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
Applicant's arguments filed 3/2/2026 have been fully considered but they are not persuasive. Applicant has amended claim 1 to recite the step of deploying as to a “fully” deployed configuration on the first side of the native valve. In Applicant’s remarks, the first side of the native valve is parenthetically referred to as the atrial side of the valve. Examiner notes the claim never specifies the first side as the atrial side. Examiner now considers the first side to be the ventricular side of Patel. As such, Patel discloses fully deploying the anchor on the first side of the valve, and rotating the distal end of the delivery device so as to simultaneously extend the anchor through the valve from the first side to a second side (the atrial side) and rotate the anchor around native chordae.
Claim Rejections - 35 USC § 102
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 1-17, 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Patel et al. (Pub. No.: US 2018/0318079)
Patel et al. (hereinafter, Patel) discloses a method for treating a diseased native valve in a patient (e.g., abstract), the method comprising: advancing a distal end of a delivery device 20 to a first side of a native valve (e.g., fig. 9 J,K, para. 106-108); deploying an anchor 1 from a delivery configuration to a fully deployed configuration on the first side of the native valve (e.g., fig. 9K, J, para. 86-87); and rotating the distal end of the delivery device (e.g., 9L, M) so as to simultaneously extend the anchor in the deployed configuration through the native valve from the first side to a second side of the native valve and rotate the anchor in the deployed configuration around native chordae (e.g., fig. 9I-K).
For claim 2, Patel discloses the method of claim 1, wherein the distal end of the delivery device comprises an anchor guide 64 having a preset curvature 67, and wherein the step of rotating comprises rotating the anchor guide relative to an outer sheath of the delivery device (e.g., fig. 9A-F).
For claim 3, Patel discloses the method of claim 2, wherein the anchor guide 64 is configured to place torsion on the anchor as the anchor transitions from the delivery configuration to the deployed configuration (e.g., para. 112-113).
For claim 4, Patel discloses the method of claim 1, wherein deploying the anchor comprises deploying the anchor concentrically about the delivery device (e.g., fig. 9A-U).
For claim 5, Patel discloses the method of claim 1, wherein rotating the distal end comprises rotating the anchor 1 concentrically around the delivery device 20 (e.g., fig. 9A-U).
For claim 6, Patel discloses the method of claim 1, wherein the anchor comprises a flat spiral in the deployed configuration (e.g., fig 2A, 9K).
For claim 7, Patel discloses the method of claim 6, further comprising aligning a plane of the flat spiral such that it is parallel with a plane of the mitral valve after the step of deploying the anchor (fig. 9K) and prior to the step of rotating the distal end (fig. 9L, M).
For claim 8, Patel discloses the method of claim 7, wherein the step of aligning is performed by steering an outer sheath of the delivery device (e.g., para. 106).
For claim 9, Patel discloses the method of claim 7, wherein the step of aligning is performed by translating or rotating an anchor guide of the delivery device, the anchor guide having a preset curvature (e.g., para. 110).
For claim 10, Patel discloses the method of claim 1, wherein the anchor is substantially straight within the delivery device in the delivery configuration (e.g., fig. 9A).
For claim 11, Patel discloses the method of claim 1, further comprising expanding a valve prosthesis within the anchor when the anchor is in the deployed configuration around the native chordae (e.g., fig. 9T).
For claim 12, Patel discloses the method of claim 11, wherein expanding the valve prosthesis comprises expanding the valve prosthesis such that a first end extends on the first side of the native valve and a second end extends on the second side of the native valve (e.g., fig. 2C)
For claim 13, Patel discloses the method of claim 1, wherein the native valve is a mitral valve, the first side of the native valve comprises a left atrium, and the second side of the native valve comprises a left ventricle (e.g., fig. 9A-U).
For claim 14, Patel discloses the method of claim 1, further comprising transeptally inserting the distal end of the delivery device into a left atrium of the heart (e.g., fig. 9A-C).
For claim 15, Patel discloses the method of claim 1, wherein deploying the anchor comprises pushing the anchor out of the delivery device (e.g., para. 87).
For claim 16, Patel discloses the method of claim I, further comprising releasing the anchor from the delivery device after an entirety of the anchor is on the second side of the valve and not on the first side of the valve (for claim 16, the anchor is considered the “lower coils” 12, which are located entirely on the second side of the valve).
For claim 17, Patel discloses the method of claim 1, further comprising extending a distal tip of the anchor through the valve at a commissure prior to the step of rotating the distal end (e.g., para. 116, fig. 9L).
For claim 19, Patel discloses the method of claim 1, wherein the delivery device comprises a steerable outer sheath, the method further comprising directing the distal end to a desired position with the steerable outer sheath (e.g., fig. 9A-C).
For claim 20, Patel discloses the method of claim I, further comprising translating the distal end of the delivery device towards the second side after the step of deploying and before the step of rotating (e.g., fig. 9E).
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.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (Pub. No.: US 2018/0318079) in view of Patel et al. (Pub. No.: US 2018/0177594) (hereinafter, Patel ‘594).
Patel is explained supra, however, Patel lacks specific disclosure of confirming a position of the anchor with fluoroscopy or echocardiography. Patel ‘594 teaches visualizing the position of a spiral anchor docking device using fluoroscopy (para. 160). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided the Patel with the method step of confirming a position of the anchor with fluoroscopy as taught by Patel ‘594 for the purpose of ensuring proper placement of the implant in a minimally invasive catheter-based implantation procedure. This modification would have occurred using known methods and would have yielded predictable results.
Conclusion
THIS ACTION IS MADE FINAL. 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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/SUBA GANESAN/Primary Examiner, Art Unit 3774
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