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 Amendment
This office action is responsive to the amendment filed on 10/27/2025. As directed by the amendment: claims 1, 12, and 15 have been amended. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see page 9, filed 10/27/2025, with respect to the USC 112(a) rejections have been fully considered and are persuasive. The applicant’s amendments to claims to remove the language that failed to comply with the written description overcomes the rejection, the language being “fixedly”. The USC 112(a) rejections have been withdrawn.
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.
Claim(s) 1-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stante et al (US 20130274855 A1), herein referenced to as “Stante” in view of Spenser (US 20130211509 A1), herein referenced to as “Spenser” and Quadri et al (US 20160135948 A1), herein referenced to as “Quadri”.
Claim 1
Stante discloses: A method of implanting a medical device 20 (see Figs. 1A-1B, [0029]) at a cardiac valve replacing a native mitral valve (see [0029]), the method including: advancing the medical device 20 to a target position (see [0002] and [0029], mitral valve) extending across the cardiac valve mitral valve (see [0029]) such that (a) a first end portion 32 + 22 (see Figs. 1A-1B, [0029]) of the medical device 20 is positioned at a first side (see [0029], free of the valve structure material) of the cardiac valve upstream outflow (see [0029], outflow are regions further away from the native valve) of a native valve anulus of the cardiac valve mitral valve and (b) a second end portion 30 (see Figs. 1A-1B, [0029]) of the medical device 20 is positioned at a second side (see [0029], valve structure, inflow) of the cardiac valve mitral valve proximate to native valve leaflets inflow (see [0029], where the flow of blood follows through the native valve) of the cardiac valve, wherein advancing the medical device 20 to the target position includes advancing the medical device 20 while the first end portion 32 + 22 of the medical device is coupled to a first shaft 70 (see Figs. 3 and 9A-11B, [0033]) and the second end portion 30 of the medical device 20 is coupled to a second shaft 80 + 84 (see Fig. 3, [0034], it is coupled onto the shaft); releasing a first side a first side of 32 + 22 of the first end portion 32 + 22 of the medical device from the first shaft 70 (see Fig. 3, [0033] and [0038]); after releasing the first side a first side of 32 + 22 of the first end portion of the medical device 20, releasing a second side a second side of 32 + 22 of the first end portion of the medical device from the first shaft 70 (see Fig. 3, [0033] and [0038]); and releasing the second end portion 30 (see Fig. 3, [0036], 82 which is connected to 84, is slidable relative to 80, which can be actuated to release the second or distal portion of the device by altering the distance relative to 62) of the medical device from the second shaft 80 + 84.
Stante does not explicitly disclose: advancing the medical device through a delivery catheter and out of the delivery catheter, wherein advancing the medical device through the delivery catheter and from the delivery catheter, the first shaft extending at least partially through the delivery catheter and the second shaft extending at least partially through the delivery catheter, wherein the medical device is longitudinally compressed when a distance between a distal end of the first shaft and a distal end of the second shaft decreases; after advancing the medical device out of the delivery catheter to the target position to release the medical device.
However, Spenser in a similar field of invention teaches a method of implanting a medical device at a cardiac valve (see Figs. 12-13j) with advancing a medical device 40 (see Figs. 12-13j) to a target position (see Figs. 13a-13j) with the medical device 40 coupled to a first shaft 48 (see Figs. 13e-13g, [0074], 40 is over 48) and a second shaft 57 (see Figs. 13e-13g). Rabito further teaches: advancing the medical device 40 through a delivery catheter 49 (see Figs. 13e-13g, [0072]-[0073], 40 is on the end of 57 and is advanced through and out of 49 into the heart chamber) and out (see Figs. 13e-13g, [0072]-[0073]) of the delivery catheter 49, wherein advancing the medical device 40 through the delivery catheter 49 and from the delivery catheter 49, the first shaft 48 extending at least partially through the delivery catheter 49 (see Figs. 13e-13g, 48 extends through 49 and into the heart) and the second shaft 57 extending at least partially through the delivery catheter 49 (see Figs. 13e-13g, 57 extends through 49 and into the heart); after advancing the medical device 40 out of the delivery catheter 49 to the target position to release the medical device (see Figs. 13e-13j, after 40 is advanced out of 49 it is released into the target position within the heart).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stante to incorporate the teachings of Spenser and have the method of implanting a medical device at the cardiac valve with advancing the medical device through a delivery catheter and out of the delivery catheter, wherein advancing the medical device through the delivery catheter and from the delivery catheter, the first shaft extending at least partially through the delivery catheter and the second shaft extending at least partially through the delivery catheter; after advancing the medical device out of the delivery catheter to the target position to release the medical device. Motivation for such can be found in Spenser as the additional delivery catheter can be used as a sheath for a transapical approach for valve replacement (see [0072]) as an alternative.
The combination of Stante and Spenser does not explicitly teach: wherein the medical device is longitudinally compressed when a distance between a distal end of the first shaft and a distal end of the second shaft decreases.
However, Quadri in a similar field of invention teaches a method for implanting a medical device 200 (see Figs. 1-7C) at a cardiac valve (see Figs. 1-7C) with a first shaft 120 + 306 (see Figs. 1-7C, which is connected to 306 and 300, [0088]) coupled to a first end portion 204 (see Figs. 2A, 3b, 6) of the medical device 200 and a second shaft 118 + 304 (see Figs. 1-7C, 304 is coupled to 308 + 302 + 118, [0083] and [0089]) coupled to a second end portion 202 (see Figs. 2A, 3b, 6) of the medical device 200. Quadri further teaches: wherein the medical device 200 is longitudinally compressed (see Figs. 7A-7C, 200 is compressed from Fig. 7B to Fig. 7C when 118 is retracted, hence the distance between 302 and 300 is reduced) when a distance between a distal end 300 (see Fig. 3B and 7B-7C, [0104]) of the first shaft 120 + 306 and a distal end 302 (see Fig. 3B and 7B-7C, [0104]) of the second shaft 118 + 304 decreases (see [0104]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stante to incorporate the teachings of Quadri and teach a method for implanting a medical device at a cardiac valve with the medical device is longitudinally compressed when a distance between a distal end of the first shaft and a distal end of the second shaft decreases. Motivation for such can be found in Quadri as this allows the device to grasp the heart valve native annulus during repositioning of the device to ensure proper positioning and implantation (see [0104]-[0106]).
Claim 2
The combination of Stante, Spenser, and Quadri teaches: the method of claim 1, see 103 rejection above. Stante further discloses: wherein releasing the first side a first side of 32 + 22 as released by one of the connectors 401 of the first end portion 32 + 22 of the medical device 20 includes actuating a handle 58 (see Fig. 3, [0031]) operably coupled to a proximal end portion 72 (see Fig. 3, [0033]) of the first shaft 70 to drive a hub assembly 62 + 400 (see Figs. 3 and 9A-11B, [0031]) coupled to a distal end portion distal end of 70, 74 (see Fig. 3, [0033], 62 extend distally from 70) of the first shaft 70 to release a plurality of first connectors 401 + 451 (see Figs. 9A-11B, [0061]) at the first side a first side of 32 + 22 (see [0061], staggered) of the first end portion 32 + 22 of the medical device 20.
Claim 3
The combination of Stante, Spenser, and Quadri teaches: the method of claim 2, see 103 rejection above. Stante further discloses: wherein releasing the second side a second side of 32 + 22 as released by one of the connectors 402 of the first end portion 32 + 22 of the medical device 20 includes further actuating the handle 58 to drive the hub assembly 62 + 400 to release a plurality of second connectors 402 + 452 (see Figs. 9A-11B, [0061]) at the second side a second side of 32 + 22 of the first end portion 32 + 22 of the medical device 20.
Claim 4 which is rejected over a selected embodiment of Stante in [0061]
The combination of Stante, Spenser, and Quadri teaches: the method of claim 1, see 103 rejection above. Stante further discloses: wherein the first end portion 32 + 22 of the medical device 20 is coupled to the first shaft 70 via a hub assembly 62 + 400 (see Figs. 3 and 9A-11B, [0031]), wherein the hub assembly includes an inner hub component 40 (see Figs. 9A-11B, [0061]) that is movable relative to an outer hub component 62 (see Figs. 9A-11B) between a first position (see [0061], all the posts are covered), a second position (see [0061], 451 released from 400), and a third position (see [0061], 452 released from 402), and wherein advancing the medical device 20 to the target position (see [0002] and [0029], mitral valve) includes advancing the medical device while the inner hub component 62 is in the first position (see [0061]), releasing the first side of the first end portion of the medical device includes moving the inner hub component from the first position (see [0061], releasing 451 which is connected to the first side of 32 + 22) to the second position, and releasing the second side of the first end portion of the medical device includes moving the inner hub component from the second position to the third position (see [0061], releasing 452 which is connected to a second side of 32 + 22).
Claim 5 which is rejected over a selected embodiment of Stante in [0062]
The combination of Stante, Spenser, and Quadri teaches: the method of claim 1, see 103 rejection above. Stante further discloses: wherein the first end portion 32 + 22 of the medical device 20 is coupled to the first shaft via a hub assembly 62 + 400 + 102 (see Figs. 3-4B and 9A-11B, [0031] and [0037]), wherein the hub assembly 62 + 400 includes an inner hub component 400 + one or more biasing member similar to 102 (see Figs. 9A-11B, [0062]) that is translatable relative to an outer hub component 62 (see Figs. 9A-11B), and wherein advancing the medical device 20 to the target position (see [0002] and [0029], mitral valve) includes advancing the medical device 20 while the inner hub component 400 is in a first position (see [0062], all the posts are contained by 400) relative to the outer hub component 62, releasing the first side a first side of 32 + 22 connected via 451 of the first end portion 32 + 22 of the medical device 20 includes translating the inner hub component to a second position (see [0062], 451 released from 400) relative to the outer hub component 400, and releasing the second side a second side of 32 + 22 connected via 452 of the first end portion 32 + 22 of the medical device 20 includes translating the inner hub component 400 to a third position (see [0062], releasing 452 which is connected to a second side of 32 + 22) relative to the outer hub component 400.
Claim 6 which is rejected over a selected embodiment of Stante in [0062]
The combination of Stante, Spenser, and Quadri teaches: the method of claim 1, see 103 rejection above. Stante further discloses: wherein the first end portion 30 + 22 of the medical device 20 is coupled to the first shaft 70 via a hub assembly 62 + 400 + 102 (see Figs. 3-4B and 9A-11B, [0031] and [0037]), wherein the hub assembly includes an inner hub component one or more biasing members similar to 102 (see Figs. 4A-4B and 9A-11B, [0062], and [0045]-[0046]) that is rotatable (102 which is within 62, when it rotates into the slots 122 and 126 it rotates relative to 62) relative to an outer hub component 62, and wherein advancing the medical device 20 to the target position includes advancing the medical device 20 while the inner hub component one or more biasing members similar to 102 is in a first position (see [0062], all the posts are contained by 400) relative to the outer hub component 62, releasing the first side a first side of 32 + 22 connected via 451 of the first end portion of the medical device includes rotating the inner hub component one or more biasing members similar to 102 to a second position (see Figs. 4A-4B, [0045]-[0046], the free end of 102, 142, deflects and rotates into 122 or 126 to disengage the post 451) relative to the outer hub component 62, and releasing the second side a second side of 32 + 22 connected via 452 of the first end portion 32 + 22 of the medical device 20 includes rotating the inner hub component to a third position (see Figs. 4A-4B, [0045]-[0046], the free end of 102, 142, deflects and rotates into a different slot to disengage the post 452) relative to the outer hub component 62.
Claim 7 which is rejected over a selected embodiment of Stante in [0061]
The combination of Stante, Spenser, and Quadri teaches: the method of claim 1, see 103 rejection above. Stante further discloses: wherein the first end portion 32 + 22 of the medical device 20 includes a plurality of connectors 451, 452, and 453 (see Figs. 11A-11B, [0061]) coupled to the first shaft 70 via a hub assembly 400 (see Figs. 11A-11B, [0061]), and wherein releasing the first side a first side of 30 + 22 connected to 451 of the first end portion 30 + 22 of the medical device 20 includes sequentially releasing individual first ones 451 (see [0061]) of the connectors 451, 452, and 453, and releasing the second side a second side of 30 + 22 connected to 452 of the first end portion 32 + 22 of the medical device 20 includes sequentially releasing individual second ones 452 (see [0061]) of the connectors.
Claim 8 which is rejected over a selected embodiment of Stante in [0062]
The combination of Stante, Spenser, and Quadri teaches: the method of claim 1, see 103 rejection above. Stante further discloses: wherein the first end portion 32 + 22 of the medical device 20 includes a plurality of connectors 451, 452, and 453 (see Figs. 11A-11B, [0061]) coupled to the first shaft 70 via a hub assembly 400 (see Figs. 11A-11B, [0061]), and wherein releasing the first side a first side of 30 + 22 connected to 451 of the first end portion 30 + 22 of the medical device 20 includes simultaneously releasing multiple first ones of the connectors (see [0062], two biasing members provided independent of a number of posts, see also [0031], can have greater than four posts), and releasing the second side a second side of 32 + 22 connected a 453 of the first end portion 32 + 22 of the medical device 20 includes simultaneously releasing multiple second ones of the connectors (see [0062], two biasing members provided independent of a number of posts, see also [0031], can have greater than four posts).
Claim 9
The combination of Stante, Spenser, and Quadri teaches: the method of claim 1, see 103 rejection above. Stante further discloses: wherein the cardiac valve (see [0005]) is a mitral valve (see [0005], mitral valve), and wherein the method further comprises capturing a portion of one or more of the native leaflets (see [0005], valve being replaced and valve leaflet-like structures, see [0024]) of the mitral valve with the medical device 20.
Claim 10 which is rejected over a selected embodiment of Stante in Figs. 6A-6C)
The combination of Stante, Spenser, and Quadri teaches: the method of claim 1, see 103 rejection above. Stante further discloses: wherein the method includes releasing the second end portion 30 (see Figs. 6A-6C, 62 is withdrawn first, thus releasing the distal end of the device, 30 before 32 + 22) of the medical device 20 before releasing the first end portion 32 + 22 of the medical device 20.
Claim 11
The combination of Stante, Spenser, and Quadri teaches: the method of claim 1, see 103 rejection above. Stante further discloses: wherein the medical device 20 includes an atrial-fixation member 22 (see Fig. 1A, [0028]) and a coaptation member 24 (see Fig. 1A, [0029]) extending from the atrial-fixation member 22, wherein the first end portion 32 + 22 is of the atrial-fixation member 22, wherein the second end portion 30 is of the coaptation member 24, and wherein releasing the first side a first side of 32 + 22 of the first end portion 32 + 22 of the medical device 20 includes releasing a posterior side side of 32 + 22 attached to 451, which is a posterior side (see Figs. 11A-11B) of the atrial-fixation member 22 that is positioned above the coaptation member 24 (see Fig. 1A); and releasing the second side a second side of 32 + 22 of the first end portion 32 + 22 of the medical device 20 includes releasing an anterior side side of 32 + 22 attached to 453 of the atrial-fixation member opposite the posterior side opposite side of 451 (see Figs. 11A-11B).
Claim 12
Stante discloses: A method of implanting a medical device 20 (see Figs. 1A-1B, [0029]) at a cardiac valve replacing a native mitral valve (see [0029]) of a heart, the method including: advancing the medical device at least partially into a chamber of the heart (see [0002] and [0029], mitral valve), wherein advancing the medical device to the chamber includes advancing the medical device while a first end portion 32 + 22 (see Figs. 1A-1B, [0029]) of the medical device 20 is coupled to a first shaft 70 (see Fig. 3, [0033] and [0061]) and a second end portion 30 (see Figs. 1A-1B, [0029]) of the medical device 20 is coupled to a second shaft 80 + 84 (see Fig. 3, [0034], it is coupled onto the shaft); longitudinally compressing the medical device by moving one or both of the first shaft 70 and the second shaft 80 + 84 relative to one another (see Figs. 1-3, especially Fig. 1B, [0031]); advancing the medical device 20 to a target position extending across the cardiac valve mitral valve such that (a) the first end portion 32 + 22 of the medical device 20 is positioned at a first side of the cardiac valve upstream outflow (see [0029], outflow are regions further away from the native valve) of a native valve anulus (see [0029]) of the cardiac valve and (b) the second end portion 30 of the medical device 20 is positioned at a second side inflow (see [0029], valve structure, inflow) of the cardiac valve mitral valve proximate to native valve leaflets mitral valve leaflets of the cardiac valve; releasing the first end 32 + 22 portion of the medical device 20 from the first shaft 70 (see Fig. 3, [0033] and [0038]); and releasing the second end portion 30 of the medical device 20 from the second shaft 80 + 84 (see Figs. 3, [0036], 82 which is connected to 84, is slidable relative to 80, which can be actuated to release the second or distal portion of the device by altering the distance relative to 62).
Stante does not explicitly disclose: longitudinally compressing the medical device within the chamber of the heart by decreasing a distance between a distal end of the first shaft and a distal end of the second shaft.
However, Spenser in a similar field of invention teaches a method of implanting a medical device at a cardiac valve (see Figs. 12-13j and 14a-14b) with advancing a medical device 40 (see Figs. 12-13j) to a target position (see Figs. 13a-13j) with the medical device 40 coupled to a first shaft 48 (see Figs. 13e-13g, [0074], 40 is over 48) and a second shaft 57 (see Figs. 13e-13g) and longitudinally compressing the medical device (see Figs. 14a-14b, the implant being longitudinally compressed in deployment from Fig. 14a to 14b, while being radially expanded). Spenser further teaches: longitudinally compressing the medical device 40 within the chamber of the heart (see Figs. 12 (step Q) and 13e-14b, the medical device 40 is longitudinally compressed while being radially expanded by the expansive balloon while within the chamber of the heart, [0074] and [0082]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stante to incorporate the teachings of Spenser and have the method of implanting a medical device at a cardiac valve with longitudinally compressing the medical device within the chamber of the heart. The motivation for such can be found in Spenser as expanding the implant within the novel orifice/chamber of the heart forces the edge of the anterior leaflet against the posterior leaflet thereby cancelling or minimizing natural opening and closing of the mating edges (see [0074]), furthermore the mesh material of the valve seating allows it to compress longitudinally and remain radially crimped while still providing sufficient radial force rigidity such that the valve seating maintains its shape once it has been radially expanded to a desired size (see [0082]).
The combination of Spenser and Stante does not explicitly teach: by decreasing a distance between a distal end of the first shaft and a distal end of the second shaft.
However, Quadri in a similar field of invention teaches a method for implanting a medical device 200 (see Figs. 1-7C) at a cardiac valve (see Figs. 1-7C) with a first shaft 120 + 306 (see Figs. 1-7C, which is connected to 306 and 300, [0088]) coupled to a first end portion 204 (see Figs. 2A, 3b, 6) of the medical device 200 and a second shaft 118 + 304 (see Figs. 1-7C, 304 is coupled to 308 + 302 + 118, [0083] and [0089]) coupled to a second end portion 202 (see Figs. 2A, 3b, 6) of the medical device 200. Quadri further teaches: by decreasing a distance (see Figs. 7A-7C, 200 is compressed from Fig. 7B to Fig. 7C when 118 is retracted, hence the distance between 302 and 300 is reduced and [0104]) between a distal end 300 (see Fig. 3B and 7B-7C, [0104]) of the first shaft 120 + 306 and a distal end 302 (see Fig. 3B and 7B-7C, [0104]) of the second shaft 118 + 304.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stante to incorporate the teachings of Quadri and teach a method for implanting a medical device at a cardiac valve with the medical device is longitudinally compressed by decreasing a distance between a distal end of the first shaft and a distal end of the second shaft. Motivation for such can be found in Quadri as this allows the device to grasp the heart valve native annulus during repositioning of the device to ensure proper positioning and implantation (see [0104]-[0106]).
Claim 13
The combination of Stante, Spenser, and Quadri teaches: the method of claim 12, see 103 rejection above. Stante further discloses: wherein the cardiac valve mitral valve is a mitral valve mitral valve (see [0024]) and the chamber is a left atrium (see [0005] and [0024], the mitral valve is adjacent to the left atrium), and wherein longitudinally compressing the medical device 20 includes longitudinally compressing the medical device 20 in the left atrium above the mitral valve (see [0028] compressed until delivered to replace the mitral valve).
Claim 14
The combination of Stante, Spenser, and Quadri teaches: the method of claim 13, see 103 rejection above. Stante further discloses: wherein the method further comprises steering the medical device 20 toward the mitral valve mitral valve after longitudinally compressing (see [0028]-[0029], compressed in catheter until delivered to the mitral valve) the medical device 20.
Claim 15
Stante discloses: A method of implanting a valve repair device 20 (see Figs. 1A-1B, [0029]) at a cardiac valve replacing a native mitral valve (see [0029]), the method comprising: endovascularly delivering a distal portion distal portion of catheter of a delivery catheter 52 (see [0027-[0028] and [0031]) to a chamber of a heart (see [0029], mitral valve); unsheathing at least a portion (see [0031]) of the valve repair device 20 from the delivery catheter delivery sheath while in the chamber (see [0029] and [0031], mitral valve) of the heart; longitudinally compressing the valve repair device 20 by moving one or both of (a) a hub shaft 70 (see Fig. 3, [0033]) secured to a first end portion 32 + 22 (see Figs. 1A-1B, [0029]) of the valve repair device 20 and (b) a core shaft 80 + 84 (see Figs. 3, [0036]) secured to a second end portion 30 (see Figs. 1A-1B, [0029]) of the valve repair device 20 relative to one another; advancing the valve repair device to a target position (see [0029], mitral valve) extending across the cardiac valve such that the first end portion 32 + 22 is positioned at a first side a first side of mitral valve of the cardiac valve upstream outflow (see [0029], outflow are regions further away from the native valve) of a native valve anulus mitral valve of the cardiac valve and the second end portion 30 is positioned at a second side second side of mitral valve of the cardiac valve proximate inflow (see [0029], valve structure, inflow) to native valve leaflets mitral valve leaflets of the cardiac valve; releasing the second end portion 20 of the valve repair device from the core shaft 80 + 84 (see Figs. 3, [0036], 82 which is connected to 84, is slidable relative to 80, which can be actuated to release the second or distal portion of the device by altering the distance relative to 62); releasing a first side a first side of 32 + 22 (see Fig. 3, [0033], connected to the posts) of the first end portion of the valve repair device 20 from the hub shaft 70; and after releasing the first side of the first end portion of the valve repair device, releasing a second side a second side of 32 + 22 of the first end portion of the valve repair device 20 from the hub shaft 70.
Stante does not explicitly disclose: longitudinally compressing the medical device within the chamber of the heart by decreasing a distance between a distal end of a single hub shaft and a distal end of a core shaft.
However, Spenser in a similar field of invention teaches a method of implanting a medical device at a cardiac valve (see Figs. 12-13j and 14a-14b) with advancing a medical device 40 (see Figs. 12-13j) to a target position (see Figs. 13a-13j) with the medical device 40 coupled to a first shaft 48 (see Figs. 13e-13g, [0074], 40 is over 48) and a second shaft 57 (see Figs. 13e-13g) and longitudinally compressing the medical device (see Figs. 14a-14b, the implant being longitudinally compressed in deployment from Fig. 14a to 14b, while being radially expanded). Spenser further teaches: longitudinally compressing the medical device 40 within the chamber of the heart (see Figs. 12 (step Q) and 13e-14b, the medical device 40 is longitudinally compressed while being radially expanded by the expansive balloon while within the chamber of the heart, [0074] and [0082]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stante to incorporate the teachings of Spenser and have the method of implanting a medical device at a cardiac valve with longitudinally compressing the medical device within the chamber of the heart. The motivation for such can be found in Spenser as expanding the implant within the novel orifice/chamber of the heart forces the edge of the anterior leaflet against the posterior leaflet thereby cancelling or minimizing natural opening and closing of the mating edges (see [0074]), furthermore the mesh material of the valve seating allows it to compress longitudinally and remain radially crimped while still providing sufficient radial force rigidity such that the valve seating maintains its shape once it has been radially expanded to a desired size (see [0082]).
The combination of Spenser and Stante does not explicitly teach: decreasing a distance between a distal end of a single hub shaft and a distal end of a core shaft.
However, Quadri in a similar field of invention teaches a method for implanting a medical device 200 (see Figs. 1-7C) at a cardiac valve (see Figs. 1-7C) with a single hub shaft 120 + 306 (see Figs. 1-7C, which is connected to 306 and 300, [0088]) coupled to a first end portion 204 (see Figs. 2A, 3b, 6) of the medical device 200 and a core shaft 118 + 304 (see Figs. 1-7C, 304 is coupled to 308 + 302 + 118, [0083] and [0089]) coupled to a second end portion 202 (see Figs. 2A, 3b, 6) of the medical device 200. Quadri further teaches: decreasing a distance (see Figs. 7A-7C, 200 is compressed from Fig. 7B to Fig. 7C when 118 is retracted, hence the distance between 302 and 300 is reduced and [0104]) between a distal end 300 (see Fig. 3B and 7B-7C, [0104]) of the single hub shaft 120 + 306 and a distal end 302 (see Fig. 3B and 7B-7C, [0104]) of the core shaft 118 + 304.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stante to incorporate the teachings of Quadri and teach a method for implanting a medical device at a cardiac valve with the medical device is longitudinally compressed by decreasing a distance between a distal end of a single hub shaft and a distal end of a core shaft. Motivation for such can be found in Quadri as this allows the device to grasp the heart valve native annulus during repositioning of the device to ensure proper positioning and implantation (see [0104]-[0106]).
Claim 16 which is rejected over a selected embodiment of Stante in [0062]
The combination of Stante, Spenser, and Quadri teaches: the method of claim 15, see 103 rejection above. Stante further discloses: wherein releasing the first side a first side of 32 + 22 connected to 451 of the first end portion 30 + 32 of the valve repair device includes actuating a handle 58 (see Fig. 3, [0031]) operably coupled to a proximal end portion 72 (see Fig. 3, [0033]) of the hub shaft 70 to drive a hub assembly 400 + one or more biasing member similar to 102 (see Figs. 9A-11B, [0062]) coupled to a distal end portion 62 (see Figs. 3 and 9A-11B, [0061]) of the hub shaft 70 to release a plurality of first connectors (see [0062], two biasing members provided independent of a number of posts, see also [0031], can have greater than four posts) at the first side a first side of 30 + 32 connected to 451 of the first end portion of the valve repair device 20, and wherein releasing the second side a second side of 32 + 22 of the first end portion 32 + 22 of the valve repair device 20 includes further actuating the handle 58 to drive the hub assembly to release a plurality of second connectors (see [0062], two biasing members provided independent of a number of posts, see also [0031], can have greater than four posts) at the second side a second side of 32 + 22 connected to 453 of the first end portion of the valve repair device.
Claim 17
The combination of Stante, Spenser, and Quadri teaches: the method of claim 15, see 103 rejection above. Stante further discloses: wherein the cardiac valve is a mitral valve and the chamber is a left atrium, wherein longitudinally compressing the valve repair device (see [0033], compressed) includes longitudinally compressing the valve repair device 20 in a left atrium left atrium is above the mitral valve above the mitral valve mitral valve, and wherein the method further comprises capturing (see [0005], valve being replaced and valve leaflet-like structures, see [0024]) a portion of one or more of the native leaflets of the mitral valve with the valve repair device 20.
Claim 18
The combination of Stante, Spenser, and Quadri teaches: the method of claim 15, see 103 rejection above. Stante further discloses: wherein the valve repair device 20 includes an atrial-fixation member 22 (see Fig. 1A, [0028]) and a coaptation member 24 (see Fig. 1A, [0029]) extending from the atrial-fixation member 22, wherein the first end portion 32 + 22 is of the atrial-fixation member 22, wherein the second end portion 30 is of the coaptation member 24, and wherein releasing the first side a first side of 32 + 22 of the first end portion 32 + 22 of the medical device 20 includes releasing a posterior side side of 32 + 22 attached to 451, which is a posterior side (see Figs. 11A-11B) of the atrial-fixation member 22 that is positioned above the coaptation member 24 (see Fig. 1A); and releasing the second side a second side of 32 + 22 of the first end portion 32 + 22 of the medical device 20 includes releasing an anterior side side of 32 + 22 attached to 453 of the atrial-fixation member opposite the posterior side opposite side of 451 (see Figs. 11A-11B).
Claim(s) 15 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lamphere et al (US 20080221672 A1), herein referenced to as “Lamphere” in view of Spenser (US 20130211509 A1), herein referenced to as “Spenser” and Quadri.
Claim 15
Lamphere discloses: A method of implanting a valve repair device 100 (see Fig. 1, [0045]) at a cardiac valve mitral valve (see [0003] and [0015]), the method comprising: endovascularly minimally invasive (see [0015], see also Figs. 3A-4I) delivering a distal portion 402 (see Figs. 4A-4I, [0063]) of a delivery catheter 400 (see Figs. 4A-4C, [0063]) to a chamber of a heart A and V (see Figs. 2-4I, [0063]); unsheathing (see Figs. 4A-4B, [0063], 402 is unsheathed from 100)at least a portion of the valve repair device 100 from the delivery catheter 302 while in the chamber of the heart atrium (see Figs. 4A-4C, [0063]); longitudinally compressing collapsed (see [0063]) the valve repair device 100 by moving one or both of (a) a hub shaft 134 (see Figs. 1-4I, [0056]) secured to a first end portion 120 (see Figs. 1-4I, [0054]) of the valve repair device 100 and (b) a core shaft 202 (see Figs. 1-4I, [0054]) secured to a second end portion 112 (see Figs. 1-4I, [0045]) of the valve repair 100 device relative to one another; advancing the valve repair device 100 to a target position (see Fig. 2) extending across the cardiac valve (see Fig. 2) such that the first end portion 120 is positioned at a first side first side of cardiac valve (see Figs. 4A-4C) of the cardiac valve upstream (see Fig. 4A-4C) of a native valve anulus of the cardiac valve mitral valve and the second end portion 112 is positioned at a second side of the cardiac valve (see Figs. 4G-4I) proximate to native valve leaflets (see Figs. 4G-4I) of the cardiac valve; releasing the second end portion 112 of the valve repair device 100 from the core shaft 202 (see [0059], separating 202 from 114 of 112); releasing a first side a first side of 120 of the first end portion 120 of the valve repair device from the hub shaft 134 using separate lengths 136 (see [0054] and [0059]); and after releasing the first side of the first end portion of the valve repair device, releasing a second side a second side of 120 of the first end portion of the valve repair device from the hub shaft 134 using separate lengths 136 (see [0054] and [0059]).
Lamphere does not explicitly disclose: longitudinally compressing the medical device within the chamber of the heart by decreasing a distance between a distal end of a single hub shaft and a distal end of a core shaft.
However, Spenser in a similar field of invention teaches a method of implanting a medical device at a cardiac valve (see Figs. 12-13j and 14a-14b) with advancing a medical device 40 (see Figs. 12-13j) to a target position (see Figs. 13a-13j) with the medical device 40 coupled to a first shaft 48 (see Figs. 13e-13g, [0074], 40 is over 48) and a second shaft 57 (see Figs. 13e-13g) and longitudinally compressing the medical device (see Figs. 14a-14b, the implant being longitudinally compressed in deployment from Fig. 14a to 14b, while being radially expanded). Spenser further teaches: longitudinally compressing the medical device 40 within the chamber of the heart (see Figs. 12 (step Q) and 13e-14b, the medical device 40 is longitudinally compressed while being radially expanded by the expansive balloon while within the chamber of the heart, [0074] and [0082]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lamphere to incorporate the teachings of Spenser and have the method of implanting a medical device at a cardiac valve with longitudinally compressing the medical device within the chamber of the heart. The motivation for such can be found in Spenser as expanding the implant within the novel orifice/chamber of the heart forces the edge of the anterior leaflet against the posterior leaflet thereby cancelling or minimizing natural opening and closing of the mating edges (see [0074]), furthermore the mesh material of the valve seating allows it to compress longitudinally and remain radially crimped while still providing sufficient radial force rigidity such that the valve seating maintains its shape once it has been radially expanded to a desired size (see [0082]).
The combination of Lamphere and Stante does not explicitly teach: by decreasing a distance between a distal end of a single hub shaft and a distal end of a core shaft.
However, Quadri in a similar field of invention teaches a method for implanting a medical device 200 (see Figs. 1-7C) at a cardiac valve (see Figs. 1-7C) with a single hub shaft 120 + 306 (see Figs. 1-7C, which is connected to 306 and 300, [0088]) coupled to a first end portion 204 (see Figs. 2A, 3b, 6) of the medical device 200 and a core shaft 118 + 304 (see Figs. 1-7C, 304 is coupled to 308 + 302 + 118, [0083] and [0089]) coupled to a second end portion 202 (see Figs. 2A, 3b, 6) of the medical device 200. Quadri further teaches: by decreasing a distance (see Figs. 7A-7C, 200 is compressed from Fig. 7B to Fig. 7C when 118 is retracted, hence the distance between 302 and 300 is reduced and [0104]) between a distal end 300 (see Fig. 3B and 7B-7C, [0104]) of the single hub shaft 120 + 306 and a distal end 302 (see Fig. 3B and 7B-7C, [0104]) of the core shaft 118 + 304.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lamphere to incorporate the teachings of Quadri and teach a method for implanting a medical device at a cardiac valve with the medical device is longitudinally compressed by decreasing a distance between a distal end of a single hub shaft and a distal end of a core shaft. Motivation for such can be found in Quadri as this allows the device to grasp the heart valve native annulus during repositioning of the device to ensure proper positioning and implantation (see [0104]-[0106]).
Claim 19
The combination of Lamphere, Spenser, and Quadri teaches: the method of claim 15, see 103 rejection above. Lamphere further discloses: wherein releasing the second end portion 112 of the valve repair device 100 from the core shaft 202 includes actuating a handle proximal cords of 136 and proximal end of 104 (see [0059] and [0065]) operably coupled to the core shaft 202 (see [0058]-[0059]) to drive the core shaft 202 to disengage a delivery attachment member 114 (see Figs. 1-2, [0059]) fixedly attached to the second end portion 112 of the valve repair device 100.
Claim 20
The combination of Lamphere, Spenser, and Quadri teaches: the method of claim 19, see 103 rejection above. Lamphere further discloses: wherein the delivery attachment member 114 is a nut (see [0059], screw thread with a corresponding socket, the socket being a nut), and wherein actuating the handle proximal cords of 136 and proximal end of 104 to drive the core shaft 202 to disengage the nut 114 includes rotating a threaded member of the core shaft to disengage the nut (see [0059], screw thread arrangement).
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.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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