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 .
Election/Restrictions
Applicant’s election of Invention I, Species A of each of Groups I-III in the reply filed on 11/19/2025 is acknowledged. Applicant’s election is readable on claims 1-14 and 18. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Rejections - 35 USC § 112
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.
Claims 1-14 and 18 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 limitation “the processor configured to: … calculate a corrected rotation amount by correcting the first rotation amount based on the second rotation amount” in Lines 13-16, wherein it’s not clear what’s meant by the rotation amount being “corrected” since the claim fails to provide clarity with respect what the “corrected rotation amount” is meant to accomplish. Appropriate correction is required.
Claim 2 recites the limitation “wherein the first sensor is configured to determine a moving amount indicating an amount by which the insertion unit moves in a longitudinal direction of the insertion unit when the insertion unit is inserted into the subject” in Lines 1-4, wherein Claim 1 indicates the first sensor is meant to detect rotational movement of the insertion unit and it’s unclear how the same sensor is able to track rotational movement and longitudinal movement of the insertion unit since it’s the examiner’s understanding these would need to be separate sensors within the sensor unit. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tojo et al. (US Patent Application Publication No. 2018/0292199, hereinafter Tojo).
In regard to claim 1, Tojo discloses an insertion state determination system (40), comprising:
a sensor unit (40) including a first sensor (103) configured to determine a first rotation amount when an elongated insertion unit of an endoscope device is inserted into a subject (Fig. 7, Par. 129,131),
wherein the first rotation amount indicates a rotation amount of the insertion unit around a center axis of the insertion unit (Par. 129), and wherein a hole through which the insertion unit passes is formed in the sensor unit (the insertion unit is attached within an opening at a distal end of the handle/sensor unit (40));
a second sensor (107) that is disposed in the sensor unit or an object fixed to the sensor unit (Fig. 7) and is configured to determine a second rotation amount indicating a rotation amount of the sensor unit around the center axis when the insertion unit is inserted into the subject (Par. 129,131); and
a processor (70) configured to: acquire the first rotation amount and the second rotation amount; and calculate a corrected rotation amount by correcting the first rotation amount based on the second rotation amount (Par. 131 teaches of adjusting the first and/or second rotational change amounts based on the other of the first and/or second rotational change amounts).
In regard to claim 18, Tojo teaches wherein the processor is configured to calculate the corrected rotation amount by performing addition or subtraction using the first rotation amount and the second rotation amount (Par. 131).
Claims 1-6 and 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gruhler (US Patent Application Publication No. 2015/0265367).
In regard to claim 1, Gruhler discloses an insertion state determination system (1, Fig. 1), comprising:
a sensor unit (1) including a first sensor (a first of the plurality of sensors (20)) configured to determine a first rotation amount when an elongated insertion unit (100) of an endoscope device is inserted into a subject (Par. 57, Figs. 2, 5),
wherein the first rotation amount indicates a rotation amount of the insertion unit around a center axis of the insertion unit (Par. 57), and wherein a hole (via hole within inner housing (5), Fig. 5) through which the insertion unit passes is formed in the sensor unit (Figs. 1, 2);
a second sensor (a second of the plurality of sensors (20)) that is disposed in the sensor unit or an object fixed to the sensor unit (Fig. 5) and is configured to determine a second rotation amount indicating a rotation amount of the sensor unit around the center axis when the insertion unit is inserted into the subject (Par. 57, wherein a rotation amount of the sensor unit can be detected by rotating the sensor unit around the insertion unit (100)); and
a processor (Par. 32 teaches of an output unit to detect longitudinal and rotational displacement) configured to: acquire the first rotation amount and the second rotation amount (first and second sensors (20) detect rotational amounts of the insertion unit and/or sensor unit); and calculate a corrected rotation amount by correcting the first rotation amount based on the second rotation amount (detection information of the sensors (20) are used in conjunction with each other to determine the rotation amount of the insertion unit by detecting patterns on the insertion unit, Par. 60).
In regard to claim 2, Gruhler teaches wherein the first sensor is configured to determine a moving amount indicating an amount by which the insertion unit moves in a longitudinal direction of the insertion unit when the insertion unit is inserted into the subject (Par. 57).
In regard to claims 3 and 4, Gruhler teaches wherein the processor is configured to record insertion state information including the corrected rotation amount and the moving amount associated with each other on a recording medium (Par. 13,32, 60).
In regard to claims 5 and 6, Gruhler teaches wherein the second sensor is configured to determine a posture of the sensor unit, and wherein the insertion state information further includes posture information that is associated with the moving amount and indicates the posture (the second sensor (20) is able to determine an orientation of the sensor unit with respect to the insertion unit by recognizing patterns on the insertion unit, Par. 13,32).
In regard to claims 11 and 12, Gruhler teaches wherein the processor is configured to generate operation information indicating an operation required for inserting the insertion unit into the subject by using the corrected rotation amount calculated in real time and the corrected rotation amount included in the insertion state information recorded on the recording medium (Par. 13).
In regard to claims 13 and 14, Gruhler teaches wherein the processor is configured to calculate a difference between the corrected rotation amount calculated in real time and the corrected rotation amount included in the insertion state information recorded on the recording medium and generate the operation information by using the difference (Par. 11, 55 teaches that as the pattern (104) changes a difference between the previously recorded pattern and the newly recorded pattern in order to determine penetration depth and rotational orientation of the insertion unit).
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.
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Gruhler (US Patent Application Publication No. 2015/0265367) in view of Fujita et al. (US Patent Application Publication No. 2015/0216391, hereinafter Fujita).
In regard to claims 7 and 8, Gruhler does not expressly teach wherein the insertion unit includes a third sensor that is disposed in a distal end portion including a distal end of the insertion unit and is configured to determine a posture of the distal end portion, and wherein the insertion state information further includes posture information that is associated with the moving amount and indicates the posture.
Fujita teaches an analogous endoscope (3, Fig. 11) comprising a unit (4, Fig. 11) for determining rotation and insertion depth of an endoscope as well as providing an endoscope with a fiber shape sensor (9) for detecting a bending state of the insertion section therefore enabling the bending state of the insertion section can be correlated with the rotation and insertion depth of the endoscope (Par. 106).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the insertion unit of Gruhler with the fiber shape sensor of Fujita enabling a bending state of the endoscope to be tracked within a body cavity providing a user with an accurate position and orientation of the endoscope while performing a procedure.
In regard to claims 9 and 10, Gruhler teaches wherein a distal end portion including a distal end of the insertion unit is bendable inside the subject based on a bending instruction input through an input device that accepts an operation performed by a user (the distal end portion of the endoscope is capable of being bent via an input unit). Gruhler does not expressly teach wherein the insertion state information further includes a bending amount that is associated with the moving amount and indicates an amount by which the distal end portion has bent.
Fujita teaches an analogous endoscope (3, Fig. 11) comprising a unit (4, Fig. 11) for determining rotation and insertion depth of an endoscope as well as providing an endoscope with a fiber shape sensor (9) for detecting a bending state of the insertion section therefore enabling the bending state of the insertion section can be correlated with the rotation and insertion depth of the endoscope (Par. 106).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the insertion unit of Gruhler with the fiber shape sensor of Fujita enabling a bending state of the endoscope to be tracked within a body cavity providing a user with an accurate position and orientation of the endoscope while performing a procedure.
In regard to claim 18, Tojo teaches wherein the processor is configured to calculate the corrected rotation amount by performing addition or subtraction using the first rotation amount and the second rotation amount (Par. 131).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN N HENDERSON whose telephone number is (571)270-1430. The examiner can normally be reached Monday-Friday 6am-5pm (PST).
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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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/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 February 7, 2026