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 .
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Claim 1 states that a correlation between any two channels can be made to determine which two channels to use for generating the electrical uterine monitoring data. However, the specification only provides support for using channels that are independent from one another, i.e. do not share an electrode (par. [0144]). The specification does not have support for the breadth of the claim terminology as currently written.
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 1-17 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 pre-AIA the applicant regards as the invention.
Claim 1 includes the step of replacing signal artifacts, outlier data points or both with a statistical value but does not use the resultant signal in the remainder of the claim. It is unclear if the resultant signal is what is used in the subsequent “generating” step or if the “replacing” step generates a signal that is not used for the remainder of the claim. If the resultant signal is what is used in the “generating” step, the Examiner suggests amending the claim to clearly indicate that the R-wave signal data sets that are used are the ones that have had artifacts or outliers removed. If the resultant signal is not used in the remainder of the claim, it is unclear as to what purpose the “replacing” step serves in the overall method. Appropriate correction and/or clarification is respectfully requested.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: Claim 3 states the sharpening step is omitted if the signal is a corrupted electrical uterine signal but Applicant never positively recites a step of determining whether or not a signal is corrupted. Within the scope of the claim, it is unclear how or when this determination is made.
Claim 9 states the extracting step comprises receiving a set of maternal ECG peaks for the pregnant human subject and then identifying R-wave peaks in the pre-processed signal channels after each of the maternal ECG peaks. However, as best understood in the specification, the input bio-potential data is a maternal ECG reading from the belly of a pregnant patient. Therefore, Applicant is essentially stating a paradoxical relationship in that the R-wave peaks of the input ECG are unknown and, to determine them, one must use R-wave peaks of the ECG. Ultimately, the difference between the input bio-potentials from a pregnant human (i.e. a maternal ECG) and the set of maternal ECG peaks of Claim 9 is unclear. They appear to be the same signal but Applicant is claiming them as two distinct and separate entities, which is confusing in light of the disclosure. Appropriate clarification and/or correction is respectfully requested.
Claim 14 states in the preamble “at least one first one of the R-wave signal channels and at least one second one of the R-wave signal channels” and then states in the body of the claim “selecting candidate R-wave signal channels from the R-wave signal channels” (emphasis added). It is unclear if “the R-wave signal channels” recited are all of the channels, all of the at least one first and at least one second channels, or some subset or combination of the at least one first and second channels.
Claim 14 is also incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: Applicant claims “…in which each of the R-wave signal channels experienced contact issues” but never positively recites a step of determining or identifying contact issues. It is unclear when in the method or how this step is performed.
Claim 14 further states “selecting, as the selected at least one first one of the R-wave signal channels and the selected at least one second one of the R-wave signal channels, the candidate R-wave signal channels of at least one of the couples based on the at least one of the couples having a correlation value that exceeds a threshold correlation value”. It is unclear from this limitation which of the candidate R-wave signal channels are selected as the at least one first and second one of the channels. Can the first and second channel be the same channel, are there two at least one first channels and only one second channel, is there one first channel and multiple at least one second channels, can one channel be from one couple and another be from another couple, etc. ? There are numerous different possible combinations creating confusion as to the final form the selected first and second channels can take.
Claim 15 states calculating a signal that is a predetermined percentile of the selected at least one first and second channels. However, Applicant has not defined any particular feature or variable for which the signal is a percentile of. It is unclear what value has to fall within the predetermined percentile.
Conclusion
This is a Continuation of applicant's earlier Application No. 18/610724, 17/592456, 17/020510 and 16/529696. All claims are drawn to the same invention claimed in the earlier applications and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Specifically, this is word-for-word the same claim set presented in 16/529696 on 08/01/2019 which was rejected in the Non-Final Rejection mailed 10/29/2019; the same claim set presented in 17/020510 on 09/14/2020 and rejected in the Final Rejection mailed 09/03/2021; the same claim set presented in 17/592456 and rejected in the Final Rejection dated 09/20/2023; and the same claim set presented in 18/610724 and rejected in the Final Rejection dated 11/22/2024. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). 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, however, event will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLEN PORTER whose telephone number is (571)270-5419. The examiner can normally be reached on Mon - Fri 9:00-6:00 EST.
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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