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 .
The current application has the effective filing date of 07/28/2020 according to the priority chain on the record.
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.
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Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 and 18 of U.S. Patent No. 12,226,238 B2 (Pat’238). Although the claims at issue are not identical, they are not patentably distinct from each other because Pat’238 teaches a system comprising an insertable cardiac monitor (ICM), remote computing device and processing circuitry, that is narrower and fully encompasses the system of the current application which discloses a system comprising an implantable medical device (IMD) and processing circuitry, see overlapping italicized limitations follows:
App. 19/038,630
US 12,226,238
Claim 1. A system comprising:
an implantable medical device (IMD): comprising:
a housing configured for subcutaneous implantation within a patient;
an accelerometer to detect motion data indicative of activity level of the patient; and
a plurality of electrodes positioned on the housing, wherein the IMD is configured to sense an electrocardiogram (ECG) of the patient via the plurality of electrodes; and processing circuitry configured to:
periodically determine a respective value for each of a plurality of patient parameters based on the ECG and the activity level;
determine a risk or occurrence of a cardiac event of the patient based on the periodically determined values of the patient parameters; and
output an indication of the cardiac event based on the determination.
1. A system comprising:
an insertable cardiac monitor (ICM) comprising:
a housing configured for subcutaneous implantation within a patient, the housing having a length, a width, and a depth,
wherein the length is greater than the width and the width is greater than the depth, and
wherein the length is within a range from 40 millimeters (mm) to 60 mm;
an accelerometer to detect motion data indicative of activity level of the patient; and
a plurality of electrodes positioned on the housing, wherein the ICM is configured to sense an electrocardiogram (ECG) of the patient via the plurality of electrodes;
a remote computing device; and
processing circuitry of at least one of the insertable cardiac monitor or the remote computing device, the processing circuitry configured to:
periodically determine a respective value for each of a plurality of patient parameters based on the ECG and the activity level;
output trends of the periodically determined values of the patient parameters at the remote computing device;
determine a risk or occurrence of a cardiac event of the patient based on the trends of the periodically determined values of the patient parameters; and
output an indication of the cardiac event based on the determination.
Claim 2. The system of claim 1, wherein the processing circuitry is further configured to: determine trends of the periodically determined values of the patient parameters; and determine the risk or occurrence of the cardiac event of the patient based on the trends of the periodically determined values of the patient parameters.
See claim 1 above: output trends of the periodically determined values of the patient parameters at the remote computing device;
Claim 3. The system of claim 1, wherein the processing circuitry is further configured to:
determine activity level changes based on the detected motion data; and
periodically determine the respective value for each of the plurality of patient parameters based on the ECG and the activity level changes.
2. The system of claim 1, wherein the processing circuitry is further configured to: determine activity level changes based on the detected motion data; and periodically determine the respective value for each of the plurality of patient parameters based on the ECG and the activity level changes.
Claim 4. The system of claim 3, wherein the processing circuitry is further configured to: determine activity level changes during a particular time window; and periodically determine the respective value for each of the plurality of patient parameters based on the ECG and the activity level changes during the particular time window.
3. The system of claim 2, wherein the processing circuitry is further configured to: determine activity level changes during a particular time window; and periodically determine the respective value for each of the plurality of patient parameters based on the ECG and the activity level changes during the particular time window.
Claim 5. The system of claim 3, wherein the processing circuitry is further configured to: determine a pattern of the activity level changes; and periodically determine the respective value for each of the plurality of patient parameters based on the ECG and the pattern of the activity level changes.
4. The system of claim 2, wherein the processing circuitry is further configured to: determine a pattern of the activity level changes; and periodically determine the respective value for each of the plurality of patient parameters based on the ECG and the pattern of the activity level changes.
Claim 6. The system of claim 5, wherein the processing circuitry is further configured to: determine a pattern of the activity level changes during a particular time window; and periodically determine the respective value for each of the plurality of patient parameters based on the ECG and the pattern of the activity level changes during the particular time window.
5. The system of claim 4, wherein the processing circuitry is further configured to: determine a pattern of the activity level changes during a particular time window; and periodically determine the respective value for each of the plurality of patient parameters based on the ECG and the pattern of the activity level changes during the particular time window.
Claim 7. The system of claim 1, wherein the motion data includes coordinate data.
6. The system of claim 1, wherein the motion data includes coordinate data.
Claim 8. The system of claim 1, wherein the accelerometer is a three-axis accelerometer configured to detect the motion data within a three-dimensional Cartesian space.
7. The system of claim 1, wherein the accelerometer is a three-axis accelerometer configured to detect the motion data within a three-dimensional Cartesian space.
Claim 9. The system of claim 1, wherein the cardiac event is a heart failure event.
8. The system of claim 1, wherein the cardiac event is a heart failure event.
Claim 10. The system of claim 1, wherein the cardiac event is a fall event.
9. The system of claim 1, wherein the cardiac event is a fall event.
Claim 11. The system of claim 1, wherein the indication that is output comprises an indication of a risk of the cardiac event.
10. The system of claim 1, wherein the indication that is output comprises an indication of a risk of the cardiac event.
Claim 12. The system of claim 1, wherein the indication comprises one or more of an alert, recommendation for treatment, or a signal to cause one or more medical devices to deliver treatment.
11. The system of claim 1, wherein the indication comprises one or more of an alert, recommendation for treatment, or a signal to cause one or more medical devices to deliver treatment.
Claim 13. The system of claim 1, wherein the processing circuitry is configured to determine a risk level of the cardiac event based on changes in the periodically determined values of the patient parameters over a time interval, and determine to present the indication of the cardiac event based the risk level.
12. The system of claim 1, wherein the processing circuitry is configured to determine a risk level of the cardiac event based on changes in the periodically determined values of the patient parameters over a time interval, and determine to present the indication of the cardiac event based the risk level.
Claim 14. The system of claim 1, the system further comprising a remote computing device, wherein the processing circuitry is positioned in at least one of the IMD or the remote computing device.
See claim 1 above: a remote computing device
Claim 15. A non-transitory computer-readable storage medium comprising program instructions that, when executed by processing circuitry, cause the processing circuitry to:
periodically determine a respective value for each of a plurality of patient parameters based on an electrocardiogram (ECG) and activity level of a patient detected by an implantable medical device (IMD), wherein the IMD comprises:
a housing configured for subcutaneous implantation within the patient;
an accelerometer to detect motion data indicative of the activity level of the patient; and
a plurality of electrodes, wherein the IMD is configured to sense the ECG via the plurality of electrodes;
determine a risk or occurrence of a cardiac event of the patient based on the periodically determined values of the patient parameters; and
output an indication of the cardiac event based on the determination
13. A non-transitory computer-readable storage medium comprising program instructions that, when executed by processing circuitry, cause the processing circuitry to:
periodically determine a respective value for each of a plurality of patient parameters based on an electrocardiogram (ECG) and activity level of a patient detected by an insertable cardiac monitor (ICM), wherein the ICM comprises:
a housing configured for subcutaneous implantation within the patient, the housing having a length, a width, and a depth, wherein the length is greater than the width and the width is greater than the depth, and wherein the length is within a range from 40 millimeters (mm) to 60 mm;
an accelerometer to detect motion data indicative of the activity level of the patient; and
a plurality of electrodes, wherein the ICM is configured to sense the ECG via the plurality of electrodes;
determine a risk or occurrence of a cardiac event of the patient based on the trends of the periodically determined values of the patient parameters; and
output an indication of the cardiac event based on the determination.
Claim 16. The non-transitory computer-readable storage medium of claim 15, wherein the program instructions that, when executed by processing circuitry, further cause the processing circuitry to determine trends of the periodically determined values of the patient parameters; and determine the risk or occurrence of the cardiac event of the patient based on the trends of the periodically determined values of the patient parameters.
See claim 13: output trends of the periodically determined values of the patient parameters at a remote computing device;
Claim 17. The non-transitory computer-readable storage medium of claim 15, wherein the program instructions that, when executed by processing circuitry, further cause the processing circuitry to determine activity level changes based on the detected motion data; and periodically determine the respective value for each of the plurality of patient parameters based on the ECG and the activity level changes.
14. The non-transitory computer-readable storage medium of claim 13, wherein the program instructions that, when executed by processing circuitry, further cause the processing circuitry to determine activity level changes based on the detected motion data; and periodically determine the respective value for each of the plurality of patient parameters based on the ECG and the activity level changes.
Claim 18. The non-transitory computer-readable storage medium of claim 17, wherein the program instructions that, when executed by processing circuitry, further cause the processing circuitry to determine activity level changes during a particular time window; and periodically determine the respective value for each of the plurality of patient parameters based on the ECG and the activity level changes during the particular time window.
15. The non-transitory computer-readable storage medium of claim 14, wherein the program instructions that, when executed by processing circuitry, further cause the processing circuitry to determine activity level changes during a particular time window; and periodically determine the respective value for each of the plurality of patient parameters based on the ECG and the activity level changes during the particular time window.
Claim 19. The non-transitory computer-readable storage medium of claim 17, wherein the program instructions that, when executed by processing circuitry, further cause the processing circuitry to determine a pattern of the activity level changes; and periodically determine the respective value for each of the plurality of patient parameters based on the ECG and the pattern of the activity level changes.
16. The non-transitory computer-readable storage medium of claim 14, wherein the program instructions that, when executed by processing circuitry, further cause the processing circuitry to determine a pattern of the activity level changes; and periodically determine the respective value for each of the plurality of patient parameters based on the ECG and the pattern of the activity level changes.
Claim 20. The non-transitory computer-readable storage medium of claim 15 wherein the program instructions that, when executed by processing circuitry, further cause the processing circuitry to determine activity level of the patient based at least in part on the motion data.
18. The non-transitory computer-readable storage medium of claim 13 wherein the program instructions that, when executed by processing circuitry, further cause the processing circuitry to determine activity level of the patient based at least in part on the motion data.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Stahmann et al. US 2005/0115561 A1 (hereinafter “Stahmann”) in view of Kadhiresan US 5,935,081 (hereinafter “Kad”).
Regarding claim 1, Stahman discloses a system (medical system 100) comprising:
an implantable medical device (IMD) ([0165-0166] patient internal medical device 110: exemplary as shown in Fig. 4A cardiac rhythm management device (CRM) 400, see [0217]): comprising:
a housing (housing 401/502) configured for subcutaneous implantation within a patient ([0217] and [0229]405 and 502 individually adapted to be implanted subcutaneously);
an accelerometer (motion sensor- accelerometer; see [0219]) to detect motion data indicative of activity level of the patient ([0219] motion sensor adapted to detect patient activity level); and
a plurality of electrodes positioned on the housing ([0229] “one or more electrodes may be located on the primary housing 502”), wherein the IMD is configured to sense an electrocardiogram (ECG) of the patient ([0082] generating ECG); and
processing circuitry (monitoring circuitry 112, 153, see [0187-0189]) configured to:
periodically determine a respective value for each of a plurality of patient parameters based on the ECG and the activity level ([0187-0189] and see Figs. 1B-1D: various sleep-related parameters, respiratory parameters, and cardiac health/event parameters etc., these parameters are all calculated periodically based on real-time detected sensor information and are all interpreted as “respective value of each of a plurality of physiological parameters” in the claim);
determine a risk or occurrence of a cardiac event of the patient based on the periodically determined values of the patient parameters ([0881] determine risk of vascular disease, [1129, 1340] risk of pulmonary complications from surgery); and
output an indication of the cardiac event based on the determination ([1410] diagnostic processor assesses the onset, progression and /or offset of a medical disease or disorder, and activates an alert based on the detection or assessment; also see [0355, 0727, 0781, 0967, 1538, 1576, 1611, 1641 and 1663] display of a variety of analyzed results for diagnosis of sleep, respiratory and cardiac related medical conditions).
Stahman discloses lead system 410 include one or more cardiac pace/sense electrodes 451-455 positioned in, on, or about one or more heart chambers for sensing electrical signals from the patient's heart 490 and/or delivering pacing pulses to the heart 490 ([0223-0224]). Stahman also teaches detecting ECG signals ([0087-0088]). Although Stahman discloses that one or more electrodes are positioned on the housing ([0229]); Stahman does not explicitly disclose wherein the IMD is configured to sense ECG of the patient via the plurality of electrodes.
Kad, another prior art reference in analogous art, discloses an implantable monitor for collecting and storing physiologic data relating to cardiopulmonary performance an implantable monitor (Abstract, Fig. 1), comprising an implantable housing (12) with surface electrodes (18, 20) for detecting ECG data, as shown in Fig.1 and col.2, ll.1-6 and col.2, ll.51-67. Kad further discloses wherein the implantable device detects accelerometer/motion data; such that an external processing circuitry is able to determine cardiac events based on detected ECG and accelerometer data (col.2, ll.10-28). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Stahman’s implantable device housing to include at least two electrodes, for detecting ECG data, in view of Kad; the motivation for doing so is to separate sensing electrodes from the defibrillating electrodes in the lead system (Stahman: [0223-0224] lead system 410), and Kad provides that implantable device surface electrodes are suitable for acquitting ECG signals for the purpose of cardiac event detection (Kad: col.2, ll.10-28).
Regarding claim 2, Stahman discloses the system of claim 1, wherein the processing circuitry is further configured to: determine trends of the periodically determined values of the patient parameters ([0199: last sentence] trending of daily measurements; [0491] trending respiratory values; [0627] trends of heart rate and activity); and determine the risk or occurrence of the cardiac event of the patient based on the trends of the periodically determined values of the patient parameters ([0881] determine risk of vascular disease, [1129, 1340] risk of pulmonary complications from surgery).
Regarding claim 3, Stahman discloses the system of claim 1, wherein the processing circuitry is further configured to: determine activity level changes based on the detected motion data ([0197, 0500-0501] overall activity level, activity level changes through the day); and periodically determine the respective value for each of the plurality of patient parameters based on the ECG and the activity level changes ([0187-0189] and see Figs. 1B-1D: various sleep-related parameters, respiratory parameters, and cardiac health/event parameters etc., these parameters are all calculated periodically based on real-time detected sensor information and are all interpreted as “respective value of each of a plurality of physiological parameters” in the claim)
Regarding claim 4, Stahman discloses the system of claim 3, wherein the processing circuitry is further configured to :determine activity level changes during a particular time window ([0197, 0500-0501] overall activity level, activity level changes through the day; [0629] activity level trends/patterns during certain time periods in the day, e.g. before 23:00-6:00); and periodically determine the respective value for each of the plurality of patient parameters based on the ECG and the activity level changes during the particular time window ([0187-0189] and see Figs. 1B-1D: various sleep-related parameters, respiratory parameters, and cardiac health/event parameters etc., these parameters are all calculated periodically based on real-time detected sensor information and are all interpreted as “respective value of each of a plurality of physiological parameters” in the claim).
Regarding claim 5, Stahmann discloses the system of claim 3, wherein the processing circuitry is further configured to: determine a pattern of the activity level changes ([0197, 0500-0501] overall activity level, activity level changes through the day; [0629] activity level trends/patterns during certain time periods in the day, e.g. before 23:00-6:00);; and periodically determine the respective value for each of the plurality of patient parameters based on the ECG and the pattern of the activity level changes ([0187-0189] and see Figs. 1B-1D: various sleep-related parameters, respiratory parameters, and cardiac health/event parameters etc., these parameters are all calculated periodically based on real-time detected sensor information and are all interpreted as “respective value of each of a plurality of physiological parameters” in the claim)
Regarding claim 6, Stahmann discloses the system of claim 5, wherein the processing circuitry is further configured to: determine a pattern of the activity level changes during a particular time window ([0197, 0500-0501] overall activity level, activity level changes through the day; [0629] activity level trends/patterns during certain time periods in the day, e.g. before 23:00-6:00); and periodically determine the respective value for each of the plurality of patient parameters based on the ECG and the pattern of the activity level changes during the particular time window. ([0187-0189] and see Figs. 1B-1D: various sleep-related parameters, respiratory parameters, and cardiac health/event parameters etc., these parameters are all calculated periodically based on real-time detected sensor information and are all interpreted as “respective value of each of a plurality of physiological parameters” in the claim).
Regarding claim 7, Stahmann discloses the system of claim 1, wherein the motion data includes coordinate data. ([0219])
Regarding claim 8, Stahmann discloses the system of claim 1, wherein the accelerometer is a three-axis accelerometer configured to detect the motion data within a three-dimensional Cartesian space. ([0913: 1st sentence] multi-axis accelerometer)
Regarding claim 9, Stahmann discloses the system of claim 1, wherein the cardiac event is a heart failure event. ([0287-0288, 0357] monitoring for heart failures, and congestive heart failure and related conditions)
Regarding claim 10, Stahmann discloses the system of claim 1, wherein the cardiac event is a fall event. ([0311, 0390] posture detection is sufficient to encompass “fall event” in the claim. Also see Fig. 46 detecting posture relative to cardiac conditions/therapies)
Regarding claim 11, Stahmann discloses the system of claim 1, wherein the indication that is output comprises an indication of a risk of the cardiac event. ([0881] determine risk of vascular disease, [1129, 1340] risk of pulmonary complications from surgery).
Regarding claim 12, Stahmann discloses the system of claim 1, wherein the indication comprises one or more of an alert, recommendation for treatment, or a signal to cause one or more medical devices to deliver treatment. ([0357] adjusting and delivery cardiac therapy; [1021] alerting the patient; [1105-1106] alert and adjust therapy; [1392] therapy change and alert.)
Regarding claim 13, Stahmann discloses the system of claim 1, wherein the processing circuitry is configured to determine a risk level of the cardiac event based on changes in the periodically determined values of the patient parameters over a time interval, and determine to present the indication of the cardiac event based the risk level. ([0881] severity and risk of vascular disease)
Regarding claim 14, Stahmann discloses the system of claim 1, the system further comprising a remote computing device ([0165-0166, 0177-0179] and Fig. 1A: patient external medical device 120, remote terminals 150, and APM patient information server 170 are all interpreted as “remote computing device” in the claim); wherein the processing circuitry is positioned in at least one of the IMD or the remote computing device. (see Fig. 1A)
Regarding claim 15, this claim is rejected by Stahmann under the same rationale as discussed to claim 1 above. Stahmann discloses a non-transitory computer-readable storage medium comprising program instructions ([0383, 0545]) for performing the various steps recited in this claim.
Claims 16-20, these claims are rejected by Stahmann and Kad under the same rationale as discussed to claims 2-6 above, respectively.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Zhou US 2022/0273236 A1 discloses an implantable medical system that can be applied as a 102 reference to reject the limitations of independent claims 21 and 33. (cited in the applicant’s IDS)
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/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
September 18, 2026
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