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 .
Response to Arguments
Applicant’s arguments, see Applicant Arguments/Remarks Made in an Amendment, filed 31 July 2026, with respect to the rejection under 35 U.S.C. § 101 have been fully considered and are persuasive, in light of the amendments. The rejection under 35 U.S.C. § 101 of claims 1 – 21 has been withdrawn.
Applicant’s arguments, see Applicant Arguments/Remarks Made in an Amendment, filed 31 July 2026, with respect to the rejection(s) of claim(s) 1 - 21 under 35 U.S.C. § 102/103 have been fully considered and are persuasive, in light of the amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kharam et al. (US PGPUB 2020/0196960 – previously cited) in view of Wesselink et al. (US PGPUB 2007/0146189).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 – 4, 7, 10, 12 – 14, 17, 20, and 21is/are rejected under 35 U.S.C. 103 as being unpatentable over Kharam et al. (US PGPUB 2020/0196960 – previously cited) in view of Wesselink et al. (US PGPUB 2007/0146189).
Regarding claims 1, 10, and 20, Kharam discloses a medical device system and method comprising: a plurality of electrodes (e.g. ¶ 88); sensing circuitry configured to sense an electrocardiogram (ECG) of a patient (e.g. ¶ 46, 88, 90); and processing circuitry configured to: determine a T-wave morphology associated with a T-wave in the ECG (e.g. ¶ 90, 109 – 110); based on the T-wave morphology, determine an estimate of serum potassium in blood of the patient (e.g. ¶ 90; the control circuit can be configured to determine a serum potassium); determine that the estimate of serum potassium in the blood satisfies a threshold (e.g. ¶ 79); and based on the estimate of serum potassium in the blood satisfying the threshold, generate an indication for output that is based at least in part on the estimate of serum potassium in the blood satisfying the threshold (e.g. ¶ 80).Kharam fails to teach controlling the sensing circuitry to increase and monitoring the ECG for arrhythmia of a heart of the patient.
Wesselink teaches it is known to control the sensing circuitry to increase and monitor the ECG for arrhythmia of a heart of the patient (e.g. ¶ 20 and 53 – 55). It would have been obvious to one having ordinary skill in the art to modify the device as taught by Kharam with the circuitry as taught by Wesselink, since such a modification would provide the predictable results of using a rate switch on Kharam’s serum-potassium estimate.
Regarding claims 2, 12, and 21, Kharam discloses the processing circuitry is further configured to: determine an R-wave morphology associated with an R-wave in the ECG, the R-wave preceding the T-wave; and normalize the T-wave morphology based on the R-wave morphology prior to determining the estimate of serum potassium in the blood (e.g. ¶ 83).
Regarding claims 3 and 13, Kharam discloses the processing circuitry is further configured to average the normalized T-wave morphology across a plurality of successive heart beats (e.g. ¶ 64).
Regarding claims 4 and 14, Kharam discloses the indication comprises at least one of an alert or a recommendation of remedial action (e.g. ¶ 80).
Regarding claims 7 and 17, Kharam discloses determining the estimate of the serum potassium in the blood comprises applying at least one of a patient specific machine learned model or a population averaged machine learned model to the morphology of the T-wave (e.g. ¶ 70).
Claim(s) 5, 6, 15, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kharam et al. in view Wesselink et al., and further in view of Soykan et al. (US PGPUB 2013/0274642 – in IDS).
Regarding claims 5, 6, 16, and 16, Kharam in view Wesselink discloses the claimed invention as described above, but fails to explicitly recite based on the estimate of serum potassium in the blood satisfying the threshold, control the sensing circuitry to increase a sampling rate of the ECG; and monitor the ECG for arrythmia of a heart of the patient and to determine an arrythmia of the heart of the patient; and based on determining the arrythmia of the heart of the patient, perform at least one of control the medical device system to pace the heart of the patient or generate an indication of arrythmia for output.
Soykan teaches it is known that potassium fluctuations could lead to cardiac arrhythmias (e.g. ¶ 219) and using ECG signals to monitor cardiovascular parameters (e.g. ¶ 277). Furthermore, it is well known in the art to increase ECG sampling rate when a cardiac event has been detected. It would have been obvious to one having ordinary skill in the art to modify the invention as taught by Kharam in view Wesselink with the increasing a sampling rate to identify and treat an arrhythmia as taught by Soykan, since such a modification would provide the predictable results of better treating a patient in the event of the determined potassium fluctuations.
Claim(s) 8, 9, 18, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kharam et al. in view Wesselink et al., and further in view of Mayo Foundation (WO 2017/091736 – in IDS).
Regarding claims 8, 9, 18, and 19¸ Kharam in view Wesselink discloses the claimed invention as discussed above, but fails to explicitly recite determining, based at least in part on an accelerometer signal, a posture of the patient; and determine, based at least in part on the posture of the patient, the estimate of serum potassium in blood of the patient, wherein the posture is supine.
Mayo teaches it is known to use an accelerometer to determine a posture of the patient and to use ECG signals to determine levels of serum potassium (e.g. ¶ 97). It would have been obvious to one having ordinary skill in the art to modify the invention as taught by Kharam in view Wesselink with the accelerometer and posture determination as taught by Mayo, since such a modification would provide the predictable results of providing more information about the patient in order to better diagnose and treat the patient.
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 JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3796
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