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 .
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-19 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by US 2019/0329043 Sharma, hereinafter “Sharma”.
Regarding claim 1, Sharma discloses a medical system (Figure 1, element 100) comprising:
an implantable cardiac device (Figure 1, element 16) configured to monitor one or more cardio-thoracic parameters of a patient (Para 50; “intrathoracic impedance”); and
one or more external devices (Figure 1, elements 102a-n) configured to:
receive, from the implantable cardiac device, cardio-thoracic data indicative of the one or more cardio-thoracic parameters over a period of time (Para 87 describes the receiving of data, Para 50 discloses the data as impedance, and Para 52 and 108 indicate time); determine a long term heart failure risk (HFR) score for the patient based on the cardio-thoracic data (Para 28-29 and 91); based on a change in the long term HFR score for the patient,
determine a modification to a therapy plan (Para 32, Figure 4, Para 25 and 87) of a second implanted device in the patient (Para 25; “implantable drug dispenser”),
wherein the second implanted device is a separate device than the implantable cardiac device (Para 25 and Figure 1, element 16 is different than element 102n) and is implanted at a different location than the implantable cardiac device (This is inherent, an implantable cardiac monitor is implanted at the heart and a drug dispenser is implanted elsewhere, this is inherent, but is also shown in Para 25 as examples “Exemplary implantable drug dispensers that can be configured to include two or more drug compartments for release into the body are shown and described in U.S. Pat. Nos. 7,001,359, 7,054,782, 7,008,413, 7,264,611, 7,160,284, all of which are incorporated by reference. In yet another embodiment, a subcutaneous drug dispenser can be used (e.g. subcutaneous implantable devices such as a drug delivery such as the Paradign Revel from MinimMed, or SC2 infuser by SC Pharmaceuticals)” all of which describe an implantable dispenser away from the heart); and cause the second implanted device to implement the modified therapy plan (Para 25 and 87).
Regarding claim 2, Sharma discloses the one or more external devices are configured to automatically cause the second implanted device to implement the modified therapy plan without human interaction (Para 26).
Regarding claim 3, Sharma discloses the one or more external devices are configured to: present a recommended modified therapy plan to a clinician (Para 112 and Figure 4, element 238, see also Para 25 “the implantable drug dispenser is configured to receive command messages to adjust dosages of drug(s) delivered”); and cause the second implanted device to implement the modified therapy plan in response to the clinician approving the recommended modified therapy plan (Para 25).
Regarding claim 4, Sharma discloses the one or more external devices are configured to store results data for the patient in a database (Para 30, 55, and 113), wherein the results data includes an indication of whether or not the clinician approved the recommended modified therapy plan (Para 113).
Regarding claim 5, Sharma discloses the results data further comprises an outcome of the patient associated with the recommended modified therapy plan (Figure 4, elements 216 and 220).
Regarding claim 6, Sharma discloses the one or more external devices are configured to determine future recommended modified therapy plans based on the results data (Figure 4 determines if the first round of medications 212 was effective at step 216, if not, the system determines future recommended therapy at step 218 and delivers second round of medication).
Regarding claim 7, Sharma discloses the one or more cardio-thoracic parameters of the patient include subcutaneous tissue impedance values (Para 30), and the one or more one or more external devices are configured to determine the long term HFR score for the patient based on the subcutaneous tissue impedance values (Para 30, 32, and 123).
Regarding claim 8, Sharma discloses to cause the second implanted device to implement the modified therapy plan, the one or more external devices are configured to modify at least one of an operating parameter or a rule set of the second implanted device (Para 25; the dosage released).
Regarding claim 9, Sharma discloses the second implanted device comprises a cardio defibrillator device (Para 45), and to cause the second implanted device to implement the modified therapy plan, the one or more external devices are configured to increase a sensitivity of arrhythmia detection by the cardio defibrillator device (Para 45 ad 79).
Regarding claim 10, Sharma discloses the long term HFR score is based on data collected for two or more days (Para 108; daily values up to 14 months).
Regarding claim 11, Sharma discloses the long term HFR score is based on data collected for two or more weeks (Para 108; daily values up to 14 months).
Regarding claim 12, Sharma discloses the long term HFR score is based on data collected for two or more months (Para 108; daily values up to 14 months).
Regarding claim 13, Sharma discloses the second implanted device comprises one of: an implantable pulse generator (Para 45); an implantable cardioverter-defibrillator (ICD) (Para 45); a subcutaneous ICD (Para 45); a ventricular assist device; or a drug pump (Para 25).
Regarding claim 14, Sharma discloses the second implanted device comprises a non-cardiac device (Para 25; drug dispenser).
Regarding claim 15, Sharma discloses the second implanted device lacks the capability to monitor at least one of the one or more cardio-thoracic parameters of the patient (Para 25; drug dispenser is not disclosed to measure anything except dosage).
Regarding claim 16, Sharma discloses the one or more external devices are configured to: receive, from the implantable cardiac device, second cardio-thoracic data indicative of the one or more cardio-thoracic parameters over a second period of time (Figure 4, element 218; BP is measured at a time period after the first risk was determined at step 202), wherein the second period of time is at least partially after the second implanted implantable device implemented the modified therapy plan (Figure 4, the BP is measured after the first dose is administered at step 212); determine a second long term HFR score for the patient based on the cardio-thoracic data (Figure 4, step 216); and determine, based on the second long term HFR score, if the modified therapy plan improved a condition of the patient (Figure 4, step 218).
Regarding claim 17, Sharma discloses the implantable cardiac device is configured to be located closer to the heart of the patient than the second implanted device when the implantable cardiac device and the second implanted device are implanted within the patient (This is inherent, an implantable cardiac monitor is implanted at the heart and a drug dispenser is implanted elsewhere, this is inherent, but is also shown in Para 25 as examples “Exemplary implantable drug dispensers that can be configured to include two or more drug compartments for release into the body are shown and described in U.S. Pat. Nos. 7,001,359, 7,054,782, 7,008,413, 7,264,611, 7,160,284, all of which are incorporated by reference. In yet another embodiment, a subcutaneous drug dispenser can be used (e.g. subcutaneous implantable devices such as a drug delivery such as the Paradign Revel from MinimMed, or SC2 infuser by SC Pharmaceuticals)” all of which describe an implantable dispenser away from the heart).
Regarding claim 18, Sharma discloses the one or more external devices comprises a smartphone (Para 25; “computing device (e.g. Iphone™”).
Regarding claim 19, Sharma discloses the one or more external devices comprises a cloud-based device (Figure 1, element 110).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0329043 Sharma, hereinafter “Sharma”, in view of US 2019/0336076 Kuhn et al., hereinafter “Kuhn”.
Regarding claim 20, Sharma discloses all the limitations of claim 1.
Sharma does not disclose the implantable cardiac device comprises an insertable cardiac monitor comprising: a housing configured for subcutaneous implantation in a patient, the housing having a length between 40 millimeters (mm) and 60 mm between a first end and a second end, a width less than the length, and a depth less than the width; a first electrode at or proximate to the first end; a second electrode at or proximate to the second end; a memory within the housing; and processing circuitry within the housing, the processing circuitry configured to generate at least some of the cardio-thoracic data based on one or signals sensed via the first electrode and the second electrode.
However, Kuhn discloses an implantable medial device that measure tissue impedance (Abstract) and teaches the implantable cardiac device comprises an insertable cardiac monitor (Para 37 and Figure 1, element 10) comprising: a housing (Figure 2, element 14) configured for subcutaneous implantation in a patient, the housing having a length between 40 millimeters (mm) and 60 mm between a first end and a second end (Para 63), a width less than the length (Para 63), and a depth less than the width (Para 63); a first electrode at or proximate to the first end (Figure 2, element 16A); a second electrode at or proximate to the second end (Figure 2, element 16B); a memory within the housing (Figure 3, element 56); and processing circuitry within the housing (Figure 3, element 50), the processing circuitry configured to generate at least some of the cardio-thoracic data based on one or signals sensed via the first electrode and the second electrode (Abstract, Para 12, and 87-91).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed an insertable cardiac monitor as taught by Kuhn, in the invention of Sharma, in order to measure cardio-thoracic data (Abstract, Para 12, and 87-91).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
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/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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