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 .
Priority
This application is a CON of 18/492,809 10/24/2023 PAT 12201528
18/492,809 is a CON of 17/072,002 10/15/2020 PAT 11826254
17/072,002 has PRO 62/915,176 10/15/2019 is acknowledged.
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 13 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.
Claim 13 recites “the tissue anchor comprises a primary tissue anchor or a secondary tissue anchor”. The tissue anchor is not positively claimed. It is unclear whether or not the applicant is trying to claim the tissue anchor. The examiner’s position is that the tissue anchor is not claimed.
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) 7-8, 10, 14-15, 17, 22-23, 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 9055940 to Chin.
Chin teaches:
Claim 7: An apparatus (302, Fig. 3A) for deploying a tissue anchor (the tissue anchor is not positively claimed) comprising:
a catheter tube (304, Fig. 3A) extending between a proximal end and a distal end (306, Fig. 3A), wherein the distal end comprises an anchor housing (the distal end with distal lumen is considered an anchor housing) configured to hold a tissue anchor before deployment (the tissue anchor is not positively claimed, the distal end 306 is capable of housing a tissue anchor);
a pusher wire (310, Fig. 3A) positioned within and extending through a length of the catheter tube, wherein the pusher wire has a proximal end and a distal end corresponding with the proximal end and the distal end of the catheter tube (Fig. 3B); and
a snare (308, Fig. 3B) having a distal end positionable adjacent to an eyelet of the tissue anchor (the tissue anchor is not positively claimed), wherein the snare is positioned within and extends through the length of the catheter tube (Figs. 3B-C), and wherein the snare is movable in a proximal direction to capture and thread a suture (suture is not positively claimed) through the length of the catheter tube (Fig. 3C).
Claim 8: The pusher wire (310, Fig. 3B) is configured to be displaced in a distal direction to deploy the tissue anchor from the anchor housing in the distal direction by pushing the tissue anchor in the distal direction (functional limitation, the anchor is not positively claimed and the pusher wire 310 is capable of pushing an anchor distally).
Claim 10: The pusher wire (310, Fig. 3A) comprises a stop (the flange at the proximal end of 310) that prevents the distal end of the pusher wire from extending beyond a distal end of the anchor housing at more than a predetermined distance.
Claim 14: A system for deploying one or more tissue anchors, comprising:
a catheter tube (304, Fig. 3A) extending between a proximal end and a distal end (306, Fig. 3A);
a pusher wire (310, Fig. 3B) positioned within and extending through a length of the catheter tube, wherein the pusher wire has a proximal end and a distal end corresponding with the proximal end and the distal end of the catheter tube (Fig. 3B);
an anchor housing (the distal end with distal lumen is considered an anchor housing) configured to hold a tissue anchor prior to deployment (the tissue anchor is not positively claimed, the distal end 306 is capable of housing a tissue anchor), wherein the anchor housing is reloadable (capable of reloading an anchor after pushing out an anchor); and
a snare (308, Fig. 3B) positionable adjacent to an eyelet of the tissue anchor (the tissue anchor is not positively claimed), wherein the snare is positioned within and extends through the length of the catheter tube (Figs. 3B-C), and wherein the snare is translatable in a proximal direction to capture and thread a suture (suture is not positively claimed) through the length of the catheter tube (Fig. 3C).
Claim 15: The pusher wire (310, Fig. 3B) is configured to be displaced in a distal direction to deploy the tissue anchor from the anchor housing in the distal direction by pushing the tissue anchor in the distal direction (functional limitation, the anchor is not positively claimed and the pusher wire 310 is capable of pushing an anchor distally).
Claim 17: The pusher wire (310, Fig. 3A) comprises a stop (the flange at the proximal end of 310) that prevents the distal end of the pusher wire from extending beyond a distal end of the anchor housing at more than a predetermined distance.
Claim 22: An apparatus comprising:
a catheter tube (304, Fig. 3A) extending between a proximal end and a distal end (306, Fig. 3A);
an anchor housing (the distal end with distal lumen is considered an anchor housing) at the distal end of the catheter tube, wherein the anchor housing is configured to receive a tissue anchor having an eyelet (the tissue anchor is not positively claimed, the distal end 306 is capable of receiving a tissue anchor);
a pusher wire (310, Fig. 3A) positioned within and extending through a length of the catheter tube, wherein the pusher wire has a proximal end and a distal end corresponding with the proximal end and the distal end of the catheter tube (Fig. 3B); and
a snare (308, Fig. 3B) positionable adjacent to the eyelet of the tissue anchor (the tissue anchor is not positively claimed), wherein the snare is positioned within and extends through the length of the catheter tube (Figs. 3B-C), and wherein the snare is translatable in a proximal direction to capture (Fig. 3C) and thread a suture (suture is not positively claimed) through the length of the catheter tube.
Claim 23: The pusher wire (310, Fig. 3B) is configured to be displaced in a distal direction to deploy the tissue anchor from the anchor housing in the distal direction by pushing the tissue anchor in the distal direction (functional limitation, the anchor is not positively claimed and the pusher wire 310 is capable of pushing an anchor distally).
Claim 25: The pusher wire (310, Fig. 3A) comprises a stop (the flange at the proximal end of 310) that prevents the distal end of the pusher wire from extending beyond a distal end of the anchor housing at more than a predetermined distance.
Claim(s) 7-8, 10, 14-15, 17, 20-23, 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2015/0018879 to Moehle et al. (Moehle).
Moehle teaches:
Claim 7: An apparatus (200, Fig. 9) for deploying a tissue anchor (the tissue anchor is not positively claimed) comprising:
a catheter tube (204, Fig. 14A) extending between a proximal end and a distal end (216, Fig. 9A), wherein the distal end comprises an anchor housing (212, Fig. 9A) configured to hold a tissue anchor (holding a suture fastener 250, Fig. 14A) before deployment (the tissue anchor is not positively claimed);
a pusher wire (234, Fig. 11B) positioned within and extending through a length of the catheter tube, wherein the pusher wire has a proximal end and a distal end corresponding with the proximal end and the distal end of the catheter tube (Fig. 11A); and
a snare (214, Fig. 9A) having a distal end positionable adjacent to an eyelet of the tissue anchor (the tissue anchor is not positively claimed), wherein the snare is positioned within and extends through the length of the catheter tube (after fastener cartridge 212 engaged with distal end of shaft 204, the snare is extending through the length of the shaft 204, Fig. 14A), and wherein the snare is movable in a proximal direction to capture and thread a suture (suture is not positively claimed) through the length of the catheter tube (Fig. 14B).
Claim 8: The pusher wire (234, Figs. 14A-D) is configured to be displaced in a distal direction to deploy the tissue anchor from the anchor housing in the distal direction by pushing the tissue anchor in the distal direction (functional limitation, the anchor is not positively claimed and the pusher wire 234 with fastener ejector 236 is capable of pushing the anchor 250 distally, Figs. 14C-D).
Claim 10: The pusher wire (234, Fig. 14A-D) comprises a stop (the push wire 234 has a predetermined length and connected at the proximal end to upper lever arm 230 that actuated by trigger 206. Therefore, it is said that the push wire 234 has a stop which is the predetermined length and the lever arm that prevent the push wire from moving distally further than it could) that prevents the distal end of the pusher wire from extending beyond a distal end of the anchor housing at more than a predetermined distance.
Claim 14: A system for deploying one or more tissue anchors, comprising:
a catheter tube (204, Fig. 14A) extending between a proximal end and a distal end (216, Fig. 9A);
a pusher wire (234, Fig. 11B) positioned within and extending through a length of the catheter tube, wherein the pusher wire has a proximal end and a distal end corresponding with the proximal end and the distal end of the catheter tube (Fig. 11A);
an anchor housing (212, Fig. 9A) configured to hold a tissue anchor prior to deployment (holding a suture fastener 250, Fig. 14A) (the tissue anchor is not positively claimed), wherein the anchor housing is reloadable (para. 0082); and
a snare (214, Fig. 9A) positionable adjacent to an eyelet of the tissue anchor (the tissue anchor is not positively claimed), wherein the snare is positioned within and extends through the length of the catheter tube (after fastener cartridge 212 engaged with distal end of shaft 204, the snare is extending through the length of the shaft 204, Fig. 14A), and wherein the snare is translatable in a proximal direction to capture and thread a suture (suture is not positively claimed) through the length of the catheter tube (Fig. 14B).
Claim 15: The pusher wire (234, Figs. 14A-D) is configured to be displaced in a distal direction to deploy the tissue anchor from the anchor housing in the distal direction by pushing the tissue anchor in the distal direction (functional limitation, the anchor is not positively claimed and the pusher wire 234 with fastener ejector 236 is capable of pushing the anchor 250 distally, Figs. 14C-D).
Claim 17: The pusher wire (234, Fig. 14A-D) comprises a stop (the push wire 234 has a predetermined length and connected at the proximal end to upper lever arm 230 that actuated by trigger 206. Therefore, it is said that the push wire 234 has a stop which is the predetermined length and the lever arm that prevent the push wire from moving distally further than it could) that prevents the distal end of the pusher wire from extending beyond a distal end of the anchor housing at more than a predetermined distance.
Claim 20: The anchor housing (212, Fig. 9A) is releasably coupled to the distal end of the catheter tube (216, Fig. 9A).
Claim 21: A suture locking device (250, Fig. 14A) to deploy a suture lock to the suture. (since the tissue anchor is not positively claimed, the suture anchor 250 is considered to be the suture locking device that deploy suture locking to the suture).
Claim 22: An apparatus comprising:
a catheter tube (204, Fig. 14A) extending between a proximal end and a distal end (216, Fig. 9A);
an anchor housing (212, Fig. 9A) at the distal end of the catheter tube, wherein the anchor housing is configured to receive a tissue anchor (holding a suture fastener 250, Fig. 14A) having an eyelet (the tissue anchor is not positively claimed);
a pusher wire (234, Fig. 11B) positioned within and extending through a length of the catheter tube, wherein the pusher wire has a proximal end and a distal end corresponding with the proximal end and the distal end of the catheter tube (Fig. 11A); and
a snare (214, Fig. 9A) positionable adjacent to the eyelet of the tissue anchor (the tissue anchor is not positively claimed), wherein the snare is positioned within and extends through the length of the catheter tube (after fastener cartridge 212 engaged with distal end of shaft 204, the snare is extending through the length of the shaft 204, Fig. 14A), and wherein the snare is translatable in a proximal direction to capture (Fig. 14B) and thread a suture (suture is not positively claimed) through the length of the catheter tube.
Claim 23: The pusher wire (234, Figs. 14A-D) is configured to be displaced in a distal direction to deploy the tissue anchor from the anchor housing in the distal direction by pushing the tissue anchor in the distal direction (functional limitation, the anchor is not positively claimed and the pusher wire 234 with fastener ejector 236 is capable of pushing the anchor 250 distally, Figs. 14C-D).
Claim 25: The pusher wire (234, Fig. 14A-D) comprises a stop (the push wire 234 has a predetermined length and connected at the proximal end to upper lever arm 230 that actuated by trigger 206. Therefore, it is said that the push wire 234 has a stop which is the predetermined length and the lever arm that prevent the push wire from moving distally further than it could) that prevents the distal end of the pusher wire from extending beyond a distal end of the anchor housing at more than a predetermined distance.
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) 9, 16, 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moehle in view of US 9351722 to Koogle, Jr. et al. (Koogle).
Moehle teaches:
The apparatus of claims 8, 15 and 23 (see rejection of claims 8, 15 and 23 above).
Moehle fails to teach:
The pusher wire is displaced in the distal direction by a force provided by one of a compression spring, a compressed gas cartridge, or a motorized or geared actuator.
Koogle teaches:
The pusher wire is displaced in the distal direction by a force provided by one of a compression spring, a compressed gas cartridge, or a motorized or geared actuator (Col. 8, ll. 44-65).
It would have been obvious to one of ordinary skill in the art at the time of the invention was filed to modify the drive mechanism of Koogle into Moehle as a substitution of one known mechanism for another that would yield predictable result of advancing the push rod and anchor distally.
Allowable Subject Matter
Claims 11-12, 18-19, 26 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including 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: Regarding claims 11, 18 and 26, none of the prior art disclose, in combination with other limitation of the claim, at least one stabilization pin deployable from a retracted position within the anchor housing to a deployed position out of the anchor housing in a distal direction. Claims 12, 19 objected for depending on objected claims 11 and 18. Prior art Moehle teaches the current invention including an anchor, a push rod for pushing the anchor out of the distal end of the catheter and a snare for capturing the suture but fails to disclose at least one stabilization pin as claimed.
There are relevant prior arts in PTO 892 that are not used for rejection but might be considered pertinent to the current invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHONG SON DANG whose telephone number is (571)270-5809. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHONG SON H DANG/Primary Examiner, Art Unit 3771
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