DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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: a user device in claim 36.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
-A user device is interpreted in view of Paragraph [0039] to include a tablet, smartphone, mobile phone, laptop, watch, wearable device (e.g., glasses).
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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 22-26, 28, 33-34 and 36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bikson et al (US Publication 2013/084779).
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 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]).
Referring to Claim 23, Bikson et al 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 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 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 26, Bikson et al teaches the system of claim 22, wherein the control system is configured to check for the set of user inputs by: checking for the request to suspend stimulation (e.g. Figure 5, Element 526); checking for the 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)); checking for the request to deliver sham stimulation (e.g. Figure 5, sham switch 516).
Referring to Claim 28, Bikson et al 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 33, Bikson et al 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 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 teaches the system of claim 22, further comprising: a user device 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]).
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.
Claim(s) 27 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bikson et al (US Publication 2013/084779).
Referring to Claim 27, Bikson et al teaches the system of claim 26, 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 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 29, Bikson et al 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).
Claim(s) 30 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 30, Bikson et al teaches the system of claim 22, wherein the control system is configured to control the stimulation device to deliver sham stimulation including an initial spike in current that then decreases to zero or a minimal current amplitude, the one or more parameters associated with the sham stimulation including: a current amplitude of the initial spike, the minimal current 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 a current amplitude of an end spike.
Romo-Nava teaches that it is known to use a sham session having a short pulse at the beginning and at the end of the session 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 a short pulse at the beginning and at the end of the session 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.
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 Tyler et al (US Publication 2017/0182285).
Referring to Claims 31-32, Bikson et al 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 Wingeier et al (US Publication 2017/0224991).
Referring to Claim 35, Bikson et al 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.
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