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 .
Response to Amendment
Amendments to claims 1, 10, 14, 16, 18, 20 of 7/23/2026 acknowledged and entered.
Cancellation of claims 8, 9, 17, 19 of 7/23/2026 acknowledged and entered.
New claims 21-24 of 7/23/2026 acknowledged and entered.
Response to Arguments
Applicant's arguments filed 7/23/2026 have been fully considered but they are not persuasive.
Regarding p. 10, para. 2, applicant asserts that a “difference” is not taught. However, applicant later asserts in para. 3 that a comparison between measurements does occur. Hence, the values measured by proximal and distal sensors are different, hence there is a difference that is calculated and measured. It is not made clear from the presented arguments or the previous interview whether applicant is making an assertion that the mathematical subtraction calculation need be explicitly involved in some way (i.e. a mathematical “difference”), but by examiner’s evaluation, in Yamamoto, the differences (i.e. the dissimilarities or variances) between a proximal and distal sensed positional value are employed in a calculation, hence a “distance difference” is measured.
Examiner will maintain standing rejections to claims 1 and 18 in light of unpersuasive arguments.
Applicant’s arguments with respect to claim(s) 16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claim(s) 1, 8-14, 16-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yamamoto (US 20170281049 A1).
Regarding claim 1, Yamamoto teaches A system for detecting bowing or looping events during a medical procedure, the system comprising:
a medical device including:
an insertion portion (fig. 2, element 203, [0061], insertion section 203) having a proximal portion and a distal end; and
a distal sensor (fig. 4, element 230, [0066], plurality of position sensors 230) disposed at the distal end of the insertion portion, wherein the distal sensor is configured to measure an acceleration or a velocity of the distal end of the insertion portion or a distance traveled by the distal end of the insertion portion ([0127], distance moved by the sensor is recorded);
a proximal sensor (fig. 4, element 230, [0066], plurality of position sensors 230) configured to measure an acceleration or a velocity of the proximal portion of the insertion portion or a distance traveled by the proximal portion of the insertion portion ([0127], distance moved by the sensor is recorded); and
a controller configured to compare one or more of the acceleration, the velocity, or the distance measured by the distal sensor to the acceleration, the velocity, or the distance measured by the proximal sensor (fig. 1, element 110, [0083], position acquisition unit 110),
wherein the comparison includes determining one or more of (a) an acceleration difference between the acceleration measured by the proximal sensor and the acceleration measured by the distal sensor, (b) a velocity difference between the velocity measured by the proximal sensor and the velocity measured by the distal sensor, or (c) a distance difference between the distance measured by the proximal sensor and the distance measured by the distal sensor ([0083], position acquisition unit 110 performs processing for the position information on the respective portions of the insertion section 203).
Regarding claim 10, Yamamoto teaches The system of claim 1,
wherein the controller is further configured to compare one or more of the acceleration difference, the velocity difference, or the distance difference to a respective threshold (fig. 21, element a1, [0134], threshold a1 tracks attention points which would create danger when extended in a position over the threshold).
Regarding claim 11, Yamamoto teaches The system of claim 10,
wherein the controller is configured to determine that looping or bowing of insertion portion is occurring upon determining that one of more of the acceleration difference, the velocity difference, or the distance difference is greater than the respective threshold ([0006], notification if a loop is formed).
Regarding claim 12, Yamamoto teaches The system of claim 10,
wherein the controller is configured to generate an alert upon determining that one of more of the acceleration difference, the velocity difference, or the distance difference is greater than the respective threshold, wherein the alert is auditory, visual, or tactile (fig. 21, element a1, [0134], threshold a1 tracks attention points which would create danger when extended in a position over the threshold and provides a warning).
Regarding claim 13, Yamamoto teaches The system of claim 10,
wherein the controller provides instructions to automatically adjust a scope upon determining that one of more of the acceleration difference, the velocity difference, or the distance difference is greater than a respective threshold (fig. 21, element a1, [0134], threshold a1 tracks attention points which would create danger when extended in a position over the threshold and provides a warning to alert a user to change operation methods).
Regarding claim 14, Yamamoto teaches The system of claim 1,
wherein the controller is configured to determine that looping or bowing of insertion portion is occurring upon determining that the difference between the proximal distance the distal distance is greater than a predetermined threshold for a predetermined interval of time ([0006], notification if a loop is formed).
Regarding claim 18, Yamamoto teaches A medical method comprising:
receiving a proximal measurement from a proximal sensor (fig. 4, element 230, [0066], plurality of position sensors 230), wherein the proximal measurement indicates a velocity or acceleration of a proximal portion of an insertion portion of a medical device or a distance traveled by the proximal portion of the insertion portion of the medical device ([0127], distance moved by the sensor is recorded);
receiving a distal measurement from a distal sensor (fig. 4, element 230, [0066], plurality of position sensors 230), wherein the distal measurement indicates a velocity or acceleration of a distal portion of an insertion portion of a medical device or a distance traveled by the distal portion of the insertion portion of the medical device ([0127], distance moved by the sensor is recorded);
comparing the proximal measurement to the distal measurement by determining a difference between the proximal measurement and the distal measurement ([0083], position acquisition unit 110 performs processing for the position information on the respective portions of the insertion section 203);
based on the comparison between the proximal measurement and the distal measurement, determine that a bowing event or a looping event has occurred or is occurring; and
providing an alert that the bowing or looping event has occurred or is occurring ([0006], notification if a loop is formed).
Regarding claim 20, Yamamoto teaches The method of claim 18,
further comprising: comparing the difference to a predetermined threshold fig. 21, element a1, [0134], threshold a1 tracks attention points which would create danger when extended in a position over the threshold and provides a warning to alert a user to change operation methods).
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto as applied to claim 1 above, and further in view of Komp (US 20210379332 A1).
Regarding claim 2, Yamamoto teaches The system of claim 1,
Yamamoto does not explicitly teach wherein the distal sensor is an inertial measurement unit (IMU).
However, Komp teaches wherein the distal sensor is an inertial measurement unit (IMU) ([0008], inertial measurement unit located at a distal end of a catheter).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor of Yamamoto to be an inertial measurement unit as taught in Komp in order to measure and record the orientation of the catheter (Komp [0010]).
Claim(s) 3-7, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto as applied to claim 1 above, and further in view of Krimsky (US 20180256263 A1).
Regarding claim 3, Yamamoto teaches The system of claim 1,
Yamamoto does not explicitly teach wherein the proximal sensor includes a fiber optic sensor or a camera.
However, Krimsky teaches wherein the proximal sensor includes a fiber optic sensor or a camera (fig. 2, element 94, [0045], EM sensor 94 or any other potential sensor allows indicators 122 to pass through and detect the color or physical dimensions of indicators 122).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor of Yamamoto to be a camera as taught in Krimsky in order to measure a change in visible indicia for indicators (Krimsky [0045]).
Regarding claim 4, Yamamoto in view of Krimsky teaches The system of claim 3,
Further, Krimsky teaches wherein the insertion portion includes a plurality of stripes, wherein a first set of the plurality of stripes has a first property, wherein a second set of the plurality of stripes has a second property, and wherein the second property differs from the first property ([0045], indicators may take on any shape including stripes, with properties such as color or physical dimension varying between indicators).
Regarding claim 5, Yamamoto in view of Krimsky teaches The system of claim 4,
Further, Krimsky teaches wherein the proximal sensor is configured to sense a passing of the plurality of stripes to determine the distance traveled by the proximal portion of the insertion portion ([0020], distance between distal portion of surgical instrument and luminal device tracked by indicators).
Regarding claim 6, Yamamoto in view of Krimsky teaches The system of claim 4,
Further, Krimsky teaches wherein the proximal sensor is configured to sense a passing of the plurality of stripes to determine the velocity of the distal end ([0041], position and time data are recorded, which is the device’s velocity).
Regarding claim 7, Yamamoto teaches The system of claim 1,
Yamamoto does not explicitly teach wherein the proximal sensor is attached to a patient’s skin.
However, Krimsky teaches wherein the proximal sensor is attached to a patient’s skin (fig. 2, element 200, [0046], access instrument 200 contains the sensor 94).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor of Yamamoto to be disposed in a trocar as taught in Krimsky in order to provide a stable tracking system point of reference (Krimsky [0040]).
Regarding claim 15, Yamamoto teaches The system of claim 1,
wherein the insertion portion is configured to be inserted into a patient’s body ([0061], endoscope insertion section 203)
Yamamoto does not explicitly teach wherein the proximal sensor is configured to remain outside of the patient’s body.
However, Krimsky teaches wherein the proximal sensor is configured to remain outside of the patient’s body (fig. 2, element 200, [0046] access instrument is attached to the skin to provide an access point, a portion of it remaining outside the body).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor of Yamamoto to be disposed in a trocar as taught in Krimsky in order to provide a stable tracking system point of reference (Krimsky [0040]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto in view of Lee (US 20170164869 A1).
Regarding claim 16, Yamamoto teaches A system for detecting bowing or looping events during a medical procedure, the system comprising:
a medical device including an insertion portion (fig. 2, element 203, [0061], insertion section 203) having a proximal portion and a distal portion, wherein the distal portion includes a first sensor (fig. 4, element 230, [0066], plurality of position sensors 230) configured to measure a first parameter of the distal portion;
a second sensor (fig. 4, element 230, [0066], plurality of position sensors 230) configured to measure a second parameter of the proximal portion;
a controller configured to:
determine a difference between the first and second parameters;
compare the difference to a threshold in order to determine whether looping or bowing of the insertion portion has occurred or is occurring ([0083], position acquisition unit 110 performs processing for the position information on the respective portions of the insertion section 203; fig. 21, element a1, [0134], threshold a1 tracks attention points which would create danger when extended in a position over the threshold; [0006], notification if a loop is formed).
Yamamoto does not explicitly teach wherein the first and second parameters are acceleration,
However, Lee teaches wherein the first and second parameters are acceleration ([0009], The first sensor unit and the second sensor units can include any suitable position and/or orientation tracking sensors to generate position and/or orientation tracking data. For example, The first sensor unit can include an accelerometer, a magnetometer, and a gyroscope that generate the position and orientation tracking data for the distal end of the endoscope. As another example, each of the plurality of second sensor units can include an accelerometer and a magnetometer that generate the position tracking data for the respective location),
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensors of Yamamoto to be accelerometers as taught in Lee in order to track the position of an endoscope within a patient (Lee [0009]).
Regarding claim 21, Yamamoto teaches The system of claim 1
Yamamoto does not explicitly teach wherein the one or more of the acceleration, the velocity, or the distance measured by the distal sensor is the acceleration measured by the distal sensor,
wherein the acceleration, the velocity, or the distance measured by the proximal sensor is the acceleration measured by the proximal sensor, and wherein the comparison includes determining the acceleration difference between the acceleration measured by the proximal sensor and the acceleration measured by the distal sensor.
However, Lee teaches wherein the one or more of the acceleration, the velocity, or the distance measured by the distal sensor is the acceleration measured by the distal sensor ,
wherein the acceleration, the velocity, or the distance measured by the proximal sensor is the acceleration measured by the proximal sensor ([0009], The first sensor unit and the second sensor units can include any suitable position and/or orientation tracking sensors to generate position and/or orientation tracking data. For example, The first sensor unit can include an accelerometer, a magnetometer, and a gyroscope that generate the position and orientation tracking data for the distal end of the endoscope. As another example, each of the plurality of second sensor units can include an accelerometer and a magnetometer that generate the position tracking data for the respective location), and
wherein the comparison includes determining the acceleration difference between the acceleration measured by the proximal sensor and the acceleration measured by the distal sensor ([0017], As another example, generating position tracking data for the locations along the length of the endoscope comprises measuring accelerations of each of the second sensor units via an accelerometer included in the respective second sensor unit).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensors of Yamamoto to be accelerometers as taught in Lee in order to track the position of an endoscope within a patient (Lee [0009]).
Regarding claim 21, Yamamoto in view of Lee teaches The system of claim 21,
Further, Yamamoto teaches wherein the controller is configured to compare the acceleration to a threshold indicative of looping or bowing (fig. 21, element a1, [0134], threshold a1 tracks attention points which would create danger when extended in a position over the threshold).
Regarding claim 23, Yamamoto in view of Lee teaches The system of claim 16,
Further, Yamamoto teaches wherein the controller is configured to determine that looping or bowing of the insertion portion is occurring upon determining that the difference between the acceleration measured by the first sensor and the acceleration measured by the second sensor is greater than a predetermined threshold for a predetermined interval of time (fig. 21, element a1, [0134], threshold a1 tracks attention points which would create danger when extended in a position over the threshold).
Regarding claim 24, Yamamoto teaches The method of The method of claim 18,
Yamamoto does not explicitly teach wherein the proximal measurement and the distal measurement are each acceleration.
However, Lee teaches wherein the proximal measurement and the distal measurement are each acceleration ([0009], The first sensor unit and the second sensor units can include any suitable position and/or orientation tracking sensors to generate position and/or orientation tracking data. For example, The first sensor unit can include an accelerometer, a magnetometer, and a gyroscope that generate the position and orientation tracking data for the distal end of the endoscope. As another example, each of the plurality of second sensor units can include an accelerometer and a magnetometer that generate the position tracking data for the respective location).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensors of Yamamoto to be accelerometers as taught in Lee in order to track the position of an endoscope within a patient (Lee [0009]).
Conclusion
THIS ACTION IS MADE FINAL. 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 TIMOTHY TUAN LUU whose telephone number is (703)756-4592. The examiner can normally be reached Monday-Tuesday, Thursday-Friday.
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, Michael Carey can be reached at 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY TUAN LUU/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795
