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 .
DETAILED ACTION
The present Office Action is in response to the Request for Continued Examination dated 2 June 2026.
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed on 17 June 2026 in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2 June 2026 has been entered.
Response to Amendment
In the amendment dated 06/02/2026, Claims 1, 12-13, 15-17 and 19 have been amended; and claim 3, 14, 20 have been canceled.
In the preliminary amendment dated 10/6/2026, Claims 1, 12 and 17 have been further amended.
Claims 1-2, 4-13 and 15-19 are pending and have been examined.
Priority
Acknowledgement is made of applicant’s claim to priority under 35 U.S.C. 120, 121, 365(c), or 386(c) and 37 CFR 1.78 for a continuing application, which claims priority to U.S. Application 16/989,749 filed 08/10/2020 (issued Patent No. 12,033,753), which claims priority to U.S. Provisional Patent Application No. 62/951,963 filed 12/20/2019.
Subject Matter Eligibility - 35 U.S.C. § 101
In the previous Office action, the Applicant amended claim 14 to recite “the action is a signal transmitted to the medical device; and the medical device administers insulin responsive to the receipt of the signal”. The independent claims 1, 12 and 17 are amended in the preliminary amendment to incorporate the limitations of claim 14. The mobile device of the independent claims initiates delivery of an action, which is received by the medical device. The action transmitted by the mobile device is an action that causes the medical device to administer insulin to the patient, thus providing a practical application under subject matter eligibility analysis Step 2A2. That is, the mobile device controls the medical device operation of administering insulin, thereby improving another technology or technological field. As such, independent claims 1, 12 and 17 (and their dependents) are subject matter eligible.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this 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 §§ 706.02(1)(1) -706.02(1)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-l.jsp.
Claims 1, 12 and 17 are rejected on the grounds of non-statutory double patenting over claims 1-2, 12, 14 and 17 of Application No. 16/989,749 (reference Application ‘749) (issued Patent No. 12,033,753) in view of US 2016/0354039 A1 to Soto et al. and US 2018/0247712 A1 to Muhsin et al. Although the claims at issue are not identical, they are not patentably distinct from each other as set forth below.
Claims 1-2, 12, 14 and 17 of the ‘749 application recite similar limitations to independent claims 1, 12 and 17 of the instant Application. Claims 1, 12 and 17 of this application are rejected as being obvious variations of the claims of the ‘749 application in view of US 2016/0354039 A1 to Soto et al. and US 2018/0247712 A1 to Muhsin et al.
The Examiner has bolded the claim language that is the same between the claims of the instant application and corresponding claims of the issued reference Application ‘749.
Claims of Instant Application ‘929
Claims of Application ‘749
1. A method, comprising: receiving, by a mobile device wirelessly coupled to a medical device implanted in a person, data from the implanted medical device including threshold homeostasis levels from the person that establish the person’s baseline dataset, wherein the baseline dataset includes user family history, user health, habits of the user, identification data about the medical device, and geographic location data associated with the medical device, and wherein the baseline dataset is related to an operation of the implanted medical device performed on the person, wherein the implanted medical device is an insulin pump; configuring the mobile device with the threshold homeostasis levels; receiving different data from the implanted medical device, wherein the different data is received from the implanted medical device as the different data is generated by the implanted medical device; analyzing the data from the implanted medical device and the different data generated by the implanted medical device; receiving, by the mobile device and responsive to the analysis, the analyzed data from the implanted medical device; and initiating delivery, via a display of the mobile device, of an action at the mobile device based on the analyzed data from the implanted medical device and the different data generated by the implanted medical device, wherein the action is a signal transmitted to the implanted medical device; and the implanted medical device receiving the action and administering insulin to the person responsive to the receipt of the signal and based on the established trend, the analyzed data from the implanted medical device, the configured threshold homeostasis levels, and the different data generated by the implanted medical device.
1. A method, comprising:
receiving, by a mobile device comprising a smartwatch including a display and wirelessly coupled to a medical device implanted in a user, data from the implanted medical device, wherein the data is a part of a baseline dataset including threshold homeostasis levels from the user that establish the user’s baseline dataset and further including identification data about the medical device, user family history, medical device geographic location, a health of the user, and habits of the user, and wherein the baseline dataset is related to an operation of the implanted medical device performed on the user,
wherein the implanted medical device is an implantable cardioverter-defibrillator (ICD),
configuring the mobile device with the threshold homeostasis levels;
receiving different data from the implanted medical device, wherein the different data is received from the implanted medical device as the different data is generated by the implanted medical device;
analyzing, via comparison to the configured thresholds, the data from the implanted medical device and the different data generated by the implanted medical device in real time;
receiving, by the mobile device and responsive to the analysis, the analyzed data from the implanted medical device;
establishing a trend specific to the user of the implanted medical device based on the analyzed data from the implanted medical device and the different data generated by the implanted medical device;
receiving an action;
displaying, via the display of the smartwatch, the established trend;
initiating, via the display of the smartwatch, at the mobile device and absent user interaction with a display of the mobile device, a delivery of an action comprising an electric shock by the implanted medical device;
the implanted medical device receiving the action and administering the electric shock to the user based on the established trend, the analyzed data from the implanted medical device, the configured thresholds, and the different data generated by the implanted medical device; and
monitoring additional trends in the different data generated by the implanted medical device, comparing the configured thresholds of the baseline dataset to the different data and updating the different data in response to the baseline dataset falling within one trend of a group of additional trends;
utilizing the different data to determine that an emergency contact for the user should be notified; and
sending, via the mobile device, a notification to the emergency contact.
Also, Claim 14 recites “the action further comprises a signal transmitted to the medical device; and the medical device generates electricity responsive to the receipt of the signal.”
12. A system, comprising: a mobile device coupled to a memory device; the memory device comprising instructions executable to cause the mobile device to: receive data from a medical device coupled to the memory device, wherein the data includes threshold homeostasis levels from the person that establish the person’s baseline dataset related to the medical device and includes family history of the person, health of the person, habits of the person, identification data about the medical device, and location data associated with the medical device, and wherein the baseline dataset is related to an operation of the medical device performed on the person; receive different data from the medical device, wherein the different data is received from the medical device as the different data is generated by the medical device; analyze the data from the medical device and the different data generated by the medical device; receiving, by the mobile device and responsive to the analysis, the analyzed data from the implanted medical device and initiate delivery of an action based on the analyzed data from the medical device and the different data generated by the medical device, wherein the action is a signal transmitted to the medical device; and the medical device, comprising an insulin pump configured to: receive the action; and administer insulin responsive to the receipt of the signal based on the established trend, the analyzed data from the medical device, the threshold homeostasis levels, and the different data generated by the medical device.
1. supra.
12. A system comprising:
a mobile device comprising a smartwatch including a display and coupled to a memory device, the memory device comprising instructions executable to cause the mobile device to: receive data from a medical device comprising an implantable cardioverter-defibrillator (ICD) coupled to the memory device, wherein the data is a baseline related to the medical device and includes threshold homeostasis levels from the user that establish the baseline user health dataset and further includes identification data about the medical device, user family history, medical device geographic location, a health of the user, and habits of the user;
configure with the threshold homeostasis levels;
receive different data from the medical device, wherein the different data is received from the medical device as the different data is generated by the medical device;
analyze the data from the medical device and the different data generated by the medical device via comparison to the configured thresholds;
establish a trend specific to a user of the medical device based on the analyzed data from the medical device and the different data generated by the medical device;
displaying, via [[a]] the display of the smartwatch, the established trend; and
initiate delivery of an action, via the smartwatch display, to the medical device comprising an electric shock by the ICD based on the established trend, the analyzed data from the medical device, the configured thresholds, and the different data generated by the medical device;
the medical device configured to:
receive the action; and
administer the electric shock to the user based on the established trend, the analyzed data from the medical device, and the
different data generated by the medical device; and
the memory device configured to cause the mobile device to:
monitor additional trends in the different data generated by the implanted medical device, compare the configured thresholds of the baseline dataset to the different data and update the different data in response to the baseline dataset falling within one trend of a group of additional trends;
utilize the different data to determine that an emergency contact for the user should be notified; and
send a notification to the emergency contact.
See also claim 14, supra.
17. A system, comprising: a memory device coupled to a mobile device; a medical device comprising an insulin pump coupled to the mobile device, the medical device to provide information about the medical device to the mobile device, wherein the medical device is implantable; and a different memory device coupled to the mobile device to receive the information about the medical device from the mobile device; the mobile device configured to: receive data from the medical device, wherein the data includes threshold homeostasis levels from a person implanted with the medical device, is stored in the memory device as a baseline dataset related to the medical device and wherein the baseline data includes identification data about the medical device, family history of the person, medical device geographic location, a health of the person, and habits of the person; configure the mobile device with the threshold homeostasis levels; transmit the data from the medical device to the different memory device; receive different data from the medical device, wherein the different data is received from the medical device as the different data is generated by the medical device; transmit the different data from the medical device to the different memory device; receive analyzed data from the different memory device responsive to the different memory device performing an analysis on the data from the medical device and the different data generated by the medical device; initiate an action based on the analyzed data from the different memory device, wherein the action is a signal transmitted to the medical device; and update the baseline dataset based on the analyzed data, the action, or both; and
the medical device configured to: receiving the action; and administering insulin responsive to the receipt of the signal based on the established trend, the analyzed data from the implanted medical device, the configured threshold homeostasis levels, and the different data generated by the implanted medical device.
12. A system comprising:
a mobile device comprising a smartwatch including a display and coupled to a memory device, the memory device comprising instructions executable to cause the mobile device to: receive data from a medical device comprising an implantable cardioverter-defibrillator (ICD) coupled to the memory device, wherein the data is a baseline related to the medical device and includes threshold homeostasis levels from the user that establish the baseline user health dataset and further includes identification data about the medical device, user family history, medical device geographic location, a health of the user, and habits of the user;
configure with the threshold homeostasis levels;
receive different data from the medical device, wherein the different data is received from the medical device as the different data is generated by the medical device;
analyze the data from the medical device and the different data generated by the medical device via comparison to the configured thresholds;
establish a trend specific to a user of the medical device based on the analyzed data from the medical device and the different data generated by the medical device;
displaying, via [[a]] the display of the smartwatch, the established trend; and
initiate delivery of an action, via the smartwatch display, to the medical device comprising an electric shock by the ICD based on the established trend, the analyzed data from the medical device, the configured thresholds, and the different data generated by the medical device;
the medical device configured to:
receive the action; and
administer the electric shock to the user based on the established trend, the analyzed data from the medical device, and the different data generated by the medical device; and
the memory device configured to cause the mobile device to:
monitor additional trends in the different data generated by the implanted medical device, compare the configured thresholds of the baseline dataset to the different data and update the different data in response to the baseline dataset falling within one trend of a group of additional trends;
utilize the different data to determine that an emergency contact for the user should be notified; and
send a notification to the emergency contact.
2. … updating the baseline dataset based at least in part on the different data received from the implanted medical device, the action, or both.
See also claim 14, supra.
Soto et al. teaches a system causing an insulin pump to vary the amount of insulin the patient receives (para. 0055).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the method of detecting worsening heart failure of the reference claims of the instant application ‘929 to include a process by which a system varies the amount of insulin administered by an insulin pump and to use this information as part of systems and methods for utilizing wireless physiological sensors as taught by Soto, with the motivation of improving resource utilization, remote patient monitoring, and patient health outcomes (see Soto at Abstract and para. 0168).
Muhsin et al. teaches a different memory device (para. 0076 teaches the hub may include a large memory for storing some or all of the data it receives, processes, and/or associates with the patient, and/or communications it has with other devices and systems).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time of filing, to have modified the method of detecting worsening heart failure of the reference claims of the instant application ‘929 to include another memory device and to use this information as part of the system for displaying medical monitoring data as taught by Muhsin, with the motivation of improving patient monitoring efficiency and increasing the quality of patient care (see Muhsin at para. 0077, 0183, 0189).
Dependent claims 2-11, 13-16 and 18-19 recite similar limitations to dependent claims 2, 4-11, 13-16 and 18-20 of the ‘749 application and are also rejected as being obvious variations of the claims of the ‘749 application in view of Muhsin et al.
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 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, 4-9, 12-13 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Houben et al. (US 2011/0105860 A1; “Houben” herein) in view of Soto et al. (US 2016/0354039 A1; “Soto” herein).
Re. Claim 1, Houben teaches a method, comprising:
receiving, by a mobile device (24) wirelessly coupled to a medical device implanted in a person (16), data from the implanted medical device including threshold homeostasis levels from the person that establish the person’s baseline dataset, wherein the baseline dataset includes user family history, user health, habits of the user, identification data about the medical device, and geographic location data associated with the medical device, and wherein the baseline dataset is related to an operation of the implanted medical device performed on the person ([0036]-[0037] teach the programmer, which may be a hand-held computing device, retrieves physiological or diagnostic information from the IMD 16 via wireless communication (see [0041]). See also [0038]. Fig. 6, step 202 and [0108]-[0110] teach the IMD measures and records baseline heart rates and baseline respiration rates (threshold homeostasis levels), e.g., for a person at rest (see also [0116], [0124]), which are used to calculate a predetermined threshold zone 272 for the person at rest (see Figs. 7B, 9B). The Examiner notes that “the baseline dataset” includes non-functional descriptive information, which are not required for the claim to be met as they neither establish the baseline dataset nor relate to any operation of the IMD performed on the person.), […]; configuring the mobile device with the threshold homeostasis levels (claim 7 teaches the IMD is configured to compare the heart rate, respiration rate, and activity level to the predetermined threshold zone (necessarily configured). See also Fig. 6 step 210. [0123] teaches the functionalities may be provided by the programmer 24.); receiving different data from the implanted medical device, wherein the different data is received from the implanted medical device as the different data is generated by the implanted medical device (see again [0036]-[0038] (receiving). Fig. 6 step 208 and [0113]-[0114] teach the IMD 16 begins monitoring short term averages of heart rate, respiration rate and activity level for the patient (different data) … system 10 continues to monitor… unless and until one or more measurements are outside of the predetermined threshold zone… system 10 may continue to monitor… even after issuing an alert.); analyzing the data from the implanted medical device and the different data generated by the implanted medical device (Fig. 6 and [0113] teach, after reviewing or imputing the predetermined TZ stored in memory of system 10, the clinician may program the IMD 16 to begin monitoring at step 208… and comparing the monitored heart rate, respiration rate and activity level to the TZ (analyzing the data and the different data) at step 210.); receiving, by the mobile device and responsive to the analysis, the analyzed data from the implanted medical device (See again [0123] (the mobile device). Fig. 6, [0114] teach, in the event that one or more measurements of heart rate, respiration rate, and activity level of the patient are outside of the predetermined TZ, either IMD 16 or programmer 24 issues an alert (necessitates receiving the analyzed data). See also Fig. 9B and [0126].); and initiating delivery, via a display on the mobile device, of an action at the mobile device or the implanted medical device, or both, based on the analyzed data from the implanted medical device and the different data generated by the implanted medical device, wherein the action is a signal transmitted to the implanted medical device (Fig. 6, step 212 and [0114] teach in the event that one or more measurements are outside of the predetermined TZ, either IMD 16 or programmer 24 issues an alert to the patient (initiating delivery of an action) … in some examples, the alert may be… transmitted to another device associated with a clinician. [0106] teaches the programmer may send such a telemetry signal to the IMD 16. [0036] teaches the programmer 24 may be a handheld computing device, including a keypad and a display, that receives input from a user.); and […] based on the established trend, the analyzed data from the implanted medical device, the configured threshold homeostasis levels, and the different data generated by the implanted medical device (see previous citations. E.g., [0126] teaches exemplary data points 477 outside the predetermined TZ indicate that the patient is experiencing worsening heart failure and that a heart failure event, such as decompensation, may occur. See additionally [0025]-[0026].)
Houben does not teach
wherein the implanted medical device is an insulin pump; or
the implanted medical device receiving the action and administering the insulin to the person responsive to the receipt of the signal.
Soto teaches
wherein the baseline dataset includes user family history, user health, habits of the user, identification data about the medical device, and geographic location data associated with the medical device [not required] ([0119] teaches demographic data means descriptive information that could be used to characterize or classify a person in a statistically meaningful way, for example, age, smoking habits, income, geographic location, marital status, race (family history), gender, military service, or drinking habits. See Fig. 27B, 32 show patient health characteristics. [0173] teaches the patient may complete a survey that provides… demographic data, lifestyle, and goals. Fig. 1B and [0075] teach registering sensors… the registration information may include a unique sensor identifier, a unique patient identifier for the patient associated with the sensor, a sensor IP address (which may also serve as the unique sensor identifier), the sensor type and/or the data-type and units of measurements for the data provided by the sensor.);
wherein the implanted medical device is an insulin pump ([0055], [0057] teach an implanted insulin pump.); and
the implanted medical device receiving the action and administering the insulin to the person responsive to receipt of the signal ([0055], [0057] teach if the model execution indicates a patient is at a significantly heightened risk, e.g., of heart failure exacerbation, the system may generate an electronic notification and transmit the notification to one or more destinations, e.g., patient’s phone… the action may include altering the operation of a medical device (necessarily receiving the action) to rectify an adverse medical condition identified via the model execution… if the model execution predicts that a patient’s glucose levels will result in hypoglycemia, the system can cause an implanted insulin pump to vary the amount of insulin the patient receives (administering).)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the method of detecting worsening heart failure of Houben to include a system performing glucose monitoring, insulin delivery, and a sensor registration process and to use this information as part of systems and methods for utilizing wireless physiological sensors as taught by Soto, with the motivation of improving resource utilization, remote patient monitoring, and patient health outcomes (see Soto at Abstract and para. 0168).
Re. Claim 4, Houben/Soto teaches the method of claim 1, further comprising transmitting the analyzed data to a computing device, wherein the computing device is within a medical center (Houben Fig. 6, [0114] teaches in the event that one or more measurements are outside the predetermined threshold zone (the analyzed data), either IMD 16 or programmer 24 issues an alert… the alert may be transmitted to another device associated with a clinician or other user (a computing device). See additionally Houben [0120], [0123], computing devices 316.)
Re. Claim 5, Houben/Soto teaches the method of claim 1, further comprising transmitting the analyzed data to another mobile device corresponding to the person (Houben Fig. 6, [0114] teaches in the event that one or more measurements are outside the predetermined threshold zone (the analyzed data), either IMD 16 or programmer 24 issues an alert to the patient (mobile device)… the alert may be transmitted to another device (another mobile device) associated with a clinician or other user, i.e., the patient. See additionally Houben [0036], [0089].)
Re. Claim 6, Houben/Soto teaches the method of claim 1, further comprising: assessing a health of the person responsive to the analyzed data (Houben Fig. 6, [0113] teaches comparing monitored data to the predetermined threshold zone based on the measured baselines; an issuing an alert when the monitored data is not within the threshold zone (necessarily assessed)); and initiating an operation of the implanted medical device based on the assessment (Houben Fig. 6, [0114] teaches the IMD 16 or programmer 24 issues the alert to the patient.)
Re. Claim 7, Houben/Soto teaches the method of claim 1, further comprising: transmitting, from the mobile device, the data from the implanted medical device to a different memory device wirelessly coupled to the mobile device; transmitting, from the mobile device, the different data from the implanted medical device to the different memory device wirelessly coupled to the mobile device (Fig. 8 and [0121] teach the server 314 may monitor respiration rate, heart rate and activity level of the patient based on signals or information received from IMD 16 and/or programmer 24 via network 312 and compare the monitored levels to predetermined levels to detect worsening heart failure (transmitting the data and the different data). [0041] teaches wireless communication. See additionally [0123].); receiving, by the mobile device, analyzed data from the different memory device wirelessly coupled to the mobile device and responsive to the different memory device wirelessly coupled to the mobile device performing an analysis on the data from the implanted medical device (Fig. 6, step 204 and [0109]-[0111] teach calculate a predetermined threshold zone (TZ) as a function of the measured baselines (performing an analysis on the data). Fig. 6 and [0113] teach once calculated, store the predetermined TZ in memory… after reviewing or imputing the predetermined TZ stored in memory of system 10, the clinician may program the IMD 16 to begin monitoring… and comparing the monitored heart rate, respiration rate and activity level to the TZ (also performing an analysis on the data). Referring to teachings of [0121] and [0123], the Examiner interprets the server 314 as performing the comparison functionality. Fig. 1 and [0036]-[0037], [0121], [0123] teach the programmer retrieves the physiological or diagnostic information from the server 314.); and performing the action at the mobile device or the implanted medical device, or both, based on the analyzed data from the implanted medical device and the different data generated by the implanted medical device (Fig. 6, step 212 and [0114] teach in the event that one or more measurements are outside of the predetermined TZ (based on the analyzed data and different data), either IMD 16 or programmer 24 issues an alert to the patient (performs an action).)
Re. Claim 8, Houben/Soto teaches the method of claim 7, wherein the different memory device (314) wirelessly coupled to the mobile device (24) is located on a private cloud (312) and communicatively coupled to at least one of the implanted medical device (16), a computing device of a medical facility (316), or both (see claim 1 prior art rejection. Houben Fig. 8, [0041], [0120], [0123] teach an example system that includes elements coupled via a network 312 (cloud)… and communicating wirelessly. See also Houben [0122]. Soto [0009] teaches establishing a virtual private network. See also Soto [0190].)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the method of detecting worsening heart failure of Houben to include a sensor registration process and establishment of a virtual private network to use this information as part of systems and methods for utilizing wireless physiological sensors as taught by Soto, with the motivation of improving communication security, resource utilization, remote patient monitoring, and patient health outcomes (see Soto at Abstract and para. 0061, 0168).
Re. Claim 9, Houben/Soto teaches the method of claim 7, wherein the different memory device wirelessly coupled to the mobile device performs the analysis on the data by comparing the baseline dataset to the different data generated by the implanted medical device (see claims 1 and 7 prior art rejectons. Houben Fig. 6 and [0111], [0113] teach monitoring data and comparing the monitored data (the different data) to the threshold zone (performs the analysis), which is a function of the measured baselines (the baseline dataset). Houben [0120]-[0121], [0123] teaches the server 314 may be wirelessly coupled to the other elements of Fig. 8; and the server 314 may provide the functionalities, for example, monitor respiration rate, heart rate and activity level of the patient based on signals or information received from the IMD 16 and/or programmer 24 via network 312; and compare the monitored levels to predetermined levels to detect worsening heart failure of the patient.)
Re. Claim 12, Houben teaches a system, comprising:
a mobile device coupled to a memory device ([0036], [0089] teach a programmer 24, which may be a hand-held computing device, includes a memory 102); the memory device comprising instructions executable to cause the mobile device to (see [0091]): receive data from a medical device (16) coupled to the memory device, wherein the data includes threshold homeostasis levels from the person that establish the person’s baseline dataset related to the medical device and includes family history of the person, health of the person, habits of the person, identification data about the medical device, and location data associated with the medical device, and wherein the baseline dataset is related to an operation of the medical device performed on the person (Fig. 1 and [0036]-[0037] teach a system 10, wherein the programmer includes a memory; and retrieves physiological or diagnostic information from the IMD 16. See also [0038] and [0113]. Fig. 6, step 202 and [0108]-[0110] teach the IMD measures and records baseline heart rates and baseline respiration rates (threshold homeostasis levels), e.g., for a person at rest (see also [0116], [0124]), which are used to calculate a predetermined threshold zone 272 for the person at rest (see Figs. 7B, 9B). The Examiner notes that the data includes “family history…”, which are non-functional descriptive information that are not required for the claim to be met as they neither establish the baseline dataset nor relate to any operation of the IMD performed on the person.); receive different data from the medical device, wherein the different data is received from the medical device as the different data is generated by the medical device (see again [0036]-[0038] (receiving). Fig. 6 step 208 and [0113]-[0114] teach the IMD 16 begins monitoring short term averages of heart rate, respiration rate and activity level for the patient (different data) … system 10 continues to monitor… unless and until one or more measurements are outside of the predetermined threshold zone… system 10 may continue to monitor… even after issuing an alert.); analyze the data from the medical device and the different data generated by the medical device (Fig. 6 and [0113] teach, after reviewing or imputing the predetermined TZ stored in memory, the clinician may program the IMD 16 to begin monitoring… and comparing the monitored heart rate, respiration rate and activity level to the TZ (analyzing the different data). [0123] teaches the functionalities may be provided by the programmer 24.); receiving, by the mobile device and responsive to the analysis, the analyzed data from the medical device (See again [0123] (the mobile device). Fig. 6, [0114] teach, in the event that one or more measurements of heart rate, respiration rate, and activity level of the patient are outside of the predetermined TZ, either IMD 16 or programmer 24 issues an alert (necessitates receiving the analyzed data). See also Fig. 9B and [0126].) and initiate delivery of an action based on the analyzed data from the medical device and the different data generated by the medical device, wherein the action is a signal transmitted to the medical device (Fig. 6, step 212 and [0114] teach in the event that one or more measurements are outside of the predetermined TZ, either IMD 16 or programmer 24 issues an alert to the patient (initiating delivery of an action) … in some examples, the alert may be… transmitted to another device associated with a clinician. [0106] teaches the programmer may send such a telemetry signal to the IMD 16.); and […] based on the established trend, the analyzed data from the implanted medical device, configured threshold homeostasis levels, and the different data generated by the implanted medical device (see previous citations. E.g., [0126] teaches exemplary data points 477 outside the predetermined TZ indicate that the patient is experiencing worsening heart failure and that a heart failure event, such as decompensation, may occur. See additionally [0025]-[0026].)
Houben does not teach the medical device, comprising an insulin pump, to: receive the action; and administer insulin responsive to receipt of the signal to the person.
Soto teaches
wherein the data… includes family history of the person, health of the person, habits of the person, identification data about the medical device, and location data associated with the medical device [not required] ([0119] teaches demographic data means descriptive information that could be used to characterize or classify a person in a statistically meaningful way, for example, age, smoking habits, income, geographic location, marital status, race (family history), gender, military service, or drinking habits. See Fig. 27B, 32 show patient health characteristics. [0173] teaches the patient may complete a survey that provides… demographic data, lifestyle, and goals. Fig. 1B and [0075] teach registering sensors… the registration information may include a unique sensor identifier, a unique patient identifier for the patient associated with the sensor, a sensor IP address (which may also serve as the unique sensor identifier), the sensor type and/or the data-type and units of measurements for the data provided by the sensor.);
the medical device, comprising an insulin pump, to: receive the action; and administer insulin responsive to receipt of the signal to the person ([0055], [0057] teach an implanted insulin pump; and also teach if the model execution indicates a patient is at a significantly heightened risk, e.g., of heart failure exacerbation, the system may generate an electronic notification and transmit the notification to one or more destinations, e.g., patient’s phone… the action may include altering the operation of a medical device (necessarily receiving the action) to rectify an adverse medical condition identified via the model execution… if the model execution predicts that a patient’s glucose levels will result in hypoglycemia, the system can cause an implanted insulin pump to vary the amount of insulin the patient receives (administering).);
and additionally teaches analyze monitored data (Abstract teaches the models may be automatically executed in response to receiving certain types and/or amount of data, such as data received from one or more physiological remote sensors.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the method of detecting worsening heart failure of Houben to include a system performing glucose monitoring, insulin delivery, a sensor registration process, and additionally remote data analysis and to use this information as part of systems and methods for utilizing wireless physiological sensors as taught by Soto, with the motivation of improving resource utilization, remote patient monitoring, and patient health outcomes (see Soto at Abstract and para. 0168).
Re. Claim 13, Houben/Soto teaches the system of claim 12, wherein the medical device is an implantable medical device (see Houben [0017]), and the data from the medical device further comprises an identifier of the medical device, an identifier of the person, a medical facility associated with the medical device, or any combination thereof [not required] (see claim 12 prior art rejection. Houben [0118]-[0119] teaches the IMD 16 can calculate the predetermined threshold zone using additional factors. Soto Fig. 1B and [0075] teaches registering sensors… the registration information may include a unique sensor identifier, a unique patient identifier for the patient associated with the sensor, a sensor IP address (which may also serve as the unique sensor identifier), the sensor type and/or the data-type and units of measurements for the data provided by the sensor. The Examiner notes that the types of data are non-functional descriptive information, which are not required for the claim to be met.)
Re. Claim 15, Houben/Soto teaches the system of claim 12, wherein: the action is also an alarm; and the alarm is generated by the mobile device in the form of providing an audible signal, providing a vibration, providing an electronic communication, administering of insulin, or any combination thereof (Houben [0106], [0114] teaches the IMD 16 provides an alert by communicating with an external device, e.g., the programmer 24; and similarly, if the alert module is implemented in the programmer, the alert module 128 may cause the programmer to send a telemetry signal to the IMD 16 that causes the IMD 16 to generate an alert (alarm) … in response to communication from alert module 128, the programmer may emit a beeping sound, display a text prompt, vibrate, or cause buttons and/or screens to flash. See also Soto [0055], [0057], “notification”, “vary the amount of insulin”.)
Re. Claim 16, Houben/Soto teaches the system of claim 12, wherein: the action is a notification; and the notification is transmitted to a computing device and includes information about the medical device (Houben [0106] teaches IMD 16 or programmer 24 provides an alert by communicating with an external device, sends a telemetry signal to the receiving device, causes the receiving device to generate the alert (notification). Houben Fig. 8, [0033], [0121] teaches the alert may be… transmitted to another device associated with a clinician or other user, such as an alert transmitted to a server 314 and relayed to a physician via a computing device 316. Soto [0055] teaches the system-generated electronic notification may be in the form of an email, SMS, MMS… the action may include altering the operation of the medical device to rectify an adverse medical condition identified via the model execution.)
Claims 2, 10-11 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Houben in view of Soto and Muhsin et al. (US 2018/0247712 A1; “Muhsin” herein).
Re. Claim 2, Houben/Soto teaches the method of claim 1, further comprising: receiving, at a memory device (102) coupled to the mobile device (24), the baseline dataset; storing the baseline dataset including the part of the baseline dataset in the memory device coupled to the mobile device (Houben [0036]-[0037] teach the programmer retrieves the physiological or diagnostic information from the IMD 16. See also Houben [0038], [0113]. Houben Fig. 6 and [0108]-[0110] teach the IMD measures and records the baselines. See additionally Houben Figs. 9A-9B. Houben [0091] teaches the memory 102 stores… information (the baseline dataset) used by processor 100 and/or diagnostic 110 to provide the functionality ascribed to programmer 24.); and […] based at least in part on the different data received from the implanted medical device (the monitored data), the action (the issuing of an alarm), or both (see claim 1 prior art rejection).
Houben/Soto may not teach updating the baseline dataset.
Muhsin teaches updating the baseline dataset ([0006] teaches the settings user interface can be user-selectable to cause… to receive an updated setting (baseline)… which may comprise adjusting a limit of an alarm (updating). See Applicant’s disclosure at para. 0048.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time of filing, to have modified the method of detecting worsening heart failure of Houben/Soto to update settings and to use this information as part of the system for displaying medical monitoring data as taught by Muhsin, with the motivation of improving patient monitoring efficiency and increasing the quality of patient care (see Muhsin at para. 0077, 0183, 0189).
Re. Claim 10, Houben/Soto teaches the method of claim 9, further comprising […] responsive to the comparison of the baseline dataset to the different data generated by the implanted medical device (see claim 9 prior art rejection).
Houbin/Soto may not teach updating the baseline dataset.
Muhsin teaches update the baseline dataset ([0006] teaches the settings user interface can be user-selectable to cause… to receive an updated setting (baseline)… which may comprise adjusting a limit of an alarm. See Applicant’s disclosure at para. 0048.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time of filing, to have modified the method of detecting worsening heart failure of Houben/Soto to update settings and to use this information as part of the system for displaying medical monitoring data as taught by Muhsin, with the motivation of improving patient monitoring efficiency and increasing the quality of patient care (see Muhsin at para. 0077, 0183, 0189).
Re. Claim 11, Houben/Soto teaches the method of claim 9, further comprising […] responsive to the comparison of the baseline dataset to the different data generated by the implanted medical device (see claim 9 prior art rejection).
Houben/Soto may not teach refraining from updating the baseline dataset.
Muhsin teaches refraining from updating the baseline dataset ([0006] teaches the settings user interface can be user-selectable to cause… to receive an updated setting (baseline)… which may comprise adjusting a limit of an alarm (updating). See Applicant’s disclosure at para. 0048. Fig. 73C, [0308]-[0310] teach refraining from changing a setting (step 7354 = NO).)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time of filing, to have modified the method of detecting worsening heart failure of Houben/Soto to update settings or to not update settings associated with an external device based on received medical data and to use this information as part of the system for displaying medical monitoring data as taught by Muhsin, with the motivation of improving patient monitoring efficiency and increasing the quality of patient care (see Muhsin at para. 0077, 0183, 0189).
Re. Claim 17, Houben teaches a system, comprising:
a memory device coupled to a mobile device ([0036], [0089] teach a programmer 24, which may be a hand-held computing device, includes a memory 102);
a medical device […] coupled to the mobile device (see Fig. 8 and [0041]), the medical device to provide information about the medical device to the mobile device (see below), wherein the medical device is implantable ([0017], “implantable medical device (IMD)”); and
a different memory device (314) coupled to the mobile device (see Fig. 8) to receive the information about the medical device from the mobile device (see below);
the mobile device configured to: receive data from the medical device (16), wherein the data includes threshold homeostasis levels from a person implanted with the medical device, is stored in the memory device as a baseline dataset related to the medical device, and wherein the baseline data includes identification data about the medical device, family history of the person, medical device geographic location, a health of the person, and habits of the person (Fig. 6, step 202 and [0108]-[0110] teach the IMD measures and records baseline heart rates and baseline respiration rates (threshold homeostasis levels), e.g., for a person at rest (see also [0116], [0124]), which are used to calculate a predetermined threshold zone 272 for the person at rest (see Figs. 7B, 9B). Fig. 1 and [0036]-[0037] teach the programmer retrieves physiological or diagnostic information from the IMD 16. See also [0038], [0113]. [0091] teaches the memory 102 stores… information (a baseline dataset) used by processor 100 and/or diagnostic unit 110 to provide the functionality ascribed to programmer 24. The Examiner notes that “the baseline data” includes non-functional descriptive information, which are not required for the claim to be met as they are neither stored nor used for configuration.); configure the mobile device with the threshold homeostasis levels (claim 7 teaches the IMD is configured to compare the heart rate, respiration rate, and activity level to the predetermined threshold zone (necessarily configured). See also Fig. 6 step 210. [0123] teaches the functionalities may be provided by the programmer 24.); transmit the data from the medical device to the different memory device (Fig. 8 and [0121] teach the server 314 may monitor respiration rate, heart rate and activity level of the patient based on signals or information received from IMD 16 and/or programmer 24 via network 312. See additionally [0123].); receive different data from the medical device, wherein the different data is received from the medical device as the different data is generated by the medical device (see again [0036]-[0038] (receiving). Fig. 6 step 208 and [0113]-[0114] teach the IMD 16 begins monitoring short term averages of heart rate, respiration rate and activity level for the patient (different data) … system 10 continues to monitor… unless and until one or more measurements are outside of the predetermined threshold zone… system 10 may continue to monitor… even after issuing an alert.); transmit the different data from the medical device to the different memory device (Fig. 8 and [0121] teach the server 314 may monitor respiration rate, heart rate and activity level of the patient based on signals or information received from IMD 16 and/or programmer 24 via network 312. See additionally [0123].); receive analyzed data from the different memory device responsive to the different memory device performing an analysis on the data from the medical device and the different data generated by the medical device (Fig. 6, step 204 and [0109]-[0111] teach calculate a predetermined threshold zone (TZ) as a function of the measured baselines (performing an analysis on the data). Fig. 6 and [0113] teach once calculated, store the predetermined TZ in memory… after reviewing or imputing the predetermined TZ stored in memory of system 10, the clinician may program the IMD 16 to begin monitoring… and comparing the monitored heart rate, respiration rate and activity level to the TZ (also analyzing the different data). Referring to teachings of [0121] and [0123], the Examiner interprets the server 314 as performing the comparison functionality. Fig. 1 and [0036]-[0037], [0121], [0123] teach the programmer retrieves the physiological or diagnostic information from the server 314.); initiate an action based on the analyzed data from the different memory device, wherein the action is a signal transmitted to the medical device (Fig. 6, step 212 and [0114] teach in the event that one or more measurements are outside of the predetermined TZ, either IMD 16 or programmer 24 issues an alert to the patient (initiate) … in some examples, the alert may be… transmitted to another device associated with a clinician. [0106] teaches the programmer may send such a telemetry signal to the IMD 16.); and […] based on the analyzed data, the action, or both (see previous citations); and
[…] based on the established trend, the analyzed data from the implanted medical device, the configured threshold homeostasis levels, and the different data generated by the implanted medical device (see previous citations. E.g., [0126] teaches exemplary data points 477 outside the predetermined TZ indicate that the patient is experiencing worsening heart failure and that a heart failure event, such as decompensation, may occur. See additionally [0025]-[0026].)
Houben does not teach
the medical device comprising an insulin pump;
update the baseline dataset…; or
the medical device to: receive the action; and administer insulin responsive to receipt of the signal to the person.
Soto teaches
the baseline data includes identification data about the medical device, family history of the person, medical device geographic location, a health of the person, and habits of the person [not required] ([0119] teaches demographic data means descriptive information that could be used to characterize or classify a person in a statistically meaningful way, for example, age, smoking habits, income, geographic location, marital status, race (family history), gender, military service, or drinking habits. See Fig. 27B, 32 show patient health characteristics. [0173] teaches the patient may complete a survey that provides… demographic data, lifestyle, and goals. Fig. 1B and [0075] teach registering sensors… the registration information may include a unique sensor identifier, a unique patient identifier for the patient associated with the sensor, a sensor IP address (which may also serve as the unique sensor identifier), the sensor type and/or the data-type and units of measurements for the data provided by the sensor.);
the medical device comprising an insulin pump ([0055], [0057] teach an implanted insulin pump.); and
the medical device to: receive the action and administer insulin responsive to receipt of the signal to the person ([0055], [0057] teach if the model execution indicates a patient is at a significantly heightened risk, e.g., of heart failure exacerbation, the system may generate an electronic notification and transmit the notification to one or more destinations, e.g., patient’s phone… the action may include altering the operation of a medical device (necessarily receiving the action) to rectify an adverse medical condition identified via the model execution… if the model execution predicts that a patient’s glucose levels will result in hypoglycemia, the system can cause an implanted insulin pump to vary the amount of insulin the patient receives (administering).)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the method of detecting worsening heart failure of Houben to include a system performing glucose monitoring, insulin delivery, and a sensor registration process and to use this information as part of systems and methods for utilizing wireless physiological sensors as taught by Soto, with the motivation of improving resource utilization, remote patient monitoring, and patient health outcomes (see Soto at Abstract and para. 0168).
Houben/Soto may not teach update the baseline dataset.
Muhsin teaches update the baseline dataset ([0006] teaches the settings user interface can be user-selectable to cause… to receive an updated setting (baseline)… which may comprise adjusting a limit of an alarm. See Applicant’s disclosure at para. 0048.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time of filing, to have modified the method of detecting worsening heart failure of Houben/Soto to update settings and to use this information as part of the system for displaying medical monitoring data as taught by Muhsin, with the motivation of improving patient monitoring efficiency and increasing the quality of patient care (see Muhsin at para. 0077, 0183, 0189).
Re. Claim 18, Houben/Soto/Muhsin teaches the system of claim 17, wherein: the mobile device is a smartwatch including a display; and the action is initiated via the display (Soto [0058], [0246] teaches the user terminals described herein may be in the form of a networked watch / a smartwatch… The user terminals may optionally include displays, etc. Houben [0090], [0098], [0106] teaches providing the alert via user interface 104, which may include a display.)
Re. Claim 19, Houben/Soto/Muhsin teaches the system of claim 18, wherein the medical device is implanted in a person (Houben [0026] teaches IMD 16 may be implanted) and the action is also an alarm of the smartwatch worn by the person (Houben [0090], [0098], [0106] teaches providing the alert (alarm action) via the programmer 24 user interface 104. Soto [0058], [0246] teaches the user terminal may be a smartwatch. Houben [0106], [0114] teaches the IMD 16 provides an alert by communicating with an external device, e.g., the programmer 24; and similarly, if the alert module is implemented in the programmer, the alert module 128 may cause the programmer to send a telemetry signal to the IMD 16 that causes the IMD 16 to generate an alert (alarm) … in response to communication from alert module 128, the programmer may emit a beeping sound, display a text prompt, vibrate, or cause buttons and/or screens to flash. See also Soto [0055], [0057], “notification”, “vary the amount of insulin”.)
Response to Arguments
Double Patenting Rejection
The rejection of canceled claims 3, 14 and 20 is rendered moot. The rejection of pending claims 1-2, 4-13, 15-19 is updated as afforded by RCE and respectfully maintained.
Rejections under 35 U.S.C. §112(b)
Re. the rejection of claims 12-19, the Applicant has canceled claim 14, rendering this rejection moot. Regarding the remaining claims 12-13 and 15-19, the Applicant has amended these to overcome the issues of indefiniteness. The rejections under 112(b) are withdrawn.
Rejection under 35 U.S.C. §103
Regarding the rejection of claims 1-19, the Applicant has cancelled claims 3 and 14, rendering the rejection of this moot. Regarding the remaining claims 1-2, 4-13 and 15-19, the Examiner has considered the Applicant’s arguments but does not find them persuasive for at least the following reasons. Applicant argues:
Re. “Houben is neither cited for nor does it describe data from the implanted medical device including threshold homeostasis levels from the person that establish the person's baseline dataset, wherein the baseline dataset includes user family history, user health, habits of the user, identification data about the medical device, and geographic location data associated with the medical device, as provided by Applicant's independent claims 1 and 12, as amended…” (emphasis omitted) (Remarks, pg. 12):
The Examiner respectfully submits the basis of rejection as afforded by RCE. Given the broadest reasonable interpretation (BRI) and in light of the specification, Houben, Soto, and/or Muhsin teach or render obvious each and every claim feature. The Examiner notes that while the claims utilize the patient’s threshold homeostasis levels (i.e., resting physiological baselines), they do not utilize the user family history, user health, user habits, identification data about the medical device, or geographic location data associated with the medical device. These types of data are not stored or used for configuration. They neither establish the baseline dataset nor relate to any operation of the IMD performed on the person. Regardless, Soto teaches these data types, such that Houben in view of Soto renders obvious the use of additional factors to calculate the predetermined threshold zone for a person at rest. (see also Houben para. 0119).
Re. the rejection of claims 2, 4-13 and 15-19, the Applicant has not offered any arguments with respect to these claims other than to reiterate the argument(s) present for analogous claim 1 or claim(s) from which they depend. As such, the rejection of these claims is also respectfully maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Degen et al. (US 2018/0060520) for teaching systems and methods for managing and analyzing data generated by an implantable device (see Abstract) including detailed message information about a medical device operation status (see Fig. 9, [0073]).
Fischell et al. (US 2011/0054264) for teaching systems and methods of alarm validation and backup in implanted medical devices.
Boute et al. (US 2010/0010832) for teaching system and method for the diagnosis and alert of a medical condition initiated by patient symptoms.
Taub et al. (US 2009/0299152) for teaching method and apparatus for providing glycemic control.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jessica M Webb whose telephone number is (469)295-9173. The examiner can normally be reached Mon-Thurs 9:30am-3:30pm CST.
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/J.M.W./Examiner, Art Unit 3683
/CHRISTOPHER L GILLIGAN/Primary Examiner, Art Unit 3683
