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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 12, 2026 has been entered.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 11-16 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by Yeung et al (US2018/0296281).
Regarding claim 11, Yeung discloses an endoscope automatic steering system, comprising: an endoscope comprising a steerable distal end with a camera producing an image signal (control system may comprise first and second image sensor [0006-0007]; plurality of sensors 209 located at or in close proximity to the distal end 207 [0110]…plurality of sensors may include optical image sensors [0112]) and an orientation sensor producing an orientation signal of an orientation of the steerable distal end (plurality of sensors may include touch/proximity sensors, motion sensors or location sensors which provide additional information about a relative position of the body portion relative to a colonic wall or lumen or lumen center or various motion properties of the colonoscope [0112]); an endoscope controller that: receives the image signal and the orientation signal (additional sensor data may be supplied to the steering control module for determining the control signal or target direction [0113]); automatically selects a steering target of the endoscope based on the image signal (navigation direction is determined that directs the robotic colonoscope towards the center position of the colon lumen using a machine learning architecture-based analysis of the center positions and locations [0037]); identifies a distal advancement of the endoscope based on the orientation signal or the image signal or both (additional sensor data may be supplied to the steering control module for determining the control signal or target direction [0113]); based on identifying the distal advancement of the endoscope (plurality of sensors, including proximity sensors, motion sensors and location sensors provide relative position and various motion properties of the endoscope [0112]), generates instructions to automatically steer the distal end of the endoscope towards the steering target during the distal advancement (input data collected from sensors located at the distal end may be used for generating the control signal [0113]), determines, based on the orientation signal or the image signal or both, that the distal advancement has stopped; and based on the distal advancement stopping, pauses automatically steering the distal end while the distal advancement remains stopped (steering direction of the endoscope is automatically controlled by the steering control system whereas insertion speed or depth may by controlled manually [0107]; plurality of sensors at the distal end of the endoscope, including optical image sensors, proximity, motion and location sensors, may provide relative position and various motion properties of the endoscope [0112]; if distal advancement is stopped or paused by the operator, automatic steering would also be paused).
Regarding claim 12, Yeung discloses the system of claim 11, further disclosing wherein the endoscope controller: determines, based on the orientation signal or the image signal or both, that the distal advancement has resumed; and resumes automatically steering the distal end based on the distal advancement resuming (similar to the rejection of claim 11, steering direction of the endoscope is automatically controlled by the steering control system whereas insertion speed or depth may by controlled manually [0107]; plurality of sensors at the distal end of the endoscope, including optical image sensors, proximity, motion and location sensors, may provide relative position and various motion properties of the endoscope [0112]; if distal advancement by the operator resumes, automatic steering would also resume).
Regarding claim 13, Yeung discloses the system of claim 11, further disclosing wherein the endoscope controller receives one or more user steering inputs while the distal advancement has stopped and changes the orientation of the distal end based on the one or more user steering inputs (user may manually control the steering of the colonoscope, which would change the orientation of the distal end of the colonoscope [0199]).
Regarding claim 14, Yeung discloses the system of claim 11, further disclosing wherein the endoscope controller automatically steers the distal end only when an automatic steering mode is activated (steering control system may be semi-automatic, thus steering direction of the endoscope is automatically controlled by the steering control system whereas the insertion speed or depth may be controlled manually [0095]; various system such as a fully-automated, semi-automated, user-supervised, manually controlled [0199]).
Regarding claim 15, Yeung discloses the system of claim 11, further disclosing wherein the endoscope controller automatically selects the steering target by identifying features of the image signal characteristic of a passage and selecting a center of the passage as the steering target (performed automated feature extraction on the series of two or more images to determine a center position of the colon lumen [0037]; determine a navigation direction that directs the robotic colonoscope towards the center position of the colon lumen using a machine learning architecture-based analysis of the center positions and locations [0037]).
Regarding claim 16, Yeung discloses the system of claim 11, further disclosing the system comprising an automatic steering icon displayed on a display screen (image map data may be displayed on viewing device [0053]; augmented information, such as a contour of the detected object of interest, analogous to applicant’s automatic steering icon, may be overlaid onto real-time images [0205]).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, and 4-9 are rejected under 35 U.S.C. 103 as being unpatentable over Yeung et al. (US2018/0296281) in view of Vunjak-Novakovic et al. (US2020/0046943) and Danna et al. (US2022/0361736).
Regarding claim 1, Yeung discloses an endoscope automatic steering system, comprising: an endoscope comprising a distal end with a camera producing an image signal (control system may comprise first and second image sensor [0006-0007]; plurality of sensors 209 located at or in close proximity to the distal end 207 [0110]…plurality of sensors may include optical image sensors [0112]) and a proximity, motion or location sensor (plurality of sensors for providing information about obstacles or portions of the colonic walls that are in proximity of the distal end, sensors may be photosensors, optical image sensors, additional touch/proximity sensors, motion sensors, or location sensors [0111-0112]); and an endoscope controller coupled to the endoscope (steering control system 210), wherein the endoscope controller: receives the image signal from the endoscope (image sensors configured to acquire image and video data [0013]; steering control system may utilize image processing algorithms to process image data input and provide a predicted steering direction and/or steering control signal as output for guiding the movement of the of the robotic endoscope [0084]); identifies, via a feature identification model, an anatomical feature in the image signal (performed automated feature extraction on the series of two or more images to determine a center position of the colon lumen [0037]), wherein the feature identification model identifies the anatomical feature by detecting an object in the image signal (object of interest, which may be a polyp, lesion, adenoma or cancerous growth [0047]); selects a center of the detected object as a steering target based on the identified anatomical feature (Fig. 5B: center of mass, which is the center of the lumen or center of the object, or a geographical center may be used to define a center location [0133]); and based on a signal from the proximity, motion or location sensor, detects the endoscope is advancing distally (steering direction is automatically controlled while insertion speed or depth is manually controlled [0107], in some instances, such as the semi-automatic mode, the steering control is configured to provide assistance to the surgeon who is actively guiding the advancing endoscope [0084], which teaches that steering is controlled automatically as the operator manually advances the endoscope); and based on the endoscope advancing distally, automatically steers the distal end of the endoscope toward the steering target during distal motion of the distal end of the endoscope (control system tracks an object of interest by providing an adaptive steering control output signal to the robotic endoscope [0040], steering control signal aligns the steering direction with the motion direction vector of the object of interest [0044]; provide a predicted steering direction and/or steering control signal as output for guiding the movement of the of the robotic endoscope [0084], steering direction is automatically controlled while insertion speed or depth is manually controlled [0107]).
While Yeung discloses a plurality of sensors such as touch/proximity sensors, motion sensors, or location sensors located at the distal end of endoscope to provide additional information about a relative position of the endoscope relative to a colonic wall or lumen center ([0111-0112]), Yeung fails to explicitly disclose these sensors to be an inertia measurement unit (IMU). In the same field of endeavor, Danna teaches a similar robotic endoscope system comprising a catheter, the catheter may be steered or advanced toward the target site in a manual manner, an autonomous manner, or a semi-autonomous manner ([0044]), further teaching wherein the system comprises proximity sensors and/or any various location or motion sensors, such as inertial measurement units, one or more gyroscopes, velocity sensors, accelerometers, magnetometers, location sensors, vision sensors, range sensors, and/or field sensors for measuring the location or motion of the imaging system ([0053]). In view of Danna, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized an inertia measurement unit, such as an accelerometer or a gyroscope, as an equivalent alternative known in the art, to proximity sensors, motion sensors or location sensors, for detecting location or motion of the device ([0053]).
Yeung also fails to disclose wherein the feature identification model generates a bounding box around the object and selects a center of the bounding box around the detected object as a steering target.
In the same field of endeavor, Vunjak-Novakovic teaches a substantially similar autonomous steerable catheter device and method comprising: an endoscope comprising a distal end with a camera producing an image signal (catheter or bronchoscope [0092]; catheter with imaging device to help steer [0093]); and an endoscope controller (controller and control system [0109]) coupled to the endoscope, wherein the endoscope controller: receives the image signal from the endoscope (Fig 22: images are obtained [0136]); identifies, via a feature identification model, an anatomical feature in the image signal (region of interest ROI, an airway branch, can be determined from computer-assisted airway pattern recognition [0136]), wherein the feature identification model identifies the anatomical feature by detecting an object in the image signal and generates a bounding box around the object (rectangle encloses the dotted regions and the center of each rectangle is identical to the center of the corresponding airway[0140]); selects a center of a bounding box around the detected object as a steering target based on the identified anatomical feature (Fig. 26A-26D: center of rectangles marked with a hollow circle or “o” [0140]); and automatically steers the distal end of the endoscope towards the steering target during distal motion of the distal end of the endoscope (Fig. 26A-D, 27: center of rectangles, which are airway centers, depicted by hollow circles, becomes the steering target as the distal tip of the catheter is steered toward the center of the target airway [0141]).
In view of Vunjak-Novakovic, 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 bounding box around the object, wherein the center of the bounding box is selected as a steering target, as it is known in the endoscope art that the bounding box around the object is an alternative method of determining the center of an object.
Regarding claim 2, Yeung, modified by Vunjak-Novakovic and Danna, discloses the system of claim 1. Yeung further discloses wherein the feature identification model identifies the anatomical feature by classifying a subset of pixels in the image signal and selects a center of the subset of pixels as the steering target (artificial intelligence algorithm used to process image data as input and provide predicted steering direct and control signals [0084]; object of interest is recognized using an automated image feature extraction comprising various methods contour mapping [0041]; determination of the location of the center of the lumen comprises (i) generating a plurality of vectors, wherein each vector is aligned in a direction that is normal to a local segment of a contour identified in an image, and (ii) counting the number of vectors that intersect a given pixel in the image [0007]).
Regarding claim 4, Yeung, modified by Vunjak-Novakovic and Danna, discloses the system of claim 1. Yeung further discloses wherein the endoscope controller identifies multiple anatomical features and selects an individual anatomical feature of the identified multiple anatomical features to determine the steering target (control system can track object of interests within a field of view of the first image sensor [0040]; object of interests may be polyp, lesion, adenoma or a cancerous growth [0047]; object of interest may be auto-tracked [0200-0201], or center of colon lumen may be selected as target [0037]).
Regarding claim 5, Yeung, modified by Vunjak-Novakovic and Danna, discloses the system of claim 1. Yeung further discloses wherein the endoscope controller: receives an updated image signal from the endoscope (first and second image sensors configured to provide a first and second input data stream comprises data relating to the position of the steerable distal portion relative to the center of a colon, walls of the colon lumen other obstacles and any combination thereof [0020-0021]; “data stream” may refer to the continuous sequence of analog or digital signals used to transmit or receive information [0089]; “real-time” update rate for the prediction of steering direction/control in response to changes in one or more input data streams [0092 & 0142]); identifies the anatomical feature based on the updated image signal; selects an updated steering target within the anatomical feature (performed automated feature extraction on the series of two or more images to determine a center position of the colon lumen [0037]); determines that the distal end is oriented away from the updated steering target (automated steering determines current orientation of the endoscope and reorients endoscope toward target [0107]); and generates updated steering instructions to cause the endoscope to automatically steer the distal end towards the updated steering target (steering control signal is adjusted to align the steering direction of the robotic endoscope with the motion direction vector of the object of interest [0044]; update rate for steering control signal may be various frequencies [0142]).
Regarding claim 6, Yeung, modified by Vunjak-Novakovic and Danna, discloses the system of claim 1. Yeung further discloses wherein an indicator representing the steering target is overlaid on a displayed image based on the image signal (contour of the detected object of interest may be overlaid onto real-time images [0205]).
Regarding claim 7, Yeung, modified by Vunjak-Novakovic and Danna, discloses the system of claim 1. Yeung further discloses wherein the steering target is a center or centroid of the identified anatomical feature, wherein the identified anatomical feature comprises a passage (determine a navigation direction that directs the robotic colonoscope towards the center position of the colon lumen using a machine learning architecture-based analysis of the center positions and locations [0037]).
Regarding claim 8, Yeung, modified by Vunjak-Novakovic and Danna, discloses the system of claim 1. Yeung further discloses wherein the steering target is selected without user steering input (steering control system may enable automated control of colonoscope [0107]).
Regarding claim 9, Yeung, modified by Vunjak-Novakovic and Danna, discloses the system of claim 1. Yeung further discloses wherein the endoscope controller identifies multiple anatomical features and selects an individual anatomical feature comprising a passage from the multiple anatomical features based on user steering input or motion of the endoscope towards the passage (control system can track object of interests within a field of view of the first image sensor [0040]; object of interests may be polyp, lesion, adenoma or a cancerous growth [0047]; object of interest may be auto-tracked [0200-0201], or center of colon lumen may be selected as target [0037]; tracking of object of interest may be manually selected by surgeon [0087]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Yeung in view of Vunjak-Novakovic, Danna and Rainis (US2021/0007810).
Regarding claim 10, Yeung, modified by Vunjak-Novakovic and Danna, discloses the system of claim 1, but fails to explicitly disclose wherein the endoscope controller: determines that the endoscope is outside a subject based on the image signal; and deactivates automatic steering based on the endoscope being outside the subject. In the same field of endeavor, Rainis discloses a similar system comprising: an endoscope comprising a distal end with a camera producing an image signal (Fig. 1B & 2A: medical imaging endoscope 245 with distal tip section 250 [0034]; distal tip section of rigid shaft 115 may comprise multiple cameras 130 and 165), an endoscope controller coupled to the endoscope (Fig. 2A: main control unit 215 [0034]), wherein the endoscope controller: receives the image signal from the endoscope, and based on the image signal, determines that the endoscope is outside a passage of the subject (image classified designed to measure the distribution of colors in an image acquired from the video camera [0055]; using the histogram of RGB colors, controller verifies if the histogram has reached a predefined value indicating that the medical imaging endoscope is placed within or outside a patient body [0059]); and deactivates the LED or ends the medical procedure based on the endoscope being outside the subject (if “OUT” is detected, the system progresses to step 440 to operate “OUT” actions of a conditional event such as stopping LED activities or declaring an “end of medical procedure”[0059]). In view of Rainis, 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 endoscope controller checks to ensure the endoscope is within a body cavity before proceeding with the medical procedure, as the conditional process prevents unnecessary steering, video recording, illumination and/or image processing from occurring while the endoscope is outside the body [0060, 0067].
Claims 21-23 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Yeung in view of Rainis (US2021/0007810).
Regarding claim 21, Yeung discloses an endoscope automatic steering system, comprising: an endoscope comprising a distal end with a camera producing an image signal (control system may comprise first and second image sensor [0006-0007]; plurality of sensors 209 located at or in close proximity to the distal end 207 [0110]…plurality of sensors may include optical image sensors [0112]); and an endoscope controller coupled to the endoscope (steering control system 210), wherein the endoscope controller: receives the image signal from the endoscope (image sensors configured to acquire image and video data [0013]; steering control system may utilize image processing algorithms to process image data input and provide a predicted steering direction and/or steering control signal as output for guiding the movement of the of the robotic endoscope [0084]); identifies, via a feature identification model, an anatomical feature in the image signal (performed automated feature extraction on the series of two or more images to determine a center position of the colon lumen [0037]); selects a steering target based on the identified anatomical feature (center of object of interest, which may be a polyp, lesion, adenoma or cancerous growth [0047]; steering control signal aligns the steering direction with the motion direction vector the object of interest [0044]); and automatically steers the distal end of the endoscope towards the steering target during distal motion of the distal end of the endoscope (control system tracks an object of interest by providing an adaptive steering control output signal to the robotic endoscope [0040], steering control signal aligns the steering direction with the motion direction vector of the object of interest [0044]; provide a predicted steering direction and/or steering control signal as output for guiding the movement of the of the robotic endoscope [0084]). Yeung fails to disclose wherein the endoscope controller determines, based on the image signal, that the endoscope is inside a passage of a subject.
In the same field of endeavor, Rainis teaches a substantially similar endoscope system, comprising an endoscope comprising a distal end with a camera producing an image signal (Fig. 1B & 2A: medical imaging endoscope 245 with distal tip section 250 [0034]; distal tip section of rigid shaft 115 may comprise multiple cameras 130 and 165); an endoscope controller coupled to the endoscope (Fig. 2A: main control unit 215 [0034]), wherein the endoscope controller: receives the image signal from the endoscope, and based on the image signal, determines that the endoscope is inside a passage of the subject (image classified designed to measure the distribution of colors in an image acquired from the video camera [0055]; using the histogram of RGB colors, controller verifies if the histogram has reached a predefined value indicating that the medical imaging endoscope is placed within a patient body [0059]); based on determining the endoscope is inside the passage, continue the medical procedure (system detects if endoscope device is “IN” or “OUT” of the body [0059]; if “OUT” is detected, the system progresses to step 440 to operate “OUT” actions of a conditional event such as stopping LED activities or declaring an “end of medical procedure”[0059]; if “IN” is detected, the system progresses to step 450 to operate “IN” actions of a conditional event such as start/stop recording the digital video, start/stop LED activity [0060]). In view of Rainis, 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 endoscope controller checks to ensure the endoscope is within a body cavity before proceeding with the medical procedure, as the conditional process prevents unnecessary steering, video recording, illumination and/or image processing from occurring while the endoscope is outside the body [0060, 0067].
Regarding claim 22, Yeung, modified by Rainis, discloses the endoscope automatic steering system of claim 21. Rainis further teaches wherein determining that the endoscope is inside the passage comprises determining that at least one of: the image signal is above a threshold of red percentage (controller verifies the position of the distal tip of the medical imaging endoscope as “IN” or “OUT” of the body by measuring and comparing the normalized histogram with a predefined value set [0059]; if maximum color value of the red channel has exceeded above the predefined value, controller proceeds to step 525 [ 0062], another step that leads to triggering an “IN” detection event).
Regarding claim 23, Yeung, modified by Rainis, discloses the endoscope automatic steering system of claim 21. Yeung further discloses wherein an indicator representing the steering target is overlaid on a displayed image based on the image signal (augmented information superimposed on the image frame may comprise a plurality of graphical elements to indicated location of a detected lumen center or a suggested steering direction [0166-0167]).
Regarding claim 25, Yeung, modified by Rainis, discloses the endoscope automatic steering system of claim 21. Yeung further discloses wherein endoscope controller is a video laryngoscope (robotic endoscope, although mentioned as possibly a colonoscope, may also be a laryngoscope if inserted through the mouth to view the larynx).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Yeung in view of Rainis and Motoki (US2017/0374292).
Regarding claim 24, Yeung, modified by Rainis, discloses the endoscope automatic steering system of claim 21. While Yeung teaches wherein sensor data or augmented data may be displayed on the display screen, Yeung fails to explicitly disclose an icon, indicative of the mode of steering, particularly, the semi-automatic steering mode, is displayed on a display screen. In the same field of endeavor, Motoki teaches a substantially similar endoscope system, comprising an endoscope and an endoscope controller (endoscope device 1 and CPU 47 [0023, 0034]), the controller configured to automatically perform bending control of a bendable endoscope shaft (front end portion 11a of insertion portion 11 [0024]; CPU 47 automatically performs bending control [0058]) further disclosing wherein the endoscope controller causes a display of an automatic steering icon on a display screen of the endoscope controller (Fig. 7: automatic adjustment mode is a mode where bending control is automatically performed, and when executed, an icon 80 on the CPU display will indicate the automatic adjustment mode is executed [0075-0076]). In view of Motoki, 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 display screen displayed an icon indicating the steering mode of the endoscope system of Yeung, as it is well-known in the endoscope art that the icon will notify the operator that the endoscope is in automatic mode, a mode where the steering is automatically controlled, to prevent the operator from entering manual inputs that would interfere with the steering/bending control [0075].
Response to Arguments
Applicant's arguments regarding claim 11 filed on May 12, 2026 have been fully considered but they are not persuasive. Applicant argues that Yeung fails to teach or suggest at least “identifies a distal advancement of the endoscope based on the orientation signal or the image signal or both; based on identifying the distal advancement of the endoscope, generate instructions to automatically steer the distal end of the endoscope towards the steering target during the distal advancement; determines, based on the orientation signal or the image signal or both, that the distal advancement has stopped; and based on the distal advancement stopping, pausing automatically steering the distal end while the distal advancement remains stopped”, as recited in claim 11. The examiner respectfully disagrees. Yeung does teach a plurality of sensors, including proximity sensors, that “provide additional information about a relative position of the body portion relative to a colonic wall or lumen center or various motion properties of the colonoscope” [0112]. The additional information or sensor data may be supplied to the steering control module for determining the control signal or target direction [0113]. Therefore, the plurality of sensors, including an optical image sensor, touch/proximity sensors, motion sensors, or location sensors, identify distal advancement of the endoscope and contribute data to determine instructions to automatically steer the distal end of the endoscope.
Regarding claim 11, the applicant also argues that the distal advancement would already be known by the system based at least on the motors controlling the advancement. The examiner respectfully disagrees. The examiner cites a separate mode of operation wherein the distal advancement of the endoscope is manually controlled, and the steering is automatically controlled, appearing to be the semi-automated control [0107].
Applicant has amended claim 1 to include an inertia measurement unit, to which the examiner has cited Danna et al. (US2022/0361736) to teach wherein an inertia measurement unit to be a well-known alternative to proximity sensors, location sensors, and/or motion sensor for determining movement of an endoscope. Therefore, this argument is moot. Like applicant arguments to the rejection of claim 11, examiner cites a separate mode of operation wherein the distal advancement of the endoscope is manually controlled, and the steering is automatically controlled, appearing to be the semi-automated control [0107].
Regarding claim 21, applicant argues that the disclosures do not establish a prima facie rejection of obviousness and is persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Rainis. Although Rainis does not explicitly teach automated steering, Rainis does teach the process of determining whether the endoscope is inside or outside the patient’s body before performing automated steps, such as starting/stopping recording video or starting/stopping LED’s activities. Yeung, modified by Rainis to include the inside/outside body determination process, teaches the subject matter of claim 21.
For the reasons stated above, claims 1, 2, 4-16, 21-25 are rejected.
Conclusion
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/LI-TING SONG/Examiner, Art Unit 3795
/TIMOTHY J NEAL/Primary Examiner, Art Unit 3795
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