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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/02/2025 has been entered.
Response to Amendment
The amendment filed 12/02/2025 has been entered. Claims 1-7, 9-14, 16-17, 20-24 & 62 remain pending in the application. Applicant’s amendments to the claims have overcome the objections and rejections previously set forth in the Final Office Action mailed 09/11/2025.
Response to Arguments
Applicant's arguments with respect to amended claims 1-7, 9-14, 16-17, 20-24 & 62 have been considered but are not seen as persuasive, see reasoning below.
Regarding amended claims 1, 24 & 62, applicant argues that Bouton does not explicitly disclose “the at least one strain sensor is electrically isolated from the user”. Examiner disagrees, and wants to point towards Paragraph [0077] of Bouton such that, the flexible base layer may be comprised of a single layer of a flexible insulating material, which looking at Figure 4, 112 is directly on the user. In this example, the insulating material would allow for the strain sensor as well as the entire circuit to be electrically isolated from the user due to the insulating material. Applicant also argues that Bouton device would not be able to provide stimulation based on if the circuit was electrically isolated, but again looking towards Paragraph [0077] of Bouton, it can still record neurological signals with this design and that the recording is separate task from the stimulation therefore, Bouton in view of Brownhill does cover the amended portion of the claim.
Regarding claim 3, Applicant argues the cited references do not disclose, suggest or render obvious “wherein the electronic circuitry is coupled with the contact layer or spaced apart from the contact layer, such that, when the contact layer is attached to the user’s joint, the electronic circuitry is spaced apart from a wound site of the user’s joint”. Examiner wants to acknowledge that the claim requires the electronic circuitry to be coupled to the contact layer OR spaced apart from the contact layer such that Bouton discloses wherein the contact layer is coupled to the flexible circuit in the Abstract. The embodiment applicant discusses as a rebuttal to the rejection is one or many embodiments that Bouton discloses, and as discussed in the claim 1 argument above, Bouton also discloses recording neurological signals as a separate task from the simulation. Therefore, Examiner stands with the rejection.
In regards to claims 2-7, 9-14, 16-17, 20-21 & 23, Examiner sees claim 1 & 24 dependents as being unpatentable over Bouton in view of Brown as taught by the non-Final action and the reasonings above.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 24 & 62 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1, 24 & 62 all require the limitation of "strain sensor being electrically isolated from the user". Examiner could not find in the specification that limitation or anything leading to an element that could cause the strain sensor to be electrically isolated from the user. Therefore, this is seen as new matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-7, 9-14, 16, 20-21, 23-24 & 62 are rejected under 35 U.S.C 103 as being unpatentable over Bouton (US 20180154140) in view of Brownhill et al. (US 20190290496) herein referred to as Brownhill.
Regarding Claim 1, Bouton discloses a monitoring and/or therapy apparatus (Figure 1), comprising: a contact layer comprising a stretchable or substantially stretchable substrate configured to be attached to a user's joint (Paragraph [0123]; wherein sensors may be incorporated into the sleeve at joints (e.g. wrist, elbow) such that bending of the joint stretches or bends the dielectric layer); at least one strain sensor coupled with the contact layer (Paragraph [0019], the at least one strain sensor electrically isolated from the user (Paragraph [0077]; wherein the flexible base layer may be comprised of a single layer of a flexible insulating material, which looking at Figure 4, 112 is directly on the user, the insulating material would allow for the strain sensor as well as the entire circuit to be electrically isolated from the user due to the insulating material); wherein a stretch sensor including a material that changes electrical resistance when stretched or strained is seen as a strain sensor); electronic circuitry electronically coupled with the at least one strain sensor (Paragraph [0123]; wherein strain sensor measures a change in resistance when stretched or strained and the change in resistance is measured with a standard electrical circuit ); wherein: the at least one strain sensor comprises a plurality of stretchable tracks positioned on the substrate (Figure 6, 642;Paragraph [0018]; wherein the traces are seen as tracks and the tracks are in a zigzag pattern to enhance flexibility); the resistance of the at least one strain sensor increases as at least some tracks of the plurality of stretchable tracks are elongated due to the contact layer being elongated (Paragraph [0019]; wherein the tracks are flexible therefore when elongation is applied, the tracks will elongate with the rest of the material as well elongation will increase strain therefore increase resistance); and the electronic circuitry is configured to determine an angle and/or a range of movement of the joint responsive to changes in the resistance of the at least one strain sensor (Paragraph [0117]; wherein Motions of the hand and arm may be derived from position sensors or from independent sensors. Other desired information includes joint angle at the elbow, wrist, thumb and fingers). However, Bouton does not explicitly disclose a source of negative pressure configured to be in fluid communication with a space under the contact layer and to supply negative pressure to the space.
Brownhill discloses a monitoring and therapy apparatus (Figure 1) comprising a source of negative pressure configured to be in fluid communication with a space under the contact layer and to supply negative pressure to the space (Paragraph [0009]; wherein the apparatus can include a negative pressure source configured to be in fluid communication with the wound dressing and further configured to apply negative pressure to the wound). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus taught by Bouton to include a negative pressure source as taught by Brownhill. The motivation being to promote wound healing by facilitating the formation of granulation tissue at the wound site and assisting the body's normal inflammatory process while simultaneously removing excess fluid, which may contain adverse cytokines or bacteria (Brownhill, Paragraph [0002]).
Regarding claim 2, Bouton in view of Brownhill discloses the apparatus of claim 1. Bouton also discloses wherein the plurality of stretchable tracks comprises conductive ink printed on the substrate (Paragraph [0110]; wherein the tracks can be printed using conductive polycellulose, a silver-based ink or carbon-based ink.)
Regarding claim 3, Bouton in view of Brownhill disclose the apparatus of claim 1. Bouton also discloses wherein the electronic circuitry is coupled with the contact layer or spaced apart from the contact layer such that, when the contact layer is attached to the user's joint, the electronic circuitry is spaced apart from a wound site of the user's joint (Abstract; wherein apparatus forming a conductive circuit on the substrate layer to form a conductive circuit layer, adhering a cover layer onto the conductive circuit layer to form a flexible circuit therefore is coupled with the contact layer)
Regarding claim 4, Bouton in view of Brownhill disclose the apparatus of claim 1. Bouton also discloses wherein at least some of the electronic circuitry is printed directly on the contact layer (Paragraph [0010]; wherein the circuitry is a flexible printed circuit board that’s printed on a cover layer)
Regarding claim 5, Bouton in view of Brownhill disclose the apparatus of claim 1. Boutin also discloses wherein the electronic circuitry is positioned at least partially within a housing that is configured to be positionable at a distance from the contact layer so that the electronic circuitry is spaced apart from the contact layer (Figure 1, 104), and wherein the housing may be coupled with the contact layer (Figure 1; wherein processor is connected to the contact layer through wires).
Regarding claim 6, Bouton in view of Brownhill disclose the apparatus of claim 1. Boutin also discloses wherein the electronic circuitry comprises a machine-readable memory configured to record information related to an elongation of the at least one strain sensor (Paragraph [0138]; Figure 3, S112; wherein processor collects the movement data therefore the strain sensor readings to alter control algorithms)
Regarding claim 7, Bouton in view of Brownhill disclose the apparatus of claim 1. Boutin also discloses wherein the at least one strain sensor and/or the electronic circuitry is positioned on or is printed on an edge portion of the contact layer (Paragraph [0018]; wherein electrodes are printed on the contact layer which contain the strain sensors; Paragraph [0010]; wherein the circuitry is a flexible printed circuit board that’s printed on a cover layer).
Regarding claim 9, Bouton in view of Brownhill disclose the apparatus of claim 1. Boutin also discloses a wireless communications device electronically coupled with the electronic circuitry (Paragraph [0137]; wherein the electronic circuitry can be operated in a wireless mode coupled to a user's mobile device and/or PC for data transfer and real time tracking/monitoring ), the wireless communications device configured to transmit a signal containing at least one of an angle or a range of movement of the joint responsive to changes in the resistance of the at least one strain sensor (Paragraph [0137]; wherein a user's mobile device and/or PC for data transfer and real time tracking/monitoring therefore transmitting a signal which it was taught in Claim 1 that the data includes the range of motion of the joint responsive to the change of resistance of the strain sensor)
Regarding claim 10, Bouton in view of Brownhill disclose the apparatus of claim 1. Boutin also discloses a source of power for at least the electronic circuitry (Paragraph [0137]; wherein power source consists of a battery), wherein the source of power comprises one or more flexible batteries (Paragraph [0137]; the battery pack and the electronics module can be strapped on the upper arm of the subject in the form of an arm band therefore is seen as a flexible battery due to it being allowed to be strapped onto the arm)
Regarding claim 11, Bouton in view of Brownhill disclose the apparatus of claim 1. Boutin also discloses wherein the at least one strain sensor comprises a first strain sensor and a second strain sensor spaced apart from the first strain sensor (Figure 6, 642; wherein there is 4 strips consisting of multiple electrodes traces; Paragraph [0019]; wherein electrode traces contain strain sensors, therefore there can be a first strain sensor spaced apart from a second strain sensor on a parallel trace).
Regarding claim 12, Bouton in view of Brownhill disclose the apparatus of claim 1. Boutin also discloses wherein the at least one strain sensor comprises a first strain sensor and a second strain sensor, wherein the second strain sensor is parallel to the first strain sensor (Figure 6, 642; wherein there is 4 strips consisting of multiple electrodes traces; Paragraph [0019]; wherein electrode traces contain strain sensors, therefore there can be a first strain sensor spaced apart from a second strain sensor on a parallel trace).
Regarding claim 13, Bouton in view of Brownhill disclose the apparatus of claim 1. Brownhill also discloses wherein the electronic circuitry is further configured to automatically collect data from the strain sensor at a predetermined frequency (Paragraph [0111]; wherein sensor measurements can be made in a frequency range of about 2.5 kHz to about 60 kHz.) Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus taught by Bouton in view of Brownhill to record a strain sensor measurement at a predetermined frequency as taught by Brownhill. The motivation being it would be obvious to try different ways to collect data from a strain sensor with the reasonable expectation of accurately recording data (MPEP 2143 (E))
Regarding claim 14, Bouton in view of Brownhill disclose the apparatus of claim 1. Brownhill also discloses wherein the electronic circuitry is further configured to automatically gather readings from the strain sensor at a plurality of time intervals and/or shorten a time interval in response to the strain sensor experiencing changes in the resistance at a higher frequency (Paragraph [0123]; wherein the control module can also log data at appropriate intervals)
Regarding claim 16, Bouton in view of Brownhill disclose the apparatus of claim 1. Brownhill also discloses a temperature sensor positioned on the substrate adjacent to the strain sensor or portion of the strain sensor (Paragraph [0087]; wherein strain sensor can be used in the sensor array; Paragraph [0095]; wherein temperature sensor is a part of the sensor array therefore are seen as adjacent to each other), and wherein the temperatures sensor is configured to provide an electrical signal indicative of a temperature of the strain sensor and the electronic circuitry is further configured to calibrate readings from the strain sensor based on the temperature of the strain sensor (Paragraph [0101]; wherein the thermal environment within the wound dressing is measured by temperature sensors and the sensor array is located within the wound dressing as taught in Paragraph [0024], Temperature sensors can be calibrated and the data obtained from the sensors can be processed to provide information about the environment therefore it is seen that since the temperature sensor can obtain data from the environment the strain sensor is in, it is therefore collecting the temperature of the strain sensor ) Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus taught by Bouton in view of Brownhill to include a temperature sensor as taught by Brownhill. The motivation being to assist in eliminating problems associated with environment temperature shifts, such as to compensate for heat flux changes away from the region of interest or compensate for physiological effects associated with ambient temperature changes (Brownhill, Paragraph [0101]).
Regarding claim 20, Bouton in view of Brownhill disclose the apparatus of claim 1. Boutin also discloses wherein the contact layer is configured to have a shape which substantially matches a joint when the contact layer is in a relaxed state, wherein the joint is an elbow joint, a wrist joint, a knee joint, a neck joint, a spine, a finger joint, or an ankle joint (Figure 22; wherein the joint is the wrist and Figure 22 is seen as a relaxed state)
Regarding claim 21, Bouton in view of Brownhill disclose the apparatus of claim 1. Brownhill also discloses wherein the contact layer is configured to be positioned over a wound, and wherein the apparatus is configured to aspirate fluid from the wound over which the contact layer is positioned (Paragraph [0002]). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus taught by Bouton in view of Brownhill to include aspirating fluid as taught by Brownhill. The motivation being assisting the body's normal inflammatory process while simultaneously removing excess fluid, which may contain adverse cytokines or bacteria (Brownhill, Paragraph [0002])
Regarding claim 23, Bouton in view of Brownhill disclose the apparatus of claim 1. Brownhill also discloses a canister configured to collect fluid that is aspirated from a wound under the contact layer (Paragraph [0048]; wherein a chamber which is seen as a canister is used to store fluids aspirated from the wound). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus taught by Bouton in view of Brownhill to include a canister as taught by Brownhill. The motivation being assisting the body's normal inflammatory process while simultaneously removing excess fluid, which may contain adverse cytokines or bacteria (Brownhill, Paragraph [0002])
Regarding claim 24, Bouton discloses a range of movement sensor apparatus (Figure 4), comprising: a sensor (Paragraph [0019]; wherein electrode traces contain multiple sensors therefore is seen as a sensor) comprising: a flexible substrate sized and configured to be attached to a skin surface of a user adjacent to a joint (Paragraph [0123]; wherein sensors may be incorporated into the sleeve at joints (e.g. wrist, elbow) such that bending of the joint stretches or bends the dielectric layer); and a strain sensor comprising a strain gauge coupled with the substrate (Paragraph [0124]; wherein stretch is seen as strain in Paragraph [0019] and strain gauges are used in these sensors, wherein the sensors are attached to the substrate), the strain gauge configured to provide data related to an amount of an elongation and/or a curvature of the substrate adjacent to the strain sensor to a processor (Figure 3; Processor receives data movement data from sensors at S112; Paragraph [0124]-[0125] the at least one strain sensor electrically isolated from the user (Paragraph [0077]; wherein the flexible base layer may be comprised of a single layer of a flexible insulating material, which looking at Figure 4, 112 is directly on the user, the insulating material would allow for the strain sensor as well as the entire circuit to be electrically isolated from the user due to the insulating material); wherein the data is related to an amount of an elongation and/or a curvature of the substrate adjacent to the strain sensor); a machine-readable memory storing executable instructions (Paragraph [0138]); and a processor in communication with the machine-readable memory and the strain sensor; Figure 1; wherein strain sensor is on 110 which is in communication with processor 104 which is in communication with computer 108 that contains the instruction as taught in Paragraph [0138]); wherein: the processor is configured to execute the instructions stored on the machine-readable memory to cause the processor to automatically collect one or more readings from the strain sensor (Figure 3, S112; wherein processor collects the movement data therefore the strain sensor readings to alter control algorithms). However, Bouton does not explicitly discloses wherein the flexible substrate is configured to connect with a source of negative pressure such that the source of negative pressure is in fluid communication with a space under the flexible substrate to supply negative pressure to the space.
Brownhill discloses a monitoring and therapy apparatus (Figure 1) comprising a source of negative pressure configured to be in fluid communication with a space under the contact layer and to supply negative pressure to the space (Paragraph [0009]; wherein the apparatus can include a negative pressure source configured to be in fluid communication with the wound dressing and further configured to apply negative pressure to the wound). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus taught by Bouton to include a negative pressure source as taught by Brownhill. The motivation being to promote wound healing by facilitating the formation of granulation tissue at the wound site and assisting the body's normal inflammatory process while simultaneously removing excess fluid, which may contain adverse cytokines or bacteria (Brownhill, Paragraph [0002]).
Regarding claim 62, Bouton discloses a monitoring and/or therapy apparatus (Figure 1), comprising: a contact layer configured to be attached to a tissue of a user (Figure 4, 112); one or more strain sensors (Paragraph [0019]; wherein a stretch sensor including a material that changes electrical resistance when stretched or strained is seen as a strain sensor), wherein the one or more strain sensors are configured to measure a strain of the contact layer and/or a tissue of the user in response to the one or more strain sensors being at least one of elongated and curved (Paragraph [0123]; wherein strain sensor measures a change in resistance when stretched or strained and the change in resistance is measured with a standard electrical circuit) the at least one strain sensor electrically isolated from the user (Paragraph [0077]; wherein the flexible base layer may be comprised of a single layer of a flexible insulating material, which looking at Figure 4, 112 is directly on the user, the insulating material would allow for the strain sensor as well as the entire circuit to be electrically isolated from the user due to the insulating material); and electronic circuitry electronically coupled with the one or more strain sensors (Paragraph [0123]; wherein strain sensor measures a change in resistance when stretched or strained and the change in resistance is measured with a standard electrical circuit), the electronic circuitry configured to determine a level of at least one of an elongation or a curvature of the one or more strain sensors (Paragraph [0123]; wherein strain sensor measures a change in resistance when stretched or strained and the change in resistance is measured with a standard electrical circuit, therefore a higher change in resistance would be considered a higher level of elongation and a lower change in resistance would be considered a lower level of elongation); wherein the electronic circuitry is configured to determine that sensors are adequately coupled with the tissue of the user or the contact layer based on determining that the strain of the contact layer and/or the tissue is greater than a threshold value (Paragraph [0019]; wherein a stretch sensor including a material that changes electrical resistance when stretched or strained therefore if there is no change to the resistance of contact layer when being strained, the sensors would not be adequately coupled to the tissue). However, Bouton does not explicitly disclose wherein one or more temperature sensors configured to be coupled with a tissue of a user or coupled with the contact layer; Electronic circuitry electronically coupled with the one or more temperature sensors;
Brownhill discloses a monitoring and therapy apparatus (Figure 1) wherein one or more temperature sensors configured to be coupled with a tissue of a user or coupled with the contact layer (Paragraph [0101]; wherein the thermal environment within the wound dressing is measured by temperature sensors and the sensor array is located within the wound dressing as taught in Paragraph [0024]); Electronic circuitry electronically coupled with the one or more temperature sensors (Paragraph [0006]; wherein he plurality of sensors can be electrically connected with a controller and a power source. The one or more sensors can include one or more temperature sensors). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus taught by Bouton to include a temperature sensor as taught by Brownhill. The motivation being to assist in eliminating problems associated with environment temperature shifts, such as to compensate for heat flux changes away from the region of interest or compensate for physiological effects associated with ambient temperature changes (Brownhill, Paragraph [0101]).
Claim 17 is rejected under 35 U.S.C 103 as being unpatentable over Bouton and Brownhill in further view of Amiot et al. (US 20170360358) herein referred to as Amiot.
Regarding Claim 17, Bouton in view of Brownhill disclose the apparatus of claim 1. However, Bouton in view of Brownhill does not explicitly disclose an alarm, and wherein the electronic circuitry is further configured to activate the alarm in response to a resistance of the strain sensor satisfying a threshold resistance.
Amoit discloses a monitoring apparatus (Figure 1) comprising an alarm (Paragraph [0025]; wherein alarm mechanism is seen as the alarm), and wherein the electronic circuitry is further configured to activate the alarm in response to a resistance of the strain sensor satisfying a threshold resistance (Paragraph [0025]; wherein analysis of strain sensor data can be used to adjust post-operative procedures and recommendations, indicating if the patient should be more active or less active, an alarm mechanism is used to indicate over-exertion which is seen as a strain being too high therefore a threshold resistance value since the strain sensor data consist of resistance measurements). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus taught by Bouton in view of Brownhill to include an alarm as taught by Amoit. The motivation being to indication an over exertion (Amoit, Paragraph [0025]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M PAPE whose telephone number is (703)756-5947. The examiner can normally be reached M-F 7:30-5:00.
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ALYSSA M. PAPE
Examiner
Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794