Claim
`Element
`
`U.S. Patent No. 8,142,413
`
`Medtronic’s Telescope Guide Extension Catheter
`
`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.
`
`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
`
`1(p)
`
`(Unasserted) Claim 1. A method of
`providing backup support for an
`interventional cardiology device for
`use in the coronary vasculature, the
`interventional cardiology device being
`adapted to be passed through a
`standard guide catheter, the standard
`guide catheter having a continuous
`lumen extending for a predefined
`length from a proximal end at a
`hemostatic valve to a distal end
`adapted to be placed in a branch
`artery, the continuous lumen of the
`guide catheter having a circular cross-
`sectional inner diameter sized such
`that interventional cardiology devices
`are insertable into and through the
`lumen, the method comprising:
`
`
`Telescope is used as a device to perform a method of providing backup support for an
`interventional cardiology device in the coronary vasculature, and Medtronic instructs
`doctors regarding that method. Exhibit B.
`
`
`“In difficult cases, GECs provide additional backup support and improve access to distal
`lesions.” Exhibit A at 2.
`
`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.
`
`“In difficult cases, guide extension catheters provide extra backup support and improve
`access to distal lesions.” Exhibit C.
`
`“Telescope(TM) Guide Extension Catheter, a newly designed catheter used to provide
`additional backup support and access to distal lesions.” Exhibit D.
`
`
`Telescope is specified for use with a standard guide catheter having a continuous lumen
`extending for a predefined length from a proximal end at a hemostatic valve to a distal end
`adapted to be placed in a branch artery.
`
` 
`1 https://www.medtronic.com/us-en/healthcare-professionals/products/cardiovascular/coronary-catheters/telescope.html
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`Telescope is specified to be used with a “required” guide catheter having a certain inner
`diameter:
`
`
`
`Exhibit A at 39 (red box added).
`
`The Telescope instructions for use provide:
`
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`2 
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`Exhibit B (red boxes added).
`
`
`
`
`The continuous lumen of the guide catheter used with Telescope has a circular cross-
`sectional inner diameter sized such that interventional cardiology devices are insertable into
`and through the lumen.
`
`
`See Exhibit A chart above identifying the inner diameters for the required guide catheters.
`
`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
`procedures that help to restore blood flow through the coronary and peripheral arteries.”
`Exhibit D.
`
`“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. . . .
`TelescopeTM Guide Extension Catheter is intended to be used in conjunction with guide
`catheters . . . .” Exhibit E at 5.
`
` 
`
`3 
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`1(a)
`
`inserting the standard guide catheter
`into a first artery over a guidewire, the
`standard guide catheter having a distal
`end;
`
`
`Telescope is configured to be used with a standard guide catheter having a lumen and a
`distal end. The guide catheter is advanced over a guidewire and into a first artery.
`
`
`Telescope is specified to be used with a “required” guide catheter having a certain inner
`diameter:
`
`
`
`Exhibit A at 39 (red box added).
`
`The Telescope instructions for use provide:
`
`
`
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`
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`
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`4 
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`Exhibit B (red box added).
`
`
`
`The distal end of the standard guide catheter is positioned in a branch artery that branches
`off from a first artery.
`
`
`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.
`
`“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. . . .
`TelescopeTM Guide Extension Catheter is intended to be used in conjunction with guide
`catheters . . . .” Exhibit E at 5.
`
`1(b)
`
`positioning the distal end of the
`standard guide catheter in a branch
`artery that branches off from the first
`artery;
`
`
`
`
` 
`
`The Telescope instructions for use provide:
`
`
`
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`
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`5 
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` ***
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` ***
`
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`Exhibit B (red box added).
`
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`6 
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`https://www.medtronic.com/us-en/healthcare-
`professionals/products/cardiovascular/coronary-catheters/guide/sherpa-nx-active-coronary-
`guide-catheter.html (“Soft distal segment enables active engagement for increased backup
`support”)
`
`https://www.medtronic.com/us-en/healthcare-
`professionals/products/cardiovascular/coronary-catheters/guide/launcher.html (“Flexible
`distal segment enables you to engage for backup support”)
`
`To the extent this limitation is not literally met, it is met under the doctrine of equivalents
`by performing substantially the same function, i.e., positioning the distal end of the
`standard guide catheter very near the location where the branch artery branches off from the
`first artery such that the axes of the distal end of the guide catheter and the branch artery are
`sufficiently aligned; in substantially the same way, i.e., by positioning the distal end next to
`or very near to the location where the branch artery branches off from the first artery; to
`achieve substantially the same result, i.e., facilitating alignment of the distal end of the
`guide catheter with the opening into the branch artery such that the coaxial guide catheter
`can be inserted into the branch artery. Positioning the distal end of the guide extension
`catheter next to or very near the location where the branch artery branches off from the first
`artery is insubstantially different from positioning the distal end of the guide extension
`catheter actually into the branch artery.
`
`In use, a flexible tip portion defining a tubular structure of Telescope, identified below,
`having a circular cross-section and a length that is shorter than a continuous lumen of a
`guide catheter with which it is used, is advanced into the continuous lumen of the guide
`catheter.
`
`
`7 
`
`inserting a flexible tip portion of a
`coaxial guide catheter defining a
`tubular structure having a circular
`cross-section and a length that is
`shorter than the predefined length of
`the continuous lumen of the standard
`guide catheter, into the continuous
`lumen of the standard guide catheter,
`and,
`
`
`1(c)
`
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`Flexible tip portion defining a tubular 
`structure having a circular cross‐section 
`
`
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`8 
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`Exhibit A at 10, 33, 39 (red boxes added).
`
`
`Telescope’s flexible tip portion has a length that is shorter than the continuous lumen of the
`guide catheter with which it is used. Exhibit A at 10, 15, 38-39. Indeed, a standard guide
`catheter is 100 cm long, while Telescope’s entire “distal guide segment” length is 25 cm
`long:
`
` 
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`Exhibit B (red box added); id. (“The 150 cm guide extension catheter consists of a
`hydrophilic-coated, 25 cm single lumen distal guide segment connected to a stainless-steel
`polytetrafluoroethylene (PTFE) coated proximal pushwire.”).
`
`
`
`The Telescope instructions for use provide:
`
`
`
`
` ***
`
` ***
`
`
`Exhibit B.
`
`
`
`
`
`
`
`1(d)
`
` 
`
`further inserting a substantially rigid
`portion that is proximal of, operably
`connected to, and more rigid along a
`
`In use, a substantially rigid portion of Telescope, identified below, that is proximal of and
`operably connected to the flexible tip portion, is inserted into the continuous lumen of the
`guide catheter.
`
`10 
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`longitudinal axis than the flexible tip
`portion, into the continuous lumen of
`the standard guide catheter, the
`substantially rigid portion defining a
`rail structure without a lumen and
`having a maximal cross-sectional
`dimension at a proximal portion that
`is smaller than the cross-sectional
`outer diameter of the flexible tip
`portion and having a length that, when
`combined with the length of the
`flexible distal tip portion, defines a
`total length of the device along the
`longitudinal axis that is longer than
`the length of the continuous lumen of
`the guide catheter;
`
`
`
`Telescope’s substantially rigid portion is more rigid along a longitudinal axis than its
`flexible tip portion.2 Telescope’s substantially rigid portion is rigid enough to allow the
`device to be advanced within the guide catheter.
`
`
`Substantially rigid portion
`
`
`
` 
`2 There may be multiple ways in which Telescope meets this limitation. One such way is to compare the rigidity of the purple tubular portion and
`the structure proximal to it with the rigidity of the green tubular portion and the structure distal to it. See Dkt. 77-16 at p. 2, 10. 
`
` 
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`Exhibit A at 10 (red boxes added).
`
`
`Exhibit A at 4.
`
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`
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`Exhibit A at 8.
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`Exhibit A at 9.
`
`The substantially rigid portion of Telescope defines a rail structure without a lumen,
`identified below. The rail structure of the Telescope facilitates monorail or sliding rail
`delivery.
`
`
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`13 
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`Rail structure without a lumen 
`
`
`
`
`As seen above, the rail structure in Telescope has a maximal cross-sectional dimension at a
`proximal portion that is smaller than the cross-sectional outer diameter of the flexible tip
`portion. Id.
`
`The combined length of the substantially rigid portion and the flexible tip portion defining
`the tubular structure of Telescope is greater than the length of the continuous lumen of the
`guide catheter.
`
`
`The Telescope instructions for use provide:
`
` 
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`14 
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`Exhibit B.
`
`
`
`
`Exhibit A at 39 (red box added). Specifically, a standard guide catheter is 100 cm long,
`while as shown in the above table Telescope is 150 cm long.
`
`
`
`The Telescope instructions for use provide:
`
`
` 
`
` ***
`
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` ***
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`Exhibit B.
`
`
`
`
`
`1(e)
`
`advancing a distal portion of the
`flexible tip portion distally beyond the
`distal end of the standard guide
`catheter and into the second artery
`such that the distal portion extends
`into the second artery and such that at
`least a portion of the proximal portion
`of the substantially rigid portion
`extends proximally through the
`hemostatic valve; and
`
`
`In use, a distal portion of the flexible tip portion of Telescope is advanced beyond the distal
`end of the guide catheter and into a second artery such that the distal portion extends into
`the second artery and such that at least a portion of the proximal portion of the substantially
`rigid portion extends proximally through the hemostatic valve.
`
`The Telescope instructions for use provide that not more than 15 cm of the device extend
`distally of the distal end of the guide catheter:
`
`
`The Telescope instructions for use provide:
`
`
` ***
`
` ***
`
` 
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`Exhibit B.
`
`
`
`
`inserting the interventional cardiology
`device into and through the
`continuous lumen of the standard
`guide catheter alongside of the
`substantially rigid portion and
`advancing the interventional
`cardiology device through and beyond
`a lumen of the flexible tip portion into
`contact with or past a lesion in the
`second artery.
`
`1(f)
`
` 
`
`
`Exhibit A at 39 (red box added). Specifically, a standard guide catheter is 100 cm long,
`while as shown in the above table Telescope is 150 cm long.
`
`
`
`In use, interventional cardiology devices are inserted into and through the continuous lumen
`of the guide catheter alongside the substantially rigid portion of Telescope and advanced
`through and beyond the lumen of the flexible tip portion into contact with or past a lesion in
`a second artery.
`
`
`The Telescope instructions for use provide:
`
`
`17 
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`8.3 Delivery procedure
` ***
`Deliver the guide extension catheter according to the follmiving 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.
` ***
`2. Open the herriostasis 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.
`
`3. Under tluoroscopy. advance the guide extension catheter beyond the distal tip of the guide catheter and into
`the desired location within the vessel.
`***
`
`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.
`***
`
`4. Use microscopyr to confirm the desired position ofthe guide extension catheter in the vessel.
`
`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 Slmh'ly re—advance.
`6. Tighten the Y—adaptor hemostasis valve securely[ on the proximal shaft ofthe guide extension catheter to
`prevent back—bleeding.
`?. Perform the catheteiimtion 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.
`
`Exhibit B.
`
`
`
`
`
` 
`
`
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`
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`18 
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`Exhibit A at 20 (red boxes added).
`
`
`
`
`Exhibit A at 21.
`
`
`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
`
`
`
`19 
`
` 
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`EXHIBIT 6
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`Page 19
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`

`

`procedures that help to restore blood flow through the coronary and peripheral arteries.”
`Exhibit D.
`In use, the substantially rigid portion of Telescope has, as identified below, a cylindrical
`portion and a partially cylindrical portion defining an opening along a side thereof.
`
`
`4
`
`Claim 4. The method as claimed
`in claim 1, further comprising
`selecting the substantially rigid
`portion of the coaxial guide catheter
`such that it comprises a cylindrical
`portion and a partially cylindrical
`portion defining an opening along a
`side thereof.
`
`Cylindrical portion
`
`
`
`
`
`
`Exhibit A at 18.
`
`Partially cylindrical 
`
`
`
`20 
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`Exhibit A at 19.
`
`
`
`Claim 7. The method as claimed
`in claim 1, further comprising
`extending a distal portion of the
`tubular structure beyond the distal end
`of the standard guide catheter while a
`proximal portion remains within the
`lumen of the standard guide catheter,
`such that the coaxial guide catheter
`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
`standard catheter from the branch
`artery.
`
`In use, a distal portion of the tubular structure of Telescope is extended beyond the distal
`end of the standard guide catheter with which it is used while a proximal portion of
`Telescope remains within the lumen of the standard guide catheter, such that Telescope
`assists in resisting axial and shear forces exerted when an interventional cardiology device
`is passed through and beyond the coaxial lumen that would otherwise tend to dislodge the
`standard guide catheter from the branch artery.
`
`
`“In difficult cases, GECs provide additional backup support and improve access to distal
`lesions.” Exhibit A at 2.
`
`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.
`
`21 
`
`7
`
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`“In difficult cases, guide extension catheters provide extra backup support and improve
`access to distal lesions.” Exhibit C.
`
`“Telescope(TM) Guide Extension Catheter, a newly designed catheter used to provide
`additional backup support and access to distal lesions.” Exhibit D.
`
`Medtronic product literature represents that, in use, the inner diameter of Telescope 6F is
`0.056”, and that the inner diameter of Telescope 7F is 0.062”.
`
`
`13
`
`Claim 13. The method of claim 1,
`further comprising selecting the cross-
`sectional inner diameter of the coaxial
`lumen of the tubular structure to be
`not more than one French smaller than
`the cross-sectional inner diameter of
`the guide catheter.
`
`
`
`
`Exhibit A at 39 (red boxes added).
`
`Telescope 6F and 7F meet this one-French 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 smaller
`than the guide catheter.
`
`22 
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`Indeed, the Telescope instructions for use provide:
`
`
`
`Exhibit B (red box added).
`
`
`
`23 
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` 
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