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 .
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/14/2026 has been entered.
Response to Arguments
2. Applicant’s arguments, see filed 09/14/2026, with respect to the rejection(s) of the claim(s) under U.S.C. 103 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 Therefore, the rejection has been withdrawn.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 Drapeau (US 20200214733 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.
3. Claim(s) 1, 3, 5-10, and 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tu (US 20020173811 A1) in view of Drapeau (US 20200214733 A1).
In regards to claims 1, Tu discloses an apparatus, comprising:
a catheter (Par. 0003-0004 teaches catheter system [19])
a ring of fibers arranged about a circumference of the distal end of the catheter and configured to perform resection of an aortic valve leaflet by laser ablation before deployment of an aortic valve replacement during a transcatheter aortic valve replacement (TAVR) procedure (Par. 0042 and Fig 4A show the ring of fiber [28A] at the distal end of the catheter. Par. 0003-004 disclose this is a system for aortic valve replacement that removes valve leaflets);
an accessory tool comprising a set of grasping elements, wherein the accessory tool is configured to travel down a vessel lumen to a situs of an aortic valve, grasp the aortic valve leaflet, and exert a pulling action (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 ring of fibers is configured to transmit laser energy to perform the resection of a portion of the aortic valve leaflet while the portion of the aortic valve leaflet is held by the set of grasping elements (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, Drapeau discloses a tissue ablation system (Abstract) wherein there is a cutting cannula [220] that is fitted inside of an outer cannula [212], i.e. a proactive sleeve (Par. 0068 and Fig 12) and wherein there is a suction means to pull the tissue into the cutting cannula (which is inside of the outer cannula/sleeve) and where it will contact the tissue (Par. 0068) in order to avoid unwanted tissue damage (Par. 0068).
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 protective sleeve, as taught and suggested by Drapeau, in order to avoid unwanted tissue damage (Par. 0068 of Drapeau).
In regards to claim 3, the combined teachings of Tu and Drapeau as applied to claim 1 discloses the apparatus of claim 1, 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 the distal end of the catheter moves in an opposite, second direction towards the aortic valve leaflet (Par. 0068 of Drapeau teaches the tissue being pulled into the sleeve [see above claim 1 rejection]).
In regards to claim 5, the combined teachings of Tu and Drapeau as applied to claim 1 discloses the apparatus of claim 1, wherein the ring of fibers is arranged about a section or an entirety of the circumference the distal end of the catheter (Fig 4A of Tu show the ring of fiber [28A] at the distal end of the catheter).
In regards to claims 6, the combined teachings of Tu and Drapeau 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 the 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 Drapeau as applied to claim 3 wherein the ring of fibers is configured to re-shape the situs of the 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 Drapeau as applied to claim 1 discloses the apparatus of claim 1, 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 ring of fibers is configured to transmit the laser to perform the resection of the aortic valve leaflet (Par. 0042 of Tu).
In regards to claim 9, the combined teachings of Tu and Drapeau 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 Drapeau 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 23, the combined teachings of Tu and Drapeau as applied to claim 1 discloses the apparatus of claim 1, further comprising a guidewire, wherein the catheter comprises a guidewire lumen, and wherein the guidewire is configured to deploy the catheter within the vessel lumen to the situs of the aortic valve (Par. 0035 of Tu teaches a guidewire lumen with the catheter assembly).
In regards to claim 24, the combined teachings of Tu and Drapeau as applied to claim 1 discloses the apparatus of claim 1, wherein the accessory tool is configured to protrude distally beyond the ring of fibers (Fig. 5A of Tu).
In regards to claim 25, the combined teachings of Tu and Drapeau as applied to claim 1 discloses the apparatus of claim 1, wherein the catheter comprises an outer sheath configured to be pulled back to expose the accessory tool (Par. 0068 of Drapeau teaches an outer and inner cannula [see claim 1 rejection]).
4. Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tu and Drapeau in view of O’Donnell (US 20140228843 A1).
In regards to claim 11, the combined teachings of Tu and Drapeau 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 the 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 Drapeau 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).
5. Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tu and Drapeau in view of Fifer (US 20120172920 A1).
In regards to claim 12, the combined teachings of Tu and Drapeau as applied to claim 1 discloses the apparatus of claim 1, except for wherein the accessory tool is configured to pass through an introducer having a size in 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 Drapeau 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
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/S.L.C./Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
