Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Applicant’s Remarks and Amendments filed 06 April 2026 have been entered. Claim 21 is cancelled. Claims 1-2, 4-14, 16,20, and 21 are pending.
Response to Arguments
Applicant's arguments filed 6 April 2026 have been fully considered but they are not persuasive. Regarding Applicant’s arguments toward the modification of Dorn in view of Dorn B2 and Beyerlein, Examiner respectfully disagrees. Dorn B2 appears to teach Applicant’s amendment “wherein said restraining sheath is configured to be withdrawn without splitting” in its figures and disclosure.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-9, 16, and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Dorn et al. (US 2011/0301689 A1), “Dorn” in view of Dorn et al. (US Pat. No. 8323326 B2), “Dorn B2”, and further in view of Beyerlein et al. (US 2006/0282152 A1), “Beyerlein”.
Regarding claim 1, Dorn teaches a self-expanding medical device delivery system (Fig. 1), comprising: a self-expanding medical device (Fig. 1, stent device 2) comprising a distal end (Fig. 1, portion of stent device 2 closest to distal tip member 15), a proximal end (Fig. 1, portion of stent device 2 closest to push member 10) and a length there between (Fig. 1, portion of stent device 2 between distal tip member 15 and push member 10); an inner catheter (Fig. 1, inner member 3) extending proximally from said medical device to a deployment handle (Fig. 1, inner member 3 extends toward proximal end of device (i.e., bottom of figure)), said inner catheter comprising a stop surface (Fig. 1, push member) adjacent said proximal end of said medical device (Fig. 1, push member 10 is next to proximal end of stent device 2) and adapted to prevent said medical device from moving proximally during deployment of said medical device (Fig. 1, push member 10 holds axial position of the stent device 2 [0042]); a restraining sheath (Fig. 1, restraining sheath 4) comprising a first portion extending over said medical device (Fig. 1, portion of restraining sheath 4 enveloping stent device 2) and adapted to prevent said medical device from self-expanding prior to deployment of said medical device (Fig. 1, restraining sheath 4 serves to maintain the stent device 2 [0042]) and a second portion extending proximally of said medical device (Fig. 1, portion of restraining sheath 4 that extends past pusher member 10) to a proximal end of said restraining sheath (Fig. 1, portion of restraining sheath 4 that extends within introducer member 13), said second portion being at least as long as said length of said medical device (Fig. 1, stent device 2 may be of any length up to 300mm [0043]), said second portion having a an outer profile that is smaller than an outer profile of said first portion (Fig. 1, portion of restraining sheath 4 within introducer member 13 has a smaller outer profile), -and the proximal end of said restraining sheath terminating distally from said deployment handle (Fig. 1, restraining sheath 4 terminates at distal end of device (i.e., top of figure)); a wire (Fig. 1, polymer thread portion 11) extending proximally from said restraining sheath to said deployment handle (Fig. 1, pull member 5 which encompasses polymer thread portion 11 extends proximally to handle (not shown) [0008]); and a covering sheath (Fig. 1, introducer member 13) extending from said restraining sheath to said deployment handle (Fig. 1, introducer member 13 extends proximally to handle (not shown)), said covering sheath extending over and disposed radially outward from an outer surface of at least said proximal end of said restraining sheath (Fig. 1, introducer member 13 surrounds restraining sheath 4); wherein said medical device is deployed by pulling said wire (Fig. 2, stent device 2 is deployed by pulling on the pulling member 5 which comprises polymer thread portion 11 [0055]) proximally to withdraw said restraining sheath proximally away from said medical device (Fig. 2, stent device 2 deployment occurs with withdrawal of restraining sheath 4 [0055]), and wherein a longitudinal space (Fig. 1, distal end of introducer member 13) inside said covering sheath is formed to receive said restraining sheath (Fig. 1, introducer sheath 13 envelopes restraining sheath 4) withdrawn proximally, away from said medical device (Fig. 2, restraining sheath 4 is pulled back by pulling member 5), but fails to teach said moveable restraining sheath withdrawn proximally, into the longitudinal space, wherein said restraining sheath is configured to be withdrawn without splitting, and that the wire is adhered to the second portion of said restraining sheath.
Dorn B2 teaches a catheter device comprising a moveable restraining sheath (Fig. 15, first telescope tube 402) withdrawn proximally, into the longitudinal space (Fig. 15, first telescope tube 402 is received within second telescope tube 404 proximal of the first (col. 14, lines 64-65)), wherein the restraining sheath is configured to be withdrawn without splitting (Fig. 15, first telescope tube 402 is received within second telescope tube 404 without splitting). Dorn B2 discloses that the telescoping tubes rotate freely relative to the remaining parts of the catheter system while it is advanced within the body (col. 15, lines 5-9)). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the delivery system taught by Dorn with the sheaths and longitudinal space taught by Dorn B2 in order to allow for increased mobility of the device in vivo. However, Dorn in view of Dorn B2 fails to teach that the wire is adhered to the second portion of said restraining sheath.
Beyerlein teaches a delivery system for a stent having a wire that is adhered to the second portion of said restraining sheath (Fig. 1, pullback wire (not shown) is attached to the sheath 108 [0007]). Beyerlein discloses that the pullback wire is attached to the sheath such that the wire can independently withdraw the sheath in order to deploy the stent [0007]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the pullback wire and its positioning and the retractable sheath taught by Beyerlein with the delivery system taught by Dorn in order to simplify the release of the stent from the delivery device.
Regarding claim 2, Dorn teaches wherein said medical device is a stent (Fig. 1, stent device 2).
Regarding claim 4, Dorn teaches wherein said medical device (Fig. 1, stent device 2) is deployed by said deployment handle (handle (not shown)) thereby pulling said wire proximally to withdraw said restraining sheath proximally away from said medical device (Fig. 2, restraining sheath 4 is pulled back by pulling member 5), but fails to explicitly teach that the deployment occurs by the handle winding up the wire.
Dorn B2 teaches a catheter device comprising a handle (Fig. 14, hand unit 214) wherein a medical device is deployed by said handle winding up the wire (Fig. 14, drum 300 within hand unit 214 winds up the pulling line 298). Dorn B2 discloses that the drum and a pawl stop any reverse movement of the toothed wheel and drum within the hand unit during return movement of the hand unit (col. 14, par. 2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to wind up the wire of a stent delivery device so as to avoid any unwanted movement of the device, wire, or implant itself and allow for a smoother implantation process.
Regarding claim 5, Dorn teaches further comprising a low friction liner (Fig. 1, protective strip 16) adhered to said restraining sheath and extending along said length of said medical device and contacting an outer surface of said medical device (Fig. 1, protective strip is between stent device 2 and restraining sheath 4), wherein said restraining sheath comprises a thermoplastic polymer covering said wire and said liner (Fig. 1, restraining sheath 4 is comprised of PET [0031]).
Regarding claim 6, Dorn teaches wherein said restraining sheath (Fig. 1, restraining sheath 4) further comprises a tapered portion (Fig. 1, portion of restraining sheath 4 at distal end of introducer member 13 is tapered) between said first portion (Fig. 1, portion of restraining sheath 4 enveloping stent device 2) and said second portion (Fig. 1, portion of restraining sheath 4 that extends past pusher member 10).
Regarding claim 7, Dorn teaches wherein said covering sheath (Fig. 1, introducer member 13) is fixed to said deployment handle (Fig. 1, introducer member 13 extends proximally to handle (not shown)) and does not move during deployment of said medical device (Fig. 2, introducer sheath does not move during deployment of stent device 2), said covering sheath extending over only a portion of said restraining sheath (Fig. 1, introducer member 13 covers proximal end of restraining sheath 4) disposed proximally from said medical device (Fig. 1, introducer member 13 is proximal to stent device 2).
Regarding claim 8, Dorn teaches wherein said covering sheath (Fig. 1, introducer member 13) comprises an inner circumference (Fig. 1, inside circumference of introducer member 13) and an outer circumference (Fig. 1, outer circumference of introducer member 13) that are both constant along an entire length of said covering sheath (Fig. 1, introducer member 13 maintains constant circumference).
Regarding claim 9, Dorn teaches wherein a distal end (Fig. 1, portion of introducer member 13 that is in contact with restraining sheath 4) of said covering sheath (Fig. 1, introducer member 13) comprises an atraumatic taper (Fig. 1, distal end of introducer member 13 tapers) and a close fitting inner diameter (Fig. 1, introducer member 13 fits closely to restraining sheath 4) around said restraining sheath (Fig. 1, restraining sheath 4) that presents a smooth transition between said restraining sheath and said covering sheath (Fig. 1, transition between restraining sheath 4 and introducer member 13 is smooth).
Regarding claim 16, Dorn teaches a self-expanding medical device delivery system, comprising: a self-expanding medical device (Fig. 1, stent device 2) comprising a distal end (Fig. 1, portion of stent device 2 closest to distal tip member 15), a proximal end (Fig. 1, portion of stent device 2 closest to push member 10) and a length therebetween (Fig. 1, portion of stent device 2 between distal tip member 15 and push member 10); an inner catheter (Fig. 1, inner member 3) extending proximally from said medical device (Fig. 1, stent device 2) to a deployment handle (handle (not shown)), said inner catheter comprising a stop surface (Fig. 1, push member 10) adjacent said proximal end of said medical device (Fig. 1, push member 10 is next to proximal end of stent device 2) and adapted to prevent said medical device from moving proximally during deployment of said medical device (Fig. 1, push member 10 holds axial position of the stent device 2 [0042]); are straining sheath (Fig. 1, restraining sheath 4) comprising a first portion extending over said medical device (Fig. 1, portion of restraining sheath 4 enveloping stent device 2) and adapted to prevent said medical device from self-expanding prior to deployment of said medical device (Fig. 1, restraining sheath 4 serves to maintain the stent device 2 [0042]) and a second portion extending proximally of said medical device (Fig. 1, portion of restraining sheath 4 that extends past pusher member 10) to a proximal end of said restraining sheath (Fig. 1, portion of restraining sheath 4 that extends within introducer member 13), said second portion having an outer profile that is smaller than an outer profile of said first portion (Fig. 1, portion of restraining sheath 4 within introducer member 13 has a smaller outer profile), and the proximal end of said restraining sheath terminating distally from said deployment handle (Fig. 1, restraining sheath 4 terminates at distal end of device (i.e., top of figure)); at least one wire (Fig. 1, polymer thread portion 11) extending proximally from said restraining sheath to said deployment handle (Fig. 1, pull member 5 which encompasses polymer thread portion 11 extends proximally to handle (not shown) [0008]); and a covering sheath (Fig. 1, introducer member 13) extending from said restraining sheath (Fig. 1, restraining sheath 4) to said deployment handle (Fig. 1, introducer member 13 extends proximally to handle (not shown)) and fixed to said deployment handle, said covering sheath extending over and disposed radially outward from an outer surface of at least said proximal end of said restraining sheath (Fig. 1, introducer member 13 surrounds restraining sheath 4), a distal end of said covering sheath (Fig. 1, portion of introducer member 13 that is in contact with restraining sheath 4) provided with an inner diameter that closely fits onto an outer diameter of said proximal end of said restraining sheath (Fig. 1, introducer member 13 fits closely to restraining sheath 4), and the distal end of said covering sheath including an atraumatic tapered end (Fig. 1, portion of restraining sheath 4 at distal end of introducer member 13 is tapered) that provides a smooth transition between said restraining sheath and said covering sheath (Fig. 1, transition between restraining sheath 4 and introducer member 13 is smooth); wherein said medical device (Fig. 1, stent device 2) is deployed by pulling said at least one wire proximally to withdraw said restraining sheath proximally away from said medical device (Fig. 2, stent device 2 is deployed by pulling on the pulling member 5 which comprises polymer thread portion 11 [0055]), and wherein a longitudinal space inside said covering sheath (Fig. 1, distal end of introducer member 13) is formed to receive said restraining sheath withdrawn proximally, away (Fig. 1, introducer sheath 13 envelopes restraining sheath 4) from said medical device (Fig. 2, restraining sheath 4 is pulled back by pulling member 5), but fails to teach said moveable restraining sheath withdrawn proximally, into the longitudinal space, and that the wire is adhered to the second portion of said restraining sheath.
Dorn B2 teaches a catheter device comprising a moveable restraining sheath (Fig. 15, first telescope tube 402) withdrawn proximally, into the longitudinal space (Fig. 15, first telescope tube 402 is received within second telescope tube 404 proximal of the first (col. 14, lines 64-65)). Dorn B2 discloses that the telescoping tubes rotate freely relative to the remaining parts of the catheter system while it is advanced within the body (col. 15, lines 5-9)). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the delivery system taught by Dorn with the sheaths and longitudinal space taught by Dorn B2 in order to allow for increased mobility of the device in vivo. However, Dorn in view of Dorn B2 fails to teach that the wire is adhered to the second portion of said restraining sheath.
Beyerlein teaches a delivery system for a stent having a wire that is adhered to the second portion of said restraining sheath (Fig. 1, pullback wire (not shown) is attached to the sheath 108 [0007]), wherein said restraining sheath is configured to be withdrawn without splitting (Figs. 1-2, pullback wire is pulled to independently withdraw the retractable sheath 108 to deploy stent 102 (i.e., without splitting the sheath)). Beyerlein discloses that the pullback wire is attached to the sheath such that the wire can independently withdraw the sheath in order to deploy the stent [0007]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the pullback wire taught by Beyerlein with the second end of the restraining sheath taught by Dorn in order to simplify the release of the stent from the delivery device.
Regarding claim 18, Dorn teaches wherein said covering sheath (Fig. 1, introducer member 13) comprises a first portion (Fig. 1, portion of introducer member 13 in contact with restraining sheath 4) and a second portion (Fig. 1, portion of introducer member 13 proximal to restraining sheath 4) extending proximally of said first portion.
However, Dorn in view of Beyerlein fails to teach that the second portion of the covering sheath has an outer profile that is smaller than an outer profile of the first portion of the covering sheath. Dorn B2 teaches a catheter device comprising a second portion of the covering sheath (Fig. 4, proximal end 67) has an outer profile that is smaller than an outer profile (Fig. 4, proximal end 67 is narrower than the distal end of tip catheter 60) of the first portion of the covering sheath (distal end of tip catheter 60 (bottom of image)).
Dorn B2 discloses that these catheters are contiguous and smooth for the progress of the guidewire, and that the outer catheter has a larger diameter than the inner catheter because it helps to ease the end orifice of the sheath open when it begins to withdraw (col. 10, par. 7). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a portion of the covering sheath with a smaller outer profile than the first portion so as to create a smooth and consistent transition for the guidewire and for ease when pulling back retracting sheaths during delivery of the implant.
Regarding claim 19, Dorn teaches a deployment handle (handle (not shown)). However, Dorn in view of Beyerlein fails to teach that the handle includes a flushing port in fluid communication with an annular space between said covering sheath and said inner catheter and between said restraining sheath and said inner catheter.
Dorn B2 teaches a catheter device comprising a handle that includes a flushing port (Fig.5, port 222 (column 12, line 20)) in fluid communication with an annular space between said covering sheath and said inner catheter (Fig. 8, telescope tube 240 is outside flushing sleeve (column 13, lines 50-51)) and between said restraining sheath and said inner catheter (Fig. 5, flushing sleeve 228 (column 12, line 26)).
Dorn B2 discloses that communication with the guidewire lumen and flushing sleeve lumen is the flushing port 222 with a lock connector portion, and that the port is used to flush the system of air bubbles (col. 12, par. 4). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a flushing port into Dorn’s delivery device in order to avoid air pockets that could impact delivery accuracy and health of the patient.
Regarding claim 20, Dorn teaches wherein said medical device (Fig. 1, stent device 2) is deployed by said deployment handle (handle (not shown)) thereby pulling said at least one wire proximally to withdraw said restraining sheath proximally away from said medical device (Fig. 2, restraining sheath 4 is pulled back by pulling member 5). However, Dorn in view of Beyerlein does not explicitly state that the deployment occurs by the handle winding up the wire.
Dorn B2 teaches a catheter device comprising a handle (Fig. 14, hand unit 214) wherein a medical device is deployed by said handle winding up the wire (Fig. 14, drum 300 within hand unit 214 winds up the pulling line 298). Dorn B2 discloses that the drum and a pawl stop any reverse movement of the toothed wheel and drum within the hand unit during return movement of the hand unit (col. 14, par. 2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to wind up the wire of a stent delivery device so as to avoid any unwanted movement of the device, wire, or implant itself and allow for a smoother implantation process.
Regarding claim 21, Dorn fails to teach the limitations of claim 21. However, Dorn B2 teaches a catheter device wherein the restraining sheath is configured to be withdrawn without splitting (Fig. 15, first telescope tube 402 is received within second telescope tube 404 without splitting). Dorn B2 discloses that the telescoping tubes rotate freely relative to the remaining parts of the catheter system while it is advanced within the body (col. 15, lines 5-9)). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the delivery system taught by Dorn with the sheaths and longitudinal space taught by Dorn B2 in order to allow for increased mobility of the device in vivo.
Claims 10-11, 14-15, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Dorn et al. (US 2011/0301689 A1), “Dorn” in view of Beyerlein et al. (US 2006/0282152 A1), “Beyerlein” and further in view of Tollner et al. (2010/0145309 A1), “Tollner”.
Regarding claim 10, Dorn teaches a self-expanding medical device delivery system, comprising: a self-expanding medical device (Fig. 1, stent device 2) comprising a distal end (Fig. 1, portion of stent device 2 closest to distal tip member 15), a proximal end (Fig. 1, portion of stent device 2 closest to push member 10) and a length therebetween (Fig. 1, portion of stent device 2 between distal tip member 15 and push member 10), an inner catheter (Fig. 1, inner member 3) extending proximally from said medical device (Fig. 1, stent device 2) to a deployment handle (handle (not shown)), said inner catheter comprising a stop surface (Fig. 1, push member) adjacent said proximal end of said medical device (Fig. 1, push member 10 is next to proximal end of stent device 2) and adapted to prevent said medical device from moving proximally during deployment of said medical device (Fig. 1, push member 10 holds axial position of the stent device 2 [0042]); a restraining sheath (Fig. 1, restraining sheath 4) comprising a first portion extending over said medical device (Fig. 1, portion of restraining sheath 4 enveloping stent device 2) and adapted to prevent said medical device from self-expanding prior to deployment of said medical device (Fig. 1, restraining sheath 4 serves to maintain the stent device 2 [0042]) and a second portion extending proximally of said medical device (Fig. 1, portion of restraining sheath 4 that extends past pusher member 10) to a proximal end of said restraining sheath (Fig. 1, portion of restraining sheath 4 that extends within introducer member 13), said second portion having an outer profile that is smaller than an outer profile of said first portion (Fig. 1, portion of restraining sheath 4 within introducer member 13 has a smaller outer profile), and the proximal end of said restraining sheath terminating distally from said deployment handle (Fig. 1, restraining sheath 4 terminates at distal end of device (i.e., top of figure)); and at least one wire (Fig. 1, polymer thread portion 11) extending proximally from said restraining sheath to said deployment handle (Fig. 1, pull member 5 which encompasses polymer thread portion 11 extends proximally to handle (not shown) [0008]); wherein said medical device (Fig. 1, stent device 2) is deployed by pulling said at least one wire proximally (Fig. 2, stent device 2 is deployed by pulling on the pulling member 5 which comprises polymer thread portion 11 [0055]) to withdraw said restraining sheath proximally away from said medical device (Fig. 2, stent device 2 deployment occurs with withdrawal of restraining sheath 4 [0055]); and wherein said restraining sheath (Fig. 1, restraining sheath 4) comprises a thermoplastic polymer (Fig. 1, restraining sheath 4 is comprised of PET [0031]), but fails to teach that the wire is adhered to the second portion of said restraining sheath, and that a coil is embedded within the thermoplastic polymer and extends along at least a portion of said length of said medical device.
Beyerlein teaches a delivery system for a stent having a wire that is adhered to the second portion of said restraining sheath (Fig. 1, pullback wire (not shown) is attached to the sheath 108 [0007]). Beyerlein discloses that the pullback wire is attached to the sheath such that the wire can independently withdraw the sheath in order to deploy the stent [0007]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the pullback wire taught by Beyerlein with the second end of the restraining sheath taught by Dorn in order to simplify the release of the stent from the delivery device. However, Dorn in view of Beyerlein fails to teach a coil that is embedded within the thermoplastic polymer and extends along at least a portion of said length of said medical device.
Tollner teaches a retractable catheter comprising a coil (Fig. 1, reinforcing structure 20 comprises wound coils or similar arrangements of connected wires [0031]) that is embedded within the thermoplastic polymer (Fig. 1, outer sheath 16 comprises flexible material 19 which has reinforcing structure embedded within [0031]) and extends along at least a portion of said length of said medical device (Fig. 1, outer sheath 16 extends the whole length of the delivery system [0028]). Tollner discloses that the reinforcing structure provides the outer sheath with better strength and resistance to necking when pulled longitudinally [0031]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the thermoplastic polymer sheath taught by Dorn with the embedded coil taught by Tollner in order to avoid kinks and necking of the device during delivery.
Regarding claim 11, Dorn teaches further comprising a low friction liner (Fig. 1, protective strip 16) disposed along an inner surface of said restraining sheath and extending along said length of said medical device and contacting an outer surface of said medical device (Fig. 1, protective strip is between stent device 2 and restraining sheath 4).
Regarding claim 14, Dorn teaches wherein said restraining sheath (Fig. 1, restraining sheath 4) further comprises a tapered portion (Fig. 1, restraining sheath 4) further comprises a tapered portion (Fig. 1, portion of restraining sheath 4 at distal end of introducer member 13 is tapered) between said first portion (Fig. 1, portion of restraining sheath 4 enveloping stent device 2) and said second portion (Fig. 1, portion of restraining sheath 4 that extends past pusher member 10).
Regarding claim 22, Dorn fails to teach the limitations of claim 22. However, Dorn B2 teaches a catheter device wherein the restraining sheath is configured to be withdrawn proximally without changing its configuration (Fig. 15, first telescope tube 402 is received within second telescope tube 404 with no change in shape or collapsing (col. 15, lines 16-18)). Dorn B2 discloses that the telescoping tubes rotate freely relative to the remaining parts of the catheter system while it is advanced within the body (col. 15, lines 5-9)). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the delivery system taught by Dorn with the sheaths and longitudinal space taught by Dorn B2 in order to allow for increased mobility of the device in vivo.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Dorn et al. (US 2011/0301689 A1), “Dorn” in view of Beyerlein et al. (US 2006/0282152 A1), “Beyerlein” and Tollner et al. (2010/0145309 A1), “Tollner” and further in view of Dorn et al. (US Pat. No. 8323326 B2), “Dorn B2”.
Regarding claim 12, Dorn teaches a stop surface (Fig. 1, push member 10), but Dorn in view of Beyerlein and Tollner fails to teach that the stop surface is a metal or polymer ring bonded to said inner catheter.
Dorn B2 teaches a catheter device comprising a stop surface (Fig. 6, pusher ring 260) that is a metal or polymer ring (Fig. 6, pusher ring 260 is stainless steel (column 13, line 4)) bonded to said inner catheter (Fig. 6, pusher ring 260 is engaged with pusher guider tube 254).
Dorn B2 discloses that axial movements of the housing relative to the bodily lumen in which the delivery system lies will be transmitted from the housing to the pusher ring (col. 14, par. 1). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to manufacture the stop surface to be made of a material like stainless steel so that it is able to withstand the forces of the implantation and delivery process of the stent so as to not damage the stent.
Regarding claim 13, Dorn teaches wherein said medical device (Fig. 1, stent device 2) is deployed by said deployment handle (handle (not shown)) thereby pulling said at least one wire proximally to withdraw said restraining sheath proximally away from said medical device (Fig. 2, restraining sheath 4 is pulled back by pulling member 5). However, Dorn in view of Beyerlein and Tollner does not explicitly teach that the deployment occurs by the handle winding up the wire.
Dorn B2 teaches a catheter device comprising a handle (Fig. 14, hand unit 214) wherein a medical device is deployed by said handle winding up the wire (Fig. 14, drum 300 within hand unit 214 winds up the pulling line 298). Dorn B2 discloses that the drum and a pawl stop any reverse movement of the toothed wheel and drum within the hand unit during return movement of the hand unit (col. 14, par. 2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to wind up the wire of a stent delivery device so as to avoid any unwanted movement of the device, wire, or implant itself and allow for a smoother implantation process.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Dorn et al. (US 2011/0301689 A1), “Dorn” in view of Dorn et al. (US Pat. No. 8323326 B2), “Dorn B2”, and Beyerlein et al. (US 2006/0282152 A1), “Beyerlein”, and further in view of Tollner et al. (2010/0145309 A1), “Tollner”.
Regarding claim 17, Dorn teaches wherein said covering sheath (Fig. 1, introducer member 13) comprises a thermoplastic polymer (Fig. 1, restraining sheath 4 is comprised of PET [0031]), and a coil (Fig. 2, wrap around portion 9 folds during deployment (i.e., creates a coil shape)) is embedded within the thermoplastic polymer (Fig. 2, wrap around portion 9 is within restraining sheath 4), but fails to teach a coil is embedded within the thermoplastic polymer.
Tollner teaches a retractable catheter comprising a coil (Fig. 1, reinforcing structure 20 comprises wound coils or similar arrangements of connected wires [0031]) that is embedded within the thermoplastic polymer (Fig. 1, outer sheath 16 comprises flexible material 19 which has reinforcing structure embedded within [0031]). Tollner discloses that the reinforcing structure provides the outer sheath with better strength and resistance to necking when pulled longitudinally [0031]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the covering sheath taught by Dorn with the embedded coil taught by Tollner in order to avoid kinks and necking of the device during delivery.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/G.G.R./ Examiner, Art Unit 3774
/THOMAS C BARRETT/ SPE, Art Unit 3799
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