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 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 10 and 19-20 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 10 recites instructions cause the controller to use a music selection for a condition for a first patient for a second patient with the condition; it is unclear if this is causing the controller to apply the stimulation to two patients, or if this is indicating that it is using a previously stores music selection that was trained by a second patient. Alternatively, it is unclear how the music selection for the first patient is transmitted to a second patient with the condition.
Claim 19 recites the limitation "the control unit" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Dependent claim 20 inherits the same deficiency.
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) 1-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jovanov (US Patent 10,688,274).
Referring to Claim 1, Jovanov teaches a device for performing a transcutaneous vagus nerve stimulation (tVNS) treatment, the device comprising: at least one electrode for generating a stimulation pulse (e.g. Figure 1, Element 10 and Column 3 lines 9-16 discloses providing several stimulations from an SSD includes electrical stimulation); at least one acoustic stimulation device (e.g. Figure 1, Element 10 and Column 3 lines 9-16 discloses an SSD includes audio stimulation); an input device for inputting feedback data (e.g. Column 3 lines 62 to Column 4 line 4 discloses receiving sensor measurements); an internal memory configured to store feedback (e.g. Figure 2, memory 36); a controller (e.g. Figure 2, Element 30/38) with instructions stored in memory thereof that when executed cause the controller to: adjust one or more parameters of an acoustic stimulation provided by the at least one acoustic stimulation device (e.g. Column 3 lines 62 to Column 4 line 4 discloses evaluating the user’s response to the stimulation and make adjustments to the stimulations in order to achieve the desired results).
Referring to Claim 2, Jovanov teaches the device of claim 1, wherein the acoustic stimulation device and the memory are communicatively coupled (e.g. Figure 1).
Referring to Claim 3, Jovanov teaches the device of claim 1, wherein the instructions further cause the controller to adjust one or more parameters of the stimulation pulse delivered by the electrode in dependence on the feedback data (e.g. Column 3 lines 62 to Column 4 line 4).
Referring to Claim 4, Jovanov teaches the device of claim 1, wherein the acoustic stimulation device is one of a pair of headphones, a musical instrument configured to contact a user's body, a musical instrument configured to operate without contacting the user's body, or singing bowls (e.g. Figure 3 discloses headphones).
Referring to Claim 5, Jovanov teaches the device of claim 1, wherein the acoustic stimulation device is configured to provide an acoustic stimulation of a user's ear (e.g. Figure 3 and Column 3 lines 36-37).
Referring to Claim 6, Jovanov teaches the device of claim 1, wherein the acoustic stimulation device is configured to provide acoustic stimulation to a user's body (e.g. Figure 3 and Column 3 lines 36-37).
Referring to Claim 7, Jovanov teaches the device of claim 1, wherein the instructions further cause the controller to generate a specific treatment profile based on the feedback data (e.g. Column 3 lines 62 to Column 4 line 4).
Referring to Claim 8, Jovanov teaches a system for performing a transcutaneous vagus nerve stimulation (tVNS) treatment, the system comprising: a device comprising a memory (e.g. Figure 2, memory 36) and a feedback module, wherein the memory is configured to store feedback input by the feedback module (e.g. Column 3 lines 62 to Column 4 line 4 discloses receiving sensor measurements); at least one electrode configured to generate a stimulation pulse, the at least one electrode communicatively coupled to the device (e.g. Figure 1, Element 10 and Column 3 lines 9-16 discloses providing several stimulations from an SSD includes electrical stimulation); at least one acoustic stimulation device configured to generate an acoustic stimulus, the at least one acoustic stimulation device communicatively coupled to the device (e.g. Figure 1, Element 10 and Column 3 lines 9-16 discloses an SSD includes audio stimulation); a controller (e.g. Figure 2, Element 30/38) with instructions stored in memory thereof that when executed cause the controller to: adjust one or more parameters of the stimulation pulse delivered by the electrode in response to the feedback data (e.g. Column 3 lines 62 to Column 4 line 4 discloses evaluating the user’s response to the stimulation and make adjustments to the stimulations in order to achieve the desired results); adjust one or more parameters of the acoustic stimulus provided by the at least one acoustic stimulation device in response to the feedback data (e.g. Column 3 lines 62 to Column 4 line 4).
Referring to Claim 9, Jovanov teaches the system of claim 8, wherein the instructions further cause the controller to generate customized music as the acoustic stimulus (e.g. Column 3 lines 62 to Column 4 line 4).
Referring to Claim 10, Jovanov teaches the system of claim 8, wherein the instructions further cause the controller to use a music selection for a condition of a first patient for a second patient with the condition (e.g. Column 3 lines 62 to Column 4 line 4).
Referring to Claim 11, Jovanov teaches the system of claim 8, wherein the at least one acoustic stimulation device is coupled to a left ear, a right ear, or both ears of a patient (e.g. Figure 3).
Referring to Claim 12, Jovanov teaches the system of claim 8, wherein the at least one acoustic stimulation device is configured to provide the acoustic stimulation to a body of a patient other than via an ear (e.g. Column 5 lines 19-21 discloses the headband can be placed in proximity to the ears; therefore the device is capable of applying acoustic stimulation to a body of a patient that is near the ears).
Referring to Claim 13, Jovanov teaches the system of claim 8, wherein the device is in communication with one or more sensors, wherein the one or more sensors is/are configured to monitor patient data (e.g. Column 3 lines 62 to Column 4 line 4 discloses receiving sensor measurements).
Referring to Claim 14, Jovanov teaches the system of claim 8, wherein one or more parameters of the acoustic stimulus that is/are adjusted comprises a volume, a frequency, a music type, a noise type, an order, and a location at which the acoustic stimulus is provided (e.g. Column 7 lines 52-54 discloses an example of adjusting the frequency and Column 8 lines 63-64 discloses providing the audio stimulation at specific times and locations).
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) 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jovanov (US Patent 10,688,274) in view of Perryman et al (US Publication 2018/0161581)
Referring to Claim 15, Jovanov teaches the system of claim 8, except wherein the memory stores feedback related to individual patient associated with the device and from other patients associated with other devices, and wherein the instructions further cause the controller to adjust one or more parameters of the stimulation pulse and the acoustic stimulus based on an abatement or worsening of the individual patient's or other patient's symptoms.
Perryman et al teaches that it is known to use the memory stores feedback related to individual patient associated with the device and from other patients associated with other devices, and wherein the instructions further cause the controller to adjust one or more parameters of the stimulation pulse and the acoustic stimulus based on an abatement or worsening of the individual patient's or other patient's symptoms as set forth in Paragraphs [0023] and [0041] to provide improving the process of parameter setting determination. 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 Jovanov, with the memory stores feedback related to individual patient associated with the device and from other patients associated with other devices, and wherein the instructions further cause the controller to adjust one or more parameters of the stimulation pulse and the acoustic stimulus based on an abatement or worsening of the individual patient's or other patient's symptoms as taught by Perryman et al, since such a modification would provide the predictable results of improving the process of parameter setting determination.
Referring to Claim 16, Jovanov teaches a system for performing a transcutaneous vagus nerve stimulation (tVNS) treatment, the system comprising: a device comprising a memory (e.g. Figure 2, memory 36) and an input module, wherein the memory is configured to store feedback input via the input module (e.g. Column 3 lines 62 to Column 4 line 4 discloses receiving sensor measurements); at least one electrode configured to generate a stimulation pulse, the at least one electrode communicatively coupled to the device (e.g. Figure 1, Element 10 and Column 3 lines 9-16 discloses providing several stimulations from an SSD includes electrical stimulation); at least one acoustic stimulation device configured to generate an acoustic stimulus, the at least one acoustic stimulation device communicatively coupled to the device (e.g. Figure 1, Element 10 and Column 3 lines 9-16 discloses an SSD includes audio stimulation); a controller (e.g. Figure 2, Element 30/38) with instructions stored in memory thereof that when executed cause the controller to: adjust one or more parameters of the stimulation pulse delivered by the electrode in response to the feedback data or to propose the parameters of the stimulation pulse delivered by the electrode for selection by the device user (e.g. Column 3 lines 62 to Column 4, line 4 discloses evaluating the user’s response to the stimulation and make adjustments to the stimulations in order to achieve the desired result); adjust one or more parameters of the acoustic stimulus provided by the at least one acoustic stimulation device (e.g. Column 3, lines 62 to Column 4, line 4). However, Jovanov does not explicitly disclose generate a data pool based on feedback provided to the device via the input module and to other devices identical to the device via other input modules. Perryman et al teaches that it is known to use generating a data pool based on feedback provided to the device via the input module and to other devices identical to the device via other input modules as set forth in Paragraphs [0023] and [0041] to provide improving the process of parameter setting determination. 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 Jovanov, with generate a data pool based on feedback provided to the device via the input module and to other devices identical to the device via other input modules as taught by Perryman et al, since such a modification would provide the predictable results of improving the process of parameter setting determination.
Referring to Claim 17, Jovanov in view of Perryman et al teaches the system of claim 16, except wherein the instructions further cause the controller to analyze variables of the data pool for whether there are positive and negative links between the variables with respect to their effects on the perceived wellbeing and generate an analyzed result, wherein the variables include weather, time of day, age, sex, preceding activity, perceived tiredness, and perceived stress, and wherein the one or more parameters of the stimulation pulse and the acoustic stimulus are adjusted based on the analyzed variables.
Perryman et al teaches that it is known to use analyze variables of the data pool for whether there are positive and negative links between the variables with respect to their effects on the perceived wellbeing and generate an analyzed result, wherein the variables include weather, time of day, age, sex, preceding activity, perceived tiredness, and perceived stress, and wherein the one or more parameters of the stimulation pulse and the acoustic stimulus are adjusted based on the analyzed variable as set forth in Paragraphs [0023] and [0041] to provide improving the process of parameter setting determination. 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 Jovanov, with analyze variables of the data pool for whether there are positive and negative links between the variables with respect to their effects on the perceived wellbeing and generate an analyzed result, wherein the variables include weather, time of day, age, sex, preceding activity, perceived tiredness, and perceived stress, and wherein the one or more parameters of the stimulation pulse and the acoustic stimulus are adjusted based on the analyzed variable as taught by Perryman et al, since such a modification would provide the predictable results of improving the process of parameter setting determination.
Referring to Claim 18, Jovanov in view of Perryman et al teaches the system of claim 16, wherein the at least one acoustic stimulation device includes a second electrode separate from the electrode (e.g. Figure 3 and Column 5 line 30 discloses one or more electrodes 120).
Referring to Claim 19, Jovanov in view of Perryman et al teaches the system of claim 16, except further comprising an external controller configured to execute an application via instructions stored in an external memory, wherein the application, the control unit, and the external memory are arranged outside of the device, wherein the control unit is configured to communicate with the controller of the device and to controllers of other devices.
Perryman et al teaches that it is known to use an external controller configured to execute an application via instructions stored in an external memory, wherein the application, the control unit, and the external memory are arranged outside of the device, wherein the control unit is configured to communicate with the controller of the device and to controllers of other devices as set forth in Figure 5a, Element 560 and Paragraph [0050] to provide improve the ease of providing feedback with reducing the risk of removing the electrode. 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 Jovanov, with an external controller configured to execute an application via instructions stored in an external memory, wherein the application, the control unit, and the external memory are arranged outside of the device, wherein the control unit is configured to communicate with the controller of the device and to controllers of other devices as taught by Perryman et al, since such a modification would provide the predictable results of improve the ease of providing feedback with reducing the risk of removing the electrode.
Referring to Claim 20, Jovanov in view of Perryman et al teaches the system of claim 19, except wherein the application is configured to generate a treatment plan for a patient associated with the device and use the treatment plan for other patients with one or more conditions similar to the patient. Perryman et al teaches that it is known to use the application is configured to generate a treatment plan for a patient associated with the device and use the treatment plan for other patients with one or more conditions similar to the patient as set forth in Paragraphs [0023] and [0041] to provide improving the process of parameter setting determination. 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 Jovanov, with the application is configured to generate a treatment plan for a patient associated with the device and use the treatment plan for other patients with one or more conditions similar to the patient as taught by Perryman et al, since such a modification would provide the predictable results of improving the process of parameter setting determination.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Zhang et al (US Publication 2012/0150003) using data sets of a population of patients sharing demographic data of the patient concerned, the demographic data comprising at least two of, age, height, weight, gender and pregnancy status.
Cartledge et al (US Publication 2015/0360030) discloses transcutaneous electrical stimulation of the vagus nerve using acoustic signals.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
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.
/William J Levicky/Primary Examiner, Art Unit 3796
