DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-2, 7, 9-14, 25-28, 30, 39, 41, 43-44 and 51-52 are pending.
Claim Objections
Claim 44 is objected to because of the following informalities: it refers to claim 42 while claim 42 is cancelled. Examiner interprets it as “claim 41”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 9-11 and 51-52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Toth et al. (US 2015/0335288 A1).
As to claim 1, Toth discloses a wearable device (Toth, see FIG. 1b, [0438], e.g., “a series of patch/module pairs 150a-e”), comprising:
a plurality of conductive modules (Toth, e.g., FIG. 3f, [0459], “multiple sensors 333a,b”; FIG. 6, [0426], “module 601”) that when mutually affixed by one or more coupling devices (Toth, e.g., FIG. 3f, [0459], “coupled with a plurality of conducting members (e.g. electrical traces, printed conductors, spun nanotube fibers, stretchable conducting traces, etc.) 336a-c”) form a circuit (Toth, e.g., see FIG. 6, [0462], “module 601 includes one or more of interconnects, sensors, optical source(s), optical detector(s), a radio, an antenna, a sensor communication circuit, a signal conditioning circuit, a processor, a memory device, a controller, a power supply, power management circuit, and/or energy harvesting circuit, and one or more peripherals”);
a power module (Toth, FIG. 6, [0462], “a power supply, power management circuit”) configured to be affixed to one or more of the plurality of conductive modules (Toth, see FIGS. 3f and 6, [0459], “module 601”);
at least one sensor module (Toth, see FIGS. 3f and 6, [0459], e.g., “multiple sensors 333a,b”) configured to be affixed to one or more of the plurality of conductive modules (Toth, see FIGS. 3f and 6, [0459], “module 601”); and
at least one actuator module (Toth, e.g., see FIG. 13, [0488], “patch/module pair 1300” comprising “a motor with an unbalanced shaft, a stroking actuator, etc.”; FIG. 15, [0490], “vibrating patch/module pair 1500” comprising “transducer 1505 that may be an electric motor”) configured to be affixed to one or more of the plurality of conductive modules (Toth, see FIGS. 3f and 6, [0459], “module 601”),
wherein the circuit (Toth, e.g., see FIG. 6, [0462], “module 601 includes one or more of interconnects, sensors, optical source(s), optical detector(s), a radio, an antenna, a sensor communication circuit, a signal conditioning circuit, a processor, a memory device, a controller, a power supply, power management circuit, and/or energy harvesting circuit, and one or more peripherals”; FIG. 12c, [0487], “module 1265 … integrated into a printed circuit board 1270” with “electrodes 1255a-c”) is configured to receive an input from the at least one sensor module affixed to one or more of the plurality of conductive modules and to output a signal to the at least one actuator module affixed to one or more of the plurality of conductive modules to initiate a response function (Toth, e.g., FIGS. 31a-c, [0577], “methods for monitoring, stressing, and/or treating one or more regions of a subject … ”; [0581], e.g., “selectively stimulating and/or stressing one or more regions of the target organ and monitoring the physiologic response at one or more sites nearby and/or systemically to the stimulus/stress”).
As to claim 2, Toth discloses the wearable device of claim 1, wherein the plurality of conductive modules (Toth, e.g., FIG. 3f, [0459], “multiple sensors 333a,b”; FIG. 6, [0426], “module 601”), is configured to connect two or more functional modules selected from (Toth, e.g., FIG. 3f, [0459], “coupled with a plurality of conducting members (e.g. electrical traces, printed conductors, spun nanotube fibers, stretchable conducting traces, etc.) 336a-c”) a power module, a sensor module (Toth, e.g., see FIG. 6, [0462], “power” and “sensor(s)”), and an actuator module (Toth, e.g., see FIG. 13, [0488], “patch/module pair 1300” comprising “a motor with an unbalanced shaft, a stroking actuator, etc.”; FIG. 15, [0490], “vibrating patch/module pair 1500” comprising “transducer 1505 that may be an electric motor”), and, optionally, a modifier module; and
wherein each of the conductive modules and each of the functional modules are configured to be interchangeable, reusable, reconfigurable, detachable, and re-attachable (Toth, [0161], “a system in accordance with the present disclosure may include a plurality of substantially similar modules (i.e. generally interchangeable modules, but with unique identifiers), for coupling with a plurality of patches, each patch, optionally different from the other patches in the system (e.g. potentially including alternative sensors, sensor types, sensor configurations, electrodes, electrode configurations, etc.)”; see FIGS. 3f and 6-7, [0463], e.g., “Such a configuration may be advantageous to provide a soft comfortable monitor, with a low cost disposable patch 710 and a miniature reusable module 705”).
As to claim 9, Toth discloses the wearable device of claim 1, each conductive module (Toth, e.g., FIG. 6, [0426], “module 601”) of the plurality of conductive modules comprises:
a conformable substrate (Toth, [0254], “a patch in accordance with the present disclosure … to maintain a sufficiently flexible, comfortable and/or breathable interface for a subject, the substrate may be formed from a thin polymeric material with thickness less than 50 µm, less than 25 µm, less than 12 µm, less than 8 µm, less than 4 µm, etc.”);
a first conductor affixed to the flexible substrate to provide power to the circuit; a second conductor affixed to the flexible substrate to provide ground to the circuit (Toth, see FIG. 6, it is reasonably inferred that there must be conductors for “power” and ground); and a third conductor affixed to the flexible substrate to transmit the signal from the at least one interchangeable sensor module to the at least one interchangeable (112) actuator module (Toth, e.g., see FIG. 13, [0488], “patch/module pair 1300” comprising “a motor with an unbalanced shaft, a stroking actuator, etc.”; FIG. 15, [0490], “vibrating patch/module pair 1500” comprising “transducer 1505 that may be an electric motor”).
As to claim 10, Toth discloses the wearable device of claim 9, the conformable substrate (Toth, [0254], the “patch”) comprising:
a first silicone material layer; a first adhesive layer; a textile stabilizer material layer; a second adhesive layer; and a second silicone material layer (Toth, [0254], “ may include a substrate, coupled to the thin adhesive layer … formed from a sufficiently thin polymeric material (e.g. … fluorocarbon rubber, fluoro silicone … etc.)”), wherein the first silicone material layer is affixed to the textile stabilizer material layer by the first adhesive layer and the textile stabilizer material layer is affixed to the second silicone material layer by the second adhesive layer (Toth, [0254], “the substrate may be coated with a thin lubricious coating of a silicone and/or silicon micro/nano bead layer. Such a coating may provide a soft, lubricious feel for the substrate while maintaining a hypoallergenic quality”).
As to claim 11, Toth discloses the wearable device of claim 9, the first conductor, the second conductor, and the third conductor comprise a flexible conductive material (Toth, e.g., FIG. 10d, [0477], “electrically conducting layers 1024, 1026 may include a flexible, stretchable material, a ferromagnetic conducting material, a conductive gel 1016, a bioadhesive gel, or the like”).
As to claim 51, Toth discloses the wearable device of claim 2, wherein at least a portion of the plurality of conductive modules are substantially identical in size and shape; and wherein the two or more functional modules are substantially identical in size and shape (Toth, [0161], “a system in accordance with the present disclosure may include a plurality of substantially similar modules (i.e. generally interchangeable modules, but with unique identifiers), for coupling with a plurality of patches, each patch, optionally different from the other patches in the system (e.g. potentially including alternative sensors, sensor types, sensor configurations, electrodes, electrode configurations, etc.)”; e.g., see FIGS. 2a-2d, [0443], “a patch 225 and a corresponding module 235”).
As to claim 52, Toth discloses the wearable device of claim 2, wherein each of the plurality of conductive modules, and/or each of the two or more functional modules further comprises a multi-layer conformable substrate conforms and adheres to skin (Toth, see FIGS. 1b-1c, e.g., [0244-0254], “adhesive layer”, “ferromagnetic layer”, “a substrate, coupled to the thin adhesive layer”, etc.; [0209], “one or more patches and/or patch/modules configured to comfortably attach to the subject and remain attached for a prolonged period of time (e.g. days, weeks, greater than 3 weeks, etc.)”).
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.
Claims 7, 12-14, 25-27, 41 and 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over Toth et al. (US 2015/0335288 A1) in view of Esposito et al. (US 2015/0177080 A1).
As to claim 7, Toth does not explicitly teach the wearable device of claim 1, wherein the two or more coupling devices comprise: one or more first coupling devices affixed to a first side of one of the conductive modules; and one or more second coupling devices affixed to a second side of another one of the conductive modules; and wherein the two or more coupling devices comprising one or more of a fastener, a snap, a hook and loop, a magnet, or slits for tessellation.
However, Esposito teaches the concepts of the two or more coupling devices (Esposito, FIGS. 6-7, [0054], “conductive leads L1 and L2” and/or “integral leads L3, L4”) comprising:
one or more first coupling devices (Esposito, FIGS. 6-7, [0054], e.g., “conductive lead L1”) affixed to a first side of one of the conductive modules (Esposito, FIGS. 6-7, [0054], e.g., left side of “sensor S1”); and
one or more second coupling devices (Esposito, FIGS. 6-7, [0054], e.g., “integral leads L3, L4”) affixed to a second side of another one of the conductive modules (Esposito, FIGS. 6-7, [0054], “similar fabric sensor S2”); and
wherein the two or more coupling devices (Esposito, FIGS. 6-7, [0054], “conductive leads L1 and L2” and/or “integral leads L3, L4”) comprising one or more of a fastener, a snap (Esposito, FIG. 8, [056], e.g., “ conductive terminals CT1, CT2 are provided as conductive mechanical snaps”), a hook and loop, a magnet, or slits for tessellation.
At the time of effective filing date, it would have been obvious to one of ordinary skill in the art to modify the “plurality of substantially similar modules (i.e. generally interchangeable modules, but with unique identifiers)” taught by Toth, to further comprise “leads L1-L4”, as taught by Esposito, in order to provide “one or more sensor(s) mounted to or incorporated in or associated with a substrate material such as … an independently positionable component” (Esposito, [0006]), so as to further secure electrical connection/communication among the modules, which may be less secure by wireless communication only.
As to claim 12, Toth in view of Esposito teaches the wearable device of claim 1, the at least one sensor module comprises:
a flexible printed circuit board; a sensor affixed to the flexible printed circuit board; a first microcontroller affixed to the flexible printed circuit board (Toth, e.g., FIG. 2c, [0450], “module 260 may include one or more components 270 (e.g. microcircuits, sensors, transducers, etc. optionally stacked/embedded into PCBs, etc.), interconnects 285, and a power source 275”); and
one or more third coupling devices (Esposito, FIGS. 6-7, [0054], another “conductive leads L1 and L2” and/or “integral leads L3, L4”) configured to couple with the one or more coupling devices such that the at least one sensor module is affixed to one or more of the plurality of conductive modules (Toth, e.g., FIG. 3f, [0459], “multiple sensors 333a,b”). Examiner renders the same motivation as in claim 7.
As to claim 13, Toth teaches the wearable device of claim 12, the first microcontroller configured to:
receive the input from the sensor; and output the signal to the at least one actuator module to initiate the response function (Toth, claims 26-28, “a module, comprising … one or more sensors … configured to interface with a sensor included on the patch interface … further comprising a stimulating device … a tactile stimulating component, a vibratory stimulating component”).
As to claim 14, Toth teaches the wearable device of claim 12, wherein the sensor (Toth, [0195], “one or more patches and/or patch/module pairs may include one or more sensors) comprises a capacitive touch sensor, a resistive sensor, a strain sensor (Toth, [0195], “surface strain sensor”), a pressure sensor (Toth, [0195], “interfacial pressure sensors (e.g. for contact assessment, compliance measurement, blood pressure, etc.)”), a biosensor (Toth, [0195], “electrophysiologic sensors”), a light sensor, an ultraviolet (“UV”) light sensor, a proximity sensor, or an environmental gas sensor; and
wherein the sensor is extendable relative to the flexible printed circuit board (Toth, e.g., FIG. 2c, [0450], “module 260 may include one or more components 270 (e.g. microcircuits, sensors, transducers, etc. optionally stacked/embedded into PCBs, etc.), interconnects 285, and a power source 275”; [0446], “multiple module interconnects 240a,b … may include snap elements, magnetic elements, etc.”).
As to claim 25, Toth in view of Esposito teaches the wearable device of claim 1, the at least one actuator module comprises:
a flexible printed circuit board; an actuator affixed to the flexible printed circuit board, wherein the actuator is extendable relative to the flexible printed circuit board (Toth, FIG. 2c, [0450], “one or more components 270 (e.g. microcircuits, sensors, transducers, etc. optionally stacked/embedded into PCBs, etc.), interconnects 285, and a power source 275”);
a second microcontroller (Toth, FIG. 6, [0462], e.g., “controller” in addition to “processor”) affixed to the flexible printed circuit board (Toth, see FIGS. 2c and 6);
and one or more fourth coupling devices (Esposito, FIGS. 6-7, [0054], another “conductive leads L1 and L2” and/or “integral leads L3, L4”) configured to couple with the one or more coupling devices such that the at least one actuator module is affixed to one or more of the plurality of conductive modules (Toth, e.g., see FIG. 13, [0488], “patch/module pair 1300” comprising “a motor with an unbalanced shaft, a stroking actuator, etc.”; FIG. 15, [0490], “vibrating patch/module pair 1500” comprising “transducer 1505 that may be an electric motor”). Examiner renders the same motivation as in claim 7.
As to claim 26, Toth teaches the wearable device of claim 25, wherein the second microcontroller (Toth, FIG. 6, [0462], e.g., “controller” in addition to “processor”) is configured to:
receive the signal from the at least one sensor module; and output a second signal to the actuator to initiate the response function (Toth, e.g., FIG. 6, [0462], “wireless communication 615, 625, 620 with an additional module 605 (e.g. perhaps situated in the same monitoring system, on the same subject, etc.)”).
As to claim 27, Toth teaches the wearable device of claim 25, wherein the actuator comprises a haptic feedback component (Toth, e.g., see FIG. 13, [0488], “patch/module pair 1300” comprising “a motor with an unbalanced shaft, a stroking actuator, etc.”; FIG. 15, [0490], “vibrating patch/module pair 1500” comprising “transducer 1505 that may be an electric motor”), a stiffness component, a thermochromic display, an audio device, a light emitting diode (“LED”), a light emitting diode (“LED”) array, an organic light emitting diode (“OLED”), a photochromic display, a buzzer, or any combinations thereof.
As to claim 41, Toth in view of Esposito teaches the wearable device of claim 1, further comprising at least one modifier module (Toth, e.g., FIG. 21, [0533], “the microcircuit may include one or more processing banks 2109a,b”) configured to be affixed to one or more of the plurality of conductive modules (Toth, e.g., FIG. 6, [0426], “module 601”), wherein the at least one modifier module (Toth, e.g., FIG. 21, [0533], “one or more processing banks 2109a,b”) comprising:
a flexible printed circuit board; a modifying device affixed to the flexible printed circuit board; a third microcontroller affixed to the flexible printed circuit board (Tith, see FIG. 21); and
one or more fifth coupling devices (Esposito, FIGS. 6-7, [0054], another “conductive leads L1 and L2” and/or “integral leads L3, L4”) configured to couple with the one or more coupling devices such that the at least one modifier module is affixed to one or more of the plurality of conductive modules (Toth, e.g., FIG. 6, [0426], “module 601”). Examiner renders the same motivation as in claim 7.
As to claim 43, Toth teaches the wearable device of claim 41, the third microcontroller (Toth, e.g., FIG. 21, [0533], “one or more processing banks 2109a,b”) configured to:
receive the signal from the at least one sensor module; transform the signal to initiate an altered response function; and output the transformed signal to the at least one actuator module to initiate the altered response function (Toth, FIG. 21, [0536], “processor 2111 may be coupled to one or more sensor conditioning circuits, control circuits, and/or ADC circuits 2119, so as to couple with one or more sensors 2117 in the patch, module, or patch/module pair, or the like”; [0537], “ processor 2111 may be coupled with a controller 2132, the controller including one or more circuits to interface with one or more stimulators 2121, energy delivery units, sensor energy delivery aspects, etc.”).
As to claim 44, Toth teaches the wearable device of claim 42, wherein the modifying device (Toth, e.g., FIG. 21, [0533], “one or more processing banks 2109a,b”) comprises an inverter and a signal modifier, wherein the signal modifier alters an amplitude associated with a response function comprising light, volume, vibration, or heat (Toth, see FIGS. 20-21, [0528], e.g., “stimulator 2095 may be configured to deliver a stimulus to an adjacent tissue volume upon interaction therewith, such stimulation may include electrical stimulation, thermal stimulation, heating, cooling, tactile stimulation, vibration, stroking, scratching, penetrating, chemical irritation of tissues, chemical block of neural traffic, tissue function, or the like”).
Claims 28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Toth et al. (US 2015/0335288 A1) in view of Esposito et al. (US 2015/0177080 A1) and Al-Husseiny et al. (US 2020/0357249 A1).
As to claim 28, Toth teaches the wearable device of claim 25, wherein the actuator comprises a haptic feedback component (Toth, e.g., see FIG. 13, [0488], “patch/module pair 1300” comprising “a motor with an unbalanced shaft, a stroking actuator, etc.”; FIG. 15, [0490], “vibrating patch/module pair 1500” comprising “transducer 1505 that may be an electric motor”).
Toth in view of Esposito does not teach “the haptic feedback component comprises a shape-memory alloy actuator configured to apply a force, a vibration, a thermal sensation, or a motion as the response function”.
However, Al-Husseiny teaches the concept that the haptic feedback component comprises a shape-memory alloy actuator configured to apply a force, a vibration, a thermal sensation, or a motion as the response function (Al-Husseiny, [0040], “haptic actuators are known in the art and may, e.g., be flexible actuated materials (such as shape memory alloy actuators)”).
At the time of effective filing date, it would have been obvious to one of ordinary skill in the art to modify, e.g., the “stroking actuator” taught by Toth to further comprise the “shape memory alloy actuators”, as taught by Al-Husseiny, as a routine engineering choice known in the art of haptic actuator.
As to claim 30, Al-Husseiny teaches the wearable system of claim 25, wherein the actuator comprises a stiffness component (Al-Husseiny, [0040], “haptic properties which are rendered to the skin of the user … a stiffness”) and the stiffness component comprising a shape memory alloy configured to enable variable-stiffness as the response function (Al-Husseiny, [0040], “haptic actuators are known in the art and may, e.g., be flexible actuated materials (such as shape memory alloy actuators)”). Examiner renders the same motivation as in claim 28.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Toth et al. (US 2015/0335288 A1) in view of Lynch (US 2023/0042347 A1).
As to claim 39, Toth teaches the wearable device of claim 1, the power module comprising one or more batteries to provide power to the wearable device (Toth, [0148], “each module may include a power source (e.g. a battery, a rechargeable battery)”).
Toth does not explicitly teach “wherein the one or more batteries comprising one or more of a lithium polymer battery, a lithium ceramic battery, or a triboelectric nanogenerator”.
However, Lynch the concept that the one or more batteries comprising one or more of a lithium polymer battery (Lynch, FIGS. 7-8, [0151], “the power source 113 in this example is a lithium polymer battery 113”), a lithium ceramic battery, or a triboelectric nanogenerator.
At the time of effective filing date, it would have been obvious to one of ordinary skill in the art to modify the “rechargeable battery” taught by Toth to be “lithium polymer battery 113”, as taught by Lynch, in order to provide that “the battery 113 is rechargeable and charged via a USB C input of the electronics module 100” (Lynch, [0151]).
Conclusion
The prior arts made of record and not relied upon are considered pertinent to applicant’s disclosure: Tan et al. (US 2009/0326406 A1) teaches the concept of “wearable electromyography-based controller … wired or wireless human-computer interface for interacting” (Abs.).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD J HONG whose telephone number is (571) 270-7765. The examiner can normally be reached on 9:00 AM to 6:00 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LunYi Lao can be reached on (571) 272-7671. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Feb. 20, 2026
/RICHARD J HONG/Primary Examiner, Art Unit 2621
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