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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/06/2023, 03/29/2024, 06/25/2024, 12/06/2024, 03/28/2025, 06/24/2025, 09/24/2025, and 12/23/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 1-2, 8-13, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Spence et al (US 2018/0153690 A1) in view of Patel et al (US 2018/0055628 A1).
Regarding claim 1, Spence discloses a method for treating a diseased native valve in a patient (paragraph 0007), the method comprising:
an anchor (Figures 5A-C, item 90),
the anchor 90 having a tether attached thereto (Figures 5A-C, tether annotated below);
translating a portion of the tether through an annulus of the diseased native valve from a first chamber of the heart to a second chamber of the heart (paragraph 0132 discloses that the anchor and tether is translated through an annulus from a first chamber to a second chamber when disposed in the catheter 96, paragraph 0317 discloses that the method could be applied to a mitral valve);
wherein translating the tether causes the tether to form a bend within the second chamber (Figure 5A shows a bend in the tether in the second chamber 22);
tracking a valve delivery device (Figures 5A-C, valve delivery device is annotated below) over the tether (Figures 5A-C, the valve delivery device 62 is translated over the catheter 96);
and releasing a valve prosthesis from the valve delivery device into the annulus of the diseased native valve (Figures 5C-D depicts a valve prosthesis released from the valve delivery device into the annulus of the diseased native valve).
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Spence discloses a tether attached to an anchor to guide the prosthetic heart valve (see Spence, paragraph 0143 and 0146), which can be used for a mitral valve (see Spence, paragraph 0317).
However, Spence does not disclose wherein the anchor encircles chordae of the diseased native valve, translating a portion of the tether through an annulus of the diseased native valve from a first chamber of the heart to a second chamber of the heart while the anchor is positioned around the chordae, and releasing a valve prosthesis from the valve delivery device into the annulus of the diseased native valve and within the anchor.
Patel discloses an anchor (see Patel, Figures 6-9, item 1) which encircles chordae of the diseased native valve (see Patel, Figures 6-9), translating a portion of the tether through an annulus of the diseased native valve from a first chamber of the heart to a second chamber of the heart while the anchor is positioned around the chordae (see Patel, Figures 6-9, when the tether of Spence is residing in combination with the anchor 1 of Patel, the tether would be translated through an annulus of the diseased native valve from a first chamber of the heart to a second chamber of the heart while the anchor 1 is positioned around the chordae), and releasing a valve prosthesis from the valve delivery device into the annulus of the diseased native valve and within the anchor (see Patel, Figure 9 depicts releasing a valve prosthesis 40 into the annulus of a diseased native valve within the anchor 1; paragraphs 0089-0091).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Spence by providing wherein the anchor encircles chordae of the diseased native valve, translating a portion of the tether through an annulus of the diseased native valve from a first chamber of the heart to a second chamber of the heart while the anchor is positioned around the chordae, and releasing a valve prosthesis from the valve delivery device into the annulus of the diseased native valve and within the anchor as taught by Patel because the anchor of Spence is circled apposed to the annulus as depicted in Figure 5B of Spence, and paragraph 0317 of Spence discloses that these same concepts could be extended to mitral or other valve implantation, therefore circling the anchor around the chordae tendinae as taught by Patel would be within the reasonable skill of a person having ordinary skill in the art. Furthermore, when the anchor encircles the chordae of the diseased native valve this more securely implants and holds the prosthetic valve at the implant site. Anchoring/docking devices around the valve and the chordae tendinae to form a more circular and/or stable annulus at the implant site, in which prosthetic valves having circular or cylindrically-shaped valve frames or stents can be expanded or otherwise implanted. In addition to providing an anchoring site for the prosthetic valve, the anchoring/docking devices can be sized and shaped to cinch or draw the native valve (e.g., mitral, tricuspid, etc.) anatomy radially inwards. In this manner, one of the main causes of valve regurgitation (e.g., functional mitral regurgitation), specifically enlargement of the heart (e.g., left ventricle) and/or valve annulus, and consequent stretching out of the native valve (e.g., mitral) annulus, can be at least partially offset or counteracted. (see Patel, paragraph 0054).
Regarding claim 2, as set forth supra, the combination discloses further comprising delivering the anchor to the diseased native valve with an anchor delivery device (see Spence, Figures 5A-C, catheter 96 depicts an anchor delivery device; paragraph 0132), the anchor delivery device comprising a steerable catheter (see Spence, Figure 35, paragraphs 0311-0312 discloses a steerable catheter).
Regarding claim 8, as set forth supra, the combination discloses wherein the tether (see Spence, Figure 5A, tether annotated above) takes on substantially a U-shaped bend within the second chamber when in a bent configuration (see Spence, Figure 5A has a substantially U-shaped bend within the second chamber 22 when in a bent configuration).
Regarding claim 9, as set forth supra, the combination discloses wherein positioning the tether in the bent configuration comprises translating the tether distally with respect to a steerable catheter to provide increased tether length within the second chamber (see Spence, Figure 5A depicts positioning the tether in the bent configuration comprises translating the tether (annotated in Figure 5A above) distally with respect to steerable catheter 96 to provide increased tether length within second chamber).
Regarding claim 10, as set forth supra, the combination discloses wherein tracking the valve delivery device (see Spence, Figures 5A-D, item 62) over the tether comprises advancing a valve delivery catheter through the annulus of the diseased native valve (see Spence, Figures 5A-C depicts advancing a valve delivery catheter 62 through the annulus of the diseased native valve).
Regarding claim 11, as set forth supra, the combination discloses wherein tracking the valve delivery device (see Spence, Figures 5A-D, item 62) over the tether comprises deploying a positioning tool over the bent tether (see Spence, Figure 5B depicts deploying a positioning tool (i.e. balloon 100) over the bent tether).
Regarding claim 12, as set forth supra, the combination discloses further comprising distally advancing the positioning tool until a distal end of the positioning tool interfaces with an attachment that is attached to a proximal end of the anchor (see Spence, paragraphs 0133-0136 discloses distally advancing the positioning tool 100 until a distal end of the positioning tool interfaces (through the resulting tension) with the anchor and the stoppers (see Spence, paragraph 0136) (i.e. attachment) which is attached to a proximal end of the anchor).
Regarding claim 13, as set forth supra, the combination discloses further comprising applying a compression force along the positioning tool to cause the positioning tool to stiffen (see Spence, Figure 5A, paragraph 0129, when the balloon is inflated a compression force would be applied along the position tooling (i.e. balloon) which stiffens the balloon).
Regarding claim 18, as set forth supra, the combination discloses further comprising adjusting a position of the anchor relative to the diseased native valve using the positioning tool (see Spence, paragraphs 0133-0136 discloses that the operator can move the prosthesis 80 (which is provided on the positioning tool 100) so that there is the correct spacing between the anchor 90 and the prosthesis 80).
Regarding claim 19, as set forth supra, the combination discloses wherein adjusting the position of the anchor comprises pulling the positioning tool proximally to move the anchor toward the annulus of the diseased valve (see Spence, Figure 5B, paragraph 0135 discloses that the position of the anchor 90 can be adjusted by pulling the positioning tool 100 proximally to the anchor 90 to provide tension).
Regarding claim 20, as set forth supra, the combination discloses wherein the position of the anchor is adjusted closer to the annulus of the diseased native valve (see Spence, paragraph 0133).
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.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Spence et al (US 2018/0153690 A1) in view of Patel et al (US 2018/0055628 A1) as applied to claim 2, and further in view of Keranen (US 2022/0226118 A1).
Regarding claim 6, as set forth supra, the combination discloses the invention substantially as claimed.
However, the combination does not disclose wherein the anchor delivery device further comprises an anchor guide that is configured to translate within the steerable catheter, wherein the anchor guide comprises an inner lumen for housing the anchor.
Keranen discloses a method for treating a diseased native valve in a patient (see Keranen, paragraph 0002) comprising an anchor (see Keranen, Figures 2 and 12, item 110, paragraph 0004) wherein the anchor delivery device (see Keranen, Figure 12, item 101; paragraph 0035) further comprises an anchor guide (see Keranen, Figure 12, item 104) that is configured to translate within the steerable catheter (see Keranen, Figure 12, item 101), wherein the anchor guide comprises an inner lumen for housing the anchor (see Keranen, Figure 12, anchor guide 104 is depicted with inner lumen housing anchor 110).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the anchor delivery device of the combination by providing wherein the anchor delivery device further comprises an anchor guide that is configured to translate within the steerable catheter, wherein the anchor guide comprises an inner lumen for housing the anchor as taught by Keranen because this allows for the catheter and implant to be delivered concentrically, so there is no need to change the direction of concentric movement of the catheter and implant, which decreases possible friction or other resistance (see Keranen, paragraph 0017).
Regarding claim 7, as set forth supra, the combination discloses wherein the anchor guide (see Keranen, Figure 12, item 104) takes on a curved shape during deployment of the anchor from the anchor guide (see Keranen, Figure 12, anchor guide 104 has curved shaped during deployment of anchor 110).
Allowable Subject Matter
Claims 3-5, and 14-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner' s statement of reasons for allowance:
The closest prior art of record is Spence et al (US 2018/0153690 A1) in view of Patel et al (US 2018/0055628 A1) as stated above, however, the combination does not teach or render obvious the cumulative claim limitations. Regarding claim 3, the combination discloses wherein the translating the portion of the tether through the annulus of the diseased native valve comprises (see Spence, Figures 5A-C): advancing the steerable catheter towards a plane of the anchor (see Spence, Figures 5A-B depicts advancing the steerable catheter 96 towards a plane of the anchor); advancing the tether while maintaining its attachment to the anchor (see Spence, Figures 5A-B depicts advancing the tether maintaining its attachment to the anchor 90), and advancing the steerable catheter across the plane of the anchor to position at least a portion of the tether into the second chamber (see Spence, Figure 5B depicts advancing the steerable catheter across the plane of the anchor to position at least a portion of the tether into the second chamber), however, the combination does not disclose generating slack in the tether that at least partially coils within the first chamber before advancing the steerable catheter across the plane of the anchor to position at least a portion of the tether into the second chamber. The combination, specifically Spence, discloses generating slack in the tether that at least partially coils within the second chamber, not the first chamber.
Additionally, the combination as stated above does not teach or render obvious the cumulative claim limitations wherein applying the compression force comprises pulling the tether proximally to place tension on the tether as recited in claim 14; and wherein applying the compression force causes the positioning tool to take on substantially a U-shaped bend sub-annular to the anchor as recited in claim 16 within the context of the cumulative claim limitations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA LYNEE ZIMMERMAN whose telephone number is (313)446-4864. The examiner can normally be reached Mon. 8:30 AM-6:30 PM, Tues. - Fri. 8:30-4:00 PM.
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/REBECCA LYNEE ZIMMERMAN/Examiner, Art Unit 3774
/BRIAN A DUKERT/Primary Examiner, Art Unit 3774