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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/18/2026 has been entered.
Response to Arguments
The previous objection of claim 3 due to minor informalities has been withdrawn in light of applicant’s amendments made 12/30/2025. An additional objection has been made in light of applicant’s amendments made 6/18/2026.
The previous rejection of claim(s) 3 over 112(b) as being indefinite has been overcome in light of the amendments made to claim(s) 3 on 6/18/2026.
Applicant's arguments filed 6/18/2026 have been fully considered but they are not persuasive. Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections. Applicant argues Drapeau et al. (2020/0214733) does not disclose or suggest the recited combination of structural relationships between the catheter/protective sleeve, the mechanical cutter, and the accessory tool but does not explicitly point out how and/or why the previously cited elements of Drapeau in the Final Rejection mailed 4/20/2026 fail to meet the claimed amendments.
It is the examiner's position that Drapeau does disclose a catheter (cannula 212; Fig. 13) comprising a protective sleeve (including tip 216 and opening 214) at a distal end of the catheter (Fig. 13), a mechanical cutter (sharp cutting surface 222; [0068]) disposed within the protective sleeve (Fig. 13), and wherein the accessory tool (one or more grasping members 30) is configured to extend through an interior of the mechanical cutter (as the grasping members 30 are deployed to secure tissue and bring it into contact with cutting surface 222; [0069]; thus, the grasping members 30 move distally and proximally with respect to the sharp cutting surface 222 and are configured to extend through 222). In other words, because the cutting surface 222 is “a sharp cutting surface 222”, it is considered a mechanical cutter. Additionally, Drapeau discloses the cutting surface 222 “may provide energy” ([0068]). Thus, the sharp mechanically cutting surface 222 may further be powered or alternatively used manually as a sharp cutting surface. Accordingly, applicant's arguments are not found persuasive over Drapeau.
Claim Objections
Claim 3 is objected to because of the following informalities: Claim 3 recites “a distal end of the catheter” in lines 3-4 which should read “the distal end of the catheter” because claim 1, from which claim 3 depends, has been amended to recite “a distal end of the catheter” in line 2. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-3, 5-6, 14, 21 and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Drapeau et al. (US 2020/0214733 A1).
Regarding claim 1, Drapeau discloses an apparatus comprising: a catheter (cannula 212; Fig. 13) comprising a protective sleeve (including tip 216 and opening 214 of the tip 216) at a distal end of the catheter (Fig. 13); a mechanical cutter (sharp cutting surface 222; [0068]) disposed within the protective sleeve (Fig. 13); and an accessory tool (grasping members 30) comprising a set of grasping elements (grasping fingers 32), wherein the accessory tool (30) is configured to extend through an interior of the mechanical cutter (as the grasping members 30 are deployed to secure tissue and bring it into contact with cutting surface 222; [0069]; thus, the grasping members 30 move distally and proximally with respect to the sharp cutting surface 222 and are configured to extend through 222) and travel down a vessel lumen to a situs of an aortic valve (as the device 10 is used within the body and is sized to fit within a 14f or an 18f lumen, similar to applicant ([0023]), because the device 10 may fit within a lumen of about 3-5 mm; [0065]), grasp a native aortic valve leaflet (via grasping fingers 32), and exert a pulling action (as grasping members 30 are deployed to secure tissue and bring it into contact with cutting surface 222; [0069]), to draw the native aortic valve leaflet towards the mechanical cutter (by pulling 30 towards 222, as grasping members 30 are deployed to secure tissue and bring it into contact with cutting surface 222; [0069]), wherein the mechanical cutter (222) is configured to perform resection of the native aortic valve leaflet for removal of the native aortic valve leaflet (as the tissue removal device 10 is provided for improved tissue resection; [0006] and is sized appropriately and capable of being used for a TAVR procedure; [0065]), such that the mechanical cutter (222) is configured to re-shape the situs of the aortic valve before deployment of an aortic valve replacement during a transcatheter valve replacement (TAVR) procedure (as the cutting element 222 resects tissue, which would inherently change the shape of the tissue being treated and the device 10 is capable of being deployed to an aortic valve, depending on a user’s manipulation of the device as it is sized appropriately to fit within a patients aortic valve).
Regarding claim 2, Drapeau discloses wherein the mechanical cutter (222) is configured to perform the resection while the native aortic valve leaflet is held by the set of grasping elements (as grasping members 30 are deployed to secure tissue and bring it into contact with cutting surface 222; [0069]).
Regarding claim 3, Drapeau discloses wherein the pulling action of the accessory tool (30) is configured to draw a portion of the native aortic valve leaflet in a first direction (towards opening 214) into an interior of the protective sleeve (including opening 214 and tip 216; as fingers 32 of grasping members 30 pull grasped tissue as they are brought back to the retracted position; [0063]) simultaneously as the distal end of the catheter (cannula 212) moves in an opposite, second direction (towards grasping members 30) towards the native aortic valve leaflet (as the grasping members 30 are slidable along the longitudinal axis of the cannula and can be slid out of the opening to capture tissue and bring it into contact with cutting surface 222 which is within the tip 216; [0061]; [0069]; and the cannula 212 can be moved distally via user manipulation).
Regarding claim 5, Drapeau discloses wherein the mechanical cutter (222) comprises a manual mechanical cutter (as cutting cannula 220, which includes sharp cutting surface 222, may be axially movable within cannula 212 or may be fixedly attached to an inner surface of cannula 212 to be mechanically moved by a user; [0068]).
Regarding claim 6, Drapeau discloses wherein the mechanical cutter (222) comprises a powered mechanical cutter (as the sharp cutting surface 222 can be energized with an electrical energy source; [0068]).
Regarding claim 14, Drapeau discloses wherein the accessory tool (30) is configured to pass through an introducer comprising a range of 14f to 18f and configured for use with a TAVR deployment catheter (as the dimensions of the device depend on the site from which tissue must be removed and can be 3 mm, which would fit through a 14F introducer that has an outer diameter of 4.67 mm; [0065]; [0040]).
Regarding claim 21, Drapeau discloses wherein the accessory tool (30) is configured to exert the pulling action to draw a portion of the native aortic valve leaflet into the protective sleeve (via retraction of grasping members 30; [0069]; [0063]), wherein the mechanical cutter (222) is configured to perform the resection of the portion of the native aortic valve leaflet that is drawn into the protective sleeve (as the cutting surface 222 cuts tissue it is in contact with, which may be the native aortic valve leaflet), wherein the resection is configured to be performed within the protective sleeve to prevent tissue damage outside the protective sleeve (as the grasping members 30 are slidable along the longitudinal axis of the cannula and can be slid out of the opening to capture tissue and bring it into contact with cutting surface 222 which is within the tip 216; [0061]; [0069]).
Regarding claim 23, Drapeau discloses wherein the set of grasping elements (32) comprises two grasping elements (three grasping finger 32 are shown in Fig. 13; therefore, Drapeau comprises at least two) each comprising a first end (proximal end) and an opposite, second end (distal end), wherein, at the first end, the two grasping elements (32) are coupled to one another (at the proximal end of 30, 32 are at least operatively coupled to one another to open and close and be retracted and extended together; [0063]), wherein, at the second end (distal end), the two grasping elements are configured to be positioned on opposite sides of the native aortic valve leaflet and capture the native aortic valve leaflet therebetween (as the grasping members 30 are manipulable to be brought into contact and grasp tissue; [0061]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Drapeau et al. (US 2020/0214733 A1) in view of Weiss (US 2007/0049952 A1).
Regarding claim 8, Drapeau fails to disclose a hemostatic valve configured to allow the accessory tool (30) to pass through the vessel lumen and seal off arterial pressure.
However, Weiss teaches a hemostatic valve (access seal) on a proximal end of a catheter configured to allow an accessory tool (clamp 22) to pass through a vessel lumen and seal off arterial pressure ([0046]; Figs. 2-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula 212 of Drapeau to include a hemostatic valve as taught by Weiss in order to allow the accessory tool and/or other instrumentation therethrough without leakage.
Conclusion
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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