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 of Group I in the reply filed on 01 December 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Newly submitted claims 21 – 27 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claims 21 – 27 introduce two new groups. Claims 21 – 24 drawn to a pulse generator that compares the cumulative total of energy against a safety threshold value, classified in A61N1/36164. Claims 25 – 27 are drawn to a pulse generator that determines a boundary mismatch by calculating a difference between the actual amount of energy delivered and the target neural dose classified in A61N1/36146.
Inventions of Group I (combination) and Groups II and III (subcombinations) are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the combination does not require comparing cumulative total of energy against a safety threshold value or calculating a difference between the actual amount of energy delivered and the target neural dosage. The subcombination has separate utility not requiring generating, based on the neural dose prescription, the electrical signals, but rather could generate a set amount of parameters that is predetermined regardless of the patient or chosen by the patient in real time.
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 21 – 27 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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 – in IDS).
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 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 – in IDS).
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.
Conclusion
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
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