DETAILED ACTION
Applicant’s arguments, filed on 05/21/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed on 05/21/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-5 are the current claims hereby under examination.
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 .
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.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Sarig-Bahat (WO 2010064237) in further view of Leip (US 20170164890), Meyer (WO 2018121886), Yang (US 11110301), and On-Trak (“The Process of Laser-Based Alignment”). Citations to WO 2018121886 will refer to the English Machine Translation that accompanies this Office Action.
Regarding independent claim 1, Sarig-Bahat teaches a device for measuring cervical range of motion (Abstract: “A system and method of motion assessment for use in medical analysis and treatment of motion impairments”) comprising:
a frame of a pair of glasses (Page 12, lines 5-6: “The HMD unit for example l-glasses HRV Pro, Virtual Realities, may be adjusted and strapped to the participant's head”).
However, Sarig-Bahat does not teach the frame of the glasses configured to be worn over each ear of a user and on a bridge of a nose of the user.
Leip discloses a system to facilitate therapeutic positioning for a body part. Specifically, Leip discloses a frame of a pair of glasses configured to be worn over each ear of a user and on a bridge of a nose of the user ([0024]: “second presentation device 108′ may be coupled to frame 102 (e.g., of a pair of the patient's eyeglasses, of nonprescription glasses, etc.)”). Sarig-Bahat and Leip are analogous arts as they are both related to systems incorporated in a pair of glasses used to monitor the position of a body part.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the frame being configured to be worn over each ear and on the bridge of the user’s nose from Leip into the device from Sarig-Bahat as the combination is silent on how the glasses sit on the user’s face, and Leip discloses a suitable confirmation in an analogous device.
However, the Sarig-Bahat/Leip combination does not teach the frame including a positioning clip and laser alignment and optics integrated into a temple of the frame.
Meyer discloses a method of determining physiological parameters of a user using a pair of glasses. Specifically, Meyer teaches the frame including a positioning clip ([0039]: “If a suitable carrying frame is already available, for example in the form of regularly worn glasses by glasses wearers, the holding device, in particular the holding element, can also be designed for connection with a glasses temple. A wearer's own glasses are usually already optimally adapted to the shape of their head, thus ensuring a secure fit and high wearing comfort. The holding device or holding element according to the invention, together with the associated pressure transmitter, can in this case, for example, be attached laterally to the eye in the area of the eye on the temple of the glasses or another suitable part of the frame of the glasses. A secure but relatively easy-to release connection, for example by means of a retaining clip or a screw connection, is preferred”; [0023]: “The holding device according to the invention comprises a pressure transmitter or dynamometer for exerting external pressure on an eye and a holding element for holding and/or positioning the pressure transmitter relative to the eye”. The retaining clip and screw connection are the positioning clips.). Sarig-Bahat, Leip, and Meyer are analogous arts as they are all related to systems incorporated in a pair of glasses used to monitor a physiological parameter of a user.
Yang discloses systems and methods for calibrating an alignment device. Specifically, Yang teaches including a laser alignment system into a medical device. Sarig-Bahat, Leip, and Yang are analogous art as they are directed to the solving the same problem of ensuring a consistent position of a user during a measurement procedure.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the positioning clip from Meyer and the laser alignment from Yang into the device from the Sarig-Bahat/Leip combination as they can both be used to align the device on the user’s body and ensure that it is in the same position before every measurement, ensuring an accurate result that can easily be compared to past measurements.
The Sarig-Bahat/Leip/Meyer/Yang combination teaches the positioning clip adjustable between multiple calibrated positions on the temple in order to ensure a repeatable initial position of the device for each measurement session (Meyer, [0039]: “If a suitable carrying frame is already available, for example in the form of regularly worn glasses by glasses wearers, the holding device, in particular the holding element, can also be designed for connection with a glasses temple. A wearer's own glasses are usually already optimally adapted to the shape of their head, thus ensuring a secure fit and high wearing comfort. The holding device or holding element according to the invention, together with the associated pressure transmitter, can in this case, for example, be attached laterally to the eye in the area of the eye on the temple of the glasses or another suitable part of the frame of the glasses. A secure but relatively easy-to release connection, for example by means of a retaining clip or a screw connection, is preferred”; [0023]: “The holding device according to the invention comprises a pressure transmitter or dynamometer for exerting external pressure on an eye and a holding element for holding and/or positioning the pressure transmitter relative to the eye”. The screw connection allows for the position to be adjusted between different calibration positions by changing how far it is screwed in.).
However, the Sarig-Bahat/Leip/Meyer/Yang combination does not teach the laser alignment system configured to project three orthogonal beams that align with marked lines in an examination room to ensure repeatable initial orientation of the device for each measurement session.
On-Trak discloses the process of laser-based alignment. Specifically, On-Trak teaches the laser alignment system configured to project three orthogonal beams that align with marked lines in an examination room to ensure repeatable initial orientation of the device for each measurement session (Page 1: “A laser is set up at one end of the desired line and a laser beam is pointed at what is called a reference target, which is positioned at the other end of the desired line. The reference target is positioned until it is at dead center. Once the laser and reference target have been centered, various targets can be set up anywhere along the beam and the proper alignments can be made to correct any deviations and variations off the x-y axis in reference to the target”. The laser can be set up on the device and the reference target can be the lines on the wall, which can be used to determine the correct position of the device. Additionally, it would have been obvious to use the laser alignment systems in all three directions, as it ensures that the device is in the same exact spot each use, making it easily repeatable.). Yang and On-Trak are analogous art as they are both related to the same field of endeavor of using laser alignment to ensure the correct placement.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the method of establishing a laser alignment system from On-Trak into the Sarig-Bahat/Leip/Meyer/Yang combination as it ensures that the device is in the correct location with each use, which allows for accurate and repeatable measurements.
The Sarig-Bahat/Leip/Meyer/Yang/On-Trak combination teaches one or more movement measurement devices integrated into the frame (Sarig-Bahat, Page 3, lines 21-24: “Embodiments described herein disclose a motion assessment system configured to monitor and analyze voluntary movements of a subject, comprising … a motion tracker configured to monitor the movements of the subject”),
the one or more movement measurement devices including one or more sensors (Sarig-Bahat, Page 7, lines 22-24: “The tracking device 300 typically includes sensors which may be placed about the subject 100 in strategic points. The tracking device 300 monitors the movements of the subject 100”), a processor (Sarig-Bahat, Page 7, lines 23-25: “The tracking device 300 monitors the movements of the subject 100, and sends information regarding these movements to the processor 400”), a memory (Sarig-Bahat, Page 7, lines 28-29: “the storage unit 500 may be provided and the processor 400 may be configured to store data therein”).
However, the Sarig-Bahat/Leip/Meyer/Yang/On-Trak combination does not teach a power supply, wherein the memory includes instructions executable by the processor.
Leip teaches a power supply ([0022]: “The hardware in user interface circuitry 124 may be incorporated within second presentation device 108 and/or may be coupled to second presentation device 108 via a wired or wireless communication medium. Power circuitry 128 may include internal power sources (e.g., battery, fuel cell, etc.)”), wherein the memory includes instructions executable by the processor ([0030]: “Firmware may be embodied as code, instructions or instruction sets and/or data that are hard-coded (e.g., nonvolatile) in memory devices. “Circuitry”, as used in any embodiment herein, may comprise, for example, singly or in any combination, hardwired circuitry, programmable circuitry such as computer processors comprising one or more individual instruction processing cores, state machine circuitry, and/or firmware that stores instructions executed by programmable circuitry.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the power supply from Leip into the Sarig-Bahat/Leip/Meyer/Yang/On-Trak combination as the combination is silent on how the power is supplied to the device, and Leip discloses a suitable power supply in an analogous device. Additionally, it would have been obvious to include the memory including instructions from Leip into the Sarig-Bahat/Leip/Meyer/Yang/On-Trak combination as the combination is silent on where the instructions for the processor are stored, and Leip discloses a suitable storage medium in an analogous device,
However, the Sarig-Bahat/Leip/Meyer/Yang/On-Trak does not teach wherein the processor is configured to calibrate the one or more movement measurement devices.
Leip teaches the step of calibrate the one or more movement measurement devices ([0024]: “at least the initial activation of system 100 may be followed by configuration and/or calibration operations … The configuration operations may be followed by calibration operations that may calibrate the operation of sensor 110 and/or the data processing circuitry based on the position of sensor 110 (e.g., at location 110A or 110B). After configuration and/or calibration operations are complete (e.g., if necessary), system 100 may enter normal operation wherein sensor 110 may generate an electronic signal corresponding to the body part on which sensor 110 is worn”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the calibration from Leip into the Sarig-Bahat/Leip/Meyer/Yang/On-Trak combination as it allows the measurement devices to be calibrated, which ensures that the measurements the device is providing are accurate and can be compared to other data.
The Sarig-Bahat/Leip/Meyer/Yang/On-Trak combination teaches wherein the processor is configured to:
determine, using the one or more movement measurement devices and the laser alignment system, an initial position and orientation for a head or neck of the user (Sarig-Bahat, Page 4, lines 23-26: “The preliminary step of determining a desired-movement-range for the subject may comprise the substeps of conducting an initial assessment of the subject to determine an initial-movement-range and selecting a desired- movement-range within the initial-movement-range”);
measure, using the one or more movement measurement devices, a cervical range of motion of the user (Sarig-Bahat, Page 12, lines 1-4: “Cervical motion assessment embodiments may integrate use of electromagnetic tracking with a Head Mounted Display (HMD). Real-time cervical motion tracking controls user interaction in the video game projected in the HMD”; Page 13, lines 16-28: “The procedure for assessing CROM with the system may be carried out as participants sit on a standard firm chair, typically with their body strapped by a seat-belt and their feet resting on the ground. Each VR session may commence with a short warm-up and introductory explanation of the virtual game. The start point for the VR game is generally set at 80% of the maximal cervical range displayed by the subject using conventional assessment techniques. The procedure may continue with targets being displayed on the HMD and the subject's cervical movements being monitored and analyzed. The selection of targets appearing on the display may be adjusted according to the performance of the subject. Typically, the process repeats until the user fails to increase his CROM a predetermined number of times and no CROM improvement is recorded”; Page 1, lines 16-19: “Cervical Range of Motion (CROM) assessment is frequently used to quantify the level of impairment associated with neck pain, to discriminate between asymptomatic persons and those with persistent neck pain related to different pathologies and to assess effectiveness of therapeutic interventions”) and a trajectory of motion of the user (Sarig-Bahat, Page 16, lines 22-26: “Reference is now made to Figure 7 and 8 illustrating a motion trajectory of a symptomatic patient in virtual reality and a motion trajectory of a control subject in virtual reality, respectively. Examples of 3D cervical motion trajectories during the VR session of one symptomatic and one control subject are presented”); and
store the cervical range of motion and the trajectory of motion of the user as movement data (Sarig-Bahat, Page 3, lines 27-28: “the system further comprises a data storage unit configured to store data received from the motion tracker”).
Regarding claim 2, the Sarig-Bahat/Leip/Meyer/Yang/On-Trak combination teaches the device of claim 1, wherein the cervical range of motion includes six components of cervical motion (Sarig-Bahat, Page 12, lines 6-9: “The electromagnetic tracking system such as the systems provided by Ascension™ or Polhemus™, for example, may be used to capture cervical motion in real time with six degrees of freedom (x, y and z coordinates and rotations)”; Page 14, lines 7-9: “CROM measures included both half-cycle Extension (E), Flexion (F), Left Rotation (LR), Right Rotation (RR), left lateral flexion (LLF), and right lateral flexion (RLF) and full-cycle (F+E, RR+LR, RLF+LLF) cervical ROM”), and the one or more sensors includes at least one accelerometer, gyroscope, and magnetometer configured to measure each component of the cervical range of motion (Sarig-Bahat, Page 12, lines 12-13: “Other tracking devices may be used, for example and without limitation accelerometers, gyroscopes, optical tracking devices and the like”).
Regarding claim 3, the Sarig-Bahat/Leip/Meyer/Yang/On-Trak combination teaches the device of claim 2, wherein the six components of the cervical range of motion include left rotation, right rotation, forward flexion, backward flexion, right flexion, and left flexion (Sarig-Bahat, Page 12, lines 6-9: “The electromagnetic tracking system such as the systems provided by Ascension™ or Polhemus™, for example, may be used to capture cervical motion in real time with six degrees of freedom (x, y and z coordinates and rotations)”; Page 14, lines 7-9: “CROM measures included both half-cycle Extension (E), Flexion (F), Left Rotation (LR), Right Rotation (RR), left lateral flexion (LLF), and right lateral flexion (RLF) and full-cycle (F+E, RR+LR, RLF+LLF) cervical ROM”).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over the Sarig-Bahat/Leip/Meyer/Yang/On-Trak combination as applied to claim 1 above, and further in view of Howard (US 20190117156).
Regarding claim 4, the Sarig-Bahat/Leip/Meyer/Yang/On-Trak combination teaches the device of claim 1, wherein the processor is further configured to record the movement data in a database (Sarig-Bahat, Page 3, lines 27-28: “the system further comprises a data storage unit configured to store data received from the motion tracker”).
However, the Sarig-Bahat/Leip/Meyer/Yang/On-Trak combination does not teach comparing the movement data to historical movement data included in the database to monitor a recovery process of the user.
Howard teaches a wearable biomechanical and physiology monitor. Specifically, Howard teaches comparing the movement data to historical movement data included in the database to monitor a recovery process of the user ([0080]: “Real-time changes in the data falling out of expected ranges compared to historical data generate notifications or alerts to the patient and the doctor. These warnings indicate an injury impact, a life-threatening complication, or a severe abnormal direction or range of movement by the joint—factors which can prolong recovery or chance of reinjury and prolonged non-deployable status”). Sarig-Bahat, Leip, and Meyer are analogous arts as they are all related to monitoring a physiological parameter of a user in a wearable device.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the comparison to historical data from Howard into the Sarig-Bahat/Leip/Meyer/Yang/On-Trak combination as it allows the device to track the user’s movement over time, which can inform the user of any changes in their health state or any progress towards recovery.
Regarding claim 5, the Sarig-Bahat/Leip/Meyer/Yang/On-Trak /Howard combination teaches the device of claim 4.
However, the Sarig-Bahat/Leip/Meyer/Yang/On-Trak/Howard combination does not teach further comprising a communications interference in communication with the motion sensing device, wherein the communications interface connects to a remote client device; and wherein the processor is further configured to transmit the movement data to the remote client device via the communications interface.
Leip teaches further comprising a communications interference in communication with the device ([0011]: “The system may further comprise communication circuitry coupled to at least the control circuitry to at least one of receive data regarding at least the therapeutic position or transmit data regarding the determined position of the body part”), wherein the communications interface connects to a remote client device; and wherein the processor is further configured to transmit the movement data to the remote client device via the communications interface ([0025]: “in at least one embodiment system 100 may store data indicating at least one determined position 214 of head 200, and may provide the information to external system 130”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the communication to the remote device from Leip into the Sarig-Bahat/Leip/Meyer/Yang/On-Trak/Howard combination as it allows a user to see the measured information at a device separate from the wearable device, which can allow for easier reading of the information and can allow for the information to be shared to other devices.
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant’s arguments with respect to claims 1-5 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.
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.
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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