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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-10 and 17-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 8-10 and 17-19 recite “and types of modulations” it is unclear what applicant is attempting to encompass when reciting “types of modulation”. The specification recites “types of modulation”, see para. [0017]-[0019] of published application US 2025/0249257, and “types of the modulation”, see para. [0101], [0124], [0129] of published application US 2025/0249257, but does not provide further specifics regarding what applicant is attempting to encompass when reciting “types of modulation” making it difficult to determine the metes and bounds of the claims, clarification is required.
Claim Rejections - 35 USC § 102
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) 1-5,11-13 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2022/0184400 to Zhu (Zhu) (cited by applicant).
In reference to at least claim 1
Zhu discloses a system (e.g. 100) for delivering neurostimulation to a patient (e.g. “neurostimulation system”, para. [0050]) using a stimulation device (e.g. stimulation device 104), the system (e.g. 100) comprising: a programming control circuit (e.g. programming device 802 includes programming control circuit 816) configured to generate information for programming the stimulation device to control the delivery of the neurostimulation according to a dynamic stimulation pattern defined by stimulation parameters (e.g. “ dynamically updates values of the plurality of stimulation parameters in response to changes in the set of one or more stimulation waveforms and transmits the plurality of stimulation parameters with the updated values to implantable stimulator 704.”, para. [0084]-[0085]) including at least one time-varying stimulation parameter (e.g. “modulated pulse sequence”, para. [0085]); and a stimulation programming circuit including a dynamic pattern composer configured to determine the dynamic stimulation pattern based on a targeted modulation of a neural response by the neurostimulation according to the dynamic stimulation pattern, the neural response being a response of the patient to the delivery of the neurostimulation (e.g. Fig. 14, “This patterned pulse sequence is used to control delivery of neurostimulation to the patient. The modulation functions can be adjusted based on the patient's response to the delivery of the neurostimulation. The patient response can include, for example, feedback reported from the patient and one or more signals sensed from the patient (e.g., neural signals such as evoked compound action potentials, other physiological signals, and physical activities).”, para. [0049]; “At 1486, the neurostimulation pulses are delivered. At 1487, the pulse sequence is adjusted based on responses to the delivery of the neurostimulation pulses.”, para. [0108]).
In reference to at least claim 2
Zhu discloses wherein the programming control circuit is further configured to generate the information for programming the stimulation device to control the delivery of the neurostimulation according to a stimulation program including multiple stimulation patterns and a schedule specifying an onset time and a duration of each stimulation pattern of the multiple stimulation patterns (e.g. “a field modulation function selection field 1274, and a field modulation parameters field 1276.”, para. [0098], “As illustrated in FIG. 12 for example, in response to the sequential modulation function being selected, field modulation parameters field 1276 presents a sequence of fields defined by the field modulation parameters including “field”, “allocated run time”, and “order”. “, para. [0101]), the multiple stimulation patterns defined by the stimulation parameters and including the dynamic stimulation pattern, and the stimulation programming circuit is configured to determine the stimulation program (e.g. Fig. 13, “Field modulation parameters field 1276 presents field modulation parameters associated with the selected field modulation function and allows for determination of the field modulation parameters.”, para. [0101]).
In reference to at least claim 3
Zhu discloses a stimulation device (e.g. 704) and a programming device (e.g. 802) configured to program the stimulation device (e.g. “External programming device 802 can be used to generate a modulated pulse sequence and can program a stimulation device such as implantable stimulator 704 for delivering neurostimulation through electrodes 706 and/or 707”, para. [0085]) and including the programming control circuit and the stimulation programming circuit (e.g. programming device 802 includes the programming control circuit 816 and stimulation control circuit 820, Fig. 8), the stimulation device configured to sense a neural signal including the neural response (e.g. Figs. 7-8, “Implantable stimulator 704 may include a sensing circuit 742 that is optional and required only when the stimulator needs a sensing capability… Sensing circuit 742, when included and needed, senses one or more physiological signals for purposes of patient monitoring and/or feedback control of the neurostimulation.”, para. [0074]), and wherein the dynamic pattern composer is configured to allow for determination of one or more features of the neural response to be modulated by the neurostimulation according to the dynamic stimulation pattern (e.g. Figs. 7-8, “In one embodiment, stimulation control circuit 714 controls the delivery of the neurostimulation pulses using the one or more sensed physiological signals.”, para. [0074]).
In reference to at least claim 4
Zhu discloses wherein the dynamic pattern composer is configured to receive input parameters defining the targeted modulation of the neural response by the neurostimulation according to the dynamic stimulation pattern (e.g. waveform modulation control panel 960 receives input parameters, “In various embodiments, waveform modulation control panel 960 can be configured to perform the function according to the present subject matter while satisfying various therapy control requirements (e.g., parameters to be adjustable and types of modulation functions needed) and design considerations (e.g., contents to be presented and their layout based on user preference and/or access control).”, para. [0089]) and to determine the dynamic stimulation pattern based on the input parameters (e.g. “Adjustable parameters field 962 presents the one or more adjustable parameters and allow for selection and programming of the parameter from the presented one or more adjustable parameters using user input device 858.”, para. [0090]).
In reference to at least claim 5
Zhu discloses wherein the dynamic pattern composer is configured to receive a neural response parameter of the input parameters by selecting the neural response parameter from a plurality of neural response parameters to be modulated by the neurostimulation according to the dynamic stimulation pattern (e.g. waveform modulation control 960, “The list presented in waveform modulation function selection field 964 can also be adjusted based on user feedback, user preference, and/or continuous learning and knowledge build-up.”, para. [0092]), the neural response parameters each being a measure of the neural response and derivable from a sensed neural signal including the neural response (e.g. Figs. 7-8, “Sensing circuit 742, when included and needed, senses one or more physiological signals for purposes of patient monitoring and/or feedback control of the neurostimulation.”, para. [0074], “Such measurable responses can include input from the patient and/or parameters measured from signals sensed from the patient in response to the delivery of the neurostimulation pulses, such as neural signals (e.g., evoked compound action potentials), other physiological signals, and physical activities.”, para. [0108]).
In reference to at least claim 11
Zhu discloses a method for delivering neurostimulation to a patient (e.g. “neurostimulation system”, para. [0050]) using a stimulation device (e.g. stimulation device 104), the method comprising: determining, using a processor of a programming device, a dynamic stimulation pattern based on a targeted modulation of a neural response by the neurostimulation according to the dynamic stimulation pattern (e.g. Fig. 14, “This patterned pulse sequence is used to control delivery of neurostimulation to the patient. The modulation functions can be adjusted based on the patient's response to the delivery of the neurostimulation. The patient response can include, for example, feedback reported from the patient and one or more signals sensed from the patient (e.g., neural signals such as evoked compound action potentials, other physiological signals, and physical activities).”, para. [0049]; “At 1486, the neurostimulation pulses are delivered. At 1487, the pulse sequence is adjusted based on responses to the delivery of the neurostimulation pulses.”, para. [0108]), the dynamic stimulation pattern defined by stimulation parameters (e.g. “ dynamically updates values of the plurality of stimulation parameters in response to changes in the set of one or more stimulation waveforms and transmits the plurality of stimulation parameters with the updated values to implantable stimulator 704.”, para. [0084]-[0085]) including at least one time-varying stimulation parameter (e.g. “modulated pulse sequence”, para. [0085]), the neural response being a response of the patient to the delivery of the neurostimulation (e.g. Fig. 14, “This patterned pulse sequence is used to control delivery of neurostimulation to the patient. The modulation functions can be adjusted based on the patient's response to the delivery of the neurostimulation. The patient response can include, for example, feedback reported from the patient and one or more signals sensed from the patient (e.g., neural signals such as evoked compound action potentials, other physiological signals, and physical activities).”, para. [0049]; “At 1486, the neurostimulation pulses are delivered. At 1487, the pulse sequence is adjusted based on responses to the delivery of the neurostimulation pulses.”, para. [0108]) and programming, a stimulation device, using the programming device to deliver the neurostimulation and control the delivery of the neurostimulation according to the determined dynamic stimulation pattern (e.g. “ dynamically updates values of the plurality of stimulation parameters in response to changes in the set of one or more stimulation waveforms and transmits the plurality of stimulation parameters with the updated values to implantable stimulator 704.”, para. [0084]-[0085]).
In reference to at least claim 12
Zhu discloses wherein determining the dynamic stimulation pattern comprises: receiving input parameters defining the targeted modulation of the neural response by the neurostimulation (e.g. waveform modulation control panel 960 receives input parameters, “In various embodiments, waveform modulation control panel 960 can be configured to perform the function according to the present subject matter while satisfying various therapy control requirements (e.g., parameters to be adjustable and types of modulation functions needed) and design considerations (e.g., contents to be presented and their layout based on user preference and/or access control).”, para. [0089]); and determining the dynamic stimulation pattern based on the input parameters (e.g. “Adjustable parameters field 962 presents the one or more adjustable parameters and allow for selection and programming of the parameter from the presented one or more adjustable parameters using user input device 858.”, para. [0090]).
In reference to at least claim 13
Zhu discloses wherein receiving the input parameters comprises receiving a neural response parameter selected from a plurality of neural response parameters to be modulated by the neurostimulation (e.g. waveform modulation control 960, “The list presented in waveform modulation function selection field 964 can also be adjusted based on user feedback, user preference, and/or continuous learning and knowledge build-up.”, para. [0092]), the neural response parameters each being a measure of the neural response and derivable from a sensed neural signal including the neural response (e.g. Figs. 7-8, “Sensing circuit 742, when included and needed, senses one or more physiological signals for purposes of patient monitoring and/or feedback control of the neurostimulation.”, para. [0074], “Such measurable responses can include input from the patient and/or parameters measured from signals sensed from the patient in response to the delivery of the neurostimulation pulses, such as neural signals (e.g., evoked compound action potentials), other physiological signals, and physical activities.”, para. [0108]).
In reference to at least claim 20
Zhu discloses a non-transitory computer-readable storage medium including instructions (e.g. “non-transitory computer-readable storage medium”, para. [0029], “In various embodiments, circuits of neurostimulation 100, including its various embodiments discussed in this document, may be implemented using a combination of hardware and software. “, para. [0060], “In one embodiment, external storage device 818 can include a non-transitory computer-readable storage medium including instructions,”, para. [0103]), which when executed by a system, cause the system to perform a method for delivering neurostimulation from a stimulation device to a patient (e.g. “neurostimulation system”, para. [0050]), the method comprising: determining a dynamic stimulation pattern based on a targeted modulation of a neural response by the neurostimulation according to the dynamic stimulation pattern (e.g. “dynamically updates values of the plurality of stimulation parameters in response to changes in the set of one or more stimulation waveforms and transmits the plurality of stimulation parameters with the updated values to implantable stimulator 704.”, para. [0084]-[0085]), the dynamic stimulation pattern defined by stimulation parameters including at least one time-varying stimulation parameter (e.g. “modulated pulse sequence”, para. [0085]), the neural response being a response of the patient to the delivery of the neurostimulation (e.g. Fig. 14, “This patterned pulse sequence is used to control delivery of neurostimulation to the patient. The modulation functions can be adjusted based on the patient's response to the delivery of the neurostimulation. The patient response can include, for example, feedback reported from the patient and one or more signals sensed from the patient (e.g., neural signals such as evoked compound action potentials, other physiological signals, and physical activities).”, para. [0049]; “At 1486, the neurostimulation pulses are delivered. At 1487, the pulse sequence is adjusted based on responses to the delivery of the neurostimulation pulses.”, para. [0108]); and programming the stimulation device to deliver the neurostimulation and to control the delivery of the neurostimulation according to the determined dynamic stimulation pattern (e.g. “ dynamically updates values of the plurality of stimulation parameters in response to changes in the set of one or more stimulation waveforms and transmits the plurality of stimulation parameters with the updated values to implantable stimulator 704.”, para. [0084]-[0085]).
Allowable Subject Matter
Claims 6-7 and 14-16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: In view of the art that is relevant to the claimed invention the prior art does not teach or reasonably suggest, within the context of the other claim limitations, a system and method that includes receiving input parameters defining targeted modulation of the neural response by the neurostimulation according to dynamic stimulation pattern and to determine the dynamic stimulation pattern based on the input parameters, wherein the input parameters includes receiving one or more quantitative parameters defining a degree to which the neural response parameter is to be modulated by the neurostimulation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2022/0347479 to Esteller et al. which discloses adjustment of time-varying pulse patterns in a spinal cord stimulator system.
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