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 .
Terminal Disclaimer
The terminal disclaimer filed on 07/01/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 12,042,656 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant’s arguments filed 07/01/2026 have been fully considered but are not persuasive or are moot in view of a new grounds of rejection.
Applicant argues, “Furthermore, and as potentially relevant to Crosby's use in a future obviousness rejection, Crosby clearly does not suggest use of his stimulation in the context of spinal cord stimulation. As noted earlier, Crosby is expressly critical of the use of spinal cord stimulation to treat the type of pain his peripheral nerve stimulation technique affects. One skilled would realize then that Crosby does not suggest using his technique in the contact of spinal cord stimulation…Spinal cord stimulation is not simply described in Crosby as "somewhat inferior." It is described as "invasive and costly"; incapable of providing "sustained relief of chronic, intractable pain"; and as targeted at "neural structures (e.g., spinal cord ...) that are not specific and focal to the region of pain, limiting the focality of the produced sensory signals and preventing the neuroplastic effects that could produce long-term pain relief." See ¶ 4. These criticisms evidence significant inferiority of spinal cord stimulation when compared to the peripheral nerve stimulation that Crosby promotes… Further, Crosby could not be used in combination with any other reference to show the obviousness of what is claimed. Crosby teaches away from-and therefore precludes-such a combination.”
Examiner respectfully disagrees. Although Crosby teaches that spinal cord stimulation is not preferred for chronic pain relief [0004] due to its invasiveness and cost [0004], it still teaches that spinal cord stimulation does provide some sustained pain relief [0004]. Thus, Crosby doesn’t teach away from spinal cord stimulation, and instead discusses a preference of stimulating a peripheral nerve [0005].
Thus, an obviousness combination involving Crosby may still be made, as demonstrated below (Claim Rejections - 35 USC 103, In re claim 1), for the recited “providing, using the implantable stimulator device, the scheduled boluses to a spinal cord of the patient according to the schedule”, as disclosed by Kent, which teaches a minimally invasive method of providing spinal cord stimulation to treat chronic pain.
Additionally, Examiner asserts that although Crosby teaches that spinal cord stimulation may not be a preferred treatment for chronic pain relief, the claim does not require chronic pain relief. Therefore, spinal cord stimulation may still be selected as a treatment option for other disorders, as taught by Kent, which teaches neurostimulation being used to manage movement disorders (Kent: [0003]), and that spinal cord stimulation is the most common type of neurostimulation (Kent: [0020]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-5, 7-14, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Crosby et al. (US 2022/0241589) in view of Kent et al. (US 2017/0232255).
In re claim 1, Crosby discloses a method [0002] for providing stimulation [0002] to a patient [0198] using an implantable stimulator device [0237], comprising:
determining stimulation parameters [0257] for the patient to address a symptom of the patient ([0195-0196]: system provides relief from chronic pain);
determining a schedule for providing scheduled boluses of stimulation for the patient ([0253]: combination of all ‘on duty cycle’ of pulses i.e. periods of stimulation is interpreted as a scheduled boluses of stimulation),
wherein each bolus comprises a first duration during which stimulation is applied to the patient in accordance with the stimulation parameters ([0253]: duration of the stimulation periods is interpreted as a first duration),
wherein the scheduled boluses are separated by off times when no stimulation is provided to the patient ([0253]: pulses may be applied intermittently with periods of activity and inactivity),
wherein the first duration of each of the scheduled boluses is 3 minutes or longer ([0253]: stimulation may be provided in periods of 5 mins), and
wherein a second duration of each of the off times is 30 minutes or greater ([0253]: inactivity periods may be 60 mins); and
providing, using the implantable stimulator device, the scheduled boluses to neural tissue ([0292]: stimulation may be applied through leads placed near neural tissue; [0237]: wireless communications may be used to control stimulation device) of the patient according to the schedule [0253, 0292].
Crosby fails to disclose providing, using the implantable stimulator device, the scheduled boluses to a spinal cord of the patient according to the schedule.
Kent teaches a neurostimulation system [0003] which provides boluses ([0020-0021]: pulses delivered to nerve tissue) of spinal cord stimulation [0019] using minimally invasive needle leads [0019], and wherein electrical pulses are delivered to nerve tissue of a spinal cord ([0020-0022]: implantable system provides spinal cord stimulation) for chronic pain control [0020].
Kent further teaches that it’s known that applying electrical stimulation to the spinal cord induces paresthesia [0020] and inhibits certain types of pain from being transmitted [0020].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify method for providing stimulation to a patient using an implantable stimulator device taught by Crosby, to provide, using the implantable stimulator device, the scheduled boluses to a spinal cord of the patient according to the schedule, as taught by the electrical pulses of Kent, because spinal cord stimulation may be provided in a minimally invasive way to treat chronic pain.
In re claim 4, the proposed combination yields (all mapping is directed to Crosby unless otherwise stated)
wherein the stimulation provided during each scheduled bolus comprises a periodic sequence of pulses ([0253]: scheduled bolus is a combination of the periods of activity, which would comprise multiple periodic pulses in a sequence),
wherein the stimulation parameters comprise one or more of
an amplitude of the pulses [0257],
a pulse width of the pulses ([0255: amplitude and pulse width may be adjusted to adjust intensity), or
a frequency of the pulses [0257].
In re claim 5, the proposed combination yields (all mapping is directed to Crosby unless otherwise stated) wherein the frequency is 1 kHz or less ([0253]: stimulation may be provided at a frequency of 100Hz).
In re claim 7, the proposed combination yields (all mapping is directed to Crosby unless otherwise stated) wherein the first durations of the scheduled boluses vary ([0253]: duty cycle varying in a random fashion would change the first durations of the scheduled pulses, for instance going from a 10% duty cycle to a 75% duty cycle would affect the on-off periods).
In re claim 8, the proposed combination yields (all mapping is directed to Crosby unless otherwise stated) wherein the second durations of the off times vary ([0253]: duty cycle varying in a random fashion would also change the second durations of the off times since the on-off periods would be affected).
In re claim 9, the proposed combination yields (all mapping is directed to Crosby unless otherwise stated) further comprising determining an activity of the patient ([0268]: muscle feedback is interpreted as determining an activity of a patient).
In re claim 10, the proposed combination yields (all mapping is directed to Crosby unless otherwise stated) wherein either or both of the first durations of the scheduled boluses or the second durations of off times are adjusted in accordance with the determined activity ([0268]: muscle feedback adjusts one or more of the stimulation parameters; [0271]: duty cycle may be adjusted based on muscle activity, which would adjust both the first and second durations [0253]).
In re claim 11, the proposed combination yields (all mapping is directed to Crosby unless otherwise stated) wherein the stimulation parameters are determined in accordance with the determined activity [0268, 0271].
In re claim 12, the proposed combination yields (all mapping is directed to Crosby unless otherwise stated) wherein the activity of the patient is determined using an activity sensor ([0034]: electronic recording device is coupled to the lead to record muscle activity in response to stimulation; [0041-0042]).
In re claim 13, the proposed combination yields (all mapping is directed to Crosby unless otherwise stated) wherein the activity sensor is within the implantable stimulator device ([0263]: recording electrode that records muscle activity may be placed near target nerves; [0036-0037]: lead includes recording electrode and stimulating electrode; see in re claim 1 above, where the lead is implanted and therefore the activity sensor would be within the implantable stimulator).
In re claim 14, the proposed combination yields (all mapping is directed to Crosby unless otherwise stated)
wherein the stimulation parameters are determined in an external device ([0237]: external device may control the implantable pulse generator; [0252]: external controllers may control stimulation parameters) in communication with the implantable stimulator device [0237, 0252], and
wherein the schedule is determined in the external device ([0252]: external controller can control stimulation parameters; [0011]: duty cycle is a parameter that can be adjusted; [0253]: changing duty cycle affects the schedule).
In re claim 20, Crosby discloses
a system [0002], comprising:
an external device ([0237]: implantable pulse generator may be controlled by external devices) and
an implantable stimulator device [0237] of a patient [0237],
wherein the external device is configured to communicate with the implantable stimulator device [0237],
the external device comprising: control circuitry ([0237]: circuitry of the external devices).
Regarding the limitations, “control circuitry configured to:
provide stimulation parameters for the patient to address a symptom of the patient,
provide a schedule of scheduled boluses of stimulation for the patient,
wherein each scheduled bolus comprises a first duration during which stimulation is applied to the patient in accordance with the stimulation parameters,
wherein the scheduled boluses are separated by off times when no stimulation is provided to the patient,
wherein the first duration of each of the scheduled boluses is 3 minutes or longer, and
wherein a second duration of each of the off times is 30 minutes or greater, and
wirelessly transmit instructions to cause the implantable stimulator device to provide the scheduled boluses to a spinal cord of the patient according to the schedule”,
see in re claim 1 above.
Claims 2 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Crosby et al. (US 2022/0241589) in view of Kent et al. (US 2017/0232255) in view of Zhu et al. (US 2016/0346546).
In re claim 2, the proposed combination fails to yield wherein the stimulation parameters provide sub-perception stimulation to address a symptom of the patient.
Zhu teaches a method for delivering neural modulation [0002] to treat chronic pain [0003], and teaches wherein stimulation parameters provide sub-perception stimulation to address a symptom of the patient ([0068]: spinal cord stimulation therapy may be used in sub-perception SCS through neuromodulation parameters; [0003]: SPS stimulation treats chronic pain syndromes)
Zhu further teaches that various stimulation therapies may be used to target neural targets [0068], including sub-perception SCS.
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for providing stimulation to a patient using an implantable stimulator device yielded by the proposed combination, to provide wherein the stimulation parameters provide sub-perception stimulation to address a symptom of the patient, as taught by Zhu, because various stimulation therapies may be used to target neural targets, including sub-perception SCS.
In re claim 6, the proposed combination fails to yield wherein the amplitude comprises a constant current amplitude.
Zhu teaches wherein amplitude [0074] comprises a constant current amplitude [0074].
Zhu further teaches that a pulse generator can supply either constant current or constant voltage [0074], and neuromodulation parameters [0056] may be varied as desired [0074, 0056].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for providing stimulation to a patient using an implantable stimulator device yielded by the proposed combination, to provide wherein the amplitude comprises a constant current amplitude, as taught by Zhu, because a pulse generator can supply either constant current or constant voltage, and neuromodulation parameters may be varied as desired.
Claims 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Crosby et al. (US 2022/0241589) in view of Kent et al. (US 2017/0232255) in view of Starkebaum et al. (US 2009/0088819)
In re claim 15, Crosby discloses wherein information concerning the boluses is transmitted to the implantable stimulator device from an external device in communication with the implantable stimulator device ([0252]: external controller can provide stimulation parameters to the implanted pulse generator, which consists of information concerning the pulses).
The proposed combination fails to yield wherein the external device comprises a graphical user interface.
Starkebaum teaches providing stimulation [0067] using an implantable programmer (fig. 1: 12; [0067]) that is in communication with an external device (14; [0067]), wherein the external device comprises a graphical user interface ([0076]: display).
Starkebaum further teaches that the user interface may provide information to a user [0076].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for providing stimulation to a patient using an implantable stimulator device yielded by the proposed combination, to provide wherein the external device comprises a graphical user interface, as taught by Starkebaum, because the user interface may provide information to a user.
In re claim 16, the proposed combination fails to yield further comprising receiving from the patient at a first time an input at the graphical user interface to immediately provide an additional bolus of stimulation.
Starkebaum teaches
receiving from a patient at a first time an input at the graphical user interface ([0041]: programmer receives request to deliver stimulation; [0039, 0073-0074]) to immediately provide an additional bolus of stimulation to tissue site [0034, 0074] in addition to providing the scheduled boluses
([0041]: if the request is received outside a lockout period, then the stimulation will be delivered immediately; [0100]: therapy schedule may be set as needed; [0117]: lockout period and therapy window may be subject to the therapy schedule and vise versa, meaning that both the additional stimulation and the scheduled stimulation will be provided; [0046]),
wherein the graphical user interface is programmed with a lockout period ([0076]: programmer 14 may notify patient of a lockout period using the display),
further comprising immediately providing the additional bolus of stimulation to the tissue site only if a third duration ([0073-0074]: third duration is when a patient requests to restart stimulation after termination of a most recent electrical stimulation; [0077]) between a first time ([0073]: first time is when a request occurs by a patient; [0077]) and a preceding one of scheduled boluses ([0073]: preceding one of scheduled boluses is a termination of the most recent electrical stimulation; [0172]: scheduled boluses occur multiple times throughout a day; [0039, 0097]) is equal to or longer than the lockout period
([0073]: lockout period which ranges from 30 to 120 minutes; [0039]: patient must wait to reactivate stimulation after the lockout period expiries, which means the third duration must be longer than the lockout period; [0073, 0077]).
Starkebaum further teaches that a lockout period prevents excessively frequent stimulation being applied to the patient [0039].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for providing stimulation to a patient using an implantable stimulator device yielded by the proposed combination, to provide receiving from the patient at a first time an input at the graphical user interface to immediately provide an additional bolus of stimulation to neural tissue in addition to providing the scheduled boluses, wherein the graphical user interface is programmed with a lockout period, and immediately providing the additional bolus of stimulation to the neural tissue only if a third duration between the first time and a preceding one of the scheduled boluses is equal to or longer than the lockout period, as taught by tissue site of Starkebaum being stimulated, because the user may request additional stimulation as needed without resulting in excessively frequent stimulation.
In re claim 17, regarding the limitation, “further comprising immediately providing the additional bolus to the neural tissue in addition to providing the scheduled boluses”, see the proposed combination yielded in re claim 16 above.
In re claim 18, regarding the limitation, “wherein the graphical user interface is programmed with a lockout period, further comprising immediately providing the additional bolus of stimulation to the neural tissue only if a third duration between the first time and a preceding one of the scheduled boluses is equal to or longer than the lockout period”, see the proposed combination yielded in re claim 16 above.
In re claim 19, the proposed combination fails to yield further comprising rescheduling at least one of the scheduled boluses after the additional bolus in accordance with the lockout period.
Starkebaum teaches rescheduling at least one of the scheduled boluses after the additional bolus in accordance with the lockout period ([0142]: patient can initiate and adjust stimulation as needed, and can reschedule the next set of scheduled boluses even after the patient initiated additional therapy; [0074]: patient may only initiate therapy after the lockout period).
Starkebaum further teaches that schedule times where stimulation may be delivered is subject to other anti-desensitization features such as the lockout period [0046, 0117], and the patient can adjust therapy as needed [0142].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify method for providing stimulation to a patient using an implantable stimulator device yielded by the proposed combination, to provide further comprising rescheduling at least one of the scheduled boluses after the additional bolus in accordance with the lockout period, as taught by Starkebaum, because schedule times where stimulation may be delivered is subject to other anti-desensitization features such as the lockout period and because the patient can adjust therapy as needed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Rao et al. (US 2014/0343655) discloses spinal cord stimulation [0005] being a promising option for patients suffering from Parkinson’s disease [0005].
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.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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.
/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
Prosecution Insights