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
Applicant’s election without traverse of claims 34-38 in the reply filed on 19 February 2026 is acknowledged.
Claims 25-33 and 39-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected set of apparatus and method claims, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 19 February 2026.
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.
Claims 34 and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mishelevich et al. (US 8052591 B2) (hereon referred as Mishelevich).
Regarding claim 34, Mishelevich teaches a magnetic stimulation system comprising a magnetic field generation device (“system…for stereotactic transcranial magnetic stimulation”, lines 66-67, Col. 5),
Wherein the magnetic field generation device includes:
A control unit determining a corresponding magnetic field in consideration of user data, including a motor threshold and a brain region to be stimulated ("control system 6, and a user interface 8 which may include one or more input device…allowing a user to select stimulation parameters and initiate a treatment sequence”, lines 50-54, Col. 6)
A power module connected to each of multi-coils configured to simultaneously stimulate a plurality of brain regions (“power is set in accordance with computations of the power necessary to exert the desired effect at the selected brain locations”, lines 60-62, Col. 6) and supplying power to each of the multi-coils (“power levels to the magnets are set to a level that will obtain the desired effect”, lines 36-37)
The control unit includes
A motor threshold measurement module measuring the motor threshold of a user by using a magnetic field change module ("stimulation dose may be derived as a predetermined percentage of the patient’s resting motor threshold…stimulation pulses over a determined region…determining the power level”, lines 62-66, Col. 10)
The magnetic field change module controlling the output magnetic field by adjusting at least one of the frequency, period, time, pulse width and intensity of the magnetic field of each of the multi-coils (“planning system might process the data sets to identify the needed stimulation parameters (such as array position, power output, relative power of each coil, pulse frequency and duration) and to control some or all of the stimulating parameters…controlling the output parameters of the stimulation pulse”, lines 56-63, Col. 12),
The motor threshold measurement module measures the user motor threshold by stepwise adjusting magnetic field intensity by the magnetic field change module (“the calculated magnetic field is moved so as to minimize the field strength at the highly conductive non-target, and to better maximize it at the less conductive target region…changing the relative power between the various coils”, lines 58-61, Col. 11), and measures the user motor threshold by increasing magnetic field frequency by a predetermined ratio and then stepwise adjusting the magnetic field intensity again when the magnetic field intensity reaches a maximum magnetic field output (“neuromodulation device…to compensate for predicted or observed magnetic/electric field maxima displacement…offset strategies may be employed”, lines 51-57, Col. 11)
The magnetic field change module determines the magnetic field of each of the multi coils by using a received MRI image of the user (“MRI and other imaging techniques are useful for helping to ensure that the stimulation is directed to the correct brain structure”, lines 27-29, Col. 1), based on a distance of a treatment position to the brain region to be stimulated (“corresponds to the region where the field strength from the electromagnet 130 is highest at any given distance from the electromagnet 130”, lines 33-34, Col. 7), a user brain state (“modulating the activity of neural tissue…without overwhelming superficial neural structures”, lines 11-14, Col. 5) including at least one of user brain shape, brain size, and head shape (“conformality of the array to the surface of the body (e.g. head) over which it is applied”, lines 41-42, Col. 10)
Regarding claim 35, Mishelevich teaches the multi-coils (coils 130, 140, 150, Fig. 1B) being positioned to respectively correspond to a brain region positioned on a right side of the user and the brain region positioned on a left side of the user (coils 140 and coils 150 for both sides of the brain of the user), and perform magnetic field stimulation on the corresponding brain regions simultaneously or with a time interval (“coils in the array are pulsed simultaneously”, abstract, “system may employ a pulse pattern…magnetic-field pulses is interrupted at various points and intervals of time”, lines 25-28, Col. 11).
Regarding claim 36, Mishelevich teaches the multi-coils performing the magnetic field stimulations simultaneously (“array of coils arranged in a predetermined configuration and pulsed simultaneously”, Col. 6, lines 1-3) or with the time interval (“system may employ a pulse pattern…pattern of the magnetic-field pulses is interrupted at various points and intervals of time”, Col. 11, lines 25-28), the magnetic field stimulations are performed by controlling the respective frequencies, periods, times, and intensities of the magnetic fields to bet he same or different from each other (“planning system might process the data sets to identify the needed stimulation parameters (such as…power output, relative power of each coil, pulse frequency and duration) and to control some or all of the stimulating parameters”, Col. 12, lines 56-60).
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 37 is rejected under 35 U.S.C. 103 as being obvious over Mishelevich in view of Pascual-Leone (WO 2008070001 A2) (hereon referred as Pascual).
Regarding claim 37, Mishelevich teaches all the limitations of claim 34, but does not teach the magnetic field change module adjusting the frequency within a range of 1 to 200 Hz, adjusts the intensity within a range of 1 to 10 tesla, and adjusts the time in units of 1 to 200 ms.
However, Pascual teaches a magnetic stimulation system (“transcranial magnetic stimulation (TMS) provides…magnetic fields to induce stimulating intracranial electric current”, paragraph 1, page 2) with a magnetic field change module adjusting the frequency within a range of 1 to 200 Hz (“intermediate frequencies may range between 1 Hz and 20 Hz…high frequency pulse trains…between 20 Hz and 200 Hz”, paragraph 2, page 8), adjusts the intensity within a range of 1 to 10 tesla (“magnetic fields used during TMS range from 0.5 Tesla to 3.0 Tesla”, paragraph 4, page 8), and adjusts the time in units of 1 to 200 ms (“anywhere between 0.01 seconds and 30 seconds may elapse between emitting the first magnetic field”, paragraph 6, page 8).
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 system of Mishelevich with the system of Pascual, and have the magnetic field change module be configured to adjust the frequency, intensity, and time between those ranges as it is most ideal when performing TMS on a patient.
Claim 38 is rejected under 35 U.S.C. 103 as being obvious over Mishelevich in view of Pascual and further in view of Neuvonen (WO 2012117166 A1).
Regarding claim 38, Mishelevich in view of Pascual teaches all the limitations of claim 37, but does not teach a cognitive training device and an integrated operator.
However, Neuvonen teaches a magnetic stimulation system (“stimulating the area of the brain with a magnetic field via a TMS coil device”, paragraph 5, page 3) with a cognitive training device performing cognitive training by presenting a predetermined question (“presenting a series of images, sounds, and/or questions to the subject and having the subject respond to each presentation”, claim 21) corresponding to the brain region to activate a brain region stimulated by the magnetic field generation device (“presenting a task to the subject a subsequent time while stimulating an area of the brain”, paragraph 2, page 3) and
An integrated operator controlling at least one of the frequency, period, and time of the magnetic field (“any or all of the parameters can be controlled automatically by the system, individually controlled by an operator or combination thereof…stimulus control can be controlled in part by an operator”, paragraph 3, page 5) generated by the magnetic field generation device and the period and time for solving a question of the cognitive training performed by the cognitive training device in consideration of at least one of the brain regions to be stimulated, the user data, and a question type of the cognitive training performed by the cognitive training device (“one or more processors being configured to perform at least some of the steps of; determining, recording and/or inputting a cognitive base line response from a subject in response to the presentation of a task”, paragraph 6, page 3).
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 system of Mishelevich in view of Pascual with the system of Neuvonen and incorporate a cognitive training device to determine the cognitive state of the patient while delivering magnetic field stimulation to the regions of the brain, in order to effectively treat the patient based on their cognitive state.
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.
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, 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.
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.
/L.L.T./Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights