Detailed Notice
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 .
Status of Claims
Claims 1-20 are currently pending.
Claims 1-20 are rejected.
Claims 1, 9, and 17 are amended.
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.
Claims 1-5, 9-13, 17-18, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 11-15, and 20 of U.S. Patent No. 11,615,891 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-5, 9-13, 17-18, and 20 are similar to claims 1-5, 11-15, and 20 of U.S. Patent No. 11,615,891 B2 as shown in the table below:
Application No. 18/112,118
U.S. Patent No. 11,615,891 B2
1. (Currently Amended) A system, comprising: a signal receiver circuit configured to receive physiologic information of a patient; a risk stratification circuit configured to determine a composite risk for the patient using a combination of signal metrics, the composite risk indicative of a risk of the patient to develop a heart failure (HF) decompensation event; and a risk assessment circuit configured to: determine an alert state for the patient using the received physiologic information; receive an indication of an occurrence of a HF event for the patient; determine a HF event rate for the alert state, the HF event rate representing a count of HF events for the alert state per unit time; and adjust the determination of the composite risk for the alert state for the patient using the determined HF event rate to increase a sensitivity or a specificity of the physiologic information in assessing the risk of the patient to develop the HF decompensation event.
1. A system, comprising:
a signal receiver circuit configured to receive physiologic information of a patient;
a risk stratification circuit configured to determine a composite heart failure (HF) risk for the patient using a combination of signal metrics, the composite HF risk indicative of a risk of the patient to develop a HF decompensation event; and
a risk assessment circuit configured to:
determine one of a plurality of alert states for the patient using the received physiologic information and a threshold;
receive an indication of an occurrence of a HF event for the patient;
determine a HF event rate for each of the plurality of alert states, the HF event rate representing a count of HF events for a specific alert state per unit time; and
adjust the determination of the composite HF risk for the patient using the determined HF event rates for each of the plurality of alert states to increase a sensitivity or a specificity of the physiologic information in assessing the risk of the patient to develop the HF decompensation event.
2. (Original) The system of claim 1, wherein the indication of the occurrence of the HF event for the patient includes an indication of HF treatment to the patient.
2. The system of claim 1, wherein the indication of the occurrence of the HF event for the patient includes an indication of HF treatment to the patient.
3. (Original) The system of claim 2, wherein the indication of HF treatment to the patient includes an admission or unscheduled visit into a hospital or clinic for HF treatment or an indication that the patient received HF treatment.
3. The system of claim 2, wherein the indication of treatment to the patient includes an admission or unscheduled visit into a hospital or clinic for HF treatment or an indication that the patient received HF treatment.
4. (Original) The system of claim 1, wherein to adjust the determination of the composite risk for the patient includes to adjust the combination of signal metrics or a weighting of a signal metric of the combination of signal metrics used to determine the composite risk.
4. The system of claim 1,
wherein to adjust the determination of the composite HF risk for the patient includes to adjust the combination of signal metrics or a weighting of a signal metric of the combination of signal metrics used to determine the composite HF risk.
5. (Original) The system of claim 1, wherein the alert state comprises an IN alert state, wherein the risk assessment circuit is configured to adjust the determination of the composite risk for the patient to minimize the occurrence of the IN alert state.
5. The system of claim 1, wherein the plurality of alert states are HF alert states,
wherein the plurality of HF alert states includes an IN alert state and an OUT alert state,
wherein to determine the HF event rate for each of the plurality of HF alert states includes to determine an IN alert state HF event rate and an OUT alert state HF event rate, and
wherein to adjust the determination of the composite HF risk includes using the determined IN alert state HF event rate and the determined OUT alert state HF event rate.
6. (Original) The system of claim 1, wherein the received physiologic information includes a sensor input, wherein to adjust the determination of the composite risk for the patient includes to adjust the sensor input or a weighting of the sensor input using the determined HF event rate for the alert state.
X
7. (Original) The system of claim 1, wherein the received physiologic information comprises the signal metrics.
X
8. (Original) The system of claim 1, wherein the risk stratification circuit is configured to determine the signal metrics using the received physiological information.
X
9. (Currently Amended) A method, comprising: receiving physiologic information of a patients using a signal receiver circuit; determining, using a risk stratification circuit, a composite risk for the patient using a combination of signal metrics, the composite risk indicative of a risk of the patient to develop a heart failure (HF) decompensation event; determining, using a risk assessment circuit, an alert state for the patient using the received physiologic information; receiving, using the risk assessment circuit, an indication of an occurrence of a HF event for the patient; determining, using the risk assessment circuit, a HF event rate for the alert state, the HF event rate representing a count of HF events for the alert state per unit time; and adjusting, using the risk assessment circuit, the determination of the composite risk for the alert state for the patient using the determined HF event rate to increase a sensitivity or a specificity of the physiologic information in assessing the risk of the patient to develop the HF decompensation event.
11. A method, comprising:
receiving physiologic information for a patients using a signal receiver circuit;
determining a composite heart failure (HF) risk for the patient using a combination of signal metrics, the composite HF risk indicative of a risk of the patient to develop a HF decompensation event;
determining, using a risk assessment circuit, one of a plurality of alert states for the patient using the received physiologic information and a threshold;
receiving, using the risk assessment circuit, an indication of an occurrence of a HF event for the patient;
determining, using the risk assessment circuit, a HF event rate for each of the plurality of alert states, the HF event rate representing a count of HF events for a specific alert state per unit time; and
adjusting, using the risk assessment circuit, the determination of the composite HF risk for the patient using the determined HF event rates for each of the plurality of alert states to increase a sensitivity or a specificity of the physiologic information in assessing the risk of the patient to develop the HF decompensation event.
10. (Original) The method of claim 9, wherein the indication of the occurrence of the HF event for the patient includes an indication of HF treatment to the patient.
12. The method of claim 11, wherein the indication of the occurrence of the HF event for the patient includes an indication of HF treatment to the patient.
11. (Original) The method of claim 10, wherein the indication of HF treatment to the patient includes an admission or unscheduled visit into a hospital or clinic for HF treatment or an indication that the patient received HF treatment.
13. The method of claim 12, wherein the indication of HF treatment to the patient includes an admission or unscheduled visit into a hospital or clinic for HF treatment or an indication that the patient received HT treatment.
12. (Original) The method of claim 9, wherein adjusting the determination of the composite risk for the patient includes adjusting the combination of signal metrics or a weighting of a signal metric of the combination of signal metrics used to determine the composite risk.
14. The method of claim 11,
wherein adjusting the determination of the composite HF risk for the patient includes adjusting the combination of signal metrics or a weighting of a signal metric of the combination of signal metrics used to determine the composite HF risk.
13. (Original) The method of claim 9, wherein the alert state comprises an IN alert state, wherein adjusting the determination of the composite risk for the patient includes to minimize the occurrence of the IN alert state.
15. The method of claim 11, wherein the plurality of alert states are HF alert states,
wherein the plurality of HF alert states includes an IN alert state and an OUT alert state,
wherein determining the HF event rate for each of the plurality of alert states includes determining an IN alert state HF event rate and an OUT alert state HF event rate, and
wherein adjusting the determination of the composite HF risk includes using the determined IN alert state HF event rate and the determined OUT alert state HF event rate.
14. (Original) The method of claim 9, wherein the received physiologic information includes a sensor input, wherein adjusting the determination of the composite risk for the patient includes adjusting the sensor input or a weighting of the sensor input using the determined HF event rate for the alert state.
X
15. (Original) The system of claim 1, wherein the received physiologic information comprises the signal metrics.
X
16. (Original) The system of claim 1, comprising determining, using the risk stratification circuit, the signal metrics using the received physiological information.
X
17. (Currently Amended) A system, comprising: a signal receiver circuit configured to receive physiologic information of a patient; a risk stratification circuit configured to determine signal metrics of the patient using the received physiologic information and to determine a composite risk of worsening status for the patient using a combination of the determined signal metrics; and a risk assessment circuit configured to: determine an alert state for the patient using the received physiologic information; receive an indication of an occurrence of an adverse medical event for the patient; determine an event rate for the alert state, the event rate representing a count of events for the alert state per unit time; and adjust the determination of the composite risk for the alert state for the patient using the determined event rate to increase a sensitivity or a specificity of the physiologic information in assessing the risk of worsening status for the patient to experience the adverse medical event.
1. A system, comprising:
a signal receiver circuit configured to receive physiologic information of a patient;
a risk stratification circuit configured to determine a composite heart failure (HF) risk for the patient using a combination of signal metrics, the composite HF risk indicative of a risk of the patient to develop a HF decompensation event; and
a risk assessment circuit configured to:
determine one of a plurality of alert states for the patient using the received physiologic information and a threshold;
receive an indication of an occurrence of a HF event for the patient;
determine a HF event rate for each of the plurality of alert states, the HF event rate representing a count of HF events for a specific alert state per unit time; and
adjust the determination of the composite HF risk for the patient using the determined HF event rates for each of the plurality of alert states to increase a sensitivity or a specificity of the physiologic information in assessing the risk of the patient to develop the HF decompensation event.
18. (Original) The system of claim 17, wherein the indication of the occurrence of the adverse medical event includes information about an unscheduled patient admission or hospitalization or a treatment or intervention associated with the worsening status for the patient.
2. The system of claim 1, wherein the indication of the occurrence of the HF event for the patient includes an indication of HF treatment to the patient.
12. The method of claim 11, wherein the indication of the occurrence of the HF event for the patient includes an indication of HF treatment to the patient.
19. (Original) The system of claim 17, wherein the composite risk of worsening status for the patient includes a composite risk indicative of a risk of the patient do develop a HF decompensation event, wherein the indication of the occurrence of the adverse medical event for the patient comprises an indication of an occurrence of a HF event for the patient, wherein the event rate comprises a HF event rate representative of a count of HF events for the alert state per unit time.
X
20. (Original) The system of claim 17, wherein the received physiologic information includes a sensor input, wherein to adjust the determination of the composite risk for the patient includes to adjust the sensor input or a weighting of the sensor input using the determined event rate for the alert state.
20. The method of claim 11, wherein the received physiologic information includes a sensor input, and wherein adjusting the determination of the composite HF risk for the patient includes adjusting the sensor input or a weighting of the sensor input using the determined HF event rates for each of the plurality of alert states.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1:
In the instant case, claims 1-8 and 17-20 are directed toward a system (i.e., machine) and claims 9-16 are directed toward a method (i.e. a process). Thus, each of the claims falls within one of the four statutory categories. Nevertheless, the claims fall within the judicial exception of an abstract idea.
Step 2A—Prong 1:
Independent claims 1, 9, and 17 recites steps that, under their broadest reasonable interpretations, cover performance of the limitations of a certain method of organizing human activity but for the recitation of generic computer components.
Claim 1 recites: “A system, comprising: a signal receiver circuit configured to receive physiologic information of a patient; a risk stratification circuit configured to determine a composite risk for the patient using a combination of signal metrics, the composite risk indicative of a risk of the patient to develop a heart failure (HF) decompensation event; and a risk assessment circuit configured to: determine an alert state for the patient using the received physiologic information; receive an indication of an occurrence of a HF event for the patient; determine a HF event rate for the alert state, the HF event rate representing a count of HF events for the alert state per unit time; and adjust the determination of the composite risk for the alert state for the patient using the determined HF event rate to increase a sensitivity or a specificity of the physiologic information in assessing the risk of the patient to develop the HF decompensation event”.
The limitations of receive physiologic information of a patient; determine a composite risk for the patient using a combination of signal metrics, the composite risk indicative of a risk of the patient to develop a heart failure (HF) decompensation event; determine an alert state for the patient using the received physiologic information; receive an indication of an occurrence of a HF event for the patient; determine a HF event rate for the alert state, the HF event rate representing a count of HF events for the alert state per unit time; and adjust the determination of the composite risk for the alert state for the patient using the determined HF event rate to increase a sensitivity or a specificity of the physiologic information in assessing the risk of the patient to develop the HF decompensation even, given the broadest reasonable interpretation, cover the abstract idea of a certain method of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions—in this case the aforementioned steps recite a process of receive, determine, and adjust, which is properly interpreted as a “personal behavior”), but instead automates the process via a computer model, e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements”, and will be discussed in further detail below.
Additionally, claim 9 recites: “A method, comprising: receiving physiologic information of a patients using a signal receiver circuit; determining, using a risk stratification circuit, a composite risk for the patient using a combination of signal metrics, the composite risk indicative of a risk of the patient to develop a heart failure (HF) decompensation event; determining, using a risk assessment circuit, an alert state for the patient using the received physiologic information; receiving, using the risk assessment circuit, an indication of an occurrence of a HF event for the patient; determining, using the risk assessment circuit, a HF event rate for the alert state, the HF event rate representing a count of HF events for the alert state per unit time; and adjusting, using the risk assessment circuit, the determination of the composite risk for the alert state for the patient using the determined HF event rate to increase a sensitivity or a specificity of the physiologic information in assessing the risk of the patient to develop the HF decompensation event”.
The limitations of receiving physiologic information of a patients; determining, a composite risk for the patient using a combination of signal metrics, the composite risk indicative of a risk of the patient to develop a heart failure (HF) decompensation event; determining, an alert state for the patient using the received physiologic information; receiving, an indication of an occurrence of a HF event for the patient; determining, a HF event rate for the alert state, the HF event rate representing a count of HF events for the alert state per unit time; and adjusting, the determination of the composite risk for the alert state for the patient using the determined HF event rate to increase a sensitivity or a specificity of the physiologic information in assessing the risk of the patient to develop the HF decompensation event, given the broadest reasonable interpretation, cover the abstract idea of a certain method of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions—in this case the aforementioned steps recite a process of receive, determine, and adjust, which is properly interpreted as a “personal behavior”), but instead automates the process via a computer model or machine learning, e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements”, and will be discussed in further detail below.
Additionally, claim 17 recites: “A system, comprising: a signal receiver circuit configured to receive physiologic information of a patient; a risk stratification circuit configured to determine signal metrics of the patient using the received physiologic information and to determine a composite risk of worsening status for the patient using a combination of the determined signal metrics; and a risk assessment circuit configured to: determine an alert state for the patient using the received physiologic information; receive an indication of an occurrence of an adverse medical event for the patient; determine an event rate for the alert state, the event rate representing a count of events for the alert state per unit time; and adjust the determination of the composite risk for the alert state for the patient using the determined event rate to increase a sensitivity or a specificity of the physiologic information in assessing the risk of worsening status for the patient to experience the adverse medical event”.
The limitations of receive physiologic information of a patient; determine signal metrics of the patient using the received physiologic information and to determine a composite risk of worsening status for the patient using a combination of the determined signal metrics; determine an alert state for the patient using the received physiologic information; receive an indication of an occurrence of an adverse medical event for the patient; determine an event rate for the alert state, the event rate representing a count of events for the alert state per unit time; and adjust the determination of the composite risk for the alert state for the patient using the determined event rate to increase a sensitivity or a specificity of the physiologic information in assessing the risk of worsening status for the patient to experience the adverse medical event, given the broadest reasonable interpretation, cover the abstract idea of a certain method of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions—in this case the aforementioned steps recite a process of receive, determine, and adjust, which is properly interpreted as a “personal behavior”), but instead automates the process via a computer model or machine learning, e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements”, and will be discussed in further detail below.
Dependent claims 2-8, 10-16, and 18-20 include other limitations, as well as specific step of data to be processed, received, and applied, but these only serve to further limit the abstract idea and do not add and additional elements, and hence are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 9, and 17. However, recitation of an abstract idea is not the end of the 35 U.S.C. 101 analysis. Each of the claims must be analyzed for additional elements that indicate the abstract idea is integrated into a practical application to determine whether the claim is considered to be “directed to” an abstract idea.
Step 2A—Prong 2:
Claims 1-20 are not integrated into a practical application because the additional elements (i.e. any limitations that are not identified as part of the abstract idea) amount to no more than limitations which:
Amount to mere instructions to apply an exception—for example, the recitation of “signal receiver circuit”, “risk stratification circuit”, and “risk assessment circuit”, which amount to merely invoking a computer as a tool to perform the abstract idea, e.g. see FIG. 1, [0014]-[0015], and [0023], of the present specification, and see further MPEP 2106.05(f);
Generally linking the abstract idea to a particular technological environment or field of use, for example, “a signal receiver circuit configured to”, “a risk stratification circuit configured to”, “a risk assessment circuit configured to”, “using a signal receiver circuit”, “using a risk stratification circuit”, “using a risk assessment circuit”, and “using the risk assessment circuit”, which amounts to limiting the abstract idea to the field of technology/the environment of computers, see MPEP 2106.05(h); and/or
Merely acquiring information for further analysis by the system and the particular manner of acquisition is not described or shown to be important, for example, “receive physiologic information of a patient” and “receive an indication of an occurrence of an adverse medical event for the patient”, which amounts to insignificant extra-solution activity in the form of mere data gathering because it merely functions tangentially to the main idea of the invention and serves only to bring in the data necessary for the inventions main analysis, see MPEP 2106.05(g).
Additionally, dependent claims 2-8, 10-16, and 18-20 include other limitations, but as stated above, the limitations recited by these claims do not include any additional elements beyond those already recited in independent claims 1, 9, and 17, and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B:
The claims do not include additional elements (i.e., “signal receiver circuit”, “risk stratification circuit”, and “risk assessment circuit”) that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the elements other than the abstract idea), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, and/or generally link the abstract idea to a particular technological environment or field of use, which even when reevaluated under the considerations of Step 2B of the analysis, do not amount to “significantly more” than the abstract idea.
Dependent claims 2-8, 10-16, and 18-20 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because, as stated above, the aforementioned dependent claims do not recite any additional elements not already recited in independent claims 1, 9, and 17, and hence do not amount to “significantly more” than the abstract idea.
Additionally, the additional elements (i.e., “receive physiologic information of a patient” and “receive an indication of an occurrence of an adverse medical event for the patient”), add extra solution activity, which comprises limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in a particular field as demonstrated by:
Relevant court decisions (See MPEP 2106.05(d)(II)):
Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) (“Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink.” (emphasis added)).
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 1-20 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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) 1-2, 4-5, 7-10, 12-13, and 15-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by An et al. (US 20130116578 A1), hereinafter An.
Regarding claims 1-2, 4-5, 7-10, 12-13, and 15-19, An teaches
1. A system, comprising: a signal receiver circuit configured to receive physiologic information of a patient ([0185]); a risk stratification circuit configured to determine a composite risk for the patient using a combination of signal metrics, the composite risk indicative of a risk of the patient to develop a heart failure (HF) decompensation event; and a risk assessment circuit configured to ([0062], [0064], and [0066]-[0068]): determine an alert state for the patient using the received physiologic information ([0049] and [0050]-[0054]); receive an indication of an occurrence of a HF event for the patient ([0050], [0081], and [0086]-[0088]); determine a HF event rate for the alert state, the HF event rate representing a count of HF events for the alert state per unit time (Fig. 4, [0046]: “the implanted device 102 computes a HRV Footprint® patient diagnostic that can include a 2-dimensional histogram that counts the number of daily heartbeats occurring at each combination of heart rate (interval between consecutive beats) and beat-to-beat variability (absolute difference between consecutive intervals)”, [0066]: “FIG. 4 is a diagram illustrating an example of relationships between alert values, alert scores, and composite alert scores. In an example, alert values 400 are sensed or detected over time and associated with a particular sensor 402. Alert values 400 may be combined first with respect to a particular sensor 402… The alert scores combined with respect to each sensor may then be combined to form the composite alert score, CAS 406. Alternatively, alert values 400 may be combined first with respect to a particular time slice…”, [0072], and [0101]); and adjust the determination of the composite risk for the alert state for the patient using the determined HF event rate to increase a sensitivity or a specificity of the physiologic information in assessing the risk of the patient to develop the HF decompensation event ([0049], [0053], [0054], [0099], and [0128]-[0132]).
2. The system of claim 1, wherein the indication of the occurrence of the HF event for the patient includes an indication of HF treatment to the patient ([0097]: “Using one or more such probabilistic measurements, a physician may change diagnosis or adjust or adapt therapy to increase the quality of life of the particular patient. For example, a physician may increase the number of follow up visits or shorten the length of time between successive follow up visits, tune one or more thresholds on one or more alert methods, or alter medication to be more aggressive or less aggressive”).
3. The system of claim 1, wherein to adjust the determination of the composite risk for the patient includes to adjust the combination of signal metrics or a weighting of a signal metric of the combination of signal metrics used to determine the composite risk ([0129], [0177], [0178], [0188]-[0191], [0193], and [0198]).
5. The system of claim 1, wherein the alert state comprises an IN alert state, wherein the risk assessment circuit is configured to adjust the determination of the composite risk for the patient to minimize the occurrence of the IN alert state ([0050]-[0051], [0060]-[0063], [0065], [0081 ]-[0083], and [0157]).
7. The system of claim 1, wherein the received physiologic information comprises the signal metrics ([0177], [0178], [O188]-[0191], [0193], and [0198]).
8. The system of claim 1, wherein the risk stratification circuit is configured to determine the signal metrics using the received physiological information (Fig. 27, [0041], [0048], and [0052]-[0054]).
9. A method, comprising: receiving physiologic information of a patients using a signal receiver circuit ([0185]); determining, using a risk stratification circuit, a composite risk for the patient using a combination of signal metrics, the composite risk indicative of a risk of the patient to develop a heart failure (HF) decompensation event ([0062], [0064], and [0066]-[0068]); determining, using a risk assessment circuit, an alert state for the patient using the received physiologic information ([0049] and [0050]-[0054]); receiving, using the risk assessment circuit, an indication of an occurrence of a HF event for the patient ([0050], [0081], and [0086]-[0088]); determining, using the risk assessment circuit, a HF event rate for the alert state, the HF event rate representing a count of HF events for the alert state per unit time (Fig. 3, [0046], [0065 ]-[0067], [0072], and [0076]); and adjusting, using the risk assessment circuit, the determination of the composite risk for the alert state for the patient using the determined HF event rate to increase a sensitivity or a specificity of the physiologic information in assessing the risk of the patient to develop the HF decompensation event ([0049], [0053], [0054], [0099], and [0128 ]-[0132]).
10. The method of claim 9, wherein the indication of the occurrence of the HF event for the patient includes an indication of HF treatment to the patient ([0097]: “Using one or more such probabilistic measurements, a physician may change diagnosis or adjust or adapt therapy to increase the quality of life of the particular patient. For example, a physician may increase the number of follow up visits or shorten the length of time between successive follow up visits, tune one or more thresholds on one or more alert methods, or alter medication to be more aggressive or less aggressive”).
12. The method of claim 9, wherein adjusting the determination of the composite risk for the patient includes adjusting the combination of signal metrics or a weighting of a signal metric of the combination of signal metrics used to determine the composite risk ([0129], [0177], [0178], [0188]-[0191], [0193], and [0198]).
13. The method of claim 9, wherein the alert state comprises an IN alert state. wherein adjusting the determination of the composite risk for the patient includes to minimize the occurrence of the IN alert state ([0050]-[0051], [0060]-[0063], [0065], [0081]-[0083], and [0157]).
15. The system of claim 1, wherein the received physiologic information comprises the signal metrics ([0177], [0178], [0188]-[0191], [0193], and [0198]).
16. The system of claim 1, comprising determining, using the risk stratification circuit, the signal metrics using the received physiological information ([0177], [0178], [0188]-[0191], [0193], and [0198]).
17. A system, comprising: a signal receiver circuit configured to receive physiologic information of a patient ([0155]); a risk stratification circuit configured to determine signal metrics of the patient using the received physiologic information and to determine a composite risk of worsening status for the patient using a combination of the determined signal metrics; and a risk assessment circuit configured to ([0062], [0064], and [0066]-[0068]): determine an alert state for the patient using the received physiologic information ([0049] and [0050]-[0054]); receive an indication of an occurrence of an adverse medical event for the patient ([0050], [0081], and [0086]-[0088]); determine an event rate for the alert state, the event rate representing a count of events for the alert state per unit time (Fig. 3, [0046], [0065]-[0067], [0072], and [0076]); and adjust the determination of the composite risk for the alert state for the patient using the determined event rate to increase a sensitivity or a specificity of the physiologic information in assessing the risk of worsening status for the patient to experience the adverse medical event ([0049], [0053], [0054], [0099], and [0128]-[0132]).
18. The system of claim 17, wherein the indication of the occurrence of the adverse medical event includes information about an unscheduled patient admission or hospitalization or a treatment or intervention associated with the worsening status for the patient ([0097], [0177], [0178], [0188]-[0191], [0193], and [0198]).
19. The system of claim 17, wherein the composite risk of worsening status for the patient includes a composite risk indicative of a risk of the patient do develop a HF decompensation event , wherein the indication of the occurrence of the adverse medical event for the patient comprises an indication of an occurrence of a HF event for the patient, wherein the event rate comprises a HF event rate representative of a count of HF events for the alert state per unit time (FIG. 29, FIG. 30, [0050], [0097], [0111], [0171], and [0172]).
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 3 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over An et al. (US 20130116578 A1), hereinafter An, in view of Amarasingham et al. (US 20150213224 A1), hereinafter Amarasingham.
Regarding claim 3 An teaches the system of claim system of claim 2. An does not teach the indication of HF treatment to the patient includes an admission or unscheduled visit into a hospital or clinic for HF treatment or an indication that the patient received HF treatment.
However, Amarasingham teaches the indication of HF treatment to the patient includes an admission or unscheduled visit into a hospital or clinic for HF treatment or an indication that the patient received HF treatment (Amarasingham, Abstract, [0037], [0043], [0044], [0048], and [0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify An to incorporate the teachings of Amarasingham and account for indication of heart failure treatment to the patient includes an admission visit into a hospital for heart failure treatment or that the patient received treatment (Amarasingham, Abstract, [0037], [0043 ], [0044], and [0061]).
Regarding claim 11 An teaches the method of claim 10. An does not teach the indication of HF treatment to the patient includes an admission or unscheduled visit into a hospital or clinic for HF treatment or an indication that the patient received HF treatment.
However, Amarasingham teaches the indication of HF treatment to the patient includes an admission or unscheduled visit into a hospital or clinic for HF treatment or an indication that the patient received HF treatment (Amarasingham, Abstract, [0037], [0043 ], [0044], [0048], and [0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify An to incorporate the teachings of Amarasingham and account for indication of heart failure treatment to the patient includes an admission visit into a hospital for heart failure treatment or that the patient received treatment (Amarasingham, Abstract, [0037], [0043], [0044], and [0061]).
Claims 6, 14, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over An et al. (US 20130116578 A1), hereinafter An, in view of Fukamachi et al. (US 20120221072 A1), hereinafter Fukamachi.
Regarding claim 6 An teaches the system of claim 1. An does not teach the received physiologic information includes a sensor input, wherein to adjust the determination of the composite risk for the patient includes to adjust the sensor input or a weighting of the sensor input using the determined HF event rate for the alert state.
However, Fukamachi teaches the received physiologic information includes a sensor input, wherein to adjust the determination of the composite risk for the patient includes to adjust the sensor input or a weighting of the sensor input using the determined HF event rate for the alert state (Fukamachi, FIG. 10, and [0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify An to incorporate the teachings of Fukamachi and account for received physiologic information includes a sensor input, wherein to adjust the determination of the composite risk for the patient includes to adjust the sensor input or a weighting of the sensor input using the determined HF event rate for the alert state (Fukamachi, Abstract and [0035]).
Regarding claim 14 An teaches the method of claim 9. An does not teach the received physiologic information includes a sensor input, wherein adjusting the determination of the composite risk for the patient includes adjusting the sensor input or a weighting of the sensor input using the determined HF event rate for the alert state.
However, Fukamachi teaches the received physiologic information includes a sensor input, wherein adjusting the determination of the composite risk for the patient includes adjusting the sensor input or a weighting of the sensor input using the determined HF event rate for the alert state (Fukamachi, FIG. 10, and [0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify An to incorporate the teachings of Fukamachi and account for received physiologic information includes a sensor input, wherein to adjust the determination of the composite risk for the patient includes to adjust the sensor input or a weighting of the sensor input using the determined HF event rate for the alert state (Fukamachi, Abstract and [0035]).
Regarding claim 20 An teaches the system of claim 17. An does not teach the received physiologic information includes a sensor input, wherein to adjust the determination of the composite risk for the patient includes to adjust the sensor input or a weighting of the sensor input using the determined event rate for the alert state.
However, Fukamachi teaches the received physiologic information includes a sensor input, wherein to adjust the determination of the composite risk for the patient includes to adjust the sensor input or a weighting of the sensor input using the determined event rate for the alert state (Fukamachi, FIG. 10, and [0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify An to incorporate the teachings of Fukamachi and account for received physiologic information includes a sensor input, wherein to adjust the determination of the composite risk for the patient includes to adjust the sensor input or a weighting of the sensor input using the determined HF event rate for the alert state (Fukamachi, Abstract and [0035]).
Response to Arguments
Applicant's arguments filed 02/20/2025 have been fully considered but they are not persuasive. Regarding the Non-Statutory Double Patenting, Applicant has requested it be held in abeyance. Examiner has noted Applicant’s request; however, the Non-Statutory Double Patenting Rejection will be updated with each amendment to the claims until a decision on allowability has been made.
Regarding the 35 U.S.C. 101 Rejection, Applicant argues the claims recite an improvement to the technology/technical field by improving the sensitivity and specificity of existing sensors in predicting or assessing CHF. Additionally, Applicant argue the claims recite an improvement where a risk assessment circuit is configured to, among other things, determine for an alert a HF event rate state representing a count of HF events for the alert state per unit time, and adjust determination of the composite risk for the alert state for the patient using the determined HF event rate to increase sensitivity or specificity. Examiner respectfully disagrees. According to MPEP 2106.04(d)(1), “the specification need not explicitly set forth the improvement, but it must describe the invention such that the improvement would be apparent to one of ordinary skill in the art. Conversely, if the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology. Second, if the specification sets forth an improvement in technology, the claim must be evaluated to ensure that the claim itself reflects the disclosed improvement”. Furthmore, MPEP 2106.05(a) states “an examiner should evaluate whether a claim contains an improvement to the functioning of a computer or to any other technology or technical field at Step 2A Prong Two and Step 2B, as well as when considering whether the claim has such self-evident eligibility that it qualifies for the streamlined analysis”. The improvement of sensitivity and specificity of existing sensors in predicting or assessing CHF is not shown in the claims. The sensor, circuit, system, etc. must show an improvement. The type or amount of data/information that is collected is not shown to be an improvement. Additionally, improving and more accurately predicting CHF is a business practice improvement and not an improvement the technology itself.
Applicant also argues the claims are similar to Example #42 of the “Subject Matter Eligibility Example: Abstract Ideas” in the 2019 Revised Patent Subject Matter Eligibility Guidance. Examiner respectfully disagrees. Example #42, Claim 1 is eligible under 101 because the claim recites “a combination of additional elements including storing information, providing remote access over a network, converting updated information that was input by a user in a non-standardized form to a standardized format, automatically generating a message whenever updated information is stored, and transmitting the message to all of the users”. The present application does not recite features of remote access over a network, converting updated information that was input by a user in a non-standardized form to a standardized format, automatically generating a message whenever updated information is stored, and transmitting the message to all of the users. Therefore, the 35 U.S.C. 101 Rejection is maintained.
Regarding the 35 U.S.C. 102 Rejection Applicant argues the prior art, An et al., hereinafter An, does not teach “a risk assessment circuit configured to determine a heart failure (HF) event rate for the alert state, the HF event rate representing a count of HF events for the alert state per unit time”. Applicant also argues the cited passages of An relate to adjusting a parameter such as a CAS threshold to tune the sensitivity or specificity of alerts, but do not teach or suggest that such adjustment is made by using an HF event rate representing a count of HF events for the alert state per unit time. Examiner respectfully disagrees. An teaches [0046] “These values may be based on the patient's heart rate or physical activity over a time period (e.g., 24-hour period) and each diagnostic parameter is saved as a function of the time period. In one example, heart-rate based diagnostics utilize only normal intrinsic beats. For heart rate variability (HRV) patient diagnostics, the average heart rate can be found at each interval within the time period, for example, at each of the 288 five-minute intervals occurring during 24 hours”, [0065] “At 308, the CAS is compared to a threshold value. In an example, the threshold is fixed, however it may be adapted, such as for particular patients or over time in other examples. When the CAS is over the threshold value in this example, then at 310, an alert state is set. If the CAS does not exceed the threshold value in this example, then at 312, the alert state is not set. In various examples, the alert state may indicate one or more of an onset of a physiological condition, a change in a physiological condition, or a predictive measure of a possibility of an onset of such a physiological condition. For example, the alert state may be used to assist in predicting physiological or patient-related events, such as HF decompensation, lead fracture, sudden cardiac death (SCD), or myocardial infarction (MI)”, [0066] “In an example, alert values 400 are sensed or detected over time and associated with a particular sensor 402. Alert values 400 may be combined first with respect to a particular sensor 402, for example, ASi, ASj, . . . , ASz 404. The alert scores combined with respect to each sensor may then be combined to form the composite alert score, CAS 406”, and [0067] “Alert values 500 may be obtained from the same sensor over time or from two or more sensors. In an example, when alert values 500 are obtained from the same sensor, the alert values 500 may be determined at periodic or recurring time intervals, such as daily, hourly, or the like. In another example, when alert values 500 are obtained from two or more sensors, the values 500 may be obtained at approximately the same time”, [0119] “In some examples, the index value may indicate how likely a patient is to enter or recover from a disease state in a particular amount of time” (e.g., “a risk assessment circuit configured to determine a heart failure (HF) event rate for the alert state, the HF event rate representing a count of HF events for the alert state per unit time” and “adjustment is made by using an HF event rate representing a count of HF events for the alert state per unit time”). Therefore, the 35 U.S.C. 102 Rejection is maintained.
Regarding the 35 U.S.C. 103, Applicant argues the other cite prior art, Amarasingham et al., hereinafter Amarasingham, and Fukamachi et al., hereinafter Fukamachi, do not teach the deficiencies of An for amendments to independent claims 1, 9, and 17. Examiner respectfully disagrees. As shown above, An still teaches the amendments to independent claims 1, 9, and 17. Therefore, the 35 U.S.C. 103 Rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/R.S.S./Examiner, Art Unit 3681
/MARC Q JIMENEZ/Supervisory Patent Examiner, Art Unit 3681
