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 .
Response to Amendment
This office action is responsive to the amendment filed on November 4, 2025. As directed by the amendment: claim(s) 1, 15 and 29 have been amended, claim(s) 2-3, 5-6, 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, 4, 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, see pg. 6, filed November 4, 2025, with respect to the objection of claim 15 have been fully considered and are persuasive. The objection of claim 15 has been withdrawn.
Applicant’s arguments with respect to claims 1, 4, 7-8, 10-11, 14-15, 17, 20-21, 23-25 and 28 have been considered but the arguments do not apply to the combination of the references being used in the new grounds of rejection set forth above. The applicant asserts that the prior art rejections do not teach or suggest the features as now amended into the amended claims; therefore, the examiner has applied a new combination of prior art to reject the claims and address the arguments necessitated by such amendment.
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(s) 1, 4, 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)).
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 is 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 4, modified Starkebaum discloses wherein the area of the patient's central nervous system is the internal globus pallidus (e.g. Starkebaum [0054] when doing deep brain stimulation it can include stimulating the globus pallidus internus (GPi))
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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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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.
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Jessandra Hough March 11, 2026
/J.F.H./Examiner, Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796