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 Arguments
1. Applicant’s arguments, see filed 02/11/2026, with respect to the rejection(s) of the claim(s) under U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Forster (US 20090209955 A1).
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.
2. Claim(s) 1-10, 13, and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tu (US 20020173811 A1) in view of Forster (US 20090209955 A1).
In regards to claims 1, Tu discloses an apparatus comprising:
a cutting element configured to perform resection of an aortic valve leaflet before deployment of an aortic valve replacement during a transcatheter aortic valve replacement (TAVR) procedure (Par. 0033 discloses a cutting mechanism. Par. 0003-0004 teaches catheter system for aortic valve replacement that removes valve leaflets);
an accessory tool comprising a set of grasping elements configured to exert a pulling action to draw an aortic valve leaflet towards the cutting element (Par. 0047 and Fig 5b show gripping means [42/44/45] that can couple or pull the leaflets to the catheter system. Par. 0033 teaches the coupling means can be a suction element that can draw in the leaflets)
wherein the cutting element is configured to perform the resection of a portion of the aortic valve leaflet that is drawn in (Par. 0042-0044 teaches fiber optic laser elements that can resect tissue.)
While Tu does teach pulling the tissue in with a suction means, they do not disclose wherein there is a protective sleeve, wherein the resection is performed within the protective sleeve to prevent tissue damage outside of the protective sleeve
However, in the same field of endeavor, Forster teaches a valve resection device (Abstract) wherein there is a protective sheath [197] that can cover the cutting means to allow the resection to be performed within the sheath (Par. 0070 and Fig 7a-7b) in order to cover any potentially traumatic surfaces during delivery (Par. 0070).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Tu and modified them by having the resection performed inside of a sheath, as taught and suggested by Forster, in order to cover any potentially traumatic surfaces during delivery (Par. 0070 of Forster).
In regards to claim 2, the combined teachings of Tu and Forster as applied to claim 1 discloses the apparatus of claim 1, wherein the cutting element is configured to perform the resection while the the aortic valve leaflet is held by the set of grasping elements within the protective sleeve (Claims 14 and 19 of Tu teach the gripping elements hold the leaflets and the optical fiber laser means can ablate the tissue; see also Par. 0042-0044 of Tu. Forster as applied above teaches the protective sleeve).
In regards to claim 9, the combined teachings of Tu and Forster as applied to claim 1 discloses the apparatus of claim 1, wherein the set of grasping elements comprises two grasping elements each comprises a first end and an opposite, second end (Par. 0047 and Fig 5b of Tu shows there being more than one grasping element with their own ends),
wherein, at the first end, the two grasping elements are coupled to one another (See Fig 5b of Tu); wherein at the second end, the two grasping elements are configured to be positioned on opposite sides of the aortic valve leaflet and capture the aortic valve leaflet therebetween (Fig 5b of Tu and Par. 0047-0048 of Tu)
In regards to claim 10, the combined teachings of Tu and Forster as applied to claim 1 discloses the apparatus of claim 1, wherein the aortic valve leaflet comprises a native valve leaflet or a bioprosthetic valve leaflet of a previously-implanted bioprosthetic valve (Par. 0012 and 0031 of Tu teach there being either a native valve or a prosthetic valve).
In regards to claim 21, the combined teachings of Tu and Forster as applied to claim 1 discloses the apparatus of claim 1, wherein the cutting element comprises one or more fibers configured to perform the resection by ablation of the aortic valve (Par. 0042-0044 of Tu teaches fiber optic laser elements that can resect tissue. Fig 4a of Tu shows the fiber optic elements in a ring-shaped fashion [28a])
In regards to claim 13, the combined teachings of Tu and Forster as applied to claim 21 discloses the apparatus of claim 21, wherein the one or more fibers are configured to transmit laser energy to perform the ablation of the aortic valve leaflet (Par. 0042-0044 of Tu teaches fiber optic laser elements that can resect or ablate tissue.)
In regards to claim 22, the combined teachings of Tu and Forster as applied to claim 1 discloses the apparatus of claim 1, further comprising a catheter, wherein the catheter comprises the cutting element, the protective sleeve, and the accessory tool (Fig 7a-b of Forster).
In regards to claim 3, the combined teachings of Tu and Forster as applied to claim 22 discloses the apparatus of claim 22, wherein the pulling action of the accessory tool is configured to draw the aortic valve leaflet in a first direction into the protective sleeve simultaneously as a distal end of the catheter moves in an opposite, second direction towards the aortic valve leaflet (Par. 0070 and Fig 7a-b of Forster that the pincher elements can pull the valve into the sleeve [197] while the catheter pinchers move forward).
In regards to claim 4, the combined teachings of Tu and Forster as applied to claim 3 discloses the apparatus of claim 3, wherein the accessory comprises a vacuum suction configured for for grasping the aortic valve leaflet (Par. 0033 of Tu teaches a suction means).
In regards to claim 5, the combined teachings of Tu and Forster as applied to claim 22 discloses the apparatus of claim 22, wherein the cutting elements comprises a ring of fibers arranged about a section or an entirety of a distal end of the catheter, wherein the ring of fibers is configured to perform the resection by ablation of the aortic valve leaflet (Fig 4b of Tu shows the optical fiber means surrounding a suction means, see also Fog 4a-4c of Tu).
In regards to claims 6, the combined teachings of Tu and Forster as applied to claim 5 discloses the apparatus of claim 5, wherein an arrangement of the ring of fibers comprises at least one of a semicircle, a one-third circle, or another fractional circle of a circumference of the distal end of the catheter (Fig 4b of Tu shows the ring making a full circle, i.e. an at least semicircle).
In regards to claim 7, the combined teachings of Tu and Forster as applied to claim 3 wherein the cutting element is configured to re-shape a situs of an aortic valve before the deployment of the aortic valve replacement at the situs (Since the applied art has the cutting structure as claimed by Applicant, it would be capable of this claimed function).
In regards to claim 8, the combined teachings of Tu and Forster as applied to claim 22 discloses the apparatus of claim 22, further comprising a power source connected at a proximal end of the catheter and configured to energize a laser (Par. 0050 of Tu teaches a power means or generator), wherein the cutting element comprises one or more fibers configured to transmit the laser to perform the resection by ablation of the aortic valve leaflet (Par. 0042 of Tu).
3. Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tu and Forster in view of O’Donnell (US 20140228843 A1).
In regards to claim 11, the combined teachings of Tu and Forster as applied to claim 1 discloses the apparatus of claim 1, except for it further comprising: a hemostatic valve at a proximal end of the catheter and configured to allow the accessory tool to pass through a vessel lumen and seal off arterial pressure.
However, in the same field of endeavor, O’Donnell teaches a system for performing aortic valve replacements (Par. 0004) wherein a hemostatic valve is utilized (Par. 0057) in order to provide a fluid seal that prevents "back-bleeding", or blood leakage or loss through the catheter.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Tu of Forster and modified them by having the system comprise a hemostatic valve, as taught and suggested by O’Donnell, in order to provide a fluid seal that prevents "back-bleeding", or blood leakage or loss through the catheter (Par. 0057 of O’Donnell).
4. Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tu and Forster in view of Fifer (US 20120172920 A1).
In regards to claim 12, the combined teachings of Tu and Forster as applied to claim 1 discloses the apparatus of claim 1, except for wherein the accessory tool is configured to pass through an introducer comprising a range of 14f to 18f and configured for use with a TAVR deployment catheter.
However, in the same field of endeavor, Fifer teaches a method/system for TAVI or for aortic valve replacement (Par. 0006 and 0072) wherein an introducer is employed with a range of 4-15F (Par. 0155) in order to allow for optimal sheath and guidewire movement with the introducer sheath
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Tu and Forster and modified them by having the system comprise an introducer of at least a range of 14f to 18f, as taught and suggested by Fifer, in order to allow for optimal sheath and guidewire movement with the introducer sheath (Par. 0155).
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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/S.L.C./Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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