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 .
Status of Claims
Claims 1-22 are currently pending and are under examination. In Applicant’s 04/01/2026 response, claims 1, 8-15, and 18-22 are amended.
Priority
The instant application (filed on 12/30/2022) is a continuation of PCT/JP2021/022945 (filed on 06/16/2021), filed under 35 USC 111(a). Acknowledgment is made of Applicant's claim for foreign priority based on an application filed in Japan (JP 2020-116599) on 07/06/2020. A translation via Espacenet (https://worldwide.espacenet.com) of JP 2022014325A was used to assess the disclosure in JP 2020-116599 (see attached translation). Instant claims 1-22 are adequately supported in the foreign application to receive an effective filing date of 07/06/2020.
Response to Arguments
Applicant's arguments, see Remarks page 10 (Rejection under 35 U.S.C. § 112(b)), filed 04/01/2026, with respect to the 35 USC § 112(b) rejections of claims 1-9 and 20-22 have been fully considered. Applicant argues:
Claims 1-9 and 20-22 stand rejected under 35 U.S.C. 112(b) as being indefinite. This rejection is respectfully traversed. The Examiner has set forth certain instances wherein the claim language lacks antecedent basis or is not clearly understood. By this amendment, Applicant has amended the claims to correct each of the deficiencies pointed out by the Examiner. Applicant respectfully submits that the claims, as amended. particularly point out and distinctly claim the subject matter which Applicant regards as the invention. Accordingly, reconsideration and withdrawal of this rejection are respectfully requested. (04/01/2026 Remarks, page 10)
These arguments are persuasive. Claims 1, 8, and 9 identify the requirement of stimulation intensity and claims 20-22 require the sound emitter. Therefore, the rejections for those claims are withdrawn (see allowable subject matter).
Applicant's arguments, see Remarks pages 10-13 (Rejections under 35 U.S.C. § 103), filed 04/01/2026, with respect to the 35 USC § 103 rejections of claims 1-19 have been fully considered. Regarding claim 1, Applicant argues:
In support of the rejection of claim 1, the Examiner alleges that the combination of Yamazaki, Matsushita, Mueller, and Cywinski render the claimed invention obvious. Specifically, the Examiner now relies on Cywinski to teach as follows (see page 11 of Office Action):
Cywinski, in the same field of endeavor of electrical stimulation of tissue (Col 1, Lines 6-13), teaches an electrical stimulator placed over the skin (Col 6, Lines 3-13) with LED display monitoring lights 14 driven by pulse signals from the electrical stimulation to synchronously change in relation to the electrical signal (Col 6, Lines 23-40). This display is meant for visual monitoring of the electrical stimulation provided by the device (Col 8, Lines 1-17). Note that only a light waveform determined by the electrical stimulation waveform is interpreted as necessary for the claim. An audio waveform determined by the electrical stimulation waveform was not found during a prior art search (see "Prior Art Rejections" at the end of this action for details).
Applicant disagrees that Cywinski cures the deficiencies of the teachings of Yamazaki, Matsushita, and Mueller.
Cywinski is directed to a device for trophic stimulation of muscles. As relied upon by the Examiner, in col. 6, lines 23-40, Cywinski discloses as follows:
The general function of this invention is best understood with reference to FIG. 5. The first three basic functional components of the invention are numbered 1,2 and 3 and have been previously described as pulse generating means, pulse conditioning means and electrode means, respectively. Component 11 is the control and timer circuit and the component 14 is the stimulating pulse monitoring display. The control and timer circuit 11 is driven by the clock input 15 coming from the pulse generating means 1. It produces an inhibit signal for the pulse generating means on it output 13. This signal stops the stimulator after a predetermined treatment time. The control and timer circuit 11 also produces a reset signal for the pulse generating means 1 on its output 12. The display monitoring lights are driven by the pulse signals on the input 16 synchronously with each pulse generated by the pulse generating means 1.
As can be seen from the above, Cywinski discloses that the display monitoring lights are driven by the pulse signals on the input 16 synchronously with each pulse generated by the pulse generating means.
Cywinski discloses driving the LEDs synchronously with each pulse generated and is used to monitor pulse occurrence. The LEDs are directly triggered by the pulse timing signal (input 16).
Cywinski discloses that the user is able to adjust the stimulation intensity through potentiometer 20, which changes pulse amplitude. However, the pulse timing is generated by prewired oscillators, clock and RC network. The pulse width is set by a monostable multivibrator with fixed RC time constants. The timing signals are completely independent of amplitude.
However, according to Applicant's proposed amended claim 1, the output unit outputs, during supply of the low-frequency pulse current by the pad portion, at least one of light and sound synchronized with a change in the stimulation intensity by the low-frequency pulse current to the contact target. Thus, according to Applicant's claim, during supply of the pulse current, light or sound is synchronized with a change in the stimulation intensity. Cywinski does not teach, during supply of the pulse current, light or sound is synchronized with a change in the stimulation intensity of the low-frequency pulse current. Therefore, Cywinski fails to cure the deficiencies of the teachings of Yamazaki, Matsushita, and Mueller. (04/01/2026 Remarks, pages 10-13)
This argument is not persuasive. The instant claim 1 limitation in question is “at least one of light and sound synchronized with a change in the stimulation intensity by the low-frequency pulse current to the contact target, wherein at least one of the light and sound is generated based on a pulse voltage waveform for supplying the low-frequency pulse current.” Yamazaki teaches synchronized, by amplitude or intensity:
• sound ([0065] – “As a result, the low-frequency voltages are applied to the first to third electrode terminals 143A to 143C in synchronization with the audio signals outputted from the sound processer 114 to the audio output circuit 120”),
• light ([0073] – “The LED 151 can be made to blink to be synchronous with the audio signals outputted to the audio output circuit 120 or the trigger signal generation circuit 130”, [0074] – “It is also possible to make the LCD 152 display graphics (indicator in a bar shape and a screen saver moving up and down in concert with the sound timing) synchronizing with the audio signals outputted to the audio output circuit”), and
• electrical stimulation outputs ([0114] – “In short, according to the low-frequency application device 21, the stimulation of the low-frequency voltage can be changed according to the magnitude of the level of the amplitude of the audio signal”);
All three of these outputs are controlled by the common audio signal. As previously discussed, as it pertains to the allowability of claims 20-22, the instant application teaches a stimulation signal being used to create an audio signal output. This is different than Yamasaki (which uses an audio signal to create a stimulation signal). No prior art could be found with the stimulation signal being used to create the audio signal (all other art found used the same approach as Yamasaki).
While an audio signal is similarly being used to determine the light output in Yamasaki, a key difference is the light in the instant application is being used as an indicator light to be seen by the patient. Prior art, such as Cywinski, exists teaching an indicator light which is synchronous with an external electrode stimulation signal. Therefore, an indicator light in Yamasaki (such as the light already used in Yamasaki) could use the electrical stimulation signal to generate the light signal and be an indicator directly of stimulation rather than the audio file.
Since the language of claim 1 states “at least one of the light and sound,” only one of the light component or sound component are necessary. Given there is a case where only the light component is present, the rejections of claims 1-7 are maintained.
Regarding independent claims 8-13, 18, and 19, Applicant argues:
Applicant respectfully submits that Applicant's amended claim 1, together with claims dependent thereon, and for similar reasons claims 8-13, 18, and 19, together with claims dependent thereon, obvious. (04/01/2026 Remarks, page 13)
This argument is not persuasive. The arguments for claim 1 were not persuasive and the rejections for claim 1 are maintained. Independent claims 8 and 9 in some manner incorporate the “generating” language “wherein at least one of the light and sound is generated based on a pulse voltage waveform for supplying the low-frequency pulse current” from claim 1, which is pertinent to the discussion of what signal is used to generate the light and sound outputs. However, independent claims 10-15 and 18-19 do not contain the "generating based on" language and are interpreted as only requiring synchronization. Therefore, the rejections of claims 8-13 and 18-19 are similarly maintained.
Summary: The 35 U.S.C. § 103 rejections for claims 1-19 are maintained. Claims 20-22 are allowable with the amended claim language.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1-6 and 8-9 are rejected under U.S.C 103 as being unpatentable over Yamazaki (US 2015/0343214 A1) in view of Matsushita (US 2018/0296831 A1), Mueller (US 2010/0042180 A1), and Cywinski (US 5,350,415).
Regarding Claim 1, Yamazaki discloses a low-frequency treatment device ([0014]), comprising:
• a pad portion ([0023]) configured to supply a low-frequency pulse current having a stimulation intensity to a contact target ([0015] – pulsed current supplied to a target via electrodes, which would naturally have an intensity, [0023] – target on the skin); and
• an output unit ([0022] – output circuits)
• including at least one of a light emitter ([0073]), and a sound emitter ([0038]), contained on the low-frequency application device ([0022] – “As illustrated in FIG. 1, the low-frequency application device 1 includes a sound source input circuit 110, an audio output circuit 120, a trigger signal generation circuit 130, an EMS output circuit 140, a display 150, a button 160, and a controller 170”; [0038] – sound ; [0071] - light)
• configured to output ([0022] – output circuits), during supply of the low-frequency pulse current by the pad portion ([0023]), at least one of light and sound synchronized ([0065] – synchronized sound; [0073-0074] – synchronized light) with a change in the stimulation intensity by the low-frequency pulse current to the contact target ([0114] – amplitude is a component of the audio signal which is used to produce synchronized light, audio, and stimulation outputs: “In short, according to the low-frequency application device 21, the stimulation of the low-frequency voltage can be changed according to the magnitude of the level of the amplitude of the audio signal”);
Yamazaki does not disclose a light emitter which is positioned on a side of the pad portion that is opposite to a side of the pad portion that supplies the low-frequency pulse current to the contact target and a speaker positioned on the side of the pad portion that is opposite to the side of the pad portion that supplies the low-frequency pulse current to the contact target. Additionally, Yamazaki does not disclose wherein at least one of the light and sound is generated based on a pulse voltage waveform for supplying the low-frequency pulse current.
Matsushita, in the same field of endeavor of electrical stimulation of tissue ([0002]), teaches a speaker placed facing away from the tissue being stimulated by the electrical stimulator (Figure 4A-4C, [0466] – placement of speaker) for user notification purposes ([0160]). A person of ordinary skill in the art would have found, in light of the device incorporating a speaker to be heard by the user in Yamazaki, the positioning of the speaker placement on the opposite side of the device relative to electrical stimulation in Matsushita (facing away toward the air to be carried to the user) to be obvious. The speaker placement in Matsushita would be recognized as a solution with a reasonable degree of success and would be included in a finite number of locations on the device the speaker can be placed. Therefore, a person of ordinary skill in the art would be motivated to try the speaker placement in Matsushita in light of the device in Yamazaki.
Mueller, in the same field of endeavor of electrical stimulation of tissue (Col 1, Lines 6-13), teaches an LED indicator placed facing away from the tissue being stimulated by the electrical stimulator (Figure 4, [0062] – placement of LED indicator) for user notification purposes ([0062]). A person of ordinary skill in the art would have found, in light of the device incorporating a visual indicator to be seen by the user in Yamazaki, the positioning of the indicator placement on the opposite side of the device relative to electrical stimulation in Mueller (facing away toward the air to be carried to the user) to be obvious. The LED indicator placement in Mueller would be recognized as a solution with a reasonable degree of success and would be included in a finite number of locations on the device the indicator can be placed. Therefore, a person of ordinary skill in the art would be motivated to try the indicator placement in Mueller in light of the device in Yamazaki.
Cywinski, in the same field of endeavor of electrical stimulation of tissue (Col 1, Lines 6-13), teaches an electrical stimulator placed over the skin (Col 6, Lines 3-13) with LED display monitoring lights 14 driven by pulse signals from the electrical stimulation to synchronously change in relation to the electrical signal (Col 6, Lines 23-40). This display is meant for visual monitoring of the electrical stimulation provided by the device (Col 8, Lines 1-17). Note that only a light waveform determined by the electrical stimulation waveform is interpreted as necessary for the claim.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Yamazaki’s electrical stimulation device with an amplitude-dependent stimulation signal and light indicator by incorporating a synchronized LED indicator for an electrical muscle stimulator in Cywinski. This would have been obvious because both Yamazaki and Cywinski provide electrical stimulation and have a light indicator and Cywinski provides a solution/improvement which provides a synchronized visual indicator for tracking a signal originating from the electrical stimulation signal. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Yamazaki by incorporating the LED output originating from the electrical stimulation signal in Cywinski.
Regarding Claim 2, the low-frequency treatment device according to Claim 1 is obvious over Yamazaki in view of Matsushita, Mueller, and Cywinski, as indicated hereinabove. Yamazaki further discloses one or more processors ([0058-0062] – processing steps to determine control signal) configured to perform control of supply of the low-frequency pulse current by the pad portion and control ([0062] - trigger signal developed for electrical stimulation), in conjunction with the control of supply of the low-frequency pulse current, of output of at least one of the light and sound by the output unit ([0065] – Sound; [0073] – Light).
Regarding Claim 3, the low-frequency treatment device according to Claim 1 is obvious over Yamazaki in view of Matsushita, Mueller, and Cywinski, as indicated hereinabove. Yamazaki further discloses the stimulation intensity includes a frequency of the low-frequency pulse current ([0015] – described as use of a low frequency current).
Regarding Claim 4, the low-frequency treatment device according to Claim 1 is obvious over Yamazaki in view of Matsushita, Mueller, and Cywinski, as indicated hereinabove. Yamazaki further discloses the stimulation intensity includes a voltage of the low-frequency pulse current ([0015] – described as use of a low frequency voltage to supply current).
Regarding Claim 5, the low-frequency treatment device according to Claim 1 is obvious over Yamazaki in view of Matsushita, Mueller, and Cywinski, as indicated hereinabove. Yamazaki further discloses the stimulation intensity includes a pulse width of the low-frequency pulse current ([0016] – pulse width adjustable).
Regarding Claim 6, the low-frequency treatment device according to Claim 1 is obvious over Yamazaki in view of Matsushita, Mueller, and Cywinski, as indicated hereinabove. Yamazaki further discloses the output unit is configured to output ([0022] – output circuits) light changing at least one of the color, brightness, and area in synchronization with a change in a supply state of the low-frequency pulse current ([0073] – the LED receives the trigger signal: “In the case of making the LED 151 blink as described above, it is only necessary to output the trigger signals generated by the first to third AID converters 132A to 132C, to a signal controller 175; [0115-1116] - the trigger signal has a variable voltage amplitude, which would affect brightness of the LED).
Regarding Claim 8, Yamazaki discloses a control method of a low-frequency treatment device ([0014] – method used to control the low-frequency device) including a pad portion ([0023]) configured to supply a low-frequency pulse current including a stimulation intensity to a contact target ([0015] – pulsed current supplied to a target via electrodes, which would naturally have an intensity, [0023] – target on the skin) including at least one of a light emitter ([0073]) and a sound emitter including a speaker ([0038]), the control method comprising:
• controlling the pad portion to supply the low-frequency pulse current ([0023]), and
• generating at least one of light emitted by the light emitter and sound emitted by the speaker contained on the low-frequency application device ([0022]; [0038] – sound ; [0071] – light), the at least one of the light and the sound that is generated is synchronized ([0065] – synchronized sound; [0073-0074] – synchronized light) with a change in the stimulation intensity by the low-frequency pulse current to the contact target and controlling the output unit to output, during supply of the low-frequency pulse current by the pad portion ([0114] – amplitude is a component of the audio signal which is used to produce synchronized light, audio, and stimulation outputs);
Yamazaki does not disclose a light emitter which is positioned on a side of the pad portion that is opposite to a side of the pad portion that supplies the low-frequency pulse current to the contact target and a speaker positioned on the side of the pad portion that is opposite to the side of the pad portion that supplies the low-frequency pulse current to the contact target. Additionally, Yamazaki does not disclose generating based on a pulse voltage waveform for supplying the low-frequency pulse current
[…] at least one of the light and sound synchronized with a change in a supply state of the low-frequency pulse current.
Matsushita, in the same field of endeavor of electrical stimulation of tissue ([0002]), teaches a speaker placed facing away from the tissue being stimulated by the electrical stimulator (Figure 4A-4C, [0466] – placement of speaker) for user notification purposes ([0160]). A person of ordinary skill in the art would have found, in light of the method incorporating a speaker to be heard by the user in Yamazaki, the positioning of the speaker placement on the opposite side of the device relative to electrical stimulation in Matsushita (facing away toward the air to be carried to the user) to be obvious. The speaker placement in Matsushita would be recognized as a solution with a reasonable degree of success and would be included in a finite number of locations on the device the speaker can be placed. Therefore, a person of ordinary skill in the art would be motivated to try the speaker placement in Matsushita in light of the method in Yamazaki.
Mueller, in the same field of endeavor of electrical stimulation of tissue ([0002]), teaches an LED indicator placed facing away from the tissue being stimulated by the electrical stimulator (Figure 4, [0062] – placement of LED indicator) for user notification purposes ([0062]). A person of ordinary skill in the art would have found, in light of the method incorporating a visual indicator to be seen by the user in Yamazaki, the positioning of the indicator placement on the opposite side of the device relative to electrical stimulation in Mueller (facing away toward the air to be carried to the user) to be obvious. The LED indicator placement in Mueller would be recognized as a solution with a reasonable degree of success and would be included in a finite number of locations on the device the indicator can be placed. Therefore, a person of ordinary skill in the art would be motivated to try the indicator placement in Mueller in light of the method in Yamazaki.
Cywinski, in the same field of endeavor of electrical stimulation of tissue (Col 1, Lines 6-13), teaches an electrical stimulator placed over the skin (Col 6, Lines 3-13) with LED display monitoring lights 14 driven by pulse signals from the electrical stimulation to synchronously change in relation to the electrical signal (Col 6, Lines 23-40). This display is meant for visual monitoring of the electrical stimulation provided by the device (Col 8, Lines 1-17). Note that only a light waveform determined by the electrical stimulation waveform is interpreted as necessary for the claim.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Yamazaki’s electrical stimulation method with an amplitude-dependent stimulation signal and light indicator by incorporating a synchronized LED indicator for an electrical muscle stimulator in Cywinski. This would have been obvious because both Yamazaki and Cywinski provide electrical stimulation and have a light indicator and Cywinski provides a solution/improvement which provides a synchronized visual indicator for tracking a signal originating from the electrical stimulation signal. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Yamazaki by incorporating the LED output originating from the electrical stimulation signal in Cywinski.
Regarding Claim 9, Yamazaki discloses a non-transitory recording medium ([0079]) in which a control program ([0080-0082]) of a low-frequency treatment device is stored, the low-frequency treatment device including a pad portion ([0023]) configured to supply a low-frequency pulse current having a stimulation intensity to a contact target ([0015] – pulsed current supplied to a target via electrodes, [0023] – target on the skin); including at least one of a light emitter ([0073]), and a sound emitter including a speaker ([0038]), the control program allowing a computer to execute:
• controlling the pad portion to supply the low-frequency pulse current ([0023]); and
• generating at least one of light emitted by the light emitter and sound emitted by the speaker contained on the low-frequency application device ([0022]; [0038] – sound; [0071] – light), and the at least one of the light and the sound is synchronized with a change ([0065] – synchronized sound; [0073-0074] – synchronized light) in the stimulation intensity by the low-frequency pulse current to the contact target and controlling the output unit to output, during supply of the low-frequency pulse current by the pad portion ([0114] – amplitude is a component of the audio signal which is used to produce synchronized light, audio, and stimulation outputs).
Note an audio file has an equivalent trigger signal used to generate electrical stimulation and play an audio file via speaker ([0033-0034]). Yamazaki does not disclose a light emitter which is positioned on a side of the pad portion that is opposite to a side of the pad portion that supplies the low-frequency pulse current to the contact target and a speaker positioned on the side of the pad portion that is opposite to the side of the pad portion that supplies the low-frequency pulse current to the contact target. Additionally, Yamazaki does not disclose generating based on a pulse voltage waveform for supplying the low-frequency pulse current […] at least one of the light and sound synchronized with a change in a supply state of the low-frequency pulse current.
Matsushita, in the same field of endeavor of electrical stimulation of tissue ([0002]), teaches a speaker placed facing away from the tissue being stimulated by the electrical stimulator (Figure 4A-4C, [0466] – placement of speaker) for user notification purposes ([0160]). A person of ordinary skill in the art would have found, in light of the device incorporating a speaker to be heard by the user in Yamazaki, the positioning of the speaker placement on the opposite side of the device relative to electrical stimulation in Matsushita (facing away toward the air to be carried to the user) to be obvious. The speaker placement in Matsushita would be recognized as a solution with a reasonable degree of success and would be included in a finite number of locations on the device the speaker can be placed. Therefore, a person of ordinary skill in the art would be motivated to try the speaker placement in Matsushita in light of the device in Yamazaki.
Mueller, in the same field of endeavor of electrical stimulation of tissue ([0002]), teaches an LED indicator placed facing away from the tissue being stimulated by the electrical stimulator (Figure 4, [0062] – placement of LED indicator) for user notification purposes ([0062]). A person of ordinary skill in the art would have found, in light of the device incorporating a visual indicator to be seen by the user in Yamazaki, the positioning of the indicator placement on the opposite side of the device relative to electrical stimulation in Mueller (facing away toward the air to be carried to the user) to be obvious. The LED indicator placement in Mueller would be recognized as a solution with a reasonable degree of success and would be included in a finite number of locations on the device the indicator can be placed. Therefore, a person of ordinary skill in the art would be motivated to try the indicator placement in Mueller in light of the device in Yamazaki.
Cywinski, in the same field of endeavor of electrical stimulation of tissue (Col 1, Lines 6-13), teaches an electrical stimulator placed over the skin (Col 6, Lines 3-13) with LED display monitoring lights 14 driven by pulse signals from the electrical stimulation to synchronously change in relation to the electrical signal (Col 6, Lines 23-40). This display is meant for visual monitoring of the electrical stimulation provided by the device (Col 8, Lines 1-17). Note that only a light waveform determined by the electrical stimulation waveform is interpreted as necessary for the claim.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Yamazaki’s electrical stimulation device with an amplitude-dependent stimulation signal and light indicator by incorporating a synchronized LED indicator for an electrical muscle stimulator in Cywinski. This would have been obvious because both Yamazaki and Cywinski provide electrical stimulation and have a light indicator and Cywinski provides a solution/improvement which provides a synchronized visual indicator for tracking a signal originating from the electrical stimulation signal. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Yamazaki by incorporating the LED output originating from the electrical stimulation signal in Cywinski.
Claim 7 is rejected under U.S.C 103 as being unpatentable over Yamazaki (US 2015/0343214 A1) in view of Matsushita (US 2018/0296831 A1), Mueller (US 2010/0042180 A1), Cywinski (US 5,350,415,), and Malchano (US 2018/0133507 A1).
Regarding Claim 7, the low-frequency treatment device according to Claim 6 is obvious over Yamazaki in view of Matsushita, Mueller, and Cywinski, as indicated hereinabove. Yamazaki further discloses the output unit is configured to output (using control unit 300) light that changes in intensity depending ([0073-0074] – synchronized light) on at least one of intensity and waveform of the low-frequency pulse current ([0114] – amplitude is a component of the stimulation signal: “In short, according to the low-frequency application device 21, the stimulation of the low-frequency voltage can be changed according to the magnitude of the level of the amplitude of the audio signal”). However, Yamazaki does not disclose light of a changing color.
Malchano, in the same field of endeavor of providing light ([0007]), sound ([0009]), and electrical stimulation ([0013]) for nerve activation, teaches light stimulation which can vary color based on treatment ([0112] – “the modality of therapy neural stimuli may be the visual stimulation modality, and the therapy parameter may include at least one of a color or an image selection. In some embodiments, the modality of the therapy neural stimuli may be the peripheral neural stimulation modality, and the therapy parameter may be a location”). Note Malchano synchronizes the application of different stimuli based on inherent nerve activity ([0045] – “The stimulus control module can determine an adjustment to the external stimuli based on the artefact identified by the neural oscillation monitor, the phase differences between the neural oscillation measurements, and the stimulus generation policy. The stimulus generator module can adjust the stimuli waveform based on the adjustment determined by the stimulus control module”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Yamazaki’s stimulation device with a light emitting device to incorporate the light stimulation which can be controlled to emit different colors in Malchano. This would have been obvious because both Yamazaki and Malchano discuss controlling light stimulators and Malchano provides a solution/improvement to incorporating light stimulation with a specific color as another mechanism to provoke a specific nervous response. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Yamazaki by incorporating the light stimulation which can be controlled to emit different colors in Malchano.
Claims 10-15 and 18-19 are rejected under U.S.C 103 as being unpatentable over Yamazaki (US 2015/0343214 A1) in view of Matsushita (US 2018/0296831 A1) and Mueller (US 2010/0042180 A1).
Regarding Claim 10, Yamazaki discloses a low-frequency treatment device ([0014]), comprising:
• a pad portion ([0023]) configured to supply a low-frequency pulse current to a contact target ([0015] – pulsed current supplied to a target via electrodes, [0023] – target on the skin); and
• an output unit ([0022] – output circuits)
• including at least one of a light emitter ([0073]), and a sound emitter ([0038]), contained on the low-frequency application device ([0022], [0038] – sound ; [0071] - light)
• configured to output ([0022] – output circuits), during supply of the low-frequency pulse current by the pad portion, at least one of light and sound synchronized ([0065] – Sound; [0073] – Light) with a change in a supply position of the low-frequency pulse current in the pad portion ([0065] – synchronized sound; [0073-0074] – synchronized light; [0062], [0114] – electrical signal synchronized with audio signal).
Yamazaki does not disclose a light emitter which is positioned on a side of the pad portion that is opposite to a side of the pad portion that supplies the low-frequency pulse current to the contact target and a speaker positioned on the side of the pad portion that is opposite to the side of the pad portion that supplies the low-frequency pulse current to the contact target.
Matsushita, in the same field of endeavor of electrical stimulation of tissue ([0002]), teaches a speaker placed facing away from the tissue being stimulated by the electrical stimulator (Figure 4A-4C, [0466] – placement of speaker) for user notification purposes ([0160]). A person of ordinary skill in the art would have found, in light of the device incorporating a speaker to be heard by the user in Yamazaki, the positioning of the speaker placement on the opposite side of the device relative to electrical stimulation in Matsushita (facing away toward the air to be carried to the user) to be obvious. The speaker placement in Matsushita would be recognized as a solution with a reasonable degree of success and would be included in a finite number of locations on the device the speaker can be placed. Therefore, a person of ordinary skill in the art would be motivated to try the speaker placement in Matsushita in light of the device in Yamazaki.
Mueller, in the same field of endeavor of electrical stimulation of tissue ([0002]), teaches an LED indicator placed facing away from the tissue being stimulated by the electrical stimulator (Figure 4, [0062] – placement of LED indicator) for user notification purposes ([0062]). A person of ordinary skill in the art would have found, in light of the device incorporating a visual indicator to be seen by the user in Yamazaki, the positioning of the indicator placement on the opposite side of the device relative to electrical stimulation in Mueller (facing away toward the air to be carried to the user) to be obvious. The LED indicator placement in Mueller would be recognized as a solution with a reasonable degree of success and would be included in a finite number of locations on the device the indicator can be placed. Therefore, a person of ordinary skill in the art would be motivated to try the indicator placement in Mueller in light of the device in Yamazaki.
Regarding Claim 11, Yamazaki discloses a control method of a low-frequency treatment device ([0014] – method used to control the low-frequency device) including a pad portion ([0023]) configured to supply a low-frequency pulse current to a contact target ([0015] – pulsed current supplied to a target via electrodes, [0023] – target on the skin) and an output unit ([0022] – output circuits), including at least one of a light emitter ([0073]) and a sound emitter ([0038]), the control method comprising:
• controlling the pad portion to supply the low-frequency pulse current ([0023]); and
• controlling the output unit to output, during supply of the low-frequency pulse current by the pad portion ([0033-0034] - Note an audio file has an equivalent trigger signal used to generate electrical stimulation and play an audio file via speaker, meaning a signal is fed into the visual, audio, and electrical stimulation components), at least one of light emitted by the light emitter and sound emitted by the speaker contained on the low-frequency application device ([0022], [0038] – sound ; [0071] - light) and the at least one of the light and the sound is synchronized with a change in a supply position of the low-frequency pulse current in the pad portion ([0065] – synchronized sound; [0073-0074] – synchronized light; [0062], [0114] – electrical signal synchronized with audio signal).
Yamazaki does not disclose a light emitter which is positioned on a side of the pad portion that is opposite to a side of the pad portion that supplies the low-frequency pulse current to the contact target and a speaker positioned on the side of the pad portion that is opposite to the side of the pad portion that supplies the low-frequency pulse current to the contact target.
Matsushita, in the same field of endeavor of electrical stimulation of tissue ([0002]), teaches a speaker placed facing away from the tissue being stimulated by the electrical stimulator (Figure 4A-4C, [0466] – placement of speaker) for user notification purposes ([0160]). A person of ordinary skill in the art would have found, in light of the method incorporating a speaker to be heard by the user in Yamazaki, the positioning of the speaker placement on the opposite side of the device relative to electrical stimulation in Matsushita (facing away toward the air to be carried to the user) to be obvious. The speaker placement in Matsushita would be recognized as a solution with a reasonable degree of success and would be included in a finite number of locations on the device the speaker can be placed. Therefore, a person of ordinary skill in the art would be motivated to try the speaker placement in Matsushita in light of the method in Yamazaki.
Mueller, in the same field of endeavor of electrical stimulation of tissue ([0002]), teaches an LED indicator placed facing away from the tissue being stimulated by the electrical stimulator (Figure 4, [0062] – placement of LED indicator) for user notification purposes ([0062]). A person of ordinary skill in the art would have found, in light of the method incorporating a visual indicator to be seen by the user in Yamazaki, the positioning of the indicator placement on the opposite side of the device relative to electrical stimulation in Mueller (facing away toward the air to be carried to the user) to be obvious. The LED indicator placement in Mueller would be recognized as a solution with a reasonable degree of success and would be included in a finite number of locations on the device the indicator can be placed. Therefore, a person of ordinary skill in the art would be motivated to try the indicator placement in Mueller in light of the method in Yamazaki.
Regarding Claim 12, Yamazaki discloses a non-transitory recording medium ([0079]) in which a control program ([0080-0082]) of a low-frequency treatment device is stored the low-frequency treatment device including a pad portion ([0023]) configured to supply a low-frequency pulse current to a contact target ([0015] – pulsed current supplied to a target via electrodes, [0023] – target on the skin); including at least one of a light emitter ([0073]), and a sound emitter ([0038]), the control program allowing a computer to execute:
• controlling the pad portion to supply the low-frequency pulse current ([0023]); and
• controlling the output unit to output, during supply of the low-frequency pulse current by the pad portion ([0033-0034] - Note an audio file has an equivalent trigger signal used to generate electrical stimulation and play an audio file via speaker, meaning a signal is fed into the visual, audio, and electrical stimulation components), at least one of light and sound emitted by the speaker contained on the low-frequency application device ([0022], [0038] – sound ; [0071] - light) and the at least one of the light and the sound is synchronized with a change in a supply position of the low-frequency pulse current in the pad portion ([0065] – synchronized sound; [0073-0074] – synchronized light; [0062], [0114] – electrical signal synchronized with audio signal).
Yamazaki does not disclose a light emitter which is positioned on a side of the pad portion that is opposite to a side of the pad portion that supplies the low-frequency pulse current to the contact target and a speaker positioned on the side of the pad portion that is opposite to the side of the pad portion that supplies the low-frequency pulse current to the contact target.
Matsushita, in the same field of endeavor of electrical stimulation of tissue ([0002]), teaches a speaker placed facing away from the tissue being stimulated by the electrical stimulator (Figure 4A-4C, [0466] – placement of speaker) for user notification purposes ([0160]). A person of ordinary skill in the art would have found, in light of the device incorporating a speaker to be heard by the user in Yamazaki, the positioning of the speaker placement on the opposite side of the device relative to electrical stimulation in Matsushita (facing away toward the air to be carried to the user) to be obvious. The speaker placement in Matsushita would be recognized as a solution with a reasonable degree of success and would be included in a finite number of locations on the device the speaker can be placed. Therefore, a person of ordinary skill in the art would be motivated to try the speaker placement in Matsushita in light of the device in Yamazaki.
Mueller, in the same field of endeavor of electrical stimulation of tissue ([0002]), teaches an LED indicator placed facing away from the tissue being stimulated by the electrical stimulator (Figure 4, [0062] – placement of LED indicator) for user notification purposes ([0062]). A person of ordinary skill in the art would have found, in light of the device incorporating a visual indicator to be seen by the user in Yamazaki, the positioning of the indicator placement on the opposite side of the device relative to electrical stimulation in Mueller (facing away toward the air to be carried to the user) to be obvious. The LED indicator placement in Mueller would be recognized as a solution with a reasonable degree of success and would be included in a finite number of locations on the device the indicator can be placed. Therefore, a person of ordinary skill in the art would be motivated to try the indicator placement in Mueller in light of the device in Yamazaki.
Regarding Claim 13, Yamazaki discloses a low-frequency treatment device ([0014]), comprising:
• a pad portion ([0023]) configured to supply a low-frequency pulse current to a contact target [0015] – pulsed current supplied to a target via electrodes, [0023] – target on the skin); and
• an output unit ([0022] – output circuits), including at least one of a light emitter ([0073]), and a sound emitter ([0038]), contained on the low-frequency application device ([0022], [0038] – sound ; [0071] - light) disposed in the pad portion (Figure 1, [0065] – electrode pads 3 and 4 placed in device with electrical stimulator, LED’s and audio output) and configured to output ([0022] – output circuits), during supply of the low-frequency pulse current by the pad portion ([0033-0034] - Note an audio file has an equivalent trigger signal used to generate electrical stimulation and play an audio file via speaker, meaning a signal is fed into the visual, audio, and electrical stimulation components), at least one of light and sound synchronized with a change in a supply state of the low-frequency pulse current ([0065] – synchronized sound; [0073-0074] – synchronized light; [0062], [0114] – electrical signal synchronized with audio signal).
Yamazaki does not disclose a light emitter which is positioned on a side of the pad portion that is opposite to a side of the pad portion that supplies the low-frequency pulse current to the contact target and a speaker positioned on the side of the pad portion that is opposite to the side of the pad portion that supplies the low-frequency pulse current to the contact target.
Matsushita, in the same field of endeavor of electrical stimulation of tissue ([0002]), teaches a speaker placed facing away from the tissue being stimulated by the electrical stimulator (Figure 4A-4C, [0466] – placement of speaker) for user notification purposes ([0160]). A person of ordinary skill in the art would have found, in light of the device incorporating a speaker to be heard by the user in Yamazaki, the positioning of the speaker placement on the opposite side of the device relative to electrical stimulation in Matsushita (facing away toward the air to be carried to the user) to be obvious. The speaker placement in Matsushita would be recognized as a solution with a reasonable degree of success and would be included in a finite number of locations on the device the speaker can be placed. Therefore, a person of ordinary skill in the art would be motivated to try the speaker placement in Matsushita in light of the device in Yamazaki.
Mueller, in the same field of endeavor of electrical stimulation of tissue ([0002]), teaches an LED indicator placed facing away from the tissue being stimulated by the electrical stimulator (Figure 4, [0062] – placement of LED indicator) for user notification purposes ([0062]). A person of ordinary skill in the art would have found, in light of the device incorporating a visual indicator to be seen by the user in Yamazaki, the positioning of the indicator placement on the opposite side of the device relative to electrical stimulation in Mueller (facing away toward the air to be carried to the user) to be obvious. The LED indicator placement in Mueller would be recognized as a solution with a reasonable degree of success and would be included in a finite number of locations on the device the indicator can be placed. Therefore, a person of ordinary skill in the art would be motivated to try the indicator placement in Mueller in light of the device in Yamazaki.
Regarding Claim 14, the low-frequency treatment device according to Claim 13 is obvious over Yamazaki in view of Matsushita and Mueller, as indicated hereinabove. Yamazaki further discloses:
• the pad portion ([0023]) includes an electrode configured to supply the low-frequency pulse current ([0063-0064] – the output circuit 140 controls the signal that reaches the electrodes), and
• the output unit is disposed at a position corresponding to the position of the electrode in the pad portion (Figure 1, [0023] – electrode pads 3 and 4 attach to the output unit via electrode terminals) and includes a light emitting unit configured to emit light [(0071] – “The display 150 includes an LED (Light Emitting Diode) 151 and an LCD (Liquid Crystal Display) 152”), in synchronization with supply of the low-frequency pulse current by the electrode ([0073] – “The LED 151 can be made to blink to be synchronous with the audio signals outputted to the audio output circuit 120 or the trigger signal generation circuit 130”).
Regarding Claim 15, the low-frequency treatment device according to Claim 14 is obvious over Yamazaki in view of Matsushita and Mueller, as indicated hereinabove. Yamazaki further discloses:
• the pad portion includes a plurality of electrodes ([0023) configured to supply the low-frequency pulse current ([0063-0064] – the output circuit 140 controls the signal that reaches the electrodes), and
• the output unit is disposed at a position corresponding to the position of each of the plurality of electrodes in the pad portion (Figure 1, [0023] – electrode pads 3 and 4 attach to the output unit via electrode terminals) and includes a plurality of light emitting units [(0071] – “The display 150 includes an LED (Light Emitting Diode) 151 and an LCD (Liquid Crystal Display) 152”), configured to respectively emit light in synchronization with supply of the low-frequency pulse current by the corresponding electrodes ([0073] – LED, [0074] – LCD).
Regarding Claim 18, Yamazaki discloses a control method of a low-frequency treatment device ([0014] – method used to control the low-frequency device) including a pad portion ([0023]) configured to supply a low-frequency pulse current to a contact target ([0015] – pulsed current supplied to a target via electrodes, [0023] – target on the skin) and an output unit ([0022] – output circuits), including at least one of a light emitter ([0073]) and a sound emitter including a speaker ([0038]), disposed in the pad portion ([0022]), the control method comprising:
• controlling the pad portion to supply the low-frequency pulse current ([0023]); and
• controlling the output unit to output, during supply of the low-frequency pulse current by the pad portion ([0033-0034] - Note an audio file has an equivalent trigger signal used to generate electrical stimulation and play an audio file via speaker, meaning a signal is fed into the visual, audio, and electrical stimulation components), at least one of light emitted by the light emitter and sound emitted by the speaker contained on the low-frequency application device ([0022] – ([0022], [0038] – sound ; [0071] - light), and the at least one of the light and the sound is synchronized with a change in the low-frequency pulse current ([0065] – synchronized sound; [0073-0074] – synchronized light; [0062], [0114] – electrical signal synchronized with audio signal).
Yamazaki does not disclose a light emitter which is positioned on a side of the pad portion that is opposite to a side of the pad portion that supplies the low-frequency pulse current to the contact target and a speaker positioned on the side of the pad portion that is opposite to the side of the pad portion that supplies the low-frequency pulse current to the contact target.
Matsushita, in the same field of endeavor of electrical stimulation of tissue ([0002]), teaches a speaker placed facing away from the tissue being stimulated by the electrical stimulator (Figure 4A-4C, [0466] – placement of speaker) for user notification purposes ([0160]). A person of ordinary skill in the art would have found, in light of the method incorporating a speaker to be heard by the user in Yamazaki, the positioning of the speaker placement on the opposite side of the device relative to electrical stimulation in Matsushita (facing away toward the air to be carried to the user) to be obvious. The speaker placement in Matsushita would be recognized as a solution with a reasonable degree of success and would be included in a finite number of locations on the device the speaker can be placed. Therefore, a person of ordinary skill in the art would be motivated to try the speaker placement in Matsushita in light of the method in Yamazaki.
Mueller, in the same field of endeavor of electrical stimulation of tissue ([0002]), teaches an LED indicator placed facing away from the tissue being stimulated by the electrical stimulator (Figure 4, [0062] – placement of LED indicator) for user notification purposes ([0062]). A person of ordinary skill in the art would have found, in light of the method incorporating a visual indicator to be seen by the user in Yamazaki, the positioning of the indicator placement on the opposite side of the device relative to electrical stimulation in Mueller (facing away toward the air to be carried to the user) to be obvious. The LED indicator placement in Mueller would be recognized as a solution with a reasonable degree of success and would be included in a finite number of locations on the device the indicator can be placed. Therefore, a person of ordinary skill in the art would be motivated to try the indicator placement in Mueller in light of the method in Yamazaki.
Regarding Claim 19, Yamazaki discloses a non-transitory recording medium ([0079]) in which a control program ([0080-0082]) of a low-frequency treatment device is stored, the low-frequency treatment device including a pad portion ([0023]) configured to supply a low-frequency pulse current to a contact target ([0015] – pulsed current supplied to a target via electrodes, [0023] – target on the skin), and an output unit ([0022] – output circuits), including at least one of a light emitter ([0073]) and a sound emitter ([0038]), disposed in the pad portion ([0022]), the control program allowing a computer to execute:
• controlling the pad portion to supply the low-frequency pulse current ([0023]); and
• controlling the output unit to output, during supply of the low-frequency pulse current by the pad portion ([0033-0034] - Note an audio file has an equivalent trigger signal used to generate electrical stimulation and play an audio file via speaker, meaning a signal is fed into the visual, audio, and electrical stimulation components), at least one of light emitted by the light emitter and sound emitted by the speaker contained on the low-frequency application device ([0022], [0038] – sound ; [0071] - light) and the at least one of the light and the sound is synchronized with a change in the low-frequency pulse current ([0065] – synchronized sound; [0073-0074] – synchronized light; [0062], [0114] – electrical signal synchronized with audio signal).
Yamazaki does not disclose a light emitter which is positioned on a side of the pad portion that is opposite to a side of the pad portion that supplies the low-frequency pulse current to the contact target and a speaker positioned on the side of the pad portion that is opposite to the side of the pad portion that supplies the low-frequency pulse current to the contact target.
Matsushita, in the same field of endeavor of electrical stimulation of tissue ([0002]), teaches a speaker placed facing away from the tissue being stimulated by the electrical stimulator (Figure 4A-4C, [0466] – placement of speaker) for user notification purposes ([0160]). A person of ordinary skill in the art would have found, in light of the device incorporating a speaker to be heard by the user in Yamazaki, the positioning of the speaker placement on the opposite side of the device relative to electrical stimulation in Matsushita (facing away toward the air to be carried to the user) to be obvious. The speaker placement in Matsushita would be recognized as a solution with a reasonable degree of success and would be included in a finite number of locations on the device the speaker can be placed. Therefore, a person of ordinary skill in the art would be motivated to try the speaker placement in Matsushita in light of the device in Yamazaki.
Mueller, in the same field of endeavor of electrical stimulation of tissue ([0002]), teaches an LED indicator placed facing away from the tissue being stimulated by the electrical stimulator (Figure 4, [0062] – placement of LED indicator) for user notification purposes ([0062]). A person of ordinary skill in the art would have found, in light of the device incorporating a visual indicator to be seen by the user in Yamazaki, the positioning of the indicator placement on the opposite side of the device relative to electrical stimulation in Mueller (facing away toward the air to be carried to the user) to be obvious. The LED indicator placement in Mueller would be recognized as a solution with a reasonable degree of success and would be included in a finite number of locations on the device the indicator can be placed. Therefore, a person of ordinary skill in the art would be motivated to try the indicator placement in Mueller in light of the device in Yamazaki.
Claim 16 is rejected under U.S.C 103 as being unpatentable over Yamazaki (US 2015/0343214 A1) in view of Matsushita (US 2018/0296831 A1), Mueller (US 2010/0042180 A1) and Rhodes (US 2016/0346565 A1).
Regarding Claim 16, the low-frequency treatment device according to Claim 14 is obvious over Yamazaki in view of Matsushita and Mueller, as indicated hereinabove. Yamazaki further discloses:
• the pad portion ([0023] – “The low-frequency application device 1 can apply a low to middle-frequency voltage (hereinafter, referred to as a "low-frequency voltage") of about 10 kHz or less to a skin surface of a person to be treated via detachable electrode pads 3, 4”)
Yamazaki does not disclose light being able to pass through a surface opposite to the contact target and an insulating layer, covering the electrode, which includes a transparent member configured to diffuse light of the light emitting unit.
Mueller, in the same field of endeavor of electrical stimulation of tissue ([0002]), teaches an LED indicator placed facing away from the tissue being stimulated by the electrical stimulator (Figure 4, [0062] – placement of LED indicator) for user notification purposes ([0062]). A person of ordinary skill in the art would have found, in light of the device incorporating a visual indicator to be seen by the user in Yamazaki, the positioning of the indicator placement on the opposite side of the device relative to electrical stimulation in Mueller (facing away toward the air to be carried to the user) to be obvious. The LED indicator placement in Mueller would be recognized as a solution with a reasonable degree of success and would be included in a finite number of locations on the device the indicator can be placed. Therefore, a person of ordinary skill in the art would be motivated to try the indicator placement in Mueller in light of the device in Yamazaki.
Rhodes, in the same field of endeavor of providing light stimulation ([0003]), teaches a light stimulator with an optical layer which is made of a light diffuser ([0068] – “In addition to the EMR delivery system 20, this embodiment contains an optical layer 16 within the cup 70 that serves as a diffuser 72 that diffuses the therapeutic EMR 24 such that the therapeutic EMR 24 is distributed relatively evenly over the surface of the wound area 32 covered by the wound dressing assembly 10”). The optical layer can be optically clear, which is interpreted as transparent ([0050] – “The optical layer 16 may have at least an optical portion comprising at least one of an optically clear material, a translucent material, and a semi-opaque material, each such material allows the therapeutic EMR to pass through with minimal optical obstruction”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Yamazaki’s stimulation device containing a light emitting unit by incorporating the light diffusing layer in Rhodes. This would have been obvious because both Yamazaki and Rhodes discuss controlling light stimulators and Rhodes provides a solution/improvement for providing more evenly distributed light emitted toward a tissue. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Yamazaki by incorporating the light emitting device covered with a light diffuser in Rhodes.
Claim 17 is rejected under U.S.C 103 as being unpatentable over Yamazaki (US 2015/0343214 A1) in view of Matsushita (US 2018/0296831 A1), Mueller (US 2010/0042180 A1), Rhodes (US PG Pub 2016/0346565 A1), and Castel (US 2019/0366115 A1).
Regarding Claim 17, the low-frequency treatment device according to Claim 14 is obvious over Yamazaki in view of Matsushita and Mueller, as indicated hereinabove. Yamazaki further discloses the use of an electrical stimulator and light applicator positioned in the same applied patch ([0022]; [0071] – “The display 150 includes an LED (Light Emitting Diode) 151 and an LCD (Liquid Crystal Display) 152”). Yamazaki does not disclose the electrode is formed of a transparent conductive film configured to diffuse light of the light emitting unit.
Castel, in the same field of endeavor of providing light stimulation ([0003]), teaches transparent electrodes made of conductive layers ([0068] – “In some embodiments, the conductive materials of one or both of the electrodes may include, but are not limited to, transparent conductive polymer materials”), interpreted as being in a film layer, paired with light sources so that light can pass through electrodes to the patient ([0066] – “Because the light source must emit light through one or both electrodes, at least one of the electrodes must be transparent”). Therefore, transparent film electrodes can be combined for use with light sources.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Yamazaki’s stimulation device by incorporating the transparent film electrodes which allow light to pass during light therapy in Castel. This would have been obvious because both Yamazaki and Castel discuss controlling light stimulators and Castel provides a solution/improvement to allow for transparent electrodes which do not block light therapy from reaching the patient. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Yamazaki by incorporating the transparent film stimulation electrodes which allow light to pass during light therapy in Castel. However, Castel does not explicitly teach a configuration to diffuse light.
Rhodes, in the same field of endeavor of providing light stimulation ([0003]), teaches a light stimulator with an optical layer which is made of a light diffuser ([0068]). The optical layer can be optically clear, which is interpreted as transparent ([0050]). The optical layer could be applied to the film electrodes to diffuse therapeutic light more evenly.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Yamazaki’s stimulation device containing a light emitting unit by incorporating the light diffusing layer in Rhodes. This would have been obvious because both Yamazaki and Rhodes discuss controlling light stimulators and Rhodes provides a solution/improvement for providing more evenly distributed light emitted toward a tissue. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Yamazaki by incorporating the light emitting device covered with a light diffuser in Rhodes.
Allowable Subject Matter
No prior art references could be found that teach or render obvious all the limitations of claims 20-22 due to the requirement of a “having tone color that changes depending on at least one of intensity and waveform of the low-frequency pulse current” (independent claims 20, 21, and 22, emphasis added). This limitation establishes that the controlling signal is the low-frequency pulse current, where this signal is used to generate the audio signals. By contrast Yamazaki (US 2015/0343214 A1) discloses an audio file is used to generate an equivalent trigger signal to control electrical stimulation and light ([0034-0035]), where the light and electrical stimulation are synchronized with a sound output ([0065] – electrical stimulation; [0073] – light). The electrical stimulation waveform is not used as a basis to generate the audio signal, meaning Yamazaki does not disclose the instant limitation. Additional searching has highlighted electrical stimulators with synchronized audio and light components (such as US 2015/036030 A1, 2017/0087364 A1, 2017/0252562 A1, 2018/0133507 A1, 2017/0353807 A1, or 2011/0045687 A1). However, these references have a similar deficiency as Yamazaki in that the audio component is used to determine the electrical stimulation or light components (e.g. music is played and the electrical stimulation and light outputs are generated to be synchronized with the audio signal).
No combination of prior art references could be found that teach or render obvious the limitations of instant claims 20-22. Therefore, Claims 20-22 are deemed allowable.
It should be noted this lack of prior art only applies to the electrical stimulation being used to generate an audio signal. Indicator lights based on and synchronized with an electrical stimulation output are known in the art, such as Cywinski (US 5,350,415).
Conclusions
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/Benjamin A Schmitt/
Examiner
Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796
Prosecution Insights