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 .
Status of Claims
Claims 1-14, filed 09/01/2023, are hereby under examination.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed 09/01/2023, 10/14/2025, and 02/03/2026 are being considered.
Claim Objections
Claim 1 is objected to because of the following informalities: “calculating effective values of the plurality of artifact component signals of each of the electroencephalogram signals” should read “calculating effective values of each of the plurality of artifact component signals of each of the plurality of electroencephalogram signals” and “the effective value of each of the artifact component signals” should read “the effective values of each of the plurality of artifact component signals” for claim language consistency. Appropriate correction is required.
Claims 3 and 13 are objected to because of the following informalities: “the effective value of the plurality of artifact component signals” should read “the effective values of each of the plurality of artifact component signals” and “each electroencephalogram signal” should read “each of the plurality of electroencephalogram signals” for claim language consistency. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: “include” should read “includes”. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: "calculating a plurality of signal quality indexes each indicating…" should read "calculating a plurality of signal quality indexes, each indicating…" and “each electroencephalogram signal” should read “each of the plurality of electroencephalogram signals” for claim language consistency. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: “calculate effective values of the plurality of artifact component signals of each of the electroencephalogram signals” should read “calculate effective values of each of the plurality of artifact component signals of each of the plurality of electroencephalogram signals” and “the effective value of each of the artifact component signals” should read “the effective values of each of the plurality of artifact component signals” for claim language consistency. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: "calculate a plurality of signal quality indexes each indicating…" should read "calculate a plurality of signal quality indexes, each indicating…" and “each electroencephalogram signal” should read “each of the plurality of electroencephalogram signals” for claim language consistency. 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 1-14 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.
Regarding Claim 1, the claim recites “a plurality of electroencephalogram signals” and "the effective value of each of the artifact component signals of the electroencephalogram signal". It is unclear to which one of the “plurality of electroencephalogram signals” “the electroencephalogram signal” refers. For the purposes of examination, "the effective value of each of the artifact component signals of the electroencephalogram signal" is herein interpreted to be "the effective value of each of the artifact component signals of each of the plurality of electroencephalogram signal". The claim also recites "the artifact associated with the artifact component signal of which the effective value satisfies the predetermined condition". There is improper antecedent basis for “the artifact”. The claim recites “different types of artifacts” earlier. It is unclear if “the artifact” refers to any number of artifacts included in “different types of artifacts”. For the purposes of examination, “the artifact” is herein interpreted to be “the different types of artifacts”. Due to the aforementioned reasons, claim 1 is rendered indefinite. Claims 2-10 are rejected due to their dependence on claim 1.
Regarding Claim 2, the claim recites “a type of artifact”. There is improper antecedent basis for this claim limitation. It is also unclear if “a type of artifact” refers to one of the “different types of artifacts” or “the artifact” recited in claim 1, from which claim 2 is dependent. For the purposes of examination “a type of artifact” is herein interpreted to be “one of the different types of artifacts”. Therefore, claim 2 is rendered indefinite.
Regarding Claim 3, the claim recites “information indicating a type of artifact”. There is improper antecedent basis for “a type of artifact”. It is also unclear if “a type of artifact” refers to one of the “different types of artifacts” or “the artifact” recited in claim 1, from which claim 3 is dependent. For the purposes of examination “a type of artifact” is herein interpreted to be “one of the different types of artifacts”. Therefore, claim 3 is rendered indefinite.
Regarding Claim 4, the claim recites “an effective value of the first artifact component signal…” and “the effective value”. It is unclear if “the effective value” refers to “an effective value of the first artifact component signal…” or one of the “effective values of each of the artifact component signals” recited in claim 1, from which claim 4 is dependent. For the purposes of examination, “the effective value” is herein interpreted to refer to “an effective value of the first artifact component signal…”. Examiner suggests amending the claim to recite “the effective value of the first artifact component signal associated with first electroencephalogram signal”. Therefore, claim 4 is rendered indefinite. Claim 5 is rejected due to its dependence on claim 4.
Regarding Claim 6, the claim recites “a living body”. It is unclear if “a living body” refers to “a subject” recited in claim 1, from which claim 6 is dependent. For the purposes of examination, “a living body” is herein interpreted to refer to the “a subject” or a different living body. Therefore, claim 6 is rendered indefinite.
Regarding Claim 7, the claim recites “effective values of at least one of the plurality of artifact component signals of each electroencephalogram signal”. It is unclear if there is a difference between “effective values of at least one of the plurality of artifact component signals of each electroencephalogram signal” and “effective values of the plurality of artifact component signals of each of the electroencephalogram signals” recited in claim 1, from which claim 7 is dependent. For the purposes of examination, “effective values of at least one of the plurality of artifact component signals of each electroencephalogram signal” and “effective values of the plurality of artifact component signals of each of the electroencephalogram signals” recited in claim 1 are herein interpreted to be the same effective values. Therefore, “effective values of at least one of the plurality of artifact component signals of each electroencephalogram signal” is herein interpreted to be “the effective values of at least one of the plurality of artifact component signals of each electroencephalogram signal”. Therefore, claim 7 is rendered indefinite. Claim 8 is rejected due to its dependence on claim 7.
Regarding Claim 8, the claim recites “the comprehensive signal quality index is equal to or less than a predetermined threshold value” and “the effective value of each of the artifact component signals of the electroencephalogram signal satisfies the predetermined condition”. Claim 1, from which claim 8 is dependent, recites “the effective value of each of the artifact component signals of the electroencephalogram signal satisfies a predetermined condition”. It is unclear if “a predetermined threshold” is the same as or different than the “a predetermined condition” recited in claim 1. For the purposes of examination, “a predetermined threshold” is herein interpreted to be the same as or different than the “a predetermined condition” recited in claim 1. Furthermore, it is unclear if “the predetermined condition” refers to “a predetermined condition” recited in claim 8 or “a predetermined condition” recited in claim 1. For the purposes of examination, “the predetermined condition” is herein interpreted to refer to “a predetermined condition” recited in claim 8 or “a predetermined condition” recited in claim 1. Due to the aforementioned reasons, claim 8 is rendered indefinite.
Regarding Claim 9, the claim recites “a living body”. It is unclear if “a living body” refers to “a subject” recited in claim 1, from which claim 9 is dependent. For the purposes of examination, “a living body” is herein interpreted to refer to the “a subject” or a different living body. The claim also recites “the electrode”. It is unclear to which one of “the plurality of electrodes” recited in claim 1 “the electrode” refers. For the purposes of examination, “the electrode” is herein interpreted to refer to “one of the plurality of electrodes”. Due to the aforementioned reasons, claim 9 is rendered indefinite.
Regarding Claim 10, the claim recites “the computer”. There is insufficient antecedent basis for this claim limitation. For the purposes of examination, “the computer” is herein interpreted to be “a computer”. Therefore, claim 10 is rendered indefinite.
Regarding Claim 11, the claim recites “a plurality of electroencephalogram signals” and "the effective value of each of the artifact component signals of the electroencephalogram signal". It is unclear to which one of the “plurality of electroencephalogram signals” “the electroencephalogram signal” refers. For the purposes of examination, "the effective value of each of the artifact component signals of the electroencephalogram signal" is herein interpreted to be "the effective value of each of the artifact component signals of each of the plurality of electroencephalogram signal". The claim also recites "the artifact associated with the artifact component signal of which the effective value satisfies the predetermined condition". There is improper antecedent basis for “the artifact”. The claim recites “different types of artifacts” earlier. It is unclear if “the artifact” refers to any number of artifacts included in “different types of artifacts”. For the purposes of examination, “the artifact” is herein interpreted to be “the different types of artifacts”. Due to the aforementioned reasons, claim 11 is rendered indefinite. Claims 12-14 are rejected due to their dependence on claim 11.
Regarding Claim 12, the claim recites “a type of artifact”. There is improper antecedent basis for this claim limitation. It is also unclear if “a type of artifact” refers to one of the “different types of artifacts” or “the artifact” recited in claim 11, from which claim 12 is dependent. For the purposes of examination “a type of artifact” is herein interpreted to be “one of the different types of artifacts”. Therefore, claim 12 is rendered indefinite.
Regarding Claim 13, the claim recites “information indicating a type of artifact”. There is improper antecedent basis for “a type of artifact”. It is also unclear if “a type of artifact” refers to one of the “different types of artifacts” or “the artifact” recited in claim 11, from which claim 13 is dependent. For the purposes of examination “a type of artifact” is herein interpreted to be “one of the different types of artifacts”. Therefore, claim 13 is rendered indefinite.
Regarding Claim 14, the claim recites “effective values of at least one of the plurality of artifact component signals of each electroencephalogram signal”. It is unclear if there is a difference between “effective values of at least one of the plurality of artifact component signals of each electroencephalogram signal” and “effective values of the plurality of artifact component signals of each of the electroencephalogram signals” recited in claim 11, from which claim 14 is dependent. For the purposes of examination, “effective values of at least one of the plurality of artifact component signals of each electroencephalogram signal” and “effective values of the plurality of artifact component signals of each of the electroencephalogram signals” recited in claim 11 are herein interpreted to be the same effective values. Therefore, “effective values of at least one of the plurality of artifact component signals of each electroencephalogram signal” is herein interpreted to be “the effective values of at least one of the plurality of artifact component signals of each electroencephalogram signal”. The claim also recites “the comprehensive signal quality index is equal to or less than a predetermined threshold value” and “the effective value of each of the artifact component signals of the electroencephalogram signal satisfies the predetermined condition”. Claim 11 recites “the effective value of each of the artifact component signals of the electroencephalogram signal satisfies a predetermined condition”. It is unclear if “a predetermined threshold” is the same as or different than the “a predetermined condition” recited in claim 11. For the purposes of examination, “a predetermined threshold” is herein interpreted to be the same as or different than the “a predetermined condition” recited in claim 11. Furthermore, it is unclear if “the predetermined condition” refers to “a predetermined condition” recited in claim 14 or “a predetermined condition” recited in claim 11. For the purposes of examination, “the predetermined condition” is herein interpreted to refer to “a predetermined condition” recited in claim 14 or “a predetermined condition” recited in claim 11. Due to the aforementioned reasons, claim 14 is rendered indefinite.
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 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
STEP 1
Regarding claim 1, the claim recites a series of steps or acts, including obtaining a plurality of electroencephalogram signals indicating an electroencephalogram of a subject. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of determining whether the effective value of each of the artifact component signals of the electroencephalogram signal satisfies a predetermined condition sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites visually presenting information related to the artifact associated with the artifact component signal of which the effective value satisfies the predetermined condition, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The visual presentation of information related to the artifact does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the visually presented information related to the artifact, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of obtaining a plurality of electroencephalogram signals indicating an electroencephalogram of a subject, using a plurality of electrodes attached to a head of the subject, each of the plurality of electroencephalogram signals being associated with a respective one of the plurality of electrodes; obtaining, from each of the plurality of electroencephalogram signals, a plurality of artifact component signals indicating different types of artifacts; and calculating effective values of the plurality of artifact component signals of each of the electroencephalogram signals. Obtaining physiological signals (EEG signals), obtaining component signals (artifact component signals) of the physiological signals (EEG signals), and calculating a metric (effective values) to compare to a threshold (predetermined condition) in order to determine the presence of artifacts is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the obtaining and calculating steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering and processing steps necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 11, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited one or more processors and one or memories are generic computer elements configured to perform pre-solutional data gathering activity, perform the Abstract Idea, and perform WURC visual presenting of information related to the artifact. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering and the display of data. The comparing and calculating steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims. Dependent claims 2, 5, and 12 further define the visually presented information. Dependent claims 3-4, 6, 9 and 12-13 further define the types of artifacts, the plurality of electroencephalogram and artifact component signals, and the method when one of the effective value exceeds the predetermined condition. Dependent claims 7-8 and 14 further limit the independent claims by reciting signal quality indexes and a comprehensive signal quality index. Dependent claim 10 defines how the method is executed.
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.
Claim(s) 1-2, 4, 5, and 7-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baxi (US Patent Pub. No. 20160055415 – cited by Applicant).
Regarding Claim 1, Baxi discloses a physiological information processing method executed by a computer (FIG. 3 shows a method 26 of evaluating physiological signals in a home health setting. The method 26 may be implemented in executable software as a set of logic instructions stored in a machine- or computer-readable medium of a memory [0019]), the physiological information processing method comprising:
obtaining a plurality of electroencephalogram signals indicating an electroencephalogram of a subject, using a plurality of electrodes attached to a head of the subject, each of the plurality of electroencephalogram signals being associated with a respective one of the plurality of electrodes (Illustrated processing block 28 provides for receiving a physiological signal from a sensor configuration associated with a mobile device. As already noted, the physiological signal may be associated with an… EEG reading [0020]; the mobile device 16 includes one or more sensors (e.g., electrodes, contacts) 18 that may be pressed against a body part (e.g., chest, arm, head) of the patient 14 in order to measure the physiological condition of the patient 14. [0015]; fig 3);
obtaining, from each of the plurality of electroencephalogram signals, a plurality of artifact component signals indicating different types of artifacts (Block 32 may extract a first noise source from the physiological signal. [0021]; Similarly, block 40 may extract a second noise source from the physiological signal. [0024]; fig 3);
calculating effective values of the plurality of artifact component signals of each of the electroencephalogram signals (Illustrated block 38 conducts a quantitative analysis for the first noise source. More particularly, a signal to noise ratio (SNR.sub.1) may be computed for the first noise source based on the estimated physiological signal strength from block 30 and the estimated and normalized noise from block 34. [0023]; Illustrated block 46 conducts a quantitative analysis for the second noise source. More particularly, an SNR.sub.2 may be computed for the second noise source based on the estimated physiological signal strength from block 30 and the estimated and normalized noise from block 42. [0025]; fig 3);
determining whether the effective value of each of the artifact component signals of the electroencephalogram signal satisfies a predetermined condition (Block 48 may also determine an overall quality level (OQL) for the physiological signal, wherein the OQL may be based on both the individual qualitative analyses (QR.sub.1, QR.sub.2, . . . ) and the individual quantitative analyses (SNR.sub.1, SNR.sub.2, . . . ). More particularly, a dynamic weighting function may combine the individual SNRs into a single value (e.g., ranging from zero to ten). The weights in the weighting function may change dynamically if a certain noise type is present in excessive quantity to tilt the physiological signal quality to unacceptable levels. [0029]; fig 3);
and visually presenting information related to the artifact associated with the artifact component signal of which the effective value satisfies the predetermined condition (Returning now to FIG. 3, a determination may be made at block 52 as to whether a quality condition has been satisfied. The quality condition may specify, for example, that no noise type has an individual QR of “Poor”, the OQR is either “Good” or “Fair”, the OQL is above a certain threshold (e.g., 5 out of 10), etc., or any combination thereof. If the quality condition is not satisfied, illustrated block 54 determines whether a maximum number of readings (e.g., three) has been reached. If not, a user prompt may be generated at block 56. The user prompt may request one or more additional readings (e.g., “Please take another ECG reading”). [0032]; fig 3).
Regarding Claim 2, Baxi discloses the invention as discussed above in claim 1. Baxi further discloses the information related to the artifact includes: information indicating a type of the artifact; and information indicating a measure for reducing the artifact (The user prompt may also include a recommendation that is tailored to one or more of the plurality of noise sources. For example, in the case of baseline wander noise, the patient might be asked to hold the device lightly and with uniform pressure. In the case of excessive muscle tremor noise, the patient may be asked to relax and support his or her hands. In the case of motion artifact noise, the patient might be asked to remain still or avoid too much chest movement during breathing. In the case of excessive power main interference or EMI, the patient may be asked to change locations and/or power off nearby devices. Other noise type-specific recommendations may also be made. [0033]; fig 3).
Regarding Claim 4, Baxi discloses the invention as discussed above in claim 1. Baxi further discloses the plurality of electrodes include a first electrode (Illustrated processing block 28 provides for receiving a physiological signal from a sensor configuration associated with a mobile device. As already noted, the physiological signal may be associated with an… EEG reading [0020]; the mobile device 16 includes one or more sensors (e.g., electrodes, contacts) 18 that may be pressed against a body part (e.g., chest, arm, head) of the patient 14 in order to measure the physiological condition of the patient 14. [0015]; fig 3; Examiner notes any of the one or more electrodes can be the first electrode), the plurality of electroencephalogram signals include a first electroencephalogram signal associated with the first electrode (Illustrated processing block 28 provides for receiving a physiological signal from a sensor configuration associated with a mobile device. As already noted, the physiological signal may be associated with an… EEG reading [0020]; fig 3; Examiner notes any of the EEG readings can be a first electroencephalogram signal from the first electrode), the plurality of artifact component signals include a first artifact component signal indicating a first artifact (Block 32 may extract a first noise source from the physiological signal. [0021]; fig 3), and in a case where an effective value of the first artifact component signal associated with the first electroencephalogram signal is greater than a predetermined threshold value associated with the effective value, information related to the first artifact mixed in the first electroencephalogram signal is visually presented (Returning now to FIG. 3, a determination may be made at block 52 as to whether a quality condition has been satisfied. The quality condition may specify, for example, that no noise type has an individual QR of “Poor”, the OQR is either “Good” or “Fair”, the OQL is above a certain threshold (e.g., 5 out of 10), etc., or any combination thereof. If the quality condition is not satisfied, illustrated block 54 determines whether a maximum number of readings (e.g., three) has been reached. If not, a user prompt may be generated at block 56. The user prompt may request one or more additional readings (e.g., “Please take another ECG reading”). [0032]; fig 3; Examiner notes the effective value of the first artifact component signal used to determine if the quality condition is satisfied).
Regarding Claim 5, Baxi discloses the invention as discussed above in claim 4. Baxi further discloses the information related to the first artifact mixed in the first electroencephalogram signal includes: information indicating a type of the first artifact; and information indicating a measure for reducing the first artifact (The user prompt may also include a recommendation that is tailored to one or more of the plurality of noise sources. For example, in the case of baseline wander noise, the patient might be asked to hold the device lightly and with uniform pressure. In the case of excessive muscle tremor noise, the patient may be asked to relax and support his or her hands. In the case of motion artifact noise, the patient might be asked to remain still or avoid too much chest movement during breathing. In the case of excessive power main interference or EMI, the patient may be asked to change locations and/or power off nearby devices. Other noise type-specific recommendations may also be made. [0033]; fig 3).
Regarding Claim 7, Baxi discloses the invention as discussed above in claim 1. Baxi further discloses calculating a plurality of signal quality indexes each indicating a signal quality of a respective one of the plurality of electroencephalogram signals, based on effective values of at least one of the plurality of artifact component signals of each electroencephalogram signal (Illustrated block 38 conducts a quantitative analysis for the first noise source. More particularly, a signal to noise ratio (SNR.sub.1) may be computed for the first noise source based on the estimated physiological signal strength from block 30 and the estimated and normalized noise from block 34. [0023]; As in the case of the first noise source, a qualitative analysis may be conducted for the second noise source at block 44. [0025]; fig 3).
Regarding Claim 8, Baxi discloses the invention as discussed above in claim 7. Baxi further discloses determining a comprehensive signal quality index indicating a comprehensive signal quality of the plurality of electroencephalogram signals, based on the plurality of signal quality indexes (the SNR.sub.1 for the first noise source may be subsequently combined with the SNRs of the other noise sources to obtain an overall quality level for the physiological signal [0023]; Block 48 may also determine an overall quality level (OQL) for the physiological signal, wherein the OQL may be based on both the individual qualitative analyses (QR.sub.1, QR.sub.2, . . . ) and the individual quantitative analyses (SNR.sub.1, SNR.sub.2, . . . ). [0029]; fig 3), wherein in a case where the comprehensive signal quality index is equal to or less than a predetermined threshold value, the determining whether the effective value of each of the artifact component signals of the electroencephalogram signal satisfies the predetermined condition is executed (Returning now to FIG. 3, a determination may be made at block 52 as to whether a quality condition has been satisfied. The quality condition may specify, for example, that no noise type has an individual QR of “Poor”, the OQR is either “Good” or “Fair”, the OQL is above a certain threshold (e.g., 5 out of 10), etc., or any combination thereof. [0032]; If either the quality condition is satisfied or the maximum number of readings is reached, block 58 may select the best physiological signal based on the qualitative and quantitative analysis results, wherein the selected best physiological signal (and associated qualitative and quantitative data) is reported to a remote location at illustrated block 60.[0034]).
Regarding Claim 9, Baxi discloses the invention as discussed above in claim 1. Baxi further discloses the plurality of artifact component signals include: a first artifact component signal indicating a first artifact caused by a living body; and a second artifact component signal indicating a second artifact caused by a factor other than the living body, and the second artifact includes: an artifact caused by attachment failure of the electrode attached to the subject; and an artifact caused by a lead wire connected to the electrode (The user prompt may also include a recommendation that is tailored to one or more of the plurality of noise sources. For example, in the case of baseline wander noise, the patient might be asked to hold the device lightly and with uniform pressure. In the case of excessive muscle tremor noise, the patient may be asked to relax and support his or her hands. In the case of motion artifact noise, the patient might be asked to remain still or avoid too much chest movement during breathing. In the case of excessive power main interference or EMI, the patient may be asked to change locations and/or power off nearby devices. Other noise type-specific recommendations may also be made. [0033]; Depending upon the sensing configuration and/or environment, a plurality of noise sources 12 (12a-12e) may be superimposed on physiological signals such as the signal 10 and therefore reduce the quality and/or reliability of those signals. For example, a power main (e.g., 50/60 Hz) interference source 12a might originate from nearby low frequency electrical equipment, building power lines, etc. Additionally, a muscle noise source 12b may originate from involuntary muscle contractions of the patient due to anxiety, and a motion artifact noise source 12c may originate from patient movement. Moreover, an electromagnetic interference (EMI) source 12d may originate from nearby high frequency devices such as mobile phones and other electronic devices, and a baseline wander noise source 12e may originate from chemical reactions and other contributors to changes in skin-electrode impedance. [0013]; The filters used in the de-noising procedure may take into consideration the frequency profile of various types of noise sources (e.g., power main interference, muscle noise, motion artifact noise, EMI, baseline wander noise). [0020]; fig 1).
Regarding Claim 10, Baxi discloses the invention as discussed above in claim 1. Baxi further discloses a non-transitory computer-readable storage medium storing a program comprising instructions which, when the program is executed by the computer, cause the computer to execute the physiological information processing method according to claim 1 (FIG. 3 shows a method 26 of evaluating physiological signals in a home health setting. The method 26 may be implemented in executable software as a set of logic instructions stored in a machine- or computer-readable medium of a memory [0019]; see claim 1 rejection above).
Regarding Claim 11, Baxi discloses a physiological information processing apparatus (Turning now to FIG. 2A a home health monitoring environment is shown in which a patient 14 uses a mobile device 16… the mobile device 16 may be configured to make automated quality assessments of the physiological signals prior to transmitting them to the healthcare network 20 as well as guide the patient 14 in taking additional readings if the assessments indicate that earlier readings lack reliability. [0015]; Turning now to FIG. 6, a computing platform 62 is shown. The platform 62 may be part of a mobile device having computing functionality (e.g., PDA, laptop, smart tablet), communications functionality (e.g., wireless smart phone), imaging functionality, media playing functionality (e.g., smart television/TV), or any combination thereof (e.g., mobile Internet device/MID). [0038]; fig 6) comprising:
one or more processors (the platform 62 includes a processor 64 [0038]; fig 6);
and one or more memories configured to store a computer readable instruction (an integrated memory controller (IMC) 66,… system memory 70,… mass storage 76 (e.g., optical disk, hard disk drive/HDD, flash memory) [0038]; fig 6), wherein in a case where the computer readable instruction is executed by the one or more processors (The method 26 may be implemented in executable software as a set of logic instructions stored in a machine- or computer-readable medium of a memory such as random access memory (RAM), read only memory (ROM), programmable ROM (PROM), firmware, flash memory, etc. [0019]; fig 3), the physiological information processing apparatus is configured to:
obtain a plurality of electroencephalogram signals indicating an electroencephalogram of a subject, using a plurality of electrodes attached to a head of the subject, each of the plurality of electroencephalogram signals being associated with a respective one of the plurality of electrodes (Illustrated processing block 28 provides for receiving a physiological signal from a sensor configuration associated with a mobile device. As already noted, the physiological signal may be associated with an… EEG reading [0020]; the mobile device 16 includes one or more sensors (e.g., electrodes, contacts) 18 that may be pressed against a body part (e.g., chest, arm, head) of the patient 14 in order to measure the physiological condition of the patient 14. [0015]; fig 3),
obtain, from each of the plurality of electroencephalogram signals, a plurality of artifact component signals indicating different types of artifacts (Block 32 may extract a first noise source from the physiological signal. [0021]; Similarly, block 40 may extract a second noise source from the physiological signal. [0024]; fig 3),
calculate effective values of the plurality of artifact component signals of each of the electroencephalogram signals (Illustrated block 38 conducts a quantitative analysis for the first noise source. More particularly, a signal to noise ratio (SNR.sub.1) may be computed for the first noise source based on the estimated physiological signal strength from block 30 and the estimated and normalized noise from block 34. [0023]; Illustrated block 46 conducts a quantitative analysis for the second noise source. More particularly, an SNR.sub.2 may be computed for the second noise source based on the estimated physiological signal strength from block 30 and the estimated and normalized noise from block 42. [0025]; fig 3),
determine whether the effective value of each of the artifact component signals of the electroencephalogram signal satisfies a predetermined condition (Block 48 may also determine an overall quality level (OQL) for the physiological signal, wherein the OQL may be based on both the individual qualitative analyses (QR.sub.1, QR.sub.2, . . . ) and the individual quantitative analyses (SNR.sub.1, SNR.sub.2, . . . ). More particularly, a dynamic weighting function may combine the individual SNRs into a single value (e.g., ranging from zero to ten). The weights in the weighting function may change dynamically if a certain noise type is present in excessive quantity to tilt the physiological signal quality to unacceptable levels. [0029]; fig 3),
and visually present information related to the artifact associated with the artifact component signal of which the effective value satisfies the predetermined condition (Returning now to FIG. 3, a determination may be made at block 52 as to whether a quality condition has been satisfied. The quality condition may specify, for example, that no noise type has an individual QR of “Poor”, the OQR is either “Good” or “Fair”, the OQL is above a certain threshold (e.g., 5 out of 10), etc., or any combination thereof. If the quality condition is not satisfied, illustrated block 54 determines whether a maximum number of readings (e.g., three) has been reached. If not, a user prompt may be generated at block 56. The user prompt may request one or more additional readings (e.g., “Please take another ECG reading”). [0032]; fig 3).
Regarding Claim 12, Baxi discloses the invention as discussed above in claim 11. Baxi further discloses the information related to the artifact includes: information indicating a type of the artifact; and information indicating a measure for removing the artifact (The user prompt may also include a recommendation that is tailored to one or more of the plurality of noise sources. For example, in the case of baseline wander noise, the patient might be asked to hold the device lightly and with uniform pressure. In the case of excessive muscle tremor noise, the patient may be asked to relax and support his or her hands. In the case of motion artifact noise, the patient might be asked to remain still or avoid too much chest movement during breathing. In the case of excessive power main interference or EMI, the patient may be asked to change locations and/or power off nearby devices. Other noise type-specific recommendations may also be made. [0033]; fig 3).
Regarding Claim 13, Baxi discloses the invention as discussed above in claim 11. Baxi further discloses in a case where at least one of the effective values of the plurality of artifact component signals in each electroencephalogram signal satisfies the predetermined condition, information indicating a type of artifact mixed in each electroencephalogram signal is visually presented (Returning now to FIG. 3, a determination may be made at block 52 as to whether a quality condition has been satisfied. The quality condition may specify, for example, that no noise type has an individual QR of “Poor”, the OQR is either “Good” or “Fair”, the OQL is above a certain threshold (e.g., 5 out of 10), etc., or any combination thereof. If the quality condition is not satisfied, illustrated block 54 determines whether a maximum number of readings (e.g., three) has been reached. If not, a user prompt may be generated at block 56. [0032]; The user prompt may also include a recommendation that is tailored to one or more of the plurality of noise sources. For example, in the case of baseline wander noise, the patient might be asked to hold the device lightly and with uniform pressure. In the case of excessive muscle tremor noise, the patient may be asked to relax and support his or her hands. In the case of motion artifact noise, the patient might be asked to remain still or avoid too much chest movement during breathing. In the case of excessive power main interference or EMI, the patient may be asked to change locations and/or power off nearby devices. Other noise type-specific recommendations may also be made. [0033]; fig 3).
Regarding Claim 14, Baxi discloses the invention as discussed above in claim 11. Baxi further discloses in a case where the computer readable instruction is executed by the one or more processors, the physiological information processing apparatus is further configured to:
calculate a plurality of signal quality indexes each indicating a signal quality of a respective one of the plurality of electroencephalogram signals, based on effective values of at least one of the plurality of artifact component signals of each electroencephalogram signal (Illustrated block 38 conducts a quantitative analysis for the first noise source. More particularly, a signal to noise ratio (SNR.sub.1) may be computed for the first noise source based on the estimated physiological signal strength from block 30 and the estimated and normalized noise from block 34. [0023]; As in the case of the first noise source, a qualitative analysis may be conducted for the second noise source at block 44. [0025]; fig 3);
determine a comprehensive signal quality index indicating a comprehensive signal quality of the plurality of electroencephalogram signals, based on the plurality of signal quality indexes (the SNR.sub.1 for the first noise source may be subsequently combined with the SNRs of the other noise sources to obtain an overall quality level for the physiological signal [0023]; Block 48 may also determine an overall quality level (OQL) for the physiological signal, wherein the OQL may be based on both the individual qualitative analyses (QR.sub.1, QR.sub.2, . . . ) and the individual quantitative analyses (SNR.sub.1, SNR.sub.2, . . . ). [0029]; fig 3);
and in a case where the comprehensive signal quality index is equal to or less than a predetermined threshold value, determine whether the effective value of each of the artifact component signals of the electroencephalogram signal satisfies the predetermined condition (Returning now to FIG. 3, a determination may be made at block 52 as to whether a quality condition has been satisfied. The quality condition may specify, for example, that no noise type has an individual QR of “Poor”, the OQR is either “Good” or “Fair”, the OQL is above a certain threshold (e.g., 5 out of 10), etc., or any combination thereof. [0032]; If either the quality condition is satisfied or the maximum number of readings is reached, block 58 may select the best physiological signal based on the qualitative and quantitative analysis results, wherein the selected best physiological signal (and associated qualitative and quantitative data) is reported to a remote location at illustrated block 60.[0034]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baxi (US Patent Pub. No. 20160055415 – cited by Applicant) as applied to claim 1 above, and further in view of Ushiba et al. (US Patent Pub. No. 20200329991 – cited by Applicant) hereinafter Ushiba.
Regarding Claim 3, Baxi discloses the invention as discussed above in claim 1. Baxi discloses in a case where at least one of the effective values of the plurality of artifact component signals in each electroencephalogram signal satisfies the predetermined condition, information indicating a type of artifact mixed in each electroencephalogram signal is visually presented (Returning now to FIG. 3, a determination may be made at block 52 as to whether a quality condition has been satisfied. The quality condition may specify, for example, that no noise type has an individual QR of “Poor”, the OQR is either “Good” or “Fair”, the OQL is above a certain threshold (e.g., 5 out of 10), etc., or any combination thereof. If the quality condition is not satisfied, illustrated block 54 determines whether a maximum number of readings (e.g., three) has been reached. If not, a user prompt may be generated at block 56. The user prompt may request one or more additional readings (e.g., “Please take another ECG reading”). [0032]; fig 3).
Baxi fails to disclose in a case where at least one of the effective values of the plurality of artifact component signals in each electroencephalogram signal satisfies the predetermined condition, information indicating a type of artifact mixed in each electroencephalogram signal is visually presented in association with a respective one of the plurality of electrodes.
However, Ushiba teaches a physiological information processing method (Also, the same function as that of the electroencephalogram measurement system 10 may also be implemented as an electroencephalogram measurement method, a (computer) program, or a non-transitory storage medium that stores the computer program thereon, for example. An electroencephalogram measurement method according to an aspect includes: acquiring electroencephalogram information representing an electroencephalogram obtained by an electrode unit 11 placed on a region of interest 51 that forms part of the subject's 5 head 52; making a decision, based on the electroencephalogram information acquired, whether or not there are any artifacts; and outputting the decision made about the artifacts. A (computer) program according to another aspect is designed to cause a computer system to carry out the electroencephalogram measurement method described above. [0177]) comprising:
wherein in a case where at least one of effective values of a plurality of artifact component signals in each electroencephalogram signal satisfies a predetermined condition (After having performed Step S7, S10, or S11, the electroencephalogram measurement system 10 makes the output unit 217 output the decision made by the decision unit 214 to the display control unit 218 (in Step S12). As a result, the decision made by the decision unit 214 is displayed on the display unit 26. [0175]; fig 11), information indicating a type of artifact mixed in each electroencephalogram signal is visually presented in association with a respective one of a plurality of electrodes (In addition, under each electroencephalogram displayed as a record in the record display area G41, an artifact mark M2 in a band shape is displayed in association with each record. [0147]; The electroencephalogram measurement system 10 according to this embodiment displays such artifact marks M2 in the record display area G41, thus allowing the subject 5 or the medical staff to easily pick a record for use in the calculation processing from among records with no artifacts. [0148]; the electroencephalogram information includes the first electroencephalogram information representing the electroencephalogram obtained by the first electrode 111 and the second electroencephalogram information representing the electroencephalogram obtained by the second electrode 112 [0167]; figs 9 & 12).
Ushiba is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Baxi such that information indicating a type of artifact mixed in each electroencephalogram signal is visually presented in association with a respective one of a plurality of electrodes, as taught by Ushiba, because it would allow the subject and medical staff to see which electrodes are measuring EEG signals with artifacts.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baxi (US Patent Pub. No. 20160055415 – cited by Applicant) as applied to claim 1 above.
Regarding Claim 6, Baxi discloses the invention as discussed above in claim 1. Baxi further discloses the plurality of electrodes include a first electrode, the plurality of electroencephalogram signals include a first electroencephalogram signal associated with the first electrode (Illustrated processing block 28 provides for receiving a physiological signal from a sensor configuration associated with a mobile device. As already noted, the physiological signal may be associated with an… EEG reading [0020]; the mobile device 16 includes one or more sensors (e.g., electrodes, contacts) 18 that may be pressed against a body part (e.g., chest, arm, head) of the patient 14 in order to measure the physiological condition of the patient 14. [0015]; fig 3; Examiner notes any of the one or more electrodes can be the first electrode and any of the EEG readings can be the first electroencephalogram signal), the plurality of artifact component signals include:
a first artifact component signal indicating a first artifact caused by a living body (Block 32 may extract a first noise source from the physiological signal. [0021]; The illustrated noise extraction and estimation procedure may be conducted for each of a plurality of noise sources in the physiological signal. For example, for the muscle noise source 12b (FIG. 1), the noise extraction may involve applying a digital BPF having a center frequency of 2 Hz or 100 Hz to the physiological signal. For the motion artifact noise source 12c (FIG. 1), the noise extraction might involve applying a digital notch filter with a center frequency of 50 Hz or 60 Hz to remove power main interference and applying a digital LPF having a cutoff frequency of 5 Hz, a cubic spline, etc. [0026]; fig 3);
and a second artifact component signal indicating a second artifact caused by a factor other than the living body (Similarly, block 40 may extract a second noise source from the physiological signal. [0024]; The illustrated noise extraction and estimation procedure may be conducted for each of a plurality of noise sources in the physiological signal. For example, for the muscle noise source 12b (FIG. 1), the noise extraction may involve applying a digital BPF having a center frequency of 2 Hz or 100 Hz to the physiological signal. For the motion artifact noise source 12c (FIG. 1), the noise extraction might involve applying a digital notch filter with a center frequency of 50 Hz or 60 Hz to remove power main interference and applying a digital LPF having a cutoff frequency of 5 Hz, a cubic spline, etc. [0026]; fig 3),
and in a case where a first effective value of the first artifact component signal associated with the first electroencephalogram signal is greater than a first threshold value associated with the first effective value, and a second effective value of the second artifact component signal associated with the first electroencephalogram signal is greater than a second threshold value associated with the second effective value (Returning now to FIG. 3, a determination may be made at block 52 as to whether a quality condition has been satisfied. The quality condition may specify, for example, that no noise type has an individual QR of “Poor”, the OQR is either “Good” or “Fair”, the OQL is above a certain threshold (e.g., 5 out of 10), etc., or any combination thereof. [0032]), information associated with the second artifact mixed in the first electroencephalogram signal is visually presented and information associated with the first artifact mixed in the first electroencephalogram signal is visually presented (The user prompt may also include a recommendation that is tailored to one or more of the plurality of noise sources. For example, in the case of baseline wander noise, the patient might be asked to hold the device lightly and with uniform pressure. In the case of excessive muscle tremor noise, the patient may be asked to relax and support his or her hands. In the case of motion artifact noise, the patient might be asked to remain still or avoid too much chest movement during breathing. In the case of excessive power main interference or EMI, the patient may be asked to change locations and/or power off nearby devices. [0033]).
Baxi fails to disclose information associated with the second artifact mixed in the first electroencephalogram signal is visually presented prior to information associated with the first artifact mixed in the first electroencephalogram signal.
However, it is noted that Applicant has failed to provide details of criticality or unexpected results in the Specification with regard to the claimed order of visually presenting information associated with the second artifact and the first artifact. As such, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date, through routine experimentation, to determine an optimum order to visually present information associated with the second artifact and the first artifact.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Chakravarthy et al. (US Patent Pub. No. 20110295142) discloses a system and method for determining the presence of abnormalities in EEG signals and visually displaying the EEG signals along with an artifact index.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANKI M BAVA whose telephone number is (571)272-0416. The examiner can normally be reached Monday-Friday 9:00-6:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached at 571-272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANKI M BAVA/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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