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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14-16 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.
Claim 14 recites the limitations "the first target" and “the second target” in lines 1 and 2. There is insufficient antecedent basis for this limitation in the claim. The previous claims stated a “first neural target” and a “second neural target”, and it is unclear if these targets as the ones stated in claim 14.
Claim 15 recites the limitations "the first target" and “the second target” in line 1. There is insufficient antecedent basis for this limitation in the claim. The previous claims stated a “first neural target” and a “second neural target”, and it is unclear if these targets as the ones stated in claim 15.
Claim 16 recites the limitations "the first target" and “the second target” in lines 1 and 2. There is insufficient antecedent basis for this limitation in the claim. The previous claims stated a “first neural target” and a “second neural target”, and it is unclear if these targets as the ones stated in claim 16.
Claim Rejections - 35 USC § 102
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 –
(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 6-8, and 14-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being unpatentable by John(US 9302111 B2).
Regarding claim 1, John discloses a method of treating a patient comprising: a) optically and electrically modulating a first neural target of the patient to provide neural protection to reduce progression of epilepsy(The invention provides for the use of electrical stimulation and other modalities of stimulation (including transcranial magnetic stimulation) directed at a variety of anatomical targets to produce changes in perfusion and cortical blood flow to treat neurological disorders, including but not limited to epilepsy(Summary, paragraph 2). In an embodiment of the invention, the light source 816 is further operable to optically stimulate brain tissue, which may result in perfusion changes or other desired neurophysiological results. For purposes of measurement, however, it is preferable to operate the light source 816 with low amplitude, duration and other characteristics that are unlikely to cause undesired effects(Detailed Description, paragraph 62)); b) identifying a triggering event indicating an elevated likelihood of actual or impending epilepsy seizure; and c) in response to the identifying, electrically modulating a second neural target of the patient to mitigate effects of the epilepsy seizure(The patient-specific collection of sensed information and subsequent responsive therapy deliveries, may be encoded into control laws. By identifying a condition of the signal related to the disorder, as will occur when detection includes the generation of one or more of a score, probability, or index, related to a characteristic of the detected event, the detection method can indicate a specific parameter of the stimulation signal which is to be varied, or set at a specific value, in the provision of treatment. In general, some characteristic or condition of detected activity may vary an output or therapy of the system; this is accomplished through the control laws.(Detailed Description, paragraph 24).[Fig. 15]).
Regarding claim 2, John discloses the method of claim 1, wherein step a) is performed using a cortical electrode positioned superficial to the brain; and step c) is performed using a deep brain stimulation electrode positioned inside the brain(FIGS. 8-13 illustrate several embodiments of probes advantageously usable in a system according to the invention to measure and modulate perfusion. The chronically implantable probes illustrated in FIGS. 8-13 are advantageously connected to a device 110 according to the invention, and in the illustrated embodiments, have distal ends generally 0.5-3 mm in diameter, are at least partially flexible, and are of a length sufficient to reach from the device 110 to a desired target. The illustrations are schematic in nature and are not to scale. The probes of FIGS. 8-13 are illustrated as generally cylindrical depth probes, capable of being positioned within the gray or white matter of a patient's brain, but it should be recognized that surface cortical probes are also advantageous in certain embodiments(Detailed Description, paragraph 58). The control module runs a therapy algorithm to increase the perfusion level at the epileptogenic focus to a target range by applying stimulation as programmed within a preset range of allowed parameters (pulse amplitude, pulse width, number of pulses in a burst, pulse to pulse interval, interval between bursts, rate of change allowed from burst to burst). If the perfusion level in the area of the seizure focus increases above the target range, the algorithm calls for the control module to stimulate other brain structures such as the caudate or structures in the contralateral hemisphere in an attempt to bring the perfusion level down to a target range (this target range may be different than the target used when stimulating the focus directly)(Summary, paragraph 10)).
Regarding claim 3, John discloses the method of claim 1, wherein step a) is performed on a periodic basis, and steps b) and c) are performed only when a triggering event is identified(The implanted control module monitors perfusion at the epileptogenic focus, taking pulsed measurements periodically, for example, every 30 seconds to save power. If sudden changes in perfusion are detected, the sampling rate (or other aspects of the sensing procedure) may be increased for improved resolution. The control module runs a therapy algorithm to increase the perfusion level at the epileptogenic focus to a target range by applying stimulation as programmed within a preset range of allowed parameters (pulse amplitude, pulse width, number of pulses in a burst, pulse to pulse interval, interval between bursts, rate of change allowed from burst to burst). If the perfusion level in the area of the seizure focus increases above the target range, the algorithm calls for the control module to stimulate other brain structures such as the caudate or structures in the contralateral hemisphere in an attempt to bring the perfusion level down to a target range (this target range may be different than the target used when stimulating the focus directly)(Summary, paragraph 10)).
Regarding claim 6, John discloses the method of claim 1, wherein step a) is performed with a lower output amplitude, duty cycle, pulse width, or frequency than step c)( The control module runs a therapy algorithm to increase the perfusion level at the epileptogenic focus to a target range by applying stimulation as programmed within a preset range of allowed parameters (pulse amplitude, pulse width, number of pulses in a burst, pulse to pulse interval, interval between bursts, rate of change allowed from burst to burst). If the perfusion level in the area of the seizure focus increases above the target range, the algorithm calls for the control module to stimulate other brain structures such as the caudate or structures in the contralateral hemisphere in an attempt to bring the perfusion level down to a target range (this target range may be different than the target used when stimulating the focus directly)(Summary, paragraph 10)).
Regarding claim 7, John discloses the method of claim 1, wherein step b) is performed by sensing electrical signals from the brain of the patient, analyzing the sensed electrical signals, and finding a divergence from a brain signal captured during an inter-ictal time period(This embodiment includes an implanted control module, implanted electrodes on a seizure focus and on the caudate nucleus, and an implanted pulse oximetry perfusion sensor in the vicinity of the seizure focus. In addition, a perfusion sensor (with electrodes) may be implanted on the contralateral lobe from the seizure focus. After implant, baseline perfusion and electrographic data may be collected for at least several days and for several seizures while the patient recovers from surgery. Commanded stimulation studies may be performed to assess the effect of different stimulation parameters at the seizure focus and at the caudate on perfusion behavior. Stimulation at the seizure focus will generally increase perfusion (the seizure focus is generally hypo-perfused in the interictal period) whereas stimulation of the brain stem structures or the caudate may decrease perfusion(Summary, paragraph 9)).
Regarding claim 8, John discloses the method of method of claim 1, wherein step c) is performed by: initiating electrical modulation of the second neural target; analyzing the trigger condition and continuing the electrical modulation of the second neural target until the trigger condition ceases(FIG. 1 depicts an intracranially implanted neurostimulator device 110 according to the invention, which in one embodiment is a small self-contained responsive neurostimulator located under the patient's scalp 112. As the term is used herein, a responsive neurostimulator is a device capable of detecting or anticipating neurological events such as ictal activity, and providing therapy to neural tissue in response to that activity, where the therapy is specifically intended to terminate the ictal activity, treat a neurological event, prevent an unwanted neurological event from occurring, or lessen the severity, frequency or likelihood of certain symptoms of a neurological disorder(Detailed Description, paragraph 2) Therapy can include electrical stimulation specifically intended to terminate the undesired activity, treat a neurological event, prevent an unwanted neurological event from occurring, or lessen the severity or frequency of certain symptoms of a neurological disorder. It will be recognized that various other types of therapy, including especially the modulation of perfusion in and around certain structures of the brain, may also be delivered.(Detailed Description, paragraph 38)).
Regarding claim 14, John discloses the method of claim 1, wherein the first target is associated with generation of malignant electrical signals that can lead to epilepsy seizure, and the second target is associated with transmission of the malignant electrical signals(Conceptually tissues or brain regions which can serve as neutral targets for providing therapy can be classified as “associated” or “non-associated.” Associated tissue is relatively related to a symptom of the disorder. For example, associated tissue may be a region related to the focus of seizure origin, or a region with abnormal metabolic activity which is related to the disorder. Non-associated tissue may be a region which is relatively less modulated by the disorder, compared to associated tissue, such as an area which is distal to a seizure focus, or an area of normal or abnormal metabolic activity which is relatively unrelated to, or unaffected by, the disorder(Summary, paragraph 4). As set forth above, for either hyperperfusion or hypoperfusion, stimulation of a variety of anatomical targets may be performed according to the invention to produce beneficial changes in cortical blood flow to treat neurological disorders(Detailed Description, paragraph 102)).
Regarding claim 15, John discloses the method of claim 1, wherein the first target is a seizure focus, and the second target is a part of the hippocampus(The method of claim 1, wherein the tissue in an area associated with a neurological event comprises a seizure focus located in a hemisphere of the brain, and the first target region comprises a contralateral hemisphere.(claim 7). The method of claim 1, wherein the second target region comprises a focus of epileptiform activity(claim 9)).
Regarding claim 16, John discloses the method of claim 1, wherein the first target is on or in the cerebral cortex, and the second target is a part of the hippocampus(Electrical stimulation may be applied directly to the cortex, or alternatively to deeper brain structures, or to the brain stem, spinal cord or to cranial or peripheral nerves(Summary, paragraph 5). Specifically, but not by way of limitation, potential stimulation targets include the cortex of the brain (including specialized structures such as the hippocampus), white matter, basal ganglia (including the caudate nucleus), the brain stem, the spinal cord, the cerebellum or any of various cranial or peripheral nerves including the vagus nerve(Detailed Description, paragraph 102)).
Regarding claim 17, John discloses a system for treating a patient having a seizure condition comprising: a cortical lead adapted for positioning inside the skull of a patient and on the outside of the brain, the cortical lead including each of an electrode and an optical output device; a deep brain stimulation lead adapted for positioning inside the brain of a patient near the hippocampus or near a seizure focal location; a pulse generator coupled to each of the cortical lead and the deep brain stimulation lead, the pulse generator comprising a control circuitry, a sensing circuitry, and a pulse generator circuit(The implantable neurostimulator device 110 is capable of being coupled to a plurality of probes 512, 514, 516, and 518. Each probe may be individually or jointly connected to the implantable neurostimulator device 110 via one or more leads, or may communicate remotely with the probe interface when the probes have their own power sources and communication telemetry, in order to achieve sensing and stimulation. In the illustrated embodiment, the coupling is accomplished through a lead connector. Although four probes are shown in FIG. 5, it should be recognized that any number is possible, and in the embodiment described in detail herein, eight electrodes on two leads are used.(Detailed Description, paragraph 40). Accordingly, the stimulation strategy is altered in light of the changed brain state, and an alternative course of therapy is initiated, which may include some or all of the following: (1) stimulation of the caudate nucleus to decrease excitability in the epileptic hemisphere; (2) stimulation of the cortical or sub-cortical structures of the contralateral hemisphere to increase perfusion there; and (3) therapeutic electrical stimulation to reduce the likelihood of seizure activity. If ictal electrographic activity is then also observed in a system, further actions may also be taken(Detailed Description, paragraph 107).[Fig. 5]), the control circuitry configured to: a) use the pulse generator circuit and the cortical lead to issue each of first optical outputs and first electrical outputs to modulate a first neural target of the patient to provide neural protection and reduce progression of epilepsy; b) use the sensing circuitry for identifying a triggering event indicating an elevated likelihood of actual or impending epilepsy seizure; and c) in response to the identifying, use the pulse generator circuit and the deep brain stimulation lead to issue second electrical outputs to modulate a second neural target of the patient to mitigate effects of the epilepsy seizure(The invention provides for the use of electrical stimulation and other modalities of stimulation (including transcranial magnetic stimulation) directed at a variety of anatomical targets to produce changes in perfusion and cortical blood flow to treat neurological disorders, including but not limited to epilepsy(Summary, paragraph 2). In an embodiment of the invention, the light source 816 is further operable to optically stimulate brain tissue, which may result in perfusion changes or other desired neurophysiological results. For purposes of measurement, however, it is preferable to operate the light source 816 with low amplitude, duration and other characteristics that are unlikely to cause undesired effects(Detailed Description, paragraph 62). The patient-specific collection of sensed information and subsequent responsive therapy deliveries, may be encoded into control laws. By identifying a condition of the signal related to the disorder, as will occur when detection includes the generation of one or more of a score, probability, or index, related to a characteristic of the detected event, the detection method can indicate a specific parameter of the stimulation signal which is to be varied, or set at a specific value, in the provision of treatment. In general, some characteristic or condition of detected activity may vary an output or therapy of the system; this is accomplished through the control laws.(Detailed Description, paragraph 24)[Fig. 15]).
Regarding claim 18, John discloses the system of claim 17, wherein the control circuitry is also configured, in step c), to use the pulse generator circuit and the deep brain stimulation lead to issue second optical outputs to modulate the second neural target of the patient(An implantable medical device for responding to a neurological disorder in a human patient comprising: a detection subsystem configured to: obtain a first perfusion measurement of tissue in an area associated with a neurological event, obtain a second perfusion measurement of tissue in an area not associated with the neurological event, and detect for one of hyperperfusion and hypoperfusion based on a metric derived from the first perfusion measurement and the second perfusion measurement; and a therapy subsystem coupled to the detection subsystem and configured to apply at least one of a stimulation to a first target region when hyperperfusion is detected, and a stimulation to a second target region when hypoperfusion is detected[claim 12]).
Regarding claim 19, John discloses the system of claim 17, wherein the first neural target includes a portion of the cerebral cortex(Electrical stimulation may be applied directly to the cortex, or alternatively to deeper brain structures, or to the brain stem, spinal cord or to cranial or peripheral nerves(Summary, paragraph 5)).
Regarding claim 20, John discloses the system of claim 17, wherein the second neural target is the hippocampus(Specifically, but not by way of limitation, potential stimulation targets include the cortex of the brain (including specialized structures such as the hippocampus), white matter, basal ganglia (including the caudate nucleus), the brain stem, the spinal cord, the cerebellum or any of various cranial or peripheral nerves including the vagus nerve(Detailed Description, paragraph 102)).
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.
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.
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over John(US 9302111 B2).
Regarding claim 4, John discloses the method of claim 1, wherein electrical modulating in step a) is performed using two electrodes that are more than at least 2 cm apart, and step c) is performed using two electrodes that are less than one cm apart(In fact, it is possible to employ an embodiment of the invention that uses a single lead with at least two electrodes, or two leads each with at least a single electrode (or embodiment), although bipolar sensing between two closely spaced electrodes on a lead is preferred to minimize common mode signals including noise.(Detailed Description, paragraph 41)). It would be obvious to one of ordinary skill in the art before the effective date to configure the electrode placement of the neurostimulator device of John to disclose the claimed material. Even though the exact distances are not stated in John, it is obvious the closely spaced electrode configuration can be interpreted to cover the distance in the claim.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over John in view of Kopell(US 20090054955 A1).
Regarding claim 5, John discloses the method of claim 1, but fails to state wherein step a) is performed at a lower power density than step c). However, Kopell teaches “In addition to wavelength, the power density of the light energy applied to the target tissue is an important factor in determining the efficacy of treatment. The light source 142 is capable of emitting light at a power sufficient to achieve a power density in the target tissue between at least 0.01 mW/cm.sup.2 and 100 mW/cm.sup.2,[0089]’. Kopell explains a range of power densities available for stimulation so the selected density for step c could be the lower value in the range to fit the patient stimulation parameters.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the neurostimulator device of John with the power density of the neurological disorder treatment of Kopell. Doing so would specify the range of power density for the optical stimulation to best fit the needs for patient therapy.
Claim(s) 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over John in view of Osorio(US 11607547 B2).
Regarding claim 9, John discloses the method of claim 1, but fails to disclose wherein step c) is performed by: initiating electrical modulation of the second neural target; continuing the electrical modulation of the second neural target until a stop-therapy condition arises.
However, Osorio teaches “Further, the system, device, and/or method initiates a second therapy 1312 (e.g., X2) based on the second system alert event 1310. In addition, a second stop stimulation event 1314 (e.g., B2) occurs which turns off all therapies and/or system alerts occurs when the heart rate returns to the approximate starting heart rate and/or a target value(Detailed Description of Specific Embodiments, paragraph 160)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the neurostimulator device of John with the stop therapy of the epilepsy treatment system of Osorio. Doing so would clarify stoppages in the therapy based on the detected patient signals and the status of disease events.
Regarding claim 10, John in view of Osorio teaches the method of claim 9, but John fails to disclose wherein the stop-therapy condition includes a patient indication that a seizure is not occurring.
However, Osorio teaches “In another example, the system, method, and/or device may stop and/or modify any initiated action based on one or more feedback signals. In addition, one or more warnings may be transmitted to the patient, a caregiver, a doctor, a medical professional, and/or logged(Detailed Description of Specific Embodiments, paragraph 158)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the neurostimulator device of John with the stop therapy of the epilepsy treatment system of Osorio. Doing so would clarify stoppages in the therapy based on the detected patient signals and the status of disease events.
Regarding claim 11, John in view of Osorio teaches the method of claim 9, but John fails to disclose wherein the stop-therapy condition includes a timeout. However, Osorio teaches “In addition, a first stop stimulation event 1234 (e.g., B1) occurs which turns off all therapies and/or system alerts may occur when the heart rate returns to the approximate starting heart rate and/or a target value(Detailed Description, paragraph 159)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the neurostimulator device of John with the stop therapy of the epilepsy treatment system of Osorio. Doing so would clarify stoppages in the therapy based on the detected patient signals and the status of disease events.
Regarding claim 12, John in view of Osorio teaches the method of claim 9, but John fails to disclose wherein the stop-therapy condition includes a determination that the patient no longer shows an elevated likelihood of actual or impending epilepsy seizure.
However, Osorio teaches “If an adverse event has occurred, the method may involve changing one or more stimulation parameters to eliminate, reduce or ameliorate the adverse event (955). If no adverse event has occurred, the method may comprise continuing to apply a signal the vagus nerve until a predetermined signal application duration has been reached (960), at which time the signal application may be stopped (970). The method may further comprise determining, after the therapy has been stopped, if the patient's heart rate remains incommensurate with the patient's activity level or type (980), in which case the signal application may be resumed or other appropriate action may be taken (e.g., local or remote alarms or alerts, notification of caregivers/healthcare providers, etc.)(Detailed Description of specific embodiments, paragraph 108)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the neurostimulator device of John with the stop therapy of the epilepsy treatment system of Osorio. Doing so would clarify stoppages in the therapy based on the detected patient signals and the status of disease events.
Regarding claim 13, John discloses the method of claim 1, but fails to disclose wherein step c) includes interrupting step a) and preventing step a) until step c) is completed.
However, Osorio teaches “The open-loop electrical signal may then be interrupted in response to the detection, and the closed-loop electrical signal may be applied—either for a predetermined time or until the detected condition has been effectively treated. The closed-loop signal may then be interrupted, and the open-loop program may be resumed. Therapeutic electrical stimulation may be applied by an implantable medical device (IMD) within the patient's body or, in some embodiments, externally(Description of Related Art, paragraph 6)”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the neurostimulator device of John with the stop therapy of the epilepsy treatment system of Osorio. Doing so would clarify stoppages in the therapy based on the detected patient signals and the status of disease events.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CATHERINE ANTHONY whose telephone number is (703)756-4514. The examiner can normally be reached 7:30 am - 4:30 pm, EST, M-F.
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/MARIA CATHERINE ANTHONY/ Examiner, Art Unit 3796
/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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