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 .
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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 19 May 2026 has been entered.
Status of Claims
Claims 1, 3, 4, 7, and 8 are pending and currently under consideration for patentability; claims 1 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 clarify that the non-responsive period samples are determined to have value outside a threshold region. The Examiner has addressed the amended limitations in the updated text of the rejection below.
Applicant argues that Kouchi fails to disclose or suggest estimating a state of the heart as the estimation target based on an occurrence time of out-of-range data, using the out-of-range data as defined in the claims. The Examiner respectfully disagrees. A non-responsive period is defined by Applicant as a period in which the value of the data is outside of a threshold processing region. Using Kouchi’s figure 1B as an example, Kouchi identifies values of the ST level data that are outside of the threshold region defined by normal range 40, which the Examiner respectfully submits is analogous to Applicant’s out-of-range data. Kouchi even refers to this data as being “out of the normal range” ([0077]) and determines the occurrence time of the out-of-range data ([0078] - [0079]). Therefore, the Examiner respectfully maintains that Kouchi in view of Cantillon suggests the claimed limitations.
The Examiner notes that Applicant has provided a summary of the claim limitations on pages 5-6 of the Arguments. However, this summary does not seem to align with the actual claim limitations, due to the confusing and often redundant manner in which the claims are written. Applicant is advised to better define responsive and non-responsive periods, the estimation target, and the out-of-range data, in order to clearly distinguish the claims from Kouchi’s description of abnormal biological information.
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 that are determined to have value outside a threshold region of processing determined according to a distribution of the non-responsive period samples, from among non-responsive period samples determined to be samples belonging to non-responsive periods 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]).
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Conclusion
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 3796
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