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 Election/Restrictions Claims 9-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 23, 2025 . 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. Claims 1-2 and 6 -8 are rejected under 35 U.S.C. 103 as being unpatentable over Tittelbach (DE 10 2018 110 239 , using US 2021/0236807 as a translation) in view of Lowry (US 8,718,777). Regarding Claim 1, Tittelbach discloses a device for electrical stimulation of a subject's brain (Abstract), the device comprising: a first electrode adapted to be implanted under a scalp of the subject and outside the subject's cranial cavity ( e.g. primary electrode 2 included in electrode assembly 1, Fig. 6; between the skull and the scalp ; [0008] ); a second electrode adapted to be implanted under the subject's scalp and outside the subject's cranial cavity ( e.g. secondary electrodes 3 included in electrode assembly 1, Fig. 6; [0008] ); insulating material surrounding a portion of the first electrode ( e.g. carrier material 6 covers one side of primary electrode 1 and is insulating; [0013]); the insulating material having an impedance higher than an impedance of a human skull ( e.g. the impedance of the carrier material 6 would inherently have a higher impedance than the skull, because stimulation is directed at the brain); and a current generator adapted to generate an electric current ( e.g. primary electrode 2 and secondary electrodes 3 are connected to an energy source 21, [0095]; electrode assembly 1 delivers alternating-current or direct-current pulses, [0040]) Tittelbach fails to explicitly disclose a current generator adapted to generate an electric current between the first electrode and the second electrode. Lowry disclose that it was well known in the field of intercran ial neurostimulation to use bipolar stimulation between a first electrode and the second electrode ( e.g. pulse generator 1050 includes a power supply 1055, Fig. 21; wherein first and second electrodes 920a and 920b can be configured to provide bipolar stimulation where each electrode has a different polarity, Fig. 36; Col. 22, Lns . 35-61). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Tittelbach with a current generator adapted to generate an electric current between the first electrode and the second electrode of Lowry , since such a modification would provide the system with the predictable results of bipolar stimulation can more effectively treat a t argeted brain condition. Regarding Claim 2, Tittelbach additionally discloses an insulating material surrounding a portion of the second electrode that has an impedance higher than the impedance of the skull ( e.g. carrier material 6 also secondary electrode 3, as shown in Figure 6). Regarding C laim 6, Tittlebach discloses the claimed invention but does not disclose expressly wherein the insulating material extends a uniform distance from a circumference of the first electrode . It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the electrode design as taught by Tittelbach with a uniformly extending insulating material, because Applicant has not disclosed that such a design provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the insulating material as taught by Tittelbach , because it provides a reliable insulating material and since it appears to be an arbitrary design consideration which fails to patentably distinguish over the prior art. Therefore, it would have been an obvious matter of design choice to modify Tittelbach to obtain the invention as specified in the claims. Regarding Claim 7, Tittelbach additionally discloses wherein the insulating material extends in non-uniform distances from a circumference of the first electrode ( e.g. carrier material 6 also extends to cover secondary electrodes 3, meaning it extends in non-uniform distances from the circumference of round primary electrode 2, Fig. 6). Regarding Claim 8, Tittelbach does not expressly disclose a first electrode that comprises a screw adapted to be screwed into the subject's skull. Lowry teaches that it was known in the art of intracranial neurostimulation for a first electrode to comprise a screw adapted to be screwed into the subject's skull ( e.g. electrode 150 is a screw with shaft 110 inside cancellous tissue 18, Fig. 3A; Col. 8, Lns . 10-15). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Tittelbach with the first electrode comprises a screw adapted to be screwed into the subject's skull of Lowry , since such a modification would provide the system with the predictable results of a more targeted electrical therapy closer to the brain without the need for multiple damaging holes to be drilled into the skull. Claim s 3- 5 are rejected under 35 U.S.C. 103 as being unpatentable over Tittelbach and Lowry in view of Gliner (US 2003/0125786). Regarding claim 3 , Tittlebach and Lowry discloses the claimed invention except the express mention of a first electrode and an insulating material are disposed on a first side of the current generator. Gliner discloses that it was well known in the art of intercranial electrical stimulation to include electrodes and insulating material on a first side of a current generator (e.g. electrodes 660 enclosed in insulating material as shown in Figure 11). It would have been obvious to one having ordinary skill in the art to include the location of the electrodes and insulating material on the pulse generator as taught by Gliner in the device of Tittlebach and Lowry in order to provide the system with the predictable results of a compact easy to implant system. Regarding claim 4 , Gliner additionally discloses a second electrode is disposed on the first side of the current generator (e.g. second electrode 660 as shown in Figure 11). Regarding claim 5, Titt e lbach , Gliner , and Lowry disclose the claimed invention except the express mention of a second electrode is disposed on a second side of the current generator. Lowry discloses that it was well known in the art to include electrodes on two different surfaces of an intercranial device (e.g. electrodes 760a and 760b as shown in Figure 28). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the electrodes of Lowry in the device of Tittelbach and Gliner since such a modification would provide the system with the predictable results of a reliable means of stimulating the desired locations in the body. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Amanda K Hulbert whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-1912 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Friday 9:00-5:00 . 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, FILLIN "SPE Name?" \* MERGEFORMAT Unsu Jung can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-8506 . 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. /Amanda K Hulbert/ Primary Examiner, Art Unit 3792