CTNF 18/835,305 CTNF 101588 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Information Disclosure Statement The information disclosure statement (IDS) submitted on Aug. 1, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. 06-49-08 The information disclosure statement filed Jan. 15, 2026 fails to comply with 37 CFR 1.98(a)(1), which requires the following: (1) a list of all patents, publications, applications, or other information submitted for consideration by the Office; (2) U.S. patents and U.S. patent application publications listed in a section separately from citations of other documents; (3) the application number of the application in which the information disclosure statement is being submitted on each page of the list; (4) a column that provides a blank space next to each document to be considered, for the examiner’s initials; and (5) a heading that clearly indicates that the list is an information disclosure statement. The citation of US 2021/0121162 A1 reference lists an inventor name that does not appear in the publication and it is unclear if this is the correct document. The information disclosure statement has been placed in the application file, but the information referred to therein has not been considered. Drawings 06-27 AIA In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application. 06-22-03 AIA The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “ 18 ” has been used to designate both “base stage” and “insertion stage” . Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Note for claim interpretation, base and insertion stage are equivalent. 06-22-06 AIA The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: element 164 “wire guide” in ¶[0032] is not in Fig. 3 ; and element 170 “force sensors” in ¶[0037] . Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. 06-22-07 AIA The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Fig. 2 element 172 . Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Specification 06-31 AIA The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. Claim Objections 07-29-01 AIA Claim s 8 and 18 are objected to because of the following informalities: “deactivate” in the last line should be changed to -- deactivated --. Appropriate correction is required. 07-29-01 AIA Claim 13 is objected to because of the following informalities: “the drive” in line 7 should be changed to -- the driver --. Appropriate correction is required. 07-29-01 AIA Claim 17 is objected to because of the following informalities: “deactived” in line 2 should be changed to -- deactivated --. Appropriate correction is required. 07-29-01 AIA Claim s 14-21 are objected to because of the following informalities: “The control system of” in line 1 should be changed to -- The method of --. Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claims 1-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 recites “the wire” in lines 5 and 9. Previous reference to wire recites “the at least one wire” and it is unclear whether “the wire” refers to all of the at least one wires or one of the at least one wires. For the purposes of examination, “the wire” will be interpreted as “one of the at least one wires”. Claims 2-12 depend from claim 1 and are rejected for the same reasons as claim 1. Claims 9 and 19 recite the limitation "the end user’s bending command" in 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the end user’s bending command” will be interpreted as “an end user’s bending command”. Claims 10 and 20 recite the limitation "the end user" in the last line. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the end user” will be interpreted as “an end user”. Claim 13 recites the limitation "the at least one motor" in the second to last line. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the at least one motor” will be interpreted as “at least one motor”. Claims 14-21 depend from claim 13 and are rejected for the same reason as claim 13. Claims 19- 20 recite the limitation "the controller" in line 1 of claim 19 and the second to last line of claim 20. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the controller” will be interpreted as “the operational controller”. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. 07-04-03 AIA 07-04-01 Section 33(a) of the America Invents Act reads as follows: Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism. Claim 7-8 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability , 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claims 7-8 recite “wherein the end user engages a button to activate”. As such, claims 7-8 encompass the claimed device to include a human subject. Applicant is suggested to amended the claims to “wherein the robotic apparatus further comprises a button to activate” or the like . Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1-7, 9, 12-17, 19, and 21 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Kincaid et al. (US 20200375682 A1, published Dec. 3, 2020, previously cited on the IDS, hereinafter referred to as “Kincaid”) . Regarding claims 1 and 13, Kincaid teaches a method for controlling a robotic apparatus and the robotic apparatus (Fig. 1A “continuum robot system 1000” ¶[0031]) comprising: a continuum robot (Fig. 1A and 2A “the steerable instrument 100 can be a wire-driven continuum robot” ¶[0039]) including a plurality of bending sections including a distal bending section and a proximal bending section (FIG. 2A “steerable section 103 divided into a plurality of bending segments or sections 106a and 106b” ¶[0039] and “FIG. 1A shows a robotically controlled steerable instrument 100 having the steerable section 103 divided into multiple bending segments or sections (1, 2, 3 . . . N) arranged along a longitudinal axis Ax and configured to bend at least one of the steerable sections at an angle β with respect to the longitudinal axis Ax” ¶[0031]; in Fig. 1A, section 1 of element 103 would be a distal bending section and section N would be proximal) wherein each of the bending sections are bent by at least one wire (“the steerable instrument 100 is controlled with a plurality of control wires 110 which are arranged inside wire conduits 104… the steerable instrument 100 can have at least two (i.e., two or more) steerable sections controlled by 3 pairs of antagonistic control wires 110 each running through a separate conduit 104.” ¶[0036]) ; a driver that drives the wire (Fig. 1B “control system 300… an actuator system 310 can mechanically operate each control wire 310. A controller 320 is used to electronically control the operation of each control wire 110 based on the tension or torsional state of each control wire” ¶[0037]) ; and an operational console that controls a movement of the driver (Fig. 1A “The control system 300 generally includes a controller or is connected to a computer system 400” ¶[0032]) , based on an input (Fig. 1A “the control system 300 and computer system 400 can provide a surgeon or other operator with an image display 420 and a graphical user interface (GUI) 422 to interact and operate the steerable instrument 100. The handle interface 200 provides electromechanical interconnection between the steerable instrument 100 and the control system 300… The handle interface 200 may also provide an access port 250 to insert medical tools, one or more mechanical dials or knobs 252 that an operator can use to manually control operations of end effectors and/or steering of the instrument, and a user interface 254 having one or more control buttons and status indicators” ¶[0032]) , wherein the operational console includes at least one motor for moving the at least one wire (Fig. 1A/1B “as part of the actuator system 310, a plurality of actuating motors (or actuators) 1 through M, where M is an integer greater than zero and equal to the number of control wires 110.” ¶[0038]) , and at least one sensor in communication with the wire for detecting a force on the at least one wire (Fig. 3 “each control wire 110 is also connected to a strain sensor and a position sensor… strain sensor 221 and 222” ¶[0057]) , and wherein the operational console further comprises a relax mode for reducing tensile or compression forces in the at least one wire for relaxing at least one of the bendable sections (“Under the passive mode, system controller makes the pose of the catheter “relaxed” and allows the catheter to get out from the “stuck” condition.” ¶[0093]) by using force feedback control of the at least one motor based on information from the at least one sensor (Fig. 8-9; ¶[0085] and ¶[0088] “actively-controlled passive bending mode”) . Kincaid also teaches the additional claim 13 limitations of wherein the method comprises: receiving an input from a user to the operational console (Fig. 1A “The handle interface 200 may also provide an access port 250 to insert medical tools, one or more mechanical dials or knobs 252 that an operator can use to manually control operations of end effectors and/or steering of the instrument, and a user interface 254 having one or more control buttons and status indicators” ¶[0032]) ; sending a signal from the operational console to the driver to drive the at least one wire to manipulate the continuum robot (Fig. 1A ““the control system 300 and computer system 400 can provide a surgeon or other operator with an image display 420 and a graphical user interface (GUI) 422 to interact and operate the steerable instrument 100. The handle interface 200 provides electromechanical interconnection between the steerable instrument 100 and the control system 300” ¶[0032]) ; monitoring the sensor to detect a force on the sensor (Fig. 3 “each control wire 110 is also connected to a strain sensor and a position sensor… strain sensor 221 and 222” ¶[0057]; Fig. 8-9; ¶[0085] and ¶[0088] “actively-controlled passive bending mode”) ; engaging a relax mode for reducing tensile or compression forces in the at least one wire for relaxing at least one of the bendable sections by using force feedback control of the at least one motor based on information from the sensor (“Under the passive mode, system controller makes the pose of the catheter “relaxed” and allows the catheter to get out from the “stuck” condition.” ¶[0093]) . Regarding claims 2 and 14, Kincaid teaches wherein relax mode further comprises reducing tensile or compression forces (fig. 2C- forces F1 and F2 can be tensile or compressive in ¶[0043]) in the at least one wire for relaxing at least one of the bendable sections (“feedback loop… moves the corresponding control wire 110 in a direction opposite to the direction of force F so as to decrease the amount of strain being applied to the control wire” in ¶[0058]) . Regarding claims 3 and 15, Kincaid teaches wherein reducing both compression and tensile forces is independent of actuator mechanical structure and accomplished by using the force feedback control to release forces on the at least one wire (fig. 2C- forces F1 and F2 can be tensile or compressive in ¶[0043]; and “feedback loop… moves the corresponding control wire 110 in a direction opposite to the direction of force F so as to decrease the amount of strain being applied to the control wire” in ¶[0058]) . Regarding claims 4-5 and 16, Kincaid teaches wherein the relax mode is enacted based on a force measurement data on the at least one wire, specifically wherein the relax mode may be passively enacted when the at least one sensor reaches a threshold force measurement (“FIG. 8, at step 1706, the system transitions from active shape control (an actively controlled mode: steps 1702- 1704) to a mode of passive bending (a passively controlled mode: 1708-1712)… if the user sets a 5% or 10% or a 15% as threshold difference between desired and measured values, the system controller software triggers a change between actively controlled mode and passively controlled mode only when the error exceeds the threshold.” ¶[0087] and “ according to description above automatic a change from an actively controlled modes to a passively controlled mode and vice versa occurs based on the external force (e.g., due patient movement) monitored by strain and/or positions sensors and certain thresholds thereof.” ¶[0093]) . Regarding claims 6-7 and 17, Kincaid teaches wherein the relax mode can be activated or deactivated (¶[0096]) by an end user by engaging a button (“FIG. 10B illustrates an exemplary algorithm which can similarly lower the tension force by releasing actuation (or adjusting displacement) of one or more control wires 110 in step 1710 of FIG. 8 or step 1810 of FIG. 9 based on a user's input… when the physician operator determines that the catheter gets stuck, the user can switch the active mode to the passive mode by, for example, pressing a button on the controller to stop the actively controlled mode and enter the passively controlled mode.”¶[0093]) . Regarding claims 9 and 19, Kincaid teaches wherein the operational console does not reflect the end user's bending command for the bendable sections in relax mode (“switch the active mode to the passive mode by, for example, pressing a button on the controller to stop the actively controlled mode and enter the passively controlled mode. Under the passive mode, system controller makes the pose of the catheter “relaxed” and allows the catheter to get out from the “stuck” condition. After that, the operator may return the mode to the active mode, and continue to use robotic control.” ¶[0093] Therefore, the user only has control in the active mode) . Regarding claims 12 and 21, Kincaid teaches wherein relax mode may be enacted for inserting and/or removing the plurality of bending sections (“The actively-controlled passive bending mode is particularly advantageous in controlling smooth and accurate bending of the steerable medical instrument during insertion and retraction through tortuous pathways of a patient's anatomy.” In ¶[0050]; ¶[0096]) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim s 8, 11, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kincaid in view of Noonan et al. (US 20220361968 A1, published Nov. 17, 2022, effective filing in 2021, hereinafter referred to as “Noonan”) . Regarding claims 8 and 18, Kincaid teaches wherein the end user engages a button to activate relax mode (“FIG. 10B illustrates an exemplary algorithm which can similarly lower the tension force by releasing actuation (or adjusting displacement) of one or more control wires 110 in step 1710 of FIG. 8 or step 1810 of FIG. 9 based on a user's input… when the physician operator determines that the catheter gets stuck, the user can switch the active mode to the passive mode by, for example, pressing a button on the controller to stop the actively controlled mode and enter the passively controlled mode.”¶[0093]) , and relax mode is automatically deactivated (“automatic change from an actively controlled modes to a passively controlled mode and vice versa occurs based on the external force (e.g., due patient movement) monitored by strain and/or positions sensors and certain thresholds thereof” ¶[0093]) . Although Kincaid disclose the device automatically returning to active mode after reaching a threshold level of force, Kincaid does not teach relax mode is automatically deactivated after a predetermined time interval. Noonan’s invention relates to co-manipulation robotic systems for assisting with laparoscopic surgical procedures (¶[0002]). As the operator manipulates a robot arm of the co-manipulation surgical robot system by applying movement to the surgical instrument coupled to the robot arm, the system may automatically transition the robot arm between various operational modes upon determination of predefined conditions. For example, the system may transition the robot arm to a passive mode responsive to determining that movement of the robot arm due to movement at the handle of the surgical instrument is less than a predetermined amount for at least a predetermined dwell time period, such that in the passive mode, the robot arm maintains a static position, e.g., to prevent damage to the equipment and/or injury to the patient (¶[0082]). Therefore, the device is capable of inputting predetermined time intervals in order to switch modes of operation. Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to change modes (such as deactivating relax mode) after a predetermined amount of time as taught by Noonan in the method and robotic apparatus of Kincaid in order to prevent damage to the equipment and/or injury to the patient. Regarding claim 11, Kincaid does not teach wherein relax mode is enacted only when the base stage is static. Noonan teaches that as the operator manipulates a robot arm of the co-manipulation surgical robot system by applying movement to the surgical instrument coupled to the robot arm, the system may automatically transition the robot arm between various operational modes upon determination of predefined conditions. For example, the system may transition the robot arm to a passive mode responsive to determining that movement of the robot arm due to movement at the handle (such as the base is static ) of the surgical instrument is less than a predetermined amount for at least a predetermined dwell time period, such that in the passive mode, the robot arm maintains a static position, e.g., to prevent damage to the equipment and/or injury to the patient (¶[0082]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to enact relax mode when the base is static as taught by Noonan in the method and robotic apparatus of Kincaid in order to prevent damage to the equipment and/or injury to the patient . 07-21-aia AIA Claim s 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kincaid in view of Sharon et al. (US 20220071723 A1, published Mar. 10, 2022, filed Nov. 15, 2021, hereinafter referred to as “Sharon”) . Regarding claims 10 and 20, Kincaid teaches the method and robotic apparatus of claims 1 and 13. Kincaid also teaches the device further comprising a base (or insertion) stage (Fig. 3 “To ensure accurate positioning (to avoid slack), the linear motor 311 is secured to a structural base 311a, and the linear motor 312 is secured to a similar base 312a. The base 311a/312a can be, for example, the housing or chassis of a patient interface unit (PIU), which encloses the interface 200 and at least part of control system 300.” ¶[0056]) . Kincaid does not teach the base/insertion stage is to move the continuum robot and driving unit in a longitudinal direction, wherein movement of the base (or insertion) stage is controlled by the operational console by instructions from the end user. Sharon’s invention relates to automated actuation of surgical tools inserted into a bodily lumen (¶[0002]). FIGS. 9A-9B illustrate moving units for linear advancement and/or rotational movement of a medical instrument ¶[0201]. The insertion device is configured to allow the linear advancement of the medical instrument within the bodily lumen along with the rotational movement thereof, by utilizing one or more actuators that further advantageously enable the smooth movement of the medical instrument, without deforming the medical instrument ¶[0273]. Operation is performed by controlling, via a user interface of the device, movement of the surgical tools received within the units (Fig. 14 element 1407). Exemplary manipulation of tools controlled by the device may include: linear advancement and/or retraction of a tool (¶[0342]). The medical device 20 includes one or more actuators/elements configured to allow the linear and/or rotation movement/advancement of the medical instrument/s. In some embodiments, as illustrated in FIG. 2A, device 20 includes a first movement control unit 26 configured to allow linear and/or rotational movement (¶[0277]). As shown in FIG. 11, movement control unit 500 includes a first movement control element 502 (such as a piezoelectric motor) configured to allow linear motion (advancement) of a medical instrument (such as guidewire 510), in any linear desired direction 505 (¶[0311]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have a base/insertion tool that move the continuum robot and driving unit in a longitudinal direction that is controlled by the operational console by instructions from the end user as taught by Sharon in the method and robotic apparatus of Kincaid in order to advance or retract the tool into/out of the patient smoothly and without deforming the medical instrument. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emily N Cirulnick whose telephone number is (571)272-9734. The examiner can normally be reached M-Th 8-5:30 and every other F 8-4:30ET. 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, Unsu Jung can be reached at (571) 272-8506. 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. /E.N.C./Patent Examiner, Art Unit 3792 /ALLEN PORTER/Primary Examiner, Art Unit 3796 Application/Control Number: 18/835,305 Page 2 Art Unit: 3792 Application/Control Number: 18/835,305 Page 3 Art Unit: 3792 Application/Control Number: 18/835,305 Page 4 Art Unit: 3792 Application/Control Number: 18/835,305 Page 5 Art Unit: 3792 Application/Control Number: 18/835,305 Page 6 Art Unit: 3792 Application/Control Number: 18/835,305 Page 7 Art Unit: 3792 Application/Control Number: 18/835,305 Page 8 Art Unit: 3792 Application/Control Number: 18/835,305 Page 9 Art Unit: 3792 Application/Control Number: 18/835,305 Page 10 Art Unit: 3792 Application/Control Number: 18/835,305 Page 11 Art Unit: 3792 Application/Control Number: 18/835,305 Page 12 Art Unit: 3792 Application/Control Number: 18/835,305 Page 13 Art Unit: 3792
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