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
The restriction requirement of 01 October 2025, and the restriction of newly presented claims 21 – 27 in the action dated 16 December 2025 are maintained. Applicant’s election of Group I (claims 1 – 8) in the reply filed 1 December 2025 was treated as an election without traverse (MPEP (MPEP § 818.01(a)) 818.01(a)).
Claims 21 – 27 are not the elected invention. Elected Group I is a pulse generator classified in A61N1/3615 that records delivery of electrical signals and calculates a total amount of energy delivered to neural tissue. Claims 21 – 24 are a distinct pulse generator that compares a cumulative energy total to a safety threshold (A61N1/36164). Claims 25 – 27 are a distinct pulse generator that calculates a difference between actual delivered energy and a target neural dose (A61N1/36146). The newly claimed inventions have separate utility and separate classification. MPEP §§ 806.05(c), 821.03.
Applicant’s argument that claims 211 – 27 fall in originally identified Group I because that group was labeled “pulse generator” is not persuasive. Group I was defined by claims 1 – 8 as originally restricted.
Newly added claims 28 and 29 do not join non-elected claims 21 – 27 to the elected invention. Dependent claims cannot overcome a restriction under 37 CFR 1.142(b). Claims 28 – 29 are examined only to the extent they depend from elected claims 1 – 8.
Claims 21 – 27 remain withdrawn from consideration as directed to a non-elected invention.
Response to Arguments
Applicant's arguments filed 30 January 2026 have been fully considered but they are not persuasive.
Applicant argues that neither Wingeier (US PGPUB 2019/0111258 – previously cited) nor Faltys et al. (US PGPUB 2018/0289970 – previously cited) discloses, teaches or suggests a pulse generator that includes a processing device and instructions which cause the processing device to "record delivery of the electrical signals" or "calculate a total amount of energy delivered to the neural tissue" as called for in the claim. Applicant further argues that the cited sections of Wingeier merely disclose general system features, physical energy transfer, instantaneous safety limits, event counts, charge per phase, and current or temperature limits. Examiner disagrees.
Claims are given their broadest reasonable interpretations consistent with the specification. See MPEP § 2111. “Record delivery of the electrical signals” is not limited to storing raw waveform samples. Instead, it includes storing that stimulation was delivered, storing delivered stimulation parameters, logging pulse or event counts, and logging measured current, charge, or impedance associated with delivered pulsed, as taught by Wingeier. Similarly, “Calculate a total amount of energy delivered to the neural tissue” is not limited to a running number of joules of a measured waveform. Rather, accumulating charge, multiplying programmed parameters by a recorded number of delivered pulses or events, or enforcing a cumulative dose over a period as taught by Wingeier reads on this limitation.
As described in the action dated 16 December 2026, Wingeier discloses current control and impedance measurement (e.g. ¶ 93), calculation of amount of charge per phase (e.g. ¶ 9), calculation of current at a set time (e.g. ¶ 20), a temperature limit (e.g. ¶ 265), and a counting of dosage and dosage limits (e.g. ¶ 204, 270). This would read on the claims as previously presented.
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.
Claim(s) 1 - 3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wingeier et al. (US PGPUB 2019/0111258 – previously cited).
Regarding claim 1, Wingeier discloses a pulse generator (¶ 254), comprising: at least one processing device (e.g. ¶ 202, 271); and at least one memory storage device (e.g. ¶ 271) storing: a neural dose prescription for releasing electrical signals to stimulate neural tissue (e.g. Figs. 17B, 26; ABSTRACT, ¶ 81, 204); and instructions which, when executed by the at least one processing device, cause the at least one processing device to: generate, based on the neural dose prescription, the electrical signals for delivery through a lead (e.g. ¶ 41, 230, 271), the electrical signals being programmed to mitigate symptoms by stimulating the neural tissue (e.g. ¶ 41, 94, 95, 291, 297); record delivery of the electrical signals (E.g. ¶ 203); and calculate a total amount of energy delivered to the neural tissue based on recorded deliveries of the electrical signals (e.g. ¶ 93, 130, 183).
Regarding claim 2, Wingeier discloses the neural dose prescription defines a discrete amount of energy for the electrical signals delivered to the neural tissue (e.g. ¶ 81, 200, 204).
Regarding claim 3, Wingeier discloses the neural dose prescription includes different dosage levels that each vary an amount of energy delivered to the neural tissue (e.g. ¶ 81, 204).
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.
Claim(s) 4 – 8, 28, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wingeier et al. in view of Faltys et al. (US PGPUB 2018/0289970 – previously cited).
Regarding claim 4, Wingeier discloses the invention as discussed above, but does not explicitly recite the different levels of dosage include a mild dosage level, a moderate dosage level, and a severe dosage level.
Faltys teaches it is known to use different levels of dosage including a mild level, a moderate level, and a severe level (e.g. ¶ 116, 129, 161). It would have been obvious to one having ordinary skill in the art to modify the dosages as taught by Wingeier with the tiered dosages as taught by Faltys, since such a modification would provide the predictable results of treating an array of diseases with varying severity levels.
Regarding claim 5, Wingeier discloses the claimed invention as discussed above, but fails to explicitly recite the neural dose prescription provides a lowest effective amount of energy for the electrical signals to mitigate the symptoms.
Faltys teaches it is known to provide a stimulation where the neural dose prescription provides a lowest effective amount of energy for the electrical signals to mitigate the symptoms (e.g. ¶ 114 – 116). It would have been obvious to one having ordinary skill in the art to modify the dosage as taught by Wingeier with the dosage that provides a lowest effective energy as taught by Faltys, since such a modification would provide the predictable results of effectively treating chronic inflammation without unwanted stimulation.
Regarding claims 6 - 8, Wingeier discloses the claimed invention as discussed above, but fails to explicitly recite the instructions, when executed by the at least one processing device, further cause the at least one processing device to: store a threshold defining a maximum amount of energy for delivery to the neural tissue over the predetermined period of time.
Faltys teaches it is known to store a threshold defining a maximum amount of energy for delivery to the neural tissue (e.g. ¶ 270) and to alert or modify the neural dose prescription when the total amount of energy delivered exceeds the threshold (e.g. ¶ 270 – 272). It would have been obvious to one having ordinary skill in the art to modify the device as taught by Wingeier with the threshold as taught by Faltys, since such a modification would provide the predictable results of effectively treating the patient while avoiding unwanted excess stimulation.
Regarding claim 28, Wingeier discloses comparing the total amount of energy against a safety threshold value, where the safety threshold value defines a maximum limit of energy to be delivered to neural tissue over a predetermined period of time; and automatically adjusting the electrical signals to lower the amount of energy delivered to the neural tissue when the cumulative total of energy exceeds the safety threshold value (e.g. ¶ 270).
Regarding claim 29, Wingeier discloses the claimed invention except for determining a boundary mismatch by calculating a difference between the actual amount of energy delivered and the target neural dose.
Faltys teaches it is known use a parameter control to achieve a desired therapeutic delivery (e.g. ¶ 270) and to alert or modify the neural dose prescription when the total amount of energy delivered exceeds the threshold (e.g. ¶ 270 – 272). It would have been obvious to one having ordinary skill in the art to modify the device as taught by Wingeier with the threshold as taught by Faltys, since such a modification would provide the predictable results of effectively treating the patient while avoiding unwanted excess stimulation.
Conclusion
THIS ACTION IS MADE FINAL. 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 JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3796
