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 § 102
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 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) 1-20 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hamner et al (2021/0252278).
Regarding claim 1, Hamner et al disclose a method of treating inflammation of a user, the method comprising:
applying a first patch on a dermis of the user adjacent to an afferent nerve, the first patch comprising first electrodes (second afferent peripheral nerve comprises the saphenous nerve – [0010]; stimulation of one, two, or more target nerves of interest, e.g., the saphenous, tibial median and/or vagus nerve – [0065]; a plurality of stimulator housings 6000 that can include…a patch 6002 having electrodes 6004 and a skin contacting surface – [0112]);
applying a second patch on the dermis of the user adjacent to a vagus nerve or a vagus nerve connecting branch, the second patch comprising second electrodes (stimulation of one, two, or more target nerves of interest, e.g., the saphenous, tibial median and/or vagus nerve – [0065]; a plurality of stimulator housings 6000 that can include…a patch 6002 having electrodes 6004 and a skin contacting surface – [0112]); and
generating a treatment protocol during a time period comprising simultaneously apply a first electrical stimuli to the afferent nerve via the first electrodes of the first patch and applying a second electrical stimuli to the vagus nerve or the vagus nerve connecting branch via the second electrodes of the second patch (multiple stimulators may be in electrical connection with multiple electrode pairs to stimulate multiple nerves simultaneously – [0112]).
Regarding claim 2, Hamner et al disclose wherein the first patch is applied on or near an occurrence of the inflammation (afferent nerve pathway associated with the inflammation response of a patient – [0012]).
Regarding claim 3, Hamner et al disclose wherein the vagus nerve connecting branch comprises at least one of a peroneal nerve, a tibial nerve or an auricular branch of the vagus nerve ([0161]).
Regarding claim 4, Hamner et al disclose wherein the second patch is applied on a lower leg of the user ([0112]; fig.6a).
Regarding claim 5, Hamner et al disclose wherein the second patch is applied on or near an ear of the user (the neuromodulation device (e.g., the neurostimulator) is placed proximate the ear of the patient – [0020];[0060]).
Regarding claim 6, Hamner et al disclose wherein the applying the first electrical stimuli is synchronous with the applying the second electrical stimuli (provide a synchronized continuous or patterned stimulation, and/or synchronize the timing of different stimulations – [0111];[0112]).
Regarding claim 7, Hamner et al disclose after the treatment protocol, sensing a state of the inflammation; and based on the state, generating a subsequent treatment protocol comprising different intensity or duration from a previous treatment protocol (treatment could also occur at irregular intervals that are human-entered or predicted by machine learning from previous days’ voiding incidents – [0072]).
Regarding claim 8, Hamner et al disclose further comprising using machine learning to sense the state of the inflammation (using machine learning these biological measures can be analyzed to serve as a predictor for inflammatory bowel disease or other inflammatory conditions – [0072];[0174]).
Regarding claim 9, Hamner et al disclose wherein the sensing the state of the inflammation comprising using one or more sensors that are included on the first or second patches (the device can include at least one stimulation electrode…and at least one biomedical sensors – [0017]; receiving data from a sensor that measures a biomarker of inflammation – claim 65).
Regarding claim 10, Hamner et al disclose wherein the sensing the state of inflammation comprising using one or more sensors that are separate from the first or second patches (the nerve stimulator and the sensor device can be separate devices that communicate wirelessly – [0131]; the sensor can be an electrode that measures galvanic response which can be correlated to…inflammation – [0131]).
Regarding claim 11, Hamner et al disclose an inflammation treatment system comprising:
a first patch adapted to be externally coupled on a dermis of a user adjacent to an afferent nerve, the first patch comprising first electrodes (second afferent peripheral nerve comprises the saphenous nerve – [0010]; stimulation of one, two, or more target nerves of interest, e.g., the saphenous, tibial median and/or vagus nerve – [0065]; a plurality of stimulator housings 6000 that can include…a patch 6002 having electrodes 6004 and a skin contacting surface – [0112]);
a second patch adapted to be externally coupled on the dermis of the user adjacent to a vagus nerve or a vagus nerve connecting branch, the second patch comprising second electrodes (stimulation of one, two, or more target nerves of interest, e.g., the saphenous, tibial median and/or vagus nerve – [0065]; a plurality of stimulator housings 6000 that can include…a patch 6002 having electrodes 6004 and a skin contacting surface – [0112]); and
one or more processors adapted to generate a treatment protocol during a time period comprising simultaneously apply a first electrical stimuli to the afferent nerve via the first electrodes of the first patch and applying a second electrical stimuli to the vagus nerve or the vagus nerve connecting branch via the second electrodes of the second patch (multiple stimulators may be in electrical connection with multiple electrode pairs to stimulate multiple nerves simultaneously – [0112]).
Regarding claim 12, Hamner et al disclose wherein the first patch is applied on or near an occurrence of the inflammation (afferent nerve pathway associated with the inflammation response of a patient – [0012]).
Regarding claim 13, Hamner et al disclose wherein the vagus nerve connecting branch comprises at least one of a peroneal nerve, a tibial nerve or an auricular branch of the vagus nerve ([0161]).
Regarding claim 14, Hamner et al disclose wherein the second patch is applied on a lower leg of the user ([0112]; fig.6a).
Regarding claim 15, Hamner et al disclose wherein the second patch is applied on or near an ear of the user (the neuromodulation device (e.g., the neurostimulator) is placed proximate the ear of the patient – [0020];[0060]).
Regarding claim 16, Hamner et al disclose wherein the applying the first electrical stimuli is synchronous with the applying the second electrical stimuli (provide a synchronized continuous or patterned stimulation, and/or synchronize the timing of different stimulations – [0111];[0112]).
Regarding claim 17, Hamner et al disclose the processor further adapted to: after the treatment protocol, sensing a state of the inflammation; and based on the state, generating a subsequent treatment protocol comprising different intensity or duration from a previous treatment protocol (treatment could also occur at irregular intervals that are human-entered or predicted by machine learning from previous days’ voiding incidents – [0072]).
Regarding claim 18, Hamner et al disclose the processor further adapted to: using machine learning to sense the state of the inflammation (using machine learning these biological measures can be analyzed to serve as a predictor for inflammatory bowel disease or other inflammatory conditions – [0072];[0174]).
Regarding claim 19, Hamner et al disclose wherein the sensing the state of the inflammation comprising using one or more sensors that are included on the first or second patches (the device can include at least one stimulation electrode…and at least one biomedical sensors – [0017]; receiving data from a sensor that measures a biomarker of inflammation – claim 65).
Regarding claim 20, Hamner et al disclose wherein the sensing the state of inflammation comprising using one or more sensors that are separate from the first or second patches (the nerve stimulator and the sensor device can be separate devices that communicate wirelessly – [0131]; the sensor can be an electrode that measures galvanic response which can be correlated to…inflammation – [0131]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROCHELLE DEANNA TURCHEN whose telephone number is (571)270-7104. The examiner can normally be reached Mon - Fri 6:30-2:30.
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/ROCHELLE D TURCHEN/Primary Examiner, Art Unit 3797
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