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 .
Election/Restrictions
Applicant’s election without traverse of Species 3: figures 18-21 (claims 1-6, 15-20) in the reply filed on 4/15/2026 is acknowledged.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
“D” in figure 13.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 18 is 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 18, the recitation “proximal” in line 2, renders the claim indefinite because the claim is unclear if “proximal” refers to being located close to or spaced distance in proximal direction from a distal tip of the sleeve. For examination purposes, examiner construes “proximal” as being located close to distal tip of the sleeve.
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 1-6, 17 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Magana (US 2010/0145278 A1).
Regarding claim 1, Magana teaches a catheter stabilization system (figure 1) comprising:
a catheter 11 having a steerable distal end (end of element 11 comprising element 42);
a stabilizer (integrated structure formed by elements 20 and 23) coupled or coupleable to the catheter 11 at a position that is proximal (see figure 1) to the steerable distal end (end of element 11 comprising element 42);
wherein the stabilizer 20, 23 is movable radially outward (paragraph 0020, lines 1-6) relative to the catheter 11 (element 20 is capable to stabilize the catheter during flexing of the steerable distal end of the catheter because element 20 is capable to be biased towards radially outward when moving out of element 44) to stabilize the catheter during flexing of the steerable distal end of the catheter;
wherein the stabilizer 20, 23 is configured to expand and engage vasculature to stabilize the catheter (see figure 1, paragraph 0018, lines 27-42); and
wherein in a non-expanded state (state shown in figure 5), the stabilizer 20, 23 is flush (examiner construes element 20, 23 being flushed with element 11 because according to figures 18-21, the stabilizer is protruding outward in non-expanded state instead of being completely flush i.e. not at all protruding in radial direction.) with the catheter.
Regarding claim 2, Magana teaches wherein the catheter 11 comprises one or more of a guide sheath (element 11 can be considered as guide sheath for element 13), a steerable catheter (element 11 can be considered as steerable catheter due to lack of claiming additional structural details), and an implant catheter (element 11 can be considered as an implant catheter due to lack of claiming additional structural details).
Regarding claim 3, Magana teaches wherein the stabilizer 20, 23 comprises one or more legs 20 coupled with the catheter 11.
Regarding claim 4, Magana teaches wherein the one or more legs 20 move radially outward (see figure 4) from the catheter 11 to stabilize the catheter 11.
Regarding claim 5, Magana teaches wherein the stabilizer 20, 23 comprises one or more skis 23 coupled to the catheter 11.
Regarding claim 6, Magana teaches wherein the one or more skis 23 can move radially outward (see figure 4).
Regarding claim 17, Magana teaches a catheter stabilization system (figure 1) comprising:
a catheter 11 having a steerable distal end (end of element 11 comprising element 42);
a sleeve 17 disposed radially around the catheter 11;
a stabilizer 20, 23 coupled with the sleeve 17; and
wherein the stabilizer 20, 23 is movable radially outward (paragraph 0020, lines 1-6) relative to the sleeve 17 to an extended state (state shown in figure 4) to stabilize the sleeve 17 and the catheter 11 during flexing of a distal end of the catheter (element 20 is capable to stabilize the catheter and the sleeve during flexing of the steerable distal end of the catheter because element 20 is capable to be biased towards radially outward when moving out of element 44); and
wherein the stabilizer 20, 23 has a non-extended state (state shown in figure 5) radially inward of the extended state (state shown in figure 4).
Regarding claim 18, Magana teaches wherein the stabilizer 20, 23 is disposed proximal (see figure 4) to a distal tip (end of element 17 supporting or touching element 20) of the sleeve 17.
Claims 1, 15 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wilson et al. (US 8,591,460 B2).
Regarding claim 1, Wilson teaches a catheter stabilization system (figure 14A including element 200 shown in figure 18) comprising:
a catheter 34c having a steerable distal end (end comprising element 98a);
a stabilizer 114 coupled or coupleable to the catheter 34c at a position that is proximal (see figure 14C) to the steerable distal end (end comprising element 98a);
wherein the stabilizer 114 is movable radially outward relative to the catheter 34c to stabilize the catheter 34c (element 114 is capable to stabilize element 34c during flexing of the steerable distal end of the catheter) during flexing of the steerable distal end of the catheter;
wherein the stabilizer 114 is configured to expand and engage vasculature to stabilize the catheter (element 114 could be expanded in the vasculature to stabilize element 34c); and
wherein in a non-expanded state (deflated state of element 114), the stabilizer 114 (uninflated state of element 114 could be construed as being flush with the element 34c since diameter of element 114 would be much smaller compared to expanded as shown in figure 18) is flush with the catheter.
Regarding claim 15, Wilson teaches comprising a valve repair or replacement device (column 10, lines 24-35, “implant”) configured to be delivered to a native heart valve by the catheter.
Regarding claim 16, Wilson teaches wherein the valve repair or replacement device (column 10, lines 24-35, “implant”) comprises at least one of a valve repair device, a valve replacement device, an annuloplasty system, an annuloplasty structure, an annuloplasty ring and a docking station.
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 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson et al. (US 8,591,460 B2) in view of Labrousse et al. (US 2017/0014097 A1).
Regarding claim 19, Wilson discloses a valve repair system (figure 14A with element 200 shown in figure 18) for repairing a valve of a patient, the valve repair system comprising:
a stabilizer 114 coupled with a catheter 34c at a position that is proximal to a steerable distal end (end comprising element 98a) of the catheter 34c;
wherein the stabilizer 114 is movable radially outward relative to the catheter 34c to stabilize the catheter 34c (element 114 is capable to stabilize element 34c during flexing of the steerable distal end of the catheter) during flexing of the steerable distal end of the catheter;
a valve repair device 200 (column 10, lines 41-43, examiner construes element 200 and “implant” as being a valve repair device, hereinafter combined to be referred by reference character 200) coupled to the catheter 34c but is silent regarding wherein the valve repair device comprises one or more anchors 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.
However, Labrousse teaches a design of a catheter system (figure 6A) to repair heart valve wherein the valve repair device 1 comprises one or more anchors (paragraph 0119, “wire”) 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 for the purpose of repairing the valves as required based on patient’s medical condition (paragraph 0010).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the valve repair device of Wilson to incorporate wherein the valve repair device comprises one or more anchors 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 as taught by Labrousse for the purpose of repairing the valves as required based on patient’s medical condition (paragraph 0010).
Regarding claim 20, Wilson discloses wherein the stabilizer 114 is configured to expand and engage vasculature to stabilize the catheter (element 114 could be expanded in the vasculature to stabilize element 34c); and wherein in a non-expanded state (deflated state of element 114), the stabilizer 114 (uninflated state of element 114 could be construed as being flush with the element 34c since diameter of element 114 would be much smaller compared to expanded as shown in figure 18) is flush with the catheter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Glenn (US 2007/0232997 A1): discloses the design of a catheter system comprising stabilizer that radially expands outward to stabilize the catheter.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHELSEA STINSON can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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