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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02 January 2026 has been entered.
Status of Claims
Claims 1-20 are pending and currently under consideration for patentability; claims 1 and 11 have been amended.
Response to Arguments
Applicant’s arguments dated 20 January 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.
Applicant has amended the independent clams to further recite wherein the processing identifies evoked compound action potential features comprising discrete phases at different temporal-frequency space locations. The Examiner has addressed the amended limitations in the updated text of the rejection below.
Applicant argues that Zhu does not disclose or suggest the use of contour analysis. Although the Examiner respectfully disagrees, the Examiner has relied upon the Osorio reference in the updated rejection below to read on this limitation, rendering moot Applicant’s arguments.
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 1-4, 6, 7, 11-14, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu (US 2020/0376263 A1) in view of Osorio (US 2011/0160795 A1).
Regarding claim 1, Zhu describes a method of providing a neurostimulation therapy to a patient using an implantable pulse generator ([0030]), comprising
generating electrical pulses by the IPG ([0031])
applying the generated electrical pulses to neural tissue of the patient using one or more electrodes of one or more stimulation leads ([0029], [0031])
measuring neural response to the applied electrical pulses through one or more electrodes of one or more stimulation leads using sensing circuitry of the IPG ([0038], [0041])
processing data reflecting the measured neural response into transformed data ([0071])
processing the transformed data to identify evoked compound action potential features in the neural response ([0041], [0071], figure 3)
Regarding claim 1, Zhu does not explicitly disclose wherein the transformed data is in two-dimensions of frequency and time, using contour analysis, and wherein the processing identifies evoked compound action potential features comprising discrete phases at different temporal-frequency space locations. However, Osorio also describes a method of providing stimulation therapy to a patient ([0039]), including transforming data in two dimensions of frequency and time and identifying evoked compound action potential features in the neural response ([0042] - [0043]; figures 1-32 show various time-frequency maps), using contour analysis ([0015]), and wherein the processing identifies evoked compound action potential features comprising discrete phases at different temporal-frequency space locations ([0036], [0041]). As Osorio is also directed towards monitoring neural activity to stimulation therapy 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 transformation and analysis steps similar to those described by Osorio when using the method described by Zhu, as doing so advantageously allows the resulting method to more accurately detect the ECAP features.
Regarding claim 11, Zhu describes a neurostimulation system for providing a neurostimulation therapy to a patient ([0030]), comprising
an implantable pulse generator for generating electrical pulses ([0030]), wherein the IPG comprises sensing circuitry for sensing neural activity of the patient in response to electrical pulses ([0038], [0041])
one or more stimulation leads with multiple electrodes for applying electrical pulses to neural tissue of the patient ([0029], [0031])
an external device adapted to wirelessly communicate with the IPG when implanted in the patient ([0030], [0033]), wherein the IPG is adapted to communicated data to the external device indicative of neural activity of the patient in response to one or more electrical pulses ([0030], [0033])
wherein the external device is adapted to process data reflecting the measured neural response into transformed data ([0071]) and to process the transformed data to identify evoked compound action potential features in neural activity of the patient in response to one or more electrical pulses ([0041], [0071], figure 3)
Regarding claim 11, Zhu does not explicitly disclose wherein the transformed data is in two-dimensions of frequency and time, using contour analysis, and wherein the processing identifies evoked compound action potential features comprising discrete phases at different temporal-frequency space locations. However, Osorio also describes a method of providing stimulation therapy to a patient ([0039]), including transforming data in two dimensions of frequency and time and identifying evoked compound action potential features in the neural response ([0042] - [0043]; figures 1-32 show various time-frequency maps), using contour analysis ([0015]), and wherein the processing identifies evoked compound action potential features comprising discrete phases at different temporal-frequency space locations ([0036], [0041]). As Osorio is also directed towards monitoring neural activity to stimulation therapy 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 transformation and analysis steps similar to those described by Osorio when using the method described by Zhu, as doing so advantageously allows the resulting method to more accurately detect the ECAP features.
Regarding claims 2 and 12, Zhu describes displaying a graph of ECAP features to a clinician on a display of a clinician programmer device ([0088], computer; figure 1, clinician programmer 18).
Regarding claims 3 and 13, Zhu describes processing data representative of the ECAP features to detect a change in posture by the patient based on one or more ECAP features ([0036], [0042]).
Regarding claims 4 and 14, Zhu describes automatically modifying at least one stimulation parameter for patient therapy in response to detecting a change in posture by the patient ([0072] - [0073]).
Regarding claims 6 and 16, Zhu describes detecting a change in relative position of a first electrode of a first stimulation lead to position of a second electrode of a second stimulation lead by processing data representative of the ECAP features ([0073]; figure 5B demonstrates that there are two leads).
Regarding claims 7 and 17, Osorio describes wherein the processing the measured neural response comprises isolating discrete phases of an ECAP response of the patient ([0036], [0041]).
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Osorio, further in view of Single (US 2017/0361101 A1).
Regarding claims 5 and 15, Zhu in view of Osorio suggests the method of claim 1 and the neurostimulation system of claim 11, but neither Zhu nor Osorio explicitly discloses wherein the automatically modifying at least one stimulation parameter comprising modifying a stimulation amplitude to maintain stimulation by the IPG below a level that generates paresthesia in the patient. However, Single also describes a method and system for neurostimulation therapy, including modifying a stimulation amplitude to maintain stimulation by an implantable pulse generator below a level that generates paresthesia in the patient ([0005] - [0006]). As Single is also directed towards providing neurostimulation 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 maintain a stimulation level similar to that described by Single when using the method and system described by Zhu and Osorio, as doing so advantageously provides an effective yet comfortable stimulation to the user, as described by Single ([0006]).
Claims 8, 9, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Osorio, further in view of McGinnis et al. (US 2007/0282217 A1).
Regarding claims 8 and 18, Zhu in view of Osorio suggests the method of claim 1 and the neurostimulation system of claim 11, but neither Zhu nor Osorio explicitly discloses detecting morphology of the neural response of the patient that differs from an expected morphology to detect an undesired patient response to application of the generated electrical pulses. However, McGinnis also describes a method and system of measuring ECAP responses ([0005]), including detecting morphology of the neural response of the patient that differs from an expected morphology to detect an undesired patient response to application of the generated electrical pulses ([0058], [0061]). As McGinnis is also directed towards measuring ECAP responses 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 detect and compare neural response morphology, similar to that described by McGinnis, when using the method and system described by Zhu and Osorio, as doing so advantageously allows the resulting system to better evaluate the effectiveness of the treatment on the patient and recommend alterations in the treatment, if necessary.
Regarding claim 9, McGinnis describes detecting muscle activation in response to the application of the generated electrical pulses according to the morphology of the ECAP features ([0009], [0039], [0087]).
Claims 10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Osorio, further in view of Montgomery et al. (US 2016/0051812 A1).
Regarding claims 10 and 19, Zhu in view of Osorio suggests the method of claim 1 and the neurostimulation system of claim 11, but neither Zhu nor Osorio explicitly discloses, after isolating ECAP features in a frequency and time domain representation, transforming data indicative of the ECAP features into a one-dimensional time domain to form a reconstructed signal of ECAP values. However, Montgomery also describes a method and system of measuring ECAP responses ([0008] - [0009]), including transforming data indicative of the evoked response features into a one-dimensional time domain to form a reconstructed signal of response values ([0064]). As Montgomery is also directed towards measuring ECAP responses 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 form a reconstructed data set, similar to that described by Montgomery, when using the method and system described by Zhu and Osorio, as doing so advantageously allows the resulting system to compare the data in the time domain as well as in a time-frequency domain.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Osorio, further in view of Dinsmoor et al. (US 2018/0078769 A1).
Regarding claim 20, Zhu in view of Osorio suggests the neurostimulation system of claim 11, but neither Zhu nor Osorio explicitly discloses wherein the IPG is adapted to provided burst stimulation to the patient for neurostimulation therapy and to provide pinging pulses between therapeutic pulses of the burst stimulation to sense of responsive neural activity of the patient. However, Dinsmoor also describes a neurostimulation system configured to measure evoked responses and adjust therapy ([0005] - [0006]), including wherein an implantable pulse generator is adapted to provided burst stimulation to the patient for neurostimulation therapy and to provide pinging pulses between therapeutic pulses of the burst stimulation to sense of responsive neural activity of the patient ([0126]). As Dinsmoor is also directed towards a neurostimulation system 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 pinging pulse similar to that described by Dinsmoor when using the system described by Zhu and Osorio, as doing so advantageously allows the resulting system to continuously monitor the nerve activity throughout an entire therapy protocol.
Statement on Communication via Internet
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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