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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/27/2026 has been entered.
Response to Arguments
Applicant’s arguments filed 02/27/2026 have been fully considered but are not persuasive or are moot in view of a new grounds of rejection.
Applicant argues, “Gliner does not disclose providing test pulses at different amplitudes to determine a function of perception threshold versus amplitude.”
Examiner respectfully disagrees. Under broadest reasonable interpretation, the limitation “test pulses” is interpreted as any set of pulses which provide information, for instance, a set of pulses provided to a patient reads on the recited “test pulses” because the pulses would provide information regarding stimulation.
Further, Examiner asserts that Gliner teaches determining information for a patient during a testing procedure ([0071]: testing occurs with a test stimulation signal to determine a particular type of response) by providing test pulses to the patient ([0070-0073]: may generate or output stimulation signals in accordance with one or more mathematical operations and/or functions, which are interpreted as multiple test pulses and are done to avoid unnecessary suprathreshold stimulation).
Additionally, Examiner asserts that Gliner is used to teach the following limitations:
“wherein a perception threshold is determined for each pulse width,
determine from the pulse widths and the perception thresholds a function of perception threshold versus pulse width,
wherein the function is used to determine the information”,
and the recited “wherein the test pulses are provided at different pulses widths” is taught by Torgerson (Torgerson: [0096]: amplitudes adjustments are made for each pulse width; Torgerson: [0063-0064]: stimulation parameters are adjusted over time).
Applicant argues, “How then would Gliner determine a perception threshold value-which itself must be an amplitude as now claimed-for each pulse having a different amplitude? You can't: if you provide a pulse of with an amplitude (say for example 7 mA), that tells one nothing about perception threshold-i.e., what amplitude would comprise a lowest amplitude at which a patient can feel paresthesia (which for example might be R = 6 mA; see Gliner 71). Providing pulses of different amplitudes (for example, 3 mA, 5 mA, 7 mA) may allow you to determine R = 6 mA in Gliner. But you could not, and would, not determine a different perception threshold for each of these different tested amplitudes. The perception threshold-i.e., R = 6 mA-remains constant for any pulse amplitude that might be tested.”
Regarding the recited “lowest amplitude”, Examiner asserts that there is a new grounds of rejection.
Regarding the limitation, “wherein a perception threshold is determined for each pulse width”,
Examiner asserts that Torgerson teaches wherein an amplitude is determined for each pulse width [0096].
Torgerson fails to disclose wherein a perception threshold is determined for each pulse width [0096].
Gliner teaches:
wherein a perception threshold is determined for each amplitude ([0071-0073]: amplitude corresponds to a fraction of a sensation i.e. a sensation is determined for each amplitude),
determine from amplitudes and perception thresholds a function of perception threshold versus amplitude [0071-0073],
wherein the function is used to determine the information ([0071-0073]: function is used to determine stimulation parameter information).
Gliner further teaches that a subthreshold stimulation amplitude may be determined as a function of amplitude and a perceptible response [0071], and that stimulation signals may be generated based on this function [0072], so that unnecessary suprathreshold stimulation is avoided [0071-0073].
Examiner asserts that there is a relationship between amplitude and pulse width, as taught by Torgerson, which recites that a perceived intensity may be achieved by adjusting “a pulse amplitude, pulse width, or combination of pulse amplitude and pulse width” [0096]. Thus, in order to achieve a specific intensity, pulse width could have been adjusted instead of amplitude, due to the relationship between amplitude and pulse width in regards to intensity.
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for controlling a stimulator device of a patient taught by Torgerson, to provide wherein a perception threshold is determined for each pulse width, determine from the pulse widths and the perception thresholds a function of perception threshold versus pulse width, wherein the function is used to determine the information, as taught by Gliner using the function of perception threshold versus amplitude by providing test pulses at different amplitude, because a function of a perception threshold versus a stimulation parameter may be used to determine stimulation parameters that avoid unnecessary suprathreshold stimulation.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 9-13, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Torgerson (US 2017/0080232) in view of Gliner et al. (US 2006/0015153) in view of Goddard et al. (US 2013/0172956).
In re claim 1, Torgerson discloses a method for controlling a stimulator device of a patient [0005], the method comprising:
determining information for the patient during a testing procedure by providing test pulses ([0095-0096]: applied stimulation is based on a user selection and is therefore considered a test pulse because it’s used to adjust the next stimulation which occurs during a testing procedure i.e. during the adjustment of stimulation; [0063-0064]: each therapy program includes stimulation parameters that vary over time and stimulation is delivered according to therapy programs) to the patient [0096, 0063, 0083],
wherein the test pulses are provided at different pulses widths ([0096]: amplitudes adjustments are made for each pulse width; [0063-0064]: stimulation parameters are adjusted over time),
wherein an amplitude is determined for each pulse width [0096],
wherein each perception threshold comprises an amplitude at which the patient can feel paresthesia ([0096]: different sensations have different amplitudes to achieve a particular sensation);
determine from the pulse widths and the perception thresholds a relationship of perception threshold versus pulse width ([0095-0096]: particular sensation desired by patient is a perception threshold and may be achieved based on adjusting amplitude for each pulse width i.e. there is a relationship between amplitude, pulse width, and perception threshold)
wherein the relationship is used to determine the information ([0095-0096]: the relationship between pulse width and perception is used to determine what therapy program is selected to deliver the desired sensation, which is used to determine if further adjustment is needed),
wherein the information comprises a range [0069] or volume of stimulation parameters [0061, 0106] for the patient ([0088]: maximum and minimum pulse amplitude may be set by a user; [0061]: therapy parameters adjusted based on adjustment to characteristic of the sensation; [0029, 0069-0070]); and
executing instructions at a patient's stimulator device (fig. 2: 26) to provide therapeutic stimulation to the patient [0072-0073, 0075],
the instructions specifying
an amplitude [0072],
a pulse width [0072], and
a frequency [0106]
of stimulation pulses provided at one of more of electrodes (fig. 2: any one or more of electrodes 21A-H) in an electrode array of the stimulator device [0072],
wherein during the execution of the instructions [0072] at least one of the
amplitude [0061, 0082],
pulse width [0082], or
frequency [0061]
is automatically varied over time [0061, 0082] within the range or volume of stimulation parameters determined for the patient [0061, 0082].
Torgerson fails to disclose
wherein a perception threshold is determined for each pulse width,
wherein each perception threshold comprises a lowest amplitude at which the patient can feel paresthesia;
determine from the pulse widths and the perception thresholds a function of perception threshold versus pulse width,
wherein the function is used to determine the information.
Gliner teaches an analogous method [0037] for affecting neural stimulation efficiency [0037] and teaches
determining information for a patient during a testing procedure ([0071]: testing occurs with a test stimulation signal to determine a particular type of response) by providing test pulses to the patient ([0070-0073]: multiple stimulation signals may be outputted and therefore tested to avoid unnecessary suprathreshold stimulation),
wherein a perception threshold is determined for each amplitude ([0071-0073]: amplitude corresponds to a fraction of a sensation i.e. a sensation is determined for each amplitude),
determine from amplitudes and perception thresholds a function of perception threshold versus amplitude [0071-0073],
wherein the function is used to determine the information ([0071-0073]: function is used to determine stimulation parameter information).
Gliner further teaches that a subthreshold stimulation amplitude may be determined as a function of amplitude and a perceptible response [0071], and that stimulation signals may be generated based on this function [0072], so that unnecessary suprathreshold stimulation is avoided [0071-0073].
Examiner asserts that there is a relationship between amplitude and pulse width, as taught by Torgerson, which recites that a perceived intensity may be achieved by adjusting “a pulse amplitude, pulse width, or combination of pulse amplitude and pulse width” [0096]. Thus, in order to achieve a specific intensity, pulse width could have been adjusted instead of amplitude, due to the relationship between amplitude and pulse width in regards to intensity.
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for controlling a stimulator device of a patient taught by Torgerson, to provide wherein a perception threshold is determined for each pulse width, determine from the pulse widths and the perception thresholds a function of perception threshold versus pulse width, wherein the function is used to determine the information, as taught by Gliner using the function of perception threshold versus amplitude by providing test pulses at different amplitude, because a function of a perception threshold versus a stimulation parameter may be used to determine stimulation parameters that avoid unnecessary suprathreshold stimulation.
Regarding the limitation, “wherein each perception threshold comprises a lowest amplitude at which the patient can feel paresthesia”, Goddard teaches a method of providing electrical stimulation therapy [0001] by controlling amplitude [0001] and teaches wherein a perception threshold ([0007]: perception amplitude is when a patient detects stimulation) comprises a lowest amplitude at which the patient can feel paresthesia [0007].
Goddard further teaches that stimulation may be adjusted based on patient comfort [0040], for instance a minimum amplitude where a patient can feel paresthesia [0040].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for controlling a stimulator device of a patient yielded by the proposed combination, to provide wherein each perception threshold comprises a lowest amplitude at which the patient can feel paresthesia, as taught by Goddard using a lowest amplitude determined for a perception threshold, because stimulation may be adjusted based on patient comfort, for instance a minimum amplitude where a patient can feel paresthesia.
In re claim 2, Torgerson discloses wherein the information comprises a model specific to the patient [0106, 0096].
In re claim 3, Torgerson discloses wherein the instructions comprise a program [0096, 0103].
In re claim 4, regarding the limitations, “wherein during the execution of the instructions at least two of
the amplitude,
the pulse width, or
the frequency
are automatically varied over time within the range or volume”, see in re claim 1 above.
In re claim 5, regarding the limitations, “wherein during the execution of the instructions
the amplitude,
the pulse width, and
the frequency
are automatically varied over time within the range or volume”, see in re claim 1 above.
In re claim 9, Torgerson discloses
wherein the information comprises a range or volume of stimulation parameters information (see in re claim 1 above) indicative of a plurality of coordinates ([0096]: therapy parameters are modified based on desired stimulation sensation characteristics; [0069]: selected stimulation intensity may be used to determine stimulation parameters for a plurality of stimulation programs),
wherein each coordinate comprises
a frequency [0060, 0063-0064],
a pulse width [0096], and
an amplitude [0096].
In re claim 10, Torgerson discloses wherein the information comprises a line in a three- dimensional space of frequency, pulse width and amplitude ([0060]: frequency, pulse width, and amplitude may be adjusted to achieve desired sensation and are therefore considered a line in a three-dimension space).
In re claim 11, Torgerson discloses wherein the information comprises a volume in a three- dimensional space of frequency, pulse width and amplitude [0060, 0096].
In re claim 12, Torgerson discloses wherein the information is determined using an external device (fig. 3: 38; [0079]) in communication with the stimulator device [0061, 0095].
In re claim 13, Torgerson discloses wherein the information is determined during the testing procedure by determining a perception threshold for the test pulses [0056, 0064].
In re claim 15, the proposed combination fails to yield wherein the function is used to determine the information by comparing the function to a model relating frequency, pulse width, and paresthesia threshold.
Gliner teaches wherein the function is used to determine the information by comparing the function to a model relating frequency, pulse width, and paresthesia threshold ([0071-0072]: function is compared to a model i.e. mathematical operations corresponding to stimulation signal parameters such as frequency, pulse width, and threshold by avoiding unnecessary suprathreshold stimulation; [0063-0064, 0095, 0121]).
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for controlling a stimulator device of a patient taught by Torgerson, to provide wherein the function is used to determine the information by comparing the function to a model relating frequency, pulse width, and paresthesia threshold, as taught by Gliner, for substantially the same reasons as discussed in re claim 1 above.
In re claim 16, Torgerson discloses further comprising transmitting the information from the external device to the stimulator device [0061, 0095].
In re claim 17, Torgerson discloses
wherein the external device comprises a clinician programmer ([0080-0083]: user adjusts stimulation therapy parameters using user interface 38),
further comprising transmitting information from the clinician programmer to a patient external controller ([0080-0083]: processor 34 i.e. patient external controller receives instructions to adjust the stimulation parameters by providing the adjusted stimulation parameters to IMD 20; fig. 3: 34).
In re claim 18, Torgerson discloses
wherein the instructions comprise a plurality of boluses of stimulation ([0069]: determines stimulation parameters for a plurality of stimulation programs),
wherein during the instructions at least one of the
amplitude [0096],
pulse width [0096], or
frequency [0060]
is automatically varied over time within the range or volume (see in re claim 1 above) during each bolus [0069].
In re claim 19, Torgerson discloses wherein the information comprises a range or volume of stimulation parameters that provide the therapeutic stimulation as sub-perception stimulation for the patient ([0056]: stimulation may be provided to provide no side effects i.e. sub-perception stimulation).
In re claim 20, Torgerson discloses wherein the information comprises frequencies of 1 kHz or less [0084, 0091].
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Torgerson (US 2017/0080232) in view of Gliner et al. (US 2006/0015153) in view of Goddard et al. (US 2013/0172956) in view of Ben-Ezra et al. (US 2014/0046407).
In re claim 6, the proposed combination fails to yield wherein the stimulation pulses provided at one or more of the electrodes comprise a pole configuration.
Ben-Ezra teaches an analogous electrical stimulator of tissue [0012]
wherein stimulation pulses [1331] provided at an electrode (fig. 12A: 140; [1342]) comprise a pole configuration [1346] and
wherein the pole configuration comprises
at least one anode pole (fig. 12A: any one of anodes 144a or 144b) and
at least one cathode pole (146)
separated in an electrode array by a focus distance (fig. 12A).
Ben-Ezra further teaches that the pole configuration allows for selective recruitment of nerve fibers [1345] in a recruitment order that mimics a body’s natural order [1345-1346].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for controlling a stimulator device of a patient yielded by the proposed combination, to provide wherein the stimulation pulses provided at one or more of the electrodes comprise a pole configuration, as taught by Ben-Ezra, because the pole configuration allows for a selective recruitment order of nerve fibers that mimics a body’s natural order.
In re claim 7, the proposed combination fails to yield wherein during the execution of the instructions a position of the pole configuration in the electrode array is varied over time.
Ben-Ezra teaches wherein during execution of instructions [1345-1346, 1426] a position of the pole configuration in an electrode array [1332] is varied over time ([1346]: recruitment order changes over time therefore pole configuration position is varied over time).
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for controlling a stimulator device of a patient yielded by the proposed combination, to provide wherein during the execution of the instructions a position of the pole configuration in the electrode array is varied over time, as taught by Ben-Ezra, for substantially the same reasons as discussed in re claim 6 above.
In re claim 8, regarding the limitations “wherein the pole configuration comprises
at least one anode pole and
at least one cathode pole
separated in the electrode array by a focus distance”,
see in re claim 6 above.
The proposed combination fails to yield wherein during the execution of the instructions the focus distance is varied over time.
Ben-Ezra teaches wherein during execution of instructions (see in re claim 7 above) the focus distance is varied over time ([1334-1335]: position of anodes may be varied; [1346]).
Ben-Ezra further teaches that the position of the anode may be varied to regulate a relative impedance between the anode and the cathode [1335], and also allows features such as cathodic stimulation and desired activation function to be controlled [1335].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for controlling a stimulator device of a patient yielded by the proposed combination, to provide wherein during the execution of the instructions the focus distance is varied over time, as taught by Ben-Ezra, because the position of the anode may be varied to regulate a relative impedance between the anode and the cathode, and also allows features such as cathodic stimulation and desired activation function to be controlled.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Sieracki et al. (US 20070265678) discloses a stimulation device (abstract) used to deliver spinal cord stimulation therapy (abstract) to a patient (abstract), wherein a minimum perception amplitude [0031] is inputted for each calibration location [0031].
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
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