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
Claims filed on February 24th, 2026 have been entered. Claims 61, 64-65, 67-71, 75-78, 80, and 84-97 are pending in the application. Claims 91- 92 remain withdrawn for being drawn to an unelected group and claims 93- 94 are herein withdrawn for being drawn to an unelected group.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 61, 64, 67, 69- 71, 74- 75, 77, and 84 under 35 U.S.C. 102(a)(1) over St. Goar et al. (US 2004/0039442) has been withdrawn in light of applicant’s amendments; specifically St. Goar does not teach a valve- delivery – assist tool for use for implanting a prosthetic aortic valve or wherein the landing support stabilizer is configured to expand and be disposed at a predetermined height below the native aortic valve, so that the landing- support stabilizer limits a depth of implantation of the prosthetic aortic valve to the predetermined height below the native aortic valve.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 65, 68, 76, and 85-89 under 35 U.S.C. 103 over St. Goar et al. (US 2004/0039442) has been withdrawn in light of applicant’s amendments; specifically St. Goar does not teach a valve- delivery – assist tool for use for implanting a prosthetic aortic valve or wherein the landing support stabilizer is configured to expand and be disposed at a predetermined height below the native aortic valve, so that the landing- support stabilizer limits a depth of implantation of the prosthetic aortic valve to the predetermined height below the native aortic valve.
The rejection of claims 78 and 80 under 35 U.S.C. 103 over St. Goar et al. (US 2004/0039442) in view of Eidenschink (US 6,517,515) has been withdrawn in light of applicant’s amendments; specifically St. Goar does not teach a valve- delivery – assist tool for use for implanting a prosthetic aortic valve or wherein the landing support stabilizer is configured to expand and be disposed at a predetermined height below the native aortic valve, so that the landing- support stabilizer limits a depth of implantation of the prosthetic aortic valve to the predetermined height below the native aortic valve.
The rejection of claim 90 under 35 U.S.C. 103 over St. Goar et al. (US 2004/0039442) in view of Eidenschink (US 2013/0345796) has been withdrawn in light of applicant’s amendments; specifically St. Goar does not teach a valve- delivery – assist tool for use for implanting a prosthetic aortic valve or wherein the landing support stabilizer is configured to expand and be disposed at a predetermined height below the native aortic valve, so that the landing- support stabilizer limits a depth of implantation of the prosthetic aortic valve to the predetermined height below the native aortic valve.
Claim(s) 61, 64- 65, 67- 71, 75- 77, 84- 89, and 95- 97 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stinis (US 2013/0109960) in view of St. Goar et al. (US 2004/0039442).
Regarding claim 61, Stinis teaches a valve- delivery- assist tool (600)(Figs. 6A- 6C)(Paragraph 0081) for use for implanting a prosthetic aortic valve during a transcatheter aortic valve implantation (TAVI) procedure on a native aortic valve having aortic valve cusps (abstract)(Paragraph 0075), the valve- delivery- assist tool comprising: a delivery catheter (606); an aortic- valve cusp guide (630a), which is releasably disposed in the delivery catheter, wherein the valve- delivery assist tool is configured such that the aortic-valve cusp guide, upon being released from the delivery catheter, deflects laterally and transitions to a deployed shape suitable for seating in one of the aortic valve cusps (Paragraphs 0082, 0084, and 0085).
Stinis does not teach a landing- support stabilizer, which is releasably disposed compressed in the delivery catheter and configured, after being released from a distal end of the delivery catheter, to expand and be disposed at a predetermined height below the native aortic valve, so that the landing- support stabilizer limits a depth of implantation of the prosthetic aortic valve to the predetermined height below the native aortic valve.
St. Goar (St. Goar et al.) teaches a valve- delivery- assist tool (abstract)(Figs. 44A- 44D) for use on a native aortic valve (abstract and Paragraphs 0003, 0004, and 0182), the valve- delivery- assist tool comprising: a delivery catheter (Paragraph 0182); a valve cusp guide (superior loop 720), which is releasably disposed in the delivery catheter, wherein the valve- delivery- assist tool is configured such that the valve cusp guide upon being released from the delivery catheter, deflects laterally and transitions to a deployed shape suitable for seating in a cusp (see annotated Fig. 44C below)(Paragraph 0182); and a landing- support stabilizer (inferior loop 721)(St. Goar teaches in Paragraph 0182 that the inferior loop grasps the valve leaflets and therefore can act as a stabilizer.), which is releasably disposed compressed in the delivery catheter and configured, after being released from a distal end of the delivery catheter to expand and be disposed at a predetermined height below the native valve (Paragraph 0182).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the valve- delivery- assist tool as taught by Stinis to have the landing- support stabilizer as taught by St. Goar, since St. Goar teaches that the stabilizer can be used with any cardiac valve (Paragraphs 0007 and 0182) and stabilizes the tool relative to the valve leaflets and other heart tissue structures during a procedure, which is desirable (Paragraph 0022).
Regarding wherein the landing- support stabilizer limits a depth of implantation of the prosthetic aortic valve to the predetermined heigh below the native aortic valve, as the landing- support stabilizer connects to the leaflet through pinching it between the aortic- valve cusp guide and the landing- support stabilizer within the combination (Paragraph 0182 of St. Goar), and the valve- delivery- assist tool would be connected to the stabilizer within the combination, then the landing- support stabilizer limits the depth of implantation of the prosthetic aortic valve to the predetermined height below the native aortic valve because when the prosthetic aortic valve goes past the landing- support stabilizer, the valve- delivery- assist tool would disconnect from the tissue and therefore the prosthetic aortic valve would not be deployed properly, making the landing- support stabilizer act as a limiter.
Regarding claim 64, Stinis and St. Goar make obvious the valve- delivery- assist tool as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the valve- delivery- assist tool as taught by Stinis to have the landing- support stabilizer as taught by St. Goar, since St. Goar teaches that the stabilizer can be used with any cardiac valve (Paragraphs 0007 and 0182) and stabilizes the tool relative to the valve leaflets and other heart tissue structures during a procedure, which is desirable (Paragraph 0022).
Regarding wherein the valve- delivery- assist tool is configured such that after lateral deflection of the aortic- valve cusp guide and expansion of the landing- support stabilizer, the released landing- support stabilizer and the released aortic- valve cusp guide are axially stationary with respect to one another such that a proximal- most point of the released landing- support stabilizer is disposed distal to the distal- most point of the released aortic- valve cusp guide, as Stinis teaches that the various parts of the valve- delivery assist tool can be secured relative to each other (Paragraph 0086) then within the combination the landing- support stabilizer could also be secured relative to the aortic- valve cusp guide after the lateral deflection of the guide and the expanding of the stabilizer and therefore be axially stationary with respect to the aortic-valve cusp guide. Furthermore, within the combination, since the proximal- most point of the released landing support stabilizer would be below the interior surface of the cusp of the aortic valve (see annotated Fig. 44C of St. Goar below)(Paragraph 0182) and as the distal- most point of the released aortic- valve cusp guide is above the exterior surface of the cusp of the aortic valve (see annotated Fig. 8A of Stinis below)(Paragraph 0085), then the proximal- most point of the released landing support stabilizer would be disposed distal to the distal-most point of the released aortic- valve cusp guide.
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Regarding claim 65, Stinis and St. Goar make obvious the valve- delivery- assist tool as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the valve- delivery- assist tool as taught by Stinis to have the landing- support stabilizer as taught by St. Goar, since St. Goar teaches that the stabilizer can be used with any cardiac valve (Paragraphs 0007 and 0182) and stabilizes the tool relative to the valve leaflets and other heart tissue structures during a procedure, which is desirable (Paragraph 0022).
Regarding wherein the valve- delivery- assist tool is configured such that after lateral deflection of the aortic- valve cusp guide and expansion of the landing- support stabilizer, the released landing- support stabilizer and the released aortic- valve cusp guide are axially stationary with respect to one another such that a proximal- most point of the released landing- support stabilizer is disposed distal to the distal- most point of the released aortic- valve cusp guide, as Stinis teaches that the various parts of the valve- delivery assist tool can be secured relative to each other (Paragraph 0086) then within the combination the landing- support stabilizer could also be secured relative to the aortic- valve cusp guide after the lateral deflection of the guide and the expanding of the stabilizer and therefore be axially stationary with respect to the aortic-valve cusp guide. Furthermore, within the combination, since the proximal- most point of the released landing support stabilizer would be below the cusp of the aortic valve (see annotated Fig. 44D of St. Goar below)(Paragraph 0182) and as the distal- most point of the released aortic- valve cusp guide is above the cusp of the aortic valve (see annotated Fig. 8A of Stinis below)(Paragraph 0085), then the proximal- most point of the released landing support stabilizer would be disposed distal to the distal-most point of the released aortic- valve cusp guide.
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The combination of Stinis and St. Goar is silent to wherein the valve- delivery- assist tool is configured such that after lateral deflection of the aortic- valve cusp guide and expansion of the landing- support stabilizer, the released landing- support stabilizer and the released aortic- valve cusp guide are axially stationary with respect to one another such that the proximal- most point of the released landing- support stabilizer is disposed between 1 and 10 mm distal to the distal- most point of the released aortic- valve cusp guide.
However, since Stinis and St. Goar teach that the valve- delivery- assist tool is used within the heart and can be used with any cardiac valve such as the aortic valve (Stinis, Paragraphs 0075 and 0081; St. Goar, Paragraphs 0007 and 0182) and aids in the process of treating a valve (Stinis, abstract; St. Goar, abstract), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the distance between the proximal-most point of the released landing support stabilizer and the distal- most point of the released valve cusp guide to be between 1 and 10 mm, as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04(IV)(A)).
Regarding claim 67, Stinis and St. Goar make obvious the valve- delivery- assist tool as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the valve- delivery- assist tool as taught by Stinis to have the landing- support stabilizer as taught by St. Goar, since St. Goar teaches that the stabilizer can be used with any cardiac valve (Paragraphs 0007 and 0182) and stabilizes the tool relative to the valve leaflets and other heart tissue structures during a procedure, which is desirable (Paragraph 0022).
Regarding wherein the one of the aortic valve cusps is a non- coronary cusp of the native aortic valve, and wherein the tool is configured such that the disposition of the released aortic- valve cusp guide within a non- coronary cusp of the native aortic valve and rotationally centering the aortic cusp guide within the non-coronary cusp, axially disposes the released landing- support stabilizer at a predetermined height below the native aortic valve, since this language is functional, as long as the combination of Stinis and St. Goar teaches a similar structure capable of accomplishing the function, the combination teaches the claim limitation. Therefore, as the combination teaches a similar structure of the valve- delivery- assist tool (see claims 61 and 64 above), comprising an aortic- valve cusp guide (630a of Stinis) that can be disposed in a cusp of the aortic valve (Paragraph 0085 of Stinis) and rotational centered (Paragraph 0086, see Fig. 8A of Stinis), and a landing- support stabilizer (721 of St. Goar) disposed below the native aortic valve (Paragraph 0182 of St. Goar), the combination teaches the claim limitation.
Regarding claim 68, Stinis and St. Goar make obvious the valve- delivery- assist tool as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the valve- delivery- assist tool as taught by Stinis to have the landing- support stabilizer as taught by St. Goar, since St. Goar teaches that the stabilizer can be used with any cardiac valve (Paragraphs 0007 and 0182) and stabilizes the tool relative to the valve leaflets and other heart tissue structures during a procedure, which is desirable (Paragraph 0022).
The combination of Stinis and St. Goar is silent to wherein the predetermined height is between 2 and 10 mm.
However, since Stinis and St. Goar teach that the valve- delivery- assist tool is used within the heart and can be used with any cardiac valve such as the aortic valve (Stinis, Paragraphs 0075 and 0081; St. Goar, Paragraphs 0007 and 0182) and aids in the process of treating a valve (Stinis, abstract; St. Goar, abstract), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the predetermined height to be between 2 and 10 mm, as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04(IV)(A)).
Regarding claim 69, Stinis and St. Goar make obvious the valve- delivery- assist tool as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the valve- delivery- assist tool as taught by Stinis to have the landing- support stabilizer as taught by St. Goar, since St. Goar teaches that the stabilizer can be used with any cardiac valve (Paragraphs 0007 and 0182) and stabilizes the tool relative to the valve leaflets and other heart tissue structures during a procedure, which is desirable (Paragraph 0022).
Regarding wherein the valve- delivery- assist tool is configured such that after lateral deflection of the aortic- valve cusp guide and expansion of the landing- support stabilizer, the released landing- support stabilizer and the released aortic- valve cusp guide are rotationally stationary with respect to one another, as Stinis teaches that the various parts of the valve- delivery assist tool can be secured relative to each other (Paragraph 0086) then within the combination the landing- support stabilizer could also be secured relative to the aortic- valve cusp guide after the lateral deflection of the guide and the expanding of the stabilizer and therefore be rotationally stationary with respect to the aortic-valve cusp guide. Furthermore, when the shafts of the aortic- valve cusp guide and the landing- support stabilizer of the combination are held steady after expansion of both the guide and the stabilizer, they would be rotationally stationary relative to one another.
Regarding claim 70, Stinis and St. Goar make obvious the valve- delivery- assist tool as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the valve- delivery- assist tool as taught by Stinis to have the landing- support stabilizer as taught by St. Goar, since St. Goar teaches that the stabilizer can be used with any cardiac valve (Paragraphs 0007 and 0182) and stabilizes the tool relative to the valve leaflets and other heart tissue structures during a procedure, which is desirable (Paragraph 0022).
The combination further teaches wherein the landing- support stabilizer (721 of St. Goar) comprises an elongate slender rod (One or more ribbons of 721, Paragraph 0182 of St. Goar).
Regarding claim 71, Stinis and St. Goar make obvious the valve- delivery- assist tool as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the valve- delivery- assist tool as taught by Stinis to have the landing- support stabilizer as taught by St. Goar, since St. Goar teaches that the stabilizer can be used with any cardiac valve (Paragraphs 0007 and 0182) and stabilizes the tool relative to the valve leaflets and other heart tissue structures during a procedure, which is desirable (Paragraph 0022).
The combination further teaches wherein the elongate slender rod (one or more ribbons of 721, Paragraph 0182 of St. Goar) of the released- landing- support stabilizer (721 of St. Goar) is shaped as a partial loop having one turn (see annotated Fig. 44C of St. Goar below).
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Regarding claim 75, Stinis and St. Goar make obvious the valve- delivery- assist tool as discussed above.
The combination does not teach the valve- delivery- assist tool further comprising an elongate valve- delivery- assist support, which links together the landing- support stabilizer and the aortic- valve cusp guide, and wherein the released landing- support stabilizer extends laterally from the elongate valve- delivery- assist support.
St. Goar (St. Goar et al.) teaches a valve- delivery- assist tool (abstract)(Figs. 44A- 44D) for use on a native aortic valve (abstract and Paragraphs 0003, 0004, and 0182), the valve- delivery- assist tool comprising: a delivery catheter (Paragraph 0182); a valve cusp guide (superior loop 720), which is releasably disposed in the delivery catheter, wherein the valve- delivery- assist tool is configured such that the valve cusp guide upon being released from the delivery catheter, deflects laterally and transitions to a deployed shape suitable for seating in a cusp (see annotated Fig. 44C below)(Paragraph 0182); and a landing- support stabilizer (inferior loop 721)(St. Goar teaches in Paragraph 0182 that the inferior loop grasps the valve leaflets and therefore can act as a stabilizer.), which is releasably disposed compressed in the delivery catheter and configured, after being released from a distal end of the delivery catheter to expand and be disposed at a predetermined height below the native valve (Paragraph 0182). St. Goar further teaches the assist tool further comprising an elongate valve- delivery- assist support (725, 726), which links together the landing- support stabilizer (721) and the aortic- valve cusp guide (720)(see annotated Fig. 44B below)(Paragraph 0182) and wherein the released landing- support stabilizer (721) extends laterally from the elongate valve- delivery- assist support (725, 726)(see annotated Fig. 44C below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combination to have an elongate valve- delivery- assist support as taught by St. Goar, since St. Goar teaches that this support aids in the deployment of the landing- support stabilizer and allows for the device to be centered and stabilized (Paragraph 0182, see Fig. 44D).
Regarding claim 76, Stinis and St. Goar make obvious the valve- delivery- assist tool as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combination to have an elongate valve- delivery- assist support as taught by St. Goar, since St. Goar teaches that this support aids in the deployment of the landing- support stabilizer and allows for the device to be centered and stabilized (Paragraph 0182, see Fig. 44D).
The combination further teaches a best- fit plane defined by the released landing- support stabilizer (721 of St. Goar) formed with the central longitudinal axis of the elongate valve- delivery- assist support (725, 726 of St. Goar) that is straight and passed through the distal end of the elongate valve- delivery- assist support (see annotated Fig. 44C below of St. Goar)(Paragraph 0182 of St. Goar).
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The combination of Stinis and St. Goar is silent to wherein a best- fit plane defined by the released landing- support stabilizer forms an angle of between 45 and 90 degrees.
However, since Stinis and St. Goar teach that the valve- delivery- assist tool is used within the heart and can be used with any cardiac valve such as the aortic valve (Stinis, Paragraphs 0075 and 0081; St. Goar, Paragraphs 0007 and 0182) and aids in the process of treating a valve (Stinis, abstract; St. Goar, abstract), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the angle of the best-fit plane to be between 45 degrees and 90 degrees, as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04(IV)(A)).
Regarding claim 77, Stinis and St. Goar make obvious the valve- delivery- assist tool as discussed above.
The combination of Stinis and St. Goar does not teach the valve- delivery- assist tool further comprises an elongate valve- delivery- assist support, which links together the landing- support stabilizer and the aortic- valve cusp guide, and wherein the elongate valve- delivery- assist support comprises: an elongate aortic- valve cusp- guide shaft, which is fixed to and supports the aortic- valve cusp guide; and an elongate landing- support- stabilizer shaft, which is fixed to and supports the landing- support stabilizer, wherein the elongate aortic- valve cusp-guide shaft and the elongate landing- support- stabilizer shaft are fixed together at least partially alongside one another.
St. Goar (St. Goar et al.) teaches a valve- delivery- assist tool (abstract)(Figs. 44A- 44D) for use on a native aortic valve (abstract and Paragraphs 0003, 0004, and 0182), the valve- delivery- assist tool comprising: a delivery catheter (Paragraph 0182); a valve cusp guide (superior loop 720), which is releasably disposed in the delivery catheter, wherein the valve- delivery- assist tool is configured such that the valve cusp guide upon being released from the delivery catheter, deflects laterally and transitions to a deployed shape suitable for seating in a cusp (see annotated Fig. 44C below)(Paragraph 0182); and a landing- support stabilizer (inferior loop 721)(St. Goar teaches in Paragraph 0182 that the inferior loop grasps the valve leaflets and therefore can act as a stabilizer.), which is releasably disposed compressed in the delivery catheter and configured, after being released from a distal end of the delivery catheter to expand and be disposed at a predetermined height below the native valve (Paragraph 0182). St. Goar further teaches the assist tool further comprising an elongate valve- delivery- assist support (725, 726), which links together the landing- support stabilizer (721) and the aortic- valve cusp guide (720)(see annotated Fig. 44B below)(Paragraph 0182) and wherein the elongate valve- delivery- assist support comprises: an elongate aortic-valve cusp- guide shaft (726), which is fixed to and supports the aortic- valve cusp guide (Paragraph 0182); and an elongate landing- support- stabilizer shaft (725), which is fixed to and supports the landing- support stabilizer (Paragraph 0182), wherein the elongate aortic- valve cusp- guide shaft and the elongate landing- support- stabilizer shaft are fixed together at least partially alongside one another (In Paragraph 0182, St. Goar teaches that the two shafts are coaxially disposed to each other, therefore, the outer diameter of the elongate landing- support- stabilizer shaft is alongside or next to, the inner diameter of the elongate aortic- valve cusp- guide shaft. Furthermore, after the aortic valve cusp guide and the landing support stabilizer are expanded, when the two shafts are held, they would be fixed in regards to one another.).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combination to have an elongate valve- delivery- assist support as taught by St. Goar, since St. Goar teaches that this support aids in the deployment of the landing- support stabilizer and allows for the device to be centered and stabilized (Paragraph 0182, see Fig. 44D).
Regarding claim 84, Stinis and St. Goar make obvious the valve- delivery- assist tool as discussed above.
Stinis further teaches wherein the aortic- valve cusp guide (630a) comprises an elongate slender rod (distal tip 633) that defines the deployed shape of the aortic- valve cusp guide and is configured to be shaped as a pigtail (Paragraph 0085)(see Fig. 8A).
Regarding claim 85, Stinis and St. Goar make obvious the valve- delivery- assist tool as discussed above.
The combination of Stinis and St. Goar does not teach in the current embodiment a conduction- tissue protector, which (a) comprises a sheet, (b) is releasably disposed compressed in the delivery catheter, and (c) is configured to expand to a deployed shape in a left ventricle upon being released from the distal end of the delivery catheter, wherein the valve- delivery- assist tool is configured such that after lateral deflection of the aortic- valve cusp guide, seating of the aortic- valve cusp guide in the one of the aortic valve cusps and expansion of the conduction- tissue protector and the landing- support stabilizer: the released landing- support stabilizer, the released conduction- tissue protector, and the released aortic- valve cusp guide are axially stationary with respect to one another such that: (i) a distal- most point of the released conduction- tissue protector is disposed distal to the distal- most point of the released aortic- valve cusp guide, (ii) a proximal- most point of the released landing- support stabilizer is disposed proximal to the distal- most point of the released conduction- tissue protector, and (iii) rotational centering of the aortic-valve cusp guide within the one of the aortic valve cusps axially and rotationally aligns the released conduction- tissue protector to face a septal wall of a left ventricular outflow tract.
St. Goar teaches in a separate embodiment, a similar valve- delivery- assist tool (orientation element 620)(Figs. 18- 21C)(Paragraph 0146) comprising a conduction- tissue protector (bladder 625, frame 626), which comprises a sheet (bladder 625)(In Paragraph 0148, St. Goar teaches that the bladder does not need to be inflated and therefore acts as a sheet.), is releasably disposed compressed in the delivery catheter, and is configured to expand upon being released from the distal end of the delivery catheter (Paragraph 0148).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the valve- delivery- assist tool of the combination to have the conduction- tissue protector of the second embodiment of St. Goar, since St. Goar teaches that the conduction- tissue protector allows for the user to orient the device within the heart and enable proper alignment of the valve- delivery- assist tool (Paragraph 0146).
Regarding wherein the conduction- tissue protector is configured to expand to a deployed shape in a left ventricle, as Stinis teaches that the device is disposed within the same location as set forth in the claim (Paragraph 0085), and as the combination has the conduction- tissue protector, then the protector would expand to a deployed shape in a left ventricle.
Regarding wherein the valve- delivery- assist tool is configured such that after lateral deflection of the aortic- valve cusp guide and expansion of the conduction- tissue protector and the landing- support stabilizer: the released landing- support stabilizer, the released conduction- tissue protector, and the released aortic- valve cusp guide are axially stationary with respect to one another such that: (i) a distal- most point of the released conduction- tissue protector is disposed distal to the distal- most point of the released aortic- valve cusp guide, and (ii) a proximal- most point of the released landing- support stabilizer is disposed proximal to the distal- most point of the released conduction- tissue protector, as the combination teaches that the conduction- tissue protector interacts with the valve and can be within it (Paragraphs 0146- 0148 of St. Goar), and that the landing support stabilizer is below the valve (Paragraph 0182 of St. Goar) and the valve cusp guide is above the valve (see Fig. 8A of Stinis, Paragraph 0085), then the distal- most point of the released conduction- tissue protector is disposed distal to the distal- most point of the valve cusp guide and a proximal-most point of the released landing- support stabilizer is disposed proximal to the distal- most point of the released conduction- tissue protector. Regarding the elements being disposed axially stationary relative to each other, as Stinis teaches that the various parts of the valve- delivery assist tool can be secured relative to each other (Paragraph 0086) then within the combination the landing- support stabilizer could also be secured relative to the aortic- valve cusp guide after the lateral deflection of the guide and the expanding of the stabilizer and therefore be rotationally stationary with respect to the aortic-valve cusp guide. Furthermore, when the shafts of the aortic- valve cusp guide and the landing- support stabilizer of the combination are held steady after expansion of both the guide and the stabilizer, they would be rotationally stationary relative to one another. Likewise, when the shaft of the conduction- tissue protector is held in conjunction with the two shafts, then it would be stationary relative to the valve cusp guide and the landing support stabilizer.
Regarding wherein the valve- delivery- assist tool is configured such that after lateral deflection of the aortic- valve cusp guide and expansion of the conduction- tissue protector and the landing- support stabilizer: the released landing- support stabilizer, the released conduction- tissue protector, and the released aortic- valve cusp guide are axially stationary with respect to one another such that: rotational centering of the aortic-valve cusp guide within the one of the aortic valve cusps axially and rotationally aligns the released conduction- tissue protector to face a septal wall of a left ventricular outflow tract, as this language is functional, the structure of the device only needs to have the ability to complete the function, therefore as the combination is within the same location, the aortic valve, has an aortic-valve cusp guide (630a of Stinis) able to be align in the aortic valve cusps axially and rotationally (Paragraphs 0085 and 0086), and as the combination teaches a conduction- tissue protector (bladder 625, frame 626, Paragraph 0148 of St. Goar), then the conduction- tissue protector would be capable of facing a septal wall of a left ventricular outflow tract with the rotational centering of the aortic- valve cusp guide.
Regarding claim 86, Stinis and St. Goar make obvious the valve- delivery- assist tool as discussed above.
The combination does not teach the valve- delivery- assist tool further comprising an elongate valve- delivery- assist support, which links together the landing- support stabilizer and the aortic- valve cusp guide, and wherein the released landing- support stabilizer extends laterally from the elongate valve- delivery- assist support.
St. Goar (St. Goar et al.) teaches a valve- delivery- assist tool (abstract)(Figs. 44A- 44D) for use on a native aortic valve (abstract and Paragraphs 0003, 0004, and 0182), the valve- delivery- assist tool comprising: a delivery catheter (Paragraph 0182); a valve cusp guide (superior loop 720), which is releasably disposed in the delivery catheter, wherein the valve- delivery- assist tool is configured such that the valve cusp guide upon being released from the delivery catheter, deflects laterally and transitions to a deployed shape suitable for seating in a cusp (see annotated Fig. 44C below)(Paragraph 0182); and a landing- support stabilizer (inferior loop 721)(St. Goar teaches in Paragraph 0182 that the inferior loop grasps the valve leaflets and therefore can act as a stabilizer.), which is releasably disposed compressed in the delivery catheter and configured, after being released from a distal end of the delivery catheter to expand and be disposed at a predetermined height below the native valve (Paragraph 0182). St. Goar further teaches the assist tool further comprising an elongate valve- delivery- assist support (725, 726), which links together the landing- support stabilizer (721) and the aortic- valve cusp guide (720)(see annotated Fig. 44B below)(Paragraph 0182) and wherein the released landing- support stabilizer (721) extends laterally from the elongate valve- delivery- assist support (725, 726)(see annotated Fig. 44C below). St. Goar further teaches wherein the elongate valve- delivery- assist support comprises an elongate conduction- tissue- protector shaft, which is fixed to and supports the released conduction- tissue protector (see annotated Fig. 21C below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combination to have an elongate valve- delivery- assist support as taught by St. Goar, since St. Goar teaches that this support aids in the deployment of the landing- support stabilizer and allows for the device to be centered and stabilized (Paragraph 0182, see Fig. 44D).
Regarding wherein the elongate conduction- tissue- protector shaft, the elongate aortic- valve cusp- guide shaft, and the elongate landing- support- stabilizer shaft are together at least partially alongside one another, as St. Goar teaches that the shafts are coaxial (Paragraph 0182), and as discussed above it would have been obvious for the conduction- tissue- protector shaft and the conduction- tissue- protector to be a part of the device, then the conduction- tissue- protector shaft would also be coaxial with the other shafts. With this coaxial arrangement, the shafts are together alongside one another.
Regarding claim 87, Stinis and St. Goar make obvious the valve- delivery- assist tool as discussed above.
Regarding wherein the valve- delivery- assist tool is configured such that after lateral deflection of the aortic- valve cusp guide and expansion of the conduction- tissue protector, the released conduction- tissue protector and the released aortic- valve cusp guide are axially stationary with respect to each other, as Stinis teaches that the various parts of the valve- delivery assist tool can be secured relative to each other (Paragraph 0086) then within the combination the landing- support stabilizer could also be secured relative to the aortic- valve cusp guide after the lateral deflection of the guide and the expanding of the stabilizer and therefore be axially stationary with respect to the aortic-valve cusp guide.
The combination is silent to wherein the valve- delivery- assist tool is configured such that after lateral deflection of the aortic- valve cusp guide and expansion of the conduction- tissue protector, the released conduction- tissue protector and the released aortic- valve cusp guide are axially stationary with respect to each other such that the distal- most point of the released conduction- tissue protector is disposed between 2 and 30 mm distal to the distal- most point of the released aortic- valve cusp guide.
However, since Stinis and St. Goar teach that the valve- delivery- assist tool is used within the heart and can be used with any cardiac valve such as the aortic valve (Stinis, Paragraphs 0075 and 0081; St. Goar, Paragraphs 0007 and 0182) and aids in the process of treating a valve (Stinis, abstract; St. Goar, abstract), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the distance between the distal- most point of the released conduction- tissue protector and the distal- most point of the released aortic- valve cusp guide to be between 2 and 30 mm, as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04(IV)(A)).
Regarding claim 88, Stinis and St. Goar make obvious the valve- delivery- assist tool as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the valve- delivery- assist tool of the combination to have the conduction- tissue protector of the second embodiment of St. Goar, since St. Goar teaches that the conduction- tissue protector allows for the user to orient the device within the heart and enable proper alignment of the valve- delivery- assist tool (Paragraph 0146).
The combination further teaches wherein the conduction- tissue protector further comprises a frame (626 of St. Goar) supporting the sheet (Paragraph 0148 of St. Goar).
Regarding claim 89, Stinis and St. Goar make obvious the valve- delivery- assist tool as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the valve- delivery- assist tool of the combination to have the conduction- tissue protector of the second embodiment of St. Goar, since St. Goar teaches that the conduction- tissue protector allows for the user to orient the device within the heart and enable proper alignment of the valve- delivery- assist tool (Paragraph 0146).
The combination further teaches wherein the released conduction- tissue protector is configured such that the sheet is generally planar (see annotated Fig. 21C below of St. Goar)(In Paragraph 0148, St. Goar teaches that the bladder does not need to be inflated and therefore acts as a sheet.).
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Regarding claim 95, Stinis and St. Goar make obvious the valve- delivery- assist tool as discussed above.
Regarding wherein the valve- delivery- assist tool is configured such that after lateral deflection of the aortic- valve cusp guide and expansion of the conduction- tissue protector, the released conduction- tissue protector and the released aortic- valve cusp guide are axially stationary with respect to each other, as Stinis teaches that the various parts of the valve- delivery assist tool can be secured relative to each other (Paragraph 0086) then within the combination the landing- support stabilizer could also be secured relative to the aortic- valve cusp guide after the lateral deflection of the guide and the expanding of the stabilizer and therefore be axially stationary with respect to the aortic-valve cusp guide.
The combination does not teach wherein the valve- delivery- assist tool is configured such that after lateral deflection of the aortic- valve cusp guide and expansion of the landing- support stabilizer, the released landing- support stabilizer and the released aortic- valve cusp guide are axially stationary with respect to one another such that the proximal- most point of the released landing- support stabilizer is disposed between 1.5 and 4 mm distal to the distal-most point of the released aortic valve- cusp guide.
However, since Stinis and St. Goar teach that the valve- delivery- assist tool is used within the heart and can be used with any cardiac valve such as the aortic valve (Stinis, Paragraphs 0075 and 0081; St. Goar, Paragraphs 0007 and 0182) and aids in the process of treating a valve (Stinis, abstract; St. Goar, abstract), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the distance between the proximal- most point of the released landing- support stabilizer and the distal- most point of the released aortic- valve cusp guide to be between 1.5 mm and 4 mm, as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04(IV)(A)).
Regarding claim 96, Stinis and St. Goar make obvious the valve- delivery assist tool as discussed above.
Stinis further teaches wherein the deployed shape of the slender rod is suitable for seating the aortic- valve cusp guide in the one of the cusps with a belly of the pigtail of the aortic- valve cusp guide on a floor of the one of the cusps and an end of the pigtail on a lateral wall of the one of the cusps (see annotated Fig. 8A below)(Paragraph 0085).
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Regarding claim 97, Stinis and St. Goar make obvious the valve- delivery- assist tool as discussed above.
Regarding wherein the valve- delivery- assist tool is configured such that the released landing- support stabilizer and the released aortic- valve cusp guide are disposed on opposite sides of the released conduction- tissue protector, as the combination teaches that the aortic- valve cusp guide can be disposed on one side of the aortic valve (see annotated Fig. 8A of Stinis below)(Paragraph 0085 of Stinis), and that the landing- support stabilizer has a portion that can be on an opposite side of the aortic- valve cusp guide (see annotated Fig. 44D of St. Goar below), then when the conduction- tissue protector of the combination is also released the aortic- valve cusp guide is disposed on an opposite side of the landing- support stabilizer.
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Claim(s) 78 and 80 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stinis (US 2013/0109960) in view of St. Goar et al. (US 2004/0039442), as applied to claim 61 above, in further view of Eidenschink (US 6,517,515).
Regarding claim 78, Stinis and St. Goar make obvious the valve- delivery- assist tool as discussed above.
Stinis further teaches wherein the tool can be used with a guide catheter, that can have a guidewire (Paragraph 0080).
The combination of Stinis and St. Goar does not teach wherein the valve- delivery- assist tool further comprising a nose cone, which is shaped so as to define (a) a wider proximal base that is removably coupled to a distal end of the delivery catheter, and (b) a narrower elongate distal safety tip that extends distally from the proximal base, wherein the nose cone is shaped so as to define a guidewire channel through the proximal base and the elongate distal safety tip, and wherein the elongate distal safety tip is configured to assume a straight shape when the guidewire is disposed in the guidewire channel, and a curved shape when the guidewire is not disposed in the guidewire channel.
Eidenschink teaches a similar tool for delivery within vasculature (Fig. 5)(abstract, Paragraph ), the tool comprising a nose cone (tip 116), which is shaped so as to define a wider proximal base that is removably coupled to a distal end of the delivery catheter and a narrower elongate distal safety tip (distal portion 118) that extends distally from the proximal base (Column 11, Lines 7- 12)(see annotated Fig. 5 below), wherein the nose cone is shaped so as to define a guidewire channel through the proximal base and the elongate distal safety tip (lumen 111)(see annotated Fig. 5 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the tool as taught by the combination to comprise guidewire catheter with a nose cone and a guidewire as taught by Eidenschink, since Eidenschink teaches that the nose cone aids the catheter in tracking the guidewire and assists in crossing a lesion to be dilated (Column 3, Lines 58- 60), as a lesion limits the size of the lumen that the catheter can pass through, it is similar to a valve within the heart, which also reduces the space for the catheter to pass through, therefore assistance is needed in crossing a valve as well as keeping track of a guidewire when inserting the delivery catheter into a vessel.
The combination does not teach wherein the elongate distal safety tip is configured to assume a straight shape when the guidewire is disposed in the guidewire channel, and a curved shape when the guidewire is not disposed in the guidewire channel.
Eidenschink teaches in a separate embodiment a similar tool for delivery within vasculature (Column 11, Lines 60- 64)(Fig. 8), the tool comprising an elongate distal safety tip (tip 116), wherein the elongate distal safety tip is configured to assume a straight shape when the guidewire is disposed in the guidewire channel, and a curved shape when the guidewire is not disposed in the guidewire channel (Column 11, Line 64- Column 12, Line 6).
It would have been obvious to one of ordinary skill in the art to modify the elongate distal safety tip of the combination to be configured to assume a straight shape when the guidewire is present and a curved shape when the guidewire is not as taught by the second embodiment of Eidenschink, since Eidenschink teaches that this configuration allows for the tip to not catching on the strut of the stent when it crosses (Column 12, Lines 3- 6), when crossing a valve within the heart, a person of ordinary skill in the art would recognize that preventing the distal tip of the catheter from catching on the valve would prevent damage that could occur and allow for the treatment of the valve to continue without interruption.
Regarding claim 80, Stinis and St. Goar make obvious teaches the valve- delivery- assist tool as discussed above.
The combination of Stinis and St. Goar does not teach the tool further comprising a safety tip, which is releasably disposed compressed in the delivery catheter, configured to be released from the distal end of the delivery catheter, and shaped so as to define a guidewire channel through the safety tip.
Eidenschink teaches in a similar tool for delivery within vasculature (Column 11, Lines 60- 64)(Fig. 8), the tool comprising a safety tip (tip 116), which is releasably disposed compressed in the delivery catheter (As Eidenschink teaches that the safety tip is able to change shape once a guidewire is removed from a lumen, and as the safety tip can be pulled back to be disposed within the outer member (see Fig. 8, Column 3, Lines 35- 40), it is releasably disposed compressed in the delivery catheter.), configured to be released from the distal end of the delivery catheter (When the tip is pushed out of the distal end of the delivery catheter, it is released from the distal end of it (see Fig. 8).), and shaped so as to define a guidewire channel (lumen 111) through the safety tip (see Fig. 8)(Column 11, Line 64- Column 12, Line 6).
It would have been obvious to one of ordinary skill in the art to modify the elongate distal safety tip of the combination to be configured to assume a straight shape when the guidewire is present and a curved shape when the guidewire is not as taught by the second embodiment of Eidenschink, since Eidenschink teaches that this configuration allows for the tip to not catching on the strut of the stent when it crosses (Column 12, Lines 3- 6), when crossing a valve within the heart, a person of ordinary skill in the art would recognize that preventing the distal tip of the catheter from catching on the valve would prevent damage that could occur and allow for the treatment of the valve to continue without interruption.
Claim(s) 90 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stinis (US 2013/0109960) in view of St. Goar et al. (US 2004/0039442), as applied to claim 85 above, in further view of Eidenschink (US 2013/0345796).
Regarding claim 90, Stinis and St. Goar make obvious the valve- delivery- assist tool as discussed above.
The combination of St. Goar does not teach wherein the sheet comprises a mesh, which comprises braided wires.
Eidenschink teaches a similar valve- delivery- assist tool (abstract)(Figs. 2C- 2D), with a delivery catheter (sheath 80), a conduction- tissue protector (60) which comprises a sheet (wings 62) that comprises a mesh which has braided wires (In Paragraph 40, Eidenschink teaches that the mesh material can have various forms, such as being a woven polymer, therefore, Eidenschink teaches that the mesh can have braided wires. ), is releasably disposed compressed in the delivery catheter and is configured to expand upon being released from the distal end of the delivery catheter (Paragraphs 0042- 0043).
It would have been obvious to one of ordinary skill in the art to modify the sheet of the conduction-tissue protector of the combination of St. Goar to comprise a mesh, as Eidenschink teaches that the mesh “may prevent calcified particles that may become detached from the native valve of the aorta during deployment of the prosthetic heart valve from entering these great vessels” (Paragraph 0047).
Response to Arguments
Regarding applicant's arguments filed February 24th, 2026 with respect to the rejection of claims 61, 64, 67, 69- 71, 74- 75, 77, and 84 under 35 U.S.C. 102(a)(1) over St. Goar et al. (US 2004/0039442), the rejection of claims 65, 68, 76, and 85-89 under 35 U.S.C. 103 over St. Goar et al. (US 2004/0039442) the rejection of claims 78 and 80 under 35 U.S.C. 103 over St. Goar et al. (US 2004/0039442) in view of Eidenschink (US 6,517,515), and the rejection of claim 90 under 35 U.S.C. 103 over St. Goar et al. (US 2004/0039442) in view of Eidenschink (US 2013/0345796), these arguments have been fully considered but are moot since, as discussed above, the previous prior art rejections have been withdrawn in light of applicant’s amendments. However, it is noted that St. Goar, Eidenschink ‘515, and Eidenschink ‘796 are still relied upon for limitations not argued.
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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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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