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 . Claims 1-20 are pending and examined below.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “contact probe” and “balloon” of claims 17 and 19, respectively, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
The drawings are objected to because it appears there is a typographical error in the word “solonoid” in Figures 2A-2B. Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 § 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) 1-2, 4, 7-14, & 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gross et al. (US 20160361169 A1) hereinafter, Gross.
Regarding claim 1, Gross teaches
a method for use at a tissue of a heart of a subject (methods are provided for repair of a dilated mitral valve of a patient, ¶0099, Gross), the method comprising:
using a catheter (404, Fig. 17C, Gross), delivering to the heart (30, Fig. 17C, Gross) a device (408, Fig. 18A, Gross) that includes a cord (480, Fig. 18A, Gross) and multiple anchors (740, Fig. 19A, Gross) distributed along the cord;
subsequently, arranging the device in an arrangement at the tissue (30, Fig. 20A, Gross) such that the cord is positioned and laid out correspondingly to the tissue (30, Fig. 20A, ¶0565, Gross);
while the device remains in the arrangement: identifying a first subset of the anchors (740, Fig. 19A, Gross) which are positioned for successful anchoring, and subsequent to the identifying, for each of the anchors of the first subset, actuating a respective anchor launcher (470, Fig. 20B, Gross) to drive the anchor into the tissue (catheter 421 may be steered toward the anchor mounts in any sequence thereof, ¶0601, Gross),
those of the anchors (740, Fig. 19A, Gross) that remain not driven into the tissue being undriven anchors (another 740, Fig. 20B, Gross); and subsequently, for each of the undriven anchors (another 740, Fig. 20B, Gross): moving the undriven anchor (another 740, Fig. 20B, Gross) to become positioned for successful anchoring, and actuating a respective anchor launcher (470, Fig. 20B, Gross) to drive the undriven anchor into the tissue (catheter 421 may be steered toward the anchor mounts in any sequence thereof, ¶0601, Gross).
Regarding claim 2, Gross teaches wherein:
the tissue (30, Fig. 20A, Gross) is tissue of an annulus (40, Fig. 20A, Gross) of a valve of the heart (20, Fig. 20A, Gross), and arranging the device (408, Fig. 18A, Gross) in the arrangement at the tissue comprises arranging the device such that the cord is positioned and laid out correspondingly to the annulus of the valve (40 of 30, Fig. 20A, ¶0565, Gross).
Regarding claim 4, Gross teaches
wherein, for each of the anchor launchers, actuating the anchor launcher comprises pressing a respective launch button (an anchor advancement rod is advanced through each lumen in order to facilitate advancing of the anchor into tissue of the patient & a proximal end of each rod is accessible from proximal end 2801 of handle 2802 by a physician who is able to push and/or rotate the rod in order to facilitate advancing of the anchor into tissue of the patient, ¶0627, Gross).
Regarding claim 7, Gross teaches
further comprising, once all of the anchors have been driven into the tissue, withdrawing the anchor launchers (421, Fig. 20B, Gross) from the subject while the anchors (4740, Fig. 28D, Gross) and the cord (4800, Fig. 28D, Gross) remain at the tissue (Fig. 28D, Gross).
Regarding claim 8, Gross teaches
further comprising, once all of the anchors have been driven into the tissue, withdrawing the catheter (4404, Fig. 28D, Gross) from the subject while the anchors (4740, Fig. 28D, Gross) and the cord (4800, Fig. 28D, Gross) remain at the tissue (Fig. 28D, Gross).
Regarding claim 9, Gross teaches
further comprising, once all of the anchors have been driven into the tissue, contracting the tissue by tensioning the cord (4800 are pulled to an extent that is based on (a) the level of dilation of the preoperative mitral valve, and/or (b) real-time monitoring of regurgitation minimization, ¶0709, Gross).
Regarding claim 10, Gross teaches
wherein, for each of the undriven anchors, moving the undriven anchor comprises moving the undriven anchor using a manipulating tool (421, Fig. 18B, Gross).
Regarding claim 11, Gross teaches
further comprising, via the catheter, advancing the manipulating tool to the device in the heart (421, Fig. 18B, Gross).
Regarding claim 12, Gross teaches
wherein, for each of the undriven anchors, moving the undriven anchor comprises grabbing the undriven anchor using a grabber (429, Fig. 20A, Gross) at a distal end of the manipulating tool (421, Fig. 20A, Gross).
Regarding claim 13, Gross teaches
wherein, for each of the undriven anchors, moving the undriven anchor comprises moving the undriven anchor by steering the catheter (421 is steerable catheter, ¶0564, Gross).
Regarding claim 14, Gross teaches
wherein the steps of (i) moving the undriven anchor, and (ii) actuating the respective anchor launcher to drive the undriven anchor into the tissue, are performed for each of the undriven anchors, successively (catheter 421 may be steered toward the anchor mounts in any sequence thereof, ¶0601, Gross).
Regarding claim 16, Gross teaches
wherein identifying the first subset comprises identifying the first subset using an imaging technique (fluoroscopic imaging, ¶0610, Gross).
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross in view of Iflah et al. (US 20180049875 A1), hereinafter, Iflah.
Regarding claim 3, Gross does not teach at least 10 anchors distributed along the cord. However, Iflah teaches a percutaneously-implantable implant and an adjustment device (abstract, Iflah) wherein
the device includes at least 10 anchors (32, Fig, 3F, about 10 or about 16 anchors, ¶0405, Iflah) distributed along the cord (222, Fig. 3F, Iflah), and delivering the device to the heart comprises delivering to the heart the device that includes the at least 10 anchors distributed along the cord (222, Fig. 3F, Iflah).
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 teachings of Gross by incorporating the teachings above as taught by Iflah in order to circumferentially tighten the valve annulus (¶0395, Iflah).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross in view of Bishop et al. (US 20200297489 A1) hereinafter, Bishop.
Regarding claim 5, Gross does not teach for each of the anchor launchers, actuating the anchor launcher comprises actuating the anchor launcher by operating a solenoid. However, Bishop teaches methods and devices for transvascular prosthetic chordae tendinae implantation (abstract, Bishop)
wherein, for each of the anchor launchers, actuating the anchor launcher comprises actuating the anchor launcher by operating a solenoid (solenoid carried by the proximal end of the catheter, ¶0300, Bishop).
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 teachings of Gross by incorporating the teachings above as taught by Bishop in order to distally project the needle (or launcher) in response to an activation signal (¶0300, Bishop).
Regarding claim 6, Gross does not teach for each of the anchor launchers, actuating the anchor launcher comprises actuating the anchor launcher by operating a mechanical linkage. However, Bishop teaches
wherein, for each of the anchor launchers, actuating the anchor launcher comprises actuating the anchor launcher by operating a mechanical linkage (electromechanical or mechanical needle driver and mechanically linked, ¶0301-0302, Bishop).
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 teachings of Gross by incorporating the teachings above as taught by Bishop in order to move between an engaged configuration, and a disengaged configuration (¶0303, Bishop).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross in view of Selvitelli et al. (US 20050187577 A1) hereinafter, Selvitelli.
Regarding claim 15, Gross does not teach each of the anchors is slidably affixed with respect to the cord. However, Selvitelli teaches a suture anchor system for repairing torn or damaged tissue (abstract, Selvitelli)
wherein: each of the anchors (18 or 19, Fig. 4, Selvitelli) is slidably affixed with respect to the cord (44, Fig. 4), and arranging the device in the arrangement comprises sliding at least one of the anchors along the cord (Fig. 4, Selvitelli).
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 teachings of Gross by incorporating the teachings above as taught by Selvitelli in order to allow the anchors 18, 19 to slide as the size of the loop is adjusted (¶0026, Selvitelli).
Claim(s) 17-18 & 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross in view of Khairkhahan (US 20190175344 A1).
Regarding claim 17, Gross does not teach a respective contact probe that is affixed to the anchor launcher. However, Khairkhahan teaches a device for use in the transcatheter treatment of mitral valve regurgitation (abstract, Khairkhahan)
wherein identifying the first subset comprises determining whether, for each of the anchor launchers, a respective contact probe (2360, Fig. 58B, Khairkhahan) that is affixed to the anchor launcher (2350, Fig. 58B, Khairkhahan) is in contact with the tissue.
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 teachings of Gross by incorporating the teachings above as taught by Khairkhahan in order to provide a visual indication of the placement of the secondary anchor guide rails and secondary anchors (¶0429, Khairkhahan).
Regarding claim 18, Gross does not teach actuating each of the anchor launchers associated with the first subset of anchors substantially simultaneously. However, Khairkhahan teaches
wherein actuating the anchor launchers (2350, Fig. 58B, Khairkhahan) associated with the first subset of anchors comprises actuating each of the anchor launchers associated with the first subset of anchors substantially simultaneously (secondary anchors can be simultaneously rotated to engage tissue, ¶0412, Khairkhahan).
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 teachings of Gross by incorporating the teachings above as taught by Khairkhahan in order to simultaneously rotate to engage tissue (¶0412, Khairkhahan).
Regarding claim 20, Gross does not teach the first subset includes at least two anchors. However, Khairkhahan teaches
wherein the first subset includes at least two anchors (secondary anchors can be simultaneously rotated to engage tissue therefore it could include at least two anchors, ¶0412, Khairkhahan).
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 teachings of Gross by incorporating the teachings above as taught by Khairkhahan in order to simultaneously rotate to engage tissue (¶0412, Khairkhahan).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross in view of Cartledge et al. (US 20130123910 A1) hereinafter, Cartledge.
Regarding claim 19, Gross does not teach the arranging the device in the arrangement comprises inflating a balloon. However, Cartledge teaches a delivery device for an annular implant (abstract, Cartledge)
wherein the arranging the device in the arrangement comprises inflating a balloon (inflation of the balloon collar 126, ¶0077, Cartledge).
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 teachings of Gross by incorporating the teachings above as taught by Cartledge in order to expand and deploy the annular implant (¶0076, Cartledge).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIA XIONG WHITE whose telephone number is (703)756-4773. The examiner can normally be reached 0830-1630 EST.
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/K.X.W./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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