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's arguments filed 2/9/2026 have been fully considered but they are not persuasive.
Regarding claims 1 and 14, Applicant contends that the prior are of Favreau (US 2022/0370222 A1) (previously of record) does not expressly or adequately disclose or suggest the amended limitations of “the second portion configure to be radially collapsed in response to rotation of the first portion relative to the second portion, where the second portion is biased in the expanded deployed configuration” on the grounds that the elongated element 200 is configured to expand the intermediate region 106 (per Para. [0053]).
The Examiner respectfully disagrees with the proposed interpretation of Favreau. Favreau provide an express disclose of wherein the implanted device 100 is configured to transition between an open configuration and closed configuration (see Para. [0007], [0011], [0018], [0040], [0041], [0045] and [0052]-[0054]) in which the “closed” configuration may be either partially closed or completely closed. This closing causes the intermediate portion extending along and disposed as part of the “second portion” as defined in Examiner’s Diagram of Fig. 2 below to radially collapse as the intermediate portion, and “first portion” are twisted by the elongate member 200. This can be shown by example in Figs. 3A-3B in which the intermediate portion transitions from a more open, larger diameter configuration to a more collapsed, radially-smaller diameter configuration. Additionally, Para. [0061] of Favreau mentioning wherein barbs (i.e., barbs 110) are disposed along the exterior of the distal end 102 of the retention member (see also Fig. 9) to engage with and anchor the distal end (i.e., enlarged-diameter “second portion”) of the device to the desired tissue; elongate element 200 may be inserted into the lumen 105 of device 100 to twist and “adjust” the amount of constriction/expansion of the intermediate portion 106 of the device while the device remains engaged with (via direct contact) tissue as seen in Figs. 3A-3B; with the distal portion (i.e., the enlarged-diameter “second portion”) anchored to tissue by the barbs, the portion of the intermediate region 106 lying in the “first portion” and portion of the enlarged proximal end of the “first portion” connecting thereto would rotate relative to the enlarged-diameter distal end of the “second portion” 102 (this can also be seen in the rotation arrows shown in Fig. 3A-3B in which no rotation is shown to occur at the distal end of the device). The Examiner therefore contends that Favreau discloses the amended limitations of claim 1, as currently presented.
Regarding claim 17, Applicant contends that the prior art of Favreau (US 2022/0370222 A1) (previously of record) does not expressly or adequately disclose or suggest the amended limitations of “closing an anatomical defect by rotating the first portion of the device relative to an elongate portion to reduce the diameter of the elongate by engaging one or more barbs on the elongate portion with the walls of the defect and pulling the walls radially inward” on the grounds that Favreau discloses that the holding feature 110 (i.e., barbs) are configured to engage and/or anchor the device to the target tissue to hold open an opening between two organs. Applicant contends that there is no reason or rationale to modify the device of Favreau to be used to close an opening between two organs.
The Examiner respectfully disagrees with the proposed interpretation of Favreau. Favreau provide an express disclose of wherein the implanted device 100 is configured to transition between an open configuration and closed configuration (see Para. [0007], [0011], [0018], [0040], [0041], [0045] and [0052]-[0054]) in which the “closed” configuration may be either partially closed or completely closed. The Examiner therefore contends that the device of Favreau is expressly disclosed to be capable of twisting and collapsing to prevent flow through the anatomical defect within which the device of Favreau is implanted. This closing causes the intermediate portion extending along and disposed as part of the “second portion” as defined in Examiner’s Diagram of Fig. 2 below to radially collapse as the intermediate portion, and “first portion” are twisted by the elongate member 200. This can be shown by example in Figs. 3A-3B in which the intermediate portion transitions from a more open, larger diameter configuration to a more collapsed, radially-smaller diameter configuration. Additionally, Para. [0061] of Favreau mentioning wherein barbs (i.e., barbs 110) are disposed along the exterior of the distal end 102 of the retention member (see also Fig. 9) to engage with and anchor the distal end (i.e., enlarged-diameter “second portion”) of the device to the desired tissue; elongate element 200 may be inserted into the lumen 105 of device 100 to twist and “adjust” the amount of constriction/expansion of the intermediate portion 106 of the device while the device remains engaged with (via direct contact) tissue as seen in Figs. 3A-3B; with the distal portion (i.e., the enlarged-diameter “second portion”) anchored to tissue by the barbs, the portion of the intermediate region 106 lying in the “first portion” and portion of the enlarged proximal end of the “first portion” connecting thereto would rotate relative to the enlarged-diameter distal end of the “second portion” 102 (this can also be seen in the rotation arrows shown in Fig. 3A-3B in which no rotation is shown to occur at the distal end of the device). The Examiner therefore contends that Favreau discloses the amended limitations of claim 1, as currently presented.
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 4
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.
Claim(s) 1, 9, 13 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Favreau (US 2022/0370222 A1) (previously of record).
Regarding claim 1, Favreau discloses:
A device for implantation at an anatomical defect in or through body tissue (device 100, see Figs. 1-2), the device comprising:
a first portion (see Examiner’s Diagram of Fig. 2 below designation a “first portion” of the device of Favreau) configured to engage the body tissue (see Para. [0061] mentioning wherein the device is configured to be implanted within and engage (via barbs) the internal tissue of a patient; see also Fig. 3A-3B and 9 showing wherein the device is in direct abutment with the target tissue); and
a second portion extending distally from the first portion (see Examiner’s Diagram of Fig. 2 below illustrating wherein a designated “second portion” extends distally from the identified “first portion”), the second portion being tubular with a lumen extending therethrough (see Examiner’s Diagram of Fig. 2 below showing wherein the “second portion” comprises a tubular shape (see also Para. [0052]-[0053] mentioning wherein the device 100 is “tubular”) and comprises a lumen 105 through which to receive at least elongated element 200 as shown in Fig. 3A-3B), the second portion being movable between an expanded diameter deployed configuration in which the lumen is open (see Figs. 3A-3B showing varied “open” configurations) and a reduced diameter twisted configuration in which the lumen is closed (see Para. [0007], [0011], [0018], [0040], [0041], [0045] and [0052]-[0054] mentioning wherein the device is configured to transition, via twisting, between open and closed configurations; wherein the “closed “configuration may be either completely closed or only partially closed), the second portion is configured to engage tissue of the anatomical defect (see Para. [0061] mentioning wherein the device is configured to be implanted within and engage (via barbs) the internal tissue of a patient; see also Fig. 3A-3B and 9 showing the “second portion” engaging the internal tissue of a patient via direct contact);
the anatomical defect having a first opening, a second opening, and a passage extending between the first opening and the second opening (see Figs. 3A-3B showing wherein tissue “T” within which the device of Favreau is disposed comprises a first and second opening with a passage extending therebetween to allow the device of Favreau to be disposed therein); and
wherein the second portion is configured to be radially collapsed and be reduced in diameter (see Figs. 3A-3B showing wherein intermediate region 106 (which has regions disposed along both the “first portion” and “second portion” as shown in Examiner’s Diagram of Fig. 2 below) is configured to expand and contract between a larger-diameter and smaller-diameter configuration; see also Para. [0007], [0011], [0018], [0040], [0041], [0045] and [0052]-[0054] mentioning this function) thereby closing the lumen (see Para. [0007], [0011], [0018], [0040]-[0042], [0052]-[0054] and [0061] mentioning wherein the device may be closed either entirely or partially depending on the needs of the procedure) in response to rotation of the first portion relative to the second portion while engaging the tissue of the anatomical defect to close the anatomical defect (see Para. [0061] mentioning wherein barbs are disposed along the exterior of the distal end 102 of the retention member (see also Fig. 9) to engage with and anchor the distal end (i.e., enlarged-diameter “second portion”) of the device to the desired tissue; elongate element 200 may be inserted into the lumen 105 of device 100 to twist and “adjust” the amount of constriction/expansion of the intermediate portion 106 of the device while the device remains engaged with (via direct contact) tissue as seen in Figs. 3A-3B; with the distal portion (i.e., the enlarged-diameter “second portion”) anchored to tissue by the barbs, the portion of the intermediate region 106 lying in the “first portion” and portion of the enlarged proximal end of the “first portion” connecting thereto would rotate relative to the enlarged-diameter distal end of the “second portion” 102 (this can also be seen in the rotation arrows shown in Fig. 3A-3B in which no rotation is shown to occur at the distal end of the device); as elongate element 200 is the only disclosed means for twisting the device, the elongate element is seen to be responsible for both expanding and contracting the device via rotation);
wherein the second portion is biased in the expanded diameter deployed configuration (see [0007], [0011], [0018], [0040], [0041], [0045] and [0052]-[0054] and Figs. 3A-3B showing wherein the portion of intermediate region 106 within the “second portion” of the device expands and contracts during twisting).
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Examiner’s Diagram of Fig. 2
Regarding claim 9, Favreau discloses the invention of claim 1, Favreau further discloses a tool for engaging the first portion (elongated element 200, see Fig. 3B and Para. [0053]-[0055]), and wherein the first portion has an opening for receiving a distal end of the tool and the tool (see Fig. 3B) is configured to be rotated when received within the opening to reduce the diameter of the second portion (see Para. [0053]-[0057]).
Regarding claim 13, Favreau discloses the invention of claim 1, Favreau further discloses wherein the first portion and the second portion are formed from one or more interwoven wires (see Fig. 2 and Para. [0046]).
Regarding claim 17, Favreau discloses:
A method of implanting an implantable medical device in an anatomical defect at or through body tissue, the method comprising:
positioning an elongate portion of the implantable medical device (device 100, see Fig. 2; see also Examiner’s Diagram of Fig. 3B below designating an “elongate portion” of the device) within the anatomical defect (see Figs. 3A-3B) while a first portion of the implantable medical device remains outside the anatomical defect (see Examiner’s Diagram of Fig. 3B below showing where the enlarged diameter portion of the “first portion” remains outside the anatomical defect while the elongate portion is disposed therein), wherein the elongate portion is in a radially expanded configuration (see Fig. 3A-3B showing varied expanded configurations of the “elongate portion”) and includes one or more barbs extending radially outwardly from the elongate portion, the one or more barbs engaging walls of the anatomical defect (see Para. [0061] mentioning wherein barbs 110 may be disposed at the distal end 102 of the device (shown in Fig. 9) to anchor the enlarged-diameter distal end of the “elongate portion” to tissue, preventing rotation at the distal end);
closing the anatomical defect (see Figs. 3A-3B showing an expandable and collapsable ability of the device within the anatomical defect; see also Para. [0007], [0011], [0018], [0040], [0041], [0045] and [0052]-[0054]) by rotating the first portion relative to the elongate portion to reduce a diameter of the elongate portion of the implantable medical device within the anatomical defect from a first, radially expanded diameter to a second, radially collapsed diameter (see Para. [0061] mentioning wherein barbs are disposed along the exterior of the distal end 102 of the retention member (see also Fig. 9) to engage with and anchor the distal end (i.e., enlarged-diameter “second portion”) of the device to the desired tissue; elongate element 200 may be inserted into the lumen 105 of device 100 to twist and “adjust” the amount of constriction/expansion of the intermediate portion 106 of the device while the device remains engaged with (via direct contact) tissue as seen in Figs. 3A-3B; with the distal portion (i.e., the enlarged-diameter “second portion”) anchored to tissue by the barbs, the portion of the intermediate region 106 lying in the “first portion” and portion of the enlarged proximal end of the “first portion” connecting thereto would rotate relative to the enlarged-diameter distal end of the “second portion” 102 (this can also be seen in the rotation arrows shown in Fig. 3A-3B in which no rotation is shown to occur at the distal end of the device); as elongate element 200 is the only disclosed means for twisting the device, the elongate element is seen to be responsible for both expanding and contracting the device via rotation);
wherein reducing the diameter of the elongate portion pulls the walls of the anatomical device radially inward to close the anatomical defect (see also Para. [0007], [0011], [0018], [0040], [0041], [0045] and [0052]-[0054] mentioning wherein the device is configured to be twisted to constrict and close a defect opening; Para. [0061] further mentions wherein barbs are placed along the exterior of the device to engage with tissue such that a closing operation would pull the tissue walls, in contact with the barbs, at least partially radially-inward, providing a closing force to the opening; taking Examiner’s Diagram of Fig. 3A-3B below for example, with barbs placed along the tissue-contacting face of the distal end 102, as the intermediate region 106 is twisted to reduce the diameter thereof, the tissue in contact with the barbs at the distal end would be pulled radially-inwardly while attempting to prevent rotation of said distal end anchored thereto); and
securing the implantable medical device at or proximate the anatomical defect in a configuration having the second, radially collapsed diameter (see Figs. 3A-3B and Para. [0040]-[0042], [0049] and [0052]-[0053] mentioning wherein after the device has been implanted at a target site, the diameter of the device may be constricted or expanded to either allow or occlude/reduce flow therethrough).
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Examiner’s Diagram of Fig. 3B
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Examiner’s Diagram of Fig. 3A-3B
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 3-8 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Favreau (US 2022/0370222 A1) (previously of record) in view of Bödewadt (US 2015/0374383 A1) (previously of record).
Regarding claim 3, Favreau discloses all of the limitations of the invention of claim 1, Favreau further discloses one or more barbs may extend along portions of the device to engage tissue (see Para. [0061]) configured to engage the tissue of the anatomical defect (see Para. [0061] and Fig. 9 showing barb(s) 110, configured to engage with and anchor the device into the target tissue) and pull walls of the anatomical defect radially inward when the second portion is rotated (see Examiner’s Diagram of Figs. 3A-3B below showing wherein the target tissue is pulled radially-inward during constricting of the intermediate portion, facilitated by the barbs at the distal end 102 providing an anchor point for which to rotate the more proximal section of the device, causing tissue to be pulled radially inwardly).
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Examiner’s Diagram of Figs. 3A-3B
However, while Favreau discloses wherein additional barbs may be disposed along the length of the device body depending on the target tissue or location thereof (see Para. [0061]), Favreau does not expressly disclose one or more barbs extending radially outward from the second portion.
In the same field of endeavor, namely constricting stent devices, Bödewadt teaches a device for implantation at an anatomical defect in or through body tissue (device 200, see Figs. 5-6; the embodiment of Figs. 5-6 is substantially similar to the embodiment shown in Figs. 1-4 per Para. [0051]), the device comprising:
a first portion (see Examiner’s Diagram of Bödewadt Fig. 5 below designation a “first portion” of the device of Bödewadt) configured to engage the body tissue (see Para. [0035], [0042] and [0056] mentioning wherein the device is configured to be implanted within and engage (via barbs 250) the walls of the vasculature of a patient); and
a second portion extending distally from the first portion (see Examiner’s Diagram of Bödewadt Fig. 5 below illustrating wherein a designated “second portion” extends distally from the identified “first portion”), the second portion is configured to engage tissue of the anatomical defect (see Para. [0035], [0042] and [0056] mentioning wherein the device is configured to be implanted within and engage (via barbs 250) the walls of the vasculature of a patient);
wherein the first and second portions comprise a plurality of barbs (barbs 250, see Fig. 5) extending along the radially-outward circumference of the first and second portions (see Fig. 5 showing wherein a plurality of barbs are located at different positions along the radially-outward circumference of the first and second portions) to engage with the tissue within which the device is implanted (see Para. [0056]), the increased number of barbs increasing the engagement ability of the device.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Favreau to comprise a plurality of barbs positioned along the radially-outward circumference of both the first potion and second portion as disclosed by Bödewadt (see Bödewadt Para. [0056] and Figs. 5-6) to improve the engaging ability of the device through the addition of more tissue-engaging barbs, as suggested to be within the scope of the device of Favreau per Para. [0061]).
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Examiner’s Diagram of Bödewadt Fig. 5
Regarding claim 4, the combination of Favreau and Bödewadt discloses all of the limitations of the invention of claim 3, Favreau, as modified by Bödewadt, further discloses wherein the one or more barbs extend in a circumferential direction around the second portion (see Bödewadt Fig. 5 showing the additional radially-outward barbs, as incorporated into the “second portion” of the device of Favreau, extending around the circumference of said “second portion”).
Regarding claim 5, Favreau discloses all of the limitations of the invention of claim 1, Favreau further discloses at least one barb (see Para. [0061] and Fig. 9 showing barb(s) 110) disposed along the length of the device and configured to engage the tissue of an anatomical defect (see Para. [0061]).
However, while Favreau discloses wherein additional “barbs” may be present along the exterior surface of the device (see Fig. 9 and Para. [0061]), Favreau does not provide an express disclosure of multiple positioned at different points along the circumference and thus does not expressly disclose:
a first set of one or more barbs extending radially-outwardly from the first portion in a first circumferential direction; and
a second set of one or more barbs extending radially-outwardly from the second portion in a second circumferential direction opposite the first circumferential direction, the second set of one or more barns configured to engage the tissue of the anatomical defect.
In the same field of endeavor, namely constricting stent devices, Bödewadt teaches a device for implantation at an anatomical defect in or through body tissue (device 200, see Figs. 5-6; the embodiment of Figs. 5-6 is substantially similar to the embodiment shown in Figs. 1-4 per Para. [0051]), the device comprising:
a first portion (see Examiner’s Diagram of Bödewadt Fig. 5 above designation a “first portion” of the device of Bödewadt) configured to engage the body tissue (see Para. [0035], [0042] and [0056] mentioning wherein the device is configured to be implanted within and engage (via barbs 250) the walls of the vasculature of a patient); and
a second portion extending distally from the first portion (see Examiner’s Diagram of Bödewadt Fig. 5 above illustrating wherein a designated “second portion” extends distally from the identified “first portion”), the second portion is configured to engage tissue of the anatomical defect (see Para. [0035], [0042] and [0056] mentioning wherein the device is configured to be implanted within and engage (via barbs 250) the walls of the vasculature of a patient);
wherein the first portion comprises a first set of barbs extending radially-outwardly along the circumference thereof (see Examiner’s Diagram of Bödewadt Fig. 5 above showing two barbs (250) disposed along the radially-outward circumference of the “first portion”) and the second portion comprises a second set of barbs (see Examiner’s Diagram of Bödewadt Fig. 5 above showing two barbs (250) disposed along the radially-outward circumference of the “second portion”) configured to engage with the tissue within which the device is implanted (see Para. [0056]), the increased number of barbs increasing the engagement ability of the device.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Favreau to comprise a first plurality of barbs positioned along the radially-outward circumference of the “first portion” and a second plurality of barbs positioned along the radially-outward circumference of the “second portion” of as disclosed by Bödewadt (see Bödewadt Para. [0056] and Figs. 5-6) to improve the engaging ability of the device through the addition of more tissue-engaging barbs.
Regarding claim 6, the combination of Favreau and Bödewadt discloses the invention of claim 5, Favreau, as modified by Bödewadt, further discloses wherein: the second set of one or more barbs is configured to engage the tissue of the anatomical defect in response to rotation of the second portion in the second circumferential direction (see Favreau Abstract and Para. [0018], [0054] and [0061] and Figs. 3A-3B and 9 showing and mentioning wherein the barbs of Favreau are configured to engage the target tissue during rotation of the device such that the intermediate, central portion is able to twist while the portions comprising the anchoring barbs provide anchor points to facilitate this twisting); see also Bödewadt Para. [0056]), and while engaging the tissue of the anatomical defect (Favreau Abstract and Para. [0018], [0054] and [0061]; see also Favreau Figs. 3A-3B and 9 showing wherein the device is rotated via elongate member 200 while disposed within the target tissue “T”), the second portion is configured to be reduced in diameter to close the anatomical defect in response to rotation of the first portion in the second circumferential direction (see Favreau Abstract and Para. [0018], [0040]-[0041], [0052] and [0054] and Figs. 3A-3B showing wherein the intermediate region, disposed along both the “First portion” and “second portion” is configured to be twisted to reduce the diameter thereof).
Regarding claim 7, the combination of Favreau and Bödewadt disclose the invention of claim 6, Favreau, as modified by Bödewadt, further discloses wherein the first set of one or more barbs are configured to engage the body tissue to prevent rotation of the first portion and the second portion in the first circumferential direction (as the barbs engage with tissue (see Favreau Figs. 3A-3B and 9), a certain amount of force is required to cause rotation of the stent device of Favreau due to the barbs disposed thereon are engaged with tissue, thereby making rotation in a circumferential direction more difficult; these barbs provide an anchor point which prevents the larger-diameter terminal ends from rotating while the intermediate region 106 is permitted to rotate relative to theses anchor points, resulting in the device twisting and constricting in diameter as opposed to having the whole device merely rotate in-place).
Regarding claim 8, Favreau discloses all of the limitations of the invention of claim 1, Favreau further discloses at least one barb (see Para. [0061] and Fig. 9 showing barb(s) 110) disposed along the length of the device and configured to engage the tissue of an anatomical defect (see Para. [0061] and Fig. 9).
However, while Favreau discloses wherein additional “barbs” may be present along the exterior surface of the device (see Fig. 9 and Para. [0061]), Favreau does not provide an express disclosure of multiple barbs positioned along the device and thus does not expressly disclose a first set of one or more barbs extending from the first portion; and a second set of one or more barbs extending from the second portion.
In the same field of endeavor, namely constricting stent devices, Bödewadt teaches a device for implantation at an anatomical defect in or through body tissue (device 200, see Figs. 5-6; the embodiment of Figs. 5-6 is substantially similar to the embodiment shown in Figs. 1-4 per Para. [0051]), the device comprising:
a first portion (see Examiner’s Diagram of Bödewadt Fig. 5 above designation a “first portion” of the device of Bödewadt) configured to engage the body tissue (see Para. [0035], [0042] and [0056] mentioning wherein the device is configured to be implanted within and engage (via barbs 250) the walls of the vasculature of a patient); and
a second portion extending distally from the first portion (see Examiner’s Diagram of Bödewadt Fig. 5 above illustrating wherein a designated “second portion” extends distally from the identified “first portion”), the second portion is configured to engage tissue of the anatomical defect (see Para. [0035], [0042] and [0056] mentioning wherein the device is configured to be implanted within and engage (via barbs 250) the walls of the vasculature of a patient);
wherein the first portion comprises a first set of barbs extending along the circumference thereof (see Examiner’s Diagram of Bödewadt Fig. 5 above showing two barbs (250) disposed along the circumference of the “first portion”) and the second portion comprises a second set of barbs (see Examiner’s Diagram of Bödewadt Fig. 5 above showing two barbs (250) disposed along the circumference of the “second portion”) configured to engage with the tissue within which the device is implanted (see Para. [0056]), the increased number of barbs increasing the engagement ability of the device.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Favreau to comprise a first plurality of barbs positioned along the circumference of the “first portion” and a second plurality of barbs positioned along the circumference of the “second portion” of as disclosed by Bödewadt (see Bödewadt Para. [0056] and Figs. 5-6) to improve the engaging ability of the device through the addition of more tissue-engaging barbs.
Regarding claim 20, Favreau discloses all of the limitations of the method of claim 17.
While Favreau discloses wherein additional barbs may be disposed along the exterior of the device for securing the implanted device to the target tissue (see Para. [0061]), does not expressly disclose wherein engaging barbs extend from the first portion of the medical device to aid in securing the device to the target tissue of the anatomical defect.
In the same field of endeavor, namely constricting stent devices, Bödewadt teaches a device for implantation at an anatomical defect in or through body tissue (device 200, see Figs. 5-6; the embodiment of Figs. 5-6 is substantially similar to the embodiment shown in Figs. 1-4 per Para. [0051]), the device comprising:
a first portion (see Examiner’s Diagram of Bödewadt Fig. 5 above designation a “first portion” of the device of Bödewadt) configured to engage the body tissue (see Para. [0035], [0042] and [0056] mentioning wherein the device is configured to be implanted within and engage (via barbs 250) the walls of the vasculature of a patient); and
a second portion extending distally from the first portion (see Examiner’s Diagram of Bödewadt Fig. 5 above illustrating wherein a designated “second portion” extends distally from the identified “first portion”), the second portion is configured to engage tissue of the anatomical defect (see Para. [0035], [0042] and [0056] mentioning wherein the device is configured to be implanted within and engage (via barbs 250) the walls of the vasculature of a patient);
wherein the first portion comprises a first set of barbs extending along the radially-outward circumference thereof (see Examiner’s Diagram of Bödewadt Fig. 5 above showing two barbs (250) disposed along the radially-outward circumference of the “first portion”) and the second portion comprises a second set of barbs (see Examiner’s Diagram of Bödewadt Fig. 5 above showing two barbs (250) disposed along the radially-outward circumference of the “second portion”) configured to engage with the tissue within which the device is implanted (see Para. [0056]), the increased number of barbs increasing the engagement ability of the device.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device of Favreau to comprise a first plurality of barbs positioned along the radially-outward circumference of the “first portion” and a second plurality of barbs positioned along the radially-outward circumference of the “second portion” of as disclosed by Bödewadt (see Bödewadt Para. [0056] and Figs. 5-6) to improve the engaging ability of the device through the addition of more tissue-engaging barbs.
Claim(s) 10 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Favreau (US 2022/0370222 A1) (previously of record) in view of Folan (US 2019/0365549 A1) (previously of record).
Regarding claim 10, Favreau discloses all of the limitations of the invention of claim 1.
However, while Favreau discloses wherein the passage of the stent device may be constricted by twisting or using a separate closure element such as a suture (see Para. [0041], [0052]-[0053] and [0066]), Favreau does not provide an express disclosure of a cord wrapped about the second portion and extending proximal of the first portion, and wherein the cord causes the second portion to be reduced in diameter in response to a tension applied to the cord.
In the same field of endeavor, namely constricting stent devices, Folan teaches a stent (stent 300, see Figs. 12-14)) that is configured to transition from an expanded state (see Fig. 13) to a constricted state (see Fig. 14) by means of a cord (suture 320, see Figs. 13-14 and Para. [0120]) extending from one end of the stent to the opposite end thereof (see Figs. 12-14 and Para. [0190]-[0120]), wherein applying tension to said cord causes the stent to transition from said expanded state to said constricted state (see Para. [0120]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the stent body of Favreau to have incorporated a suture embedded along a length thereof as taught and suggested by Folan to, in this case, provide a known means of constricting the radial dimension of a stent body by applying tension to said suture thread (see Folan Para. [0120] and Figs. 12-14). Since Favreau provides a disclosure of wherein the stent is twisted to cause the intermediate portion of the stent to constrict (see Para. [0041], [0052]-[0053]) but does not provide adequate details pertaining to the mechanism of this constricting force outside of a broad disclosure of wherein elongate element 200 rotates to “adjust” or “expand” the diameter of the stent device, one of ordinary skill in the art would have looked to the prior art to incorporate a known constricting method into the device of Favreau to accomplish the disclosed function. The resulting device would have the elongate element 200 attached to said suture to cause constriction of the stent body via rotation of the elongate element, applying tension to the suture and constricting the stent body.
Regarding claim 19, Favreau discloses all of the limitations of the method of claim 17.
However, while Favreau discloses wherein the passage of the stent device may be constricted by twisting or using a separate closure element such as a suture (see Para. [0041], [0052]-[0053] and [0066]), Favreau does not provide an express disclosure of wherein reducing the diameter of the elongate portion comprises applying a tension to a cord wrapped about the elongate portion.
In the same field of endeavor, namely constricting stent devices, Folan teaches a stent (stent 300, see Figs. 12-14)) that is configured to transition from an expanded state (see Fig. 13) to a constricted state (see Fig. 14) by means of a cord (suture 320, see Figs. 13-14 and Para. [0120]) extending from one end of the stent to the opposite end thereof (see Figs. 12-14 and Para. [0190]-[0120]), wherein applying tension to said cord causes the stent to transition from said expanded state to said constricted state (see Para. [0120]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the stent body of Favreau to have incorporated a suture embedded along a length thereof as taught and suggested by Folan to, in this case, provide a known means of constricting the radial dimension of a stent body by applying tension to said suture thread (see Folan Para. [0120] and Figs. 12-14). Since Favreau provides a disclosure of wherein the stent is twisted to cause the intermediate portion of the stent to constrict (see Para. [0041], [0052]-[0053]) but does not provide adequate details pertaining to the mechanism of this constricting force outside of a broad disclosure of wherein elongate element 200 rotates to “adjust” or “expand” the diameter of the stent device, one of ordinary skill in the art would have looked to the prior art to incorporate a known constricting method into the device of Favreau to accomplish the disclosed function. The resulting device would have the elongate element 200 attached to said suture to cause constriction of the stent body via rotation of the elongate element, applying tension to the suture and constricting the stent body.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Favreau (US 2022/0370222 A1) (previously of record) in view of Folan (US 2019/0365549 A1) (previously of record), further in view of Gray (US 2018/0361127 A1) (previously of record), further in view of Green (US 2021/0045731 A1) (previously of record).
Regarding claim 11, the combination of Favreau and Folan disclose all of the limitations of the invention of claim 10.
However, neither Favreau nor Folan expressly disclose a clip, and wherein the clip is configured to be secured to the cord at a location proximate the first portion when a tension is applied to the cord to maintain the tension on the cord.
In the same field of endeavor, namely expandable stent devices, Gray teaches a stent (see Fig. 6A) having a thread (filament 160, see Fig. 6A) attached thereto and configured to undergo tension (see Para. [0036]-[0038]) to cause the stent to transition from an expanded state to a collapsed state (see Para. [0036]-[0038]), wherein the stent is provided with a locking means (locking means 166, see Figs. 6A-6B) configured to securingly receive/engage a portion of the filament after experiencing a desired amount of tension to maintain the thread in a desired amount of tension, thereby maintaining the stent at a desired amount of contraction (see Figs. 6A-6B and Para. [0036]-[0038]), wherein the locking means may be in the form of a cleat, tie-off or any other securing means known in the art (see Para. [0036]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the stent body of Favreau, as modified by Folan, to have included a suture/filament thread securement means thereon as taught and suggested by Gray to, in this case, securingly receive/engage the suture/filament thread at a desired amount of tension, securing the stent body at a desired amount of constriction (see Gray Para. [0036]-[0038]).
In the relevant field of endeavor of maintaining tension within a suture for a medical device, Green teaches wherein, in medical devices, an alligator clip (clip 425, see Fig. 16C) may be applied to a device to grasp a suture filament to hold a suture filament at a desired tension (see Para. [0132] and Fig. 16C).
It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of modifying the suture/filament locking means of Gray, as incorporated into the device of Favreau, to be in the form of a clip as disclosed by Green. Since Gray provides an express disclosure of wherein the suture/filament locking means may comprise different structure(s) not limited to the disclosure (see Gray Para. [0036] mentioning wherein the locking means may be any of a cleat, tie-off or any other known means), one of ordinary skill in the art would have expected the locking means of Gray, as incorporated into the device of Favreau, to function equally well with either a cleat, tie-off of clip since the structure of said locking means is not critical to the function of the locking means disclosed by Gray. So long as the locking mechanism is configured to hold a suture/filament at a desired tension within a surgical setting, the locking mechanism of Gray is understood to be interchangeable for other suture/filament locking means within the surgical art.
Regarding claim 12, the combination of Favreau and Folan disclose all of the limitations of the invention of claim 10.
However, neither Favreau nor Folan expressly disclose wherein the first portion includes a wedge configured to receive the cord after the tension is applied to the cord and maintain the tension on the cord.
In the same field of endeavor, namely expandable stent devices, Gray teaches a stent (see Fig. 6A) having a thread (filament 160, see Fig. 6A) attached thereto and configured to undergo tension (see Para. [0036]-[0038]) to cause the stent to transition from an expanded state to a collapsed state (see Para. [0036]-[0038]), wherein the stent is provided with a locking means (locking means 166, see Figs. 6A-6B) configured to securingly receive/engage a portion of the filament after experiencing a desired amount of tension to maintain the thread in a desired amount of tension, thereby maintaining the stent at a desired amount of contraction (see Figs. 6A-6B and Para. [0036]-[0038]), wherein the locking means may be in the form of a cleat, tie-off or any other securing means known in the art (see Para. [0036]).
It would have been obvious toe one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the stent body of Favreau, as modified by Folan, to have included a suture/filament thread securement means within the first portion thereof as taught and suggested by Gray to, in this case, securingly receive/engage the suture/filament thread at a desired amount of tension, securing the stent body at a desired amount of constriction (see Gray Para. [0036]-[0038]).
In the relevant field of endeavor of maintaining tension within a suture for a medical device, Green teaches wherein, in medical devices, an a locking wedge (wedge having groove 428, see Fig. 16D) may be applied to a device to grasp a suture filament to hold a suture filament at a desired tension (see Para. [0133] and Fig. 16D).
It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of modifying the suture/filament locking means of Gray, as incorporated into the device of Favreau, to be in the form of a locking wedge having a V-shaped groove as disclosed by Green. Since Gray provides an express disclosure of wherein the suture/filament locking means may comprise different structure(s) not limited to the disclosure (see Gray Para. [0036] mentioning wherein the locking means may be any of a cleat, tie-off or any other known means), one of ordinary skill in the art would have expected the locking means of Gray, as incorporated into the device of Favreau, to function equally well with either a cleat, tie-off of V-shaped wedge since the structure of said locking means is not critical to the function of the locking means disclosed by Gray. So long as the locking mechanism is configured to hold a suture/filament at a desired tension within a surgical setting, the locking mechanism of Gray is understood to be interchangeable for other suture/filament locking means within the surgical art.
Claim(s) 14, 16 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Favreau (US 2022/0370222 A1) (previously of record) in view of Gupta (US 2021/0244523 A1) (previously of record), further in view of Folan (US 2019/0365549 A1) (previously of record).
Regarding claim 14, Favreau discloses:
A system for implanting an implantable device in an anatomical defect at or through body tissue (see Fig. 1), the system comprising:
an elongate tube configured for insertion to the body tissue proximate the anatomical defect (delivery catheter/endoscope, see Para. [0021] and [0049]);
a deployment device (elongated element 200, see Fig. 3B);
an implantable medical device (device 100, see Fig. 2) configured to engage the deployment device (see Fig. 3B and Para. [0053]);
the implantable medical device configured to be received within the elongate tube (see Para. [0021] and [0049] mentioning wherein the device 100 is delivered to a target site through a delivery catheter/endoscope) comprising:
a first portion (see Examiner’s Diagram of Fig. 2 below designation a “first portion” of the device of Favreau) configured to engage the body tissue (see Para. [0061] mentioning wherein the device is configured to be implanted within and engage (via barbs) the internal tissue of a patient; see also Fig. 3A-3B and 9 showing wherein the device is in abutting contact with the target tissue); and
a second portion extending distally from the first portion (see Examiner’s Diagram of Fig. 2 below illustrating wherein a designated “second portion” extends distally from the identified “first portion”), the second portion being tubular with a lumen extending therethrough (see Examiner’s Diagram of Fig. 2 below showing wherein the “second portion” comprises a tubular shape (see also Para. [0052]-[0053] mentioning wherein the device 100 is “tubular”) and comprises a lumen 105 through which to receive at least elongated element 200 as shown in Fig. 3A-3B), the second portion being movable between an expanded diameter deployed configuration in which the lumen is open (see Figs. 3A-3B showing varied “open” configurations), an a reduced diameter twisted configuration in which the lumen is closed (see Para. [0007], [0011], [0018], [0040], [0041], [0045] and [0052]-[0054] mentioning wherein the device is configured to transition, via twisting, between open and closed configurations; wherein the “closed “configuration may be either completely closed or only partially closed), the second portion is configured to be radially collapsed into the reduced diameter configuration (see Figs. 3A-3B showing wherein intermediate region 106 (which has regions disposed along both the “first portion” and “second portion” as shown in Examiner’s Diagram of Fig. 2 below) is configured to expand and contract between a larger-diameter and smaller-diameter configuration; see also Para. [0007], [0011], [0018], [0040], [0041], [0045] and [0052]-[0054] mentioning this function) in response to rotation of the first portion relative to the second portion while engaging tissue of the anatomical defect to close the anatomical defect (see Para. [0061] mentioning wherein barbs are disposed along the exterior of the distal end 102 of the retention member (see also Fig. 9) to engage with and anchor the distal end (i.e., enlarged-diameter “second portion”) of the device to the desired tissue; elongate element 200 may be inserted into the lumen 105 of device 100 to twist and “adjust” the amount of constriction/expansion of the intermediate portion 106 of the device while the device remains engaged with (via direct contact) tissue as seen in Figs. 3A-3B; with the distal portion (i.e., the enlarged-diameter “second portion”) anchored to tissue by the barbs, the portion of the intermediate region 106 lying in the “first portion” and portion of the enlarged proximal end of the “first portion” connecting thereto would rotate relative to the enlarged-diameter distal end of the “second portion” 102 (this can also be seen in the rotation arrows shown in Fig. 3A-3B in which no rotation is shown to occur at the distal end of the device); as elongate element 200 is the only disclosed means for twisting the device, the elongate element is seen to be responsible for both expanding and contracting the device via rotation);
the anatomical defect having a first opening, a second opening, and a passage extending between the first opening and the second opening (see Figs. 3A-3B showing wherein tissue “T” within which the device of Favreau is disposed comprises a first and second opening with a passage extending therebetween to allow the device of Favreau to be disposed therein).
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Examiner’s Diagram of Fig. 2
However, while Favreau discloses wherein elongate element 200 is configured to “adjust” or “expand” the diameter of the stent device (see Para. [0040]-[0042], [0045] and [0052]-[0053]) by providing a twisting force which is configured to constrict or expand the intermediate portion of the stent device (see Para. [0040]-[0042], [0045] and [0052]), in addition to wherein the stent device is configured to be navigated to a target site through a delivery catheter/endoscope (see Para. [0021] and [0049]), Favreau does not expressly disclose an exact methods or means of deploying said stent device from the delivery catheter/endoscope in sufficient detail as to the steps required to perform such an action and thus does not expressly disclose:
wherein the deployment device is configured to be received within the elongate tube;
wherein the deployment device is configured to advance the second portion of the implantable medical device out of the elongate tube to said anatomical defect;
wherein the deployment device is configured to be actuated to engage the first portion to navigate the implantable medical device to a target location in a deployed configuration having the expanded diameter within the anatomical defect and to then rotate the first portion relative to the second portion to reduce a diameter of the second portion of the implantable medical device within the anatomical defect to the reduced diameter, thereby closing the anatomical defect.
In the same field of endeavor, namely collapsible stent devices, Gupta teaches a collapsible stent device (see Fig. 9C) comprising flared proximal and distal ends (see Fig. 9C) and a collapsible middle portion disposed therebetween (see Fig. 9C and Para. [0045]); and, wherein during delivery, the stent is disposed within an outer delivery sheath (outer sheath 305, see Figs. 3-5 and Para. [0031]-[0032]) having an inner tubular member (inner member 315, see Figs. 3-5 and Para. [0031]-[0032]) inserted through the entirety of the stent device which comprises a plurality of protrusions and recesses along the length thereof configured to retain the stent device until navigated to a desired tissue location (see Para. [0031]-[0032]).
Since Favreau does not expressly disclose an exact method pertaining to how the stent is delivered to a target site aside from wherein the stent is fit within a working channel of a delivery catheter or endoscope (see Para. [0021] and [0049]), it would have been obvious to one of ordinary skill in the art to look to the prior art for known methods of deploying an expandable/collapsible stent utilizing an outer delivery catheter and inner tubular member, since those are the mechanisms disclosed to be part of the delivery/manipulation system of Favreau. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the delivery catheter and elongated element of Favreau to be utilized to deliver the stent device of Favreau, in the method disclosed by Gupta, wherein the stent device of Favreau disposed within a working channel of the delivery catheter with the inner elongated element disposed through the lumen of the stent device (i.e., engaging at least “the first portion” since this is disclosed to be the side of the device the elongate element is inserted into per Para. [0052]-[0053]) to retain the stent device thereon during delivery, until such time as the stent device has been navigated to a desired location and the outer delivery catheter is withdrawn (see Gupta Para. [0031]-[0032]). Since the device of Favreau needs to have at least a partially open lumen to allow the engaging member 200 to be inserted therein, the device is understood to be delivered to the target tissue in at least a partially expanded configuration. Upon delivery, the engaging member of Favreau may then be utilized to twist and collapse the device as normal per the recitation in Para. see Para. [0040]-[0042], [0045] and [0053]-[0055].
However, while Favreau discloses wherein the inner elongated member is configured to “adjust” the diameter of the stent device (see Para. [0040]-[0042], [0045] and [0053]-[0055]) by twisting the stent device, Favreau focuses on the elongate element’s ability to “expand” the stent device diameter while remaining substantially silent in regards to how the elongate element “constricts” the diameter of the stent device aside from the broad disclosure of “twisting” or “utilizing an addition closure element, such as a suture (see Para. [0040]-[0042], [0045], [0052]-[0053] and [0064] and [0066]). Therefore, Favreau does not adequately disclose wherein the deployment device (i.e., elongated element 200) is configured to reduce the diameter of the stent device from a first diameter to a second diameter.
In the same field of endeavor, namely constricting stent devices, Folan teaches a stent (stent 300, see Figs. 12-14)) that is configured to transition from an expanded state (see Fig. 13) to a constricted state (see Fig. 14) by means of a cord (suture 320, see Figs. 13-14 and Para. [0120]) extending from one end of the stent to the opposite end thereof (see Figs. 12-14 and Para. [0190]-[0120]), wherein applying tension to said cord causes the stent to transition from said expanded state to said constricted state (see Para. [0120]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the stent body of Favreau to have incorporated a suture embedded along a length thereof as taught and suggested by Folan to, in this case, provide a known means of constricting the radial dimension of a stent body by applying tension to said suture thread (see Folan Para. [0120] and Figs. 12-14). Since Favreau provides a disclosure of wherein the stent is twisted to cause the intermediate portion of the stent to constrict (see Para. [0041], [0045] and [0052]-[0053]) but does not provide adequate details pertaining to the mechanism of this constricting force outside of a broad disclosure of wherein elongate element 200 twists the stent device body to “adjust” or “expand” the diameter of the stent device, one of ordinary skill in the art would have looked to the prior art to incorporate a known constricting method into the device of Favreau to accomplish the disclosed function. The resulting device would have the elongate element 200 attached to said suture to cause constriction of the stent body via twisting/rotation of the elongate element, applying tension to the suture and constricting the stent body.
Regarding claim 16, the combination of Favreau, Gupta and Folan disclose the invention of claim 14, Favreau, as modified by Folan, further discloses wherein: the implantable medical device comprises a cord wrapped about the second portion (filament cord of Folan, as incorporated into the device of Favreau, is wrapped around the body of the stent device as shown in Folan Figs. 12-14); and the deployment device is configured to engage the cord and apply a tension to the cord to reduce the diameter of the second portion of the implantable medical device to the second diameter (elongate element 200 of Favreau is configured to rotate and twist the body of the stent device by applying tension to the suture of Folan, as incorporated into the device of Favreau).
Regarding claim 22, the combination of Favreau, Gupta and Folan discloses all of the limitations of the invention of claim 14, Favreau further discloses wherein the first portion has a flange shape (see Fig. 3A-3B showing wherein the larger-diameter portion of the “first portion” comprises a flange shape; see also Para. [0051] describing the enlarged terminal ends as “flanges”), wherein the first portion acts as a barrier that prevents fluid or material from passing through the anatomical defect when the device is implanted within the anatomical defect (see Para.[0040]-[0043], [0045], [0052]-[0053] mentioning wherein the intermediate portion (i.e., portion 106 extending between the “first portion” and “second portion” may be either partially closed completely closed, blocking all material from passing through the anatomical defect when the device is implanted therein).
Favreau does not indicate the relative radial dimensions of the enlarged terminal ends of the device serve any specific purpose or function, indicating that the first and second ends “may be widened and are preferably are formed to be sufficiently wide and to have enough retention strength to hold the adjustable tubular device 100 in place…The retention members 102, 104 may any of a variety of shapes, such as concave, convex, disc-shaped, cylindrical (e.g., having a longer longitudinal extent then illustrated), etc., or other configurations, the particular shape and configuration not being limited by the present disclosure” (see Para. [0051]).
However, Favreau does not expressly disclose wherein flange-shape of the first portion extends radially beyond an outer diameter of the second portion in both the reduced diameter and the expanded diameter.
In the same field of endeavor, namely collapsible stent devices, Gupta further teaches a collapsible stent device (see Fig. 9A) comprising a flared “first end” (flange 710’, see Fig. 9A) and a flared “second end” (flange 705’, see Fig. 9A) and a collapsible middle portion disposed therebetween (see Fig. 9A and Para. [0045]); wherein the two enlarged ends may have diameters that are either equal, or different diameters so long as the diameters exceed the size of the opening in the anatomical defect through which the device is implanted (see Para. [0035]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of one known terminal flange arrangement for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of having formed the enlarged-diameter section of the “first portion” of Favreau with a diameter that is larger than that of the enlarged-diameter section of the “second portion” as disclosed as an alternative, interchangeable flange arrangement by Gupta. Since Favreau does not disclose any criticality to the relative sizes of the two enlarged-diameter terminal ends aside from being sized to have retention strength to hold the adjustable tubular device 100 in place (see Para. [0051]), one of ordinary skill in the art would have expected the device of Favreau to function equally well should the larger-diameter section of the “first portion” have a larger diameter than the enlarged-diameter section of the “second portion” as disclosed by Gupta. Further, Gupta provide an express recitation that a similar stent configured to be placed across an anatomical defect may have enlarged-diameter terminal ends that are either of equal diameter or of different diameters without affecting the function of the device (see Gupta Para. [0035]).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Favreau (US 2022/0370222 A1) (previously of record) in view of Gupta (US 2021/0244523 A1) (previously of record).
Regarding claim 21, Favreau discloses all of the limitations of the invention of claim 1, Favreau further discloses wherein the first portion has a flange shape (see Fig. 3A-3B showing wherein the larger-diameter portion of the “first portion” comprises a flange shape; see also Para. [0051] describing the enlarged terminal ends as “flanges”), wherein the first portion acts as a barrier that prevents fluid or material from passing through the anatomical defect when the device is implanted within the anatomical defect (see Para.[0040]-[0043], [0045], [0052]-[0053] mentioning wherein the intermediate portion (i.e., portion 106 extending between the “first portion” and “second portion” may be either partially closed completely closed, blocking all material from passing through the anatomical defect when the device is implanted therein).
Favreau does not indicate the relative radial dimensions of the enlarged terminal ends of the device serve any specific purpose or function, indicating that the first and second ends “may be widened and are preferably are formed to be sufficiently wide and to have enough retention strength to hold the adjustable tubular device 100 in place…The retention members 102, 104 may any of a variety of shapes, such as concave, convex, disc-shaped, cylindrical (e.g., having a longer longitudinal extent then illustrated), etc., or other configurations, the particular shape and configuration not being limited by the present disclosure” (see Para. [0051]).
However, Favreau does not expressly disclose wherein flange-shape of the first portion extends radially beyond an outer diameter of the second portion in both the reduced diameter and the expanded diameter.
In the same field of endeavor, namely collapsible stent devices, Gupta teaches a collapsible stent device (see Fig. 9A) comprising a flared “first end” (flange 710’, see Fig. 9A) and a flared “second end” (flange 705’, see Fig. 9A) and a collapsible middle portion disposed therebetween (see Fig. 9A and Para. [0045]); wherein the two enlarged ends may have diameters that are either equal, or different diameters so long as the diameters exceed the size of the opening in the anatomical defect through which the device is implanted (see Para. [0035]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of one known terminal flange arrangement for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of having formed the enlarged-diameter section of the “first portion” of Favreau with a diameter that is larger than that of the enlarged-diameter section of the “second portion” as disclosed as an alternative, interchangeable flange arrangement by Gupta. Since Favreau does not disclose any criticality to the relative sizes of the two enlarged-diameter terminal ends aside from being sized to have retention strength to hold the adjustable tubular device 100 in place (see Para. [0051]), one of ordinary skill in the art would have expected the device of Favreau to function equally well should the larger-diameter section of the “first portion” have a larger diameter than the enlarged-diameter section of the “second portion” as disclosed by Gupta. Further, Gupta provide an express recitation that a similar stent configured to be placed across an anatomical defect may have enlarged-diameter terminal ends that are either of equal diameter or of different diameters without affecting the function of the device (see Gupta Para. [0035]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2009/0187214 A1 to Amplatz, US 2008/0051830 A1 to Eldenschink, US 2003/0153935 A1 to Mialhe, US 6254633 B1 to Pinchuk, US 12203549 B1 to Freeman and US 9597204 B2 to Benary all disclose collapsible stents comprising a means or feature to maintain tension or collapsed position of the stent and/or a manipulation cable.
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 MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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