CTNF 18/937,888 CTNF 85428 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Information Disclosure Statement Applicant should note that the large number of references in the attached IDS, see IDS filed 11/5/2024, have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this Office Action. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-15-aia AIA Claim(s) 1 and 3-20 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by US 2020/0138324 to Sinclair et al. (Sinclair) . In reference to at least claim 1 Sinclair discloses a method for providing deep brain stimulation (DBS) to a patient’s brain using one or more electrode leads implanted in the patient’s brain (e.g. “The present disclosure relates to deep brain stimulation (DBS)”, para. [0002]), wherein each of the one or more electrode leads comprises a plurality of electrodes configured to contact the patient’s brain tissue (e.g. “The lead tip 70 comprises a first electrode 72 a , a second electrode 72 b , a third electrode 72 c , and a fourth electrode 72 d . Once implanted into the brain, each of the electrodes 72 a , 72 b , 72 c , 72 d may be used to apply a stimulus to one or more neural structures or monitor and optionally record the evoked response (including ERNA) from neural circuits”, para. [0225]), the method comprising: using one or more of the electrodes to provide non-therapeutic stimulation to the patient’s brain (e.g. “first stimulus and/or the second stimulus may be a therapeutic stimulus or a non-therapeutic stimulus”, para. [0026]) , wherein the non-therapeutic stimulation is configured to evoke first evoked neural resonant activity (ERNA) in the patient’s brain and is not configured to treat the patient’s symptoms (e.g. Fig. 5a, “The inventors have realised that by controlling the DBS parameters in certain ways, a non-therapeutic stimulus can be administered which evokes a resonant neural response (ERNA) in a patient without having any therapeutic impact “, para. [0190]) , using one or more of the electrodes to record first signals in the patient’s brain indicative of the first ERNA (e.g. “and the ERNA is measured during this period of no stimulation.”, para. [0190]) , wherein the first ERNA is indicative of the patient’s brain state in the absence of therapeutic stimulation (e.g. “the measured ERNA provides information concerning the patient's natural state (without therapy).”, para. [0190]) , using one of more of the electrodes to provide therapeutic stimulation to the patient’s brain (e.g. “first stimulus and/or the second stimulus may be a therapeutic stimulus or a non-therapeutic stimulus”, para. [0026]’ “selecting one or more of the at least one electrode to use for therapeutic stimulation”, para. [0055]) , wherein the therapeutic stimulation is configured to treat the patient’s symptoms, using one or more of the electrodes to record second signals indicative of second ERNA (e.g. “the inventors have determined that patterned stimulation can be used to monitor and analyse evoked resonant neural activity during therapeutic stimulation of a patient.”, para. [0191]), wherein the second ERNA is indicative of the patient’s brain state in the presence of therapeutic stimulation, comparing the first ERNA and the second ERNA (e.g. “comparing the different ERNA features, including relative differences between or spatial derivatives of amplitude, rate of decay, rate of change, and frequency, across different combinations of electrodes used for stimulation and measurement.”, para. [0243], [0238] “comparing the measured evoked responses at each electrode in response to stimulation at another electrode”, para. [0247], “since the application of non-therapeutic patterned stimulation also enhances HFO activity, such activity can be used to track the effects of medication, a disease state or to assist in the placement of electrodes or to decide which electrode of a plurality of electrodes positioned within the brain is the optimal electrode to use for stimulation “, para. [0274], “comparing the measured response with a template ERNA response, or by comparing a measured ERNA characteristic with a desired range”, para. [0275]) , and configuring the therapeutic stimulation based on the comparison (e.g. “comparing different ERNA features, including relative differences between or spatial derivatives of amplitude, rate of decay, rate of change, and frequency, across different combinations of electrodes used for stimulation and measurement.”, para. [0243],[0238] “comparing the measured evoked responses at each electrode in response to stimulation at another electrode, a determination can be made firstly of whether any of the electrodes are positioned within the target neural structure, secondly whether any of the electrodes are positioned at an optimum location within the target neural structure, and thirdly the direction and/or distance of a particular electrode from that target neural structure”, para. [0247], “since the application of non-therapeutic patterned stimulation also enhances HFO activity, such activity can be used to track the effects of medication, a disease state or to assist in the placement of electrodes or to decide which electrode of a plurality of electrodes positioned within the brain is the optimal electrode to use for stimulation “, para. [0274], “comparing the measured response with a template ERNA response, or by comparing a measured ERNA characteristic with a desired range”, para. [0275]). In reference to at least claim 3 Sinclair discloses wherein the therapeutic stimulation has a frequency of about 100 to about 150 Hz (e.g. “For example, a stimulus signal may comprise a series of 10-pulse bursts at 130 Hz.”, para. [0193]). In reference to at least claim 4 Sinclair discloses wherein comparing the first and second ERNA comprises extracting one or more features from the first and second signals (e.g. “Processing the evoked responses may involve comparing different ERNA features”, para. [0243], [0238]). In reference to at least claim 5 Sinclair discloses wherein the one or more features comprise one or more of a latency of one or more peaks and an amplitude of one or more peaks (e.g. “different ERNA features, including relative differences between or spatial derivatives of amplitude, rate of decay, rate of change, and frequency, across different combinations of electrodes used for stimulation and measurement.”, para. [0243], [0238]). In reference to at least claim 6 Sinclair discloses wherein comparing the first and second ERNA comprises measuring a difference between the one or more extracted features of the first signal and the one or more extracted features of the second signal (e.g. “different ERNA features, including relative differences between or spatial derivatives of amplitude, rate of decay, rate of change, and frequency, across different combinations of electrodes used for stimulation and measurement.”, para. [0243], [0238]) . In reference to at least claim 7 Sinclair discloses wherein comparing the first and second ERNA comprises determining a ratio of the one or more extracted features of the first signal and the one or more extracted features of the second signal (e.g. “different ERNA features, including relative differences between or spatial derivatives of amplitude, rate of decay, rate of change, and frequency, across different combinations of electrodes used for stimulation and measurement.”, para. [0243], [0238]) . In reference to at least claim 8 Sinclair discloses wherein the second signals are recorded while the therapeutic stimulation is provided to the patient’s brain (e.g. “The therapy may comprise one or more of medication and deep brain stimulation.”, para. [0047], “the inventors have determined that patterned stimulation can be used to monitor and analyse evoked resonant neural activity during therapeutic stimulation of a patient.”, para. [0191]) . In reference to at least claim 9 Sinclair discloses wherein recording the second signals comprises: providing the therapeutic stimulation for a first duration (e.g. first duration of therapeutic stimulation, Fig. 2, 182, Fig. 23,) , ceasing the therapeutic stimulation and providing the non-therapeutic stimulation (e.g. non-therapeutic patterned stimulation signal, Fig. 2, 184, Fig. 23) , and recording the second signals in response to the non-therapeutic stimulation (e.g. resonant activity features during non-therapeutic patterned stimulation signal, Fig. 2, 184, Fig. 23, “and the ERNA is measured during this period of no stimulation.”, para. [0190]) . In reference to at least claim 10 Sinclair discloses providing the non-therapeutic stimulation for a second duration and recording a progression of the ERNA during the second duration (e.g. resonant activity features during multiple non-therapeutic patterned stimulation signal Fig. 2, 184, Fig. 23, “and the ERNA is measured during this period of no stimulation.”, para. [0190], “by patterning non-therapeutic and therapeutic stimuli, an evoked response can be monitored over a longer period of time than with conventional non-patterned stimulation. Accordingly, stimuli are preferably applied in bursts of multiple pulses, each burst separated by a first time period t.sub.1 of no stimulation, each pulse separated by a second time period t.sub.2.”, para. [0193]) . In reference to at least claim 11 Sinclair discloses wherein configuring the therapeutic stimulation comprises adjusting the stimulation to maintain a feature of the second ERNA with respect to a threshold value and/or a range of values (e.g. “In some embodiments, preferred ranges for different ERNA characteristics may be defined (e.g. stimulation is controlled such that the ERNA frequency remains within 250-270 Hz).”, para. [0259]). In reference to at least claim 12 Sinclair discloses issuing an alert if the feature of the second ERNA is outside the threshold and/or range of values (e.g. “provide medical alerts to the patient, a caregiver or a clinician in the event that the patient's state (as determined by ERNA/HFO activity) deteriorates towards an undesirable or critical state”, para. [0283]). In reference to at least claim 13 Sinclair discloses wherein configuring the therapeutic stimulation comprises adjusting an amplitude of the stimulation (e.g. “Such response characteristics and HFO characteristics may be used to adjust amplitude, frequency, pulse width, and shape of a stimulation waveform.”, para. [0250], “ From this information, therapeutic stimulation parameters required to produce the preferred therapeutic state may be identified.”, para. [0266], “if the resonant circuit is in a preferred resonant state, e.g. if the measured ERNA substantially matches a template or if an ERNA characteristic is within a desired range, the amplitude of the therapeutic stimulation may be reduced by the signal generator 94 in response to an instruction from the processing unit 92.”, para. [0268]). In reference to at least claim 14 Sinclair discloses wherein configuring the therapeutic stimulation comprises determining an optimized electrode configuration for providing the therapeutic stimulation, wherein the optimized electrode configuration comprises optimized one or more electrodes used to deliver the therapeutic stimulation (e.g. “The profiles of evoked responses are then compared at step 118 in order to determine whether a preferred electrode location can be identified. The identification of preferred electrode location may be based on different ERNA features”, para. [0238], “If at step 120 a preferred electrode location can be identified, the electrode lead tip 70 can be repositioned at step 122, such that an electrode is positioned at the preferred location. Alternatively, for embodiments that include electrode lead tips with a large number of electrodes, the electrode positioned closest to the preferred location can be nominated for subsequent use in applying therapeutic stimulation.”, para. [0240], “Another embodiment of the present disclosure provides a system and method for determining the relative positions of an array of electrodes with respect to a target neural structure and then selecting a preferred electrode to use for applying therapeutic stimulation.”, para. [0241]). In reference to at least claim 15 Sinclair discloses wherein determining an optimized electrode configuration comprises: (i) applying the non-therapeutic stimulation and the therapeutic stimulation using a trial electrode configuration comprising a trial one or more electrodes for delivering the stimulation (e.g. therapeutic and non-therapeutic stimulation is applied, Figs. 5a-5c, 6a-6c, Fig. 23, “stimulation from therapeutic stimulation to non-therapeutic stimulation (FIG. 5 c )”, para. [0197], [0203], “a stimulus is applied to the first electrode of an array of X electrodes (electrode 72 a in the case of the lead tip 70). The stimulus applied may be a burst patterned stimulus as described above.”, para. [0242], “a stimulation regime 178 comprising a patterned therapeutic stimulation signal 182 followed by a non-therapeutic patterned stimulation signal (comprising one or more bursts of pulses) 184 “, para. [0276]) , (ii) determining if one or more features of the first and second ERNAs differ by greater than a predetermined threshold value (e.g. “The identification of preferred electrode location may be based on different ERNA features, including relative differences between or spatial derivatives of amplitude, rate of decay, rate of change, and frequency, at different insertion positions (e.g. the location that produces the largest resonances).”, para. [0238], “The identification of a preferred electrode location may also be based on comparison with template ERNA activity, where the templates have been derived from recordings from other patients.”, para. [0239], “ For example, the processing may involve identifying the electrode that measures the largest evoked resonance amplitude for each stimulation condition)”, para. [0243], [0245], [0247]) (iii) if the one or more of the features differ by greater than the predetermined threshold value, using the trial electrode configuration as the optimized electrode configuration for the therapeutic stimulation (e.g. “If at step 120 a preferred electrode location can be identified, the electrode lead tip 70 can be repositioned at step 122, such that an electrode is positioned at the preferred location.”, para. [0240], “Based on the processing of the evoked responses, a preferred electrode to use for therapeutic stimulation may be chosen at step 142.”, para. [0244]), and (iv) if the one or more of the features do not differ by greater than the predetermined threshold value, iteratively repeating steps (i-iii) with different trial electrode configurations until the one or more of the features differ by greater than the predetermined threshold value for that trial electrode configuration and using that trial electrode configuration as the optimized electrode configuration for the therapeutic stimulation (e.g. “By repeating steps 112 and 114, a profile or map of evoked responses at different locations along the insertion trajectory may be generated. The profile of evoked responses may include measurements from multiple electrodes or from just one electrode”, para. [0238], “ then the process repeats, applying a stimulus to the next selected electrode in the array.”, para. [0242], “Processing the evoked responses may involve comparing different ERNA features, including relative differences between or spatial derivatives of amplitude, rate of decay, rate of change, and frequency, across different combinations of electrodes used for stimulation and measurement.”, para. [0243], “For example, ERNA could be measured and/or recorded from different combinations of electrodes.”, para. [0246]). In reference to at least claim 16 Sinclair discloses wherein the one or more features comprise one or more of a latency of one or more peaks and an amplitude of one or more peaks (e.g. “different ERNA features, including relative differences between or spatial derivatives of amplitude, rate of decay, rate of change, and frequency, across different combinations of electrodes used for stimulation and measurement.”, para. [0243], [0238]) . In reference to at least claim 17 Sinclair discloses tracking one or more values of one or more features of the first ERNA over time (e.g. “by patterning non-therapeutic and therapeutic stimuli, an evoked response can be monitored over a longer period of time than with conventional non-patterned stimulation.”, para. [0193],[201], “the amplitude and frequency of the ERNA remain relatively constant indicating that the stimulus did not strongly affect the resonant state of the target neural structure over time.”, para. [0198], “In a further application of the embodiments of the present invention ERNA and/or HFO measurements may be recorded and tracked over time to monitor the progression or remission of a disease or syndrome”, para. [0283]). In reference to at least claim 18 Sinclair discloses determining one or more trends of the one or more values of one or more features of the first ERNA over time (e.g. “the measurement window is made long enough to observe three resonant peaks, allowing ERNA to be characterised.”, para. [0203], “the amplitude and frequency of the ERNA remain relatively constant indicating that the stimulus did not strongly affect the resonant state of the target neural structure over time.”, para. [0198], “In a further application of the embodiments of the present invention ERNA and/or HFO measurements may be recorded and tracked over time to monitor the progression or remission of a disease or syndrome”, para. [0283]). In reference to at least claim 19 Sinclair discloses wherein the one or more trends are indicative of a progression or an improvement in the patient’s disease state (e.g. “In a further application of the embodiments of the present invention ERNA and/or HFO measurements may be recorded and tracked over time to monitor the progression or remission of a disease or syndrome”, para. [0283]). In reference to at least claim 20 Sinclair discloses adjusting the stimulation based on the one or more trends (e.g. “Based on the ERNA data, the processing unit 92 may then instruct the signal generator to adjust one or more parameters of the stimulation signal applied to one of the electrodes 72a, 72b, 72c, 72d (step 168).” para. [0260]) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim (s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0138324 to Sinclair et al. (Sinclair) in view US 2022/0047872 to Ince et al. (Ince) . In reference to at least claim 2 Sinclair teaches a method according to claim 1 but does not explicitly teach the wherein the non-therapeutic stimulation has a frequency of about 5 to about 50 Hz. Ince discloses a method for locating an implantation site in the brain which discloses providing non-therapeutic stimulation that is 20Hz (e.g. “While ECA was observed in both therapeutic and non-therapeutic (20 Hz) stimulation,”, para. [0051]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Sinclair to include the non-therapeutic stimulation having a frequency of 20 Hz, as taught by Ince, in order to provide a stimulation that allows for measurement but does not substantially damage tissue. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER L GHAND whose telephone number is (571)270-5844. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JENNIFER L GHAND/Examiner, Art Unit 3796 Application/Control Number: 18/937,888 Page 2 Art Unit: 3796 Application/Control Number: 18/937,888 Page 3 Art Unit: 3796 Application/Control Number: 18/937,888 Page 4 Art Unit: 3796 Application/Control Number: 18/937,888 Page 5 Art Unit: 3796 Application/Control Number: 18/937,888 Page 6 Art Unit: 3796 Application/Control Number: 18/937,888 Page 7 Art Unit: 3796 Application/Control Number: 18/937,888 Page 8 Art Unit: 3796 Application/Control Number: 18/937,888 Page 9 Art Unit: 3796 Application/Control Number: 18/937,888 Page 10 Art Unit: 3796 Application/Control Number: 18/937,888 Page 11 Art Unit: 3796 Application/Control Number: 18/937,888 Page 13 Art Unit: 3796
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