DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed June 9, 2026 has been entered. Claims 1-2, 4, 6-9, 12-13, 15, 17-20 have been amended. Currently, claims 1-20 are pending for examination.
Response to Arguments
Applicant’s arguments, see pages 8-10, filed June 9, 2026, with respect to the rejection(s) of claim(s) 1-20 under 35 U.S.C. 102 or 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Dinsmoor et al. (US 2020/0171313).
Claim Interpretation
Claim 1 states, “determine, based on a duration of the stimulation window of time, a number of stimulation pulses deliverable during the stimulation window of time…”. The “a duration of the stimulation window of time” is broadly claimed such that it is interpreted as a duration of time that is within the stimulation window of time. For example, paragraph [0057] of the published application states, “a number of durations of the inter-pulse interval that fit within the duration of the second window of time”. Therefore, it is reasonably to interpret the phrase “a duration” as a duration of an inter-pulse interval or other time intervals as long as it is within the stimulation window of time.
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.
Claims 1-18 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to limitations reciting an judicial exception without significantly more. The claim(s) recite(s) determine a first sensing window of time to sense a first physiological signal; determine, based on the first sensing window of time, a stimulation window of time for delivering electrical stimulation before a second sensing window of time to sense a second physiological signal; determine, based on a duration of the stimulation window of time, a number of stimulation pulses deliverable during the stimulation window of time at one or more pulse frequencies; wherein the stimulation window of time is adjacent to the first sensing window of time. This judicial exception is not integrated into a practical application because it is directed to a mental process or a process that can be performed with pen and paper.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they are either an outputting of data, also regarded as a display of certain results TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48; or recite generic computer components such as a processor (claim 1,), processing circuitry (claim 12), or an implantable medical device, a medical device programmer, and processing circuitry (claim 20), without significantly more. These devices are also well understood, routine and conventional as evidenced by Yeager (US 6,216,200) disclosing conventional processors (col. 1, lines 19-20); Jiang et al. (US 2012/0096234) disclosing programmer 602 is a conventional computer ([0060]); and Bourget et al. (US 2013/0110008) disclosing conventional implantable medical devices ([0076]).
While the independent claims allude to the delivery of stimulation pulses, the claims do not deliver actual stimulation and recite additional elements that apply or use the recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. Claim 19 positively recites delivering spinal cord stimulation to the patient, wherein the spinal cord stimulation is at least partially defined by the at least one selectable stimulation parameter, therefore positively reciting an application or use of the judicial exception in a manner that meaningfully limits the claim by going beyond generally linking the use of the judicial exception to a particular technological environment, and thus transforms a claim into patent-eligible subject matter. Therefore claim 19 is patent eligible under 35 U.S.C. 101.
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2, 4-5, 9-13, 15-16, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor et al. (US 2020/0171313) in view of Yeh et al. (US 2022/0314008).
Regarding claims 1, 12 and 20, Dinsmoor et al. discloses a system, device and method comprising: processing circuitry configured to: determine a first sensing window of time to sense a first physiological signal 336; determine, based on the first sensing window of time 338, a stimulation window of time 342 before a second sensing window of time 336 (feedback loop generates a second sensing window of time); wherein the stimulation window of time is adjacent to the first sensing window of time (fig. 13).
Dinsmoor et al. does not expressly disclose determine, based on duration of the stimulation window of time, a number of stimulation pulses deliverable during the stimulation window of time at one or more pulse frequencies; and output, based on the number of stimulation pulses deliverable during the stimulation window of time, at least one selectable stimulation parameter that at least partially defines the electrical stimulation. Yeh et al. teaches it is known in the art to determine, based on a duration (“1/f” fig. 89) of a stimulation window of time, a number of stimulation pulses 8954 deliverable during the stimulation 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) and a frequency of the inflammation stimulation... the inflammation stimulation 8954 can include a neurostimulation pulses from about 250 Hz to about 500 Hz” [0467]); and to output, based on the number of stimulation pulses deliverable during the stimulation window of time, at least one selectable stimulation parameter that at least partially defines the electrical stimulation (“an amplitude of a pulse can be varied” [0467]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dinsmoor et al. to use a duration within the stimulation window of time such as the inter-stimulation time (1/f) to determine the number of stimulation pulses deliverable during the stimulation window of time at one or more pulse frequencies as taught by Yeh et al. in order to be able to program additional stimulation parameters such as amplitude to ensure safe selection of stimulation parameters within the stimulation window of time.
Regarding claims 2 and 13, Dinsmoor et al. in view of 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).
Regarding claims 4 and 15, Dinsmoor et al. discloses wherein the first physiological signal comprises one or more evoked compound action potential (ECAP) signals 336, wherein the first sensing window of time comprises an ECAP control interval ([0174-0175], the sensed ECAP is used to determine the control of the stimulation parameters), and wherein the stimulation window of time comprises a duration between two adjacent ECAP control intervals (fig. 13).
Regarding claims 5 and 16, Dinsmoor et al. discloses wherein the ECAP control interval comprises a control pulse configured to elicit an ECAP signal of the one or more ECAP signals ([0174]).
Regarding claim 9, Dinsmoor et al. in view of Yeh et al. discloses the processing circuitry is further configured to deliver the electrical stimulation, wherein the electrical stimulation is at least partially defined by the at least one selectable stimulation parameter ([0467]).
Regarding claim 10, Dinsmoor et al. discloses the processing circuitry controls an implanted medical device to deliver the electrical stimulation (fig. 1).
Regarding claim 11, Dinsmoor et al. discloses wherein the device is a medical device programmer 20 comprising the processing circuitry ([0157]).
Regarding claim 19, Dinsmoor et al. discloses delivering, by processing circuitry, spinal cord stimulation to a patient, wherein the spinal cord stimulation is at least partially defined by the at least one selectable stimulation parameter (fig. 1).
Claim(s) 6 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor et al. (US 2020/0171313) in view of Yeh et al. (US 2022/0314008) and further in view of Lambert (US 2015/0328454).
Regarding claims 6 and 17, Dinsmoor 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 Dinsmoor 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]).
Statement Regarding Prior Art
The prior art 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. However, claims 3, 7-8, 14 and 18 are rejected under 35 U.S.C. 101.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA S LEE/Primary Examiner, Art Unit 3796
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