Office Action 2: Final Rejection (2024-05-07)
Rejection types: 112 - Written Description/Enablement

CLAIMS:
Listing of claims:

Amendments to Claims:

This listing of claims will replace all prior versions, and listings, of claims in the Application.

1\. (Currently Amended) A device for assessing anesthesia of an animal subject in real-time from electroencephalography (EEG) measurements of the animal subject during application of anesthesia, the device comprising:a signal pre-processor comprising a first filter with a first filtering frequency, a second filter with a second filtering frequency, and a down-sampler to pre-process sequentially an incoming measured EEG signal from the EEG measurements of the animal subject;wherein the pre-processing comprises: removing unwanted signals and noise from the incoming measured EEG signal using the first filter and the second filter to generate a filtered incoming measured EEG signal; and down-sampling the filtered incoming measured EEG signal by the down-sampler to generate a down-sampled filtered incoming measured EEG signal ;
an epoch generator configured to generate an epoch signal containing epochs of 1-second epoch duration each and 10% overlapping of consecutive epochs;wherein the epoch generator comprises a two-input multiplexer, an address generator, and a memory\[\[,\]\];
wherein the two-input multiplexer is configured to:receive the down-sampled filtered incoming measured EEG signal , a feedback of the epoch signal,
and a selector input from the address generator; andgenerate a multiplexer output from the down-sampler output signal or the feedback of the epoch signal based on the selector input;

wherein the address generator comprises:a slow counter configured to generate write addresses, and count from a slow counter start count to a slow counter end count in repeating slow count cycles; and
a fast counter configured to generate read addresses, and count from a fast counter start count to a fast counter end count in repeating fast count cycles that starts after each of the slow count cycles;
 wherein the slow counter is further configured to repeat each of the slow count cycles after each of the fast count cycles;
wherein the fast counter is further configured to repeat each of the fast count cycles after each of the slow count cycles;
wherein the address generator is further configured to:generate the selector input to the multiplexer to generate the multiplexer output from the down-sampler output signal during each of the slow count cycles and from the feedback of the epoch signal during each of the fast count cycles;
wherein the memory is configured to: receive the multiplexer output, the write addresses,and the read addresses\[\[,\]\];
store the received multiplexer output according to the received write addresses; and
output a memory output data according to the received read addresses;
wherein the epoch signal being the memory output data;

a feature extractor configured to:
receive the epoch signal from the epoch generator;
extract a derivative feature ofthe received epoch signal by computing a mean ofaccumulated sqiuared-differences among the epochs in the received epoch signal; and
extract a variance feature ofthe received epoch signal by computing a square root ofan average squared-deviation ofthe epochs in the received epoch signal;
a classifier configured to:perform a feature mapping on the derivative feature and the variancefetr;and
set a decision boundary from output ofthe feature mapping to generate a classifier output, the classifier output being either that the animal subject being awake or anesthetized or that the animal subject being awake or anesthetized; and
a predictor comprising a predictor circuit configured to: accumulate a plurality of the classifier's outputs\[\[,\]\];

 compute a decision value effrom the accumulated classifier's outputs
 determine a level of anesthesia of the animal subject i-n from the decision value ' ;and
predict the animal subject's anesthesia condition from a plurality of determined levels of anesthesia of the animal subject.

2\. (Currently Amended) The system of claim 1, wherein \[\[a\]\] the first filter of the signal pre-processor is configured with the first filtering frequency for compensating a power-line interference of the incoming measured EEG signal .

3\. (Currently Amended) The system of claim 1, wherein \[\[a\]\] the second filter of the signal pre-processor is configured with the second filtering frequency being comparable to an average frequency of a wide electroencephalography frequency region of the incoming measured EEG signal
wherein the average frequency of the wide electroencephalography band of the incoming measured EEG signal is in the range of 0-250 Hz.

4\. (Currently Amended) The system of claim 1, wherein the incoming measured EEG signal is down sampled at least ten times after being subjected to the second filter using the down-sampler.

5\. (Currently Amended) The system of claim 1, wherein the epoch generator creates a sliding window to divide each electroencephalography channel into short-overlapped epochs.
6\. (Currently Amended) The system of claim 1, wherein the computing of a mean of accumulated squared-differences among different epochs in the received epoch signal comprises: Docket No. P2096US00 5 computing a difference between two consecutive epochs of the epochs in the received epoch signal and a square of the difference to obtain a squared difference;
repeating the computation to obtain a squared difference for each pair of consecutive epochs in the received epoch signal;
accumulating all of the squared differences obtained; and
determining the mean of the accumulated squared differences.
7\. (Currently Amended) The system of claim 1, wherein the computing of a square root of an average squared-deviation of the epochs in the received epoch signal comprises: obtaining an absolute epoch value of each of the epochs in the received epoch signal;
accumulating all of the absolute epoch values obtained;
determining a mean of the accumulated absolute epoch values;
computing a difference between each of the absolute epoch values and the mean of the accumulated absolute epoch values and a square of the difference to obtain a squared deviation;
computing an average of all of squared deviations for all of the absolute epoch values; and
computing a square root of the average of all of squared deviations.

8\. (Canceled)
9\. (Currently Amended) The system of claim 1, wherein the predictor is configured to accumulate the plurality of the determined levels of anesthesia in terms of percentage and constrain an output value as a decision score between 0 and 1 with respect Docket No. P2096US00 6 to the percentage of the anesthesia of the animal subject, wherein a 100% anesthesia corresponds to the decision score of 1, while a 0% anesthesia corresponds to the decision score of 0.

10\. (Currently Amended) A method for determining depth of anesthesia (DOA) of an animal subject in real-time from electroencephalography (EEG) measurements , the method comprising:detecting and measuring an EEG signal of the animal subject using an EEGelectrode;
 filtering the EEG signal to remove unwanted signals and noise;
down-sampling the filtered EEG signal for reducing data size and accelerating subsequent processing without losing essential features of the EEG signal for subsequent classification;
generating from the down-sampled EEG signal an epoch signal containing epochs of 1-second epoch duration each and 10% overlapping of consecutive epochs ;
extracting a derivative feature of the epoch signal by computing a mean of accumulated squared-differences among the epochs in the epoch signal;
extracting a variance feature of the epoch signal by computing a square root of an average squared-deviation of the epochs in the epoch signal;mapping the derivative feature and the variance feature to determine a classification boundary, followed by using an output of the mapping to determine a sigmoid function as a decision boundary between awake and anesthetized state comprising:if the mapping output value is lower than 0.5 or 50%, a classifier output is set to that the animal subject being awake during a time duration of the epochs; otherwise, the classifier Docket No. P2096US00 7 output is set to that the animal subject being anesthetized during a time duration of the epochs;and
accumulating a plurality of the classifier outputs of consecutive awake and anesthetized epochs, respectively to generate a prediction output of a likelihood of the animal subject being awake or anesthetized in a successive epoch.

11\. (New) The method of claim 10, further comprising:increasing a prediction probability of the animal subject being anesthetized if the prediction output is that the animal subject being anesthetized, or decreasing the probability of the animal subject being anesthetized if the prediction output is that the animal subject being awake; and
adjusting a successive prediction output based on the prediction probability.

12\. (New) The method of claim 10, further comprising:generating a confident prediction output of the animal subject being awake if the prediction output is at or below 25% likelihood of the animal subject being anesthetized;
and generating a confident prediction output of the animal subject being anesthetized if the prediction output is at or above 75% likelihood of the animal subject being anesthetized.

13\. (New) The method of claim 10, wherein the filtering of the EEG signal to remove unwanted signals and noise comprising:filtering the EEG signal at a filtering frequency being comparable to an average frequency of a wide electroencephalography frequency band of the incoming measured EEG signal;
wherein the average frequency of the wide electroencephalography band of the incoming measured EEG signal is in the range of 0-250 Hz.

14\. (New) The method of claim 10, wherein the computing of a mean of accumulated squared-differences among different epochs in the epoch signal comprises:computing a difference between two consecutive epochs of the epochs in the epoch signal and a square of the difference to obtain a squared difference;
repeating the computation to obtain a squared difference for each pair of consecutive epochs in the epoch signal;
accumulating all of the squared differences obtained; and
determining the mean of the accumulated squared differences.

15\. (New) The method of claim 10, wherein the computing of a square root of an average squared-deviation of the epochs in the epoch signal comprises:obtaining an absolute epoch value of each of the epochs in the epoch signal;
accumulating all of the absolute epoch values obtained;
determining a mean of the accumulated absolute epoch values;
computing a difference between each of the absolute epoch values and the mean of the accumulated absolute epoch values and a square of the difference to obtain a squared deviation;
computing an average of all of squared deviations for all of the absolute epoch values; and
computing a square root of the average of all of squared deviations.

OFFICE ACTION:
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 .
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 1-7 and 9-15 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 phrase “the down-sampler output signal” in lines 25 and 40 lacks proper antecedent basis. The Examiner suggests amending the phrase to read “the down-sampled filtered incoming measured EEG signal” in order to properly refer back to the previously recited down-sampled filtered incoming measured EEG signal. The phrase “wherein the epoch signal being the memory output data” in line 51 of claim 1 renders the claim indefinite. Is the epoch signal the memory output data (i.e., wherein the epoch signal is the memory output data), or is an action taken upon the epoch signal that is somehow connected to the memory output data? Clarification is requested. Lines 64-65 of claim 1 recite that “the animal subject being awake or anesthetized or that the animal subject being awake or anesthetized”. Duplication of the phrase “being awake or anesthetized” renders the claim indefinite; both output results of the classifier are the same. Furthermore, while not a rejection, it is noted that the term “being” in both phrases should be amended to read “is”. Regarding claim 2, the wording of the claim renders the claim indefinite (it is unclear how a filter compensates a power-life interference). As best understood, the first filter of the signal pre-processor is configured to remove or reduce a power-line interference of the incoming measured EEG signal. Regarding claim 3, the wording of the claim renders the claim indefinite. What does it mean for a filtering frequency to be “comparable” to an average frequency of a wide EEG frequency region? Furthermore, the phrase “wide electroencephalography frequency region” is indefinite. What is to be considered a “wide” EEG frequency region? The same indefiniteness issue is present in claim 13. Regarding claim 5, the phrase “each electroencephalography channel” lacks proper antecedent basis as there is no previous mention of EEG channels. Further regarding claim 5, the phrase “short-overlapped epochs” renders the claim indefinite in that the term “short” is a relative term that is not defined by the claim, and it is unclear if the short-overlapped epochs of claim 5 are the same overlapping epochs of claim 1 or different overlapping epochs. Regarding claim 7, the phrase “computing a difference between each of the absolute epoch values and the mean of the accumulated absolute epoch values and a square of the difference to obtain a squared deviation” renders the claim indefinite. The phrase “the difference” is singular, but performing the steps recited in claims 1 and 7 results in a plurality of difference values (a difference between each of the absolute epoch values and the mean of the accumulated absolute epoch values is determined). Furthermore, in order to compute an average of all of the squared deviations for all of the absolute epoch values, more than one squared deviation would need to be obtained. The Examiner suggests amending the phrase to read “computing a difference between each of the absolute epoch values and the mean of the accumulated absolute epoch values and a square of each difference to obtain squared deviations” in order to clarify the claim. Further regarding claim 7, it is suggested that the term “the” be added before the phrase “squared deviations” in lines 11 and 13. The same indefiniteness issues and suggestions also apply to claim 15. Regarding claim 9, the phrase “the percentage of the anesthesia of the animal subject” lacks proper antecedent basis. It is suggested that the phrase be amended to read “a percentage of the anesthesia level of the animal subject”. Regarding claim 10, the “mapping the derivative feature” and “accumulating a plurality of the classifier outputs” limitations render the claim indefinite. What are the derivative feature and variance featured mapped to? What is the output of the mapping and how is it determined? The phrase “the mapping output value” further renders the claim indefinite. The phrase lacks proper antecedent basis, and it remains unclear how the mapping output value is determined. The accumulating step is indefinite in that it is unclear how accumulating consecutive classifier outputs would result in generating a prediction output of a likelihood of the animal subject being awake or anesthetized in a successive epoch. The indefiniteness issues within claim 10 have rendered a proper prior art search unable to be performed. Regarding claim 11, it is unclear what the phrase “increasing a prediction probability” is referring to as there is no previous mention of determining a prediction probability of the animal subject being either anesthetized or awake. The phrases “being anesthetized” and “being awake” in claim 11 should be amended to read “is anesthetized” and “is awake”, respectively.
Claims not explicitly rejected above are rejected due to their dependence on a rejected base claim.
Response to Arguments
Applicant’s arguments with respect to the rejections of the claims have been considered. The rejection of the claims under 35 U.S.C. 101 has been withdrawn as a particular machine is used to perform the Abstract Idea. Regarding rejections of the claims under 35 U.S.C. 112(b), current indefiniteness issues within the claims are discussed in paragraph 3 above. Regarding the previous prior art rejection of claim 10, as noted in paragraph 3 above, the amendments to the claim have rendered a prior art search of the claim unable to be performed.
Examiner’s Note
Regarding claim 1, none of the prior art teaches or suggests, either alone or in combination a device comprising an epoch generator, wherein the epoch generator comprises a two-input multiplexer, an address generator, and a memory, wherein the two-input multiplexer is configured to receive a down-sampled filtered incoming measured EEG signal, a feedback of an epoch signal, and a selector input from the address generator, and further wherein the address generator is configured to generate the selector input to the multiplexer to generate a multiplexer output from the down-sampler output signal during each of a plurality of slow count cycles and from the feedback of the epoch signal during each of a plurality of fast count cycles, in combination with the other claimed elements.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Tabassum et al. (Novel Multirate…) teaches a device for processing EEG signals, wherein the device comprises a signal pre-processor configured to perform a first filtering technique, a second filtering technique, and a down-sampling technique on acquired EEG signals. Tabassum et al. further teaches use of a two-input multiplexer to process the filtered and down-sampled EEG signals.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action.  Accordingly, THIS ACTION IS MADE FINAL.  See MPEP § 706.07(a).  Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action.  In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action.  In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.

APPLICANT REBUTTAL: Remarks:
The above Amendments and these Remarks are in reply to the final Office Action mailed May 7, 2024. Reconsideration and allowance of the application in view of the foregoing amendments and in view of the remarks to follow are respectfully requested.
I.
Summary of
Examiner's Rejections
Claims 1-7 and 9-15 are rejected under 35 U.S.C. 112 as being indefinite for failing to particularly point out and distinctly claim the subject matter.
TI.
Summary of
Applicant's Amendment
By the present amendments, Claims 1-3, 7, 9-13, and 15 are amended, and Claim 5 is cancelled, leaving for the Examiner's consideration Claims 1-4, 6-7, and 9-15. The Applicant respectfully submits that the proposed amendments contain no new matter. The Applicant respectfully reserves the right to prosecute any originally presented, canceled, or withdrawn claims in a continuing or future application.
III.
Claim re
jections under 35 U.S.C.
Claims 1-7 and 9-15 arc rejected under 35 U.S.C. 112 as being indefinite for failing to particularly point out and distinctly claim the subject matter.
should bewithdrawn.
TV.
Fees
A request for continued examination and the prescribed fee of $544 at small entity status are duly submitted with this Response.
V.
Conclusion

NEXT OFFICE ACTION: 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.  Applicant's submission filed on 30 July 2024 has been entered.
Claim Objections
Claims 3, 6, 11, and 13 are objected to because of the following informalities: the phrase “within a” in line 4 of claim 3 should be amended to read “within an”; the phrase “different epochs” in line 2 of claim 6 should be amended to read “the epochs”; the phrase “with be” in line 6 of claim 11 should be amended to read “will be”; the term “comprising” in line 2 of claim 13 should be amended to read “comprises”; the phrase “within a” in line 4 of claim 13 should be amended to read “within an”.  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 1-4, 6, 7 and 9-15 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 that “the epoch generator is configured to generate and output the epoch signal from the memory output”. This limitation renders the claim indefinite. As currently written, the claim requires the epoch generator to generate the epoch signal from the memory output. It is unclear what is meant by this recitation. For this examination, the limitation is being interpreted as “the epoch generator is configured to generate the epoch signal and output the epoch signal from the memory output”. Further regarding claim 1, it is unclear how the predictor accumulates “a plurality of the classifier’s outputs” and predicts the animal subject’s anesthesia condition from “a plurality of determined levels of anesthesia” if there is one output and determined level of anesthesia per epoch signal and only one epoch signal. As currently written, claim 1 extracts a derivative feature and a variance feature “of the received epoch signal”, and provides a classifier output of the epoch signal. As best understood by the specification, while the claim recites performing the extracting steps and the classifying step for an epoch signal, the steps are actually performed for each epoch of the epoch signal. The same indefiniteness is present in claim 10. Claim 10 extracts features “of the epoch signal”, and classifies “the epoch signal”, but also recites “the classifier output is a probability value of the animal subject is under anesthetized state given the current epoch” and “accumulating a plurality of the classifier output values for consecutive classified epochs”. This provides further confusion as to whether the steps are being performed per epoch signal or per epoch of the epoch signal. Clarification is requested. As noted above, according to the specification, the extracting and classifying steps recited in claims 1 and 10 are meant to be performed on each epoch of an epoch signal such that multiple classifications per epoch signal are determined. Regarding claim 3, it is unclear how a bandpass filter would operate within a range of 0-250Hz. It is unclear how a bandpass filter would filter out signals below 0Hz. Regarding claim 9, the phrase “an output value” lacks proper antecedent basis. Clarification is requested as to what the output value of claim 9 is. Regarding claim 10, the phrase “the classifier output value” lacks proper antecedent basis. Regarding claim 11, the wording of the claim makes it difficult to understand what the claim is reciting. For example, it is unclear what is meant by “increasing the prediction probability of likelihood” and “decreasing the prediction probability of likelihood”. Clarification is requested. Regarding claim 12, the wording of the claim renders the claim indefinite (i.e., grammatical errors and verb tense errors). Further regarding claims 11 and 12, the phrase “the prediction probability” lacks proper antecedent basis.
Claims not explicitly rejected above are rejected due to their dependence on a rejected base claim.
Response to Arguments
Applicant’s arguments with respect to the rejections of the claims have been considered. Regarding rejections of the claims under 35 U.S.C. 112(b), current indefiniteness issues within the claims are discussed in paragraph 5 above. While no prior art was found to read on the claims as currently written, the claims are not in condition for allowance due to the indefiniteness issues within the claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Tabassum et al. (Novel Multirate… – previously cited) teaches a device for processing EEG signals, wherein the device comprises a signal pre-processor configured to perform a first filtering technique, a second filtering technique, and a down-sampling technique on acquired EEG signals. Tabassum et al. further teaches use of a two-input multiplexer to process the filtered and down-sampled EEG signals.