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 .
Election/Restrictions
During a telephone conversation with Mitchell Hadley on July 6, 2026, a provisional election was made without traverse to prosecute the invention of the product/system in claims (1-15). Affirmation of this election must be made by applicant in replying to this Office action. Claims 16-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 5-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blacker (US Publication No. 2017/0348060), hereinafter, Blacker.
Regarding claim 1, Blacker discloses a system for advancing a guidewire through a patient lumen (drive assembly 400 in figs. 4-5; para [0025-0026]), the system comprising:
a first advancement device (body 402 in figs. 4-5) configured to move between a first position and a second position a distance from the first position (linear drive mechanism 418 is then used to advance body 402, proximal pinch 404 and guide wire 412 a predetermined distance from a first position to a second position that is proximate to the distal pinch 406; para [0030]), wherein the first position is proximal to the second position (proximal pinch 404 is positioned on the first end 408 of body 402; para [0026]), the first advancement device comprising:
a first clamp (proximal pinch or grip 404 in figs. 4-5) configured to move between an open configuration and a closed configuration (proximal pinch 404 is then actuated to disengage from or release the guide wire 412 and linear drive mechanism 418 is then used to retract the body 402 and proximal pinch 404 and return to the first position; para [0026-0031]),
wherein the first clamp (proximal pinch or grip 404 in figs. 4-5) is configured to contact the guidewire when the (proximal pinch or grip 404 in figs. 4-5) first clamp is in the closed configuration (proximal pinch 404 is then actuated to disengage from or release the guide wire 412 and linear drive mechanism 418 is then used to retract the body 402 and proximal pinch 404 and return to the first position; para [0026-0031]);
a second advancement device (vertical support 416 in fig. 4) positioned between the first advancement device and an access point to the patient lumen (vertical support 416 positioned between body 402 and access point via guide wire 412 in fig. 4), the second advancement device comprising:
a second clamp (distal pinch or grip 406 in fig. 4) configured to move between an open configuration and a closed configuration (distal pinch 406 is configured to releasably engage a percutaneous interventional device such as guide wire 412; para [0026-0031]);
wherein the second clamp (distal pinch or grip 406 in fig. 4) is configured to contact the guidewire when the second clamp is in the closed configuration (distal pinch 406 may be any mechanism configured to alternately engage with and disengage from the guide wire 412, para [0026-0031]);
wherein the first advancement device is configured to move from the first position to the second position when the first clamp (proximal pinch or grip 404 in figs. 4-5) is in the closed configuration to advance the guidewire the distance through the patient lumen (proximal pinch 404 and distal pinch 406 may be any mechanism configured to alternately engage with and disengage from the guide wire 412, for example, a bi-stable mechanism or collet; para [0026-0031]).
Regarding claim 2, Blacker discloses the system of Claim 1, wherein the first advancement device (body 402 in figs. 4-5) is coupled to a rail system (linear drive mechanism 418 with linear motor 420 in figs 4-5), wherein the rail system is configured to move the first advancement device between the first position and the second position (linear drive mechanism 418 is then used to advance body 402, proximal pinch 404 and guide wire 412 a predetermined distance from a first position to a second position that is proximate to the distal pinch 406; para [0030]).
Regarding claim 3, Blacker discloses the system of Claim 1, wherein the second advancement device (distal pinch or grip 406 in fig. 4) is coupled to a microcatheter (percutaneous devices include working catheters; para [0025]), and wherein the guidewire (guide wire 412 in figs. 4-5) is inserted through the microcatheter (drive assembly 400 may be used to drive other percutaneous devices such as a guide catheter, a working catheter or other elongated medical device; para [0025]; In addition, the stroke length may also be based on how coaxial the percutaneous device is with the device into which it is being advanced (e.g., an introducer sheath or guide catheter); para [0030]).
Regarding claim 5, Blacker discloses the system of Claim 1, wherein the second clamp (distal pinch or grip 406 in fig. 4) is in the open configuration when the first advancement device moves from the first position to the second position (proximal pinch 404 and distal pinch 406 may be any mechanism configured to alternately engage with and disengage from the guide wire 412, for example, a bi-stable mechanism or collet; para [0026-0027]).
Regarding claim 6, Blacker discloses the system of Claim 5, wherein the first clamp (proximal pinch or grip 404 in figs. 4-5) is configured to move from the closed configuration to the open configuration after the first advancement device moves from the first position to the second position, and wherein the second clamp (distal pinch or grip 406 in fig. 4) is configured to move from the open configuration to the closed configuration after the first advancement device moves from the first position to the second position (after the guide wire 412 is advanced to the second position, the distal pinch 406 is actuated to engage (e.g., grip or pinch) to fix the guide wire 412; para [0026-0031]).
Regarding claim 7, Blacker discloses the system of Claim 6, wherein the first advancement device is configured to move from the second position to the first position when the first clamp (proximal pinch or grip 404 in figs. 4-5) is in the open configuration (proximal pinch 404 is then actuated to disengage from or release the guide wire 412 and linear drive mechanism 418 is then used to retract the body 402 and proximal pinch 404 and return to the first position; para [0026-0031]).
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 4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Blacker in view of Kirschenman (US Patent No. 8,317,744), hereinafter, Kirschenman.
Regarding claim 4, Blacker discloses the system of Claim 3 comprising a second advancement device (vertical support 416 in fig. 4).
Blacker fails, however, to disclose that the second advancement device is configured to move between a third position and a fourth position the distance from the third position, wherein the third position is proximal to the fourth position, and wherein second advancement device is configured to move from the third position to the fourth position to advance the microcatheter through the patient lumen.
Kirschenman teaches that a second advancement device is configured to move between a third position (Kirschenman: D1 in fig. 3a) and a fourth position (Kirschenman: D2 in fig. 3a) the distance from the third position (Kirschenman: distal cartridge 404 is connected to base 310 an is capable of travel in the longitudinal direction of the catheter/sheath between position D1 and D2 the distance from D1 in fig. 3a; col. 8, line 58 – col. 9, line 10; moves relative to catheter 406 to prevent buckling; col. 8, lines 34-38), wherein the third position is proximal to the fourth position, and wherein second advancement device is configured to move from the third position to the fourth position to advance the microcatheter through the patient lumen (Kirschenman: D1 is proximal to D2 along the longitudinal axis of catheter 406 in fig 3a; cartridge 402 and 404 control distal movement of either catheter 406 or sheath 410; col. 9, line 65 – col. 10, line 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second advancement device of Blacker to be configured to move between a third (proximal) position and fourth (distal) position the distance from the third position to advance the microcatheter, as taught by Kirschenman, in order to provide precise controlled advancement of the outer catheter while preventing buckling.
Regarding claim 8, Blacker discloses the system of Claim 1, but fails to disclose that the distance is between about 20 mm and about 60 mm.
Kirschenman teaches a distance that encompasses the range of about 20 mm and about 60 mm (Kirschenman: distance D1 to D2 may each represent a translation of approximately 8 linear inches, covering the range of 20-60 mm; col. 9, lines 4-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the advancement distance of Blacker, as modified Kirschenman in claim 4, to be between about 20 mm and about 60 mm, as taught by Kirschenman’s high-precision linear drive mechanism, in order to optimize safe incremental advancement tailored to endovascular procedures.
Claims 9-15 are rejected under 35 U.S.C. 103 as being unpatentable over Klem (US Publication No. 2022/0233264), hereinafter, Klem, in view of Tan (CN Patent No. 115120845), hereinafter, Tan.
Regarding claim 9, Klem discloses a tool advancement device comprising (robotic system 910 in figs. 12A-12F);
a housing comprising a first recess (recessed portions of cassette cover 924 and collet drive housing 926 that house double-gear collet-drive assembly 944 in fig. 12A);
a first gear (second collet coupler 960 with second driven bevel gear 952 in figs. 12B-12C) positioned in the first recess (second driven bevel gear 952 is housed in recessed portion of cassette cover 924 and double-gear collet-drive housing 926 in fig. 12A), the first gear configured to rotate in a first direction around a guidewire and a second direction around the guidewire, the second direction opposite the first direction (double-gear collet-drive assembly 944 uses two rotational degrees of freedom from motors 936 and 938 to achieve four operations, namely, to pinch Elongated Medical Device (EMD) 912, to un-pinch EMD 912, to rotate clockwise double-gear collet-drive assembly 944, and to rotate counterclockwise double-gear collet-drive assembly 944; para [0285-0286]), the first gear comprising:
a second recess (internal cavity of gear 952/wheel 956 in figs. 12C-12D);
a first collet clamp (second portion 966 in figs. 12D-12F) positioned in the second recess (internal cavity of in gear 952/wheel 956 in figs. 12C-12D), the first collet clamp configured to rotate with the first gear (second portion 966 rotates with second collet coupler 960 in fig. 12F), the first collet clamp comprising a third recess (internal cavity of second portion 966 in figs. 12D-12F),
a second gear (first compound assembly 958 with first driven bevel gear 950 in figs. 12B-12C) positioned in the first recess (first driven bevel gear 950 is housed in recessed portions of cassette cover 924 and collet drive housing 926 that house double-gear collet-drive assembly 944 in fig. 12A), the second gear configured to rotate in the first direction and the second direction (double-gear collet-drive assembly 944 uses two rotational degrees of freedom from motors 936 and 938 to achieve four operations, namely, to pinch Elongated Medical Device (EMD) 912, to un-pinch EMD 912, to rotate clockwise double-gear collet-drive assembly 944, and to rotate counterclockwise double-gear collet-drive assembly 944; para [0285-0286]);
a first input (second motor 938 in fig. 12A) configured to rotate the first gear in the first direction and the second direction (rotates second driven bevel gear 952; para [0269-0272] and [0285-0286]);
a second input (first motor 936 in fig. 12A) configured to rotate the second gear in the first direction and the second direction (rotates first driven bevel gear 950; para [0269-0272] and [0285-0286]); and
a second collet clamp (inner collet portion 965 which includes collet tapered second section 970 in figs. 12D-12F) comprising a fourth recess (recessed portion of inner collet portion 965 which includes collet tapered second section 970 in figs. 12D-12F),
wherein the second collet clamp is configured to extend into the third recess of the first collet clamp (internal cavity of second portion 966 in fig. 12F);
a collet (inner gripping side of inner collet portion 965 which includes collet tapered second section 970 with jaws 972 in figs. 12D-12F) positioned in the fourth recess (internal cavity of inner collet portion 965 in figs. 12D-12F) of the second collet clamp , the collet configured to move between an open configuration and a closed configuration, wherein the collet contact a guidewire when the collet is in the closed configuration (movement of inner collet portion 965 in the direction of screw spline 966 causes the jaws 972 of collet tapered second section 972 to move toward one another to pinch EMD 912; para [0284-0285]);
wherein the internal threading and the external threading are configured to translate the first collet clamp towards the second collet clamp to move the collet to the closed configuration when the first gear is rotated relative to the second gear in the first direction, and wherein the internal threading and the external threading are configured to translate the first collet clamp away from the second collet clamp to move the collet to the open configuration when the first gear is rotated relative to the second gear in the second direction (double-gear collet-drive assembly 944 uses two rotational degrees of freedom from motors 936 and 938 to achieve four operations, namely, to pinch Elongated Medical Device (EMD) 912, to un-pinch EMD 912, to rotate clockwise double-gear collet-drive assembly 944, and to rotate counterclockwise double-gear collet-drive assembly 944; para [0285-0286]).
Klem does not, however, explicitly disclose that the third recess comprises internal threading configured to interact with external threading on the second collet clamp.
Tan teaches an internal recess comprising internal threading and external threading configured to interact with the internal threading of the first collet clamp (Tan: first inner cavity 11a comprises internal threads that mate with the external threads of second locking member 12 in fig. 7; this is the nested inner portion that receives and interacts with chuck 132; page 5, para 8 – page 6, para 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first collet clamp of Klem to include a third recess comprising internal threading, as taught by Tan, in order to provide precise, controllable axial translation of the nested collet components upon relative gear rotation for reliable opening and closing of the grip on the guidewire.
Regarding claim 10, modified Klem discloses the tool advancement device of Claim 9, wherein the second gear (first collet coupler 958 with first driven bevel gear 950 in figs. 12B-12C) is positioned proximal to the first gear (second collet coupler 960 with second driven bevel gear 952 in figs. 12B-12C), and wherein the second collet clamp (inner collet portion 965 which includes collet tapered second section 970 in figs. 12D-12F) is positioned in a fifth recess of the second gear (internal cavity of gear 950/wheel 954 holds the proximal end of inner collet portion 965 in figs. 12C-12D).
Regarding claim 11, modified Klem discloses the tool advancement device of Claim 10, wherein when the collet is in the closed configuration, the collet is configured to rotate the guidewire when the first gear (second collet coupler 960 with second driven bevel gear 952 in figs. 12B-12C) and the second gear (first collet coupler 958 with first driven bevel gear 950 in figs. 12B-12C) are rotated in the first direction or the second direction (EMD is rotated during pinch when first coupler 940, the input shaft, is rotated clockwise; para [0286]).
Regarding claim 12, modified Klem discloses the tool advancement device of Claim 10, wherein the first gear (second collet coupler 960 with second driven bevel gear 952 in figs. 12B-12C) is rotated in the first direction and the second gear (first collet coupler 958 with first driven bevel gear 950 in figs. 12B-12C) is rotated in the second direction to rotate the first gear relative to the second gear in the first direction, and wherein the first gear is rotated in the second direction and the second gear is rotated in the first direction to rotate the first gear relative to the second gear in the second direction (double-gear collet-drive assembly 944 uses two rotational degrees of freedom from motors 936 and 938 to achieve four operations, namely, to pinch Elongated Medical Device (EMD) 912, to un-pinch EMD 912, to rotate clockwise double-gear collet-drive assembly 944, and to rotate counterclockwise double-gear collet-drive assembly 944; para [0285-0286]).
Regarding claim 13, modified Klem discloses the tool advancement device of Claim 9, wherein the second collet clamp is coupled to the housing (inner collet portion 965 is integrated with the cassette cover 924 and collet drive housing 926 in figs. 12A-12F; the entire double-gear collet-drive assembly is mounted within the housing).
Regarding claim 14, modified Klem discloses the tool advancement device of Claim 9, wherein the second gear (first collet coupler 958 with first driven bevel gear 950 in figs. 12B-12C) is positioned distal to the first gear (second compound assembly 960 with second driven bevel gear 952 in figs. 12B-12C), and wherein the second gear comprises a fifth recess (internal cavity of gear 950/wheel 954 in figs. 12C-12D), the fifth recess configured extend distally from the first recess of the housing (recessed portions of cassette cover 924 and collet drive housing 926 that house double-gear collet-drive assembly 944 in fig. 12A), wherein the fifth recess is configured to receive a microcatheter positioned over the guidewire (elongated medical device (EMD) refers to, but is not limited to, catheters (e.g., guide catheters, microcatheters, balloon/stent catheters), wire-based devices (e.g., guidewires, embolization coils, stent retrievers, etc.), and medical devices comprising any combination of these; para [0186]; inner collet portion 965 contains a radial longitudinal slit 992 in collet first section 968 to allow for side or radial loading of EMD 912 into lumen 996; para [0282]).
Regarding claim 15, modified Klem discloses the tool advancement device of Claim 14, wherein the second gear (first collet coupler 958 with first driven bevel gear 950 in figs. 12B-12C) is configured to rotate the microcatheter (EMD 912 in figs. 12A-12F) in the first direction when the second gear rotates in the first direction, and wherein the second gear is configured to rotate the microcatheter in the second direction when the second gear rotates in the second direction (double-gear collet-drive assembly 944 uses two rotational degrees of freedom from motors 936 and 938 to achieve four operations, namely, to pinch Elongated Medical Device (EMD) 912, to un-pinch EMD 912, to rotate clockwise double-gear collet-drive assembly 944, and to rotate counterclockwise double-gear collet-drive assembly 944; para [0285-0286]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARIAH K WHITROCK whose telephone number is (571) 272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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