`Element
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`U.S. Patent No. RE46,116
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`25(p)
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`25(a)
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`(Unasserted) Claim 25: A method,
`comprising:
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`advancing a distal end of a guide
`catheter having a lumen through a
`main blood vessel to an ostium of a
`coronary artery;
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`Medtronic’s Telescope Guide Extension Catheter
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`Medtronic’s Telescope product is available in two sizes: 6F and 7F. When both products
`are discussed collectively they will be referred to as “Telescope.” If referred to separately,
`they will be referred to as “Telescope 6F” and “Telescope 7F,” respectively.
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`Exhibit A – Telescope PowerPoint Presentation
`Exhibit B – Telescope Instructions for Use
`Exhibit C – Website for Telescope1
`Exhibit D – Telescope Press Release
`Exhibit E – FDA letter re: Medtronic’s 510k for Telescope
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`Telescope is used to perform a method, and Medtronic instructs doctors regarding that
`method. Exhibit B.
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`Telescope is configured to be used with a guide catheter having a lumen, a distal end of
`which is advanced through a main blood vessel to an ostium of a coronary artery.
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`Telescope is specified for use with a guide catheter having a lumen.
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`Telescope is specified to be used with a “required” guide catheter having a certain inner
`diameter:
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`1 https://www.medtronic.com/us-en/healthcare-professionals/products/cardiovascular/coronary-catheters/telescope.html
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`Exhibit A at 39 (red box added).
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`The Telescope instructions for use provide:
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`Exhibit B (red boxes added).
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`In use, a distal end of a tubular structure of Telescope, identified below, is advanced
`through, and beyond the distal end of, the guide catheter, while a segment defining a side
`opening, identified below, remains within the lumen of the guide catheter.
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`advancing a distal end of a guide
`extension catheter through, and
`beyond the distal end of, the guide
`catheter, including advancing a distal
`end portion of a tubular structure of
`the guide extension catheter beyond
`the distal end of the guide catheter
`while a segment defining a side
`opening of the guide extension
`catheter remains within the guide
`catheter, the side opening extending
`for a distance along a longitudinal
`axis of the guide extension catheter
`and accessible from a longitudinal
`side defined transverse to the
`longitudinal axis, the tubular structure
`having a cross-sectional inner
`diameter that is not more than one
`French size smaller than a cross-
`sectional inner diameter of the lumen
`of the guide catheter;
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`25(b)
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`Segment defining side opening
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`Distal end of tubular structure
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`The Telescope instructions for use provide:
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`Exhibit B.
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`The side opening of Telescope extends for a distance along a longitudinal axis and is
`accessible from a longitudinal side defined transverse to the longitudinal axis to receive
`interventional cardiology devices when positioned within the lumen of the guide catheter.
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`Exhibit A at 20 (red boxes added).
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`Exhibit A at 21.
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`The Telescope instructions for use state: “The Telescope guide extension catheter is a
`single-lumen rapid exchange catheter. The guide extension catheter is designed to act as
`an extension to a traditional guide catheter and to facilitate the delivery of interventional
`devices into the vasculature. The guide extension catheter is intended to be used within
`the coronary and/or peripheral vasculature to provide support.” Exhibit B.
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`“After positioning a GEC, the ability to deliver stents, balloons, and other interventional
`devices through the catheter is critical.” Exhibit C.
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`“Telescope(TM) Guide Extension Catheter, a newly designed catheter used to provide
`additional backup support and access to distal lesions. Guide extension catheters help
`deliver coronary stents, balloons and other interventional devices during angioplasty
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`procedures that help to restore blood flow through the coronary and peripheral arteries.”
`Exhibit D.
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`Telescope 6F literally meets this limitation. The lumen of Telescope 6F’s tubular structure
`has a uniform cross-sectional inner diameter that is not more than one French size smaller
`than the cross-sectional inner diameter of the lumen of the guide catheter with which it is
`used.
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`The Telescope instructions for use provide:
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`Exhibit B (red box added).
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`Exhibit A at 39 (red box added).
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`Medtronic product literature represents that the inner diameter of Telescope 6F is 0.056”,
`and that the inner diameter of Telescope 7F is 0.062”.
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`Exhibit A at 39 (red boxes added).
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`If “one-French size” is construed to mean mathematically one French (0.0131”), then
`Telescope 6F and 7F meet this one-French size limitation under the doctrine of equivalents
`by performing substantially the same function, i.e., maximizing use of space inside the
`guide catheter to allow interventional cardiology devices to pass into Telescope without
`catching or binding; in substantially the same way, i.e., by inserting the device into a guide
`catheter with a very small gap between the outer diameter of the device and the inner
`diameter of the guide catheter; to achieve substantially the same result, i.e., facilitating
`passage of interventional cardiology devices to the site in the patient’s blood vessel that
`needs treatment. Mathematically, one French is 0.0131”. Using a Telescope that has an
`inner diameter that is 0.0009” more than one French smaller for the 6F or 0.0029” more
`than one French smaller for the 7F than the inner diameter of the required guide catheters
`with which they are used is only insubstantially different from being not more than one
`French size smaller than the guide catheter.
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`Indeed, the Telescope instructions for use provide:
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`maintaining the distal end portion of
`the tubular structure of the guide
`extension catheter in position beyond
`the distal end of the guide catheter;
`and
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`while maintaining the distal end of the
`guide extension catheter positioned
`beyond the distal end of the guide
`catheter, advancing a balloon catheter
`or stent at least partially through the
`guide catheter and the guide extension
`catheter and into the coronary artery,
`including advancing the balloon
`catheter or stent through a hemostatic
`valve associated with a proximal end
`of the guide catheter, along a
`substantially rigid segment of the
`guide extension catheter, through the
`side opening, and through the tubular
`structure.
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`25(c)
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`Exhibit B (red box added).
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`In use, while maintaining a position of the distal end of Telescope beyond the distal end of
`the guide catheter, a balloon catheter or stent is advanced at least partially through the guide
`catheter and Telescope and into the coronary artery. The balloon catheter or stent is
`advanced through a hemostatic valve associated with a proximal end of the guide catheter,
`along a substantially rigid segment of Telescope (identified below), through the side
`opening of Telescope, and through the tubular structure of Telescope.
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`The Telescope instructions for use provide:
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`8.3 Delivery procedure
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`Deliver the guide extension catheter according to the follmnring steps:
`1 . Secure the previously inserted guidewire and backload the distal tip ofthe guide extension catheter onto the
`guidewire. Advance the guide extension catheter until the catheter is proximal to the hemostasis valve.
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`2. Open the hemostasis valve and advance the guide extension catheter through the hemostasis valve and into
`the guide catheter. Ensure that the device distal segment fills with blood, to ensure that no air enters the
`bloodstream.
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`3. Under tluoroscopy. advance the guide extension catheter beyond the distal tip of the guide catheter and into
`the desired location within the vessel.
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`Warning: Do not advance the guide extension catheter more than 15 cm beyond the tip of the guide catheter
`as the guide extension catheter can become lodged in the guide catheter making it difficult to remove.
`***
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`4. Use fiuoroecopyr to confirm the desired position ofthe guide extension catheter in the vessel.
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`It performing an interventional procedure. backload the interventional device over the existing guidewire.
`5.
`Advancethe device through the guide catheter and guide extension catheter into the desired vascular space.
`Exhibit B.
`Note: If a second wire is used duringthe intervention and encounters resistance within the guide catheter. pull
`the wire back several centimeters and Slmly re—advance.
`6. Tighten the Y—adaptor hemostasis valve securely[ on the proximal shaft ofthe guide extension catheter to
`prevent back—bleeding.
`?. Perform the catheterimtion procedure according to the instructions provided by the manufacturer of the
`interventional device. After completing the procedure. remove the guide extension catheter before removing
`the guide catheter from the vessel.
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`Exhibit B.
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`Page 10
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`Medtronic Exhibit 1508
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`Exhibit A at 20 (red boxes added).
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`Exhibit A at 21.
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`The Telescope instructions for use state: “The Telescope guide extension catheter is a
`single-lumen rapid exchange catheter. The guide extension catheter is designed to act as
`an extension to a traditional guide catheter and to facilitate the delivery of interventional
`devices into the vasculature. The guide extension catheter is intended to be used within
`the coronary and/or peripheral vasculature to provide support.” Exhibit B.
`
`“After positioning a GEC, the ability to deliver stents, balloons, and other interventional
`devices through the catheter is critical.” Exhibit C.
`
`“Telescope(TM) Guide Extension Catheter, a newly designed catheter used to provide
`additional backup support and access to distal lesions. Guide extension catheters help
`deliver coronary stents, balloons and other interventional devices during angioplasty
`
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`11
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`EXHIBIT 7
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`Page 11
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`procedures that help to restore blood flow through the coronary and peripheral arteries.”
`Exhibit D.
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`Telescope’s substantially rigid segment is rigid enough to allow the device to be advanced
`within the guide catheter.
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`Substantially rigid segment
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`Exhibit A at 10 (red box added).
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`Exhibit A at 4.
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`Exhibit A at 8.
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`45
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`(Unasserted) Claim 45: The method
`of claim 25, wherein advancing the
`balloon catheter or stent at least
`partially through the side opening
`includes advancing the balloon
`catheter or stent through a side-
`opening structure having at least two
`inclined slopes.
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`Exhibit A at 9.
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`In use, advancing the balloon catheter or stent at least partially through the side opening of
`Telescope includes advancing the balloon catheter or stent through a side-opening structure
`in Telescope having at least two inclined slopes.
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`Inclined slopes
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`Side opening
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`Exhibit A at 18.
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`Inclined slope
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`Claim 46: The method of any one of
`claims 25 or 40-45, wherein
`advancing the balloon catheter or
`stent at least partially through the side
`opening includes advancing the
`balloon catheter or stent through an
`opening formed by a material or
`material combination more rigid than
`the distal end portion of the tubular
`structure.
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`In use, advancing the balloon catheter or stent at least partially through the side opening of
`Telescope includes advancing the balloon catheter or stent through an opening in Telescope
`formed by a material or material combination more rigid than the distal end portion of the
`tubular structure.
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`The opening, which Telescope documents confirm is formed from a “rigid” and “stiff”
`polymer while the tube is formed from a “flexible” polymer, is more rigid than a material or
`material combination forming the distal end portion of the tubular structure. See Dkt. 77-16
`at p. 2, 10.
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`46
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`Exhibit A at 10, 19, 28 (red box added).
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