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 .
Status of Claims
The amendments and remarks filed on 11MAY2026 have been entered and considered.
Claims 1, 3, 6-7, & 11-19 are currently pending.
Claims 1, 6-7, & 19 have been amended.
Claims 1, 3, 6-7, & 11-19 are under examination.
Response to Arguments
Applicant's arguments filed 11MAY2026 regarding the rejections under 35 USC 103 have been fully considered and have been found to be not persuasive. Parts deemed not persuasive discussed below:
Applicant states (see Pages 1-3 of the Remarks):
The applied combination does not teach or suggest the amended claim 1 as a whole. The Office Action relies on Chahine for a textile garment with conductive pathways and electronics, Lunau for a knee brace or band providing compression, Mahfouz for dual IMU placement above and below a kneecap, and Justice for the flexible battery belt concept. However, even if these teachings are considered together, the cited references do not disclose or suggest the specific claimed arrangement in which a knee brace includes a stiffened, flush or continuous dock positioned above the kneecap and a flexible battery belt having an elastomer-encapsulated, multi-unit battery assembly located in the belt portion that wraps around the knee.
However, the argument is not persuasive as the Examiner maintains that the references in combination teach the claim limitations as further detailed below in the `103 rejection section.
Justice does not teach a battery assembly located in a belt portion of a knee brace, made from a plurality of battery units housed together in an elastomeric material, with adjacent battery units connected by connecting portions to provide flexibility to the battery assembly. As amended, claim 1 requires the battery assembly itself to have the recited flexible, elastomer-encapsulated, linked-unit structure and to be located in the belt portion that wraps around the knee. By contrast, the Office Action's mapping to Justice relies on flexible segments of a composite band and on energy-storage cells positioned in battery compartments or rigid segments. Justice TT[0009], [0015]. A flexible segment that routes electrical connections between components is not the same as an elastomeric material housing a plurality of battery units in a battery assembly located in a knee-wrapping belt portion. Nor does Justice's disclosure that a flexible segment may be elastomeric establish that the energy-storage cells themselves are housed in an elastomeric material as part of the claimed battery assembly.
However, the examiner is not persuaded because the claims required the battery units are housed in an elastomeric material rather than the argued encapsulation Justice Figure 1A shows that the wristband is formed by multiple battery units or other functional units (depicted as part 16) formed in the band of the watch device and are located along the belt portion of the wristband. The Examiner further maintains that the disclosure of a rigid material does not exclude the material from also being an elastomeric material.
The stated rationale for combining Justice with the other references also does not supply the missing teaching. The Office Action states that Justice would provide a suitable power source for improved functionality and battery life. Even assuming a skilled artisan would have looked to Justice for a wearable power source generally, that rationale does not explain why the skilled artisan would have modified the proposed knee brace to include the specific claimed configuration: a battery assembly located in the belt portion, made from battery units housed in an elastomeric material and connected by connecting portions, in combination with a stiffened, flush or continuous dock positioned above the kneecap. A general desire to provide power does not provide a reason to arrive at the particular claimed docking and elastomer- encapsulated battery-belt architecture.
However, the argument is not persuasive because one of ordinary skill in the art would know that distributing battery units across a belt portion with flexible connections around the knee would be a predictable design choice with the intention of optimizing the size, weight and user comfort while using the device.
Claims 6, 7, 11-16, and 17-19 depend from claim 1, either directly or indirectly. Because the applied combination fails to teach or suggest amended independent claim 1, the rejection of these dependent claims is deficient for at least the same reasons.
However, the examiner disagrees as discussed above.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1, 3, 6-7, & 11-19 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 recites be “said dock is positioned above a kneecap of said knee, is a stiffened area of said knee brace, and has a surface that is flush or continuous with the rest of said knee brace”, “said first IMU is disposed at a first position above a kneecap of said knee and is configured to detect an orientation of an upper leg of said wearer”, and “said second IMU sensor is disposed at a second position below said kneecap of said knee and is configured to detect an orientation of a lower leg of said wearer”. The limitations lack required “configured to” language and therefore are claiming the user. Claims 1, 3, 6-7, & 11-19 are rejected for depending upon the rejected claim 1.
Claim 3 recites “the stretch sensor extends from above a kneecap of the knee to below the kneecap of the knee.”. The limitations lack required “configured to” language and therefore are claiming the user.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 6-7, 11-16, 17 & 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Chahine et al (US Publication No. 20200367823; Previously Cited) in view of Lunau et.al (WO Publication No. 2010135288; Previously Cited), Mahfouz et al. (ES Publication No. 2900643-T3; Previously Cited), and Justice et al (US Publication No. 20150342525; Previously Cited).
Regarding claim 1, Chahine discloses a tubular garment for monitoring a body part of a wearer (Chahine ¶0028 “For purposes of demonstration only, the tubular garment 10 is described in relation to being worn on (i.e. covering) a wearer's foot, ankle and calf body parts. However, it is also recognized that the tubular garment can be worn about the wrist (i.e. covering the hand, wrist and forearm), about the elbow (i.e. covering the forearm, elbow and bicep), or about the knee (i.e. covering the shin, knee, and thigh).”), the garment comprising: a textile article shaped to cover at least part of a knee of the wearer (Chahine Figure 9 as described in ¶0029 showing tubular garment 10 around the knee; ¶0029 “The garment 10 includes (and is not limited to) any one of a knitted textile, a woven textile, or a cut and sewn textile, a knitted fabric, a non-knitted fabric, in any combination and/or permutation thereof (any equivalent thereof). The garment 10 can include an integrated functional textile article.”), the textile article including conductive yarn arranged to define a first conductive path (Chahine ¶0036 “It will be understood that the stretch sensor 34 (e.g. conductive thread) when attached/integrated to/into the fabric body layer 11 of a garment 10 can stretch when a skin surface underlying the stretch sensor 34 moves and/or stretches.”; ¶0042; ¶0055; ¶0069; ¶0044 “The conductive pathways 42 can comprise conductive fibres interlaced with the non-conductive interlaced fibres of the material of the body 11 of the garment 10.; ¶0045);a dock for removably receiving a control module, the control module electrically coupled with the dock when received therein (Chahine ¶0043 “ It is recognized that the controller device 40 can be decoupled rom the housing 124 for ease of cleaning of the garment 10, i.e. the controller device 40 can be releasably secured to the conductive pathway 42 network via the housing 124 coordinating electrical connection between the controller device 40 and the conducive pathways 42.”) and has a surface that continuous with the rest of said knee brace (Chahine Figure 10 showing the housing 124 as being integrated with the knee brace).; a sensor for measuring a physiological state of the wearer(Chahine ¶0052 “Also connected to the PCB 125 can be the IMU sensor 32 for measuring the motion activity of the wearer 8.”), the sensor being electrically coupled to the control module by way of the first conductive path when the control module is received in the dock (Chahine ¶0006 “a network of conductive pathways in the body for connecting to a controller device; a strain sensor of the body positioned about the intermediate portion and coupled to the network of conductive pathways; an IMU sensor mounted on the body and configured for communication with the controller device; a plurality of sensors of the body for providing EMG and EMS functionality with respect to one or more muscles of the wearer positioned adjacent to the body when the garment is worn by the wearer, the plurality of sensors connected to the network of conductive pathways; wherein the controller device is programed to operate the EMG and EMS functionality based on signal data obtained from the IMU sensor.”), wherein: said sensor is a first inertial measurement unit (IMU) (Chahine ¶0052 “Also connected to the PCB 125 can be the IMU sensor 32 for measuring the motion activity of the wearer 8.”) and the garment includes a second IMU (Chahine ¶0031 “the garment 10 (shown only by example as a sock) can have an inertial measurement unit (IMU) sensor 32”; ¶0080 “For example, in reference to FIG. 11B, it is recognized that any of the garments 10 can include one or more of the sensor types 32,34,36,38,39,41,43, in any combination of sensor types as desired (i.e. one type, many types selected from the types but not all types, or all types).”);, wherein said knee brace further comprises a resistive heating element inlaid within the textile article for providing heat to at least a part of the knee (Chahine ¶0079 “It can be appreciated that this time-domain based pulse-width-modulated temperature control method 500 can be applied to resistive heating element 50 based system where the resistance of the heating element is changing.”; ¶0077; ¶0036 “It will be understood that the stretch sensor 34 (e.g. conductive thread) when attached/integrated to/into the fabric body layer 11 of a garment 10 can stretch when a skin surface underlying the stretch sensor 34 moves and/or stretches”), said heating element being electrically coupled to said control module by a second conductive path defined by the conductive yarn that extends between at least one power terminal of said heating element and at least one power terminal of said control module (Chahine ¶0076 “Each of the resistive elements is connected in parallel to a pair of power buses 52 connected on either end of the resistive elements 50, being in parallel. The power buses 50 are connected to the controller device 40 (and thus the power supply and processor 116) via the conductive pathways 42.”; ¶0078 “A typical example would be a 12V DC power source 128 (see FIG. 10) applied to a knitted conductive yarn resistive heating element(s) 50”).
Chahine does not disclose a knee brace, such that said belt provides compression pressure for supporting said knee, wherein said dock is a stiffened area of said knee brace ; an IMU, wherein said dock is positioned above a kneecap of said knee and said IMU is disposed at a first position above a kneecap of a knee of a wearer and is configured to detect an orientation of an upper leg of a wearer; said second IMU sensor is disposed at a second position below said kneecap of said knee and is configured to detect an orientation of a lower leg of said wearer; a control module is configured to determine a physiological state based at least in part on said detected orientations of said upper leg and said lower leg, and a battery assembly located in the belt portion and configured to supply power to said sensor and said control module the battery assembly being made from a plurality of battery units housed in an elastomeric material, each battery unit of the plurality of battery units being connected to an adjacent battery unit of the plurality of battery units by connecting portions.
Lunau in a similar field of endeavor of electrostimulation and joint stabilization teaches a electrostimulation and joint stabilization device knee brace (Lunau Figure 1 showing Knee brace 10”; Figure 24A as described in ¶0096 “The illustrated orthotic device comprises a knee brace 201 with two electrostimulation pads 204 and 205”); wherein said dock is a stiffened area of said knee brace (Lunau ¶0146 “Connection portion 251 is configured to allow an electrical connection to be formed between the electrode and an electrostimulation unit.”; ¶0148 “In some embodiments , such as embodiments where the electrode is disposed on a rigid or semirigid portion of an orthotic device, the conductive middle layer 254 may comprise rigid or semirigid conductive material.”) and a belt portion configured to wrap around said knee, such that said belt provides compression pressure for supporting said knee (Lunau ¶0143 “Band 203 may comprise an elastic or other type of resilient material coupled to the brace hinge or other brace elements to provide positional stability and a surface upon which electrostimulation elements may be disposed.” & ¶00150 “For example, this may be achieved by reducing or eliminating the conductive interface layer 253 at the connection point, such that the connection member 257 connects directly to the conductive middle layer 254. In other embodiments, this may be achieved by compressive force imparted on the pad by connection member 257 when engaged).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify Chahine in view of Lunau by modifying the brace system of Chahine with Lunau’s a knee brace and a belt portion configured to wrap around said knee, such that said belt provides compression pressure for supporting said knee wherein said dock is a stiffened area of said knee brace, for the purpose of providing and optimized joint treatment versus using either the joint stabilizing assembly or electrostimulation unit alone (Chahine ¶0003).
Additionally, Chahine in view of Rahman and Lunau does not disclose an IMU, wherein said dock is positioned above a kneecap of said knee and said IMU is disposed at a first position above a kneecap of a knee of a wearer and is configured to detect an orientation of an upper leg of a wearer; said second IMU sensor is disposed at a second position below said kneecap of said knee and is configured to detect an orientation of a lower leg of said wearer; a control module is configured to determine a physiological state based at least in part on said detected orientations of said upper leg and said lower leg and a battery assembly located in the belt portion and configured to supply power to said sensor and said control module the battery assembly being made from a plurality of battery units housed in an elastomeric material, each battery unit of the plurality of battery units being connected to an adjacent battery unit of the plurality of battery units by connecting portions . Mahfouz in a similar field of joint stabilizers integrated with motion sensors teaches an IMU (Mahfouz Abstract “A joint monitoring apparatus comprising: a first inertial monitoring unit (48A) configured to engage and detect movement of a first portion of a patient's joint using a first inertial monitoring sensor (36) comprising an accelerometer (56) , a gyroscope (58) and a magnetometer (60), and to collect and transmit data indicative of detected motion; a first ultrasound module (52) located in a fixed position with respect to the first inertial monitoring unit (48A), wherein the first ultrasound module is configured to transmit a first ultrasound pulse to the first portion of the patient and receive an echo of the first ultrasound pulse; a second inertial monitoring unit (48B) configured to connect to and detect movement of a second portion of the patient's joint using a second inertial monitoring sensor (36)”; Page 3 Lines 7-14; ); said dock is positioned above a kneecap of said knee and said first IMU is disposed at a first position above a kneecap of a knee of a wearer (Mahfouz Figure 1 as described on Page 5 Lines 1-5 “A joint monitoring apparatus 30 is illustrated in the form of a knee splint 32 for use in monitoring and tracking the movement of the knee joint 28. The knee splint 32 may include a housing that supports the monitoring apparatus. of joints 30. The housing may include an upper section 34A having an inertial monitoring unit 48A, and a lower section 34B having an inertial monitoring unit 48B.” where the housing 34 is described to contain IMU sensors in ¶0048 such that when the IMU sensor is above the kneecap the housing dock will simultaneously be in that location )and is configured to detect an orientation of an upper leg of said wearer (Mahfouz Page 3 Lines 56-57 “FIG. 9 is a flowchart illustrating a sequence of instructions for calculating the orientation of an object from data received from the inertial monitoring unit of FIG. two.); said second IMU sensor is disposed at a second position below said kneecap (Mahfouz Figure 1 as described on Page 5 Lines 1-5 “A joint monitoring apparatus 30 is illustrated in the form of a knee splint 32 for use in monitoring and tracking the movement of the knee joint 28. The knee splint 32 may include a housing that supports the monitoring apparatus. of joints 30. The housing may include an upper section 34A having an inertial monitoring unit 48A, and a lower section 34B having an inertial monitoring unit 48B.”) and is configured to detect an orientation of a lower leg of said wearer (Mahfouz Abstract “process the gyro angular rate data (58) from the first inertial monitoring unit (48A) including a calibration calculation that compensates for scale and bias to calculate the relative change in orientation of the first inertial monitoring unit (48A ) in quaternion; process the angular rate data of the gyroscope (58) from the second inertial monitoring unit (48B) including a calibration calculation that compensates for scale and bias to calculate the relative change in orientation of the second inertial monitoring unit (48B ) in quaternion; prepare a local reference model using the quaternion orientations; and use the global reference model and the local reference model to determine an orientation of the patient's joint.”); a control module is configured to determine said physiological state based at least in part on said detected orientations of said upper leg and said lower leg; (Mahfouz Page 28 Lines 65-66 & Page 29 Lines 1-3 “Vibroarthrography algorithm 454 is configured to identify and evaluate various vibration patterns associated with movement and/or joints of the bones and tissues comprising the joint being treated. is evaluating. In one embodiment of the invention, the output of vibroarthrography algorithm 454 and joint kinematics module 460 may be provided to a trainable neural network that provides a computer-aided diagnostic module 462 that generates a diagnosis for the joint.”; Page 7 Lines 19-20 “The observed vibration can then provide a useful indicator for diagnosing a joint condition”).
Before the effective filing date, it would have been obvious to a person of skill in the art to combine Mahfouz with Chahine and Lunau because integrating Mahfouz’s IMU wherein said dock is positioned above a kneecap of said knee and said IMU is disposed at a first position above a kneecap of said knee and is configured to detect an orientation of an upper leg of said wearer; said second IMU sensor is disposed at a second position below said kneecap of said knee and is configured to detect an orientation of a lower leg of said wearer; said control module is configured to determine said physiological state based at least in part on said detected orientations of said upper leg and said lower leg allows for a system that provides the brace for a knee that is also capable of monitoring the recovery of the injured joint and patient recovery based on gait changes detected as they use the device.
Lastly, Chahine in view of Lunau, and Mahfouz does not expressly disclose a flexible battery belt comprising a module for attaching to a dock and a battery assembly located in the belt portion and configured to supply power to said sensor and said control module the battery assembly being made from a plurality of battery units housed in an elastomeric material, each battery unit of the plurality of battery units being connected to an adjacent battery unit of the plurality of battery units by connecting portions. Justice in a similar field of endeavor teaches a flexible battery belt (Justice ¶0015 “Electrical connections between the energy storage cells and the functional components are routed through flexible segments 14.”) comprising a module for attaching to a dock (Justice Flexible segment 14 as shown in Figure 1A). and a battery assembly located in the belt portion and configured to supply power to said sensor and said control module the battery assembly being made from a plurality of battery units housed in an elastomeric material(Justice ¶0015 “Electrical connections between the energy storage cells and the functional components are routed through flexible segments 14…The functional components of wearable electronic device 10 draw power from one or more energy-storage cells 34. A battery—e.g., a lithium ion battery—is one type of energy-storage cell suitable for this purpose.”; ¶0009 “A flexible segment may be elastomeric in some examples.”), each battery unit of the plurality of battery units being connected to an adjacent battery unit of the plurality of battery units by connecting portions (Justice ¶0015 “Electrical connections between the energy storage cells and the functional components are routed through flexible segments 14.”).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify Chahine, Lunau, and Mahfouz in view of Justice by integrating Justice’s a flexible battery belt comprising a module for attaching to said dock and a battery assembly located in the belt portion and configured to supply power to said sensor and said control module the battery assembly being made from a plurality of battery units housed in an elastomeric material, each battery unit of the plurality of battery units being connected to an adjacent battery unit of the plurality of battery units by connecting portions, since distributing battery units across a belt portion with flexible connections around the knee would be a predictable design choice with the intention of optimizing the size, weight and user comfort while using the device.
As per claim 6, Claim 1 is obvious over Chahine, Lunau, Mahfouz, and Justice. Chahine, Lunau, and Mahfouz do not disclose wherein the control module is electrically coupled to said battery; and the control module and the battery form said flexible battery belt. Justice further teaches wherein the control module is electrically coupled to said battery; and the control module and the battery form said flexible battery belt. (Justice ¶0015 “Electrical connections between the energy storage cells and the functional components are routed through flexible segments 14.”).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify Lunau, Chahine, and Mahfouz in view of Justice by combining the system of Lunau, Chahine, and Mahfouz with Justice’s control module which is electrically coupled to said battery; and the control module and the battery form said flexible battery belt. The motivation to integrate the electrostimulation and joint stabilization device of claim 1 with Justice’s battery configuration is because this provides a suitable power source for the garment to provide improved functionality and battery life (Justice ¶0001).
As per claim 7, Claims 1 & 6 are obvious over Chahine, Lunau, Mahfouz, and Justice. Chahine, Mahfouz, and Justice do not disclose wherein said battery is a battery assembly including a battery unit. Lunau further teaches wherein said battery is a battery assembly including a battery unit (Lunau ¶0076 “The conductors 67 are connected to an electrical source (not shown) such as a portable and lightweight battery pack that can easily be carried on the user's body.”, ¶0144)
Before the effective filing date, it would have been obvious to a person of skill in the art to modify Lunau, Chahine, and Mahfouz in view of Justice by combining the system of Lunau, Chahine, and Mahfouz with Justice’s control module which is electrically coupled to said battery; and the control module and the battery form said flexible battery belt. The motivation to integrate the electrostimulation and joint stabilization device of Lunau with Justice’s battery configuration is because this provides a suitable power source for the garment to provide improved functionality and battery life.
Lunau, Chahine, and Mahfouz further do not disclose a plurality of battery units housed in an elastomeric material; being connected to an adjacent battery unit of the plurality of battery units by a flexible connecting member wherein connecting portions between adjacent battery units are curved or bent to allow for flexibility and movement between battery units. Justice in a similar field teaches a plurality of battery units housed in an elastomeric material (Justice ¶0015 “The functional components of wearable electronic device 10 draw power from one or more energy-storage cells 34. A battery—e.g., a lithium ion battery—is one type of energy-storage cell suitable for this purpose.”; ¶0009 “A flexible segment may be elastomeric in some examples.”); being connected to an adjacent battery unit of the plurality of battery units by a flexible connecting member (Justice ¶0015 “Electrical connections between the energy storage cells and the functional components are routed through flexible segments 14.”).
Justice discloses the claimed invention except for wherein connecting portions between adjacent battery units are curved or bent to allow for flexibility and movement between battery units. It would have been an obvious matter of design choice to change the shape of the connecting units, for the purpose of increased flexibility, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976). Before the effective filing date, it would have been obvious to a person of skill in the art to modify Lunau, Chahine, and Mahfouz in view of Justice by combining the system of Lunau, Chahine, and Mahfouz with Justice’s plurality of battery units housed in an elastomeric material; being connected to an adjacent battery unit of the plurality of battery units by a flexible connecting member wherein connecting portions between adjacent battery units are curved or bent to allow for flexibility and movement between battery units. The motivation to integrate the electrostimulation and joint stabilization device of claim 1 with Justice’s battery configuration is because this provides a suitable power source for the garment to provide improved functionality and battery life.
As per claim 11, Claim 1 is obvious over Chahine, Lunau, Mahfouz, and Justice. Chahine further discloses wherein, when the control module is received in the dock, the stimulator is electrically coupled to the control module by a third conductive path defined by the conductive yarn that extends between at least one power terminal of the stimulator and at least one power terminal of the dock. (Chahine ¶0076 “Each of the resistive elements is connected in parallel to a pair of power buses 52 connected on either end of the resistive elements 50, being in parallel. The power buses 50 are connected to the controller device 40 (and thus the power supply and processor 116) via the conductive pathways 42.”; ¶0078 “A typical example would be a 12V DC power source 128 (see FIG. 10) applied to a knitted conductive yarn resistive heating element(s) 50”).
Chahine in combination with Mahfouz and Justice further do not disclose a stimulator integrated within the textile article for providing stimulation to a nerve or muscle of the knee. Lunau further discloses a stimulator integrated within the textile article for providing stimulation to a nerve or muscle of the knee (Lunau ¶0096 “Electrostimulation pads 204 and 205 may be used in conjunction with electrostimulation controller (i.e. electrostimulation unit) 208 to provide electrophysical modalities. Such electrophysical modalities might include, for example…Transcutaneous Electrical Stimulator for Arthritis (TESA), or Micro Current Electrical Stimulation (MCES).”).
Before the effective filing date, it would have been obvious to a person of skill in the art to add Chahine’s garment with stretch sensors comprising a textile article including conductive yarn arranged to define a third conductive path to the joint stabilization device. Chahine discloses the claimed invention except for having a multitude of conductive yarn pathways coupled to electrical components. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use multiple paths of conductive fibers, for the purpose of integration of electrical components into the brace itself which simplifies the device for patient convenience, since It has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Additionally, the addition of a stimulator as disclosed in Lunau serves as additional therapy to the patient wearing the brace, resulting in optimized joint treatment versus using either the joint stabilizing assembly or electrostimulation unit alone.
As per claim 12, Claims 1 & 11 are obvious over Chahine, Lunau, Mahfouz, and Justice. Chahine, Mahfouz, and Justice do not disclose wherein the stimulator includes an electrode configured to provide electrical stimulation to a target area of the knee; and when the knee brace is worn by the wearer, the stimulator is positioned proximate the target area of the knee. Lunau further teaches wherein the stimulator includes an electrode configured to provide electrical stimulation to a target area of the knee; and when the knee brace is worn by the wearer, the stimulator is positioned proximate the target area of the knee. (Lunau ¶0077 “By using these electrical pulses to stimulate the nerve endings at or near the site of the pain, the user feels diminished pain that is replaced by a tingling or massage-like sensation.”, ¶0078).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify Lunau, Chahine, and Mahfouz in view of Justice by combining the system of Lunau, Chahine, and Mahfouz with Justice’s control module which is electrically coupled to said battery; and the control module and the battery form said flexible battery belt. The motivation to integrate the electrostimulation and joint stabilization device of claim 1 with Justice’s battery configuration is because this provides a suitable power source for the garment to provide improved functionality and battery life.
As per claim 13, Claims 1 & 11-12 are obvious over Lunau, Chahine, Mahfouz, and Justice. Chahine, Mahfouz, and Justice does not disclose wherein the stimulator is a transcutaneous electrical nerve stimulator. Lunau further discloses wherein the stimulator is a transcutaneous electrical nerve stimulator. (Lunau ¶0096 “Electrostimulation pads 204 and 205 may be used in conjunction with electrostimulation controller (i.e. electrostimulation unit) 208 to provide electrophysical modalities. Such electrophysical modalities might include, for example…Transcutaneous Electrical Stimulator for Arthritis (TESA), or Micro Current Electrical Stimulation (MCES).”).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify Lunau, Chahine, and Mahfouz in view of Justice by combining the system of Lunau, Chahine, and Mahfouz with Justice’s control module which is electrically coupled to said battery; and the control module and the battery form said flexible battery belt. The motivation to integrate the electrostimulation and joint stabilization device of claim 1 with Justice’s battery configuration is because this provides a suitable power source for the garment to provide improved functionality and battery life.
As per claim 14, Claim 1 is obvious over Lunau, Chahine, Mahfouz, and Justice. Chahine further discloses wherein the knee brace comprises at least one electromyography (EMG) sensor for measuring electric potential generated by a muscle of the knee (Chahine ¶0047 “The textile integrated EMG sensor 38 can monitor the wearer's 8 muscle activity”; ¶0055 “The example operation combines stretch sensors 34 and IMU sensor 32 signals with EMG/EMS sensors 36,38 to adaptively (e.g. iteratively) adjust muscle stimulation for foot neuropathy or similar applications.”); wherein, when the control module is received in the dock, the EMG sensor is electrically coupled to the control module by a fourth conductive path defined by the conductive yarn that extends between at least one power terminal of the EMG sensor and at least one power terminal of the dock (Chahine ¶0076 “Each of the resistive elements is connected in parallel to a pair of power buses 52 connected on either end of the resistive elements 50, being in parallel. The power buses 50 are connected to the controller device 40 (and thus the power supply and processor 116) via the conductive pathways 42.”; ¶0078 “A typical example would be a 12V DC power source 128 (see FIG. 10) applied to a knitted conductive yarn resistive heating element(s) 50”).
As per claim 16, Claims 1 & 15 are obvious over Lunau, Chahine, Mahfouz, and Justice. Chahine, Mahfouz, and Justice do not disclose wherein the transceiver is a wireless transceiver. Lunau further teaches wherein the transceiver is a wireless transceiver (Lunau ¶0141 “The information of the angle, velocity, or acceleration of the arm 220' during gait is fed into the signal generator 208' via a wire 218', or wireless signal, in real-time.”).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify Lunau, Chahine, and Mahfouz in view of Justice by combining the system of Lunau, Chahine, and Mahfouz with Justice’s control module which is electrically coupled to said battery; and the control module and the battery form said flexible battery belt. The motivation to integrate the electrostimulation and joint stabilization device of claim 1 with Justice’s battery configuration is because this provides a suitable power source for the garment to provide improved functionality and battery life.
As per claim 17, claim 1 is obvious over Lunau, Rahman, Chahine, Mahfouz, and Justice. Lunau, Rahman, Chahine, and Mahfouz do not expressly disclose wherein the control module is secured to the dock using magnets. Justice in a similar field of wearable garments teaches wherein the control module is secured to the dock using magnets (Justice ¶0016 “In some examples, recharge power may be provided through a universal serial bus (USB) port 36, which includes a magnetic latch to releasably secure a complementary USB connector”).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify Lunau, Rahman, Chahine, and Mahfouz in view of Justice by combining the system of Lunau, Rahman, Chahine, and Mahfouz with Justice’s magnetic securement of parts. The motivation to integrate the electrostimulation and joint stabilization device of Lunau with Justice’s magnetic configuration is because this provides a modular design for the garment to provide improved functionality of the device(Justice ¶0001).
As per claim 18, Claim 1 is obvious over Lunau, Chahine, Mahfouz, and Justice. Chahine, Mahfouz, and Justice do not disclose wherein the control module is secured to the dock using a mechanical latch. Lunau further teaches wherein the control module is secured to the dock using a mechanical latch. (Lunau ¶00145 “Alternatively, feature 232 could also be configured to function as a snap-fit or latch mechanism to lock the electrostimulation unit 208 in place.”).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify Lunau, Chahine, and Mahfouz in view of Justice by combining the system of Lunau, Chahine, and Mahfouz with Justice’s control module which is electrically coupled to said battery; and the control module and the battery form said flexible battery belt. The motivation to integrate the electrostimulation and joint stabilization device of claim 1 with Justice’s battery configuration is because this provides a suitable power source for the garment to provide improved functionality and battery life.
As per claim 19, Claim 1 is obvious over Lunau, Chahine, Mahfouz, and Justice. Chahine. Mahfouz and Justice does not disclose wherein said dock is a stiffened area of said knee brace and includes terminals made of conductive material that connect to the first conductive path. Lunau further teaches wherein said dock is a stiffened area of said knee brace and includes terminals made of conductive material that connect to the first conductive path (Lunau ¶0146 “Connection portion 251 is configured to allow an electrical connection to be formed between the electrode and an electrostimulation unit.”; ¶0148 “In some embodiments, such as embodiments where the electrode is disposed on a rigid or semirigid portion of an orthotic device, the conductive middle layer 254 may comprise rigid or semirigid conductive material.”).
Before the effective filing date, it would have been obvious to a person of skill in the art to modify Lunau, Chahine, and Mahfouz in view of Justice by combining the system of Lunau, Chahine, and Mahfouz with Justice’s control module which is electrically coupled to said battery; and the control module and the battery form said flexible battery belt that includes terminals made of conductive material that connect to the first conductive path. The motivation to integrate the electrostimulation and joint stabilization device of claim 1 with Justice’s battery configuration is because this provides a suitable power source for the garment to provide improved functionality and battery life.
Claims 3 & 15 are rejected under 35 U.S.C. 103 as being unpatentable over Chahine et al (US Publication No. 20200367823; Previously Cited) in view of Lunau et.al (WO Publication No. 2010135288; Previously Cited), Mahfouz et al. (ES Publication No. 2900643-T3; Previously Cited), Justice et al (US Publication No. 20150342525; Previously Cited), and Rahman et. al (US Patent No. 7166063; Previously Cited).
As per claim 3, Claim 1 is obvious over Chahine, Lunau, Mahfouz, and Justice. Lunau, Chahine, Mahfouz, and Justice do not disclose wherein the sensor is a stretch sensor configured to detect and monitor movement of the knee; and the stretch sensor extends from above a kneecap of the knee to below the kneecap of the knee. Rahman in a similar field of endeavor of brace compliance monitors teaches wherein the sensor is a stretch sensor configured to detect and monitor movement of the knee (Rahman Abstract “The brace compliance monitor may also include a secondary sensor such as a tilt sensor, a pressure sensor, a force sensor, an acceleration sensor, or a velocity sensor.”, Column 4 Lines 36-38; Wherein the force sensor can act as a stretch sensor by monitoring the tension created during use, and the tilt sensor can be used to monitor bending of the knee and thereby used to determine the stretching force.); and the stretch sensor extends from above a kneecap of the knee to below the kneecap of the knee (Rahman Column 4 Lines 25-26 “The secondary sensor 42 would be located on an appropriate position on the brace for the type of sensor being used.”. Wherein the knee brace typically wraps around the knee both on the thigh and calf area to support it.). Before the effective filing date, it would have been obvious to a person of skill in the art to modify the system of claim 1 in view of Rahman by integrating Rahman’s stretch sensor configured to detect and monitor movement of the knee where the stretch sensor extends from above a kneecap of the knee to below the kneecap of the knee. The motivation to integrate the electrostimulation and joint stabilization device of claim 1 simplifies the device for patient convenience and results in optimized joint treatment versus using either the joint stabilizing assembly or electrostimulation unit alone.
As per claim 15, Claim 1 is obvious over Chahine, Lunau, Mahfouz, and Justice. Lunau, Chahine, Mahfouz, and Justice do not expressly disclose wherein the control module includes: a communication port; a transceiver; one or more processors; and non-transitory machine-readable memory storing instructions executable by the one or more computer processors and configured to cause the one or more computer processors to: receive via the communication port from the sensor data indicative of the measured physiological state of the knee of the wearer; and transmit the data via the transceiver to a remote server which stores the data. Rahman in an analogous field teaches wherein the control module includes: a communication port (Rahman Column 3 Lines 32-35 “The microcontroller 18 provides outputs to a compliance display 36, and may be connected through a computer interface 38, such as a serial connection or port for data transfer with a computer.”); a transceiver(Rahman Column 4 Lines 9-12 “In alternative embodiments, the compliance display could be located remotely from the brace by wire or wireless connections with the compliance signal processing unit.”); one or more processors; and non-transitory machine-readable memory storing instructions executable by the one or more computer processors and configured to cause the one or more computer processors to (Rahman Column 3 Lines 24-27 “With reference now to FIG. 2, the compliance signal processing unit 16 includes a circuit that has a microcontroller 18 connected to a power supply 20, a clock 22 and non-volatile random access memory (RAM) 24.”): receive via the communication port from the sensor data indicative of the measured physiological state of the knee of the wearer (Rahman Column 2 Lines 12-16 “The information of the angle, velocity, or acceleration of the arm 220' during gait is fed into the signal generator 208' via a wire 218', or wireless signal, in real-time.”); and transmit the data via the transceiver to a remote server which stores the data. (Rahman Column 3 Lines 32-35).
Therefore, it would have been obvious to combine the technology of Rahman with Lunau, Chahine, Mahfouz, and Justice to create a joint stabilization device with a control module including a communication port, transceiver, one or more processors, and non-transitory machine-readable memory with instructions to store data indicative of the measured physiological state of the knee of the wearer and transmit the data to a terminal. This would allow for an easy way to monitor knee healing and usage by the patient so that the doctor can use the information to develop a comprehensive rehabilitation plan based on ongoing data updates.
Conclusion
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/MEGAN T FEDORKY/
Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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