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
The Amendment filed 6/12/2026 has been entered. Claims 1-12 have been amended, and claims 13-20 have been cancelled. Claims 1-12 are addressed in the following office action.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5, and 7-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WALES et al. (US 2018/0000321), cited in previous office action.
Regarding claim 1, an invention relating to surgical tools, Wales discloses (Figs. 1-2C, 7C, 8) a system (10, 20, 50), comprising: a catheter (12 & 52) configured with a first lumen (16) and a second lumen [i.e. the lumen of the sheath which element 54 may be delivered through] (Par. 0047); and a cutting sheath (24) configured with a cutting mechanism [i.e. needles, knife, or blade] (Par. 0036), wherein the catheter and the cutting sheath are configured for removal of a valve clip implanted on a heart valve leaflet [i.e. opening in element 24 is large enough to receive the clip during or after the clipped tissue is cut by a knife or blade, and then removing the clip by retracting elements 12, 24, and 52 from the body] (Par. 0036-0038 & 0047) [Note, the valve clip is not positively recited, so it is not considered part of the claimed invention and will be treated as a functional limitation], wherein the first lumen is configured to deploy a first snare (54; Par. 0046) [Note, the first snare is not positively recited, so it is not considered part of the claimed invention and will be treated as a functional limitation], wherein the first snare is configured to secure a first section of the valve clip (Par. 0037), wherein the second lumen is configured to deploy a second snare (112; Par. 0047) [Note, the second snare is not positively recited, so it is not considered part of the claimed invention and will be treated as a functional limitation], wherein the second snare is configured to: secure a second section of the valve clip (Par. 0047); and pull the cutting sheath over the second section of the valve clip [i.e. guiding the elements 12, 24, and 52 along the second snare until the second section of the valve clip is within the cutting sheath], wherein the cutting sheath is configured to: capture the valve clip; and detach the valve clip from the heart valve leaflet [i.e. opening in element 24 is large enough to receive the clip during or after the clipped tissue is cut by a knife or blade considered part of the cutting sheath] (Par. 0036-0038 & 0047).
Regarding claim 2, Wales discloses the system of claim 1. Wales further discloses (Fig. 4) wherein the first snare is a lasso-type snare (54; Par. 0035).
Regarding claim 3, Wales discloses the system of claim 2. Wales further discloses (Fig. 7C) wherein the second snare is a hook-type snare configured to hook to the second section of the valve clip (112; Par. 0047).
Regarding claim 5, Wales discloses the system of claim 3. Wales further discloses wherein the hook-type snare is configured attach to the valve clip; exert a straight upward force to compensate for an offset direction caused by a torque action on the valve clip when the first section is secured by the lasso-type snare; and redirect the valve clip for positioning so the cutting sheath can progress forward over the valve clip for the removal of the valve clip (Par. 0038, 0044, 0047).
Regarding claim 7, Wales discloses the system of claim 5. Wales further discloses wherein a combination of the first snare and the second snare is configured to provide stability for a concentric orientation for the cutting sheath to progress over the valve clip (Par. 0047).
Regarding claim 8, Wales discloses the system of claim 2. Wales further discloses wherein the second snare is a forceps-type snare configured to extend to a top of the second section of the valve clip to secure the valve clip via a grasping action (Par. 0026 & 0037).
Regarding claim 9, Wales discloses the system of claim 8. Wales further discloses wherein the forceps-type snare is configured: attach to the valve clip; exert a straight upward force to compensate for an offset direction caused by a torque action on the valve clip when the first section is secured by the lasso-type snare; and redirect the valve clip for positioning so the cutting sheath can progress forward over the valve clip for the removal of the valve clip (Par. 0038, 0044, 0047).
Regarding claim 10, Wales discloses the system of claim 9. Wales further discloses wherein the forceps-type snare is configured to provide a rail that enables the cutting sheath to slide over the forceps-type snare and to progress forward over the valve clip (Par. 0026 & 0037).
Regarding claim 11, Wales discloses the system of claim 10. Wales further discloses where, in a venous-transseptal approach to access a left atrium for the removal of the valve clip, the lasso-type snare and the forceps-type snare are configured to be used (Par. 0004, 0026, 0037).
Regarding claim 12, Wales discloses the system of claim 11. Wales further discloses wherein the cutting sheath comprises a laser fiber bundle for a laser sheath or a laser-cut hypotube for a mechanical cutting sheath, wherein the cutting sheath is insertable through a deflectable sheath to achieve deflectability required for the cutting sheath to access a heart valve for the removal of the valve clip (Par. 0033 & 0036).
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 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over WALES et al. (US 2018/0000321) as applied to claim 3 above, and further in view of Syed (US 2017/0119563).
Concerning claim 4, Wales discloses the valve clip removal system of claim 3. However, Wales fails to disclose wherein, in a transapical approach to access a mitral valve for the removal of the valve clip, the lasso-type snare and the hook-type snare are configured to be used, and wherein the lasso-type snare is configured with a diameter in a range of 10mm to 20mm.
In the same field of endeavors, which is snares, Syd teaches wherein, in a transapical approach to access a mitral valve for the removal of the valve clip, the lasso-type snare and the hook-type snare are configured to be used, and wherein the lasso-type snare is configured with a diameter in a range of 10mm to 20mm (Par. 0058 & 0065).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wales to have wherein, in a transapical approach to access a mitral valve for the removal of the valve clip, the lasso-type snare and the hook-type snare are configured to be used, and wherein the lasso-type snare is configured with a diameter in a range of 10mm to 20mm. Doing so would stabilize working catheters for carotid percutaneous intervention of vessels originating from a tortuous aortic arch (Abstract), as taught by Syed.
Regarding claim 6, Wales, as modified by Syd, discloses the valve clip removal system of claim 4. Wales discloses further wherein, after progression of the cutting sheath to a position over the valve clip, the cutting sheath is configured to activate the cutting mechanism to liberate the valve clip from the heart valve leaflet, wherein the heart valve leaflet is a leaflet of a mitral valve or a tricuspid valve (Par. 0036).
Response to Arguments
Applicant’s arguments, see page 6, filed 05/12/26, with respect to claims 8-12 have been fully considered and are persuasive. The 35 USC § 112 rejection of claims 8-12 has been withdrawn.
Applicant’s arguments, see page 6, filed 05/12/26, with respect to claim 17 have been fully considered and are persuasive. The claim objection of claim 17 has been withdrawn.
Applicant's remaining arguments have been fully considered but they are not persuasive. Applicant argues previously cited prior art reference Wales does not disclose or suggest "wherein the catheter and the cutting sheath are configured for removal of a valve clip implanted on a heart valve leaflet", "wherein the second snare is configured to: ... pull the cutting sheath over the second section of the valve clip", and "wherein the cutting sheath is configured to: ... detach the valve clip from the heart valve leaflet". Examiner respectfully disagrees.
Wales discloses (Figs. 1-2C, 7C, 8) wherein the catheter and the cutting sheath are configured for removal of a valve clip implanted on a heart valve leaflet [i.e. opening in element 24 is large enough to receive the clip during or after the clipped tissue is cut by a knife or blade, and then removing the clip by retracting elements 12, 24, and 52 from the body] (Par. 0036-0038 & 0047) [Note, the valve clip is not positively recited, so it is not considered part of the claimed invention and will be treated as a functional limitation], wherein the second snare is configured to: pull the cutting sheath over the second section of the valve clip [i.e. guiding the elements 12, 24, and 52 along the second snare until the second section of the valve clip is within the cutting sheath] (Par. 0036-0038 & 0047). Note, applicant’s original disclosure only describes in detail how the second snare pulls the cutting sheath over the second section of the valve clip in paragraphs 0030 and 0034, wherein applicant describes the snare being used as a guide/rail that the cutting sheath slides over. Furthermore, the second snare is not positively recited as part of the claimed invention, therefore the second snare and associated structures are interpreted as functional language.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.U.I/ Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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