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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 24SEP2024 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“sensor module” in Claims 1 & 8:
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Claim limitation “sensor module”, has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because they use a generic placeholder “unit” coupled with functional language without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. A review of the specification shows that the as-filed specification does not seem to disclose any corresponding structures for performing the function of sensing “biometric information of the subject wearing the helmet” as recited in claims 1 and 8 (see the rejections under 35 U.S.C. 112(a) and (b) below. For the purpose of examination, the “sensor module” is interpretated as any type of biometric sensor.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claims 1 & 8:
For the limitation of “sensor module”, the specification provides the following.[0043] As used herein, the term “module” can include a unit implemented in hardware, software, or firmware, and can be used interchangeably with terms such as, for example, logic, logic block, component, or circuit. A module can be an integrally formed component or a minimum unit or a part of the component that performs one or more functions.
[0059] The non-invasive stimulation device 100 of the present invention can further include one or more sensor modules 130 for measuring various conditions of the user. The sensor module 130 can be adhered to at least one area of the head of the subject, for example, the back of the ear of the subject, the back of the head of the subject, and the back of the neck of the subject. The sensor module 130 can measure more effective biometric information, such as oxygen saturation, heart rate, stress index, and brain waves, and provide the same to the control unit 140.
It is noted that “module” described in [0043] of the specification would not be sufficient to provide the recited function of sensing “biometric information of the subject wearing the helmet” since hardware, software, or firmware are components of a computer, not sensors. The specification further discloses that the sensor module can measure oxygen saturation, heart rate, stress index, and brain waves without disclosing any examples of sensors for detecting these parameters.
MPEP 2163(II)(A)(3)(a)(ii)states the following:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ( "[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
The as-filed specification does not adequately disclose species that would be representative of the entire genus of “sensor module” as claimed since the specification does not even disclose a single species representing the “sensor module.” Since a representative number of adequately described species are not disclosed for the limitation of “sensor module”, as-filed specification lacks adequate written description under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.
Claims 2-7 are further rejected for depending upon rejected claim 1.
Claims 9-10 are further rejected for depending upon rejected claim 8.
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.
Claims 1-10 are 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.
Regarding Claims 1 & 8:
For the limitation of “sensor module”, the specification provides the following.
[0043] As used herein, the term “module” can include a unit implemented in hardware, software, or firmware, and can be used interchangeably with terms such as, for example, logic, logic block, component, or circuit. A module can be an integrally formed component or a minimum unit or a part of the component that performs one or more functions.
[0059] The non-invasive stimulation device 100 of the present invention can further include one or more sensor modules 130 for measuring various conditions of the user. The sensor module 130 can be adhered to at least one area of the head of the subject, for example, the back of the ear of the subject, the back of the head of the subject, and the back of the neck of the subject. The sensor module 130 can measure more effective biometric information, such as oxygen saturation, heart rate, stress index, and brain waves, and provide the same to the control unit 140.
It is noted that “module” described in [0043] of the specification would not be sufficient to provide the recited function of sensing “biometric information of the subject wearing the helmet” since hardware, software, or firmware are components of a computer, not sensors. The specification further discloses that the sensor module can measure oxygen saturation, heart rate, stress index, and brain waves without disclosing any examples of sensors for detecting these parameters.
Claims 2-7 are further rejected for depending upon rejected claim 1.
Claims 9-10 are further rejected for depending upon rejected claim 8.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 1 & 8 recite “a plurality of electrodes each including a patch configured to adhere to a head of a subject” in line 1. The limitation is unclear because the lack of punctuation makes the limitation have multiple meanings. This includes each electrode comprises a patch, and the electrodes are configured to adhere to the head of a subject; or each electrode includes a patch that adheres to the head of a subject (where the electrode is not included in such adherence); or if this is describing a general electrode assembly since all electrodes will need adherence to a subject to function. For the purposes of examination, the examiner is interpreting this as a general electrode, since citations such as ¶0009 of the specification teach away from the use of an explicitly adhesive patch. Clarification is required.
Claims 2-7 are further rejected for depending upon rejected claim 1.
Claims 9-10 are further rejected for depending upon rejected claim 8.
Regarding Claims 1, 2, 8, & 9:
The term “normal” in claims 1, 2, 8, and 9 is a relative term which renders the claim indefinite. The term “normal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The parameter of biometric information is rendered in definite by the use of the relative term “normal” range. Claims 3-7 and 10 are further rejected for depending upon rejected claims 1, 2, 8, and 9.
Regarding Claims 1, 2, 8, & 9:
The term “abnormal” in claims 1, 2, 8, and 9 is a relative term which renders the claim indefinite. The term “normal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The parameter of resistance value state is rendered in definite by the use of the relative term “abnormal”. Claims 3-7 and 10 are further rejected for depending upon rejected claims 1, 2, 8, and 9.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Wingeier et al. (US Patent No. 10315033) in view of Lee et al. (KR Publication No 101566786).
Regarding Claim 1, Wingeier discloses a non-invasive stimulation device comprising: a plurality of electrodes each including a patch configured to adhere to a head of a subject are disposed (Wingeier Column 3 Lines 14-18 “The method can be implemented, at least in part, using a system including an electrical stimulation device having a body-mountable portion and a set of electrodes coupled to the body-mountable portion,”); at least one sensor module configured to sense biometric information of the subject wearing the helmet (Wingeier Column 6 Lines 22-32 “The set of current pulses can additionally or alternatively be provided at a constant frequency (e.g., with constant time spacing between pulses, at a frequency between 2 and 20 Hz, etc.), or can alternatively be provided with non-uniform time spacing between pulses (e.g., random time spacing between pulses). Still alternatively, current pulses can be output whenever a sensor (e.g., accelerometer, gyroscope, magnetometer, force sensor, etc.) of the electrical stimulation device detects a change in position of the electrical stimulation device -during the first impedance monitoring state.”); and a control unit ( Wineiger Column 2 Lines 17-22 “during the first impedance monitoring state, guiding, with the controller, an adjustment of a position of the electrical stimulation device at a body region of the user until a first impedance criterion associated with the first impedance monitoring state is satisfied S120”) configured to apply a direct current stimulation signal to at least one selected electrode in a transcranial direct current stimulation (tDCS) step , provide an alternating current stimulation signal to at least one selected electrode in a transcranial alternating current stimulation (tACS) step (Wingeier Column 11 Lines 42-50 “The stimulation session of the stimulation regime of Block S130 preferably includes transcranial electrical stimulation (TES) configured to stimulate a brain region of the user in the form of at least one of: transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), transcranial magnetic stimulation (TMS), transcranial random noise stimulation (tRNS), transcranial variable frequency stimulation (tVFS), and any other suitable form of transcranial stimulation.”), and automatically switch from the tDCS step to the tACS step when an abnormal state in which a resistance value of the electrode exceeds a reference value or the biometric information exceeds a normal range is detected (Wingeier Figure 2 showing S130 Current (I) is a DC waveform initially, and secondarily Current (I) switches to an AC waveform in S140 of Figure 2).
Wingeier does not explicitly disclose a helmet. Lee in a similar field of endeavor of stimulation teaches a helmet (Lee Figure 1 showing the stimulation device configured as a helmet.). Before the effective filing date, one of ordinary skill in the art would be motivated to combine the system of Wingeier with the helmet as taught in Lee for the purposes of creating a more complex brain stimulation system. Wingeier shows a headset stimulation device in Figure 6. One would see this and be motivated to create a larger system fitting in a helmet when the goal is to reach larger portions of the brain for treatment or to allow for more complex controls of the electrodes.
Regarding claim 2, claim 1 is anticipated by Wingeier in view of Lee. Wingeier further discloses wherein the control unit applies the alternating current signal that swings around a base level in a first tACS step to the electrode selected in the tDCS step, (Wingeier Column 3 Lines 30-34 “The system can further include a controller that transmits the stimulation waveform definition and guides adjustment of the set of electrodes at the head region of the user in cooperation with the first impedance monitoring state.”) increases an intensity of a current applied to the electrode selected in the tACS step to an activation level higher than the base level (Wingeier Figure 2 S110-S120 showing the beginning of a stimulation period where the graph increases from a zero start; Figure 2 provided below) during a ramp-up period after the first tACS step, enters a second tACS step and applies the alternating current signal that swings around the activation level to the electrode selected in the tACS step when the abnormal state is detected (Wingeier Figure 2 (Provided Below) S130), and resumes the tDCS step after a predetermined period of time when a normal state in which the resistance value of the electrode is lower than or equal to the reference value and the biometric information changes within a normal range is detected (Wingeier Figure 2 (provided below) S130-S140; Column 9 Lines 19-24 “Upon achieving an impedance value lower than a threshold impedance value (e.g., 16 kΩ, 5-25 kΩ, etc.) the example application of the method 100 can include transitioning the electrical stimulation device from the first impedance monitoring state to the stimulation regime, as described in relation to Block S130 “), and then gradually lowers the intensity of the current applied to the electrode selected in the tACS step from the activation level to the base level during a ramp-down period (Wingeier Figure 2 S110-S150 provided below).
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Regarding claim 3, Claims 1-2 are obvious over Wingeier in view of Lee. Wingeier further discloses wherein the control unit applies a current of the base level to the electrodes for a predetermined standby time immediately after a power of the non-invasive stimulation device is turned on (Wineiger Figure 2 S110 showing the initial period),applies a patch detection signal pattern (Wingeier Column 8 Lines 42-45 “Alternatively, Block S120 can additionally or alternatively include automatic adjustment of the electrical stimulation device to provide suitable impedance through the stimulation path(s) to initialize stimulation in Block S130.”)in a form of the alternating current signal to the electrodes when the start key input is received, measures resistances of the electrodes, compares the resistance value of each of the electrodes with the reference value, and determines a degree of adhesion of the patch (Wingeier Figures 1 & 2 S120 where the detection signal is occurring with the adjustments recorded by the user), and enters the first tACS step after the patch detection signal pattern (Wingeier Figure 2 S120-S130 showing the calibration of signals between steps s120 and s130 ).
Regarding claim 4 , Claims 1-3 are obvious over Wingeier in view of Lee. Wingeier further discloses wherein an amplitude of the alternating current signal generated in the first tACS step is greater than an amplitude of the patch detection signal pattern (Wingeier Figure 2 S130 Vs S120 (patch signal detection)showing that the amplitude is larger in the current and Voltage waveforms).
Regarding claim 5, Claims 1-2 are obvious over Wingeier in view of Lee. Wingeier further discloses wherein an amplitude of the alternating current signal generated in the second tACS step is lower than an amplitude of the alternating current signal generated in the first tACS step (Wingeier Figure 2 S140 as compared to the initial S120 where the amplitude difference is better shown in the voltage graph of Figure 2. The examiner maintains that the resistance, voltage, and current are used together and therefore can be representative of the same values shown in varying ways).
Regarding claim 6, Claims 1-2 are obvious over Wingeier in view of Lee. Wingeier does not explicitly discloses wherein a frequency of the alternating current signal generated in the second tACS step is different from a frequency of the alternating current signal generated in the first tACS step, but does depict varying frequencies in Figure 2(Wingeier Figure 2 Comparing S120 and S140 in the Current(I) graph which shows the pulse frequency changes between S120 and S140 also shown depicted as an example in the voltage graphs S120/S140). Before the effective filing date, one of ordinary skill in the art would think to create a system wherein a frequency of the alternating current signal generated in the second tACS step is different from a frequency of the alternating current signal generated in the first tACS step for the purpose of target multiple, distinct brain networks in a single session.
Regarding claim 7, Claims 1-2 are obvious over Wingeier in view of Lee. Wingeier does not explicitly disclose the alternating current signal generated in at least one of the first tACS step and the second tACS step includes a section in which an amplitude changes. Wingeier does provide Figure 2 which shows that the alternating voltage signal generated in at least one of the first tACS step and the second tACS step includes a section in which an amplitude changes (Wingeier Figure 2 S120 and S140 of the voltage & resistance graphs showing an amplitude change during both steps.). Before the effective filing date, one of ordinary skill in the art would understand that the current, voltage, and resistance of a stimulation series are related in a manner such that providing a graph of one variety (i.e voltage or resistance) would provide information regarding the remaining portions (i.e current).
Regarding claim 8, Wingeier discloses a non-invasive stimulation method which uses in which a plurality of electrodes each including a patch configured to adhere to a head of a subject are disposed (Wingeier Column 3 Lines 14-18 “The method can be implemented, at least in part, using a system including an electrical stimulation device having a body-mountable portion and a set of electrodes coupled to the body-mountable portion,”), at least one sensor module configured to sense biometric information of the subject wearing the system (Wingeier Column 6 Lines 22-32 “The set of current pulses can additionally or alternatively be provided at a constant frequency (e.g., with constant time spacing between pulses, at a frequency between 2 and 20 Hz, etc.), or can alternatively be provided with non-uniform time spacing between pulses (e.g., random time spacing between pulses). Still alternatively, current pulses can be output whenever a sensor (e.g., accelerometer, gyroscope, magnetometer, force sensor, etc.) of the electrical stimulation device detects a change in position of the electrical stimulation device during the first impedance monitoring state.”), and a control unit (Column 2 Lines 17-22 “during the first impedance monitoring state, guiding, with the controller, an adjustment of a position of the electrical stimulation device at a body region of the user until a first impedance criterion associated with the first impedance monitoring state is satisfied S120”) configured to apply a direct current stimulation signal to at least one selected electrode in a transcranial direct current stimulation (tDCS) step, and provide an alternating current stimulation signal to at least one selected electrode in a transcranial alternating current stimulation (tACS) step (Wingeier Column 11 Lines 42-50 “The stimulation session of the stimulation regime of Block S130 preferably includes transcranial electrical stimulation (TES) configured to stimulate a brain region of the user in the form of at least one of: transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), transcranial magnetic stimulation (TMS), transcranial random noise stimulation (tRNS), transcranial variable frequency stimulation (tVFS), and any other suitable form of transcranial stimulation.”), wherein the method comprises the steps of: measuring a resistance value of the electrodes and comparing the resistance value with a reference value (Wingeier Column 7 Lines 41-49 “The first impedance criterion of the first impedance monitoring state is preferably an impedance or resistance-based criterion that involves measurement of impedance in non-stimulating regimes of the electrical stimulation device. In one variation, impedance can be determined as a total peak-to-peak voltage measured during a biphasic pulse divided by a total peak-to-peak current output during the biphasic pulse. In another variation, impedance/resistance can be measured in any other suitable manner.”; Figure 2 Block S130); receiving an output signal of the sensor module and comparing the biometric information with a normal range (Wingeier Column 6 Lines 27-36 “Still alternatively, current pulses can be output whenever a sensor (e.g., accelerometer, gyroscope, magnetometer, force sensor, etc.) of the electrical stimulation device detects a change in position of the electrical stimulation device during the first impedance monitoring state. For instance, a current pulse or set of current pulses can be output after each of a set of adjustments to the position of the electrical stimulation device, detected by way of an above threshold motion of the electrical stimulation device detected using accelerometers.”); and automatically switching from the tDCS step to the tACS step when an abnormal state in which the resistance value exceeds the reference value or the biometric information exceeds the normal range is detected (Wingeier Figure 2 showing S130 Current (I) is a DC waveform initially, and secondarily Current (I) switches to an AC waveform in S140 of Figure 2).
Wingeier does not explicitly disclose a helmet. Lee in a similar field of endeavor of stimulation teaches a helmet (Lee Figure 1 showing the stimulation device configured as a helmet.). Before the effective filing date, one of ordinary skill in the art would be motivated to combine the system of Wingeier with the helmet as taught in Lee for the purposes of creating a more complex brain stimulation system. Wingeier shows a headset stimulation device in Figure 6. One would see this and be motivated to create a larger system fitting in a helmet when the goal is to reach larger portions of the brain for treatment or to allow for more complex controls of the electrodes.
Regarding claim 9, claim 8 is obvious over Wingeier in view of Lee. Wingeier further discloses the steps of: applying the alternating current signal that swings around a base level in a first tACS step to the electrode selected in the tDCS step (Wingeier Column 3 Lines 30-34 “The system can further include a controller that transmits the stimulation waveform definition and guides adjustment of the set of electrodes at the head region of the user in cooperation with the first impedance monitoring state.”); increasing an intensity of a current applied to the electrode selected in the tACS step to an activation level higher than the base level during a ramp-up period after the first tACS step (Wingeier Figure 2 S110-S120 showing the beginning of a stimulation period where the graph increases from a zero start; Figure 2 provided below); entering a second tACS step and applying the alternating current signal that swings around the activation level to the electrode selected in the tACS step when the abnormal state is detected (Wingeier Figure 2 (Provided Below) S130); resuming the tDCS step after a predetermined period of time when a normal state in which the resistance value of the electrode is lower than or equal to the reference value and the biometric information changes within a normal range is detected (Wingeier Figure 2 (provided below) S130-S140; Column 9 Lines 19-24 “Upon achieving an impedance value lower than a threshold impedance value (e.g., 16 kΩ, 5-25 kΩ, etc.) the example application of the method 100 can include transitioning the electrical stimulation device from the first impedance monitoring state to the stimulation regime, as described in relation to Block S130 “); and gradually lowering the intensity of the current applied to the electrode selected in the tACS step from the activation level to the base level during a ramp-down period after the tDCS step is resumed (Wingeier Figure 2 S150 provided below).
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Regarding claim 10, Claims 8-9 are obvious over Wingeier in view of Lee. Wingeier further discloses the steps of: applying a current of the base level to the electrodes for a predetermined standby time immediately after a power of the non-invasive stimulation device is turned on (Wingeier Figure 2 S110 showing the initial period), applying a patch detection signal pattern (Wingeier Column 8 Lines 42-45 “Alternatively, Block S120 can additionally or alternatively include automatic adjustment of the electrical stimulation device to provide suitable impedance through the stimulation path(s) to initialize stimulation in Block S130.”)in a form of the alternating current signal to the electrodes, measuring resistances of the electrodes, comparing the resistance value of each of the electrodes with the reference value, and determining a degree of adhesion of the patch (Wingeier Figures 1 & 2 S120 where the detection signal is occurring with the adjustments recorded by the user); and entering the first tACS step after the patch detection signal pattern (Wingeier Figure 2 S120-S130 showing the calibration of signals between steps s120 and s130)
Conclusion
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached on Mon-Fri 9am-5pm ET. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MEGAN T FEDORKY/Examiner, Art Unit 3796
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
Prosecution Insights