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 .
Response to Preliminary Amendment
This Office Action is responsive to the preliminary amendment filed 15 December 2025. As directed by the amendment: claims 1, 6, and 8-16 have been amended, and no claims have been cancelled or added. Thus, claims 1-20 are presently pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 15 December 2025 and 13 January 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Response to Arguments Regarding 35 USC § 112
Applicant’s amendments to claims 13 and 14 have overcome the previously cited 112(b) rejection in the Non-Final Action mailed 30 September 2025.
Response to Arguments Regarding 35 USC § 102/103
Applicant’s arguments, see pg. 9-10 of Remarks, filed 15 December 2025, with respect to the rejection(s) of claim(s) 1-9 and 15-20 under 35 USC 102(a)(1) as anticipated by Torgerson have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Osorio (US 2014/0277256 A1), hereinafter Osorio.
Applicant has amended independent claims 1, 15, and 16 to recite “wherein the first cycling defines a first stimulation on-time and a first stimulation off-time for the first electric stimulation doses… wherein the second cycling defines a second stimulation on-time and a second stimulation off-time for the second electric stimulation doses”. Examiner agrees that Torgerson fails to explicitly disclose this amended limitation and has thus used Osorio to teach the limitation, as described in detail below.
Additionally, the amendments to claim 6 have overcome the previous 35 U.S.C. 102 rejection and thus a new ground of rejection has been made using Chavan et al. (US 2012/0095530 A1), hereinafter Chavan.
Thus, claims 1-8, and 15-20 are now rejected under 35 U.S.C. 103, as described in detail below.
No additional specific arguments were presented for previously set forth 35 U.S.C. 103 rejections of dependent claims 9-14, nor specifically with respect to the previously cited references: Gerber, Brink, King, and Srivastava.
Therefore, claims 9-14 remain rejected as described in detail below.
Claim Objections
Claim 11 objected to because of the following informalities:
Claim 11, line 15 reads “the sec fourth electric stimulation doses” should read “the .
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 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) 1-5, 7-8, and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Torgerson (US 2020/0038660 A1, previously cited), hereinafter Torgerson in view of Osorio (US 2014/0277256 A1), hereinafter Osorio.
Regarding claim 1, Torgerson discloses a system (implantable medical device (IMD) 102) comprising:
electrical stimulation circuitry (Figure 2: stimulation generator 202) configured to generate electrical stimulation ([0060] “stimulation generator 202 generates electrical stimulation signals”);
electrodes (electrodes 116 and 118) configured to deliver the electrical stimulation to a patient ([0032] “deliver electrical stimulation therapy to patient 12 via electrodes of leads 16A, 16B, e.g”, [0034] “The electrodes may transfer electrical stimulation generated by an electrical stimulation generator in IMD 102 to tissue of patient 12.”); and processing circuitry (Figure 2: processor 210) configured to:
determine, for a patient, a first cycling of first electric stimulation doses ([0101]-[0102]: “Processor 210 may control the delivery of electrical stimulation therapy according to one or more electrical stimulation therapy programs defining the therapy…delivery of electrical stimulation therapy to patient 12 according to the one or more electrical stimulation programs (402)”, Figure 4: step 402, The initial therapy program that is delivered is interpreted to be the first cycling of electrical doses.);
deliver the first electric stimulation doses according the determined first cycling ([0101]-[0102]: “Processor 210 may control the delivery of electrical stimulation therapy according to one or more electrical stimulation therapy programs defining the therapy…delivery of electrical stimulation therapy to patient 12 according to the one or more electrical stimulation programs (402)”, Figure 4: step 402, The initial therapy program that is delivered);
receive patient feedback representing a response of the patient to the first electric stimulation doses delivered according to the first cycling (Step 504,[0103] “Processor 210 may determine that the compound action potentials are evoked by sensing the compound action potential via electrodes 116, 118, or other sensing device. In other examples, processor 210 may receive patient input indicating that the patient is experiencing paresthesia.”);
determine, based on the patient feedback, a second cycling of the electric stimulation doses (Step 506,[0102] “processor 210 determines when the delivered electrical stimulation 402 evokes a compound action potential and adjusts the stimulation therapy in response to the determination (404)”, [0103] “In response to the receipt of the patient input, processor 210 may adjust the electrical stimulation therapy.” The adjusted electrical stimulation therapy is interpreted to be the second cycling of the electrical stimulation doses.); and
deliver the second electric stimulation doses to the patient according the determined second cycling ([0114] “In response to detecting an evoked compound action potential, IMD 102 reduces the magnitude of the amplitude of the electrical stimulation therapy program to a default or preprogrammed magnitude and resumes delivery of electrical stimulation therapy (606)” , [0110] “subsequent delivery of the electrical stimulation therapy.”), wherein delivering the second electric stimulation doses for the patient according to the determined second cycling consumes less power of an implanted device than delivering the first electric stimulation doses for the patient according to the determined first cycling ([0028] “the system may perform titration of one or more parameters defining the electrical stimulation therapy delivered to the patient to adjust the electrical stimulation therapy such that the electrical stimulation provides efficacious therapy to the patient (e.g., by providing pain relief) while remaining substantially below a threshold that evokes a compound action potential in the tissue of the patient (e.g., an amplitude having a magnitude 5%, 10%, 15%, or 20% below a threshold amplitude that evokes a compound action potential). Generally speaking, the lower the amplitude, the less risk of evoking compound action potentials in the tissue of patient 12 and the less power consumption by IMD 102.” It would be obvious to one skilled in the art that the first cycling would be the parameters that result in an evoked compound action potential and thus the second cycling would use amplitudes that are below the first amplitude to reduce the changes of evoking an action potential.).
Torgerson fails to explicitly disclose wherein the first cycling defines a first stimulation on-time and a first stimulation off-time for the first electrical stimulation doses and wherein the second cycling defines a second stimulation on-time and a second stimulation off-time for the second electrical stimulation doses.
However, Osorio teaches a medical device system and method capable of automated titration of an electrical therapy provided by an implantable medical device ([0002]) wherein “the titration may involve increasing or decreasing electrical therapy parameters, and may comprise adjusting one or more parameters (e.g., current (or voltage) amplitude, frequency, pulse width, on-time, off-time, and/or duty cycle) defining the therapy by incremental changes from the first value to the target value." ([0027], view Figure 8) and wherein “the electrical therapy signal may be characterized by a plurality of parameters, e.g., an amplitude, a pulse width, a pulse frequency, a signal on-time, or a signal off-time, among others. The electrical therapy module 150 may be configured to deliver an electrical therapy signal having a low initial or first value of one or more parameters upon initiation of the treatment regimen." ([0041]).
Although, a first on-time, first off-time, second on-time, and second off-time isn’t explicitly stated in Osorio it would be obvious to one skilled in the art that since the electrical therapy is characterized by a on-time and off-time ([0041]) and as shown in Figure 8, Block 810-830 the device delivers the therapy at the first (initial values) for electrical therapy parameters programmed into the medical device ([0069], Examiner interprets these electrical therapy parameters to be the first on-time and first off-time) and which is then titrated and the presence of an adverse event is detected, if no adverse event is detected and the target value has not been reached the parameters are adjusted again or if an adverse event is detected the parameter is reduced to a prior tolerable value ([0071]-[0072] Examiner interprets the next titrated parameter values to be the second on-time and second off-time). Examiner would also like to note that the adverse effect/event is selected from discomfort, pain, dyspnea, increase/decreased heart rate ([0004]10.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torgerson to incorporate the teachings of Osorio to have wherein the first cycling defines a first stimulation on-time and a first stimulation off-time for the first electrical stimulation doses and wherein the second cycling defines a second stimulation on-time and a second stimulation off-time for the second electrical stimulation doses, as these prior art references are directed to titrating stimulation parameters based on patient feedback. One would be motivated to do this to be able to determine the therapeutically effective, tolerable, and safe therapy dosage levels, as recognized by Osorio ([0027[]).
Regarding claim 2, Torgerson in view of Osorio teaches the system of claim 1 (as shown above). Torgerson further discloses wherein the patient feedback comprises one or more of a physiological signal ([0103] “a compound action potential in the target tissue site of patient 12”), a patient input ([0103] “receive patient input”), or patient posture data ([0103] “In some example, processor 210 may initiate the adjustment to the therapy based on patient activity. For example, processor 210 may determine the patient has transitioned from a prone position to a sitting position, from a prone position to a supine position, from a sitting position to a running position, etc.”, [0026]).
Regarding claim 3, Torgerson in view of Osorio teaches the system of claim 2 (as shown above). Torgerson further discloses, wherein the physiological signal comprises one of an evoked compound action potential (ECAP) ([0067] “Sensor 212 may output patient parameter values that may be used as feedback to control delivery of therapy.”, [0048] “IMD 102 receives a signal indicative of the compound action potential from one or more sensors internal or external to patient 12. Such an example signal may include a signal indicating an electrically-evoked compound action potential (eCAP) of the tissue of the patient 12”).
Regarding claim 4, Torgerson in view of Osorio teaches the system of claim 2 (as shown above). Torgerson further discloses wherein the patient input comprises one of an amount of paresthesia ([0023] “input from the patient indicating that he/she is experiencing paresthesia”).
Regarding claim 5, Torgerson in view of Osorio teaches the system of claim 2 (as shown above). Torgerson further discloses wherein the patient posture data comprises one of a patient position, a patient movement ([0104] “IMD may receive a signal from an accelerometer, a pressure sensor, a bending sensor, a sensor configured to detect a posture of patient 12, or a sensor configured to detect a respiratory function of patient 12. Such a sensor, for example, may be configured to detect when patient 112 is running, walking, standing, sitting, laying down, prone, supine, and the like (e.g., for a posture sensor)”).
Regarding claim 7, Torgerson in view of Osorio teaches the system of claim 1 (as shown above). Torgerson further discloses wherein the cycling frequency of the second cycling is less than the cycling frequency of the first cycling ([0083] “upon detecting the evoked compound action potential, processor 210 automatically titrates one or more parameters defining the plurality of electrical stimulation therapy programs, for example, a voltage amplitude (for voltage controlled devices), a current amplitude (for current-controlled devices), a pulse width, or a pulse frequency, to gradually reduce the magnitude of the one or more parameters defining the plurality of electrical stimulation therapy programs”).
Regarding claim 8, Torgerson in view of Osorio teaches the system of claim 1 (as shown above). Torgerson further discloses wherein one of the amplitude, pulse width, or pulse frequency of the second electric stimulation doses of the second cycling is less than the amplitude, pulse width, or pulse frequency of the first electric stimulation doses of the first cycling ([0083] “upon detecting the evoked compound action potential, processor 210 automatically titrates one or more parameters defining the plurality of electrical stimulation therapy programs, for example, a voltage amplitude (for voltage controlled devices), a current amplitude (for current-controlled devices), a pulse width, or a pulse frequency, to gradually reduce the magnitude of the one or more parameters defining the plurality of electrical stimulation therapy programs”).
Regarding claim 15, Torgerson discloses a computer readable medium comprising instructions that when executed cause one or more processors to ([0124] “The techniques described in this disclosure may also be embodied or encoded in a computer-readable medium, such as a computer-readable storage medium, containing instructions. Instructions embedded or encoded in a computer-readable storage medium may cause a programmable processor, or other processor, to perform the method, e.g., when the instructions are executed.”):
determine, for a patient, a first cycling of first electric stimulation doses ([0101]-[0102]: “Processor 210 may control the delivery of electrical stimulation therapy according to one or more electrical stimulation therapy programs defining the therapy…delivery of electrical stimulation therapy to patient 12 according to the one or more electrical stimulation programs (402)”, Figure 4: step 402, The initial therapy program that is delivered is interpreted to be the first cycling of electrical doses.);
deliver the first electric stimulation doses according the determined first cycling ([0101]-[0102]: “Processor 210 may control the delivery of electrical stimulation therapy according to one or more electrical stimulation therapy programs defining the therapy…delivery of electrical stimulation therapy to patient 12 according to the one or more electrical stimulation programs (402)”, Figure 4: step 402, The initial therapy program that is delivered is interpreted to be the first cycling of electrical doses.);
receive patient feedback representing a response of the patient to the first electric stimulation doses delivered according to the first cycling (Step 504,[0103] “Processor 210 may determine that the compound action potentials are evoked by sensing the compound action potential via electrodes 116, 118, or other sensing device. In other examples, processor 210 may receive patient input indicating that the patient is experiencing paresthesia.”);
determine, based on the patient feedback, a second cycling of second electric stimulation doses (Step 506,[0102] “processor 210 determines when the delivered electrical stimulation 402 evokes a compound action potential and adjusts the stimulation therapy in response to the determination (404)”, [0103] “In response to the receipt of the patient input, processor 210 may adjust the electrical stimulation therapy.” The adjusted electrical stimulation therapy is interpreted to be the second cycling of the electrical stimulation doses.); and
deliver the second electric stimulation doses to the patient according the determined second cycling ([0114] “In response to detecting an evoked compound action potential, IMD 102 reduces the magnitude of the amplitude of the electrical stimulation therapy program to a default or preprogrammed magnitude and resumes delivery of electrical stimulation therapy (606)” , [0110] “subsequent delivery of the electrical stimulation therapy.”), wherein delivering the second electric stimulation doses for the patient according to the determined second cycling consumes less power of an implanted device than delivering the first electric stimulation doses for the patient according to the determined first cycling ([0028] “the system may perform titration of one or more parameters defining the electrical stimulation therapy delivered to the patient to adjust the electrical stimulation therapy such that the electrical stimulation provides efficacious therapy to the patient (e.g., by providing pain relief) while remaining substantially below a threshold that evokes a compound action potential in the tissue of the patient (e.g., an amplitude having a magnitude 5%, 10%, 15%, or 20% below a threshold amplitude that evokes a compound action potential). Generally speaking, the lower the amplitude, the less risk of evoking compound action potentials in the tissue of patient 12 and the less power consumption by IMD 102.”)
wherein one or both of an amount of on-time of each cycle or a frequency of the second cycling is less than one or both of a corresponding amount of on-time of each cycle or a corresponding frequency of the first cycling ([0083] “upon detecting the evoked compound action potential, processor 210 automatically titrates one or more parameters defining the plurality of electrical stimulation therapy programs, for example, a voltage amplitude (for voltage controlled devices), a current amplitude (for current-controlled devices), a pulse width, or a pulse frequency, to gradually reduce the magnitude of the one or more parameters defining the plurality of electrical stimulation therapy programs”),
wherein the patient feedback comprises one or more of a physiological signal ([0103] “a compound action potential in the target tissue site of patient 12”), a patient input ([0103] “receive patient input”), patient posture data ([0103] “In some example, processor 210 may initiate the adjustment to the therapy based on patient activity. For example, processor 210 may determine the patient has transitioned from a prone position to a sitting position, from a prone position to a supine position, from a sitting position to a running position, etc.”, [0026]), an evoked compound action potential (ECAP) ([0067] “Sensor 212 may output patient parameter values that may be used as feedback to control delivery of therapy.”, [0048] “IMD 102 receives a signal indicative of the compound action potential from one or more sensors internal or external to patient 12. Such an example signal may include a signal indicating an electrically-evoked compound action potential (eCAP) of the tissue of the patient 12”) an amount of paresthesia ([0023] “input from the patient indicating that he/she is experiencing paresthesia”).
Torgerson fails to explicitly disclose wherein the first cycling defines a first stimulation on-time and a first stimulation off-time for the first electrical stimulation doses and wherein the second cycling defines a second stimulation on-time and a second stimulation off-time for the second electrical stimulation doses.
However, Osorio teaches a medical device system and method capable of automated titration of an electrical therapy provided by an implantable medical device ([0002]) wherein “the titration may involve increasing or decreasing electrical therapy parameters, and may comprise adjusting one or more parameters (e.g., current (or voltage) amplitude, frequency, pulse width, on-time, off-time, and/or duty cycle) defining the therapy by incremental changes from the first value to the target value." ([0027], view Figure 8) and wherein “the electrical therapy signal may be characterized by a plurality of parameters, e.g., an amplitude, a pulse width, a pulse frequency, a signal on-time, or a signal off-time, among others. The electrical therapy module 150 may be configured to deliver an electrical therapy signal having a low initial or first value of one or more parameters upon initiation of the treatment regimen." ([0041]).
Although, a first on-time, first off-time, second on-time, and second off-time isn’t explicitly stated in Osorio it would be obvious to one skilled in the art that since the electrical therapy is characterized by an on-time and off-time ([0041]) and as shown in Figure 8, Block 810-830 the device delivers the therapy at the first (initial values) for electrical therapy parameters programmed into the medical device ([0069], Examiner interprets these electrical therapy parameters to be the first on-time and first off-time) and which is then titrated and the presence of an adverse event is detected, if no adverse event is detected and the target value has not been reached the parameters are adjusted again or if an adverse event is detected the parameter is reduced to a prior tolerable value ([0071]-[0072] Examiner interprets the next titrated parameter values to be the second on-time and second off-time). Examiner would also like to note that the adverse effect/event is selected from discomfort, pain, dyspnea, increase/decreased heart rate ([0004]10.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torgerson to incorporate the teachings of Osorio to have wherein the first cycling defines a first stimulation on-time and a first stimulation off-time for the first electrical stimulation doses and wherein the second cycling defines a second stimulation on-time and a second stimulation off-time for the second electrical stimulation doses, as these prior art references are directed to titrating stimulation parameters based on patient feedback. One would be motivated to do this to be able to determine the therapeutically effective, tolerable, and safe therapy dosage levels, as recognized by Osorio ([0027[]).
Regarding claim 16, Torgerson discloses a method of titrating a therapy ([0004] “medical devices, systems, and techniques for automatically adjusting electrical stimulation therapy delivered to a patient”), the method comprising:
determining, for a patient, a first cycling of first electric stimulation doses ([0101]-[0102]: “Processor 210 may control the delivery of electrical stimulation therapy according to one or more electrical stimulation therapy programs defining the therapy…delivery of electrical stimulation therapy to patient 12 according to the one or more electrical stimulation programs (402)”, Figure 4: step 402, The initial therapy program that is delivered is interpreted to be the first cycling of electrical doses.);
delivering, via an implanted device (IMD 102), the first electric stimulation doses to the patient according the determined first cycling ([0101]-[0102]: “Processor 210 may control the delivery of electrical stimulation therapy according to one or more electrical stimulation therapy programs defining the therapy…delivery of electrical stimulation therapy to patient 12 according to the one or more electrical stimulation programs (402)”, Figure 4: step 402, The initial therapy program that is delivered);
receiving patient feedback representing a response of the patient to the first electric stimulation doses delivered according to the first cycling (Step 504,[0103] “Processor 210 may determine that the compound action potentials are evoked by sensing the compound action potential via electrodes 116, 118, or other sensing device. In other examples, processor 210 may receive patient input indicating that the patient is experiencing paresthesia.”);
determining, based on the patient feedback, a second cycling of the second electric stimulation doses (Step 506,[0102] “processor 210 determines when the delivered electrical stimulation 402 evokes a compound action potential and adjusts the stimulation therapy in response to the determination (404)”, [0103] “In response to the receipt of the patient input, processor 210 may adjust the electrical stimulation therapy.” The adjusted electrical stimulation therapy is interpreted to be the second cycling of the electrical stimulation doses.); and
delivering, via the implanted device, the second electric stimulation doses to the patient according the determined second cycling ([0114] “In response to detecting an evoked compound action potential, IMD 102 reduces the magnitude of the amplitude of the electrical stimulation therapy program to a default or preprogrammed magnitude and resumes delivery of electrical stimulation therapy (606)” , [0110] “subsequent delivery of the electrical stimulation therapy.”), wherein delivering the second electric stimulation doses for the patient according to the determined second cycling consumes less power of the implanted device than delivering the first electric stimulation doses for the patient according to the determined first cycling ([0028] “the system may perform titration of one or more parameters defining the electrical stimulation therapy delivered to the patient to adjust the electrical stimulation therapy such that the electrical stimulation provides efficacious therapy to the patient (e.g., by providing pain relief) while remaining substantially below a threshold that evokes a compound action potential in the tissue of the patient (e.g., an amplitude having a magnitude 5%, 10%, 15%, or 20% below a threshold amplitude that evokes a compound action potential). Generally speaking, the lower the amplitude, the less risk of evoking compound action potentials in the tissue of patient 12 and the less power consumption by IMD 102.”).
Torgerson fails to explicitly disclose wherein the first cycling defines a first stimulation on-time and a first stimulation off-time for the first electrical stimulation doses and wherein the second cycling defines a second stimulation on-time and a second stimulation off-time for the second electrical stimulation doses.
However, Osorio teaches a medical device system and method capable of automated titration of an electrical therapy provided by an implantable medical device ([0002]) wherein “the titration may involve increasing or decreasing electrical therapy parameters, and may comprise adjusting one or more parameters (e.g., current (or voltage) amplitude, frequency, pulse width, on-time, off-time, and/or duty cycle) defining the therapy by incremental changes from the first value to the target value." ([0027], view Figure 8) and wherein “the electrical therapy signal may be characterized by a plurality of parameters, e.g., an amplitude, a pulse width, a pulse frequency, a signal on-time, or a signal off-time, among others. The electrical therapy module 150 may be configured to deliver an electrical therapy signal having a low initial or first value of one or more parameters upon initiation of the treatment regimen." ([0041]).
Although, a first on-time, first off-time, second on-time, and second off-time isn’t explicitly stated in Osorio it would be obvious to one skilled in the art that since the electrical therapy is characterized by an on-time and off-time ([0041]) and as shown in Figure 8, Block 810-830 the device delivers the therapy at the first (initial values) for electrical therapy parameters programmed into the medical device ([0069], Examiner interprets these electrical therapy parameters to be the first on-time and first off-time) and which is then titrated and the presence of an adverse event is detected, if no adverse event is detected and the target value has not been reached the parameters are adjusted again or if an adverse event is detected the parameter is reduced to a prior tolerable value ([0071]-[0072] Examiner interprets the next titrated parameter values to be the second on-time and second off-time). Examiner would also like to note that the adverse effect/event is selected from discomfort, pain, dyspnea, increase/decreased heart rate ([0004]10.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torgerson to incorporate the teachings of Osorio to have wherein the first cycling defines a first stimulation on-time and a first stimulation off-time for the first electrical stimulation doses and wherein the second cycling defines a second stimulation on-time and a second stimulation off-time for the second electrical stimulation doses, as these prior art references are directed to titrating stimulation parameters based on patient feedback. One would be motivated to do this to be able to determine the therapeutically effective, tolerable, and safe therapy dosage levels, as recognized by Osorio ([0027[]).
Regarding claim 17, Torgerson in view of Osorio teaches the method of claim 16 (as shown above). Torgerson further discloses wherein the patient feedback comprises one or more of a physiological signal ([0103] “a compound action potential in the target tissue site of patient 12”), a patient input ([0103] “receive patient input”), or patient posture data ([0103] “In some example, processor 210 may initiate the adjustment to the therapy based on patient activity. For example, processor 210 may determine the patient has transitioned from a prone position to a sitting position, from a prone position to a supine position, from a sitting position to a running position, etc.”, [0026]).
Regarding claim 18, Torgerson in view of Osorio teaches the method of claim 17 (as shown above). Torgerson further discloses wherein the physiological signal comprises one of an evoked compound action potential (ECAP) ([0067] “Sensor 212 may output patient parameter values that may be used as feedback to control delivery of therapy.”, [0048] “IMD 102 receives a signal indicative of the compound action potential from one or more sensors internal or external to patient 12. Such an example signal may include a signal indicating an electrically-evoked compound action potential (eCAP) of the tissue of the patient 12”).
Regarding claim 19, Torgerson in view of Osorio teaches the method of claim 17 (as shown above). Torgerson further discloses wherein the patient input comprises one of an amount of paresthesia ([0023] “input from the patient indicating that he/she is experiencing paresthesia”).
Regarding claim 20, Torgerson in view of Osorio teaches the method of claim 17 (as shown above). Torgerson further discloses wherein the patient posture data comprises one of a patient position, a patient movement ([0104] “IMD may receive a signal from an accelerometer, a pressure sensor, a bending sensor, a sensor configured to detect a posture of patient 12, or a sensor configured to detect a respiratory function of patient 12. Such a sensor, for example, may be configured to detect when patient 112 is running, walking, standing, sitting, laying down, prone, supine, and the like (e.g., for a posture sensor)”).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Torgerson in view of Osorio as applied to claim 1 above, and further in view of Chavan et al. (US 2012/0095530 A1), hereinafter Chavan.
Regarding claim 6, Torgerson in view of Osorio discloses the system of claim 1 (as shown above). Although, Osorio further discloses, Torgerson and Osorio, alone or in combination fail to teach wherein: a ratio between the first stimulation on-time and the first stimulation off-time defines a first duty cycle, a ratio between the second stimulation on-time and the second stimulation off-time defines a second duty cycle, and the second duty cycle is less than the first duty cycle.
However, Chavan et al. (US 2012/0095530 A1) teaches a neurostimulation system that adjusts stimulation parameters according to a patient’s physical state such as posture and/or activity level ([0002]) wherein “the duty cycle is the ratio of on-time (time period during which the neurostimulation pulses are delivered) to off-time (time period during which the neurostimulation pulses are not delivered)” ([0138]) and “At 2506, the duty cycle is changed (increased or decreased) in response to the request” ([0138], view Figure 25).
Although, Chavan does not explicitly disclose that the second duty cycle is less than the first duty cycle, it would have been obvious to one skilled in the art that when the duty cycle is decreased at 2506 a second dose is defined which would have a duty cycle that is less than the duty cycle of the original dose that was delivered before the duty cycle was changed.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torgerson and Osorio to incorporate the teachings of Chavan to have a ratio between the first stimulation on-time and the first stimulation off-time defines a first duty cycle, a ratio between the second stimulation on-time and the second stimulation off-time defines a second duty cycle, and the second duty cycle is less than the first duty cycle, as these prior art references are directed to adjusting/titrating neurostimulation parameters based on patient feedback/input. One would be motivated to do this to arrive at the optimal electrical stimulation parameters.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Torgerson in view of Osorio as applied to claim 1 above, and further in view of Gerber et al. (US Patent 8,032,229 B2, previously cited), hereinafter Gerber.
Regarding claim 9, Torgerson in view of Osorio teaches the system of claim 1 (as shown above). Torgerson and Osorio, alone or in combination, fail to explicitly teach, wherein the processing circuitry is further configured to: determine based on the patient feedback, an intermediate cycling of third electrical stimulation doses, wherein the intermediate cycling is at least partially defined by an intermediate stimulation on-time and an intermediate stimulation off-time for the electrical stimulation doses; and deliver the third electrical stimulation doses to the patient according to do the determined intermediate cycling, wherein at least one of the intermediate stimulation on-time is greater than the first stimulation on-time, a cycling frequency of the intermediate cycling is greater than a cycling frequency of the first cycling, or an amplitude, pulse width, or pulse frequency of the electrical stimulation doses of the intermediate cycling is greater than an amplitude, pulse width, or pulse frequency of the first electrical stimulation doses of the first cycling.
However, Gerber teaches a system and method for adjusting a therapy delivered to a patient based on a sensed patient parameter (Abstract) wherein the processing circuitry is further configured to: determine based on the patient feedback, an intermediate cycling of the third electrical stimulation doses (Column 3, lines 57-67: “The processor controls the medical device to deliver the therapy to the patient according to a first therapy program associated with a first value of the patient parameter detected via the sensor, detect a change in the first value to a second value of the patient parameter detected via the sensor, identify a third value patient parameter within the data structure that is closest to the second value, wherein the third value is associated with a second therapy program within the data structure, and interpolate at least one therapy parameter between therapy parameters of the first and second therapy programs to generate an intermediate therapy program.”), wherein the intermediate cycling is at least partially defined by an intermediate stimulation on-time and an intermediate stimulation off-time for the electrical stimulation doses (Column 6, lines 8-17: “A therapy program may be defined by a set of one or more therapy parameters that define an aspect of the therapy delivered by IMD 12. For example, a program that controls delivery of stimulation by IMD 12 in the form of pulses may define…a cycle of stimulation delivery (e.g., a timing of when IMD 12 is in an on mode or an off/sleep mode) and so forth.”, Column 2, lines 3-9: “Each therapy program may define one or more therapy parameters such as…stimulation cycling (e.g., on/off times of an electrical stimulator) or frequency or dosage of drug delivery.”) ; and deliver the third electrical stimulation doses to the patient according to do the determined intermediate cycling (Column 7, lines 54-60: “After selecting a program or generating an intermediate program by interpolating between the therapy parameters of two therapy programs based on a sensed patient parameter value, programming device 20 may send commands to IMD 12 based on therapy information stored in the table to implement closed-loop delivery of therapy.”), wherein at least one of the intermediate stimulation on-time is greater than the first stimulation on-time , a cycling frequency of the intermediate cycling is greater than a cycling frequency of the first cycling, or an amplitude, pulse width, or pulse frequency of the electrical stimulation doses of the intermediate cycling is greater than an amplitude, pulse width, or pulse frequency of the first electrical stimulation doses of the first cycling (Column 18, lines 50-57: “Processor 34 may also implement a linear interpolation algorithm or a nonlinear interpolation algorithm to determine the therapy parameters, such as voltage or current amplitude, pulse width or pulse frequency of electrical stimulation, for the intermediate program. The shifting of stimulation energy between two programs, e.g., between the electrode combinations of FIGS. 7A and 7C may be implemented via any suitable technique.”, Column 19, lines 16-20: “For example, to shift between therapy program 1 (FIG. 7A) and an interpolated therapy program (FIG. 7C),…the amplitude of current provided to electrode 30D on lead 16A is increased.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torgerson and Osorio to incorporate the teachings of Gerber to have the processing circuitry is further configured to: determine based on the patient feedback, an intermediate cycling of third electrical stimulation doses, wherein the intermediate cycling is at least partially defined by an intermediate stimulation on-time and an intermediate stimulation off-time for the electrical stimulation doses; and deliver the third electrical stimulation doses to the patient according to do the determined intermediate cycling, wherein at least one of the intermediate stimulation on-time is greater than the first stimulation on-time, a cycling frequency of the intermediate cycling is greater than a cycling frequency of the first cycling, or an amplitude, pulse width, or pulse frequency of the electrical stimulation doses of the intermediate cycling is greater than an amplitude, pulse width, or pulse frequency of the first electrical stimulation doses of the first cycling., as these prior art references and the instant application are directed to adjusting stimulation parameters based on patient feedback. One would be motivated to do this as an intermediate cycling allows for a gradual transition between the first and second therapy programs to prevent the patient from noticing any abrupt changes in therapy, as recognized by Gerber (Column 10, lines 55-67).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Torgerson in view of Osorio as applied to claim 1 above, and further in view of Brink et al. (US 2018/0154144 A1, previously cited), hereinafter Brink.
Regarding claim 10, Torgerson in view of Osorio teaches the system of claim 1 (as shown above). Torgerson and Osorio, alone or in combination, fail to explicitly teach wherein the processing circuitry is further configured to: receive patient feedback representing a response of the patient to the second electric stimulation doses according to the second cycling; determine, based on the patient feedback representing the response, to deliver the first electric stimulation doses to the patient according to the first cycling; and deliver the first electric stimulation doses to the patient according the first cycling.
However, Brink teaches an implantable medical device that may control delivery of electrical stimulation therapy based on feedback received from patient ([0055]) wherein the processing circuitry is further configured to: receive patient feedback representing a response of the patient to the second electric stimulation doses according to the second cycling (Figure 5: step 508); determine, based on the patient feedback representing the response, to deliver the first electric stimulation doses to the patient according to the first cycling; and deliver the first electric stimulation doses to the patient according the first cycling ([0108] “In response to detecting that the urinary activity has ceased (508), processing circuitry 210 of IMD 102 controls stimulation generator 202 to cease delivery of the electrical stimulation therapy comprising the second electrical stimulation pulses and deliver electrical stimulation therapy comprising the first electrical stimulation pulses (502).”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torgerson in view of Osorio to incorporate the teachings of Brink to have the processing circuitry is further configured to: receive patient feedback representing a response of the patient to the second electric stimulation doses according to the second cycling; determine, based on the patient feedback representing the response, to deliver the first electric stimulation doses to the patient according to the first cycling; and deliver the first electric stimulation doses to the patient according the first cycling, as these prior art references and the instant application are directed to titrating neurostimulation parameters based on patient feedback. One would be motivated to do this as first cycling may be considered to be the effective or beneficial stimulation rather than the second cycling, therefore it is revered back to first cycling.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Torgerson in view of Osorio as applied to claim 1 above, and further in view of King et al. (US 2014/0350636 A1, previously cited), hereinafter King.
Regarding claim 11, Torgerson in view of Osorio teaches the system of claim 1 (as shown above). Torgerson and Osorio, alone or in combination, fail to explicitly teach wherein the processing circuitry is further configured to: determine, for the patient, a third cycling of third electric stimulation doses, wherein the third cycling defined a third stimulation on-time and a third stimulation off-time for third electrical stimulation doses; deliver the third electric stimulation doses to the patient according the determined third cycling; receive patient feedback representing a response of the patient to the third electric stimulation doses delivered according to the third cycling; determine, based on the patient feedback, a fourth cycling of fourth electric stimulation doses, wherein the fourth cycling is at least partially defined by a fourth stimulation on-time and a fourth stimulation off-time for the fourth electrical stimulation doses; and deliver the fourth electric stimulation doses to the patient according the determined fourth cycling, wherein delivering the second electric stimulation doses for the patient according to the determined fourth cycling consumes less power of the implanted device than delivering the third electric stimulation doses for the patient according to the determined third cycling.
However, King teaches a closed-loop therapy system may include a sensing module that senses a physiological parameter of the patient and controls the stimulation based on the detected patient state (Abstract) wherein the processing circuitry ([0158] “processor 44 of IMD 14 is primarily referred to in the description of FIGS. 15A and 15B”) is further configured to: determine, for the patient, a third cycling of third electric stimulation doses (Figure 15B: step 158), wherein the third cycling defines a third stimulation on-time and a third stimulation off-time for third electrical stimulation doses ([0056] “therapy parameters, such as pulse amplitude, pulse width, pulse rate, electrode polarity and duty cycle. IMD 14 may deliver the PNFS according to a therapy program that defines values for each of a plurality of such therapy parameters.”, [0103] “processor 44 decreases the intensity of stimulation, such as by…modifying the frequency, duty cycle or pulse width of the stimulation signal.”, Examiner notes that although a third stimulation on-time and third stimulation off-time is not specifically recited, King’s therapy program is defined by therapy parameters such as duty cycle ([0056]_ which are also modified ([0103] in response to a physiological signal.); deliver third electric stimulation doses to the patient according the determined third cycling (Figure 15B: step 160); receive patient feedback representing a response of the patient to the third electric stimulation doses delivered according to the third cycling (Figure 15B:Step 136); determine, based on the patient feedback, a fourth cycling of fourth electric stimulation doses (Figure 15B: step 162), wherein the fourth cycling is at least partially defined by a fourth stimulation on-time and a fourth stimulation off-time for the fourth electrical stimulation doses ([0056] “therapy parameters, such as pulse amplitude, pulse width, pulse rate, electrode polarity and duty cycle. IMD 14 may deliver the PNFS according to a therapy program that defines values for each of a plurality of such therapy parameters.”, [0103] “processor 44 decreases the intensity of stimulation, such as by…modifying the frequency, duty cycle or pulse width of the stimulation signal.”, Examiner notes that although a third stimulation on-time and third stimulation off-time is not specifically recited, King’s therapy program is defined by therapy parameters such as duty cycle ([0056] which are also modified ([0103] in response to a physiological signal.); and deliver the fourth electric stimulation doses to the patient according the determined fourth cycling (Figure 15B: step 164), wherein delivering the fourth electric stimulation doses for the patient according to the determined fourth cycling consumes less power of the implanted device than delivering the third electric stimulation doses for the patient according to the determined third cycling ([0167] “ The technique shown in FIGS. 15A-15B may be used to determine a modification to a therapy program that increases the stimulation intensity and minimizes power usage in order to help conserve power source 48 of IMD 14 (FIG. 2A).”)
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torgerson and Osorio to incorporate the teachings of King to have the processing circuitry is further configured to: determine, for the patient, a third cycling of third electric stimulation doses, wherein the third cycling defined a third stimulation on-time and a third stimulation off-time for third electrical stimulation doses; deliver the third electric stimulation doses to the patient according the determined third cycling; receive patient feedback representing a response of the patient to the third electric stimulation doses delivered according to the third cycling; determine, based on the patient feedback, a fourth cycling of fourth electric stimulation doses, wherein the fourth cycling is at least partially defined by a fourth stimulation on-time and a fourth stimulation off-time for the fourth electrical stimulation doses; and deliver the fourth electric stimulation doses to the patient according the determined fourth cycling, wherein delivering the second electric stimulation doses for the patient according to the determined fourth cycling consumes less power of the implanted device than delivering the third electric stimulation doses for the patient according to the determined third cycling, as these prior art references and the instant application are directed to adjusting stimulation parameters based on patient feedback. One would be motivated to do this as this can help minimize the energy required while generating and delivering what is to be the efficacious stimulation therapy.
Regarding claim 12, Torgerson in view of Osorio in view of King teaches the system of claim 11 (as shown above). Torgerson and Osorio, alone or in combination, fail to teach wherein one or more of an electrode combination, an amplitude, and a pulse width of the first and second electric stimulation doses is different from a respective electrode combination, an amplitude, and a pulse width of the third and fourth electric stimulation doses.
However, King teaches wherein one or more of an electrode combination, an amplitude, and a pulse width of the first and second electric stimulation doses is different from a respective electrode combination, an amplitude, and a pulse width of the third and fourth electric stimulation doses ([0163] “The intensity of stimulation may be decreased (158) by modifying the same or a different therapy parameter value as the stimulation parameter modified in order to increase the intensity of stimulation (154). In addition, the intensity of stimulation may be decreased using a different rate than the rate used to increase the intensity (154).”, [0165] “processor 44 may modify the third therapy program to increase the intensity stimulation (162), thereby generating a fourth therapy program. In this iteration of increasing the intensity of stimulation, processor 44 may increase the intensity of stimulation by a smaller factor (e.g., a percentage or incremental parameter value) than the prior modification to increase the stimulation intensity (154).”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torgerson and Osorio to incorporate the teachings of King to have the one or more of an electrode combination, an amplitude, and a pulse width of the first and second electric stimulation doses is different from a respective electrode combination, an amplitude, and a pulse width of the third and fourth electric stimulation doses, as these prior art references and the instant application are directed to adjusting stimulation parameters based on patient feedback. One would be motivated to do this to be able to deliver an efficacious therapy, as recognized by King ([0159]).
Regarding claim 13, Torgerson in view of King teaches the system of claim 11 (as shown above) Torgerson fails to explicitly teach wherein the first cycling and third cycling are the same, wherein the second cycling and fourth cycling are the same.
However, King teaches “the intensity of stimulation may be decreased (158) by modifying the same or a different therapy parameter value as the stimulation parameter modified in order to increase the intensity of stimulation (154). In addition, the intensity of stimulation may be decreased using a different rate than the rate used to increase the intensity (154). That is, in some examples, processor 44 may increase the intensity of stimulation (154) by increasing the value of a stimulation parameter by a first percentage or value, and processor 44 may decrease the intensity of stimulation (158) by decreasing the value of the same stimulation parameter by a second percentage or value that is lower than the first percentage or value.” and “processor 44 may modify the third therapy program to increase the intensity stimulation (162), thereby generating a fourth therapy program. In this iteration of increasing the intensity of stimulation, processor 44 may increase the intensity of stimulation by a smaller factor (e.g., a percentage or incremental parameter value) than the prior modification to increase the stimulation intensity (154).” ([0165]).
It would have been obvious to one having ordinary skill in the art at the time of the invention to have the first cycling and third cycling are the same, and the second cycling and fourth cycling as the primary purpose of the titration is to deliver an effective stimulation therapy by testing different parameter values, additionally this can be done by a finite number of ways by either increasing or decreasing the parameters by a percentage of the parameter value (0-100%), for the recognized need of effective stimulation, one of ordinary skill in the art could have pursued the cycles in a way where the first and third cycles are the same, and the second and fourth cycles are the same, with reasonable expectation of success. Additionally, upon review of Applicant’s disclosure ([0087]), there appears to be no criticality for the first and third cycling being the same, wherein the second and fourth cycling being the same. Thus, one of ordinary skill in the art would have had a reasonable expectation of success in optimizing the parameters to make the first and third cycling the same, and the second and fourth cycling the same.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Torgerson in view Osorio in view of King as applied to claim 11 above, and further in view of Srivastava et al. (US 2019/0022397 A1, previously cited), hereinafter Srivastava.
Regarding claim 14, Torgerson in view of Osorio in view of King the system of claim 11 (as shown above). Torgerson and Osorio, alone or in combination, fail to teach wherein a frequency of the first cycling and the second cycling of the first electric stimulation doses corresponds to one of a voiding frequency or network excitability, and wherein a frequency of the third cycling and fourth cycling of the second electric stimulation doses corresponds to a circadian rhythm of the patient.
However, King teaches wherein “detectable efferent responses from delivery of PNFS to region 18 of patient 12 may result in a physiological effect that may be detected by monitoring a physiological parameter of patient, such as a heart rate, respiratory rate, electrodermal activity (e.g., galvanic skin response or skin conductance response), muscle activity (e.g., electromyogram (EMG)), blood flow rate, sweat gland activity, pilomotor reflex, or thermal activity of the patient's body.” ([0045]) and the cycling is adjusted based on received physiological signals (Figure 15A-15B: step 102).
Although, King does not explicitly state network excitability, King detects network excitability by measuring different physiological parameters ([0045]) which are used to adjust the first and third cycling frequencies. It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torgerson and Osorio to incorporate the teachings of King to have a frequency of the first cycling and the second cycling of the first electric stimulation doses corresponds to one of a voiding frequency or network excitability , as these prior art references are directed to adjusting stimulation based on patient feedback. One would be motivated to do this to be able to adjust the stimulation to be effective based on the signal.
Torgerson, Osorio, and King, alone or in combination fail to teach wherein a frequency of the third cycling and fourth cycling of the second electric stimulation doses corresponds to a circadian rhythm of the patient. However, Srivastava teaches systems and methods for managing pain of a subject using a closed-loop stimulation therapy (Abstract) wherein “the pain score is generated based on the functional signals, such as based on…sleep state signals…” ([0033]) and “delivering a pain therapy to the patient according to the pain score.” ([0110]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Torgerson, Osorio, and King to incorporate the teachings of Srivastava to have a frequency of the third cycling and fourth cycling of the second electric stimulation doses corresponds to a circadian rhythm of the patient, as these prior art references are directed to adjusting stimulation parameters based on patient feedback. One would be motivated to do this to be able to adjust the stimulation to be effective based on the signal.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/ATTIYA SAYYADA HUSSAINI/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792