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AMENDMENTS TO THE CLAIMS
`
`Application No. 14/984,273
`
`A detailed listing of all claims that are, or were, in the present application, irrespective of
`
`whether the claim(s) remain(s) under examination in the application is presented below. The
`
`claims are presented in ascending order and each includes one status identifier. Those claims not
`
`cancelled or withdrawn but amended by the current amendment utilize the following notations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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`Page 1
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`Medtronic Exhibit 1510
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`

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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
`
`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
`
`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
`
`continuous lumen of the guide catheter~ and
`
`a device adapted for use with the guide catheter, including:
`
`a flexible tip portion defining a tubular structure and having a circular cross-section and a length
`
`that is shorter than the predefined length of the continuous lumen of the guide catheter,
`
`the tubular structure 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; and
`
`a substantially rigid portion proximal of and operably connected to, and more rigid along a
`
`longitudinal axis than, the flexible tip portion and defining a rail structure without a
`
`lumen 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, 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
`
`4
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`Page 2
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`Medtronic Exhibit 1510
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`

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`hemostatic valve in common with interventional cardiology devices that are insertable
`
`Application No. 14/984,273
`
`into the guide catheter.
`
`2.
`
`(Cancelled) The system of claim 1, wherein the tubular structure includes a distal portion
`
`adapted to be extended beyond the distal end of the guide catheter while a proximal portion
`
`remains within the lumen of the guide catheter, such that the device assists in resisting axial and
`
`shear forces exerted by the interventional cardiology device passed through and beyond the
`
`coaxial lumen that would otherwise tend to dislodge the guide catheter from the branch artery.
`
`3.
`
`(Cancelled) The system of claim 2, wherein the proximal portion of the tubular structure
`
`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
`
`axis, to receive the interventional cardiology devices into the coaxial lumen while the proximal
`
`portion remains within the lumen of the guide catheter.
`
`4.
`
`(Cancelled) The system of claim 3, wherein the proximal side opening includes structure
`
`defining a full circumference portion and structure defining a partially cylindrical portion.
`
`5.
`
`(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
`
`distal tip portion.
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`5
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`Page 3
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`Medtronic Exhibit 1510
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`6.
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`(Cancelled) The system of claim 5, wherein the flexible cylindrical reinforced portion is
`
`reinforced with metallic elements in a braided or coiled pattern.
`
`Application No. 14/984,273
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`7.
`
`(Cancelled) The system of claim 2, wherein the flexible cylindrical distal tip portion
`
`further comprises a radiopaque marker proximate a distal tip.
`
`8.
`
`(Cancelled) The system of claim l, wherein the cross-sectional inner diameter of the
`
`coaxial lumen of the tubular structure is not more than one French smaller than the cross(cid:173)
`
`sectional inner diameter of the guide catheter.
`
`9.
`
`(Cancelled) The system of claim 1, wherein the substantially rigid portion includes from
`
`distal to proximal direction, a cross-sectional shape having a full circumference portion, a
`
`hemicylindrical portion and an arcuate portion.
`
`10.
`
`(Cancelled) The system of claim l, wherein the predefined length of the guide catheter is
`
`about 100 cm and the total length of the device is about 125 cm.
`
`11.
`
`(Cancelled) The system of claim l, further comprising a kit that includes the guide
`
`catheter and the device in a common sterile package.
`
`12.
`
`(Cancelled) A system for use with interventiortal cardiology devices adapted to be
`
`insertable into a branch artery, the system comprising:
`
`6
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`Page 4
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`Medtronic Exhibit 1510
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`

`

`Application No. I 4/984,273
`
`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
`
`a device adapted for use with the guide catheter, including:
`
`an elongate structure having an overall length that is longer than the predefined length of the
`
`continuous lumen of the guide catheter, the elongate structure including:
`
`a flexible tip portion defining a tubular structure and having a circular cross-section that is
`
`smaller than the circular cross-section of the continuous lumen of the guide catheter and a
`
`length that is shorter than the predefined length of the continuous lumen of the guide
`
`catheter, the flexible tip portion 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;
`
`a reinforced portion proximal to the flexible tip portion; and
`
`a substantially rigid portion proximal of, connected to, and more rigid along a longitudinal axis
`
`than, the flexible tip portion and defining a rail structure without a lumen having a
`
`maximal cross-sectional dimension at a proximal portion that is smaller than the cross(cid:173)
`
`sectional outer diameter of the flexible tip portion, such 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 continuous lumen
`
`of the guide catheter, at least a portion of the proximal portion of the substantially rigid
`
`7
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`Page 5
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`Medtronic Exhibit 1510
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`

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`portion extends proximally through the hemostatic valve in common with interventional
`
`cardiology devices that are insertable into the guide catheter.
`
`Application No. 14/984,273
`
`13.
`
`(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
`
`otherwise tend to dislodge the guide catheter from the branch artery.
`
`14.
`
`(Cancelled) The system of claim 12, wherein the substantially rigid portion further
`
`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
`
`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.
`
`15.
`
`(Cancelled) The system of claim 12, wherein, after the device is inserted into the
`
`continuous lumen of the guide catheter, the device presents an overall effective length of a
`
`coaxial lumen through which an interventional cardiology device may be inserted while utilizing
`
`only a single hemostatic valve and without any telescoping structure preassembled prior to the
`
`device being inserted into the continuous lumen of the guide catheter.
`
`8
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`Page 6
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`Medtronic Exhibit 1510
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`

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`16.
`
`(Cancelled) The system of claim 12, the device further comprising a radiopaque marker
`
`proximate the distal portion of the flexible tip portion.
`
`Application No. I 4/984,273
`
`17.
`
`(Cancelled) The system of claim 12, wherein the reinforced portion of the device is
`
`reinforced with metallic elements in a braided or coiled pattern.
`
`18.
`
`(Cancelled) The system of claim 12, wherein the cross-sectional inner diameter of the
`
`coaxial lumen of the flexible distal portion is not more than one French smaller than the cross(cid:173)
`
`sectional inner diameter of the guide catheter.
`
`19.
`
`(Cancelled) The system of claim 12, wherein the substantially rigid portion includes,
`
`from distal to proximal, a cross-sectional shape having a full circumference portion, a
`
`hemicylindrical portion and an arcuate portion.
`
`20.
`
`(Cancelled) The system of claim 12, wherein the elongate structure includes, starting at
`
`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.
`
`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
`
`10,000 PSI, and the third portion flexural modulus is about 49,000 PSI plus or minus 10,000 PSI.
`
`9
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`Page 7
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`Medtronic Exhibit 1510
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`

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`Application No. 14/984,273
`
`22.
`
`(Cancelled) The system of claim 20, in which the first portion is about O. I cm in length,
`
`the second portion is about three cm in length, and the third portion is about five cm in length.
`
`23.
`
`(Cancelled) The system of claim 12, wherein the predefined length of the guide catheter
`
`is about 100 cm and the total length of the device is about I 25 cm.
`
`24.
`
`(Cancelled) The system of claim 12, further comprising a kit that includes the guide
`
`catheter and the device in a common sterile package.
`
`Please add new claims 25-45 as follows:
`
`25.
`
`<New) 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 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;
`
`eccentrically positioning the distal end portion of the substantially rigid segment relative to a
`
`longitudinal axis of the proximal end portion of the reinforced segment: and
`
`coaxially aligning the distal end portion of the reinforced segment and a proximal end portion of
`
`the tip segment,
`
`10
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`Page 8
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`Medtronic Exhibit 1510
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`

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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
`
`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.
`
`<New) The method of claim 25, 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.
`
`27.
`
`<New) The method of claim 25, wherein providing the substantially rigid segment
`
`includes providing one or more relief openings at its distal end portion.
`
`28.
`
`<New) The method of claim 27, wherein the one or more relief openings include a first
`
`relief opening and a second relief opening, the openings spaced apart from one another.
`
`29.
`
`<New) The method of claim 25, wherein providing the substantially rigid segment
`
`includes forming or obtaining a hypotube or a metal rail structure.
`
`30.
`
`<New) 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
`
`11
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`Page 9
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`Medtronic Exhibit 1510
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`

`

`or obtaining at least a first device portion having a first flexural modulus and a second device
`
`portion having a second flexural modulus. the second flexural modulus greater than the first
`
`Application No. 14/984,273
`
`flexural modulus.
`
`31.
`
`<New) The method of claim 25. wherein providing the reinforced segment includes
`
`covering one or more braided or coiled metallic elements with the polymer.
`
`32.
`
`<New) The method of claim 31. wherein a length of the one or more braided or coiled
`
`metallic elements is in a range of 20 centimeters to 30 centimeters.
`
`33.
`
`<New) 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 about one French smaller than an inner diameter of the lumen of the guide catheter.
`
`34.
`
`<New) The method of claim 33, wherein the lumen of the reinforced segment is greater
`
`than or equal to 0.056 inches and the lumen of the guide catheter is greater than or equal to 0.070
`
`inches.
`
`35.
`
`<New) The method of claim 25, wherein providing one or both of the reinforced segment
`
`and the tip segment includes lining the lumens thereof with polytetrafluoroethylene.
`
`36.
`
`(New) The method of claim 25. wherein providing the tip segment includes providing an
`
`atraumatic bumper formed of a polymer or an elastomeric material.
`
`12
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`Page 10
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`Medtronic Exhibit 1510
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`Application No. 14/984,273
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`37.
`
`<New) The method of claim 36, wherein providing the tip segment includes covering a
`
`marker band with the polymer or the elastomeric material.
`
`38.
`
`<New) 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 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 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
`
`arranging, in a proximal to distal direction. the substantially rigid segment. the segment defining
`
`the side opening. the reinforced segment, and the tip segment.
`
`39.
`
`<New) The method of claim 38. wherein providing the substantially rigid segment, the
`
`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
`
`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
`
`13
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`Page 11
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`Medtronic Exhibit 1510
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`

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`flexural modulus, and a third device portion having a third flexural modulus greater than the
`
`second flexural modulus.
`
`Application No. 14/984,273
`
`40.
`
`{New) The method of claim 38, wherein providing the segment defining the side opening
`
`includes providing an angled entrance into the lumen of the reinforced segment.
`
`41.
`
`{New) 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.
`
`<New) 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.
`
`<New) The method of claim 38, wherein providing the segment defining the side opening
`
`includes forming a concave track.
`
`44.
`
`<New) The method of claim 38, wherein providing the segment defining the side opening
`
`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.
`
`45.
`
`<New) The method of claim 38, wherein providing the substantially rigid segment, the
`
`segment defining the side opening, the reinforced segment, and the tip segment includes forming
`
`14
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`Page 12
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`Medtronic Exhibit 1510
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`

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`a device cross-sectional size and shape configured to be passed. at least in part. into the lumen of
`
`Application No. 14/984,273
`
`the guide catheter.
`
`15
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`Page 13
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`Medtronic Exhibit 1510
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`

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