DETAILED ACTION
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
This Final Office Action is in response to the new claims and remarks filed 07/02/2025, where:
Claim 21 is new; and
Claims 1-16 and 18-21 are pending and considered herein.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2018/0133481 A1 to Von Zitzewitz, hereinafter “Von Zitzewitz,” in view of U.S. 2015/0149096 A1 to Soykan, hereinafter “Soykan,” in view of U.S. 2014/0276164 A1 to Thakur et al., hereinafter “Thakur” and further in view of U.S. 2020/0345587 A1 to Aon et al., hereinafter “Aon.”
Regarding claim 1, Von Zitzewitz discloses A heart failure treatment management system comprising: a sensor system comprises a non-implantable sensor and an implantable sensor to provide patient data about a patient or an environment related to the patient (See Von Zitzewitz at least at Paras. [0008], [0011], [0028]-[0038], [0041], [0072]).
Von Zitzewitz may not specifically describe but Soykan teaches a heart failure treatment delivery system to administer treatment based on a heart failure treatment regimen (See Soykan at least at Abstract; Paras. [0001]-[0002], [0012], [0191]-[0193], [0249], [0256]-[0259]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Von Zitzewitz to incorporate the teachings of Soykan and provide treatment based on a heart failure treatment regimen and compliance data. Soykan is directed to systems and methods for monitoring health conditions and treatments including for heart failure. Incorporating the health monitoring as in Soykan with the active closed-loop medical system for implantable sensors as in Von Zitzewitz would thereby improve the applicability, efficacy, and accuracy of the claimed heart failure treatment management system.
The references may not specifically describe but Aon teaches to determine whether the updated treatment regimen is within a predetermined physician-limited parameter region, and in response to determining that the updated treatment regimen is within the predetermined physician-limited parameter region (See Aon at least at Abstract; Paras. [0010], [0034]-[0035] (“[T]he payer management server 195 updates the patient treatment profile data 170 based on the real-time medication adherence score 190, the measured patient physical parameters 125, and the prescription 145), [0045], [0099]-[0121], [0183]-[0184] (“[I]n response to determining the patient's blood pressure is above normal range, dispensing a blood pressure medication dose determined as a function of the blood pressure measurement and prescribing guidelines determined by the patient's physician; and, in response to determining the patient's blood pressure is not above normal range, dispensing an anti-anxiety medication dose prescribed by the patient's physician.” i.e. updated regimen following guidelines of physician); Figs. 7-11). Aon further teaches a system to provide treatment compliance data comprising whether the patient received the treatment (See Aon at least at Abstract; Paras. [0004]-[0010], [0034]-[0036] (The payer management server 195 updates the patient treatment profile data 170 based on the real-time medication adherence score 190, the measured patient physical parameters 125, and the prescription 145.”), [0045], [0151]-[0162], [0181]-[0199]; Figs. 1-11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Von Zitzewitz, Soykan and Thakur to incorporate the teachings of Aon and provide treatment compliance and updating a treatment regimen and determining it is within a physician’s approved region or control. Aon is directed to a patient treatment adherence system and techniques. Incorporating the patient treatment adherence as in Aon with the heart failure management as in Thakur, the health monitoring as in Soykan and the active closed-loop medical system for implantable sensors as in Von Zitzewitz would thereby improve the applicability, efficacy, and accuracy of the claimed heart failure treatment management system.
Von Zitzewitz as modified by Soykan and Aon may not specifically describe but Thakur teaches a heart failure treatment optimization system operably coupled to the sensor system and the heart failure treatment delivery system to update a heart failure treatment regimen based on the patient data from the sensor system and the treatment compliance data from the heart failure treatment delivery system and to provide the updated heart failure treatment regimen to the heart failure treatment delivery system (See Thakur at least at Paras. [0007], [0010]-[0011], [0018]-[0021], [0027]-[0028]; Figs. 1, 2; See also Soykan at least at Abstract; Paras. [0001]-[0002], [0012], [0191]-[0193], [0249], [0256]-[0259]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Von Zitzewitz, Soykan and Aon to incorporate the teachings of Thakur and provide a heart failure optimization system. Thakur is directed to a heart failure management in order to avoid rehospitalization. Incorporating the heart failure management as in Thakur with the treatment compliance as in Aon, the health monitoring as in Soykan and the active closed-loop medical system for implantable sensors as in Von Zitzewitz would thereby improve the applicability, efficacy, and accuracy of the claimed heart failure treatment management system.
Regarding claim 2, Von Zitzewitz as modified by Soykan, Aon and Thakur teaches all the limitations of claim 1, and Thakur further teaches wherein the heart failure treatment optimization system is configured to update the heart failure treatment regimen at least daily (See Thakur at least at Para. [0080]; Fig. 6).
Regarding claim 10, Von Zitzewitz as modified by Soykan, Aon and Thakur teaches all the limitations of claim 1, and Von Zitzewitz further discloses wherein the non-implantable sensor of the sensor system comprises a patient wearable sensor (See Von Zitzewitz at least at Para. [0017]).
Regarding claim 11, Von Zitzewitz as modified by Soykan, Aon and Thakur teaches all the limitations of claim 1, and Von Zitzewitz further discloses wherein the implantable sensor of the sensor system comprises one or more electrical contacts (See id. at least at Paras. [0028]-[0038], [0068]-[0069]).
Regarding claim 12, Von Zitzewitz as modified by Soykan, Aon and Thakur teaches all the limitations of claim 11, and Von Zitzewitz further discloses wherein the non-implantable sensor comprises at least one of an imaging sensor, a perfusion sensor, a weight scale, a bed scale, a pressure sensor, or microphone, operably coupled to circuitry of an external device (See id. at least at Paras. [0035]-[0036]).
Regarding claim 13, Von Zitzewitz as modified by Soykan, Aon and Thakur teaches all the limitations of claim 1, and Thakur further teaches wherein the heart failure treatment delivery system comprises at least one of a drug dispenser to contain one or more drugs, an automated treatment pump, a graphical user interface to provide treatment information to the patient, or an implantable electrical stimulator (See Thakur at least at Paras. [0007], [0010]-[0011], [0018]-[0021]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Von Zitzewitz, in view of Soykan, in view of Aon, in view of Thakur and further in view of U.S. 2015/0119966 A1 to Richter et al., hereinafter “Richter.”
Regarding claim 3, Von Zitzewitz as modified by Soykan, Aon and Thakur teaches all the limitations of claim 1. Von Zitzewitz, Soykan, Aon and Thakur may not specifically describe, but Richter teaches wherein the heart failure treatment optimization system is configured to update the heart failure treatment regimen automatically between physician inputs to maintain the patient in a stable region (See Richter at least at Paras. [0007]-[0008], [0036], [0049]-[0050]; Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Von Zitzewitz, Soykan, Aon and Thakur to incorporate the teachings of Richter and provide updating a treatment regimen after physician inputs. Richter is directed to a system for characterizing stimulus sights for medical implant sensors. Incorporating the implant device treatment system as in Richter with the heart failure management as in Thakur, the treatment compliance as in Aon, the health monitoring as in Soykan and the active closed-loop medical system for implantable sensors as in Von Zitzewitz would thereby improve the applicability, efficacy, and accuracy of the claimed heart failure treatment management system.
Claims 4 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Von Zitzewitz, in view of Soykan, in view of Aon, in view of Thakur and further in view of U.S. 2009/0299424 A1 to Narayan, hereinafter “Narayan.”
Regarding claim 4, Von Zitzewitz as modified by Soykan, Aon and Thakur teaches all the limitations of claim 1. Von Zitzewitz, Soykan, Aon and Thakur may not specifically describe, but Narayan teaches wherein the heart failure treatment optimization system is operably coupled to a remote system to receive related treatment data to train a risk score generator, a treatment regimen generator, or both, to update the heart failure treatment regimen (See Narayan at least at Paras. [0142]-[0144], [0159]-[0168], [0201]-[0206]; Figs. 11, 12A, 12B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Von Zitzewitz, Soykan, Aon and Thakur to incorporate the teachings of Narayan and provide training a risk score generator to update a treatment regimen. Narayan is directed to methods and systems for treating heart instability. Incorporating the systems for treating heart instability as in Narayan with the heart failure management as in Thakur, the treatment compliance as in Aon, the health monitoring as in Soykan and the active closed-loop medical system for implantable sensors as in Von Zitzewitz would thereby improve the applicability, efficacy, and accuracy of the claimed heart failure treatment management system.
Regarding claim 7, Von Zitzewitz as modified by Soykan, Aon and Thakur teaches all the limitations of claim 1. Von Zitzewitz, Soykan, Aon and Thakur may not specifically describe, but Narayan teaches wherein the heart failure treatment optimization system comprises a risk score generator to provide one or more risk scores based on patient data (See id. at least at Paras. [0142]-[0144], [0160]-[0165], [0201]-[0206]; Figs. 11, 12A, 12B).
Regarding claim 8, Von Zitzewitz as modified by Soykan, Aon and Thakur teaches all the limitations of claim 1. Von Zitzewitz, Soykan, Aon and Thakur may not specifically describe, but Narayan teaches wherein at least one of the heart failure treatment delivery system or the heart failure treatment optimization system is configured to collect patient data to corroborate one or more risk scores (See id.).
Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Von Zitzewitz, in view of Soykan, in view of Aon, in view of Thakur and further in view of U.S. 2020/0297955 A1 to Shouldice, hereinafter “Shouldice.”
Regarding claim 5, Von Zitzewitz as modified by Soykan, Aon and Thakur teaches all the limitations of claim 1. Von Zitzewitz, Soykan, Aon and Thakur may not specifically describe, but Shouldice teaches wherein the heart failure treatment optimization system comprises an override mode to suspend the heart failure treatment regimen, the heart failure treatment delivery system comprises an override mode to suspend treatment administration, or both (See Shouldice at least at Paras. [0102]-[0103]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Von Zitzewitz, Soykan, Aon and Thakur to incorporate the teachings of Shouldice and provide an override mode to suspend a particular treatment. Shouldice is directed to systems for monitoring and the management of chronic disease. Incorporating the monitoring and treatment systems as in Shouldice with the heart failure management as in Thakur, the treatment compliance as in Aon, the health monitoring as in Soykan and the active closed-loop medical system for implantable sensors as in Von Zitzewitz would thereby improve the applicability, efficacy, and accuracy of the claimed heart failure treatment management system.
Regarding claim 14, Von Zitzewitz as modified by Soykan, Aon and Thakur teaches all the limitations of claim 1. Von Zitzewitz, Soykan, Aon and Thakur may not specifically describe, but Shouldice teaches wherein the heart failure treatment delivery system comprises a processor to transmit a request over a communication interface to deliver one or more drugs from a remote location based on the heart failure treatment regimen to store locally in the heart failure treatment delivery system (See id. at least at Paras. [0084]-[0085], [0179]; Fig. 1).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Von Zitzewitz, in view of Soykan, in view of Aon, in view of Thakur and further in view of U.S. 2004/0087864 A1 to Grouse, hereinafter “Grouse.”
Regarding claim 6, Von Zitzewitz as modified by Soykan, Aon and Thakur teaches all the limitations of claim 1. Von Zitzewitz, Soykan, Aon and Thakur may not specifically describe, but Grouse teaches wherein the heart failure treatment optimization system comprises a treatment regimen generator to provide the heart failure treatment regimen based on one or more risk scores (See Grouse at least at Paras. [0012], [0032]; Claim 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Von Zitzewitz, Soykan, Aon and Thakur to incorporate the teachings of Grouse and provide a treatment regimen based on a risk score. Grouse is directed to a method and apparatus for assessment and treatment of cardiac risk. Incorporating the cardiac risk system as in Grouse with the heart failure management as in Thakur, the treatment compliance as in Aon, the health monitoring as in Soykan and the active closed-loop medical system for implantable sensors as in Von Zitzewitz would thereby improve the applicability, efficacy, and accuracy of the claimed heart failure treatment management system.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Von Zitzewitz, in view of Soykan, in view of Aon, in view of Thakur, in view of U.S. 2018/0272066 A1 to McMahon et al., hereinafter “McMahon” and further in view of U.S. 2018/0358114 A1 to Schecter, hereinafter “Schecter.”
Regarding claim 9, Von Zitzewitz as modified by Soykan, Aon and Thakur teaches all the limitations of claim 1. Von Zitzewitz, Soykan, Aon and Thakur may not specifically describe, but McMahon teaches wherein the heart failure treatment optimization system comprises a treatment regimen generator to provide the heart failure treatment regimen based on a patient score determined based on at least one score selected from: a risk score indicating a decline in patient health; a treatment score indicating a difference between a physician-based treatment regimen and a current treatment regimen being administered to the patient (See McMahon at least at Paras. [0167]-[0169], [0181]; Fig. 18). Schecter further teaches a symptom score indicating patient symptoms not included in the patient data (See Schecter at least at Paras. [0127]-[0128]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Von Zitzewitz, Soykan, Aon and Thakur to incorporate the teachings of McMahon and Shecter and provide a treatment regimen determined based on a risk score, treatment score and symptom score. McMahon is directed to patient management systems and adherence recommendation methods. Schecter relates to optimizing management of patients with medical devices. Incorporating the patient management and adherence techniques of McMahon with the patient management as in Schecter, the heart failure management as in Thakur, the treatment compliance as in Aon, the health monitoring as in Soykan and the active closed-loop medical system for implantable sensors as in Von Zitzewitz would thereby improve the applicability, efficacy, and accuracy of the claimed heart failure treatment management system.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Von Zitzewitz, in view of Soykan, in view of Aon, in view of Narayan and further in view of U.S. 2017/0245794 A1 to Sharma et al., hereinafter “Sharma.”
Regarding claim 15, Von Zitzewitz discloses a heart failure treatment optimization system comprising: a sensor system comprises a non-implantable sensor and an implantable sensor to provide patient data about a patient or an environment related to the patient (See Von Zitzewitz at least atParas. [0008], [0011], [0028]-[0038], [0041], [0072]).
Von Zitzewitz may not specifically describe but Soykan teaches a data communication interface operably couplable to: the sensor system, the data communication interface configured to receive the patient data from the sensor system (See Soykan at least at Abstract; Paras. [0001]-[0002], [0012], [0191]-[0193], [0249], [0256]-[0259]). Soykan further teaches a heart failure treatment delivery system configured to administer a treatment based on a heart failure treatment regimen (See id. at least at Abstract; Paras. [0001]-[0002], [0012], [0191]-[0193], [0249], [0256]-[0259]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Von Zitzewitz to incorporate the teachings of Soykan and provide treatment based on a heart failure treatment regimen and compliance data. Soykan is directed to systems and methods for monitoring health conditions and treatments including for heart failure. Incorporating the health monitoring as in Soykan with the active closed-loop medical system for implantable sensors as in Von Zitzewitz would thereby improve the applicability, efficacy, and accuracy of the claimed heart failure treatment management system.
Von Zitzewitz as modified by Soykan may not specifically describe, but Aon teaches a system to provide treatment compliance data comprising whether the patient received the treatment (See Aon at least at Abstract; Paras. [0004]-[0010], [0034]-[0036], [0045], [0151]-[0162], [0181]-[0199]; Figs. 1-11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Von Zitzewitz and Soykan to incorporate the teachings of Aon and provide a treatment compliance data for whether a patient received treatment. Aon is directed to a treatment compliance system and method. Incorporating the treatment compliance as in Aon with the health monitoring as in Soykan and the active closed-loop medical system for implantable sensors as in Von Zitzewitz would thereby improve the applicability, efficacy, and accuracy of the claimed heart failure treatment management system.
Von Zitzewitz, Soykan and Aon may not specifically describe but Narayan teaches a memory configured to store data representing a risk score generator and a heart failure treatment regimen generator (See Narayan at least at Paras. [0142]-[0144], [0159]-[0168], [0201]-[0206]; Figs. 11, 12A, 12B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Von Zitzewitz, Soykan and Aon to incorporate the teachings of Narayan and provide generating a patient risk score. Narayan is directed to methods and systems for treating heart instability. Incorporating the heart treatment methods as in Narayan with the treatment compliance as in Aon, the health monitoring as in Soykan and the active closed-loop medical system for implantable sensors as in Von Zitzewitz would thereby improve the applicability, efficacy, and accuracy of the claimed heart failure treatment management system.
Von Zitzewitz, Soykan, Aon and Narayan may not specifically describe but Sharma teaches a processor operably coupled to the data communication interface and the memory, the processor configured to: update a patient score in response to administering a previous heart failure treatment based on a previous treatment regimen, wherein the patient score is based on the treatment compliance data and at least one score selected from the one or more risk scores, one or more treatment scores, and one or more symptom scores (See Sharma at least at Paras. [0076]-[0079]); determine an updated heart failure treatment regimen in response to the updated patient score and the previous heart failure treatment regimen (See id. at least at Abstract; Paras. [0020], [0110]-[0127]); and provide the updated heart failure treatment regimen to the treatment delivery system (See id. at least at Paras. [0062]-[0063], [0116]-[0119]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Von Zitzewitz, Soykan, Aon and Narayan to incorporate the teachings of Sharma and provide updating a patient risk score and determining a treatment regimen to be delivered. Sharma is directed to a medical system for seamless therapy adjustment. Incorporating the therapy adjustment techniques in Sharma with the heart treatment methods as in Narayan, the treatment compliance as in Aon, the health monitoring as in Soykan and the active closed-loop medical system for implantable sensors as in Von Zitzewitz would thereby improve the applicability, efficacy, and accuracy of the claimed heart failure treatment management system.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Von Zitzewitz, in view of Soykan, in view of Aon, in view of Narayan, in view of Sharma and further in view of U.S. 2020/0251213 A1 to Tran et al., hereinafter “Tran.”
Regarding claim 16, Von Zitzewitz as modified by Soykan, Aon, Narayan and Sharma teaches all the limitations of claim 15. Von Zitzewitz, Soykan, Aon, Narayan and Sharma may not specifically describe, but Tran teaches wherein the heart failure treatment regimen is configured to minimize the patient score to minimize at least one of a risk score, a treatment deviation, or a patient symptom (See Tran at least at Paras. [0482]-[0485]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Von Zitzewitz, Soykan, Aon, Narayan and Sharma to incorporate the teachings of Tran and provide to minimize a patient score or risk score. Tran is directed to a blockchain gene system. Incorporating the gene system as in Tran with the heart treatment methods as in Narayan, the therapy adjustment techniques in Sharma, the treatment compliance as in Aon, the health monitoring as in Soykan and the active closed-loop medical system for implantable sensors as in Von Zitzewitz would thereby improve the applicability, efficacy, and accuracy of the claimed heart failure treatment management system.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Von Zitzewitz, in view of Soykan, in view of Aon, in view of Narayan, in view of Sharma and further in view of Schecter.
Regarding claim 18, Von Zitzewitz as modified by Soykan, Aon Narayan and Sharma teaches all the limitations of claim 15. Von Zitzewitz, Soykan, Aon, Narayan and Sharma may not specifically describe but Schecter teaches wherein the processor is further configured to update the patient score based on patient corroboration of the one or more risk scores (See Schecter at least at Para. [0069]; Fig. 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Von Zitzewitz as modified by Soykan, Aon, Narayan and Sharma incorporate the teachings of Schecter and provide updating a treatment based on compliance. Schecter is directed to optimizing the management of patients with medical devices. Incorporating the patient management as in Schecter with the heart treatment methods as in Narayan with the therapy adjustment techniques in Sharma, the treatment compliance as in Aon, the health monitoring as in Soykan and the active closed-loop medical system for implantable sensors as in Von Zitzewitz would thereby improve the applicability, efficacy, and accuracy of the claimed heart failure treatment management system.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Von Zitzewitz, in view of Soykan, in view of Aon, in view of Narayan, in view of Sharma and further in view of U.S. 2004/0087864 A1 to Grouse, hereinafter “Grouse.”
Regarding claim 19, Von Zitzewitz as modified by Soykan, Aon, Narayan and Sharma teaches all the limitations of claim 15. Von Zitzewitz, Aon, Soykan, Narayan and Sharma may not specifically describe but Grouse teaches wherein the processor is further configured to initiate a physician contact process in response to determining that the updated heart failure treatment regimen is outside of the predetermined physician-limited parameter region (See Grouse at least at Abstract; Paras. [0050], [0118], [0121]; See also Aon at least at Abstract; Paras. [0010], [0035], [0045], [0099]-[0121], [0183]-[0184]; Figs. 7-11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Von Zitzewitz, Soykan, Aon, Narayan and Sharma to incorporate the teachings of Grouse and provide a treatment regimen within physician settings and contact if outside of a threshold. Grouse is directed to the assessment and treatment of cardiac risk. Incorporating the cardiac risk assessment and treatment as in Grouse with the heart treatment methods as in Narayan with the therapy adjustment techniques in Sharma, the adherence as in Aon, the health monitoring as in Soykan and the active closed-loop medical system for implantable sensors as in Von Zitzewitz would thereby improve the applicability, efficacy, and accuracy of the claimed heart failure treatment management system.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2013/0116666 A1 to Shih et al., hereinafter “Shih,” in view of U.S. 2016/0371462 A1 to Wallen et al., hereinafter “Wallen” and further in view of Aon.
Regarding claim 20, Shih teaches a heart failure treatment delivery system comprising: a plurality of receptacles, each receptacle to retain a different drug or a different dose (See Shih at least at Paras. [0005]-[0013], [0035]-[0045]; Fig. 3); one or more cartridges, each cartridge to contain a different drug, each cartridge comprising a different drug identifier associated with a different drug or different dose to load into a respective receptacle (See id.).
Shih may not specifically describe but Wallen teaches a controller configured to detect each drug identifier of the one or more cartridges and to transmit a request over a data communication interface of a new cartridge associated with a specific drug identifier in response to an updated treatment regimen (See Wallen at least at Paras. [0024]-[0026], [0031]-[0033], [0043]-[0044], [0049], [0058]-[0059], [0078]-[0079]; Figs. 1, 2A-D).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Shih to incorporate the teachings of Wallen and provide a drug identifier for each drug cartridge. Shih is directed to refilling drug devices. Wallen relates to a medication dispensing device and method. Incorporating the drug device refilling as in Shih with the medication dispensing and delivery techniques of Wallen would thereby improve the applicability, efficacy, and accuracy of the claimed heart failure treatment delivery system.
Aon teaches to provide an order to initiate delivery of a new cartridge (See Aon at least at Abstract; Paras. [0004]-[0036], [0042]-[0052], [0151]-[0162], [0181]-[0199]; Figs. 1-11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Shih and Wallen to incorporate the teachings of Aon and provide an order to deliver a medication. Aon is directed to a pill dispenser and treatment adherence system. Incorporating the treatment adherence and medication dispensing techniques of Aon with the drug device refilling as in Shih and the medication dispensing and delivery techniques of Wallen would thereby improve the applicability, efficacy, and accuracy of the claimed heart failure treatment delivery system.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Von Zitzewitz, in view of Soykan, in view of Aon and further in view of Sharma.
Regarding claim 21, Von Zitzewitz as modified by Soykan, Aon and Thakur teaches all the limitations of claim 1. Von Zitzewitz, Soykan, Aon and Thakur may not specifically describe, but Sharma teaches wherein the heart failure treatment optimization system comprises a risk score generator to provide a risk score based on the patient data from the sensor system (See Sharma at least at Abstract (seamless adjustment of treatment for heart failure); Paras. [0008], [0015], [0020], [0025]-[0028] (thresholds), [0030]-[0035] (heart failure risk and thresholds), [0046]-[0048] (generate risk score for heart failure from patient sensors), [0049] (rates of change for parameters over time), [0065]-[0083] (thresholds and risk and different rates of change and including heart rate) Figs. 1-6); and wherein the heart failure treatment optimization system is configured to determine a rate of change of the risk score and to update the heart failure treatment regimen in response to rate of change exceeding a particular threshold rate of change (See id.).
Aon further teaches risks based on and the treatment compliance data from the heart failure treatment delivery system (See Aon at least at Abstract; Paras. [0004]-[0010], [0034]-[0036] (“[T]he payer management server 195 updates the patient treatment profile data 170 based on the real-time medication adherence score 190, the measured patient physical parameters 125, and the prescription 145.”), [0045], [0151]-[0162], [0181]-[0199]; Figs. 1-11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Von Zitzewitz, Soykan and Thakur to incorporate the teachings of Sharma and Aon and provide a particular patient risk score and determining a treatment regimen to be delivered when a threshold is exceeded. Sharma is directed to a medical system for seamless therapy adjustment. Incorporating the therapy adjustment techniques in Sharma with the heart failure management as in Thakur, the treatment compliance as in Aon, the health monitoring as in Soykan and the active closed-loop medical system for implantable sensors as in Von Zitzewitz would thereby improve the applicability, efficacy, and accuracy of the claimed heart failure treatment management system.
Response to Arguments
Applicant’s response filed July 2, 2025 has been fully considered, but the arguments therein are not persuasive. The following explains why:
Applicant’s arguments pertaining to prior art rejections are not persuasive. The claims have been addressed with regard to the 35 U.S.C. §103 rejection discussed above. The arguments pertaining to prior art references of the Applicant’s Remarks at Pages 8-19 are not persuasive. The Examiner disagrees that the Von Zitzewitz reference is not appropriately applicable; it is in the same medical field of endeavor and does not disable or render useless the claimed invention. The references is relied on for implantable and non-implantable sensors, and can still be applied with other references. The Examiner disagrees that Aon does not read on the limitations, and Aon has been shown read on them (See explanations and quoted citations above). The physical decision tree of Aon, among other teachings, and the repercussions of it being followed for treatments reads on the broadly worded claims and under a broadest reasonable interpretation thereof. Whether a computing device “automatically” performs an action, and a computer performing an action as a matter of function after conditions are met is the same as “automatic” and the Applicant’s arguments are not persuasive. The Examiner respectfully disagrees that any of the recited art is not compliant or does not read on the current claims.
As such, it is submitted that the cited prior art, including those identified by Applicant, in the same field of endeavor, i.e., medical diagnostics and health sensing techniques teaches and/or suggests all of the limitations of the pending claims under a broad and reasonable interpretation thereof.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM T. MONTICELLO whose telephone number is (313)446-4871. The examiner can normally be reached M-Th; 08:30-18:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MARC Q. JIMENEZ can be reached at (571) 272-4530. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM T. MONTICELLO/ Examiner, Art Unit 3681
/MARC Q JIMENEZ/ Supervisory Patent Examiner, Art Unit 3681