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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 23, 2026 has been entered.
Response to Amendment
The Declaration of Inventor under 37 CFR 1.132 filed July 23, 2026 is insufficient to overcome the rejection of claims 1, 4, 7-8, 11, 15, 20-21 and 24-25 based upon Starkebaum in view of De Ridder and Dobak as set forth in the last Office action because: The declaration as submitted by the Inventor, Aryn Gittis, opined that it would not have been obvious to an individual with experience in the field of neurostimulation to combine the nerve stimulation from Dodak in which “the off period is equal or longer than the on period” with the method described by Starkebaum. However, the affidavit fails to provide factual or objective evidence as to why it would not be obvious to combine the prior art of Dodak with Starkebaum, it merely provides an opinion testimony from the Inventor. Please refer to MPEP 716.01(C)(I)-(III).
This office action is responsive to the amendment filed on July 23, 2026. As directed by the amendment: claim(s) 1 and 29 have been amended, claim(s) 2-6, 9, 12-13, 16, 18-19, 22, 26-27, 31-33, 36 and 38-40 have been cancelled, and no claim(s) have been added. Thus, claims 1, 7-8, 10-11, 14-15, 17, 20-21, 23-25, 28-30, 34-35 and 37 are currently pending in the application.
Response to Arguments
Applicant's arguments filed July 23, 2026 have been fully considered but they are not persuasive. The applicant has amended independent claim 1 and submitted a Declaration of Inventor Dr. Aryn Gittis which reasons that based on the respective disclosures of Dobak and Starkebaum it would not have been obvious to combine the nerve stimulation from Dobak in which “the off period is qual or longer than the on period” with the method described by Starkebaum. The examiner respectfully disagrees. As mentioned above, the Declaration of Inventor submitted is merely opinion-based evidence without factual or objective evidence. The applicant has not submitted data or literature which would support the opinion of the Inventor as evidence of nonobviousness. Therefore, the Declaration of Inventor is inefficient to overcome the previous rejection of the claims.
Furthermore, the applicant argues that the desired result of Dobak to prevent the rise in mean arterial blood pressure (MAP) would be entirely irrelevant to the method of Starkebaum. However, as previously mentioned the examiner believes that it is simply a bi-product of utilizing the method of Dobak. Both prior arts Starkebaum and Dobak aim to treat obesity, and the primary art Starkebaum fails to disclose a specific limitation in which the "on periods" are shorter than the "off periods." The applicant argues that there wouldn't be an increase in mean arterial blood pressure for the stimulation in the (internal or external) globus pallidus; however, the applicant or the Declaration of the Inventor has not provided evidence that there would not be an increase in mean arterial blood pressure or would cause harm to the user if implemented. Furthermore, the examiner would note that one of ordinary skill in the art would choose a technique that is safer (i.e. limiting an increase in mean arterial blood pressure) even if just as a pre-caution to implementation. Therefore, the examiner is not convinced and the rejection is maintained.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 7-8, 11, 15, 20-21, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Starkebaum (US 2011/0071589 A1) in view of De Ridder (US 2019/0015666 A1) and Dobak (US 2008/0033511 A1).
Regarding claim 1, Starkebaum discloses A method of modulating a plurality of neurons in a patient (e.g. [0054]), comprising: stimulating an area of the patient's central nervous system (e.g. [0054]), the stimulation comprising alternating first periods when a plurality of pulses of electrical stimulation (e.g. [0112]-[0113] Fig 5:62a-h) are delivered and second periods when no pulses of electrical stimulation are delivered (e.g. [0110]-[0113] Fig 5:T(1)), wherein the area of the patient’s central nervous system comprises the internal globus pallidus or the external globus pallidus (e.g. [0054] when doing deep brain stimulation it can include stimulating the globus pallidus internus (GPi)).
Starkebaum is silent regarding wherein the first periods have a duration of about 100 to about 400 ms and the second periods have a duration of about 500 ms to about 1900 ms, and wherein the pulses have a frequency of about 100 Hz to about 250 Hz.
However, Starkebaum does disclose that the parameters for different embodiments such as pulse width and addition to duty cycle are defined based on the disorder and disease that is being treated (e.g. [0049]). Furthermore, Starkebaum discloses some embodiments can have series of pulses with a pulse width between approximately 0.05 milliseconds and approximately 1000 milliseconds (e.g. [0203]) and that the duty cycle of some embodiments can be approximately 5% up to 100% of the time (e.g. [0124]).
Additionally, De Ridder discloses a system to deliver nested stimulation to brain tissue wherein the burst stimulus applied to deliver parameters to the brain (e.g. [0147]-[0148]), and the burst stimulus being applied in a more particular range of 250 ms to 1000 ms, which overlaps the range of about 100 to 400 ms.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Starkebaum to incorporate the teachings of De Ridder wherein the first periods have a duration of about 100 to about 400 ms for the purpose of utilizing a known parameter for treatment of a particular disease or disorder (e.g. Starkebaum [0049]).
Furthermore, Dobak discloses dynamic nerve stimulation wherein the “off period” is equal or longer than the “on period” of the nerve stimulation to achieve a desired result (e.g. [0118]; [0149]; [0153]).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the method of Starkebaum to incorporate the teachings of Dobak wherein the “off period” is equal or longer than the “on period” of the nerve stimulation to achieve a desired result, specifically choosing a duty cycle less than 50% which is within the desired range as disclosed in Starkebaum (e.g. [0124]).
Regarding claim 7, modified Starkebaum discloses wherein the first periods have a duration of about 150 ms to about 250 ms (De Ridder [0148] the burst stimulus is desired more particularly in the range of 250ms to 1000ms which overlaps the desired range at the 250ms).
Regarding claim 8, modified Starkebaum is silent regarding wherein the pulses have a frequency of about 150 Hz to about 175 Hz.
However, De Ridder discloses a system to deliver nested stimulation to brain tissue wherein the burst stimulus applied to deliver parameters to the brain wherein the pulses have a frequency of about 150 Hz to about 175 Hz (e.g. [0147]-[0148] the burst frequency can be in the range of about 100 Hz and the spike frequency can be in the range of about 200Hz which are both about 150 Hz to about 175 Hz).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Starkebaum to incorporate the teachings of De Ridder wherein the burst stimulus applied to deliver parameters to the brain wherein the pulses have a frequency of about 150 Hz to about 175 Hz for the purpose of utilizing known parameters for treatment of a particular disease or disorder.
Regarding claim 11, modified Starkebaum discloses wherein the pulses are biphasic pulses (e.g. Starkebaum [0109]-[0113] Fig 5).
Regarding claim 15, modified Starkebaum discloses wherein the areas of the patient’s central nervous system is the basal ganglia Starkebaum [0054] when doing deep brain stimulation it can include stimulating the globus pallidus internus (GPi)).
Modified Starkebaum is silent regarding the patient has a movement disorder and the stimulation is of the patient’s basal ganglia, wherein the stimulation improves one or more motor symptoms of the movement disorder.
However, De Ridder discloses a system to deliver nested stimulation to brain tissue wherein the areas of the patient’s central nervous system is the basal ganglia [0121], the patient has a movement disorder and the stimulation is of the patient’s basal ganglia (e.g. De Ridder [0173]-[0176] Parkinson’s Disease), and wherein the stimulation improves one or more motor symptoms of the movement disorder (e.g. De Ridder [0003]; [0173]-[0176] specifically stated in [0176] “Thus, it is envisioned that that the neuromodulation or stimulation system or method of embodiments herein will alter or disrupt or override the regular bursting rhythm associated with PD (Parkinson’s disease)”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Starkebaum to incorporate the teachings of De Ridder wherein the areas of the patient’s central nervous system is the basal ganglia [0121], the patient has a movement disorder and the stimulation is of the patient’s basal ganglia, and wherein the stimulation improves one or more motor symptoms of the movement disorder for the purpose of treating a known disease that is affected by this portion of the brain.
Regarding claim 20, newly modified Starkebaum discloses wherein the first periods have a duration of about 150 ms to about 250 ms (e.g. De Ridder [0148] the burst stimulus is desired more particularly in the range of 250ms to 1000ms which overlaps the desired range at the 250ms).
Regarding claim 21, modified Starkebaum is silent regarding wherein the pulses have a frequency of about 150 Hz to about 175 Hz.
However, De Ridder discloses a system to deliver nested stimulation to brain tissue wherein the burst stimulus applied to deliver parameters to the brain wherein the pulses have a frequency of about 150 Hz to about 175 Hz (e.g. [0147]-[0148] the burst frequency can be in the range of about 100 Hz and the spike frequency can be in the range of about 200Hz which are both about 150 Hz to about 175 Hz).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Starkebaum to incorporate the teachings of De Ridder wherein the burst stimulus applied to deliver parameters to the brain wherein the pulses have a frequency of about 150 Hz to about 175 Hz for the purpose of utilizing known parameters for treatment of a particular disease or disorder.
Regarding claim 24, modified Starkebaum discloses wherein the pulses are biphasic pulses (e.g. Starkebaum [0109]-[0113] Fig 5).
Regarding claim 25, modified Starkebaum discloses wherein the movement disorder is selected from Parkinson's Disease, essential tremor, dystonia, and Miege Syndrome (e.g. De Ridder [0003]; [0173]-[0176]).
Claim(s) 10 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Starkebaum in view of De Ridder and Dobak as applied to claims 1 and 15 above, and further in view of Moffitt (US 2009/0118787 A1)
Regarding claims 10 and 23, modified Starkebaum is silent regarding wherein the pulses have an amplitude of about 0.1 to about 4 mA.
However, Moffitt discloses a method and system for stimulating tissue including Parkinson’s Disease (e.g. [0002]) wherein the pulses have an amplitude of about 0.1 to about 4 mA (e.g. [0070]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Starkebaum to incorporate the teachings of Moffitt wherein the pulses have an amplitude of about 0.1 to about 4 mA for the purpose of utilizing a well-known amplitude for pulse stimulation to brain tissue.
Claim(s) 14, 17 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Starkebaum in view of De Ridder and Dobak as applied to claims 1 and 15 above, and further in view of Wu (US 2012/0271375 A1)
Regarding claim 14, modified Starkebaum is silent regarding wherein the globus pallidus of each hemisphere is stimulated.
However, Wu discloses electrical brain therapy wherein the targeted area of treatment for Parkinson’s Disease (e.g. [0063]; Fig 5 ) includes wherein the globus pallidus of each hemisphere is stimulated (e.g. [0076] “In some examples, leads 520 may be implanted within the right and left hemispheres of brain 514 (e.g., as illustrated in FIG. 5) while, in other cases, only one, or both of leads 520, may be implanted within one of the right or left hemispheres.”).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the method of Starkebaum to incorporate the teachings of Wu wherein the targeted area of treatment for Parkinson’s Disease (e.g. [0063]; Fig 5 ) includes wherein the globus pallidus of each hemisphere is stimulated for the purpose of utilizing a known treatment method for Parkinson’s Disease.
Regarding claim 17, newly modified Starkebaum discloses wherein only a single stimulating electrode is used, and the stimulating electrode lead is implanted in the patient’s external globus pallidus or internal globus pallidus (e.g. Wu [0063]; [0076] “In some examples, leads 520 may be implanted within the right and left hemispheres of brain 514 (e.g., as illustrated in FIG. 5) while, in other cases, only one, or both of leads 520, may be implanted within one of the right or left hemispheres.” ).
Regarding claim 28, newly modified Starkebaum discloses wherein two stimulating electrode leads are implanted, and wherein one electrode lead is implanted in the globus pallidus of each hemisphere (e.g. Wu [0063]; [0076] “In some examples, leads 520 may be implanted within the right and left hemispheres of brain 514 (e.g., as illustrated in FIG. 5) while, in other cases, only one, or both of leads 520, may be implanted within one of the right or left hemispheres.” ).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSANDRA F HOUGH whose telephone number is (571)270-7902. The examiner can normally be reached Monday-Thursday 7 am - 4 pm.
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, David Hamaoui can be reached at (571)270-5625. 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.
Jessandra Hough September 23, 2026
/J.F.H./Examiner, Art Unit 3796 /William J Levicky/ Primary Examiner, Art Unit 3796
