DETAILED ACTION
This Office Action is in response to the communication dated 30 December 2025 concerning Application No. 18/565,062 filed on 28 November 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 1-20 are pending and currently under consideration for patentability; claims 1, 6, and 11 have been amended; claim 20 has been added as a new claim.
Response to Arguments
Applicant’s arguments dated 30 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 claim to recite “wherein selecting the one individual heart IBI signal based on the comparisons comprises selecting the one individual heart IBI signal for further use only if both the absolute difference between the value of the second parameter of the one individual heart IBI signal and the value of the second parameter of the subsequent individual heart IBI signal is below a predetermined second threshold.” The Examiner has addressed the amended limitations in the updated text of the rejection below.
Applicant argues that Korhonen does not disclose or suggest the IBI selection process as recited in the amended claims. The Examiner respectfully disagrees and directs Applicant to those sections of the Korhonen reference which describes that the heart rate data is required to have a certain stability ([0041]), meaning that the heart rate variability between subsequent beats is required to be below a certain threshold. Similarly, Korhonen describes using the mean absolute difference/deviation of heart rate signals, in which heart rate variability values are compared to previously detected values and are used if they fall below a certain threshold ([0008], [0041]). Therefore, the Examiner respectfully submits that Korhonen, at the very least, suggests an IBI selection step similar to that recited in the amended 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, 2, and 4-20 are rejected under 35 U.S.C. 103 as being unpatentable over Korhonen et al. (US 2020/0129130 A1).
Regarding claim 1, Korhonen describes a method for selecting one or more heart interbeat interval IBI signals ([0023]), the method comprising
capturing a sequence of individual heart IBI signals using one or more sensors ([0023])
comparing the value of a first parameter of one individual heart IBI signal of the sequence of individual heart IBI signals with a predetermined first threshold ([0041])
determining the value of a second parameter from one or more or all of the individual heart IBI signals of the sequence ([0041] - [0042])
comparing the value of a second parameter of the one individual heart IBI signal with the value of the second parameter determined from one or more or all of the individual heart IBI signals of the sequence ([0041], using heart rate, heart rate variability, and artefact percentage, for example)
selecting the one individual heart IBI signal based on the comparisons ([0041], data is saved if it meets the quality criteria)
Regarding claim 1, Korhonen does not explicitly disclose wherein selecting the one individual heart IBI signal based on the comparisons comprises selecting the one individual heart IBI signal for further use only if both the absolute difference between the value of the second parameter of the one individual heart IBI signal and the value of the second parameter of the subsequent individual heart IBI signal is below a predetermined second threshold. Korhonen does, however, describe comparing one individual heart IBI signal with its neighboring heart IBI signals in order to assess the stability in the heart rate and heart rate variability ([0008], [0041]), which the Examiner respectfully submits would require that the differences between subsequent IBI values falls below a threshold (i.e., is stable). Therefore, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to configure Korhonen’s method such that it selected an individual IBI signal for further use if the absolute difference between the value of the second parameter of the one individual heart IBI signal and the value of the second parameter of the subsequent individual heart IBI signal is below a predetermined second threshold, as doing so advantageously ensures that the resulting data is stable from one beat to the next.
Regarding claim 2, Korhonen describes repeating the steps of comparing the value of a first parameter, determining the value of a second parameter, comparing the value of the second parameter, and selecting the one individual heart IBI signal based on the comparisons for each of the individual heart IBI signals of the sequence ([0027], [0046], segmenting the data and repeating the analysis for each segment).
Regarding claim 4, Korhonen describes wherein the first and the second parameter each comprise one or more of heart IBI RR interval, normal-to-normal interval, or a low frequency and high frequency density distribution ([0030], [0041]).
Regarding claim 5, Korhonen describes wherein comparing the value of a first parameter comprises comparing the one individual heart IBI signal to physiologically valid individual heart IBI signals of a database ([0041], previously saved values), and wherein selecting the one individual heart IBI signal based on the comparisons comprises selecting the one individual heart IBI signal for further use if the one individual heart IBI signal is within a predetermined range of the physiologically valid individual heart IBI signals, based on the comparison to the database and dismissing the one individual heart IBI signal for further use if the one individual heart IBI signal is not within a predetermined range of the physiologically valid individual heart IBI signals, based on the comparison to the database ([0041], data that meets the criteria are saved and data that does not meet the criteria are disqualified, discarded, and/or not recorded).
Regarding claim 6, Korhonen describes wherein comparing the value of the second parameter comprises determining the absolute difference between the value of the second parameter of the one of the individual heart IBI signals and the value of the second parameter of the subsequent individual heart IBI signal of the sequence ([0008], determining mean absolute difference or deviation), and wherein selecting the one individual heart IBI signal based on the comparisons further comprises dismissing the one individual heart IBI signal for further use if the absolute difference between the value of the second parameter of the one individual heart IBI signal and the value of the second parameter of the subsequent individual heart IBI signal is above the predetermined second threshold ([0008], [0041], data that meets the criteria are saved and data that does not meet the criteria are disqualified, discarded, and/or not recorded).
Regarding claim 7, Korhonen describes wherein comparing the value of the second parameter comprises determining the relative difference between the value of the second parameter of the one of the individual heart IBI signals and the value of the second parameter of the subsequent individual heart IBI signal of the sequence ([0041], comparing deviations between successive segments/data points or successive time periods), and wherein selecting the one individual heart IBI signal based on the comparisons comprises selecting the one individual heart IBI signal for further use if the relative difference between the value of the second parameter of the one individual heart IBI signal and the value of the second parameter of its subsequent individual heart IBI signal is below a predetermined third threshold and dismissing the one individual heart IBI signal for further use if the relative difference between the value of the second parameter of the one individual heart IBI signal and the value of the second parameter of its subsequent individual heart IBI signal is above the predetermined third threshold ([0041], data that meets the criteria are saved and data that does not meet the criteria are disqualified, discarded, and/or not recorded).
Regarding claim 8, Korhonen describes wherein determining the value of a second parameter comprises determining an average of the values of the second parameter of two or more or all individual heart IBI signals of the sequence ([0041] - [0042]).
Regarding claim 9, Korhonen describes wherein comparing the value of the second parameter comprises determining a deviation of the value of the second parameter of the one individual heart IBI signal from the average of the values of the second parameter of two or more or all individual heart IBI signal of the sequence ([0041], [0045], claim 11), and selecting the one individual heart IBI signal for further use if the deviation of the value of the second parameter of the one individual heart IBI signal from the average of the value of the second parameter of two or more or all individual heart IBI signal of the sequence is below a predetermined fourth threshold and dismissing the one individual heart IBI signal for further use if the deviation of the value of the second parameter of the one individual heart IBI signal from the average of the value of the second parameter of two or more or all individual heart IBI signal of the sequence is above the predetermined fourth threshold ([0041], data that meets the criteria are saved and data that does not meet the criteria are disqualified, discarded, and/or not recorded).
Regarding claims 10 and 11, Korhonen describes the method of claim 1 but does not explicitly disclose dismissing one or more selected individual heart IBI signals if the preceding individual heart IBI signal was dismissed and the two direct neighboring individual heart IBI signals of the preceding individual heart IBI signal were selected (claim 10) or dismissing one or more groups of selected individual heart IBI signals if the one or more groups of individual heart IBI signals are preceded and followed by groups of dismissed individual heart IBI signals, wherein a group of individual heart IBI signals comprises one re more individual heart IBI signals (claim 11). However, Korhonen does describe that only data representing qualified time periods is saved ([0037]), including the use of multiple threshold tests to determine the qualification of the data ([0037]). Korhonen also describes that “values differing too much from previously saved values may be disqualified” and, using the example of heart rate, that values are “required to have certain stability” ([0041]). Based on this, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to dismiss an individual signal using the comparison criteria recited in claim 10 or claim 11, as doing so advantageously ensures that the resulting data, if selected, meets the similarity and stability criteria described by Korhonen.
Regarding claim 12, Korhonen describes extracting one or more subsequences of individual heart IBI signals from the sequence of individual heart IBI signals and performing any of the preceding methods on the one or more subsequences individually ([0027], [0036]).
Regarding claim 13, Korhonen describes extracting a subsequence of individual heart IBI signals from the sequence of individual heart IBI signals ([0036]) and selecting the subsequence of individual heart IBI signals for further use if the number of dismissed individual heart IBI signals is below a predetermined fifth threshold and dismissing the subsequence of individual heart IBI signals for further use if the number of dismissed individual heart IBI signals is above the predetermined fifth threshold ([0009], [0041], artefact percentage must be below a predetermined threshold value in order for the data to qualify for being saved for further use).
Regarding claim 14, Korhonen describes wherein the first, second, third, fourth and fifth thresholds depend on the desired quality of the set of selected individual heart IBI signals ([0041], thresholds may be predetermined; the Examiner respectfully submits that it is inherent that changing the individual thresholds results in a change in the quality of the signal passing through the threshold tests).
Regarding claim 15, Korhonen describes a system for selecting one or more heart interbeat interval signals ([0023]), the system comprising
a sensor for acquiring one or more individual heart interbeat interval signals ([0059], [0062])
a computing device ([0056] - [0057])
wherein the system is configured to execute the method of any of claim 1 (please refer to discussion of claim 1, above)
Regarding claims 16 and 17, although Korhonen does not explicitly disclose the absolute difference (claim 16) and relative difference (clam 17) thresholds recited, the Examiner respectfully submits that, as Korhonen describes the use of absolute and relative thresholds ([0008], [0041]), it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the thresholds as necessary in order to obtain data of a desired quality, as doing so would be a matter of optimizing a result-effective variable through routine experimentation (please see MPEP 2144.05).
Regarding claim 18, although Korhonen does not explicitly disclose wherein the average value of the second parameter is derived from five individual heart IBI signals, the Examiner respectfully submits that, as Korhonen describes generating average data from a number of individual heart beat signals ([0041] - [0043]), it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to adjust the number of individual data entries used when calculating the average, as doing so would be a matter of optimizing a result-effective variable through routine experimentation (please see MPEP 2144.05).
Regarding claim 19, Korhonen describes wherein the one or more subsequences comprise individual heart IBI signals from a time window of 5 min, more preferably from a time window of 100 sec. ([0036]).
Regarding claim 20, although Korhonen does not explicitly disclose wherein the absolute difference is calculated by subtracting the value of the second parameter of an individual heart IBI signal n from the value of the second parameter of the n+1th individual heart IBI signal, and wherein the relative difference is determined by dividing the absolute difference by the value of the nth signal, the Examiner respectfully submits that, as the claim merely recites the mathematical manner in which absolute and relative differences are calculated, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to ensure that Korhonen’s method calculated the absolute relative differences as claimed.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Korhonen in view of Kaur (US 2020/0250447 A1).
Regarding claim 3, Korhonen describes the method of claim 1 but does not explicitly disclose wherein capturing the sequence of individual heart IBI signals is performed using a non-medical, contactless sensor. However, Kaur also describes a method for selecting one or more individual heart interbeat intervals ([0110]) including capturing a sequence of individual heart beat signals using a non-medical, contactless sensor ([0024], [0026]). As Kaur is also directed towards selecting individual heart beats 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 non-medical, contactless sensor similar to that described by Kaur when using the method described by Korhonen, as doing so advantageously allows the resulting method to obtain the relevant data without needing to adhere or attach a sensor to the user’s skin.
Statement on Communication via Internet
Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant:
“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
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 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 thr six ough 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