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 § 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 1-5 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over SASAKI et al.
CN Pat.: CN 108025172 A, hereinafter Sasaki in view of XU et al. CN Pat.: CN 113426010 A, hereinafter Xu in view of Hammer et al. US Pub.: US 20210252278 A1, hereinafter Hammer.
Regarding claim 1, Sasaki teaches a wearable device for alleviating lower limb ischemia,
comprising: a main control unit (14), an electrocardiosignal monitoring unit (100) configured to be worn on a chest of a human body, and being in signal connection with the main control unit (14) (fig. 1-4; paragraph 35-42 and 53-62);
a first electrical pulse assembly (60) configured to be worn on a thigh of the human body, and being in signal connection with the main control unit (14) (fig. 1-4; paragraph 35-42 and 53-62); Electrode 102 is provided with a right electrode portion 60 installed on the right side of human body and a left electrode portion 61 installed on the left side of human body. The right electrode part 60 can be installed on the lower right thigh of the human body.
wherein the first electrical pulse assembly (60) comprises at least two groups of first pulse stimulation electrodes (102) (fig. 1-4; paragraph 35-42 and 53-62); The electrode section 60 is provided with at least two positive and negative electrodes, including a + electrode and a - electrode.
and a second electrical pulse assembly (61) configured to be worn on a lower leg of the human body, and being in signal connection with the main control unit (14), wherein the second electrical pulse assembly (61) comprises at least two groups of second pulse stimulation electrodes (102) (fig. 1-4; paragraph 35-42 and 53-62); The electrode section 61 is provided with at least two positive and negative electrodes, including a + electrode and a - electrode. The electrode section 61 can be installed on the ankle and knee, which equates to the lower leg.
the at least two groups of the second pulse stimulation electrodes (102) are respectively disposed corresponding to a lateral side and a medial side of the lower leg, and one ends, away from the electrocardiosignal monitoring unit (100) (fig. 1-4; paragraph 35-42 and 53-62); The configuration and installation method of electrode 102 are not limited to this configuration and installation method as long as they can transmit electrical signals to the lower leg and thigh of human body.
wherein the first pulse stimulation electrodes (102) and the second pulse stimulation electrodes (102) have a pulse frequency of 20-30Hz (fig. 1-4; paragraph 57); The frequency of the electrical signal can be appropriately set by those skilled in the art, but it is preferred, for example, to be set to 20Hz to 30Hz. Electrical signals with frequencies above 20Hz tend to compress arteries continuously, while motor nerves are more likely to respond to pulse waves with frequencies below 30Hz, making it easier for muscles to contract.
However, Sasaki does not teach each group of the first pulse stimulation electrodes comprises at least three first pulse stimulation electrodes; the at least two groups of the first pulse stimulation electrodes are respectively disposed corresponding to an outer thigh and an inner thigh, and one ends, away from the electrocardiosignal monitoring unit, of the first pulse stimulation electrodes are provided with at least one group of third pulse stimulation electrodes; each group of the second pulse stimulation electrodes comprises at least three second pulse stimulation electrodes; of the second pulse stimulation electrodes are provided with at least one group of fourth pulse stimulation electrodes; wherein the first pulse stimulation electrodes and the second pulse stimulation electrodes have a pulse frequency of 1-100 KHz, and the third pulse stimulation electrodes and the fourth pulse stimulation electrodes have a pulse frequency of 50-300 Hz.
Sasaki discloses the claimed invention but does not disclose expressly “each group of the second pulse stimulation electrodes comprises at least three second pulse stimulation electrodes.” It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system as taught by Sasaki with “each group of the second pulse stimulation electrodes comprises at least three second pulse stimulation electrodes,” because Applicant has not disclosed that this specific three second stimulation duration provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the stimulation duration 0.15-0.25 seconds as taught by Sasaki because it provides “the improvement and assistance of the heart's blood pumping function, which will not hinder blood circulation (return flow) and is unlikely to have an adverse effect on the self-regulating cardiac systolic and diastolic functions” (paragraph 57 and 70-71) and since it appears to be an arbitrary design consideration which fails to patentably distinguish over Sasaki.
Therefore, it would have been an obvious matter of design choice to modify [Reference A] to obtain the invention as specified in the claim(s).
Xu teaches Vein Thrombus Preventive Instrument based on blood flow monitoring, mainly used for electrical stimulation therapy on the thigh of a patient and further teaches each group of the first pulse stimulation electrodes comprises at least three first pulse stimulation electrodes (fig. 1-2; paragraph 32-36); The restraint strap 11 comprise one group containing stimulation electrode 15 and monitoring electrode 17. The figure shows three restraint straps 11 configured to be worn on the high, middle, and lower areas of a patient’s leg. Therefore, at least three first pulse stimulation electrodes are disclosed.
the at least two groups of the first pulse stimulation electrodes are respectively disposed corresponding to an outer thigh and an inner thigh, and one ends, away from the electrocardiosignal monitoring unit, of the first pulse stimulation electrodes (15) are provided with at least one group of third pulse stimulation electrodes (15) (fig. 1-2; paragraph 32-36); The restraint strap 11 comprise one group containing stimulation electrode 15 and monitoring electrode 17. The figure shows three restraint straps 11 configured to be worn on the high, middle, and lower areas of a patient’s leg. The straps 11 may be rotated to a position corresponding to an outer thigh and an inner thigh.
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 wearable system of Sasaki with the restraint strap and electrode configuration from Xu for the benefit of binding the stimulation electrode sets to the inner and outer sections of the patient’s thigh.
Hammer teaches a peripheral nerve stimulation system attached to the lower leg of the patient (fig. 6A) and further teaches the second pulse stimulation electrodes are provided with at least one group of fourth pulse stimulation electrodes (fig. 6A; paragraph 112); Four electrodes are attached to the patient’s leg to provide stimulation.
wherein the first pulse stimulation electrodes and the second pulse stimulation electrodes have a pulse frequency of 1-100 KHz, and the third pulse stimulation electrodes and the fourth pulse stimulation electrodes have a pulse frequency of 50-300 Hz (paragraph 66-67 and 149-151). Stimulation frequencies between about 1 kHz-100 kHz and 1 Hz-100 Hz are disclosed.
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 amount of straps of Sasaki in view of Xu to add a fourth strap as suggested by Hammer for the benefit of providing more stimulation to specific areas of the patient’s leg.
Also, 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 frequency range of Sasaki in view of Xu to apply the frequency ranges of Hammer for the benefit of avoiding the discomfort (tingling, numbness, pain) that can be associated with peripheral nerve stimulation
Regarding claim 2, Sasaki in view of Xu in view of Hammer teaches the modified claimed
invention and Xu further teaches wherein the first electrical pulse assembly (1) further comprises a first wearing portion (11), the first wearing portion comprises a first wearing portion body (11), and the first pulse stimulation electrodes (15) and the third pulse stimulation electrodes (15) are attached to an inner wall of the first wearing portion body (11) (fig. 1-2; paragraph 32-36); The restraint strap 11 comprise one group containing stimulation electrode 15 and monitoring electrode 17. The figure shows three restraint straps 11 configured to be worn on the high, middle, and lower areas of a patient’s leg. At least three first pulse stimulation electrodes are disclosed. The straps 11 may be rotated to a position corresponding to an outer thigh and an inner thigh.
However the modified invention does not teach the first wearing portion body is connected with at least one first adjustable connecting part, a wearing space is enclosed by the first wearing portion body and the first adjustable connecting part, and the first wearing portion body is also connected with a first temperature control module.
Xu further teaches wherein the first wearing portion body (11) is connected with at least one first adjustable connecting part (13), a wearing space is enclosed by the first wearing portion body (11) and the first adjustable connecting part (13) (fig. 1-2; paragraph 32-36); Each restraint strap are adjustable with a hook and loop fastener/velcro 13, which acts as a connecting part.
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 wearable system of Sasaki in view of Xu in view of Hammer with the connecting part from Xu for the benefit of adjustably binding the stimulation electrode sets to the inner and outer sections of the patient’s thigh.
Hammer further teaches the first wearing portion body is also connected with a first temperature control module (paragraph 57, 69, 124, 164 and 174). Skin temperature can be measured with a thermistor, thermocouple, or temperature sensor. The controller 22 may take information from the sensors and control the temperature
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 wearable system of Sasaki in view of Xu in view of Hammer with the temperature sensor and control settings from Hammer for the benefit of limiting skin irritation based on temperature and modulating the stimulation of electrodes more efficiently.
Regarding claim 3, Sasaki in view of Xu in view of Hammer teaches the modified claimed
invention and Xu further teaches wherein the second electrical pulse assembly (1) further comprises a second wearing portion (11), the second wearing portion (11) comprises a second wearing portion body (11), and the second pulse stimulation electrodes (15) and the fourth pulse stimulation electrodes (15) are attached to an inner wall of the second wearing portion body (11) (fig. 1-2; paragraph 32-36); The restraint strap 11 comprise one group containing stimulation electrode 15 and monitoring electrode 17. The figure shows three restraint straps 11 configured to be worn on the high, middle, and lower areas of a patient’s leg. At least three first pulse stimulation electrodes are disclosed. The straps 11 may be rotated to a position corresponding to an outer thigh and an inner thigh.
However the modified invention does not teach the second wearing portion body is connected with at least one second adjustable connecting part, a wearing space is enclosed by the second wearing portion body and the second adjustable connecting part, and the second wearing portion body is also connected with a second temperature control module.
Xu further teaches wherein the second wearing portion body (11) is connected with at least one second adjustable connecting part (13), a wearing space is enclosed by the second wearing portion body (11) and the second adjustable connecting part (13) (fig. 1-2; paragraph 32-36); Each restraint strap are adjustable with a hook and loop fastener 13, which acts as a connecting part.
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 wearable system of Sasaki in view of Xu in view of Hammer with the connecting part from Xu for the benefit of adjustably binding the stimulation electrode sets to the inner and outer sections of the patient’s thigh.
Hammer further teaches the second wearing portion body is also connected with a second temperature control module (paragraph 57, 69, 124, 164 and 174). Skin temperature can be measured with a thermistor, thermocouple, or temperature sensor. The controller 22 may take information from the sensors and control the temperature
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 wearable system of Sasaki in view of Xu in view of Hammer with the temperature sensor and control settings from Hammer for the benefit of limiting skin irritation based on temperature and modulating the stimulation of electrodes more efficiently.
Regarding claim 4, Sasaki in view of Xu in view of Hammer teaches the modified claimed
invention and Sasaki further teaches wherein the main control unit (100) comprises a main controller (300), and the main controller (300) comprises a microprocessor (output control unit 12 is configured to include a microcomputer), and a communication module (wireless and non-wireless applications), a data analysis and processing module (301), a data storage module (13), a display module (16) and a control module (12) which are in signal connection with the microprocessor (fig. 1-4; paragraph 35-42 and 53-62).
Hammer further teaches wherein the main control unit (312’) comprises an adjustable wristband (328) and a main controller (321) connected to the adjustable wristband (328) (fig. 13-14C; paragraph 168 and 191-193). The wearable monitor unit 312′ is a smart watch or other wearable device, such as the Apple Watch or an Android based smart watch, with an application that allows the wearable device to communicate with the therapy unit and perform as a monitor unit. The device can also communicate with an external computing device wirelessly.
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 system of Sasaki in view of Xu in view of Hammer to add a wearable wristwatch monitor from Hammer for the benefit of providing accessible data to the patient during therapy.
Regarding claim 5, Sasaki in view of Xu in view of Hammer teaches the modified claimed
invention and Sasaki further teaches wherein the electrocardiosignal monitoring unit (100) comprises an electrocardiosignal acquisition module (200), the electrocardiosignal acquisition module (200) being wirelessly connected with the communication module (fig. 1; paragraph 35-36 and 40-42). The ECG data acquisition device 200 detection electrode extends out of the experimenter mounted on the chest. The acquisition of ECG data output from ECG data acquisition unit 201 and the output of trigger signals generated in trigger signal generation unit 302 can be performed via wireless communication unit and/or wired communication unit.
However, the modified invention does not teach explicitly teach the electrocardiosignal monitoring unit comprises an adjustable chest strap and an electrocardiosignal acquisition module connected to the adjustable chest strap.
Hammer further teaches the electrocardiosignal monitoring unit comprises an adjustable chest strap and an electrocardiosignal acquisition module connected to the adjustable chest strap (paragraph 57, 105, 117, 155, and 169). Electrocardiogram may be worn on the chest of the patient using a chest strap.
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 ECG data acquisition module of Sasaki in view of Xu in view of Hammer to add the chest strap from Hammer for the benefit of adjusting and securing ECG sensors in appropriate areas of the patient for more effective monitoring.
Regarding claim 7, Sasaki in view of Xu in view of Hammer teaches the modified claimed
invention and Sasaki further teaches comprising the steps of: obtaining human body signals, the human body signals comprising at least electrocardiosignals (fig. 1; paragraph 35-40); The ECG data acquisition unit 201 collects electrocardiosignals.
processing the human body signals, and generating control signals according to a processing result comprising R-wave signals, T-wave signals, or P-wave signals in the obtained electrocardiosignals (fig. 3; paragraph 42-50); figure 3 shows the processing of R-waves, T-waves, and P-waves using an analysis unit 301.
and controlling the first electrical pulse assembly (60) and the second electrical pulse assembly (61) to output pulse modulated waves based on the control signals to alternately perform positive stimulation and negative stimulation (fig. 1; paragraph 56-61) The output control unit 12 causes the output port 11 to generate and output an electrical signal at the same time as the trigger signal is input. Each assembly contains output port 11.
Regarding claim 8, Sasaki in view of Xu in view of Hammer teaches the modified claimed
invention and Sasaki further teaches wherein controlling the first electrical pulse assembly (60) and the second electrical pulse assembly (61) to output pulse modulated waves based on the control signals for positive stimulation comprises: controlling the second pulse stimulation electrodes (102) to sequentially output pulse modulated waves in a direction from a distal end of a lower leg to a proximal end of the lower leg (fig. 1; paragraph 56-61); The output control unit 12 causes the output port 11 to generate and output an electrical signal at the same time as the trigger signal is input. Each assembly contains output port 11.
and controlling the first pulse stimulation electrodes (102) to sequentially output pulse modulated waves in a direction from a distal end of a thigh to a proximal end of the thigh after a preset time interval (fig. 1; paragraph 38-41 and 54-56); The trigger signal generation unit 302 generates a trigger signal for causing the electrical stimulation device 100 to output an electrical signal at the output time transmitted from the analysis unit 301. The output control unit 12 controls the output timing of the electrical signal based on the trigger signal input from the electrocardiogram data analysis device 300 (trigger signal generation unit 302). When the trigger signal contains information about the output time, the output control unit 12 causes the output port 11 to generate and output an electrical signal after the output time has arrived.
Regarding claim 9, Sasaki in view of Xu in view of Hammer teaches the modified claimed
invention and Sasaki further teaches wherein controlling the first electrical pulse assembly (60) and the second electrical pulse assembly (61) to output pulse modulated waves based on the control signals for negative stimulation comprises: controlling the first pulse stimulation electrodes (102) to sequentially output pulse modulated waves in a direction from the proximal end of the thigh to the distal end of the thigh (fig. 1; paragraph 56-61); The output control unit 12 causes the output port 11 to generate and output an electrical signal at the same time as the trigger signal is input. Each assembly contains output port 11. The three positive and negative electrodes are designed to include at least a + electrode and a - electrode, so that the polarity of the positive and negative electrodes installed on the ankle and waist is different from that of the positive and negative electrodes installed on the thigh.
controlling the second pulse stimulation electrodes (102) to sequentially output pulse modulated waves in a direction from the proximal end of the lower leg to the distal end of the lower leg; and until T-waves are monitored, controlling the first pulse stimulation electrodes and the second pulse stimulation electrodes to stop working (fig. 1 and 3; paragraph 38-56); The trigger signal generation unit 302 generates a trigger signal for causing the electrical stimulation device 100 to output an electrical signal at the output time transmitted from the analysis unit 301. The output control unit 12 controls the output timing of the electrical signal based on the trigger signal input from the electrocardiogram data analysis device 300 (trigger signal generation unit 302). figure 3 shows the processing of R-waves, T-waves, and P-waves using an analysis unit 301.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Sasaki in view of Xu in view
of Hammer in view of Connor et al. US Pub.: US 20170135633 A1, hereinafter Connor.
Regarding claim 6, Sasaki in view of Xu in view of Hammer teaches the modified claimed
invention and Xu further teaches wherein the first adjustable connecting part (13) connected to one end of the first wearing portion body (11), and first adjustable elastic bands connected to the other end of the first wearing portion body (11); and the second adjustable connecting part (13) connected to one end of the second wearing portion body (11), and second adjustable elastic bands connected to the other end of the second wearing portion body (11) (fig. 1-2; paragraph 34-36 and 53). The three adjacent restraint straps 11 are made of elastic material.
However, the modified invention does not teach a first and second hinge connector.
Connor teaches a wearable cardiac rhythm managing system and further teaches a first and second hinge connector (paragraph 426 and 429-432). The wearable device comprise a joint (and/or hinge) between these portions on a first side of these portions, and a connector which reversibly connects these portions on a second side of these portions.
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 connectors of Sasaki in view of Xu in view of Hammer to replace it with the hinge connector from Connor for the benefit of securing the wearable device on the patient.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Sasaki in view of Xu in
view of Hammer in view of Lycke et al. US Pub.: US 20220184406 A1, hereinafter Lycke.
Regarding claim 10, Sasaki in view of Xu in view of Hammer teaches the modified claimed
invention and Sasaki further teaches wherein the negative stimulation further comprises a step of controlling the third pulse stimulation electrodes and the fourth pulse stimulation electrodes to output pulse modulated waves;
and the method further comprises the steps of controlling the third pulse stimulation electrodes and the fourth pulse stimulation electrodes to output pulse modulated waves.
However, the modified claimed invention does not teach controlling the first electrical pulse assembly and the second electrical pulse assembly to be heated to 35- 45°C before controlling the first electrical pulse assembly and the second electrical pulse assembly to output pulse modulated waves based on the control signals to alternately perform positive stimulation and negative stimulation.
Lycke teaches a wearable medical device with temperature managed electrodes and further teaches using a Peltier device to control the first electrical pulse assembly and the second electrical pulse assembly to be heated to 35- 45°C before controlling the first electrical pulse assembly and the second electrical pulse assembly to output pulse modulated waves based on the control signals to alternately perform positive stimulation and negative stimulation (fig. 6-8; paragraph 81-82 and 89-94). The device will transfer the heat from electrodes to the electrode assembly towards a desirable temperature to remove heat proximal to the patient’s skin.
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 system of Sasaki in view of Xu in view of Hammer to add the Peltier device from Lycke for the benefit of cooling the temperature proximal to the patient’s skin for comfort and effective stimulation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THIEN J TRAN whose telephone number is (571)272-0486. The examiner can normally be reached M-F. 8:30 am - 5:30 pm.
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/T.J.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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