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 .
Claim Rejections - 35 USC § 102
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 reinjection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4-7. 10, 12-13, 16-18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipates by Wen et al. (U.S. Patent Application Publication 2020/0170515).
Regarding claim 1, Wen et al. disclose a medical-device system for detecting and managing heart failure in a patient, the medical-device system comprising:
a storage device (“storage device,” see [0057], [0089], for example) configured to store a correspondence between (i) one or more heart failure comorbidities (see [0049], [0072], ) and (ii) corresponding one or more heart failure detection settings (interpreted sensed or detected parameters/ conditions and/or physiological signals, [0069]); and
a heart failure detector circuit (“circuit sets comprising one or more other circuits or sub-circuits, including a gait analyzer circuit 221 and a HF detector circuit 224,” see [0060], [0069]-[0070] and figure 2) configured to:
receive physiological information sensed from the patient and heart failure comorbidity information of the patient (see [0006], [0008], [0021], [0023], and figure 2, and alternate/equivalent counterparts in other embodiments);
determine a detection setting (see [0067], interpreted as the selected one or more physiological signals/sensors, see [0071]) for the patient based at least on the received heart failure comorbidity information and the stored correspondence; and
detect a heart failure status in the patient using the received physiological information and the determined detection setting (see abstract, [0006]-[0007] for example).
Regarding claim 4, Wen et al. disclose the claimed invention including the stored one or more heart failure detection settings each include one or more sensor signals or signal metrics corresponding to the one or more heart failure comorbidities (see [0049] and [0072]), wherein the heart failure detector circuit is configured to detect the heart failure status in the patient using at least a portion of the received physiological information sensed from the patient that corresponds to the heart failure comorbidity information of the patient (see abstract, [0006]-[0007] for example)..
Regarding claim 5, Wen et al. disclose the claimed invention including compute a composite signal index using the received physiological information and the determined heart failure detection setting (see [0074], and [0093]); and detect the heart failure status in response to the composite signal index satisfying a specific condition (see [0093]-[0094]).
Regarding claim 6, Wen et al. disclose the claimed invention including the heart failure detector circuit is configured to determine or adjust a threshold value based on the received heart failure comorbidity information, and to detect the heart failure status based on a comparison between the composite signal index and the determined or adjusted threshold value (see [0064], and [0067]).
Regarding claim 7, Wen et al. disclose the claimed invention including the determine or adjust weights for one or more of a plurality of signal metrics derived from the received physiological information; and compute the composite signal index using a weighted combination of the plurality of signal metrics (see [0067], and [0071] for example).
Regarding claim 10, Wen et al. disclose the claimed invention including a processor (“processor circuit 220,” see [0060] and figure 2) configured to:
determine, for each of the one or more heart failure comorbidities, a corresponding heart failure detection setting (see [0067]) by modifying a base heart failure detection setting to include one or more signal metrics from a comorbidity-specific sensor (see [0064], [0067], [0081], and [0092] for example); and
establish the correspondence between the one or more heart failure comorbidities and the determined corresponding one or more heart failure detection settings (since the interpreted sensed or detected parameters/ conditions and/or physiological signals correspond to comorbidities, [0069]).
Regarding claim 12, Wen et al. disclose the claimed invention including a therapy circuit configured to generate and deliver a heart failure therapy in accordance with the detected heart failure status (“therapy circuit 250 may deliver a therapy to the patient in response to the detection of a WHF event, or the WHF risk satisfying a condition such as exceeding the risk threshold,” see [0071] and figure 2).
Regarding claim 13, Wen et al. disclose a method for detecting and managing heart failure in a patient using a medical-device system, the method comprising:
receiving physiological information and heart failure comorbidity information of the patient (see abstract, [0006], [0008], especially [0049]);
receiving stored information (stored instructions) about a correspondence between (i) one or more heart failure comorbidities (see [0049], and [0072] for example) and (ii) corresponding one or more heart failure detection settings;
determining a detection setting for the patient based at least on the received heart failure comorbidity information and the stored correspondence; and
detecting a heart failure status in the patient using the received physiological information and the determined detection setting (the selected one or more physiological signals/sensors, see [0071]).
Regarding claim 16, Wen et al. disclose the claimed invention including detecting the heart failure status in the patient includes:
computing a composite signal index using one or more signal metrics derived from the received physiological information and the determined heart failure detection setting (see [0074], and [0093]); and
detecting the heart failure status in response to the composite signal index satisfying a specific condition (see [0093]-[0094]).
Regarding claim 17, Wen et al. disclose the claimed invention including determining or adjusting a threshold value (see [0064]) based on the received heart failure comorbidity information, wherein detecting the heart failure status is based at least on a comparison between the composite signal index and the determined or adjusted threshold value (see [0067]).
Regarding claim 18, Wen et al. disclose the claimed invention including computing the composition signal index includes: determining or adjusting weights for the one or more signal metrics (see [0067]); and computing the composite signal index using a weighted combination of the one or more signal metrics (see [0093]).
Regarding claim 20, Wen et al. disclose the claimed invention including determining, for each of the one or more heart failure comorbidities, a corresponding heart failure detection setting by modifying a base heart failure detection setting to include one or more signal metrics from a comorbidity-specific sensor; and establishing the correspondence between the one or more heart failure comorbidities and the determined corresponding one or more heart failure detection settings (see [0077]-[0078]).
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 2, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Wen et al. (U.S. Patent Application Publication 2020/0170515) as applied to claims 1, and 13 above, and further in view of Connolly et al. (U.S. Patent Application Publication 2018/0060521).
Regarding claims 2, and 14, Wen et al. disclose the heart failure detector circuit is configured to receive the heart failure comorbidity information in the form of medical records (see for example [0057], [0089] for example).
Wen et al. fail to explicitly recite the heart failure detector circuit is configured to receive the heart failure comorbidity information from a medical record of patient referral chain.
Like Wen et al., Connolly et al. disclose a system and method for monitoring and treating patients with heart failure (see [0003], [008, [0095] for example) and teach “ care metrics may be determined by analyzing historical information obtained from medical records, healthcare provider operations/performance information, and/or the like,” (see [0138]) which includes a patient referral chain (see “care trajectory indicator 402” comprising the one or more of 404, 406, 408, 410, 412, 414, 416, 418, 420, 420, 422, 424, 426, 428, 430, 432, 434, see [0098]-[0104] and figure 4) in order to provide a known and workable example of providing medical information in the form of medical records to the processor in order monitor and treatment patient’s confronted with heart failure or likely heart failure.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Wen et al., as taught by Connolly et al., to provide a heart failure detector circuit is configured to receive the heart failure comorbidity information from a medical record of patient referral chain in order to further provide a known and workable example of providing medical information in the form of medical records to the processor in order monitor and treatment patient’s confronted with heart failure or likely heart failure.
Claims 3, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Wen et al. (U.S. Patent Application Publication 2020/0170515) as applied to claims 1, and 13 above, and further in view of Thakur et al. (U.S. Patent Application Publication 2020/0178850).
Regarding claims 3, and 15, Wen et al. disclose the claimed invention including the received physiological information includes heart sound (see [0040], [0048], [0057], [0069] for example) information sensed from the patient.
But Wen et al. fail to recite the heart failure detector is configured to detect the heart failure status including to detect a presence or absence of a heart failure with preserved ejection fraction (HFpEF) using at least the heart sound information sensed from the patient.
Like Wen et al., Thakur et al. disclose monitoring/sensing physiological information from a patient including heart sounds (see [0036-[0037]) and teach further using heart sounds to detect HFpEF in order to enhance heart failure monitoring (see [0038]).
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Wen et al., as taught by Connolly et al., to using heart sounds to detect HFpEF in order to enhance heart failure monitoring.
Claims 8-9, 11, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Wen et al. (U.S. Patent Application Publication 2020/0170515) as applied to claims 1, 10, and 13 above, and further in view of Thakur et al. (U.S. Patent Application Publication 2018/0325402).
Regarding claims 8, and 19, Wen et al. show the invention above,
but fail to recite:
1) the storage device is further configured to store information about respective prevalence of the one or more heart failure comorbidities in heart failure patient population, wherein the heart failure detector circuit is configured to determine the detection setting for the patient further based on the prevalence associated with the received heart failure comorbidity information {for claim 8}, or similarly
2) determine the corresponding heart failure detection setting for each of the one or more heart failure comorbidities further includes using a prevalence of the corresponding heart failure comorbidity in heart failure patient population {for claim 11}, or similarly
3) receiving information about respective prevalence of the one or more heart failure comorbidities in heart failure patient population, wherein determining the detection setting for the patient is further based on the prevalence associated with the received heart failure comorbidity information {for claim 19}.
Like Wen et al., Thakur et al. disclose monitoring/sensing physiological information from a patient suffering from or likely to suffer from heart failure and teach further using “the prevalence of confirmation or denial of AF detection by the ICM (or AF detection using ICM information) can be used to refine AF detection in either a specific patient, or across a target population. In an example, a higher incidence of denials can be used to increase an AF detection threshold in the ICM or using ICM information, for example, to improve detection specificity. In contrast, a higher incidence of confirmations can be used to reduce an AF detection threshold in the ICM or using ICM information, for example, to increase detection sensitivity,” (see [0033]).
Therefore the combination makes obvious the recited:
the storage device is further configured to store information about respective prevalence of the one or more heart failure comorbidities in heart failure patient population (taught by Thakur et al.),
wherein the heart failure detector circuit is configured to determine the detection setting for the patient (already taught by Wen et al.) further based on the prevalence associated with the received heart failure comorbidity information (already taught by Thakur et al.).
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Wen et al., as taught by Thakur et al., to use “the prevalence of confirmation or denial of AF detection by the ICM (or AF detection using ICM information) can be used to refine AF detection in either a specific patient, or across a target population. In an example, a higher incidence of denials can be used to increase an AF detection threshold in the ICM or using ICM information, for example, to improve detection specificity. In contrast, a higher incidence of confirmations can be used to reduce an AF detection threshold in the ICM or using ICM information, for example, to increase detection sensitivity.”
Additionally for claims 11 and 19, the combination makes obvious the recited:
2) “determine the corresponding heart failure detection setting for each of the one or more heart failure comorbidities further includes using a prevalence of the corresponding heart failure comorbidity in heart failure patient population {for claim 11}”, or similarly
3) “receiving information about respective prevalence of the one or more heart failure comorbidities in heart failure patient population, wherein determining the detection setting for the patient is further based on the prevalence associated with the received heart failure comorbidity information {for claim 19}.”
Regarding claim 9, Wen et al. disclose the claimed invention including the received comorbidity information includes first and second comorbidities with respective prevalence, wherein the heart failure detector circuit is configured to determine the
detection setting for the patient using a combination of stored heart failure detection
settings corresponding to the first and second comorbidities (see [0067], and [0071] for example).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm.
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/AARON F ROANE/Primary Examiner, Art Unit 3792