DETAILED ACTION
The amendment filed on 11/20/25 has been received and considered. By this amendment, claims 1, 5, 11, 14, and 17 are amended. Claims 1-20 are pending in the application.
Response to Arguments
Applicant’s arguments, see pages 5-7, filed 11/20/25, with respect to the rejection(s) of claim(s) 1 and 11 under 35 USC 102(a)(1) and claim 17 under 35 USC 103 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 Therefore, the rejection has been withdrawn.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 Soltis et al. (PG Pub. 2018/0178006).
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.
Claim(s) 1, 3-5, 8, 11, 13, 14, and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Soltis et al. (PG Pub. 2018/0178006).
Regarding Claim 1, Soltis discloses a biostimulator transport system, comprising:
A sleeve having a sleeve lumen (see tubular member 402 and lumen 408; Fig. 8 and par. 97);
A support member extending through the sleeve lumen to a distal member end (see wall 412 and distal end region 404; Fig. 8, par. 97); and
A belt extending longitudinally through the sleeve lumen and laterally between the sleeve and a side of the support member to a loop distal to the distal member end (see tether 414; Fig. 8, par. 99).
Regarding Claims 3 and 13, Soltis discloses wherein the distal member end has a socket to receive a portion of a biostimulator (see funnel 406; Fig. 8 and par. 96).
Regarding Claim 4, Soltis discloses the support member has a lubricious surface (see PTFE; par. 81 and 110).
Regarding Claims 5 and 14, Soltis discloses wherein the support member includes a lateral surface having a track (see par. 97). The examiner considers in configurations where the wall(s) divide the lumen into four lumens, the right angle can technically be considered a track through which the tether extends (see par. 97).
Regarding Claims 8 and 16, Soltis discloses wherein the loop has a gripping surface facing the distal member end (see Fig. 8). The examiner considers the loop grips retention structure 36 and therefore, necessarily has a gripping surface. Furthermore, the loop naturally faces the distal end member because it extends from it [emphasis added].
Regarding Claim 11, see rejection of similarly worded Claim 1 above. Soltis further discloses a biostimulator system, comprising: a biostimulator (see device 10; par. 60) including a pacing electrode (see electrode electrodes 20 and 22; par. 60) electrically connected to pacing circuitry contained within a housing of the biostimulator (see par. 61). Soltis further discloses wherein a portion of the biostimulator between the pacing electrode and the housing extends through the loop (see tether retention structure 36; par. 63 and Fig. 8).
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(s) 2 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soltis et al. (PG Pub. 2018/0178006) in view of Eggen et al. (PG Pub. 2016/0310723).
Regarding Claims 2 and 12, Soltis discloses having sleeves that are longitudinally moveable relative to each other (see inner, intermediate, and outer tubular members; par. 20), but does not explicitly disclose the inner tubular member 402 moves longitudinally relative to wall 412. Eggen discloses a similar biostimulator transport system wherein the sleeve (see advancement tool 518; Fig. 9A and par. 69) is longitudinally moveable relative to the support member (see inner steering tool 504; Fig. 9A/9B and par. 70). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the sleeve retractable because Eggen teaches it allows the loop to be exposed when it is time for positioning (see par. 70).
Claim(s) 6-7, 15, 17-18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soltis et al. (PG Pub. 2018/0178006) in view of in view of Ward et al. (PG Pub. 2015/0094735).
Regarding Claims 6 and 15, Soltis discloses a handle (see handle assembly 120; par. 95), but does not explicitly disclose coupling to the support member. Ward discloses a handle (see handle assembly 210) coupled to the support member and the belt (see Fig. 2A), wherein the handle includes a drive mechanism (see control member 211and inner assembly 220; Fig. 5A and par. 21) to drive the belt through the track (see par. 22). It would have been obvious to one of ordinary skill in the art at the time of the invention to use Ward’s drive mechanism to drive the electrode into the tissue because Ward teaches the controlled articulation via the drive mechanism allows the electrode toward the implant site with increased maneuverability (see par. 27 and 31).
Regarding Claim 7, Ward discloses the drive mechanism includes a knob (see member 211), and wherein rotation of the knob causes the belt to slide in the track (see par. 22). It would have been obvious to one of ordinary skill in the art at the time of the invention to include knobs to actuate the belt because Ward teaches it helps to articulate the distal end to bend in whatever direction necessary to get to the target tissue location (see par. 24).
Regarding Claim 17, see rejection of similarly worded Claims 1 and 11 above. Eggen further discloses advancing the biostimulator transport system to a target tissue and retracting the sleeve to expose the biostimulator to direct a pacing electrode toward the target tissue (see par. 70, 76, 78, and 85). Eggen does not disclose actuating a drive mechanism of the biostimulator transport system to move the belt relative to the support member such that the belt turns the pacing electrode of the biostimulator into the target tissue. Ward discloses a similar leadless biostimulator implantation system with a drive mechanism (see control member 211 and inner assembly 220; Fig. 5A and par. 21) to move the belt (see pull wire 224) relative to the support member (see tube 230) such that the belt turns the pacing electrode of the biostimulator into the target tissue (see par. 22 and 27). It would have been obvious to one of ordinary skill in the art at the time of the invention to use Ward’s drive mechanism to drive the electrode into the tissue because Ward teaches the controlled articulation via the drive mechanism allows the electrode toward the implant site with increased maneuverability (see par. 27 and 31).
Regarding Claim 18, Soltis discloses when the biostimulator is within the sleeve, an electrode axis of the pacing electrode extends in a same direction as a housing axis of a housing of the biostimulator (see Fig. 2).
Regarding Claim 20, Soltis discloses cutting the belt to release the biostimulator (see par. 65).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soltis et al. (PG Pub. 2018/0178006) in view of Wood et al. (PG Pub. 2017/0340316).
Regarding Claims 9-10, see rejection of Claim 8 above. Soltis does not specify a rough or tacky surface. Wood discloses a similar leadless stimulator positioning system where tacky material is added to the “loop” (see par. 26). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the loop rough or tacky because it is well known that doing so increases the friction at the interface which, in turn, increases the ability to grip as evidenced by Wood (see par. 26).
Claim 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soltis et al. (PG Pub. 2018/0178006) in view of in view of Ward et al. (PG Pub. 2015/0094735) as applied to Claim 17 above, and further in view of Eggen et al. (PG Pub. 2016/0310723).
Regarding Claim 19, Soltis and Ward do not disclose an electrode direction different from the axis of the housing of the biostimulator when the biostimulator is exposed from the sleeve. Eggen discloses when the biostimulator is exposed from the sleeve, an electrode axis of the pacing electrode extends in a different direction than a housing axis of a housing of the biostimulator (see Fig. 9B). It would have been obvious to one of ordinary skill in the art at the time of the invention to allow the electrode to face in a different direction relative to the housing because Eggen teaches it helps facilitate positioning of the electrode at a target pacing site relative to the housing (see par. 37).
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.
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/N.P/Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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