REISSUE PATENT APPLICATION
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re the application of:
`
`Root et al.
`
`Attorney Docket No.: 2005.86USREI7
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`Confirmation No.: 5700
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`Application No.:
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`14/984,273
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`Examiner: Catherine Serke Williams
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`Filed:
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`December 30, 2015
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`Group Art Unit: 3993
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`For: COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY
`PROCEDURES
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`SECOND PRELIMINARY AMENDMENT
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`Mail Stop Reissue
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`Commissioner:
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`INTRODUCTORY COMMENTS
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`Prior to examination, please amend the above-identified application as follows:
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`The present amendment comprises the following sections:
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`A. Amendments to the Specification
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`B. Amendments to the Claims
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`C. Remarks
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`Please grant any extension of time necessary for entry; cltarge a11y fee due to Deposit Account No. I 6-0631.
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`AMENDMENTS TO THE SPECIFICATION
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`Application No. 14/984,273
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`In the specification, please substitute the following amended paragraph (where deleted
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`matter is shown by double brackets or strikethrough and added matter is shown by underlining):
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`Page l, section regarding "Related Applications":
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`Related Applications
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`This Application is~ continuation reissue of Application No. 14/195,435., filed March 3,
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`[[2015]] 2014, and entitled "Coaxial Guide Catheter for Interventional Cardiology Procedures"
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`now U.S. Patent RE46,116, which is a continuation reissue of Application No. 14/070,161, filed
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`November 1, 2013, and entitled "Coaxial Guide Catheter for Interventional Cardiology
`
`Procedures" now U.S. Patent RE45.380, which is an application for reissue of U.S. Patent
`
`8,292,850., which issued from Application No. 13/359,059, filed January 26, 2012, and is entitled
`
`"Coaxial Guide Catheter for Interventional Cardiology Procedures," which is a divisional of
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`Application No. 12/824,734, filed June 28, 2010, and entitled "Coaxial Guide Catheter for
`
`Interventional Cardiology Procedures" now U.S. Patent 8,142,413, which is divisional of
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`Application No. 11/416,629, filed May 3, 2006, and aew U.S. PateRt 8,Q48,Q32 entitled "Coaxial
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`Guide Catheter for Interventional Cardiology Procedures" now U.S. Patent 8,142,413
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`8,048,032.[[;]] Notice: more than one reissue application has been filed for the reissue of U.S.
`
`Patent 8,292,850; the reissue application.§. are Application Nos. 14/070,161., filed November 1,
`
`2013, now Reissue RE45.,380, this 01313lieati0n Application, and continuation reissue Application
`
`Nos. 14/195,385., filed March 3, 2014., now Reissue RE45.,760, 14/195,413., filed March 3, 2014.,
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`now Reissue RE45.,776., and 14/195,435., filed March 3, 2014, now Reissue RE46,l 16.
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`AMENDMENTS TO THE CLAIMS
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`Application No. 14/984,273
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`A detailed listing of all claims that are, or were, in the present application, irrespective of
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`whether the claim(s) remain(s) under examination in the application is presented below. The
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`claims are presented in ascending order and each includes one status identifier. Those claims not
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`cancelled or withdrawn but amended by the current amendment utilize the following notations
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`for amendment: 1. deleted matter is shown by double brackets or strikethrough; and 2. added
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`matter is shown by underlining.
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`3
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`Application No. I 4/984,273
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`I.
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`(Cancelled) A system for use with interventional cardiology devices adapted to be
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`insertable into a branch artery, the system comprising:
`
`a 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 the branch artery, the
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`continuous lumen of the guide catheter having a circular cross-sectional inner diameter
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`sized such that interventional cardiology devices are insertable into and through the
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`continuous lumen of the guide catheter~ and
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`a device adapted for use with the guide catheter, including:
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`a flexible tip portion defining a tubular structure and having a circular cross-section and a length
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`that is shorter than the predefined length of the continuous lumen of the guide catheter,
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`the tubular structure having a cross-sectional outer diameter sized to be insertable through
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`the cross-sectional inner diameter of the continuous lumen of the guide catheter and
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`defining a coaxial lumen having a cross-sectional inner diameter through which
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`interventional cardiology devices are insertable; and
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`a substantially rigid portion proximal of and operably connected to, and more rigid along a
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`longitudinal axis than, the flexible tip portion and defining a rail structure without a
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`lumen having a maximal cross-sectional dimension at a proximal portion that is smaller
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`than the cross-sectional outer diameter of the flexible tip portion and having a length that,
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`when combined with the length of the flexible distal tip portion, defines a total length of
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`the device along the longitudinal axis that is longer than the length of the continuous
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`lumen of the guide catheter, such that when at least a distal portion of the flexible tip
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`portion is extended distally of the distal end of the guide catheter, at least a portion of the
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`proximal portion of the substantially rigid portion extends proximally through the
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`hemostatic valve in common with interventional cardiology devices that are insertable
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`Application No. 14/984,273
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`into the guide catheter.
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`2.
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`(Cancelled) The system of claim 1, wherein the tubular structure includes a distal portion
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`adapted to be extended beyond the distal end of the guide catheter while a proximal portion
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`remains within the lumen of the guide catheter, such that the device assists in resisting axial and
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`shear forces exerted by the interventional cardiology device passed through and beyond the
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`coaxial lumen that would otherwise tend to dislodge the guide catheter from the branch artery.
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`3.
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`(Cancelled) The system of claim 2, wherein the proximal portion of the tubular structure
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`further comprises structure defining a proximal side opening extending for a distance along the
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`longitudinal axis, and accessible from a longitudinal side defined transverse to the longitudinal
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`axis, to receive the interventional cardiology devices into the coaxial lumen while the proximal
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`portion remains within the lumen of the guide catheter.
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`4.
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`(Cancelled) The system of claim 3, wherein the proximal side opening includes structure
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`defining a full circumference portion and structure defining a partially cylindrical portion.
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`5.
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`(Cancelled) The system of claim l, wherein the tubular structure includes a flexible
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`cylindrical distal tip portion and a flexible cylindrical reinforced portion proximal to the flexible
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`distal tip portion.
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`5
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`6.
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`(Cancelled) The system of claim 5, wherein the flexible cylindrical reinforced portion is
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`reinforced with metallic elements in a braided or coiled pattern.
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`Application No. 14/984,273
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`7.
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`(Cancelled) The system of claim 2, wherein the flexible cylindrical distal tip portion
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`further comprises a radiopaque marker proximate a distal tip.
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`8.
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`(Cancelled) The system of claim l, wherein the cross-sectional inner diameter of the
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`coaxial lumen of the tubular structure is not more than one French smaller than the cross(cid:173)
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`sectional inner diameter of the guide catheter.
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`9.
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`(Cancelled) The system of claim 1, wherein the substantially rigid portion includes from
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`distal to proximal direction, a cross-sectional shape having a full circumference portion, a
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`hemicylindrical portion and an arcuate portion.
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`10.
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`(Cancelled) The system of claim l, wherein the predefined length of the guide catheter is
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`about 100 cm and the total length of the device is about 125 cm.
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`11.
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`(Cancelled) The system of claim l, further comprising a kit that includes the guide
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`catheter and the device in a common sterile package.
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`12.
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`(Cancelled) A system for use with interventiortal cardiology devices adapted to be
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`insertable into a branch artery, the system comprising:
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`6
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`Application No. I 4/984,273
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`a 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 the branch artery, the
`
`continuous lumen of the guide catheter having a circular cross-section and a cross(cid:173)
`
`sectional inner diameter sized such that interventional cardiology devices are insertable
`
`into and through the continuous lumen of the guide catheter; and
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`a device adapted for use with the guide catheter, including:
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`an elongate structure having an overall length that is longer than the predefined length of the
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`continuous lumen of the guide catheter, the elongate structure including:
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`a flexible tip portion defining a tubular structure and having a circular cross-section that is
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`smaller than the circular cross-section of the continuous lumen of the guide catheter and a
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`length that is shorter than the predefined length of the continuous lumen of the guide
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`catheter, the flexible tip portion having a cross-sectional outer diameter sized to be
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`insertable through.the cross-sectional inner diameter of the continuous lumen of the guide
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`catheter and defining a coaxial lumen having a cross-sectional inner diameter through
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`which interventional cardiology devices are insertable;
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`a reinforced portion proximal to the flexible tip portion; and
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`a substantially rigid portion proximal of, connected to, and more rigid along a longitudinal axis
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`than, the flexible tip portion and defining a rail structure without a lumen having a
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`maximal cross-sectional dimension at a proximal portion that is smaller than the cross(cid:173)
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`sectional outer diameter of the flexible tip portion, such that when at least a distal portion
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`of the flexible tip portion is extended distally of the distal end of the guide catheter with
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`at least proximal portion of the reinforced portion remaining within the continuous lumen
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`of the guide catheter, at least a portion of the proximal portion of the substantially rigid
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`portion extends proximally through the hemostatic valve in common with interventional
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`cardiology devices that are insertable into the guide catheter.
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`Application No. 14/984,273
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`13.
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`(Cancelled) The system of claim 12, wherein, when the distal portion of the flexible tip
`
`portion is insertable through the continuous lumen of the guide catheter and beyond the distal
`
`end of the guide catheter, the device assists in resisting axial and shear forces exerted by an
`
`interventional cardiology device passed through and beyond the coaxial lumen that would
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`otherwise tend to dislodge the guide catheter from the branch artery.
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`14.
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`(Cancelled) The system of claim 12, wherein the substantially rigid portion further
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`includes a partially cylindrical portion defining an opening extending for a distance along a side
`
`thereof defined transverse to a longitudinal axis that is adapted to receive an interventional
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`cardiology device passed through continuous lumen of the guide catheter and into the coaxial
`
`lumen while the device is inserted into the continuous lumen, the opening extending substantially
`
`along at least a portion of a length of the substantially rigid portion.
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`15.
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`(Cancelled) The system of claim 12, wherein, after the device is inserted into the
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`continuous lumen of the guide catheter, the device presents an overall effective length of a
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`coaxial lumen through which an interventional cardiology device may be inserted while utilizing
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`only a single hemostatic valve and without any telescoping structure preassembled prior to the
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`device being inserted into the continuous lumen of the guide catheter.
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`16.
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`(Cancelled) The system of claim 12, the device further comprising a radiopaque marker
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`proximate the distal portion of the flexible tip portion.
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`Application No. I 4/984,273
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`17.
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`(Cancelled) The system of claim 12, wherein the reinforced portion of the device is
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`reinforced with metallic elements in a braided or coiled pattern.
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`18.
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`(Cancelled) The system of claim 12, wherein the cross-sectional inner diameter of the
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`coaxial lumen of the flexible distal portion is not more than one French smaller than the cross(cid:173)
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`sectional inner diameter of the guide catheter.
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`19.
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`(Cancelled) The system of claim 12, wherein the substantially rigid portion includes,
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`from distal to proximal, a cross-sectional shape having a full circumference portion, a
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`hemicylindrical portion and an arcuate portion.
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`20.
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`(Cancelled) The system of claim 12, wherein the elongate structure includes, starting at
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`the distal portion of the flexible distal portion, at least a first portion having a first flexural
`
`modulus, a second portion having a second flexural modulus greater than the first flexural
`
`modulus, and a third portion having a third flexural modulus greater than the second flexural
`
`modulus.
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`21.
`
`(Cancelled) The system of claim 20, in which the first flexural modulus is about 13,000
`
`PSI plus or minus 5000 PSI, the second flexural modulus is about 29,000 PSI plus or minus
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`10,000 PSI, and the third portion flexural modulus is about 49,000 PSI plus or minus 10,000 PSI.
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`Application No. 14/984,273
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`22.
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`(Cancelled) The system of claim 20, in which the first portion is about O. I cm in length,
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`the second portion is about three cm in length, and the third portion is about five cm in length.
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`23.
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`(Cancelled) The system of claim 12, wherein the predefined length of the guide catheter
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`is about 100 cm and the total length of the device is about I 25 cm.
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`24.
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`(Cancelled) The system of claim 12, further comprising a kit that includes the guide
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`catheter and the device in a common sterile package.
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`Please add new claims 25-45 as follows:
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`25.
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`<New) A method of forming a device adapted for use with a guide catheter having a
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`lumen, the method comprising:
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`providing a tip segment having a lumen therethrough:
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`providing a reinforced segment having a lumen therethrough, including one or more metallic
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`elements covered with a polymer, and extending from a proximal end portion to a distal
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`end portion, the proximal end portion more rigid or having a flexural modulus greater
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`than the tip segment;
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`providing a substantially rigid segment extending from a proximal end portion to a distal end
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`portion;
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`eccentrically positioning the distal end portion of the substantially rigid segment relative to a
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`longitudinal axis of the proximal end portion of the reinforced segment: and
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`coaxially aligning the distal end portion of the reinforced segment and a proximal end portion of
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`the tip segment,
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`10
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`Application No. 14/984,273
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`wherein providing the substantially rigid segment. the reinforced segment, and the tip segment
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`includes forming a device length such that when a distal end portion of the tip segment is
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`extended distally of a distal end of the guide catheter, at least part of the proximal end
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`portion of the substantially rigid segment extends proximally of a proximal end of the
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`guide catheter.
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`26.
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`<New) The method of claim 25, further comprising providing a segment defining a side
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`opening and positioning the segment proximal of the proximal end portion of the reinforced
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`segment. the side opening extending for a distance along a longitudinal axis of the segment and
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`accessible from a longitudinal side defined transverse to the longitudinal axis.
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`27.
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`<New) The method of claim 25, wherein providing the substantially rigid segment
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`includes providing one or more relief openings at its distal end portion.
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`28.
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`<New) The method of claim 27, wherein the one or more relief openings include a first
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`relief opening and a second relief opening, the openings spaced apart from one another.
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`29.
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`<New) The method of claim 25, wherein providing the substantially rigid segment
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`includes forming or obtaining a hypotube or a metal rail structure.
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`30.
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`<New) The method of claim 25, wherein providing the substantially rigid segment and
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`the reinforced segment includes, starting at the distal end portion of the reinforced segment and
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`moving proximally toward the proximal end portion of the substantially rigid segment forming
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`or obtaining at least a first device portion having a first flexural modulus and a second device
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`portion having a second flexural modulus. the second flexural modulus greater than the first
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`Application No. 14/984,273
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`flexural modulus.
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`31.
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`<New) The method of claim 25. wherein providing the reinforced segment includes
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`covering one or more braided or coiled metallic elements with the polymer.
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`32.
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`<New) The method of claim 31. wherein a length of the one or more braided or coiled
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`metallic elements is in a range of 20 centimeters to 30 centimeters.
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`33.
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`<New) The method of claim 25. wherein providing the reinforced segment includes
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`forming or obtaining a reinforced segment including a lumen having a uniform inner diameter
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`that is about one French smaller than an inner diameter of the lumen of the guide catheter.
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`34.
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`<New) The method of claim 33, wherein the lumen of the reinforced segment is greater
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`than or equal to 0.056 inches and the lumen of the guide catheter is greater than or equal to 0.070
`
`inches.
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`35.
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`<New) The method of claim 25, wherein providing one or both of the reinforced segment
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`and the tip segment includes lining the lumens thereof with polytetrafluoroethylene.
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`36.
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`(New) The method of claim 25. wherein providing the tip segment includes providing an
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`atraumatic bumper formed of a polymer or an elastomeric material.
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`Application No. 14/984,273
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`37.
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`<New) The method of claim 36, wherein providing the tip segment includes covering a
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`marker band with the polymer or the elastomeric material.
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`38.
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`<New) A method of forming a device adapted for use with a guide catheter having a
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`lumen, the method comprising:
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`providing a tip segment having a lumen therethrough~
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`providing a reinforced segment including one or more metallic elements covered with a polymer
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`and having a lumen for coaxial alignment with the lumen of the tip portion;
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`providing a substantially rigid segment extending from a proximal end portion to a distal end
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`portion;
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`providing a segment defining a side opening extending for a distance along a longitudinal axis of
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`the device and accessible from a longitudinal side, defined transverse to the longitudinal
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`axis. to receive a balloon catheter or stent; and
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`arranging, in a proximal to distal direction. the substantially rigid segment. the segment defining
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`the side opening. the reinforced segment, and the tip segment.
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`39.
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`<New) The method of claim 38. wherein providing the substantially rigid segment, the
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`segment defining the side opening, and the reinforced segment includes, starting at a distal end
`
`portion of the reinforced segment and moving proximally toward the proximal end portion of the
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`substantially rigid segment, forming or obtaining at least a first device portion having a first
`
`flexural modulus, a second device portion having a second flexural modulus greater than the first
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`flexural modulus, and a third device portion having a third flexural modulus greater than the
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`second flexural modulus.
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`Application No. 14/984,273
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`40.
`
`{New) The method of claim 38, wherein providing the segment defining the side opening
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`includes providing an angled entrance into the lumen of the reinforced segment.
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`41.
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`{New) The method of claim 38, wherein providing the segment defining the side opening
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`includes forming an arcuate cross-sectional shape having a length of about 15 centimeters.
`
`42.
`
`<New) The method of claim 38, wherein providing the segment defining the side opening
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`includes forming, in a proximal to distal direction, an arcuate cross-sectional shape and a
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`hemicylindrical cross-sectional shape.
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`43.
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`<New) The method of claim 38, wherein providing the segment defining the side opening
`
`includes forming a concave track.
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`44.
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`<New) The method of claim 38, wherein providing the segment defining the side opening
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`includes forming a first inclined sidewall. forming a second inclined sidewall. and separating the
`
`first inclined sidewall and the second inclined sidewall by a non-inclined region.
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`45.
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`<New) The method of claim 38, wherein providing the substantially rigid segment, the
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`segment defining the side opening, the reinforced segment, and the tip segment includes forming
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`a device cross-sectional size and shape configured to be passed. at least in part. into the lumen of
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`Application No. 14/984,273
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`the guide catheter.
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`Application No. 14/984,273
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`REMARKS
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`Claims 25-45 are pending. By this second Preliminary Amendment, no claims are
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`cancelled, claims 25, 26, 30, 33, 34 and 36-45 are amended as related to the first Preliminary
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`Amendment, and no claims are added.
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`This application is a continuation reissue application and is to be given priority in
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`examination. MPEP § 708.
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`The filed broadening reissue claims are directed to an additional invention, embodiment
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`or species not originally claimed and represent an overlooked aspect of the invention in the
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`issued patent.
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`The amendments to the claims are made to correct one or more defects causing U.S.
`
`Patent No. 8,292,850 to be partly inoperative or invalid.
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`Examination and reconsideration of this application are respectfully requested.
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`FORMAL REQUEST FOR TELEPHONIC INTERVIEW
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`If the present amendments do not result in allowance of this reissue application, the
`
`undersigned formally requests a telephonic interview be held between the Examiner and the
`
`undersigned, at the Examiner's convenience. The Examiner is kindly requested to phone the
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`undersigned at 612.349.5766 to arrange a time for such telephonic interview.
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`EXPLANATION OF CLAIM AMENDMENTS
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`Claims 25, 26, 30, 33, 34 and 36-45 are amended as follows relative to the similarly
`
`numbered claims filed in the first preliminary amendment in this application.
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`25.
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`(Currently Amended) A method of forming a device adapted for use with a guide
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`Application No. I 4/984,273
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`catheter having a lumen, the method comprising:
`
`· providing a tip segment having a lumen therethrough;
`
`providing a reinforced segment having a lumen therethrough, including one or more
`
`metallic elements covered with a polymer, and extending from a proximal end
`
`portion to a distal end portion, the proximal end portion more rigid or having a
`
`flexural modulus greater than the tip segment;
`
`providing a substantially rigid segment extending from a proximal end portion to a distal
`
`end portion;
`
`eccentricaJly eo~lie.g positioning the distal end portion of the substantially rigid segment
`
`[[and]] relative to a longitudinal axis of the proximal end portion of the reinforced
`
`segment; and
`
`coaxially eouplie.g aligning the distal end portion of the reinforced segment and a
`
`proximal end portion of the tip segment,
`
`wherein providing the substantially rigid segment, the reinforced segment, and the tip
`
`segment includes forming a device length such that when a distal end portion of
`
`the tip segment is extended distally of a distal end of the guide catheter, at least
`
`part of the proximal end portion of the substantially rigid segment extends
`
`proximally of a proximal end of the guide catheter.
`
`26.
`
`(Currently Amended)
`
`The method of claim 25, whereie. provieiag the
`
`substantially rigid segment iaehules pmvieie.g a first 01:1ter tlimeasioe. at the prmcimal ene
`
`portion aHa previtlie.g a seoone 01:1ter tlimeasioa at the distal ene portioa, tke seooae out
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`Application No. 14/984,273
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`aimeasiea greater than the first euter eimeaisoa further comprising providing a segment
`
`defining a side opening and positioning the segment proximal of the proximal end portion
`
`of the reinforced segment, the side opening extending for a distance along a longitudinal
`
`axis of the segment and accessible from a longitudinal side defined transverse to the
`
`longitudinal axis.
`
`30.
`
`(Currently Amended)
`
`The method of claim 25, wherein providing the
`
`substantially rigid segment and the reinforced segment includes, starting at the distal end
`
`portion of the reinforced segment and moving proximally toward the proximal end
`
`portion of the substantially rigid segment, forming or obtaining at least a first structure
`
`device portion having a first flexural modulus and a second strueture device portion
`
`having a second flexural modulus, the second flexural modulus greater than the first
`
`flexural modulus.
`
`33.
`
`(Currently Amended) The method of claim 25, wherein providing the reinforced
`
`segment includes forming or obtaining a reinforced segment including a lumen having a
`
`uniform inner diameter that is aot more than about one French smaller than an inner
`
`diameter of the lumen of the guide catheter.
`
`34.
`
`(Currently Amended) The method of claim 33, wherein the lumen of the
`
`reinforced segment is eoafigured to reeeive one er mere stents or balloon eatheters vlfl.en
`
`the proximal end portion of tke reinforeed segmeet is positioaed vAthie tile lumea of the
`
`guide eatketer aad the distal ead 13ortioH of the tip segment e,cteeds beyond tile distal eed
`
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`ef the g1:1iae eatheter greater than or equal to 0.056 inches and the lumen of the guide
`
`catheter is greater than or equal to 0.070 inches.
`
`Application No. 14/984,273
`
`36.
`
`(Currently Amended) The method of claim 25, wherein providing the tip segment
`
`includes providing a tip segmeat an atraumatic bumper formed of a lev,r Elttreffleter
`
`polymer or an elastomeric material.
`
`37.
`
`(Currently Amended) The method of claim 36, wherein providing the tip segment
`
`includes covering a marker band with the law EIHreffleter polymer or the elastomeric
`
`material.
`
`38.
`
`(Currently Amended) A method of forming a device adapted for use with a guide
`
`catheter having a lumen, the method comprising:
`
`providing a tip segment having a lumen therethrough;
`
`providing a reinforced segment including one or more metallic elements covered with a
`
`polymer and having a lumen for coaxial plaeeffl.eat alignment with the lumen of
`
`the tip portion;
`
`providing a substantially rigid segment extending from a proximal end portion to a distal
`
`end portion[[,]];
`
`providing a segment defining the aistal eRa pertiea inelHaiag at least part ef a side
`
`opening extending for a distance along a longitudinal axis of the device and
`
`accessible from a longitudinal side, defined transverse to the longitudinal axis, to
`
`receive a balloon catheter or stent; and
`
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`Application No. 14/984,273
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`arranging, in a proximal to distal direction, the substantially rigid segment, the segment
`
`defining the side opening, the reinforced segment, and the tip segment.
`
`eet:1J31iBg the distal eeel J3eftiee ef the st:1estaBtially r-igiel segmeat aiul a flFeJEimal eHel
`
`J3eftiea efthe FeiRfeFeeel segmeet; aaa
`
`eet:lflliRg a elistal eael fl0ftiea ef the reiafereee segmem aae a pF01dmal eael paFtiea af the
`
`tifl segmeet,
`
`wheFeia flF0Yiaieg the st:1estaBtiaJly r-igiel segmeRt, the reiRfaFeeel segmeHt, aael the tifl
`
`segmeat iReh:1Eles, startiag at the elistal eaa peFtiea ef the tifl segmeat aael meving
`
`flFeJdmally tev.<are the :f3F0Jdmal eaa peFtiea ef ilie st:1estaatially r-igie segmeat,
`
`farming er eetaiaiag at least a first struett:1re having a first fl~n:1Fal meet:1ll:ls, a
`
`seeena struett:IFe haviag a seeeaEl flemlfal m0Elt:1lt:1s greateF than the first fl~cl:lfal
`
`m0Ell:llt:1s, ane a thira strueEl:IFe ha-viag a thira flent:IFal meel~-dt:1s gFeater thaa the
`
`seeeael flent:1Fal meelt:1lt:1s.
`
`39.
`
`(Currently Amended) The method of claim 38, wherein funning er eetaiaiag the
`
`first straett:IFe having tke first fleJEl:lral meelt:1lt:1s iaeleEles funning a struett:IFe haviag a
`
`flem1ral meaell:ls ef aBet:It 13,QQQ PSI 13It:1s er miat:1s §,QQQ PSI, vmereiR furmiRg er
`
`eetaiRiRg the seeeaa struett:1re kaviRg the seeeaEl fle1£t:1Fal m0Elt:1lt:1s iRelt:1eles furmiag a
`
`stmekife haviag a fle11::t:IFal meell:llus ef aeet:It 29,QQQ PSI ph:1s er miRHS H>,QQQ PSI, aaa
`
`WH.eFeia furmiag 0F eetainiHg £he thira Sff1:i6tt:1re haviag the taiFe fleimra} ffl0Sl:tll:lS
`
`ieelt:1Eles furmiBg a struetHFe haYiag a fle1rt1ral meelt:1les ef aBeat 49,QQQ PSI pll:ls er miRHS
`
`I Q,QQQ PSI providing the substantially rigid segment, the segment defining the side
`
`opening, and the reinforced segment includes, starting at a distal end portion of the
`
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`Application No. 14/984,273
`
`reinforced segment and moving proximally toward the proximal end portion of the
`
`substantially rigid segment, forming or obtaining at least a first device portion having a
`
`first flexural modulus, a second device portion having a second flexural modulus greater
`
`than the first flexural modulus, and a third device portion having a third flexural modulus
`
`greater than the second flexural modulus.
`
`40.
`
`(Currently Amended) The method of claim 38, wherein providing the segment
`
`defining the side opening includes providing an angled entrance[[ to]] into the lumen of
`
`the reinforced segment, the Mglee eaa=anee arigiaatiag at the eistal eHEl parties ef the
`
`saestamially rigie segmeHt 8:RS enteaeiag eistally iate the ~FeJCimal eae pertieB ef the
`
`reiafereee segmeHt.
`
`41.
`
`(Currently Amended) The method of claim 38, wherein providing the segment
`
`defining the side opening includes forming an arcuate cross-sectional shape having a
`
`length of about 15 centimeters.
`
`42.
`
`(Currently Amended) The method of claim 38, wherein providing the segment
`
`defining the side opening includes forming, in a proximal to distal direction, an arcuate
`
`cross-sectional shape and a hemicylindrical cross-sectional shape.
`
`43.
`
`(Currently Amended) The method of claim 38, wherein providing the segment
`
`defining the side opening includes forming a concave track e1rteaeing fer a length in a
`
`raage ef aeel:11 2Q eeatimeters te aeeut 75 eeHtimeters.
`
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