DETAILED ACTION
This Office Action is in response to the communication dated 10 December 2025 concerning Application No. 18/283,295 filed on 21 September 2023.
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 .
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 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.
Status of Claims
Claims 1, 3, 4, 7, and 8 are pending and currently under consideration for patentability; claims 1, 3, 4, and 7 have been amended; claims 2, 5, and 6 have been cancelled.
Response to Arguments
Applicant’s arguments dated 10 December 2025 have been fully considered, but they are not persuasive or moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant has amended the independent claims to recite limitations similar to those appearing in previously presented claims 3 and 5. The Examiner has addressed the amended limitations in the updated text of the rejection below.
Regarding the Kouchi reference, Applicant argues that Kouchi is non-analogous art. In support of this, Applicant argues that Kouchi is in a different field of endeavor, as Kouchi “relates to a method for displaying biological trend,” whereas “Applicant’s claimed invention is directed to a technique for reducing the amount of calculation required for estimating the state in the heart” (Arguments, p. 6). The Examiner respectfully submits that the claims do not recite any limitations directed towards a technique for reducing an amount of calculation required for estimating a subject’s cardiac status. The claims merely recite acquiring a cardiac data and estimating the state of the heart based on certain cardiac parameters, which is similar to the method described by Kouchi.
Applicant further argues that Kouchi is not pertinent to the problem faced by the Applicant, for the similar reason that “Applicant presents a technique of reducing the amount of calculation required for estimation while not reducing a large amount of data sampled frequently” (Arguments, p. 6), contrasting this with Kouchi’s disclosure that “its objective is to provide a display device that allows easy visual recognition of abnormalities and trends” (Arguments, p. 6). Again, the Examiner respectfully submits that the claims do not recite the limitations argued by Applicant. Specifically regarding this argument, the Examiner respectfully submits that Applicant’s own statements seem to be contradictory when stating that “detecting a heart disease with high reliability is limited to a medical device such as a large Holter electrocardiograph…thus it is not possible to perform heart disease detection processing mounted on the Holter electrocardiograph” (Arguments, p. 6). As part of a larger argument regarding the wearability of the device, which again the Examiner respectfully submits is not a recited claim limitation, Applicant appears to argue that reliably detecting heart disease is limited to a Holter monitor but that a Holter monitor is not able to perform heart disease detection. The Examiner respectfully submits that the wearability of the device, the amount of data being processed, and the use of a Holter electrocardiograph appear nowhere in the recited claims. The claims merely recite a state estimation device comprising a processor and a storage medium configured to acquire cardiac data and estimate the likelihood of a cardiac arrest state based on evaluating the cardiac data. As the prior art references of Kouchi and Cantillon describe similar limitations, the Examiner respectfully maintains that the prior art is analogous and obviates the pending claims.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3, 4, 7, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kouchi et al. (US 2005/0246366 A1) in view of Cantillon (US 2020/0275854 A1).
Regarding claims 1 and 7, Kouchi describes a state estimation device and method ([0157]) comprising
a processor ([0086])
a storage medium having computer program instructions stored thereon ([0086]), wherein the computer program instructions, when executed by the processor, perform processing of
acquiring a cardiac state time series that is a time series of a cardiac state quantity that is a quantity indicating a state of a heart as an estimation target ([0009], [0073])
estimating a state of the heart as the estimation target based on an occurrence time of out-of-range data, using, as the out-of-range data, a non-responsive period sample whose value is outside a threshold region of processing determined according to a distribution of the non-responsive period sample among non-responsive period samples that are non-responsive period samples among samples of the cardiac state time series ([0045], [0077], figures 1B and 5, for example)
wherein the state of the heart as the estimation target is also estimated based on a time interval RR-interval of an R wave in the cardiac state time series ([0185]), such that assuming a position in a time axis direction of each of the samples of the cardiac state time series as a time position ([0097], [0073]), analyzing information after an abnormality occurrence time position, which is a time position at which the state of the heart as the estimation target is estimated to be abnormal by any one or both of an estimation result of the state of the heart as the estimation target based on the time interval RRI of the R wave in the cardiac state time series and an estimation result of the state of the heart as the estimation target based on the occurrence time of the out-of-range data ([0045], [0077], [0146] - [0147])
Regarding claims 1 and 7, Kouchi does not explicitly disclose wherein the state of the heart as the estimation target is estimated as being a state of cardiac arrest in a case where a deviation of a distribution of cardiac state quantities within a predetermined period after an abnormality occurrence time position is equal to or less than a predetermined threshold value. However, Cantillon also describes a state estimation device ([0005]), including wherein the state of the heart as the estimation target is estimated as being a state of cardiac arrest in a case where a deviation of a distribution of cardiac state quantities within a predetermined period after an abnormality occurrence time position is equal to or less than a predetermined threshold value ([0095], [0098]). As Cantillon is also directed towards a state estimation device and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use a device similar to that described by Kouchi in order to determine a potential cardiac arrest, similar to that described by Cantillon, as doing so advantageously allows the resulting device to alert the patient or a caregiver of this critical condition.
Regarding claim 3, Kouchi describes wherein the state of the heart as the estimation target is estimated as being abnormal in a case where an estimation result of the state of the heart as the estimation target based on the time interval RRI of the R wave in the cardiac state time series is an estimation result that the state of the heart as the estimation target is abnormal ([0185]), and an estimation result of the state of the heart as the estimation target based on the occurrence time of the out-of-range data is also an estimation result that the state of the heart as the estimation target is abnormal ([0077]).
Regarding claim 4, Kouchi describes wherein in a case where an estimation result of the state of the heart as the estimation target based on the time interval RRI of the R wave in the cardiac state time series is an estimation result that the state of the heart as the estimation target is abnormal, the state of the heart as the estimation target is estimated as being abnormal regardless of an estimation result of the state of the heart as the estimation target based on the occurrence time of the out-of-range data ([0185], the measures may represent alternative embodiments, so one measure can provide an estimation result regardless of whether another measure provides the estimation result).
Regarding claim 8, Kouchi describes a non-transitory computer readable medium which stores a program for causing a computer to function as the state estimation device according to claim 1 ([0087]).
Statement on Communication via Internet
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“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Carl Layno, can be reached by telephone at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3792
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