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 .
Response to Amendment
The amendment filed on 09/19/2025 has been entered. Claims 1-8 are pending.
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.
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.
Claim(s) 1, 2, 5, is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka (US 20100204547) in view of Fujita (US 20150216391) and further in view of Inoue (US 20170135557).
Regarding claim 1, Tanaka discloses an endoscope system (FIGS. 18, 24) comprising: an endoscope (endoscope system 201) that is configured to be inserted in and pulled out from a subject, and includes a tip portion provided with an imaging unit (image pickup section 215a; para [0271]) including an optical system (a light condensing optical system 226 that condenses the illumination light passed through the diaphragm 224 and supplies the illumination light to the incident end surface of the light guide 221. FIG. 18; Para [0275]) and an image sensor (image pickup section 215a; para [0271]);
a posture control sensor (A plurality of UPD 36a, 36b, 36c; FIGS. 4, 6B; Para [0067]- [0074]) that is arranged at the tip portion of the endoscope, and detects posture information (Displays the insertion shape. flexible tube portion 117; FIG. 24; Para [0074]) in at least three directions, a front-rear direction, an up-down direction, and a left-right direction, of the tip portion (A front-rear direction, an up-down direction, and a left-right direction is detected; and FIGS. 4, 6B; A plurality of UPD coils36a, 36b, 36c; Para [0067]-[0074]; Note the insertion shape data in FIG. 6A; coil coordinates data; FIG. 6C; para [0014]-[0016]; Display of insertion shape; FIGS. 18, 24; Para [0281]); and
a calculation device that calculates posture (PC main body 7; para [0088]), based on the posture information in the three directions detected by the posture control sensor (Shape is displayed in the display; an insertion shape image Ib1 of the insertion portion 111 based on the insertion shape image signal is displayed on the monitor 110b. FIGS. 18, 24; para [0234]),
stores in a memory (Memory 52) the posture information in the three directions detected by the posture control sensor (Shape data is stored with time; Para [0105]- [0107]; and displayed in the display; [0234]),
after the endoscope is inserted into the subject, calculates an amount of rotation of the tip portion from the initial state, when capturing an image of the subject (sensed data is taken and stored as temporal sequence; sensor coils Ca-Cm; FIG. 5; Para [0105]- [0107], [0110], [0114], [0127]; a-m coil coordinates (Xja, Yja, Zja),…. (Xjm, Xjm, Xjm); Note the insertion shape data in FIG. 6A; coil coordinates data in FIG. 6C; para [0014]-[0016]; Display of insertion shape; FIGS. 18, 24; Para [0281]; Since the shape of the insertion section is sensed with temporal (time) sequence of data and the sensed shape is displayed in a display, the data is taken before and after the insertion into a subject.), and
displays an indicator indicating the posture of the tip portion when the tip portion during capturing of an image is rotated from the initial state in the up-down direction (an insertion shape image 1b2 of the insertion portion 211 according to the insertion shape image signal is displayed on the monitor 210; para [0281]; Image pick up section 215a; para [0284]-[0285]; Sensed data is taken and stored as temporal sequence; para [0217]-[0106]) of the image in association with the image on a monitor.
Tanaka does not expressly disclose storing, as calibration data, the posture information in the three directions detected by the posture control sensor in an initial state that is before the endoscope is inserted into the subject and calculating presence or absence of deviation in the up-down direction of an image captured by the imaging unit, based on the posture information in the three directions detected by the posture control sensor, and
wherein the amount of rotation is rotation around an optical axis of the optical system, the optical axis extending in the front-rear direction of the tip portion.
Fujita is directed to an observation apparatus (abstract) and teaches storing, as calibration data, the posture information in the three directions detected by the posture control sensor in an initial state that is before the endoscope is inserted into the subject (An inserting state acquiring section is configured to acquire inserting state information of an inserting section 31, that is to be inserted into an insertion subject. Abstract; FIG. 5; Para [0054]-[0056]; Inserting state is used for calculation; FIG. 5; This information can be considered as calibration information.) and calculating presence or absence of deviation in the up-down direction of an image captured by the imaging unit, based on the posture information in the three directions detected by the posture control sensor (State before rotation, FIG. 8A; state after the rotation, FIG. 8B to indicate the change of the acquired image due to the rotation of the inserting section 31; FIGS. 8A, 8B; Para [0046], [0051]).
Inoue is directed to an endoscope system (abstract) and teaches wherein the amount of rotation is rotation around an optical axis of the optical system, the optical axis extending in the front-rear direction of the tip portion (Imaging part 22 is rotated around the optical axis and is displayed in a display; FIGS. 4, 6A; Para [0070], [0120]; claim 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tanaka’s system to include the state information of an insertion section in accordance with the teaching of Fujita so that Tanaka’s system is capable of using the initial state of the insertion section for calculating a posture of the tip of the endoscope after insertion.
Further, it would have been obvious to further modify Tanaka to calculate the rotation of the tip of the endoscope around the optical axis and display the tip posture in accordance with the teaching of Inoue so that rotation of the tip could be shown display. Since Tanaka already includes sensors for calculating rotational direction (FIG. 4), it would have been obvious to use such sensors to calculate rotation around the optical axis and display the rotation in a display.
Regarding claim 2, Tanaka discloses wherein the posture control sensor is arranged so that a relative position of the posture control sensor with respect to the image sensor is fixed (Position of coils 36a, 36b, 36c, 36a’, 36a’’ with respect to the image sensor is fixed; FIG. 4; Para [0036]).
Regarding claim 5, Tanaka discloses a drive device that fixes a transmission cable connecting from a proximal end portion to the tip portion of the endoscope at a proximal end portion side (Left/right direction bending wires 411, 41r. Para [0085]-[0087]), and applies a rotational force around an axial direction of the transmission cable to the tip portion via the transmission cable (The pulleys 42a, 42b are connected to a rotational axis of an UD motor 43a for up/down bending (driving) and a rotational axis of an RL motor 43b for left/right bending, , and rotated according to the rotation direction of the motors 43a, 43b which are rotatable normally and reversely. FIG.3; Para [0087]), wherein the calculation device calculates the rotational force for rotating the tip portion around the axial direction based on a difference between the posture information in the three directions detected by the posture control sensor after the endoscope is inserted into the subject and instructs the drive device to rotate the tip portion in the axial direction based on a calculation result of the rotational force (CPU controls the bending; Para [0104]; FIGS. 7, 13; Direction of endoscope distal end, and desired bending angle; FIG. 9; FIG. 10 provides processing function for generating desired bending angle from the current direction of endoscope.).
Tanaka does not expressly disclose calculating rotational force based the calibration data.
Fujita teaches calculating rotational force based on calibration data (An inserting state acquiring section is configured to acquire inserting state information of an inserting section 31, that is to be inserted into an insertion subject. Abstract; FIG. 5; Para [0054]-[0056]; Correction is added for the calculation using the shape and state information; FIG. 5; This correction can be considered as calibration information.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Tanaka to include the calibration information (i.e., initial position/posture state of the insertion section) in the rotation so that accurate rotation and bending could be determined and a posture of the tip of the endoscope after insertion could be accurately calculated.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka (US 20100204547) in view of Fujita (US 20150216391) and further in view of Inoue (US 20170135557) and Jensen (US 20200100663).
Regarding claim 3, Tanaka does not expressly disclose wherein the imaging unit and the posture control sensor are fixed by a sealing material filled in the tip portion.
Jensen is directed to method for manufacture of a tip part for an endoscope and teaches wherein the imaging unit and the posture control sensor are fixed by a sealing material filled in the tip portion (Step (f) may include injecting the adhesive into the spacing of the distal end segment of the bending section so that a gap in the overlap of the proximal end of the exterior housing and the distal end of the distal end segment of the bending section is filled with the adhesive, potentially so that the adhesive seals the gap in the overlap and/or attaches the proximal end of the exterior housing and the distal end of the distal end segment of the bending section to each other by the overlap. Para [0103]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tanaka in accordance with the teaching of Jensen to fill the spacing in the distal end segment by a sealing material so that the sensors and other elements are positioned compactly in the distal end segment.
Claim(s) 4, 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka (US 20100204547) in view of Fujita (US 20150216391) and further in view of Inoue (US 20170135557) and Barbagli (US 20180078318).
Regarding claim 4, Tanaka does not expressly disclose wherein the calculation device corrects, using the calibration data, the posture information in the three directions detected by the posture control sensor after the endoscope is inserted into the subject.
Barbagli is directed to a method performed by a computing system comprises receiving shape information for an elongate flexible portion of a medical instrument (abstract) and teaches wherein the calculation device corrects, using the calibration data (If the insertion stage has a curved or otherwise non-linear shape, the calibration procedure may determine the non-linear shape so that for every measurement of the position device, the position and orientation of the portion 616 in the surgical environment may be determined. Para [0071]; For each position of the reference portion 616, the position and orientation of the constraint structure 622 in the surgical reference frame may be predicted by combining the calibrated insertion position information and the shape information. Para [0072]), the posture information in the three directions detected by the posture control sensor after the endoscope is inserted into the subject.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tanaka in accordance with the teaching of Barbagli to provide the posture/shape information by using the calibration data so that correct posture/shape information could be determined and used.
Regarding claim 6, Tanaka does not expressly disclose wherein the calculation device further calculates a direction in which the tip portion is rotated in the axial direction based on the difference.
Barbagli teaches wherein the calculation device further calculates a direction in which the tip portion is rotated in the axial direction based on the difference (For each position of the reference portion 616, the position and orientation of the constraint structure 622 in the surgical reference frame may be predicted by combining the calibrated insertion position information and the shape information. Para [0072]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tanaka so that the tip movement could be controlled by way of referencing a posture state for accurate control of the tip movement.
Regarding claim 7, Tanaka is silent regarding wherein the calculation device repeatedly executes the calculation of the rotational force and the instruction to the drive device.
Barbagli teaches a wherein the calculation device repeatedly executes the calculation of the rotational force and the instruction to the drive device (For each position of the reference portion 616, the position and orientation of the constraint structure 622 in the surgical reference frame may be predicted by combining the calibrated insertion position information and the shape information. Para [0072]; The operation is performed in real-time. Para [0050]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tanaka in accordance with the teaching of Barbagli to repeatedly execute the calculation so that the instruction could be update in real time.
Regarding claim 8, Tanaka does not expressly disclose wherein the difference is a value in a predetermined range centered on zero.
Barbagli teaches a wherein the difference is a value in a predetermined range centered on zero (For each position of the reference portion 616, the position and orientation of the constraint structure 622 in the surgical reference frame may be predicted by combining the calibrated insertion position information and the shape information. Para [0072]).
Response to Arguments
Applicant' s arguments submitted on 9/19/2025 have been fully considered. In view of amendment, the previous rejection dated 7/3/2025 has been withdrawn. However, a new rejection has been made in view of amendment.
Regarding newly recited feature – calculation of rotation around an optical axis, a new art Inoue (US 20170135557) has been relied upon.
Inoue is directed to an endoscope system (abstract) and teaches wherein the amount of rotation is rotation around an optical axis of the optical system, the optical axis extending in the front-rear direction of the tip portion (Imaging part 22 is rotated around the optical axis and the image is displayed in a display; FIGS. 4, 6A; Para [0070], [0120]; claim 1).
See rejection under 103 above.
In page 8 of the response, the applicant further argues that –
Tanaka does not include an image linked user interface.
Tanaka does not appear to display any indicator in association with the image.
Tanaka focuses on displaying the insertion shape, but does not provide a user specific interface that combines and displays a rotational indicator referenced to an up down direction of the endoscopic image itself.
In para [0234], Tanaka discloses that the insertion shape of the insertion portion is estimated based on the three-dimensional coordinate information (X, Y, and Z coordinate sensors; FIG. 4) outputted from the source coil position/orientation detecting section 146. The estimated insertion shape is outputted and displayed. Thus, outputted shape includes rotation of the tip. This shape display is based on the data received from the sensors. Therefore, as the shape changes, the display of the shape changes. Therefore, this shape can be considered as indicator associated with the image.
Regarding “an image linked user interface” and “displaying of a rotational indicator,” the examiner’s position is that these features are not specifically recited in the claim yet.
Accordingly, applicants’ arguments are not persuasive at this time.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANKAR R GHIMIRE whose telephone number is (571)272-0515. The examiner can normally be reached 8 AM - 5 PM.
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, 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.
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.
/SHANKAR RAJ GHIMIRE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
11/13/25