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 Arguments
Applicant argues in the response filed 07/06/2026 that the term “coupled” as claimed is clear and well-supported in the description and figures corresponding to the elected species and the amendment “operatively coupled” should overcome the 112 rejection. The examiner agrees that there is support in the elected species that the inner component 50 is operatively coupled to the outer component 40, however the examiner maintains “an anchor portion operatively coupled to an intravascular tapered body at a the wide distal end” is not supported by the elected species. Species A, B, supports “an intravascular tapered body, but the elected species C does not seem to support “an intravascular tapered body”. Further, the elected species does support that the inner component 50 can be moved into the passageway of the outer component 40 to expand the outer component, but there isn’t any specific positive support of the engagement of the outer component 40 with the wide distal end of the inner component 50, let alone the wide distal end of the intravascular tapered body. The specification does specifically support the engagement at the distal end and it would not be inherent. As discussed in the interview of 07/01/2026, the wording used for the different components can help to advance prosecution. The examiner suggests uses “inner component” and “outer component comprising an anchor portion” where the “inner component is operatively coupled to the outer component” as supported by the elected species, instead of “an intravascular tapered body” and “an anchor portion operatively coupled to the intravascular tapered body at the wide distal end”. The 112 rejections are maintained below.
Of note: the examiner disagrees with the statement “the anchor feet 46 may be directly coupled to the outer portion 40” since it would seem the anchor feet 46 is a part of the outer portion 40. Instead, the anchor feet 46 may be operatively coupled to the ribs 44 and the outer component 40 may comprise the anchor feet 46.
The applicant argues prior art Stopek in view of Evans and Tegels/Walters/Nash would not be combinable to read on the claims of record since there wouldn’t be motivation to combine the reference and/or the combination would result in an inoperable embodiment. However, Stopek does disclose the plug member 6 can be other shapes, have a generally flat proximal portion, have a curvature that can conform to the tissue perforation and can be expandable (paragraph 25, 26). Tegels teaches a similar “plug member” or anchor assembly 208 that comprises two elements 240,242. Portion 240 can comprise the flat proximal portion where the portion 242 can have the curvature which can help mate with portion 240 and prevent fluid flow through the tissue puncture. The two part assembly of Tegels can be used as a substitute for the “plug member 6” of Stopek which can help seal the tissue puncture based on using a wider flat surface matable with a plug member. The portion 240 of Tegels can read on the claimed “anchor portion” since it does have the expandable deployed configuration. The portion 242 can read on the intravascular tapered body since it does have the tapered body. Tegels may not positively teach that the wide distal end of the 242 can engage the portion 240 but Tegels does teach tapered surface 270 can match the tapered surface 256 of 240. Therefore, a wide distal end of the tapered surface can operatively couple to the anchor portion based on the matching tapers. Walters further teaches and/or provides evidence of how the distal end of a wider taper can engage with a similar expanded planar anchor portion as seen in figure 1b. Nash can further provide evidence that the “intravascular tapered body” can engage the “anchor proton” at the wide distal end of the intravascular tapered body since the dome projection 52 is connected to the top surface 46 at its distal end. This will help position the projection 52 to seal the puncture. The spacing can be applied to the anchor portion 240 and tapered body 242 of Tegels where the wide distal end 242 can engage with the anchor portion 240. The use of the two part component of Tegels as a substitute for the “plug portion 6” of Stopek can help anchor and seal the tissue puncture based on using a wider anchor portion and the adaptability of the device. Further the combination would yield the predictable result and an operable embodiment to help seal to the tissue puncture. The examiner maintains the rejections below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-24, 26, 27, 39-45 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 21 states “an anchor portion operatively coupled to the intravascular tapered body at the wide distal end” in lines 4-5. It is to be noted that the applicant elected Species C, figures 19-22 in the reply filed 03/17/2025. The vascular closure device 30 of the elected species seems to comprise an inner component 50, outer component 40, locking element 60, seal component 70, and tensioning element 80, where the outer component comprises an anchor portion defined by a plurality of anchor feet 46 at the bottom of the ribs 44. The elected species does not specifically support “an intravascular tapered body” (it is noted though, Species A, B do support an intravascular body). The inner component 40 does comprise a tapered body with a wide distal end, but is not specifically supported to be “intravascular body”. The inner component 50 and outer component 40 can seem to be operatively coupled based on the inner component 50 is advanced into the outer component 40 to expand the outer component. However, there is no specific support of the operative coupling of the wide distal end of the intravascular tapered body to the anchor portion. Not only is the inner component 50 not supported to be the “intravascular tapered body”, the nature of the wide distal end of the operative coupling to the anchor portion is unknown. It would seem based on the taper of the inner component 50 as seen in figure 20, the wide distal end may not contact the anchor portion let alone the outer component. Figures 21, 22 shows the proximity between the inner component 50 to the anchor feet 46, but there is no specific support in the specification as originally filed for the contact and/or engagement. Figures are interpreted to be not drawn to scale, and paragraph 108, 116-119 use figures 21-22 as support for the anchor feet radial dimension and locking capabilities of the vascular closure device, not any “operative coupling”. Because there isn’t any specific support for “an anchor portion operatively coupled to the intravascular tapered body at the wide distal end” and it wouldn’t necessarily be known, the limitation is interpreted to be new matter.
It is noted claim 42 states “a wire operatively couples the anchor portion to the wide distal end of the intravascular tapered body”. While there can be support the wire 80 operatively couples the inner component 50 to the outer component 40, based on similar reasoning’s as argued above, there is no support for a wire operatively coupling the anchor portion to the wide distal end of the intravascular tapered body.
It is noted claim 43 states “the wire is configured to operatively couple the anchor portion to the wide distal end of the portion of the intravascular tapered body…”. While there can be support the wire 80 operatively couples the inner component 50 to a portion of the outer component 40, based on similar reasoning’s as argued above, there is no support for the wire operatively coupling the anchor portion to the wide distal end of the portion of the intravascular tapered body.
The examiner suggests using the same terminology and structural relationship in the specific as originally supported for the elected species. For instance: “inner component”, “outer component”, “anchor feet” instead of “intravascular tapered body” and “anchor portion” and the “the inner component configured to be advanced into the outer component to expand the outer component” instead of “operatively coupled at the wide distal end”.
Claim 39 states “the anchor portion is operatively coupled to a collar” in line 3. It is to be noted that the applicant elected Species C, figures 19-22 in the reply filed 03/17/2025. The vascular closure device 30 of the elected species seems to comprise an inner component 50, outer component 40, locking element 60, seal component 70, and tensioning element 80, where the outer component comprises an anchor portion defined by a plurality of anchor feet 46 at the bottom of the ribs 44 and a collar 42. The elected species does not specifically support “an intravascular tapered body” (it is noted though, Species A, B do support an intravascular body). It is unknown if the anchor portion is supposed to be the anchor feet 46 or the outer component 40. The outer component 40 may comprise a collar at the proximal end and anchor feet at the distal end, but it would be unclear the specific scope of how the anchor portion is operatively coupled to the collar since both the collar and the anchor feet are a part of the same outer component. Therefore the limitation is considered to be new matter.
The examiner suggests using the same terminology and structural relationship in the specific as originally supported for the elected species. For instance: “inner component”, “outer component”, “anchor feet” instead of “intravascular tapered body” and “anchor portion” and the “outer component comprising an anchor portion and a collar, where an inner component is configured to be advanced into the outer component to expand the outer component”.
Claim Objections
Claims 28-31, 35, 36, are objected to because of the following informalities: The term “intravascular tapered body” should be amended to read “tapered body”, “outer component” or similar nomenclature as supported by species C as elected by the applicant. Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 21-24, 26-31, 35, 36, 41-45 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2010/0087854 to Stopek in view of U.S. Patent Publication 5,681,334 to Evans, U.S. Patent Publication 2013/0138149 to Tegels, U.S. Patent Publication 2011/0301638 to Walters, and/or U.S. Patent 5,700,277 to Nash.
As to claim 21, Stopek discloses a device capable of being a vascular closure device (paragraph 8) comprising an anchor portion (6), the anchor portion comprising a delivery configuration (figure 2a) and a deployed configuration (figure 2b), wherein the anchor portion comprises an anchor width measured transverse to the device axis, wherein the anchor width when the anchor portion is in the deployed configuration is greater than the anchor width when the anchor portion is in the delivery configuration (paragraph 26, the plug member can expand to a larger shape which will have the greater width), wherein the anchor portion is configured for location within a blood vessel when in the deployed configuration (figure 2b), a seal ring (10), and a sealing component (8) comprising a tubular seal (paragraph 28, the elongate body 4 is positioned through the inner member, which can then allow the inner member 8 to read on a tube), wherein the tubular seal is located between the anchor portion and the seal ring when moving along the device axis (figure 1, 2a-d), and wherein the seal ring is configured to compress the tubular seal along the device axis when the anchor portion is in the deployed configuration (paragraph 28, 31, figure 2a-d) but is silent about the intravascular tapered body extending from a narrow proximal end to a wide distal end and having a device axis that extends through the intravascular tapered body, where the anchor portion is coupled to the intravascular tapered body at the wide distal end. Stopek does disclose the plug member 6 can be conical as well as other shapes and capable of undergoing change during delivery (paragraph 25,26).
If, however, it would not be known that the plug member 8 of Stopek can read on the tubular seal, Evans teaches a similar device (closure device, abstract) having a tubular seal 22 (figure 9-12, col. 7 ll. 10-23) for the purpose of using shaped mass that can be delivered to resist the passage of fluid therethrough. It would have been obvious to one of ordinary skill in the art before the effective filing date to use a tubular seal in the device of Stopek in order for using a shaped mass that can be delivered to resist the passage of fluid therethrough.
Tegels teaches a similar device (vascular closure system, abstract) having an intravascular tapered body (242) extending from a narrow proximal end to a wide distal end (figure 6-9) and having a device axis that extends through the intravascular tapered body, and an anchor portion (240) operatively coupled to the intravascular tapered body (figure 6,7, paragraph 52-53), wherein the anchor portion comprising a delivery configuration (figure 6) and a deployed configuration (figure 7), wherein the anchor portion comprises an anchor width measured transverse to the device axis, wherein the anchor width when anchor portion is in the deployed configuration is greater than the anchor width when the anchor portion is in the delivery configuration (figure 6-8), wherein the anchor portion is configured for location within a blood vessel when in the deployed configuration for the purpose of helping to anchor the device within the vessel to limit movement back through the puncture (paragraph 54). Tegels does teach that the “tapered portion 270” can match and couple to “the tapered surface 256” (paragraph 53, 54, 63-66). Therefore, if the taper portions match, the distal end of taper portion 270 can be the wide distal end of intravascular tapered body which can be operatively coupled to the anchor portion (taper 254). Walters teaches a similar device (closure device, abstract) having an anchor (32) coupled to a wide distal end of an intravascular tapered body (32a, figure 1b) for the purpose of allowing the proximal end of the intravascular tapered body to extend within the opening which will aid in occluding the opening (paragraph 69). The projection 32a is coupled to the extension at the distal end of the dome. Nash can further teach that it is known an anchor portion can be coupled to a wider distal end of a tapered portion (figure 3) since the dome 52 is coupled to top surface 46 at the distal end of the dome 52. Therefore the similar spacing can be applied to components 240, 242 of Tegels for the anchor portion operatively coupled to the intravascular tapered body at the wide distal end. This will allow the assembly to better conform to the tissue puncture and seal the tissue puncture. Stopek does disclose the “the plug 6” of the device can be different shapes and be expandable during delivery (paragraph 25,26). The “plug 6” of Stopek can be substituted with the assembly 240,242 of Tegels where the assembly 240, 242 can read on the anchor portion and tapered body, where the anchor portion is operatively coupled to the intravascular tapered body at the wide distal end. Using the assembly will yield the predictable result of allowing the device to be positioned within the blood vessel and seal the opening. It would have been obvious to one of ordinary skill in the art before the effective filing date to use an intravascular tapered body, with the device axis, extending from a narrow proximal surface to a wide distal end and an anchor portion coupled to the intravascular tapered body at the wide distal end, where the anchor portion has the greater width deployed configuration as the “plug component 6” of Stopek in order for helping to anchor the device within the vessel to limit movement back through the puncture while aiding in occluding the puncture.
As to claim 22, with the device of Stopek, Evans, and Tegels/Walters/Nash above, Nash further teaches a seal ring defining a cone shape (36a, figure 11) comprising an apex and a base, and a passageway (62) extending therethrough along the device axis between the apex and the base for the purpose of having a device to apply a compressive force which can also allow for a locking mechanism. Stopek does disclose the seal ring 10 can be used to engage the elongate body 4 to help lock the device. Using the seal ring of Nash can help aid in the locking mechanism. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the cone shape seal ring of Nash as the seal ring of Stopek in order for having a device to apply a compressive force which can assist in providing a locking mechanism.
As to claim 23, with the device of Stopek, Evans, and Tegels/Walters/Nash above, Stopek discloses the tubular seal comprises collagen or a collagen-like substance (paragraph 28).
As to claim 24, with the device of Stopek, Evans, and Tegels/Walters/Nash above, Evans further teaches the tubular seal comprises a delivery configuration (figure 1) and a deployed configuration (figure 14), wherein the tubular seal extends radially from the device axis beyond the seal ring when the tubular seal is in the deployed configuration (figure 14) for the purpose of helping to secure the tubular seal in place to seal the opening (col. 8 ll. 39-56). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the tubular seal extend radially from the device axis beyond the seal ring when the tubular seal in the deployed configuration in order for helping to secure the tubular seal in place to seal the opening.
As to claim 26, with the device of Stopek, Evans, and Tegels/Walters/Nash above, Evans further teaches the tubular seal comprises a delivery configuration (figure 1) and a deployed configuration (figure 14), wherein the tubular seal is configured to deform from the delivery configuration to the deployed configuration for the purpose of helping to secure the tubular seal in place to seal the opening (col. 8 ll. 39-56). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the tubular seal deform from the delivery configuration to the deployed configuration in order for helping to secure the tubular seal in place to seal the opening.
As to claim 27, with the device of Stopek, Evans, and Tegels/Walters/Nash above, Tegels further teaches the anchor portion is configured to expand radially relative to the device axis when the intravascular tapered body advances therethrough (figure 6-7). The claim does not state how or why the anchor expands. The petals of the anchor portion can expand further as the intravascular tapered body is set within the anchor. Further Stopek does disclose the member 6 can expand during delivery (paragraph 26). Therefore the anchor can be configured to expand radially when the intravascular tapered body advanced therethrough.
As to claim 28, Stopek discloses a device capable of being a vascular closure device (paragraph 8) comprising an anchor portion (6), the anchor portion comprising a delivery configuration (paragraph 26, compressible during delivery) and a deployed configuration (paragraph 26), a seal ring (10) and a tubular seal (8, paragraph 28, the elongate body 4 is positioned through the inner member, which can then allow the inner member 8 to read on a tube) located between the anchor portion and the seal ring (figure 12), wherein the seal ring is configured to compress the tubular seal along the device axis (paragraph 28) wherein the seal ring is located closer to the anchor portion when the anchor portion is in the deployed configuration, relative to the anchor portion in the delivery configuration (figure 2a-d) but is silent about the intravascular tapered body extending from a narrow proximal end to a wide distal end, wherein a device axis extends through the intravascular body, where the anchor portion is attached to the wide distal end of intravascular tapered body, and the tubular seal expands radially away from the device when the anchor portion is in the deployed configuration.
If, however, it would not be known that the plug member 8 of Stopek can read on the tubular seal, Evans teaches a similar device (closure device, abstract) having a tubular seal 22 (figure 9-12, col. 7 ll. 10-23) for the purpose of using shaped mass that can be delivered to resist the passage of fluid therethrough. Evans further teaches that the tubular seal expands radially from a device axis when a seal ring compresses the tubular seal (figure 14) for the purpose of helping to hold the tubular seal in place. It would have been obvious to one of ordinary skill in the art before the effective filing date to use a tubular seal in the device of Stopek in order for using a shaped mass that can be delivered and secured in place, to resist the passage of fluid therethrough.
Tegels teaches a similar device (vascular closure system, abstract) having an intravascular tapered body (242) extending from a narrow proximal end to a wide distal end (figure 6-9) and having a device axis that extends through the intravascular tapered body, and an anchor portion (240) attached to the intravascular tapered body (figure 6,7, paragraph 52-53), wherein the anchor portion comprising a delivery configuration (figure 6) and a deployed configuration (figure 7), wherein the anchor portion comprises an anchor width measured transverse to the device axis, wherein the anchor width when anchor portion is in the deployed configuration is greater than the anchor width when the anchor portion is in the delivery configuration (figure 6-8), wherein the anchor portion is configured for location within a blood vessel when in the deployed configuration for the purpose of helping to anchor the device within the vessel to limit movement back through the puncture (paragraph 54). Tegels does teach that the “tapered portion 270” can match and couple to “the tapered surface 256” (paragraph 53, 54, 63-66). Therefore, if the taper portions match, the distal end of taper portion 270 can be the wide distal end of intravascular tapered body which can be attached to the anchor portion (taper 254). Walters teaches a similar device (closure device, abstract) having an anchor (32) attached to a wide distal end of an intravascular tapered body (32a, figure 1b) for the purpose of allowing the proximal end of the intravascular tapered body to extend within the opening which will aid in occluding the opening (paragraph 69). The projection 32a is coupled to the extension at the distal end of the dome. Nash can further teach that it is known an anchor portion can be attached to a wider distal end of a tapered portion (figure 3) since the dome 52 is attached to top surface 46 at the distal end of the dome 52. Therefore the similar spacing can be applied to components 240, 242 of Tegels for the anchor portion attached to the intravascular tapered body at the wide distal end. This will allow the assembly to better conform to the tissue puncture and seal the tissue puncture. Stopek does disclose the “the plug 6” of the device can be different shapes and be expandable during delivery (paragraph 25,26). The “plug 6” of Stopek can be substituted with the assembly 240,242 of Tegels where the assembly 240, 242 can read on the anchor portion and tapered body, where the anchor portion is attached to the intravascular tapered body at the wide distal end. Using the assembly will yield the predictable result of allowing the device to be positioned within the blood vessel and seal the opening. It would have been obvious to one of ordinary skill in the art before the effective filing date to use an intravascular tapered body, with the device axis, extending from a narrow proximal surface to a wide distal end and an anchor portion attached to the intravascular tapered body at the wide distal end, where the anchor portion has the greater width deployed configuration as the “plug component 6” of Stopek in order for helping to anchor the device within the vessel to limit movement back through the puncture while aiding in occluding the puncture.
As to claim 29, with the device of Stopek, Evans, and Tegels/Walters/Nash above, Nash further teaches a seal ring defining a cone shape (36a, figure 11) comprising an apex and a base, and a passageway (62) extending therethrough along the device axis between the apex and the base for the purpose of having a device to apply a compressive force which can also allow for a locking mechanism. Stopek does disclose the seal ring 10 can be used to engage the elongate body 4 to help lock the device. Using the seal ring of Nash can help aid in the locking mechanism. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the cone shape seal ring of Nash as the seal ring of Stopek in order for having a device to apply a compressive force which can assist in providing a locking mechanism.
As to claim 30, with the device of Stopek, Evans, and Tegels/Walters/Nash above, Stopek discloses the tubular seal comprises collagen or a collagen-like substance (paragraph 28).
As to claim 31, with the device Stopek, Evans, Tegels/Walters/Nash above, Evans further teaches the tubular seal extends away from the device axis beyond the seal ring when the anchor portion is in the deployed configuration (figure 14).
As to claim 35, Stopek discloses a method of implanting a vascular closure device in a vascular access site (paragraph 43), the method comprising delivering a portion of a vascular closure device defining a device axis (paragraph 25, 43) through the vascular access site, wherein the device axis extends through the vascular access site (paragraph 25, 54), the vascular closure device comprising an anchor portion (66) attached to the intravascular tapered body, the anchor portion comprising a deployed configuration (figure 2d, paragraph 26) and a delivery configuration (figure 2a, paragraph 26, as it is compressed), a seal ring (10), and a sealing component (8) comprising a tubular seal (paragraph 28, the elongate body 4 is positioned through the inner member, which can then allow the inner member 8 to read on a tube), wherein the tubular seal is located between the anchor portion and the seal ring (figure 2a) when moving along the device axis, wherein the seal ring is configured to compress the tubular seal along the device axis when the anchor portion is in the deployed configuration (paragraph 28, figure 2c-d), positioning the anchor portion (figure 2a), converting the anchor portion from the delivery configuration to the deployed configuration after positioning the anchor portion in the blood vessel (figure 2a-b, paragraph 26, the plug 6 expands once delivered), positioning the tubular seal over the vascular access site (figure 2b-d), positioning the seal ring over the intravascular tapered body after positioning the anchor portion in the blood vessel (figure 2b-d), wherein positioning the seal ring over the intravascular tapered body compresses the tubular seal to seal the blood vessel and maintain such compression (figure 2c-d, paragraph 28, 35, 43) but is silent about delivering the closure device into a blood vessel, the intravascular tapered body extending from a narrow proximal end to a wide distal end, where the anchor portion is attached to the wide distal end of the intravascular tapered body.
If, however, it would not be known that the plug member 8 of Stopek can read on the tubular seal, Evans teaches a similar device (closure device, abstract) having a tubular seal 22 (figure 9-12, col. 7 ll. 10-23) for the purpose of using shaped mass that can be delivered to resist the passage of fluid therethrough. Evans further teaches that the closure device can be delivered to treat a blood vessel (col. 2 ll. 15-24, col. 6 ll. 7-27) along with other similar punctures for the purpose of using similar methods and devices to close similar punctures. Stopek does disclose that that the device and method can be used on different types of tissue (paragraph 23) and applying the method to the vasculature to deploy the anchor into the blood vessel will yield the predictable result of sealing the access site into a blood vessel. It would have been obvious to one of ordinary skill in the art before the effective filing date to use a tubular seal in the method of Stopek which is used to treat an access site in a blood vessel in order for using a shaped mass that can be delivered and secured in place, to resist the passage of fluid in an access site of a blood vessel.
Tegels teaches a similar device and method (vascular closure, abstract) having an intravascular tapered body (242) extending from a narrow proximal end to a wide distal end (figure 6-9), and anchor portion (240) attached to the intravascular tapered body (figure 6,7, paragraph 52-53), wherein the anchor portion comprising a delivery configuration (figure 6) and a deployed configuration (figure 7), and converting the anchor portion from the delivery configuration to the deployed configuration after positioning the anchor portion in the blood vessel (figure 6-8) for the purpose of helping to anchor the device within the vessel to limit movement back through the puncture (paragraph 54). Tegels does teach that the “tapered portion 270” can match and couple to “the tapered surface 256” (paragraph 53, 54, 63-66). Therefore, if the taper portions match, the distal end of taper portion 270 can be the wide distal end of intravascular tapered body which can be attached to the anchor portion (taper 254). Walters teaches a similar device (closure device, abstract) having an anchor (32) attached to a wide distal end of an intravascular tapered body (32a, figure 1b) for the purpose of allowing the proximal end of the intravascular tapered body to extend within the opening which will aid in occluding the opening (paragraph 69). The projection 32a is coupled to the extension at the distal end of the dome. Nash can further teach that it is known an anchor portion can be attached to a wider distal end of a tapered portion (figure 3) since the dome 52 is attached to top surface 46 at the distal end of the dome 52. Therefore the similar spacing can be applied to components 240, 242 of Tegels for the anchor portion attached to the intravascular tapered body at the wide distal end. This will allow the assembly to better conform to the tissue puncture and seal the tissue puncture. Stopek does disclose the “the plug 6” of the device can be different shapes and be expandable during delivery (paragraph 25,26). The “plug 6” of Stopek can be substituted with the assembly 240,242 of Tegels where the assembly 240, 242 can read on the anchor portion and tapered body, where the anchor portion is attached to the intravascular tapered body at the wide distal end. Using the assembly will yield the predictable result of allowing the device to be positioned within the blood vessel and seal the opening. It would have been obvious to one of ordinary skill in the art before the effective filing date to use an intravascular tapered body extending from a narrow proximal surface to a wide distal end and an anchor portion attached to the intravascular tapered body at the wide distal end, where the anchor portion is converted to the deployed position after positioning the anchor in the blood vessel as the “plug component 6” in the method of Stopek in order for helping to anchor the device within the vessel to limit movement back through the puncture while aiding in occluding the puncture.
As to claim 36, with the method of Stopek, Evans, and Tegels/Walters/Nash, Stopek discloses the tubular seal comprises collagen or a collagen-like substance (paragraph 28).
As to claim 41, with the method of Stopek, Evans, and Tegels/Walters/Nash, Stopek discloses a tensioning element (4) extending through the intravascular tapered body, the seal ring, and the tubular seal (figure 2a).
As to claim 42, with the device of Stopek, Evans, and Tegels/Walters/Nash, Tegels discloses a wire (204) that operatively couples the anchor portion to the wide distal end of the intravascular tapered body.
As to claim 43, with the device of Stopek, Evans, and Tegels/Walters/Nash, Tegels discloses the anchor portion includes a portion that is separate from a wide distal end of a portion of the intravascular tapered body (figure 7, the inner taper 254 of 240 is separate from the wide distal end of 242), and wherein the wire is configured to couple the anchor portion to the wide distal end of the portion of the intravascular tapered body by applying a tensile force (figure 6-8, paragraph 69) .
As to claim 44, with the device of Stopek, Evans, and Tegels/Walters/Nash, Tegels discloses the anchor portion extends in a direction parallel to the device axis in the delivery configuration (figure 6), and wherein the anchor portion extends in a direction transverse to the device axis in the deployed configuration (figure 7) in which the width of the anchor portion is greater than the width of the anchor portion in the delivery configuration (figure 6,7).
As to claim 45, with the device of Stopek, Evans, and Tegels/Walters/Nash, Stopek teaches the seal ring is configured to compress the tubular seal against an outer wall of the blood vessel win the anchor portion is in the deployed configuration (figure 2d). Evans further teaches the claim limitation (figure 13-15). Nash also provides evidence on the claim limitation (figure 3).
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 ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
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