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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/07/2025 and 08/29/2025 are being considered by the examiner.
Specification
The use of the term Bluetooth, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 5 and 13 are objected to because of the following informalities:
Claim 5, line 2, reads “EMG” should read “electromyography (EMG) signal”.
Claim 13, line 2, reads “processing circuitry by processing circuitry” should read “processing circuitry”.
C.
Appropriate correction is required.
Applicant is advised that should claim 13 be found allowable, claim 21 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 9, and 13 of U.S. Patent No. 11717208 B2, and in view of Pflugh et al. (US 20170366921 A1), hereinafter Pflugh, and in further view of Korzinov et al. (US 9968274 B2), hereinafter Korzinov. The claims of the instant application and the claims of the reference patent are compared in the table below.
Instant application
US 11717208 B2
Claim 1
Claim 1
A system comprising: an insertable cardiac monitor comprising a plurality of electrodes; one or more memories; and processing circuitry in communication with the one or more memories, wherein the processing circuitry is configured to: detect, in a cardiac signal sensed by the insertable cardiac monitor via the plurality of electrodes, a set of premature ventricular contractions (PVCs) of a heart of a patient;
A medical system comprising: a plurality of electrodes configured to sense a cardiac electrogram (EGM) signal of a patient, a memory; and processing circuitry in communication with the memory, wherein the processing circuitry is configured to: detect a premature ventricular contraction (PVC) within the cardiac EGM signal;
Claim 1
Claim 9
compare, for each respective PVC of the set of PVCs, a PVC morphology of the respective PVC to a respective PVC morphology of a set of one or more patient-based waveforms; classify, based on the comparison, each respective PVC of the set of PVCs, according to a corresponding PVC type of a plurality of corresponding PVC types,
The medical system of claim 1, wherein the processing circuitry is further configured to classify the PVC by: comparing the morphology of the PVC to each PVC morphology classification of a set of PVC morphology classifications, wherein each PVC morphology classification of the set of PVC morphology classifications comprises a mean morphology of detected PVCs from that PVC morphology classification;
Claim 1
Claim 5
and determine, based on the classification, a PVC burden.
The medical system of claim 1, wherein the processing circuitry is configured to classify the PVC as one of a set of PVC morphology classifications stored by the medical system; and wherein the processing circuitry is further configured to determine a PVC burden for each PVC morphology classification of the set of PVC morphology classifications stored by the medical system.
Claim 1
Claim 13
the plurality of corresponding PVC types comprising a couplet and a triplet
The medical system of claim 1, wherein the processing circuitry is configured to determine that the PVC storage criteria is met when the PVC is part of a Bigeminy, Trigeminy, Quadrigeminy, Couplet, or Triplet event.
Claims 1, 5, 9, and 13 of the reference patent recites all the limitations of claim 1 of the instant application except “an insertable cardiac monitor” and “morphology of a set of one or more patient-based waveforms”. However, Pflugh teaches an insertable cardiac monitor (Fig. 3A, element 400 – monitoring device, para. 0044 (400 is a device capable of recording heart electrical … 400 is a subcutaneous EGM-based monitor)) comprising a plurality of electrodes (para. 0044 (may include two or more electrodes electrically connected to the device to sense cardiac events)).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have an insertable cardiac monitor, as disclosed in Pflugh, within the medical system of claim 1 of the reference patent. Doing so enhances the system by providing a device that is connected to the electrodes, ensuring that the electrodes are secured and are able to detect the cardiac signals within range.
Pflugh does not teach comparing of a morphology of a set of one or more patient-based waveforms.
However, Korzinov teaches compare, for each respective PVC of the set of PVCs, a PVC morphology of the respective PVC to a respective PVC morphology of a set of one or more patient-based waveforms (col. 8, lines 9-11 (morphology of the suspected PVC may be compared to stored, previously-existing PVC templates), col. 7, lines 64-67 (A PVC “template” is, for example, a representation of a suspected PVC beat that is derived from (e.g., is an average of) the characteristics of a plurality of suspected PVC beats having a similar morphology), col. 8, lines 3-5 (each patient may have a plurality of different PVC templates)).
Korzinov and Pflugh are considered to be analogous to the claimed invention because they are in the same field of analyzing cardiac signals for PVC detection. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pflugh to incorporate the teachings of Korzinov listed above, and provide a comparison a morphology of a set of one or more patient-based waveforms, within the medical system of claim 1 of the reference patent. Doing so enhances the medical system by incorporating the comparison of the set of PVCs detected to a set of patient-based waveforms, allowing the comparison to be tailored to the patient’s health.
Claim 1-7, 13-14, 16, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-8, 10-11, 15-19, and 21 of U.S. Patent No. 12226217 B2, and in view of Su et al. (US 20200297283 A1), hereinafter Su. The claims of the instant application and the claims of the reference patent are compared in the table below.
Instant application
US 12226217 B2
Claim 1
Claim 1
A system comprising :an insertable cardiac monitor comprising a plurality of electrodes; one or more memories; and processing circuitry in communication with the one or more memories, wherein the processing circuitry is configured to: detect, in a cardiac signal sensed by the insertable cardiac monitor via the plurality of electrodes, a set of premature ventricular contractions (PVCs) of a heart of a patient; compare, for each respective PVC of the set of PVCs, a PVC morphology of the respective PVC to a respective PVC morphology of a set of one or more patient-based waveforms
A system comprising:an insertable cardiac monitor comprising a plurality of electrodes;one or more memories; andprocessing circuitry in communication with the one or more memories, wherein the processing circuitry is configured to:detect, in a cardiac signal sensed by the insertable cardiac monitor via the plurality of electrodes, a set of premature ventricular contractions (PVCs) of a heart of a patient;compare, for each respective PVC of the set of PVCs, a PVC morphology of the respective PVC to a respective PVC morphology of a set of one or more patient-based waveforms;
Claim 1
Claim 3
classify, based on the comparison, each respective PVC of the set of PVCs, according to a corresponding PVC type of a plurality of corresponding PVC types
The system of claim 1, wherein the processing circuitry is configured to determine a type of each of the first one or more PVCs from among a plurality of PVC types.
Claim 1
Claim 4
the plurality of corresponding PVC types comprising a couplet and a triplet;
The system of claim 3, wherein the plurality of PVC types comprise couplets and triplets.
Claim 1
Claim 8
and determine, based on the classification, a PVC burden.
The system of claim 1, wherein the at least one PVC criterion comprises a PVC burden threshold, and wherein as part of determining that the first one or more PVCs of the set of PVCs meet the at least one PVC criterion, the processing circuitry is configured to:determine a PVC burden based on the first one or more PVCs of the set of PVCs; anddetermine that the PVC burden meets the PVC burden threshold.
2. The system of claim 1, wherein the PVC burden comprises a daily PVC burden.
5. The system of claim 3, wherein the processing circuitry is further configured to determine a daily PVC burden for at least one of the plurality of PVC types.
3. The system of claim 2, wherein the daily PVC burden comprises a daily PVC burden for at least one of the plurality of corresponding PVC types.
5. The system of claim 3, wherein the processing circuitry is further configured to determine a daily PVC burden for at least one of the plurality of PVC types.
Instant application
US 12226217 B2
4. The system of claim 2, wherein the processing circuitry is further configured to determine, based on the daily PVC burden, a daily PVC burden trend.
7. The system of claim 6, wherein the processing circuitry is further configured to determine a daily PVC burden tend based on the daily PVC burden.
5. The system of claim 1, wherein as part of detecting the set of PVCs, the processing circuitry is configured to monitor via the plurality of electrodes an EMG of the heart of the patient during a PVC burden monitoring period of time.
10. The system of claim 1, wherein as part of detecting the set of PVCs, the processing circuitry is configured to monitor via the plurality of electrodes an EMG of the heart of the patient during a PVC burden monitoring period of time.
6. The system of claim 5, wherein the period of time comprises a day, a week, or a month.
11. The system of claim 10, wherein the PVC burden monitoring period of time comprises a day, a week, or a month.
7. The system of claim 1, wherein the set of one or more patient-based waveforms is adaptive.
2. The system of claim 1, wherein the set of one or more patient-based waveforms is adaptive.
Claim 13
Claim 15
A method comprising: detecting, by processing circuitry by processing circuitry and in a cardiac signal sensed by an insertable cardiac monitor via a plurality of electrodes, a set of premature ventricular contractions (PVCs) of a heart of a patient; comparing, by the processing circuitry and for each respective PVC of the set of PVCs, a PVC morphology of the respective PVC to a respective PVC morphology of a set of one or more patient-based waveforms;
A method comprising: detecting, by processing circuitry of an insertable cardiac monitor and in a cardiac signal sensed by the insertable cardiac monitor via a plurality of electrodes, a set of premature ventricular contractions (PVCs) of a heart of a patient; comparing, by the processing circuitry and for each respective PVC of the set of PVCs, a PVC morphology of the respective PVC to a respective PVC morphology of a set of one or more patient-based waveforms;
Claim 13
Claim 17
classifying, by the processing circuitry and based on the comparison, each respective PVC of the set of PVCs, according to a corresponding PVC type of a plurality of corresponding PVC types,
The method of claim 15, further comprising, determining, by the processing circuitry, a type of each of the first one or more PVCs of the set of PVCs from among a plurality of PVC types.
Claim 13
Claim 18
the plurality of corresponding PVC types comprising a couplet and a triplet;
The method of claim 17, wherein the plurality of PVC types comprise couplets and triplets.
Claim 13
Claim 22
determining, by the processing circuitry, and based on the classification, a PVC burden
The method of claim 15, wherein the at least one PVC criterion comprises a PVC burden threshold, and wherein determining that the first one or more PVCs of the set of PVCs meet the at least one PVC criterion comprises: determining, by the processing circuitry, a PVC burden based on the first one or more PVCs of the set of PVCs;
Instant application
US 12226217 B2
Claim 13
Claim 22
comparing, by the processing circuitry, the PVC burden to a PVC burden threshold;
and determining, by the processing circuitry, that the PVC burden meets a PVC burden threshold.
Claim 13
Claim 15
and sending, via communication circuitry and to an external device based on the PVC burden exceeding the PVC burden threshold, PVC data associated with at least one of the respective PVCs.
sending, via the communication circuitry and to the external device and based on the second one or more PVCs of the set of PVCs not meeting the at least one PVC criterion, for each respective PVC of the second one or more PVCs of the set of PVCs, a portion of an electrogram (EGM) associated with the respective PVC of the second one or more PVCs of the set of PVCs.
14. The method of claim 13, wherein the PVC burden comprises a daily PVC burden.
19. The method of claim 17, further comprising determining, by the processing circuitry, a daily PVC burden for at least one of the plurality of PVC types.
16. The method of claim 14, further comprising determining, by the processing circuitry and based on the daily PVC burden, a daily PVC burden tend.
21. The method of claim 20, further comprising determining, by the processing circuitry, a daily PVC burden trend based on the daily PVC burden.
19. The method of claim 13, wherein the set of one or more patient-based waveforms is adaptive.
16. The method of claim 15, wherein the set of one or more patient-based waveforms is adaptive.
Claims 1, 3, 4, and 8 of the reference patent recites all the limitations of claim 1 of the instant application except “classify, based on the comparison, each respective PVC of the set of PVCs, according to a corresponding PVC type of a plurality of corresponding PVC types” and “determine, based on the classification, a PVC burden”.
However, Su teaches classify, based on the comparison, each respective PVC of the set of PVCs (para. 0033 (the selected physiological parameter can be ventricular premature beat) according to a corresponding PVC type of a plurality of corresponding PVC types comprising a couplet and a triplet (Fig. 6 – shows the statistical result of the ventricular premature beat classified (couplet, triplet) within a specified time interval, para. 0033 (classification rule can be based on the number of consecutive ventricular premature beat, and the physiological parameter type can be divided into… two consecutive ventricular premature beats (2 V), short consecutive ventricular premature beats (3 to 5 V))); and
determine, based on the classification, a PVC burden (para. 0034 (the extracted physiological parameter result may be segmented according to a specified time interval. In step 403, the statistical analysis may be performed according to a specified physiological parameter type to obtain a classification result of each segment of the physiological parameter result)).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to classify each respective PVC of the set of PVCs, according to a corresponding PVC type of a plurality of corresponding PVC types, and determine a PVC burden, as disclosed in Su, within the medical system of claim 1 of the reference patent. Doing so provides further information on the type of PVC detected, providing medical staff with information to determine the severity of the PVCs, such as a risk of an R-on-T phenomenon. Additionally, the PVC burden tracks the amount of PVC’s, allowing medical staff to monitor the patient, and determine a treatment plan.
Claim 5 of the reference patent recites all the limitations of claims 2-3 of the instant application.
Claim 7 of the reference patent recites all the limitations of claim 4 of the instant application.
Claim 10 of the reference patent recites all the limitations of claim 5 of the instant application.
Claim 11 of the reference patent recites all the limitations of claim 6 of the instant application.
Claim 12 of the reference patent recites all the limitations of claim 7 of the instant application.
Claims 15, 17-18, and 22 of the reference patent recites all the limitations of claim 13 of the instant application except “classifying, by the processing circuitry and based on the comparison, each respective PVC of the set of PVCs, according to a corresponding PVC type of a plurality of corresponding PVC types” and “determining, by the processing circuitry, and based on the classification, a PVC burden”.
Su teaches classifying, by the processing circuitry (Fig. 14, element 1401 – processor) and based on the comparison, each respective PVC of the set of PVCs (para. 0033 (the selected physiological parameter can be ventricular premature beat)) according to a corresponding PVC type of a plurality of corresponding PVC types, the plurality of corresponding PVC types comprising a couplet and a triplet (Fig. 6 – shows the statistical result of the ventricular premature beat classified (couplet, triplet) within a specified time interval, para. 0033 (classification rule can be based on the number of consecutive ventricular premature beat, and the physiological parameter type can be divided into… two consecutive ventricular premature beats (2 V), short consecutive ventricular premature beats (3 to 5 V))); and
and determining, by the processing circuitry, and based on the classification, a PVC burden (para. 0034 (the extracted physiological parameter result may be segmented according to a specified time interval. In step 403, the statistical analysis may be performed according to a specified physiological parameter type to obtain a classification result of each segment of the physiological parameter result)).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to classify each respective PVC of the set of PVCs, according to a corresponding PVC type of a plurality of corresponding PVC types, and determine a PVC burden, as disclosed in Su, within the method of claim 13 of the reference patent. Doing so provides further information on the type of PVC detected, providing medical staff with information to determine the severity of the PVCs, such as a risk of an R-on-T phenomenon. Additionally, the PVC burden tracks the amount of PVC’s, allowing medical staff to monitor the patient, and determine a treatment plan.
Claim 19 of the reference patent recites all the limitations of claim 14 of the instant application.
Claim 21 of the reference patent recites all the limitations of claim 16 of the instant application.
Claim 16 of the reference patent recites all the limitations of claim 19 of the instant application.
Claim Rejections - 35 USC § 112
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.
Claim 7 is 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.
The term “adaptive” in claim 7 is not defined by the claim, the specification does not define what characteristics render a patient-based waveform “adaptive”. Accordingly, the scope of the limitation “adaptive” is unclear
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 1-25 are rejected under 35 U.S.C. 103 as being unpatentable over Nabutovsky (US 8027722 B1) and in view of Korzinov et al. (US 9968274 B2), hereinafter Korzinov, and in further view of Su et al. (US 20200297283 A1), hereinafter Su and Pflugh et al. (US 20170366921 A1), hereinafter Pflugh.
Regarding claim 1, Nabutovsky teaches a system (Fig. 1) comprising:
a cardiac monitor (Fig. 1, element 110 – ICD device) comprising a plurality of electrodes (Fig. 1, elements 120, 122, and 124 – electrodes);
one or more memories (Fig. 1, element 130– memory); and
processing circuitry in communication with the one or more memories (Fig. 1, element 114 – microprocessor, col. 3, lines 44-46 (114 further has a memory circuit 130 coupled thereto)), wherein the processing circuitry is configured to:
detect, in a cardiac signal sensed by the insertable cardiac monitor via the plurality of electrodes, a set of premature ventricular contractions (PVCs) of a heart of a patient (col. 3, lines 9-11 (lead 118 preferably also includes at least one electrode for pacing and sensing functions, such as electrode 124), col. 3, lines 21-23 (128 senses (or sample) the electrical activity of the heart 126 to determine an electrogram signal), col. 10, lines 29-30 (602, a first PVC is detected), col. 10, line 37 (606, a second PVC is detected));
Nabutovsky does not teach an insertable cardiac monitor, compare, for each respective PVC of the set of PVCs, a PVC morphology of the respective PVC to a respective PVC morphology of a set of one or more patient-based waveforms; classify, based on the comparison, each respective PVC of the set of PVCs, according to a corresponding PVC type of a plurality of corresponding PVC types, the plurality of corresponding PVC types comprising a couplet and a triplet; and determine, based on the classification, a PVC burden.
Korzinov teaches compare, for each respective PVC of the set of PVCs, a PVC morphology of the respective PVC to a respective PVC morphology of a set of one or more patient-based waveforms (col. 8, lines 9-11 (morphology of the suspected PVC may be compared to stored, previously-existing PVC templates), col. 7, lines 64-67 (A PVC “template” is, for example, a representation of a suspected PVC beat that is derived from (e.g., is an average of) the characteristics of a plurality of suspected PVC beats having a similar morphology), col. 8, lines 3-5 (each patient may have a plurality of different PVC templates));
and a PVC burden (col. 9, lines 1-2 (At the end of a pre-defined interval (e.g., a day), the total number of PVC beats may be calculated)).
Korzinov does not teach an insertable cardiac monitor classify, based on the comparison, each respective PVC of the set of PVCs, according to a corresponding PVC type of a plurality of corresponding PVC types, the plurality of corresponding PVC types comprising a couplet and a triplet.
Su teaches classify, based on the comparison, each respective PVC of the set of PVCs (para. 0033 (the selected physiological parameter can be ventricular premature beat) according to a corresponding PVC type of a plurality of corresponding PVC types comprising a couplet and a triplet (Fig. 6 – shows the statistical result of the ventricular premature beat classified (couplet, triplet) within a specified time interval, para. 0033 (classification rule can be based on the number of consecutive ventricular premature beat, and the physiological parameter type can be divided into… two consecutive ventricular premature beats (2 V), short consecutive ventricular premature beats (3 to 5 V))); and
determine, based on the classification, a PVC burden (para. 0034 (the extracted physiological parameter result may be segmented according to a specified time interval. In step 403, the statistical analysis may be performed according to a specified physiological parameter type to obtain a classification result of each segment of the physiological parameter result)).
Su does not teach an insertable cardiac monitor.
Pflugh teaches an insertable cardiac monitor (Fig. 3A, element 400 – monitoring device, para. 0044 (400 is a device capable of recording heart electrical … 400 is a subcutaneous EGM-based monitor)) comprising a plurality of electrodes (para. 0044 (may include two or more electrodes electrically connected to the device to sense cardiac events)).
Nabutovsky, Korzinov, Su, and Pflugh are all considered to be analogous to the claimed invention because they are in the same field of analyzing cardiac signals for PVC detection. Although Nabutovsky teaches a set of PVCs that are compared to a patients morphology threshold, Nabutovsky does not teach where each respective PVC is compared to a PVC morphology of the patient-based waveforms (Nabutovsky, col. 3, lines 38-39, col. 9, lines 61-67). However, Koriznov teaches each respective PVC is compared to a morphology template based on the patient (Koriznov, col. 8, lines 9-11, col. 7, lines 64-67). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky to incorporate the teachings of Korzinov listed above, and provide a comparison, for each respective PVC of the set of PVCs, a PVC morphology of the of a set of one or more patient-based waveforms. Doing so allows for the comparison of each PVC detected, to be able to detect false positives since the waveform is based on the patient’s template.
It would also have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky to incorporate the teachings of Korzinov listed above, and provide a PVC burden. Doing so tracks the amount of PVC’s, allowing medical staff to monitor the patient, and determine a treatment plan.
Additionally, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky to incorporate the teachings of Su and provide a classifying each respective PVC of the set of PVCs, according to a corresponding PVC type of a plurality of corresponding PVC types, comprising a couplet and a triplet. Doing so provides further information on the type of PVC detected, providing medical staff with information to determine the severity of the PVCs, such as a risk of an R-on-T phenomenon.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky’s device to incorporate the teachings of Pflugh listed above, and provide an insertable cardiac monitor. Doing so prevents the invasive procedure of having an implantable cardiac monitor, and instead the insertable cardiac monitor taught by Pflugh, is subcutaneously implanted in the chest of the patient, allowing for a less invasive procedure (Pflugh, para. 0044).
Regarding claims 2 and 3, Nabutovsky (in view of Korzinov, Su, and Pflugh) teaches the system of claim 1. Nabutovsky does not teach wherein the PVC burden comprises a daily PVC burden and wherein the daily PVC burden comprises a daily PVC burden for at least one of the plurality of corresponding PVC types.
Korzinov teaches wherein the PVC burden comprises a daily PVC burden (col. 9, lines 1-2 (At the end of a pre-defined interval (e.g., a day), the total number of PVC beats may be calculated)).
Korzinov does not teach wherein the daily PVC burden comprises a daily PVC burden for at least one of the plurality of corresponding PVC types.
Su teaches the PVC burden comprising at least one of the plurality of corresponding PVC types (para. 0034 (the extracted physiological parameter result may be segmented according to a specified time interval), Fig. 6, elements 602 & 603, para. 0053 (602 may represent the number of the two consecutive ventricular premature beats, 603 may represent the number of the short consecutive ventricular premature beats)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky to incorporate the teachings of Korzinov listed above, and provide a daily PVC burden. Doing so would allow medical staff to facilitate more accurate determination of cardiac wellness within the patient during the day.
It would also have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky (in view of Korzinov) to incorporate the teachings of Su listed above, and provide the daily PVC burden comprising at least one of the plurality of corresponding PVC types. Doing so would allow medical staff to be able to view the type of PVC (couplet, triplet) within the overall daily burden, to localize the origin on the PVC or determine if there are multiple triggers causing PVC.
Regarding claim 4, Nabutovsky (in view of Korzinov, Su, and Pflugh) teaches the system of claim 2. Nabutovsky teaches the processing circuitry (Fig. 1, element 114 – microprocessor). Nabutovsky does not teach wherein the processing circuitry is further configured to determine, based on the daily PVC burden, a daily PVC burden trend.
Korzinov teaches a daily PVC burden (col. 9, lines 1-2 (At the end of a pre-defined interval (e.g., a day), the total number of PVC beats may be calculated)).
Korzinov does not teach a daily PVC burden trend.
Su teaches a processing circuitry (Fig. 14, element 1401 – processor) and a PVC burden (para. 0034 (the extracted physiological parameter result may be segmented according to a specified time interval…number of occurrence of the corresponding physiological parameter type may be counted according to the physiological parameter type specified by the user)).
Although Su does not explicitly disclose determining a PVC burden trend, Su teaches a monitoring apparatus comprising a processor, that is able to calculate and set the physiological parameter for statistical analysis (Su, Fig. 3, element 303) and provide a bar graph (Fig. 6). It would have been obvious to someone of ordinary skill in the art to provide a trend within the statistical analysis, as Su already provides bar graphs showing the amount of counts of each PVC type. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky (in view of Korzinov) to incorporate the teachings of Su listed above, and provide a daily PVC burden trend. Doing so allows medical staff to determine the significance of the PVC burden within a day, a provides another visual to represent the PVC burden data.
Regarding claims 5 and 6, Nabutovsky (in view of Korzinov, Su, and Pflugh) teaches the system of claim 1, wherein as part of detecting the set of PVCs, the processing circuitry (Fig. 1, element 114 – microprocessor) is configured to monitor via the plurality of electrodes a cardiac signal. (col. 4, lines 14-17 (the control/timing circuit 114 is based on a microprocessor which includes the ability to process or monitor input signals (data) in a prescribed manner)).
Nabutovsky does not teach monitoring an EMG of the heart of the patient during a PVC burden monitoring period of time, wherein the period of time comprises a day, a week, or a month.
Korzinov teaches monitoring a cardiac signal (col. 1, lines 18-22 ( ECG monitoring, electrodes attached to a patient's skin are used to detect electrical activity of the heart over a period of time, and electrical impulses generated by the heart during each heartbeat are detected and recorded)) during a PVC burden monitoring period of time, wherein the period of time comprises a day, a week, or a month (col. 9, lines 1-2 (At the end of a pre-defined interval (e.g., a day), the total number of PVC beats may be calculated)).
Korzinov does not explicitly disclose an EMG of the heart.
Su teaches monitoring an EMG of the heart of the patient (para. 0003 (physiological parameters measured and monitored by the monitoring apparatus may include ECG (Electrocardiograph) signal, EMG (Electromyography) signal)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky to incorporate the teachings of Korzinov listed above, and provide monitoring an EMG of the heart of the patient during a PVC burden monitoring period of time. Doing so enhances the system by continuously detecting cardiac signals while analyzing the signals, ensuring that the PVC burden is determined as the signals are received, thus providing efficient workflow.
Additionally, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky (in view of Korzinov) to incorporate the teachings of Su listed above, and provide the cardiac monitor to be able to monitor an EMG signal of the heart while detecting PVCs. Doing so enhances the system by being able to detect multiple types of cardiac signals from the electrodes.
Regarding claim 7, Nabutovsky (in view of Korzinov, Su, and Pflugh) teaches the system of claim 1. Nabutovsky does not teach wherein the set of one or more patient-based waveforms is adaptive.
Korzinov teaches wherein the set of one or more patient-based waveforms is adaptive (col. 8, lines 48-55 (if the template ID is confirmed as a PVC by the user, all beats associated with the template ID may be confirmed and added to the PVC count, and the labels associated with each confirmed heartbeat may be updated to indicate that the heartbeats are PVCs)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky to incorporate the teachings of Korzinov listed above, and provide adaptive patient-based waveforms. Doing so would allow the stored waveforms of the patient to update in response to new PVC detections that are added to the PVC templates/morphologies.
Regarding claim 8, Nabutovsky (in view of Korzinov, Su, and Pflugh) teaches the system of claim 1, and the processing circuitry (Fig. 1, element 114 – microprocessor).
Nabutovsky does not teach wherein the processing circuitry is part of a device different from the insertable cardiac monitor.
Su teaches a processing circuitry that is part of a monitoring apparatus, which acquires ECG signals (Fig. 14, element 1401 – processor, para. 0031 (monitoring apparatus may use a physiological signal input module or a physiological signal acquisition device to acquire the physiological signal of a patient… physiological signal may include electrocardiographic signal)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky to incorporate the teachings of Su listed above, and provide a processing circuitry that is different from the cardiac monitor. Doing so reduces the processing burden within the cardiac monitor and clears up space in the memory within the circuitry.
Regarding claim 9, Nabutovsky (in view of Korzinov, Su, and Pflugh) teaches the system of claim 1, wherein the processing circuitry (Fig. 1, element 114 – microprocessor) is further configured to: send, via communication circuitry (Fig. 1, element 132 – telemetry circuit) and to an external device (Fig. 1, element 134 – external programmer), PVC data associated with at least one of the respective PVCs (col. 3, lines 60-61 (a telemetry circuit 132, in telecommunicative contact with an external programmer 134), col. 4, lines 5-10 (telemetry circuit 132 advantageously allows status information relating to the operation of the ICD 110… and the morphology templates and coupling interval measurements to be sent to the external programmer 134 through the established link 138)).
Nabutovsky does not teach compare the PVC burden to a PVC burden threshold and sending PVC data based on the PVC burden exceeding the PVC burden threshold.
Korzinov teaches wherein the processing circuitry (col. 5, lines 38-39 (monitor 20 may include integrated circuits (microprocessor)) is further configured to:
compare the PVC burden to a PVC burden threshold (col. 9, lines 1-6 (At the end of a pre-defined interval (e.g., a day), the total number of PVC beats may be calculated. In one example, if the total number is more than a predefined threshold (e.g., 100), the PVC statistics may be displayed by one or more of the monitor 20 or by a device used by the clinician for review)); and
send, via communication circuitry and to an external device based on the PVC burden exceeding the PVC burden threshold, PVC data associated with at least one of the respective PVCs (col. 4, lines 51-53 (monitor 20 may transfer at least a portion of the measured ECG data (or other physiologic data) to a remote analysis station 60 for analysis), col. 5, lines 19-22 (analysis station 60 may analyze the received data to determine if it indicates an anomaly (e.g., an arrhythmia, an unexpected trend in the data, etc.))).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky to incorporate the teachings of Korzinov listed above, and provide a comparison of the PVC burden to a threshold, and sending the PVC data to an external device when the threshold is exceeded. Doing so would notify medical staff that a patient has exceeded a PVC threshold within an external device, allowing communication with the cardiac monitor, thus allowing staff to possibly intervene in their patient’s treatment.
Regarding claim 10, Nabutovsky (in view of Korzinov, Su, and Pflugh) teaches the system of claim 9, wherein the PVC data comprises the PVC morphology of the at least one respective PVC (col. 4, lines 5-10 (telemetry circuit 132 advantageously allows status information relating to the operation of the ICD 110… and the morphology templates and coupling interval measurements to be sent to the external programmer 134 through the established link 138)).
Regarding claim 11, Nabutovsky (in view of Korzinov, Su, and Pflugh) teaches the system of claim 9. Nabutovsky does not teach wherein the PVC data comprises an alert.
Korzinov teaches the PVC data (col. 5, lines 19-22 (analysis station 60 may analyze the received data to determine if it indicates an anomaly (e.g., an arrhythmia, an unexpected trend in the data, etc.))).
Korzinov does not teach wherein the PVC data comprises an alert.
Su teaches an alert (para. 0033 (the selected physiological parameter can be ventricular premature beat), 0079 (it can be determined whether the statistical result of the physiological parameter exceeds the alarm threshold. When the statistical result of the physiological parameter exceeds the alarm threshold, the step 1203, the alarm operation may be performed), 0083 (monitoring apparatus can determine the satisfied alarm condition according to the physiological parameter statistical information and the preset alarm threshold, and perform the corresponding alarm operation to notify the user in time)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky (in view of Korzinov) to incorporate the teachings of Su listed above, and provide an alert from the PVC data. Doing so would immediately notify medical staff about the PVC burden exceeding the threshold, allowing them to take precaution in their patient’s cardiac treatment.
Regarding claim 12, Nabutovsky (in view of Korzinov, Su, and Pflugh) teaches the system of claim 9, further comprising an application configured to execute on the external device (Fig. 1, element 134 – external programmer), the application being configured to receive the PVC data (col. 3, lines 60-61 (a telemetry circuit 132, in telecommunicative contact with an external programmer 134), col. 4, lines 5-10 (telemetry circuit 132 advantageously allows status information relating to the operation of the ICD 110… and the morphology templates and coupling interval measurements to be sent to the external programmer 134 through the established link 138)).
Nabutovsky does not teach wherein the external device comprises a cellular phone or a smartphone.
Korzinov teaches an external device comprising a cellular phone or a smartphone, the application being configured to receive the PVC data (col. 7, lines 1-2 (monitor 20 may transmit information to the stand-alone display, cell phone, or other communication device via any type of wireless network), col. 1, lines 48-49 (monitor may transmit ECG data to a health care provider for analysis)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky to incorporate the teachings of Korzinov listed above, and provide the external device comprising a cellular phone or a smartphone. Doing so provides easier access for medical staff to view the PVC data in a portable device, allowing instant communication from the cardiac monitor to the staff.
Regarding claim 13, Nabutovsky teaches a method (Fig. 6) comprising:
detecting, by processing circuitry (Fig. 1, element 114 – microprocessor) and in a cardiac signal sensed by a cardiac monitor via a plurality of electrodes (Fig. 1, element 110 – ICD device, Fig. 1, elements 120, 122, and 124 – electrodes), a set of premature ventricular contractions (PVCs) of a heart of a patient (col. 3, lines 9-11 (lead 118 preferably also includes at least one electrode for pacing and sensing functions, such as electrode 124), col. 3, lines 21-23 (128 senses (or sample) the electrical activity of the heart 126 to determine an electrogram signal), col. 10, lines 29-30 (602, a first PVC is detected), col. 10, line 37 (606, a second PVC is detected));
sending, via communication circuitry (Fig. 1, element 132 – telemetry circuit) and to an external device (Fig. 1, element 134 – external programmer), PVC data associated with at least one of the respective PVCs (col. 3, lines 60-61 (a telemetry circuit 132, in telecommunicative contact with an external programmer 134), col. 4, lines 5-10 (telemetry circuit 132 advantageously allows status information relating to the operation of the ICD 110… and the morphology templates and coupling interval measurements to be sent to the external programmer 134 through the established link 138)).
Nabutovsky does not teach an insertable cardiac monitor, comparing, by the processing circuitry, and for each respective PVC of the set of PVCs, a PVC morphology of the respective PVC to a respective PVC morphology of a set of one or more patient-based waveforms; classifying, by the processing circuitry and based on the comparison, each respective PVC of the set of PVCs, according to a corresponding PVC type of a plurality of corresponding PVC types, the plurality of corresponding PVC types comprising a couplet and a triplet; and determining, by the processing circuitry, and based on the classification, a PVC burden, comparing, by the processing circuitry, the PVC burden to a PVC burden threshold; and sending PVC data based on the PVC burden exceeding the PVC burden threshold.
Korzinov teaches comparing, by the processing circuitry (col. 5, lines 38-39 (monitor 20 may include integrated circuits (microprocessor), and for each respective PVC of the set of PVCs, a PVC morphology of the respective PVC to a respective PVC morphology of a set of one or more patient-based waveforms (col. 8, lines 9-11 (morphology of the suspected PVC may be compared to stored, previously-existing PVC templates), col. 7, lines 64-67 (A PVC “template” is, for example, a representation of a suspected PVC beat that is derived from (e.g., is an average of) the characteristics of a plurality of suspected PVC beats having a similar morphology), col. 8, lines 3-5 (each patient may have a plurality of different PVC templates));
and determining, by the processing circuitry, a PVC burden, (col. 9, lines 1-2 (At the end of a pre-defined interval (e.g., a day), the total number of PVC beats may be calculated)); and
comparing, by the processing circuitry, the PVC burden to a PVC burden threshold (col. 9, lines 1-6 (At the end of a pre-defined interval (e.g., a day), the total number of PVC beats may be calculated. In one example, if the total number is more than a predefined threshold (e.g., 100), the PVC statistics may be displayed by one or more of the monitor 20 or by a device used by the clinician for review)); and
send, via communication circuitry and to an external device based on the PVC burden exceeding the PVC burden threshold, PVC data associated with at least one of the respective PVCs (col. 4, lines 51-53 (monitor 20 may transfer at least a portion of the measured ECG data (or other physiologic data) to a remote analysis station 60 for analysis), col. 5, lines 19-22 (analysis station 60 may analyze the received data to determine if it indicates an anomaly (e.g., an arrhythmia, an unexpected trend in the data, etc.))).
Korzinov does not teach an insertable cardiac monitor, and classifying, by the processing circuitry and based on the comparison, each respective PVC of the set of PVCs, according to a corresponding PVC type of a plurality of corresponding PVC types, the plurality of corresponding PVC types comprising a couplet and a triplet.
Su teaches classifying, by the processing circuitry (Fig. 14, element 1401 – processor) and based on the comparison, each respective PVC of the set of PVCs (para. 0033 (the selected physiological parameter can be ventricular premature beat)) according to a corresponding PVC type of a plurality of corresponding PVC types, the plurality of corresponding PVC types comprising a couplet and a triplet (Fig. 6 – shows the statistical result of the ventricular premature beat classified (couplet, triplet) within a specified time interval, para. 0033 (classification rule can be based on the number of consecutive ventricular premature beat, and the physiological parameter type can be divided into… two consecutive ventricular premature beats (2 V), short consecutive ventricular premature beats (3 to 5 V))); and
and determining, by the processing circuitry, and based on the classification, a PVC burden (para. 0034 (the extracted physiological parameter result may be segmented according to a specified time interval. In step 403, the statistical analysis may be performed according to a specified physiological parameter type to obtain a classification result of each segment of the physiological parameter result)).
Su does not teach an insertable cardiac monitor.
Pflugh teaches an insertable cardiac monitor (Fig. 3A, element 400 – monitoring device, para. 0044 (400 is a device capable of recording heart electrical … 400 is a subcutaneous EGM-based monitor)) comprising a plurality of electrodes (para. 0044 (may include two or more electrodes electrically connected to the device to sense cardiac events)).
Although Nabutovsky teaches a set of PVCs that are compared to a patients morphology threshold, Nabutovsky does not teach where each respective PVC is compared to a PVC morphology of the patient-based waveforms (Nabutovsky, col. 3, lines 38-39, col. 9, lines 61-67). However, Koriznov teaches each respective PVC is compared to a morphology template based on the patient (Koriznov, col. 8, lines 9-11, col. 7, lines 64-67). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky to incorporate the teachings of Korzinov listed above, and provide a comparison, for each respective PVC of the set of PVCs, a PVC morphology of the of a set of one or more patient-based waveforms. Doing so allows for the comparison of each PVC detected, to be able to detect false positives since the waveform is based on the patient’s template.
It would also have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky to incorporate the teachings of Korzinov listed above, and provide a PVC burden. Doing so tracks the amount of PVC’s, allowing medical staff to monitor the patient, and determine a treatment plan.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky to incorporate the teachings of Korzinov listed above, and provide a comparison of the PVC burden to a threshold, and sending the PVC data to an external device when the threshold is exceeded. Doing so would notify medical staff that a patient has exceeded a PVC threshold within an external device, allowing communication with the cardiac monitor, thus allowing staff to possibly intervene in their patient’s treatment.
Additionally, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky to incorporate the teachings of Su and provide a classifying each respective PVC of the set of PVCs, according to a corresponding PVC type of a plurality of corresponding PVC types, comprising a couplet and a triplet. Doing so provides further information on the type of PVC detected, providing medical staff with information to determine the severity of the PVCs, such as a risk of an R-on-T phenomenon.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky’s device to incorporate the teachings of Pflugh listed above, and provide an insertable cardiac monitor. Doing so prevents the invasive procedure of having an implantable cardiac monitor, and instead the insertable cardiac monitor taught by Pflugh, is subcutaneously implanted in the chest of the patient, allowing for a less invasive procedure (Pflugh, para. 0044).
Regarding claims 14 and 15, Nabutovsky (in view of Korzinov, Su, and Pflugh) teaches the method of claim 13. Nabutovsky does not teach wherein the PVC burden comprises a daily PVC burden and wherein the daily PVC burden comprises a daily PVC burden for at least one of the plurality of corresponding PVC types.
Korzinov teaches wherein the PVC burden comprises a daily PVC burden (col. 9, lines 1-2 (At the end of a pre-defined interval (e.g., a day), the total number of PVC beats may be calculated)).
Korzinov does not teach wherein the daily PVC burden comprises a daily PVC burden for at least one of the plurality of corresponding PVC types.
Su teaches the PVC burden comprising at least one of the plurality of corresponding PVC types (para. 0034 (the extracted physiological parameter result may be segmented according to a specified time interval), Fig. 6, elements 602 & 603, para. 0053 (602 may represent the number of the two consecutive ventricular premature beats, 603 may represent the number of the short consecutive ventricular premature beats)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky to incorporate the teachings of Korzinov listed above, and provide a daily PVC burden. Doing so would allow medical staff to facilitate more accurate determination of cardiac wellness within the patient during the day.
It would also have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky (in view of Korzinov) to incorporate the teachings of Su listed above, and provide the daily PVC burden comprising at least one of the plurality of corresponding PVC types. Doing so would allow medical staff to be able to view the type of PVC (couplet, triplet) within the overall daily burden, to localize the origin on the PVC or determine if there are multiple triggers causing PVC.
Regarding claim 16, Nabutovsky (in view of Korzinov, Su, and Pflugh) teaches the method of claim 14. Nabutovsky teaches the processing circuitry (Fig. 1, element 114 – microprocessor). Nabutovsky does not teach wherein the processing circuitry is further configured to determine, based on the daily PVC burden, a daily PVC burden trend.
Korzinov teaches a daily PVC burden (col. 9, lines 1-2 (At the end of a pre-defined interval (e.g., a day), the total number of PVC beats may be calculated)).
Korzinov does not teach a daily PVC burden trend.
Su teaches a processing circuitry (Fig. 14, element 1401 – processor) and a PVC burden (para. 0034 (the extracted physiological parameter result may be segmented according to a specified time interval…number of occurrence of the corresponding physiological parameter type may be counted according to the physiological parameter type specified by the user)).
Although Su does not explicitly disclose determining a PVC burden trend, Su teaches a monitoring apparatus comprising a processor, that is able to calculate and set the physiological parameter for statistical analysis (Su, Fig. 3, element 303) and provide a bar graph (Fig. 6). It would have been obvious to someone of ordinary skill in the art to provide a trend within the statistical analysis, as Su already provides bar graphs showing the amount of counts of each PVC type. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky (in view of Korzinov) to incorporate the teachings of Su listed above, and provide a daily PVC burden trend. Doing so allows medical staff to determine the significance of the PVC burden within a day, a provides another visual to represent the PVC burden data.
Regarding claims 17 and 18, Nabutovsky (in view of Korzinov, Su, and Pflugh) teaches the method of claim 13, wherein as part of detecting the set of PVCs, the processing circuitry (Fig. 1, element 114 – microprocessor) is configured to monitor via the plurality of electrodes a cardiac signal (col. 4, lines 14-17 (the control/timing circuit 114 is based on a microprocessor which includes the ability to process or monitor input signals (data) in a prescribed manner)).
Nabutovsky does not teach monitoring an EMG of the heart of the patient during a PVC burden monitoring period of time, wherein the period of time comprises a day, a week, or a month.
Korzinov teaches monitoring a cardiac signal (col. 1, lines 18-22 ( ECG monitoring, electrodes attached to a patient's skin are used to detect electrical activity of the heart over a period of time, and electrical impulses generated by the heart during each heartbeat are detected and recorded)) during a PVC burden monitoring period of time, wherein the period of time comprises a day, a week, or a month (col. 9, lines 1-2 (At the end of a pre-defined interval (e.g., a day), the total number of PVC beats may be calculated)).
Korzinov does not explicitly disclose an EMG of the heart.
Su teaches monitoring an EMG of the heart of the patient (para. 0003 (physiological parameters measured and monitored by the monitoring apparatus may include ECG (Electrocardiograph) signal, EMG (Electromyography) signal)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky to incorporate the teachings of Korzinov listed above, and provide monitoring an EMG of the heart of the patient during a PVC burden monitoring period of time. Doing so enhances the system by continuously detecting cardiac signals while analyzing the signals, ensuring that the PVC burden is determined as the signals are received, thus providing efficient workflow.
Additionally, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky (in view of Korzinov) to incorporate the teachings of Su listed above, and provide the cardiac monitor to be able to monitor an EMG signal of the heart while detecting PVCs. Doing so enhances the system by being able to detect multiple types of cardiac signals from the electrodes.
Regarding claim 19, Nabutovsky (in view of Korzinov, Su, and Pflugh) teaches the method of claim 13. Nabutovsky does not teach wherein the set of one or more patient-based waveforms is adaptive.
Korzinov teaches wherein the set of one or more patient-based waveforms is adaptive (col. 8, lines 48-55 (if the template ID is confirmed as a PVC by the user, all beats associated with the template ID may be confirmed and added to the PVC count, and the labels associated with each confirmed heartbeat may be updated to indicate that the heartbeats are PVCs)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky to incorporate the teachings of Korzinov listed above, and provide adaptive patient-based waveforms. Doing so would allow the stored waveforms of the patient to update in response to new PVC detections that are added to the PVC templates/morphologies.
Regarding claim 20, Nabutovsky (in view of Korzinov, Su, and Pflugh) teaches the method of claim 13, and the processing circuitry (Fig. 1, element 114 – microprocessor).
Nabutovsky does not teach wherein the processing circuitry is part of a device different from the insertable cardiac monitor.
Su teaches a processing circuitry that is part of a monitoring apparatus, which acquires ECG signals (Fig. 14, element 1401 – processor, para. 0031 (monitoring apparatus may use a physiological signal input module or a physiological signal acquisition device to acquire the physiological signal of a patient… physiological signal may include electrocardiographic signal)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky to incorporate the teachings of Su listed above, and provide a processing circuitry that is different from the cardiac monitor. Doing so reduces the processing burden within the cardiac monitor and clears up space in the memory within the circuitry.
Regarding claim 21, Nabutovsky (in view of Korzinov, Su, and Pflugh) teaches the method of claim 13, wherein the processing circuitry (Fig. 1, element 114 – microprocessor) is further configured to: send, via communication circuitry (Fig. 1, element 132 – telemetry circuit) and to an external device (Fig. 1, element 134 – external programmer), PVC data associated with at least one of the respective PVCs (col. 3, lines 60-61 (a telemetry circuit 132, in telecommunicative contact with an external programmer 134), col. 4, lines 5-10 (telemetry circuit 132 advantageously allows status information relating to the operation of the ICD 110… and the morphology templates and coupling interval measurements to be sent to the external programmer 134 through the established link 138)).
Nabutovsky does not teach comparing the PVC burden to a PVC burden threshold and sending PVC data based on the PVC burden exceeding the PVC burden threshold.
Korzinov teaches comparing, by the processing circuitry (col. 5, lines 38-39 (monitor 20 may include integrated circuits (microprocessor), the PVC burden to a PVC burden threshold (col. 9, lines 1-6 (At the end of a pre-defined interval (e.g., a day), the total number of PVC beats may be calculated. In one example, if the total number is more than a predefined threshold (e.g., 100), the PVC statistics may be displayed by one or more of the monitor 20 or by a device used by the clinician for review)); and
sending, via communication circuitry and to an external device based on the PVC burden exceeding the PVC burden threshold, PVC data associated with at least one of the respective PVCs (col. 4, lines 51-53 (monitor 20 may transfer at least a portion of the measured ECG data (or other physiologic data) to a remote analysis station 60 for analysis), col. 5, lines 19-22 (analysis station 60 may analyze the received data to determine if it indicates an anomaly (e.g., an arrhythmia, an unexpected trend in the data, etc.))).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky to incorporate the teachings of Korzinov listed above, and provide a comparison of the PVC burden to a threshold, and sending the PVC data to an external device when the threshold is exceeded. Doing so would notify medical staff that a patient has exceeded a PVC threshold within an external device, allowing communication with the cardiac monitor, thus allowing staff to possibly intervene in their patient’s treatment.
Regarding claim 22, Nabutovsky (in view of Korzinov, Su, and Pflugh) teaches the method of claim 21, wherein the PVC data comprises the PVC morphology of the at least one respective PVC (col. 4, lines 5-10 (telemetry circuit 132 advantageously allows status information relating to the operation of the ICD 110… and the morphology templates and coupling interval measurements to be sent to the external programmer 134 through the established link 138)).
Regarding claim 23, Nabutovsky (in view of Korzinov, Su, and Pflugh) teaches the method of claim 21. Nabutovsky does not teach wherein the PVC data comprises an alert.
Korzinov teaches the PVC data (col. 5, lines 19-22 (analysis station 60 may analyze the received data to determine if it indicates an anomaly (e.g., an arrhythmia, an unexpected trend in the data, etc.))).
Korzinov does not teach wherein the PVC data comprises an alert.
Su teaches an alert (para. 0033 (the selected physiological parameter can be ventricular premature beat), 0079 (it can be determined whether the statistical result of the physiological parameter exceeds the alarm threshold. When the statistical result of the physiological parameter exceeds the alarm threshold, the step 1203, the alarm operation may be performed), 0083 (monitoring apparatus can determine the satisfied alarm condition according to the physiological parameter statistical information and the preset alarm threshold, and perform the corresponding alarm operation to notify the user in time)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky (in view of Korzinov) to incorporate the teachings of Su listed above, and provide an alert from the PVC data. Doing so would immediately notify medical staff about the PVC burden exceeding the threshold, allowing them to take precaution in their patient’s cardiac treatment.
Regarding claim 24, Nabutovsky (in view of Korzinov, Su, and Pflugh) teaches the method of claim 21, wherein the external device (Fig. 1, element 134 – external programmer) comprises an application configured to receive the PVC data (col. 3, lines 60-61 (a telemetry circuit 132, in telecommunicative contact with an external programmer 134), col. 4, lines 5-10 (telemetry circuit 132 advantageously allows status information relating to the operation of the ICD 110… and the morphology templates and coupling interval measurements to be sent to the external programmer 134 through the established link 138)).
Nabutovsky does not teach wherein the external device comprises a cellular phone or a smartphone.
Korzinov teaches an external device comprising a cellular phone or a smartphone, comprising an application configured to execute on the external device, and wherein the application is configured to receive the PVC data (col. 7, lines 1-2 (monitor 20 may transmit information to the stand-alone display, cell phone, or other communication device via any type of wireless network), col. 1, lines 48-49 (monitor may transmit ECG data to a health care provider for analysis)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky to incorporate the teachings of Korzinov listed above, and provide the external device comprising a cellular phone or a smartphone. Doing so provides easier access for medical staff to view the PVC data in a portable device, allowing instant communication from the cardiac monitor to the staff.
Regarding claim 25, Nabutovsky teaches a processing circuitry comprising instructions (col. 3 lines 44-52 (control/timing circuit 114 further has a memory circuit 130 coupled thereto. The operating parameters and instructions used by the control/timing circuit 114 are stored in the memory circuit 130… operating instructions define the method steps performed by circuit 114 to implement the ICD functions)) to a cardiac monitor having a plurality of electrodes (Fig. 1, element 110 – ICD device, Fig. 1, elements 120, 122, and 124 – electrodes) to:
detect, in a cardiac signal sensed by the insertable cardiac monitor via the plurality of electrodes, a set of premature ventricular contractions (PVCs) of a heart of a patient (col. 3, lines 9-11 (lead 118 preferably also includes at least one electrode for pacing and sensing functions, such as electrode 124), col. 3, lines 21-23 (128 senses (or sample) the electrical activity of the heart 126 to determine an electrogram signal), col. 10, lines 29-30 (602, a first PVC is detected), col. 10, line 37 (606, a second PVC is detected));
Nabutovsky does not teach a non-transitory computer-readable storage media, compare, for each respective PVC of the set of PVCs, a PVC morphology of the respective PVC to a respective PVC morphology of a set of one or more patient-based waveforms; classify, based on the comparison, each respective PVC of the set of PVCs, according to a corresponding PVC type of a plurality of corresponding PVC types, the plurality of corresponding PVC types comprising a couplet and a triplet; and determine, based on the classification, a PVC burden.
Korzinov teaches a non-transitory computer-readable medium (col. 2, lines 33 non-transitory computer-readable medium)) and a processing circuitry (col. 5, lines 38-39 (monitor 20 may include integrated circuits (microprocessor)) and
compare, for each respective PVC of the set of PVCs, a PVC morphology of the respective PVC to a respective PVC morphology of a set of one or more patient-based waveforms (col. 8, lines 9-11 (morphology of the suspected PVC may be compared to stored, previously-existing PVC templates), col. 7, lines 64-67 (A PVC “template” is, for example, a representation of a suspected PVC beat that is derived from (e.g., is an average of) the characteristics of a plurality of suspected PVC beats having a similar morphology), col. 8, lines 3-5 (each patient may have a plurality of different PVC templates);
and a PVC burden (col. 9, lines 1-2 (At the end of a pre-defined interval (e.g., a day), the total number of PVC beats may be calculated)).
Korzinov does not teach an insertable cardiac monitor classify, based on the comparison, each respective PVC of the set of PVCs, according to a corresponding PVC type of a plurality of corresponding PVC types, the plurality of corresponding PVC types comprising a couplet and a triplet.
Su teaches classify, based on the comparison, each respective PVC of the set of PVCs (para. 0033 (the selected physiological parameter can be ventricular premature beat) according to a corresponding PVC type of a plurality of corresponding PVC types comprising a couplet and a triplet (Fig. 6 – shows the statistical result of the ventricular premature beat classified (couplet, triplet) within a specified time interval, para. 0033 (classification rule can be based on the number of consecutive ventricular premature beat, and the physiological parameter type can be divided into… two consecutive ventricular premature beats (2 V), short consecutive ventricular premature beats (3 to 5 V))); and
determine, based on the classification, a PVC burden (para. 0034 (the extracted physiological parameter result may be segmented according to a specified time interval. In step 403, the statistical analysis may be performed according to a specified physiological parameter type to obtain a classification result of each segment of the physiological parameter result)).
Su does not teach an insertable cardiac monitor.
Pflugh teaches an insertable cardiac monitor (Fig. 3A, element 400 – monitoring device, para. 0044 (400 is a device capable of recording heart electrical … 400 is a subcutaneous EGM-based monitor)) comprising a plurality of electrodes (para. 0044 (may include two or more electrodes electrically connected to the device to sense cardiac events)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky to incorporate the teachings of Korzinov listed above, and provide a non-transitory computer-readable medium. Doing so would provide extra storage, reducing the load of the memory within the cardiac monitor taught by Nabutovsky.
Although Nabutovsky teaches a set of PVCs that are compared to a patients morphology threshold, Nabutovsky does not teach where each respective PVC is compared to a PVC morphology of the patient-based waveforms (Nabutovsky, col. 3, lines 38-39, col. 9, lines 61-67). However, Koriznov teaches each respective PVC is compared to a morphology template based on the patient (Koriznov, col. 8, lines 9-11, col. 7, lines 64-67). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky to incorporate the teachings of Korzinov listed above, and provide a comparison, for each respective PVC of the set of PVCs, a PVC morphology of the of a set of one or more patient-based waveforms. Doing so allows for the comparison of each PVC detected, to be able to detect false positives since the waveform is based on the patient’s template.
It would also have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky to incorporate the teachings of Korzinov listed above, and provide a PVC burden. Doing so tracks the amount of PVC’s, allowing medical staff to monitor the patient, and determine a treatment plan.
Additionally, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky to incorporate the teachings of Su and provide a classifying each respective PVC of the set of PVCs, according to a corresponding PVC type of a plurality of corresponding PVC types, comprising a couplet and a triplet. Doing so provides further information on the type of PVC detected, providing medical staff with information to determine the severity of the PVCs, such as a risk of an R-on-T phenomenon.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nabutovsky’s device to incorporate the teachings of Pflugh listed above, and provide an insertable cardiac monitor. Doing so prevents the invasive procedure of having an implantable cardiac monitor, and instead the insertable cardiac monitor taught by Pflugh, is subcutaneously implanted in the chest of the patient, allowing for a less invasive procedure (Pflugh, para. 0044).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant' s disclosure. Ferrise et al. (US 7778699 B1) is an example of an ICD comprising a plurality of electrodes for cardiac signal measurement, for PVC triggers.
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/EILEEN ROBLES/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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