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 .
Claim Objections
Claim 17 objected to because of the following informalities: In line 17, “tool lumens snares” should read “tool lumens; snares”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites the limitation "the second snare is a forceps-type snare" in line 2. It is unclear how the second snare is a forceps-type snare when claim 3 divulges the second snare is a hook-type snare, and claim depends on claim 3. Claims 9-12 are rejected for the same reasons as claim 8 by virtue of dependency on claim 8.
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 7-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WALES et al. (US 2018/0000321).
Regarding claim 1, an invention relating to surgical tools, Wales discloses (Figs. 1-2C, 7C, 8) a valve clip removal 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); a cutting sheath (24) configured with a cutting mechanism [i.e. needles, knife, or blade] (Par. 0036); wherein the first lumen is used to deploy a first snare (54) that enables securing a first section of a valve clip (Par. 0046); wherein the second lumen is used to deploy a second snare (112) that enables securing of a second section of the valve clip (Par. 0047); upon securing the first section of the valve clip, the second snare pulls the cutting sheath over part of the second section of the valve clip [i.e. element 112 maintains element 54 relative to element 10, hence element 112 is capable of pulling the sheath over the clip] for the cutting sheath to: capture part of a second section of valve clip and grasp the valve clip in a stable position [i.e. the clip pulled against and inside element 24, it is considered stable], and execute a removal action across the part of the second section of valve clip to detach the valve clip from a valve leaflet whilst the valve clip is grasped [i.e. further pulling elements 112 and 54 would lead to detachment of the clip]; and after performing the removal action and liberating the valve clip from the valve leaflet, the cutting sheath and grasped valve clip are removed through the catheter [i.e. opening in element 24 is considered large enough to remove ethe clip] (Par. 0036-0038 & 0047).
Regarding claim 2, Wales discloses the valve clip removal system of claim 1. Wales discloses (Fig. 4) further comprising: wherein the first snare is a lasso-type snare (54) that is configured to secure the first section of the valve clip (Par. 0035).
Regarding claim 3, Wales discloses the valve clip removal system of claim 2. Wales discloses (Fig. 7C) further comprising: wherein the second snare is a hook-type snare (112) that is hooked to the second section of the valve clip (Par. 0047).
Regarding claim 5, Wales discloses the valve clip removal system of claim 3. Wales discloses further comprising: in response to a torque action caused to the valve clip when the first section is secured by the lasso-type snare, the hook-type snare is configured to attach to the first section of the valve clip and to exert a straight upward force to compensate for an offset direction caused by the torque action to the first section of the valve clip, and to redirect the valve clip for positioning so the cutting sheath can progress forward over the valve clip for a clip removal procedure (Par. 0038, 0044, 0047).
Regarding claim 7, Wales discloses the valve clip removal system of claim 5. Wales further discloses wherein a combination of the first and second types of snares provides stability for a concentric orientation for the cutting sheath to progress over the valve clip (Par. 0047).
Regarding claim 8, Wales discloses the valve clip removal system of claim 5. Wales further discloses further comprising: wherein the second snare is a forceps-type snare that is extended 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 valve clip removal system of claim 8. Wales discloses further comprising: in response to the torque action caused to valve clip when the first section is secured by the lasso-type snare, the forceps-type snare is configured to attach to the first section of the valve clip and to exert the straight upward force to compensate for the offset direction caused by the torque action to the first section of the valve clip, and to redirect the valve clip for positioning so the cutting sheath can progress forward over the valve clip for the clip removal procedure (Par. 0038, 0044, 0047).
Regarding claim 10, Wales disclose the valve clip removal system of claim 9. Wales discloses further comprising: 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 valve clip removal system of claim 10. Wales discloses further comprising: wherein in a venous-transseptal approach to access a left atrium for a valve clip removal because of a deflectability required by the cutting sheath for positioning concentrically over a valve clip, the lasso-type snare and the forceps-type snare are used (Par. 0004, 0026, 0037).
Regarding claim 12, Wales discloses the valve clip removal system of claim 11. Wales discloses further comprising: wherein the cutting sheath is configured as a laser- cut hypotube for a mechanical cutting sheath that contains the cutting mechanism for deflection and is insertable through a deflectable sheath of adequate size while achieving the deflectability required by the cutting sheath to access a valve for the valve clip removal (Par. 0033 & 0036).
Regarding claim 13, an invention relating to surgical tools, Wales discloses (Figs. 1-2C, 7C, 8) a valve clip removal apparatus (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); a cutting sheath (24) configured with a cutting mechanism [i.e. needles, knife, or blade] (Par. 0036); wherein the first lumen is used to deploy a first snare (54) that enables securing a lower part of a valve clip (Par. 0046); wherein the second lumen is used to deploy a second snare (112) that enables securing of an upper part of the valve clip (Par. 0047); upon securing the first section of the valve clip, the second snare is configured to pull the cutting sheath over the upper part of the valve clip [i.e. element 112 maintains element 54 relative to element 10, hence element 112 is capable of pulling the sheath over the clip] to enable the cutting sheath to hold the valve clip in a stable position [i.e. the clip pulled against and inside element 24, it is considered stable] and to detach the valve clip from a valve leaflet whilst the valve clip is held [i.e. further pulling elements 112 and 54 would lead to detachment of the clip]; and after the valve clip is freed from the valve leaflet, the cutting sheath is configured for removal whilst the valve clip is held [i.e. opening in element 24 is considered large enough to remove ethe clip] (Par. 0036-0038 & 0047).
Regarding claim 14, Wales discloses the valve clip removal apparatus of claim 13. Wales discloses further comprising: wherein in a transapical approach to access the mitral valve for a valve clip removal, the first snare is configured as a lasso-type snare and the second snare is configured as a hook-type snare; and wherein in a venous-transseptal approach to access a valve for the valve clip removal, the first snare is configured as the lasso-type snare and the second snare is configured as either a lasso type snare or a forceps-type snare (Par. 0004, 0026, 0037, 0047).
Regarding claim 15, Wales discloses the valve clip removal apparatus of claim 13. Wales discloses further comprising: wherein in a venous-transseptal approach to access a valve for a valve clip removal, in a first instance, the first snare is configured as a lasso-type snare and the second snare is configured as a lasso snare, and in a second instance, the first snare is configured as a lasso snare and the second snare is configured as a forceps-type snare (Par. 0004, 0026, 0037).
Regarding claim 16, Wales discloses the valve clip removal apparatus of claim 15. Wales discloses further comprising: in response to a torque action caused to valve clip when the lower part is secured by the lasso-type snare, either a hook-type snare or the forceps-type snare is configured to attach to the upper part of the valve clip and to pull or grasp the valve clip for a concentric orientation for a clip removal procedure (Par. 0038, 0044, 0047).
Regarding claim 17, Wales discloses (Figs. 1-2C, 7C, 8) a valve clip removal system (10, 20, 50) comprising a pair of tool lumens [i.e. 16 & the lumen of the sheath which element 54 may be delivered through] (Par. 0047) snares composed of a first snare (54) of a lasso-type snare (Par. 0004), and a second snare (112) that is either a hook-type snare or a forceps-type snare (Par. 0004, 0026, 0037, 0047), and a cutting sheath to remove a valve clip, the valve clip removal system comprising: wherein the cutting sheath is configured large enough to pass through at least a single snare with a cutting mechanism [i.e. needles, knife, or blade] (Figs. 3D-F; Par. 0036); wherein the cutting sheath is used to pass through the first snare to secure a lower part of a valve clip [i.e. element 112 maintains element 54 relative to element 10, hence element 112 is capable of pulling the sheath over the clip]; wherein the cutting sheath is used to pass through the second snare to secure an upper part of the valve clip [i.e. the clip pulled against and inside element 24, it is considered stable]; in response to securing the lower part of the valve clip, the second snare attaches to the upper part of the valve clip to pull the cutting sheath downward over the upper part of the valve clip for the cutting sheath to both hold and remove the valve clip from a valve leaflet whilst the valve clip is held [i.e. further pulling elements 112 and 54 would lead to detachment of the clip]; and after the valve clip is detached from the valve leaflet, the cutting sheath is configured for removal whilst holding the valve clip [i.e. opening in element 24 is considered large enough to remove ethe clip] (Par. 0036-0038 & 0047).
Regarding claim 18, Wales discloses the valve clip removal system of claim 17. Wales discloses further comprising: wherein the second snare is not deployed and the valve clip is secured by only the first snare and the cutting sheath for a valve clip removal procedure (Figs. 2A-C).
Regarding claim 19, Wales discloses the valve clip removal system of claim 17. Wales discloses further comprising: in response to a torque action caused to valve clip when the lower part is secured by the lasso-type snare, either the hook-type snare or the forceps-type snare is configured to attach to the upper part of the valve clip and to pull or grasp the valve clip for a concentric orientation for a valve clip removal procedure (Par. 0038, 0044, 0047).
Regarding claim 20, Wales discloses the valve clip removal system of claim 18. Wales discloses further comprising: wherein in a transapical approach to access the mitral valve for the valve clip removal procedure, the second snare is the hook-type snare; and wherein in a venous-transseptal approach to access the mitral valve for the valve clip removal, the second snare is either a lasso or forceps-type snare (Par. 0004, 0026, 0037, 0047).
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 further comprising: wherein in a transapical approach to access the mitral valve for a valve clip removal, the lasso-type snare and the hook-type snare are used, and the lasso-type snare is configured in a range of 10mm to 20mm in diameter.
In the same field of endeavors, which is snares, Syd teaches wherein in a transapical approach to access the mitral valve for a valve clip removal, the lasso-type snare and the hook-type snare are used, and the lasso-type snare is configured in a range of 10mm to 20mm in diameter (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 the mitral valve for a valve clip removal, the lasso-type snare and the hook-type snare are used, and the lasso-type snare is configured in a range of 10mm to 20mm in diameter. 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 comprising: after progression of the cutting sheath to a position over the valve clip, the cutting sheath is configured to activate a cutting mechanism to liberate the valve clip from the valve leaflet coupled to a valve wherein the valve comprises a Mitral valve or a tricuspid valve (Par. 0036).
Conclusion
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
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 March 10, 2026