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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/10/2026 has been entered.
Response to Arguments
Applicant’s arguments, see pg. 6, filed 04/10/2026, with respect to the 35 USC 102(a)(1) rejection of claims 1, 3-5, 8, 11, 13-14 have been fully considered and are persuasive. The 35 USC 102(a)(1) rejection of claims 1, 3-5, 8, 11, 13-14 has been withdrawn. Since independent claims 1, 11, 17 are amended to include new limitations, new grounds for rejection are warranted for independent claims 1, 11, and 17 and dependent claims. See prior art rejections below.
Applicant’s arguments, see pg. 7-9, filed 04/10/2026, with respect to the 35 USC 103 rejection, have been fully considered but they are not persuasive.
The amendment to independent claims 1, 11, and 17 to include the limitations: “a belt having a plurality of legs” and “a drive mechanism coupled to the belt to cause the plurality of legs to slide along the side of the support member” (and associated method limitation in claim 17), do not overcome the prior art of record.
Soltis discloses in Fig. 8, [0099] that “The tether 414 may be assembled with the implantable device 10 and the delivery device 400 such that a portion of the tether 414a passes through the first lumen 410a of the bifurcated portion of the lumen 408 and a second portion of the tether 414b passes through the second lumen 410b of the bifurcated portion of the lumen 408.” The first portion of the tether (414a) corresponds to one leg, and the second portion of the tether (414b) corresponds to the second leg. Therefore, this reads on the amendment to independent claims 1, 11, and 17 to include the limitation: “a belt having a plurality of legs”.
Ward discloses in Fig. 5A, [0022] that “movement of first control member 211, per arrow A, actuates pull wire 224 to bend inner assembly 220 and deployment tube 230”. The first control member of Ward corresponds to the drive mechanism, the inner assembly of Ward corresponds to the support member, and the pull wire of Ward corresponds to the belt.
Ward additionally discloses in Fig. 3B, [0028] that “FIG. 3B further illustrates inner assembly 220 including a multi-lumen tube 320 to which distal member 222 is coupled (FIG. 2B), according to some embodiments… According to the illustrated embodiment, multi-lumen tube 320 includes one, relatively large lumen 321, and three, relatively small lumens 322-324, wherein pull wire 224 extends within lumen 324”. See Fig. 3B (annotations added) below.
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Ward discloses the inner assembly 220 includes a lumen 324 wherein a pull wire 224 extends. It is the Examiner’s interpretation that actuation of pull wire 224 (as disclosed in [0022], Fig. 5A of Ward) would necessarily cause the pull wire to slide along the side of the lumen 324, therefore the side of the inner assembly. Therefore, this reads on the amendment to independent claims 1, 11, and 17 to include the limitation: “a drive mechanism coupled to the belt to cause the plurality of legs to slide along the side of the support member”.
Applicant maintains the same arguments in dependent claims 2, 6-7, 9-10, 12, 15, and 17-20. Applicant is referred to the above discussion of Soltis in view of Ward for independent claims 1, 11, and 17. See new grounds of rejections below.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-8, 11, 13-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Soltis et al. (US Pre-Grant Publication 2018/0178006), hereinafter ‘Soltis’, in view of Ward et al. (US Pre-Grant Publication 2015/0094735), hereinafter ‘Ward’.
Regarding claim 1, Soltis teaches a biostimulator transport system (Fig. 1), comprising:
a sleeve (inner tubular member 402, Fig. 8) having a sleeve lumen (lumen 408, Fig. 8) ([0097]);
a support member (wall 412, Fig. 8) extending through the sleeve lumen to a distal member end (distal end region 404, Fig. 8) ([0097]); and
a belt (tether 414, Fig. 8) having a plurality of legs (tether portions 414a/b, Fig. 8) 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 ([0099]).
Soltis teaches an actuation mechanism 122 with an external rotatable member 124 to threadingly engage an internal member (see [0076], Fig. 4), but does not specifically teach a drive mechanism coupled to the belt to cause the plurality of legs to slide along the side of the support member.
Ward teaches a medical tool configured to facilitate deployment of implantable medical devices (Fig. 2A, [0002]), further comprising:
a drive mechanism (control member 211, Fig. 5A) coupled to the belt (pull wire 224, Fig. 3B) to cause the plurality of legs to slide along the side of the support member (inner assembly 220, Figs. 5A, 3B) (see [0022], [0028], Figs. 5A, 3B).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Soltis to incorporate the teachings of Ward to include a drive mechanism coupled to the belt to cause the plurality of legs to slide along the side of the support member. Doing so would allow for the deployment of the device, as recognized by Ward [0022].
Regarding claim 11, see rejection of similarly worded claim 1 above. Soltis further discloses a biostimulator system, comprising: a biostimulator (implantable device 10, Fig. 1) including a pacing electrode (first/second electrodes 20, 22, Fig. 1) electrically connected to pacing circuitry ([0061], pulse generator with electrical circuitry) contained within a housing (housing 12, Fig. 1) of the biostimulator. Soltis further discloses wherein a portion of the biostimulator between the pacing electrode and the housing extends through the loop (tether retention structure 36, Fig. 8, [0063]).
Regarding claims 3 and 13, Soltis and Ward teach the device/system of claims 1/11. Soltis teaches the device/system further comprising:
wherein the distal member end has a socket (funnel 406, Fig. 8) to receive a portion of a biostimulator ([0096]).
Regarding claim 4, Soltis and Ward teach the device of claim 1. Soltis teaches the device further comprising:
wherein the support member has a lubricious surface ([0081], lubricious liner such as PTFE).
Regarding claims 5 and 14, Soltis and Ward teach the device/system of claims 1/11. Soltis teaches the device/system further comprising:
wherein the side of the support member includes a lateral surface having a track (first and second lumens 410a/b, Fig. 8), and wherein the belt extends longitudinally through the track ([0097]).
Regarding claims 6 and 15, Soltis and Ward teach the device/system of claims 5/14. Soltis teaches the device/system further comprising:
a handle (handle assembly 120, Fig. 4, [0067]) coupled to the support member and the belt.
Soltis does not specifically teach that the handle includes a drive mechanism to drive the belt through the track.
Ward teaches a medical tool configured to facilitate deployment of implantable medical devices (Fig. 2A, [0002]), further comprising:
wherein the handle (handle assembly 210, Fig. 5A) includes the drive mechanism (control member 211, Fig. 5A) to drive the belt through the track ([0022]).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Soltis to incorporate the teachings of Ward to include a drive mechanism to drive the belt through the track. Doing so would facilitate maneuverability of the tool, as recognized by Ward [0027].
Regarding claim 7, Soltis and Ward teach the device of claim 1. Ward teaches the device further comprising:
wherein the drive mechanism includes a knob (control member 211, Fig. 5A), and wherein rotation of the knob causes the belt to slide in the track ([0022]).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Soltis to incorporate the teachings of Ward to include a knob that rotates to cause the belt to slide in the track. Doing so would allow for the operator to navigate/articulate the tool to deploy the device, as recognized by Ward [0038].
Regarding claims 8 and 16, Soltis and Ward teach the device/system of claims 1/11. Soltis teaches the device/system further comprising:
wherein the loop has a gripping surface facing the distal member end (tether retention structure 36, Fig. 8, [0063]). It is the Examiner’s interpretation that the loop grips retention structure and therefore has a gripping surface.
Regarding claim 17, see rejections of similarly worded claims 1 and 11 above. Soltis further discloses advancing a biostimulator transport system to a target tissue ([0064], advanced through vasculature to target region) and retracting the sleeve of the biostimulator transport system to expose the biostimulator and direct a pacing electrode (first electrode 20, Fig. 2) of the biostimulator toward the target tissue ([0072], inner tubular member used to push device out/anchor in target region). Soltis further discloses that the belt turns the pacing electrode of the biostimulator into the target tissue ([0073-0074], actuation of the device).
Regarding claim 18, Soltis and Ward teach the method of claim 17. Soltis teaches the method further comprising:
wherein, 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 (Fig. 2).
Regarding claim 20, Soltis and Ward teach the method of claim 17. Soltis teaches the method further comprising:
cutting the belt to release the biostimulator ([0065], cutting the loop for final delivery of device).
Claims 2, 12, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Soltis et al. (US Pre-Grant Publication 2018/0178006) in view of Ward et al. (US Pre-Grant Publication 2015/0094735), further in view of Eggen et al. (US Pre-Grant Publication 2016/0310723), hereinafter ‘Eggen’.
Regarding claims 2 and 12, Soltis and Ward teach the device/system of claims 1/11, but do not specifically teach that the sleeve is longitudinally moveable relative to the support member.
Eggen teaches an implantable pacemaker system (abstract), further comprising:
wherein the sleeve (advancement tool 518, Fig. 9A/B) is longitudinally moveable relative to the support member (inner steering tool 504, Fig. 9A/B) ([0070], inner steering tool follows contour of advancement tool).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Soltis and Ward to incorporate the teachings of Eggen to include a longitudinally moveable relative to the support member sleeve. Doing so would allow for a retractable sleeve to expose the loop to position the device, as recognized by Eggen [0070].
Regarding claim 19, Soltis and Ward teach the method of claim 17, but do not explicitly teach an electrode axis extending in a different direction than a housing axis when the biostimulator is exposed from the sleeve.
Eggen teaches an implantable pacemaker system (abstract), further comprising:
wherein, 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 (Fig. 9B).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Soltis and Ward to incorporate the teachings of Eggen to include an electrode axis extending in a different direction than a housing axis when the biostimulator is exposed from the sleeve. Doing so would allow for positioning of the electrode at different angles and distances, as recognized by Eggen [0037].
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Soltis et al. (US Pre-Grant Publication 2018/0178006) in view of Ward et al. (US Pre-Grant Publication 2015/0094735), further in view of Wood et al. (US Pre-Grant Publication 2017/0340316), hereinafter ‘Wood’.
Regarding claim 9, Soltis and Ward teach the device of claim 8, but do not specifically teach that the gripping surface is a rough surface.
Wood teaches a stimulator positioning system (Fig. 4), further comprising:
wherein the gripping surface includes a rough surface ([0026], friction fit).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Soltis and Ward to incorporate the teachings of Wood to include a rough gripping surface. Doing so would allow for components to lock by increasing friction, as recognized by Eggen [0026].
Regarding claim 10, Soltis and Ward teach the device of claim 8, but do not specifically teach that the gripping surface is a tacky surface.
Wood teaches a stimulator positioning system (Fig. 4), further comprising:
wherein the gripping surface includes a tacky surface ([0026], tacky material).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Soltis and Ward to incorporate the teachings of Wood to include a tacky gripping surface. Doing so would allow for components to lock by increasing friction, as recognized by Eggen [0026].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Regnier et al. (US Pre-Grant Publication 2020/0360664) teaches a tool for positioning a device at an implantation site ([0002]). See Fig. 6, [0088].
Hilukka et al. (US Pre-Grant Publication 2018/0280703) teaches a delivery system for a leadless pacemaker (abstract). See Fig. 5B, [0096].
Tegg (US Pre-Grant Publication 2012/0029334) teaches a mechanism for directional deflection of a catheter shaft (abstract). See Fig. 32.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH L OKONAK whose telephone number is (571)272-1594. The examiner can normally be reached Monday-Friday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.L.O./Examiner, Art Unit 3792
/SHIRLEY X JIAN/Primary Examiner, Art Unit 3792
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