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 .
Response to Amendment
The amendment filed 7/24/2026 has been entered. Claims 1-5,9-12,15-19,21-24 and 26-27 are pending in the application.
Claim Objections
Claim 26 is objected to because of the following informalities:
Regarding claim, “a second half” should be corrected to “the second half” 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, 22-23, and 27 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 (the top half, or portion, of graft member 707, which is a flat piece of material, wrapped partially around shaft 502, or a folded sheet, 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 and see annotated Fig. 1M below; one half, or a first portion, of the top half of graft 707 is being interpreted as the first portion and the other half, or second portion, of the top half of graft 707 is being interpreted as the second portion; the Examiner notes that annotated Fig. 1M is an illustration of a cross sectional view of graft 707, similar to the cross sectional view of implant 306 in Fig. 3B of Norris), wherein the first portion of the folded sheet is attached to the expandable device (both portions of the top half of graft 707 are disposed on, and necessarily in contact with, the balloon to facilitate expansion, [0006] and [0053] & Fig. 7A-7C and 5A-5D), and wherein the folded sheet extends along only a portion of a circumference of the expandable device (the top half of graft 707 extends along only a portion of, the top half of, a circumference of the expandable balloon, [0053] and [0067] & Fig. 5A-5D and 7A); 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 folded sheet (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 folded sheet is completely underneath the patch (the top half of 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 second portion of the top half of graft 707, [0067]-[0069] & Fig. 7C; line 720 also described as being “woven through”, [0068]).
The Examiner notes that graft 707 does not necessarily have to be split in equal halves. Any top portion of graft member 707 may be interpreted as the folded sheet and, for example, a left quarter of a top portion of graft member 707 may be interpreted as a first portion and a remaining right three quarters of a top portion of graft member 707 may be interpreted as a second portion. Additionally, the interpretation of the portions of graft 707 may vary depending on the rotational position of graft 707, providing for different splitting arrangements.
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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; steering line 720 is removed from stent 705 and the second portion of the top half of graft 707, see annotated Fig. 1M above).
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 second portion of the top half of graft 707 necessarily including openings for reception of steering line 720 as it is threaded, or woven, through, [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).
Regarding claim 27, Norris discloses all the limitations of claim 16. Norris further discloses the medical device wherein the second portion is folded over the first portion (as seen in annotated Fig. 1M above, a half, or first portion, of the top half of graft 707 is folded over the other half, or second portion, of the top half of graft 707), such that a surface of the first portion faces a surface of the second portion (as seen in annotated Fig. 1M above, the two internal surfaces of the portions of the top half of graft 707 face each other).
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, 9-12, 21, and 26 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 claim 1, 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 (the top half of 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 completely underneath the patch and between the patch and the expandable device, and wherein the connector extends along only a portion of a circumference of the expandable device (the top half of 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; the top half of second stent 14 extends along only a portion of a circumference of potion 42, see Fig. 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).
Regarding claim 2, Tischler, as modified, discloses all the limitations of claim 1. Tischler discloses that “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).
However, Tischler fails to explicitly disclose 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
However, Sisken teaches a medical device wherein the first tube includes a lumen in fluid communication with the expandable device to supply a fluid to the expandable device (catheter 10 includes a lumen 26 in fluid communication with balloon 12 to supply pressurized fluid to balloon 12 to facilitate inflation, [0057] & Fig. 2). 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 catheter of Tischler, as modified, with Sisken to include a lumen in fluid communication with the expandable device to supply a fluid to the expandable device since such a modification would provide structure to inflate the expandable balloon and yield predictable results pertaining to balloon facilitated stent deployment ([0006]-[0007] and [0057] of Sisken).
Regarding claim 3, Tischler, as modified, discloses all the limitations of claim 1. Tischler further discloses the medical device wherein the connector extends longitudinally along a portion of the expandable device (the top half of second stent 14 seen extending longitudinally along a portion of portion 42, see Fig. 14 and [0046]).
Regarding claim 4, Tischler, as modified, discloses all the limitations of claim 1. Tischler further discloses the medical device wherein the connector comprises a folded sheet forming a first half and a second half of the folded sheet (the top half, or portion, of second stent 14 may be interpreted as a flat piece of material, wrapped partially around portion 42, or a folded sheet, [0046]-[0047] & Fig. 14-17; the top half, or portion, of second stent 14 forms a first half, one half of the top half of stent 14, and a second half, the other half of the top half of stent 14, as seen annotated in Fig. 3 below), wherein the first half of the folded sheet is attached to the expandable device (both halves of the top half of stent 14 are attached to portion 42, [0046]-[0047 & see annotated Fig. 3 below and Fig. 14), and the second half of the folded sheet is attached to the patch (the second half of the top half of stent 14 is attached to first stent 12, [0046]-[0047 & annotated Fig. 3 below and Fig. 14).
Regarding claim 5, Tischler, as modified, discloses all the limitations of claim 4. Tischler 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 (the second half of the top half of stent 14 includes a first surface next to, or adjacent, the first half of the top half of stent 14, see annotated Fig. 3 below) and a second surface adjacent to the patch, wherein the second surface is attached to the patch (the second half of the top half of stent 14 includes a second surface next to, or adjacent, first stent 12 and attached to first stent 12, [0046]-[0047 & see annotated Fig. 3 below and Fig. 14).
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Regarding claim 9, Tischler, as modified, discloses all the limitations of claim 1. Tischler further discloses the medical device wherein the wire is sutured linearly through the patch and the connector, along a longitudinal length of the connector (tether 44 extends through, or is sutured, linearly through first stent 12 and second stent 14, along a longitudinal length of stent 14, [0046]-[0047] & Fig. 14; “a tether extends through a plurality of openings of the stent along the longitudinal length of the stent to the proximal end of the catheter.”, [0010]).
Regarding claim 10, Tischler, as modified, discloses all the limitations of claim 1. Tischler further discloses the medical device wherein the connector includes a plurality of openings configured to receive the sutured wire (“a tether extends through a plurality of openings of the stent along the longitudinal length of the stent to the proximal end of the catheter.”, [0010]; stent 14 includes a plurality of openings through which tether 44 extends through, [0045]-[0047] & see Figs. 4-6 and 13).
Regarding claim 11, Tischler, as modified, discloses all the limitations of claim 1. Tischler further discloses the medical device wherein a proximal end of the wire is coupled to the actuator (as modified with Sisken, a proximal end of tether 44 is coupled to an actuator, see [0052] & Fig. 1 of Sisken), and wherein the actuator is configured to be pulled so that pull the wire translates proximally, thereby removing the wire from the patch and the connector (“the tether 44 is pulled in a proximal direction so that the tether 44 disengages from the stent 10, disposed about the stent receiving region 42 of the catheter 40. In some embodiments, the stent 10 deploys when the tether 44 is disengaged from the stent 10”, [0047] & Fig. 14).
Regarding clam 12, Tischler, as modified, discloses all the limitations of claim 11. Tischler further discloses the medical device wherein the distal end of the wire is removably secured 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 50.”, [0046] & Fig. 14; distal end of tether 44 connected to the distal portion of catheter 40, Fig. 14; “the tether 44 is pulled in a proximal direction so that the tether 44 disengages from the stent 10”, [0047]; tether 44 is removably secured to catheter 40) but fails to explicitly disclose the wire being removably secured 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 Tischler, 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).
Additionally, the Examiner notes that the limitation of “secured via a heat shrink or a crimp” is considered to be a product-by-process limitation. A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art. The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
Regarding claim 21, Tischler, as modified, discloses all the limitations of claim 4. Tischler further discloses the medical device wherein a portion of the wire is sutured through the patch and the second half of the folded sheet (tether 44 extends, or is sutured, through stent 12 and the second half of the top half of second stent 14, see annotated Fig. 3 above and Fig. 14).
The Examiner notes that the interpretation of the halves of stent 14 may vary depending on the rotational position of stent 14, providing for different splitting arrangements.
Regarding claim 26, Tischler, as modified, discloses all the limitations of claim 4. Tischler further discloses the medical device wherein the first half is folded over the second half, such that a surface of the first half faces a surface of a second half (as seen in annotated Fig. 3 above, the first half is folded over the second half, with the two internal surfaces of the halves facing each other).
Claim 15 is 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), and in further view of Smith (US 20200038005 A1).
Regarding claim 15, Tischler, as modified, discloses all the limitations of claim 1. Tischler discloses that “It is within the scope of the invention for the first stent body 12 of the stent 10 to be made from shape memory materials, plastically deformable materials, expanded polytetrafluoro-ethylene (ePTFE), biocompatible materials, grafts, or coverings, biodegradable materials and any combination thereof.” ([0040]).
However, Tischler 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 Tischler, 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 (a top half, or portion, of second stent 14 may be interpreted as a flat piece of material, wrapped partially around portion 42, or a folded sheet, Fig. 14 and annotated Fig. 3 above; “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 wherein the folded sheet extends along only a portion of a circumference of the expandable device (the top half, or portion, of second stent 14 extends along only a portion of a circumference of portion 42, see Fig. 14 and annotated Fig. 3 above); 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 a first half of the top half of second stent 14, which is being interpreted as a first portion of stent 14, [0046] & Fig. 14 and annotated Fig. 3 above; “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 a second half of the top half of stent 14 (see annotated Fig. 3 above), which is being interpreted as a second portion of stent 14, via tether 44 which extends through stent 12 and the second portion of stent 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). The Examiner notes that the interpretation of the portions of stent 14 may vary depending on the rotational position of stent 14, providing for different splitting arrangements.
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 first portion of the top half of stent 14 of Tischler.
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. Independent claim 16 is rejected using an alternate interpretation of Norris and independent claims 1 and 24 are rejected using an alternate interpretation of Tischler.
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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