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 Arguments
Applicant’s arguments filed 09/10/2025 have been fully considered but are moot in view of a new grounds of rejection.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“…using a feedback processing unit, to generate feedback” in claim 1.
In re claim 10, see in re claim 1 above.
In re claim 20, see in re claim 1 above.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 19 is 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.
In re claim 19, the limitation “the intensity” lacks antecedent basis. Appropriate correction is required.
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.
Claims 1, 5, 8, 10, 14, 17, and 19-20 rejected under 35 U.S.C. 103 as being unpatentable over Ólaighin et al (US 2022/0118256) in view of Tass (US 2021/0401664) in view of Hao et al. (US 2021/0369532).
In re claim 1, Ólaighin discloses a method for providing brain therapy [0001] to maintain neural synchronization through timed and controlled vibrational stimulation pulses ([0365]: electrical and mechanical stimulation may be applied; [0028-0029]), the method comprising:
stimulating for a first time interval ([0274]: duration of stimulation; [0312]) followed by a first delay interval (fig. 35A: stimulation is applied to a first set of arm/leg based on a first gait stride time and then there’s a delay dependent on when a next gait stride time is detected before stimulus to a second set of arm/leg is delivered; [0311-0314, 0278]), a first limb of a body ([0312]: detection of arm swing for instance a left arm) located on a first side of a median plane ([0312]: left arm will be on a first side of a median plane) and a top side of a transverse plane ([0309]: left arm is located on a top side of a transverse plane), while stimulating a second limb ([0313-0313]: right leg) located on a second, opposite side of the median plane and a second, bottom side of the transverse plane ([0312-0313]: stimulation delivered to the arm will result in simultaneous delivery of stimulus to a contralateral leg, which would be on the opposite side of the median and transverse plane of the left arm i.e. to the right leg);
subsequently stimulating during a second time interval followed by a second delay interval (see above where there’s a delay interval after stimulation is provided; [0277-0278]: bilateral cueing provides alternating stimulation to the left and right side to stimulate walking; [0311-0314]) a third limb located on a second side of the median plane and the top side of the transverse plane ([0311-0313]: the right arm will be stimulated next; [0277-0278]), while stimulating a fourth limb located on the first side of the median plane and the bottom side of the transverse plane ([0312-0313]: stimulation delivered to the right arm will result in simultaneous delivery of stimulus to a contralateral leg i.e. to the left leg; [0027, 0268]),
wherein
stimulation pulses include the
first time interval [0311-0314],
the first delay interval ([0311-0314]: delay before stimulation pulses to the next two limbs are provided),
the second time interval [0311-0314], and
the second delay interval [0311-0314], and
the median plane is defined as a vertical plane that divides the body into left and right halves (see above where the first side of the median plane consist of the left halves (left arm and leg) and the second side of the median plane consist of the right halves (right arm and leg)), and
the transverse plane is defined as a horizontal plane that divides the body into upper and lower parts (see above where the first side of the transverse plane consist of the lower part (legs) and the second side of the transverse plane consist of the upper sides (arms));
dynamically adjusting synchronization of the stimulation pulses to deliver stimulation across the first, second, third, and fourth limbs [0311-0312, 0365] based on timing signals generated by a software-controlled algorithm ([0029]: stimulation adjusted based on user’s gait cycle; [0038, 0167]),
wherein the first delay interval and the second delay interval are adjusted based on stimulation requirements of patient ([0311-0314]: delay intervals are adjusted based on patient’s gait cycle and detection of arm swing i.e. stimulation requirements of the patient to stimulate walking at appropriate times [0043]);
collecting real-time patient data ([0064]: modulate stimuli in real-time using closed loop control; [0285]: current gait cycle time predicted by measuring previous gait cycle times using a motion sensing system), including muscle activity ([0051]: motion sensing system disposed on leg and/or arm and would provide muscle activity when motion is sensed), using a feedback device [0051, 0285] positioned with the patient [0051, 0285];
processing the collected real-time patient data, using a feedback processing unit ([0285]: motion sensing system is processed to compute a predicted value for a current cycle time), to generate feedback ([0029]: cueing is activated based on gait cycle feedback; [0035]);
calibrating the synchronization of the stimulation pulses across the first, second, third, and fourth limbs by monitoring a ([0311-0312]: synchronization of the stimulation pulses is based on detection of the start of swing of a leg; [0319]: detection of the start of a swing is done through a motion sensing system which indirectly monitors neural activity because a patient moving their leg or arm will require some amount of neural activity from the patient so that the motion sensor can detect motion; [0034]) and recalculating the stimulation pulses based on the real-time patient data ([0311-0313]: stimulation pulses are determined based on detection of initial contact; [0064]: stimuli provided in real-time based on patient data; [0027]: recalculating the stimulation pulses is interpreted as determining if the stimulation pulses are provided on the left or right side of the patient; [0319-0320]); and
dynamically adjusting stimulation parameters in real time based on the feedback ([0029]: stimulation is adjusted to be provided at the right time; [0064]: stimuli is modulated in real-time using closed loop control; [0035, 0285]).
Ólaighin fails to explicitly disclose
dynamically adjusting synchronization of the stimulation pulses to deliver kinematic stimulation across the first, second, third, and fourth limbs based on timing signals generated by a software-controlled algorithm,
collecting real-time patient data, including muscle strength, using a feedback device positioned with the patient.
Tass teaches an treating brain disorders using stimulation [0004], and teaches dynamically adjusting synchronization of stimulation pulses ([0035]: timing of vibrotactile stimuli) to deliver kinematic stimulation across first, second, third, and fourth limbs ([0028]: vibratory stimulators 11-14 can be secured to arm, leg, hand, and foot; fig. 15: vibratory stimulators 11-14) based on timing signals [0035, 0082-0083].
Tass further teaches that depending on the brain disorder to be treated, vibration may be applied to different parts of the body of a patient [0028] to stimulate different target regions in the brain [0027], and treats various movement disorders [0007].
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 providing brain therapy taught by Ólaighin, to provide dynamically adjusting synchronization of the stimulation pulses to deliver kinematic stimulation across the first, second, third, and fourth limbs, as taught by Tass, because vibration may be applied to different parts of the body of a patient to stimulate different target regions in the brain, which treats various movement disorders.
Regarding the limitation, “collecting real-time patient data, including muscle strength, using a feedback device positioned with the patient”, Hao teaches an analogous rehabilitation system [0001] and teaches collecting real-time patient data [0107], including muscle strength ([0107]: real-time condition of patient’s core muscle strength parameters), using a feedback device ([0107]: first feedback device) positioned with a patient (fig. 4; [0030]: rehabilitation training equipment which is positioned with a patient includes the first feedback device).
Hao further teaches that the muscle strength parameters are used to dynamically adjust a rehabilitation training equipment [0009], so that a paralyzed patient’s core muscle strength is restored [0009].
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 providing brain therapy yielded by the proposed combination, to provide collecting real-time patient data, including muscle strength, using a feedback device positioned with the patient, as taught by Hao, because muscle strength is used to dynamically adjust a rehabilitation training equipment, so that a paralyzed patient’s core muscle strength is restored.
In re claim 5, the proposed combination yields (all mapping directed to Ólaighin unless otherwise stated) varying stimulation intensity between the first and second limbs, and the third and fourth limbs ([0361]: cueing may be delivered based on a point or event in the gait cycle which will affect the intensity between the first and second limbs and the third and fourth limbs since they occur at different times; [0029]),
with intensity modulation occurring in synchronization with timing based on the software-controlled algorithm [0065, 0361].
In re claim 8, the proposed combination yields (all mapping directed to Ólaighin unless otherwise stated) further comprising modulating intensity and frequency of the stimulation pulses in response to detected changes in heart rate of the patient ([0224]: heart rate used to detect impending FOG events so stimulation is delivered which requires modulating intensity and frequency of the stimulation pulses; [0012, 0214]).
In re claim 10, Ólaighin discloses a system for providing brain therapy to maintain neural synchronization through timed and controlled vibratory stimulation pulses ([0365]: both haptic and electrical stimulation may be provided; [0028-0029]), the system comprising:
a plurality of transducers ([0167]: electrical stimulation electrodes) configured to be positioned on
a first limb located on a first side of a median plane and a top side of a transverse plane, and (see in re claim 1 above and [0026]: cueing actuators disposed at cueing sites on each side of a patient’s body to provide bilateral stimulation)
a second limb located on a second, opposite side of the median plane and a bottom, opposite side of the transverse plane (see in re claim 1 above; [0026, 0058]), as well as
a third limb located on a second side of the median plane and the top side of the transverse plane (see in re claim 1 above; [0026, 0058]), and
a fourth limb located on the first side of the median plane and the bottom side of the transverse plane (see in re claim 1 above; [0026, 0058]);
a control unit operatively connected to the plurality of transducers [0058],
the control unit configured to generate and deliver a plurality of stimulation pulses to the transducers [0071]
wherein: stimulation pulses include:
a first time interval and a first delay interval delivered to the first limb and the second limb (see in re claim 1 above); and
a second time interval and a second delay interval delivered to the third limb and the fourth limb (see in re claim 1 above);
a timing circuit or software-controlled algorithm in the control unit, configured to dynamically adjust synchronization of the stimulation pulses across the first, second, third, and fourth limbs (see in re claim 1 above) by generating timing signals to deliver stimulation (see in re claim 1 above);
a feedback device positioned with a patient configured to, collect real-time patient data including muscle activity (see in re claim 1 above);
a feedback processing unit operatively connected to sensors configured to monitor physiological data of a patient ([0034]: controller activates cueing in response to signals from motion signals from a patient; [0064, 0085],
the feedback processing unit configured to process the collected real-time patient data to generate feedback (see in re claim 1 above); and
recalibrate ([0311-0314]: stimulation based on gait cycle) and adjust the synchronization of the stimulation pulses (see in re claim 1 above) based on stimulation requirements of the patient (see in re claim 1 above);
wherein the control unit is configured to adjust the synchronization of the stimulation pulses [0038-0039, 0311-0313]; and
dynamically adjusting stimulation parameters in real time based on the feedback (see in re claim 1 above).
Ólaighin fails to disclose
a timing circuit or software-controlled algorithm in the control unit, configured to dynamically adjust synchronization of the stimulation pulses across the first, second, third, and fourth limbs by generating timing signals to deliver kinetic stimulation;
a feedback device positioned with a patient configured to, collect real-time patient data including muscle strength.
Regarding the limitation, “…dynamically adjust synchronization of the stimulation pulses across the first, second, third, and fourth limbs by generating timing signals to deliver kinetic stimulation,” see the proposed combination yielded in re claim 1, where the proposed combination would be for the transducers (electrodes) of Ólaighin to be replaced with the vibratory stimulators of Tass, so that the software-controlled algorithm in the control unit is configured to dynamically adjust synchronization of the stimulation pulses across the first, second, third, and fourth limbs by generating timing signals to deliver kinetic stimulation.
Regarding the limitation, “a feedback device positioned with a patient configured to, collect real-time patient data including muscle strength”, see the proposed combination yielded in re claim 1 above.
In re claim 14, regarding the limitation, “wherein the control unit is further configured to vary stimulation intensity between the first and second limbs, and the third and fourth limbs, wherein intensity modulation occurs in synchronization with timing and is controlled by the software-controlled algorithm,” see in re claim 5 above.
In re claim 17, regarding the limitation, “wherein the control unit is further configured to modulate intensity and frequency of the stimulation pulses in response to detected changes in heart rate of the patient,” see in re claim 8 above.
In re claim 19, the proposed combination yields (all mapping directed to Ólaighin unless otherwise stated) wherein the control unit is further configured to dynamically adjust the synchronization and the intensity of the stimulation pulses based on real-time feedback signals measured by a plurality of sensors monitoring physiological data of the patient ([0152]: freezing of gait can be automatically detected using a range of sensors; [0246]: real-time close loop technique used to modulate stimuli; [0361]: intensity adjusted based on gait cycle; [0187, 0198]).
In re claim 20, Ólaighin discloses a non-transitory computer-readable medium [0026, 0040] storing instructions that [0026, 0040], when executed by one or more processors [0085, 0181-0182], cause a system to perform a method for providing brain therapy [0001, 0152] to maintain neural synchronization through timed and controlled vibratory stimulation pulses (see in re claim 1 above).
Regarding the limitations, “the method comprising:
stimulating for a first time interval followed by a first delay interval, a first limb of a body located on a first side of a median plane and a top side of a transverse plane, while stimulating a second limb located on a second, opposite side of the median plane and a bottom, opposite side of the transverse plane;
subsequently stimulating during a second time interval followed by a second delay interval a third limb located on a second side of the median plane and the top side of the transverse plane, while stimulating a fourth limb located on the first side of the median plane and the bottom side of the transverse plane;
wherein
stimulation pulses include the first time interval, the first delay interval, the second time interval, and the second delay interval, and
the median plane is defined as a vertical plane that divides the body into left and right halves, and
the transverse plane is defined as a horizontal plane that divides the body into upper and lower parts;
dynamically adjusting synchronization of the stimulation pulses to deliver kinetic stimulation across the first, second, third, and fourth the limbs based on timing signals generated by a software-controlled algorithm,
wherein the first delay interval and the second delay interval are adjusted based on stimulation requirements of patient;
collecting real-time patient data, including muscle strength, using a feedback device positioned with the patient;
processing the collected real-time patient data, using a feedback processing unit, to generate feedback;
calibrating the synchronization of the stimulation pulses across the limbs by monitoring and recalculating the timing signals based on the real-time patient data collected from patient-specific physiological parameters;
dynamically adjusting stimulation parameters in real time based on the feedback” ,
see the proposed combination yielded in re claim 1 above.
Regarding the limitations, “generating control signals to deliver the stimulation pulses to a plurality of transducers operatively connected to the limbs, said control signals ensuring that the synchronization of the stimulation pulses is maintained within specified timing intervals,” the proposed combination yields
generating control signals (Ólaighin: [0028]) to deliver the stimulation pulses to a plurality of transducers (Tass: proposed combination would yield vibratory stimulators 11-14 to be considered transducers; Ólaighin: [0309-0312]) operatively connected to the limbs ([0309-0313]: stimulation provided to limbs; [0072-0074]),
said control signals ensuring that the synchronization of the stimulation pulses is maintained within specified timing intervals (Ólaighin: [0038-0040, 0311-0314].
Claims 2-4, 6, 9, 11-13, 15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Ólaighin et al (US 2022/0118256) in view of Tass (US 2021/0401664) in view of Hao et al. (US 2021/0369532) in view of Ziv (US 2018/0028809).
In re claim 2, the proposed combination yields (all mapping directed to Ólaighin unless otherwise stated) wherein the synchronization timing of the stimulation pulses is dynamically adjusted, based on timing signals generated by the software-controlled algorithm see in re claim 1 above.
The proposed combination fails to yield wherein timing of the stimulation pulses is dynamically adjusted within a range of 100 to 200 milliseconds, based on the software-controlled algorithm.
Ziv teaches a stimulation therapy system [0007-0008] that
provides
simultaneous stimulation to a first acupoint pair (fig. 7: 1710a and 1710b; [0271]) and
simultaneous stimulation to a second acupoint pair (1720a and 1720b; [0271]),
wherein synchronization timing of stimulation pulses is dynamically adjusted within a range of 100 to 200 milliseconds ([0217]: 100-500 millisecond delay between the first acupoint pair and the second acupoint pair), based on timing signals generated by software-controlled algorithm [0072, 0223, 0271],
automatically adjusting a frequency [0215] and intensity [0214-0215] of the stimulation pulses based on real-time system feedback from the software-controlled algorithm [0214-0215; 0276], while maintaining synchronization within a range of less than 200 milliseconds ([0014]: each pulse is delayed between 100 millisecond to about 500 millisecond, which includes a range of less than 200 milliseconds)
wherein the synchronization of the stimulation pulses occurs with a delay of less than 150 milliseconds ([0014]: each pulse is delayed between 100 millisecond to about 500 millisecond, which includes a range of less than 150 milliseconds), based on clock-based synchronization signals [0014, 0103, 0135]
Ziv further teaches that the intensity can be increased in real-time until a muscle contraction sensor indicates a motor threshold has been reached [0214], and that stimulation parameters such as frequency and maximum intensity may be adjusted in real-time based on monitored physiological parameters [0215]. Additionally, Ziv teaches that a subsequent stimulation pulse can be “delayed by 1 μsec to 1 sec or by 10 μsec to 100 msec” [0092] respective of the first stimulation pulse [0092].
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 providing brain therapy yielded by the proposed combination, to provide wherein synchronization timing of stimulation pulses is dynamically adjusted within a range of 100 to 200 milliseconds, based on software-controlled algorithm, automatically adjusting a frequency and intensity of the stimulation pulses based on real-time system feedback from the software-controlled algorithm, while maintaining synchronization within a range of less than 200 milliseconds, wherein the synchronization of the stimulation pulses occurs with a delay of less than 150 milliseconds, based on clock-based synchronization signals, as taught by Ziv, because doing so allows for stimulation parameters such as frequency and intensity to be adjusted in real-time based on patient data, and because the synchronization of the stimulation pulses can be adjusted based on various values.
Additionally, at the time the instant application was filed it would be obvious to try to provide wherein the synchronization timing of the stimulation pulses is dynamically adjusted within a range of 100 to 200 milliseconds. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed synchronization timing of the stimulation pulses is not disclosed as being crucial or unexpected. Further, a person of ordinary skill in the art would consider a synchronization timing of the stimulation pulses that was high enough for the patient to receive therapeutic outcomes, but not too high because that could harm the patient.
Even if the proposed combination fails to yield “wherein the synchronization timing of the stimulation pulses is dynamically adjusted within a range of 100 to 200 milliseconds”, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the synchronization timing of the stimulation pulses is dynamically adjusted within a range of 100 to 200 milliseconds, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
In re claim 3, regarding the limitations, “further comprising automatically adjusting a frequency and intensity of the stimulation pulses based on real-time system feedback from the software-controlled algorithm, while maintaining synchronization within a range of less than 200 milliseconds”, see in re claim 2 above.
In re claim 4, regarding the limitations, “wherein the synchronization of the stimulation pulses occurs with a delay of less than 150 milliseconds, based on clock-based synchronization signals”, see in re claim 2 above.
In re claim 6, the proposed combination yields (all mapping directed to Ólaighin unless otherwise stated)
wherein the stimulation pulses are delivered in predetermined waveform patterns [0207],
The proposed combination fails to yield
wherein the stimulation pulses are delivered in predetermined waveform patterns selected from sinusoidal, square, or triangular,
with a waveform type being dynamically selected by a control system based on
system-specific feedback and
patient-specific neural response profiles.
Ziv teaches
wherein the stimulation pulses are delivered in predetermined waveform patterns selected from
sinusoidal [0090],
square [0090], or
triangular [0090],
with a waveform type being dynamically selected by a control system [0091, 0096] based on
system-specific feedback ([0215]: adjustment based on loop feedback circuitry),
feedback signal received from a plurality of sensors sensing physiological parameters of a patient ([0215, 0100]), and
patient-specific neural response profiles ([0267]: adjustment made based on neuro-stimulation; [0098]).
Ziv further teaches that different stimulation algorithms and corresponding sets (which includes waveforms [0276]) can be determined for different respective stimulation session goals [0277], and that real-time physiological data can be used to adjust waveform [0215]. Ziv additionally teaches that stimulation pulses can vary in waveform [0092], for instance first stimulation pulses may be sine waves [0092], while second stimulation pulses may be square waves [0092].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed t to modify the method for providing brain therapy yielded by the proposed combination, to provide wherein the stimulation pulses are delivered in predetermined waveform patterns selected from sinusoidal, square, or triangular, with a waveform type being dynamically selected by a control system based on system-specific feedback and patient-specific neural response profiles, as taught by Ziv, because different stimulation algorithms and sets can be determined for different stimulation session goals, and because real-time physiological data can be used to adjust waveform, for instance, first stimulation pulses may be sine waves while second stimulation pulses may be square waves.
In re claim 9, the proposed combination in re claim 6 above yields further comprising:
dynamically adjusting, via the control system,
the waveform type (see Ólaighin in view of Ziv in re claim 6 above),
intensity (Ólaighin : [0053-0054]), and
frequency (Ólaighin: [0065])
of the stimulation pulses based on feedback signal received from a plurality of sensors sensing physiological parameters of the patient (see Ólaighin in view of Ziv in re claim 6 in regards to waveform type; see Ólaighin in view of Ziv in re claim 19 in regards to intensity; see Ólaighin [0166]: patient’s characteristics used to adjust frequency and characteristics received from sensors [0177-0178]); and
dynamically adjusting the synchronization and the intensity of the stimulation pulses based on the feedback signal measured by the plurality of sensors (see in re claim 19 above).
In re claim 11, regarding the limitation, “wherein the control unit is further configured to adjust synchronization timing of the stimulation pulses within a range of 100 to 200 milliseconds, based on timing signals generated by the software-controlled algorithm,” see in re claim 2 above.
In re claim 12, regarding the limitation, “wherein the control unit is further configured to automatically adjust frequency and intensity of the stimulation pulses based on real-time feedback processed by the feedback processing unit, while maintaining synchronization within a range of less than 200 milliseconds,” see in re claim 3 above.
In re claim 13, regarding the limitation, “wherein the synchronization of the stimulation pulses occurs with a delay of less than 150 milliseconds, based on clock-based synchronization signals generated by the control unit,” see in re claim 4 above.
In re claim 15, regarding the limitation, “wherein the stimulation pulses are delivered in predetermined waveform patterns selected from sinusoidal, square, or triangular, and a waveform type is dynamically selected by the control unit based on feedback from patient-specific neural response profiles,” see in re claim 6 above.
In re claim 18, regarding the limitation, “wherein the control unit is further configured to dynamically adjust waveform type, intensity, and frequency of the stimulation pulses based on feedback signals received from a plurality of sensors configured to sense physiological parameters of the patient,” see in re claim 9 above.
Claims 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Ólaighin et al (US 2022/0118256) in view of Tass (US 2021/0401664) in view of Hao et al. (US 2021/0369532) in view of Gourine (US 2023/0293881).
In re claim 7, the proposed combination yields (all mapping directed to Ólaighin unless otherwise stated)
wherein the stimulation pulses are synchronized by distributing clock signals [0030-0031] to
a control unit [0038-0039] and
effectors ([0026]: cueing actuator; [0058]) and
wherein the synchronization of the stimulation pulses is further adjusted based on real-time measurements of electrical impedance ([0106]: skin impendence used to adjust stimulation).
The proposed combination fails to yield wherein the synchronization of the stimulation pulses is further adjusted based on real-time measurements of electrical impedance from electrodes attached to the body of the patient.
Gourine teaches wherein synchronization of the stimulation pulses is further adjusted based on measurements of electrical impedance from electrodes [0019] attached to a body of a patient ([0035-0036]: voltage and current adjusted in response to impedance).
Gourine further teaches that electrical impedance is used to sense that the electrodes are connected to the patient [0122], and that impedance can be used to control the stimulation to compensate for variation in conductivity [0036].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed t to modify the method for providing brain therapy yielded by the proposed combination, to provide wherein electrical impedance is measured from electrodes attached to the body of the patient, as taught by Gourine, because measuring electrical impedance from the electrodes senses whether or not the electrodes are connected to the patient, and because the impedance from the electrodes can be used to control the stimulation to compensate for variation in conductivity.
In re claim 16, regarding the limitation, “wherein the synchronization of the stimulation pulses is controlled by distributing clock signals to the control unit and the plurality of transducers, and further adjusted based on real-time measurements of electrical impedance from electrodes attached to a body of the patient,” see in re claim 7 above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Shen et al. (US 2022/0257185) discloses measuring motion of a shoe (abstract) wherein motion of a foot pushing of a ground [0059] is used to determine strength of leg muscles [0059].
Contact
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796