Claim
`Element
`
`U.S. Patent No. RE46,116
`
`25(p)
`
`25(a)
`
`(Unasserted) Claim 25: A method,
`comprising:
`
`advancing a distal end of a guide
`catheter having a lumen through a
`main blood vessel to an ostium of a
`coronary artery;
`
`
`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
`
`Telescope is used to perform a method, and Medtronic instructs doctors regarding that
`method. Exhibit B.
`
`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.
`
`Telescope is specified for use with a guide catheter having a lumen.
`
`
`Telescope is specified to be used with a “required” guide catheter having a certain inner
`diameter:
`
`
`
`1 https://www.medtronic.com/us-en/healthcare-professionals/products/cardiovascular/coronary-catheters/telescope.html
`
`
`
`1
`
`EXHIBIT 7
`
`Page 1
`
`Medtronic Exhibit 1508
`
`
`Element
`
`U.S. Patent No. RE46,116
`
`25(p)
`
`25(a)
`
`(Unasserted) Claim 25: A method,
`comprising:
`
`advancing a distal end of a guide
`catheter having a lumen through a
`main blood vessel to an ostium of a
`coronary artery;
`
`
`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
`
`Telescope is used to perform a method, and Medtronic instructs doctors regarding that
`method. Exhibit B.
`
`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.
`
`Telescope is specified for use with a guide catheter having a lumen.
`
`
`Telescope is specified to be used with a “required” guide catheter having a certain inner
`diameter:
`
`
`
`1 https://www.medtronic.com/us-en/healthcare-professionals/products/cardiovascular/coronary-catheters/telescope.html
`
`
`
`1
`
`EXHIBIT 7
`
`Page 1
`
`Medtronic Exhibit 1508
`
`
`
`
`Exhibit A at 39 (red box added).
`
`The Telescope instructions for use provide:
`
`
`
`
`
`
`
`
` ***
`
`
`
`
`
`
`
`
`
`
`
`2
`
`
`
`EXHIBIT 7
`
`Page 2
`
`Medtronic Exhibit 1508
`
`
`
` ***
`
`
`Exhibit B (red boxes added).
`
`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.
`
`
`
`3
`
`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;
`
`
`25(b)
`
`
`
`EXHIBIT 7
`
`Page 3
`
`Medtronic Exhibit 1508
`
`
`
`Segment defining side opening
`
`Distal end of tubular structure
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`4
`
`EXHIBIT 7
`
`Page 4
`
`Medtronic Exhibit 1508
`
`
`
`The Telescope instructions for use provide:
`
`
` ***
`
` ***
`
`
`
`
`
`
`
`
`Exhibit B.
`
`
`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.
`
`
`
`5
`
`EXHIBIT 7
`
`Page 5
`
`Medtronic Exhibit 1508
`
`
`
`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
`
`
`
`6
`
`EXHIBIT 7
`
`Page 6
`
`Medtronic Exhibit 1508
`
`
`
`procedures that help to restore blood flow through the coronary and peripheral arteries.”
`Exhibit D.
`
`
`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.
`
`
`The Telescope instructions for use provide:
`
`
`
`Exhibit B (red box added).
`
`
`
`Exhibit A at 39 (red box added).
`
`
`
`
`
`7
`
`
`
`EXHIBIT 7
`
`Page 7
`
`Medtronic Exhibit 1508
`
`
`
`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”.
`
`
`
`
`
`Exhibit A at 39 (red boxes added).
`
`
`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.
`
`Indeed, the Telescope instructions for use provide:
`
`
`
`8
`
`EXHIBIT 7
`
`Page 8
`
`Medtronic Exhibit 1508
`
`
`
`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
`
`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.
`
`
`25(c)
`
`
`
`
`Exhibit B (red box added).
`
`
`
`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.
`
`
`The Telescope instructions for use provide:
`
`
`
`
`
`
`
`
`
`
`9
`
`EXHIBIT 7
`
`Page 9
`
`Medtronic Exhibit 1508
`
`
`
`
`
`8.3 Delivery procedure
` ***
`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.
` ***
`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.
`
`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 fiuoroecopyr 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 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.
`
`
`
`Exhibit B.
`
`
`
`
`
`
`
`
`
`
`10
`
`EXHIBIT 7
`
`Page 10
`
`Medtronic Exhibit 1508
`
`
`
`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
`
`
`
`11
`
`
`
`EXHIBIT 7
`
`Page 11
`
`Medtronic Exhibit 1508
`
`
`
`procedures that help to restore blood flow through the coronary and peripheral arteries.”
`Exhibit D.
`
`Telescope’s substantially rigid segment is rigid enough to allow the device to be advanced
`within the guide catheter.
`
`
`Substantially rigid segment
`
`
`
`
`
`12
`
`EXHIBIT 7
`
`Page 12
`
`Medtronic Exhibit 1508
`
`
`
`
`Exhibit A at 10 (red box added).
`
`
`Exhibit A at 4.
`
`
`
`
`Exhibit A at 8.
`
`
`
`
`
`
`
`13
`
`EXHIBIT 7
`
`Page 13
`
`Medtronic Exhibit 1508
`
`
`
`
`
`45
`
`(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.
`
`Exhibit A at 9.
`
`
`
`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.
`
`
`
`
`
`14
`
`EXHIBIT 7
`
`Page 14
`
`Medtronic Exhibit 1508
`
`
`
`Inclined slopes
`
`Side opening
`
`
`
`
`
`Exhibit A at 18.
`
`
`
`Inclined slope
`
`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.
`
`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.
`
`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.
`
`15
`
`46
`
`
`
`EXHIBIT 7
`
`Page 15
`
`Medtronic Exhibit 1508
`
`
`
`
`
`
`
`
`Exhibit A at 10, 19, 28 (red box added).
`
`
`
`
`
`
`
`16
`
`EXHIBIT 7
`
`Page 16
`
`Medtronic Exhibit 1508
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
