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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/30/2025 has been entered.
Cited Prior Art
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all relevant portions of the cited prior art if traversing a rejection based on the cited prior art.
Claim Objections
Claim 25 is objected to because of the following informalities:
Claim 25 contains a misspelling: “poisition"
Appropriate correction is required.
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.
Claim(s) 1, 6, 11, 24, 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Douglas et al. US11,207,133 and further in view of Cobanoglu et al US2018/0024622, Seth US2020/0011669, Barber US2021/0233429, and Bell US 20150223903 A1.
For claim 1,
Douglas discloses “A device comprising:
a surgical tool (scalpel/knife 2330; fig 23; 27:55-28:46);
a display monitor (head display unit 12:48-49);
an inertial measurement unit (IMU) (IMU 2315; fig 23) ”;
a processor (image processor 906/computer 2300; fig 23; 13:62-14:8 describes the processor along with the program 914 running thereon of steps shown in fig 1 involved with geo-registering tools such as the scalpel using IMU data, including determining position and orientation tracking of the tools 28:9-11);
software, executing on the processor for performing the functions of:
receiving data indicative of an (x, y, z) position of the surgical tool (program 914 running on computer 2300, steps shown in fig 1 involved with geo-registering tools such as the scalpel using IMU data, including determining position and orientation tracking of the tools 28:9-11 and describes the IMUs are used for xyz position determination);
determining an absolute orientation of the surgical tool based on the pitch, roll and yaw information (28:9-11).
Douglas does not disclose:
an inertial measurement unit “disposed on a printed flexible circuit board and attached to or integrated with the surgical tool”. To this end, Douglas does describe the components as circuits, but does not specifically describe the details of the IMU arrangement, i.e. the flexible circuit board. Cobanoglu teaches the particulars of the IMU arrangement, i.e. IMUs mounted on a Kapton flexible circuit board (0047, 0058; to further clarify, 0024 describes the IMU’s may be formed on ordinary PCB’s and may be coated with coatings; 0024 “The IMU's may be formed on ordinary PCB's” and 0047 further describes “Ribbons formed of flexible material such as textile or plastic or conductive yarns, electrically couple the IMU's and microprocessor and any other devices, and are also disposed inside the seams to provide a true wearable activity tracker with the flexible circuit boards and the IMU's contained within the seams”). Since Douglas fails to disclose the nature of the IMU circuit, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used any suitable mounting arrangement known in the art, including the one taught by Cobanoglu, to achieve the predictable result of electrically connecting the IMU circuit.
“the IMU comprising a gyroscope, a magnetometer, and an accelerometer; the gyroscope, magnetometer and accelerometer each being 3-axis devices and each providing (x, y, z) position information with respect to a coordinate system defined in a CAD model of a surgical field ”. To this end, Douglas does disclose tracking the surgical tool based on pitch, roll, and yaw along with xyz position (28:9-11 describes the IMUs are used for xyz position determination), simply lacking a specific disclosure involving the IMU type. As such, Seth teaches in the same field of endeavor, tracking a position/location and orientation of an object using IMUs which include a gyroscope, magnetometer, and an accelerometer (0046) and fusing the data (0003 provides the background for motion tracking aspects of Seth’s device, specifically, detecting the precise position and location of an object by recognizing rotation – pitch, yaw, and roll and translational movements; and 0040 describes the treatment specifically e.g. yaw) for this purpose (0041). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Seth into the invention of Douglas in order to configure the device, e.g. as claimed because it helps to correct for drift (0037).
determining an absolute orientation of the surgical tool based on the pitch, roll and yaw information “with respect to the coordinate system”; “localizing the surgical tool within the CAD model and displaying the localization of the tool on the display monitor”. Barber teaches in the same field of endeavor, an endoscopic surgical simulation system (0087) which uses CAD models of a surgical field, i.e. physical head model (0087) to track the location and angle of a surgical tool, i.e. endoscope (0087), in a pre-planned surgical path, i.e. the system is configured for preoperative planning and practice (0090) and updates the path and position of the device, i.e. track the device (0087). Additionally, 0066 describes tracking the tool location in the CAD model, i.e. providing real time updates of the tool with respect to a preplanned path as the claimed updating. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Barber into the invention of Douglas in order to configure the device e.g. as claimed because it provides a manner to determine the location of a tip of the device within a particular section of the surgical field and to determine a field of view of an endoscope in the simulated surgical field (“determine a location of a tip of the device representing an endoscope within a nasal cavity of the physical head model, and to determine a field of view of an endoscope” 0087). Barber does not specify the nature of the CAD model, i.e. utilizing a coordinate system, but Bell teaches in the same field of endeavor, a CAD model tracking system using a coordinate system (0140, 0165). Since Barber fails to disclose the nature of the CAD system, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used any suitable CAD system known in the art, including the one taught by Bell, to achieve the predictable result of surgical tool tracking with a CAD system.
Modified Douglas discloses software, executing on the processor for performing the functions of:
receiving data indicative of an (x, y, z) position of the surgical tool “from each of the gyroscope, the magnetometer and the accelerometer (Seth: 0041, 0046)”
“fusing the (x, y, z) positions received from the IMU to provide pitch, roll, and yaw information (Seth: 0041, 0046; 0003 provides the background for motion tracking aspects of Seth’s device, specifically, detecting the precise position and location of an object by recognizing rotation – pitch, yaw, and roll and translational movements; and 0040 describes the treatment specifically e.g. yaw; also fig 4D describes step 432 which determines a position and rotation based on data from each of the IMUs)”; and
determining an absolute orientation along pitch, roll and yaw axes of the surgical tool “based on the fused data (Seth: 0041, 0046)”.
For claim 6, Douglas discloses “The device of claim 1 further comprising means for communicating data generated by the IMU off-board (27:55-28:46 describes send/receive elements 2314 and wireless capabilities for each)”.
For claim 11, Douglas discloses “The device of claim wherein the support circuit defined on the flexible circuit board includes components supporting wireless communication of data generated by the IMU off-board (27:55-28:46 describes send/receive elements 2314 and wireless capabilities for each)”.
For claim 24, Douglas discloses “The device of claim 1 wherein: the localization of the tool is displayed with respect to a pre-planned surgical path; and the pre-planned surgical path is updated based on the localization of the surgical tool (fig 15A-C with corresponding text describes the tool localization and surgical path planning)”.
For claim 25, Douglas discloses “The device of claim 22 wherein a movement and position of a distal tip of the surgical tool is calculated from the determined absolute orientation of the surgical tool (fig 6 e.g. step 2; 12:33-49 describes tool tracking)”.
Claim(s) 2, 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Douglas, Cobanoglu, Seth, Barber, and Bell as applied to claim 1 above, and further in view of Nakamura et al. US4,495,546.
For claim 2, Douglas does not disclose “The device of claim 1 wherein the flexible circuit board comprises copper circuit pathways defined on a temperature-stable polyimide film and a plurality of surface-mounted integrated circuits”. Nakamura teaches the particulars of the flexible circuit board, including copper circuit pathways defined on a temperature stable polyimide film and a plurality of surface-mounted integrated circuits (figs 2, 3; 3:22-48). Since Douglas fails to disclose the nature of the flexible circuit board, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used any suitable flexible circuit board known in the art, including the one taught by Nakamura, to achieve the predictable result of providing a flexible circuit board for an IMU.
For claim 4, modified Douglas discloses “The device of claim 2 further comprising a protective layer of a polyimide film on the defined circuit, the polyimide film having cutouts for the plurality of surface-mounted integrated circuits (Nakamura: figs 2, 3; 3:22-48)”.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Douglas, Cobanoglu, Seth, Barber, and Bell as applied to claim 1 above, and further in view of Onoda et al. US 20110098533 A1.
For claim 5, Douglas does not disclose “The device of claim 1 wherein each of the gyroscope, the magnetometer and the accelerometer is a triple-axis MEMS sensor”. Onoda teaches the particulars of the IMU, as a three axis MEMS sensor (fig 20, 0139). Since Douglas fails to disclose the particular IMU, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used any suitable IMU known in the art, including the one taught by Onoda, to achieve the predictable result of providing for an IMU.
Claim(s) 7, 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Douglas, Cobanoglu, Seth, Barber, and Bell as applied to claim 6 above, and further in view of Lahr et al. US9,891,705.
For claim 7, modified Douglas discloses transmission of the IMU data (27:55-28:46), but does not disclose “The device of claim 6 wherein the software performs the further function of: receiving a metric indicating a calibration confidence for each reading received from the IMU; filtering the received data based on the received metric; and outputting filtered data indicative of movements of the IMU in three dimensional space”. Lahr teaches in the same field of endeavor, calibrating IMU data and providing a confidence level (i.e. a metric indicative of data validity) of the acquired data using a processor (7:62-8:30) along with conditionally updating the IMU based on a confidence threshold (step 220; 8:25+). Additionally, Seth teaches in the same field of endeavor, providing dynamic calibration of IMU units, i.e. real time calibration (0048). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Lahr into the invention of Douglas in order to configure the device e.g. as claimed because it provides a measure of confidence and accuracy control in the acquired data which can be preset/predetermined by an operator (Lahr: 8:25-30) and allows dynamic calibrations occurring multiple times as necessary (Seth: 0048).
For claim 8, modified Douglas as in claim 7 discloses “The device of claim 6 wherein the software performs the further function of calibrating the IMU and initializing its operational parameters for data acquisition (Lahr: 4:54, 8:25-30).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Douglas, Cobanoglu, Seth, Barber, and Bell as applied to claim 1 above, and further in view of Anagnos US2021/0067896.
For claim 21 Douglas does not disclose “The device of claim 1 wherein the IMU further comprises: one or more programmable digital filters to limit the range of measurement data from the magnetometer; and a 1x average filter applied data collected from the gyroscope and accelerometer”. Anagnos teaches in the same field of endeavor, programmable digital filters for simplifying the averaging of IMU data (0030). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Anagnos into the invention of Douglas in order to configure the device e.g. as claimed because it allows programmatically adjustable filtering and averaging IMU data (0030).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Douglas, Cobanoglu, Seth, Barber, and Bell as applied to claim 1 above, and further in view of Rakuff et al. US2020/0272139.
For claim 22 Douglas does not disclose “The device of claim 1 wherein the IMU is attached to or integrated with the surgical tool as close as possible to a central pivot point of all three axes of rotation of the surgical tool”. Rakuff teaches in the same field of endeavor, placing IMUs such as accelerometers at a suitable location such as a central point of a housing (0035) deemed to include a central pivot point. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Rakuff into the invention of Douglas in order to configure the device e.g. as claimed because Rakuff discloses such placement as an appropriate location for tracking (0035).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Douglas, Cobanoglu, Seth, Barber, and Bell as applied to claim 1 above, and further in view of Jeka US9,558,399.
Douglas does not disclose for claim 23, “The device of claim 1 wherein the pitch, roll and yaw information of the surgical tool is calculated from the fused (x, y, z) data received from the gyroscope, the magnetometer and the accelerometer based on Tait-Brown angles or Euler angles”. Douglas discloses a calculation for pitch, roll, and yaw, but simply does not detail the particular nature of the method used. Jeka teaches in the same field of endeavor, using Euler angles for calculating pitch, roll, and yaw (12:64-13:2). Since Douglas fails to disclose the nature of the calculation method, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used any method known in the art, including the one taught by Jeka to achieve the calculation of pitch, roll, and yaw.
Response to Arguments
Applicant's arguments filed 12/30/2025 have been fully considered but they are not persuasive.
Applicant’s first argument at page 8 asserts that the IMU is not disposed on a PCB. 0024 has been recited in the rejection above to further clarify that the IMUs are formed on ordinary PCBs, including flexible PCBs which are considered to be ordinary and not a special form or version of PCBs.
Applicant’s next argument at page 9 asserts that the prior art base the surgical tracking on pitch, roll, and yaw and lack xyz position information for the instrument tracking. This is refuted in the rejection which has been clarified to show that the instrument tracking involves the use of xyz position information, e.g. 28:9-11 describes the IMUs are used for xyz position determination, including other sections which may also further clarify this disclosure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO892.
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/Jae Woo/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
03/11/2026