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 Amendment
This Office Action is in response to the Amendment filed 01/12/2026. As directed by the Amendment, claims 1 and 8 are amended. Claims 1-8 are pending in the Application.
Response to Arguments
Applicant’s arguments, see Remarks, filed 01/12/2026, with respect to the rejections of claims 1-8 under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Kim et al. (KR 20190079223 A).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 8 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 8, as amended, recites the limitation “the first drive unit further comprising a first endovascular insertion device advance assembly mount region having a first surface side and an opposed second surface side, the first endovascular insertion device advance assembly mountable to the first surface side, the first pinion motor spaced from the second mounting surface side wherein the second surface side is disposed between the pinion and the first surface side, and the slider is interposed between the second surface side and the pinion.” These limitations do not appear to be described by the specification as originally filed, nor has Applicant pointed out where such support for the amendment exists. In particular, the specification appears to lack any relationship between the pinion, slider, and the rest of the advance assembly with the newly recited first endovascular insertion device advance assembly mount region and its two surface sides. Figures 9A and 9B involve the pinion, slider, and an element disclosed as a mounting plate 822. However, there is no description or explanation of a first endovascular insertion device advance assembly mount region and its relationship with the pinion and slider of the claimed invention such that one skilled in the art would reasonably understand that the inventor had possession of the invention as now claimed.
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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Canale et al. (WO 2021011554 A1 – Cited by Applicant), hereinafter Canale, in view of Kim et al. (JP2020526237A – Cited by Applicant), hereinafter Kim, further in view of Kim et al. (KR 20190079223 A), hereinafter ‘223.
Regarding claim 1, Canale discloses a system for an endovascular procedure [treatment system 10, see in ¶ 0168], the system comprising:
a first drive unit [device module 32a, see in Fig. 3 and ¶ 0168] comprising a first drive assembly [drive module 68a, see in ¶ 0175], the first drive assembly comprising a first rotational actuator [independent stage translation motor 64a, see in ¶ 0168], the first drive assembly being configured to be mechanically coupled to a first endovascular insertion device advance assembly [stage 62a, see in ¶ 0168] of a first cassette [cassette 66a, see in ¶ 0169];
a second drive unit [device module 32b, see in Fig. 3 and ¶ 0168] comprising a second drive assembly [drive module 68b, see in ¶ 0175], the second drive assembly comprising a second rotational actuator [independent stage translation motor 64b, see in ¶ 0168], the second drive assembly being configured to be mechanically coupled to a second endovascular insertion device advance assembly [stage 62b, see in ¶ 0168] of a second cassette [cassette 66b, see in ¶ 0169];
a third drive unit [device module 32c, see in Fig. 3 and ¶ 0168] comprising a third drive assembly [drive module 68c, see in ¶ 0175], the third drive assembly comprising a third rotational actuator [independent stage translation motor 64c, see in ¶ 0168], the third drive assembly being configured to be mechanically coupled to a third endovascular insertion device advance assembly [stage 62c, see in ¶ 0168] of a third cassette [cassette 66c, see in ¶ 0169]; and
a track [linear member 60, see in Fig. 3], the first drive unit, the second drive unit, and the third drive unit each being mechanically coupled to the track, the second drive unit being disposed between the first drive unit and the third drive unit along the track, the second drive unit and the third drive unit being mechanically coupled to and moveable along the track [see in Fig. 3 and ¶ 0168].
Canale fails to disclose that the first drive unit being mechanically coupled in a fixed position relative to the track.
However, Kim discloses that the first drive unit being mechanically coupled in a fixed position relative to the track [with the sheath driver 62 fixedly connected to a robotic controller base 60, see in ¶ 0010].
Canale and Kim are both analogous to the claimed invention because they are in the same field of robotic guidewire and catheter systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Canale to incorporate the teachings of Kim to include the first drive unit being mechanically coupled in a fixed position relative to the track to allow for more controlled and precise guidewire and sheath movement [see in Kim, ¶ 0010].
Canale, as modified by Kim above, still fails to disclose the track further comprising a fixed rack and a guide, the guide comprising a first groove and a second groove; the first drive unit further comprising a first pinion drive motor, a pinion and a slider; the pinion engageable with the rack, and the slider engages the first groove and second groove of the guide.
However, ‘223 discloses a track comprising a fixed rack [first rack gear 3411 in Fig. on pg. 19 and ¶ 0075] and a guide [first rail 3610, see in ¶ 0078 and Fig. on pg. 19], the guide comprising a first groove and a second groove [one groove of 3610 seen in Fig. on pg. 19, other groove of 3610 see in Fig. on pg. 18]; the first drive unit further comprising a first pinion drive motor, a pinion, and a slider [A first front drive unit of the plurality of front drive units includes a first drive motor, a first pinion gear unit coupled to the first drive motor and rotating together … first slider, see in ¶ 0028]; the pinion engageable with the rack [the first rack gear 3411 engaged with the first pinion gear 3710, see in ¶ 0080 and Fig. on pg. 19], and the slider engages the first groove and second groove of the guide [3510 and 3610 engagement in Fig. on pg. 19].
Canale and ‘223 are both analogous to the claimed invention because they are in the same field of vascular robotic controllers. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Canale to incorporate the teachings of ‘223 and include that track further comprising a fixed rack and a guide, the guide comprising a first groove and a second groove, the first drive unit further comprising a first pinion drive motor, a pinion and a slider, the pinion engageable with the rack, and the slider engages the first groove and second groove of the guide to ensure precise control and steering of the endovascular control system.
Regarding claim 2, and substantially similar limitations in claims 3 and 6, Canale, as modified, discloses the system of claim 1, wherein:
the second drive unit comprises a fourth drive assembly, the fourth drive assembly comprising a fourth rotational actuator [The drive module 68 shown in FIGs. 5 and 6 has one coupler 98, however, it should be understood that the drive module 68 may have more than one coupler 98 and more than one motor 94, as described further below, see in ¶ 0175], the fourth drive assembly being configured to be mechanically coupled to a first endovascular insertion device rotation assembly of the second cassette [cassette 111 may be configured to provide rotation … Such as cassette may be mounted to, for example, a drive module with two or more couplers, see in ¶ 0176]; and
the third drive unit comprises a fifth drive assembly, the fifth drive assembly comprising a fifth rotational actuator [The drive module 68 shown in FIGs. 5 and 6 has one coupler 98, however, it should be understood that the drive module 68 may have more than one coupler 98 and more than one motor 94, as described further below, see in ¶ 0175], the fifth drive assembly being configured to be mechanically coupled to a second endovascular insertion device rotation assembly of the third cassette [cassette 111 may be configured to provide rotation ... Such as cassette may be mounted to, for example, a drive module with two or more couplers, see in ¶ 0176].
Regarding claim 4, Canale, as modified, discloses the system of claim 1, wherein:
the first drive unit comprises a fourth drive assembly, the fourth drive assembly comprising a fourth rotational actuator [The drive module 68 shown in FIGs. 5 and 6 has one coupler 98, however, it should be understood that the drive module 68 may have more than one coupler 98 and more than one motor 94, as described further below, see in ¶ 0175], the fourth drive assembly being configured to be mechanically coupled to a first endovascular insertion device pinch assembly of the first cassette [cassette 66a, see in ¶ 0169; cassette 111 may be configured to provide rotation and to pinch and unpinch an elongated medical device 113 positioned in a channel 115. Such as cassette may be mounted to, for example, a drive module with two or more couplers, see in ¶ 0176];
the second drive unit comprises a fifth drive assembly, the fifth drive assembly comprising a fifth rotational actuator [The drive module 68 shown in FIGs. 5 and 6 has one coupler 98, however, it should be understood that the drive module 68 may have more than one coupler 98 and more than one motor 94, as described further below, see in ¶ 0175], the fifth drive assembly being configured to be mechanically coupled to a second endovascular insertion device pinch assembly of the second cassette [cassette 66b, see in ¶ 0169; cassette 111 may be configured to provide rotation and to pinch and unpinch an elongated medical device 113 positioned in a channel 115. Such as cassette may be mounted to, for example, a drive module with two or more couplers, see in ¶ 0176]; and
the third drive unit comprises a sixth drive assembly, the sixth drive assembly comprising a sixth rotational actuator [The drive module 68 shown in FIGs. 5 and 6 has one coupler 98, however, it should be understood that the drive module 68 may have more than one coupler 98 and more than one motor 94, as described further below, see in ¶ 0175], the sixth drive assembly being configured to be mechanically coupled to a third endovascular insertion device pinch assembly of the third cassette [cassette 66c, see in ¶ 0169; cassette 111 may be configured to provide rotation and to pinch and unpinch an elongated medical device 113 positioned in a channel 115. Such as cassette may be mounted to, for example, a drive module with two or more couplers, see in ¶ 0176].
Regarding claim 5, Canale, as modified, discloses the system of claim 1 further comprising a fourth drive unit [device module 32d, see in Fig. 3 and ¶ 0168] comprising a fourth drive assembly [drive module 68d, see in ¶ 0175], the fourth drive assembly comprising a fourth rotational actuator [independent stage translation motor 64d, see in ¶ 0168], the fourth drive assembly being configured to be mechanically coupled to a fourth endovascular insertion device advance assembly [stage 62d, see in ¶ 0168] of a fourth cassette [cassette 66d, see in ¶ 0169], the fourth drive unit being mechanically coupled to the track, the fourth drive unit being disposed between the second drive unit and the third drive unit along the track, the fourth drive unit being mechanically coupled to and moveable along the track [see in Fig. 3].
Regarding claim 7, Canale, as modified, discloses the system of claim 5, wherein the fourth drive unit comprises a fifth drive assembly, the fifth drive assembly comprising a fifth rotational actuator [The drive module 68 shown in FIGs. 5 and 6 has one coupler 98, however, it should be understood that the drive module 68 may have more than one coupler 98 and more than one motor 94, as described further below, see in ¶ 0175], the fifth drive assembly being configured to be mechanically coupled to an endovascular insertion device pinch assembly of the fourth cassette [cassette 66d, see in ¶ 0169; cassette 111 may be configured to provide rotation and to pinch and unpinch an elongated medical device 113 positioned in a channel 115. Such as cassette may be mounted to, for example, a drive module with two or more couplers, see in ¶ 0176].
Regarding claim 8, Canale, as modified, discloses the system of claim 1, wherein:
the second drive unit is mechanically coupled to the track by a first translation assembly [stage translation motors 64a-d, see in ¶ 0168 and Fig. 3];
the third drive unit is mechanically coupled to the track by a second translation assembly [stage translation motors 64a-d, see in ¶ 0168 and Fig. 3];
Canale fails to disclose that the first drive unit further comprising a first endovascular insertion device advance assembly mount region having a first surface side and an opposed second surface side, the first endovascular insertion device advance assembly mountable to the first surface side, the first pinion motor spaced from the second mounting surface side wherein the second surface side is disposed between the pinion and the first surface side, and the slider is interposed between the second surface side and the pinion.
However, ‘223 discloses a first endovascular insertion device advance assembly mount region having a first surface side and an opposed second surface side [mounting frames 3251 and 3253, see in ¶ 0030, ¶ 0036, and ¶ 0090; see also Fig. on pg. 18], the first endovascular insertion device advance assembly mountable to the first surface side [first surface side showing of 3251 in Fig. on pg. 18], the first pinion motor spaced from the second mounting surface side [drive motor 3110 is spaced away from downward surface of mount frame 3251, see in Fig. on pg. 19] wherein the second surface side is disposed between the pinion and the first surface side [downward surface side of 3251 in between first surface side and one of the two pinions in Fig. on pg. 19], and the slider is interposed between the second surface side and the pinion [see slider and pinion height-wise orientation in relation to 3251 in Fig. on pg. 19].
Canale and ‘223 are both analogous to the claimed invention because they are in the same field of vascular robotic controllers. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Canale to incorporate the teachings of ‘223 and include that the first drive unit further comprising a first endovascular insertion device advance assembly mount region having a first surface side and an opposed second surface side, the first endovascular insertion device advance assembly mountable to the first surface side, the first pinion motor spaced from the second mounting surface side wherein the second surface side is disposed between the pinion and the first surface side, and the slider is interposed between the second surface side and the pinion, for the purpose of keeping the system structure compact.
Conclusion
Applicant's amendment necessitated the new grounds 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 HY KHANH DOAN whose telephone number is (703)756-5434. The examiner can normally be reached Monday - Friday 8:00 a.m. - 5 p.m..
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/HY KHANH DOAN/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791
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