DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/03/2026 has been placed in record and considered by the examiner.
Summary
This action is in reply to Applicant’s Amendments and Remarks filed on 02/03/2026.
Claims 1-9, 11-19 and 21-22 are pending.
Claims 21-22 are added new.
Claims 10 and 20 are canceled.
Response to Arguments
Applicant’s arguments dated 08/22/2025 with respect to claims 1-9, 11-19 and 21-22 have been fully considered but they are not persuasive.
Claim Rejections - 35 U.S.C. § 102
Applicant presented argument, citing that LaLonde discloses, teaches, or suggests a precision time source synchronized to an external reference within its communicator, packet-level timestamping for purposes of maintaining a time-ordered view across multiple channels, or time-ordering alarm delivery in a multi-path transmission context, as recited in the context of amended independent Claim 1. (REMARKS, Page 7)
The Examiner respectfully disagrees and presents that LaLonde discloses-
Col 6 lines 14-16: … networked patient management system, referred to herein as an advance patient management (APM) system or server…
Col 51 Lines 8-18: The data produced by the sensors may be transmitted to the PIMD and then to the PPC or directly from the sensors to the PPC. The PPC can stream data from any of these or other sensor to provide the physician with data concerning the patient's present condition or status. It may also be useful to know if the PPC is mobile or in its docking hub. Voice output from the PPC may be used to time-correlate sensor data (e.g., EGM data) so that the physician knows what to look for and the patient's reaction. Also, time stamp data may be appended to sensor data….
(Construed to apply timestamps to the input packets to maintain a time-ordered view of the patient monitoring alarms transmitted over the plurality of communications channels)
Col 61 Lines 24-24: Time stamp data may be appended to sensor data and/or an event marker may be appended to sensor data that results from patient actuation of a PPC button when an event is felt by the patient. This aids in time correlating sensor data to other physiologic data and contextual events. Timing (e.g., clock time) used by the PIMD 802 and PPC 800 may be coordinated or synchronized using various time/clock standards, such as APM server time, ……. time indicated by cellular infrastructure, or other standard.
(Construed a precision time service synchronized to an external time reference and is configured to apply timestamps to the input packets, since it is well known that at least APM servers are usually kept synchronized with Network Time Protocol (NTP) server for time precision by default or cellular infrastructure relies on precise time synchronization using IEEE-1588 Precision Time Protocol (PTP) and Global Navigation Satellite System (GNSS), and both APM server and cellular infrastructure are external to PPC)).
Accordingly claim 1, and similarly claim 11 are rejected.
Dependent claims 2-9, 12-19 and 21-22, being dependent on claims 1 and 11, are also rejected for the same reason as above.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-7 and 11-17 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by LaLonde et al. (US 7978062 B2, of IDS, hereinafter ‘LALONDE’).
Regarding claim 1, LALONDE teaches a system (Fig. 1A.
Col. 7 Line 15: FIG. 1A is a system diagram of a life critical network) for providing patient monitoring data over a network (
Col 7 Lines 23-32:
The life critical network 200 essentially provides a private network that is configured to operate on top of existing mobile and fixed facility networks. The LCN 200 utilizes …. nodes include, for example, portable patient communicators 14, patient sensors 17A-17B, PIMD programmer systems 23, clinician mobile devices 25, clinician workstations 27, patient advocate mobile devices 21, and smart hubs 19, among others.), the system comprising:
a medical edge router having one or more hardware processors (
Fig. 1A, portable patient communicators (PPC) 14
Fig. 14, Hub 1000 housing PPC 800
Col. 2 Lines 26-30: a portable patient communicator PPC includes a housing configured for portability by an ambulatory patient. A processor is coupled to memory, and the processor and the memory are provided in the housing.), the medical edge router comprising:
a plurality of inputs in communication with a plurality of point of care devices (
Fig. 1A, PPC 14 receives communication from Patient 12A PIMD 13 and Patient 12C PIMD 13);
a plurality of outputs in communication with a plurality of communication channels (
Fig. 1B, PPC 14 communication with APM using Mobile Network 20 and/or WLAN 32,
Col 10 Lines 41-47: When information is to be transmitted between the medical devices 13 and an APM server 16A, the PPC 14 paired with a respective medical device(s) 13 serves to wirelessly communicate the information over one or more networks. In one embodiment, the PPC 14 communicates by way of a mobile network(s) 20, such as a cellular network.
Col Lines 1-5: The PPC 14 may first communicate via a proximity network(s) 32 such as a wireless local area network (WLAN). ….a WLAN (e.g., IEEE 802.11b/g network).
);
a traffic inspector (Fig. 1A, PPC 14,
Col. 2 Lines 26-30: a portable patient communicator PPC includes ….processor is coupled to memory,
Col. 13 lines 26-35: The physician may be interested in receiving arrhythmia (e.g., atrial or ventricular tachyarrhythmia) related data whenever such event occurs, for example. This selected sub-set of data is tagged for transfer to the PPC 14 in accordance with the physician's request. Depending on the severity of the event type, the physician may have requested that the event data be automatically transferred to the remote server via the PPC 14 immediately when the event occurs, or, for less serious events, be transferred the next time the PPC 14 connects with the remote server.) configured to:
receive input packets from the plurality of point of care devices, the input packets comprising information related to patient monitoring data (
Col 9 Lines 55-63: Each patient 12A, 12B, 12C, 12D involved with the APM environment is associated with one or more data sources or medical devices 13 (hereinafter medical devices) associated with that patient.
Col 10 Lines 18-21, 41-45: Each patient 12A, 12B, 12C, 12D involved with the APM environment is also associated with at least one PPC 14 capable of wirelessly communicating information with an APM system represented by one or more APM servers 16A, 16B, 16C. …..
When information is to be transmitted between the medical devices 13 and an APM server 16A, the PPC 14 paired with a respective medical device(s) 13 serves to wirelessly communicate the information over one or more networks.), the information related to patient monitoring data comprising physiological parameter values, trend data representing trends in the physiological parameter values, and patient monitoring alarms representing the physiological parameter values reaching alarm limits, and analyze the input packets to identify the patient monitoring alarms in the input packets (
Col 6 Lines 29-38: Exemplary services that may be provided through use of the PIMD-PPC pair involve medication management for the patient …. prescription refills, and/or information relayed to the patient's physician, patient advocate or APM server if patient activity, exercise or physiological tests indicate a change that needs attention.
(Indicating receiving input and reporting physiological parameter values for monitoring trend data representing trends in the physiological parameter values)
Col. 9 Lines 64-66: patient medical device 13 can generate one or more types of patient data and can incorporate one or more components for delivering therapy, sensing physiological data…
Col. 10 Lines 41-45: When information is to be transmitted between the medical devices 13 and an APM server 16A, the PPC 14 paired with a respective medical device(s) 13 serves to wirelessly communicate the information over one or more networks.
Col. 13 lines 26-35: The physician may be interested in receiving arrhythmia (e.g., atrial or ventricular tachyarrhythmia) related data whenever such event occurs, for example. This selected sub-set of data is tagged for transfer to the PPC 14 in accordance with the physician's request. Depending on the severity of the event type, the physician may have requested that the event data be automatically transferred to the remote server via the PPC 14 immediately when the event occurs, or, for less serious events, be transferred the next time the PPC 14 connects with the remote server.
Col 23 Line 61 – Col 24 Line 3: The PPC 14 and remote APM server 16A have many different reasons to exchange data. …. These data have different priorities, including urgent, nominal, or low priority, or even optional. The PPC 14, according to some embodiments, may be configured to determine some or more of the degree of urgency, purpose of the data exchange.); and
in response to detecting a patient monitoring alarm in the input packets, transmit the input packets over the plurality of communications channels (
Col 14 Lines 8-12: A tiered connection strategy may be employed to effect communications between the remote server, medical device, and PPC 14 that is dependent on a number of factors, including severity of a patient event,… status of communication link(s) (e.g., availability, quality of service …).
Col 24 Lines 6-17: it is assumed that the highest degree of priority or urgency is associated with an emergency or time critical situation … In such case, the PPC 14 is preferably programmed to utilize all communications protocols and mediums available to it. Some of these channels may be reliable while others may be unreliable. Parallel messages over multiple channels (data channels, SMS, two cell towers, Wi-Fi to local network) are preferably transmitted by the PPC 14 in an attempt to reach the APM server 16A. The PPC 14 preferably sends the same urgent message on all the mediums.),
wherein the medical edge router (
Fig. 1A, portable patient communicators (PPC) 14
Fig. 14, Hub 1000 housing PPC 800) further comprises a precision time service synchronized to an external time reference and is configured to apply timestamps to the input packets to maintain a time-ordered view of the patient monitoring alarms transmitted over the plurality of communications channels (
Col 6 lines 14-16: … networked patient management system, referred to herein as an advance patient management (APM) system or server…
Col 51 Lines 8-18: The data produced by the sensors may be transmitted to the PIMD and then to the PPC or directly from the sensors to the PPC. The PPC can stream data from any of these or other sensor to provide the physician with data concerning the patient's present condition or status. It may also be useful to know if the PPC is mobile or in its docking hub. Voice output from the PPC may be used to time-correlate sensor data (e.g., EGM data) so that the physician knows what to look for and the patient's reaction. Also, time stamp data may be appended to sensor data….
(Construed to apply timestamps to the input packets to maintain a time-ordered view of the patient monitoring alarms transmitted over the plurality of communications channels)
Col 61 Lines 24-24: Time stamp data may be appended to sensor data and/or an event marker may be appended to sensor data that results from patient actuation of a PPC button when an event is felt by the patient. This aids in time correlating sensor data to other physiologic data and contextual events. Timing (e.g., clock time) used by the PIMD 802 and PPC 800 may be coordinated or synchronized using various time/clock standards, such as APM server time, ……. time indicated by cellular infrastructure, or other standard.
(Construed a precision time service synchronized to an external time reference and is configured to apply timestamps to the input packets, since it is well known that at least APM servers are usually kept synchronized with Network Time Protocol (NTP) server for time precision by default or cellular infrastructure relies on precise time synchronization using IEEE-1588 Precision Time Protocol (PTP) and Global Navigation Satellite System (GNSS), and both APM server and cellular infrastructure are external to PPC)).
Regarding claim 2, LALONDE teaches the system of Claim 1, wherein the traffic inspector is configured to transmit the input packets over the plurality of communications channels to a medical network service (
Col. 13 lines 26-35: The physician may be interested in receiving arrhythmia (e.g., atrial or ventricular tachyarrhythmia) related data whenever such event occurs, for example. This selected sub-set of data is tagged for transfer to the PPC 14 in accordance with the physician's request. Depending on the severity of the event type, the physician may have requested that the event data be automatically transferred to the remote server via the PPC 14 immediately when the event occurs…
Col 24 Lines 6-17: it is assumed that the highest degree of priority or urgency is associated with an emergency or time critical situation … In such case, the PPC 14 is preferably programmed to utilize all communications protocols and mediums available to it. Some of these channels may be reliable while others may be unreliable. Parallel messages over multiple channels (data channels, SMS, two cell towers, Wi-Fi to local network) are preferably transmitted by the PPC 14 in an attempt to reach the APM server 16A. The PPC 14 preferably sends the same urgent message on all the mediums
(APM server 16A construed as a device for medical network service)).
Regarding claim 3, LALONDE teaches the system of claim 1, wherein the traffic inspector is configured to transmit the input packets over the plurality of communications channels to a clinician device (
Col 24 Lines 6-17: it is assumed that the highest degree of priority or urgency is associated with an emergency or time critical situation … In such case, the PPC 14 is preferably programmed to utilize all communications protocols and mediums available to it. Some of these channels may be reliable while others may be unreliable. Parallel messages over multiple channels (data channels, SMS, two cell towers, Wi-Fi to local network) are preferably transmitted by the PPC 14 in an attempt to reach the APM server 16A. The PPC 14 preferably sends the same urgent message on all the mediums.
Col 29 Lines 46-53: Various types of diagnostic information acquired by the PPC 800 are preferably made available to the physician or authorized user via a dashboard display 842, which may be presented in a region of the display 840 of a laptop 835 as shown in FIG. 9B. In addition to dashboard information, various types of patient information received from the APM server 850 may be displayed in a patient data portion 853 of the display 840.
(PPC 800 == PPC 14, and APM server 850==APM server 16A)).
Regarding claim 4, LALONDE teaches the system of claim 1, wherein the plurality of communication channels comprise multiple Internet Service Providers (ISPs) (
Fig. 1B, PPC 14 communicating with APM 16A using WLAN 32 and /or Mobile Networks 20).
Regarding claim 5, LALONDE teaches the system of claim 1, wherein the plurality of communication channels comprise a wired ISP and a wireless ISP (
Fig. 14 PPC 800 with Hub 1000,
Col 68, Lines 23-42:
PPC with Rechargeable Hub
FIG. 14 shows a base station or hub 1000 that is configured to physically and electrically receive the PPC 800…
The hub 1000 may also include a telephone, modem, or network communications interface 1012 that allows for connection to a traditional land line (e.g., POTS or cable) communication link. The hub 1000 may incorporate or be connectable to a Wi-Fi node/wireless access point for communicating with a household Wi-Fi system
Col. 69 Lines 25-27:
PPC 800 may be capable of providing full functionality while seated in the hub 1000.
See also Fig. 1B, PPC 14 communication with APM via WLAN.
(Disclosing PPC 14/800 with Hub 1000 have landline (wired ISP), cellular and WLAN communication interface or capability (wireless ISP) to communicate with APM)).
Regarding claim 6, LALONDE teaches the system of claim 5, wherein the wireless ISP is in communication with a local access point (
Fig. 1B, PPC 14 communication with APM via WLAN 32,
Col 68, Lines 40-42:
The hub 1000 may incorporate or be connectable to a Wi-Fi node/wireless access point for communicating with a household Wi-Fi system).
Regarding claim 7, LALONDE teaches the system of claim 1, wherein the plurality of communication channels comprise an ISP and a cellular network (
Col 9 Lines 45-47: PPC 14 communicates by way of a mobile network(s) 20, such as a cellular network.
Col 11 Lines 15-18: data networks 22 may cooperatively operate with the mobile network(s) 20 to facilitate data transfers to and from the relevant APM server 16A. For example, the illustrated data network 22 may represent the Internet…
Col 33 Line 58 – Col 34 Line 1: The PPC 800 may be viewed as having different sets of firmware. …. These sets of firmware operate substantially independently yet cooperatively to seamlessly effect communications between a governmentally regulated "medical device" (e.g., an implanted CRM device, which is a classified by the FDA as a Class III medical device) and a public communications infrastructure (e.g., cellular network and the Internet).)
Regarding claim 11, the claim with features mutatis mutandis of claim 1, is rejected for the same reason as set forth for claim 1.
Regarding claim 12, the claim is interpreted and rejected for the same reason as set forth for claim 2.
Regarding claim 13, the claim is interpreted and rejected for the same reason as set forth for claim 3.
Regarding claim 14, the claim is interpreted and rejected for the same reason as set forth for claim 4.
Regarding claim 15, the claim is interpreted and rejected for the same reason as set forth for claim 5.
Regarding claim 16, the claim is interpreted and rejected for the same reason as set forth for claim 6.
Regarding claim 17, the claim is interpreted and rejected for the same reason as set forth for claim 7.
Claim Rejections - 35 USC § 102 or 103
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21 and 22 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by LaLonde et al. (US 7978062 B2, of IDS, hereinafter ‘LALONDE’), or in the alternative under pre-AIA 35 U.S.C. 103(a) as being unpatentable over LALONDE in view of Moreno-Muñoz et al. (“Power quality in clinical facilities”, of record, hereinafter ‘MUNOZ’).
Regarding claim 21, LALONDE teaches the system of claim 1, wherein the medical edge router (
Fig. 1A, portable patient communicators (PPC) 14
Fig. 14, Hub 1000 housing PPC 800) is configured to draw primary operating current from an external uninterruptible power supply (UPS) (
Col. 61, lines 41-54, “the PPC 800 may include a rechargeable battery 821”:
It is understood that various hardwire connection protocols allow for the transmission of power in addition to data signals (e.g., USB), and that such connections may be used to recharge an internal or backup battery source 812 of the PPC 800.
PPC Power Features
…. the PPC 800 may include a secondary battery 812 as fail-over mechanism ….”.
(The above disclosing that the secondary battery 812 becomes a primary power source for a fail-over mechanism when main or internal, see Fig. 13, rechargeable battery 821 power source fails. Further, as illustrated by Fig. 13, that while rechargeable battery 821 is internal power source for PPC 800, secondary battery 812 is a backup battery for PPC 800 and backup battery 812 may be connected to PPC using USB indicating backup battery 812 is external to PPC 800 as indicated by Fig. 13, indicating a backup battery system usage similar to a UPS usage)).
However, assuming arguendo that the claim must be so narrowly construed such that LALONDE does not expressly disclose a medical edge router ….. configured to (always) draw primary operating current from an external uninterruptible power supply (UPS), then alternatively,
In an analogous art, Munoz teaches a medical edge router ….. configured to (always) draw primary operating current from an external uninterruptible power supply (UPS) (
Page 5 Left Column:
“For protection of high-cost diagnostic equipment, the most cost-effective technology is online double-conversion UPS technology. As opposed to an offline or line-interactive UPS (only recommended for outages), an online UPS protects against all nine types of power contamination and creates clean, perfect sine wave power for downstream systems. Critical clinical equipment and hospital IT systems are completely isolated from raw utility power and all its irregularities, using the AC-DC dual conversion schema....”, and
Page 9 Left Column:
“telecommunications and cable local area network circuits, which are extremely vulnerable to voltage transients”.
(It is obvious that Hospital IT systems includes local area network, indicating router(s) as known in the art, are to be connected with online UPS for primary power source to isolate from raw utility power and all its irregularities))
Therefore, it would have been obvious to one of the ordinary skill in the art at the time of the invention was made to provide the technique of using UPS for Critical clinical equipment and hospital IT systems of MUNOZ to the system of detection of severity of medical information for patient monitoring and transporting the information over a network of LALONDE providing a method for completely isolating from raw utility power and all its irregularities (MUNOZ: Page 5 Left Column).
Regarding claim 22, the claim is interpreted and rejected for the same reason as set forth for claim 21.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 8 and 18 is rejected under 35 U.S.C. 103(a) as being unpatentable over LaLonde et al. (US 7978062 B2, of IDS, hereinafter ‘LALONDE’) in view of Boot et al. (US 20120297482 A1, of record, hereinafter ‘BOOT’).
Regarding claim 8, LALONDE teaches the system of claim 1, wherein the traffic inspector is configured to identify the patient monitoring alarms in the input packets (
Col 23 Line 61 – Col 24 Line 3: The PPC 14 and remote APM server 16A have many different reasons to exchange data. …. These data have different priorities, including urgent, nominal, or low priority, or even optional. The PPC 14, according to some embodiments, may be configured to determine some or more of the degree of urgency, purpose of the data exchange).
LALONDE does not explicitly disclose to identify the patient monitoring alarms in the input packets by searching for a payload in one of the input packets.
In an analogous art, BOOT teaches to identify the patient monitoring alarms in the input packets by searching for a payload in one of the input packets (
[0024] a proprietary medical network, the Internet, or another network may be utilized to facilitate communication between various medical devices, such as patient monitoring devices, physician devices, …., and/or various managing controllers and/or service providers.
Fig. 2, [0049] to identify the patient monitoring alarms in the input packets by searching for a payload in one of the input packets ……. The inspection application 262 may perform a deep packet inspection of the content (e.g., data payload, etc.) of the communication, and the content may be compared to the lists of acceptable content and/or otherwise evaluated utilizing the lists of acceptable content. Based at least in part upon the evaluation, the inspection application 262 may determine whether the content is acceptable or valid content……. In certain embodiments, the inspection application 262 may direct communication of an alert message to the managing controller 225 for further processing.).
Therefore, it would have been obvious to one of the ordinary skill in the art at the time of the invention was made to provide the technique of alerting based on payload inspection by an intermediate device between medical devices and a controller device of BOOT to the system of detection of severity of medical information for patient monitoring and transporting the information over a network of LALONDE providing a method for generating alerts or alarms based on inspection of data payload and evaluation of content to take one or more control actions (BOOT: [0018, 0049]).
Regarding claim 18, the claim is interpreted and rejected for the same reason as set forth for claim 8.
Claims 9 and 19 are rejected under 35 U.S.C. 103(a) as being unpatentable over LaLonde et al. (US 7978062 B2, of IDS, hereinafter ‘LALONDE’) in view of Boot et al. (US 20120297482 A1, of record, hereinafter ‘BOOT’) and with further in view of Kim et al. (KR 20110067937 A, of record, hereinafter ‘KIM’).
Regarding claim 9, LALONDE, in view of BOOT, teaches the system of Claim 8.
LALONDE and BOOT do not explicitly disclose wherein the payload includes alarm information in a header.
In an analogous art, KIM teaches wherein the payload includes alarm information in a header (
Fig. 2, Page 5 Paragraphs 4-5:
Figure 2 is a view showing an emergency alert message according to an embodiment of the present invention.
2, the emergency according to an embodiment of the present invention warning message transmission device 100 is an emergency alert message transmitted to the subscriber station sync byte (SyncByte), PID, null (Null) packets containing other information (Other) having a value header (Packet Header ) and an emergency alarm and a message section (Message Section) comprises a payload (Pay Load).
(Figure 2 showing the alarm information in the other field in the header of the packet)).
Therefore, it would have been obvious to one of the ordinary skill in the art at the time of the invention was made to provide the technique of inserting emergency alert or alarm information in packet header by a data reporting device of KIM to the system of detection of severity of medical information for patient monitoring and transporting the information over a network of LALONDE and BOOT providing a method for efficiently transmitting the emergency alert message (KIM: Page 2 TECH-PROBLEM).
Regarding claim 19, the claim is interpreted and rejected for the same reason as set forth for claim 9.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Etchegoyen; Craig S. (US 20130226604 A1), describing HEALTH ASSESSMENT BY REMOTE PHYSICAL EXAMINATION
Libbus et al. (US 20120108917 A1), describing PATIENT MONITORING SYSTEMS AND METHODS
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAH M RAHMAN whose telephone number is (571)272-8951. The examiner can normally be reached 9:30AM-5:30PM PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, UN C CHO can be reached at 571-272-7919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAH M RAHMAN/Primary Examiner, Art Unit 2413