DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed 7/10/2026 with respect to the rejection of Claim 10 under 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement have been fully considered but they are not persuasive. As explained at Para. 11 of the Non-Final Office Action dated 4/14/2026, Claim 10 stands so-rejected because the Present Specification does not describe determining such an “index” as recited by Claim 10 from electrodes positioned in the brain as claimed in a manner 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 traverses the rejection, citing Pg. 27, Ln. 9-16 of the Present Specification, and highlighting the “signals related to a neurologic index” listed therein in support:
The MD 200 may also comprise one or more sensor(s) 212 coupled via sensor lead(s) 211 to the MD 200. Sensor(s) 212 are capable of detecting one or more body signals from a patient's body. Exemplary body signals include, but are not limited to, those related to an autonomic index, such as the patient's heart beat, blood pressure, and/or temperature, among others; signals related to a neurologic index, signals related to a metabolic index, signals related to an endocrine index, and signals related to a tissue stress marker index. For example, the body15 signals may be at least one of cardiac signals, body movement signals, or brain electrical activity signals from the patient's body. Present Specification at Pg. 27, Ln. 9-16 (emphasis added by Applicant in Remarks dated 7/10/2026).
The Examiner respectfully disagrees that Pg. 27, Ln. 9-16 of the Present Specification’s disclosure of “signals related to a neurologic index” supports “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” as recited by Claim 10.
The Examiner agrees that such “body signals” as described at Pg. 27, Ln. 9-16 of the Present Specification (a) are disclosed as including such electrical activity as recited by Claim 10; (b) are disclosed as being used “to detect an epileptic event ( e.g., a seizure onset, a seizure effect, a seizure end)” (see Present Specification at Pg. 28, Ln. 10-12); and (c) include “signals related to a neurologic index” (see Present Specification at Pg. 27, Ln. 9-16).
The Examiner disagrees that Pg. 27, Ln. 9-16 of the Present Specification supports “determining an index between the first electrical activity and the second electrical activity; and applying an electrical stimulation … based on the index being within a range.”
The Examiner agrees that the “first electrical activity” and the “second electrical activity” recited by Claim 10 reasonably correspond to the subset of “body signals” comprising “signals related to a neurologic index” described at Pg. 27, Ln. 9-16 of the Present Specification.
The Examiner agrees that the “one or more sensor(s) 212 … capable of detecting one or more body signals” described at Pg. 27, Ln. 9-16 of the Present Specification reasonably correspond to the Claim 10 limitations “detecting via one or more sensors a first electrical activity…” and “detecting via the one or more sensors a second electrical activity….”
The Examiner disagrees that the Pg. 27, Ln. 9-16 disclosure “Exemplary body signals include… signals related to a neurologic index…” pertain to either “determining an index between the first electrical activity and the second electrical activity” or “applying an electrical stimulation … based on the index being within a range.” That is, Pg. 27, Ln. 9-16 says nothing about either “determining an index” or “applying … stimulation … based on the index…,” but instead describes what “body signals” gathered by the “one or more sensor(s) 212” may be.
The Present Specification describes several embodiments, and the only embodiments which reasonably pertain to such an “index” as recited by Claim 10 are different embodiments than that of Claim 10. Claim 10 does not reasonably correspond to any embodiment in which a “neurologic index” is used, because all such embodiments require applying stimulation prior to determining an index. Claim 10 precludes such embodiments, because Claim 10 detects electrical activity prior to applying stimulation. This is confirmed by Claim 11, which recites “receiving an efficacy body signal after applying the electrical stimulation” (emphasis added). The Present Specification does not disclose or reasonably envision any embodiment wherein “neurologic signals” are first detected, and index between them is next determined, and stimulation is thereafter applied based on the determined index. Claim 10 thus fails to comply with the written description requirement. See MPEP 2163(II)(A), citing Stored Value Solutions, Inc. v. Card Activation Techs., 499 Fed.App’x 5, 13-14 (Fed. Cir. 2012) (non-precedential) (Finding inadequate written support for claims drawn to a method of processing debit purchase transactions requiring three separate authorization codes because “the written description [did] not contain a method that include[d] all three codes” and “[e]ach authorization code is an important claim limitation, and the presence of multiple authorization codes in [the claim] was essential”.).
This is addressed at Para. 11(a) of the Non-Final Office Action dated 4/14/2026, where (consistent with Applicant’s arguments) the Examiner acknowledged that “[t]he ‘index’ of Claim 10 appears to correspond to a ‘neurologic index,’” but explained that the problem is such a “neurologic index” “…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.” The Examiner continued that “(as confirmed by Claim 11), the ‘index’ of Claim 10 appears to actually detect an epileptic event.” Applicant’s arguments do not address the problem cited by the Examiner, and are therefore not persuasive.
Were Claim 10 to reflect a discrete embodiment described in the Present Specification, and citations to the portion of the Specification that describe that embodiment to be provided, the Examiner’s position would merit reconsideration. See MPEP 2163(II)(A), citing Hyatt v. Dudas, 492 F.3d 1365, 1371, 83 USPQ2d 1373, 1376-1377 (Fed. Cir. 2007) (holding the “examiner was explicit that while each element may be individually described in the specification, the deficiency was lack of adequate description of their combination” and, thus, “[t]he burden was then properly shifted to [inventor] to cite to the examiner where adequate written description could be found or to make an amendment to address the deficiency.”)
Applicant’s arguments regarding the rejection of Independent Claim 10 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 5,361,773 A to Ives (“Ives”) in view of US 2010/0274303 A1 to Bukhman (“Bukhman”) have been fully considered but are not persuasive.
Applicant argues that the combination of Ives and Bukhman fails to teach the Claim 10 limitations “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” because “Ives does not disclose detecting two separate electrical activities relating to two separate epileptic activities.” This argument is not persuasive.
Respectfully, it is not clear why Applicant believes that “Ives does not disclose detecting two separate electrical activities relating to two separate epileptic activities.” As explained at Para. 14(b) through 14(c) of the Non-Final Office Action dated 4/14/2026, Ives positions a multitude of sensors (i.e., Ives’s “electrodes”) at several different brain regions to map via EEG electrical brain activity reflective of epileptic seizures (see Ives at Col. 4, Ln. 1-10; Col. 4, Ln. 14-21; Claim 2; Claim 3). Ives’s sensors (i.e., Ives’s “electrodes”) detect “Brain activity occurring in the mesial temporal lobes and the lateral temporal lobes…” (Col. 4, Ln. 14-21).
Such “Brain activity occurring in the mesial temporal lobes and the lateral temporal lobes” are “two separate electrical activities:” a first separate electrical activity occurring in the mesial temporal lobes, and a second separate electrical activity occurring in the lateral temporal lobes.
Such “Brain activity occurring in the mesial temporal lobes and the lateral temporal lobes” are “two separate epileptic activities:” a first separate epileptic activity occurring in the mesial temporal lobes, and a second separate epileptic activity occurring in the lateral temporal lobes.
Ives notes that “…the great majority of focal seizures, such as partial complex epileptic seizures, occur in the temporal lobes….” Thus, there is a diagnostic advantage to such a distinction.
Relevantly, the Examiner notes that Claim 10 does not require “two separate electrical activities relating to two separate epileptic activities” as Applicant argues, because Claim 10 does not recite that the first electrical activity is different from the second electrical activity, or that the first epileptic activity is different from the second epileptic activity. While Claim 10 certainly is broad enough to read on such an instance, the breadth of Claim 10 also envisions an instance wherein the same electrical and/or epileptic activity is measured twice, each time via a different sensor. Such a dual measurement of a single signal could be advantageous for a variety of diagnostic reasons.
The Examiner notes that it is uncertain whether the Present Specification would support the exclusion of such a dual measurement configuration, as the Present Specification does not appear to make such a distinction.
To the extent that Applicant’s position is that two distinct epileptic events are required by Claim 10, such an interpretation is not supported by either the language of Claim 10 (which uses distinct terminology in reference to “epileptic activity” and a singular “epileptic event”) or the Present Specification.
Applicant’s arguments regarding the rejection of dependent Claims 11-14 are based on Applicant’s arguments regarding Independent Claim 10. Applicant’s arguments have been fully considered but are not persuasive for the same reasons as explained above with respect to Claim 10.
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, at the time the application was filed, had possession of the claimed invention. The rejection is maintained.
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 previously cited US 5,361,773 A to Ives (“Ives”) in view of previously cited US 2010/0274303 A1 to Bukhman (“Bukhman”). The rejection is maintained.
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 previously cited 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 2005/0049649 A1 to Luders et al. (“Luders”). The rejection is maintained.
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 previously cited 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”). The rejection is maintained.
Regarding Claim 14, 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
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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/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.
