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 .
Abstract
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract is currently less than 50 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Claim Objections
Claims 2, 13, and 16 are objected to because of the following informalities:
Claim 2 recites “determining variances of the patient EEG data of a plurality of segments of the patient EEG data” in lines 3-4, but should read “determining variances of a plurality of segments of the patient EEG data”
Claim 13 recites “determining variances of the patient EEG data of a plurality of segments of the patient EEG data” in lines 3-4, but should read “determining variances of a plurality of segments of the patient EEG data”
Claim 16 recites “the patient EEG for the change in the EEG data” in lines 2-3, but should read “the patient EEG data for the change in the patient EEG data”
Claim 16 recites “the EEG data” in line 4, but should read “the patient EEG data”
Appropriate correction is required.
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 1-22 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 1 recites “to obtain preprocessed patient EEG data” in lines 5-6. It is unclear as to whether this limitation is referring to the “patient EEG data collected” previously recited in line 4 of Claim 1, or a separate element.
Claim 1 recites the limitation "the preprocessing" in line 6. There is insufficient antecedent basis for this limitation in the claim. Although Claim 1 previously recited “preprocessing” in line 4, Examiner notes that “preprocessing” was used as a verb, instead of a noun.
Claim 2 recites “one or more segments” in line 5. It is unclear as to whether this limitation is referring to one or more segments of the “plurality of segments” previously recited in Claim 2, or a separate element.
Claim 2 recites “with variances that do not satisfy a variance threshold” in lines 5-6. It is unclear as to whether “variances” in line 5 of Claim 2 is referring to the “variances” that were previously recited in line 3 of Claim 2, or a separate element.
Claim 2 recites “modifying one or more segments of the patient EEG data with variances that do not satisfy a variance threshold that changes based on the variances of the plurality of segments” in lines 5-6. It is unclear as to exactly what this limitation entails. Specifically, it is unclear as to how a segment is modified with variances, and it is further unclear as to how variances that do not satisfy a threshold are determined, if the threshold is changed based on those variances. Clarification is requested.
Claim 4 recites “wherein the variance threshold is increased by a multiplier responsive to not encountering a segment of the patient EEG data with a variance that is smaller than the current value of the variance threshold during a threshold period of time” in lines 1-4. Claim 4 is dependent on Claim 3, which previously recited “setting the variance threshold to the variance of the segment of the patient EEG data” in lines 2-3. If the variance threshold does not encounter a segment of the patient EEG data with a variance that is smaller than the current value of the variance threshold, that is equivalent to the current value of the variance threshold being larger than a variance of a segment of the patient EEG data. Therefore, it is unclear as to how the variance threshold could simultaneously be set to the variance of the segment of the patient EEG data and be increased by a multiplier. Clarification is requested.
Claim 7 recites “a change in the patient EEG data” in line 2. It is unclear as to whether this limitation is referring to the previous “a change in the patient EEG data” previously recited in line 7 of Claim 1, or a separate element.
Claim 12 recites “to obtain preprocessed patient EEG data” in line 4. It is unclear as to whether this limitation is referring to the “patient EEG data collected” previously recited in line 3 of Claim 12, or a separate element.
Claim 12 recites the limitation "the preprocessing" in line 5. There is insufficient antecedent basis for this limitation in the claim. Although Claim 12 previously recited “preprocess” in line 3, Examiner notes that “preprocess” was used as a verb, instead of a noun.
Claim 13 recites “one or more segments” in line 5. It is unclear as to whether this limitation is referring to one or more segments of the “plurality of segments” previously recited in Claim 13, or a separate element.
Claim 13 recites “with variances that do not satisfy a variance threshold” in lines 5-6. It is unclear as to whether “variances” in line 5 of Claim 13 is referring to the “variances” that were previously recited in in line 3 of Claim 13, or a separate element.
Claim 13 recites “modifying one or more segments of the patient EEG data with variances that do not satisfy a variance threshold that changes based on the variances of the plurality of segments” in lines 5-7. It is unclear as to exactly what this limitation entails. Specifically, it is unclear as to how a segment is modified with variances, and it is further unclear as to how variances that do not satisfy a threshold are determined, if the threshold is changed based on those variances. Clarification is requested.
Claim 15 recites “wherein the variance threshold is increased by a multiplier responsive to not encountering a segment of the patient EEG data with a variance that is smaller than the current value of the variance threshold during a threshold period of time” in lines 1-4. Claim 15 is dependent on Claim 14, which previously recited “setting the variance threshold to the variance of the segment of the patient EEG data” in line 4. If the variance threshold does not encounter a segment of the patient EEG data with a variance that is smaller than the current value of the variance threshold, that is equivalent to the current value of the variance threshold being larger than a variance of a segment of the patient EEG data. Therefore, it is unclear as to how the variance threshold could simultaneously be set to the variance of the segment of the patient EEG data and be increased by a multiplier. Clarification is requested.
Claim 18 recites “a change in the patient EEG data” in lines 2-3. It is unclear as to whether this limitation is referring to the previous “a change in the patient EEG data” previously recited in lines 5-6 of Claim 12, or a separate element.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7 and 18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 7 recites “wherein adjusting the at least one parameter of the preprocessing is performed responsive to not detecting a change in the patient EEG data over a duration of time” in lines 1-3. However, Claim 7 is dependent on Claim 5, which previously recited “adjusting the at least one parameter of the preprocessing responsive to the change in the patient EEG data” in lines 2-3. Therefore, claim 7 fails to further limit the subject matter of the claim upon which it depends from.
Claim 18 recites “wherein adjusting the at least one parameter of the preprocessing is performed responsive to not detecting a change in the patient EEG data over a duration of time” in lines 1-3. However, Claim 18 is dependent on Claim 16, which previously recited “adjust the at least one parameter of the preprocessing responsive to the change in the EEG data” in lines 3-4. Therefore, claim 18 fails to further limit the subject matter of the claim upon which it depends from.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-22 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 1-22 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 1
Claims 1-11 recites a series of steps or acts for detecting seizure events. Thus, the claims are directed to a process, which is one of the statutory categories of invention.
Claims 12-22 recite a non-transitory computer readable medium for detecting seizure events. Thus, the claims are directed to a machine, which is one of the statutory categories of invention.
Step 2A, Prong 1
Each of Claims 1-22 recites at least one step or instruction for detecting seizure events, which is grouped as a mental process under the 2019 PEG. Both Claims 1 and 12 recite abstract ideas in the form of mental processes, as consistent with Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012). If a claim, under its broadest reasonable interpretation, covers performance in the mind but for the recitation of generic computer components, then it is still in the mental processes category unless the claim cannot practically be performed in the mind, see Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016). Preprocessing data and detecting a seizure event from said data are assessments that may be performed by a human. This applies for all claims dependent on claims 1 and 12. Accordingly, each of Claims 1-22 recites an abstract idea.
Specifically, Claim 1 recites the abstract idea of: “preprocessing patient EEG data collected, from a scalp of a particular patient, by a plurality of discrete wireless EEG sensors to obtain preprocessed patient EEG data, wherein at least one parameter of the preprocessing changes over time responsive to a change in the patient EEG data; and detecting a seizure event from the preprocessed patient EEG data”.
Specifically, Claim 12 recites the abstract idea of: “preprocess patient EEG data collected, from a scalp of a particular patient, by a plurality of discrete wireless EEG sensors to obtain preprocessed patient EEG data, wherein at least one parameter of the preprocessing changes over time responsive to a change in the patient EEG data; and detect a seizure event from the preprocessed patient EEG data”.
Further, dependent Claims 2-11 and 13-22 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 each of independent Claims 1 and 12 (and their respective dependent Claims 2-11 and 13-22) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claims 1 and 12), 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: “one or more processors”, “plurality of discrete wireless EEG sensors”, and “non-transitory computer readable medium” are generically recited computer elements in independent Claims 1 and 12 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field or considered as data-gathering elements for insignificant extra-solution activity. 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 Claims 1 and 12 (and their respective 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) using rules (e.g., computer instructions) executed by a computer (e.g., “one or more processors” 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 Claims 1 and 12 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 1 and 12 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1-22 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: “one or more processors”, “plurality of discrete wireless EEG sensors”, and “non-transitory computer readable medium”. 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 data-gathering and computing, as demonstrated by the Applicant’s specification (e.g. paragraphs [0030-0054] and [0335-0346]) which discloses that the sensor(s) are configured to perform data-gathering steps and that the processor(s) comprise generic computer components that are configured to perform the generic computer functions (e.g. preprocessing and detecting) that are well-understood, routine, and conventional activities previously known to the pertinent industry; the Applicant’s Background in the specification; and the non-patent literature of record in the application.
Accordingly, in light of Applicant’s specification, the claimed term “one or more processors” 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 “one or more processors”. 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 1-22 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 and medium of Claims 1-22 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 1-22 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 Claims 1 and 12 (and their 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 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 1-22 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 1-22 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-22 are not patent eligible and rejected under 35 U.S.C. 101.
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 (i.e., changing from AIA to pre-AIA ) 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 1, 5-6, 8-12, 16-17, and 19-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sackellares et al (U.S. Publication No. 2009/0124923 A1).
Regarding Claim 1, Sackellares discloses a method of detecting seizure events from electroencephalogram (EEG) signals (System for seizure monitoring and detection; Abstract) comprising: with one or more processors (The digital signals are evaluated by an EEG processor 20 to determine if the patient is experiencing seizure activity; [0029]):
preprocessing patient EEG data collected, from a scalp of a particular patient (Figures 3A-3B), by a plurality of discrete wireless EEG sensors to obtain preprocessed patient EEG data (The SMDS 10 has electrodes (not explicitly shown) for capturing electrical signals 12 from the patient's brain in a known manner. It is envisioned that the electrodes would be placed on the patient's head according to the international 10-20 system shown in FIGS. 3A and 3B; [0025]), wherein at least one parameter of the preprocessing changes over time responsive to a change in the patient EEG data ([0033-0046]); and detecting a seizure event from the preprocessed patient EEG data (The EEG processor 20 runs a monitoring and detection process 100 as described below with respect to FIG. 6. If the SMDS 10 is being used for real-time seizure monitoring and seizure activity is detected, the SMDS 10 will provide notification such as by an alarm 22 or other like means; [0029]).
Regarding Claim 5, Sackellares discloses monitoring the patient EEG data for the change in the patient EEG data and adjusting the at least one parameter of the preprocessing responsive to the change in the patient EEG data ([0037-0046]).
Regarding Claim 6, Sackellares discloses wherein the change is due to a position or orientation of a discrete wireless EEG sensor of the plurality of discrete wireless EEG sensors (The seizure detection algorithm utilizes the linear and nonlinear characteristics of the EEG signals, where nonlinear features are used for detection of events and linear features are used for rejections of recording artifacts and normal physiological activities (for example, sleep, muscle activity, chewing, etc); [0011]; The STM, the difference between STX and STM, and DAmp can reject false detections caused by certain sleep patterns; [0053]; sleep EEG pattern; [0058-0060]; sleep activities; [0068-0069]; This criterion is to reduce the chance that the detection is due to a muscle and/or chewing activity artifact; [0085]; Examiner’s Note: The changes in patient EEG data may be caused by activities such as sleep, muscle activity, chewing, etc. Therefore, these changes are a result of the positioning of the EEG sensors, since if the EEG sensors were placed in other locations, they would not result in the same changes in data caused by activities such as sleep, muscle activity, chewing, etc., as other positions would not be affected in the same way).
Regarding Claim 8, Sackellares discloses wherein the plurality of discrete wireless EEG sensors are configured to collect the patient EEG data without a common reference electrode (The SMDS 10 has electrodes (not explicitly shown) for capturing electrical signals 12 from the patient's brain in a known manner. It is envisioned that the electrodes would be placed on the patient's head according to the international 10-20 system shown in FIGS. 3A and 3B; [0025]; Examiner’s Note: No common reference electrode is recited to be included in the electrodes that are placed on the patient).
Regarding Claim 9, Sackellares discloses wherein preprocessing further comprises denoising the patient EEG data to remove at least one frequency component in the patient EEG data (the SMDS 10 filters the signal segment in two desired frequency ranges to generate filtered EEG or EEG signals. The two frequency ranges are referred to as filter-A and filter-B so that resulting signals are filter-A EEG signals and filter-B EEG signals. The rationale for the filtering process is to reduce the possibility of false detections caused by the signal artifacts from patients' normal activities. For example, muscle movement, chewing activity, coughing and the like may create false positives. Within the frequency ranges, the information of seizure activity is preserved. In one embodiment, the SMDS 10 uses a Butterworth filter of order 5 with two frequency ranges of approximately 1 to 50 Hz and 1 to 20 Hz for a scalp EEG; [0035]).
Regarding Claim 10, Sackellares discloses wherein denoising comprises: identifying one or more noise signals in the patient EEG data; and removing the one or more noise signals from the patient EEG data (the SMDS 10 filters the signal segment in two desired frequency ranges to generate filtered EEG or EEG signals. The two frequency ranges are referred to as filter-A and filter-B so that resulting signals are filter-A EEG signals and filter-B EEG signals. The rationale for the filtering process is to reduce the possibility of false detections caused by the signal artifacts from patients' normal activities. For example, muscle movement, chewing activity, coughing and the like may create false positives. Within the frequency ranges, the information of seizure activity is preserved. In one embodiment, the SMDS 10 uses a Butterworth filter of order 5 with two frequency ranges of approximately 1 to 50 Hz and 1 to 20 Hz for a scalp EEG; [0035]).
Regarding Claim 11, Sackellares discloses wherein identifying the one or more noise signals comprises: dividing the patient EEG data into a plurality of segments; and identifying the one or more noise signals responsive to a determination that linear combinations of frequency components do not satisfy a threshold associated with a frequency variance (Referring still to FIG. 6, at step 106, the SMDS 10 filters the signal segment in two desired frequency ranges to generate filtered EEG or EEG signals. The two frequency ranges are referred to as filter-A and filter-B so that resulting signals are filter-A EEG signals and filter-B EEG signals. The rationale for the filtering process is to reduce the possibility of false detections caused by the signal artifacts from patients' normal activities. For example, muscle movement, chewing activity, coughing and the like may create false positives. Within the frequency ranges, the information of seizure activity is preserved. In one embodiment, the SMDS 10 uses a Butterworth filter of order 5 with two frequency ranges of approximately 1 to 50 Hz and 1 to 20 Hz for a scalp EEG. For an intracranial EEG, the SMDS 10 may use frequency ranges of approximately 1 to 50 Hz and 1 to 35 Hz. The SMDS 10 applies the filtering procedure to each of the EEG channels analyzed; [0035]).
Regarding Claim 12, Sackellares discloses a non-transitory computer readable medium (It should be appreciated that the subject technology can be implemented and utilized in numerous ways, including without limitation as a process, an apparatus, a system, a device, a method for applications now known and later developed, or a computer-readable medium; [0015]) storing instructions that, when executed by one or more processors (The digital signals are evaluated by an EEG processor 20 to determine if the patient is experiencing seizure activity; [0029]), cause the one or more processors to: preprocess patient EEG data collected, from a scalp of a particular patient (Figures 3A-3B), by a plurality of discrete wireless EEG sensors to obtain preprocessed patient EEG data (The SMDS 10 has electrodes (not explicitly shown) for capturing electrical signals 12 from the patient's brain in a known manner. It is envisioned that the electrodes would be placed on the patient's head according to the international 10-20 system shown in FIGS. 3A and 3B; [0025]), wherein at least one parameter of the preprocessing changes over time responsive to a change in the patient EEG data ([0033-0046]); and detect a seizure event from the preprocessed patient EEG data (The EEG processor 20 runs a monitoring and detection process 100 as described below with respect to FIG. 6. If the SMDS 10 is being used for real-time seizure monitoring and seizure activity is detected, the SMDS 10 will provide notification such as by an alarm 22 or other like means; [0029]).
Regarding Claim 16, Sackellares discloses wherein the instructions are further configured to cause the one or more processors to monitor the patient EEG for the change in the EEG data and adjust the at least one parameter of the preprocessing responsive to the change in the EEG data ([0037-0046]).
Regarding Claim 17, Sackellares discloses wherein the change is due to a position or orientation of a discrete wireless EEG sensor of the plurality of discrete wireless EEG sensors (The seizure detection algorithm utilizes the linear and nonlinear characteristics of the EEG signals, where nonlinear features are used for detection of events and linear features are used for rejections of recording artifacts and normal physiological activities (for example, sleep, muscle activity, chewing, etc); [0011]; The STM, the difference between STX and STM, and DAmp can reject false detections caused by certain sleep patterns; [0053]; sleep EEG pattern; [0058-0060]; sleep activities; [0068-0069]; This criterion is to reduce the chance that the detection is due to a muscle and/or chewing activity artifact; [0085]; Examiner’s Note: The changes in patient EEG data may be caused by activities such as sleep, muscle activity, chewing, etc. Therefore, these changes are a result of the positioning of the EEG sensors, since if the EEG sensors were placed in other locations, they would not result in the same changes in data caused by activities such as sleep, muscle activity, chewing, etc., as other positions would not be affected in the same way).
Regarding Claim 19, Sackellares discloses wherein the plurality of discrete wireless EEG sensors are configured to collect the patient EEG data without a common reference electrode (The SMDS 10 has electrodes (not explicitly shown) for capturing electrical signals 12 from the patient's brain in a known manner. It is envisioned that the electrodes would be placed on the patient's head according to the international 10-20 system shown in FIGS. 3A and 3B; [0025]; Examiner’s Note: No common reference electrode is recited to be included in the electrodes that are placed on the patient).
Regarding Claim 20, Sackellares discloses wherein the instructions are further configured to cause the one or more processors to preprocess the patient EEG data by denoising the patient EEG data to remove at least one frequency component in the patient EEG data (the SMDS 10 filters the signal segment in two desired frequency ranges to generate filtered EEG or EEG signals. The two frequency ranges are referred to as filter-A and filter-B so that resulting signals are filter-A EEG signals and filter-B EEG signals. The rationale for the filtering process is to reduce the possibility of false detections caused by the signal artifacts from patients' normal activities. For example, muscle movement, chewing activity, coughing and the like may create false positives. Within the frequency ranges, the information of seizure activity is preserved. In one embodiment, the SMDS 10 uses a Butterworth filter of order 5 with two frequency ranges of approximately 1 to 50 Hz and 1 to 20 Hz for a scalp EEG; [0035]).
Regarding Claim 21, Sackellares discloses wherein the instructions are further configured to cause the one or more processors to denoise the patient EEG data by: identifying one or more noise signals in the patient EEG data; and removing the one or more noise signals from the patient EEG data (the SMDS 10 filters the signal segment in two desired frequency ranges to generate filtered EEG or EEG signals. The two frequency ranges are referred to as filter-A and filter-B so that resulting signals are filter-A EEG signals and filter-B EEG signals. The rationale for the filtering process is to reduce the possibility of false detections caused by the signal artifacts from patients' normal activities. For example, muscle movement, chewing activity, coughing and the like may create false positives. Within the frequency ranges, the information of seizure activity is preserved. In one embodiment, the SMDS 10 uses a Butterworth filter of order 5 with two frequency ranges of approximately 1 to 50 Hz and 1 to 20 Hz for a scalp EEG; [0035]).
Regarding Claim 22, Sackellares discloses wherein the instructions are further configured to cause the one or more processors to identify the one or more noise signals by: dividing the patient EEG data into a plurality of segments; and identifying the one or more noise signals responsive to a determination that linear combinations of frequency components do not satisfy a threshold associated with a frequency variance (Referring still to FIG. 6, at step 106, the SMDS 10 filters the signal segment in two desired frequency ranges to generate filtered EEG or EEG signals. The two frequency ranges are referred to as filter-A and filter-B so that resulting signals are filter-A EEG signals and filter-B EEG signals. The rationale for the filtering process is to reduce the possibility of false detections caused by the signal artifacts from patients' normal activities. For example, muscle movement, chewing activity, coughing and the like may create false positives. Within the frequency ranges, the information of seizure activity is preserved. In one embodiment, the SMDS 10 uses a Butterworth filter of order 5 with two frequency ranges of approximately 1 to 50 Hz and 1 to 20 Hz for a scalp EEG. For an intracranial EEG, the SMDS 10 may use frequency ranges of approximately 1 to 50 Hz and 1 to 35 Hz. The SMDS 10 applies the filtering procedure to each of the EEG channels analyzed; [0035]).
Conclusion
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/CHANEL J YOON/Examiner, Art Unit 3791
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