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 amendments and remarks directed to claims 2, 52, and 77 on pp. 12-13 are considered persuasive and these claims are objected to as depending from a rejected claim.Applicant's remaining arguments filed 5/26/2026 have been fully considered but they are not persuasive.
On p. 10 of the Remarks filed 5/26/2026, Applicant states that it is not reasonable to one of skill in the art to construe “data files” as recited in Claim 1 to be equivalent to “at least two ECG values” further explaining that “at least two ECG values” at best appear to correspond to the “capture(d) values” that are recited in Claim 1 and further in quotations “... the data record is a standalone computer file having at least some of the captured values as contents.”
It is the examiner’s position that a standalone computer file having at least some of the captured values as contents is a computer file comprising at least two captured ECG values. Therefore, the processing of the data record as taught in the rejection below appears to meet the BRI of the claimed invention. The examiner maintains that there is nothing in the claims that requires any “entire record” of any particular length.
On p. 11 of the Remarks filed 5/26/2026, Applicant states that Kalidas does not teach that the 10 second segments are data records in a standalone computer file, and therefore, Kalidas cannot be said to teach performing any alternative actions with respect to the data record.
Applicant is reminded that the claims are taught by a combination of Kim and Kalidas. The Kim reference teaches data records as individual files. Kalidas teaches performing sorting on portions of data. It is the examiner’s position that performing a sorting process on any size portion of data is an obvious modification to apply to data records created in Kim. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
On p. 11 of the Remarks filed 5/26/2026, Applicant states that the proposed modification “would require a fundamental redesign of Kalidas’ arrhythmia analysis systems.”
This is not found persuasive as it lacks any particular evidence for the conclusion arrived at by applicant. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). There appears to be no reason why the improvement provided by noise segment rejection taught by Kalidas would not provide said improvement to the data records of Kim.
Further on p. 13 of the Remarks filed 5/26/2026, Applicant states that Kalidas does not teach a High Frequency noise criterion, characterizing the teachings of Kalidas as teaching a 1D Denoising Convolutional Autoencoder, which does not correspond to a noise criterion. This is found persuasive, therefore the rejection of claims 7, 57, and 82 in view of Kalidas is withdrawn. However, these claims are still rejected in view of Firoozabadi, a rejection which has not been addressed by Applicant. The citations for claims 7, 57, and 82 were previously found in the rejection of claim 1, 51, and 76 (the independent claims).
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 3-4, 51, 53-54, 76, 78-79, and 100-102 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (U.S. Patent Application Publication No. 2019/0209853) hereinafter referred to as Kim; in view of Kalidas et al. (U.S. Patent Application Publication No. 2022/0015711) hereinafter referred to as Kalidas.
Regarding claim 1, Kim teaches a pre-analyzing computer system for pre-analyzing and characterizing a data record of a patient (¶[0065] available to external clients…for later review by external users), the data record created by a wearable medical system (WMS) worn by the patient (¶[0027] ambulatory medical device), the pre-analyzing computer system comprising:
the WMS worn by the patient comprises:
an energy storage module configured to store an electrical charge (¶[0047]),
an electrode (¶[0031], ¶[0048] electrodes),
a support structure configured to be worn by the patient so as to maintain the electrode on a body of the patient (¶[0030] support structure),
a sensor configured to sense a parameter of the patient, the parameter including an Electrocardiogram (ECG) signal of the patient (¶[0041] electrodes to detect ECG data),
a measurement circuit configured to render a patient input responsive to the sensed parameter, the patient input including values for the ECG signal (¶[0039], ¶[0051], ¶[0054]), and
a WMS processor (¶[0054] processor) configured to:
determine, from the patient input, whether or not a shock criterion is met (¶[0041] detecting…whether the patient is in need of a shock, ¶[0055]), and cause, responsive to the shock criterion being met, at least some of the stored electrical charge to be discharged via the electrode through the patient while the support structure is worn by the ambulatory patient so as to deliver a shock to the patient (¶[0056]),
detect, from the patient input, when an alert criterion is met (¶[0089]),
capture at least some of the values of the ECG signal when the alert criterion is met (¶[0045] records of episodes and intervention, ¶[0065]),
create the data record so that the data record is a standalone computer file and has as contents at least some of the captured values (¶[0065] create a record), and
cause the data record to be transmitted to the pre-analyzing computer system (¶[0065] available to external clients…for later review by external users),
Kim does not teach the pre-analyzing computer system including at least:
one or more pre-analyzing computer system processors distinct from the WMS processor and not controlled by the WMS processor; and
a non-transitory computer- readable pre-analyzing storage medium having stored thereon instructions which, when executed by the one or more computer pre-analyzing computer system processors, result in operations including at least:
receiving, by the pre-analyzing computer system, the data record that has been caused to be transmitted;
parsing the contents of the received data record;
applying a sorting criterion to the parsed contents to determine a given score for the data record, the given score being one of a set including at least a first score and a second score, wherein the sorting criterion comprises a noise criterion applied to the values of the ECG signal;
performing a characterizing action with reference to the data record responsive to the given score being the first score, and not performing the characterizing action with reference to the data record responsive to the given score being the second score, and
performing an alternative action with reference to the data record responsive to the given score being the second score, and not performing the alternative action with reference to the data record responsive to the given score being the first score, the alternative action being different from the characterizing action.
Attention is brought to the Kalidas reference, which teaches a pre-analyzing computer system (¶[0044] server) including at least:
one or more pre-analyzing computer system processors distinct from the WMS processor and not controlled by the WMS processor (¶[0044] remote server, including operating on the cloud); and
a non-transitory computer- readable pre-analyzing storage medium having stored thereon instructions which, when executed by the one or more computer pre-analyzing computer system processors (¶[0044] server, ¶[0201] memory), result in operations including at least:
receiving, by the pre-analyzing computer system, a data record that has been caused to be transmitted (¶[0045]);
parsing the contents of the received data record (¶[0045] results review component);
applying a sorting criterion to the parsed contents to determine a given score for the data record (¶[0070] scores), the given score being one of a set including at least a first score and a second score (¶[0065] signal quality assessment step, scores include more or less than 0.5 and exceeding 0.9), wherein the sorting criterion comprises a noise criterion (¶[0070] the scores represent a noise criterion) applied to the values of the ECG signal (¶[0064] applied to the denoised ECG signal, which comprises ECG signal values, Fig. 2 and 8 shows a flowchart for this application to the obtained signal values);
performing a characterizing action with reference to the data record responsive to the given score being the first score (¶[0065] high noise segments are suppressed), and not performing the characterizing action with reference to the data record responsive to the given score being the second score (¶[0065] high quality segments are not suppressed, ¶[0070]); and
performing an alternative action (Fig. 8, decision step element “EM noise score <=0.9” with YES or NO alternative paths, the YES path considered to be the alternative action) with reference to the data record responsive to the given score being the second score (¶[0065] more or less than 0.5 and not exceeding 0.9), and not performing the alternative action with reference to the data record responsive to the given score being the first score (¶[0096] omitting steps for missed beat detection, false beat removal, and threshold update phase), the alternative action being different from the characterizing action (¶[0096] these omitted steps differ from ¶[0065] suppressing high noise segments).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the wearable patient monitor of Kim to include robust noise classification, as taught by Kalidas, because Kalidas teaches that it is “imperative that beat detection algorithms and related processes are extremely robust to noise without compromising on detection accuracy, especially under arrhythmic conditions” (Kalidas ¶[0072]).
Regarding claim 3, Kim as modified teaches the pre-analyzing computer system of claim 1.
Kalidas further teaches wherein the set includes three or more scores (¶[0070] more than 0.5, less than 0.5 and greater than 0.9.
Regarding claim 4, Kim as modified teaches the pre-analyzing computer system of claim 1.
Kalidas further teaches wherein the sorting criterion has been trained by artificial intelligence training from other data records to which scores were assigned previously (¶[0069] noise classification model).
Regarding claims 51-54, 57, 76-79, and 82, the claims are directed to a method and computing system comprising substantially the same subject matter as claims 1-4 and 7 and are rejected under substantially the same sections of Kim and Kalidas.
Regarding claims 100-102, Kim as modified teaches the pre-analyzing computer system of claim 1.
Kim further teaches wherein the WMS further comprises a motion detector configured to detect motion event data indicative of a change in posture of the patient from a baseline posture (¶[0043], ¶[0069] posture change detector).
Claim(s) 1, 3-4, 7, 51, 53-54, 57, 76, 78-79, 82, and 100-102 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (U.S. Patent Application Publication No. 2019/0209853) hereinafter referred to as Kim; in view of Kalidas et al. (U.S. Patent Application Publication No. 2022/0015711) hereinafter referred to as Kalidas; in view of Firoozabadi et al. (U.S. Patent Application Publication No. 2018/0242872) hereinafter referred to as Firoozabadi.
Regarding claim 1, Kim teaches a pre-analyzing computer system for pre-analyzing and characterizing a data record of a patient (¶[0065] available to external clients…for later review by external users), the data record created by a wearable medical system (WMS) worn by the patient (¶[0027] ambulatory medical device), the pre-analyzing computer system comprising:
the WMS worn by the patient comprises:
an energy storage module configured to store an electrical charge (¶[0047]),
an electrode (¶[0031], ¶[0048] electrodes),
a support structure configured to be worn by the patient so as to maintain the electrode on a body of the patient (¶[0030] support structure),
a sensor configured to sense a parameter of the patient, the parameter including an Electrocardiogram (ECG) signal of the patient (¶[0041] electrodes to detect ECG data),
a measurement circuit configured to render a patient input responsive to the sensed parameter, the patient input including values for the ECG signal (¶[0039], ¶[0051], ¶[0054]), and
a WMS processor (¶[0054] processor) configured to:
determine, from the patient input, whether or not a shock criterion is met (¶[0041] detecting…whether the patient is in need of a shock, ¶[0055]), and cause, responsive to the shock criterion being met, at least some of the stored electrical charge to be discharged via the electrode through the patient while the support structure is worn by the ambulatory patient so as to deliver a shock to the patient (¶[0056]),
detect, from the patient input, when an alert criterion is met (¶[0089]),
capture at least some of the values of the ECG signal when the alert criterion is met (¶[0045] records of episodes and intervention, ¶[0065]),
create the data record so that the data record is a standalone computer file and has as contents at least some of the captured values (¶[0065] create a record), and
cause the data record to be transmitted to the pre-analyzing computer system (¶[0065] available to external clients…for later review by external users),
Kim does not teach the pre-analyzing computer system including at least:
one or more pre-analyzing computer system processors distinct from the WMS processor and not controlled by the WMS processor; and
a non-transitory computer- readable pre-analyzing storage medium having stored thereon instructions which, when executed by the one or more computer pre-analyzing computer system processors, result in operations including at least:
receiving, by the pre-analyzing computer system, the data record that has been caused to be transmitted;
parsing the contents of the received data record;
applying a sorting criterion to the parsed contents to determine a given score for the data record, the given score being one of a set including at least a first score and a second score, wherein the sorting criterion comprises a noise criterion applied to the values of the ECG signal;
performing a characterizing action with reference to the data record responsive to the given score being the first score, and not performing the characterizing action with reference to the data record responsive to the given score being the second score, and
performing an alternative action with reference to the data record responsive to the given score being the second score, and not performing the alternative action with reference to the data record responsive to the given score being the first score, the alternative action being different from the characterizing action.
Attention is brought to the Kalidas reference, which teaches a pre-analyzing computer system (¶[0044] server) including at least:
one or more pre-analyzing computer system processors distinct from the WMS processor and not controlled by the WMS processor (¶[0044] remote server, including operating on the cloud); and
a non-transitory computer- readable pre-analyzing storage medium having stored thereon instructions which, when executed by the one or more computer pre-analyzing computer system processors (¶[0044] server, ¶[0201] memory), result in operations including at least:
receiving, by the pre-analyzing computer system, a data record that has been caused to be transmitted (¶[0045]);
parsing the contents of the received data record (¶[0045] results review component);
applying a sorting criterion to the parsed contents to determine a given score for the data record (¶[0070] scores), the given score being one of a set including at least a first score and a second score (¶[0065] signal quality assessment step, scores include more or less than 0.5 and exceeding 0.9), wherein the sorting criterion comprises a noise criterion (¶[0070] the scores represent a noise criterion) applied to the values of the ECG signal (¶[0064] applied to the denoised ECG signal, which comprises ECG signal values, Fig. 2 and 8 shows a flowchart for this application to the obtained signal values);
performing a characterizing action with reference to the data record responsive to the given score being the first score (¶[0065] high noise segments are suppressed), and not performing the characterizing action with reference to the data record responsive to the given score being the second score (¶[0065] high quality segments are not suppressed, ¶[0070]); and
performing an alternative action (Fig. 8, decision step element “EM noise score <=0.9” with YES or NO alternative paths, the YES path considered to be the alternative action) with reference to the data record responsive to the given score being the second score (¶[0065] more or less than 0.5 and not exceeding 0.9), and not performing the alternative action with reference to the data record responsive to the given score being the first score (¶[0096] omitting steps for missed beat detection, false beat removal, and threshold update phase), the alternative action being different from the characterizing action (¶[0096] these omitted steps differ from ¶[0065] suppressing high noise segments).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the wearable patient monitor of Kim to include robust noise classification, as taught by Kalidas, because Kalidas teaches that it is “imperative that beat detection algorithms and related processes are extremely robust to noise without compromising on detection accuracy, especially under arrhythmic conditions” (Kalidas ¶[0072]).
The Examiner’s position is that Kalidas teaches applying a sorting criterion to the parsed contents to determine a given score for the data record, the given score being one of a set including at least a first score and a second score, wherein the sorting criterion comprises a noise criterion applied to the values of the ECG signal based on the teachings of Kim and Kallidas.
However, in case Applicant disagrees with the BRI of the rejection and to move prosecution forward, attention is drawn to the Firoozabadi reference, which teaches applying a sorting criterion to the parsed contents to determine a given score for the data record, the given score being one of a set including at least a first score and a second score, wherein the sorting criterion comprises a noise criterion applied to the values of the ECG signal (¶[0073], ¶¶[0075-0090], HFN is high-frequency noise, LFN is low-frequency noise).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the computer system of Kim as modified to include additional specificity in noise sorting criteria, as taught by Firoozabadi, because Firoozabadi teaches a beneficial “novel and unique evaluating” of high-frequency and low-frequency noise levels within ECG segments (Firoozabadi ¶[0096]).
Regarding claim 3, Kim as modified teaches the pre-analyzing computer system of claim 1.
Kalidas further teaches wherein the set includes three or more scores (¶[0070] more than 0.5, less than 0.5 and greater than 0.9.
Regarding claim 4, Kim as modified teaches the pre-analyzing computer system of claim 1.
Kalidas further teaches wherein the sorting criterion has been trained by artificial intelligence training from other data records to which scores were assigned previously (¶[0069] noise classification model).
Regarding claim 7, Kim as modified teaches the pre-analyzing computer system of claim 6.
Firoozabadi further teaches wherein the noise criterion includes a High-Frequency noise criterion (¶[0073], ¶¶[0075-0090], HFN is high-frequency noise, LFN is low-frequency noise).
Regarding claims 51-54, 57, 76-79, and 82, the claims are directed to a method and computing system comprising substantially the same subject matter as claims 1-4 and 7 and are rejected under substantially the same sections of Kim, Kalidas, and Firoozabadi.
Regarding claims 100-102, Kim as modified teaches the pre-analyzing computer system of claim 1.
Kim further teaches wherein the WMS further comprises a motion detector configured to detect motion event data indicative of a change in posture of the patient from a baseline posture (¶[0043], ¶[0069] posture change detector).
Allowable Subject Matter
Claims 2, 52, and 77 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record does not fairly teach or make obvious the combination of noise criterion and impedance criterion in the claimed invention. Closest prior art of Kim, Kalidas, and Firoozabadi are considered to teach, in combination, applying a sorting criterion to a parsed data record comprising at least some captured ECG values in order to perform actions with respect to the data record, and the sorting criterion includes at least noise criteria comprising a high frequency criterion—but none of these references teach including an impedance criterion in the sorting algorithm, or provides guidance on how PHOSITA would perform such a modification.
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 AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792
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