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 .
Information Disclosure Statement
The information disclosure statement (IDS) filed on August 9, 2024 is being considered by the examiner.
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, 2, 4-8, 11, 12, 14-18, and 21 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by Yeung et al. (US2018/0296281)
Regarding claim 1, Yeung discloses a medical apparatus comprising: a medical device with at least one bendable section and a distal end (Fig. 1A &1B: robotic endoscope may be a colonoscope 110 [0095] with bendable/extendable section stretching proximally from the distal end 103 [0097]); at least one imaging device at the distal end (imaging device may be attached to the distal end of the colonoscope [0125]); at least one sensor (proximity sensor, which may be a capacitive touch sensor comprising multiple sensing electrodes, at the distal end of the robotic endoscope [0015, 0115]); and a controller (controller 201 and steering control system 210) which performs: receiving input data from user input, the imaging device, the sensor, or combinations thereof (steering control may be semi-automated…insertion movement may be controlled by input from operator through joystick, button, etc. interface [0107]; steering control system generates steering direction based on a plurality of input sensor data streams which may include image data [0100]); determining a bending plane and a bending angle of the distal end of the medical device (bending angle and bending direction are controlled by the motion of a number of tendons that run through the flexible section [0106]; steering direction may be determined using a plurality of input sensor data streams… once determined, distal end may be actuated by actuators, which are connected to the tendons, in order to affect movement of the distal end [0100-0101]); predicting location movement and position of the at least one bendable section based on the input data (a motion vector between current location and the position predicted by the target navigation direction may be generated [0099]); displaying an image view based on the input data (Fig. 8C: user interface 820 receives user input to output sensor data and steering control information [0165]); and displaying the predicted location movement and position of the at least one bendable section on the image view (augmented information may be overlaid onto the image data, augmented information may comprise steering vector data for the endoscope [0210]).
Regarding claim 2, Yeung discloses the medical apparatus according to claim 1, further disclosing wherein the controller further performs detecting collision of the medical device based on the input data (capacitive sensor data may be transmitted to steering control module and used to determine a target steering direction such that the distal end may be positioned to avoid contact with the object or to move away from the object [0121]; steering control system may steer the scope in a direction away from the object or portion of the colonic wall [0121]).
Regarding claim 4, Yeung discloses the medical apparatus according to claim 1, further disclosing wherein the controller further performs limiting a bending angle of the distal end of the medical device to avoid future collisions with an airway wall (steering control system may steer the scope in a direction away from the object or portion of the lumen wall [0121], indicating that the bending angle or plane is controlled and limited to avoid collisions with a lumen wall).
Regarding claim 5, Yeung discloses the medical apparatus according to claim 1, further disclosing wherein the medical device is a steerable catheter (Fig. 1A &1B: colonoscope 110 [0095] with bendable/extendable section stretching proximally from the distal end 103 [0097]).
Regarding claim 6, Yeung discloses the medical apparatus according to claim 1, further disclosing wherein a rigid tip is at the distal end of the medical device (rigid portion of the distal end [0117, 0119]).
Regarding claim 7, Yeung discloses the medical apparatus according to claim 6, further disclosing wherein the rigid tip is aligned with a normal vector of the at least one bendable section (Fig. 1B: rigid tip appears to be aligned with a normal vector, similar to a longitudinal axis, of the bendable section).
Regarding claim 8, Yeung discloses the medical apparatus according to claim 6, further disclosing wherein the predicted location movement and position of the at least one bendable section is based on an insertion distance and a length of the rigid tip (although not explicitly stated, the length of the distal end 103, the insertion distance and length of the bendable/extendable section contribute to the predicted location movement and position; for example, should the bend radius of the bendable/extendable section be a constant along the entire length of the bendable/extendable section, the degree of bending would also depend on the length of the bendable/extendable section).
Regarding claim 11, Yeung discloses a method for a medical apparatus with a medical device with at least one bendable section and a distal end (Fig. 1A &1B: robotic endoscope may be a colonoscope 110 [0095] with bendable/extendable section stretching proximally from the distal end 103 [0097]), at least one imaging device (imaging device may be attached to the distal end of the colonoscope [0125]), and at least one sensor (proximity sensor, which may be a capacitive touch sensor comprising multiple sensing electrodes, at the distal end of the robotic endoscope [0015, 0115]), the method comprising: receiving input data from user input, the imaging device, the sensor, or combinations thereof (steering control may be semi-automated…insertion movement may be controlled by input from operator through joystick, button, etc. interface [0107]; steering control system generates steering direction based on a plurality of input sensor data streams which may include image data [0100]); determining a bending plane and a bending angle of the distal end of the medical device (bending angle and bending direction are controlled by the motion of a number of tendons that run through the flexible section [0106]; steering direction may be determined using a plurality of input sensor data streams… once determined, distal end may be actuated by actuators, which are connected to the tendons, in order to affect movement of the distal end [0100-0101]); predicting location movement and position of the at least one bendable section based on the input data (a motion vector between current location and the position predicted by the target navigation direction may be generated [0099]); displaying an image view based on the input data (Fig. 8C: user interface 820 receives user input to output sensor data and steering control information [0165]); and displaying the predicted location movement and position of the at least one bendable section on the image view (augmented information may be overlaid onto the image data, augmented information may comprise steering vector data for the endoscope [0210]).
Regarding claim 12, Yeung discloses the method according to claim 11, further disclosing the method comprising detecting collision of the medical device based on the input data (capacitive sensor data may be transmitted to steering control module and used to determine a target steering direction such that the distal end may be positioned to avoid contact with the object or to move away from the object [0121]; steering control system may steer the scope in a direction away from the object or portion of the colonic wall [0121]).
Regarding claim 14, Yeung discloses the method according to claim 11, further disclosing the method comprising limiting a bending angle of the distal end of the medical device to avoid future collisions with an airway wall (steering control system may steer the scope in a direction away from the object or portion of the lumen wall [0121], indicating that the bending angle or plane is controlled and limited to avoid collisions with a lumen wall).
Regarding claim 15, Yeung discloses the method according to claim 11, further disclosing wherein the medical device is a steerable catheter (Fig. 1A &1B: colonoscope 110 [0095] with bendable/extendable section stretching proximally from the distal end 103 [0097]).
Regarding claim 16, Yeung discloses the method according to claim 11, further disclosing wherein a rigid tip is at the distal end of the medical device (rigid portion of the distal end [0117, 0119]).
Regarding claim 17, Yeung discloses the method according to claim 16, further disclosing wherein the rigid tip is aligned with a normal vector of the at least one distal bendable section (Fig. 1B: rigid tip appears to be aligned with a normal vector, similar to a longitudinal axis, of the bendable section).
Regarding claim 18, Yeung discloses the method according to claim 11, further disclosing wherein the predicted location movement and position of the at least one bendable section is based on an insertion distance and a length of the rigid tip (although not explicitly stated, the length of the distal end 103, the insertion distance and length of the bendable/extendable section contribute to the predicted location movement and position; for example, should the bend radius of the bendable/extendable section be a constant along the entire length of the bendable/extendable section, the degree of bending would also depend on the length of the bendable/extendable section).
Regarding claim 21, Yeung discloses a storage medium storing a program for causing a computer to execute a method for a medical apparatus (steering control module comprising one or more processors that may be operatively coupled to non-transitory computer readable medium [0108-0109]) with a medical device with at least one bendable section and a distal end (Fig. 1A &1B: robotic endoscope may be a colonoscope 110 [0095] with bendable/extendable section stretching proximally from the distal end 103 [0097]), at least one imaging device (imaging device may be attached to the distal end of the colonoscope [0125]), and at least one sensor (proximity sensor, which may be a capacitive touch sensor comprising multiple sensing electrodes, at the distal end of the robotic endoscope [0015, 0115]), the method comprising: receiving input data input data from user input, the imaging device, the sensor, or combinations thereof (steering control may be semi-automated…insertion movement may be controlled by input from operator through joystick, button, etc. interface [0107]; steering control system generates steering direction based on a plurality of input sensor data streams which may include image data [0100]); determining a bending plane and a bending angle of the distal end of the medical device (bending angle and bending direction are controlled by the motion of a number of tendons that run through the flexible section [0106]; steering direction may be determined using a plurality of input sensor data streams… once determined, distal end may be actuated by actuators, which are connected to the tendons, in order to affect movement of the distal end [0100-0101]); predicting location movement and position of the at least one bendable section based on the input data (a motion vector between current location and the position predicted by the target navigation direction may be generated [0099]); displaying an image view based on the input data (Fig. 8C: user interface 820 receives user input to output sensor data and steering control information [0165]); and displaying the predicted location movement and position of the at least one bendable section on the image view (augmented information may be overlaid onto the image data, augmented information may comprise steering vector data for the endoscope [0210]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Yeung in view of Shelton et al. (US2021/0196385).
Regarding claim 3, Yeung discloses the medical apparatus according to claim 1. Yeung does not explicitly disclose wherein the controller further performs providing a collision warning of the medical device based on the input data.
In the same field of endeavor, Shelton teaches a medical apparatus comprising: a medical device with a shaft and a distal end (surgical visualization system 100 comprises surgical device 102 [0138]); at least one imaging device (imaging device 120 [0139]); at least one sensor (distance sensor system 104 [0139]); and a controller (control circuit 132 [0148]) which performs: receiving input data from user input, the imaging device, or both (control circuit is in signal communication with the camera and imaging system wherein the control circuit is configured to determine a distance from the surgical device to the embedded critical structure and provide a signal to the imaging system indicative of the distance [0223]); displaying up-to-date information based on the input data regarding the proximity of the medical device to a critical structure within the body cavity ([0138],[0224]), further teaching wherein the controller further performs providing a collision warning for the medical device based on the input data (distance between surgical device and critical structure can be viewed by the clinician and in certain instances, an alert and/or warning can be provided by the imaging system when the surgical device is moved within a predefined proximity and/or zone of the critical structure; in certain instances the alert and/or warning can be provided when the trajectory of the surgical device indicates a likely collision with a “no-fly” zone in the proximity of the critical structure [0224]). In view of Shelton, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included wherein the controller performs a warning signal to indicate potential collision or close proximity to a critical structure, such as taught in Shelton, as it is known in the art to benefit the user of the device to maintain momentum through the surgical procedure without requiring the user to monitor the working area too closely, therefore allowing the procedure to be performed more quickly, with fewer pauses/interruptions, and/or with improved accuracy [0224].
Regarding claim 13, Yeung discloses the method according to claim 11. Yeung does not explicitly disclose the method further comprising providing a collision warning of the medical device based on the input data.
In the same field of endeavor, Shelton teaches a medical apparatus comprising: a medical device with a shaft and a distal end (surgical visualization system 100 comprises surgical device 102 [0138]); at least one imaging device (imaging device 120 [0139]); at least one sensor (distance sensor system 104 [0139]); and a controller (control circuit 132 [0148]) which performs: receiving input data from user input, the imaging device, or both (control circuit is in signal communication with the camera and imaging system wherein the control circuit is configured to determine a distance from the surgical device to the embedded critical structure and provide a signal to the imaging system indicative of the distance [0223]); displaying up-to-date information based on the input data regarding the proximity of the medical device to a critical structure within the body cavity ([0138],[0224]), further teaching wherein the controller further performs providing a collision warning for the medical device based on the input data (distance between surgical device and critical structure can be viewed by the clinician and in certain instances, an alert and/or warning can be provided by the imaging system when the surgical device is moved within a predefined proximity and/or zone of the critical structure; in certain instances the alert and/or warning can be provided when the trajectory of the surgical device indicates a likely collision with a “no-fly” zone in the proximity of the critical structure [0224]). In view of Shelton, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included wherein the controller performs a warning signal to indicate potential collision or close proximity to a critical structure, such as taught in Shelton, as it is known in the art to benefit the user of the device to maintain momentum through the surgical procedure without requiring the user to monitor the working area too closely, therefore allowing the procedure to be performed more quickly, with fewer pauses/interruptions, and/or with improved accuracy [0224].
Claims 9, 10, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Yeung in view of Tal et al. (US2023/0045709).
Regarding claim 9, Yeung discloses the medical apparatus according to claim 6. While Yeung discloses the medical apparatus displaying the predicted location movement and position of the at least one bendable section on the image view (augmented information may be overlaid onto the image data, augmented information may comprise steering vector data for the endoscope [0210]), Yeung fails to specify the overlaid steering vector data being a constant arc by assuming an insertion distance so that a tip of the at least one bendable section can be projected onto the bending plane wherein the predicted location movement and position of the at least one bendable section is based on an insertion distance and a length of the rigid tip.
In the same field of endeavor, Tal teaches a medical apparatus comprising: a medical device with at least one bendable section and a distal end (tissue penetrating apparatus 22 with a distal end, as seen in Fig. 4B); at least one imaging device (endoscope 30); and a controller (system 10 comprising processor for processing digital image capturing [0032-0033]) which performs: receiving input data from user input, the imaging device, or both (system 10 comprising processor receives image signals for processing [0073], surgical device may be maneuvered manually, automatically or robotically [0080]); determining a bending plane and a bending angle of the distal end of the medical device (apparatus 22 extends along a restricted chosen penetration path CPP [0074], the chosen penetration path CPP formed of a bending plane and a bending angle); predicting location movement and position of the at least one bendable section based on the input data (system 10 calculates an estimated or predicted curved penetration path of the apparatus 22 [0079]); displaying an image view based on the input data (Fig. 3D-3F: image displayed on screen 41/11 [0073]); displaying the predicted location movement and position of the at least one bendable section on the image view (graphic representation 29 is a predicted curved penetration path of the tissue penetrating apparatus [0079], displayed on the screen 41/11, as seen in Fig. 3D-3F). Tal further teaches the medical apparatus comprising displaying a constant arc by assuming an insertion distance so that a tip of the at least one bendable section can be projected onto the bending plane wherein the predicted location movement and position of the at least one bendable section is based on an insertion distance and a length of the tip (graphic representation 29 is a displayed constant arc, such as in Fig. 3D-3F, so that the tip of the tissue penetrating apparatus 22 is projected onto the plane on which it bends, the predicted location movement and position of the apparatus 22 is based on the insertion distance and length of the tip of the apparatus, since the degree of bending is dependent on the length of apparatus 22 being bent).
In view of Tal, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the constant arc displayed on the screen to indicate the projected path of the medical device, as taught by Tal, to the medical apparatus of Yeung, as it allows for the user to view the point in which the device may intercept tissue or verify the device is traversing in the correct direction.
Regarding claim 10, Yeung, modified by Tal, discloses the medical apparatus according to claim 9. Tal further teaches wherein the constant arc is represented by an intersection line on the image view (Fig. 3C-3F: graphical representation 29).
Regarding claim 19, Yeung discloses the method according to claim 11. While Yeung discloses the medical apparatus displaying the predicted location movement and position of the at least one bendable section on the image view (augmented information may be overlaid onto the image data, augmented information may comprise steering vector data for the endoscope [0210]), Yeung fails to specify the overlaid steering vector data being a constant arc by assuming an insertion distance so that a tip of the at least one bendable section can be projected onto the bending plane wherein the predicted location movement and position of the at least one bendable section is based on an insertion distance and a length of the rigid tip.
In the same field of endeavor, Tal teaches a medical apparatus comprising: a medical device with at least one bendable section and a distal end (tissue penetrating apparatus 22 with a distal end, as seen in Fig. 4B); at least one imaging device (endoscope 30); and a controller (system 10 comprising processor for processing digital image capturing [0032-0033]) which performs: receiving input data from user input, the imaging device, or both (system 10 comprising processor receives image signals for processing [0073], surgical device may be maneuvered manually, automatically or robotically [0080]); determining a bending plane and a bending angle of the distal end of the medical device (apparatus 22 extends along a restricted chosen penetration path CPP [0074], the chosen penetration path CPP formed of a bending plane and a bending angle); predicting location movement and position of the at least one bendable section based on the input data (system 10 calculates an estimated or predicted curved penetration path of the apparatus 22 [0079]); displaying an image view based on the input data (Fig. 3D-3F: image displayed on screen 41/11 [0073]); displaying the predicted location movement and position of the at least one bendable section on the image view (graphic representation 29 is a predicted curved penetration path of the tissue penetrating apparatus [0079], displayed on the screen 41/11, as seen in Fig. 3D-3F). Tal further teaches the medical apparatus comprising displaying a constant arc by assuming an insertion distance so that a tip of the at least one bendable section can be projected onto the bending plane wherein the predicted location movement and position of the at least one bendable section is based on an insertion distance and a length of the tip (graphic representation 29 is a displayed constant arc, such as in Fig. 3D-3F, so that the tip of the tissue penetrating apparatus 22 is projected onto the plane on which it bends, the predicted location movement and position of the apparatus 22 is based on the insertion distance and length of the tip of the apparatus, since the degree of bending is dependent on the length of apparatus 22 being bent).
In view of Tal, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the constant arc displayed on the screen to indicate the projected path of the medical device, as taught by Tal, to the medical apparatus of Yeung, as it allows for the user to view the point in which the device may intercept tissue or verify the device is traversing in the correct direction.
Regarding claim 20, Yeung, modified by Tal, discloses the method according to claim 19. Tal further teaches wherein the constant arc is represented by an intersection line on the image view (Fig. 3C-3F: graphical representation 29).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See reference cited in PTO-892.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LI-TING SONG/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
03/21/2026