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 .
Election/Restrictions
Claims 19-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected apparatus and method claims, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11 June 2026.
Applicant’s election with traverse of claims 1-5, 7, 8, 12-14, 17 and 18 in the reply filed on 11 June 2026 is acknowledged. The traversal is on the ground(s) that the present record does not support the conclusion that the three claim groups are independent or distinct, nor that examination together would impose the serious search or examination burden. This is not found persuasive because the groupings are distinct inventions/embodiments with distinct limitations and classifications. The groupings of the patently distinct inventions/embodiments require multiple class/subclass searches as well as keyword searches resulting in a burdensome search. Additionally, burden is required for US practice restrictions but not for unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
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 14 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.
Regarding claim 14, it contains the trademark/trade name “Bluetooth”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a wireless connection between the NEST controller and a network and, accordingly, the identification/description is indefinite.
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.
Claims 1-5, 7, 8, 12-14, 17, and 18 are rejected under 35 U.S.C. 103 as being obvious over Phillips (EP 2197534 B1) in view of Pascual-Leone et al. (US 20100113959 A1) (hereon referred as Pascual).
Regarding claim 1, Phillips teaches a transcranial magnetic stimulation (TMS) device (“transcranial magnetic stimulation (TMS) device”, paragraph 2, page 3) comprising:
A neuro-electroencephalogram synchronization therapy (NEST) headset (“NEST device…subject is lying with the head against the concave surface…to deliver therapy to the subject…subject’s head is pressed against the button EEG electrode”, paragraph 3, page 12; NEST device 88 in Fig. 7 and 8) operable to capture electroencephalogram (EEG) data;
A database (“varying frequencies…within a specified EEG band of a healthy population database”, paragraph 7, page 4) and customized TMS treatment system, in communication with the NEST headset, wherein the database and customized TMS treatment system is operable to:
Receive the EEG data (“computer readable format…that receives and records the EEG signal”, paragraph 5, page 27),
Analyze the EEG data to compute analyzed EEG data (“device…may comprise logic…that determines the intrinsic frequency of a specified EEG band of the subject”, paragraph 1, page 28), and
Determine a treatment based on the analyzed EEG data (“adjusting output of a magnetic field for influencing an intrinsic frequency of a specified EEG band of the subject”, paragraph 2, page 28); and wherein the NEST headset comprises a plurality of magnets operable to deliver synchronized transcranial magnetic stimulation based on the treatment (“magnets 2a, 2b are rotated synchronously to provide a more uniform phase for the magnetic field in the brain of a subject”, paragraph 2, page 16).
Phillips does not teach an electrophysiology database in communication with the NEST headset.
However, Pascual teaches a transcranial magnetic stimulation (TMS) device (“portable transcranial magnetic stimulation (TMS) device”, abstract) comprising an electrophysiology database and customized TMS treatment system (“EEG device and protocol that allows recording of electrophysiological signals…during transcranial magnetic stimulation”, paragraph [0116]), in communication with the NEST headset (“helmet adapted to fit a user’s head”, abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the device of Phillips with Pascual and incorporate an electrophysiology database that receives electrophysiological signals of the patient in order to provide effective, customized, and patient-specific TMS treatment protocols.
Regarding claim 2, Phillips in view of Pascual teaches all the limitations of claim 1.
Furthermore, Pascual teaches the NEST headset being portable (“portable TMS device”, abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Phillips in view of Pascual and make the NEST headset portable in order for easier accessibility for the operator and patient.
Regarding claim 3, Phillips in view of Pascual teaches all the limitations of claim 1.
Furthermore, Pascual teaches the NEST headset further comprising a portable power source (“portable transcranial magnetic stimulation (TMS) device…comprising at least one coil…generates electromagnetic energy”, paragraph [0006]). The portable device comprises a power source that is the coil that generates energy.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Phillips in view of Pascual and make the power source portable as well, as the NEST headset is made to be portable for the convenience of the operator and patient.
Regarding claim 4, Phillips in view of Pascual teaches all the limitations of claim 1.
Furthermore, Pascual teaches the NEST headset further comprising a safety feature (“temperature sensors and safety switches”, paragraph [0140]) operable to prevent misuse.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Phillips in view of Pascual and provide a safety feature in order to prevent any harm to the patient during TMS treatment.
Regarding claim 5, Phillips in view of Pascual teaches the plurality of magnets being a plurality of rotating magnets (“rotating one or more permanent magnets in close proximity to the subject’s head”, paragraph 4, page 13) operable to generate an alternating magnetic field to facilitate the synchronized transcranial magnetic stimulation based on the treatment (“magnets 2a, 2b are rotated synchronously to provide a more uniform phase for the magnetic field in the brain of a subject”, paragraph 2, page 16).
Regarding claim 7, Phillips in view of Pascual teaches all the limitations of claim 1.
Furthermore, Pascual teaches the NEST headset further comprising one or more of a removable strap or a removable headband (“fasteners and/or strips may be positioned and arranged to form a skeleton that can engage the TMS coil at precisely the intended location”, paragraph [0072]; fasteners shown in Fig. 1B-1D).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Phillips in view of Pascual and provide a removable element to adjust the headset according to the patient for comfortability and ensuring that it fits snugly where the TMS treatment can be delivered.
Regarding claim 8, Phillips in view of Pascual teaches the device further comprising a NEST controller (“NEST device and its controller subunit”, paragraph 1, page 13).
Regarding claim 12, Phillips in view of Pascual teaches the device further comprising a base station (“base 1936 for mounting the NEST device”, paragraph 4, page 41; base 1936 in Fig. 19).
Regarding claim 13, Phillips in view of Pascual teaches the base station having an upper surface diameter and a lower surface diameter different from the upper surface diameter, and a columnar upper surface operable to hold the headset (shown in annotated Fig. 19 below).
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Regarding claim 14, Phillips in view of Pascual teaches the base station further comprising a wireless connection from an exterior surface (“transfer such formatted data and/or instructions through wireless…signaling”, paragraph 3, page 46).
Regarding claim 17, Phillips in view of Pascual teaches the treatment comprising the synchronized transcranial magnetic stimulation delivered using one or more of: one or more pulse frequency values (“applying a magnetic field with varying frequencies”, paragraph 2, page 29), or one or more strengths (“the strength of the at least one permanent magnet is from about 1 mT to about 4 T”, paragraph 4, page 5).
Furthermore, Pascual also teaches delivering TMS using one or more physical locations (“generally portable TMS device…device adapted for home use…at a workplace”, paragraph [0058]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Phillips in view of Pascual and provide TMS treatment at various physical locations with the portable NEST headset device in order for the patient to receive treatment at home.
Regarding claim 18, Phillips in view of Pascual teaches the treatment further comprising an additional neuromodulation stimulus comprising one or more of transcranial electrical stimulation (“applying microcurrent levels of electrical stimulation across the head via transcutaneous electrodes”, paragraph 5, page 33), light stimulation, or vibrational stimulation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARA LINH TRAN whose telephone number is (571)272-3598. The examiner can normally be reached 7:30am-5:00pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at 5712724233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.L.T./Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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