO AMEND
`U.S. PATENT 8,048,032 UNDER 37 C.F.R. § 42.121
`
`
`
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`PAGE
`
`INTRODUCTION ........................................................................................... 1
`I.
`LEGAL STANDARDS FOR AMENDING CLAIMS ................................... 1
`II.
`III. CLAIM LISTING ............................................................................................ 1
`IV. SCOPE OF THE SUBSTITUTE CLAIMS ..................................................... 2
`V. WRITTEN DESCRIPTION SUPPORT .......................................................... 2
`A.
`Substitute Claim 23 ............................................................................... 3
`B.
`Substitute Claim 24 ............................................................................... 5
`C.
`Substitute Claim 25 ............................................................................... 7
`VI. THE LEVEL OF ORDINARY SKILL IN THE ART .................................... 8
`VII. THE SCOPE AND CONTENT OF THE PRIOR ART .................................. 8
`VIII. THE PROPOSED SUBSTITUTE CLAIMS ARE PATENTABLE ............... 9
`A.
`Substitute Claims 23-25: None of the Prior Art Discloses or Suggests
`the Claimed Combination of Features Including the Recited Complex
`Side Opening ......................................................................................... 9
`Substitute Claims 23 and 25: The Prior Art Does Not Disclose or
`Suggest the Claimed Combination of Elements, Including a Tubular
`Structure Having a Coaxial 0.056 Lumen Configured For Use With a
`6 French Guide Catheter ..................................................................... 15
`Substitute Claims 24-25: The Prior Art Does Not Disclose or Suggest
`the Claimed Combination of Elements, Including a Coaxial Lumen
`With a Reinforced Portion Having a Uniform, Fixed Outer Diameter
`Where the Reinforced and Substantially Rigid Portions Provide
`Backup Support ................................................................................... 18
`IX. CONCLUSION .............................................................................................. 20
`
`
`B.
`
`C.
`
`
`
`i
`
`
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`Cooper Cameron Corp. v. Kvaerner Oilfields Prods., Inc.,
`291 F.3d 1317 (Fed. Cir. 2002) .............................................................................. 3
`Graham v. John Deere Co.,
`383 U.S. 1 (1966) .................................................................................................. 13
`Indivior Inc. v. Dr. Reddy’s Labs., S.A.,
`930 F.3d 1325 (Fed. Cir. 2019) .............................................................................. 2
`KSR Int'l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .............................................................................................. 13
`Lectrosonics, Inc. v. Zaxcom, Inc.,
`IPR2018-01129, Paper 15 (PTAB Feb. 25, 2019) .................................................. 1
`Memorandum re: Guidance on Motions to Amend in view of Aqua
`Products (Nov. 21, 2017) ....................................................................................... 1
`
`Vas-Cath Inc. v. Mahurkar,
`935 F.2d 1555 (Fed. Cir. 1991) .............................................................................. 3
`Statutes
`35 U.S.C. § 102 .......................................................................................................... 9
`35 U.S.C. § 103 .......................................................................................................... 9
`35 U.S.C. § 316 ......................................................................................................1, 2
`Other Authorities
`37 C.F.R. § 42.121 ............................................................................................ 1, 2, 9
`37 C.F.R. § 42.22 ....................................................................................................... 1
`
`
`
`
`
`ii
`
`
`
`I.
`
`INTRODUCTION
`Patent Owner Teleflex submits this Contingent Motion to Amend U.S.
`
`Patent 8,048,032 (“Motion”), with the Declaration of Peter T. Keith in Support of
`
`Motions to Amend (“Ex-2124”), under 37 C.F.R. § 42.121. This motion does not
`
`seek preliminary guidance. If, after considering Teleflex’s Patent Owner
`
`Responses, the Board finds any of issued claims 1, 11, or 16 of the ’032 patent
`
`invalid, Teleflex respectfully requests that the Board substitute the invalid claim(s)
`
`with the respective proposed substitute claim of claims 23-25. See 37 C.F.R. §
`
`42.22(a)(2); 35 U.S.C. § 316(d).
`
`II. LEGAL STANDARDS FOR AMENDING CLAIMS
`A motion to amend must (1) propose a reasonable number of substitute
`
`claims, (2) that respond to a ground of unpatentability involved in the trial, (3) that
`
`do not enlarge the scope of the claims or introduce new matter, and (4) are not
`
`shown by a preponderance of the evidence to be unpatentable. See Memorandum
`
`re: Guidance on Motions to Amend in view of Aqua Products (Nov. 21, 2017) at 2;
`
`35 U.S.C. § 316(d); 37 C.F.R. § 42.121. It is Petitioner’s burden to show that the
`
`proposed substitute claims are unpatentable. Lectrosonics, Inc. v. Zaxcom, Inc.,
`
`IPR2018-01129, Paper 15 at 4 (PTAB Feb. 25, 2019).
`
`III. CLAIM LISTING
`Pursuant to 37 C.F.R. § 42.121(b), Appendix A lists the changes made to the
`
`issued claims of the ’032 patent that would be replaced under this Motion. This
`1
`
`
`
`
`
`claim listing includes one replacement claim for each of claims 1, 11, and 16. The
`
`number of proposed substitute claims is reasonable under 35 U.S.C. § 316(d)(1)(B)
`
`and 37 C.F.R. § 42.121(a)(3).
`
`IV. SCOPE OF THE SUBSTITUTE CLAIMS
`The proposed substitute claims comply with 35 U.S.C. § 316(d)(3) and 37
`
`C.F.R. § 42.121(a)(2)(ii) because no substitute claim enlarges the scope of, or
`
`eliminates any element from, the original claim it replaces. All amendments
`
`reflected in substitute claims 23-25 are narrowing amendments, in that all
`
`amendments only add limitations to the claims without removing language.
`
`V. WRITTEN DESCRIPTION SUPPORT
`Substitute claims 23-25 are fully supported by the priority application1
`
`because “the disclosure . . . reasonably conveys to those skilled in the art that the
`
`inventor had possession of the claimed subject matter as of the filing date.”
`
`Indivior Inc. v. Dr. Reddy’s Labs., S.A., 930 F.3d 1325, 1347 (Fed. Cir. 2019)
`
`(citation to quoted case omitted); 37 C.F.R. § 42.121(b); see Ex-2124, ¶¶ 22-27.
`
`“Drawings constitute an adequate description if they describe what is claimed and
`
`
`1 The parties have stipulated that all patents at issue in these IPRs have
`
`substantively identical disclosures, and have agreed to cite only the priority
`
`application, IPR2020-00126, Ex. 1003, cited herein as “Ex. 1003 at XX.”
`
`
`
`2
`
`
`
`convey to those of skill in the art that the patentee actually invented what is
`
`claimed.” Cooper Cameron Corp. v. Kvaerner Oilfields Prods., Inc., 291 F.3d
`
`1317, 1322 (Fed. Cir. 2002); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1566
`
`(Fed. Cir. 1991).
`
`A.
`Substitute Claim 23
`The priority application discloses a device for use with a standard 6 French
`
`guide catheter that has 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, Ex. 1003 at 6:15-17; 7:3-10, 12-13; 10:1-19; 11:15-16; 12:13-15;
`
`17:3-16; 37, where the continuous lumen of the guide catheter has a circular cross-
`
`sectional inner diameter sized such that interventional cardiology devices are
`
`insertable into and through the lumen to the branch artery, id. at 6:15-17; 10:3-13;
`
`11:15-18; 17:10-12; 18:5-14; 22:3-15.
`
`The application discloses that the device comprises, in a distal-to-proximal
`
`direction, a flexible tip portion defining a tubular structure, id. at 8:4-16; 12:1-2;
`
`14:7-15:2; 32, having a circular cross-section and a length that is shorter than the
`
`predefined length of the continuous lumen of the standard 6 French guide catheter
`
`and a cross-sectional outer diameter sized to be insertable through the cross-
`
`sectional inner diameter of the continuous lumen of the guide catheter, id. at 6:15-
`
`17; 7:8-10, 17-18; 8:12-16; 12:1-2, 5-6; 13:7-8; 14:7-9; 14:20-15:2; 32; 34; 41 at
`
`
`
`3
`
`
`
`Figure 14, and defining a coaxial lumen having a cross-sectional inner diameter of
`
`at least 0.056 inches through which interventional cardiology devices are
`
`insertable, id. at 6:15-17; 7:17-18; 10:3-13; 11:16-18; 17:10-12; 18:5-14; 22:3-15.
`
`The application discloses that the device includes a substantially rigid side
`
`opening that includes a first inclined region, a second inclined region, and a non-
`
`inclined concave track between the first and second inclined regions, id. at 8:18-
`
`9:3; 12:7-8, 11-12; 15:4-15; 35; 36 at Figure 6; Ex-2124, ¶¶ 45-50, 52. The claim
`
`need not expressly recite that the side opening is in the substantially rigid segment.
`
`Id. ¶¶ 30-44, 51. Petitioner admits that Figure 4 “discloses a non-inclined region,”
`
`IPR2020-00137 Petition at 15, and that the application discloses two inclined
`
`slopes: “Figure 4 shows, at best, only two inclined slopes,” which is a “disclosure
`
`of only two different inclined slopes,” IPR2020-01344 Petition at 69. The
`
`application discloses that the device includes a substantially rigid portion proximal
`
`of and operably connected to, and more rigid along a longitudinal axis than, the
`
`flexible tip portion, that defines a rail structure without a lumen, Ex. 1003 at 6:15-
`
`17; 8:4-5; 8:17-9:5; 12:1-2; 14:7-9; 15:3-7; 16:18-17:2; 19:12-18; 32; 41, with a
`
`maximal cross-sectional dimension at a proximal portion that is smaller than the
`
`cross-sectional outer diameter of the flexible tip portion, id. at 6:15-17; 12:1-2; 32,
`
`and 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
`
`
`
`4
`
`
`
`the length of the continuous lumen of the guide catheter, such that when at least a
`
`distal portion of the flexible tip portion is extended distally of the distal end of the
`
`guide catheter, at least a portion of the proximal portion of the substantially rigid
`
`portion extends proximally through the hemostatic valve in common with
`
`interventional cardiology devices that are insertable into the guide catheter, id. at
`
`7:3-7; 8:5-6; 10:3-9; 11:15-18; 22:3-23:2.
`
`B.
`Substitute Claim 24
`The application discloses a device for use with a standard guide catheter that
`
`has 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, id. at 6:15-
`
`17; 7:3-10, 12-13; 10:1-19; 11:15-16; 12:13-15; 17:3-16; 37, where the continuous
`
`lumen of the guide catheter having a circular cross-section and a cross-sectional
`
`inner diameter sized such that interventional cardiology devices are insertable into
`
`and through the lumen to the branch artery, id. at 6:15-17; 10:3-13; 11:15-18;
`
`17:10-12; 18:5-14; 22:3-15.
`
`The application discloses that the device has an elongate structure with an
`
`overall length longer than the predefined length of the continuous lumen of the
`
`guide catheter, id. at 7:3-7; 8:5-6; 10:3-9; 11:15-16; 22:3-23:2, including a flexible
`
`tip portion defining a tubular structure, id. at 8:4-16; 12:1-2; 14:7-15:2; 32, having
`
`a circular cross-section that is smaller than the circular cross-section of the
`
`
`
`5
`
`
`
`continuous lumen of the guide catheter and a length that is shorter than the
`
`predefined length of the continuous lumen of the guide catheter, id. at 6:15-17;
`
`8:12-16; 12:1-2, 5-6; 13:7-8; 14:7-9; 14:20-15:2; 32; 34; 41 at Figure 14, the
`
`flexible tip portion being sized having a cross-sectional outer diameter sized to be
`
`insertable through the cross-sectional inner diameter of the continuous lumen of
`
`the guide catheter and defining a coaxial lumen having a cross-sectional inner
`
`diameter through which interventional cardiology devices are insertable, id. at
`
`6:15-17; 7:5-7, 17-18; 10:3-13; 11:16-18; 12:1-2; 14:20-21; 17:10-12; 18:5-14;
`
`22:3-15; 32.
`
`The application discloses that the elongate structure comprises a reinforced
`
`portion having a uniform, fixed cross-sectional outer diameter proximal to the
`
`flexible tip portion, id. at 8:3-16; 12:1-2; 14:7-15:2; 21:11-13; 32, and a
`
`substantially rigid portion proximal of and connected to, and more rigid along a
`
`longitudinal axis than, the flexible tip portion and defining a rail structure without
`
`a lumen, id. at 6:15-17; 8:4-5; 8:17-9:5; 12:1-2; 14:7-9; 15:3-7; 16:18-17:2; 19:12-
`
`18; 32; 41, 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, id.
`
`at 6:15-17; 12:1-2; 32. The application discloses that when at least a distal portion
`
`of the flexible tip portion is extended distally of the distal end of the guide catheter
`
`with at least proximal portion of the reinforced portion remaining within the
`
`
`
`6
`
`
`
`continuous lumen of the guide catheter, at least a portion of the proximal portion of
`
`the substantially rigid portion extends proximally through the hemostatic valve in
`
`common with interventional cardiology devices that are insertable into the guide
`
`catheter. Id. at 7:3-7; 8:5-6; 10:3-9; 11:15-18; 22:3-23:2.
`
`The application discloses a side opening positioned between a proximal end
`
`of the reinforced portion and a distal end of the substantially rigid portion, id. at
`
`8:18-9:3; 12:7-8; 15:4-15; 16:19-17:2; 19:12-18; 35, the side opening having a first
`
`inclined sidewall that tapers into a non-inclined concave track that is proximate a
`
`second inclined sidewall, id. at 8:18-9:3; 12:7-8, 11-12; 15:4-15; 35; 36 at Figure
`
`6; Ex-2124, ¶¶ 30-53. The application discloses that the device is configured so
`
`that, when the reinforced portion extends into the branch artery, the reinforced
`
`portion and the substantially rigid segment assist in resisting forces exerted by the
`
`interventional cardiology devices passed through and beyond the coaxial lumen
`
`that would otherwise tend to dislodge the guide catheter from the artery, Ex. 1003
`
`at 10:7-11:12; 12:16-20; 18:5-14; 22:16-23:2; 38, 39; Ex-2124, ¶¶ 25-27.
`
`C.
`Substitute Claim 25
`The application discloses that the reinforced portion is reinforced with
`
`metallic elements in a braided or coiled pattern, Ex., 1003 at 8:12-16; 14:17-15:2;
`
`16:8-17:2; 21:9-10, the standard guide catheter is a standard 6 French guide
`
`catheter, id. at 7:8-10, 12-13; and each of the flexible tip portion and reinforced
`
`
`
`7
`
`
`
`portion has a cross-sectional inner diameter greater than or equal to 0.056 inches
`
`through which the interventional cardiology devices are insertable, id. at 6:15-17;
`
`7:5-7; 7:17-18; 10:3-13; 11:16-18; 17:10-12; 18:5-14; 22:3-15.
`
`VI. THE LEVEL OF ORDINARY SKILL IN THE ART
`In this Motion, Teleflex applies Petitioner’s definition of a POSITA.
`
`IPR2020-00126 Petition at 14-15; IPR2020-00127 Petition at 12-13.
`
`VII. THE SCOPE AND CONTENT OF THE PRIOR ART
`Before Teleflex’s effective filing date, the prior art described the use of a
`
`standard full-length 5 French guide catheter being inserted through a 6 French
`
`guide catheter to provide backup support for interventional cardiology devices
`
`(Takahashi (Ex. 1010)). It also described embolic protection devices (Ressemann
`
`(Ex. 1008); Adams ’280 (Ex. 1035)), suction catheters (Kataishi (Ex. 1025)),
`
`balloon catheters (e.g., Enger (Ex. 1050)), and support catheters for fixed-wire
`
`devices (Kontos (Ex. 1009); Adams ’292 (Ex. 1034)). No prior art2 known to
`
`Teleflex or its expert, Mr. Keith, including that cited by Petitioner in these IPR
`
`proceedings, described a rapid exchange guide extension catheter with the features
`
`
`2 Itou (Ex. 1007) also discloses a suction catheter. As explained in Patent Owner’s
`
`Consolidated Response Brief on Conception and Reduction to Practice, filed
`
`herewith, Itou is not prior art.
`
`
`
`8
`
`
`
`recited in the substitute claims. The closest art known to Teleflex and Mr. Keith is
`
`listed in this paragraph. Ex-2124, ¶ 19.
`
`VIII. THE PROPOSED SUBSTITUTE CLAIMS ARE PATENTABLE
`As required by 37 C.F.R. § 42.121(a)(2)(i), the amendments reflected in the
`
`proposed substitute claims are responsive to the grounds of unpatentability upon
`
`which institution was granted. Each of substitute claims 23-25 is novel and
`
`nonobvious under 35 U.S.C. §§ 102 and 103, as set forth below. Patentability
`
`further is supported by the objective evidence.
`
`A.
`
`Substitute Claims 23-25: None of the Prior Art Discloses or
`Suggests the Claimed Combination of Features Including the
`Recited Complex Side Opening
`The priority disclosure discloses a guide extension catheter having a
`
`substantially rigid proximal pushrod, a distal tubular portion, and a partially
`
`cylindrical opening in between that facilitates entry of interventional cardiology
`
`devices into the distal tubular portion while the tubular portion is located deep
`
`within a surrounding guide catheter. The disclosure discloses side openings that
`
`are beyond a single-incline skived opening, and have a complex shape that further
`
`improves the ability of interventional cardiology devices (particularly larger
`
`devices such as stents) to smoothly enter into the distal tubular portion without
`
`hanging up. Ex. 1003 at 8:18-9:3; 12:7-8; 12:11-12; 15:4-15; 35; 36 at Figure 6;
`
`41. An example of this is shown in Figure 4:
`
`
`
`9
`
`
`
`Complex Side Opening
`
`
`
`Id. at 35.
`
`While the exact language varies by claim, substitute claims 23 and 24-25 all
`
`add complex side opening limitations:
`
`Claims 23:
`
`“a substantially rigid side opening that includes a first inclined
`
`region, a second inclined region, and a non-inclined concave track
`
`between the first and second inclined regions”; and
`
`Claims 24-25: “the side opening having a first inclined sidewall that tapers into a
`
`non-inclined concave track that is proximate a second inclined
`
`sidewall.”
`
`None of the prior art discloses or suggests the claimed combination of
`
`features including the complex side opening recited in each of these substitute
`
`claims. In response to existing claims of the GuideLiner patents that recite a
`
`complex side opening, Petitioner has asserted obviousness arguments using Itou
`
`(Ex. 1007), Ressemann (Ex. 1008) or Kontos (Ex. 1009) as the primary reference.
`
`Petitioner does not assert that any of these references disclose a device with a
`
`complex side opening at the proximal end of a distal tubular section, and with good
`
`reason. Itou and Ressemann both disclose devices having a single-incline
`10
`
`
`
`
`
`proximal opening. Kontos does not disclose a side opening at all, much less a
`
`“complex” one.
`
`Petitioner has relied on Kataishi, Ressemann and Enger to argue that it
`
`would have been obvious to modify the primary references to add a complex side
`
`opening. Petitioner’s arguments are pure hindsight. Kataishi discloses a suction
`
`catheter having a distal opening with a complex shape that, in combination with its
`
`flexibility, facilitates the ability of the distal end to conform around a thrombus
`
`attached to the side wall of a vessel to suction it out. Ex. 1025 at [0027]-[0028].
`
`As the Board preliminarily found in its Institution Decisions, the Petitioner “does
`
`not explain sufficiently why the inclined shape of Kataishi’s distal opening would
`
`have been applicable to” the proximal opening of Itou or Kontos’s device.
`
`IPR2020-0135, Paper 22 at 23; IPR2020-00136, Paper 20 at 29. The Board’s
`
`preliminary conclusion was correct.
`
`As for Ressemann, it is undisputed that none of the embodiments of
`
`Ressemann’s embolic protection device have a proximal opening with a complex
`
`profile. Instead, Petitioner focuses on a single component of Ressemann’s
`
`assembly—the support collar 2141 shown in Figure 16J. Petitioner asserts that
`
`Ressemann’s support collar has a complex side opening having inclined slopes 1
`
`and 2:
`
`
`
`11
`
`
`
`
`
`IPR2020-00135 Petition at 72-73. Petitioner argues that it would have been
`
`obvious to incorporate Ressemann’s collar on top of the push wire of the primary
`
`references (Itou, Kontos, or Ressemann’s Figure 1 embodiment) in order to create
`
`an “on ramp” into the opening of those references. Id. at 74.
`
`This analysis is overflowing with hindsight. In Ressemann’s device, what
`
`Petitioner calls “incline #1” of the support collar is not an “incline” or an “on-
`
`ramp” at all. The entire tab portion 2141b of Ressemann’s collar (including the tip
`
`that supposedly defines an on ramp) is buried deep inside Ressemann’s device,
`
`underneath at least three other components. Moreover, the purpose of the tab
`
`portion has nothing to do with guiding components into an opening; rather, it
`
`provides a “flexibility transition” between the proximal end of Ressemann’s
`
`evacuation head and the shaft. Ex. 1008 at 24:62-67. And the tiny asserted incline
`
`at the end of that tab portion (which Petitioner relies on for “incline #1) serves no
`
`purpose whatsoever; it is merely the incidental result of how the tip of the collar is
`12
`
`
`
`
`
`machined. Petitioner’s expert admitted that he did even not try to determine how
`
`the tab 2141b of Ressemann’s collar was actually used in Ressemann’s device,
`
`explaining that “I’m not overly concerned with what the collar was being done
`
`before I chose to use it.” Ex. 2137 at 131:21-133:6. Such testimony shows that
`
`Petitioner’s expert did exactly what the law prohibits – he used the knowledge
`
`gained from reading Teleflex’s patent disclosure to recreate the invention from
`
`pieces in various prior art references. See KSR Int'l Co. v. Teleflex Inc., 550 U.S.
`
`398, 421 (2007) (“warning against a temptation to read into the prior art the
`
`teachings of the invention in issue and instructing courts to guard against slipping
`
`into use of hindsight”) (citing Graham v. John Deere Co., 383 U.S. 1, 36 (1966))
`
`(internal quotations omitted).
`
`Moreover, Ressemann explicitly states that the function of providing a
`
`flexibility transition is provided by placing the tab portion of the collar adjacent the
`
`exterior walls of Ressemann’s multi-lumen tube. Ex. 1008 at 24:62-67. In
`
`Ressemann’s device, both the evacuation head and the shaft have multiple lumens
`
`that must connect together and maintain their patency in order for the device to
`
`function properly. Id. at e.g., 6:18-20, 35-65, Figs. 1A, 1B, 6C, 16D, 16E. Placing
`
`the tab portion of the collar outside these lumens (i.e., below the inflation lumen
`
`and core wire lumen of Ressemann’s shaft) provides a flexibility transition that
`
`helps maintain this patency. Yet Petitioner’s obviousness theory is premised on
`
`
`
`13
`
`
`
`placing Ressemann’s collar on top of the shaft of the primary references, instead of
`
`at the bottom of the shaft as shown in and taught by Ressemann. This is further
`
`evidence that Petitioner’s obviousness theory is based on hindsight, not the
`
`teaching of the references.
`
`Finally, Enger shows a typical example of a rapid exchange balloon catheter,
`
`with a distal portion having a guidewire lumen that receives a guidewire to
`
`facilitate delivery of the balloon catheter. Petitioner claims that the proximal
`
`opening of Enger’s guidewire lumen has a complex shape including two inclined
`
`portions. But as Petitioner’s own expert admitted, Enger does not disclose a side
`
`opening having two inclined regions. Ex. 2137 at 236:2-21, 237:7-11. What
`
`Petitioner pointed to as the alleged second incline is not part of the guidewire
`
`opening, but is simply a cross-sectional view of a tubular “necked structure” where
`
`a separate part of the distal portion receives a metal tube of the push rod. Id. at
`
`236:2-21, 237:7-11, see also id. at 228:10-229:3 (admitting that immediately distal
`
`to the opening is a tube with a convex outer surface). And to make matters worse
`
`for Petitioner, the proximal opening of Enger’s guidewire lumen is not even an
`
`entrance opening; it is an exit opening. All the experts agree that this proximal
`
`opening could not and would not be used to receive even a guidewire while the
`
`device is positioned within the guide catheter (as required by the claims). Ex. 2116
`
`
`
`14
`
`
`
`at 202:24-203:15; Ex. 2137 at 346:12-347:6, see also id. at 90:15-23. Petitioner’s
`
`obviousness argument based on Enger borders on specious.
`
`
`
`B.
`
`Substitute Claims 23 and 25: The Prior Art Does Not Disclose or
`Suggest the Claimed Combination of Elements, Including a
`Tubular Structure Having a Coaxial 0.056 Lumen Configured
`For Use With a 6 French Guide Catheter
`Substitute claims 23 and 25 are directed to a guide extension catheter for use
`
`with “a standard 6 French guide catheter” that has a “tubular structure . . . defining
`
`a coaxial lumen having a cross-sectional inner diameter of at least 0.056 inches
`
`through which interventional cardiology devices are insertable,” as recited in
`
`substitute claim 23, or where “each of the flexible tip portion and reinforced
`
`portion has a cross-sectional inner diameter greater than or equal to 0.056 inches
`
`through which the interventional cardiology devices are insertable” with a “coaxial
`
`lumen,” as recited in substitute claim 24, from which substitute claim 25 depends.
`
`As discussed in the disclosure, an important feature of the disclosed device is the
`
`ability to provide only a one French size difference between the guide catheter and
`
`the guide extension catheter. Ex. 1003 at 7:8-18. According to the specification, a
`
`one French size difference for a 6 French guide catheter corresponds to an inner
`
`diameter of 0.056 inches for the guide extension catheter. Id.
`
`None of the prior art discloses or renders obvious the combination of
`
`elements recited in substitute claims 23 and 25, including the coaxial and size
`
`limitations, in a rapid exchange device. The Itou reference is not prior art. In the
`
`
`
`15
`
`
`
`related Petitions, Petitioner has relied on a combination of Ressemann and
`
`Takahashi or Kontos and Takahashi to argue for the obviousness of claims
`
`containing “not more than one French size” limitations. As for the alleged
`
`Ressemann/Takahashi combination, Ressemann is an “embolic protection device”
`
`designed to stop blood flow within a cardiac artery. Ex. 1008 at 2:56-61, 6:10-15.
`
`To provide this function, Ressemann’s evacuation head includes both balloons on
`
`the outer surface of the device, as well as a multi-lumen tube having at least an
`
`evacuation lumen and an inflation lumen. Id., e.g., 6:35-65, Figs. 1A, 1B, 11A,
`
`11B, 16D, 16E. As the Board already correctly found in denying institution of a
`
`related IPR, the presence of multiple lumens means that the evacuation lumen of
`
`Ressemann is not configured to be “coaxial” with the lumen of the guide catheter.
`
`IPR2020-00133, Paper 20 at 14-15. Moreover, the presence of the balloons and
`
`the inflation lumen preclude the ability to make a device that would both fit in a 6
`
`French guide catheter and has an 0.056 inch evacuation lumen. And the Board
`
`correctly criticized any argument that it would have been obvious to modify
`
`Ressemann to remove the balloons and the inflation lumen, noting that “[t]hese
`
`modifications would extinguish the capability of the device to act as an aspiration
`
`catheter.” IPR2020-00129, Paper 22 at 33. The presence of the balloons also
`
`means that Ressemann’s device does not have “a reinforced portion having a
`
`
`
`16
`
`
`
`uniform, fixed cross-sectional outer diameter,” as recited in substitute claim 25 (via
`
`substitute claim 24, from which substitute claim 25 depends).
`
`A similar analysis applies with respect to the alleged Kontos/Takahashi
`
`combination. Kontos teaches a distal body structure 12 that has a narrow central
`
`tube 16 designed to snugly receive the balloon of a balloon catheter, together with
`
`projections at the distal and proximal ends that project outwardly to fill the gap
`
`between the outer surface of the tube and the guide catheter:
`
`Distal protrusion
`
`Proximal protrusion
`
`
`
`
`
`
`
`Ex. 1009 at Fig. 1 and 4:48-56. Petitioner has argued that it would have been
`
`obvious to replace the funnel at the proximal end of Kontos’s device with an
`
`angled opening. E.g., IPR2020-00136, Petition at 68-72. However, even assuming
`
`such a modification would have been obvious (which it would not), it still would
`
`not be possible to meet for an 0.056 inner diameter that still fits in a 6F guide
`
`catheter in light of the other structures that project from the outer surface of
`
`Kontos’s tube. Moreover, if modified as proposed by Petitioner to remove the
`
`
`
`17
`
`
`
`funnel, it would render Kontos’s support catheter asymmetric at the proximal end,
`
`with the axis of its lumen located substantially above the axis of the guide catheter
`
`lumen:
`
`Thus, Kontos’s device modified as proposed by Petitioner would not have a tubular
`
`structure or a flexible tip portion “defining a coaxial lumen,” as recited in
`
`substitute claims 23 and 24. It also does not (and would not even if modified as
`
`proposed by Petitioner) have “a reinforced portion having a uniform, fixed cross-
`
`sectional outer diameter,” as recited in substitute claim 25.
`
`C.
`
`Substitute Claims 24-25: The Prior Art Does Not Disclose or
`Suggest the Claimed Combination of Elements, Including a
`Coaxial Lumen With a Reinforced Portion Having a Uniform,
`Fixed Outer Diameter Where the Reinforced and Substantially
`Rigid Portions Provide Backup Support
`Substitute claims 24-25 are directed to a guide extension catheter that has a
`
`“coaxial lumen” and “a reinforced portion having a uniform, fixed cross-sectional
`
`outer diameter proximal to the flexible tip portion” where “the device is configured
`
`so that, when the reinforced portion extends into the branch artery, the reinforced
`
`portion and the substantially rigid segment assist in resisting forces exerted by the
`18
`
`
`
`
`
`interventional cardiology devices passed through and beyond the coaxial lumen
`
`that would otherwise tend to dislodge the guide catheter from the artery.”
`
`Particularly in the context of a rapid exchange device such as that required by
`
`claims 24-25,3 this additional requirement for added backup support further
`
`distinguishes claims 24-25 over the Kontos reference.
`
`The device of Kontos is not designed to resist backout forces, nor would a
`
`POSITA expect that Kontos’s device would do so. As discussed above, Kontos’s
`
`device has a long, narrow tube 16 in its center portion, with larger-diameter
`
`protrusions at its proximal and distal ends. Ex. 1009 at Fig. 1 and 4:48-56. As a
`
`result of this design, when the distal end of Kontos’s device is extended out the end
`
`of the guide catheter, there is a substantial gap between the tube and the walls of
`
`the guide catheter, with the primary point of contact being limited to the proximal
`
`“base portion” 18. Moreover, Kontos’s device is disclosed as being made of a
`
`“pliable” material such as polyethylene, and it does not disclose any reinforcement
`
`in the central, narrow portion of its tube 16. Id. at 4:1-4. As a result, the device
`
`
`3 The rapid exchange functionality is reflected, inter alia, in the claim requirements
`
`for a tubular structure connected to a proximal substantially rigid portion that
`
`defines a rail structure.
`
`
`
`19
`
`
`
`would be akin to a “wet noodle.” When subjected to backout forces, a POSITA
`
`would expect it to twist, buckle and/or “crunch up,” rather than resist the forces.
`
`IX. CONCLUSION
`Teleflex respectfully requests that, if any of original claims 1, 11, or 16 is
`
`found unpatentable, the Board enter the respective substitute claim(s) 23-25 in its
`
`place and find it to be patentable.
`
`
`
`Dated: September 24, 2020
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`
`/J. D