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 .
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 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 27 May 2026 has been entered.
Status of Claims
Claims 1-6, 8-18, and 20-22 are pending and currently under consideration for patentability; claims 1, 14, and 20 have been amended; claims 7 and 19 previously were cancelled.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 27 May 2026 has been acknowledged and considered by the Examiner.
Response to Arguments
Applicant’s arguments dated 27 May 2026 have been fully considered, but they are not persuasive or moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicants have amended the independent claims to recite that the first train of electrical stimulation pulses are varied by the variation of the first parameter and not by the variation of the second parameter and the second train of electrical stimulation pulses are varied by the variation of the second parameter and not by the first parameter, arguing that the prior art does not disclose or suggest such limitations. The Examiner has addressed the amended limitations in the updated text of the rejection below.
Claim Rejections - 35 USC § 102 / 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-6, 10-18, and 20 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by, or, in the alternative, under 35 U.S.C. 103 as obvious over Peterson et al. (US 2019/0160294 A1).
Regarding claims 1, 14, and 20, Peterson describes a system, method, and non-transitory computer readable storage medium comprising processing circuitry ([0005]) configured to
control stimulation circuitry to deliver a sequence of a plurality of trains of electrical stimulation pulses ([0016], [0042]), wherein the plurality of trains comprises
a first train of electrical stimulation pulses at least partially defined by a first unique parameter variation pattern of a plurality of parameter variation patterns defining variation of a first parameter ([0028], [0072], use of various stimulation profiles)
a second train of electrical stimulation pulses at least partially defined by a second unique parameter variation pattern of the plurality of parameter variation patterns defining variation of a second parameter different from the first parameter ([0103] - [0105]; figures 5A-5D show pulse trains with different parameter variations), wherein the first train of electrical stimulation pulses are varied by the variation of the first parameter and wherein the second train of electrical stimulation pulses are varied by the variation of the second parameter ([0018], [0075])
control the stimulation circuitry to repeatedly deliver the sequence of the plurality of trains of electrical stimulation pulses ([0043])
Specifically regarding the limitations that “the first train of electrical stimulation pulses are varied by the variation of the first parameter and not by the variation of the second parameter and the second train of electrical stimulation pulses are varied by the variation of the second parameter and not by the first parameter” (emphasis added), the Examiner respectfully directs Applicant to Peterson’s paragraphs [0018] and [0075]. In paragraph [0018], Peterson describes delivering “up to 12 independent stimulation patterns, delivering up to 2500 pulses per second across all patterns, while changing pulse amplitude, width, or interphase delay, based on requirements of a modulating function” (emphasis added). Similarly, Peterson describes in paragraph [0075] that “processor 201 may modulate at least one of the values for the stimulation parameters (e.g., amplitude or pulse width) associated with the selected profile and update stimulation generator 202 based on the at least one modulated value for the stimulation parameters associated with the selected profile” (emphasis added). Based at least on the above passages, the Examiner respectfully submits that Peterson discloses that a single parameter may be varied for each pulse train, and that parameter may be selected by the user. Therefore, Peterson describes wherein a first parameter and a second parameter may be independently varied, such that “the first train of electrical stimulation pulses are varied by the variation of the first parameter and not by the variation of the second parameter and the second train of electrical stimulation pulses are varied by the variation of the second parameter and not by the first parameter” as disclosed. However, in the event that the Examiner’s contention of inherency is challenged, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to vary one unique parameter for each pulse train, as doing so advantageously allows the resulting stimulation scheme to identify which parameters evoke a desired response from the subject. The Examiner further directs Applicant to those sections of the Peterson reference which describe that different numbers of parameters can be uniquely varied for the pulse trains ([0103]: “the first and second active profiles are unique in pulse amplitude, pulse width, and frequency”; [0104]: “the first and second active profiles are unique in pulse amplitude and pulse width”; [0105]: “all twelve active profiles use unique stimulation settings”, “the pulse frequencies are the same across all twelve profiles…but different pulse frequencies may also be used”).
Regarding claims 2 and 15, Peterson describes wherein the first unique parameter variation pattern defines a varied pulse width of at least some pulses of the first train of electrical stimulation pulses ([0017]).
Regarding claims 3 and 16, Peterson describes wherein the first unique parameter variation pattern defines a varied polarity of at least some pulses of the first train of electrical stimulation pulses ([0028]).
Regarding claims 4 and 17, Peterson describes wherein the first unique parameter variation pattern defines a varied frequency of at least some pulses of the first train of electrical stimulation pulses ([0003], [0032]).
Regarding claims 5 and 18, Peterson describes wherein the first unique parameter variation pattern defines a varied amplitude of at least some pulses of the first train of electrical stimulation pulses ([0017]).
Regarding claim 6, Peterson describes wherein the first unique parameter variation pattern defines a varied electrode combination of at least some pulses of the first train of electrical stimulation pulses ([0028]).
Regarding claim 10, Peterson describes wherein the processing circuitry is configured to separate consecutive trains of the plurality of trains of electrical stimulation pulses within the sequence by an inter-train delay period ([0018]; figures 5A-5D).
Regarding claim 11, Peterson describes wherein the processing circuitry is configured to separate consecutive deliveries of the sequence by an inter-sequence delay period ([0018]; figures 5A-5D).
Regarding claim 12, Peterson describes wherein the sequence of the plurality of trains of electrical stimulation pulses comprises at least four trains of electrical stimulation pulses (figure 5D), each train of the four trains of electrical stimulation pulses comprising respective pulses that are varied according to respective unique parameter variation patterns of the plurality of parameter variation patterns ([0032], [0075]), wherein the four trains of electrical stimulation pulses comprises the first train and the second train (figures 5A-5D).
Regarding claim 13, Peterson describes an implantable medical device comprising the processing circuitry and the stimulation circuitry ([0022]).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 8, 9, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Peterson in view of Torgerson et al. (US 8,918,184 B1).
Regarding claims 8 and 21, Peterson describes the system of claim 1 and the method of claim 14, including wherein the sequence is a first sequence ([0016]), but Peterson does not explicitly disclose wherein the processing circuitry is configured to
receive a request to skip one or more trains of the plurality of trains of electrical stimulation pulses
responsive to receiving the request to skip the one or more trains, remove the one or more trains from the first sequence to generate a second sequence of trains of electrical stimulation pulses
control the stimulation circuitry to deliver the second sequence of trains of electrical stimulation pulses
However, Torgerson also describes a system and method for controlling stimulation circuitry, including processing circuitry configured to
receive a request to skip one or more trains of the plurality of trains of electrical stimulation pulses (col 43:23-49)
responsive to receiving the request to skip the one or more trains, remove the one or more trains from the first sequence to generate a second sequence of trains of electrical stimulation pulses (col 43:23-49)
control the stimulation circuitry to deliver the second sequence of trains of electrical stimulation pulses (col 43:64-44:7)
As Torgerson is also directed towards controlling stimulation circuitry and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a skip function similar to that described by Togerson when using the system and method described by Peterson, as doing so advantageously allows a user to dynamically update the resulting system, as described by Torgerson.
Regarding claims 9 and 22, Peterson describes wherein the processing circuitry is configured to generate the second sequence of trains by adding a new train of electrical stimulation pulses comprising pulses varied according to a third unique parameter variation pattern different from the first unique parameter variation pattern and the second unique parameter variation pattern (([0017], [0028], [0032] list the various parameter variation patterns which may be used).
Statement on Communication via Internet
Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant:
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the Examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno, can be reached by telephone at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3796
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