DETAILED ACTION
The Examiner acknowledges the amendments received 27 January 2026. Claims 15-20 are withdrawn; claims 1-14 are pending.
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, see “Remarks”, filed 27 January 2026, with respect to the rejection(s) of claim(s) 1-14 under Corbitt and Wallace have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Purcell.
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 1-2, 4-5 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Purcell et al (U.S. 2019/0216601). Purcell discloses (Figures 2A-2B) an elongate element (suture 74); a needle (sharpened distal end 64) disposed at a distal end of the elongate element; and at least one radiopaque marker element (66) comprising a coil (par. 055) coupled to or disposed on at least a portion of an outer surface of the elongate element (“A coil spring 71 is concentrically carried over the core wire 62 and biases the radiopaque marker 66 in the distal direction. The radiopaque marker 66 is thus held in position against a proximal surface of the stop 70. In use, the marker 66 rides on the surface of tissue at the target attachment site. As the helical coil anchor 54 is rotated and advances distally into tissue, the marker 66 rides proximally on the core wire 62 along with the tissue surface, compressing the coil spring 71 until the marker 66 is retracted proximally to the hub when the tissue anchor is fully embedded.”).
Regarding claim 2, Purcell discloses (Figures 2A-2B) the elongate element is suture (74).
Regarding claim 4, Purcell discloses (par. 0055) the at least one radiopaque marker element includes a helical coil (“A coil spring 71 is concentrically carried over the core wire 62 and biases the radiopaque marker 66 in the distal direction. The radiopaque marker 66 is thus held in position against a proximal surface of the stop 70. In use, the marker 66 rides on the surface of tissue at the target attachment site. As the helical coil anchor 54 is rotated and advances distally into tissue, the marker 66 rides proximally on the core wire 62 along with the tissue surface, compressing the coil spring 71 until the marker 66 is retracted proximally to the hub when the tissue anchor is fully embedded.”).
Regarding claim 5, Purcell discloses (par. 0055) the helical coil is wrapped around the elongate element (“A coil spring 71 is concentrically carried over the core wire 62 and biases the radiopaque marker 66 in the distal direction. The radiopaque marker 66 is thus held in position against a proximal surface of the stop 70. In use, the marker 66 rides on the surface of tissue at the target attachment site. As the helical coil anchor 54 is rotated and advances distally into tissue, the marker 66 rides proximally on the core wire 62 along with the tissue surface, compressing the coil spring 71 until the marker 66 is retracted proximally to the hub when the tissue anchor is fully embedded.”).
Regarding claim 14, Purcell discloses (par. 0056) the at least one radiopaque marker element includes a plurality of connected radiopaque marker elements (“The suture may additionally carry one or two or more radiopaque markers 82 spaced apart from the hub 57, and may extend proximally through the proximal connector and a central lumen in the rotational driver.”).
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 3 and 6-13 are rejected under 35 U.S.C. 103 as being unpatentable over Purcell et al (U.S. 2019/0216601) in view of Wallace et al (U.S. 7,695,484). Purcell discloses the claimed invention except for the at least one radiopaque marker includes portions having different radiopacities. Wallace, however, discloses (col. 6, lines 4-59) a helically coiled radiopaque device that varies its pitch from open to closed along its length in order to provide variable thickness and density.
Wallace and Purcell both disclose systems for providing helically coiled radiopaque elements in an implanted device. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Purcell’s needle system with Wallace’s varying winding along the length of the elongate element in order to provide variable shape and flexibility for stability in placement of the device.
Regarding claim 6, Wallace discloses (col. 6, lines 4-59) the helical coil includes portions having different winding densities, and wherein the different winding densities have different radiopacities.
Regarding claim 7, Wallace discloses (col. 6, lines 4-59) the helical coil includes a plurality of high-density winding portions that are spaced apart along at least a portion of the elongate element.
Regarding claim 8, Wallace discloses (col. 6, lines 4-59) the plurality of high-density winding portions are unconnected.
Regarding claim 9, Wallace discloses (col. 6, lines 4-59) the helical coil includes a plurality of high-density winding portions that are separated by low-density winding portions along at least a portion of the elongate element.
Regarding claim 10, Wallace discloses (col. 6, lines 4-59) the plurality of high-density winding portions comprise different radiopacities.
Regarding claim 11, Wallace discloses (col. 6, lines 4-59) the high-density winding portions and the low-density winding portion create a pattern of radiopacity.
Regarding claim 12, Wallace discloses (col. 6, lines 4-59) the pattern of radiopacity repeats along the elongate element.
Regarding claim 13, Wallace discloses (col. 6, lines 4-59) the at least one radiopaque marker element is configured for varying tactile and visual feedback via modifications of a coil density of the helical coil.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792
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