DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 23rd 2025 has been entered.
Claim Objections
Claim 21 is objected to because of the following informalities:
Regarding claim 21, “a wire” should be corrected to “the wire” for claim language consistency. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 16-19 and 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Norris (US 20130245742 A1).
Regarding claim 16, Norris discloses a medical device (catheter assembly 500, [0084] & Fig. 5A-5D), comprising: a tube (catheter shaft 502, [0087] & Fig. 5A-5D);
an expandable device at a distal portion of the tube, the expandable device having a collapsed state and an expanded state (expandable balloon to expand the implant, [0006] and [0053]; the balloon necessarily positioned under implant 506, which is positioned at a distal end of catheter 502, to facilitate implant expansion, [0084] & Fig. 5A);
a connector comprising a folded sheet forming a first portion and a second portion (graft member 707 is being interpreted as a connector, as it is the connecting structure between stent 705 and catheter 502/the balloon, [0067]-[0069] & Fig. 7A-7H; the bottom half of graft 707 is being interpreted as the first portion and the top half of graft 707 is being interpreted as the second portion; graft member 707 may be interpreted as a flat piece of material, wrapped around shaft 502, or a folded sheet), wherein the first portion of the folded sheet is attached to the expandable device (the bottom half of graft 707 disposed on top of, and necessarily in contact with, the balloon to facilitate expansion, [0006] and [0053] & Fig. 7A-7C and 5A-5D); a patch surrounding at least a portion of an outer surface of the expandable device (stent 705 necessarily surrounding at least a portion of the balloon, Fig. 2A-2B, 5A-5D, and 7A-7C), the patch being removably attached to the expandable device via the connector (stent 705 may be interpreted as removably attached to the balloon via graft 707 as graft 707 would necessarily have to be removed from the balloon in order for stent 705 to also be removed from the balloon),
wherein the connector is completely underneath the patch (graft 707 seen disposed completely underneath stent 705, Fig. 7A-7H); and a wire, wherein a portion of the wire is sutured through the patch and the second portion of the folded sheet (steering line 720 threaded through stent 705 and the top half of graft 707, [0067]-[0069] & Fig. 7C; line 720 also described as being “woven through”, [0068]).
Regarding claim 17, Norris discloses all the limitations of claim 16. Norris further discloses the medical device wherein the wire extends proximally along a length of the tube, and a proximal portion of the wire is coupled to an actuator (steering line 720/520/220 passing proximally through catheter shaft 502/202 to the outside of the patient, [0064], [0087] & Fig. 2A-2B and 5A-5D; steering line 720/520 “can be connected to one or more dials or other mechanisms for applying the tension at the trailing end of catheter shaft 502. In this configuration, the dial can be used to apply a desired tension, as well as maintain the correct amount of tension once a desired angle of bending of expandable implant 506 has been achieved.”, [0087] and see [0049]).
Regarding claim 18, Norris discloses all the limitations of claim 17. Norris further discloses the medical device wherein the actuator comprises a knob configured to pull the wire proximally (the dial is being interpreted as a knob, [0087], [0093], and [0049]; the dial is configured to apply tension to, or pull on, the steering line 720/220/520 from outside the body, [0064] and [0087] & Fig. 5A-5D; “tension can be applied to steering lines 520 by pulling the lines from the outside of the body of the patient”), thereby removing the wire from the patch and the second portion of the folded sheet (“steering lines 520 can be released from coupling with catheter shaft 502 and can be removed from expandable implant 506 and catheter assembly 500. As illustrated in FIG. 5D, after primary and secondary coupling members 524 and 534, steering lines 520, and lock wire 580 are removed from catheter assembly 500, catheter assembly 500 is fully disengaged from expandable implant 506, and can be removed from the vasculature of the patient.”, [0093]-[0094] & Fig. 5C-5D; “steering line 220 passes from the outside of the body of a patient, through catheter shaft 202, and is releasably coupled to expandable implant 206.”, [0064] & Fig. 2A-2B).
Regarding claim 19, Norris discloses all the limitations of claim 17. Norris further discloses the medical device wherein the actuator is positioned on a proximal portion of the tube (the one or more dials positioned outside the body of the patient, which renders the dials on a proximal portion of catheter shaft 502, [0087] and [0049] & Fig. 5A-5D).
Regarding claims 22-23, Norris discloses all the limitations of claim 16. Norris further discloses the medical device wherein the second portion of the folded sheet comprises a plurality of openings configured to receive the wire (the top half of graft 707 necessarily including openings for reception of steering line 720 as it is threaded, or woven, though, [0067]-[0069] & Fig. 7C; the openings being the puncture sites of line 720 as it is threaded through), wherein the plurality of openings is linearly arranged along a length of the second portion of the folded sheet (steering line 720 seen threaded linearly along the top half of graft 707, see Fig. 7C and 2B; the puncture sites of line 720 as it is threaded through graft 707 are linearly arranged along the top half of graft 707, following the linear threading of line 720).
Claim Rejections - 35 USC § 103
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 1-5, 9-11, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Nishio (US 20150328027 A1) in view of Andreas (US 20070276461 A1), and further in view of Lee (US 6183481 B1).
Regarding claims 1, 9, and 11, Nishio discloses a medical device (apparatus for treating urethral stricture, [0041]), comprising: a first tube (the first tube is being interpreted as elongated member 10, which is an indwelling catheter, [0043] & Fig. 1 and 24b) an expandable device at a distal portion of the first tube (delivery member/expandable member 200, [0044] and [0062] & Fig. 1, 18a, and 24b), the expandable device having a collapsed state and an expanded state (the expandable member 200 has an adjustable outer circumference, [0062], [0069] & Fig. 20a and 20b); a patch surrounding at least a portion of an outer surface of the expandable device (treatment membrane 30, [0068] & Fig. 18a-18b); and a connector for holding the patch to the expandable device (attachment parts 310 designed to attach membrane 30 to expandable member 200, [0068] & Fig. 18a-18b) and for releasing the patch from the expandable device (“The delivery member can also include attachment parts to assist in attaching and detaching the treatment membrane to and from the delivery device”, [0068]; the attachment parts configured to assist in attaching and detaching the membrane 30 from the delivery device, [0068] and [0071] & Fig. 18a-18b and 20a-20b), wherein the connector is disposed between the patch and the expandable device (parts 310 seen disposed between membrane 30 and member 200, see Figs. 18a-18b; attachment parts 310 may also be provided across the treatment membrane 30 in the embodiment illustrated in Figure 23e, [0072]), and
a wire (“opposite edges of the treatment membrane 30 are sutured directly to the attachment parts 310”, [0068] and [0071] & Fig. 18b; the wire inherently needed for suturing membrane 30 to parts 310 is being interpreted as the wire), the wire is sutured linearly through the patch and the connector, along a longitudinal length of the connector (“opposite edges of the treatment membrane 30 are sutured directly to the attachment parts 310”, [0068] and [0071]; the wire is sutured linearly through the attachment parts 310 along a length that is being interpreted as a longitudinal length, see Fig. 18b).
However, Nishio fails to explicitly disclose a second tube configured to sheath at least a portion of the first tube and configured to translate along a length of the first tube, and the connector for holding the patch to the expandable device when the second tube covers the patch and the expandable device, and for releasing the patch from the expandable device after the second tube uncovers the patch and the expandable device, wherein a distal end of the wire is coupled to the distal portion of the first tube, and the wire extends proximally through a lumen of the second tube, outside of the first tube, and to an actuator, and
wherein a proximal end of the wire is coupled to the actuator, and wherein the actuator is configured to pull the wire translates proximally, thereby removing the wire from the patch and the connector.
However, Andreas teaches a medical device (stent delivery catheter 20, [0092] & Fig. 1) comprising a second tube (outer sheath 25, Fig. 2) configured to sheath at least a portion of the first tube and configured to translate along a length of the first tube (outer sheath 25 is slidably disposed over an inner shaft 27, [0092], [0095] & Fig. 1-3). The outer sheath 25 is capable of allowing a connector to hold a drug coated stent 32 made of biocompatible/bioabsorbable materials, similar to membrane 30 of Nishio, to an inflated member 24 when sheath 25 covers the stent 32 and inflatable member 24 ([0097], [0109]-[0110], and [0119] & Fig. 2A and 5A) and allowing the release of the stent 32 from the inflatable member 24 after the sheath 25 uncovers the stent 32 and inflatable member 24 ([0098], [0117], [0121]-[0122] & Fig. 2B and 5B-5E).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Nishio with Andreas to include the second tube since such a modification would cover and protect the expandable device and patch before use and prevent undesired expansion of the expandable device until the sheath is retracted (see [0030] of Andreas). As combined, the outer sheath 25 of Andreas can be included with the delivery device of Nishio.
Further, Lee teaches the medical device (introducer 100, abstract and Col 6 lines 5-15 & Fig. 1-6) wherein a distal end of the wire is coupled to the distal portion of the first tube (the distal end of release wire 112 coupled to lead element 106, Col 6 lines 5-15 and Col 7 lines 35-50 & Fig. 6), and the wire extends proximally through a lumen of the second tube, outside of the first tube, and to an actuator (release wire 112 extending proximally through entry sheath 308, outside of catheter 104, and to a tab or pull ring 310, Col 6 lines 52-63 & Fig. 1-4),
wherein a proximal end of the wire is coupled to the actuator, and wherein the actuator is configured to pull the wire translates proximally, thereby removing the wire from the patch and the connector (“Release element 112 extends outward from entry sheath 308, and is suitably terminated at its proximal end with a tab or pull ring 310… Referring to FIG. 3B, once prosthesis 102 is in position, release element 112 is pulled in the proximal direction and extracted, releasing sheath 110 so that prosthesis 102 expands”, Col 6 lines 50-67 & Fig. 1-6; proximal end of release wire 112 is coupled to pull ring 310, which is configured to pull release wire 112 and remove it from sheath 110 and cover 118, Col 6 last paragraph-Col 7 second paragraph & Fig. 6; “release element 112, maintaining prosthesis 102 in a compressed state.”, Col 6 third paragraph & Fig. 3A-3B).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Nishio, as modified, with Lee to include a distal end of the wire coupled to the distal portion of the first tube and the wire extending proximally through a lumen of the second tube, wherein a proximal end of the wire is coupled to the actuator, and wherein the actuator is configured to pull the wire translates proximally, thereby removing the wire from the patch and the connector, since such a modification would provide structure to maintain the patch in a compressed state and facilitate controlled deployment of the patch and yield predictable results pertaining to patch release from a medical device (Col 6 lines 14-30 and Col 6 last paragraph-Col 7 second paragraph of Lee).
As modified, the wire suturing membrane 30 to attachment parts 310 would extend proximally along the outside of elongated member 10, like wire 112 along catheter 104 of Lee, and be coupled to an actuator, like pull ring 310 of Lee, to allow for removal of the wire to facilitate controlled separation of membrane 30 from member 200 of Nishio. At least a portion of the distal end of the wire would be coupled to a distal portion of elongated member 10, like the distal end of wire 112 of Lee on element 106 of catheter 104 of Lee. As combined, the wire would run through outer sheath 25 of Andreas.
With regard to 2, operation member 50, which is disclosed as a tube (see [0045]), is being interpreted as part of elongated member 10, or part of the first tube. Member 200 is disposed at a distal portion of operation member 50 (see Fig. 1 and Fig. 24b) and the outer sheath of 25 of Andreas would still be configured to sheath at least a portion of operation member 50.
In this configuration, Nishio, as modified, discloses all the limitations of claim 1. Nishio further discloses the medical device wherein the first tube includes a lumen in fluid communication with the expandable device to supply a fluid to the expandable device (operation member 50 can be a tube for inflating the expandable member 200, see [0045]).
Regarding claim 3, Nishio, as modified, discloses all the limitations of claim 1. Nishio further discloses the medical device wherein the connector extends longitudinally along a portion of the expandable device (attachment parts 310 extend longitudinally along a portion of expandable member 200, Fig. 18a).
Regarding claim 4, Nishio, as modified, discloses all the limitations of claim 1. Nishio further discloses the medical device wherein the connector comprises a folded sheet (attachment parts 310 are being interpreted as folded sheets, [0068]; Figs. 18a-18b illustrate how parts 310 would fold over the membrane 30) forming a first half and a second half of the folded sheet, wherein the first half of the folded sheet is attached to the expandable device, and the second half of the folded sheet is attached to the patch (the portion of parts 310, directly connected to member 200, enclosed by membrane 30 is being interpreted as the first half and the remaining portion of parts 310, encircled around the outer surface of membrane 30, is being interpreted as the second half, see Figs. 18a-18b and 20).
Regarding claim 5, Nishio, as modified, discloses all the limitations of claim 4. Nishio further discloses the medical device wherein the second half of the folded sheet includes a first surface adjacent to the first half of the folded sheet and a second surface adjacent to the patch, wherein the second surface is attached to the patch (the bottom side of the second half of parts 310 is being interpreted as the first surface and the top side of the second half of parts 310 is being interpreted as the second surface which is adjacent to the membrane 30, see [0068] & Figs. 18a-18b).
Regarding clam 10, Nishio, as modified, discloses all the limitations of claim 8. Nishio further discloses the medical device wherein the connector includes a plurality of openings configured to receive the sutured wire (attachment parts 310 would inherently comprise openings configured to receive the wire; the openings being the puncture sites on parts 310 formed by the wire as it is sutured through, see Fig. 18a-18b).
Regarding claim 21, Nishio, as modified, discloses all the limitations of claim 4. Nishio further discloses the medical device further comprising a wire, wherein a portion of the wire is sutured through the patch and the second half of the folded sheet (“opposite edges of the treatment membrane 30 are sutured directly to the attachment parts 310”, [0068] and [0071] & Fig. 18b; the wire inherently needed for suturing membrane 30 to parts 310 is being interpreted as the wire; the second portion of parts 310 would receive the suture along with membrane 30).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Nishio (US 20150328027 A1), in view of Andreas (US 20070276461 A1), in view of Lee (US 6183481 B1), and in further view of Sisken (US 20070021820 A1).
Regarding clam 12, Nishio, as modified, discloses all the limitations of claim 11. However, Nishio fails to explicitly disclose the medical device wherein the distal end of the wire is removably secured to the distal portion of the first tube via a heat shrink or a crimp.
However, Sisken teaches a medical device (abstract) wherein the distal end of the wire is removably secured to the distal portion of the first tube via a crimp (the surfaces 68 and 70 in lumen 64, which hold the distal end 62 of wire 40, are being interpreted as crimping onto the wire 40 to removably secure it to the distal end 14 of catheter 10, see [0064] & Figs. 2 and 4).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Nishio, as modified, with Sisken to include the distal end of the wire removably secured to the distal portion of the first tube via a crimp since such a modification would provide structure to securely attach the distal end of the wire to the first tube and yield predictable results pertaining to wire securement and withdrawal (see [0060] and [0064] of Sisken).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Nishio (US 20150328027 A1), in view of Andreas (US 20070276461 A1), in view of Lee (US 6183481 B1), and in further view of Smith (US 20200038005 A1).
Regarding claim 15, Nishio, as modified, discloses all the limitations of claim 1. Nishio discloses the treatment membrane 30 as any biocompatible sheet, see [0042]. However, Nishio fails to explicitly disclose the medical device wherein the patch comprises chitosan and/or a chitosan modified material. However, Smith teaches the medical device wherein the patch comprises chitosan and/or a chitosan modified material (the patch 860 may be made of chitosan, [0008], [0028], [0036], & Fig. 5D).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Nishio, as modified, with Smith to include the patch comprising chitosan since such a modification would give the sheet antimicrobial and naturally bio-adhesive properties to aid in the adhesion of the patch to the internal wall of a vessel (see [0028] of Smith).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Tischler (US 20100010619 A1), in view of Dutta (US 6506202 B1).
Regarding claim 24, Tischler discloses a medical device (catheter assembly 40, [0046] & Fig. 14), comprising: a tube (catheter 40 extending proximally including stent receiving region 42, [0046] & Fig. 14); an expandable device at a distal portion of the tube (“the first stent body 12 of the stent 10 is deployed when the tether 44 is disengaged from the stent 10 and the second stent body 14 is deployed by a balloon as is known in the art. In one embodiment, the balloon forms the stent receiving region 42 of the catheter 40.”, [0047] & Fig. 14); a patch surrounding at least a portion of an outer surface of the expandable device (first stent 12, which is being interpreted as a patch, surrounding the balloon forming the stent receiving portion 42, [0046]-[0047] & Fig. 14);
a folded sheet disposed between the expandable device and the patch, wherein the folded sheet is completely underneath the patch (second stent 14 may be interpreted as a flat piece of material, wrapped around portion 42, or a folded sheet; “the second stent body 14 may be created by methods including cutting or etching a design from… a flat sheet which is cut or etched and which is subsequently rolled to form a tubular stent…”, [0045]; second stent 14 is disposed between stent 12 and portion 42 and is completely underneath stent 12, [0037] & see Fig. 2-5 and 14); and
a wire extending from a proximal end to a distal end and coupled to the distal portion of the tube (“The catheter assembly 40 further comprises a tether 44 that extends from the distal end region to the proximal end region of the catheter assembly”, [0046] & Fig. 14-17; tether 44 is a wire, [0046]; tether 44 seen connected to the distal portion of catheter 40, see Fig. 14-17); wherein the expandable device is coupled to a first portion of the folded sheet (portion 42 is connected to the bottom half of stent 14, which is being interpreted as a first portion of stent 14, [0046] & see Fig. 14; “The second stent 14 of the stent 10 is disposed about the stent receiving region 42”); and
wherein the patch is coupled to a second portion of the folded sheet via a portion of the wire sutured through the patch and the second portion of the folded sheet (stent 12 is connected to the top half of stent 14, which is being interpreted as a second portion of stent 14, via tether 44 which extends through stents 12 and 14, [0046]-[0047] & Fig. 14; “…the first stent 12 of the stent 10 is disposed about the second stent 14… the tether 44 extends through the stent bodies 12 and/or 14 of the stent 10, thereby maintaining the stent 10 in position on the stent receiving region 42. In some embodiments, the tether 44 extends through the overlap region 28 of the stent 10.”, [0046]; “the first stent body 12 of the stent 10 is deployed when the tether 44 is disengaged from the stent 10 and the second stent body 14 is deployed by a balloon as is known in the art.”, [0047]; stent 12 is deployed only after tether 44 is removed from stent 12 and stent 14).
However, Tischler fails to explicitly disclose the medical device wherein the expandable device is coupled to a first portion of the folded sheet via an adhesive.
However, Dutta teaches a medical device (system 10 including catheter 16 configured to implant a balloon expandable stent 30 using balloon 32, abstract and Col 5 second paragraph-end & Fig. 5-6) wherein the expandable device is coupled to a first portion of the folded sheet via an adhesive (balloon 32 is coupled to the bottom half of expandable stent 30 via adhesive coating 44; “the expandable balloon 32 may be comprised of a layer 40 including an outer surface 42 and a coating 44. The layer 40 may be comprised of a material which has a substantially low axial growth and which is adapted to substantially retain the unexpanded axial dimension of the expandable stent 30 upon expansion of the expandable member 32 and the expandable stent 30”, Col 6 third paragraph and Col 8 lines 30-42 & Fig. 5-6).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the expandable device of Tischler with Dutta to include an adhesive coating since such a modification would provide structure to increase the friction between the folded sheet and the expandable device to help maintain the folded sheet in place while continuing to allow for release of the folded sheet upon expansion of the expandable device and yield predictable results pertaining to stent and balloon connection (Col 6 lines 36-54 and Col 7 lines 45-60 of Dutta). As modified, adhesive coating 44 would be provided on balloon portion 42 of Tischler, in contact with the bottom half of stent 14 of Tischler.
Claims 1 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Tischler (US 20100010619 A1), in view of Andreas (US 20070276461 A1), and further in view of Sisken (US 20070021820 A1).
Regarding claims 1 and 25, Tischler discloses a medical device (catheter assembly 40, [0046] & Fig. 14), comprising: a first tube (catheter 40 extending proximally including stent receiving region 42, [0046] & Fig. 14);
an expandable device at a distal portion of the first tube, the expandable device having a collapsed state and an expanded state (“the first stent body 12 of the stent 10 is deployed when the tether 44 is disengaged from the stent 10 and the second stent body 14 is deployed by a balloon as is known in the art. In one embodiment, the balloon forms the stent receiving region 42 of the catheter 40.”, [0047] & Fig. 14; the balloon having an expanded and collapsed state to facilitate stent deployment, see Fig. 16-17); a patch surrounding at least a portion of an outer surface of the expandable device (first stent 12, which is being interpreted as a patch, surrounding the balloon forming the stent receiving portion 42, [0046]-[0047] & Fig. 14);
a connector for holding the patch to the expandable device and for releasing the patch from the expandable device (second stent 14, which is being interpreted as a connector, is part of the retention mechanism for stent 12, [0046]-[0047] & Fig. 14-17; “…the first stent 12 of the stent 10 is disposed about the second stent 14… the tether 44 extends through the stent bodies 12 and/or 14 of the stent 10, thereby maintaining the stent 10 in position on the stent receiving region 42. In some embodiments, the tether 44 extends through the overlap region 28 of the stent 10.”, [0046]; “the first stent body 12 of the stent 10 is deployed when the tether 44 is disengaged from the stent 10 and the second stent body 14 is deployed by a balloon as is known in the art.”, [0047]; stent 12 is deployed/released only after tether 44 is removed from stent 12 and stent 14), wherein the connector is disposed between the patch and the expandable device, wherein the connector is completely underneath the patch (second stent 14 is disposed between stent 12 and portion 42 and is completely underneath stent 12, [0037] and [0046] & see Fig. 2-5 and 14); and
a wire, wherein a distal end of the wire is coupled to the distal portion of the first tube (“The catheter assembly 40 further comprises a tether 44 that extends from the distal end region to the proximal end region of the catheter assembly”, [0046] & Fig. 14-17; tether 44 is a wire, [0046]; tether 44 seen connected to the distal portion of catheter 40, see Fig. 14-17), the wire is sutured through the patch and the connector, and the wire extends proximally outside of the first tube (“the tether 44 extends through the stent bodies 12 and/or 14 of the stent 10, thereby maintaining the stent 10 in position on the stent receiving region 42. In some embodiments, the tether 44 extends through the overlap region 28 of the stent 10.”, [0046]; tether 44 extends through stents 12 and 14 and is seen threaded, or sutured, through stents 12 and 14, see Fig. 14; tether 44 “extends from the distal end region to the proximal end region of the catheter assembly 50”, [0046]; tether 44 seen extending proximally outside of catheter 40 and is configured to be pulled proximally, [0047] & Fig. 14).
However, Tischler fails to explicitly disclose the medical device comprising a second tube configured to sheath at least a portion of the first tube and configured to translate along a length of the first tube;
a connector for holding the patch to the expandable device when the second tube covers the patch and the expandable device and for releasing the patch from the expandable device after the second tube uncovers the patch and the expandable device, and the wire extends proximally through a lumen of the second tube and to an actuator.
However, Andreas teaches a medical device (stent delivery catheter 20, [0092] & Fig. 1) comprising a second tube (outer sheath 25, Fig. 2) configured to sheath at least a portion of the first tube and configured to translate along a length of the first tube (outer sheath 25 is slidably disposed over an inner shaft 27, [0092], [0095] & Fig. 1-3). The outer sheath 25 is capable of allowing a connector to hold a stent 32, similar to stent 12 of Tischler, to an inflated member 24 when sheath 25 covers the stent 32 and inflatable member 24 ([0097], [0109]-[0110], and [0119] & Fig. 2A and 5A) and allowing the release of the stent 32 from the inflatable member 24 after the sheath 25 uncovers the stent 32 and inflatable member 24 ([0098], [0117], [0121]-[0122] & Fig. 2B and 5B-5E).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Tischler with Andreas to include the second tube since such a modification would cover and protect the expandable device and patch before use and prevent undesired expansion of the expandable device until the sheath is retracted (see [0030] of Andreas). As modified, the outer sheath 25 of Andreas can be included with the catheter assembly of Tischler. As combined, tether 44 would continue to extend along an outside of the catheter of Tischler (see Fig. 14 of Tischler) and further extend through a lumen of outer sheath 25 of Andreas.
Further, Sisken teaches a medical device (intraluminal catheter 10 configured to deploy a stent 24, [0056] & Fig. 1) wherein the wire extends proximally to an actuator (handle 54 provided at a proximal end 56 of retention wire 40, [0062] & Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the wire of Tischler, as modified, with Sisken to include the wire extending proximally to an actuator since such a modification would provide structure to allow a user/physician to actuate the wire to facilitate withdrawal of the wire ([0062] of Sisken).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. To further prosecution, the Examiner recommends amending limitations to the independent claims to further limit the structure of the folded sheet, such as the limitations of claims 4-5, 21, and 25 combined.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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