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 .
Continuity Data
The claimed subject matter in dependent claims 4-11, 13, and 14 appears to be original to this CIP as the parent application 18/754,919 does not appear to support this subject matter. Thus, the examiner is giving this subject matter an effective filing date of 7/2/2025.
Response to Arguments
Applicant's arguments filed 2/20/2026 have been fully considered.
Applicant 1st argues on page 9 that [0041] of Maschino teaches away from treating sleep disorders. The examiner is not persuaded. Maschino discloses “[0041] Embodiments of the present invention provides for adjusting at least one parameter of a therapeutic stimulation signal generated by an implantable medical device using results of an external and/or internal stimulus delivered to a portion of a patient's body. Cranial nerve stimulation has been proposed to treat a number of nervous system disorders, including epilepsy and other movement disorders, mood and other neuropsychiatric disorders, dementia, coma, migraine headache, obesity, eating disorders, sleep disorders”. The vagus nerve is a cranial nerve and thus the prior art teaches treating sleep disorders.
Applicant 2nd argues on page 10 “The Maschino figures show polarity-alternating pulses characterized by pulse width and pulse period, but they do not disclose bursts containing multiple pulses separated by defined silent inter-burst intervals”. The examiner finds this argument to be persuasive. The examiner is issuing a 2nd non-final rejection in view of Craig to address the limitations requiring silent inter-burst intervals and the bursts comprise 2-20 pulses.
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.
Claim(s) 1-3, 12, and 18-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschino et al. (Pub. No.: US 2007/0179557 A1); hereinafter referred to as “Maschino”, in view of Lesser et al. (Pub. No.: US 2008/0208266 A1); hereinafter referred to as Lesser, and Craig (Pub. No.: US 2007/0233193 A1).
Regarding claim 1, Maschino discloses a system for enhancing sleep (e.g. see [0041]), the system comprising: a nerve stimulator (e.g. see figure 1A element 125, [0051]. Note: Per dependent claim 18 of the current application and [0051] of the Maschino reference, the applicant and Maschino are both stimulating the vagus nerve), with electrical impulses comprising bursts of pulses (e.g. see [0093]-[0094]), with each burst having a frequency of about 1 to about 100 bursts per second and each pulse has a duration of about 50 to about 1000 microseconds in duration (e.g. see [0094]. Note: The examiner understands 1 burst per second to be the same thing as 1 Hz) and a sensory stimulator configured to deliver one or more stimuli to a sense organ or a brain of a user (e.g. see figures 2, 9, and 10, “external evoking signal”, [0046], [0107] explicitly disclose sensory stimulus).
Maschino discloses the claimed invention but is silent as to an electrode configured for contacting the outer skin surface at, or near a target location and an energy source coupled to the stimulator and wherein the energy source is configured to generate at least one electrical impulse and to transmit the at least one electrical impulse transcutaneously from the electrode through the outer skin surface of the user to a selected nerve in the user adjacent to, or near, the target location. Lesser teaches that it is known to use such a modification as set forth in figure 2 elements 40, 42, [0046]-[0047] to locate a current source for such methods and systems outside the body, for patients who do not need or desire an implanted power supply or battery operated device (e.g. see [0010]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use non-invasive, skin electrodes capable of vagus nerve stimulation as taught by Lesser in the system of Maschino, since said modification would provide the predictable results of a current source for such methods and systems outside the body, for patients who do not need or desire an implanted power supply or battery-operated device.
Maschino and Lesser disclose the claimed invention except for the bursts each
comprise about 2 to 20 pulses and the bursts are separated by an inter-burst period that comprises zero pulses. Craig teaches that it is known to use such a modification as set forth in [0039], figure 4A to produce enhanced vagal evoked potentials (eVEP) in therapeutically significant areas of the brain (e.g. see [0015]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use 2 to 20 pulses and the bursts are separated by an inter-burst period that comprises zero pulses as taught by Craig in the system of Maschino and Lesser, since said modification would provide the predictable results of enhanced vagal evoked potentials (eVEP) in therapeutically significant areas of the brain.
Regarding claim 2, Maschino discloses the sensory stimulator comprises one or more of a visual stimulator, an auditory stimulator, a tactile stimulator or a combination thereof (e.g. see figures 2, 9, and 10, “external evoking signal”, [0046], [0107]. Maschino discloses “electrical, chemical, auditory, visual, and/or mechanical signals”. Note: “mechanical signals” will read on “tactile”).
Regarding claim 3, Maschino discloses the sensory stimulator comprises an auditory stimulator and a visual stimulator (e.g. see figures 2, 9, and 10, “external evoking signal”, [0046], [0107]. Maschino discloses “electrical, chemical, auditory, visual, and/or mechanical signals”).
Regarding claim 12, Maschino discloses the nerve stimulator comprises a housing, wherein the electrode is coupled to the housing (e.g. see [0050], figure 1A elements 112, 121).
Regarding claim 13, Maschino discloses the energy source is disposed within the housing (e.g. see figure 8 element 830, [0098]).
Regarding claim 14, Maschino discloses a signal generator disposed within the housing and electrically coupled to the energy source and the electrode (e.g. see [0050], figure 1A element 110).
Regarding claim 18, Maschino discloses the nerve is a vagus nerve (e.g. see [0051]).
Regarding claim 19, Maschino discloses the claimed invention but is silent as to the electrode is configured for contacting an outer skin surface of the neck of the user. Lesser teaches that it is known to use such a modification as set forth in figure 2 elements 40, 42, [0046]-[0047] to locate a current source for such methods and systems outside the body, for patients who do not need or desire an implanted power supply or battery operated device (e.g. see [0010]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use non-invasive, skin electrodes capable of vagus nerve stimulation as taught by Lesser in the system of Maschino, since said modification would provide the predictable results of a current source for such methods and systems outside the body, for patients who do not need or desire an implanted power supply or battery operated device.
Regarding claim 20, Maschino discloses the energy source is configured to transmit a plurality of electrical impulses to the selected nerve according to a treatment paradigm (e.g. see [0045]-[0048], figures 2, 9, and 10).
Regarding claims 21-25, the prior art establishes the structure and treatment parameters in the rejection for claim 20 above. Claims 21-25 add no structure or stimulation parameters. Applicant is reminded these are system/device claims, not method claims. The prior art is capable of and/or configured to meet the intended use and intended results limitations of claims 21-25 as the structure and treatment parameters are taught by the rejection for claim 20 above.
Claim(s) 4-7 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschino and Lesser as applied to claims 1 and 3 above, and further in view of Malchano (Pub. No.: US 2018/0133507 A1).
Regarding claim 4, Maschino and Lesser disclose the claimed invention except for the auditory stimulator is configured to deliver binaural tones to the brain of the user. Malchano teaches that it is known to use such a modification as set forth in figure 11A, [0416]-[0419] to entrain the brain of the subject to the particular frequency and improve the cognitive states or functions of the brain (e.g. see [0032]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use binaural tones as taught by Malchano in the system of Maschino and Lesser, since said modification would provide the predictable results of entraining the brain of the subject to the particular frequency and improve the cognitive states or functions of the brain.
Regarding claim 5, Maschino and Lesser disclose the claimed invention except for a wearable device comprising one or more sensors for measuring brainwave activity and a processor configured to compute an effective brainwave frequency based on the brainwave activity. Malchano teaches that it is known to use such a modification as set forth in [0113] to entrain the brain of the subject to the particular frequency and improve the cognitive states or functions of the brain (e.g. see [0032]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a brainwave sensor and processor as taught by Malchano in the system of Maschino and Lesser, since said modification would provide the predictable results of entraining the brain of the subject to the particular frequency and improve the cognitive states or functions of the brain.
Regarding claim 6, Maschino and Lesser disclose the claimed invention except for the binaural tones are synchronized with the effective brainwave frequency. Malchano teaches that it is known to use such a modification as set forth in figure 11A, [0416]-[0419] to entrain the brain of the subject to the particular frequency and improve the cognitive states or functions of the brain (e.g. see [0032]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use binaural tones synchronized with brainwave frequency as taught by Malchano in the system of Maschino and Lesser, since said modification would provide the predictable results of entraining the brain of the subject to the particular frequency and improve the cognitive states or functions of the brain.
Regarding claim 7, Maschino and Lesser disclose the claimed invention except for the visual stimulator is configured to deliver light patterns synchronized with the binaural tones. Malchano teaches that it is known to use such a modification as set forth in figure 11A, [0416]-[0419] and [0045]-[0046] to entrain the brain of the subject to the particular frequency and improve the cognitive states or functions of the brain (e.g. see [0032]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the visual stimulator is configured to deliver light patterns synchronized with the binaural tones as taught by Malchano in the system of Maschino and Lesser, since said modification would provide the predictable results of entraining the brain of the subject to the particular frequency and improve the cognitive states or functions of the brain.
Regarding claim 11, Maschino and Lesser disclose the claimed invention except for the light patterns comprise light waves have a wavelength of about 600 nm to about 720 nm. Malchano teaches that it is known to use such a modification as set forth in [0249] to entrain the brain of the subject to the particular frequency and improve the cognitive states or functions of the brain (e.g. see [0032]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the light patterns comprising light waves have a wavelength of about 600 nm to about 720 nm as taught by Malchano in the system of Maschino and Lesser, since said modification would provide the predictable results of entraining the brain of the subject to the particular frequency and improve the cognitive states or functions of the brain.
Claim(s) 8-10, 13, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschino, Lesser, and Malchano as applied to claims 4 and 7 above, and further in view of Poltorak (Pub. No.: US 2019/0321583 A1).
Regarding claim 8, Maschino, Lesser, and Malchano disclose the processor is configured to adjust the binaural tones and the light patterns to entrain the brain of the user (e.g. see [0019]) but are silent as to achieving deep sleep through entrainment. Poltorak teaches that it is known to use such a modification as set forth in [0066]-[0072] to provide improved sleep quality and a decrease in sleep requirements (e.g. see [0092]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to entrainment to achieve deep sleep as taught by Poltorak in the system of Maschino, Lesser, and Malchano, since said modification would provide the predictable results of improved sleep quality and a decrease in sleep requirements.
Regarding claim 9, Maschino and Lesser disclose the claimed invention except for the binaural tones have frequencies of about 10 Hz to about 100 Hz. Malchano teaches that it is known to use such a modification as set forth in [0395]-[0400] to entrain the brain of the subject to the particular frequency and improve the cognitive states or functions of the brain (e.g. see [0032]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the binaural tones having frequencies of about 10 Hz to about 100 Hz as taught by Malchano in the system of Maschino and Lesser, since said modification would provide the predictable results of entraining the brain of the subject to the particular frequency and improve the cognitive states or functions of the brain.
Regarding claim 10, Maschino, Lesser, and Malchano disclose the claimed invention except for the binaural tones have a beat frequency of about 0.5 to about 4 Hz. Poltorak teaches that it is known to use such a modification as set forth in [0090]-[0094] to provide improved sleep quality and a decrease in sleep requirements (e.g. see [0092]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use binaural tones having a beat frequency of about 0.5 to about 4 Hz as taught by Poltorak in the system of Maschino, Lesser, and Malchano, since said modification would provide the predictable results of improved sleep quality and a decrease in sleep requirements.
Regarding claim 13, Maschino discloses the energy source is disposed within the housing (e.g. see figure 8 element 830, [0098]).
Regarding claim 14, Maschino discloses a signal generator disposed within the housing and electrically coupled to the energy source and the electrode (e.g. see [0050], figure 1A element 110).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschino and Lesser as applied to claim 1, and further in view of Kara et al. (Pub. No.: US 2004/0260356 A1); hereinafter referred to as “Kara”.
Regarding claim 15, Maschino and Lesser disclose the claimed invention except for pulses have a frequency of about 1 kHz to about 20 kHz. Kara teaches that it is known to use such a modification as set forth in [0024]-[0025] and [0027], figures 3 and 4 to provide improved adjustment of the vagus nerve stimulation (VNS) device settings for an individual patient (e.g. see [0006]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the electrical impulse comprises pulses having a frequency of about 1 kHz to about 20 kHz as taught by Kara in the system of Maschino and Lesser, since said modification would provide the predictable results of improved adjustment of the vagus nerve stimulation (VNS) device settings for an individual patient.
Conclusion
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/P.C.E/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792