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 .
Election/Restrictions
Claims 1-5, 12-14, 16-17, 19, 21-27, 29-30, and 32-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Groups I and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 17th, 2025.
Applicant’s election without traverse of Group II (Claims 6-11, 15, 18, 20, 28, 31, and 34-35) in the reply filed on December 17th, 2025 is acknowledged.
Claim Objections
Claims 9 and 35 are objected to because of the following informalities:
Claim 9 recites “DC signal” in line 2, but should read “direct current (DC) signal”
Claim 35 recites “active circuit[s]” in line 2, but should read “active circuit”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“seizure control system” in dependent claim 15: [0088] of the Applicant’s Specification discloses wherein the seizure control system can deliver electrical stimulation via a “pulse generator”
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 6-11, 15, 18, 20, 28, 31, and 34-35 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Each of Claims 6-11, 15, 18, 20, 28, 31, and 34-35 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 1
Claims 6-11, 15, 18, 20, 28, 31, and 34-35 recite a series of steps or acts for detecting seizures. Thus, the claims are directed to a process, which is one of the statutory categories of invention.
Step 2A, Prong 1
Each of Claims 6-11, 15, 18, 20, 28, 31, and 34-35 recites at least one step or instruction for detecting seizures, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. Accordingly, each of Claims 6-11, 15, 18, 20, 28, 31, and 34-35 recites an abstract idea.
Specifically, Claim 6 recites:
receiving a first series of electroencephalograph (EEG) signals from a first sensor and a second corresponding series of EEG signals from a second sensor, wherein the first sensor and the second sensor are positioned on a scalp of an individual;
applying a frequency filter to a first electroencephalograph (EEG) signal from a first sensor and a second EEG signal from a second sensor, the frequency filter comprises a Remez filter;
receiving, in a computing device, a first series of filtered EEG signals and a second corresponding series of filtered EEG signals;
calculating, by the computing device, a phase lock value (PLV) synchrony level based at least in part on the first series of filtered EEG signals and the second corresponding series of filtered EEG signals, wherein the PLV synchrony level is determined using the exponential power of the differences between a calculated phase of the first series of EEG signals at time t, and a calculated phase of the second series of EEG signals at time t with a sliding window;
detecting, by the computing device, an onset of a seizure event for the individual by comparing the PLV synchrony level with a calculated patient threshold for the individual, wherein the calculated patient threshold is selected in order to separate normal chaotic neural activity from highly synchronized neural activity found in a seizure state and is determined based on a sharp increase in the slope of PLV occurrences versus synchrony level between chaotic basal neural firing and abnormal seizure firing; and
transmitting, by the computing device, a notification indicating a seizure prediction horizon of the seizure event for the individual based on the comparison.
The claimed steps of filtering, calculating, detecting, and determining can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas. The steps of receiving and transmitting recite steps related to data-gathering and data-outputting, which are considered extra-solution activity.
Further, dependent Claims 7-11, 15, 18, 20, 28, 31, and 34-35 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in independent Claim 6 (and its dependent Claims 7-11, 15, 18, 20, 28, 31, and 34-35) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claim 6), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: “first sensor”, “second sensor”, and “computing device” in independent Claim 6; “third sensor” and “fourth sensor” in dependent claim 8; “electrode(s)” in dependent claims 10 and 35; and “receiver” in dependent claim 31 are generically recited computer elements in independent Claim 6 (and its dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claim 6 (and its dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., “computing device” as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claim 6 (and its dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claim 6 (and its dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 6-11, 15, 18, 20, 28, 31, and 34-35 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “first sensor”, “second sensor”, and “computing device” in independent Claim 6; “third sensor” and “fourth sensor” in dependent claim 8; “electrode(s)” in dependent claims 10 and 35; and “receiver” in dependent claim 31.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for computing, as demonstrated by the Applicant’s specification (e.g. paragraphs [0095-0113]) which discloses that the additional elements comprise generic components that are configured to perform generic computer functions (e.g. applying, calculating, detecting) as well as data-gathering and data-outputting steps that are well-understood, routine, and conventional activities previously known to the pertinent industry; and the non-patent literature of record in the application.
Accordingly, in light of Applicant’s specification, the claimed term “computing device” is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “computing device”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 6-11, 15, 18, 20, 28, 31, and 34-35 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the method of Claims 6-11, 15, 18, 20, 28, 31, and 34-35 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 6-11, 15, 18, 20, 28, 31, and 34-35 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claim 6 (and its dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 6-11, 15, 18, 20, 28, 31, and 34-35 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 6-11, 15, 18, 20, 28, 31, and 34-35 amounts to significantly more than the abstract idea itself. Accordingly, Claims 6-11, 15, 18, 20, 28, 31, and 34-35 are not patent eligible and rejected under 35 U.S.C. 101.
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 6-11, 15, 18, 20, 28, 31, and 34-35 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 6 recites “a first electroencephalograph (EEG) signal” in line 5. It is unclear as to whether the “first electroencephalograph (EEG) signal” is referring to one of the signals from the previously introduced “first series of electroencephalograph (EEG) signals” from line 2 of Claim 6, or a separate element.
Claim 6 recites “a first sensor” in lines 5-6. It is unclear as to whether the “first sensor” is referring to the previously introduced “first sensor” from line 2 of Claim 6, or a separate element.
Claim 6 recites “a second EEG signal” in line 6. It is unclear as to whether the “second EEG signal” is referring to one of the signals from the previously introduced “second corresponding series of EEG signals” from line 3 of Claim 6, or a separate element.
Claim 6 recites “a second sensor” in line 6. It is unclear as to whether the “second sensor” is referring to the previously introduced “second sensor” from line 3 of Claim 6, or a separate element.
Claim 6 recites the limitation "the exponential power" in lines 12-13. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the differences" in line 13. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites “the first series of EEG signals” in line 13. It is unclear as to whether the “first series of EEG signals” is referring to the previously introduced “first series of filtered EEG signals” from line 8 of Claim 6, or “first series of electroencephalograph (EEG) signals” from line 2 of Claim 6.
Claim 6 recites “the second series of EEG signals” in line 14. It is unclear as to whether the “second series of EEG signals” is referring to the previously introduced “second corresponding series of filtered EEG signals” from lines 8-9 of Claim 6, or “second corresponding series of EEG signals” from line 3 of Claim 6.
Claim 6 recites the limitation "the slope" in line 20. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites “wherein the second sensor is a reference EEG signal” in lines 1-2. It is unclear as to how a “sensor” can be a “signal”. Examiner will interpret this limitation as “wherein the second sensor is used to obtain a reference EEG signal”.
Claim 15 recites the limitation "the brain" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "the arctan(imaginary/real) part" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "the square root" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "the sum" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 35 recites the limitation "the attenuation" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
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.
Claims 6-7, 11, 18, 20, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NPL Myers et al (Myers, Mark H., and Robert Kozma. "Seizure prediction through dynamic synchronization measures of neural populations." 2009 International Joint Conference on Neural Networks. IEEE, 2009; cited by Applicant).
Regarding Claim 6, NPL Myers discloses a method comprising:
receiving a first series of electroencephalograph (EEG) signals (EEG System; II. EEG DATA) from a first sensor and a second corresponding series of EEG signals from a second sensor (two electrodes…a pair of electrodes; A. Hilbert Transformations-B. Measuring the degree of synchrony), wherein the first sensor and the second sensor are positioned on a scalp of an individual (A high density array of electrodes was placed onto the surface of the scalp of a neurosurgical patient; II. EEG DATA);
applying a frequency filter to a first electroencephalograph (EEG) signal from a first sensor and a second EEG signal from a second sensor, the frequency filter comprises a Remez filter (EEG data filtering was accomplished using a Remez filter within the 12- 20 Hz range in order to isolate the seizure occurrence; IV. RESULTS); -3-Application Number: 16/081,551 Docket Number: 822038-1010
receiving, in a computing device, a first series of filtered EEG signals and a second corresponding series of filtered EEG signals (The two selected channels are analyzed; IV. RESULTS);
calculating, by the computing device, a phase lock value (PLV) synchrony level based at least in part on the first series of filtered EEG signals and the second corresponding series of filtered EEG signals (phase lock value (PLV); B. Measuring the degree of synchrony), wherein the PLV synchrony level is determined using the exponential power of the differences between a calculated phase of the first series of EEG signals at time t, and a calculated phase of the second series of EEG signals at time t (See Equation (5) defining how to calculate phase lock value; B. Measuring the degree of synchrony) with a sliding window (The mean phase is determined through PLY calculations, using a sliding window technique; B. Measuring the degree of synchrony);
detecting, by the computing device, an onset of a seizure event for the individual by comparing the PLV synchrony level with a calculated patient threshold for the individual (C. Prediction and State Quantification-V. DISCUSSION), wherein the calculated patient threshold is selected in order to separate normal chaotic neural activity from highly synchronized neural activity found in a seizure state (individual patient based phase-locking threshold is introduced for seizure prediction and for differentiating seizure and non-seizure states; Abstract; A threshold PLV of the is used to predict raise an alarm in order predict an impending seizure, illustrated in Figs 4c. The optimal threshold is determined retrospectively as follows…It is found that PLV values within the abnormal/normal channel comparison rises above a threshold mark that represents the seizure state of the time series. The PLV values that rises above the threshold line within the time series may represent an alarm that predicts the occurrence of the seizure state; B. Measuring the degree of synchrony) and is determined based on a sharp increase in the slope of PLV occurences versus synchrony level between chaotic basal neural firing and abnormal seizure firing (See "S" and "P" arrows that correspond to the sharp increases in slope of the PLV occurrences in Figures 4(b), 5(b-g)); and
transmitting, by the computing device, a notification indicating a seizure prediction horizon of the seizure event for the individual based on the comparison (A threshold PLV of the is used to predict raise an alarm in order predict an impending seizure…the alarm must be set within a proper distance before a seizure occurrence…a time interval after an alarm is set, which is called the seizure prediction horizon (SPH) and denoted as prediction marker; B. Measuring the degree of synchrony).
Regarding Claim 7, NPL Myers discloses wherein the second sensor is a reference EEG signal (We also take the channel with lowest STD as our comparison or reference channel. These two channels will be used as input to our algorithm; IV. RESULTS).
Regarding Claim 11, NPL Myers discloses wherein the comparison indicates that the PLV synchrony level exceeds the calculated patient threshold for a time period (It is found that PLV values within the abnormal/normal channel comparison rises above a threshold mark that represents the seizure state of the time series. The PLV values that rises above the threshold line within the time series may represent an alarm that predicts the occurrence of the seizure state. Our current direction is to provide a 10 minute window of warning for our method to be considered feasible. Additional experimentation may be able to increase this alarm system to 20-30 minutes; B. Measuring the degree of synchrony).
Regarding Claim 18, NPL Myers discloses wherein the notification indicating the onset of the seizure event for the individual comprises a time interval determined from prior EEG data from the individual (A threshold PLV of the is used to predict raise an alarm in order predict an impending seizure, illustrated in Figs 4c; B. Measuring the degree of synchrony; Examiner’s Note: Figure 4C shows the alarm containing the time interval data for the patient).
Regarding Claim 20, NPL Myers discloses wherein after receiving, in the computing device, the first and second series of filtered EEG signals (The two selected channels are analyzed; IV. RESULTS), applying EEG signal decompose to the first and second filtered signals using Hilbert transformations in order to calculate a phase and an amplitude of the signals (A. Hilbert Transformations) and then calculating, by the computing device, the phase lock synchrony level based at least in part on the first series of filtered EEG signals and the second corresponding series of filtered EEG signals (phase lock value (PLV); B. Measuring the degree of synchrony).
Regarding Claim 28, NPL Myers discloses wherein the phase is calculated by the arctan(imaginary/real) part of the signal (See Equation 4) following Hilbert transformations (A. Hilbert Transformations), and the amplitude is calculated by the square root of the sum of the real and imaginary parts of the Hilbert transformation (See Equation 3).
Claim Rejections - 35 USC § 103
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.
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.
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over NPL Myers in view of Luo et al (U.S. Publication No. 2012/0197092; cited by Applicant).
Regarding Claim 8, NPL Myers fails to disclose wherein a third sensor is positioned on a lobe of a first ear of the individual and a fourth sensor as a ground reference is positioned on a lobe of a second ear of the individual.
In a similar technical field, Luo teaches a dry sensor EEG/EMG and motion sensing system for seizure detection and monitoring (Abstract), wherein a third sensor is positioned on a lobe of a first ear of the individual (In some embodiments, seizure detection system 400 includes more than one EEG sensor 402. In some embodiments, EEG sensor 402 is located in different locations based on each user's needs and/or preferences…In some embodiments, the seizure detection system 400 includes a grounded ear clip 406 to reduce the amount of noise; [0026]) and a fourth sensor as a ground reference (reference EEG sensor 404 is mounted/provided on appropriate locations of the user's head for EEG signal detection; [0026]) is positioned on a lobe of a second ear of the individual (Figure 4; Element 404 is positioned on the earlobe of the individual).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the ear teachings of Luo into those of NPL Myers in order to have the ears serve as reference points to reduce the amount of noise (Luo [0026]).
Regarding Claim 10, NPL Myers fails to disclose wherein the first sensor, the second sensor, or both, are a dry active electrode.
In a similar technical field, Luo teaches a dry sensor EEG/EMG and motion sensing system for seizure detection and monitoring (Abstract), wherein the first sensor is a dry active electrode (a system for seizure detection/monitoring is provided that can be mounted directly on a user's head using active dry EEG sensors; Paragraph 17; active EEG sensor 320; Figure 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the dry electrode teachings of Luo into those of NPL Myers in order to eliminate the need for conductive gels or glues for installation (Luo [0013]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over NPL Myers in view of NPL Abdelhalim (“Phase-Synchronization Early Epileptic Seizure Detector VLSI Architecture” IEEE Trans Biomed Circuits Syst. 2011;5(5):430-438. doi:10.1109/TBCAS.2011.2170686; cited by Applicant).
Regarding Claim 9, NPL Myers fails to disclose wherein the frequency filter passes frequencies from 0.1 Hz to 50 Hz and using low pass filtering to remove DC signal components with a low pass filter, high pass filtering to eliminate aliasing effects with a high pass filter, and notch filtering to attenuate power line noise with a notch filter.
In a similar technical field of seizure detection, NPL Abdelhalim teaches wherein the frequency filter passes frequencies from 0.1 Hz to 50 Hz (Then, for each contact pair, the signal spectrum was separated into five frequency bands via high-Q bandpass filters: delta (0.5–4 Hz), theta (4–8 Hz), alpha (8–13 Hz), a sub-band of beta (15–25 Hz) and gamma (30–48 Hz); Page 6 Column 1) and using low pass filtering to remove DC signal components with a low pass filter, high pass filtering to eliminate aliasing effects with a high pass filter (The proposed analog front-end utilizes two stages of AC-coupled amplifiers with a gain of 1000 V/V (60 dB), and tuneable low-pass and high-pass filters to maintain a bandwidth between 0.1 Hz and 5 kHz; Page 2 Column 2), and notch filtering to attenuate power line noise with a notch filter (finite impulse (FIR) filters can be classified as notch filtering; Page 3 Column 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the filtering teachings of NPL Abdelhalim into those of NPL Myers in order to eliminate noise in order to accurately predict a seizure condition.
Claims 15, 31, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over NPL Myers in view of Bukhman (U.S. Publication No. 2011/0270095; cited by Applicant).
Regarding Claim 15, although NPL Myers discloses wherein the notification is directed to a seizure control system (A threshold PLV of the is used to predict raise an alarm in order predict an impending seizure…the alarm must be set within a proper distance before a seizure occurrence…a time interval after an alarm is set, which is called the seizure prediction horizon (SPH) and denoted as prediction marker; B. Measuring the degree of synchrony), NPL Myers fails to disclose wherein the seizure control system is configured to deliver electrical stimulation to the brain of the individual when the PLV rises above the calculated patient threshold.
In a similar technical field, Bukhman teaches methods, systems, and apparatus for detecting an epilepsy event in a patient using a medical device (Abstract), wherein the notification is directed to a seizure control system, wherein the seizure control system is configured to deliver electrical stimulation to the brain of the individual when the PLV rises above the calculated patient threshold (With regard to an electrical stimulation treatment, the parameters of electrical signal therapy…The combination of treatment, if any, may be determined based upon the results of the comparison of the calculated nonlinear analysis parameter(s) to threshold values; [0208]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the electrical stimulation teachings of Bukhman into those of NPL Myers in order to provide treatment or therapy when threshold values are surpassed (Bukhman [0208]).
Regarding Claim 31, although NPL Myers discloses transmitting a notification (A threshold PLV of the is used to predict raise an alarm in order predict an impending seizure; B. Measuring the degree of synchrony), NPL Myers fails to specifically disclose wherein the notification is configured as a text, email, or vibration notification transmitted to a receiver.
In a similar technical field, Bukhman teaches methods, systems, and apparatus for detecting an epilepsy event in a patient using a medical device (Abstract), wherein the notification is configured as a text, email, or vibration notification transmitted to a receiver (Based upon this determination, the nonlinear analysis module 285 may initiate one or more of several responsive actions, including generating an indication of at least one of an epileptic event or an impending epileptic event…Nonlinear analysis module 285 may initiate other responsive actions such as providing an audible, visible, or tactile alert to the patient…communicating with one or more of database unit 250 or remote device 292, or notifying emergency services via email or autophone communications; [0185]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the notification teachings of Bukhman into those of NPL Myers in order to allow the patient, caregiver, or physician to take measures protective of the patient’s well-being and those of others in different situations (Bukhman [0079]).
Regarding Claim 34, although NPL Myers discloses wherein the notification is deemed to be a false positive (false prediction; B. Measuring the degree of synchrony), NPL Myers fails to specifically disclose wherein the notification is deemed to be a false positive if not followed by a seizure event within one hour of the notification.
In a similar technical field, Bukhman teaches methods, systems, and apparatus for detecting an epilepsy event in a patient using a medical device (Abstract), wherein the notification is deemed to be a false positive if not followed by a seizure event within one hour of the notification (It should be noted that an epilepsy event involving a prediction may sometimes be a false positive (e.g., an actual seizure may not occur within a specified time for example 1 hr., 30 minutes, or 5 minutes, depending upon the type of warning desired—of the seizure prediction or indication of elevated risk; [0086]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the timeframe teachings of Bukhman into those of NPL Myers in order to accurately account for false positives within a specified time and keep up a consistent standard for the type of warning and indication of elevated risk (Bukhman [0086]).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over NPL Myers and NPL Abdelhalim as applied to claim 9 above, and further in view of Luo.
Regarding Claim 35, NPL Abdelhalim discloses wherein the attenuation occurs within an active circuit of the first and second sensors (finite impulse (FIR) filters can be classified as notch filtering; Page 3 Column 1; Examiner’s Note: as stated in Claim 9, the notch filters are used to attenuate noise).
NPL Myers and NPL Abdelhalim fail to disclose wherein the first sensor and the second sensor are dry active electrodes.
In a similar technical field, Luo teaches a dry sensor EEG/EMG and motion sensing system for seizure detection and monitoring (Abstract), wherein the first sensor and second sensor are dry active electrodes (a system for seizure detection/monitoring is provided that can be mounted directly on a user's head using active dry EEG sensors; Paragraph 17; active EEG sensor 320; Figure 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the dry electrode teachings of Luo into those of NPL Myers and NPL Abdelhalim in order to eliminate the need for conductive gels or glues for installation (Luo [0013]).
Conclusion
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/CHANEL J JHIN/Examiner, Art Unit 3791