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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 12,042,656 (Doan). Although the claims at issue are not identical, they are not patentably distinct from each other because:
In re claim 1, Claim 4 of Doan claims a method for providing stimulation to a patient using an implantable stimulator device (Col. 27, lines 56-58), comprising:
determining stimulation parameters for the patient to address a symptom of the patient (Col. 27, lines 59-61);
determining a schedule for the provision of scheduled boluses of stimulation for the patient (Col. 27, lines 63-64: scheduled boluses of stimulation must be determined),
wherein each bolus comprises a first duration during which stimulation is applied to the patient in accordance with the stimulation parameters (Col. 27, lines 64-67),
wherein the scheduled boluses are separated by off times when no stimulation is provided to the patient (Col. 27, line 67- Col. 28, lines 1-2),
wherein the first duration of each of the scheduled boluses is 3 minutes or longer (Col. 28, lines 16-17), and
wherein a second duration of each of the off times is 30 minutes or greater (Col. 28, lines 29-30); and
providing, using the implantable stimulator device, the scheduled boluses to neural tissue of the patient according to the schedule (Col. 28, lines 8-10).
In re claim 20, Claim 4 of Doan claims an external device configured to communicate with an implantable stimulator device implanted in a patient (Col. 27, lines 56-58), comprising: control circuitry (Col. 27, lines 56-59: inherent that there is control circuitry performing the method steps) configured to:
provide stimulation parameters for the patient to address a symptom of the patient (Col. 27, lines 56-67),
provide a schedule for the provision of scheduled boluses of stimulation for the patient (Col. 27, lines 62-64),
wherein each scheduled bolus comprises a first duration during which stimulation is applied to the patient in accordance with the stimulation parameters (Col. 27, lines 64-67),
wherein the scheduled boluses are separated by off times when no stimulation is provided to the patient (Col. 27, line 67- Col. 28, lines 1-2),
wherein the first duration of each of the scheduled boluses is 3 minutes or longer (Col. 28, lines 16-17), and
wherein a second duration of each of the off times is 30 minutes or greater (Col. 28, lines 29-30), and
transmit instructions to cause the implantable stimulator device to provide the scheduled boluses to neural tissue of the patient according to the schedule (Col. 28, lines 8-10: inherent that instructions would be transmitted to provide the scheduled boluses).
Claims 4, 5, and 7-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 12,042,656 (Doan) in view of Crosby et al. (US 2022/0241589).
In re claim 4, claim 4 of Doan fails to claim
wherein the stimulation provided during each scheduled bolus comprises a sequence of periodic pulses,
wherein the stimulation parameters comprise one or more of an amplitude of the pulses, a pulse width of the pulses, or a frequency of the pulses.
Crosby teaches 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 the provision of 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),
providing, using the implantable stimulator device, the scheduled boluses to neural tissue ([0292]: stimulation may be applied through leads placed near neural tissue) of the patient according to the schedule [0253, 0292],
wherein the stimulation provided during each scheduled bolus comprises a sequence of periodic pulses ([0253]: scheduled bolus is a combination of the periods of activity, which would comprise multiple periodic pulses in a sequence), and
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].
Crosby further teaches that various stimulation parameters may be used to evoke sensations [0257], including those that evoke a more desirable response [0257].
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 recited in claim 4 of Doan, to provide wherein the stimulation provided during each scheduled bolus comprises a sequence of periodic pulses, wherein the stimulation parameters comprise one or more of an amplitude of the pulses, a pulse width of the pulses, or a frequency of the pulses, as taught by Crosby, because various stimulation parameters may be used to evoke sensations, including those that evoke a more desirable response.
In re claim 5, Claim 4 of Doan fails to claim wherein the frequency is 1 kHz or less.
Crosby teaches wherein the frequency is 1 kHz or less ([0253]: stimulation may be provided at a frequency of 100Hz).
Crosby further teaches that certain frequencies [0257] may be used to evoke sensations [0257] or comfortable paresthesia [0257] in target regions [0257].
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 recited in claim 4 of Doan, to provide wherein the frequency is 1 kHz or less, as taught by Crosby, because certain frequencies may be used to evoke sensations or comfortable paresthesia in target regions.
Additionally, even if Crosby fails to teach wherein the frequency is 1 kHz or less, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the frequency is 1 kHz or less, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
In re claim 7, Claim 4 of Doan fails to claim wherein the first durations of the scheduled boluses vary.
Crosby teaches 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).
Crosby further teaches that the duty cycle may be varied to ward off habituation [0253], and would also vary the on-off periods [0253].
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 recited in claim 4 of Doan, to provide wherein the first durations of the scheduled boluses vary, as taught by Crosby, because the duty cycle may be varied to ward off habituation, and would also vary the on-off periods.
In re claim 8, Claim 4 of Doan fails to claim wherein the second durations of the off times vary.
Crosby teaches 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).
For substantially the same reasons as discussed in re claim 7 above, 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 recited in claim 4 of Doan, to provide wherein the second durations of the off times vary.
In re claim 9, Claim 4 of Doan fails to claim further comprising determining an activity of the patient.
Crosby teaches further comprising determining an activity of the patient ([0268]: muscle feedback is interpreted as determining an activity of a patient).
Crosby further teaches that muscle feedback may be used to automatically adjust stimulation parameters [0268] to maintain a desired response [0268].
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 recited in claim 4 of Doan, to provide further comprising determining an activity of the patient, as taught by Crosby, because muscle feedback may be used to automatically adjust stimulation parameters to maintain a desired response.
In re claim 10, Claim 4 of Doan fails to claim 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.
Crosby teaches 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]).
For substantially the same reasons as discussed in re claim 9 above, 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 recited in claim 4 of Doan, to provide 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.
In re claim 11, Claim 4 of Doan fails to claim wherein the stimulation parameters are determined in accordance with the determined activity.
Crosby teaches wherein the stimulation parameters are determined in accordance with the determined activity [0268, 0271].
For substantially the same reasons as discussed in re claim 9 above, 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 recited in claim 4 of Doan, to provide wherein the stimulation parameters are determined in accordance with the determined activity.
In re claim 12, Claim 4 of Doan fails to claim wherein the activity of the patient is determined using an activity sensor.
Crosby teaches 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]).
For substantially the same reasons as discussed in re claim 9 above, 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 recited in claim 4 of Doan, to provide wherein the activity of the patient is determined using an activity sensor.
In re claim 13, Claim 4 of Doan fails to claim wherein the activity sensor is within the implantable stimulator device.
Crosby teaches 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 4 above, where the lead is implanted and therefore the activity sensor would be within the implantable stimulator).
For substantially the same reasons as discussed in re claim 9 above, 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 recited in claim 4 of Doan, to provide wherein the activity sensor is within the implantable stimulator device.
In re claim 14, Claim 4 of Doan fails to claim
wherein the stimulation parameters are determined in an external device in communication with the implantable stimulator device, and
wherein the schedule is determined in the external device.
Crosby teaches
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).
Crosby further teaches that the external controller can be used to provide stimulation parameters to the pulse generator to control stimulation [0252].
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 yielded by the proposed combination, to provide wherein the stimulation parameters are determined in an external device in communication with the implantable stimulator device, and wherein the schedule is determined in the external device, as taught by Crosby, because the external controller can be used to provide stimulation parameters to the pulse generator to control stimulation.
Claims 2-3 and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 12,042,656 (Doan) in view of Zhu et al. (US 2016/0346546).
In re claim 2, Claim 4 of Doan fails to claim 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 recited in claim 4 of Doan, 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 3, Claim 4 of Doan fails to claim wherein the neural tissue comprises a spinal cord of the patient.
Zhu teaches stimulating neural tissues [0093], wherein the neural tissue comprises a spinal cord of a patient [0093].
Zhu further teaches that neural stimulation to neural tissue may be delivered to various nerves [0093] to provide functional modulation [0093].
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 recited in claim 4 of Doan, to provide wherein the neural tissue comprises a spinal cord of the patient, as taught by Zhu, because neural stimulation may be delivered to various nerves to provide functional modulation as needed.
In re claim 6, Claim 4 of Doan fails to claim 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 recited in claim 4 of Doan, 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 on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 12,042,656 (Doan) in view of Crosby et al. (US 2022/0241589) in view of Starkebaum et al. (US 2009/0088819).
In re claim 15, Claim 4 of Doan claims wherein the external device comprises a graphical user interface (Col. 27, lines 56-63).
Claim 4 of Doan fails to claim wherein information concerning the boluses is transmitted to the implantable stimulator device from an external device in communication with the implantable stimulator device.
Crosby teaches 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).
For substantially the same reasons as discussed in re claim 14 above, 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 recited in claim 4 of Doan, to provide wherein information concerning the boluses is transmitted to the implantable stimulator device from an external device in communication with the implantable stimulator device.
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 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, Claim 4 of Doan fails to claim 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 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, Claim 4 of Doan fails to claim further comprising immediately providing the additional bolus to the neural tissue in addition to providing the scheduled boluses.
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, Claim 4 of Doan fails to claim
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.
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, Claim 4 of Doan fails to claim 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 the method 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In re claim 1, the limitation, “the provision” lacks antecedent basis.
In re claim 4, the limitation “the pulses” is unclear. Specifically, it is unclear whether the recited “the pulses” are directed to the earlier recited “periodic pulses”, or if it’s directed to a new limitation that lacks antecedent basis. For examination purposes, the limitation, “the pulses” will be interpreted as being directed to the earlier recited “periodic pulses”.
In re claim 20, regarding the limitation, “the provision”, see in re claim 1 above.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea without significantly more.
Step 1:
Independent claim 20 is directed an external device configured to communicate with an implantable stimulator device implanted in a patient. Thus, it is directed to statutory categories of invention.
Step 2A, Prong 1:
Claim 20 recites the following claim limitations which are directed to abstract ideas, specifically mental processes (see MPEP § 2106.04(a)(2)):
In re claim 20:
provide stimulation parameters for the patient to address a symptom of the patient (mental process – requires evaluation and organizing data to result in a person providing stimulation parameters to a patient)
provide a schedule for the provision of scheduled boluses of stimulation for the patient (mental process – requires evaluation and organizing data to provide a patient with a schedule of stimulation)
These limitations, under their broadest reasonable interpretation, cover concepts that can be practically performed in the human mind.
Therefore, the claim limitations fall within the 'mental processes' grouping of abstract ideas.
Step 2A, Prong 2:
Claim 20 recites the following additional elements:
an external device configured to communicate with an implantable stimulator device implanted in a patient, comprising: control circuitry configured to:
…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
transmit instructions to cause the implantable stimulator device to provide the scheduled boluses to neural tissue of the patient according to the schedule.
The following limitations:
an external device configured to communicate with an implantable stimulator device implanted in a 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,
are pre-solution activities (see MPEP 2106.05(g)), because they’re used to obtain additional information to provide a schedule for the provision of scheduled boluses of stimulation for the patient.
Additionally, regarding the limitations, “transmit instructions to cause the implantable stimulator device to provide the scheduled boluses to neural tissue of the patient according to the schedule”, Examiner asserts that this limitation is directed to additional elements, specifically insignificant post solution activity (see MPEP 2106.05(g)).
The above recited limitations merely process and move information around. Additionally, the recited “transmit” is neither particular enough to meaningfully limit the recited exception nor does it have more than a nominal relationship to the exception. In other words, the breadth of the recited “transmit” is such that it substantially encompasses all applications of the recited exception (such as moving information without requiring stimulation to actually be provided to neural tissue of the patient).
There is nothing in the claims which show how transmitting the above recited limitations integrates the judicial exception into a practical application.
Further, there is no evidence of record that would support the assertion that this step is an improvement to a computer or a technological solution to a technological problem.
Regarding the limitations, “control circuitry configured to…”, Examiner asserts that the above recited limitations amount to nothing more than mere instructions to apply the abstract idea using a generic computer (MPEP 2106.05(f), Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983).
Additionally, the above recited claim’s recitation control circuitry is merely reciting the computer components at a high-level of generality. In other words, the computer components are being used as a tool to carry out the system’s functions (See MPEP 2106.05(f)).
Thus, the abstract idea is not integrated into a practical application. The combination of these additional elements is no more than insignificant extra solution activity, and generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than insignificant extra solution activity and generic computer components.
The same analysis applies here in 2B and does not provide an inventive concept.
Therefore, claim 20 does not amount to significantly more than the abstract idea itself. Accordingly, claim 20 is not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
In re claim 1, Examiner asserts that claim 1 is not rejected under 35 U.S.C. 101. Specifically, claim 1 recites “providing, using the implantable stimulator device, the scheduled boluses to neural tissue of the patient according to the schedule”. The cited limitation is being interpreted as integrating the judicial exception into a practical application (see MPEP 2106.04(d)), since it requires stimulation to be provided to neural tissue of the patient based on the determined scheduled.
In re claims 2-19, see in re claim 1 above.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4-5, 7-14, and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Crosby et al. (US 2022/0241589).
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 the provision of 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) of the patient according to the schedule [0253, 0292].
In re claim 4, Crosby discloses
wherein the stimulation provided during each scheduled bolus comprises a sequence of periodic 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, Crosby discloses wherein the frequency is 1 kHz or less ([0253]: stimulation may be provided at a frequency of 100Hz).
In re claim 7, Crosby discloses 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, Crosby discloses 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, Crosby discloses further comprising determining an activity of the patient ([0268]: muscle feedback is interpreted as determining an activity of a patient).
In re claim 10, Crosby discloses 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, Crosby discloses wherein the stimulation parameters are determined in accordance with the determined activity [0268, 0271].
In re claim 12, Crosby discloses 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, Crosby discloses 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, Crosby discloses
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 an external device ([0237]: implantable pulse generator may be controlled by external devices configured to communicate with an implantable stimulator device implanted in a patient [0237], 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 for the provision 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
transmit instructions to cause the implantable stimulator device to provide the scheduled boluses to neural tissue of the patient according to the schedule”,
see in re claim 1 above.
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.
Claim 2-3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Crosby et al. (US 2022/0241589) in view of Zhu et al. (US 2016/0346546)
In re claim 2, Crosby fails to disclose 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 method for providing stimulation to a patient using an implantable stimulator device taught by Crosby, 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 3, Crosby discloses wherein the neural tissue comprises a peripheral nerve ([0029-0030]) of the patient [0029-0030].
Crosby fails to disclose wherein the neural tissue comprises a spinal cord of the patient.
Zhu teaches stimulating neural tissues [0093], wherein the neural tissue comprises a spinal cord of a patient [0093].
Zhu further teaches that neural stimulation to neural tissue may be delivered to various nerves [0093] to provide functional modulation [0093].
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 wherein the neural tissue comprises a spinal cord of the patient, as taught by Zhu, because neural stimulation may be delivered to various nerves to provide functional modulation as needed.
In re claim 6, Crosby fails to disclose 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 method for providing stimulation to a patient using an implantable stimulator device taught by Crosby, 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 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).
Crosby fails to explicitly disclose 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 method for providing stimulation to a patient using an implantable stimulator device taught by Crosby, 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 teach 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 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:
Ben-Ezra et al. (US 2008/0065158) discloses an apparatus (abstract) for providing stimulation (abstract) and teaches switching pulses on and off according to a schedule [0012].
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