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 .
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.
Claim Objections
Claim 3 is objected to because of the following informalities: In line 7, “respective first curved longitudinal portion” and in line 10, “respective first curved longitudinal portion” are assumed to be a typo. The examiner suggests amending these informalities to be “ a respective first curved longitudinal portion” and “ a respective second curved longitudinal portion”, and have been examined as such. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: In lines 4-5, “respective curved central longitudinal axes” is assumed to be a typo. The examiner suggests amending these informalities to be “ a respective curved central longitudinal axes”, and has been examined as such. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: In lines 3-4, “respective curved central longitudinal axes” is assumed to be a typo. The examiner suggests amending these informalities to be “ a respective curved central longitudinal axes”, and has been examined as such. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 9-10, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Iamberger et al. (US PG Pub No. 2019/0038405 A1) in view of Morin et al. (US PG Pub No. 2018/0055631 A1).
Regarding claim 1, Iamberger discloses a prosthetic heart valve (Figs. 10A-10B, implant 320b) configured for transcatheter implantation (Fig. 2, catheter 90), the prosthetic heart valve (320b) comprising: a prosthetic valve frame (Figs. 10A-10B, inner frame 330b) that surrounds a central longitudinal axis of the prosthetic heart valve to define a lumen along the axis when the prosthetic heart valve is in an expanded state (Paragraphs [0372 and 0384]); and a plurality of prosthetic leaflets, disposed within the lumen (Paragraph [0041]), and arranged to facilitate one-way inflow-to-outflow (Figs. 10A-10B, upstream end 334b (inflow), downstream end 336b (outflow)) fluid flow through the lumen (Paragraphs [0041, 0372, and 0384]) in a proximal-to-distal (334b, 336b) direction when the prosthetic heart valve is in the expanded state (Paragraphs [0372 and 0384]), wherein the prosthetic valve frame: comprises a plurality of struts (Figs. 10A-10B, joists 28, pairs of joists 108), and is shaped so as to define a plurality of intermediate nodes (Figs. 10A-10B, nodes 102, minor nodes 204, major nodes 106) that are intermediate (Figs. 10A-10B) proximal (334b) and distal ends (336b) of the prosthetic valve frame, wherein each intermediate node (102, 104, 106) has at least four struts (Figs. 10A-10B, Paragraph [0374]) extending therefrom, the at least four struts comprising (a) a distally-extending pair of two struts of the at least four struts (see annotated Fig. 10A below), and (b) a proximally-extending pair of two struts of the at least four struts (see annotated Fig. 10A below), wherein for each pair of circumferentially adjacent intermediate nodes (102, 104, 106): (i) a first distally-extending strut (see annotated Fig. 10A below) that extends from one intermediate node (see annotated Fig. 10A below, 102, 104, 106) of the pair of intermediate nodes (see annotated Fig. 10A below, 102, 104, 106) converges at a distal junction (see annotated Fig. 10A below) with (ii) a second distally-extending strut (see annotated Fig. 10A below) that extends from the other intermediate node (see annotated Fig. 10A below, 102, 104, 106) of the pair of intermediate nodes (see annotated Fig. 10A below, 102, 104, 106), (i) a first proximally-extending strut (see annotated Fig. 10A below) that extends from the one intermediate node (see annotated Fig. 10A below, 102, 104, 106) of the pair of intermediate nodes (see annotated Fig. 10A below, 102, 104, 106) converges at a proximal junction (see annotated Fig. 10A below) with (ii) a second proximally-extending strut (see annotated Fig. 10A below) that extends from the other intermediate node (see annotated Fig. 10A below, 102, 104, 106) of the pair of intermediate nodes (see annotated Fig. 10A below, 102, 104, 106).
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Iamberger fails to disclose wherein a portion of the plurality of struts are intermediate struts, (i) a first intermediate strut extends proximally from an intermediate location along the first distally-extending strut, and (ii) a second intermediate strut extends proximally from an intermediate location along the second distally-extending strut, the intermediate location along the first distally-extending strut being between the one intermediate node and the distal junction, and the intermediate location along the second distally-extending strut being between the other intermediate node and the distal junction, wherein the first and second intermediate struts converge at an intermediate junction that points in a proximal direction, wherein the intermediate junction is intermediate the distal junction and the proximal junction, and wherein the proximal junction, the intermediate junction, and the distal junction are circumferentially aligned, so as to be angularly aligned with respect to the central longitudinal axis, spaced apart in the proximal-to-distal direction.
Morin also discloses a prosthetic heart valve (Fig. 6C, stent 402) configured for transcatheter implantation (Paragraph [0002]), proximally-extending struts (Paragraph [0077], “proximalmost annular row x”, see annotated Fig. 6C below), distally-extending struts (see annotated Fig. 6C below), proximal junction (see annotated Fig. 6C below), distal junction (see annotated Fig. 6C below), and intermediate nodes (see annotated Fig. 6C below). Morin teaches wherein a portion of the plurality of struts are intermediate struts (see annotated Fig. 6C below), (i) a first intermediate strut extends proximally (see annotated Fig. 6C below) from an intermediate location (see annotated Fig. 6C below) along the first distally-extending strut (see annotated Fig. 6C below), and (ii) a second intermediate strut extends proximally from an intermediate location along the second distally-extending strut (see annotated Fig. 6C below), the intermediate location along the first distally-extending strut being between the one intermediate node and the distal junction (see annotated Fig. 6C below), and the intermediate location along the second distally-extending strut being between the other intermediate node and the distal junction (see annotated Fig. 6C below), wherein the first and second intermediate struts converge at an intermediate junction (see annotated Fig. 6C below) that points in a proximal direction (Paragraph [0077], “proximalmost annular row x), wherein the intermediate junction is intermediate the distal junction and the proximal junction (see annotated Fig. 6C below), and wherein the proximal junction, the intermediate junction, and the distal junction are circumferentially aligned (see annotated Fig. 6C below), so as to be angularly aligned with respect to the central longitudinal axis, spaced apart in the proximal-to-distal direction (see annotated Fig. 6C below).
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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 Iamberger’s valve wherein a portion of the plurality of struts are intermediate struts, (i) a first intermediate strut extends proximally from an intermediate location along the first distally-extending strut, and (ii) a second intermediate strut extends proximally from an intermediate location along the second distally-extending strut, the intermediate location along the first distally-extending strut being between the one intermediate node and the distal junction, and the intermediate location along the second distally-extending strut being between the other intermediate node and the distal junction, wherein the first and second intermediate struts converge at an intermediate junction that points in a proximal direction, wherein the intermediate junction is intermediate the distal junction and the proximal junction, and wherein the proximal junction, the intermediate junction, and the distal junction are circumferentially aligned, so as to be angularly aligned with respect to the central longitudinal axis, spaced apart in the proximal-to-distal direction, as taught by Morin, in order to help mitigate paravalvular leakage (Paragraph [0077]), which relates to the radial strength and stiffness of the prosthetic valve.
Regarding claim 2, Iamberger as modified by Morin discloses wherein when the prosthetic heart valve (Fig. 6C, stent 402) is in the expanded state, for each pair of circumferentially adjacent intermediate nodes (see annotated Fig. 6C below): a smaller rhombus (see annotated Fig. 6c below) of the prosthetic valve frame is bounded by (1) distal portions of the first and the second distally-extending struts (see annotated Fig. 6C below), and (2) the first and the second intermediate struts (see annotated Fig. 6C below), and a larger rhombus (see annotated Fig. 6C below) of the prosthetic valve frame is bounded by (1) the first and the second distally-extending struts (see annotated Fig. 6C below), and (2) the first and second proximally-extending struts (see annotated Fig. 6C below), wherein the smaller rhombus is within the larger rhombus (see annotated Fig. 6C below).
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Regarding claim 9, Iamberger in view of Morin discloses wherein each intermediate node (102, 104, 106) has at least six struts extending therefrom (Figs. 9A-10B, Paragraph [0374]), wherein the proximally-extending pair of the two struts defines a first proximally-extending pair of two struts of the at least six struts (see annotated fig. 10A, below), wherein the at least six struts comprise a second proximally-extending pair of two struts of the at least six struts (see annotated fig. 10A, below), wherein the proximal junction defines a first proximal junction (see annotated fig. 10A, below), and wherein for each pair of circumferentially adjacent intermediate nodes (102, 104, 106): (i) a third proximally-extending strut (see annotated fig. 10A, below) that extends from the one intermediate node (see annotated fig. 10A, below) of the pair of intermediate nodes converges at a second proximal junction (see annotated fig. 10A, below) with (ii) a fourth proximally-extending strut (see annotated fig. 10A, below) that extends from the other intermediate node (see annotated fig. 10A, below) of the pair of intermediate nodes, the third proximally-extending strut is proximal to the first proximally-extending strut (see annotated fig. 10A, below), the fourth proximally-extending strut is proximal to the second proximally-extending strut (see annotated fig. 10A, below), the second proximal junction is proximal to the first proximal junction (see annotated fig. 10A, below), and the second proximal junction and the first proximal junction are circumferentially aligned (see annotated fig. 10A, below), so as to be angularly aligned with respect to the central longitudinal axis, spaced apart in the proximal-to-distal direction (Paragraph [0382], Fig. 9A, longitudinal axis ax1).
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Regarding claim 10, Iamberger in view of Morin discloses wherein when the prosthetic heart valve is in the expanded state, for each pair of circumferentially adjacent intermediate nodes (102, 104, 106), a larger rhombus (see annotated fig. 10A, below) of the prosthetic valve frame is bounded by (1) the first and second distally-extending struts (see annotated fig. 10A, below), and (2) the first and second proximally-extending struts (see annotated fig. 10A, below), and a largest rhombus (see annotated fig. 10A, below) of the prosthetic valve frame is bounded by (1) the first and second distally-extending struts (see annotated fig. 10A, below), and (2) the third and fourth proximally-extending struts (see annotated fig. 10A, above), and the larger rhombus is within the largest rhombus (see annotated fig. 10A, below).
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Iamberger as modified by Morin fails to disclose a smaller rhombus of the prosthetic valve frame is bounded by (1) distal portions of the first and second distally-extending struts, and (2) the first and second intermediate struts wherein the smaller rhombus is within the larger rhombus. Morin further teaches a smaller rhombus (see annotated Fig. 6c above) of the prosthetic valve frame is bounded by (1) distal portions of the first and second distally-extending struts (see annotated Fig. 6C below), and (2) the first and second intermediate struts (see annotated Fig. 6C below) wherein the smaller rhombus is within the larger rhombus (see annotated Fig. 6C below). 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 Iamberger’s in view of Morin valve to include a smaller rhombus of the prosthetic valve frame is bounded by (1) distal portions of the first and second distally-extending struts, and (2) the first and second intermediate struts wherein the smaller rhombus is within the larger rhombus, as further taught by Morin, in order to help mitigate paravalvular leakage (Paragraph [0077]), which relates to the radial strength and stiffness of the prosthetic valve.
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Regarding claim 13, Iamberger in view of Morin discloses wherein each intermediate node (102, 104, 106) has at least eight struts extending therefrom (Figs. 9A-10B, Paragraph [0374], “106 connect 6-8 joists”), wherein the distally-extending pair of two struts is a first distally-extending pair of two struts of the at least eight struts (see annotated Fig. 10A below), and wherein for each pair of circumferentially adjacent intermediate nodes (see annotated Fig. 10A below): (i) a third distally-extending strut (see annotated Fig. 10A below) that extends from the one intermediate node (see annotated Fig. 10A below) of the pair of intermediate nodes converges at the distal junction (see annotated Fig. 10A below) with(ii) a fourth distally-extending strut (see annotated Fig. 10A below) that extends from the other intermediate node of the pair of intermediate nodes (see annotated Fig. 10A below), the third distally-extending strut is distal to the first distally-extending strut (see annotated Fig. 10A below), and the fourth distally-extending strut is distal to the second distally-extending strut (see annotated Fig. 10A below).
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Regarding claim 14, Iamberger in view of Morin discloses wherein the prosthetic valve frame (Figs. 10A-10B, implant 320b) is an inner frame (Figs. 10A-10B, inner frame 330b) that surrounds the central longitudinal axis of the prosthetic heart valve to define the lumen along the axis when the prosthetic heart valve is in the expanded state (Paragraphs [0372 and 0384]), and wherein the prosthetic heart valve comprises a prosthetic valve frame assembly (Fig. 10B) comprising the inner frame (330b) and an outer frame (Fig. 10B, outer frame 60) that is coupled to and surrounds the inner frame (Paragraph [0378], Fig. 10B).
Claims 3-8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Iamberger et al. (US PG Pub No. 2019/0038405 A1) in view of Morin et al. (US PG Pub No. 2018/0055631 A1), as applied to claims 1 and 14 above, and further in view of Cooper et al. (US PG pub No. 2019/0262129 A1).
Regarding claim 3, Iamberger as modified by Morin fails to disclose wherein the first and the second intermediate struts have respective sequential longitudinal portions, and wherein when the prosthetic heart valve is in the expanded state, the respective sequential longitudinal portions: extend at an angle of 75 - 105 degrees from respective upstream sides of the first and the second distally-extending struts, respectively, curve partially upstream and partially toward the respective closest intermediate nodes along a respective first curved longitudinal portions of the first and the second intermediate struts, and curve partially upstream and partially away from the respective closest intermediate nodes along a respective second curved longitudinal portions of the first and the second intermediate struts. Cooper also discloses a prosthetic heart valve (Fig. 1, prosthesis 100, Figs. 6A and 7B, outer frame 140, outer frame body 142) comprising a plurality of struts (Figs. 6A and 7B, struts 156), a first intermediate strut (Figs. 6A and 7B, strut 156b, see annotated fig. 7B below), and a second intermediate strut (Figs. 6A and 7B, strut 156b, see annotated fig. 7B below). Cooper teaches wherein the first and the second intermediate struts (156b) have respective sequential longitudinal portions (see annotated fig. 7B below), and wherein when the prosthetic heart valve is in the expanded state (Fig. 1, 100), the respective sequential longitudinal portions (see annotated fig. 7B below): extend at an angle from respective upstream sides of the first and the second distally-extending struts (see annotated fig. 7B below), respectively, curve partially upstream and partially toward the respective closest intermediate nodes (see annotated fig. 7B below) along respective first curved longitudinal portions of the first and the second intermediate struts (see annotated fig. 7B below), and curve partially upstream and partially away from the respective closest intermediate nodes (see annotated fig. 7B below) along respective second curved longitudinal portions of the first and the second intermediate struts (see annotated fig. 7B below). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the intermediate struts of Iamberger as modified by Morin wherein the first and the second intermediate struts have respective sequential longitudinal portions, and wherein when the prosthetic heart valve is in the expanded state, the respective sequential longitudinal portions: extend at an angle from respective upstream sides of the first and the second distally-extending struts, respectively, curve partially upstream and partially toward the respective closest intermediate nodes along respective first curved longitudinal portions of the first and the second intermediate struts, and curve partially upstream and partially away from the respective closest intermediate nodes along respective second curved longitudinal portions of the first and the second intermediate struts, as taught by Cooper, in order to have more even expansion and compression of the valve (Paragraph [0167]).
However, Iamberger as modified by Morin and Cooper does not explicitly disclose the respective sequential longitudinal portions extend at an angle of 75-105 degrees as required by the claim. There is no evidence of record hat established that changing the angle of the respective sequential longitudinal portions would result in a difference in function of the Iamberger as modified by Morin and Cooper heart valve. Further a person having ordinary skill in the art would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angles. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the angle is in this range only “for some applications” (Paragraph [0327]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the angle of Iamberger as modified by Morin and Cooper to have an angle between 75-105 degrees as an obvious matter of design choice within the skill of the art.
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Regarding claim 4, Iamberger as modified by Morin and Cooper discloses wherein each of the first curved longitudinal portions has a length (see annotated fig. 7B above), and each of the second curved longitudinal portions has a length (see annotated fig. 7B above), the lengths measured along a respective curved central longitudinal axes of the curved longitudinal portions (Paragraph [0164]).
However, Iamberger as modified by Morin and Cooper does not explicitly disclose the first curved longitudinal portions has a length of 0.2-0.75 mm, or the second curved longitudinal portions has a length of 1-1.75 mm as required by the claim. There is no evidence of record that established that changing the length of the curved longitudinal portions would result in a difference in function of the Iamberger as modified by Morin and Cooper heart valve. Further a person having ordinary skill in the art would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed lengths. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the curved longitudinal portions “may have” the lengths in these ranges (Paragraph [0333]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the lengths of the curved longitudinal portions of Iamberger as modified by Morin and Cooper to have the first curved longitudinal portions has a length of 0.2-0.75 mm, and the second curved longitudinal portions has a length of 1-1.75 mm as an obvious matter of design choice within the skill of the art.
Regarding claim 5, Iamberger as modified by Morin and Cooper discloses wherein each of the first curved longitudinal portions (see annotated fig. 7B above) has a first length (see annotated fig. 7B above) and each of the second curved longitudinal portions (see annotated fig. 7B above) has a second length (see annotated fig. 7B above), the lengths measured along a respective curved central longitudinal axes of the curved longitudinal portions (Paragraph [0164]).
However, Iamberger as modified by Morin and Cooper does not explicitly disclose a ratio of the second length to the first length is 2 – 8 as required by the claim. There is no evidence of record that established that changing the length of the curved longitudinal portions, and therefore the ratio, would result in a difference in function of the Iamberger as modified by Morin and Cooper heart valve. Further a person having ordinary skill in the art would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed length ratio. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the ratio of the lengths of curved longitudinal portions “may be” in this range (Paragraph [0333]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the lengths of the curved longitudinal portions, and therefore the ratio, of Iamberger as modified by Morin and Cooper to have a ratio of the second length to the first length is 2 – 8 as an obvious matter of design choice within the skill of the art.
Regarding claim 6, Iamberger as modified by Morin and Cooper discloses wherein each of the first curved longitudinal portions has a first inner radius of curvature (see annotated fig. 7B above), and each of the second curved longitudinal portions has a second inner radius of curvature (see annotated fig. 7B above).
However, Iamberger as modified by Morin and Cooper does not explicitly disclose the first curved longitudinal portions has a first inner radius of curvature of 0.05 – 0.2 mm, or the second curved longitudinal portions has a second inner radius of curvature of 0.4 – 0.8 mm as required by the claim. There is no evidence of record that established that changing the first or second inner radius of curvature of the curved longitudinal portions would result in a difference in function of the Iamberger as modified by Morin and Cooper heart valve. Further a person having ordinary skill in the art would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed ranges of first or second inner radius of curvature. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that first or second inner radius of curvature of the curved longitudinal portions “may” be in these ranges (Paragraph [0334]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the first or second inner radius of curvature of the curved longitudinal portions of Iamberger as modified by Morin and Cooper to have the first curved longitudinal portions has a first inner radius of curvature of 0.05 – 0.2 mm, and the second curved longitudinal portions has a second inner radius of curvature of 0.4 – 0.8 mm as an obvious matter of design choice within the skill of the art.
Regarding claim 7, Iamberger as modified by Morin and Cooper discloses wherein each of the first curved longitudinal portions has a first inner radius of curvature (see annotated fig. 7B above), and each of the second curved longitudinal portions has a second inner radius of curvature (see annotated fig. 7B above).
However, Iamberger as modified by Morin and Cooper does not explicitly disclose wherein a ratio of the second inner radius of curvature to the first inner radius of curvature is 2 – 10 as required by the claim. There is no evidence of record that established that changing the first or second inner radius of curvature of the curved longitudinal portions, and therefore the ratio, would result in a difference in function of the Iamberger as modified by Morin and Cooper heart valve. Further a person having ordinary skill in the art would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed ratio of the inner radii of curvature. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the ratio of the first and second inner radius of curvature of the curved longitudinal portions “may be” in these ranges (Paragraph [0334]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the first or second inner radius of curvature of the curved longitudinal portions of Iamberger as modified by Morin and Cooper to have the ratio of the second inner radius of curvature to the first inner radius of curvature is 2 – 10 as an obvious matter of design choice within the skill of the art.
Regarding claim 8, Iamberger as modified by Morin and Cooper fails to disclose wherein the prosthetic valve frame has an overall height of 20-26 mm when the prosthetic heart valve is in the expanded state. Cooper further teaches wherein the prosthetic valve frame (Fig. 1, prosthesis 100, Figs. 6A and 7B, outer frame 140, outer frame body 142) has an overall height of 18-30 mm (Paragraph [0162]) when the prosthetic heart valve is in the expanded state (Fig. 6A and 7B, 140 and 142). 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 prosthetic valve frame of Iamberger as modified by Morin and Cooper wherein the prosthetic valve frame has an overall height of 18-30 mm when the prosthetic heart valve is in the expanded state, as further taught by Cooper, in order to have an axially compact configuration (Paragraph [0162]).
Iamberger as modified by Morin and Cooper does not explicitly disclose the overall height of the prosthetic valve frame of 20-26 mm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the height of Iamberger as modified by Morin and Cooper from between 18-30 mm to 20-26 mm as claimed since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 15, Iamberger as modified by Morin fails to disclose wherein the outer frame is coupled to the inner frame by stitching, wherein the inner frame is shaped so as to define a plurality of inner-frame distal end nodes, wherein each of the inner-frame distal end nodes is shaped so as to define two inner-frame notches, wherein the outer frame is shaped so as to define a plurality of outer-frame distal end nodes, wherein each of the outer-frame distal end nodes is shaped so as to define two outer-frame notches, and wherein the inner-frame notches and the outer-frame notches facilitate the stitching of the outer frame to the inner frame. Cooper also discloses a prosthetic heart valve (Fig. 1, prosthesis 100), an inner frame (Figs. 1-2, inner frame 120), and an outer frame (Figs. 8A-8B, outer frame 140). Cooper teaches wherein the outer frame (140) is coupled to the inner frame (120) by stitching (Paragraph [0170]), wherein the inner frame is shaped so as to define a plurality of inner-frame distal end nodes (Fig. 2, enlarged head 132b), wherein each of the inner-frame distal end nodes is shaped so as to define two inner-frame notches (Fig. 2, enlarged head 132b, “mushroom shape”), wherein the outer frame (140) is shaped so as to define a plurality of outer-frame distal end nodes (Figs. 8A-8B, tab 145), wherein each of the outer-frame distal end nodes is shaped so as to define two outer-frame notches (Figs. 8A-8B, tabs 145, “mushroom tab”), and wherein the inner-frame notches (132b) and the outer-frame notches (145) facilitate the stitching of the outer frame to the inner frame (Paragraph [0170]). 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 Iamberger’s as modified by Morin, valve wherein the outer frame is coupled to the inner frame by stitching, wherein the inner frame is shaped so as to define a plurality of inner-frame distal end nodes, wherein each of the inner-frame distal end nodes is shaped so as to define two inner-frame notches, wherein the outer frame is shaped so as to define a plurality of outer-frame distal end nodes, wherein each of the outer-frame distal end nodes is shaped so as to define two outer-frame notches, and wherein the inner-frame notches and the outer-frame notches facilitate the stitching of the outer frame to the inner frame, as taught by Cooper, in order to provide more area to couple the inner frame to the outer frame (Paragraph [0170]).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Iamberger et al. (US PG Pub No. 2019/0038405 A1) in view of Morin et al. (US PG Pub No. 2018/0055631 A1), as applied to claim 9 above, and further in view of Straubinger et al. (US Patent No. 8,317,858 B2).
Regarding claim 11, Iamberger as modified by Morin discloses wherein the portion of the plurality of struts comprises a first portion of the plurality of struts (see annotated Fig. 6C below).
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Iamberger as modified by Morin fails to disclose wherein the prosthetic valve frame comprises a second portion of the plurality of struts, and wherein for each intermediate node: (i) a first proximal strut extends proximally from an intermediate location along a first strut of the second proximally-extending pair of the two struts of the at least six struts, and (ii) a second proximal strut extends proximally from an intermediate location along a second strut of the second proximally-extending pair of the two struts of the at least six struts, each intermediate location along the respective first and second struts of the second proximally-extending pair of two struts being between the intermediate node and respective proximal ends of each of the first and second struts of the second proximally-extending pair of two struts, the first and second proximal struts converge at a proximally-pointing junction of the first and second proximal struts, (a) the proximally-pointing junction of the first and the second proximal struts and (b) the intermediate node are circumferentially aligned, so as to be angularly aligned with respect to the central longitudinal axis, spaced apart in the proximal-to-distal direction, and the proximally-pointing junctions are circumferentially offset with respect to the second proximal junction, so as to be angularly offset with respect to the central longitudinal axis.
Straubinger also discloses a prosthetic heart valve (Figs. 2C and 2E, stent 10) configured for transcatheter implantation (Fig. 2C, catheter retaining means 23) comprising a first proximal junction (Fig. 2C, connecting portion 30), and intermediate nodes (Fig. 2C, connecting portion 22). Straubinger teaches wherein the prosthetic valve frame comprises a second portion of the plurality of struts (Fig. 2C, auxiliary arches 18a), and wherein for each intermediate node (22): (i) a first proximal strut (Fig. 2C, 18a) extends proximally (Col. 6, lines 2-5, Figs. 2C and 2E, proximal end 2) from an intermediate location (Fig. 2C, lower end 14) along a first strut of the second proximally-extending pair of the two struts (Fig. 2C, retaining arches 16a) of the at least six struts (Fig. 2E, 16a, 18a, 19a), and (ii) a second proximal strut (Fig. 2C, 18a) extends proximally (Col. 6, lines 2-5) from an intermediate location (Fig. 2C, lower end 14) along a second strut of the second proximally-extending pair of the two struts (Fig. 2C, retaining arches 16a) of the at least six struts (Fig. 2E, 16a, 18a, 19a), each intermediate location (14) along the respective first and second struts of the second proximally-extending pair of two struts (16a) being between the intermediate node (22) and respective proximal ends (30) of each of the first and second struts of the second proximally-extending pair of two struts (16a), the first and second proximal struts (18a) converge at a proximally-pointing junction of the first and second proximal struts (Fig. 2C, enlarged head 31), (a) the proximally-pointing junction of the first and the second proximal struts (31) and (b) the intermediate node (22) are circumferentially aligned (Figs. 2C and 2E), so as to be angularly aligned with respect to the central longitudinal axis (Fig. 2E, longitudinal axis L), spaced apart in the proximal-to-distal direction (Col. 6, lines 2-5, Figs. 2C and 2E, proximal end 2), and the proximally-pointing junctions (30) are circumferentially offset with respect to the second proximal junction (31), so as to be angularly offset (Figs. 2C and 2E) with respect to the central longitudinal axis (L).
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 Iamberger’s as modified by Morin, valve wherein the prosthetic valve frame comprises a second portion of the plurality of struts, and wherein for each intermediate node: (i) a first proximal strut extends proximally from an intermediate location along a first strut of the second proximally-extending pair of the two struts of the at least six struts, and (ii) a second proximal strut extends proximally from an intermediate location along a second strut of the second proximally-extending pair of the two struts of the at least six struts, each intermediate location along the respective first and second struts of the second proximally-extending pair of two struts being between the intermediate node and respective proximal ends of each of the first and second struts of the second proximally-extending pair of two struts, the first and second proximal struts converge at a proximally-pointing junction of the first and second proximal struts, (a) the proximally-pointing junction of the first and the second proximal struts and (b) the intermediate node are circumferentially aligned, so as to be angularly aligned with respect to the central longitudinal axis, spaced apart in the proximal-to-distal direction, and the proximally-pointing junctions are circumferentially offset with respect to the second proximal junction, so as to be angularly offset with respect to the central longitudinal axis, as taught by Straubinger, in order to secure the anchoring of the valve in the heart (Col. 18, lines 13-16).
Regarding claim 12, Iamberger as modified by Morin and Straubinger discloses wherein the proximally-pointing junctions (Figs. 2C and 2E, 30) are longitudinally aligned (Figs. 2C and 2E) with the second proximal junctions (Figs. 2C and 2E, 31) at a same height along the central longitudinal axis(Figs. 2C and 2E, L), at the proximal end of the prosthetic valve frame (Figs. 2C and 2E, proximal end 2).
Claim 16 are rejected under 35 U.S.C. 103 as being unpatentable over Iamberger et al. is PG Pub No. 2019/0038405 A1) in view of Morin et al. (US PG Pub No. 2018/0055631 A1), as applied to claim 1 above, further in view of Gifford, III et al. (US PG Pub No. 2023/0115137 A1).
Regarding claim 16, Iamberger as modified by Morin fails to disclose wherein the struts of the prosthetic valve frame have an average wall thickness of 0.35-0.55 mm. Gifford, III also discloses a prosthetic heart valve (Figs. 2A-2B, stent 101) configured for transcatheter implantation (Paragraphs [0231-0232]) comprising struts (Figs. 2A-2B, struts 110). Gifford, III teaches wherein the struts (110) of the prosthetic valve frame (101) have an average wall thickness of 0.2-0.6 mm. 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 Iamberger as modified by Morin wherein the struts of the prosthetic valve frame have an average wall thickness of 0.2-0.6 mm, as taught by Gifford, in order to allow the stent to expand in the desired shape (Paragraph [0325]).
Iamberger as modified by Morin and Gifford, III fails to disclose the average wall thickness of the struts of the prosthetic valve frame of 0.35-0.55 mm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the average wall thickness of the struts of the prosthetic heart valve of Iamberger as modified by Morin and Gifford, III from about 0.2-0.6 mm to 0.35-0.55 mm as claimed since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zhang et al. (US PG Pub No. 2023/0277311 A1) discloses a prosthetic heart valve (Fig. 3, prosthetic heart valve 100) with intermediate struts (Fig. 3, outer skirt section 42).
Peterson et al. (US PG Pub No. 2022/0104940 A1) discloses a prosthetic heart valve (Fig. 2, prosthesis 200), and nodes (Fig. 2, enlarged head 236) with notches (Fig. 2, enlarged head 236, “mushroom shaped”).
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/K.L.C./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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