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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/9/2026 has been entered.
Acknowledgment
Claims 1, 14, 16, 18 are amended and filed on 2/9/2026
Claims 22-24 is newly added.
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) 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clark et al. (WO-2021011551-A1) (“Clark”).
Re claim 14, Clark discloses an elongated medical device (EMD) drive system (Figs. 1-36, Fig.1 discloses overall of the device and Fig, 25 discloses a drive module see ¶0110), comprising: a robotic drive (24, ¶0110) having a robotic drive longitudinal axis (axis of 76, Fig. 3), the robotic drive having a housing (housing of 24, ¶0081) including a bottom surface being closest to a patient in a robotic drive in-use position (lower surface of 24, Fig. 1-3); a drive module movable along the robotic drive longitudinal axis (68a-d in Fig. 3 id 310 in Fig. 25, ¶0094), the drive module extending from the robotic drive with a bracket (78a-d, Fig. 1-3, ¶0093) defining a drive plane extending along the robotic drive longitudinal axis (right side of 62a-d, Fig. 3), and the bracket extending perpendicular to the bottom surface (Fig. 3), wherein the drive module extends solely from one side of the drive plane (Fig. 3), and the drive module includes a drive module housing (cases 68 a-d, ¶0094 and the housing of 310), a motor (¶0110, a motor under 314) and a drive train (belt, ¶0110) operationally coupling the motor to an EMD within the drive module (¶0110, ¶0112), the motor and the drive train arranged in the drive module housing (¶0110); and a sterile barrier (¶0095, such as a drape that cover 24) removably attached to the bottom surface of the robotic drive on a second side of the drive plane opposite the one side of the drive plane (Fig. 3, ¶0095).
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) 1, 4-6, 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark et al. (WO-2021011551-A1) (“Clark”) in view of Plicchi et al. (US 20040254566A1) (“Plicchi”).
Re claim 1, Clark discloses an elongated medical device (EMD) drive system (Figs. 1-36, Fig.1 discloses overall of the device and Fig, 25 discloses a drive module see ¶0110), comprising: a robotic drive (24, ¶0110) having a robotic drive longitudinal axis ( axis of 76, Fig. 3); a device module movable along the robotic drive longitudinal axis (68a-d in Fig. 3 id 310 in Fig. 25, ¶0094), the device module including a housing (cases 68 a-d, ¶0094 and the housing of 310) and a motor arranged in the housing (¶0110, a motor under 314), and a drive train (belt, ¶0110) arranged in the housing (¶110), the drive train coupling the motor shaft to a driven member (314) configured to rotate an elongated medical device about an EMD longitudinal axis (¶0110), but it fails to discloses that the motor having a motor shaft with a motor longitudinal axis substantially parallel to the robotic drive longitudinal axis, wherein a length of the motor, including the motor shaft, along the motor longitudinal axis is less than a length of the housing along the robotic drive longitudinal axis.
However, Plicchi discloses a medical device manipulated system ( Fig. 1-2) and wherein the motor (17, ¶0027) comprising a shaft ( shaft of 17) along a motor longitudinal axis ( motor rotational axis, Fig. 2) is substantially parallel to the robotic drive longitudinal axis (axis on the catheter C, Fig. 2) and wherein the length of the motor, including the motor shaft, along the motor longitudinal axis is less than a length of the housing along the robotic drive longitudinal axis ( length of 17 is less than the length of the housing 1taken along the axis of the motor).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the motor of Clark so that the motor having a motor shaft with a motor longitudinal axis substantially parallel to the robotic drive longitudinal axis, wherein a length of the motor, including the motor shaft, along the motor longitudinal axis is less than a length of the housing along the robotic drive longitudinal axis as taught by Plicchi for the purpose of using specific motor orientation with specific train/ gears to generate a specific angular position or specific speed (Plicchi, ¶0027).
Re claim 4, Clark discloses a stage member (78a-d, Fig.3) extending from the robotic drive (Fig, 3), the stage member capable to move the device module along the robotic drive longitudinal axis (¶0093), the device module extending solely from a first side of the stage member (right or bottom side of 78a-d).
Re claim 5, Blacker fails to disclose wherein the drive train includes a worn gear and a worn wheel.
However, Plicchi discloses a medical device manipulated system ( Fig. 1-7) and wherein the drive train (1, 62, Fig. 7) includes a worn gear (168) and a worn wheel (70).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the drive train of Blacker so that the drive train includes a worn gear and a worn wheel. as taught by Plicchi for Plicchi for the purpose of using specific motor orientation with specific train/ gears to generate a specific angular position or specific speed (Plicchi, ¶0027).
Re claim 6, Clark fails to disclose fails to disclose wherein the drive train includes an intermediate shaft being parallel to the motor shaft, the worm gear being rotated by the intermediate shaft and the worm gear being intermediate a proximal end of the motor and a distal end of the motor.
However, Plicchi discloses a medical device manipulated system (Fig. 1-7) and wherein the motor (17, 33, 027) and a drive train (23) includes an intermediate shaft (29) being parallel to the motor shaft (17), the worm gear (168) being rotated by the intermediate shaft (68) and the worm gear (168) being intermediate a proximal end of the motor (lower end of 17. Fig. 3) and a distal end of the motor (top end of 33, Fig. 6).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the drive train of Blacker so that the drive train includes an intermediate shaft being parallel to the motor shaft, the worm gear being rotated by the intermediate shaft and the worm gear being intermediate a proximal end of the motor and a distal end of the motor as taught by Plicchi for Plicchi for the purpose of using specific motor orientation with specific train/ gears to generate a specific angular position or specific speed (Plicchi, ¶0027).
Re claim 22, Clark discloses wherein the robotic drive is mounted at an end of a robotic arm (22, Fig. 1), and wherein, the robotic arm is configured to attach to a patient table (18, ¶0081).
Re claim 23, Clark discloses wherein the motor and drive train are disposed entirely in the housing (Fig. 3) and the driven member (314) is disposed at least partially in the housing (Fig. 25).
Re claim 24, Clark discloses wherein the robotic drive includes a bracket (78a-d) extending perpendicular to a bottom surface of the robotic drive (60, Fig. 3); and the device module is mounted to a proximal side of the bracket (Fig. 3).
Claim(s) 3, 7-10, 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark in view of Plicchi and further in view of Blacker (US, 20170348060A1).
Re claim 3, Clark fails to disclose wherein the drive train includes a drive gear rotating about an axis perpendicular to the motor longitudinal axis of the motor shaft , the drive gear removably engaged with the driven member.
However, Blacker discloses the drive train (Fig, 5) includes a drive gear (424 of Blacker) rotating about an axis perpendicular to the motor longitudinal axis of the motor shaft (axis of 428), the drive gear removably engaged with the driven member (402 can be removably engaged with 424, ¶0028).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the train of Blacker so that the drive train includes a drive gear rotating about an axis perpendicular to the motor longitudinal axis of the motor shaft, the drive gear removably engaged with the driven member.as taught by Blacker for the purpose of using a desired transmission elements for conveying the motor rotation to the right orientation (Blacker, ¶0028).
Re claim 7, Clark discloses a collet (¶0112) removably received within the device module (Fig. 25, can be removed) between a collet in-use position (¶0112, Fig. 25, 314 is engaged with 327) and a collet external position (314 and 327 are non- engaging, ¶0112), the collet being manually adjustable in the collet in-use position between a first fixed position (Fig, 25 is engaged the collet, but the collet is not engaged with the guidewire) affixing an EMD thereto and a second unfixed position in which the EMD is not affixed thereto (¶0112 when the collet is releasing the guidewire).
Re claim 8, Clark discloses wherein the drive train is capable to rotate the collet about a collet longitudinal axis (¶0112), the drive train is capable to rotate the EMD when the EMD is fixed to the collet (¶0112).
Re claim 9, Clark discloses wherein the device module includes a drive module 68a-d, ¶0094) and a cassette (66a-d, Fig. 3, and 318 in Fig. 25, ¶0094) removably coupled to the drive module (Fig. 3, ¶0094), the drive module includes the housing (housing of 68a-d, 310 in Fig. 25) which supports the motor and the drive gear (¶0110, as indicated in claim 1), and the cassette includes the driven member and configured to removably receive the collet and the EMD (Fig. 25, ¶0112).
Re claim 10, Clark discloses wherein the collet includes a first portion operatively connected to the drive train (327, an right portion of 326, ¶0112) and a second portion ( left portion that can be rotated ) movable by a user with respect to the first portion to fix and unfix the EMD to the collet, wherein the second portion is proximal to the first portion when the collet is in an in-use position ( in order to engage the wire 324, ¶0112).
Re claim 12, Clark discloses wherein the drive train is configured to rotate the collet (326, ¶0112) about a longitudinal axis of the collet ( ¶0112), and to rotate the EMD when the EMD is fixed to the collet (¶0112).
Re claim 13, Clark discloses wherein the collet includes a gear (327) operationally engaged with the driven member (314) and a proximal portion is configured to be manipulated by a user when the collet is in the collet in-use position (, ¶0110, ¶0112).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark in view of Plicchi and Blacker evidenced by https://www.wmberg.com/resources/blogs/guide-to-worm-gear-drive.
Re claim 11, Clark fails to discloses wherein the drive train prevents back drive in response to a force applied to the collet to adjust the collet between the first fixed position and the second unfixed position.
However, Plicchi discloses a medical device manipulated system ( Fig. 1-7) and wherein the motor (17, 33, ¶0027) and a drive train (29) includes an intermediate shaft (29) being parallel to the motor shaft (17), the worm gear (229) being rotated by the intermediate shaft (¶0029) and the worm gear (229) being intermediate a proximal end of the motor ( lower end of 17. Fig. 3) and a distal end of the motor ( top end of 33) and the worm gear prevent to rotate back due to a force or torque applied to rotate of a wheel gear or drive train gear which mean if a force applied to rotate 229 will not rotate 32. This is special feature of the worm gear evidence by https://www.wmberg.com/resources/blogs/guide-to-worm-gear-drive see annotated Fig. 1 of https://www.wmberg.com/resources/blogs/guide-to-worm-gear-drive).
PNG
media_image1.png
265
752
media_image1.png
Greyscale
Annotated Fig. 1 of https://www.wmberg.com/resources/blogs/guide-to-worm-gear-drive
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the drive train of Clark so that the drive train prevents back drive in response to a force applied to the collet to adjust the collet between the first fixed position and the second unfixed position as taught by Plicchi for the purpose of using gear box with gear to generate a specific angular position or specific speed (Plicchi, ¶0027).
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark in view of Laby et al. (US 20180311473A1) (“Laby”).
Re claim 15, Clark fails to disclose wherein the motor comprises a drive shaft that has a longitudinal axis that is parallel with the drive plane.
However, Laby discloses a medical device manipulated system ( Fig. 1, Fig. 31a-33b) and wherein the robotic drive (506) has a longitudinal axis (510) and wherein the motor (590, Fig. 33a) comprises a shaft have a longitudinal axis ( shaft that connected to the worm gear 594, ¶0107) that is substantially parallel to the drive plane (510).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the motor of Clark so that the motor comprises a drive shaft that has a longitudinal axis that is parallel with the drive plane as taught by Laby for the purpose of using an art motor for maintaining rotational and lateral alignment of the drive and medical device axis (Laby, ¶0106).
Re claim 16, Clark discloses further including a cassette (66a-d, ¶0095, Fig. 3) removably attached to the drive module (Fig. 3, ¶0094 and 316 in Fig. 25, ¶0110), and a collet (326, ¶0112) removably received within the cassette between a collet external position (disengaged with 314, ¶0112) and a collet in-use position (as the 326 is engaged with 314. ¶0112), a portion of the collet being operatively connected to the drive train (327, Fig.3, ¶0112).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark in view of Laby et al. (US 20180311473A1) (“Laby”) evidenced by https://www.wmberg.com/resources/blogs/guide-to-worm-gear-drive.
Re claim 17, Clark fails to disclose wherein the drive train includes a worm gear preventing back drive of the drive train when the collet is manually adjustable in the collet in-use position between a first fixed position affixing the EMD to the collet and a second unfixed position in which the EMD is not affixed to the collet.
However, Laby discloses a medical device manipulated system ( Fig. 1, Fig. 31a-33b) and wherein the robotic drive (506) has a longitudinal axis (510) and wherein the motor (590, Fig. 33a) comprises a shaft ( shaft that connected to the worm gear 594, ¶0107) the drive train includes a worm gear (the worm gear 594, ¶0107) preventing back drive of the drive train when a force is applied to the drive train from an EMD (the worm gear prevent to rotate due to a force or torque applied to rotate of a wheel gear or drive train gear which mean if a force applied to rotate 598 will not rotate 594. This is special feature of the worm gear evidence by https://www.wmberg.com/resources/blogs/guide-to-worm-gear-drive see annotated Fig. 1 of https://www.wmberg.com/resources/blogs/guide-to-worm-gear-drive).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the motor of Clark so that the drive train includes a worm gear preventing back drive of the drive train when the collet is manually adjustable in the collet in-use position between a first fixed position affixing the EMD to the collet and a second unfixed position in which the EMD is not affixed to the collet as taught by Laby for the purpose of using an art motor for maintaining rotational and lateral alignment of the drive and medical device axis (Laby, ¶0106).
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blacker in view of Laby et al. (US. 20180311473A1) (“Laby”) evidenced by https://www.wmberg.com/resources/blogs/guide-to-worm-gear-drive.
Re claim 18, Clark discloses an elongated medical device (EMD) drive system (Figs. 1-36, Fig.1 discloses overall of the device and Fig, 25 discloses a drive module see ¶0110) comprising: a robotic drive (24, ¶0110) having a robotic drive longitudinal axis ( axis of 76, Fig. 3); a device module movable along the robotic drive longitudinal axis (68a-d in Fig. 3 id 310 in Fig. 25, ¶0094), the device module including a housing (cases 68a-d, ¶0094) and a motor having a motor shaft (a motor with rotary shaft, ¶0110), the motor arranged in the housing (¶0110); and a drive train arranged in the housing (belt, ¶0110), the drive train coupling the motor shaft to a driven member (314, ¶0110) configured to rotate an elongated medical device about an EMD longitudinal axis (¶0110. ¶112), but it fails to disclose that the drive train including a worm gear preventing back drive of the drive train when a force is applied to the drive train from an EMD.
However, Laby discloses a medical device manipulated system ( Fig. 1, Fig. 31a-33b) and wherein the robotic drive (506) has a longitudinal axis (510) and wherein the motor (590, Fig. 33a) comprises a shaft ( shaft that connected to the worm gear 594, ¶0107) the drive train includes a worm gear (the worm gear 594, ¶0107) preventing back drive of the drive train when a force is applied to the drive train from an EMD (the worm gear prevent to rotate due to a force or torque applied to rotate of a wheel gear or drive train gear which mean if a force applied to rotate 598 will not rotate 594. This is special feature of the worm gear evidence by https://www.wmberg.com/resources/blogs/guide-to-worm-gear-drive see annotated Fig. 1 of https://www.wmberg.com/resources/blogs/guide-to-worm-gear-drive).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the motor of Clark so that the drive train includes a worm gear and a worm wheel as taught by Laby for the purpose of using an art motor for maintaining rotational and lateral alignment of the drive and medical device axis (Laby, ¶0106).
Re claim 19, Clark fails to discloses wherein a motor longitudinal axis of the motor shaft is parallel to the robotic drive longitudinal axis.
However, Laby discloses a medical device manipulated system ( Fig. 1, Fig. 31a-33b) and wherein the robotic drive (506) has a longitudinal axis (510) and wherein the motor (590, Fig. 33a) comprises a shaft ( shaft that connected to the worm gear 594, ¶0107) being substantially parallel to the robotic drive longitudinal axis (510).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the motor of Clark so that the longitudinal axis of the motor shaft is parallel to the robotic drive longitudinal axis as taught by Laby for the purpose of using an art motor for maintaining rotational and lateral alignment of the drive and medical device axis (Laby, ¶0106).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark in view of Laby evidenced by https://www.wmberg.com/resources/blogs/guide-to-worm-gear-drive and further in view of Plicchi et al. (US 20040254566A1) (“Plicchi”).
Re claim 20, Clark fails to disclose wherein the drive train includes an intermediate shaft extending parallel to the motor shaft, wherein the driven member is configured to rotate about an axis spaced a part from and perpendicular to the motor longitudinal axis and a longitudinal axis of the intermediate shaft; and wherein the worm gear is positioned on the intermediate shaft.
However, Plicchi discloses a medical device manipulated system ( Fig. 1-7) and wherein the motor (17, 33, ¶0027) and a drive train (23) includes an intermediate shaft (29) extending parallel to the motor shaft (17), the worm gear (229) being positioned on the intermediate shaft, the driven member (126) rotating about an axis spaced from and perpendicular to the motor longitudinal axis (axis of 17) and a longitudinal axis of the intermediate shaft (axis of 29); and wherein the worm gear is positioned on the intermediate shaft (Fig. 3-4).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the drive train of Clark so that the drive train includes an intermediate shaft extending parallel to the motor shaft, wherein the driven member is configured to rotate about an axis spaced a part from and perpendicular to the motor longitudinal axis and a longitudinal axis of the intermediate shaft; and wherein the worm gear is positioned on the intermediate shaft as taught by Plicchi for the purpose of using gear box with gear to generate a specific angular position or specific speed (Plicchi, ¶0027).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark in view of Plicchi and further in view of Weitzner et al. (US 20090105639 A1) (“Weitzner”)
Re claim 21, Blacker discloses that the robotic drive has a liner mechanism (418, ¶0028), but it fails to disclose the robotic drive comprises a screw drive.
However, Weitzner discloses a medical device manipulated system ( Fig. 1-7) and wherein the robotic drive (202, 214, 215, ¶0037) includes screw drive (214, ¶0037).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the robotic drive of Clark so that the robotic drive comprises a screw drive.as taught by Weitzner for the purpose of using art recognized automatic linear mechanism that drive the housing forward and backward (Weitzner, ¶0037).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 14, 19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights