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
The amendments made to claims 20, 22, 24,26, 30, 34, and 36-39 in the response filed on 8/11/2025 are acknowledged. Claims 20-39 are still pending in the application and are examined below.
Response to Arguments
Applicant's arguments, see page 11, filed 8/11/2025, with respect to the objections of claims 20, 22, 30, 36, 38, and 39 have been fully considered and are persuasive. Therefore, the objections have been withdrawn.
Applicant's arguments, see page 12, filed 8/11/2025, with respect to the rejection of claims 26, 34, and 39 under 35 U.S.C. 112(b) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
Applicant's arguments, see pages 12-13, filed 8/11/2025, with respect to the rejection of claim 20 under 35 U.S.C. 102(a)(2) have been fully considered but are not persuasive. Please see arguments below.
Applicant argues “While disclosing a brace 500 with straps 506 and a control unit 516 that collects and transmits data (paras. [0112] — [0119]), Embodiment A of Stark does not disclose or describe that the control unit informs or guides the patient in real time or provides any indication for strap tightening, as required by the wearable device of claim 20. In this regard, there is no disclosure in Embodiment A of Stark that brace 500, including control unit 516, provides any instruction or recommendation to a patient for tightening straps 506, nor any disclosure of ‘real-time’ guidance for ‘incentivizing a patient to wear the back brace by at least providing indications to the patient for tightening the at least one strap’, as required by independent claim 20”; however, examiner respectfully disagrees. In Embodiment A of Stark et al., it discloses that the control unit can include a microprocessor, wherein the location of the force applicators can be programmed into the control unit. Based on force measurements taken from force sensors (pressure sensors), the forces are monitored by the control unit to evaluate forces applied over time to the spine; therefore, there is real-time guidance to the clinician and assists in assessing the progress of the spine with the brace. Straps or other adjustments can also be made to alter the pressure applied to the user to assist with fitting and to ensure that proper levels of force is used to correct the spinal curvature (paragraph 0034/0090-0091/0111-0112/0114).
Applicant argues “Claim 20 also recites that the wearable device is configured for informing and guiding in real time and incentivizing a patient to wear the back brace by at least providing indications to the patient for tightening the at least one strap ‘by comparing a pressure value provided by the at least one pressure sensor with at least one calibration value’. Embodiment A of Stark does not disclose the use of a ‘calibration value’ in this context, nor does it describe ‘real time’ comparison of pressure values for the purpose of ‘informing and guiding...by at least providing indications to the patient…’, as required by claim 20. Although Embodiment A of Stark mentions ‘predetermined desired values’ (para. [0034], these are used internally by a microprocessor to potentially activate a release valve or report data, not to generate indications for the patient to tighten the strap. There is no disclosure in Embodiment A of Stark of a real-time comparison of sensor data with a calibration value that results in actionable guidance to the patient, such as an indication to tighten a strap, as required by independent claim 20”; however, examiner respectfully disagrees. Embodiment A of Stark et al. discloses that in an initial examination of the patient, measurements are made of deformity parameters as well as normative data on progression of curve shape and resolution patterns needed to design treatment. The above measurements would be considered the calibration value because initial measurements of deformity parameters are inputted into the control unit (microprocessor) in order to correct the spine via location and force of the force applicators. The corrective forces from the force applicator are established according to desired parameters and on initial measurements taken. Furthermore, the control unit can alter the forces within the brace to ensure proper levels of force to correct for unexpected changes in the forces or to alter the forces as a function of time in response to expected changes in spinal curvature (paragraph 0090-0091/0114-0116).
Applicant argues “Claim 20 further recites a wearable device ‘for enabling a doctor to monitor, intervene, and manage the patient and treatment in real time,’ While disclosing that a doctor may eventually access collected data through a base station (paras. [0114] — [0119]), Embodiment A of Stark does not disclose or describe ‘real time’ monitoring, intervention and management of the patient and treatment, as required by claim 20”; however, examiner respectfully disagrees. Embodiment of A of Stark discloses that the force sensors are connected to a microprocessor, which provides the capability to monitor the variation in applied corrective force over time. The monitored forces provided by the microprocessor assist invaluably with the assessment of the progress with the brace (paragraph 0090-0091/0114-0116).
Applicant's arguments, see pages 13-14, filed 8/11/2025, with respect to the rejection of claim 30 under 35 U.S.C. 102(a)(2) have been fully considered but are not persuasive. Please see arguments below.
Applicant argues “Amended claim 30 requires ‘at least one pressure sensor passively configured to measure a pressure at an area of contact between the back brace and a corresponding pressure point on the patient’s torso, without applying force or actuation’. In contrast, the brace 500 in Embodiment A of Stark uses pressure sensors in conjunction with active force applicators to apply and monitor corrective force vectors. More specifically, Stark’s brace applies corrective force vectors using actuators, not merely passive monitoring (e.g., paras. [0027], [0035], [0088], [0116])”; however, examiner respectfully disagrees. The amendment made points to a pressure sensor that measures pressure at an area of contact between the back brace and corresponding pressure point on the torso, without applying force or actuation. However, the embodiment A of Stark et al. still reads on this limitation because the sensors are not applying the force or actuation, it is the force applicators doing that function. The sensors are passively reading the force applied from the force applicators.
Applicant's arguments, see page 14 and 22, filed 8/11/2025, with respect to the rejection of claim 23 under 35 U.S.C. 102(a)(2) have been fully considered and are persuasive. However, upon further consideration, a new ground of rejection was made in view of Embodiment A of Stark et al. (US 20050043660 A1) in view of Ishikawa et al. (US 20160120733 A1) to meet the limitation of claim 23 since the scope of the claim has changed.
Applicant's arguments, see page 14, filed 8/11/2025, with respect to the rejection of claim 24 under 35 U.S.C. 102(a)(2) have been fully considered but are not persuasive. Please see arguments below.
Applicant argues “Amended claim 24 includes the additional limitation that the wearable device includes a processor, a memory for storing pressure measurements, and a communication module configured to wirelessly transmit pressure data to the at least one external computing apparatus. Embodiment A of Stark does not disclose or describe the wireless transmission of pressure data to an external computing apparatus. In this regard, there is no disclosure of a communication module (e.g., a Bluetooth module) in the control unit 516 or elsewhere in Embodiment A of Stark”; however, examiner respectfully disagrees. In Embodiment of A of Stark et al. it was disclosed that the measurements and corrective vector prescription determined can be downloaded from the base station to the control unit via radio frequencies (using transmitters and receivers) (paragraph 0090-0091/0112-0115/0118).
Applicant's arguments, see pages 14-15, filed 8/11/2025, with respect to the rejection of claim 29 under 35 U.S.C. 102(a)(2) have been fully considered but are not persuasive. Please see arguments below.
Applicant argues “Amended claim 29 includes the additional limitation that: the least one pressure sensor comprises a plurality of pressure sensors each configured to be attached to the back brace at a point of pressure with the body of a patient; that the at least one strap comprises a plurality of straps configured to be tightened for adjusting pressures at the respective points of pressure to which the respective plurality of pressure sensors are attached; and that the wearable device is configured for informing and guiding in real time and incentivizing the patient to wear the back brace by at least providing indications to the patient for tightening each of the plurality of straps by comparing a corresponding pressure value provided by a corresponding one of the plurality of pressure sensors with a corresponding calibration value. No corresponding structural and functional combination is disclosed or described by Embodiment A of Stark. For example, Embodiment A of Stark does not disclose or describe that the control unit informs or guides the patient in real time or provides any indication for strap tightening, as set forth above for independent claim 20, from which claim 29 depends”; however, respectfully disagrees. In Embodiment A of Stark et al., it discloses that the control unit can include a microprocessor, wherein the location of the force applicators can be programmed into the control unit. Based on force measurements taken from a plurality of force sensors (pressure sensors), the forces are monitored by the control unit to evaluate forces applied over time to the spine; therefore, there is a real-time guidance to the clinician and assists in assessing the progress of the spine with the brace. The plurality of straps or other adjustments can also be made to alter the pressure applied to the user to assist with fitting and to ensure that proper levels of force is used to correct the spinal curvature (paragraph 0034/0090-0091/0111-0112/0114).
Applicant's arguments, see page 15, filed 8/11/2025, with respect to the rejection of claim 34 under 35 U.S.C. 102(a)(2) have been fully considered but are not persuasive. Please see arguments below and new rejection in view of Embodiment A of Stark et al. (US 20050043660 A1) in view of Lou et al. (US 20110230806 A1).
Applicant argues “Amended claim 34 includes the additional limitation that the at least one calibration value is established by a clinician during an initial fitting session by physically adjusting the at least one strap of the back brace to exert a desired corrective pressure, and that the calibration value is stored on the server for subsequent comparisons during patient use. As noted above, the wearable device of amended claim 30, from which claim 34 now indirectly depends, relies on real-world, clinician-driven calibration, not automated force prescription as required by Embodiment A of Stark”; however, examiner respectfully disagrees. Embodiment A of Stark et al. discloses that in an initial examination of the patient, measurements are made of deformity parameters as well as normative data on progression of curve shape and resolution patterns needed to design treatment. The above measurements would be considered the calibration value because initial measurements of deformity parameters are inputted into the control unit (microprocessor) in order to correct the spine via location and force of the force applicators. The corrective forces from the force applicator are established according to desired parameters and on initial measurements taken. Additionally, straps or other adjustments can also be made to alter the pressure applied to the user to assist with fitting initially and to ensure that proper levels of force is used to correct the spinal curvature (paragraph 0034/0090-0091/0111-0112/0114). Furthermore, the control unit can alter the forces within the brace to ensure proper levels of force to correct for unexpected changes in the forces or to alter the forces as a function of time in response to expected changes in spinal curvature (paragraph 0090-0091/0114-0116).
Applicant's arguments, see page 15, filed 8/11/2025, with respect to the rejection of claim 35 under 35 U.S.C. 102(a)(2) have been fully considered but are not persuasive. Please see arguments below and a new rejection in view of Embodiment A of Stark et al. (US 20050043660 A1) in view of Lou et al. (US 20110230806 A1).
Applicant argues “Amended claim 35 includes the additional limitation that the server is further configured to generate usage metrics indicative of both the duration of brace wear and the correctness of brace fit, based on a comparison of real-time pressure measurements to the at least one calibration value. No corresponding features are disclosed or described by Embodiment A of Stark, at least as set forth above for amended independent claim 30, from which claim 35 now indirectly depends”; however, examiner respectfully disagrees. Embodiment A of Stark et al. discloses a method of use and generates usage metrics of duration and correctness of brace fit based on measurements made of deformity parameters as well as normative data on progression of curve shape and resolution patterns needed to design treatment. This information is first input into a base station, which is a microprocessor used by a health professional to track patient's condition and progress. The above measurements would be considered the calibration value because initial measurements of deformity parameters are inputted into the control unit (microprocessor) in order to correct the spine via location and force of the force applicators. The corrective forces from the force applicator are established according to desired parameters and on initial measurements taken. Furthermore, the control unit (connected to sensors) can alter the forces within the brace to ensure proper levels of force to correct for unexpected changes in the forces or to alter the forces as a function of time in response to expected changes in spinal curvature (paragraph 0090-0091/0114-0116).
Applicant's arguments, see pages 16-19, filed 8/11/2025, with respect to the rejection of claims 36, 37, and 39 under 35 U.S.C. 102(a)(2) have been fully considered and are not persuasive. Please see arguments below regarding claims 37 and 39.
Applicant argues “Claim 37 is directed to the specific structure and function of the patient computing device, which is not disclosed or described by Embodiment B of Stark at least as identified below: -Claim 37 recites a patient computing device with its own memory module and processor, running a software application that stores and processes pressure data. Embodiment B of Stark does not disclose a separate patient computing device with a processor that runs software to manage sensor data or provide patient feedback and tracking. -Claim 37 requires that the patient computing device stores sensor data (pressure measurements, sensor IDs, time-stamps) and transmits it to a server for further analysis. Embodiment B of Stark lacks any teaching of cloud-based or server interaction, where data is transmitted for long-term storage and further processing. -The system of claim 37 presents real-time metrics such as pressure measurements, adjustments to the back brace, time use, and benefits to the patient. Embodiment B of Starks does not include features for real-time presentation of pressure data or personalized adjustments and recommendations to the patient based on the data. -Claim 37 requires that the patient computing device is configured to gamify the experience by providing metrics, target accomplishments, and rewards. Embodiment B of Stark does not disclose or suggest gamification or motivational tools for patients to encourage adherence to treatment. -Claim 37 requires a system that presents prescribed physical exercises for the patient as part of the treatment process. Embodiment B of Stark does not discuss integrating prescribed exercises or dynamic real-time adjustments for the patient based on sensor data. - The system of claim 37 is configured for indicating adjustments to the back brace to modify pressure measurements for more effective treatment. Stark’s disclosure is limited to automated actuator adjustment but does not include real-time feedback for the patient to make adjustments based on pressure measurements. Moreover, while acknowledging that Embodiment B of Stark does not expressly disclose many of the functions recited in claim 37, such as “presenting benefits, associated with the metrics, to the patient, presenting target accomplishments associated with the metrics, gamifying a use of the back brace by presenting a game using the metrics, associating the game with at least one award, and presenting physical exercises, prescribed by the doctor for the spine deformation treatment,” the OA concludes that the patient computing device disclosed in Embodiment B of Stark is nonetheless “capable of performing these functions,” merely by virtue of being a “computer.” Applicant respectfully disagrees. The mere capability of a computing device to perform functions when appropriately programmed does not amount to a disclosure or teaching of such functions being actually implemented or suggested. The Federal Circuit has consistently held that a system does not anticipate a claim simply because it is capable of being modified to perform the claimed functionality, unless there is clear teaching or suggestion that it actually does so. See Hewlett- Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469 (Fed. Cir. 1990); Finisar Corp. v. DirecTV Group, Inc., 523 F.3d 1323 (Fed. Cir. 2008). Here, Embodiment B of Stark fails to disclose or suggest a software application or interface that implements the claimed interactive and motivational features, such as presenting benefits derived from use metrics, gamification elements, award associations, or doctor- prescribed exercises. These features represent purposeful and non-trivial functional distinctions that go beyond the capabilities of a generic computing device and reflect inventive contributions directed to improving patient compliance and engagement”; however, examiner respectfully disagrees. The processor of the base station/computer in Embodiment B of Stark et al. is not a generic computing device. It is a processor that aids in correction of scoliosis and is connected to a wearable device (210, control unit) and pressure sensors. It can also take pressure measurements (over time) from the wearable device (210) and download it to the computer/base station [or vice-versa]; hence, pressure measurements from the pressure sensors can be saved for the physician to see on the computer/base station’s server, which allows the physician to evaluate the pressure fluctuations within each bladder (206) and design a desirable exercise routing and monitor the patient’s compliance with the target exercise routine. Although it was not explicitly disclosed by Embodiment B of Stark et al. that it could “present benefits derived from use metrics, gamification elements, award associations, or doctor-prescribed exercises”, the processor of Embodiment B of Stark et al. is fully capable of performing the intended use if the algorithm to perform these functions are inputted into the processor.
Applicant argues “Claim 39 depends on claim 37 and includes the additional limitation that the back brace comprises at least one strap configured to be tightened for adjusting a pressure at the point of pressure in the area of contact of the back brace to which the at least one pressure sensor is attached, and that the processor of the wearable device is further configured to run the first set of instructions causing the processor to transmit the at least one pressure measurement and associated sensor identifier and one time-date data field to the patient computing device for informing and guiding the patient in real time to incentivize the patient to wear the back brace by providing indications to the patient for tightening the at least one strap. No corresponding structural and functional combination is disclosed or suggested by Embodiment B of Stark”; however, examiner respectfully disagrees. The processor of the wearable device [210] receives data from each pressure measurement from each bladder [206] that has a pressure sensor [208] and transmits the data to the patient computing device; the pressure sensors [208] accounts for the pressure fluctuations within the bladder [206], which allows the plurality of straps [222] to be adjusted to alter resting pressure on the bladder [206] or to reposition the bladders [206] throughout the back brace [200] to accommodate the patient. Since the patient computing device receives the data from the processor of the wearable device [210], it allows physicians to design a desirable exercise routing and monitor the patient’s compliance with the target exercise routine: paragraph 0062-0065/0069/0077).
Applicant's arguments, see pages 19-21, filed 8/11/2025, with respect to the rejection of claims 21 and 32 under 35 U.S.C. 103 have been fully considered. However, the argument regarding claim 21 is not persuasive while claim 32 has a new rejection in view of Embodiment A of Stark et al. (US 20050043660 A1) in view of Lou et al. (US 20110230806 A1) due to the change of scope. Please see argument below regarding claim 21.
Applicant argues “Stark discloses a system integrated within or associated with a rigid back brace shell and relies on fasteners and mounting hardware for attachment of components, not adhesive. The OA fails to identify any teaching, suggestion, or motivation in either Embodiment A of Stark or Chen that would have prompted a person of ordinary skill in the art to modify the brace of Embodiment A of Stark to include a sensor with adhesive material on its bottom surface, especially given the different sensor and brace constructions in Chen. Additionally, Embodiment A of Stark emphasizes the secure integration of components via mechanical mounting and structured frameworks. Introducing adhesive-based attachments would compromise the intended structural integrity and sensor calibration described in Embodiment A of Stark, thereby teaching away from the proposed modification”; however, examiner respectfully disagrees. In Embodiment A of Stark et al., it disclosed how the force applicators (bladder) can include force sensors, but it did not disclose how the force sensors are specifically fixed to the force applicators. Rather, Embodiment A of Stark et al. disclosed how the force applicators are attached to the back brace via hook and loop. Therefore, by adding an adhesive material on the bottom of an analogous sensor, it allows the pressure sensor of Embodiment A of Stark et al. to effectively fix onto the force applicator (utility model content, Chen et al.). In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Furthermore, we are not persuaded by Applicant’s argument because to teach away, a reference must actually criticize, discredit, or otherwise discourage the claimed solution. In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (prior art does not teach away from claimed subject matter merely by disclosing a different solution to a similar problem unless the prior art also criticizes, discredits, or otherwise discourages the solution claimed). In this case, there was no passages in Chen that does so and Applicant does not point to any passage in "Chen" that in any way criticizes, discredits, or otherwise discourages the use of adhesive with sensors and force applicators, as taught by Embodiment A of Stark et al.
Applicant's arguments, see page 21, filed 8/11/2025, with respect to the rejection of claims 22 and 33 under 35 U.S.C. 103 have been fully considered. However, the argument regarding claim 22 is not persuasive while claim 33 has a new rejection in view of Embodiment A of Stark et al. (US 20050043660 A1) in view of Lou et al. (US 20110230806 A1) and in further view of Vigano’ et al. (US 20170086519 A1) due to the change of scope. Please see argument below regarding claim 22.
Applicant argues “There is no disclosure in Stark that the pressure sensors used are of the passive type, nor that they are resistive or capacitive sensors specifically. To the contrary, Stark focuses on feedback mechanisms within an active control loop involving force application, not on standalone passive sensing without any actuation. Accordingly, Stark does not teach or suggest the claimed configuration of passive, resistive or capacitive pressure sensors unaccompanied by any actuation or force-generating components. The secondary reference to Vigano does not cure the foregoing deficiencies of Embodiment A of Stark and, therefore, one ordinarily skilled in the art would not have been led to modify the references to attain the claimed subject matter”; however, examiner respectfully disagrees. The embodiment A of Stark et al. discloses sensors that are not applying the force or actuation, it is the force applicators doing that function. The sensors are passively reading the force applied from the force applicators (paragraph 0112). Additionally, Vigano teaches analogous sensors that are resistive pressure sensors and a foam that is on the upper side of an analogous pressure sensor, therefore, it still reads on the limitations of claims 22 and 33.
Applicant's arguments, see page 22, filed 8/11/2025, with respect to the rejection of claim 25 under 35 U.S.C. 103 have been fully considered but are not persuasive. Please see argument below.
Applicant argues “Palmer does not cure the deficiencies of Embodiment A of Stark with respect to the subject matter of independent claim 20, from which claim 25 depends and, therefore, one of ordinary skill in the art would not have been led to modify the references to attain the claimed subject matter”; however, examiner respectfully disagrees. The embodiment A of Stark et al. discloses sensors that are not applying the force or actuation, it is the force applicators doing that function. The sensors are passively reading the force applied from the force applicators (paragraph 0112). Additionally, Palmer teaches a foam material that is disposed between an analogous pressure sensor and the patient’s body, which improves comfortability for the user.
Applicant's arguments, see page 23, filed 8/11/2025, with respect to the rejection of claim 26 under 35 U.S.C. 103 have been fully considered but are not persuasive. Please see argument below.
Applicant argues “The cited combination of references fails to teach or suggest the claimed arrangement of claim 26 in which the pressure sensor is embedded between two adhesive surfaces: one affixing the sensor to the back brace and another affixing the sensor to a foam material. Rather, the combination presented by the OA constitutes a hindsight reconstruction lacking a clear teaching, suggestion, or motivation in the prior art to embed the pressure sensor between two adhesive surfaces in the claimed configuration”; however, examiner respectfully disagrees. Chen et al. teaches an adhesive surface (5 - see annotated figure 1 above, a pressure sensitive adhesive patch: detailed description) attaching the at least one analogous pressure sensor (3 - see annotated figure 1 above, there is a pressure sensor within the sensor patch [2 - see annotated figure 1 above]: detailed description) to an analogous back brace (1 - see annotated figure 1 above, an orthosis for adolescent idiopathic scoliosis: background technique/utility model content) (see annotated figure 1 above, the adhesive material [5] is on the bottom side of the one pressure sensor [3], which is used to attach the one pressure sensor [3] to the back brace [1]: utility model content) while Vigano’ et al. teaches another adhesive surface attaching the at least one analogous pressure sensor (12/14 - figure 1, a resistive pressure sensors: paragraph 0055) to the foam material (the one pressure sensor [12/14] is associated with a substrate [can be a synthetic foam] that is capable of being worn directly against the skin: paragraph 0018) (the synthetic foam is attached to the upper side of the one pressure sensor [12/14] via an adhesive material applied to the underlying synthetic foam to connect to the upper side of the one pressure sensor [12/14]: paragraph 0018/0021). By combining these references (Embodiment A of Stark et al., Chen et al., and Vigano’ et al.) there is an adhesive layer on both sides of the pressure sensor of Embodiment A of Stark et al.; one adhesive layer from Chen et al. attaches the pressure sensor of Embodiment A of Stark et al. to the back brace of Embodiment A of Stark et al. while the other adhesive layer from Vigano’ et al. attaches the pressure sensor of Embodiment A of Stark et al. to the foam material of Vigano’ et al.). Additionally, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant's arguments, see pages 24-25, filed 8/11/2025, with respect to the rejection of claims 27 and 38 under 35 U.S.C. 103 have been fully considered. However, the argument regarding claim 27 is not persuasive while claim 38 has a new rejection in view of Embodiment B of Stark et al. (US 20050043660 A1) in view of DeLuke et al. (US 20150119780 A1) due to the change of scope. Please see argument below regarding claim 27.
Applicant argues “The OA acknowledges that Embodiment A of Stark et al. does not disclose a pressure sensor selected from a resistive pressure sensor, a capacitive pressure sensor, or a sensor with integrated wireless capabilities. The OA relies on Turner for disclosure of pressure sensors with integrated wireless communication capability. Applicants respectfully submit that the cited combination does not render claim 27 obvious because neither reference, individually or in combination, teaches or suggests the selective use of a pressure sensor from the specific group recited in the claim: a resistive sensor, a capacitive sensor, or a sensor with integrated wireless capability. In particular, Embodiment A of Stark does not disclose any detail regarding the sensor technology, let alone a specific type from the claimed group. Turner’s mention of wireless sensors is general and not limited to pressure sensors of the type used in orthopedic braces or patient-wearable systems”; however, examiner respectfully disagrees. It was mentioned in Turner that there were pressure sensors that have the ability to transmit data wirelessly (paragraph 0071); this reads on the limitation of the claim because the claim language stated “least one pressure sensor is selected from a resistive pressure sensor, a capacitive pressure sensor, or a sensor with integrated wireless capabilities”. Embodiment A of Stark et al. also disclosed pressure sensors (paragraph 0112); therefore, the sensor of Turner is analogous to the sensor of Embodiment A of Stark et al. Additionally, both devices are used as a back support system.
Applicant's arguments, see pages 25-26, filed 8/11/2025, with respect to the rejection of claim 28 under 35 U.S.C. 103 have been fully considered but are not persuasive. Please see arguments below.
Applicant argues “Embodiment A of Stark is directed primarily to a brace configured to detect spinal curvature and adjust tightness based on pressure sensor data. There is no teaching or suggestion in Embodiment A of Stark that the brace contemplates motion or orientation detection, or any form of biomechanical analysis. The secondary to Kanchan, by contrast, is directed to a sports performance monitoring system that uses IMU data to assess fatigue and athletic activity. The objectives of these references differ significantly. The Examiner has not provided a sufficient rationale that bridges these divergent fields to show why one of ordinary skill in the art would be motivated to incorporate an IMU into the brace of Embodiment A of Stark, particularly given that Embodiment A of Stark does not discuss or suggest movement tracking or fatigue analysis” and “Additionally, Embodiment A of Stark appears to be concerned with reducing unnecessary complexity, particularly for pediatric scoliosis patients, by providing focused pressure feedback to ensure proper brace usage. Adding an IMU, which requires power, processing capabilities, and additional software for orientation/motion interpretation, introduces significant system complexity that is counter to the focus in Embodiment A of Stark. Thus, applicant respectfully submits that Embodiment A of Stark teaches away from such a modification”; however, examiner respectfully disagrees. Although the device of Kachan serves a different purpose compared to the device of Embodiment A of Stark, the IMU used serves a similar purpose of detecting motion on a body (it measures acceleration, angular velocity, and orientation of the body) which can assist in collecting valuable bio-mechanical data of the body (Kachan, paragraph 0040). Additionally, a reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention. Furthermore, we are not persuaded by Applicant’s argument because to teach away, a reference must actually criticize, discredit, or otherwise discourage the claimed solution. In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (prior art does not teach away from claimed subject matter merely by disclosing a different solution to a similar problem unless the prior art also criticizes, discredits, or otherwise discourages the solution claimed). In this case, there was no passages in Kachan that does so and Applicant does not point to any passage in "Kachan" that in any way criticizes, discredits, or otherwise discourages the use of IMU with a brace to detect spinal curvature and adjust tightness based on pressure sensor data, as taught by Embodiment A of Stark et al. As such, we find that the disclosure of Kachan does not teach away the use of IMU with a brace to detect spinal curvature and adjust tightness based on pressure sensor data from Applicant’s claimed invention.
Claim Objections
Claim 36 objected to because of the following informalities: “more efficiently” should be removed. Appropriate correction is required.
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)(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.
Claims 20, 24, 29-31, and 34-35 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Embodiment A of Stark et al. (US 20050043660 A1).
Regarding claim 20, Embodiment A of Stark et al. discloses a back brace (500 - figure 11, a corrective back orthosis: paragraph 0109) configured to be worn by a patient for treating spinal deformations (the back brace [500] can be used to correct spinal misalignment: paragraph 0034/0109), the back brace (500) comprising: at least one pressure sensor (514 - figure 12, pressure sensors: paragraph 0112) configured to be attached to the back brace (500) at a point of pressure with a body of a patient (figure 12, the one pressure sensor [514] is attached to the back brace [500]; it is located on the bladder [508 - figure 12] to measure the pressure within the bladder [508] that is applied to the body of the patient: paragraph 0110-0112); at least one strap (506 - figure 11/12, straps: paragraph 0109) configured to be tightened for adjusting a pressure at the point of pressure (the one strap [506] can be made to alter the pressure of the bladder [508], which is then applied to the user wearing the back device [500]: paragraph 0091); and a wearable device (516 - figure 11, a control unit: paragraph 0112) configured (a) for being attached to one of an outside of the back brace and inside a cavity formed in the back brace (500) (figure 11, the wearable device [516] is attached to the outside of the back brace [500, facing away from the user]), (b) for processing signals from the at least one pressure sensor (514) (figure 12, the wearable device [516] is connected to the one pressure sensor [514] via wires; the pressure sensors [514] sends measurements to the wearable device [516]: paragraph 0034/0112), (c) for communicating with at least one external computing apparatus (the wearable device [516] communicates with a base station; the base station can download information from the wearable device [516] and vice-versa: paragraph 0112/0114-0119), (d) for informing and guiding in real time and incentivizing a patient to wear the back brace (500) by at least providing indications to the patient for tightening the at least one strap (506) by comparing a pressure value provided by the at least one pressure sensor (514) with at least one calibration value (the microprocessor of the wearable device [516] monitors pressure measured by the one pressure sensor [514] and determines variation in the measured pressure and predetermined desired values [calibrated value]; additionally, the microprocessor can also be interfaced with a graphic display [indication] to provide a graphic analysis of the spinal deterioration and the vectors of the corrective forces used to correct the deterioration. Based on the graphic analysis, the microprocessor can control a release valve to adjust the pressure within the bladder [508, which affects the amount of pressure applied to the user] or the strap [506] can be adjusted to alter the pressure. As a result, this incentivizes the patient to wear the back brace [500] to efficiently correct spinal deformations since physicians have the measurements and analysis: paragraph 0034/0090-0091/0112/0114), and (e) for enabling a doctor to monitor, intervene, and manage the patient and treatment in real time (measurements can be taken in real time and information can be directly be inputted into the wearable device [516]; the information can then be downloaded from the base station to the wearable device [516]; because of this process, it allows the doctor to track the patient’s condition and progress. Furthermore, the control unit can alter the forces within the brace to ensure proper levels of force to correct for unexpected changes in the forces or to alter the forces as a function of time in response to expected changes in spinal curvature: paragraph 0090-0091/0114-0119).
Regarding claim 24, Embodiment A of Stark et al. discloses the invention as discussed in claim 20. Embodiment A of Stark et al. further discloses wherein the wearable device (516) includes a processor, a memory for storing pressure measurements, and a communication module configured to wirelessly transmit pressure data to the at least one external computing apparatus (the wearable device [516] includes a microprocessor and a communication module [transmitters and receivers] to wirelessly communicate with the base station; it was also implied that the wearable device [516] includes a memory for storage since the wearable device [516] can monitor force/pressure and later be downloaded to a base station: paragraph 0115-0117).
Regarding claim 29, Embodiment A of Stark et al. discloses the invention as discussed in claim 20. Embodiment A of Stark et al. further discloses wherein the least one pressure sensor (514) comprises a plurality of pressure sensors (figure 12, there are multiple pressure sensors [514]: paragraph 0112) each configured to be attached to the back brace (500) at a point of pressure with the body of a patient (figure 12, each pressure sensor [514] is attached to the back brace via the bladders [508]: paragraph 0111-0112); wherein the at least one strap (506) comprises a plurality of straps (figure 11/12, there are two straps [506]: paragraph 0109) configured to be tightened for adjusting pressures at the respective points of pressure to which the respective plurality of pressure sensors are attached (the microprocessor can control a release valve to adjust the pressure within the bladder [508], which affects the pressure from the back brace [500] onto the user, or the strap [506] can be adjusted to alter the pressure of the back brace [500] depending on the user’s need/fit: paragraph 0034/0091/0112/0114); and wherein the wearable device (516) is configured for informing and guiding in real time and incentivizing the patient to wear the back brace (500) by at least providing indications to the patient for tightening each of the plurality of straps (506) by comparing a corresponding pressure value provided by a corresponding one of the plurality of pressure sensors (514) with a corresponding calibration value (the microprocessor of the wearable device [516] monitors pressure measured by the one pressure sensor [514] and determines variation in the measured pressure and predetermined desired values [calibrated value]; additionally, the microprocessor can also be interfaced with a graphic display [indication] to provide a graphic analysis of the spinal deterioration and the vectors of the corrective forces used to correct the deterioration. Based on the graphic analysis, the microprocessor can control a release valve to adjust the pressure within the bladder [508, which affects the amount of pressure applied to the user] or the strap [506] can be adjusted to alter the pressure. As a result, this incentivizes the patient to wear the back brace [500] to efficiently correct spinal deformations since physicians have the measurements and analysis. Additionally, Embodiment A of Stark et al. discloses that in an initial examination of the patient, measurements are made of deformity parameters as well as normative data on progression of curve shape and resolution patterns needed to design treatment. The above measurements would be considered the calibration value because initial measurements of deformity parameters are inputted into the wearable device [516] in order to correct the spine via location and force of the force applicators. The corrective forces from the force applicator are established according to desired parameters and on initial measurements taken. Furthermore, the control unit can alter the forces within the brace to ensure proper levels of force to correct for unexpected changes in the forces or to alter the forces as a function of time in response to expected changes in spinal curvature via data collected from pressure sensors [514] (paragraph 0034/0090-0091/0112/0114).
Regarding claim 30, Embodiment A of Stark et al. discloses a back brace (500 - figure 11, a corrective back orthosis: paragraph 0109) configured to be worn by a patient for treating spinal deformations (the back brace [500] can be used to correct spinal misalignment: paragraph 0034/0109), the back brace (500) comprising: at least one strap (506 - figure 11/12, straps: paragraph 0109) configured to be tightened to apply corrective pressure to the patient's torso (the one strap [506] can be made to alter the pressure of the bladder [508], which is then applied to the user wearing the back device [500]: paragraph 0091); at least one pressure sensor (514 - figure 12, pressure sensors: paragraph 0112) passively configured to measure a pressure at an area of contact between the back brace (500) and a corresponding pressure point on the patient's torso, without applying force or actuation (the pressure sensors [514] are not applying the force or actuation, it is the force applicators doing that function. The sensors are passively reading the force applied from the force applicators: paragraph 0110-0112); and a wearable device (516 - figure 11, a control unit: paragraph 0112) operatively connected to the at least one pressure sensor (514) (figure 12, the wearable [516] is connected to the one pressure sensor [514] via wires; the pressure sensors [514] sends measurements to the control unit [516]: paragraph 0026/0034/0112) and configured to receive pressure measurements in real time from the at least one pressure sensor (514) and to compare the received pressure measurements with at least one calibration value that corresponds to a target pressure defined by a clinician during an initial fitting of the back brace (500) (Embodiment A of Stark et al. discloses that in an initial examination of the patient, measurements are made of deformity parameters as well as normative data on progression of curve shape and resolution patterns needed to design treatment. The above measurements would be considered the calibration value because initial measurements of deformity parameters are inputted into the wearable device [516] in order to correct the spine via location and force of the force applicators. The corrective forces from the force applicator are established according to desired parameters and on initial measurements taken. Furthermore, the control unit can alter the forces within the brace to ensure proper levels of force to correct for unexpected changes in the forces or to alter the forces as a function of time in response to expected changes in spinal curvature via data collected from pressure sensors [514] (paragraph 0034/0090-0091/0112/0114).
Regarding claim 31, Embodiment A of Stark et al. discloses the invention as discussed in claim 30. Embodiment A of Stark et al. further discloses wherein the at least one pressure sensor (514) is provided at an inner side of the back brace (figure 11, the one pressure sensor [514] is at the inner side of the back brace [facing the user]) and the control unit (516) is provided on an outer side of the back brace (figure 11, the control unit [516] is attached to the outside of the back brace [500, facing away from the user]).
Claims 36-37 and 39 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Embodiment B of Stark et al. (US 20050043660 A1).
Regarding claim 36, Embodiment B of Stark et al. discloses a back brace (200 - figure 6, a back orthosis: paragraph 0074) configured to be worn by a patient for efficient management of spine deformation treatments (the back brace [200] is an orthopedic restraining device that allows for passive correction of biological deformities: paragraph 0014), the back brace (200) comprising: at least one pressure sensor (208 - figure 6, a plurality of pressures sensors: paragraph 0075) configured to be attached to the back brace at an area of contact containing a point of pressure to be applied to a corresponding area of a patient's torso for correcting a spinal deformation and/or constraining a spine (figure 5/6, the plurality of pressure sensors [208] are attached to the bladders [206 - figure 6] and the bladders [206] are attached to the back brace [200] that wraps around the user’s torso; the pressure within the bladders [206] reflects the forces exerted by the patient. Therefore, the pressure changes can be used to design a desirable exercise routine to help treat the user’s back and allows the ability to monitor the patient’s compliance with the exercise routing: paragraph 0075/0077); and a wearable device (210 - figure 6, a controller with a microprocessor that functions similarly to the controller of figure 1: paragraph 0063/0075) having a real-time clock module (the wearable device [210] has a real time clock: paragraph 0063), a first memory module (the wearable device [210] has a non-volatile storage: paragraph 0063), a first communication module (the wearable device [210] comprises an interface with port for connection to another computer or to a modem: paragraph 0062), and a first processor (the wearable device [210] has a microprocessor: paragraph 0063) connected to the at least one pressure sensor (208) (figure 6, the wearable device [210] containing the real-time clock module, memory module, and processor are connected to the plurality of pressure sensors [208] via a wire [212 - figure 6]: paragraph 0075), the real-time clock module, and the first memory module, and the first communications module, the first processor being configured to run a first set of instructions causing the first processor to: receive at least one pressure measurement from the at least one pressure sensor in real time (figure 6, the wearable device [210] comprising the processor is connected to the plurality of pressure sensors [208]; the wearable device [210] receives pressure measurements over time via the real time clock: paragraph 0019-0020/0066/0069); associate the at least one pressure measurement with a sensor identifier of the at least one pressure sensor (figure 6, the wearable device [210] comprising the processor is capable of associating each pressure measurement with one of the plurality of pressure sensors [208] since each sensor are connected to the wearable device [210] via a wire [212]; each bladder [206] has a pressure sensor [208] that accounts for the pressure fluctuations within the bladder to allow physicians to design a desirable exercise routine and monitor the patient’s compliance with the exercise. Additionally, the wearable device [210] counts and tracks exercises: paragraph 0019-0020/0065/0075/0077); receive at least one time-date data field from the real-time clock module (the wearable device [210] comprises a real time clock module to measure the pressure of the bladders over time during exercises: paragraph 0062-0063/0075); associate the at least one pressure measurement with the at least one time-date data field and the sensor identifier (the wearable device [210] comprises a real time clock module to measure the pressure of the bladders [via pressure sensors for each bladder] over time during exercises: paragraph 0062-0063/0075); save the at least one pressure measurement, the sensor identifier, and the at least one time-date data field to the first memory module (the pressure measurements taken over time from the wearable device [210] can be downloaded at the base station; hence, the one pressure measurement from the pressure sensors can be saved for the health clinician to evaluate: paragraph 0062/0115-0119); connect to a computing device of the patient (the wearable device [210] communicates with a base station; the base station can download information from the wearable device [210] and vice-versa: paragraph 0062/0114-0119); and transmit the at least one pressure measurement, the sensor identifier, and the at least one time-date data field to the patient computing device for informing and guiding in real time, and incentivizing the patient to more efficiently wear the back brace, and enabling a doctor to more efficiently monitor, intervene, and manage the patient's spine deformation treatment in real time (the wearable device [210] comprising the processor transfers the real-time data collected from the plurality of pressure sensors [208] to a patient computing device, which allows the physician to evaluate the pressure fluctuations within each bladder [206] and design a desirable exercise routing and monitor the patient’s compliance with the target exercise routine: paragraph 0062-0065/0069/0077).
Regarding claim 37, Embodiment B of Stark et al. discloses the invention as discussed in claim 36. Embodiment B of Stark et al. further discloses the patient computing device comprising a second memory module and a second processor (information monitored by the wearable device [210] can be periodically downloaded to a computer or base station for health care professionals to evaluate; it also has a processor of its own as well: paragraph 0062-0065/0114-0119), wherein the second processor runs a software application configured to: store the at least one pressure measurement, the at least one sensor identifier, and the at least one time-date data field to the second memory module; associate the at least one pressure measurement, the at least one sensor identifier, and the at least one time-date data field with the patient; transmit the at least one pressure measurement, the at least one sensor identifier, and the at least one time-date data field associated with the patient to a server; and receive from the server and execute a second set of instructions for: presenting in real time the at least one pressure measurement together with a description of the associated pressure sensor; indicating adjustments to the back brace for modifying the at least one pressure measurement; presenting metrics on time use and the at least one pressure measurement; presenting benefits, associated with the metrics, to the patient; presenting target accomplishments associated with the metrics; gamifying a use of the back brace by presenting a game using the metrics; associating the game with at least one award; and presenting physical exercises, prescribed by the doctor for the spine deformation treatment (the pressure measurements taken over time from the wearable device [210] can be downloaded to the computer/base station [or vice-versa]; hence, the one pressure measurement from the pressure sensors can be saved for the physician to see on the computer/base station’s server, which allows the physician to evaluate the pressure fluctuations within each bladder [206] and design a desirable exercise routing and monitor the patient’s compliance with the target exercise routine. Furthermore, since the patient computing device is a processor, it is capable of performing the functions listed in the claim [see argument above regarding claim 37]: paragraph 0062-0065/0069/0077/0114-0119).
Regarding claim 39, Embodiment B of Stark et al. discloses the invention as discussed in claim 37. Embodiment B of Stark et al. further discloses at least one strap (222 - figure 6, a plurality of straps: paragraph 0076) configured to be tightened for adjusting a pressure at the point of pressure in the area of contact of the back brace to which corresponding the at least one pressure sensor (208) is attached (the plurality of straps [222] can be adjusted to alter the resting pressure on the bladder [206] or to reposition the bladders [206] throughout the back brace [200] to accommodate the patient; the bladders [206] have a pressure sensor attached to it to measure the pressure within the bladders [206] to reflect the forces exerted by the patient: paragraph 0059/0075); and wherein the processor of the wearable device (210) is further configured to run the first set of instructions causing the processor to transmit the at least one pressure measurement and associated sensor identifier and one time-date data field to the patient computing device for informing and guiding the patient in real time to incentivize the patient to wear the back brace (200) by providing indications to the patient for tightening the at least one strap (222) (the processor of the wearable device [210] receives real time data [there is real-time clock] from each pressure measurement from each bladder [206] that has a pressure sensor [208] and transmits the data to the patient computing device; the pressure sensors [208] accounts for the pressure fluctuations within the bladder [206], which allows the plurality of straps [222] to be adjusted to alter resting pressure on the bladder [206] or to reposition the bladders [206] throughout the back brace [200] to accommodate the patient. Since the patient computing device receives the data from the processor of the wearable device [210], it allows physicians to design a desirable exercise routing and monitor the patient’s compliance with the target exercise routine: paragraph 0062-0065/0069/0077).
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.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Stark et al. (US 20050043660 A1) in view of Chen et al. (CN 209342139 U).
Regarding claim 21, Embodiment A of Stark et al. discloses the invention as discussed in claim 20.
However, Embodiment A of Stark et al. fails to disclose wherein the at least one pressure sensor is attached to the back brace at a point of pressure between the back brace and the patient's body with an adhesive material applied to a bottom side of the at least one pressure sensor.
Chen et al. teaches wherein the at least one analogous pressure sensor (3 - see annotated figure 1 below, there is a pressure sensor within the sensor patch [2 - see annotated figure 1 below]: detailed description) is attached to an analogous back brace (1 - see annotated figure 1 below, an orthosis for adolescent idiopathic scoliosis: background technique/utility model content) at a point of pressure between the analogous back brace (1) and the patient's body (the at least one pressure sensor [3] is located at a point of pressure to sense the pressure of the position of the back brace [1] with the body: detailed description) with an adhesive material (5 - see annotated figure 1 below, a pressure sensitive adhesive patch: detailed description) applied to a bottom side of the at least one analogous pressure sensor (3) (see annotated figure 1 below, the adhesive material [5] is on the bottom side of the one pressure sensor [3], which is used to attach the one pressure sensor [3] to the back brace [1]: utility model content).
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Annotated Figure 1: cross section of the sensor patch attached to the back brace
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 provided the pressure sensor of Embodiment A of Stark et al. with an adhesive material applied to the bottom side of the pressure sensor to allow the pressure sensor to attach to the back brace as taught by Chen et al. in order to provide a back brace that has an improved pressure sensor to allow the pressure sensor to effectively fix onto the inside of the back brace when worn by the patient (utility model content, Chen et al.).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Stark et al. (US 20050043660 A1) in view of Vigano’ et al. (US 20170086519 A1).
Regarding claim 22, Embodiment A of Stark et al. discloses the invention as discussed in claim 20.
However, Embodiment A of Start et al. fails to disclose wherein the at least one pressure sensor is covered with a synthetic foam, wherein the synthetic foam is attached to the at least one pressure sensor with an adhesive material applied to an upper side of the at least one pressure sensor.
Vigano’ et al. teaches wherein the at least one analogous pressure sensor (12/14 - figure 1, a resistive pressure sensors: paragraph 0055) is covered with a synthetic foam (the one pressure sensor [12/14] is associated with a substrate [can be a synthetic foam] that is capable of being worn directly against the skin: paragraph 0018), wherein the synthetic foam is attached to the at least one analogous pressure sensor (12/14) with an adhesive material applied to an upper side of the at least one analogous pressure sensor (12/14) (the synthetic foam is attached to the upper side of the one pressure sensor [12/14] via an adhesive material applied to the underlying synthetic foam to connect to the upper side of the one pressure sensor [12/14]: paragraph 0018/0021).
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 provided the pressure sensor of Embodiment A of Stark et al. with an adhesive material applied to the upper side of the pressure sensor to allow the synthetic foam to attach to the pressure sensor as taught by Vigano’ et al. in order to provide a back brace that has an improved pressure sensor including the synthetic foam to provide additional comfort on the user’s skin and allow the capability of moving in concert with the physiological structures the synthetic foam is covering (paragraph 0018, Vigano’).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Stark et al. (US 20050043660 A1) in view of Ishikawa et al. (US 20160120733 A1).
Regarding claim 23, Embodiment A of Stark et al. discloses the invention as discussed in claim 20.
However, Embodiment A of Stark et al. fails to disclose wherein the at least one pressure sensor is connected to the wearable device via a wireless connection between the at least one pressure sensor and the wearable device.
Ishikawa et al. teaches wherein the at least one analogous pressure sensor (108 – figure 1A, one or more activity sensors that can be a pressure sensor: paragraph 0051), is connected to an analogous wearable device (112 – figure 1A, a control system that can be sized and configured to be conveniently worn by the subject: paragraph 0036) via a wireless connection between the at least one pressure sensor (108) and the wearable device (112) (the pressure sensors [108] can be wirelessly coupled to the wearable device [112]: paragraph 0036).
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 one pressure sensor of Embodiment A of Stark et al. to be wirelessly connected to the wearable device as taught by Ishikawa et al. in order to provide a back brace that has an improved sensor to ease the process of downloading or uploading data to/or from computing devices (paragraph 0040, Ishikawa et al.).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Stark et al. (US 20050043660 A1) in view of Palmer (US 20180153725 A1).
Regarding claim 25, Embodiment A of Stark et al. discloses the invention as discussed in claim 20.
However, Embodiment A of Stark et al. fails to disclose wherein a foam material disposed between the at least one pressure sensor and the patient's body to provide comfort while the back brace is worn by the patient.
Palmer teaches a foam material (26 - figure 3, a padding that can be a soft foam: paragraph 0024) disposed between the at least one analogous pressure sensor (pressure sensors can be placed within the foam material: 0029) and the patient's body to provide comfort while an analogous back brace (10 - figure 3, a hip orthotic that has a back panel to support a patient’s lumbar area: abstract/paragraph 0020) is worn by the patient (the foam material [26] provides comfort to the patient: paragraph 0024).
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 provided the back brace of Embodiment A of Stark et al. with a foam material between the patient and the sensor as taught by Palmer in order to provide a back brace with improved comfortability for the user and better hygiene of using the back brace since the foam material is removable and can be replaced (paragraph 0024, Palmer).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Stark et al. (US 20050043660 A1) in view of Chen et al. (CN 209342139 U) and in further view of Vigano’ et al. (US 20170086519 A1).
Regarding claim 26, Embodiment A of Stark et al. discloses the invention as discussed in claim 20.
However, Embodiment A of Stark et al. fails to disclose wherein the at least one pressure sensor is embedded between an adhesive surface attaching the at least one pressure sensor to the back brace and another adhesive surface attaching the at least one pressure sensor to a foam material.
Chen et al. teaches an adhesive surface (5 - see annotated figure 1 above, a pressure sensitive adhesive patch: detailed description) attaching the at least one analogous pressure sensor (3 - see annotated figure 1 above, there is a pressure sensor within the sensor patch [2 - see annotated figure 1 above]: detailed description) to an analogous back brace (1 - see annotated figure 1 above, an orthosis for adolescent idiopathic scoliosis: background technique/utility model content) (see annotated figure 1 above, the adhesive material [5] is on the bottom side of the one pressure sensor [3], which is used to attach the one pressure sensor [3] to the back brace [1]: utility model content).
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 provided the pressure sensor of Embodiment A of Stark et al. with an adhesive material applied to allow the pressure sensor to attach to the back brace as taught by Chen et al. in order to provide a back brace that has an improved pressure sensor to allow the pressure sensor to effectively fix onto the inside of the back brace when worn by the patient (utility model content, Chen et al.).
However, Stark et al. in view of Chen et al. fails to disclose wherein the at least one pressure sensor is embedded between another adhesive surface attaching the at least one pressure sensor to a foam material.
Vigano’ et al. teaches another adhesive surface attaching the at least one analogous pressure sensor (12/14 - figure 1, a resistive pressure sensors: paragraph 0055) to a foam material (the one pressure sensor [12/14] is associated with a substrate [can be a synthetic foam] that is capable of being worn directly against the skin: paragraph 0018) (the synthetic foam is attached to the upper side of the one pressure sensor [12/14] via an adhesive material applied to the underlying synthetic foam to connect to the upper side of the one pressure sensor [12/14]: paragraph 0018/0021).
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 provided the pressure sensor of Embodiment A of Stark et al. in view of Chen et al. with an adhesive surface to allow the synthetic foam to attach to the pressure sensor as taught by Vigano’ et al. in order to provide a back brace that has an improved pressure sensor including the synthetic foam to provide additional comfort on the user’s skin and allow the capability of moving in concert with the physiological structures the synthetic foam is covering (paragraph 0018, Vigano’).
The combination of Embodiment A of Stark et al., Chen et al., and Vigano’ et al. further discloses wherein the at least one pressure sensor is embedded between an adhesive surface attaching the at least one pressure sensor to the back brace and another adhesive surface attaching the at least one pressure sensor to a foam material (Embodiment A of Stark et al., Chen et al., and Vigano’ et al.: when combining the primary reference with the two teaching references, there is an adhesive layer on both sides of the pressure sensor of Embodiment A of Stark et al.; one adhesive layer from Chen et al. attaches the pressure sensor of Embodiment A of Stark et al. to the back brace of Embodiment A of Stark et al. while the other adhesive layer from Vigano’ et al. attaches the pressure sensor of Embodiment A of Stark et al. to the foam material of Vigano’ et al.).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Stark et al. (US 20050043660 A1) in view of Turner et al. (US 20170340472 A1).
Regarding claim 27, Embodiment A of Stark et al. discloses the invention as discussed in claim 20.
However, Embodiment A of Stark et al. fails to disclose wherein the at least one pressure sensor is selected from a resistive pressure sensor, a capacitive pressure sensor, or a sensor with integrated wireless capabilities.
Turner et al. teaches wherein the at least one analogous pressure sensor is selected from a resistive pressure sensor, a capacitive pressure sensor, or a sensor with integrated wireless capabilities (there can be one or more pressure sensors that have wireless capabilities: paragraph 0070-0071).
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 one pressure sensor of Embodiment A of Stark et al. with an integrated wireless capability as taught by Turner et al. in order to provide a back brace that has an improved sensor to transmit data wirelessly to allow the possibility of reducing the software package to a mobile software application (“app”) that can be conveniently implemented on a mobile phone, tablet, smart watch, or other mobile electronic device (paragraph 0071, Turner et al.).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Stark et al. (US 20050043660 A1) in view of Kanchan et al. (US 20160338621 A1).
Regarding claim 28, Embodiment A of Stark et al. discloses the invention as discussed in claim 20.
However, Embodiment A of Stark et al. fails to disclose wherein the wearable device includes an inertial measurement unit (IMU) configured to detect motion, orientation, and acceleration of the patient's body.
Kanchan et al. teaches wherein an analogous wearable device (52 - figure 6, a hub that includes sensors: paragraph 0052) includes an inertial measurement unit (IMU) configured to detect motion, orientation, and acceleration of the patient's body (the wearable device [52] can have a sensor that is an IMU; it measures acceleration, angular velocity, and orientation of the body: paragraph 0038/0052/0067/0073).
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 provided the wearable device of Embodiment A of Stark et al. with an inertial measurement unit as taught by Kanchan et al. in order to provide a back brace that has an improved wearable device to assist in collecting valuable bio-mechanical data of the body, such as orientation of body or body segments (paragraph 0040/0067/0083, Kanchan et al.).
Claims 32, 34, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Stark et al. (US 20050043660 A1) in view of Lou et al. (US 20110230806 A1).
Regarding claim 32, Embodiment A of Stark et al. discloses the invention as discussed in claim 30. Embodiment A of Stark et al. further discloses a remote server configured to: receive calibration data and pressure measurements from the wearable device (516) (the wearable device [516] can send calibration data [initial deformity parameters] and pressure measurements [based on the initial deformity parameters that needs to be corrected] to a base station [microprocessor]: paragraph 0112-0119); and store and analyze time-based and pressure-based usage metrics indicative of both the duration and quality of brace wear (the base station processor can store pressure-based usage metrics over a period of time to determine if the pressure-based metrics are actively correcting the deformities: paragraph 0112-0119); and a web-based clinician interface configured to allow a clinician to: monitor pressure trends and compliance metrics remotely; update calibration values in response to observed deviations; and schedule patient interventions based on the monitored data (there can be a representation of the deformed spine and corrective force vectors that can be graphically displayed by the base station. Additionally, the data captured by the wearable device [516] can also be periodically downloaded to the base station [via radio waves/frequencies {wireless}] for the health care professional to evaluate. As a result, this allows for periodic examinations to remeasure the deformity parameters and to select new corrective force vector prescription. This process is repeated until treatment can be terminated: paragraph 0112-0119).
However, Embodiment A fails to disclose a mobile application configured to: present to the patient guidance for tightening the at least one strap based on a comparison of current pressure values with the at least one calibration value; and provide indications that the at least one strap has been properly tightened when the pressure value matches the calibration value.
Lou et al. teaches a mobile application configured to: present to the patient guidance for tightening the at least one analogous strap based on a comparison of current pressure values with the at least one calibration value; and provide indications that the at least one analogous strap has been properly tightened when the pressure value matches the calibration value (the pressure sensors are coupled to the microcontroller to record sensor readings and perform corrections as required if the target pressure value is not met. Furthermore, the microcontroller can communicate to a secondary device such as a cellular phone, which can be used to configure target force levels. The cellular phone provides the patient a way to view the current status of treatment and the data collected while wearing the orthosis. It can also comprise of information and means to display advice on how the patient can wear the orthosis to ensure proper prescribed target level tightness. The information can be presented graphically or textually: paragraph 0009-0010/0080).
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 provided the system of Embodiment A of Stark et al. with a mobile application as taught by Lou et al. in order to provide a back brace that has an improved system to allow patients to conveniently see the status of their treatment on a cellular phone and allow patients to easily adjust force levels in order to reach the target force level required for treatment (paragraph 0009-0010/0080, Lou et al.).
Regarding claim 34, Embodiment A of Stark et al. in view of Lou et al. discloses the invention as discussed in claim 32. Embodiment A of Stark et al. further discloses wherein the at least one calibration value is established by a clinician during an initial fitting session by physically adjusting the at least one strap (506) of the back brace (500) to exert a desired corrective pressure (Embodiment A of Stark et al. discloses that in an initial examination of the patient, measurements are made of deformity parameters as well as normative data on progression of curve shape and resolution patterns needed to design treatment. The above measurements would be considered the calibration value because initial measurements of deformity parameters are inputted into the control unit (microprocessor) in order to correct the spine via location and force of the force applicators. The corrective forces from the force applicator are established according to desired parameters and on initial measurements taken. Furthermore, the control unit can alter the forces within the brace to ensure proper levels of force to correct for unexpected changes in the forces or to alter the forces as a function of time in response to expected changes in spinal curvature; adjustment to straps can also be made to adjust to a desired corrective pressure: paragraph 0090-0091/0114-0119), and wherein the calibration value is stored on the server for subsequent comparisons during patient use (the calibration values are stored in the base station [microprocessor] information; the wearable unit [516] can be downloaded to the base station processor, which allows periodic examinations to remeasure the deformity parameters. The deformity parameters [calibration value] is inputted into the base station and/or the control unit. The new deformity parameters are used to select a new corrective force vector prescription. This process is then repeated until treatment can be terminated: paragraph 0090-0091-0114-0119).
Regarding claim 35, Embodiment A of Stark et al. in view of Lou et al. discloses the invention as discussed in claim 32. Embodiment A of Stark et al. further discloses wherein the server is further configured to generate usage metrics indicative of both the duration of brace (500) wear and the correctness of brace fit, based on a comparison of real-time pressure measurements to the at least one calibration value (Embodiment A of Stark et al. discloses a method of use and generates usage metrics of duration and correctness of brace fit based on measurements made of deformity parameters as well as normative data on progression of curve shape and resolution patterns needed to design treatment. This information is first input into a base station, which is a microprocessor used by a health professional to track patient's condition and progress. The above measurements would be considered the calibration value because initial measurements of deformity parameters are inputted into the control unit (microprocessor) in order to correct the spine via location and force of the force applicators. The corrective forces from the force applicator are established according to desired parameters and on initial measurements taken. Furthermore, the control unit (connected to sensors) can alter the forces within the brace to ensure proper levels of force to correct for unexpected changes in the forces or to alter the forces as a function of time in response to expected changes in spinal curvature: paragraph 0090-0091/0114-0116).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Stark et al. (US 20050043660 A1) in view of Lou et al. (US 20110230806 A1) and in further view of Vigano’ et al. (US 20170086519 A1).
Regarding claim 33, Embodiment A of Stark et al. in view of Lou et al. discloses the invention as discussed in claim 32.
However, Embodiment A of Stark et al. in view of Lou et al. fails to disclose wherein the at least one pressure sensor is selected from a resistive pressure sensor or a capacitive pressure sensor and is passively configured to detect applied pressure without any actuation or force generation mechanism.
Vigano’ et al. teaches wherein the at least one analogous pressure sensor is selected from a resistive pressure sensor or a capacitive pressure sensor (42/44 – figure 4B, resistive pressure sensors: paragraph 0060) and is passively configured to detect applied pressure without any actuation or force generation mechanism (the resistive pressure sensor detects pressure without any actuation or force generation mechanism: paragraph abstract/0011/0014).
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 one pressure sensor of Embodiment A of Stark et al. in view of Lou et al. to be a resistive pressure sensor as taught by Vigano’ et al. in order to provide a back brace that has an improved sensor to improve comfort of wearing the sensors under many conditions while still sensing force or pressure exerted on or against the sensor by skin or external object/component (paragraph 0011-0012, Vigano’ et al.).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Embodiment B of Stark et al. (US 20050043660 A1) in view of DeLuke et al. (US 20150119780 A1).
Regarding claim 38, Embodiment B of Stark et al. discloses the invention as discussed in claim 37.
However, Embodiment B of Stark et al. fails to disclose the server comprising: a third processor that runs software configured to allow the doctor to: manage an account associated with the patient; create a personalized spine deformation treatment associated with the patient's account, the back brace, and the at least one pressure sensor; receive from the patient computing device the at least one pressure measurement, the sensor identifier, and the at least one time-date data field associated with the patient; associate the at least one pressure measurement, the sensor identifier, and the at least one time-date data field with the patient's account; create metrics on time use and the at least one pressure measurements received from the patient computing apparatus; associate benefits and target accomplishments with the metrics; gamify a use of the back brace by using the metrics; associate the gamified use of the back brace with at least one award; and prescribe physical exercises for the patient for the spine deformation treatment.
DeLuke et al. teaches an analogous server (304/306/308 – figure 9, a computer or smartphone [304] that in turn, communicates with the internet server [306], which allows doctors to see data on the web portal [308]: paragraph 0071) comprising: a third processor (a computer/smart phone contains a processor) that runs software configured to allow the doctor to: manage an account associated with the patient; create a personalized spine deformation treatment associated with the patient's account, the back brace, and the at least one pressure sensor; receive from the patient computing device the at least one pressure measurement, the sensor identifier, and the at least one time-date data field associated with the patient; associate the at least one pressure measurement, the sensor identifier, and the at least one time-date data field with the patient's account; create metrics on time use and the at least one pressure measurements received from the patient computing apparatus; associate benefits and target accomplishments with the metrics; gamify a use of the back brace by using the metrics; associate the gamified use of the back brace with at least one award; and prescribe physical exercises for the patient for the spine deformation treatment (figure 13, the server [304/306/308] allows for physicians to assess data collected; in the web portal of the server [308], an account of the patient can be seen, duration of the back brace worn, tension of the straps, etc. This allows the physicians to quickly and efficiently assess brace usage for his/her patients. It is further contemplated that the systems/methods of the present disclosure may support and/or facilitate an incentive and/or reward program based on patient usage Furthermore, since the server [304/306/308] contains a processor, it is capable of performing the functions listed in the claim: paragraph 0082-0083).
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 provided the server (base station processor) of Embodiment B of Stark et al. with a third processor that runs software as taught by DeLuke et al. in order to provide a back brace that has an improved server to allow physicians to quickly and efficiently assess brace usage for his/her patients (paragraph 0082-0083, DeLuke et al.).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW JUN-WAI MOK whose telephone number is (703)756-4605. The examiner can normally be reached 8am-4pm.
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/ANDREW JUN-WAI MOK/Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786
