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 .
Response to Arguments
Applicant's arguments filed 8/26/2026 have been fully considered but they are not persuasive. Applicant argues Romo-Nava describes a sham session that consists of short pulses at the beginning and end of sessions rather than ramping up and ramping does of the current amplitude during an initial spike and during an end spike. The examiner respectfully disagrees as the claim as currently written does not preclude additional pulses in the beginning and end session. Romo-Nava discloses the first of the short pulses (at the beginning of the session), which includes ramping up the intensity and ramping down the pulse. This pulse decrease enables the delivery of additional pulses. The claim as currently written does not provide a time period for the ramp up and ramp down. Romo-Nava discloses the pulses are delivered at the beginning and end sessions and therefore no pulses are delivered during the intermediate session. Romo-Nava discloses the end session (last pulse) includes ramping up the intensity and ramping down the pulse.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 39 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 39 requires gradually ramping down but provides no indication of a rate that satisfies gradual. A review of the disclosure did not provide a standard for ascertaining the requisite degree for what includes gradually ramping down. This makes the claim unclear because gradual ramping down is relative and may be 1ns or 10 minutes.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 22-25, 27-30, 33-34, and 36-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bikson et al (US Publication 2013/084779) in view of Romo-Nava (US Publication 2019/0134386).
Referring to Claim 22, Bikson et al teaches a system for delivering electrical stimulation to a user, the system comprising: an electrical stimulation device (e.g. Figure 1, Element 100 and Paragraph [0044] discloses the tDCS device 100 initiates a flow of electrical current); a control system including a processing system that includes a stimulation stack (e.g. Figure 5, Element 500), the control system configured to, during a stimulation session, implement the stimulation stack to: control the electrical stimulation device to deliver active stimulation (e.g. Figure 2A, Element 214 indicates enabling stimulation) or sham stimulation (e.g. Figure 5, Element 516 and Paragraph [0099] discloses activating or deactivating sham stimulation, while activated the tDCS device emits a brief current but then remains off for the remainder of the stimulation time) according to an electrical stimulation plan, the electrical stimulation plan including a set of stimulation parameters for delivering the active stimulation or the sham stimulation (e.g. Figure 2A, Element 206 illustrates the human sets the desired electrical current and duration, before activation and Paragraph [0099] discloses the sham stimulation is a brief current followed by remaining off for the remainder of the stimulation time); while the electrical stimulation device is delivering the active stimulation or sham stimulation, and at a predetermined frequency during the stimulation session, check for each of a set of user inputs received at a client application (e.g. Paragraph [0014] discloses adjusting the one or more stimulation parameters associated with delivery in real-time) wherein the set of user inputs includes at least one of (i) a request to suspend stimulation (e.g. Figure 5, activation switch 534 or stop button 526), (ii) a request to adjust at least one of the set of stimulation parameters (e.g. Figure 5, duration knob 514 or current knob 522 or voltage slider 510), or (iii) a request to deliver sham stimulation (e.g. Figure 5, sham switch 516); modify the electrical stimulation plan based on checking for the set of user inputs (e.g. Paragraphs [0099]-[0100] discloses applying a sham stimulation when activated or stopping the stimulation when the stop button is pressed and Paragraph [0098] discloses adjusting the duration of the stimulation); control the electrical stimulation device to deliver the active stimulation or the sham stimulation or to suspend the active stimulation or the sham stimulation according to the modified electrical stimulation plan (e.g. Figure 5 and Paragraphs [0098]-[0100] and [0103]). However, Bikson et al does not disclose wherein delivering the sham stimulation includes delivering an initial spike in which current is ramped up from zero or a minimum amplitude to a first amplitude and ramped down from the first amplitude to zero or the minimum amplitude and an end spike in which the current is ramped up from the minimum amplitude to a second amplitude and ramped down from the second amplitude to zero to end the sham stimulation. Romo-Nava teaches that it is known to use a sham session wherein delivering the sham stimulation includes delivering an initial spike in which current is ramped up from zero or a minimum amplitude to a first amplitude and ramped down from the first amplitude to zero or the minimum amplitude and an end spike in which the current is ramped up from the minimum amplitude to a second amplitude and ramped down from the second amplitude to zero to end the sham stimulation as set forth in Paragraph [0082] to provide the feeling of stimulation being delivered to better mimic the sensation of active treatment. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Bikson et al, with sham session having wherein delivering the sham stimulation includes delivering an initial spike in which current is ramped up from zero or a minimum amplitude to a first amplitude and ramped down from the first amplitude to zero or the minimum amplitude and an end spike in which the current is ramped up from the minimum amplitude to a second amplitude and ramped down from the second amplitude to zero to end the sham stimulation as taught by Romo-Nava, since such a modification would provide the predictable results of the feeling of stimulation being delivered to better mimic the sensation of active treatment.
Referring to Claim 23, Bikson et al in view of Romo-Nava teaches the system of claim 22, wherein at least a portion of the control system is arranged to be onboard the electrical stimulation device (e.g. Figure 1 , Element 100 and Figure 5, Element 500 illustrates the tDCS device and Paragraph [0058] discloses the tDCS includes the know and setting the operational parameters and Figure 6 and Paragraph [0106] discloses the tDCS includes microcontroller 650).
Referring to Claim 24, Bikson et al in view of Romo-Nava teaches the system of claim 22, wherein the set of stimulation parameters includes a current and an amplitude (e.g. Paragraphs [0096], and [0099]-[0100]).
Referring to Claim 25, Bikson et al in view of Romo-Nava teaches the system of claim 24, wherein the set of stimulation parameters further includes a type of waveform, a type of electrical stimulation, a duration of stimulation, or an activity type to be effected by the electrical stimulation (e.g. Paragraph [0098] discloses a setting a duration of stimulation and Paragraph [0099] discloses the sham remains off for the remainder of the stimulation time).
Referring to Claim 27, Bikson et al teaches the system of claim 22, except wherein the request to suspend stimulation is checked prior to the request to adjust at least one of the set of stimulation parameters, and the request to adjust at least one of the set of stimulation parameters is checked prior to the request to deliver the sham stimulation.
Since there are a finite number of user inputs, it would have been obvious to try, by one of ordinary skill in the art before effective filing date of the invention, to perform wherein the request to suspend stimulation is checked prior to the request to adjust at least one of the set of stimulation parameters, and the request to adjust at least one of the set of stimulation parameters is checked prior to the request to deliver sham stimulation and to incorporate it into the system of Bikson et al since there are a finite number of identified, predictable potential solutions to the recognized need of an order for checking each of the inputs to determine when an adjustment has been made by the user and one of ordinary skill in the art would have pursued the known potential solutions with a reasonable expectation of success since checking each of the inputs to determine when an adjustment has been made by the user would require a process or order.
Referring to Claim 28, Bikson et al in view of Romo-Nava teaches the system of claim 22, wherein the client application is configured to provide a visual graphic indicating at least one of a set of modified parameters of the modified electrical stimulation plan (e.g. Figure 5, Element 506 and Paragraph [0094] 506 indicates the voltage being applied across the electrodes or across the tDCS device output terminals).
Referring to Claim 29, Bikson et al in view of Romo-Nava teaches the system of claim 22, except wherein the predetermined frequency is at least every 1 millisecond (ms).
Checking for updates of user settings at a high frequency would have been obvious especially with the use of a stop/pause button which allow the user to stop the stimulation in a timely manner and to provide timely changes when the user makes a change. Therefore, it would have been obvious to try, by one of ordinary skill in the art before effective filing date of the invention, to perform the predetermined frequency is at least every 1 millisecond and to incorporate it into the system of Bikson et al since there are a finite number of identified, predictable potential solutions to provide input to occur within a timely and effective manner after the user makes the change and one of ordinary skill in the art would have pursued the known potential solutions with a reasonable expectation of success at checking for user input at a frequency sufficient to provide changes that are occur at a time setting that is nearly undetectable to the patient.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Bikson et al with a predetermined frequency is at least every 1 millisecond, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Referring to Claim 30, Bikson et al teaches the system of claim 22, wherein the set of stimulation parameters associated with the sham stimulation including: the first amplitude of the initial spike, the minimum amplitude, and a parameter associated with ramping up or down of current amplitude (e.g. Paragraph [0099] discloses the sham stimulation emits a brief current but then remains off for the remainder of the stimulation time). However, Bikson et al does not disclose the second amplitude of an end spike.
Romo-Nava teaches that it is known to use a sham session wherein delivering the sham stimulation includes delivering an initial spike in which current is ramped up from zero or a minimum amplitude to a first amplitude and ramped down from the first amplitude to zero or the minimum amplitude and an end spike in which the current is ramped up from the minimum amplitude to a second amplitude and ramped down from the second amplitude to zero to end the sham stimulation as set forth in Paragraph [0082] to provide the feeling of stimulation being delivered to better mimic the sensation of active treatment. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Bikson et al, with sham session delivering the sham stimulation includes delivering an initial spike in which current is ramped up from zero or a minimum amplitude to a first amplitude and ramped down from the first amplitude to zero or the minimum amplitude and an end spike in which the current is ramped up from the minimum amplitude to a second amplitude and ramped down from the second amplitude to zero to end the sham stimulation as taught by Romo-Nava, since such a modification would provide the predictable results of the feeling of stimulation being delivered to better mimic the sensation of active treatment.
Referring to Claim 33, Bikson et al in view of Romo-Nava teaches the system of claim 22, wherein the control system further includes a memory, the memory configured to retain a record of the set of user inputs (e.g. Paragraph [0093] discloses display 504 provides information about the history of the stimulation; therefore the control system necessarily requires a memory).
Referring to Claim 34, Bikson et al in view of Romo-Nava teaches the system of claim 22, wherein the electrical stimulation includes transcranial direct current stimulation (tDCS) (e.g. Paragraphs [0001], [0003], and [0091]).
Referring to Claim 36, Bikson et al in view of Romo-Nava teaches the system of claim 22, further comprising: a user device including a user interface and a processor, the processor configured to execute the client application (e.g. Paragraph [0141] discloses one or more processors for execution of the computer program are embedded in a mobile telephone, a PDS) to: receive a selection of the electrical stimulation plan (e.g. Figure 5); send the electrical stimulation plan to the control system (e.g. Paragraphs [0096-0099] and [0103]).
Referring to Claim 37, Bikson et al in view of Romo-Nava teaches the system of claim 22, except wherein the first amplitude is the same as the second amplitude. Romo-Nava teaches that it is known to use a sham session wherein the first amplitude is the same as the second amplitude at 2.0 mA as set forth in Paragraph [0082] to provide the feeling of stimulation being delivered to better mimic the sensation of active treatment. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Bikson et al, with sham session having the first amplitude is the same as the second amplitude at 2.0 mA as taught by Romo-Nava, since such a modification would provide the predictable results of the feeling of stimulation being delivered to better mimic the sensation of active treatment.
Referring to Claim 38, Bikson et al in view of Romo-Nava teaches the system of claim 22, except wherein the first amplitude and the second amplitude are 2 milliamps (mA) and the minimum amplitude is 0 mA. Romo-Nava teaches that it is known to use a sham session wherein the first amplitude and the second amplitude are 2 milliamps (mA) and the minimum amplitude is 0 mA as set forth in Paragraph [0082] to provide the feeling of stimulation being delivered to better mimic the sensation of active treatment. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Bikson et al, with sham session having he first amplitude and the second amplitude are 2 milliamps (mA) and the minimum amplitude is 0 mA as taught by Romo-Nava, since such a modification would provide the predictable results of the feeling of stimulation being delivered to better mimic the sensation of active treatment.
Referring to Claim 39, Bikson et al in view of Romo-Nava teaches the system of claim 22, except wherein the current is ramped down gradually from the first amplitude to zero or the minimum amplitude.
Romo-Nava teaches that it is known to use a sham session wherein delivering the sham stimulation includes delivering an initial spike in which current is ramped up from zero or a minimum amplitude to a first amplitude and gradually ramped down from the first amplitude to zero or the minimum amplitude and an end spike in which the current is ramped up from the minimum amplitude to a second amplitude and ramped down from the second amplitude to zero to end the sham stimulation as set forth in Paragraph [0082] to provide the feeling of stimulation being delivered to better mimic the sensation of active treatment. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Bikson et al, with sham session having wherein delivering the sham stimulation includes delivering an initial spike in which current is ramped up from zero or a minimum amplitude to a first amplitude and gradually ramped down from the first amplitude to zero or the minimum amplitude and an end spike in which the current is ramped up from the minimum amplitude to a second amplitude and ramped down from the second amplitude to zero to end the sham stimulation as taught by Romo-Nava, since such a modification would provide the predictable results of the feeling of stimulation being delivered to better mimic the sensation of active treatment.
Referring to Claim 40, Bikson et al in view of Romo-Nava teaches the system of claim 22, further including: a plurality of electrical stimulation devices including the electrical stimulation device (e.g. Paragraph [0144] discloses multiple stimulation devices are connected), the client application configured to receive, for each electrical stimulation device from the plurality of electrical stimulation devices, the set of user inputs to control the plurality of electrical stimulation devices to deliver the active stimulation or the sham stimulation (e.g. Paragraph [0144] discloses these multiple devices are connected to the body using one or more known electrical switching mechanisms forming a circuit).
Referring to Claim 41, Bikson et al in view of Romo-Nava teaches the system of claim 40, wherein the plurality of electrical stimulation devices are associated with participants of a clinical trial, and control systems associated with a predetermined set of electrical stimulation devices from the plurality of electrical stimulation devices are configured to cause the predetermined set of electrical stimulation devices to deliver the sham stimulation in response to receiving requests, at the client application, for the predetermined set of electrical stimulation devices to deliver the sham stimulation (e.g. Paragraph [0144]).
Claim(s) 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bikson et al (US Publication 2013/084779) in view of Romo-Nava (US Publication 2019/0134386), as applied above, and further in view of Tyler et al (US Publication 2017/0182285).
Referring to Claims 31-32, Bikson et al in view of Romo-Nava teaches the system of claim 22, except wherein the control system is further configured to modify the electrical stimulation plan based on an input that is generated automatically in response to a user schedule, a temporal parameter, or information received by a sensor; wherein the input is generated automatically at the control system.
Tyler et al teaches that it is known to use automatically modify stimulation parameters based on sensed sleep quality and based on when an amount of time before the subject falls asleep as set forth in Paragraphs [0046] and [0051] to provide improved treatment of a condition by modifying the therapy based on the patient’s needs/condition. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Bikson et al, with the control system is further configured to modify the electrical stimulation plan based on an input that is generated automatically in response to a user schedule, a temporal parameter, or information received by a sensor; wherein the input is generated automatically at the control system. as taught by Tyler et al, since such a modification would provide the predictable results of improved treatment of a condition by modifying the therapy based on the patient’s needs/condition.
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bikson et al (US Publication 2013/084779) in view of Romo-Nava (US Publication 2019/0134386), as applied above, and further in view of Wingeier et al (US Publication 2017/0224991).
Referring to Claim 35, Bikson et al in view of Romo-Nava teaches the system of claim 22, except wherein the control system is further configured to interface with a digital-to-analog converter (DAC) component of the electrical stimulation device, the control system further configured to modify the electrical stimulation plan based on a feature of the DAC component. Wingeier et al teaches that it is known to use DAC component to convert a digital wave from the controller to an analog output to modulate the waveform delivered by the electrodes as set forth in Paragraphs [0041]-[0042] to provide various digital software adjustments that are used to optimize or adjust the stimulation according to the user input. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Bikson et al, with the control system is further configured to interface with a digital-to-analog converter (DAC) component of the electrical stimulation device, the control system further configured to modify the electrical stimulation plan based on a feature of the DAC component as taught by Bikson et al, since such a modification would provide the predictable results of various digital software adjustments that are used to optimize or adjust the stimulation according to the user input.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Wei et al (US Publication 2015/0352357) discloses automatically delivering stimulation based on a clock (Paragraph [0038]).
Wu et al (US Publication 2011/0112590) discloses adjusting stimulation based on a time schedule, such as time of day in which patient is typically awake.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William J Levicky/Primary Examiner, Art Unit 3796
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