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 .
Election/Restrictions
Applicant’s election with traverse of Group A, Embodiment 2 and Group B, Embodiment 5 (i.e. claims 1, 4-7, 9, 13-14, and 16-18) in the reply filed on 7/15/2026 is acknowledged. The traversal is on the grounds that there would be no search burden on the examiner because the system is capable of using multiple different embodiments together. This is not found persuasive because there is still a search burden as the embodiments are directed to different combinations/variations of calculations and methodologies for determining the readmission scores and the baseline values for a patient. These embodiments require different search queries as well as different applications of prior art. Applicant has not submitted evidence or clearly admitted on the record that the different embodiments would be obvious variants.
The requirement is still deemed proper and is therefore made FINAL.
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, 4-7, 9, 13-14, and 16-18 are rejected under 35 U.S.C 103 as being unpatentable over An et al. (US Pub.: 2018/0008204) and further in view of Thakur et al. (US Pub.: 2017/0095160 A1).
Regarding claim 1, An teaches a medical device system for improving heart failure readmission risk determination to optimize resources of the medical device system (e.g. abstract), comprising:
a signal receiver circuit (e.g. Fig. 4 – sensor circuit 410) configured to receive physiologic information of a patient (e.g. paragraph 0068);
and an assessment circuit (e.g. Fig. 4 – readmission risk generator 430) configured to:
analyze the physiologic information occurring over specific time periods relative to a prior heart failure event with respect to a baseline value for the patient (e.g. paragraphs 0065, 0095);
determine a readmission score for the patient based on the analyzed physiologic information (e.g. paragraph 0007), the readmission score for the patient indicative of a risk of subsequent readmission after treatment or discharge from hospitalization or treatment of the prior heart failure event (e.g. paragraph 0007, 0042);
and provide a control signal to control a mode or operation of the medical device system based on the readmission score to optimize resources of the medical device system (e.g. paragraphs 0031, 0045-0046).
However, An does not explicitly teach adjusting, in response to a detected or received trigger event, the baseline value for the patient from a long-term baseline value to one of a shorter-term baseline value or a static value indicative of a baseline value at a prior time relative to the detected or received trigger event.
Thakur, in a same field of endeavor of cardiac monitoring systems, discloses adjusting, in response to a detected or received trigger event, the baseline value for the patient from a long-term baseline value to one of a shorter-term baseline value or a static value indicative of a baseline value at a prior time relative to the detected or received trigger event (e.g. paragraphs 0066, 0072).
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 the system of An to incorporate adjusting, in response to a detected or received trigger event, the baseline value for the patient from a long-term baseline value to one of a shorter-term baseline value or a static value indicative of a baseline value at a prior time relative to the detected or received trigger event, as taught and suggested by Thakur, in order to mitigate the risk of worsening heart failure events in a patient as well as to reduce healthcare cost (Thakur, paragraph 0005).
Regarding claim 4, An in view of Thakur teach the medical device system of claim 1 as discussed above, and An further teaches wherein the assessment circuit is configured to determine the readmission score for the patient as a composite function of the analyzed physiologic information, including two or more of: S1 heart sound information, S3 heart sound information, thoracic impedance, activity information, respiration information, and heart rate (e.g. paragraphs 0057, 0070).
Regarding claim 5, An in view of Thakur teach the medical device system of claim 4 as discussed above, and An further teaches wherein the signal receiver circuit or the assessment circuit is configured to receive an indication of patient discharge from hospitalization or treatment of the prior heart failure event (e.g. paragraphs 0065, 0078), wherein to determine the readmission score for the patient includes to determine an indication that the patient is likely to experience readmission or an indication that the prior heart failure event and discharge is likely to result in readmission within a specific time period after the received indication of patient discharge from hospitalization or treatment of the prior heart failure event (e.g. paragraphs 0065, 0078).
Regarding claim 6, An in view of Thakur teach the medical device system of claim 1 as discussed above, and An further teaches wherein the readmission score is indicative of a future heart failure event (e.g. paragraphs 0042).
Regarding claim 7, An in view of Thakur teach the medical device system of claim 1 as discussed above, and An further teaches wherein the assessment circuit is configured to determine the baseline value for the patient (e.g. paragraph 0065), including to: determine the long-term baseline value as a function of 30 or more days of preceding physiologic information of the patient (e.g. paragraphs 0047, 0055); and determine the shorter-term baseline value as a function of a time period of physiologic information of the patient between 3 and 10 days of preceding physiologic information of the patient (e.g. paragraphs 0047, 0055), wherein to adjust the baseline value for the patient includes to adjust the baseline value for the patient from the long-term baseline to the shorter-term baseline value (e.g. paragraphs 0047, 0062).
Regarding claim 9, An in view of Thakur teach the medical device system of claim 1 as discussed above, and An further teaches wherein the assessment circuit is configured to determine the baseline value as a function of the long-term baseline value, the shorter-term baseline value, and the static value over a transition period until the determined readmission score or the long-term baseline meets the static value (e.g. paragraph 0057).
Regarding claim 13, An in view of Thakur teach the medical device system of claim 1 as discussed above, and An further teaches wherein the trigger event is one or more of a received request to adjust the respective baseline value, a detected in-alert state, or a received or detected indication of a first heart failure event or hospitalization or treatment of the first heart failure event of the patient, wherein the first heart failure event is the prior heart failure event (e.g. paragraphs 0065, 0073).
Regarding claim 14, An teaches a method for improving heart failure readmission risk determination to optimize resources of a medical device system (e.g. abstract), comprising:
receiving, using a signal receiver circuit (e.g. Fig. 4 – sensor circuit 410), physiologic information of a patient (e.g. paragraph 0068);
analyzing, using an assessment circuit (e.g. Fig. 4 – readmission risk generator 430), the physiologic information occurring over specific time periods relative to a prior heart failure event with respect to a baseline value for the patient (e.g. paragraphs 0065, 0095);
determining, using the assessment circuit, a readmission score for the patient based on the analyzed physiologic information (e.g. paragraph 0007), the readmission score for the patient indicative of a risk of subsequent readmission after treatment or discharge from hospitalization or treatment of the prior heart failure event (e.g. paragraph 0007, 0042);
and providing, using the assessment circuit, a control signal to control a mode or operation of the medical device system based on the readmission score to optimize resources of the medical device system (e.g. paragraphs 0031, 0045-0046).
However, An does not explicitly teach adjusting, using the assessment circuit, in response to a detected or received trigger event, the baseline value for the patient from a long-term baseline value to one of a shorter-term baseline value or a static value indicative of a baseline value at a prior time relative to the detected or received trigger event.
Thakur, in a same field of endeavor of cardiac monitoring methods, discloses adjusting, using the assessment circuit, in response to a detected or received trigger event, the baseline value for the patient from a long-term baseline value to one of a shorter-term baseline value or a static value indicative of a baseline value at a prior time relative to the detected or received trigger event.
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 the method of An to incorporate adjusting, using the assessment circuit, in response to a detected or received trigger event, the baseline value for the patient from a long-term baseline value to one of a shorter-term baseline value or a static value indicative of a baseline value at a prior time relative to the detected or received trigger event, as taught and suggested by Thakur, in order to mitigate the risk of worsening heart failure events in a patient as well as to reduce healthcare cost (Thakur, paragraph 0005).
Regarding claim 16, An in view of Thakur teach the method of claim 14 as discussed above, and An further teaches wherein determining the readmission score for the patient includes determining a composite function of the analyzed physiologic information, including two or more of: S1 heart sound information, S3 heart sound information, thoracic impedance, activity information, respiration information, and heart rate (e.g. paragraphs 0057, 0070).
Regarding claim 17, An in view of Thakur teach the method of claim 16 as discussed above, and An further teaches comprising: receiving an indication of patient discharge from hospitalization or treatment of the prior heart failure event (e.g. paragraphs 0065, 0078), wherein determining the readmission score for the patient includes determining an indication that the patient is likely to experience readmission or an indication that the prior heart failure event and discharge is likely to result in readmission within a specific time period after the received indication of patient discharge from hospitalization or treatment of the prior heart failure event (e.g. paragraphs 0065, 0078).
Regarding claim 18, An in view of Thakur teach the method of claim 14 as discussed above, and An further teaches comprising: determining the baseline value for the patient (e.g. paragraph 0065), including: determining the long-term baseline value as a function of 30 or more days of preceding physiologic information of the patient (e.g. paragraphs 0047, 0055); and determining the shorter-term baseline value as a function of a time period of physiologic information of the patient between 3 and 10 days of preceding physiologic information of the patient (e.g. paragraphs 0047, 0055), wherein adjusting the baseline value for the patient includes adjusting the baseline value for the patient from the long-term baseline to the shorter-term baseline value (e.g. paragraphs 0047, 0062).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
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/D.T./Examiner, Art Unit 3792
/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
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