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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 10, 13-14, 19-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu (US Pub No.: 2024/0033085).
Regarding claim 1, Wu (US Pub No.: 2024/0033085) discloses a system for use at a valve disposed between an atrium and a ventricle of a heart of a subject (deployment of a heart implant for a mitral valve treatment in [0019]), the system comprising: a catheter (in [0021]), transluminally advanceable to the heart (advancement to a heart in [0022]); an implant (implant in [0019] and [0023]), deployable from the catheter within the heart (implant delivery with a catheter in [0023]), and comprising: a first anchoring assembly and a second anchoring assembly (being the first and second anchor in [0022]), each comprising: multiple anchors (as the first anchor is coupled to another first anchor in [0022], multiple anchors are present. Second anchor part 120 in figure 5 is a T-Bar as per [0057], implying multiple anchoring areas in said anchor. Additional anchors in [0061]), and a connector, connecting the multiple anchors to each other (being the coupling means in [0060]); a bridge (part 130 In [0061]), coupling the first anchoring assembly to the second anchoring assembly (bridging element coupling to a first and second anchor in [0060]), and having an adjustable bridging length (as a shortening of a length of a bridging element is present in [0022], an adjustable length is present); a driver, extendable through the catheter (being the guidewire 54 that is attached to the bridging element in [0051]. As the guidewire advances the bridge element in [0051], a driving is present), and configured to use the anchors of the first anchoring assembly to anchor the first anchoring assembly, within the atrium, at a first side of the valve (as the guidewire moves the bridging element in [0051], and the bridging element interfaces with the anchor to attach the anchor to a valve annulus in [0066], the guide wire does guide the anchor to attach to the valve), and to use the anchors of the second anchoring assembly to anchor the second anchoring assembly, within the atrium at a second side of the valve (present in [0065]-[0066] with the guidewire moving the bridging element in [0051]), such that the bridge spans at least partway across the valve shown visually in figures 6A-6B and 7A-7B where the bridging element is part 12); and a tool, transluminally advanceable to the heart, and configured to adjust a distance between the first anchoring assembly and the second anchoring assembly by adjusting the bridging length of the bridge (the bridge stop part 300 is considered to be a tool, with the purpose of adjusting a bridging element in [0094]. Shortening of a length in [0060]).
Regarding claim 2, Wu (US Pub No.: 2024/0033085) discloses the system according to claim 1, wherein the valve has an annulus and leaflets, the annulus circumscribing an orifice within which the leaflets are disposed (as per the geometry of a natural valve, the valve will have an annulus and leaflets. This is shown in figures 6A-6B), and wherein the tool is configured to engage the implant, within the atrium, over the orifice (as bridge stop 300 is installed over the guidewire in [0094] to engage the bridging element when the bridging element is in the body. As the bridging element is positioned against a septal member in [0094], the bridging element is implied to be in the heart of a user).
Regarding claim 3, Wu (US Pub No.: 2024/0033085) discloses the system according to claim 1, wherein the valve has an annulus, and wherein the tool is configured to contract the annulus by adjusting the bridging length (adjusting a length in [0060] with a bridge stop adjusting a bridging element in [0094]).
Regarding claim 4, Wu (US Pub No.: 2024/0033085) discloses the system according to claim 1, wherein the valve has an annulus, a first leaflet, and a second leaflet (as per the geometry of a natural valve, the valve will have an annulus and leaflets. This is shown in figures 6A-6B), the annulus circumscribing an orifice within which the first and second leaflets are disposed (leaflet details in [0010]-[0014]. Figure 2E shows multiple mitral valve leaflets), and wherein the tool is configured to reshape the annulus by adjusting the bridging length in a manner that draws the first leaflet and the second leaflet towards each other (the implant part 10 reshapes the leaflets in [0072], where the tool 300 and bridging element 12 in [0094] modify the implant to adjust tension and the length between anchors attached to said leaflets) .
Regarding claim 5, Wu (US Pub No.: 2024/0033085) discloses the system according to claim 1, wherein the tool is configured to engage the implant between the first anchoring assembly and the second anchoring assembly, exclusive (as the tool is interfacing with the bridging element in [0094] and as the bridging element is between a posterior and anterior anchor in [0091]-[0093]).
Regarding claim 10, Wu (US Pub No.: 2024/0033085) discloses the system according to claim 1, wherein the connector of each of the anchoring assemblies comprises a polymer (polymer to make up the entire device of Wu in [0073]-[0074].
Regarding claim 13, Wu (US Pub No.: 2024/0033085) discloses the system according to claim 1, wherein the bridge is articulatably coupled to one of the first and second anchoring assemblies (bridge coupled to both anchors in [0034]-[0035]. As a bridge stop is detailed in [0040]-[0041], an actuating of a bridge element is present).
Regarding claim 14, Wu (US Pub No.: 2024/0033085) discloses the system according to claim 1, wherein the bridge is slidably coupled to one of the first and second anchoring assemblies(bridge coupled to both anchors in [0034]-[0035]. As a bridge stop is detailed in [0040]-[0041], an actuating of a bridge element is present. In [0086], as a tension of a bridging element between the anchors is adjusted so that it is increased, and as the anchor extends across the heart between anchors (shown in figure 6A with bridge part 12) a slidable coupling is present between the anchors to allow for a tension adjustment).
Regarding claim 19, Wu (US Pub No.: 2024/0033085) discloses the system according to claim 1, wherein the tool is transluminally advanceable to the implant, and is configured to engage the implant within the atrium (the bridge stop part 300 is considered to be a tool, with the purpose of adjusting a bridging element in [0094]. Shortening of a length in [0060]. As the lock adjusts the tension of a bridging element in [0094], it also affects the interface with the atrium present in areas like the abstract and [0068]).
Regarding claim 20, Wu (US Pub No.: 2024/0033085) discloses the system according to claim 1, wherein Wu discloses that the bridge comprises a tether (a suture bridging element is present in [0051], where a suture is equivalent to a tether. Threads in [0074]-[0075]).
Regarding claim 21, Wu (US Pub No.: 2024/0033085) discloses the system according to claim 20, wherein adjusting the bridging length of the tether comprises adjusting tension in the tether (adjusting a tension in a bridge element in [0094].
Regarding claim 22, Wu (US Pub No.: 2024/0033085) discloses the system according to claim 21, further comprising a lock, the tool being configured to lock the tension in the tether by locking the lock to the tether (being the bridge stop element 300 in [0094]).
Regarding claim 23, Wu (US Pub No.: 2024/0033085) discloses the system according to claim 20, wherein adjusting the bridging length of the tether comprises tensioning the tether (tensioning of a bridge in [0094], where a tensioning by definition adjusts a length).
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) 6-9 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu (US Pub No.: 2024/0033085) in view of Nia (US Pub No.: 2021/0378817).
Regarding claim 6, Wu discloses the system according to claim 1. However, Wu does not disclose wherein the connector of each of the anchoring assemblies is rigid.
Instead, Nia (US Pub No.: 2021/0378817) teaches a connector of each of the anchoring assemblies is rigid (rigid connector in [0012]. The connector parts 400 connects to the anchors part 500 in [0074] and figure 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a rigid connector in [0012] as a rigid connector is used to position the anchor means of Nia, with a rigid connector being configurable to “provide predetermined angles of the septum anchoring” for a valve treatment in [0023].
Regarding claim 7, Wu discloses the system according to claim 1. However, Wu does not disclose wherein the connector of each of the anchoring assemblies is semi-rigid.
Instead, Nia (US Pub No.: 2021/0378817) teaches a connector of each of the anchoring assemblies is semi-rigid (semi-rigid connector in [0093]. The connector parts 400 connects to the anchors part 500 in [0074] and figure 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a semi-rigid connector of Nia into Wu for the purpose of providing a semi-rigid portion of a connector (in [0096]) that can be made of a polymeric material that can be adjustable (part 436 is adjustable in [0095])
Regarding claim 8, Wu discloses the system according to claim 1. However, Wu does not disclose wherein the connector of each of the anchoring assemblies is flexible.
Instead, Nia teaches wherein the connector of each anchoring material is flexible (flexible cord connector in [0011]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the flexible connectors of Nia into Wu for the purpose of providing a deformable connector as presented in [0074] that is “configured to facilitate transcatheter delivery to their respective sites” with respect to the implant as per [0074].
Regarding claim 9, Wu discloses the system according to claim 1. However, Wu does not disclose wherein the connector of each of the anchoring assemblies is non-isometrically flexible.
Instead, Nia teaches wherein the connector of each anchoring material is non-isometrically flexible (flexible cord connector in [0011]. Materials such as PLGA in [0074] are non-isometrically flexible). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the flexible connectors of Nia into Wu for the purpose of providing a deformable connector as presented in [0074] that is “configured to facilitate transcatheter delivery to their respective sites” with respect to the implant as per [0074].
Regarding claim 11, Wu discloses the system according to claim 1. However, Wu does not disclose wherein the connector of each of the anchoring assemblies is axially contractible.
Instead, Nia teaches wherein the connector of each of the anchoring assemblies is axially contractible (flexible cord connector in [0011], where a flexible cord is axially contractable. Materials such as PLGA in [0074] are non-isometrically flexible). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the flexible connectors of Nia into Wu for the purpose of providing a deformable connector as presented in [0074] that is “configured to facilitate transcatheter delivery to their respective sites” with respect to the implant as per [0074].
Regarding claim 12, Wu discloses the system according to claim 1. However, Wu does not disclose wherein the connector of each of the anchoring assemblies is resistant to axial contraction.
Instead, Nia (US Pub No.: 2021/0378817) wherein the connector of each of the anchoring assemblies is resistant to axial contraction (rigid connector in [0012], where a rigid connector resists a contraction. The connector parts 400 connects to the anchors part 500 in [0074] and figure 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a rigid connector in [0012] as a rigid connector is used to position the anchor means of Nia, with a rigid connector being configurable to “provide predetermined angles of the septum anchoring” for a valve treatment in [0023].
Claim(s) 15-17 and 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu (US Pub No.: 2024/0033085) in view of Machold (US Pub No.: 2017/0165068).
Regarding claim 15, Wu discloses the system according to claim 1, wherein: the bridge is a first bridge (in [0070]), extending from a first part of the first anchoring assembly (interface to an anchor with a bridge in [0070]).
However, Wu does not further comprise a second bridge, extending from a second part of the first anchoring assembly. Instead, Machold (US Pub No.: 2017/0165068) teaches further comprises a second bridge (in [0079]), extending from a second part of the first anchoring assembly (in [0079]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a second bridge as presented in Machold into Wu for the purpose of providing multiple means that interface with the anchors of the implant “so as to conform to anatomy against which the posterior anchor is engaged” as per [0029].
Regarding claim 16, Wu discloses the system according to claim 1. However, Wu does not teach, wherein: the bridge comprises first and second bridge components axially slidable with respect to each other, and the implant further comprises one or more adjustment mechanisms, each of the adjustment mechanisms being operatively coupled to the bridge such that, for each of the adjustment mechanisms, actuation of the adjustment mechanism adjusts the bridging length of the bridge by sliding the first and second bridge components of the bridge with respect to each other.
Instead, Instead, Machold teaches wherein: the bridge comprises first and second bridge (multiple bridging elements in [0029], first and second bridge in [0079]), components axially slidable with respect to each other (sliding of an anchor due to a bridge element in [0017]. Tensioning of bridge elements in the abstract and [0025]), and the implant further comprises one or more adjustment mechanisms (being the link 151 with hinge 150 tension bridging elements in [0063]), each of the adjustment mechanisms being operatively coupled to the bridge (shown in figures 7A-7B, where the anchor is part 152) such that, for each of the adjustment mechanisms, actuation of the adjustment mechanism adjusts the bridging length of the bridge by sliding the first and second bridge components of the bridge with respect to each other(in [0082], applying a tension to multiple bridging elements is present, where applying a tension at various angles will deform a LA wall and mitral valve annulus. Doing so adjusts the bridge components with respect to one another). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a second bridge as presented in Machold into Wu for the purpose of providing multiple means that interface with the anchors of the implant “so as to conform to anatomy against which the posterior anchor is engaged” as per [0029].
Regarding claim 17, Wu discloses the system according to claim 1. However, Wu does not teach wherein the bridge is a first bridge of one or more bridges of the implant, and wherein the implant further comprises one or more adjustment mechanisms, each of the adjustment mechanisms being operatively coupled to at least one of the bridges, such that, for each of the adjustment mechanisms, movement of an element of the adjustment mechanism along a first axis causes contraction of the at least one of the bridges along a second axis, the second axis being orthogonal to the first axis.
Instead, Machold teaches wherein the bridge is a first bridge of one or more bridges of the implant (multiple bridging elements in [0029], first and second bridge in [0079]), and wherein the implant further comprises one or more adjustment mechanisms (being the link 151 with hinge 150 tension bridging elements in [0063]), each of the adjustment mechanisms being operatively coupled to at least one of the bridges, such that, for each of the adjustment mechanisms, movement of an element of the adjustment mechanism along a first axis causes contraction of the at least one of the bridges along a second axis, the second axis being orthogonal to the first axis (in [0082], applying a tension to multiple bridging elements is present, where applying a tension at various angles will deform a LA wall and mitral valve annulus. Doing so will adjust the bridge components with respect to one another, with a contraction of bridge element 105 in figures 7B to 7A). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a second bridge as presented in Machold into Wu for the purpose of providing multiple means that interface with the anchors of the implant “so as to conform to anatomy against which the posterior anchor is engaged” as per [0029].
Regarding claim 25, Wu discloses a system for use at a valve disposed between an atrium and a ventricle of a heart of a subject (deployment of a heart implant for a mitral valve treatment in [0019]), the system comprising: a catheter (in [0021]), transluminally advanceable to the heart (advancement to a heart in [0022]); an implant (implant in [0019] and [0023]), deployable from the catheter within the heart (implant delivery with a catheter in [0023]), and comprising: multiple anchoring assemblies (being the first and second anchor in [0022]), each of the anchoring assemblies comprising: multiple anchors (as the first anchor is coupled to another first anchor in [0022], multiple anchors are present. Second anchor part 120 in figure 5 is a T-Bar as per [0057], implying multiple anchoring areas in said anchor. Additional anchors in [0061]), and a connector (being the coupling means in [0060]), connecting the multiple anchors of the anchoring assembly to each other; a driver, extendable through the catheter (being the guidewire 54 that is attached to the bridging element in [0051]. As the guidewire advances the bridge element in [0051], a driving is present), and configured to anchor the implant within the atrium by, for each of the anchoring assemblies, using the anchors of the anchoring assembly to anchor the anchoring assembly within the atrium (as the guidewire moves the bridging element in [0051], and the bridging element interfaces with the anchor to attach the anchor to a valve annulus in [0066], the guide wire does guide the anchor to attach to the valve), such that the bridges span, between the anchoring assemblies, at least partway across the valve (shown in figure 6A with bridge part 12); and a tool, transluminally advanceable to the heart, and configured to adjust a distance between the first anchoring assembly and the second anchoring assembly by adjusting the bridging length of the bridge (the bridge stop part 300 is considered to be a tool, with the purpose of adjusting a bridging element in [0094]. Shortening of a length in [0060]).
However, Wu does not teach multiple bridges, coupling the anchoring assemblies to each other, each of the bridges having an adjustable bridging length;
Instead, Machold (US Pub No.: 2017/0165068) teaches multiple bridges (in [0079]), coupling the anchoring assemblies to each other (bridging elements affixed to anchors in [0079]), each of the bridges having an adjustable bridging length (in [0081]. Tensioning of bridge elements in [0025] also affects length). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a second bridge as presented in Machold into Wu for the purpose of providing multiple means that interface with the anchors of the implant “so as to conform to anatomy against which the posterior anchor is engaged” as per [0029].
Regarding claim 26, Wu in view of Machold teaches the system according to claim 25, wherein Machold teaches that the multiple anchoring assemblies comprise: a first anchoring assembly (anchoring assemblies in [0070], shown in figures 10A and 10B), and one or more other anchoring assemblies, and each of the multiple bridges couples the first anchoring assembly to one of the one or more other anchoring assemblies (in [0070] of Machold). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a second bridge as presented in Machold into Wu for the purpose of providing multiple means that interface with the anchors of the implant “so as to conform to anatomy against which the posterior anchor is engaged” as per [0029].
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu (US Pub No.: 2024/0033085) in view of Smith (US Patent No.: 5,006,104).
Regarding claim 18, Wu discloses the system according to claim 1, wherein the bridge is a first bridge of one or more bridges of the implant (being the bridging element in [0022] with multiple ends in [0022]), and wherein the implant further comprises one or more adjustment mechanisms (being the bridge stop elements in [0040]-[0041]), However, Wu does not teach that each of the adjustment mechanisms being operatively coupled, in a Scott Russell linkage, to at least one of the bridges.
Instead, Smith (US Patent No.: 5,006,104) teaches wherein the implant further comprises one or more adjustment mechanisms (Scott Russell linkage in column 5 lines 25-35. Medical device disclosure in column 1 lines 9-19). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the Scott Russell Linkage of Smith into Wu for the purpose of providing a means to interface with a bridge and bridge stop of Wu that operates in a straight line (as per column 5 lines 25-35), which is beneficial to the device of Wu as this can provide a means to actuate a bridge stop as an actuation to cause a locking in [0093]-[0094] is not present.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu (US Pub No.: 2024/0033085) in view of Subramanian (US Pub No.: 2020/0276017).
Regarding claim 24, Wu discloses the system according to claim 1. However, Wu does not teach wherein: the bridge is a first bridge, the implant further comprises: a third anchoring assembly, comprising: multiple anchors, and a connector that connect the multiple anchors of the third anchoring assembly to each other; and a second bridge, coupling the third anchoring assembly to an anchoring assembly selected from the group of: the first anchoring assembly and the second anchoring assembly, and having an adjustable bridging length, and the tool is further configured to adjust a distance between the first anchoring assembly and the selected anchoring assembly by adjusting the bridging length of the second bridge.
Instead, Subramanian (US Pub No.: 2020/0276017) teaches wherein: the bridge is a first bridge (the bridge being the third suture in [0028] and [0222]), the implant further comprises: a third anchoring assembly (in [0028] and [0373]), comprising: multiple anchors (being parts 1012 in figure 106c and detailed in [0373]), and a connector that connect the multiple anchors of the third anchoring assembly to each other (being part 1018 to which the anchors are connected to in [0384]); and a second bridge, coupling the third anchoring assembly to an anchoring assembly (being the second suture attached to a third anchor in [0028] selected from the group of: the first anchoring assembly and the second anchoring assembly, and having an adjustable bridging length, and the tool is further configured to adjust a distance between the first anchoring assembly and the selected anchoring assembly by adjusting the bridging length of the second bridge (a pledget to apply tension to a suture is present in [0300], where a tension adjustment of a suture will require a modification of the length of the suture between the disclosed anchors of Subramanian). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the third anchor and related parts presented in [0028] of Subramanian for the purpose of providing multiple anchor members (as presented in [0373]) such that multiple points of contact to hold multiple sutures in place within a heart valve is present (in [0373]), where multiple sutures are used to stabilize an implant in a valve body in [0028].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sheps (US Pub No.: 2015/0272734) discloses a catheter that is advanced toward an anatomical site in the abstract with valve details in [0011] and anatrioventricular valve in [0233]). Delgado (US Pub No.: 2018/0325661) considered for an implantable prosthetic device with a plurality of anchors in the abstract used for sealing native heart valves in [0002].
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/AREN PATEL/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774