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 .
DETAILED ACTION
Claim Rejections - 35 USC § 112b
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.
Claim 1 and dependent claims 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 “an inertial measurement unit (IMU) disposed on a printed flexible circuit board and 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”. This claim limitation is currently deemed indefinite in light of applicant’s newly presented comments and arguments.
Based on the newly presented comments and arguments, applicant states that their interpretation of the “central pivot point of all three axes of rotation” differs from what is found in the previously presented prior art rejection, i.e. via Rakuff. In earlier office actions, the claimed “central pivot point of all three axes of rotation” was interpreted as a central point of a housing because it was deemed to be a reasonable interpretation for a claim limitation that could be considered indefinite due to lacking clear definition and scope. Regarding the potential indefiniteness, applicant was granted the benefit of doubt and the claim language was allowed to be interpreted as given in the rejection, but as applicant argues, this is not the case. As a result, applicant has revoked the granted benefit of doubt which now brings into question what the clear definition and scope of the term is. The explanation and description provided in the arguments is not considered sufficient and thus the reason for the new 112b indefiniteness rejection.
The explanation is deemed insufficient because applicant states, “the central pivot point is a specific, biomechanical, and ergonomic location defined by the user's grip and manipulation of the surgical instrument” and cites 0025 as providing supporting details. Upon closer reading of 0025, it does not expressly define the “central pivot point” as the center of the palm. It states that the placement of the tool in the center of the palm is done for certain reasons, and states separately, that the IMU is attached to a “central pivot” of the surgical tool. Nowhere in 0025 is there an explicit description of the “central pivot point” of the tool as “the center of the palm” of the surgeon. Applicant seeks to span this gap or missing detail in the specification by providing it in their response, i.e. “As detailed in paragraph [0025] of the Specification, placement at the central pivot point (e.g., the center of the palm) …”. Since this clarification was not present prior to this office action nor in the specification, the central pivot point was interpreted in the broadest reasonable manner. Applicant now seeks to narrow the interpretation of the term as offered in their response to read over Rakuff, but in doing so, has exposed the indefiniteness of the term due to the unclear and indefinite description in 0025. This does not even take into consideration that applicant is appearing to define “the central pivot point” as “the center of the palm” by their comment, i.e. the pivot point is a part of the tool and the palm is a part of the surgeon, thereby potentially attempting to claim a part of the human body.Based on the indefiniteness of the central pivot point, the claim limitation “as close as possible” is now also currently deemed indefinite because it introduces another degree of potential indefiniteness with respect to the central pivot point. The extent of what is “as possible” in light of the new interpretation is not defined. It is unclear and undefined as to what constraints or capabilities mitigate or facilitate this claimed, “disposing as close as possible” since it is now not simply a central point of a housing but could be a number of different points.
Additionally, the “central pivot point of all three axes of rotation” is deemed indefinite. An axis of rotation of the surgical tool is deemed any axis that the surgical tool rotates around. Therefore, there are many possible axes of rotation for the surgical tool, which includes any axis that runs through the tool. As such, this claim limitation is indefinite as it does not specify which three axes of rotation are to be used.
Additionally, how “central pivot point” of an axis of rotation is to be defined is deemed indefinite, e.g. a central pivot point could be the geometric center of the axis or it could be the center of gravity of the axis of the tool which could differ from each other. The specification appears to lack any further guidance or detail regarding the central pivot point. As such, there are multiple layers of indefiniteness that need to be addressed.
Indefiniteness will be interpreted as provided in the rejection.
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, and Rakuff et al. US2020/0272139.
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).
localizing the surgical tool within the coordinate system (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) and displaying the localization of the tool on the display monitor (2:54)”.
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.
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).
“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”. 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).
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 0054, 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, 0054)”.
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, and Rakuff 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) 7, 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Douglas, Cobanoglu, Seth, and Rakuff 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, and Rakuff 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) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Douglas, Cobanoglu, Seth, and Rakuff 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 6/23/2026 have been fully considered but they are not persuasive.
For applicant’s argument regarding “as close as possible to a central pivot point of all three axes of rotation of the surgical tool”, this has been deemed indefinite and interpreted per the rejection. As such, the arguments are not found to be persuasive. See rejection for additional details.
For applicant’s argument regarding the specific data fusion of the claims, Seth discloses using all three claimed types of IMUs for position determination, such that the data provided by the IMUs is considered position data (0016, 0018). Specifically, applicant asserts that “standard IMU’s use magnetometers to provide heading (magnetic flux) data, not raw (x, y, z) position spatial coordinates” and that Seth’s use of IMU’s, specifically magnetometers falls under this use description. Applicant provides no evidence that supports Seth uses magnetometers only to provide heading data and as such it is considered a mere allegation of patentability. Additionally, applicant argues that the “claims specifically demand receiving distinct (x, y, z) position coordinates from each of the three sensors” which is considered to be interpreting the claims in an overly narrow manner, which simply states “receiving data indicative of an (x, y, z) position”. The applicant equating “distinct position coordinates” with “indicative” is not considered reasonable since indicative allows for a much broader interpretation including data that is not explicitly raw xyz position data, as long as it indicates or is suggestive of; per the Collins Dictionary definition: indicative 1. Adjective: If one thing is indicative of another, it suggests what the other thing is likely to be. As such, Seth discloses at step 408 in fig 4A at each IMU, detecting movement of the object and generating inertial output data representing (i.e. indicative) a location and/or orientation of the object. The flow diagram then describes the fusing of the data.
For applicant’s argument that impermissible hindsight was used is also not persuasive. The rejection of record clearly points out the teachings of the references and also the motivations. Citing the mere number of references is not a persuasive argument as to why a rejection is improper. Each reference cited is relevant in the disclosure it provides, e.g. Cobanoglu’s disclosure of the particulars of the IMU and circuitry aims to fill in details that Douglas does not go into. IMUs are used in many different fields and a teaching of a particular configuration of an IMU is not simply limited to the specific field that the disclosure is found in. Details of IMUs can be used and applied across any field which implements them. This applies to the other references that the applicant mentions, including Seth, and Rakuff.
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
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
07/31/2026
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