DETAILED ACTION
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
During a telephone conversation with Robert Paladino on 17 July 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-19. Affirmation of this election must be made by applicant in replying to this Office action. Claim 20 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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 “guide portion” of claim 1, the “first obstruction” of claim 3, the “second abutment portion” of claim 8, the “spring members” of claim 12, the “single control input” of claim 14, “anchor deployment mechanism” of claim 18 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.
Specification
The disclosure is objected to because of the following informalities: reference numeral 221 is used to refer to both the “shoulder portion” and “piercing section” on page 80, line 4 of the Specification.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-11, 13-15, and 17-18 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Guo et al. (WO 2019/014158 A1), “Guo”.
Regarding claim 1, Guo teaches
A catheter device for implanting a soft tissue anchor system in heart tissue (Figs. 11A-C exhibit an implanting a suture implant [0095]), the catheter device comprising:
a housing section (Fig. 11A, cartridge 360),
wherein the housing section extends from a distal end of the catheter device along the length of the catheter device toward a proximal end of the catheter device (Fig. 11A, cartridge 360 extends from proximal end 362 to distal end 364);
a soft tissue anchor system (Fig. 11A, suture implant 300) comprising a plurality of anchor members (Fig. 11A, first and second tissue anchors 302A-B); and
a deployment system configured to simultaneously implant each of the anchor members in the heart tissue (Fig. 11A, delivery device 395 includes anchor drivers [00145]);
wherein the deployment system comprises a plurality of wire guide members (Fig. 11A, first and second tissue anchor drivers 392A-B),
wherein each wire guide member comprises a guide portion located at a distal end of the wire guide member and configured to engage a respective anchor member (Fig. 11A, region of tissue anchors 302A-B distal to anchor drivers 392A-B); and
wherein the deployment system is configured to maintain a coplanar alignment between the guide portions of the plurality of wire guide members during implantation of the anchor members (Fig. 11A-C, anchors 302A-B and anchor drivers 392A-B maintain alignment throughout deployment).
Regarding claim 2, Guo teaches
wherein each wire guide member comprises a bulge portion (Figs. 11A-B, anchor drivers 392A-B comprise a narrowed region and a proximal flared region near anchors 302A-B).
Regarding claim 3, Guo teaches
wherein each wire guide member is movable between a first configuration (Fig. 11A) and a second configuration (Fig. 11B),
wherein in the first configuration the bulge portion is configured to engage a first obstruction configured to limit a translation of the wire guide member in the proximal direction (Fig. 11A, narrowed region of anchor drivers 392A-B proximal to anchors 302A-B fits within narrowed region of cartridge body 366 and cannot retract further proximally), and
wherein in the second configuration the wire guide member is configured to engage a respective anchor member (Fig. 11B, anchor drivers 392A-B deploy suture implant 300).
Regarding claim 4, Guo teaches
wherein the first obstruction is an abutment portion located in a proximal part of the housing section (Fig. 11A, narrowed region of cartridge body 366 is located proximal to distal end 364).
Regarding claim 5, Guo teaches
wherein the abutment portion is complementary to a shape of the bulge portion, such that the bulge portion is configured to mate with the abutment portion in the first configuration (Fig. 11A, narrowed region of anchor drivers 392A-B proximal to anchors 302A-B fits within narrowed region of cartridge body 366 and cannot retract further proximally).
Regarding claim 6, Guo teaches
wherein the bulge portion is configured to abut a complementary portion of the anchor member in the second configuration (Fig. 11B, narrowed region of anchor drivers 392A-B are directly adjacent anchors 302A-B).
Regarding claim 7, Guo teaches
wherein each wire guide member comprises a control portion extending from the guide portion and located towards a proximal end of the wire guide member (Fig. 11A, regions of anchor drives 392A-B proximal to narrowed, then flared, region),
wherein the control portion has a greater diameter than the guide portion (Fig. 11A, proximal regions of anchor drivers 392A-B are continuous is tubular shape and do not narrow (i.e., are larger in diameter)); and
wherein the bulge portion is located between the guide portion and the control portion (Fig. 11A, narrowed, then flared, regions of anchor drivers 392A-B are proximal to anchors 302A-B, but distal to the further proximal region of said anchor drivers 392A-B).
Regarding claim 8, Guo teaches
wherein the bulge portion is configured to abut a second abutment portion located in a distal part of the housing section in the second configuration (Fig. 11B, narrowed, then flared region of anchor drivers 392A-B further comprise suture loops 322A-B which engage with tensioner 310 that abuts against tensioner stop 390),
wherein the second abutment portion is configured to limit a translation of the wire guide member in the distal direction (Figs. 11B-C, tensioner stop 390 engages with tensioner 310 to limit distal movement of anchor drivers 392A-B).
Regarding claim 9, Guo teaches
wherein each wire guide member comprises a control portion extending from the guide portion and located towards a proximal end of the wire guide member (Fig. 11A, regions of anchor drives 392A-B proximal to narrowed, then flared, region),
wherein the control portion has a greater diameter than the guide portion (Fig. 11A, proximal regions of anchor drivers 392A-B are continuous is tubular shape and do not narrow (i.e., are larger in diameter)); and
wherein the bulge portion is located within the control portion (Fig. 11A, narrowed, then flared, regions of anchor drivers 392A-B are proximal to anchors 302A-B, but distal to the further proximal region of said anchor drivers 392A-B).
Regarding claim 10, Guo teaches
wherein the wire guide member comprises a shoulder portion extending between the control portion and the guide portion (Figs. 11A-B, anchor drivers 392A-B comprise a narrowed region and a proximal flared region near anchors 302A-B),
wherein the shoulder portion is configured to abut a complementary portion of the anchor member (Fig. 11B, narrowed region of anchor drivers 392A-B are directly adjacent anchors 302A-B).
Regarding claim 11, Guo teaches
comprising a spring arrangement configured to automatically restore the coplanar alignment between the guide portions of the plurality of wire guide members during delivery of the catheter device to the heart (Fig. 27B, return spring 625 allows for pushing and/or detaching of the anchor body [00162]).
Regarding claim 13, Guo teaches
wherein the spring arrangement is located in a delivery handle of the catheter device (Fig. 17B, handgrip 606 comprises return spring 625).
Regarding claim 14, Guo teaches
comprising a single control input configured to simultaneously translate each of the wire guide members (Fig. 17A, anchor release button 608).
Regarding claim 15, Guo teaches
wherein the anchor member comprises an opening configured to receive the wire guide member (Figs. 11B-C, anchors 302A-B are fitted onto anchor drivers 392A-B and detached after placement (i.e., comprise a hole which fits to anchor drivers)).
Regarding claim 17, Guo teaches
wherein the soft tissue anchor system (Fig. 11A, suture implant 300) comprises: a line (Fig. 11C, suture 308); and
a plurality of tubular cap members (Fig. 11C, tissue anchors 302A-B);
wherein an end of the line is fixed to each tubular cap member and extends from a central portion thereof (Fig. 11C, suture 308 comprises first and second suture loops 322A-B that are passed through respective tissue anchors 302A-B) such that, in use,
each tubular cap member is configured to extend in a plane parallel to a surface of the soft body tissue when implanted in the soft body tissue and under tension of the line when it is passing through the tissue in a direction away from the surface thereof (Fig. 11C, tissue anchors 302A-B are positioned in a plane parallel to a patient’s skin when implanted and tensioned by suture 308 [00145-00147]);
wherein each tubular cap member comprises an opening configured to receive a wire guide member (Fig. 11C, tissue anchors 302A-B comprise openings which sutures loops 322A-B are threaded through); and
wherein each anchor member is a tubular cap member of the soft tissue anchor system (Fig. 11C tissue anchors 302A-B act as anchors and are pointed tubular ends of suture implant 300).
Regarding claim 18, Guo teaches
comprising an anchor deployment mechanism configured to hold the soft tissue anchor system during deployment (Fig. 11A, delivery device 395 retains and delivers suture implant 300);
wherein the anchor deployment mechanism comprises a sheath (Fig. 28, outer sheath 1595),
wherein the soft tissue anchor system is held within the sheath (Fig. 28, outer sheath 1595 retains tissue anchor [00184]); and
wherein the sheath is configured to crumple to aid deployment of the soft tissue anchor system from the catheter device (Fig. 28, outer sheath 1595 is collapsible to retain tissue anchor [00184]).
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.
Claims 12, 16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Guo et al. (WO 2019/014158 A1), “Guo” in view of Sugimoto et al. (WO 2007/005394), “Sugimoto”.
Regarding claim 12, Guo teaches the spring arrangement (Fig. 27B, return spring 625) and wherein the spring member is configured to provide a restoring force to a respective wire guide member (Fig. 27B, return spring 625 allows for pushing and/or detaching of the anchor body [00162]), but fails to teach a plurality of spring members.
However, regarding the plurality of spring members, “the courts have held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP § 2144.04-VI-B. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to comprise a plurality of spring members each selectively connected to a respective guide wire member.
Regarding claim 16, Guo teaches the soft tissue anchor system (Fig. 11A, suture implant 300), and an end cap fixed at an end of each arm portion distal to the base portion (Fig. 11C, tissue anchors 302A-B); wherein each end cap comprises an opening configured to engage a wire guide member (Figs. 11B-C, anchors 302A-B are fitted onto anchor drivers 392A-B and detached after placement (i.e., comprise a hole which fits to anchor drivers)); and wherein each anchor member is an end cap of the soft tissue anchor system (Fig. 11C tissue anchors 302A-B act as anchors and are pointed tubular ends of suture implant 300), but fails to teach a U-shaped fabric body.
Sugimoto teaches a tissue anchor wherein the soft tissue anchor system (Fig. 1, tissue anchor 10) comprises: a U-shaped fabric body (Fig. 2D, elongate strip 14 of tissue anchor 10 is folded to form u-shape when implanted) comprising a base portion (Fig. 2A, region of tissue anchor 10 nearest tissue 20) and at least two arm portions extending from the base portion (Fig. 2A, regions of tissue anchor 10 extending on either side of region of tissue anchor 10 nearest tissue 20); wherein each arm portion is configured to collapse in folds towards the base portion (Fig. 2E, tissue anchor 10 comprises elongate strip 14 which if folded in on itself toward region nearest tissue 20) such that, in use, the body tissue is sandwiched between the base portion and each of the arm portions (Fig. 2E, tissue 20 is between folded ends of elongate strip 14 of tissue anchor 10). Sugimoto discloses that the suture portion of the implant may extend outside the patient’s body and be pulled or tensioned or grasped by a suitable mechanism within a catheter device for delivery and placement [0037]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the U-shaped fabric body taught by Sugimoto with the soft tissue anchor system and catheter device taught by Guo in order to more accurately place and tension the implant.
Regarding claim 19, Guo fails to teach the limitations of claim 19. Sugimoto teaches a tissue anchor comprising a leaflet anchor for placement in a leaflet of a heart valve (Figs. 4A-E, tissue anchor 10 is deployed within mitral valve 40 of heart 42), wherein the leaflet anchor is the soft tissue anchor system (Fig. 1, tissue anchor 10), wherein the leaflet anchor is arranged to be coupled to the artificial line (Figs. 4A-B, tissue anchor 10 is folded on itself and on tensioning member 12). Sugimoto discloses that the suture portion of the implant may extend outside the patient’s body and be pulled or tensioned or grasped by a suitable mechanism within a catheter device for delivery and placement [0037]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the U-shaped fabric body taught by Sugimoto with the soft tissue anchor system and catheter device taught by Guo in order to more accurately place and tension the implant.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. WO 2020/109596, US 20080140092.
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/G.G.R./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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