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 .
Claim Objections
Claims 9 and 14 objected to because of the following informalities: Both claims recite a “telephone App”. This should read “telephone app”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 2,3,7, and 14 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation "when the first button and the second button and the third button are depressed simultaneously". There is insufficient antecedent basis for this limitation in the claim as the buttons are not claimed in dependent claim 2 or independent claim 1. Claim 3 is rejected for being dependent upon a rejected independent claim.
Claim 7 recites the limitation “closed-loop control” however, the parameters that allow closed loop control and the parameter that is affected by the closed-loop control are not clear. Therefore, greater definiteness of claim language is required.
Claim 14 recites the limitation of “the wrist-worn acupuncture stimulation device is activated for a set period of time” and this activation is caused by “the PPG device detecting a negative HRV level”. This limitation causes indefiniteness of claim language because claim 10, upon which claim 14 depends, claims that “the wrist-worn acupuncture stimulation device is activated for a set period of time” based on the “the cortisol aptasensor detecting increased cortisol”. It is unclear which set of conditions causes activation of the device.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 6, 8-11, 13, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (US20220054856A1) in view of Chen et al (US20090228084A1); hereinafter Chen and Hirashiki et al (US 20180116906 A1); hereinafter Hirashiki.
Regarding claims 1 and 10, Wang teaches a wrist-worn ([0092] wrist band or watch type device) acupuncture stimulation device ([0003] electrical current passed through skin including acupuncture sites)comprising:
a watch-like case having a top side and bottom side;
a wrist strap or band attachable to the watch-like case constructed to allow the case to be worn on a human wrist ([0092] wrist band or watch type device);
three supply electrodes and a ground electrode, each of the three supply electrodes and the ground electrode being mounted on the bottom side of the case ([0006] One or more electrodes are on the inner surface of the housing which is placed in contact with skin. The device is placed so that the electrode/electrodes overlie the target skin area or acupuncture points known to affect a desired therapy).
Wang further teaches stimulation of the Lu9 point ([0004] Taiyang - the Lu9 point is the same as the Taiyang point).
Wang fails to teach stimulating the H7 point and the P6 point. Hirashiki teaches stimulating the H7 point ([0045] stimulation of acupoint H7). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Wang with Hirashiki because there is some teaching, suggestion, or motivation to do so. Hirashiki teaches that stimulating the H7 point “may block situational stress” ([0045]). Additionally in paragraph [0006], Wang teaches that the device can improve brain function and the teaching of Hirashiki to reduce situational stress can assist in this function.
The combination of Wang and Hirashiki fails to teach stimulating the P6 point. Chen teaches stimulating the P6 point ([0031] acupressure/acupuncture point P6). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Wang and Hirashiki with Chen because there is some teaching, suggestion, or motivation to do so. Chen teaches “to treat certain diseases in accordance with Eastern traditional medicine” ([0031]).
Hirashiki further teaches a galvanic skin response (GSR) sensor configured to measure changes in electrical conductivity of a skin on the human wrist, wherein upon the GSR sensor detecting increased conductivity, the wrist-worn acupuncture stimulation device is activated for a set period of time applying a plurality of direct current pulses via the three supply electrodes ([0049] If galvanic skin response (GSR) measurements are taken before each discharge, the array will detect the change in resistance across all positions and maintain constant discharge intensity as well as auto redirect to the lowest resistance point, thus effecting a self-compensating and self-correcting operation).
Regarding claim 2, the combination of Wang, Chen, and Hirashiki teaches the wrist-worn acupuncture stimulation device of claim 1. Wang further teaches the current is injected into all three of the H7, Lu9 and H7 acupuncture points simultaneously ([0004] current invention is directed towards stimulating one or more of areas including acupuncture points) when the first button and the second button and the third button are depressed simultaneously ([0073] power control buttons control the output power level of the electrodes).
Regarding claim 3, the combination of Wang, Chen, and Hirashiki teaches the wrist-worn acupuncture stimulation device of claim 2. It would have been obvious to modify the invention to include three LEDs mounted on the top side of the case, each LED corresponding to one of the three buttons. It would be obvious because LEDs are commonly used in consumer electronic devices and medical devices to indicate status of an operation.
Regarding claim 6, the combination of Wang, Chen, and Hirashiki teaches the device of claim 1. Wang further teaches short-range communications with a mobile telephone, wherein the mobile telephone executes a stored application program utilizing said shortrange communications ([0063] communication module).
Regarding claim 8, the combination of Wang, Chen, and Hirashiki teaches the device of claim 1. Wang further teaches a display screen ([0044] OLED display).
Regarding claims 9 and 15, the combination of Wang, Chen, and Hirashiki teaches the device of claim 1. Wang further teaches a microcontroller in communication with the three supply electrodes and the ground electrode, wherein the microcontroller is configured to communicate bi-directionally via short-range communication with a telephone App ([0063] communication module).
Regarding claim 11, the combination of Wang, Chen, and Hirashiki teaches the device of claim 10. Wang further teaches the current pulse repetition rate is between 2 Hz and 3 Hz ([0037] In some embodiments, the preferred (but not limited to) electrical pulse frequency used by the method and device of the current invention is between 2-100 Hz or the combinations of the frequency within 2-100 Hz).
Regarding claim 13, the combination of Wang, Chen, and Hirashiki teaches the device of claim 10. Wang further teaches the current is limited to 600 uA ([0037] the preferred current is 0.5-100 milliamperes - 0.5 mA=500 uA).
Claim(s) 4 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Wang, Chen, and Hirashiki in view of Clausen et al (US 20190343205 A1); hereinafter Clausen.
Regarding claims 4 and 14, the combination of Wang, Chen, and Hirashiki teaches the device of claim 1. The combination fails to teach using PPG to read HRV. Clausen teaches a photoplethysmography (PPG) device configured to measure at least heart rate variability rate (HRV) and heart rate (HR) ([0012]). The bumps of the apparatus are equipped with sensors that provide health data and activity monitoring and tracking. The sensors measure health data such as—pulse (heart rate), temperature, muscle tension (in order to detect the muscle knots and tense muscles)). It would have been obvious to modify the combination with Clausen because there is some teaching, suggestion, or motivation to do so. Clausen teaches that these sensors “provide data trends and monitor any health changes with connection to and communications with a control panel”.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Wang, Chen, Hirashiki, and Clausen in view of Fahey et al (US 20190269903 A1); hereinafter Fahey. The combination of Wang, Chen, Hirashiki, and Clausen teaches the device of claim 1. The combination fails to teach the stimulation device activation depending on a negative HRV level. Fahey teaches upon the PPG device detecting a negative HRV level, the wrist-worn acupuncture stimulation device is activated for a set period of time ([0186] The electrical stimulation signal may be determined based on an input from a sensor, temperature sensitive element or both). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination with Fahey because Fahey teaches “using a device that communicates with the array to automatically optimize the electrical stimulation parameters, the location of stimulus application, or both. Following optimization, safe and effective NMES may be initiated automatically without requiring additional involvement of the operator” ([0016]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Wang, Chen, and Hirashaki in view of Lu et al (US 5957862 A); hereinafter Lu. The combination of Wang, Chen, and Hirashaki teaches the device of claim 1, however the combination fails to teach closed-loop control. Lu teaches closed-loop control of said current (In one embodiment, the acupuncture needle system further comprises a temperature sensor and a closed-loop temperature control mechanism and/or algorithm). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Wang, Chen, and Hirashaki with Lu because there is some teaching, suggestion, or motivation to do so. Lu teaches “supply the heat at a desired temperature to the specific site 15. When the temperature reaches the desired preset point, the power is turned off immediately”.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Wang, Chen, and Hirashiki in view of Cartledge et al (US 20150360030 A1); hereinafter Cartledge. The combination of Wang, Chen, Hirashiki, and Clausen teaches the device of claim 10. The combination fails to teach that the current is a square wave. Cartledge teaches the current is a square wave (fig. 144 - constant polarity square wave with breaks). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination with Cartledge because there is some teaching, suggestion, or motivation to do so. Cartledge teaches that the square wave shape allows to “form an uninterrupted transition between polarities” ([0357]).
Conclusion
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/D.S.D./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796