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 on July 16, 2026 have been fully considered but they are not persuasive.
In regards to Applicant’s arguments, Applicant states the following argument:
“ Only after all stimulation sequences have been completely applied (step 1012) does the process return to the detection step (1002). Thus, in Fischell, there is no step of waiting for a period of time between the completion of application of all stimulation sequences included in the stimulation signal (i.e., step 1012) and the re-detection (i.e., step 1002). Even if the break interval in Fischell were viewed as a "pause," such a pause occurs before the completion of the stimulation signal (i.e., between stimulation sequence A and stimulation sequence B included within the same electrical stimulation signal), rather than after the stimulation signal has been fully applied. The detection step in Fischell is performed immediately after all stimulation sequences are completed (step 1012), without any intervening interval for charge balancing or any other purpose.” The examiner respectfully disagrees.
As can be seen in annotated fig. 10 below and para [0048] and para [0062], Fischell states the following:
Para [0048] – “ The pulses of the signal may have any suitable pulse width, pulse morphology, pulse-to-pulse interval, pulse amplitude. One or more of these characteristics may be altered between subsequent pulses….The pulses may be biphasic to achieve charge balance, but it should be appreciated that a waveform may comprise a net DC component.”
Para [0062] – “Once the stimulation sequence or sequences have been applied, the detection subsystem (122) may again monitor electrical activity of the brain. If the detection subsystem (122) determines that the detected condition is still present, the stimulation subsystem (124) may deliver one or more additional stimulation sequences to tissue. In some variations, the neurostimulator may wait a period of time before applying a subsequent stimulation sequence (1014)….. The subsequent stimulation sequences may be the same as or may be different from a preceding stimulation sequence. Subsequent stimulation sequences may be applied to tissue until either a) the detected condition is no longer detected by the detection subsystem (122), or b) a predetermined number of stimulation sequences have been delivered to the patient. ”
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This is not necessarily the case. As can be seen in annotated fig. 10 above, stimulation from a first pair of electrodes on the first lead and on the second lead may be provided, and following stimulation on the second lead, the system at step 1012 can have a dual function of determining whether (a) the detected condition is no longer present or (b) the predetermined number of stimulation sequences have been delivered to the patient.
Therefore, although not explicitly displayed on fig. 10, the system described in Fischell must utilize some condition detection at step 1012.
If it is determined that the detected condition is still present, a waiting period (such as in step 1014) is executed, and following execution of the waiting period in step 1014, subsequent stimulation sequences (which can either be the same as or different from the preceding stimulation sequences) will be applied via the first electrode pair on the first lead and the second electrode pair on the second lead. Therefore, the “pause” can occur after the completion of the stimulation from electrode pairs on the first lead and the second lead, as opposed to the pause occurring between stimulation sequence A and stimulation sequence B as stated by the Applicant.
Furthermore, Applicant states that “Fischell merely teaches that after the stimulation signal (the one or more stimulation sequences) is applied, the electrical activity of the brain is monitored again to determine whether it is necessary to apply the stimulation again”, and further states the following: “Fischell does not disclose any adjustment of stimulation parameters (such as duration or amplitude) based on the post-stimulation detection. That is, Fischell does not mention that if the electrical activity monitored again is abnormal, the parameters of the stimulation signal need to be adjusted.” The examiner respectfully disagrees with this statement.
As can be seen in the explanation above and in annotated fig. 10 above, Fischell does not merely teach whether it is necessary to apply the stimulation signal, but further teaches that if an abnormality is still present, the system will go through a waiting period (1014), and following the waiting period, subsequent stimulation sequences can be applied via the first electrode pair on the first lead and the second electrode pair on the second lead. Furthermore, when the subsequent stimulation sequences are applied, the stimulation sequences can be applied in the same manner as before, or may be different from the preceding stimulation sequences (see para [0048] and para [0062] below):
Para [0048] - “The stimulation signal may be pulsatile, non-pulsatile (e.g., sinusoidal or quasi-sinusoidal waveforms), a DC signal, or a combination thereof. In variations where the first signal is pulsatile, the pulses may comprise one or more monophasic or biphasic square pulses. The pulses of the signal may have any suitable pulse width, pulse morphology, pulse-to-pulse interval, pulse amplitude. One or more of these characteristics may be altered between subsequent pulses. ”
Para [0062] – “The subsequent stimulation sequences may be the same as or may be different from a preceding stimulation sequence.”
Therefore, the change in the stimulation sequences can equate to a change in either the pulse duration or pulse amplitude following the first stimulation sequence.
Furthermore, in regard to Applicant’s arguments that to previously disclosed reference(s) do not disclose the claim amendment, this argument is not persuasive, as can be seen from the explanation above and the explanation of the claim amendments shown below.
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.
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 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(s) 1-3, 7, 11-21, 36, 40-41, 49-52, 55, 59-60, 64, 66-68, 71, 73-76 and 80-82 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0319962 A1 to Jianping et al. (hereinafter “Jianping”) in view of US 2022/0062643 A1 to De Ridder and US 2014/0081348 A1 to Fischell et al. (hereinafter “Fischell”).
Regarding claims 1, 55, and 66, Jianping discloses method and a device comprising;
and comprising a non-transitory storage medium, a processor, and an implantable electrode device, wherein the non-transitory storage medium has an instruction executable by the processor (pars. [0006]-[0007]), and the instruction is run to perform the following steps:
detecting a physiological activity signal of each brain region in at least one brain region of a patient through an implantable electrode device (Fig. 1B and pars. [0022]: …two or more lead electrodes may be utilized to obtain two or more bioelectrical signals associated with neural activity, [0039]: …the sensing electrode combination may be used to monitor brain neural network activities such as, for example, oscillatory behavior in bioelectrical brain signals);
comparing the detected physiological activity signal of each brain region with a preset detection condition to determine whether the detected physiological activity signal of each brain region belongs to an abnormal physiological activity signal (par. [0056]: Processor 40 may compare the determined oscillatory behavior to a normal or stable behavior associated with the brain site to determine whether the determined behavior deviates from the normal or stable behavior…);
and,
in response to a determination result that the detected physiological activity signal of the each brain region belongs to the abnormal physiological activity signal, controlling to apply an electrical stimulation signal to the at least one brain region for a duration through the implantable electrode device (seen in para [0045]-[0051], [0059], and para [0024]- first sentence and the following sentence: “The IMD may deliver stimulation to alter the state from an abnormal state to a normal state. The stimulation (e.g., electrical stimulation or drug delivery) may be continuous, intermittent series of stimulations, or a single electrical pulse or drug dose.”— the claim amendment “for a duration” is addressed here for the current claim and all subsequent claims containing this statement as discussed below), but does not disclosed wherein a predetermined time interval after the implantable electrode device stops applying the electrical stimulation signal is used for charge balancing,
and detecting, through the implantable electrode device, the physiological activity signal of each brain region in the at least one brain region of the patient after the charge balancing, and
wherein the method comprises:
detecting, through the implantable electrode device, the physiological activity signal of each brain region in the at least one brain region of the patient after the charge balancing,
and,
in response to a determination that the physiological activity signal detected after the charge balancing belongs to the abnormal physiological activity signal, adjusting at least one of the duration or an amplitude of the electrical stimulation signal for a subsequent application based on the physiological activity signal detected after the charge balancing.
However, Fischell, which is in the same field of endeavor: Neuromodulation devices and methods for delivering a stimulation signal to tissue (see abstract, first sentence and para [0004]) teaches wherein a predetermined time interval after the implantable electrode device stops applying the electrical stimulation signal is used for charge balancing,
and detecting, through the implantable electrode device, the physiological activity signal of each brain region in the at least one brain region of the patient after the charge balancing (para [0004]- last two sentences, para [0017]-last three sentences, para [0046] - last sentence, para [0048], and para [0062] – essentially, because the pulses are biphasic, charge balancing occurs between each pulse. Furthermore, following charge balancing, the physiologic activity signal is detected (around step 1012 as previously explained above)), and
in response to a determination that the physiological activity signal detected after the charge balancing belongs to the abnormal physiological activity signal, adjusting at least one of the duration or an amplitude (where the different stimulation sequence is comparable to a change in duration and/or pulse amplitude) of the electrical stimulation signal for a subsequent application (subsequent stimulation sequences) based on the physiological activity signal detected after the charge balancing (see para [0048] and para [0061]-[0062] – as previously explained above, since step 1012 as indicated by either (a) or (b) in para [0062] indicates that step 1012 of fig. 10 can apply stimulation sequences either when a condition is no longer detected or when a predetermined number of stimulation sequences have been delivered, if an abnormal physiologic activity signal is detected, subsequent stimulation sequences can be applied (which can be different than the previous stimulation sequences)).
Therefore, 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 system of Jianping with the charge balancing system and detection system of Fischell to arrive at the claimed invention. Such modification would improve the system by preventing unwanted stimulation delivery while also completely eliminating the neurological disease/disorder with a protocol that maintains treatment efficacy over long periods of time while preventing habituation or adaptation.
Regarding claims 2, 59 and 67 the Jianping as modified discloses the method of claim 1 and the device of claims 55, 58 and 66, wherein the preset detection condition comprises an abnormal state mode (Jianping, par. [0022]: … the signals are obtained during an abnormal state (e.g., during a period when the patient is showing signs of an abnormal state…), wherein the abnormal state mode comprises a change in at least one parameter of an abnormal physiological activity signal of each of the at least one brain region over time (Jianping, pars. [0024]: The effects of timing and characteristics of the stimulation (e.g., intensity, amplitude, duration, pulse width, frequency, and the like) relative to the oscillations of the neural brain network activity may be monitored. In some examples, the abnormal state may exhibit oscillatory behavior, and the normal state may be a fixed or stable point. In other examples, the abnormal state may exhibit oscillatory behavior at a first frequency, and the normal state may exhibit oscillatory behavior at a second frequency, [0035]: While the neural activity exhibits an abnormal behavior, i.e., on circle 2, the IMD may provide variable stimulation (e.g., at different timings in terms of location on circle 2, different stimulation parameter values) to determine how application of different stimulations affects the neural activity behavior, and the observed behavior may be also measured by electrodes X and Y).
wherein the abnormal state mode is generated based on a preset abnormal state mode (Jianping, par. [0065]: Processor 74 may also select one or more stimulation electrode combinations to provide DBS to sites in the brain that may require therapy to correct a condition such as, for example, a sensed abnormal oscillatory pattern).
Regarding claims 3, 60 and 68, the Jianping as modified discloses the method of claim 2, the device of claim 59 and the device of claim 67, wherein the at least one parameter of the abnormal physiological activity signal comprises at least one of an intensity of the abnormal physiological activity signal or a characteristic frequency of the abnormal physiological activity signal (Jianping, par. [0027]: In the example where applying the stimulation shifts the neural activity behavior from an abnormal oscillatory state (circle 2) to a normal oscillatory state (circle 4), the applied stimulation may be shifting the signal of the neural behavior from a low frequency path or rhythm to a high frequency path or rhythm).
Regarding claims 7, 64 and 71, the Jianping as modified discloses the method of claim 2, the device of claim 59 and the device of claim 67, wherein comparing the detected physiological activity signal of the each brain region with the preset detection condition comprises: performing a similarity comparison between a change in at least one parameter of the detected physiological activity signal of the each brain region over time and the change in the at least one parameter of the abnormal physiological activity signal of the each brain region over time comprised in the abnormal state mode (Jianping, par. [0072]: As measurements are obtained over time, a model for the limit cycle of the oscillatory behavior may be monitored and analyzed to determine whether the neural network exhibits a normal/stable behavior or an abnormal behavior (108). In one example, if the pattern associated with the relationship between X and Y is similar to that of an abnormal behavior of neural activity).
Regarding claims 11 and 12, Jianping as modified discloses the method of claim 1, comprising periodically controlling to apply the electrical stimulation signal to the at least one brain region through the implantable electrode device at a predetermined time interval (par. [0056]), and controlling the electrical stimulation signal to the at least one brain region through the implantable electrode device (par. [0056]), wherein the predetermined time interval is 0.01 milliseconds to 1 hour (see para [0044]-[0049]), but does not explicitly disclose wherein applying the electrical stimulation to the brain region is for 1 second to 1 hour.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to apply the electrical stimulation to the brain region for 1 second to 1 hour 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.
Regarding claims 13 and 73, Jianping as modified discloses the method of claim 1 and the device of claim 66, wherein controlling whether to apply the electrical stimulation signal to the at least one brain region for a duration through the implantable electrode device comprises:
controlling the implantable electrode device to apply the electrical stimulation signal to the at least one brain region for a duration and controlling the amplitude of the applied electrical stimulation signal (Jianping, para [0045]-[0051] and para [0056]: …processor 40 may control therapy delivered by stimulation electrode combinations by, at least in part, sensing bioelectrical brain signals with one or more of the sense electrode combinations associated with a respective one of the stimulation electrode combinations and analyzing a frequency domain characteristic of the sensed bioelectrical brain signals).
Regarding claim 14, Jianping as modified discloses the method of claim 13, wherein the duration and amplitude of the applied electrical stimulation signal are positively correlated with the detected physiological activity signal (Jianping, par. [0056]: …processor 40 may determine an oscillatory behavior of neural activity of a brain site based on frequency domain characteristic, e.g., phase, or based on time domain characteristic, e.g., frequency or voltage amplitude, based on bioelectrical signals sensed by two or more sense electrodes, and compare the relative values of the signals sensed by a plurality of sense electrode combinations…).
Regarding claims 15 and 74, the Jianping and DeRidder combination discloses the method of claim 1 and the device of claim 66, wherein controlling whether to apply the electrical stimulation signal to the at least one brain region through the implantable electrode device comprises: intermittently applying the electrical stimulation signal to the at least one brain region through the implantable electrode device (Jianping, par. [0024]: The IMD may deliver stimulation to alter the state from an abnormal state to a normal state. The stimulation….may be…intermittent series of stimulations...).
Regarding claim 17, the Jianping as modified discloses the method of claim 1, wherein an amplitude range of the electrical stimulation signal is 0.5 V to 10 V (Jianping par. [0047]: 2. Voltage Amplitude: …between approximately 0.5 volts and approximately 20 volts, or approximately 5 volts).
Regarding claim 18, Jianping as modified discloses the method of claim 1, wherein detecting the physiological activity signal of the each brain region in the at least one brain region of the patient through the implantable electrode device comprises: detecting the physiological activity signal of the each brain region in the at least one brain region of the patient through at least one detection contact of the implantable electrode device (Jianping, Fig. 1B and pars. [0022]: …two or more lead electrodes may be utilized to obtain two or more bioelectrical signals associated with neural activity, [0028]: …the pairs of electrodes may be electrodes 0 and 1, 1 and 2, and 2 and 3); and controlling whether to apply the electrical stimulation signal to the at least one brain region through the implantable electrode device comprises: controlling whether to apply the electrical stimulation signal to the at least one brain region through at least one stimulation contact of the implantable electrode device (par. [0056]: …if the determined oscillatory behavior deviation is indicative of a condition that requires correction, processor 40 may control stimulation generator 44 to deliver stimulation via the appropriate stimulation electrode combinations to deliver therapy to the brain site associated with the condition, to shift the associated behavior from the abnormal state to the normal or stable state).
Regarding claims 19 and 75, Jianping as modified discloses the method of claim 18 and the device of claim 66, wherein the at least one detection contact comprises a plurality of detection contacts (Jianping, par. [0073]: Two or more spatially-distinct DBS electrodes may be defined as sensing electrodes and used to monitor neural activity signals from a particular brain site. One electrode may be selected from a plurality of available electrodes…), and the at least one stimulation contact comprises a plurality of stimulation contacts (Jianping, Fig. 3 (24) (26) and par. [0036]: …electrodes 24, 26 of leads 20A, 20B are positioned to deliver electrical stimulation to a tissue site within brain 28…some of electrodes 24, 26 may be configured to sense bioelectrical brain signals and others of electrodes 24, 26 may be configured to deliver electrical stimulation to brain 28…all of electrodes 24, 26 may be configured to both sense bioelectrical brain signals and deliver electrical stimulation to brain 28, as needed).
Regarding claims 20 and 76, Jianping as modified discloses the method of claim 19 and the device of claim 75, wherein a number of the plurality of detection contacts is the same as a number of the plurality of stimulation contacts (Jianping, par. [0036]: …electrodes 24, 26 may be configured to sense bioelectrical brain signals and others of electrodes 24, 26 may be configured to deliver electrical stimulation to brain 28), and a range of a brain region detected by each of the plurality of detection contacts overlaps a range of a brain region affected by a respective one of the plurality of stimulation contacts corresponding to the each of the plurality of detection contacts (Jianping, par. [0042]: … corresponding sense and stimulation electrode combinations may comprise some or all of the same electrodes).
Regarding claim 21, Jianping as modified discloses the method of claim 19, wherein a number of the plurality of detection contacts is the same as a number of the plurality of stimulation contacts, and a range of a brain region detected by each of the plurality of detection contacts does not overlap a range of a brain region affected by a respective one of the plurality of stimulation contacts corresponding to the each of the plurality of detection contacts (Jianping, par. [0042]: …however, …all of the electrodes in corresponding sense and stimulation electrode combinations may be different).
Regarding claim 36, Jianping as modified discloses the method of claim 1, wherein detecting the physiological activity signal of the each brain region in the at least one brain region of the patient through the implantable electrode device comprises: detecting the physiological activity signal of the each brain region in the at least one brain region of the patient through a plurality of groups of implantable electrodes of the implantable electrode device (Jianping, Fig. 1B and pars. [0022]: …two or more lead electrodes may be utilized to obtain two or more bioelectrical signals associated with neural activity, [0028]: …the pairs of electrodes may be electrodes 0 and 1, 1 and 2, and 2 and 3), and controlling whether to apply the electrical stimulation signal to the at least one brain region through the implantable electrode device based on the determination result of the physiological activity signal of the each brain region comprises: controlling whether to apply the electrical stimulation signal to the at least one brain region through the plurality of groups of implantable electrodes based on the determination result of the physiological activity signal of the each brain region (Jianping, par. [0056]: …if the determined oscillatory behavior deviation is indicative of a condition that requires correction, processor 40 may control stimulation generator 44 to deliver stimulation via the appropriate stimulation electrode combinations to deliver therapy to the brain site associated with the condition, to shift the associated behavior from the abnormal state to the normal or stable state), wherein at least one group of implantable electrodes comprises a detection contact and a stimulation contact (Fig. 3 (24) (26) and par. [0036]: …electrodes 24, 26 of leads 20A, 20B are positioned to deliver electrical stimulation to a tissue site within brain 28…some of electrodes 24, 26 may be configured to sense bioelectrical brain signals and others of electrodes 24, 26 may be configured to deliver electrical stimulation to brain 28…).
Regarding claims 40 and 41, Jianping as modified discloses the method of claim 1, wherein the electrical stimulation signal is used for the treatment of mental and behavioral disorders (Jianping, par. [0033]: …deep brain stimulation (DBS) system 10 that manages a medical condition of patient 12. The medical condition may be, for example, a movement disorder, neurodegenerative impairment, a mood disorder, or a seizure disorder of patient 12); and
wherein the mental and behavioral disorders comprises addiction, obsessive compulsive disorders, depressive disorders, anxiety disorders (Jianping, par. [0033]: ...therapy system 10 may provide therapy to manage symptoms of other patient conditions, such as, but not limited to,…mood (or psychological) disorders (e.g., major depressive disorder (MDD), bipolar disorder, anxiety disorders, …and obsessive-compulsive disorder (OCD)), or Alzheimer's disease).
Regarding claim 49, Jianping as modified discloses the method of claim 1, wherein controlling whether to apply the electrical stimulation signal to the at least one brain region through the implantable electrode device comprises: controlling whether to apply the electrical stimulation signal to the at least one brain region through a plurality of stimulation contacts of the implantable electrode device (par. [0050] Accordingly, in some examples, stimulation generator 44 generates electrical stimulation signals in accordance with the electrical stimulation parameters…Stimulation generator 44 may shift the delivery of stimulation energy between two therapy programs, and processor 40 of IMD 16 may provide instructions that cause stimulation generator 44 to time-interleave stimulation energy between the electrode combinations of the two therapy programs). Jianping also discloses controlling whether to apply the electrical stimulation signal to the at least one brain region through a plurality of stimulation contacts of the implantable electrode device (par. [0050]), but does not expressly disclose that the plurality of stimulation contacts apply the same electrical stimulation signal.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to try and apply the same stimulation signal parameters to the plurality of electrode combinations since there are a finite number of solutions on how to apply stimulation parameters to each electrode (either each contact applies the same electrical stimulation signal or each contact applies a different stimulation signal) each having reasonable expectation of success.
Regarding claim 50, Jianping as modified discloses the method of claim 1, wherein controlling whether to apply the electrical stimulation signal to the at least one brain region through the implantable electrode device comprises: controlling whether to apply the electrical stimulation signal to the at least one brain region through a plurality of stimulation contacts of the implantable electrode device, wherein the plurality of stimulation contacts apply different electrical stimulation signals (Jianping, par. [0050] Accordingly, in some examples, stimulation generator 44 generates electrical stimulation signals in accordance with the electrical stimulation parameters…Stimulation generator 44 may shift the delivery of stimulation energy between two therapy programs…).
Regarding claims 51 and 80, Jianping as modified discloses the method of claim 1 and the device of claim 66, wherein controlling whether to apply the electrical stimulation signal to the at least one brain region through the implantable electrode device comprises: controlling whether to apply the electrical stimulation signal to the at least one brain region through a plurality of stimulation contacts of the implantable electrode device, wherein at least one parameter of the electrical stimulation signal applied by the plurality of stimulation contacts is associated with each other (Jianping, par. [0050] Accordingly, in some examples, stimulation generator 44 generates electrical stimulation signals in accordance with the electrical stimulation parameters…processor 40 of IMD 16 may provide instructions that cause stimulation generator 44 to time-interleave stimulation energy between the electrode combinations of the two therapy programs).
Regarding claims 52 and 81, Jianping discloses the method of claim 1 and the device of claim 66, wherein controlling whether to apply the electrical stimulation signal to the at least one brain region through the implantable electrode device comprises: controlling whether to apply the electrical stimulation signal to the at least one brain region through a plurality of stimulation contacts of the implantable electrode device, wherein each of the plurality of stimulation contacts corresponds to at least one detection contact, the each of the plurality of stimulation contacts and the at least one detection contact corresponding to the each of the plurality of stimulation contacts constitute a detection-stimulation group, and each detection- stimulation group independently detects the physiological activity signal and applies the electrical stimulation signal (Jianping, Fig. 3 (24) (26) and pars. [0036]: …electrodes 24, 26 of leads 20A, 20B are positioned to deliver electrical stimulation to a tissue site within brain 28…In other examples, all of electrodes 24, 26 may be configured to both sense bioelectrical brain signals and deliver electrical stimulation to brain 28, as needed, [0037]: The subset of electrodes 24, 26 that is used to deliver electrical stimulation to patient 12, and, in some cases, the polarity of the subset of electrodes 24, 26, may be referred to as a stimulation electrode combination or configuration. The subset of electrodes 24, 26 that is used to sense bioelectrical brain signals may be referred to as a sensing electrode combination or configuration).
Regarding claim 82, Jianping as modified discloses a computer-readable storage medium storing a computer program, wherein a processor executes the program to perform the method for neuro-stimulation of claim 1 (Jianping, Fig. 3 and pars. [0041], [0043]: …memory 42 stores therapy programs 54, sense electrode combinations and associated stimulation electrode combinations 56, operating instructions 58, and algorithm 60 in separate memories within memory 42 or separate areas within memory 42…).
Claims 42-46 are rejected under 35 U.S.C. 103 as being unpatentable over Jianping in view of De Ridder and Fischell as applied to claims 1-3, 7, 11-21, 36, 40-41, 49-52, 55, 59-60, 64, 66-68, 71, 73-76 and 80-82 above, and further in view of US 2022/0233860 A1 to Hamner et al. (hereinafter “Hamner”).
Regarding claims 42-44, Jianping as modified discloses the method of claim 41, except wherein the addiction comprises substance addiction or non- substance addiction;
wherein the substance addiction comprises drug addiction, alcohol addiction, nicotine addiction, or caffeine addiction; and
wherein the drug addiction comprises legal drug addiction or illegal drug addiction;
the legal drug addiction comprises hallucinogen addiction, inhalant drug addiction, anesthetic drug addiction, sedative drug addiction, hypnotic drug addiction, anxiolytic drug addiction, or stimulant drug addiction; the illegal drug addiction comprises: opioid drug addiction, cannabis addiction, methamphetamine addiction, or lysergic acid diethylamide (LSD) addiction.
However Hamner, in the same field of endeavor: wearable nerve stimulation for the treatment of diseases, discloses wherein the addiction comprises substance addiction or non- substance addiction (par. [0302]: …examples of disorders that may be treated by any of the methods disclosed herein…Substance-related disorders include substance dependence, substance addiction, substance-induced anxiety disorder, and substance-induced mood disorder);
the substance addiction comprises drug addiction, alcohol addiction, nicotine addiction, or caffeine addiction (par. [0302]: …examples of disorders that may be treated by any of the methods disclosed herein…Substance-related disorders include substance dependence, substance addiction, substance-induced anxiety disorder, and substance-induced mood disorder. Substance dependence and addiction can occur with a variety of substances, including but not limited to, alcohol, nicotine…caffeine), and the non-substance addiction comprises gambling addiction, sexual behavior disorder/addiction, or gaming disorder (par. [0302]: …examples of disorders that may be treated by any of the methods disclosed herein…methods provided can be used to treat subjects experiencing intermittent excessive behaviors (IEB). IEB characterize a variety of disorders including…aberrant sexual conduct, and compulsive gambling), wherein the drug addiction comprises legal drug addiction or illegal drug addiction;
the legal drug addiction comprises hallucinogen addiction, inhalant drug addiction, anesthetic drug addiction, sedative drug addiction, hypnotic drug addiction, anxiolytic drug addiction, or stimulant drug addiction; the illegal drug addiction comprises: opioid drug addiction, cannabis addiction, methamphetamine addiction, or lysergic acid diethylamide (LSD) addiction (par. [0302]: …examples of disorders that may be treated by any of the methods disclosed herein…Substance-related disorders include substance dependence, substance addiction, substance-induced anxiety disorder, and substance-induced mood disorder. Substance dependence and addiction can occur with a variety of substances, including but not limited to…cocaine, opioids, narcotics, hallucinogens, amphetamines, phencyclidines, phencyclidine-like substances, inhalants, and sedatives) to provide the benefit of treating conditions with a neurological component (par. [0302]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the method and device for neuro-stimulation of the brain region to treat mental and behavioral disorders, as taught by the modified system of Jianping with treating for non-substance, substance, legal and illegal substance abuse, as taught by Hamner, in order to treat conditions with a neurological component.
Regarding claims 45 and 46, Jianping as modified discloses the method of claim 1, wherein the electrical stimulation signal is used for the treatment of drug addiction, obsessive compulsive disorders, or depressive disorders (par. [0033]: ...therapy system 10 may provide therapy to manage symptoms of other patient conditions, such as, but not limited to,…mood (or psychological) disorders (e.g., major depressive disorder (MDD)…and obsessive-compulsive disorder (OCD))…), but does not disclose wherein the electrical stimulation signal is used for the treatment of drug addiction, and the electrical stimulation signal inhibits drug addition of the patient.
However, Hamner discloses the electrical stimulation signal is used for the treatment of drug addiction, and the electrical stimulation signal inhibits drug addition of the patient (par. [0302]: …examples of disorders that may be treated by any of the methods disclosed herein…Substance-related disorders include substance dependence, substance addiction…) to provide the benefit of treating conditions with a neurological component (par. [0302]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the method and device for neuro-stimulation of the brain region to treat mental and behavioral disorders, as taught by the modified system of Jianping, and treating for non-substance, substance, legal and illegal substance abuse, as taught by Hamner, in order to treat conditions with a neurological component.
Claims 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Jianping in view of De Ridder and Fischell as applied to claims 1-3, 7, 11-21, 36, 40-41, 49-52, 55, 59-60, 64, 66-68, 71, 73-76 and 80-82 above, and further in view of US 2021/0085962 A1 to Patel and US 2008/0183098 A1 to Denison et al. (hereinafter, “Denison”).
Regarding claim 37, Jianping as modified discloses the method of claim 1, wherein detecting the physiological activity signal of the each brain region in the at least one brain region of the patient through the implantable electrode device comprises: detecting the physiological activity signal of the each brain region in the at least one brain region of the patient through at least one detection contact of the implantable electrode device (Jianping, Fig. 3 (24) (26) and par. [0036]: …electrodes 24, 26 of leads 20A, 20B are positioned to deliver electrical stimulation to a tissue site within brain 28…some of electrodes 24, 26 may be configured to sense bioelectrical brain signals and others of electrodes 24, 26 may be configured to deliver electrical stimulation to brain 28…), wherein a frequency range of the physiological activity signal is 0.5 Hz to 150 Hz (par. [0046] 1. Frequency…approximately 130 Hz), but does not disclose wherein a diameter range of each of the at least one detection contact is 0.1 mm to 3 mm; and
an amplitude range of a physiological activity signal acquired by each of the at least one detection contact is 5 uV to 12.5 mV.
However, Patel, which is in the same field of endeavor: method and device for deep brain stimulation, discloses a diameter range of each of the at least one detection contact is 0.1 mm to 3 mm (par. [0108] The electrode lead…an outer diameter of the electrode lead may be around 1.3 mm or less) for the purpose of dimensioning for insertion into the user's brain (par. [0108]), but does not disclose wherein an amplitude range of a physiological activity signal acquired by each of the at least one detection contact is 5 uV to 12.5 mV.
Yet Denison, which is in the same field of endeavor: instrumentation for impedance measurement, discloses an amplitude range of a physiological activity signal acquired by each of the at least one detection contact is 5 uV to 12.5 mV (paras. [0036]: …useful as an instrumentation…monitoring of brain signals, and other physiological monitoring applications that require micro power systems for precision sensor measurements, [0043]: …instrumentation …can provide …physiological signals…requiring a supply voltage of …less than or equal to approximately 1.5 volts.) to achieve stable measurement at low frequency with very low power (par. [0043]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the physiological sensing contact of the modified system of Jianping and an electrode diameter of 1.3 mm or less of Patel, as well as a physiological monitoring amplitude of less than 1.5 volts of Denison in order to dimension for insertion into the user's brain, and to achieve stable measurement at low frequency with very low power.
Regarding claim 38, Jianping as modified discloses the method of claim 1, wherein detecting the physiological activity signal of the each brain region in the at least one brain region of the patient through the implantable electrode device comprises: detecting the physiological activity signal of the each brain region in the at least one brain region of the patient through at least one detection contact of the implantable electrode device (Jianping, Fig. 3 (24) (26) and par. [0036]: …electrodes 24, 26 of leads 20A, 20B are positioned to deliver electrical stimulation to a tissue site within brain 28…some of electrodes 24, 26 may be configured to sense bioelectrical brain signals and others of electrodes 24, 26 may be configured to deliver electrical stimulation to brain 28…), wherein a frequency range of the physiological activity signal is 150 Hz to 30000 Hz (Jianping, par. [0046] 1. Frequency: between approximately 100 Hz and approximately 500 Hz, such as approximately 130 Hz), but does not disclose
a diameter range of each of the at least one detection contact is 0.1 mm to 0.5 mm; and
an amplitude range of a physiological activity signal acquired by each of the at least one detection contact is 5 uV to 10 mV.
However, Patel discloses a diameter range of each of the at least one detection contact is 0.1 mm to 0.5 mm (par. [0108] The electrode lead may be dimensioned for insertion into the user's brain…an outer diameter of the electrode lead may be around 1.3 mm or less) for the purpose of dimensioning for insertion into the user's brain (par. [0108]), but the modified system of Jianping and the system of Patel does not disclose an amplitude range of a physiological activity signal acquired by each of the at least one detection contact is 5 uV to 10 mV.
However, Denison discloses an amplitude range of a physiological activity signal acquired by each of the at least one detection contact is 5 uV to 10 mV (pars. [0036]: …useful as an instrumentation…monitoring of brain signals, and other physiological monitoring applications that require micro power systems for precision sensor measurements, [0043]: …instrumentation…can provide …physiological signals …requiring a supply voltage of …less than or equal to approximately 1.5 volts.) to achieve stable measurement at low frequency with very low power (par. [0043]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the physiological sensing contact of the modified system of Jianping and an electrode diameter of 1.3 mm or less of Patel, and a physiological monitoring amplitude of less than 1.5 volts of Denison in order to dimension for insertion into the user's brain, and to achieve stable measurement at low frequency with very low power.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Jianping in view of De Ridder and Fischell as applied to claims 1-3, 7, 11-21, 36, 40-41, 49-52, 55, 59-60, 64, 66-68, 71, 73-76 and 80-82 above, and further in view of Patel.
Regarding claim 39, Jianping as modified discloses the method of claim 1, wherein detecting the physiological activity signal of the each brain region in the at least one brain region of the patient through the implantable electrode device comprises: detecting the physiological activity signal of the each brain region in the at least one brain region of the patient through at least one detection contact of the implantable electrode device (Jianping, Fig. 3 (24) (26) and par. [0036]: …electrodes 24, 26 of leads 20A, 20B are positioned to deliver electrical stimulation to a tissue site within brain 28…some of electrodes 24, 26 may be configured to sense bioelectrical brain signals and others of electrodes 24, 26 may be configured to deliver electrical stimulation to brain 28…), but does not disclose wherein a diameter range of each of the at least one detection contact is 5 um to 100 um.
However, Patel discloses a diameter range of each of the at least one detection contact is 5 um to 100 um (par. [0108] The electrode lead may be dimensioned for insertion into the user's brain…an outer diameter of the electrode lead may be around 1.3 mm or less) for the purpose of dimensioning for insertion into the user's brain (par. [0108]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in the physiological sensing contact of the modified system of Jianping, and an electrode diameter of 1.3 mm or less of Patel in order to dimension for insertion into the user's brain.
Claims 53, 54, and 56-58 are rejected under 35 U.S.C. 103 as being unpatentable over Jianping in view of De Ridder and Fischell as applied to claims 1-3, 7, 11-21, 36, 40-41, 49-52, 55, 59-60, 64, 66-68, 71, 73-76 and 80-82 above, and further in view of WO 2021081097 A1 to Linde et al. (hereinafter “Linde”).
Regarding claims 53 and 54, Jianping as modified discloses all of the method of claim 52, except wherein a time when each detection-stimulation group performs physiological activity signal detection is not synchronized with a time when at least one detection- stimulation group performs physiological activity signal detection, and a time when the each detection-stimulation group applies the electrical stimulation signal is not synchronized with a time when the at least one detection-stimulation group applies the electrical stimulation signal.
wherein different detection-stimulation groups perform physiological activity signal detection synchronously, and different detection-stimulation groups perform electrical stimulation signal application synchronously.
However Linde, in the same field of endeavor: multi-target adaptive neurostimulation therapy control, discloses a time when each detection-stimulation group performs physiological activity signal detection is not synchronized with a time when at least one detection- stimulation group performs physiological activity signal detection (pars. [0091], [0093]: In some examples, the state machine may define a control policy algorithm for controlling the delivery of therapy based on sensed and/or classified physiological states of patient 14.), and a time when the each detection-stimulation group applies the electrical stimulation signal is not synchronized with a time when the at least one detection-stimulation group applies the electrical stimulation signal (Fig. 2 and par. [0092] To control IMD 16 to deliver electrical stimulation therapy, processor 32 may cause stimulation generator 36 to deliver electrical stimulation therapy to one or more tissue sites of brain 12 of patient 14 via lead 18. In some cases, processor 32 may subdivide electrodes 20 into different subsets of electrodes and cause each of the different subsets of electrodes to deliver electrical stimulation to a respective one of a plurality of target tissue sites. For example, processor 32 may cause stimulation generator 36 to deliver electrical stimulation to a first target tissue site via a first subset of electrodes 20 (e.g., electrodes 20 located on lead segment 28) in a first stimulation mode and to deliver electrical stimulation to a second target area via a second subset of electrodes 20 (e.g., electrodes 20 located on lead segment 30) in a second stimulation mode).
wherein different detection-stimulation groups perform physiological activity signal detection synchronously, and different detection-stimulation groups perform electrical stimulation signal application synchronously (par. [0092]: The electrical stimulation that is delivered via each of the subsets of electrodes 20 may be controlled independently and may be controlled and delivered either simultaneously or alternately in time) for the purpose of obtaining and subsequently classifying the patient's state (par. [0093]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the method and device for neuro-stimulation of the brain region with different electrode sensing and stimulating groups, as taught by Jianping and De Ridder, synchronously and asynchronously performing stimulation, as taught by Linde, in order to stimulate based on obtained and subsequently classified the patient's state.
Regarding claims 56, 57 and 58, Jianping as modified discloses the device of claim 55, wherein the implantable electrode device comprises a first implantable electrode (Jianping, Fig. 2 (24)) and a second implantable electrode (Jianping, Fig. 2 (26)), and wherein the brain regions comprises the nucleus accumbens and the anterior limb of internal capsule (paras. [0055]: …deep brain…implantation is employed in some embodiments, [0057]: …brain tissue can include subcortical targets…nucleus accumbens…internal capsula, anterior… Further, in addition to grey matter, also white matter tracts may be targeted, such as the anterior limb of the interior capsula…),
but does not disclose wherein the first implantable electrode is configured to be implanted into a first brain region of the patient and detect a physiological activity signal of the first brain region;
and the second implantable electrode is configured to be implanted into a second brain region of the patient and detect a physiological activity signal of the second brain region;
wherein the controller is configured to control whether to apply the electrical stimulation signal to the at least one brain region through the implantable electrode device in the following manner: controlling the first implantable electrode and the second implantable electrode to synchronously or asynchronously apply the electrical stimulation signal to the first brain region and the second brain region; and
wherein the electrical stimulation signal applied to the first brain region and the electrical stimulation signal applied to the second brain region differ from each other in at least one of parameters: a duration, an amplitude, a frequency, or a pulse width.
However, Linde discloses the first implantable electrode is configured to be implanted into a first brain region of the patient (Fig. 2 (28)) and detect a physiological activity signal of the first brain region; and the second implantable electrode is configured to be implanted into a second brain region of the patient (Fig. 2 (30)) and detect a physiological activity signal of the second brain region (par. [0089]: The state machine may generate one or more therapy decisions based on one or more sensed states of patient 14. The state machine may have a structure that is defined at least in part by one or more programmable state parameters); and
the electrical stimulation signal applied to the first brain region and the electrical stimulation signal applied to the second brain region differ from each other in at least one of parameters: a duration, an amplitude, a frequency, or a pulse width (par. [0101]: Each program may specify a set of stimulation parameters, such as amplitude, pulse width and pulse rate, if applicable and may specify one or more stimulation patterns (e.g., cycling, randomized, staircase, etc.)…parameters may include amplitude and frequency. In addition, each program may specify a particular electrode combination for delivery of stimulation, and an electrode configuration in terms of the polarities and regulated/unregulated status of the electrodes. Again, the electrode combination may specify particular electrodes in a single array or multiple arrays, and on a single lead or among multiple leads) for the purpose of obtaining and subsequently classifying the patient's state (par. [0093]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to include in the method and device for neuro-stimulation of the brain region with different electrode sensing and stimulating groups, as taught by Jianping and De Ridder, synchronously and asynchronously performing stimulation, as taught by Linde, in order to stimulate based on obtained and subsequently classified the patient's state.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dou US 2016/0089532 A1 teaches a lead system for providing deep brain stimulation to a patient (see abstract).
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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