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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/6/2026 has been entered.
Response to Amendment
This office action is in response to the amendment filed on 2/6/2026. Currently claims 1-20 are pending.
Response to Arguments
Applicant’s arguments, see pg. 10, filed 2/6/2026, with respect to the previous rejection under 35 USC 101 of claims 1-20 have been fully considered and are persuasive based on applicant’s amendments to the claims. The previous rejection under 35 USC 101 of claims 1-20 has been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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 1-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 as amended recites the limitation:
“classify the pulse segment based on pulse morphology”
This amendment appears to be broader than what is supported in applicant’s disclosure. If one looks to the disclosure about how classification occurs, the best support appears to be para 20 of applicant’s specification received on 5/18/2022 which states the following:
“According to another aspect of the disclosure, a system for monitoring cardiac
arrhythmias may include: an ECG monitor configured to obtain ECG data, the ECG data being obtained by measuring cardiac potentials during cardiac cycles; a blood flow monitor configured to obtain secondary data, the secondary data being obtained by measuring a physiological parameter indicative of blood flow; a memory storing instructions; and one or more processors configured to execute the instructions to: detect a presence of an arrhythmia based on the ECG data; classify a pulse segment of secondary data obtained during the arrhythmia based on pulse morphology; assign a slope to the pulse segment based on the classification; multiply the slope of the pulse segment by a length of the pulse segment to obtain a segment value; calculate a shortage value by adding a previous shortage value and the segment value; compare shortage value to a predefined threshold; and trigger an alarm based on the shortage value exceeding a predefined threshold.”
Specifically, that classification is performed using data that occurs during an arrhythmia. However, claim 1 has been amended so that there is no longer an arrhythmia detected and the classification can occur regardless if an arrhythmia occurs or not. Thus, what is claimed appears to be broader in scope than what is actually supported in applicant’s disclosure. Thus, claim 1 appears to fail to comply with the written description requirement. Claims 2-16 are also rejected under 35 USC 112(a) based on dependency to claim 1.
Claims 1-20 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 claims 1-16:
As outlined above in claim 1 appears to claim a broader scope that what is actually disclosed (i.e. specifically that classification of a pulse segment based on pulse morphology alone without any indication if this pulse segment is obtained during the arrhythmia). Since the disclosure fails to fully support this broader scope, the metes and boundaries of the embodiments covered by this broader scope are not clear rendering this the limitation “classify the pulse segment based on pulse morphology” in claim 1 indefinite. Thereby, rendering claim 1 indefinite. Additionally, claims 2-16 are rejected under 35 USC 112(b) as well based on dependency to claim 1.
Regarding claims 17-20:
Claim 17 recites the limitation "the arrhythmia" in the limitation “classify the pulse segment of secondary data obtained during the arrhythmia based on pulse morphology”.
Claim 20 recites the limitation “the arrhythmia” in the limitation “classifying, in real time or near real time, a-the pulse segment of secondary data obtained during the arrhythmia based on pulse morphology”.
There is insufficient antecedent basis for this limitation in either claim. For this examination, the “the arrhythmia” is interpreted as referring to some type of previously detected arrhythmia. Regardless if this is applicant’s intention or not, the claims should be amended to give proper antecedent support for arrhythmia. Claims 18-19 are also rejected under 35 USC 112(b) based on dependency to at least one of claims 17 or 20.
Allowable Subject Matter
Claims 1-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.SC. 112(a) or 35 U.S.C. (pre-AIA ), 1st paragraph 35 and/or U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action. Please note indication of allowable subject matter is dependent on the interpretation taken and outlined under the 35 USC 112 section above.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 1 is the broadest independent claim. Claim 1 recites a system for monitoring cardiac arrhythmias. The closest prior art is Kaski. Kaski discloses the invention substantially as claimed as outlined in the previous non-final rejection mailed on 3/5/2025 (see outline under pertinent prior art in that office action). However, Kaski fails to disclose the processor and memory as specifically assigning “a segment value to the pulse segment based on the classification”. Also Kaski fails to disclose the processor and memory as performing the steps of “calculate a shortage value based on a cumulative function in which a previous shortage value is added to the segment value”, “update the shortage value in response to detecting a second heartbeat in the ECG data” and “generate an arrhythmia severity indicator based on the shortage value in which a severity of the indicator tracks a change in the shortage value as the shortage value is updated.” as claimed. Furthermore, nothing in the prior art when viewed with Kaski obviates these deficiencies. It is important to note, that no one single limitation renders the invention allowable. Rather, it is the combination of all the limitations together that defines the invention over the prior art. Therefore, the combination of claimed limitations recited by claim 1 is neither anticipated, nor obviated in view of the prior art.
Conclusion
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792