DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/19/2025 has been entered.
Response to Arguments
Applicant’s arguments regarding the rejection of Claim 10 under 35 USC 112, First Paragraph as failing to comply with the written description requirement have been fully considered. Applicant’s arguments are persuasive with respect to the term “sub-region,” but are not persuasive with respect to the term “phase-locking index.”
Applicant argues that the term “sub-region” is defined at Pg. 26, Ln. 8 of the Present Specification, which states “the neural structure may be one or more of a target area of the brain region of the patient.” Applicant states that “[a] target area of a region is a sub-region.” The Examiner agrees. Accordingly, the rejection is withdrawn.
Applicant has amended Claim 10 such that the term “phase-locking index” instead recites “index.” Applicant’s arguments are not persuasive. As elaborated upon below, despite Applicant’s amendments the Present Specification does not describe determining such an “index” as claimed from electrodes positioned in the brain in the manner recited in a way sufficient to reasonably convey to one skilled in the relevant art that he inventor had possession of the claimed invention at the time the application was filed.
Applicant’s arguments with respect to the rejection of Independent Claim 10 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2005/0273017 A1 to Gordon (“Gordon”) in view of US 2010/0274303 A1 to Bukhman (“Bukhman”) have been fully considered and are persuasive. Applicant argues that the combination of Gordon and Bukhman does not teach the Claim 10 recitations of “both detecting a first electrical activity relating to a first epileptic activity in a first brain sub-region of a patient and detecting a second electrical activity relating to a second epileptic activity in a second brain sub-region of the patient … because Gordon does not disclose detecting two separate electrical activities in two separate brain sub-regions (and/or regions)” (Applicant’ Remarks at Pg. 12 of 13). The Examiner agrees. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of US 5,361,773 A.
Applicant’s arguments regarding dependent Claims 11-14 are based on Applicant’s arguments regarding Claim 10. Applicant’s arguments have been fully considered and are persuasive for the same reasons as explained above with respect to Claim 10. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of US 5,361,773 A.
Domestic Benefit
The pending application claims domestic benefit to U.S. Provisional Application Number 61/210,850 filed 3/23/2009, U.S. Application Number 12/729,093 filed 3/22/2010, U.S. Application Number 13/280,178 filed 10/24/2011, U.S. Application Number 15/367,757 filed 12/2/2016, and U.S. Application Number 16/743,142 filed 1/15/2020. The pending application is a continuation of U.S. Application Number 16/743,142, which is a continuation of U.S. Application Number 15/367,757, which is a divisional of U.S. Application Number 13/280,178. As such, the pending application shares a specification with U.S. Application Number 16/743,142, U.S. Application Number 15/367,757, and U.S. Application Number 13/280,178. U.S. Application Number 13/280,178 is a continuation-in-part of U.S. Application Number 12/729,093, and contains subject matter which was not disclosed in either of U.S. Provisional Application Number 61/210,850 filed 3/23/2009, U.S. Application Number 12/729,093 filed 3/22/2010. Accordingly, subject matter first disclosed U.S. Application Number 13/280,178 has a domestic benefit date of 10/24/2011.
Claim 10 recites “determining an index between the first electrical activity and the second electrical activity; and applying an electrical stimulation to a neural target of the patient for treating an epileptic event based on the index being within a range.” Neither U.S. Provisional Application Number 61/210,850 filed 3/23/2009 nor U.S. Application Number 12/729,093 filed 3/22/2010 disclose such an index1, and as such neither provides support for the above limitation.
The Present Specification uses the term “index” a total of 79 times. To the extent the Present Specification provides support for Claim 10 (see rejection of Claim 10 under 35 USC 112, First Paragraph, below), the subject matter therein claimed is entitled to a domestic benefit date of 10/24/2011.
Claim 11 recites “…receiving an efficacy body signal after applying the electrical stimulation to the neural target of the patient … determining whether the efficacy body signal indicates that the electrical stimulation to the neural target of the patient has an efficacious effect; and terminating the application of the electrical stimulation to the neural target of the patient based on a determination that indicates that the electrical stimulation to the neural target of the patient has an efficacious effect.” Neither U.S. Provisional Application Number 61/210,850 filed 3/23/2009 nor U.S. Application Number 12/729,093 filed 3/22/2010 disclose either such an “efficacy body signal” or the recited determinations based thereupon, and, accordingly, neither provides support for the above limitation.
The Present Specification provides support for the above Claim 11 limitation, and as such the subject matter therein claimed is entitled to a domestic benefit date of 10/24/2011.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 10, and Claims 11-14 by dependency, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claim 10, Claim 10 recites “detecting via one or more sensors a first electrical activity relating to a first epileptic activity in a first brain sub-region of a patient; detecting via the one or more sensors a second electrical activity relating to a second epileptic activity in a second brain sub-region of the patient; determining an index between the first electrical activity and the second electrical activity; and applying an electrical stimulation to a neural target of the patient for treating an epileptic event based on the index being within a range.” The Present Specification describes a variety of “indexes.” However, the Present Specification does not describe determining such an “index” as claimed from electrodes positioned in the brain in the manner recited in a way sufficient to reasonably convey to one skilled in the relevant art that he inventor had possession of the claimed invention at the time the application was filed.
The Present Specification describes (in pertinent part) “an epileptic seizure detection module configured to detect a first epileptic seizure based on at least one of a cardiac index and a kinetic index” and “an efficacy determination module configured to receive said collected one or more body signals and detect a response of said epileptic event to said therapy, wherein said detection is based on said collected one or more body signals…” (see Present Specification at Pg. 11, Ln. 13-21). The “index” of Claim 10 appears to correspond to a “neurologic index,” which is described only in the context of the above-noted “efficacy determination module” (see Present Specification at Pg. 34, Ln. 1-7), which “efficacy determination module” is used only to “detect a response of said epileptic event to said therapy” rather than to actually detect an epileptic event itself. However (as confirmed by Claim 11), the “index” of Claim 10 appears to actually detect an epileptic event.
One of ordinary skill in the art would not understand from the Present Specification what is envisioned by the “index” of Claim 10, as such an index does not appear to be described by the Present Specification.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 10 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 5,361,773 A to Ives (“Ives”) in view of previously cited US 2010/0274303 A1 to Bukhman (“Bukhman”).
Regarding Independent Claim 10, Ives teaches:
A medical device including one or more processors configured to perform a method, the method comprising: (Col. 1, Ln. 8-13, “…a topographic map and a method for creating the map in which brain activities occurring in respective temporal lobe regions of a brain are displayed adjacent to each other and brain activities occurring in respective mid-line regions of the brain are displayed remotely;” Col. 4, Ln. 33-34, “If the map is generated using computer techniques, for example…” Col. 6, Ln. 1-18, “The topographic map of the present invention and the method for mapping electrical activity such as discharges the basal view map may be used in a variety of brain mapping devices in the field of neurophysiology. For example, the topographic map and method of mapping of the present invention is useful to physicians in the fields of electroencephalography (EEG) evoked potential (EP) and electromagnetoencepholography (MEG). When used in conjunction with a portable discharge, sensing and recording system such as the Home Monitoring System available from Digitrace Care Services, Boston, Mass., the present invention may be used to provide additional information concerning ictal (actual discharge) and interictal (activity between discharges) events.”);
detecting via one or more sensors a first electrical activity relating to a first epileptic activity in a first brain sub-region of a patient; (Claim 2, “…wherein the first set of points and the second set of points are respectively derived from electrical activity sensed by at least one sphenoidal electrode disposed proximate a mesial temporal lobe;” . Col. 4, Ln. 14-21, “Brain activity occurring in the mesial temporal lobes and the lateral temporal lobes is represented near the center of the map, and thus, activity therefore can be more contiguously presented. Because the great majority of focal seizures, such as partial complex epileptic seizures, occur in the temporal lobes, a more diagnostically useful map is presented since the temporal lobe surfaces are contiguously represented;” Col. 4, Ln. 1-10);
Ives uses sets of electrodes placed in different brain regions to map via EEG electrical brain activity reflective of epileptic seizures.
detecting via the one or more sensors a second electrical activity relating to a second epileptic activity in a second brain sub-region of the patient; (Claim 3, “…wherein the third set of points and the fourth set of points are derived from electrical activity sensed by a set of electrodes located according to an International 10-20 Electrode Placement System;” Col. 4, Ln. 14-21; Col. 4, Ln. 1-10);
Ives uses sets of electrodes placed in different brain regions to map via EEG electrical brain activity reflective of epileptic seizures.
determining an index between the first electrical activity and the second electrical activity; (Col. 6, Ln. 16-29, “The recorded data may then be used to create the map of the present invention. A number of signals corresponding to waveforms within an ictal and/or interictal event, wherein each waveform represents an individual discharge, may be averaged together to provide data for mapping such that the map, particularly in the three dimensional version, more accurately represents the effect of the discharging epileptic surface as sensed by the sphenoidal electrodes to permit better visualization of the location and shape of the discharging epileptic surface. Averaging of signals over time tends to reduce noise and artifacts so that a more accurate picture of the discharge over time is obtained.”);
Ives’s averaging of Ives’s two EEG signals is such “determining an index” as claimed.
Ives does not disclose:
and applying an electrical stimulation to a neural target of the patient for treating an epileptic event based on the index being within a range.
Bukhman describes “Methods and Systems for Detecting Epileptic Events Using Nonlinear Analysis Parameters” (Title). Bukhman is analogous art.
Bukhman teaches:
and applying an electrical stimulation to a neural target of the patient for treating an epileptic event (Para. [0074], “The treatment may be one or more treatments known in the art. In one embodiment, the treatment comprises at least one of applying an electrical signal to a neural structure of a patient; delivering a drug to a patient; or cooling a neural structure of a patient;” Para. [0073], “The term “treatment” may refer to intervening in an ongoing epilepsy event in an effort to reduce the impact or intensity of the epilepsy event, or it may refer to an attempt to reduce the impact or intensity of a seizure, or abort the seizure entirely, at a time before a seizure has begun…”);
based on the index being within a range. (Paras. [0075], “A plurality of thresholds may be provided, referring to either any combination of a plurality of nonlinear analysis parameters, a plurality of time periods, or a plurality of conditional events. For example, a physician may require both a SampEN value below 0.25 and a SOD value above 0.75 at the same time for the device to declare an epileptic event; or an SOD−SampEN value of 0.5 to remain for at least 1-10 seconds for the device to declare an epileptic event; or a SampEN value below about 0.25 from 1-10 seconds after a SOD value above about 0.75 for the device to declare an epileptic event, among others.”)
Bukhman administers treatment when a threshold is exceeded. Such treatment based on exceeding a threshold is treatment “based on the index being within a range” as claimed (i.e., the range is all values above the threshold).
It would have been obvious for a person of ordinary skill in the art at the time invention was made to modify the device of Ives with the teachings of Bukhman (i.e., to apply electrical stimulation to treat an identified epileptic event based on an index being within a particular range) in order to optimize neurostimulation for treatment of epilepsy (Bukhman at Para. [0008]).
Claims 11-13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 5,361,773 A to Ives (“Ives”) in view of previously cited US 2010/0274303 A1 to Bukhman (“Bukhman”) as applied to Claim 10 above, and further in view of US 2005/0049649 A1 to Luders et al. (“Luders”).
Regarding Claim 11, the combination of Ives and Bukhman renders obvious the entirety of Claim 10 as explained above.
The combination of Ives and Bukhman does not disclose:
where the method further includes: receiving an efficacy body signal after applying the electrical stimulation to the neural target of the patient, wherein the efficacy body signal is selected from at least one of an autonomic signal, a neurologic signal, a metabolic signal, an endocrine signal, and a tissue stress marker signal;
determining whether the efficacy body signal indicates that the electrical stimulation to the neural target of the patient has an efficacious effect;
and terminating the application of the electrical stimulation to the neural target of the patient based on a determination that indicates that the electrical stimulation to the neural target of the patient has an efficacious effect
Luder describes “…electrical stimulation of white matter tracts in the brain to mitigate or help control seizures” (Para. [0008]). Luder is analogous art.
Luder teaches:
where the method further includes: receiving an efficacy body signal after applying the electrical stimulation to the neural target of the patient, wherein the efficacy body signal is selected from at least one of an autonomic signal, a neurologic signal, a metabolic signal, an endocrine signal, and a tissue stress marker signal; (Para. [0031]. “…the brain stimulation system 10 can be implemented as a closed loop system in which the control system 18 is operative to activate the stimulator 12 in response a sensed characteristic of the brain 16. For example, one or more sensors 22 can be used to sense electrical activity associated with the onset of a seizure or other neurological condition. The sensors 22 can be subdural or external probes located at or near the determined epileptogenic zones. … The control system 18 thus can control the signal generator 20 to operate the stimulator 12 to provide stimulation as a function of sensed electrical (or chemical) activity of the brain 16.”);
Luder’s “sensed characteristic of the brain” is such a “neurological signal” as claimed.
determining whether the efficacy body signal indicates that the electrical stimulation to the neural target of the patient has an efficacious effect; (Para. [0031]);
Luder’s Para. [0031] describes closed-loop stimulation based on brain signals. Per Luder’s Para. [0031], stimulation is provided if the received signal indicates that that a seizure is ongoing or imminent (i.e., as-of-then provided stimulation has not had an efficacious effect) and stimulation is not provided if the received signal indicates that that a seizure is neither ongoing nor imminent (i.e., as-of-then provided stimulation has had an efficacious effect).
and terminating the application of the electrical stimulation to the neural target of the patient based on a determination that indicates that the electrical stimulation to the neural target of the patient has an efficacious effect (Para. [0031]);
As explained above, Luder’s Para. [0031] describes a closed-loop system wherein stimulation is not provided if the received signal indicates that that a seizure is neither ongoing nor imminent (i.e., as-of-then provided stimulation has had an efficacious effect). This is such “terminating the application of the electrical stimulation … based on a determination … that the electrical stimulation … has an efficacious effect” as claimed.
It would have been obvious for a person of ordinary skill in the art at the time of the invention to modify the device of combined Ives and Bukhman with the teachings of Luder (i.e., to employ such closed loop stimulation based on brain activity as taught by Luder in the device of combined Ives and Bukhman) in order to “mitigate or help control seizures” (Luder at Para. [0008]).
Regarding Claim 12, the combination of Ives and Bukhman renders obvious the entirety of Claim 10 as explained above/
The combination of Ives and Bukhman does not disclose:
where the method further comprising continuing the application of the electrical stimulation to the neural target of the patient based on a determination indicating that the first electrical stimulation to the neural target of the patient has not had an efficacious effect
Luder describes “…electrical stimulation of white matter tracts in the brain to mitigate or help control seizures” (Para. [0008]). Luder is analogous art.
Luder teaches:
where the method further comprising continuing the application of the electrical stimulation to the neural target of the patient based on a determination indicating that the first electrical stimulation to the neural target of the patient has not had an efficacious effect; (Para. [0031]. “…the brain stimulation system 10 can be implemented as a closed loop system in which the control system 18 is operative to activate the stimulator 12 in response a sensed characteristic of the brain 16. For example, one or more sensors 22 can be used to sense electrical activity associated with the onset of a seizure or other neurological condition. The sensors 22 can be subdural or external probes located at or near the determined epileptogenic zones. … The control system 18 thus can control the signal generator 20 to operate the stimulator 12 to provide stimulation as a function of sensed electrical (or chemical) activity of the brain 16.”);
Luder’s Para. [0031] describes closed-loop stimulation based on brain signals. Per Luder’s Para. [0031], stimulation is provided if the received signal indicates that that a seizure is ongoing or imminent (i.e., as-of-then provided stimulation has not had an efficacious effect) and stimulation is not provided if the received signal indicates that that a seizure is neither ongoing nor imminent (i.e., as-of-then provided stimulation has had an efficacious effect).
It would have been obvious for a person of ordinary skill in the art at the time of the invention to modify the device of combined Ives and Bukhman with the teachings of Luder (i.e., to employ such closed loop stimulation based on brain activity as taught by Luder in the device of combined Ives and Bukhman) in order to “mitigate or help control seizures” (Luder at Para. [0008]).
Regarding Claim 13, the combination of Ives, Bukhman and Luder renders obvious the entirety of Claim 12 as explained above.
Bukhman additionally teaches:
where the method continues the electrical stimulation to the neural target of the patient for a predetermined duration (Para. [0118], “More specifically, treatment unit 630 may be an implanted unit with programmed electrical parameters (e.g., amplitude, pulse width, frequency, on-time, off-time, etc.) that defines a therapeutic stimulation signal provided by a stimulation unit 220 (FIG. 2) to the electrodes 128 via the leads 201 (FIG. 2).”).
Claim 14 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 5,361,773 A to Ives (“Ives”) in view of previously cited US 2010/0274303 A1 to Bukhman (“Bukhman”) as applied to Claim 10 above, and further in view of previously cited US 6,463,328 B1 to John (“John”).
Regarding Claim 12, the combination of Ives and Bukhman renders obvious the entirety of Claim 10 as explained above/
The combination of Ives and Bukhman does not disclose:
where the method further comprises terminating the application of the electrical stimulation to the neural target of the patient based on a safety duration constraint.
John describes “Adaptive brain stimulation systems and methods aids in the rehabilitation of patients from traumatic brain injury, coma, movement disorder, or other brain dysfunction” (Abstract), including seizure (Col. 27, Ln. 32). John is analogous art.
John teaches:
where the method further comprises terminating the application of the electrical stimulation to the neural target of the patient based on a safety duration constraint (Col. 23, Ln. 67 through Col. 24, Ln. 3).
It would have been obvious for a person of ordinary skill in the art at the time of the invention to modify the device of combined Ives and Bukhman with the teachings of John (i.e., to terminate the application of stimulation based on a safety duration constraint) in order to prevent unwanted side effects (John at Col. 24, Ln. 1-5).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J MUTCHLER whose telephone number is (571)272-8012. The examiner can normally be reached M-F 7:00 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.J.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
1 12/729,093 uses the term “index” only twice: at Pg. 13, Ln. 11, and at Pg. 19, Ln. 9. The former use is in reference to a “rhythmicity index” whose particulars are not specified, and the latter in reference to cognitive function. Neither use supports the “index” of Claim 10.