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 .
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 20 and 24 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by “Ruiz et al.,” US application 18/649,757 (provisional application 63/499,1281 filed on 04/28/2023, hereinafter Ruiz).
Regarding to claim 20, Ruiz teaches a method of treating a patient suffering from pain (treatment for joint pain and muscle soreness [0004]), the method comprising:
placing a thermal device on a portion of the patient's body, the thermal device comprising a plurality of heating elements and a plurality of cooling elements arranged in a thermal array (flexible Peltier device for combining heating and cooling [0003] Appendix page 18); and
activating the plurality of heating elements and the plurality of cooling elements (applying heat to the skin [0006] page 11 Appendix Figure 12 shows activation circuit)
Regarding to claims 24, Ruiz teaches all limitations of claim 21 as set forth above.
Ruiz further teaches wherein the activating the plurality of heating and the plurality of cooling elements comprises alternating between operating the thermal device only in a heating mode and only in a cooling mode (switch between two modes [0002] Appendix Figure 12 page 11).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3, 10-16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over “Dijkstra et al.,” US application 18/408,626 (filed on 1/10/2024, US 2025/0073117, hereinafter Dijkstra) and “Alvarez et al.,” US 2021/0169682 (hereinafter Alvarez).
Regarding to claim 1, Dijkstra teaches a system configured to alleviate pain (therapeutic device for pain relief [0002]), the system comprising:
a thermal device (therapeutic device includes stimulation elements of heating and cooling and others [0010]) comprising:
a plurality of heating elements and a plurality of cooling elements arranged in a thermal array (one or more stimulation elements first and second structures; stimulation element being heating and cooling element [0063]-[0064]);
at least one temperature sensor proximate to at least one of the plurality of heating elements and the plurality of cooling elements (temperature sensors coupled to the stimulation elements [0068]);
a printed circuit board (224 Figure 2 printed circuit board [0071]-[0072]);
a microcontroller (microcontroller [0029])
at least one temperature reader communication with the at least one temperature sensor (temperature sensor sensing the temperature of the elements [0068], [0025]);
at least one driver in communication with the plurality of heating elements and the plurality of cooling elements (activation and control of specific stimulation elements [0060]; activated by user interface [0068]);
a non-volatile memory device (memory [0075]); and
a power supply (power source [0072]); and
a patient remote device in electronic communication with the thermal device (user interface [0066]-[0068]; Figure 5 therapeutic device in communication with user computing device 520 via network cloud [0075]).
Dijkstra does not explicitly disclose a microcontroller, a driver and memory device, temperature reader all on the printed circuit board as claimed.
However, in the analogous field of endeavor in therapeutic device, Alvarez teaches therapy device with heating element, includes PCB wherein a temperature sensor is mounted or connected, control unit includes a microprocessor, circuits, a battery and software/firmware, and a memory (MCU mounted on a printed circuit board, controls the supply of the energy with a predetermined program, thus reads on claimed driver [0027], control unit comprises PCB encapsulated by a housing, and MCU mounted on PCB wherein MCU includes a memory configured to store data measures by a sensor component, thus reads on temperature reader [0100]-[0101]; Figure 4 [0152], temperature sensor monitoring and providing information relating to the parameter to the microcontroller and stored [0157], and data captured by the sensors into memory chips on the PCB [0160]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify PCB as taught by Dijkstra to incorporate teaching of Alvarez, since controller on the PCB was well known in the art as taught by Alvarez. One of ordinary skill in the art could have combined the elements as claimed by Dijkstra with no change in their respective functions, configuring and manufacturing controller, memory, and temperature reader to be mounted on the PCB and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide wearable and/or compact housing of therapeutic device for the user ([0100]), and there was reasonable expectation of success.
Regarding to claims 3 and 10-14, Dijkstra and Alvarez together teach all limitations of claim 1 as set forth above.
Dijkstra further teaches following limitations:
Of claim 3, wherein the plurality of heating elements is a plurality of resistive heating elements (heating element coupled to resistive heating coil [0068]), and wherein the plurality of cooling elements is a plurality of Peltier devices each comprising a cold side configured to face a user (cooling element may be a thermoelectric cooler, known as a Peltier heat pump [0064]).
Of claim 10, wherein the non-volatile memory device includes computer-readable instructions which, when executed by the microcontroller in response to a temperature measurement from the at least one temperature sensor, automatically adjust current and/or voltage supplied to the plurality of heating elements or the plurality of cooling elements (electric power supplied to the stimulation element modified in correlation with the sensed temperature [0068], [0075]; power is AC or DC power supply [0072])
Of claim 11, further comprising at least one light-emitting element configured to project light in between or through the plurality of heating elements and the plurality of cooling elements ([0071]).
Of claim 12, wherein the at least one light-emitting element is configured to emit light having a wavelength in a range from approximately 500 nm to approximately 1,200 nm ([0017] and [0071]).
Of claim 13, wherein the at least one light-emitting element comprises at least one light-emitting diode ([0015]).
Of claim 14, wherein the at least one light-emitting element comprises at least one laser diode ([0015])
Regarding to claims 15-16 and 19, Dijkstra and Alvarez together teach all limitations of claim 1 as set forth above.
Alvarez further teaches following limitations:
Of claim 15, further comprising at least one vibration element ( vibrational energy [0190]).
Of claim 16, wherein the at least one vibration element comprises an ultrasound element (ultrasonic [0190]).
Of claim 19, wherein the thermal device further comprises a wireless communication component on the printed circuit board, and wherein the wireless communication component is configured to communicate with the patient remote device via a wireless communication protocol (RF wireless antenna or inductive mounted on PCB [0106] and [0160])
Claims 2 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Dijkstra and Alvarez as applied to claim 1 above, and further in view of “Ruiz et al.,” US application 18/649,757 (provisional application 63/499,1282 filed on 04/28/2023, hereinafter Ruiz).
Regarding to claim 2, Dijkstra and Alvarez together teach all limitations of claim 1 as set forth above.
Dijkstra and Alvarez do not further explicitly disclose wherein the plurality of heating elements is a plurality of Peltier devices each comprising a warm side configured to face a user, and wherein the plurality of cooling elements is a plurality of Peltier devices each comprising a cold side configured to face the user.
However, in the analogous field of endeavor in heating and cooling device, Ruiz teaches using Peltiers for providing both heating and cooling in a single device ([0003]), providing high temperature (warm side as claimed) on one side, while producing low temperature on the other side (cold side) ([0005]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify treatment device as taught by Dijkstra to incorporate teaching of Ruiz, since Peltier heating and cooling devices was well known in the art as taught by Ruiz. One of ordinary skill in the art could have combined the elements as claimed by Dijkstra with no change in their respective functions, configuring its heating and cooling element to be Peltier device and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide wearable thermal treatment device ([0004]) and there was reasonable expectation of success.
Regarding to claims 8-9, Dijkstra and Alvarez and Ruiz together teach all limitations of claims 1 and 2 as set forth above.
Dijkstra further teaches wherein the non-volatile memory device includes computer-readable instructions which, when executed by the microcontroller in response to a signal from the patient remote, cause the at least one driver to alternate a direction of electric current from the power supply to the plurality of Peltier devices (activating stimulation element independently activated by user interface [0069]; alternating current power [0072] and a control module remote [0075]).
But does not explicitly disclose that switching at a predefined switching frequency to switch each of the plurality of Peltier devices between hot and cold and simultaneously deliver power from the power supply to the heating and cooling elements.
However, Ruiz teaches switching at a predefined switching frequency to switch each of the plurality of Peltier devices between hot and cold (Figure 12 appendix shows switching between heating and cooling control unit, Figure 18 shows alternating temperature in a predefined frequency as claimed) and further discloses that simultaneously deliver power from the power supply to the heating and cooling elements (Figure 8).
Claims 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Dijkstra and Alvarez as applied to claim 1 above, and further in view of “Tabaie et al.,” “Human body heat-driven thermoelectric generators as a sustainable power supply for wearable electronic devices: recent advances, challenges, and future perspectives,” Heliyon 9 (2023) (hereinafter Tabaie).
Regarding to claims 4-8, Dijkstra and Alvarez together teach all limitations of claim 1 as set forth above.
Dijkstra and Alvarez do not further explicitly disclose arrangement of checkboard pattern, alternating stripes, alternating concentric rings and alternating dots of heating and cooling elements.
However, in the analogous field of endeavor in treatment device, Tabaie teaches thermoelectric devices in a wearable form to a user, wherein checkboard, stripes and concentric rings as well as alternating dots are shown (Figure 6 shows alternating dots, Figure 7 shows alternating stripes, Figure 8 shows checkboard designs of thermoelectric devices, Fig. 14 shows alternating concentric rings, Figure 15 shows checkboard, Fig. 16 shows alternating dots).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Peltier (Thermoelectric) device as taught by Dijkstra and Alvarez to incorporate teaching of Tabaie, since various configurations of alternating stripes, dots, concentric rings and checkboard pattern of heating and cooling elements was well known in the art as taught by Tabaie. One of ordinary skill in the art could have combined the elements as claimed by Dijkstra and Alvarez with no change in their respective functions, configuring the heating and cooling element to be arranged in alternating stripes, dots, concentric rings and checkboard pattern and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide wearable thermoelectric devices (page 2), and there was reasonable expectation of success.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Dijkstra and Alvarez as applied to claim 15 above, and further in view of “Kelleher et al.,” US 2020/0179168 (hereinafter Kelleher).
Regarding to claims 17-18, Dijkstra and Alvarez together teach all limitations of claim 15 as set forth above.
Dijkstra and Alvarez do not explicitly disclose specific frequency ranges of vibration elements.
However, in the analogous field of endeavor in treatment device, Kelleher teaches heating the tissue while applying vibrational energy ([0182]) wherein vibration of frequency extends into ultrasonic frequency ranges from 1 Hz to 20 KHz ([0183]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the treatment device as taught by Dijkstra to incorporate teaching of Kelleher, since specific ranges of ultrasonic frequency for vibration was well known in the art as taught by Kelleher. One of ordinary skill in the art could have combined the elements as claimed by Dijkstra and Alvarez with no change in their respective functions, configuring the frequency of ultrasound vibrational element, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide most effective treatment ([0183]), and there was reasonable expectation of success.
Claim 21 and 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz as applied to claim 20 above, and further in view of “Franke et al.,” US 2020/0188660 (hereinafter Franke).
Regarding to claim 21, Ruiz teaches all limitations of claim 20 as set forth above.
Ruiz does not teach wherein the portion of the patient's body is a lower back of the patient, and wherein the activating of the plurality of heating elements and the plurality of cooling elements reduces symptoms of back pain due to gate control theory.
However, in the analogous field of endeavor in thermal treatment method, Franke teaches using cooling and heating radiation to a lower back ([0572] and [0925]) and wherein the activating of the plurality of heating elements and the plurality of cooling elements reduces symptoms of back pain due to gate control theory (principal of gate control theory of pain [0600]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify treatment device as taught by Ruiz to incorporate teaching of Franke, since applying cooling/heating treatment to a lower back was well known in the art as taught by Franke. One of ordinary skill in the art could have combined the elements as claimed by Ruiz with no change in their respective functions, using its treatment device to apply a lower back, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide reduce the pain according to gate control theory of pain ([0600]), and there was reasonable expectation of success.
Regarding to claims 30 and 32, Ruiz teaches all limitations of claim 20 as set forth above.
Ruiz does not teach vibrating with vibrations generated from at least one vibration element of the thermal device, and wherein the vibration causes an analgesic effect and increased blood circulation in the portion of the patient's body.
However, in the analogous field of endeavor in thermal treatment of the patient’s body, Franke teaches applying ultrasound vibration ([0598]) for temporarily blocking pain (thus reads on analgesic as claimed [0600]) and increased blood circulation (blood supply increased by heating the blood vessel [0666]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify treatment device as taught by Ruiz to incorporate teaching of Franke, since applying cooling/heating treatment with vibrational element was well known in the art as taught by Franke. One of ordinary skill in the art could have combined the elements as claimed by Ruiz with no change in their respective functions, using its treatment device combined with vibrational element, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide pain relief ([0600]), and there was reasonable expectation of success.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Ruiz as applied to claim 20 above, and further in view of “Taylor et al.,” US 2023/0390154 (hereinafter Taylor).
Regarding to claim 22, Ruiz teaches all limitations of claim 20 as set forth above.
Ruiz does not further teach wherein the portion of the patient's body is the patient's head or neck, and wherein the activating of the plurality of heating elements and the plurality of cooling elements stimulates the patient's trigeminal nerve and reduces symptoms of a migraine.
However, in the analogous field of endeavor in thermal treatment method, Taylor teaches thermal treatment method that cooling/heating applies to the head ([0074]) or to the neck ([0889]) wherein the treatment stimulates trigeminal nerve that associates with headaches ([0141] and [0144]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify treatment device as taught by Ruiz to incorporate teaching of Taylor, since applying cooling/heating treatment to neck or head was well known in the art as taught by Taylor. One of ordinary skill in the art could have combined the elements as claimed by Ruiz with no change in their respective functions, using its treatment device to apply head or neck to stimulate trigeminal nerve, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide intended outcome of treatment of migraines ([0765]), and there was reasonable expectation of success.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Ruiz as applied to claim 20 above, and further in view of “Edwards et al.,” US 2015/0048178 (hereinafter Edwards).
Regarding to claim 23, Ruiz teaches all limitations of claim 20 as set forth above.
Ruiz does disclose activating cooling and heating element in a single device but does not explicitly disclose simultaneously activating heating elements and cooling elements and wherein the heating and cooling elements are alternately arranged.
However, in the analogous field of Peltier device and method, Edwards discloses Peltier devices of heating and cooling elements are controlled individually, and can be activated simultaneously and concurrently ([0157]), and Peltier devices can be arranged alternately (Peltier devices 146a-d Figures 6 [0155]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify treatment device as taught by Ruiz to incorporate teaching of Edwards, since simultaneous activation of heating and cooling was well known in the art as taught by Edwards. One of ordinary skill in the art could have combined the elements as claimed by Ruiz with no change in their respective functions, using the Peltier device to be activated simultaneously for heating and cooling, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to individualized control of the Peltier devices ([0157]), and there was reasonable expectation of success.
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz as applied to claim 20 above, and further in view of “Treen et al.,” US 2020/0352633 (hereinafter Treen).
Regarding to claim 25, Ruiz teaches all limitations of claim 20 as set forth above.
Ruiz further teaches wherein the activating the plurality of heating elements and the plurality of cooling elements comprises:
activating the plurality of heating elements and the plurality of cooling elements in a first spatially alternating pattern for a first period of time (timer relay, heating function for 20 minutes [0006]);
deactivating the plurality of cooling elements and the plurality of heating elements after expiration of the first period of time (OFF phase shown in Figure 16 Appendix page 14);
activating the plurality of heating elements and the plurality of cooling elements (cyclic testing Figure 16)
deactivating the plurality of heating elements and the plurality of cooling elements after expiration of the second period of time (Second OFF phase shown in Figure 16 Appendix page 14).
Ruiz does not further disclose limitations of:
activating the plurality of heating elements and the plurality of cooling elements, in a second spatially alternating pattern different than the first spatially alternating pattern, for a second period of time after the expiration of the first period of time; and
However, in the analogous field of endeavor in heating treatment device, Treen teaches activating heating or cooling element for specified time period and in alternating pattern on region, shifting between different zones and actively heating them before switching to another zone ([0399]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify treatment device as taught by Ruiz to incorporate teaching of Treen, since alternating pattern of activating spatially different zones was well known in the art as taught by Treen. One of ordinary skill in the art could have combined the elements as claimed by Ruiz with no change in their respective functions, configuring timer of activating heating and cooling element to activate and deactivate with different spatial zones and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to maintain desired temperature range for the tissue until the overall treatment time reaches ([0399]), and there was reasonable expectation of success.
Regarding to claim 26, Ruiz and Treen together teach all limitations of claim 25 as set forth above.
Ruiz further teaches wherein each of the first period of time and the second period of time is in a range from approximately 1 minute to approximately 20 minutes (heating function for 20 minutes [0006]) and
Treen further teaches wherein the activating in the first spatially alternating pattern and the activating in the second spatially alternating pattern are repeated substantially continuously ([0399]).
Claims 27-29 is rejected under 35 U.S.C. 103 as being unpatentable over Ruiz as applied to claim 20 above, and further in view of “Dijkstra et al.,” US application 18/408, 626 (US 2025/0073117, hereinafter Dijkstra).
Regarding to claim 27, Ruiz teaches all limitations of claim 20 as set forth above.
Ruiz does not further teach further comprising irradiating, with light emitted from at least one light-emitting element of the thermal device, the portion of the patient's body.
However, in the analogous field of endeavor in thermal treatment, Dijkstra teaches thermal treatment including plurality of heating and cooling elements including irradiating with light emitted from one light-emitting element of the thermal device, the portion of the patient’s body ([0071]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify treatment device as taught by Ruiz to incorporate teaching of Dijkstra, since applying light therapy was well known in the art as taught by Dijkstra. One of ordinary skill in the art could have combined the elements as claimed by Ruiz with no change in their respective functions, using its treatment device to configure the light emitting diode, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide light therapy ([0071]), and there was reasonable expectation of success.
Regarding to claims 28-29, Ruiz and Dijkstra together teach all limitations as set forth above.
Dijkstra further teaches following limitations:
Of claim 28, wherein the light has a wavelength in the range from approximately 500 nm to approximately 1,200 nm wavelength (ranging between 300 nm and 1200 nm [0071]).
Of claim 29, wherein the at least one light-emitting element comprises at least light-emitting diode or at least one laser diode (light emitting diode LEDs [0071]).
Claims 31 are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz and Franke as applied to claim 30 above, and further in view of “Kelleher et al.,” US 2020/0179168 (hereinafter Kelleher).
Regarding to claim 31, Ruiz and Franke together teach all limitations of claim 30 as set forth above.
Ruiz and Franke do not explicitly disclose specific frequency ranges of vibration elements.
However, in the analogous field of endeavor in thermal treatment method, Kelleher teaches heating the tissue while applying vibrational energy ([0182]) wherein vibration of frequency extends into ultrasonic frequency ranges from 1 Hz to 20 KHz ([0183]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the treatment device as taught by Ruiz and Franke to incorporate teaching of Kelleher, since specific ranges of ultrasonic frequency for vibration was well known in the art as taught by Kelleher. One of ordinary skill in the art could have combined the elements as claimed by Ruiz and Franke with no change in their respective functions, configuring specific range of frequency of ultrasound vibrational element, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide most effective treatment ([0183]), and there was reasonable expectation of success.
Conclusion
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/PATRICIA J PARK/Primary Examiner, Art Unit 3798
1 The examiner reviewed specification and drawings of 63/499,128 and confirmed that the content of disclosure matches between provisional application and the publication. The cited paragraphs are from specification of 63/499,128.
2 The examiner reviewed specification and drawings of 63/499,128 and confirmed that the content of disclosure matches between provisional application and the publication. The cited paragraphs are from specification of 63/499,128.
Prosecution Insights