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 .
The current application has the effective filing date of 11/07/2022 according to the priority chain on the record.
Claim Status
As per applicant’s amendment received on 04/23/2026, claims 1, 8, 10-11, 13, 16, 18-21, 23-24, 29 and 46-52 are pending; claims 2-7, 9, 12, 14-15, 17, 22, 25-28 and 30-34 have been cancelled. All pending claims have been amended.
Response to Amendment
The 35 USC 112(d) rejection to claims 8, 10, 11 and 15 are withdrawn in view of current claim amendments.
As for the 35 USC 101 rejection, the rejection is withdrawn in view of current claim amendments.
As for the 35 USC 102 and 103 rejections, the applicants’ arguments have been fully considered in view of the current claim amendments. But the arguments are moot in view of new grounds of rejections below.
Claim Interpretation
With regard to claim 1 limitation “a communication interface configured to receive hemodynamic data from a controller of a first heart pump system and medical data from a patient monitoring device”; under the broadest reasonable interpretation, the “first heart pump system” and “patient monitoring device” are not positively recited features, but are functional features of the recited “auxiliary monitor” being “configured to receive hemodynamic data… and medical data…” As such, this limitation is met when a reference teaches a communication interface capable of receiving data.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 8, 10, 13, 16, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Degen et al. US 2018/0060520 A1 (hereinafter “Degen”).
PNG
media_image1.png
470
817
media_image1.png
Greyscale
Regarding claim 1, Degen discloses an auxiliary monitor (control device 60) for a patient monitoring system (Fig.1), the auxiliary monitor (60, exemplary as shown in Fig.4 and [0049]) comprising:
a communication interface (Fig. 4: transceiver 65; [0049]; also see communication network as shown in Fig. 1) configured to receive hemodynamic data (e.g. pump operational data) from a controller of a first heart pump system (implantable device 15 has an electromechanical pump 15, see [0038], see “Claim Interpretation” section above) and medical data from a patient monitoring device (implantable device 15 and 20 has a plurality of sensor for detecting physiological data, see [0040-0042, 0066]; see “Claim Interpretation” section above); and
at least one computer processor (Fig.4: processor 61) programmed to:
display in a first portion (Fig. 9: 74; also see [0073-0074]) of a user interface (graphical user interface 61), an indication of the hemodynamic data (i.e. operational data of pump, see Fig. 9 and also see [0044:3rd to last sentence]);
display in a second portion (Fig.9: 73) of the user interface (61), an indication of the medical data (physiological data, see [0072]);
process the hemodynamic data and the medical data to generate heart health data indicative of a heart health of a patient (analysis steps are discussed in Fig.7 and [0066]); and
display in a third portion (see Fig.9 bottom: box 78) of the user interface (61), an indication of the heart health data ([0078, 0079] graphical representation of health condition shown in box 78; also see [0084-0088] analysis pertaining to heart health/condition).
Note: With regard to “hemodynamic data”, Degen teaches the implantable device 15 comprising an electromechanical pump, see incorporation by reference to US Pat. 9,039,652 for detail (see Degen [0012] for incorporation details). “The pump may be an electromechanical pump designed to move fluid from one body cavity to another body cavity, e.g. a first body cavity to a second body cavity” ([0038]) This is taken to encompass first heart pump system” in the claim based on broadest reasonable interpretation.
Regarding claim 8, Degen discloses the auxiliary monitor of claim 1, wherein
the communication interface is further configured to receive operational data (Fig. 9: operation data box) for the first heart pump system ([0073-0074]) from the controller of the first heart pump system (implantable pump 15),
the at least one computer processor (61) is further programmed to determine a recommendation to change an operation of the first heart pump system based at least in part, on the heart health data and the operational data ([0079] “…clinician graphic user interface 71 may display a warning that the pump experienced a malfunction such as a clog and may even suggest methods for fixing the problem such as reversing flow direction…”; this is a recommendation), and
the indication of the heart health data includes the recommendation (see immediately above).
Regarding claim 10, Degen discloses the auxiliary monitor of claim 1, wherein the medical data includes vital signs measured by the patient monitoring device. (see Fig.9: 73, physiological data include blood pressure, respiratory rate, temperature, heart rate; also see [0042])
Regarding claim 13, Degen discloses the auxiliary monitor of claim 1, wherein the heart health data includes a likelihood of heart failure for the patient. ([0054] “…generation of analyst data which may include a diagnosis a medical condition and/or an indication a heightened risk of a medical condition.” Also see [0086] “…compare data generated by implantable device 15 to various trends to determine the risk of a given condition or medical event. If a risk of a medical condition or event is determined to be high, the instructions may also generate a warning of the risk…” In here, the discussed risk is taken to encompass “likelihood” in the claim. Also see [0085] mentions detecting for heart failure condition)
Regarding claim 16, Degen discloses the auxiliary monitor of claim 1, wherein the at least one computer processor is further programmed to:
issue a request via the communication interface (65) to the controller of the first heart pump system (implantable pump 15) and/or the patient monitoring device (implantable sensors 15), the request including a request for the hemodynamic data and/or the medical data, wherein the communication interface is configured to receive the hemodynamic data and/or the medical data in response to the request. ([0046] “Microprocessor 41 may include firmware having instructions stored on non-transitory computer readable medium configured for receiving command inputs from monitoring control device 60 and/or mobile device 80 and for transmitting those command inputs to implantable device 15”)
Regarding claim 19, Degen discloses at least one storage device (remote server 95) configured to store one or more of the hemodynamic data, the medical data, or the heart health. ([0052: 1st sentence] “Remote server 95, as shown in FIG. 1, may receive physiological and/or operational data generated by implantable device 15 and may store the physiological and/or operational data”)
Regarding claim 20, Degen discloses at auxiliary monitor of claim 1, wherein the heart health data derived from the hemodynamic data and/or the medical data includes historical data associated with the first heart pump system and/or the patient monitoring device. (box 78 is a graphical representation of health condition, see [0078] “Graphic representation 78 may be generated by the physician to analyze a given parameter over a certain period of time. ” This implicitly teaches a historical data since the illustrated parameter is over a certain period of time. Alternatively, see [0020] “The analyst data may include trends in the data and may compare the operational and/or physiological data to past data received from that individual's implantable device and/or to data from other implantable devices.” This indicated past/historic data is considered.)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Degen as applied to claim 1 above.
Regarding claim 11, Degen discloses the auxiliary monitor of claim 1, Degen does not explicitly disclose wherein the medical data includes information describing operation of a second controller of a second heart pump system. Degen discloses receiving operational data and physiological data from the patient’s own implantable device/sensors, and also data from other implantable devices for the purposes of establishing thresholds and for comparison purposes (see [0020] “The analyst data may include trends in the data and may compare the operational and/or physiological data to past data received from that individual's implantable device and/or to data from other implantable devices.”). This way, it would have been obvious to a person of ordinary skill in the art at the time of invention to modify Degen, so as to further receive data from a second controller of a second heart pump system (belonging to the same or another patient), the motivation for doing so is for comparison of thresholds and/or operational parameters (Degen [0019: last sentence]: “… the implantable device may communicate operational data and/or physiological data to the other devices within the system and similarly the other devices within the system may wirelessly communicate operational parameters and/or instructions to the implantable device.”)
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Degen as applied to claim 1 above, and further in view of Ramesh et al. US 2019/0046037 A1 (hereinafter “Ramesh”, cited in PTO-892 dated 01/23/2026).
Regarding claim 18, Degen discloses the auxiliary monitor of claim 1, wherein the communication interface coupled with the controller of the first heart pump system and the patient monitoring device via short-range wireless, e.g. Bluetooth™, Zigbee™, and also long-range wireless, e.g. Wi-Fi, GSM; but Degen does not disclose wherein the commination interface is configured to be connected to a connectivity gateway, the connectivity gateway communicatively coupling the communication interface to the controller of the first heart pump system and the patient monitoring device.
Ramesh, another prior art reference in the analogous art of health monitoring system comprising various sensing nodes joining to a patient’s body, sensing vital characteristics and employing transmission circuitry for transmitting sensed data by a short-range network, and a local gateway having wireless circuitry receiving transmitted data from the sensor nodes, for further transmission of the sensed and processed data over a long-range network (abstract, [0011, 0077-0078]). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Degen in view of Ramesh, so as to employ a local connectivity gateway, for receiving data from implantable devices via short-range wireless communication, and to further transmit data over a long-range wireless communication to a remote server; the advantages of employing a connectivity gateway include: 1) bridging between short-range and long-range communication protocols, and 2) the gateway device can serve multiple patients in the same household or adjacent households (Ramesh: [0126-0127]).
Claims 21-24 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Degen (cited above), in view of Marseille et al. US 2015/0038771 A1 (hereinafter “Marseille”), and Ramesh (cited above).
Regarding claim 21, Degen discloses a patient monitoring system (Fig. 1), comprising:
a first heart pump system (implantable device 15; as shown in Fig.2) comprising an implantable pump ([0038] electromechanical pump designed to move fluid from one body cavity to another body cavity) and a controller configured to control operation of the implantable pump (Fig.2: microprocessor 22, [0039-0040]);
a patient monitoring device (implantable sensors 15 and also implantable device 20, see [0041, 0042, 0066] physiological sensors, e.g. humidity, temperature, blood pressure, respiratory rate, heart rate, accelerometer);
an auxiliary monitor (control device 60; as shown in Fig. 4) comprising at least one computer processor (processor 61) and a display (implicitly taught, as shown in Fig. 1; see [0059]), wherein the at least one computer processor is programmed to:
display in a first portion (Fig. 9: 74; also see [0073-0074]) of a user interface (graphical user interface 61), an indication of the hemodynamic data (i.e. operational data of pump, see Fig. 9 and also see [0044:3rd to last sentence]);
display in a second portion (Fig.9: 73) of the user interface (61), an indication of the medical data (physiological data, see [0072]);
process the hemodynamic data and the medical data to generate heart health data indicative of a heart health of a patient (analysis steps are discussed in Fig.7 and [0066]); and
display in a third portion (see Fig.9 bottom: box 78) of the user interface (61), an indication of the heart health data ([0078, 0079] graphical representation of health condition shown in box 78; also see [0084-0088] analysis pertaining to heart health/condition).
Degen does not explicitly disclose wherein the first pump system (15) is a heart pump. Marseille, another prior art reference in the analogous art teaches a fluid flow system for a patient comprising a controller and an implantable heart pump (as shown in Fig. 1: pump 50 and controller 100; [0065-0068]); the heart pump comprising additional sensors for detecting operational parameters and physiological data ([0066, 0068, 0086]). The pump system communications wirelessly with a local processing device 400, with a communications network 600, and with a remote monitoring server device 300 (Fig.1, [0065]). It would have been obvious to a person of ordinary skill in the art at the time of invention to replace Degen’s implantable electromechanical pump with a heart pump assembly, such as disclosed in Marseille; the motivation for doing so is because: 1) Degen provides a system that can be adapted for use with a heart pump system (Degen; [0038:1st sentence] “Implantable device 15 further may include hardware for treating a medical condition subcutaneously such as a pump”), and 2) Marseille generally discloses an ambulatory implantable system having the an analogous communications infrastructure to that of Degen (Degen: Fig.1 and Marseille: Fig. 1)
Degen discloses the auxiliary monitor of claim 1, wherein the communication interface coupled with the controller of the first heart pump system and the patient monitoring device via short-range wireless, e.g. Bluetooth™, Zigbee™, and also long-range wireless, e.g. Wi-Fi, GSM; but Degen does not disclose wherein the patient monitoring system comprises a connectivity gateway configured to communicatively couple the controller and the patient monitoring device to the auxiliary monitor.
Ramesh, another prior art reference in the analogous art of health monitoring system comprising various sensing nodes joining to a patient’s body, sensing vital characteristics and employing transmission circuitry for transmitting sensed data by a short-range network, and a local gateway having wireless circuitry receiving transmitted data from the sensor nodes, for further transmission of the sensed and processed data over a long-range network (abstract, [0011, 0077-0078]). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Degen in view of Ramesh, so as to employ a local connectivity gateway, for receiving data from implantable devices via short-range wireless communication, and to further transmit data over a long-range wireless communication to a remote server; the advantages of employing a connectivity gateway include: 1) bridging between short-range and long-range communication protocols, and 2) the gateway device can serve multiple patients in the same household or adjacent households (Ramesh: [0126-0127]).
Regarding claim 23, Degen modified disclose the patient monitoring system of claim 21, but none of Degen, Marseille and Ramesh explicitly disclose wherein the medical data includes information describing operation of a second controller of a second heart pump system. However, Degen further discloses receiving operational data and physiological data from the patient’s own implantable device/sensors, and also data from other implantable devices for the purposes of establishing thresholds and for comparison purposes (see [0020] “The analyst data may include trends in the data and may compare the operational and/or physiological data to past data received from that individual's implantable device and/or to data from other implantable devices.”). This way, it would have been obvious to a person of ordinary skill in the art at the time of invention to modify Degen, so as to further receive data from a second controller of a second heart pump system (belonging to the same or another patient), the motivation for doing so is for comparison of thresholds and/or operational parameters (Degen [0019: last sentence]: “… the implantable device may communicate operational data and/or physiological data to the other devices within the system and similarly the other devices within the system may wirelessly communicate operational parameters and/or instructions to the implantable device.”)
Regarding claim 24, Degen modified discloses the patient monitoring system of claim 23, a third patient monitoring device (Degen: [0041] “Physiological data is indicative of the physiological state of the patient and also may be generated by sensors incorporated into system 10.” This is taken to encompass “third patient monitoring device” in the claim) communicatively coupled to the auxiliary monitor (60) via the connectivity gateway (see rejection to claim 21), wherein the third patient monitoring device comprises a patient monitor configured to monitor vital signs of a patient. Alternatively, Ramesh discloses the health monitoring system comprising a plurality of sensing nodes adapted for sending vital characteristics, it would have been further obvious to modify Degen to further include a sensor node in view of Ramesh, the motivation for doing so is to provide detection of additional physiological parameters that is not provided in Degen’s implantable pump/sensor 15. (Ramesh: [0011, 0047])
Regarding claim 52, Degen modified further discloses the patient monitoring system of claim 21, wherein the at least one computer processor (61) is further programmed to determine an alert (Degen: Fig. 9: warning 79) based at least in part on the heart health data, wherein the alert includes a recommendation to change an operation of the first heart pump system, and wherein the indication of the heart health data comprises the alert. (Degen” [0079] “…clinician graphic user interface 71 may display a warning that the pump experienced a malfunction such as a clog and may even suggest methods for fixing the problem such as reversing flow direction…”; this is a recommendation)
Claims 29 and 46-51 are rejected under 35 U.S.C. 103 as being unpatentable over Degen (cited above) in view of Marseille (cited above).
Regarding claim 29, Degen discloses a method (see abstract) of monitoring heart health of a patient using an auxiliary monitor (control device 60 and/or data analyst device 100), the method comprising:
receiving, from a first pump system (implantable device 15 has an electromechanical pump 15, see [0038],), first data associated with operation of the first pump system (e.g. pump operational data; “[0041] Operational data is indicative of the operation of implantable device 15 and/or hardware incorporated into implantable device 15 and may be generated by sensors incorporated into implantable device 15” also see [0042]);
receiving, from a cardiac support device (implantable device 15 and implantable device 20 has a plurality of sensor for detecting cardiac data, e.g. ECG, heart rate, blood pressure, see [0040-0042, 0066]), second data associated with operation of the cardiac support device ([0041] “[0041] Operational data is indicative of the operation of implantable device 15 and/or hardware incorporated into implantable device 15 and may be generated by sensors incorporated into implantable device 15”);
processing the first data and the second data to generate third data, the third data indicative of a heart health of the patient (analysis steps are discussed in Fig.7 and [0066], the output of the analysis is taken to encompass “heart health” in the claim, also see [0084-0088] analysis pertaining to heart health/condition);
displaying, on a first portion (Fig. 9: 74; also see [0073-0074]) of a user interface (graphical user interface 61) of the auxiliary monitor (60), an indication of the first data (i.e. operational data of pump, see Fig. 9 and also see [0044:3rd to last sentence]);
displaying, on a second portion (Fig.9: 73) of the user interface (61), an indication of the second data (physiological data, see [0072]); and
displaying, on a third portion (see Fig.9 bottom: box 78) of the user interface (60), an indication of the third data ([0078, 0079] graphical representation of health condition shown in box 78, also see [0084-0088] analysis pertaining to heart health/condition).
Degen does not explicitly disclose wherein the first pump system (15) is a heart pump, the first data associated with operation of the first heart pump system. Marseille, another prior art reference in the analogous art teaches a fluid flow system for a patient comprising a controller and an implantable heart pump (as shown in Fig. 1: pump 50 and controller 100; [0065-0068]); the heart pump comprising additional sensors for detecting operational parameters of the heart pump and physiological data ([0068, 0086]). The pump system communications wirelessly with a local processing device 400, with a communications network 600, and with a remote monitoring server device 300 (Fig.1, [0065]). It would have been obvious to a person of ordinary skill in the art at the time of invention to replace Degen’s implantable electromechanical pump with a heart pump assembly, such as disclosed in Marseille; the motivation for doing so is because: 1) Degen provides a system that can be adapted for use with a heart pump system (Degen; [0038:1st sentence] “Implantable device 15 further may include hardware for treating a medical condition subcutaneously such as a pump”), and 2) Marseille generally discloses an ambulatory implantable system having the an analogous communications infrastructure to that of Degen (Degen: Fig.1 and Marseille: Fig. 1)
Regarding claim 46, Degen modified discloses the method of claim 29, further comprising determining an alert (Degen: Fig. 9: warning 79) based, at least in part, on the third data (graphical representation of health 78), wherein the alert includes a recommendation to change an operation of the first heart pump system, and wherein the indication of the third data comprises the alert. (Degen” [0079] “…clinician graphic user interface 71 may display a warning that the pump experienced a malfunction such as a clog and may even suggest methods for fixing the problem such as reversing flow direction…”; this is a recommendation)
Regarding claim 47, Degen modified discloses the method of claim 46, Degan discloses adjusting pump operational parameter for based on the monitored user’s condition ([0070, 0076]), but Degen does not explicitly teach wherein the alert includes a recommendation to change an amount of heart support provided by the first heart pump system. Marseille, further discloses the heart pump system comprising an alarm system based on threshold comparisons, and adjusting the heart pump operational parameters accordingly so as to provide less or more heart support ([0018, 0070]). (See motivation for modification to claim 20 above.)
Regarding claim 48, Degen modified discloses the method of claim 47, wherein the alert includes a recommendation to change a speed of a heart pump of the first heart pump system. (Degen: [0076]; Marseille: [0068, 0080-0081])
Regarding claim 49, Degen modified discloses method of claim 47, neither Degen nor Marseille discloses wherein the alert includes a recommendation to wean a patient off the first heart pump system. However, this would have been an obvious design choice based on the teaching of Degen, because Degen discloses monitoring physiological or heart health over a period of time (see discussion of heart health trends in [0075] “ a data analyst may analyze measured physiological and/or operational parameters on data analyst device 100 and generate actionable insight by comparing data to known trends or correlations” Also see [0080, 0084-0085]), in the event of an upward heart health trend, it would have been obvious to note that the patient does not require cardiac assistance.
Regarding claim 50, Degen modified discloses the method of claim 29, wherein the first data includes one or more of a speed of a heart pump, a flow rate of blood through the heart pump, or a pressure measurement. (Degen: [0073-0074], Marseille: [0015, 0036])
Regarding claim 51, Degen modified discloses the method of claim 29, wherein the third data includes a likelihood of heart failure for a patient being monitored by the first heart pump system and/or the cardiac support system. (Degen: [0054] “…generation of analyst data which may include a diagnosis a medical condition and/or an indication a heightened risk of a medical condition.” Also see [0086] “…compare data generated by implantable device 15 to various trends to determine the risk of a given condition or medical event. If a risk of a medical condition or event is determined to be high, the instructions may also generate a warning of the risk…” In here, the discussed risk is taken to encompass “likelihood” in the claim. Also see [0085] mentions detecting for heart failure condition)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kamen et al. 2013/0191513 A1 discloses a method and system comprising a connectivity gateway for connecting a plurality of patients, and associated implanted monitoring devices, infusion pumps, and vital monitoring device. The system includes algorithms for automatically adjusting medication/therapy/doses. Kamen teaches displaying data, but does not explicitly teach a heart pump.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
July 9, 2026
Prosecution Insights