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
The amendments, dated 8/3/2026, have overcome:
The objection(s) to claim(s) 1, 9, 12;
The rejection of claim(s) 1-20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph;
The rejection of claim(s) 18-20 under 35 U.S.C. 103 based on Zhang et al. (US 2023/0277311 A1 – as previously cited) and Gregg et al. (US 2013/0116778 A1 – as previously cited);
The aforementioned objections/ rejections have been withdrawn.
Applicant's arguments (see page 8 of Applicant’s response), with respect to the rejection of claim(s) 1-10, 12-17 under 35 U.S.C. 103 based on Zhang et al. (US 2023/0277311 A1 – as previously cited) and Gregg et al. (US 2013/0116778 A1 – as previously cited), filed 8/3/2026, have been fully considered but they are not persuasive.
With respect to claim(s) 1 and 12 (and those that depend therefrom) Applicant argues:
Zhang et al. does not disclose the outer skirt (flow blocking film 413) and the inner skirt (flow blocking film 320) to be attached to each other by the seal (first and second set of stitches) as claimed – instead the outer skirt (flow blocking film 413) and the inner skirt (flow blocking film 320), as disclosed by Zhang et al., are attached to each other in another way. Thus the only motivation for searching for the claim skirt seal (with the first and second set of stitches) is due to hindsight reasoning. Examiner disagrees with this argument. It must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant’s disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Applicant is correct that the outer skirt (flow blocking film 413) and the inner skirt (flow blocking film 320), as disclosed by Zhang et al., are attached to each other by an alternative method from the claim skirt seal (with the first and second set of stitches). However, Zhang et al. specifically discloses the use of the outer skirt (flow blocking film 413) and the inner skirt (flow blocking film 320) to create a seal (Zhang et al. paragraphs [0073, 0114]); and the outer skirt (flow blocking film 413) and the inner skirt (flow blocking film 320) being indirectly coupled to each other via the connection holes (351, 471) (Zhang et al. paragraph [0092]). As such, the knowledge gleaned from Gregg et al. concerning a method of attaching similar materials (flexible graft materials within a vascular prosthesis) which prevents leakage therebetween provide sufficient justification for the reconstruction of the search.
The stitches, as taught by Gregg et al., only couple together adjacent leaflets of a prosthetic valve they do not couple the prosthetic valve to a frame as currently claimed. Examiner disagrees with this argument. In making the combination of Zhang et al. and Gregg et al. Examiner is not using the stitches, as taught by Gregg et al., to connect leaflets of the valve, as disclosed by Zhang et al.. Instead, Examiner is relying on the stitches, as taught by Gregg et al., to connect the outer skirt (flow blocking film 413) and the inner skirt (flow blocking film 320), as disclosed by Zhang et al.. The outer skirt (flow blocking film 413) and the inner skirt (flow blocking film 320), as disclosed by Zhang et al., are indirectly attached to each other (via their connections through the connection holes (351, 471) of the inner and outer portions of their frames), but this indirect attachment must result in a sealed connection therebetween (the entire function of the outer skirt (flow blocking film 413) and the inner skirt (flow blocking film 320) is to prevent leakage). As such, it is considered obvious to one having ordinary skill in the art at the time the invention was made to additionally include the stitches, as taught by Gregg et al., at the edges of the outer skirt (flow blocking film 413) and the inner skirt (flow blocking film 320), as disclosed by Zhang et al., where a sealed connection is already being made/ intended to be made to further ensure that said sealed connection is made thus further preventing what would be a disastrous leakage therebetween. Further, in making the aforementioned combination the stitches, as taught by Gregg et al., would not only go through (stitch through) the edges of the outer skirt (flow blocking film 413) and the inner skirt (flow blocking film 320), as disclosed by Zhang et al., but the stitches would also have go around the connection structures (35, 47) of the inner and outer portion (inner and outer frames 30, 40). Thus the stitches, as taught by Gregg et al., create a connection between the edges of the outer skirt (flow blocking film 413) and the inner skirt (flow blocking film 320) AND the connection structures (35, 47) of the inner and outer portion (inner and outer frames 30, 40), as disclosed by Zhang et al..
Applicant presented no additional meaningful remarks concerning the rejection of claim(s) 11 under 35 U.S.C. 103 based on Zhang et al. (US 2023/0277311 A1 – as previously cited) and Gregg et al. (US 2013/0116778 A1 – as previously cited) and FU et al. (US 2019/0070025 A1 – as previously cited).
Claim Objections
Claim(s) 1 and 12 is/are objected to because of the following informalities:
Within claim 1, line 12: Applicant claims, “a set of first stitches configured to align”; additionally, within claim 1, line 16: Applicant claims, “a set of second stitches coupling”; the aforementioned claim clauses are not grammatically parallel – as both sets of stitches are positively recited (with both either including “configured to” language” or neither).
Within claim 12, line 12: Applicant claims, “a set of first stitches configured to align”; additionally, within claim 12, line 16: Applicant claims, “a set of second stitches coupling”; the aforementioned claim clauses are not grammatically parallel – as both sets of stitches are positively recited (with both either including “configured to” language” or neither).
Appropriate correction is required.
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) 1-8, 10, 12-17, 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 2023/0277311 A1 – as previously cited) in view of Gregg et al. (US 2013/0116778 A1 – as previously cited).
With respect to claim 1:
Zhang et al. discloses the invention substantially as claimed. Specifically, Zhang et al. discloses a transcatheter heart valve prosthesis (prosthetic heart valve 500), as can be seen in figs. 17-19 (paragraph [0114]), comprising:
a frame including:
an inner portion (inner frame 30) configured to support a prosthetic valve component (leaflets 20) (paragraphs [0059, 0064]), and
an outer portion (outer frame 40) coupled to the inner portion (inner frame 30), the outer portion (outer frame 40) being sized to surround the inner portion (inner frame 30) and configured to anchor the prosthesis (prosthetic heart valve 500) (paragraphs [0059, 0072, 0081]);
an inner skirt (flow blocking film 311, 320, 360) disposed within and coupled to the inner portion (inner frame 30), the inner skirt (flow blocking film 311, 320, 360) having a first edge (at outflow end, near inner connection units 350) (paragraphs [0070, 0072-0073, 0077]);
an outer skirt (flow blocking film 413) disposed within and coupled to the outer portion (outer frame 40), the outer skirt (flow blocking film 413) having a first edge (at outflow end, near inner connection units 470) (paragraphs [0091, 0114]); and
the inner skirt (flow blocking film 311, 320, 360) and the outer skirt (flow blocking film 413) form a double sealing thereby reducing the risk of paravalvular leakage (paragraph [0114]).
However, Zhang et al. does not disclose if or how the inner skirt (flow blocking film 311, 320, 360) and the outer skirt (flow blocking film 413) are connected to each other. Specifically, the creation of a skirt seal configured to provide a seal between the first edges (at outflow ends, near inner connection units 350, 470) of the inner skirt (flow blocking film 311, 320, 360) and the outer skirt (flow blocking film 413), the skirt seal including:
a set of first stitches configured to align the first edge (at outflow end, near inner connection units 350) of the inner skirt (flow blocking film 311, 320, 360) with the first edge (at outflow end, near inner connection units 470) of the outer skirt (flow blocking film 413), the set of first stitches forming a seam that is space longitudinally from the first edges (at outflow ends, near inner connection units 350, 470) of the inner and outer skirts (flow blocking film 311, 320, 360, flow blocking film 413), and
a set of second stitches configured to couple the first edge (at outflow end, near inner connection units 350) of the inner skirt (flow blocking film 311, 320, 360) with the first edge (at outflow end, near inner connection units 470) of the outer skirt (flow blocking film 413), the set of second stitches being formed at the first edges (at outflow ends, near inner connection units 350, 470) of the inner and outer skirts (flow blocking film 311, 320, 360, flow blocking film 413), the second set of stitches further coupling the inner skirt (flow blocking film 311, 320, 360) and the outer skirt (flow blocking film 413) to the inner portion (inner frame 30) of the frame,
wherein the first stitches are a first type of stitch, and the second stitches are a second type of stitch different from the first type of stitch.
Gregg et al. teaches a mode of attachment (creating a seal) between edges of two layers of flexible material within a prosthetic heart valve (abstract). The attachment/ seal (plurality of sutures 22) including:
a set of first stitches (first and second running stitches 64a, 64b) configured to align the edges of the two layers of material, the set of first stitches (first and second running stitches 64a, 64b) forming a seam that is disposed/spaced inwardly of the edges of two layers of material (paragraphs [0033-0034]), and
a set of second stitches (first and second pattern of whip stitches 62a, 62b) configured to couple the edges of the two layers of material, the set of second stitches (first and second pattern of whip stitches 62a, 62b) being formed at the edges of the two layers of material (paragraph [0028-0031]),
wherein the first stitches (first and second running stitches 64a, 64b) are a first type of stitch (whipstitches) (paragraphs [0028-0031]), and the second stitches (first and second running stitches 64a, 64b) are a second type of stitch (running stitch) different from the first type of stitch (first and second running stitches 64a, 64b) (paragraph [0033-0034]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the mode of attachment (thereby creating a seal) between edges of two layers of flexible material, as taught by Gregg et al., to connect (thereby creating a seal therebetween) the first edges (at outflow ends, near inner connection units 350, 470) of the inner skirt (flow blocking film 311, 320, 360) and the outer skirt (flow blocking film 413), as disclosed by Zhang et al., as the sealing between the first edges (at outflow ends, near inner connection units 350, 470) of the inner skirt (flow blocking film 311, 320, 360) and the outer skirt (flow blocking film 413), as disclosed by Zhang et al., will require connection, and the sealing connection, as taught by Gregg et al., is a proven methodology within the same art (connection between flexible materials of a heart valve) and would have been an obvious methodology to try. (Please note: In making the aforementioned combination the stitches (first and second running stitches 64a, 64b), as taught by Gregg et al., would not only go through (stitch through) the first edges (at outflow ends, near inner connection units 350, 470) of the inner skirt (flow blocking film 311, 320, 360) and the outer skirt (flow blocking film 413), as disclosed by Zhang et al., but the stitches(first and second running stitches 64a, 64b) would also have go around the connection structures (35, 47) of the inner and outer portions (inner and outer frames 30, 40) of the frame. Thus the stitches (first and second running stitches 64a, 64b), as taught by Gregg et al., create a connection between the edges of the outer skirt (flow blocking film 413) and the inner skirt (flow blocking film 320) AND the connection structures (35, 47) of the inner and outer portion (inner and outer frames 30, 40) of the frame, as disclosed by Zhang et al..)
With respect to claim 2:
Wherein the inner portion (inner frame 30), as disclosed by Zhang et al., has a stent-like structure (inner mesh structure 33) with a second end (at inflow end) and a first end (at outflow end), the stent-like structure (inner mesh structure 33) including a plurality of crowns (at valleys 315B) defining apertures (openings 322) at the first end (at outflow end) (paragraphs [0071-0072]).
With respect to claim 3:
Wherein the outer portion (outer frame 40), as disclosed by Zhang et al., has a stent-like structure (outer mesh structure 44) with a second end (at inflow end 450) and a first end (at outflow end 451), the stent-like structure (outer mesh structure 44) including a plurality of crowns (from which outer connection structure 47 extends) defining apertures (cells 441) at the first end (at outflow end 451) (paragraphs [0082, 0088-0091]).
With respect to claim 4:
Wherein the plurality of the crowns (from which outer connection structure 47 extends) at the first end (at outflow end 451) of the outer portion (outer frame 40) are coupled (incapable of separation) to the plurality of crowns (at valleys 315B) at the first end (at outflow end) of the inner portion (inner frame 30) so as to form a plurality of pairs of adjoining crowns (at valleys 315B, 444B), as disclosed by Zhang et al..
With respect to claim 5:
Wherein the first edge (at outflow end, near inner connection units 350) of the inner skirt (flow blocking film 311, 320, 360) is an outflow edge and the first edge (at outflow end, near inner connection units 470) of the outer skirt (flow blocking film 413) is an outflow edge, as disclosed by Zhang et al..
With respect to claim 6:
Wherein the same number of second stitches (first and second pattern of whip stitches 62a, 62b), as taught by Gregg et al., are disposed within a width of each cell defined by each pair of adjoining crowns (at valleys 315B, 444B), as disclosed by Zhang et al.. (PLEASE NOTE: the space between each pair of adjoining crowns (at valleys 315B, 444B), as disclosed by Zhang et al., as seen in the fig. 8a of Zhang et al. is consistent; additionally, second stitches (first and second pattern of whip stitches 62a, 62b), as taught by Gregg et al., as seen in figs. 5A-6H have a consistent size/ width; as such, when adding the second stitches (first and second pattern of whip stitches 62a, 62b), as taught by Gregg et al., a consistent number will extend between consistently spaced other structures (such as the adjoining crowns (at valleys 315B, 444B), as disclosed by Zhang et al..)
With respect to claim 7:
Wherein exactly three second stitches (first and second pattern of whip stitches 62a, 62b), as taught by Gregg et al., are disposed within a width of each cell defined by each pair of adjoining crowns (at valleys 315B, 444B), as disclosed by Zhang et al.. (PLEASE NOTE: Although the structure, as disclosed by Zheng et al. as modified by Gregg et al., is silent concerning the number of second stitches (first and second pattern of whip stitches 62a, 62b), as taught by Gregg et al., which would be positioned between each pair of adjoining crowns (at valleys 315B, 444B), as disclosed by Zhang et al., this is considered a result effective variable that contributes to the sealing therebetween (thus preventing the paravalvular leakage therebetween). Since this is a result effective variable that contributes to the seal therebetween it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art and modifying the number of second stitches (first and second pattern of whip stitches 62a, 62b), as taught by Gregg et al., would optimized to create the best seal. In re Aller, 105 USPQ 233.)
With respect to claim 8:
Wherein the first type of stitch (first and second running stitches 64a, 64b), as taught by Gregg et al., is a double running stitch or a single running stitch (paragraphs [0033-0034]).
With respect to claim 10:
Wherein the second type (first and second pattern of whip stitches 62a, 62b), as taught by Gregg et al., of stitch is a double whipstitch (paragraph [0028-0031]).
With respect to claim 24:
Wherein the inner portion (inner frame 30), as disclosed by Zhang et al., includes nodes (connection structure 35) adjacent to and spaced longitudinally from the adjoining crowns (from which connection structure 35 extends), wherein the second set of stitches (first and second pattern of whip stitches 62a, 62b), as taught by Gregg et al., couple the inner skirt (flow blocking film 311, 320, 360) and the outer skirt (flow blocking film 413) to the nodes (connection structure 35) (indirectly).
With respect to claim 12:
Zhang et al. discloses the invention substantially as claimed. Specifically, Zhang et al. discloses a transcatheter heart valve prosthesis (prosthetic heart valve 500), as can be seen in figs. 17-19 (paragraph [0114]), comprising:
a frame including:
an inner portion (inner frame 30) having a plurality of crowns (at valleys 315B) at a first end (at outflow end) thereof (paragraphs [0059, 0064, 0071-0072]), and
an outer portion (outer frame 40) having a plurality of crowns (from which outer connection structure 47 extends) at a first end thereof (at outflow end 451) (paragraphs [0082, 0088-0091]), the plurality of crowns (from which outer connection structure 47 extends) of the outer portion (outer frame 40) being coupled to the plurality of crowns (at valleys 315B) of the inner portion (inner frame 30) so as to form a plurality of pairs of adjoining crowns, as can be seen in fig. 5;
a prosthetic heart valve (leaflets 20) coupled to the inner portion (inner frame 30) (paragraphs [0059, 0064]);
an inner skirt (flow blocking film 311, 320, 360) coupled to the inner portion (inner frame 30), the inner skirt (flow blocking film 311, 320, 360) having a first edge (at outflow end, near inner connection units 350) (paragraphs [0070, 0072-0073, 0077]);
an outer skirt (flow blocking film 413) coupled to the outer portion (outer frame 40) and having a first edge (at outflow end, near inner connection units 470) (paragraphs [0091, 0114]);
the inner skirt (flow blocking film 311, 320, 360) and the outer skirt (flow blocking film 413) form a double sealing thereby reducing the risk of paravalvular leakage (paragraph [0114]).
However, Zhang et al. does not disclose if or how the inner skirt (flow blocking film 311, 320, 360) and the outer skirt (flow blocking film 413) are connected to each other. Specifically, the creation of a skirt seal configured to provide a seal between the first edges (at outflow ends, near inner connection units 350, 470) of the inner skirt (flow blocking film 311, 320, 360) and the outer skirt (flow blocking film 413), the skirt seal including:
a set of first stitches configured to align the first edge (at outflow end, near inner connection units 350) of the inner skirt (flow blocking film 311, 320, 360) with the first edge (at outflow end, near inner connection units 470) of the outer skirt (flow blocking film 413), the set of first stitches forming a seam that is spaced longitudinally from the first edges (at outflow ends, near inner connection units 350, 470) of the inner and outer skirts (flow blocking film 311, 320, 360, flow blocking film 413), and
a set of second stitches coupling the first edge (at outflow end, near inner connection units 350) of the inner skirt (flow blocking film 311, 320, 360) with the first edge (at outflow end, near inner connection units 470) of the outer skirt (flow blocking film 413), the set of second stitches being formed at the first edges (at outflow ends, near inner connection units 350, 470) of the inner and outer skirts (flow blocking film 311, 320, 360, flow blocking film 413), the second set of stitches further coupling the inner skirt (flow blocking film 311, 320, 360) and the outer skirt (flow blocking film 413) to the inner portion (inner frame 30) of the frame,
wherein the first stitches are a first type of stitch, and the second stitches are a second type of stitch different from the first type of stitch.
Gregg et al. teaches a mode of attachment (creating a seal) between edges of two layers of flexible material within a prosthetic heart valve (abstract). The attachment/ seal (plurality of sutures 22) including:
a set of first stitches (first and second running stitches 64a, 64b) configured to align the edges of the two layers of material, the set of first stitches (first and second running stitches 64a, 64b) forming a seam that is disposed/spaced inwardly of the edges of two layers of material (paragraphs [0033-0034]), and
a set of second stitches (first and second pattern of whip stitches 62a, 62b) configured to couple the edges of the two layers of material, the set of second stitches (first and second pattern of whip stitches 62a, 62b) being formed at the edges of the two layers of material (paragraph [0028-0031]),
wherein the first stitches (first and second running stitches 64a, 64b) are a first type of stitch (whipstitches) (paragraphs [0028-0031]), and the second stitches (first and second running stitches 64a, 64b) are a second type of stitch (running stitch) different from the first type of stitch (first and second running stitches 64a, 64b) (paragraph [0033-0034]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the mode of attachment (creating a seal) between edges of two layers of flexible material, as taught by Gregg et al., to connect (thereby creating a seal therebetween) the first edges (at outflow ends, near inner connection units 350, 470) of the inner skirt (flow blocking film 311, 320, 360) and the outer skirt (flow blocking film 413), as disclosed by Zhang et al., as the sealing between the first edges (at outflow ends, near inner connection units 350, 470) of the inner skirt (flow blocking film 311, 320, 360) and the outer skirt (flow blocking film 413), as disclosed by Zhang et al., will require connection, and the sealing connection, as taught by Gregg et al., is a proven methodology within the same art (connection between flexible materials of a heart valve) and would have been an obvious methodology to try. (Please note: In making the aforementioned combination the stitches (first and second running stitches 64a, 64b), as taught by Gregg et al., would not only go through (stitch through) the first edges (at outflow ends, near inner connection units 350, 470) of the inner skirt (flow blocking film 311, 320, 360) and the outer skirt (flow blocking film 413), as disclosed by Zhang et al., but the stitches (first and second running stitches 64a, 64b) would also have go around the connection structures (35, 47) of the inner and outer portions (inner and outer frames 30, 40) of the frame. Thus the stitches (first and second running stitches 64a, 64b), as taught by Gregg et al., create a connection between the edges of the outer skirt (flow blocking film 413) and the inner skirt (flow blocking film 320) AND the connection structures (35, 47) of the inner and outer portion (inner and outer frames 30, 40) of the frame, as disclosed by Zhang et al..)
With respect to claim 13:
Wherein the first type of stitch (first and second running stitches 64a, 64b), as taught by Gregg et al., is a double running stitch (paragraphs [0033-0034]).
With respect to claim 14:
Wherein the second type (first and second pattern of whip stitches 62a, 62b), as taught by Gregg et al., of stitch is a double whipstitch (paragraph [0028-0031]).
With respect to claim 15:
Wherein the same number of second stitches (first and second pattern of whip stitches 62a, 62b), as taught by Gregg et al., are disposed within a width of each cell defined by each pair of adjoining crowns (at valleys 315B, 444B), as disclosed by Zhang et al.. (PLEASE NOTE: the space between each pair of adjoining crowns (at valleys 315B, 444B), as disclosed by Zhang et al., as seen in the fig. 8a of Zhang et al. is consistent; additionally, second stitches (first and second pattern of whip stitches 62a, 62b), as taught by Gregg et al., as seen in figs. 5A-6H have a consistent size/ width; as such, when adding the second stitches (first and second pattern of whip stitches 62a, 62b), as taught by Gregg et al., a consistent number will extend between consistently spaced other structures (such as the adjoining crowns (at valleys 315B, 444B), as disclosed by Zhang et al..)
With respect to claim 16:
Wherein exactly three second stitches (first and second pattern of whip stitches 62a, 62b), as taught by Gregg et al., are disposed within the width of each cell defined by each pair of adjoining crowns (at valleys 315B, 444B), as disclosed by Zhang et al.. (PLEASE NOTE: Although the structure, as disclosed by Zheng et al. as modified by Gregg et al., is silent concerning the number of second stitches (first and second pattern of whip stitches 62a, 62b), as taught by Gregg et al., which would be positioned between each pair of adjoining crowns (at valleys 315B, 444B), as disclosed by Zhang et al., this is considered a result effective variable that contributes to the sealing therebetween (thus preventing the paravalvular leakage therebetween). Since this is a result effective variable that contributes to the seal therebetween it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art and modifying the number of second stitches (first and second pattern of whip stitches 62a, 62b), as taught by Gregg et al., would optimized to create the best seal. In re Aller, 105 USPQ 233.)
With respect to claim 17:
Wherein the first edge (at outflow end, near inner connection units 350) of the inner skirt (flow blocking film 311, 320, 360) is an outflow edge and the first edge (at outflow end, near inner connection units 470) of the outer skirt (flow blocking film 413) is an outflow edge, as disclosed by Zhang et al..
With respect to claim 25:
Wherein the inner portion (inner frame 30), as disclosed by Zhang et al., includes nodes (connection structure 35) adjacent to and spaced longitudinally from the adjoining crowns (from which connection structure 35 extends), wherein the second set of stitches (first and second pattern of whip stitches 62a, 62b), as taught by Gregg et al., couple the inner skirt (flow blocking film 311, 320, 360) and the outer skirt (flow blocking film 413) to the nodes (connection structure 35) (indirectly).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 2023/0277311 A1 -as previously cited) as modified by Gregg et al. (US 2013/0116778 A1 – as previously cited) as applied to claim(s) 1-8, 10, 12-17, 24-25 above, and further in view of FU et al. (US 2019/0070025 A1 – as previously cited).
With respect to claim 11:
Zhang et al. as modified by Gregg et al. discloses the invention substantially as claimed, as discussed above. However, Zhang et al. as modified by Gregg et al. does not disclose the diameter of the sutures used to make the first stitches (first and second running stitches 64a, 64b) and the second stitches (first and second running stitches 64a, 64b), as taught by Gregg et al..
FU et al. teaches a prosthesis, as can be seen in figs. 2a, comprising a frame (annular stent 120) and a graft (membrane 150) connected by a suture (suture 101), the suture has a diameter of 50-250 μm (0.05-0.25 mm) (paragraph [0077]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the 50-250 μm diameter suture, as taught by FU et al., for the first stitches (first and second running stitches 64a, 64b) and the second stitches (first and second running stitches 64a, 64b), as taught by Gregg et al., as both sutures are used to join structures within vascular prosthesis and a such should be made from the same/ similar/ interchangeable materials (including the dimensions therefore).
Allowable Subject Matter
Claim(s) 18-23 is/are allowable over the prior art of record.
The following is a statement of reasons for the indication of allowable subject matter: Examiner can find no references alone nor in combination which render obvious:
With respect to claim 18:
A method of manufacturing a heart valve prosthesis comprising:
attaching an inner skirt to an inner stent of a frame, the inner skirt having a first edge;
attaching an outer skirt to an outer stent of a frame, the outer skirt having a first edge;
coupling a first end of the inner stent to a first end of the outer stent;
aligning the first edge of the inner skirt with the first edge of the outer skirt;
coupling the inner skirt to the outer skirt using a set of first stitches and a set of second stitches;
wherein the first set of stitches being spaced longitudinally from the first edges of the inner skirt and the outer skirt;
wherein a plurality of adjoining crowns are defined at the points where the inner stent portion and the outer stent portion are coupled, wherein the first edges of the inner and outer skirts and the second set of stitches are spaced longitudinally from the adjoining crowns (i.e. the connection point of the inner and outer stent which is at the adjoining crowns is longitudinally offset from the first edges of the inner and outer skirts).
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 REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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REBECCA STRASZHEIM PRESTON
Primary Examiner
Art Unit 3774
/REBECCA S PRESTON/Primary Examiner, Art Unit 3774
Prosecution Insights