DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
20. 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.
Claim Rejections - 35 USC § 112
3. 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.
4. Claims 1 and 11, as well as claims 2-10 for being dependent on claim 1, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
5. Claim 1 recites the limitation "the EEG response marker" in the second to last line of the claim. There is insufficient antecedent basis for this limitation in the claim. Previously, Claim 1 recites “an EEG response biomarker”, but fails to specify whether the ‘biomarker’ and ‘marker’ are the same or different. Therefore, the claim is indefinite and requires correction.
6. Claim 11 recites similar language as Claim 1 in regards to the ‘response marker’ vs. ‘response biomarker’. Proper correction is required.
Claim Rejections - 35 USC § 103
7. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
8. Claims 1 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Machado U.S. 2021/0228880 (herein referred to as “Machado”) and in view of Carlson U.S. 2013/0053722 (herein referred to as “Carlson”).
9. Regarding Claim 1, Machado teaches an EEG system (Fig. 1) for facilitating placement of a deep brain stimulation (DBS) device (Fig. 1, ref num 10; abstract “deep brain stimulation (DBS)…”) within a brain of a subject to treat a brain disorder (para 0038, “DBS system to stimulate a cerebellar pathway connecting to a brainstem, a diencephalon, or a cerebrum of a patient to treat a neurological disorder in the patient”), the DBS device configured for implantation within a brain region of the subject (Fig. 1, ref num 13) and comprising at least two stimulation electrodes configured to deliver a stimulation to the brain region of the subject (Fig. 1, ref num 15; para 0038, “one or more implanted DBS electrodes 15”), wherein the EEG system comprises:
a. an EEG sensing device configured for placement over a scalp of the subject (Fig. 1, ref num 16; para 0038, “external 16 data from one or more EEG scalp electrodes [17] in response to a patient”), the EEG sensing device comprising a plurality of EEG electrodes (Fig. 1, ref num 17; para 0052, “a plurality of external EEG scalp electrodes are shown as element 17”), the EEG sensing device configured to detect a plurality of EEG signals at the scalp of the subject (para 0045, “receive signals from… the external 16 portion… an external data (e.g., EEG data)…”); and
b. a computing device operatively coupled to the DBS device and the EEG sensing device (Fig. 1, ref num 12), the computing device comprising at least one processor (Fig. 2, ref num 24), wherein the at least one processor is configured to:
i. operate the DBS device to deliver the stimulation to the brain region of the subject (para 0043, “the controller 12 can perform steps related to the configuration, including one or more of: electrical stimulation of any component of a neural pathway associated with the neurological condition”);
ii. receive the plurality of EEG signals from the EEG sensing device before and after the stimulation (para 0043, “internal recordings of electrophysiology of sub-cortical areas and/or deep brain tissue, external recordings of conduction from the primary motor cortex, secondary motor cortex, primary sensory cortex, and/or secondary sensory cortex”; Fig. 4, ref nums 44 and 46; see Fig. 9 for DBS turned OFF and ON);
iii. transform the plurality of EEG signals received before and after the stimulation into an EEG response biomarker (para 0037, “the present disclosure relates to systems and methods for configuring the DBS system based on biomarkers used to determine optimal stimulation patterns of the DBS on related neural networks… The biomarkers are derived from one or more of the following electrophysiological and/or biomechanical techniques…), the EEG response biomarker indicative of a potential extent of neural network interaction accessible by the DBS device (para 0037, “the present disclosure relates to systems and methods for configuring the DBS system based on biomarkers used to determine optimal stimulation patterns of the DBS on related neural networks (e.g., the cerebellothalamocortical pathways for stroke)… Described herein is the use of several of these biomarkers to configure a DBS system to stimulate a cerebellar pathway connecting to a brainstem”); and
iv. output the EEG response marker to an operator of the EEG system (para 0055, “the optimal parameters for the DBS and the at least one of the potential stimulation electrode to deliver the DBS output… for guiding configuration of the DBS system for the user. In some instances, these optimal parameters and ideal electrodes selected are presented as a check or guide for the medical professional (e.g., the medical professional can try the optimal parameters and ideal settings first). However, in other instances the configuration can be done in an automated fashion”).
Machado fails to specifically teach that the EEG response biomarker is displayed to an operator of the EEG system.
Carlson teaches a system of analogous art (Figs. 1, 16, 18, and 19), wherein the system displays an EEG response biomarker to an operator (para 0186, “external circuitry may include a screen on which information can be presented. The output of a screen may be controlled by control circuitry. A screen may display outputs as described herein, such as an indication of the presence of a biomarker”). Since Machado already teaches outputting the response marker to the operator, then it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Machado to display the biomarker to the operator in order to provide the operator with the needed information in order to select the appropriate stimulation therapy for the target site (para 0186, 0188).
10. Regarding Claim 7, Machado teaches the EEG sensing device comprises a wearable scalp EEG electrode array (para 0039, “the external 16 portion is not implanted in the patient. The external EEG scalp electrodes are illustrated as a plurality of electrodes, but should be understood as including any number of electrodes that is limited by the size of the patient's head and greater than one”).
11. Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Machado and Carlson, and further in view of Wang U.S. 2024/0157149 (herein referred to as “Wang”).
12. Regarding Claim 2, Machado fails to teach the EEG response biomarker comprises a root-mean-square value or a Z-score of an EEG response to the stimulation.
Wang teaches an EEG system of analogous art (Fig. 1), wherein the EEG response biomarker comprises a root-mean-square value of an EEG response to the stimulation (para 0040, “In an implementation, denoised iEEG signals are bandpass filtered via an FIR filter into theta and/or gamma oscillation(s), and the instantaneous root mean square (RMS) power is extracted from the theta and/or gamma oscillation(s)”). This provides useful feedback to the user in order to adjust any parameters as desired for the treatment (para 0034, 0040, 0047). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Machado to have the EEG response biomarker comprise a root-mean-square value in response to the stimulation in order to collect the appropriate feedback for adjusting stimulation parameters of the treatment.
13. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Machado and Carlson, and further in view Wang and Widge U.S. 2024/0100337 (herein referred to as “Widge”).
14. Regarding Claim 3, Machado as modified fails to teach the EEG response to the stimulation is evaluated within a 500 µs window after the delivery of the stimulation by the DBS device.
Widge teaches an EEG system of analogous art (Fig. 1), wherein the system an EEG response to stimulation is evaluated within a 500 µs window after delivery of the stimulation by the device (para 0061, “INS can be configured to provide a stimulation in a response time within 250 μs”). This target window is to ensure the appropriate stimulation is achieved based on specific parameters and observed responses from the brain structures (para 0067). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Machado to have the response time be within the desired time window in order to achieve the desired stimulation effects.
15. Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Machado and Carlson, and further in view Deli U.S. 2024/0165410 (herein referred to as “Deli”).
16. Regarding Claims 4 and 6, Machado teaches the stimulation comprises a series of single stimulation pulses delivered at a pulse frequency (para 0068-0069).
However, Machado fails to teach the pulse frequency ranges from about 1 Hz to about 190 Hz (claim 4), and further that the pulse frequency is selected from about 1 Hz, about 25 Hz, and about 50 Hz (claim 6).
Deli teaches an EEG system of analogous art (Figs. 1 and 2), wherein the system teaches stimulation pulses delivered at a pulse frequency from about 1 Hz to about 190 Hz, and further that the pulse frequency is selected from about 1 Hz, about 25 Hz, and about 50 Hz (para 0094, “stimulation signals may have a stimulation frequency in a high frequency range from a lower limit of 8 Hz, more preferably 40 Hz to an upper limit of 150 Hz, or preferably 120 Hz”). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the pulse frequency within the stated range or the desired value, 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, as well as that discovering an optimum value of a result effective variable involves only routine skill in the art. (In re Aller, 105 USPQ 233; In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
17. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Machado and Carlson, and further in view Deli and Widge.
18. Regarding Claim 5, Machado teaches the single stimulation pulses comprise pulses deliver at 6 mA intensity (para 0070, “pulse amplitude ranging from 1.0 mA to 9.0 mA. The response at 2.0 mA and 6.0 mA”). But, Machado fails to teach the pulses being delivered for 200 µs pulse duration and 120 seconds stimulation duration.
Widge teaches a system of analogous art (Fig. 1), wherein the system operates to apply pulses being delivered for 200 µs pulse duration (para 0061, “a stimulation pulse width between 50 and 500 μs”) and 120 seconds stimulation duration (para 0067). Since Machado already teaches applying the pulses for a duration, then it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the desired pulse duration and stimulation duration, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
19. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Machado and Carlson, and further in view Malekmohammadi U.S. 2024/0136047 (herein referred to as “Malekmohammadi”).
20. Regarding Claim 8, Machado teaches the system is configured to operate postoperatively after implantation of the at least two stimulation electrodes of the DBS device (para 0004, “DBS electrodes have been implanted in a patient's brain in one or more areas known to experience the spurious brain activity and one or more of these DBS electrodes can be used to deliver electrical stimulation to the one or more areas”).
Machado fails to teach the system is configured to operate intraoperatively during implantation of the at least two stimulation electrodes of the DBS device.
Malekmohammadi teaches a system of analogous art (Fig. 5A), wherein the system is configured to operate intraoperatively during implantation of the at least two stimulation electrodes of the DBS device (para 0023, “GUI 99 is particularly useful in an DBS context because it provides a clinician with a visual indication of how stimulation selected for a patient will interact with the brain tissue in which the electrodes are implanted. GUI 99 can be used during surgical implantation of the leads 18 or 19 and its IPG 10”), postoperatively after implantation of the at least two stimulation electrodes of the DBS device (para 0023, “GUI 99 can be used… after implantation to assist in selecting a therapeutically useful stimulation program for the patient”), and any combination thereof (para 0023). By operating the system intraoperatively because it provides the clinician with a visual indication of placement of the electrodes for stimulation (para 0023). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Machado to have the system operate intraoperatively to provide visual context to the user when placing the electrodes for stimulation.
21. Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Machado and Carlson, and further in view Hershey U.S. 2017/0143972 (herein referred to as “Hershey”).
22. Regarding Claim 9, Machado fails to teach the at least one processor is further configured to: a. operate the DBS device to deliver at least two different stimulations to the brain region of the subject, each stimulation delivered by a different pair-wise combination of the at least two electrodes; b. compare at least two EEG biomarkers, each EEG biomarker corresponding to each pair-wise combination of the at least two electrodes; c. select a final pair-wise combination of stimulation electrodes for subsequent DBS treatment of the subject, the final pair-wise combination of stimulation electrodes corresponding to the maximum EEG biomarker value; and d. display to the operator of the system the final pair-wise combination of stimulation electrodes for use in subsequent DBS treatments.
Hershey teaches an EEG system of analogous art (Figs. 1 and 2), wherein the system comprises a processor (Fig. 2, ref num 208) configured to:
a. operate the DBS device (Fig. 2, ref num 214) to deliver at least two different stimulations to the brain region of the subject (para 0054, “the neuromodulation parameter set includes parameters specifying the electrode configuration”; para 0055, “the number of electrodes available combined with the ability to generate a variety of complex electrical pulses, presents a huge selection or neuromodulation parameters sets”), each stimulation delivered by a different pair-wise combination of the at least two electrodes (para 0055, “if the neuromodulation system to be programmed has sixteen electrodes, millions of modulation parameter sets may be available for programming into the neuromodulation system. Furthermore, for example SCS systems may have thirty-two electrodes which exponentially increases the number of modulation parameters sets available for programming”);
b. compare at least two EEG biomarkers, each EEG biomarker corresponding to each pair-wise combination of the at least two electrodes (para 0055 describes how each biomarker corresponds to a different combination of electrodes; para 0087, “At 908, one or more biomarker parameters are each compared to a reference value… the reference value or value range can be a previously sensed value of the corresponding biomarker parameter”; Fig. 9, ref num 908);
c. select a final pair-wise combination of stimulation electrodes for subsequent DBS treatment of the subject, the final pair-wise combination of stimulation electrodes corresponding to the maximum EEG biomarker value (para 0088, “At 910, the neuromodulation parameter set are adjusted using an outcome of the comparison. In one example, the reference value or value range represents a threshold indicative of a need for treating neuroinflammation, and the outcome of the comparison indicates such a need. In one example, the reference value or value range represents a degree of neuroinflammation, and the outcome of the comparison indicates an intensity of the neuromodulation needed for treating the neuroinflammation at the indicted degree”; para 0081, “Modulation thresholds vary from patient to patient and from electrode to electrode within a patient. An electrode/tissue coupling calibration of the electrodes may be performed to account for these different modulation thresholds”); and
d. display to the operator of the system the final pair-wise combination of stimulation electrodes for use in subsequent DBS treatments (para 0050, “a graphical user interface (GUI) 108 that allows the user to set or adjust values of the user-programmable neuromodulation parameters”; para 0090, “instructions can also cause the machine for displaying an output”).
This configuration allows the user to determine a patient-specific therapy, and to adjust the parameters as necessary to achieve the same expected result of stimulating the desired target area dependent on the patient-specific needs (para 0089). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Machado to configure the processor to operate as described above in order to personalize the treatment to the specific patient and perform the expected result of stimulating the target area as needed.
23. Claims 10, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Machado and in view of Hershey.
24. Regarding Claim 10, Machado teaches computer-implemented method of positioning and configuring the operation of a DBS device within a brain region of a subject (Fig. 1, ref num 10; abstract “deep brain stimulation (DBS)…”; para 0038, “DBS system to stimulate a cerebellar pathway connecting to a brainstem, a diencephalon, or a cerebrum of a patient to treat a neurological disorder in the patient”), the method comprising;
a. positioning an EEG sensing device comprising a plurality of EEG electrodes and configured to detect a plurality of EEG signals on a scalp of the subject (Fig. 1, ref num 16; para 0038, “external 16 data from one or more EEG scalp electrodes [17] in response to a patient”), and implanting the DBS device comprising at least two stimulation electrodes within the brain region of the subject (Fig. 1, ref num 13) and comprising at least two stimulation electrodes configured to deliver a stimulation to the brain region of the subject (Fig. 1, ref num 13, 15; para 0038, “one or more implanted DBS electrodes 15”).
Machado fails to teach b. obtaining, using the computing device, at least two candidate EEG biomarker values during implantation of the DBS device within the brain region of the subject, wherein the at least two candidate EEG biomarker values are obtained for at least one DBS treatment parameter; c. comparing, using the computing device, the at least two EEG biomarker values to identify a maximum EEG biomarker value; and d. configuring the operation of the DBS device to match the at least one treatment parameter of the DBS device associated with the maximum EEG biomarker.
Hershey teaches a method of operating a DBS device of analogous art (Figs. 1 and 2), the method comprising:
b. obtaining, using the computing device, at least two candidate EEG biomarker values during implantation of the DBS device within the brain region of the subject, wherein the at least two candidate EEG biomarker values are obtained for at least one DBS treatment parameter (abstract, “memory may be configured to store a neuromodulation parameter set selected to modulate neural activity at the tissue site and a sensed biomarker parameter”; para 0054, “the neuromodulation parameter set includes parameters specifying the electrode configuration”; para 0055, “the number of electrodes available combined with the ability to generate a variety of complex electrical pulses, presents a huge selection or neuromodulation parameters sets”);
c. comparing, using the computing device, the at least two EEG biomarker values to identify a maximum EEG biomarker value (para 0055 describes how each biomarker corresponds to a different combination of electrodes; para 0087, “At 908, one or more biomarker parameters are each compared to a reference value… the reference value or value range can be a previously sensed value of the corresponding biomarker parameter”; Fig. 9, ref num 908); and
d. configuring the operation of the DBS device to match the at least one treatment parameter of the DBS device associated with the maximum EEG biomarker (para 0088, “At 910, the neuromodulation parameter set are adjusted using an outcome of the comparison. In one example, the reference value or value range represents a threshold indicative of a need for treating neuroinflammation, and the outcome of the comparison indicates such a need. In one example, the reference value or value range represents a degree of neuroinflammation, and the outcome of the comparison indicates an intensity of the neuromodulation needed for treating the neuroinflammation at the indicted degree”; para 0081, “Modulation thresholds vary from patient to patient and from electrode to electrode within a patient. An electrode/tissue coupling calibration of the electrodes may be performed to account for these different modulation thresholds”).
This configuration allows the user to determine a patient-specific therapy, and to adjust the parameters as necessary to achieve the same expected result of stimulating the desired target area dependent on the patient-specific needs (para 0089). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method taught by Machado to operate as described above in order to personalize the treatment to the specific patient and perform the expected result of stimulating the target area as needed.
25. Regarding Claim 12, Machado as modified teaches the method of claim 11, as well as the at least one DBS treatment parameter is selected from one or more positions of the at least one stimulation electrodes within the brain region of the subject (para 0051, “The DBS electrodes (DBS electrodes 15) can be implanted in at least one cerebellar pathway connecting to a brainstem, a diencephalon, or a cerebrum. Based on the electrophysiology data, at least one of the electrodes can be identified as implanted closest to a neuronal populations involved in control of the at least one motor task”).
26. Regarding Claim 13, Machado as modified teaches the method of claim 11, as well as the DBS operating parameters are selected from a pulse frequency, a pulse duration, a pulse amplitude, a treatment duration, and any combination thereof (para 0054, “ At Step 48, the optimal parameters for the DBS can be determined. In some instances, the optimal parameters are parameters that provide a response indicative of modulation with a lowest magnitude. For example, the optimal parameters comprise an optimal stimulation amplitude, one or more optimal burst parameters, an optimal stimulation frequency, and an optimal stimulation pulse width”).
27. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Machado and Hershey, and further in view Carlson.
28. Regarding Claim 11, Machado as modified teaches the method of claim 11, as well as
a. operate the DBS device to deliver the stimulation to the brain region of the subject (para 0043, “the controller 12 can perform steps related to the configuration, including one or more of: electrical stimulation of any component of a neural pathway associated with the neurological condition”);
b. receiving, using the computing device, the plurality of EEG signals from the EEG sensing device before and after the stimulation (para 0043, “internal recordings of electrophysiology of sub-cortical areas and/or deep brain tissue, external recordings of conduction from the primary motor cortex, secondary motor cortex, primary sensory cortex, and/or secondary sensory cortex”; Fig. 4, ref nums 44 and 46; see Fig. 9 for DBS turned OFF and ON);
c. transforming, using the computing device, the plurality of EEG signals received before and after the stimulation into an EEG response biomarker (para 0037, “the present disclosure relates to systems and methods for configuring the DBS system based on biomarkers used to determine optimal stimulation patterns of the DBS on related neural networks… The biomarkers are derived from one or more of the following electrophysiological and/or biomechanical techniques…), the EEG response biomarker indicative of a potential extent of neural network interaction accessible by the DBS device (para 0037, “the present disclosure relates to systems and methods for configuring the DBS system based on biomarkers used to determine optimal stimulation patterns of the DBS on related neural networks (e.g., the cerebellothalamocortical pathways for stroke)… Described herein is the use of several of these biomarkers to configure a DBS system to stimulate a cerebellar pathway connecting to a brainstem”);
d. output the EEG response marker to an operator of the EEG system (para 0055, “the optical parameters for the DBS and the at least one of the potential stimulation electrode to deliver the DBS output… for guiding configuration of the DBS system for the user. In some instances, these optimal parameters and ideal electrodes selected are presented as a check or guide for the medical professional (e.g., the medical professional can try the optimal parameters and ideal settings first). However, in other instances the configuration can be done in an automated fashion”).
Machado fails to specifically teach that the EEG response marker is displayed to an operator of the EEG system.
Carlson teaches a method and system of analogous art (Figs. 1, 16, 18, and 19), wherein the system displays an EEG response biomarker to an operator (para 0186, “external circuitry may include a screen on which information can be presented. The output of a screen may be controlled by control circuitry. A screen may display outputs as described herein, such as an indication of the presence of a biomarker”). Since Machado already teaches outputting the response marker to the operator, then it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Machado to display the biomarker to the operator in order to provide the operator with the needed information in order to select the appropriate stimulation therapy for the target site (para 0186, 0188).
29. Claims 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Hershey and in view of Machado.
30. Regarding Claim 14, Hershey teaches a computer-implemented method of monitoring an efficacy of a DBS treatment of a brain disorder of a subject comprising a computing device operatively coupled to an sensing device configured to detect a plurality of signals (para 0003, “Deep Brain stimulation (DBS)”; para 0054, “neuromodulation system 100 can be configured to modulate… brain tissue”; Figs. 1 and 2), wherein the method comprises:
a. administering a first DBS treatment and obtaining a first biomarker using the system (para 0054, “the neuromodulation parameter set includes parameters specifying the electrode configuration”; para 0055, “the number of electrodes available combined with the ability to generate a variety of complex electrical pulses, presents a huge selection or neuromodulation parameters sets”; Fig. 9, ref num 906);
b. administering a second DBS treatment and obtaining a second biomarker using the system (para 0054-0055; Fig. 9, ref num 906; para 0086, “the one or more biomarker parameters”);
c. obtaining, using the computing device, a change in the second biomarker value relative to the first biomarker value (para 0055 describes how each biomarker corresponds to a different combination of electrodes; para 0087, “At 908, one or more biomarker parameters are each compared to a reference value… the reference value or value range can be a previously sensed value of the corresponding biomarker parameter”; Fig. 9, ref num 908);
d. evaluating, using the computing device, the efficacy of the DBS treatment based on a predetermined correlation of the efficacy and the change in the second EEG biomarker value relative to the first EEG biomarker value (para 0088, “At 910, the neuromodulation parameter set are adjusted using an outcome of the comparison. In one example, the reference value or value range represents a threshold indicative of a need for treating neuroinflammation, and the outcome of the comparison indicates such a need. In one example, the reference value or value range represents a degree of neuroinflammation, and the outcome of the comparison indicates an intensity of the neuromodulation needed for treating the neuroinflammation at the indicted degree”; para 0081, “Modulation thresholds vary from patient to patient and from electrode to electrode within a patient. An electrode/tissue coupling calibration of the electrodes may be performed to account for these different modulation thresholds”).
Hershey fails to teach an EEG system and EEG sensing device configured to detect a plurality of EEG signals on a scalp of the subject.
Machado teaches a method of analogous art (Figs. 1 and 4), wherein the system is an EEG system and EEG sensing device configured to detect a plurality of EEG signals on a scalp of the subject (Fig. 1, ref nums 13, 16, 17; para 0038, 0054-0055). Since Hershey teaches a method using DBS, then it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hershey to have an EEG system using an EEG sensing device, as this is a regularly used system and device when operating a method to perform DBS.
31. Regarding Claim 16, Hershey as modified teaches the method of claim 14, but fails to teach the brain disorder comprises one of Parkinson’s disease and epilepsy.
Machado teaches the brain disorder comprises one of Parkinson’s disease and epilepsy (para 0004, 0026, 0036). Since Hershey teaches a method using DBS, then it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hershey treat the targeted brain disorder, since the target disease would still achieve the expected result of brain stimulation applied by the system.
32. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Hershey and Machado, and further in view Carlson.
33. Regarding Claim 15, Hershey as modified teaches the method of claim 14, but fails to teach the brain region comprises a centromedian thalamic nucleus region.
Carlson teaches the brain region comprises a centromedian thalamic nucleus region (para 0212). Since Hershey teaches a method using DBS, then it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hershey to target a centromedian thalamic nucleus region, since the target region would still achieve the expected result of brain stimulation applied by the system.
Conclusion
34. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANNIE L SHOULDERS/Examiner, Art Unit 3794