DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/12/2026 has been entered.
Response to Amendment
Applicant’s amendment, filed on 08/12/2026, has been entered and carefully considered.
Claim 1, 4, 8, 10, 14 and 18 have been amended; claim 5, 13, 19-22 are cancelled and Claims 1-4, 6-12, 14-18 are pending.
Response to Arguments
Applicant's arguments filed on 08/03/2026 have been fully considered but they are not persuasive.
With respect to claims 1, 8, 14 and 17, the Applicant argued that the prior art fail to teach or suggest the limitation
“receive a first wireless transmission from the CIED; execute a medical device detector in the processing agent to determine that the first wireless transmission originated from the CIED by determining that a signal characteristic, header data, and/or payload data of the first wireless transmission matches a predetermined medical device signal characteristic, header data, and/or payload data;
upon determining that the first wireless transmission originated from the CIED, identify, via the processing agent, a set of ports from the ports of the connected device for communication with the CIED and instruct the firewall to allow medical data access to the processing agent via the set of ports, to restrict access of non-medical data to the processing agent via the set of ports, and to lock a remainder of the ports from accessing the processing agent; receive a second wireless transmission from the CIED;
upon determining that the second wireless transmission originated from the CIED, read an … signal from the second wireless transmission using a data management module in the processing agent”.
Applicant particularly argues that Stair’s computing device sends an SPA request specifying a port and protocol, and that Stair therefore fails to teach a processing agent that, upon determining that a first wireless transmission originated from the CIED, identifies a set of ports for communication with the CIED (Remarks, pp. 13-14). The Examiner respectfully disagrees.
First, Stair teaches the claimed order of operations. Before validation, virtual firewall 122 denies access in accordance with its policies (Stair, [0035], op.210). SPA service 124 then validates SPA request 116 by verifying that the request is encoded with proper credentials and that the requested resource is allowed (Stair [0036], op.212). Only after validation does the SPA service implement a temporary firewall policy that allows packets from the client IP address on the identified protocol and port, e.g., TCP port 22 (Stair, [0036]; op. 214 of [0037]). Stair thus identifies the port for communication with the source upon determining that the request originated from an authenticated source, as claimed.
Second, the fact that Stair’s client indicates the desired port does not distinguish the claim 1 over Stair. Claim 1 recites only that the processing agent identifies a set of ports for communication with the CIED upon determining that the first wireless transmission originated from the CIED; it does not recite how the set of ports is selected, and it does not exclude the set of ports being indicated by the transmitting device. In Stair, the SPA service, not the client, selects which port to open and implements the corresponding firewall policy and it does so only after validating the request (Stair, [0036], op 212). Applicant’s own specification confirms that identification of ports indicated by the transmitting device fails within the claims, describing the processing agent as identifying “a set of ports requested by the medical device” (Spec. [0031], [0043]; Fig. 3B, 530).
Third, Applicant’s argument that Stair does not teach receiving a wireless transmission from a CIED again attacks Stair individually. Mahajan teaches the external device receiving transmission from the CIED over wireless link 115 (Mahajan Fig. 1; [0051]). In the combination, Stair’s validation and port control are applied to those transmissions. The test for obviousness is what the combined teachings would have suggested to one of ordinary skill in the art, not whether a feature of the secondary reference may be bodily incorporated into the primary reference.
Applicant contends that the specification discloses content-aware handling of medical data (citing Spec. [0015], [0017]). The Examiner respectfully disagrees that the claim requires content-based classification of traffic. Paragraphs [0015], [0017] describe inspecting a wireless transmission to determine whether it originated from the medical device. Paragraph [0043] identifies that inspection (526) as a sub-step of set-up 502. The specification does not describe the firewall classifying data on the identified ports as medical or non-medical by content. Instead, it describes restricting non-medical data by identifying the ports requested by the medical device and locking the remainder of the ports (Spec [0031]-[0032]). It also describes non-medical devices as a separate source of traffic handled by the connected device (Spec [0015]).
Under the broadest reasonable interpretation, allowing medical data and restricting non-medical data via the set of ports is met by Stair’s temporary policy. That policy allows packets from the validated source on the identified port, while packets from any other source do not match the policy and remain denied (Stair [0035]-[0036]). In the combination the validated source is the CIED, so the allowed data is medical data and the restricted data is non-medical data.
Further, the terms “medical” and “non-medical” describe the content of the data and do not change how the claimed firewall operates. Because claim 1 is an apparatus claim, the prior art needs only be capable of performing the recited functions.
Even under Applicant’s content-aware reading, Stair determines access based on the contents of the received packet, namely whether it is encoded with proper credentials (Stair, [0036]), and based on header fields, namely client IP address, protocol, and destination port (Stair [0036]).
For the reasons stated above, Examiner believes that the prior art still discloses the amended limitations of Claim 1, 8 and 14.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1-4, 6-12 and 14-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites a limitation “a CIED detector”. It’s not clear whether it refer to the “a medical device detector” recited in claim 1.
Claim 18 is rejected for the same reason indicated above.
Claim 1 recites limitation “upon determining that the second wireless transmission originated from the CIED”, but never recites doing that determination. It’s unclear whether the medical device detector is reused.
Claim 8 and 14 are rejected for the same reason stated above.
Claims 2-4, 6-7, 9-12 and 15-18 are dependent claims of Claims 1, 8 and 14, thus are rejected for the same deficiency.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 8, 14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Mahajan et al (US 2020/0016420) in view of Stair et al (US 2018/0241718 A1), further in view of Yoon et al (US 2020/0252436).
Regarding claims 1, 8, Mahajan teaches a computing system, comprising:
a cardiovascular implantable electronic device (CIED) ([0046], “Examples of the implantable device may include, but are not limited to, pacemakers, pacemaker/defibrillators, cardiac resynchronization therapy (CRT) devices”); and
one or more connected devices (Fig. 1, external device 120) configured to communicate with a server over a computer network (Fig. 1, remote device 124, [0053], “the remote device 124 may include a centralized server”, it’s noted that external device 120 communicates with a remote device 124 over a computer network 122), each connected device of the one or more connected devices including ports (Fig. 1, external device 120 inherently as ports for transmission) and processing circuitry configured to:
receive a first wireless transmission from the CIED (Fig. 1, wireless transmission between IMD 110 and external device 120 via wireless link 115; [0051], “the external system 125 may receive device data from the AMD 110 via the communication link 115. Examples of the device data received by the external system 125 may include real-time or stored physiologic data from the patient 102”);
receive a second wireless transmission from the CIED;
upon determining that a cardiac event has occurred, transmit a notification of the cardiac event over the computer network to a recipient address ([0059], “One or more of the external device 120 or the remote device 124 may output the detected physiologic events to a user such as the patient or a clinician”) of a registered account at the server ([0057], “Users, such as clinicians or other qualified medical specialists, may use the clients to securely access stored patient data assembled in the database in the server”, it implies that the stored patient data each would have its own account in the server; also see [0056]).
Mahajan doesn’t explicitly teach that the connected device includes ports and execute a firewall that controls permission to communicate via the ports of the connected devices; execute a processing agent on the connected device; executes a medical device detector in the processing agent to determine that the first wireless transmission originated from the CIED by determining that a signal characteristic, header data, and/or payload data of the first wireless transmission matches a predetermined header data, and/or payload data of the first wireless transmission matches a predetermined header data, and/or payload data; upon that determination, identifies via the processing agent a set of ports for communication with the CIED and instructs the firewall to allow medical data access to the processing agent via the set of ports, restrict access of non-medical data to the processing agent via the set of ports, and lock a remainder of the ports from accessing the processing agent; and upon determining that a second transmission originated from the source, process the second transmission.
Stairs teaches that a computing device including ports and processing circuitry configured to:
executing a firewall that controls permission to communicate via the ports of the connected device (Stair, [0001], “a default drop firewall policy dynamically configured to allow temporary connections”; [0008], “port 22”); execute a processing agent on the connected device ([0026], “A SPA service”);
receive a first transmission from a source ([0035]-[0036], SPA request 116 from SPA client 110);
executes a detector in the processing agent to determine that the first wireless transmission originated from the source by determining that header data, and/or payload data of the first wireless transmission matches a predetermined medical device signal characteristic, header data, and/or payload data of the first wireless transmission matches a predetermined header data, and/or payload data ([0002], the SPA service passively captures and validates an encrypted packet; [0036], op.212, the validation routine verifies authentication, i.e., that SPA request 116 is encoded with proper credentials, and authorization, i.e., that the requested resource is allowed);
upon that determination, identifies via the processing agent a set of ports for communication with the CIED and instructs the firewall to allow medical data access to the processing agent via the set of ports, restrict access of non-medical data to the processing agent via the set of ports, and lock a remainder of the ports from accessing the processing agent ([0036], once validated, a temporary firewall policy is implemented for the request, e.g., SSH access on TCP port 22), and instruct the firewall:
to allow data access to the processing agent via the set of ports ([0036], the temporary policy allows packets from the client IP address with TCP protocol and destination port 22 to be forwarded to cloud workload 112; [0037, op.214);
to restrict access of other data to the processing agent via the set of ports ([0036], the temporary policy is keyed to the client IP address, so packets from other sources to port 22 do not match the policy and remain denied under the default policy of ([0035], [0001]); and
to lock a remainder of the ports from accessing the processing agent ([0001], “default drop policy”; [0035], op 210, access denied in accordance with firewall polices absent validation);
and upon determining that a second transmission originated from the source, process the second transmission ([0037], op 216-218, SPA client 110 sends application data packets and virtual firewall 122 allows them in accordance with the temporary policy established upon validation).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify external device 120 of Mahajan to execute the virtual firewall and SPA service of Stair, so that the external device validates the CIED before opening only the ports used by the CIED and keeps the remaining ports closed. The motivation would have been to reduce the attack surface of a device that relays sensitive patient data over a network and to protect it from unauthorized access (Stair, [0002]). This is the use of a known technique to improve a similar device in the same way, yielding predictable results.
The combination of Mahajan and Stair doesn’t explicitly teach that read an encoded cardiac signal from the second wireless transmission using a data management module.
Yoon teaches that read an encoded cardiac signal from the wireless transmission using a data management module ([0021], The second device may decode the message using a second encryption key; also see Fig. 3, memory 64 comprising encryption keys).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to utilize the teaching of Yoon in the system disclosed by Mahajan in view of Stair to secure sensitive information such as collected patient data (see paragraph 0004 of Yoon).
Regarding claim 14, Mahajan teaches a connected device, comprising:
a communications suite including at least one module selected from the group consisting of a Zigbee module, a Bluetooth Low Energy (BLE) module, a narrow- band internet of things (NB-IoT) module, a Wi-Fi module, a LoRa module, and a long-term evolution (LTE) module ([0051], “IEEE 802.11 wireless fidelity “WiFi” interfacing standards”, it implies that a Wi-Fi module is used for the wireless communication); ports (Fig. 1, external device 120 inherently as ports for transmission); and processing circuitry configured to:
receive a first wireless transmission from a cardiovascular implantable electronic device (CIED) via the at least one module of the communications suits (Fig. 1, wireless transmission between IMD 110 and external device 120 via wireless link 115; [0051], “the external system 125 may receive device data from the AMD 110 via the communication link 115. Examples of the device data received by the external system 125 may include real-time or stored physiologic data from the patient 102” and [0046]);
receive a second wireless transmission from the CIED (Fig. 1, wireless transmission between IMD 110 and external device 120 via wireless link 115; [0051], “the external system 125 may receive device data from the AMD 110 via the communication link 115. Examples of the device data received by the external system 125 may include real-time or stored physiologic data from the patient 102” and [0046])
upon determining that an adverse healthy or device event has occurred, transmit a notification of the adverse health or device event to a recipient address ([0059], “One or more of the external device 120 or the remote device 124 may output the detected physiologic events to a user such as the patient or a clinician”) of a registered account at a server ([0057], “Users, such as clinicians or other qualified medical specialists, may use the clients to securely access stored patient data assembled in the database in the server”, it implies that the stored patient data each would have its own account in the server; also see [0056]) via a wide area network ([0052], network 122 is a telecommunication network which is considered as a wide area network).
Mahajan doesn’t explicitly teach that the connected device includes ports and execute a firewall that controls permission to communicate via the ports of the connected devices; execute a processing agent on the connected device; executes a medical device detector in the processing agent to determine that the first wireless transmission originated from the CIED by determining that a signal characteristic, header data, and/or payload data of the first wireless transmission matches a predetermined header data, and/or payload data of the first wireless transmission matches a predetermined header data, and/or payload data; upon that determination, identifies via the processing agent a set of ports for communication with the CIED and instructs the firewall to allow medical data access to the processing agent via the set of ports, restrict access of non-medical data to the processing agent via the set of ports, and lock a remainder of the ports from accessing the processing agent; and upon determining that a second transmission originated from the source, process the second transmission.
Stairs teaches that a computing device including ports and processing circuitry configured to:
executing a firewall that controls permission to communicate via the ports of the connected device (Stair, [0001], “a default drop firewall policy dynamically configured to allow temporary connections”; [0008], “port 22”); execute a processing agent on the connected device ([0026], “A SPA service”);
receive a first transmission from a source ([0035]-[0036], SPA request 116 from SPA client 110);
executes a detector in the processing agent to determine that the first wireless transmission originated from the source by determining that header data, and/or payload data of the first wireless transmission matches a predetermined medical device signal characteristic, header data, and/or payload data of the first wireless transmission matches a predetermined header data, and/or payload data ([0002], the SPA service passively captures and validates an encrypted packet; [0036], op.212, the validation routine verifies authentication, i.e., that SPA request 116 is encoded with proper credentials, and authorization, i.e., that the requested resource is allowed);
upon that determination, identifies via the processing agent a set of ports for communication with the CIED and instructs the firewall to allow medical data access to the processing agent via the set of ports, restrict access of non-medical data to the processing agent via the set of ports, and lock a remainder of the ports from accessing the processing agent ([0036], once validated, a temporary firewall policy is implemented for the request, e.g., SSH access on TCP port 22), and instruct the firewall:
to allow data access to the processing agent via the set of ports ([0036], the temporary policy allows packets from the client IP address with TCP protocol and destination port 22 to be forwarded to cloud workload 112; [0037, op.214);
to restrict access of other data to the processing agent via the set of ports ([0036], the temporary policy is keyed to the client IP address, so packets from other sources to port 22 do not match the policy and remain denied under the default policy of ([0035], [0001]); and
to lock a remainder of the ports from accessing the processing agent ([0001], “default drop policy”; [0035], op 210, access denied in accordance with firewall polices absent validation);
and upon determining that a second transmission originated from the source, process the second transmission ([0037], op 216-218, SPA client 110 sends application data packets and virtual firewall 122 allows them in accordance with the temporary policy established upon validation).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify external device 120 of Mahajan to execute the virtual firewall and SPA service of Stair, so that the external device validates the CIED before opening only the ports used by the CIED and keeps the remaining ports closed. The motivation would have been to reduce the attack surface of a device that relays sensitive patient data over a network and to protect it from unauthorized access (Stair, [0002]). This is the use of a known technique to improve a similar device in the same way, yielding predictable results.
Mahajan in view of Stair doesn’t explicitly teach that read an encoded cardiac signal from the wireless transmission using a data management module.
Yoon teaches that that read an encoded cardiac signal from the wireless transmission using a data management module ([0021], The second device may decode the message using a second encryption key; also see Fig. 3, memory 64 comprising encryption keys).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to utilize the teaching of Yoon in the system disclosed by Mahajan in view of Stair to secure sensitive information such as collected patient data (see paragraph 0004 of Yoon).
Regarding claim 17, the aforementioned references further teach that the module is the Wi-Fi module or the Bluetooth Low Energy (BLE) module, the connected device further comprising: a Wi-Fi radio configured to receive the wireless transmission from the CIED (Mahajan, [0051], “The telemetry link 115 may be an inductive telemetry link, a capacitive telemetry link, or a radio-frequency (RF) telemetry link, or wireless telemetry based on, for example, “strong” Bluetooth or IEEE 802.11 wireless fidelity “WiFi” interfacing standards” and Fig. 1; it implied that a Wi-Fi radio is used for the Wi-Fi communication).
Claims 3, 9 are rejected under 35 U.S.C. 103 as being unpatentable over Mahajan in view of Stair, Yoon, further in view of Zilbershlag (US 2021/0046234).
Regarding claims 3, 9, the aforementioned references teach all of the limitations of the parent claim, Mahajan further teach:
a radio transceiver configured to transmit and receive on …, wherein the wireless transmission is received via the radio transceiver, a Wi-Fi radio configured to receive the wireless transmission from the CIED ([0051], “IEEE 802.11 wireless fidelity “WiFi” interfacing standards”). However, Mahajan doesn’t explicitly teach that transmitting and receiving on medical device radiocommunications service spectrum. Zilbershalg teaches that transmitting and receiving on medical device radiocommunications service spectrum (“MedRadio Spectrum”). Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to utilize the teaching of Zilbershlag in the system disclosed by Mahajan in view of Stair and Yoon for the purpose of reduce interference for medical data transmission.
Claims 2, 4, 10 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Mahajan in in view of Stair and Yoon, further in view of Bonn (US 9,877,332).
Regarding claim 2, the aforementioned references teach all of the limitations except that the transmitting upon determining that a cardiac event has occurred includes prioritizing processing of data contained in the wireless transmission over processing of data contained in other wireless transmissions. Bonn teaches the above limitation (Col 6, lines 52-56, “increase the quality of service of the user’s connection when the medical data indicates that the user in a medical state or emergency situation”).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to utilize the teaching of Bonn in the system disclosed by Mahajan in view of Stair and Yoon for the purpose of provide priority service for important data transmission such as urgent medical data.
Regarding claim 4, 10, 18, the aforementioned references further teach that: execute a processing agent including a CIED detector configured to perform:
the inspecting of the wireless transmission to identify the signal characteristic, header data, or payload data of the wireless transmission; and the determining that the signal characteristic, header data, and/or payload data of the wireless transmission matches a predetermined medical device signal characteristic, header data, and/or payload data (Bonn, Col 3, line 33, “Wireless access node 110 determines a quality of service level for communication device 101 based on the medical data”, “The medical data indicating high stress or anxiety levels would result in a higher quality of service level than medical data indicating a calm and relaxed physical state of the user”).
Claims 6-7, 11-12, 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Mahajan in view of Stair, Yoon, further in view of Bardy et al (US 2022/0219001).
Regarding claim 6, 11, 15, the aforementioned references teach the CIED ([0046], “Examples of the implantable device may include, but are not limited to, pacemakers, pacemaker/defibrillators, cardiac resynchronization therapy (CRT) devices”). However, the aforementioned references don’t teach that the processing circuitry is further configured to: store medical data transmitted by the medical device and forward the medical data at a subsequent point in time, the subsequent point in time being determined in part by at least one of the following: a user-selection of a time period. Bardy teaches the above limitation ([0105]- [0106]). Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to utilize the teaching of Bardy in the system disclosed by Mahajan in view of Stair and Yoon for the purpose of protecting patient privacy.
Regarding claim 7, 12, 16, the aforementioned references teach all of the limitations except that the performing medical device-specific processing on the wireless transmission includes: encrypting the wireless transmission according to an encryption protocol; and transmitting the encrypted wireless transmission to a destination server. Bardy teaches the above limitation ([0113). Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to utilize the teaching of Bardy in the system disclosed by Mahajan in view of Stair and Yoon for the purpose of protecting patient privacy.
Conclusion
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/SIMING LIU/ Primary Examiner, Art Unit 2411
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