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 .
DETAILED ACTION
The replies filed 9/24/2025 and 10/24/2025 were received and considered.
Claims 1-5, 8-15 and 18-20 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/24/2025 has been entered.
Response to Arguments
Applicant's arguments filed 9/24/2025 have been fully considered but they are not persuasive.
Applicant’s remarks (p. 5, regarding rejections under 35 U.S.C. §112 and claim objections) are persuasive. The rejections and objections are withdrawn.
Applicant’s remarks (p. 6) suggest:
“The Examiner relies on Virolainen as disclosing using at least one demographic identifier to authenticate a user. However, Virolainen fails to disclose anything pertaining to authenticating a user. Instead, Virolainen only discloses using patient demographic data to predict patient outcomes. As one having ordinary skill in the art would recognize, predicting patient outcomes has nothing to do with authenticating a user's identity” and
“Because Virolainen is in a completely unrelated art, predicting patient outcomes, from art of claim 1, user authentication, one having ordinary skill in the art would not have seen any obvious benefit with combining a user authentication method with a patent outcome prediction method. Specifically, since Virolainen fails to disclose anything pertaining to user authentication, there is no motivation to combine Virolainen with Kurson and Contreras”.
The Examiner agrees that Virolainen does not teach authenticating a user, but disagrees that Virolainen is in an unrelated art. Virolainen teaches a patient monitor 22 is communicatively connected to the patient 12 with a plurality of transducers that obtain physiological information 24 from the patient 12, including , electrocardiograph (ECG), and including monitoring blood oxygen saturation (SP02) (¶15). Therefore, the Examiner respectfully maintains that a skilled artisan would have turned to Virolainen in using collected data, such as for predicting outcomes.
Regarding claims 1 and 11, the claims recite “the user is authenticated using the user demographic identifier, first cardiac indicator, second cardiac indicator that are each compared to a plurality of other users to identify at least one similar user to the user being authenticated”. However, the claimed subject matter was not described in the original specification. The specification discloses receiving the biometric identifiers and cardiac identifiers and the comparison (Fig. 11, ¶47). The specification further discloses performing analysis against a centralized database, including receiving demographic information and a biometric identifier from a database and gathering information from patients with similar demographics (Fig. 8, ¶42). However, the specification does not teach “the user is authenticated using the user demographic identifier, first cardiac indicator, second cardiac indicator” (emphasis added). Further, In Fig. 8, the biometric information is compared to other biometric information from similar demographics (see also specification, ¶42). Therefore, the specification does not teach “the user demographic identifier, first cardiac indicator, second cardiac indicator that are each compared to a plurality of other users” (emphasis added).
In the interest of compact prosecution, Alameh is provided for teaching the use of demographics in authentication. Alameh, in an analogous art to Kursun (biometric authentication, ¶31, ¶42, ¶67), teaches that it was known to utilize more than one factor in authenticating a user (may require additional authentication factors, ¶37), where an additional factor can include demographic information in the form of location information (¶¶49-50, ¶78). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Kursun such that the user is authenticated using the user demographic [indicator] to utilize an additional factor in authenticating the user, for increased security, as taught by Alameh.
Claim Objections
Claims 1-5, 8-15 and 18-20 are objected to because of the following informalities:
In claim 1, line 20, “demographic identifier” should be replaced with “demographic indicator” to match the previously-recited “demographic indicator” (alternatively, amending the first recitation to recite “identifier”).
In claim 1, lines 20-21, “first cardiac indicator, second cardiac indicator” should be replaced with “first cardiac identifier, second cardiac identifier”, for consistency with the previously-recited “first cardiac identifier” and “second cardiac identifier”.
In claim 11, line 17, “demographic indicator” should be replaced with “demographic identifier” for consistency with the previously-recited “demographic identifier” (line 6).
Claims 2-5, 8-10, 12-15 and 18-20 inherit the deficiencies.
Appropriate correction is required.
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.
Claims 1-5, 8-15 and 18-20 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.
Regarding claims 1 and 11, the claims recite “the user is authenticated using the user demographic identifier, first cardiac indicator, second cardiac indicator that are each compared to a plurality of other users to identify at least one similar user to the user being authenticated”. However, the claimed subject matter was not described in the original specification. The specification discloses receiving the biometric identifiers and cardiac identifiers and the comparison (Fig. 11, ¶47). The specification further discloses performing analysis against a centralized database, including receiving demographic information and a biometric identifier from a database and gathering information from patients with similar demographics (Fig. 8, ¶42). However, the specification does not teach “the user is authenticated using the user demographic identifier, first cardiac indicator, second cardiac indicator” (emphasis added).
Regarding claims 1 and 11, the claims recite “the user demographic identifier, first cardiac indicator, second cardiac indicator that are each compared to a plurality of other users”. However, the claimed subject matter was not described in the original specification. Fig. 8 describes receiving and using demographics:
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In Fig. 8, the biometric information is compared to other biometric information from similar demographics (see also specification, ¶42). Therefore, the specification does not teach “the user demographic identifier, first cardiac indicator, second cardiac indicator that are each compared to a plurality of other users” (emphasis added).
Claims 2-5, 8-10, 12-15 and 18-20 inherit the deficiencies.
Claims 1-5, 8-15 and 18-20 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Regarding claims 1 and 11, the claims recite “the user is authenticated using the user demographic identifier, first cardiac indicator, second cardiac indicator that are each compared to a plurality of other users to identify at least one similar user to the user being authenticated”. However, the claimed subject matter was not described in the original specification. The specification discloses receiving the biometric identifiers and cardiac identifiers and the comparison (Fig. 11, ¶47). The specification further discloses performing analysis against a centralized database, including receiving demographic information and a biometric identifier from a database and gathering information from patients with similar demographics (Fig. 8, ¶42). However, the specification does not enable a skilled artisan to make and use an authentication system where “the user is authenticated using the user demographic identifier, first cardiac indicator, second cardiac indicator”.
Claims 2-5, 8-10, 12-15 and 18-20 inherit the deficiency.
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 1-5 and 8-10 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 claim 1, the claim is directed to a system “identification system including a cardiac unit having a memory operating software” and recites “the cardiac unit including … the user is authenticated …”. It is unclear how act of “the user is authenticated” is related to the claimed “identification system”. The Examiner suggests clarifying that a component of the identification system performs the authentication, such as a processor executing the claimed software in memory, where the software is configured to perform the authentication (specification, ¶¶24-25).
Claims 2-5 and 8-10 inherit the deficiency.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-5, 11 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over US 9,892,576 B2 to Kursun et al. (Kursun), in view of US 2012/0226120 A1 to Contreras et al. (Contreras), US 2012/0265549 A1 to Virolainen and US 2019/0130082 A1 to Alameh et al. (Alameh).
Regarding claim 1, Kursun discloses an identification system including a cardiac unit having a memory operating software (Fig. 1: system comprising sensors including heart monitor and EKG device; col.5, lines 61-65), the cardiac unit including: a first biometric identifier (col.6, lines 51-61: acquire fingerprint for profile; see also col.12, lines 40-43); a second biometric identifier (col.8:48-67, col.9:1-12: acquire biometric such as fingerprint for authentication); a first cardiac identifier gathered from at least one sensor communicatively connected to the cardiac unit that is used to create a first electrocardiogram (EKG and heart rate are all parts of the user profile, col.8, lines 23-34; see also col. 3, lines 8-16 and col. 5, lines 61-64), with the first cardiac identifier indicator being logically related to the first biometric identifier (col.6, lines 51-57: acquire EKG or heart rate for profile; see also col.12, lines 40-43; the fingerprint, EKG and heart rate are all parts of the user profile, col.8:23-34); a second cardiac identifier gathered from the at least one sensor communicatively connected to the cardiac unit that is used to create a second electrocardiogram (col.8, lines 48-67, col.9, lines 1-12: acquire biometric identifier for authentication; see col.12, lines 40-43, the biometric identifier being a EKG or heart rate; the fingerprint, EKG and heart rate are all parts of the user profile, col.8, lines 23-34), with the second cardiac indicator being logically related to the second biometric identifier (col.8, lines 48-67, col.9, lines 1-12: acquire biometric identifier for authentication; see col.12, lines 40-43, the biometric identifier being a EKG or heart rate; the fingerprint , EKG and heart rate are all parts of the user profile, col.8, lines 23-34), wherein, the first electrocardiogram (user profile, col. 8, lines 14-18) and second electrocardiogram (sensor-read, col. 8, lines 43-60 and col. 8, line 62 – col. 9, line 20) must match to authenticate the user (acquire biometrics from user and check against profile, col. 8, line 48 – col. 9, line 20), and the first biometric identifier (profile fingerprint) and second biometric identifier (sensor-read fingerprint) must match to authenticate the user (acquire biometrics from user and check against profile, col. 8, line 48 – col. 9, line 20), the user is authenticated using the first cardiac indicator, second cardiac indicator (acquire biometrics from user and check against profile, col. 8, line 48 – col. 9, line 20).1 Kursun discloses implantable devices (col.4, lines 50-57), continuous measurement and measuring EKG data (col. 6, lines 4-6 and col. 6, lines 51-55), but lacks at least one sensor communicatively connected to the cardiac unit and directly positioned inside a user's heart to directly and continuously measure central mixed venous oxygenation. However, Contreras teaches gathering a cardiac identifier (measuring an electrocardiogram, ¶15, ¶26) in the form of directly and continuously measuring central mixed venous oxygenation (¶26) through a sensor (intracardiac electrocardiogram) communicatively connected to a processor and directly positioned inside the user’s heart (ventricle, ¶28). Contreras teaches that an implantable sensor simplifies patient monitoring (¶19). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Kursun such that the first cardiac identifier is gathered from at least one sensor communicatively connected to the cardiac unit and directly positioned inside a user's heart to directly and continuously measure central mixed venous oxygenation in a portion of the heart (ventricle). One of ordinary skill in the art would have been motivated to perform such a modification to monitor the EKG (intracardiac electrocardiogram) using a known sensor for achieving such a reading, as taught by Contreras.2 Kurson, as modified, lacks at least one demographic indicator related to the user, the user demographic identifier, first cardiac indicator, second cardiac indicator are compared to a plurality of users to identify at least one similar user to the authenticated user. However, Virolainen, in an analogous art (monitoring clinical patient data to predict outcomes, ¶4), teaches that it was known to maintain historical records comprising physiological information gathered from a patient, including cardiac indicators (patient monitor gathers physiological information, including blood oxygen saturation, ¶14) and demographic information (¶26) and for a cardiac unit (computer, Fig. 1, 14) and compare the user demographic identifier and physiological data to a plurality of other users to identify at least one similar user (plurality of filters are used to create a similar patient subset, sorting patient demographics and monitored parameters, ¶27, which is then used to predict outcomes for the monitored patient, ¶¶28-29; “records are processed by the outcome prediction program to rate a correspondence of the historical record with the predicted outcome 64 to the current patient data 56”, ¶29). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Kurson to include at least one demographic indicator related to the user, such that the user demographic identifier, first cardiac indicator, second cardiac indicator are compared to a plurality of other users to identify at least one similar user to the authenticated user. One of ordinary skill in the art would have been motivated to perform such a modification to identify similar patients for predicting outcomes, as taught by Virolainen. As modified, Kursun lacks that the user is authenticated using the user demographic [indicator]. However, Alameh, in an analogous art (biometric authentication, ¶31, ¶42, ¶67), teaches that it was known to utilize more than one factor in authenticating a user (may require additional authentication factors, ¶37), where an additional factor can include demographic information in the form of location information (¶¶49-50, ¶78). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Kursun such that the user is authenticated using the user demographic [indicator]. One of ordinary skill in the art would have been motivated to perform such a modification to utilize an additional factor in authenticating the user, for increased security, as taught by Alameh.3
Regarding claim 11, the claim is similar in scope to claim 1, and is therefore rejected using a similar rationale.
Regarding claims 3 and 13, Kursun, as modified, teaches comparing live biometrics to a profile to detect anomalies, the profile including biometrics such as fingerprints, EKG and heart rate (col.8, lines 23-34; see also col. 3, lines 8-16 and col. 5, lines 61-64),but lacks wherein the second biometric identifier is the continuously measured central mixed venous oxygenation. However, Contreras teaches that it was known to utilize continuous SvO2 monitoring to ensure hemodynamic stability (¶¶55-54; see also ¶20). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Kursun such that the second biometric identifier is the hemodynamic status (hemodynamic status, monitored against biometric profile) of the user calculated using the continuously measured central mixed venous oxygenation (as modified previously by Contreras). One of ordinary skill in the art would have been motivated to perform such a modification to guide a patient using data from the sensors to detect anomalies related to hemodynamic status to ensure hemodynamic stability, as taught by Contreras.
Regarding claims 4 and 14, Kursun discloses wherein the first biometric identifier is one of a fingerprint, a facial feature or an iris pattern (Kursun col.6:51-57: eye, fingerprint).
Regarding claims 5 and 15, Kursun discloses, wherein the second biometric identifier is one of a fingerprint, a facial feature or an iris pattern (Kursun col.6:51-57: eye, fingerprint).
Claim 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kursun, Contreras, Virolainen and Alameh, as applied to claims 1 and 11, in view of US 2001/0033220 A1 to Stone et al. (Stone).
Regarding claims 2 and 12, Kursun, as modified, lacks wherein the first biometric identifier is gathered simultaneously with the first cardiac identifier. However, Stone teaches a user measuring finger and heart biometrics simultaneously (¶29) to ensure liveliness of the fingerprint sensor (¶21). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Kursun such that the first biometric identifier is gathered simultaneously with the first cardiac identifier. One of ordinary skill in the art would have been motivated to perform such a modification to ensure liveliness of the first biometric identifier, as taught by Stone.
Claims 8-9 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kursun, Contreras, Virolainen and Alameh, as applied to claims 1 and 11, in view of US 2021/0228134 A1 to Trapero Martin et al. (Trapero).
Regarding claims 8 and 18, Kursun, as modified, teaches the system of claim 1, but does not teach wherein the first and second cardiac identifiers are normalized. However, Trapero teaches a device for acquiring an electrocardiogram ECG (¶¶9-10), where the ECG signal can be normalized to increase accuracy (¶156). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Kursun to normalize the cardiac identifiers as taught by Trapero to increase accuracy, as taught by Trapero.4
Regarding claims 9 and 19, Kursun, as modified, teaches the system of claim 8, wherein the normalized cardiac identifiers are logically related to the first biometric identifier and the second biometric identifier (Kursun col.8:23-43: integrated profile using all captured identifiers, the cardiac identifiers being normalized according to Trapero, ¶156).
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kursun, Contreras, Virolainen and Alameh, as applied to claims 1 and 11, in view of WO 2018/137662 A1 to Rahmei et al. (Rahmei).
Regarding claims 10 and 20, Kursun, as modified, teaches the system of claim 1, but does not explicitly teach wherein the biometric and cardiac identifiers are gathered from a mobile communication device. However, Rahmei, in an analogous art (biometric authentication), discloses authenticating a user biometric and physiological data wherein the biometric and cardiac identifiers are gathered from a mobile communication device (p.2., under Summary, continuing to p.3, lines 1-10: device housing the physiological monitor and the biometric reader; the device being a wearable device that can be worn on different parts of the body including chest (p.2, lines 11-15)). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Kursun to gather the identifiers from a mobile communication device. One of ordinary skill in the art would have been motivated to perform such a modification because such mobile communication device is adaptable to different activities, including when the user is exercising or resting, broadening the opportunities to authenticate the user, as taught by Rahmei.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20200220870 A1 (Wagner; Kim et al.) teaches utilize demographic information to retrieve a biometric template for authenticating a user (¶100).
US 20120079581 A1 (Patterson; Barbara E.) teaches utilizing demographic information in addition to biometric data, as a second factor in authenticating a user (¶74).
US 20220012969 A1 (Robertson; Timothy et al.) teaches authenticating a user using physiological signals, including factors such as electro cardiogram signals, GPS and proximity (¶¶41-48).
US 20180225437 A1 (SUH; Kanghyun et al.) teaches authenticating a user based on biometric measurements, including biometrics based on oxygen saturation information (¶¶146-149).
US 9946942 B2 (Wang; Fei et al.) teaches authenticating a user based on biometric measurements, including biometrics based on electrocardiogram signals (cols. 3-4).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J SIMITOSKI whose telephone number is (571)272-3841. The examiner can normally be reached on Monday - Friday, 7:00-3:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Colin can be reached on 571-272-38623862. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michael Simitoski/ Primary Examiner, Art Unit 2493
December 15, 2025
1 US 20160042219 A1 (BAE; Chisung et al.) also teaches authenticating a biometric and ECG (Fig. 9 and ¶¶102-107).
2 US 7909764 B1 (Wenzel; Brian Jeffrey et al.) teaches a similar concept.
3 US 20120079581 A1 (Patterson; Barbara E.) also teaches utilizing demographic information in addition to biometric data, as a second factor in authenticating a user (¶74)
4 US 20120242501 A1 (Tran; Bao et al.) describes a similar concept (¶330).