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 8/27/2026 has been entered. Claims 1, 2, 5, 15-17 and 19-28 remain pending in the application. Applicant’s amendments to the Drawings and Claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 6/5/2026.
The drawings were received on 827/2026. This drawing is acceptable.
Claim Objections
Claims 17 and 19 are objected to because of the following informalities:
Regarding claim 17, line 9, the recitation “a distal end” appears to be amended to recite “the distal end” in order to refer to “a steerable distal end” recited in claim 17, line 2.
Regarding claim 19, line 3, the recitation “a two stabilizers” appears to be amended to recite “two stabilizers” in order to correct grammatical error.
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 26 and 27 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.
Regarding claim 26, the recitation “two pairs of wires” in line 1 renders the claim indefinite because the claim is unclear if two pairs refers to having 4 wires in total i.e. each pair contains two wires and claim requires two pairs or if two pairs of wires refers to having two wires. For examination purposes, examiner construes that two wires are being referred when reciting “two pairs of wires”. Claim 26 could overcome the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph if claims are amended properly to clarify if a single pair or two pairs are being referred.
Claim 27 being dependent on claim 26 is also rejected.
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.
Claims 1, 2, 5, 15-17, 19-26 and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bielefeld (US 2014/0214152 A1).
Regarding claim 1, Bielefeld teaches a catheter stabilization system (figure 2) comprising:
a catheter 11 having a steerable distal end 12;
a pair of wires 45 (figure 3c) that extend along a length of the catheter 11 (paragraph 0044, lines 1-3, extending through element 30a, 30b) and radially exit the catheter at a position that is spaced apart proximally (see figures 1B and 2) from the steerable distal end 12;
a stabilizer (integrated structure formed by elements 40, 30a, 30b and 22) comprising an extension 40 coupled to the pair of wires 45;
wherein pushing the pair of wires 45 (paragraph 0045, lines 1-10) distally toward the steerable distal end 12 pushes the stabilizer extension 40 radially outward relative to the catheter 11 to stabilize (due to element 40, the movement of the element 11 would be limited) the catheter 11 during flexing of the steerable distal end of the catheter; and
wherein in a non-expanded state (state shown in figure 1A), the stabilizer 40, 30a, 30b, 22 is flush with the catheter 11 (see figure 1A).
Regarding claim 2, Bielefeld teaches wherein the catheter 11 comprises one or more of a guide sheath, a steerable catheter 11 (due to lack of further structure, element 11 cold be construed as a steerable catheter or an implant catheter), and an implant catheter 11.
Regarding claim 5, Bielefeld teaches wherein the stabilizer extension 40 comprises a ski 40 (see figures 3A, 3C) coupled with the pair of wires 45.
Regarding claim 15, Bielefeld teaches further comprising a valve repair or replacement device 60, 65 (paragraph 0052, lines 1-13, the claim requires delivery of the valve repair or replacement device by the catheter and not through the catheter. The positioning of element 60, 65 is only possible due to element 11 by following same path that element 11 followed thereby construing that the valve repair or replacement device is delivered by the catheter) configured to be delivered to a native heart valve by the catheter 11.
Regarding claim 16, Bielefeld teaches wherein the valve repair or replacement device 60, 65 comprises at least one of a valve repair device 60, 65, a valve replacement device, an annuloplasty system, an annuloplasty structure, an annuloplasty ring, and a docking station.
Regarding claim 17, Bielefeld teaches a catheter stabilization system (figures 1A-2) comprising:
a catheter 11 having a steerable distal end 12;
a sleeve (paragraph 0052, lines 10-13, “separate catheter”) disposed radially around the catheter 11; a pair of wires 45 that extend along a length of the catheter 11 (paragraph 0044, lines 1-3, extending through element 30a, 30b) and radially exit the catheter 11 at a position that is spaced apart proximally from the steerable distal end 12;
a stabilizer (integrated structure formed by elements 40, 30a, 30b and 22) comprising an extension 40 coupled to the pair of wires 45; and wherein pushing the pair of wires distally towards the steerable distal end 12 pushes the stabilizer extension 40 (see figure 2) radially outward relative to the sleeve (paragraph 0052, lines 10-13, “separate catheter”) to an extended state (state shown in figure 2) to stabilize the sleeve and the catheter 11 (due to element 40, the movement of the element 11 and the separate catheter would be limited) during flexing of a distal end 12 of the catheter 11; and wherein the stabilizer extension 40 has a non-extended state (state shown in figure 1a) radially inward of the extended state (state shown in figure 2).
Regarding claim 19, Bielefeld teaches a valve repair system (figure 2) for repairing a valve of a patient, the valve repair system comprising:
a two stabilizers 30a, 30b coupled with a catheter 11 at a position that is proximally spaced apart from a steerable distal end 12 of the catheter 11;
wherein the two stabilizers 30a, 30b are asymmetrically (when viewing from side view as shown in figure 2, both stabilizers are extending on one side thereby being asymmetrically arranged) arranged around an outside surface of the catheter 11;
wherein the two stabilizers 30a, 30b are movable radially outward (see figure 2) relative to the outside surface of the catheter 11 to stabilize (due to element 40, the movement of element 11 is limited) the catheter;
a valve repair device 40, 45 coupled to the catheter 11; and wherein the valve repair device 40, 45 comprises one or more anchors 40 that are configured to engage one or more leaflets of a native heart valve to attach the valve repair device to the native heart valve.
Regarding claim 20, Bielefeld teaches wherein the two stabilizers 30a, 30b are configured to expand (see figure 1b) and engage vasculature to stabilize the catheter 11 and wherein in a non-expanded state (see figure 1a), the stabilizers 30a, 30b are flush with the catheter 11.
Regarding claim 21, Bielefeld teaches wherein the extension is a first extension 40 (associated with element 30a) and the stabilizer comprises a second extension 40 (associated with element 30b), wherein the first and second extension 40 are asymmetrically (when viewing from side view as shown in figure 2, both stabilizers are extending on one side thereby being asymmetrically arranged) arranged around an outside surface of the catheter 11.
Regarding claim 22, Bielefeld teaches wherein the sleeve comprises a guide sheath (paragraph 0052, lines 10-13, “separate catheter”) and the catheter comprises a steerable catheter 11 (due to lack of specific structure, element 11 can be construed as a steerable catheter).
Regarding claim 23, Bielefeld teaches wherein the sleeve comprises a steerable catheter (paragraph 0052, lines 10-13, “separate catheter”, the separate catheter guides the movement of element 11) and the catheter comprises an implant catheter 11 (due to lack of specific structure, element 11 can be construed as an implant catheter).
Regarding claim 24, Bielefeld teaches wherein the stabilizer extension 40 comprises a ski 40 (see figures 3A, 3C) coupled with a pair of wires 45.
Regarding claim 25, Bielefeld teaches wherein two pairs of wires 45 extend along a length of the catheter 11 and radially exit the catheter 11 at the two stabilizers 30a, 30b.
Regarding claim 26, Bielefeld teaches wherein the two pairs of wires 45 are connected (loosely connected, see figure 2) to the two stabilizers 30a, 30b respectively.
Regarding claim 28, Bielefeld teaches wherein in a non-expanded state (state shown in figure 1, the two stabilizers 30a, 30b are flush with the catheter 11.
Allowable Subject Matter
Claim 27 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record, Bielefeld (US 2014/0214152 A1), is silent regarding wherein the pushing the two pairs of wires distally toward the steerable distal end pushes the two stabilizers radially outward relative to the catheter in combination with other claimed limitations of claim 27 because the wire are moving out of the stabilizers of Bielefeld and pushing the wires will have no impact on positioning or movement of the stabilizers.
Response to Arguments
Applicant’s arguments with respect to claims 1, 17 and 19 have been considered but are moot because the arguments do not apply in view of the present rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Li et al. (US 10,398,547 B2): a catheter with anchoring device extending radially outward from the catheter body.
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 NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
