DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-11) in the reply filed on December 17, 2025 is acknowledged. The traversal is on the ground(s) that Groups I, II and III do not lack unity of invention for the reasons provided in the restriction requirement. After further consideration of applicant’s remarks, this argument is persuasive. The restriction requirement between inventions I, II and III, as set forth in the Office action mailed on October 17, 2025, is hereby withdrawn and claims 12-20 are hereby fully examined for patentability.
Response to Amendment
Claims 1-20 are pending for examination.
Claim Objections
Claim 6 is objected to because of the following informalities: lines 2 and 3 each recite, “the selectable stimulation parameter”. It is suggested to amend this to recite “the at least one selectable stimulation parameter” to maintain consistency with claim 1. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: lines 2-3 recite, “the selectable stimulation parameter”. It is suggested to amend this to recite “the at least one selectable stimulation parameter” to maintain consistency with claim 1. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: line 3 recites, “the at least one selectable stimulation parameters”. It is suggested to amend this to recite “the at least one selectable stimulation parameter” to maintain consistency with claim 12. Appropriate correction is required.
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.
Claim 9 is 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.
Claim 9 recites the limitation "the one or more selectable stimulation parameters" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Claim 1 only states, “at least one selectable stimulation parameter”. The inconsistency of the terminology makes it unclear if claim 9 is intending to refer back to the at least one selectable stimulation parameter of claim 1 or attempting to reference other selectable stimulation parameters.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1, 9-12, 19-20 is/are rejected under 35 U.S.C. 102(a)(1) and/or (a)(2) as being anticipated by Yeh et al. (US 2022/0314008).
Regarding claims 1 and 12, Yeh et al. discloses a device and method comprising: processing circuitry 1110, 8824 (fig. 11a; fig. 88) configured to: determine a first window of time to sense a physiological signal (“sense electricity from nerve signals within the body” [0339]; any period of time for sensing electric nerve signals is regarded as a “first window of time”); determine, based on the first window of time, a second window of time for delivering electrical stimulations (“A response to sensed neural activity can include adjusting or updating one or more electrostimulation parameters for use by an electrostimulation device. Electrostimulation parameters can include a stimulation pulse amplitude, pulse shape, pulse frequency, or therapy duration, among other things” [0304]; pulse frequency and therapy duration is determined based on the sensed neural activity within “the first window of time”; fig. 89 any portion of repeating 8950, 8952 can be considered a second window of time); determine, based on a duration (“1/f” fig. 89) of the second window of time, a number of stimulation pulses 8954 deliverable during the second window of time at one or more pulse frequencies (“additional neurostimulation is called inflammation stimulation 8954.“ [0466]; “The number of pulses can include be determined based on the inter-stimulation time (1/f)... the inflammation stimulation 8954 can include a neurostimulation pulses from about 250 Hz to about 500 Hz” [0467]); and output, based on the number of stimulation pulses deliverable during the second window of time, at least one selectable stimulation parameter that at least partially defines the electrical stimulation (“number of pulses can be a pseudorandom number within a range of integers… an amplitude of a pulse can be varied based on a pseudorandom number within a range of values” [0467]; “the pseudorandom number can be used to determine an amplitude, frequency, number of pulses, time between pulses, time between tonic and inflammation stimulation, or the like” [0468]), wherein the second window of time is adjacent to the first window of time (“concurrent or nearly-concurrent sensing and therapy delivery” [0304]; applicant’s specification does not limit the phrase “adjacent” to a specific meaning, therefore its ordinary meaning of “near, next to” is met by “concurrent or nearly-concurrent”).
Regarding claim 9, Yeh et al. discloses wherein the processing circuitry is further configured to deliver the electrical stimulation ([0470]), wherein the electrical stimulation is at least partially defined by the one or more selectable stimulation parameters (“number of pulses can be a pseudorandom number within a range of integers… an amplitude of a pulse can be varied based on a pseudorandom number within a range of values” [0467]; “the pseudorandom number can be used to determine an amplitude, frequency, number of pulses, time between pulses, time between tonic and inflammation stimulation, or the like” [0468]).
Regarding claim 10, Yeh et al. discloses wherein the processing circuitry 8824 controls an implanted medical device 210 to deliver the electrical stimulation ([0368]).
Regarding claim 11, Yeh et al. discloses wherein the device 202 is a medical device programmer comprising the processing circuitry 1110 ([0361]).
Regarding claim 19, Yeh et al. discloses delivering, by processing circuitry, spinal cord stimulation to a patient ([0167]), wherein the spinal cord stimulation is at least partially defined by the at least one selectable stimulation parameters (“number of pulses can be a pseudorandom number within a range of integers… an amplitude of a pulse can be varied based on a pseudorandom number within a range of values” [0467]; “the pseudorandom number can be used to determine an amplitude, frequency, number of pulses, time between pulses, time between tonic and inflammation stimulation, or the like” [0468]).
Regarding claim 20, Yeh et al. discloses a system comprising: an implanted medical device 210 ([0368]); a medical device programmer 202; and processing circuitry 1110, 8824 (fig. 11a; fig. 88) configured to: determine a first window of time to sense a physiological signal (“sense electricity from nerve signals within the body” [0339]; any period of time for sensing electric nerve signals is regarded as a “first window of time”); determine, based on the first window of time, a second window of time for delivering electrical stimulations (“A response to sensed neural activity can include adjusting or updating one or more electrostimulation parameters for use by an electrostimulation device. Electrostimulation parameters can include a stimulation pulse amplitude, pulse shape, pulse frequency, or therapy duration, among other things” [0304]; pulse frequency and therapy duration is determined based on the sensed neural activity within “the first window of time”; fig. 89 any portion of repeating 8950, 8952 can be considered a second window of time); determine, based on a duration (“1/f” fig. 89) of the second window of time, a number of stimulation pulses 8954 deliverable during the second window of time at one or more pulse frequencies (“additional neurostimulation is called inflammation stimulation 8954.“ [0466]; “The number of pulses can include be determined based on the inter-stimulation time (1/f)... the inflammation stimulation 8954 can include a neurostimulation pulses from about 250 Hz to about 500 Hz” [0467]); and output, based on the number of stimulation pulses deliverable during the second window of time, at least one selectable stimulation parameter that at least partially defines the electrical stimulation (“number of pulses can be a pseudorandom number within a range of integers… an amplitude of a pulse can be varied based on a pseudorandom number within a range of values” [0467]; “the pseudorandom number can be used to determine an amplitude, frequency, number of pulses, time between pulses, time between tonic and inflammation stimulation, or the like” [0468]), wherein the second window of time is adjacent to the first window of time (“concurrent or nearly-concurrent sensing and therapy delivery” [0304]; applicant’s specification does not limit the phrase “adjacent” to a specific meaning, therefore its ordinary meaning of “near, next to” is met by “concurrent or nearly-concurrent”).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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) 2 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yeh et al. (US 2022/0314008).
Regarding claims 2 and 13, Yeh et al. discloses wherein the processing circuitry configured to determine the number of stimulation pulses that are deliverable comprises processing circuitry that, for each frequency of the one or more pulse frequencies: determines a duration of an inter-pulse interval (“time between pulses” [0468]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that in determining a number of pulses based on an inter-stimulation time, determining the frequency of the stimulation ([0467]) and determining the inter-pulse interval ([0468]), that a number of durations of the inter-pulse interval that fit within the duration of the second window of time would also be contemplated as each pulse comprises an inter-pulse interval (fig. 90); and the number of stimulation pulses less than or equal to the number of durations of the inter-pulse interval that fit within the duration of the second window of time would also be selected as all of these features are being contemplated for the stimulation 8954 (fig. 90).
Claim(s) 4-5, 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yeh et al. (US 2022/0314008) in view of Dinsmoor et al. (US 2019/0388692).
Regarding claims 4 and 15, Yeh et al. discloses wherein the physiological signal comprises one or more neural electrical signals (“sensing electrical signals within the patient” [0288]; “sensed neural activity” [0304]) but does not expressly disclose evoked compound action potential (ECAP) signals, wherein the first window of time comprises an ECAP control interval, and wherein the second window of time comprises a duration between two adjacent ECAP control intervals. Dinsmoor et al. teaches specifically ECAPs are signals representative of depolarizing nerve fibers caused by stimulation pulses ([0032]) and to deliver a control test pulse to elicit a detectable ECAP signal during a first window of time ([0033]) that is then used to determine the stimulation parameters of informed pulses to contribute to therapy to the patient during a second window of time ([0032]), the second window of time comprising a duration between two adjacent ECAP control intervals as the sensing is repeated (fig. 5). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Yeh et al. to consider the sensed neural activity as detecting ECAP signals as it is a known term in the art evidenced by Dinsmoor et al.. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Yeh et al. to modify the first window of time to comprise an ECAP control interval and the second window of time to comprise a duration between two adjacent ECAP control intervals as taught by Dinsmoor et al. in order to maintain repeated window of time for sensing neural signals that are useful in determining appropriate stimulation pulses that can be defined by a respective signal and therefore be more effective ([0032]).
Regarding claims 5 and 16, Dinsmoor et al. discloses a control test pulse configured to elicit an ECAP signal of the one or more ECAP signals ([0033]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Yeh et al. to incorporate a control pulse for eliciting an ECAP signal as taught by Dinsmoor et al. since it is a known technique in the art to elicit such desired sensed signals, the results of such a modification being reasonably predictable.
Claim(s) 6 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yeh et al. (US 2022/0314008) in view of Lambert (US 2015/0328454).
Regarding claims 6 and 17, Yeh et al. does not expressly disclose wherein the processing circuitry is further configured to validate the selectable stimulation parameter, wherein the processing circuitry validates the selectable stimulation parameter by iteratively determining a set of updated parameters, determining, based on the set of updated parameters a validation condition, determining a violation of the validation condition, and responsive to determining the violation of the validation condition, adjusting a value of the at least one selectable stimulation parameter. Lambert teaches it is known in the art to provide a validation of stimulation parameters are within pre-defined safety tolerance levels ([0233]). For example, a set of updated parameters 35 are checked against the safety tolerance levels 25, and if it violates these safety tolerance levels 26, the stimulation parameters are adjusted 35 (fig. 5). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Yeh et al. to incorporate a validation of the selectable stimulation parameter against a validation condition such as safety tolerance levels and respond accordingly as taught by Lambert in order to ensure safe stimulation is provided to the patient ([0233]).
Allowable Subject Matter
Claims 3, 7-8, 14 and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Yeh et al. (US 2022/0314008) is the closest prior art identified, where inflammation neurostimulation pulses are delivered during inter-stimulation rests of neurostimulation pulses for treating pain. Yeh et al. does not disclose the inter-pulse interval as required by claims 3 and 14 or updating the first window of time, second window of time or determining an idle phase of the inter-pulse interval as required by claims 7 and 18.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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/ERICA S LEE/Primary Examiner, Art Unit 3796