DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/28/2026 has been entered.
Response to Arguments
Applicant’s arguments filed 08/28/2026 have been fully considered but are moot in view of a new grounds of rejection.
Claim Interpretation
As best understood, the recited “prior to testing” is being understood as occurring after a plurality of tests have been planned out and are all ready for testing of the plurality of tests to be performed. Applicant is asked to confirm or correct this interpretation.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In re claim 1, the limitations, “wherein the processor is programmed to arrange the control parameter settings in the ordered sequence such that exploitation of known control parameter settings is maximized by prioritizing settings with highest upper confidence bound values and regret in exploration of unknown control parameter settings is minimized by selecting exploratory settings that maximize information gain from pairwise comparisons between consecutively tested settings in the ordered sequence”, fail to comply with the written description requirement since the specification fails to mention support for how exploitation of known control parameter settings is maximized and how regret in exploration of unknown control parameter settings is minimized to arrange the ordered sequence.
Furthermore, the example provided in Applicant’s specification seems contrary to what is claimed. For example, an ordered sequence of “{2,5,3,2,4,3,1,4,2,3,6,1,3,1,2,6,2,1,5,1}” (instant specification [0046]) is provided. The recited “regret in exploration of unknown control parameter settings is minimized by selecting exploratory settings that maximize information gain from pairwise comparisons between consecutively tested settings in the ordered sequence”, under broadest reasonable interpretation, is interpreted as a preference for gaining information, for instance, by testing consecutive pairs that haven’t been tested already. However, the ordered sequence provides the combinations, {1,3,1}, {2,6,2}, and {1,5,1}, which are consecutive test pairs that have just been tested (e.g. testing 1 and 3 and then testing 3 and 1).
Thus, it is unclear how this ordered sequence is arranged such that exploitation of known control parameter settings is maximized and regret in exploration of unknown control parameter settings is minimized.
Further, it is unclear what is required by the recited “exploitation of known control parameter settings is maximized” and “regret in exploration of unknown control parameter settings is minimized” limitations.
In re claim 3, see in re claim 1 above.
In re claim 13, 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.
Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Grado (WO 2019/152858) in view of Burdick et al. (US 2019/0374777) in view of Erickson (US 7,295,876) in view of Bradley (US 2008/0071325).
In re claim 13, Grado discloses a controller (fig. 1: controller; [0028-0029]) for controlling a controllable medical device [0028], comprising:
an input configured to receive feedback data representative of a treatment response or effect in a subject [0009];
a memory (fig. 10: 1014; [0057]),
wherein the memory stores
the feedback data received from the input [0058-0059] and
control parameter settings for controlling a controllable medical device [0058-0059];
a processor [0009] in communication with the input [0009] and the memory [0009, 0058-0059],
the processor being programmed to:
receive the feedback data from the input [0009];
receive control parameter settings from the memory [005-0059, 0009]; and
arrange the control parameter settings for testing the control parameter settings ([0062]: control parameter settings are updated for the controllable medical device; [0059-0060]: optimized settings are used to deliver electrical stimulations to a subject)
Grado fails to disclose the processor being programmed to:
…arrange the control parameter settings in an ordered sequence for testing the control parameter settings by the subject based at least in part on the feedback data such that
exploitation of known control parameter settings is maximized by selecting settings with highest demonstrated preference values and
regret in exploration of unknown control parameter settings is minimized by arranging exploratory settings to maximize information gain from each pairwise comparison while preventing direct comparisons between unknown settings,
wherein the processor is programmed to generate a sequencing table that tracks comparisons between settings and blocks entries corresponding to comparisons between unknown settings;
an output that communicates the ordered sequence of control parameter settings to a controllable medical device; and
wherein the controllable medical device delivers electrical stimulation to a subject in accordance with the ordered sequence of control parameter setting.
Burdick teaches a neurostimulator device [0006] for stimulation [0006],
comprising a processor [0285, 0295] programmed to: arrange control parameter settings by a subject based at least in part on the feedback data ([0256]: complex stimulation waveform is ranked) in an ordered sequence for testing the control parameter settings ([0264]: tests are arranged which compare two arms; [0064]: multiple pairs of arms are tested in a sequence; [0251]: feedback from subject are used to determine next set of stimuli to be tested; [0208-0209]),
wherein the processor is programmed to arrange the control parameter settings in the ordered sequence such that
exploitation of known control parameter settings is maximized by prioritizing settings with highest upper confidence bound values
([0264]: when comparting arms to determine optimal arms, the arm with upper confidence value less than the other arm is eliminated until the most confident arm is left i.e. an optimal complex stimulation pattern is found, which maximizes exploitation since the arms are tested until an optimal complex stimulation pattern is found; [0207-0208]: determines highest upper confidence bound acquisition function values is determined i.e. a performance function that uses an upper confidence bound update rule and converges with high probability; [0065-0066]) and
regret in exploration of unknown control parameter settings is minimized ([0064]: goal is to minimize cumulative regret compared to the best arm by using a feedback of comparison between a pair of arms in each test) by selecting exploratory settings ([0066]: there’s a need to reduce exploration while exploiting correlations with known parameters; [0207]) that maximize information gain from pairwise comparisons ([0270]: each pairwise preferences may be used to maximize information gain i.e. choosing between two arms is interpreted as maximizing information gain since it gathers information; [0063, 0264]) between consecutively tested settings in the ordered sequence ([0251]: set of stimuli to be tested may be determined based on feedback results),
wherein a memory [0294] stores the ordered sequence of control parameter settings generated by the processor [0294];
an output [0214-0215, 0252] that communicates the ordered sequence of control parameter settings to a controllable medical device (fig. 1: 120; [0091, 0213, 0252]); and
wherein the controllable medical device delivers electrical stimulation to a subject in accordance with the ordered sequence of control parameter setting ([0251]: neurostimulator devices 120 operate according to the dueling bandits algorithm and feedback is used to determine next set of stimuli to be tested).
Burdick further teaches that all dueling bandit algorithms [0065] must trade off exploration of unknown parameters and exploitation of high performing stimuli [0065], and that there is a need to limit an amount of time in the exploration process [0065] and increase an amount of time spent in useful exploitation [0065]. Burdick additionally teaches that a goal is to explore possible stimuli to improve patient performance [0215], while exploiting optimal stimuli [0215].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the controller taught by the Grado, to provide the processor being programmed to: arrange the control parameter settings in an ordered sequence for testing the control parameter settings by the subject based at least in part on the feedback data such that exploitation of known control parameter settings is maximized by selecting settings with highest demonstrated preference values and regret in exploration of unknown control parameter settings is minimized by arranging exploratory settings to maximize information gain from each pairwise comparison, an output that communicates the ordered sequence of control parameter settings to a controllable medical device; and wherein the controllable medical device delivers electrical stimulation to a subject in accordance with the ordered sequence of control parameter setting, as taught by Burdick, because there is a tradeoff between exploration of unknown parameters and exploitation of high performing stimuli that is achieved by limiting an amount of time in the exploration process while increasing an amount of time spent in useful exploitation, and also because possible stimuli should be explored to improve patient performance, while exploiting optimal stimuli.
Regarding the limitation, “while preventing direct comparisons between unknown settings”, Erickson teaches an analogous stimulation system (Col. 1, lines 25-37), wherein control parameter settings (Col. 7, lines 8-16) are arranged in an ordered sequence for testing (Col. 7, lines 17-45: treatment programs are tested by having the patient choose between a current best program and a new program) such that regret in exploration of unknown control parameter settings is minimized (Col. 7, lines 17-35: minimizes regret in exploration by comparing one new program with one previously tested program) by arranging exploratory settings (Col. 7, lines 17-30: exploratory settings are programs not yet tested; Col. 7, lines 8-14) to maximize information gain from each pairwise comparison (Col. 7, lines 17-30: comparing between two programs is a pairwise comparison) while preventing direct comparisons between unknown settings (Col. 7, lines 16-30: a previously tested “best-so-far” program is compared against a new test program, and a patient chooses which of the two programs is better and then the better of the two is stored to be tested in a new ordered sequence for testing).
Erickson further teaches that comparing between a previously tested program and a new program is quickly developed similar to a process of determining an eyeglasses prescription (col 7, lines 17-24), and ends when the patient indicates that full-coverage relief has been achieved (Col. 7, lines 31-35), or when best practical coverage has been achieved (Col. 7, lines 31-35).
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the controller yielded by the proposed combination, to provide wherein regret in exploration of unknown control parameter settings is minimized by arranging exploratory settings to maximize information gain from each pairwise comparison while preventing direct comparisons between unknown settings, as taught Erickson, because comparing between a previously tested program and a new program is quickly developed similar to a process of determining an eyeglasses prescription, and ends when the patient indicates that full-coverage relief has been achieved, or when best practical coverage has been achieved.
Regarding the limitation, “wherein the processor is programmed to generate a sequencing table that tracks comparisons between settings and blocks entries corresponding to comparisons between unknown settings”, Bradley teaches a spinal cord stimulation system [0002] and teaches wherein a processor ([0013]: part of system which generates steering table; [0015]) is programmed to generate a sequencing table ([0053-0055]: steering table) that tracks comparisons between settings and blocks entries corresponding to comparisons between unknown settings ([0053-0054]: stimulation parameters are tested to evaluate effectiveness of stimulation and moving down a row of a table indicates new stimulation parameters being tested and compared, which would is interpreted as tracking comparisons between unknown settings, since the process happens iteratively until no further improvements are detected)
Bradley further teaches that the steering table is used to compare possible stimulation sets to determine the most effective stimulation [0056] and allows for fine tuning the stimulation parameter set [0055].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the controller yielded by the proposed combination, to provide wherein the processor is programmed to generate a sequencing table that tracks comparisons between settings and blocks entries corresponding to comparisons between unknown settings, as taught Bradley, because the table is used to compare possible stimulation sets to determine the most effective stimulation and allows for fine tuning the stimulation parameter set.
In re claim 14, regarding the limitation, “wherein the processor is configured to arrange the control parameter settings in the ordered sequence such that information in the feedback data obtained from pairwise comparison of the control parameter settings is maximized,” see the proposed combination yielded in re claim 13 above.
In re claim 15, the proposed combination yields wherein the processor is configured to arrange the control parameter settings in the ordered sequence such that information from the feedback data about subject preference to different control parameter settings is maximized (Burdick: 0214]: patient feedback is used to determine next optimal complex stimulation pattern so that good stimuli parameter choices are exploited; [0207-0209]: patient preference regarding different control parameter settings is maximized by testing new stimuli and using feedback to update the next tested stimuli).
In re claim 16, regarding the limitation, “wherein the processor is configured to arrange the control parameter settings in the ordered sequence such that exploitation of known control parameter settings is maximized and regret in exploration of unknown control parameter settings is minimized,” see in re claim 13 above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Lineaweaver (US 2021/0031039) discloses developing fitting data for a sense prosthesis [0007] based on obtained data [0007] and teaches using a table [0068-0071] to assist a recipient in navigating through different designs [0068] to find an optimal setting [0068].
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached on (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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