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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/16/2026 has been entered.
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The examiner notes Applicant argues that the TA is a backend authority that manages provisioning, verification, medical safeguards, and performance; it is not a clinician-side programmer. The examiner respectfully disagrees as Figure 3 and Paragraph [0171] discloses “the TA service provider 1060 includes a user interface 1061 (FIG. 3), which among other functions may allow users (e.g. clinicians) to modify IMD parameters”. This means that while there are other examples for how the TA operates, there is no support for it “is not a clinician-side programmer” argument as Rondoni teaches allowing clinicians to use the TA to program/modify IMD parameters. In addition Paragraph [0146] discloses communication platform 1040 acts as an intermediary for first secure communications 1070A, 1070B between the IMD 1020 and the TA service provider 1060. Therefore, the TA is more than a backend authority. In light of the above, the argument that substituting a clinician programmer for the TA would alter Rondoni’s trust and security authority is not persuasive.
Applicant also argues since the TA is trusted there is no need to authenticate itself using a certificate provider. The examiner respectfully disagrees as Paragraph [0035] discloses a communication platform at least partially implements first secure communications between an implantable medical device and a trusted authority service provider. Paragraph [0075] discloses the communication platform 40 may act as an intermediary which does not have access to the content of the secure communications. The examiner notes that since the intermediate device does not have access to the content of the secure communication it is not trusted. Furthermore, Paragraph [0193] discloses all communications between the communication platform 1040 (including application 1050) and the TA service provider 1060 can be further encrypted utilizing security protocols. Therefore, Rondoni discloses there is the ability for additional security protocols between the user device and the TA service provider and does not preclude the use of a certificate provider.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 4-6, 8-12, 14-17 and 20-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rondoni et al (US Publication 2020/086128) in view Durrant et al (US Publication 2016/0321400) and Horton et al (US Publication 2022/0392630).
Referring to Claims 1 and 16, Rondoni et al teaches a system/method configured to communicate via at least one cloud server, comprising: a user device (e.g. Figures 1A or 3, Elements 40/1040), a clinician programmer (e.g. Figures 1A or 3, Elements 60/1060), wherein the clinician programmer and the user device are configured to establish, using a first security protocol (e.g. Paragraph [0193] discloses further encryption, such as using SSL), a first encrypted communication channel between the clinician programmer and the user device through the at least one cloud server, wherein the first security protocol authenticates entities and establishes a first key set for encrypting and decrypting messages transmitted within the first encrypted communication channel (e.g. Figures 1 or 3, channel 70B/1070B and Figure 1D, cloud 161 and Paragraph [0193] discloses the security protocol between the communication platform and the TA service provider (clinician programmer) is encrypted using security protocols); an implantable medical device configured to deliver a therapy according to user-programmable therapy parameters (e.g. Paragraph [0060] discloses treating diseases via therapy), wherein the user device and the implantable medical device are configured to wirelessly communicate with each other through a secure wireless connection (e.g. Paragraph [0071] discloses the IMD using inductive communication with the communication platform 40/1040), wherein the implantable medical device (e.g. Figures 1 or 3 Elements 20 or 1020) and the clinician programmer are configured to establish, using a second security protocol, a second encrypted communication channel at least partially within the first encrypted communication channel, wherein the second encrypted communicated channel is established by establishing at least a first secret key for exchanging encrypted messages, and wherein the second encrypted communication channel extends between implantable medical device and the clinician programmer (e.g. Figure 1A or 3, Element 70A and 70 B/ 1070A and 1070B and Paragraphs [0052], [0074]-[0075] discloses cryptographic protection protocol for communication between 60 and IMD 20 and intermediary communication platform 40 does not have access to the content of the secure communications), wherein the clinician programmer is configured to program the user programmable therapy parameters of the implantable medical device (e.g. Paragraphs [0040] and [0171] states the trusted authority (TA) service provider includes a user interface which allows a user (e.g. clinician) to modify IMD parameters via the first secure communications) by encrypting digital data using the second security protocol to create second encrypted messages (e.g. Figure 1A, Element 70A and 70B or Figure 3 Element 1070A and 1070B and Paragraphs [0052], [0074]-[0075] discloses cryptographic protection protocol for communication between 60 and IMD 20 and intermediary communication platform 40 does not have access to the content of the secure communications), encrypting the second encrypted messages using the first security protocol to create first encrypted messages that wrap the second encrypted messages (e.g. Figures 1 or 3, channel 70B or 1070B and Figure 1D, cloud 161 and Paragraph [0193] discloses further encrypting), and communicating with the user device using the first encrypted messages within the first encrypted communication channel (e.g. Paragraph [0193] discloses communication between platform 40 (1040) and TA/programmer 60 and Paragraph [0075] discloses platform 40 cannot decrypt the second encryption), and communicating with the implantable medical device using the second encrypted messages within the second encrypted communication channel (e.g. Figures 1A or 3, Elements 70A and 70 B or 1070A and 1070B and Paragraphs [0052], [0074]-[0075] discloses cryptographic protection protocol for communication between 60 and IMD 20 and intermediary communication platform 40 does not have access to the content of the secure communications), wherein the at least one cloud server does not know the first secret key and is unable to decipher messages between the clinician programmer and the implantable device using the first secret key (e.g. Figure 1D, Cloud 161 and Paragraph [0052]). However, Rondoni et al does not disclose the clinician programmer uses a first security protocol uses certificate-based mutual authentication between the clinician programmer and the user device, wherein the clinician programmer and the user device each possess digital certificates issued by a certificate authority and the certificates are verifiable with the issuing certificate authority, and wherein the clinician programmer authenticates itself to the user device by presenting its digital certificate. Durrant et al teaches that it is known to use certificate-based mutual authentication between two devices, wherein the first device and the second device each possess digital certificates issued by a certificate authority and the certificates are verifiable with the issuing certificate authority, and wherein the first device authenticates itself to the second device by presenting its digital certificate as set forth in Figure 8 and Paragraphs [0093]-[0095] to provide a simple substitution of one known security protocol for anther in order to establish a secure channel. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Rondoni et al, with certificate-based mutual authentication between two devices, wherein the first device and the second device each possess digital certificates issued by a certificate authority and the certificates are verifiable with the issuing certificate authority, and wherein the first device authenticates itself to the second device by presenting its digital certificate as taught by Durrant et al, since such a modification would provide the predictable results of a simple substitution of one known security protocol for anther in order to establish a secure channel.
In the alternative, that the modifying of IMD parameters is not programming therapy parameters. Horton et al teaches that it is known to use a remote monitoring server where CP 3 is used to remotely program medical device 7 as set forth in Figure 1 and Paragraph [0181] to provide improved quality of care for the patients and efficiency in the clinic workflow. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Rondoni et al, with using a remote clinician programmer to program the implantable medical device as taught by Horton et al, since such a modification would provide the predictable results of improved quality of care for the patients and efficiency in the clinic workflow.
Referring to Claims 2 and 17, Rondoni et al in view of Durrant et al and Horton et al teaches the claimed invention, wherein the user device does not know the first secret key and is unable to decipher messages between the clinician programmer and the implantable device using the first secret key (e.g. Paragraph [0052]).
Referring to Claim 4, Rondoni et al in view of Durrant et al and Horton et al teaches the system of claim 1, except wherein the first security protocol includes Transport Layer Security (TLS). Durrant et al teaches that it is known to use certificate-based mutual authentication between two devices, wherein the first security protocol includes EAP-TLS as set forth in Figure 8 and Paragraphs [0093]-[0095] to provide a simple substitution of one known security protocol for anther in order to establish a secure channel. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Rondoni et al, with wherein the first security protocol includes Transport Layer Security (TLS) as taught by Durrant et al, since such a modification would provide the predictable results of a simple substitution of one known security protocol for anther in order to establish a secure channel. In addition, Horton et al teaches that it is known to use security protocol that include TLS as an alternative as set forth in Paragraph [0188] to provide a simple substitution of one known security protocol for another to provide secure communications and reduce unwanted access to the IMD. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Rondoni et al, with security protocol that include TLS as taught by Horton et al, since such a modification would provide the predictable results of simple substitution of one known security protocol for another to provide secure communications and reduce unwanted access to the IMD.
Referring to Claim 5, Rondoni et al in view of Durrant et al and Horton et al teaches the system of claim 1, wherein the user device includes a smart phone or a tablet with a downloadable app configured to communicate over the first encrypted communication channel with the clinician programmer, configured to communicate over the secure wireless connection with the implantable medical device, and configured to relay messages between the implantable medical device and the clinician programmer using the second encrypted communication channel within the first encrypted communication channel (e.g. Figure 1A, Element 40 and Paragraphs [0040] and [0049]).
Referring to Claim 6, Rondoni et al in view of Durrant et al and Horton et al teaches the system of claim 1, wherein the user device includes a remote control programming device configured to communicate over the first encrypted communication channel with the clinician programmer, configured to communicate over the secure wireless connection with the implantable medical device, and configured to relay messages between the implantable medical device and the clinician programmer using the second encrypted communication channel within the first encrypted communication channel (e.g. Figure 1A).
Referring to Claims 8 and 21, Rondoni et al in view of Durrant et al and Horton et al teaches the claimed invention, wherein the implantable medical device includes a neuromodulator (e.g. Paragraph [0060] disclose neurostimulation).
Referring to Claim 9, Rondoni et al in view of Durrant et al and Horton et al teaches the system of claim 8, wherein the neuromodulator includes a spinal cord stimulator (SCS), a deep brain stimulator (DBS), a peripheral nerve stimulator (PNS), a peripheral nerve field stimulator (PNFS), or a functional electric stimulator (FES) (the examiner notes the claim has been carefully reviewed and the recitation of functional use of the neuromodulator does not appear to further limit the claimed structure. There is no indication that the device of Rondoni et al is not capable of performing the above uses).
However, in order to advance prosecution, Horton et al teaches that it is known to use the neuromodulator includes a SCS as set forth in Paragraph [0025] to provide treatment for pain. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Rondoni et al, with the neuromodulator includes a spinal cord stimulator (SCS) as taught by Horton et al, since such a modification would provide the predictable results of treatment for pain.
Referring to Claims 10 and 21, Rondoni et al in view of Durrant et al and Horton et al teaches the claimed invention, wherein the implantable medical device includes a cardiac stimulator configured to stimulate myocardia (e.g. Paragraph [0200] discloses treating cardiac irregularities).
Referring to Claims 11 and 22, Rondoni et al in view of Durrant et al and Horton et al teaches the claimed invention, wherein the implantable medical device includes at least one sensor configured to sense at least one health-related parameter (e.g. Figure 2A, Element 422); and communicating the at least one-health related parameter from the IMD to the clinician programmer (e.g. Paragraph [0112]).
Referring to Claims 12 and 23, Rondoni et al in view of Durrant et al and Horton et al teaches the claimed invention, wherein the secure wireless connection includes inductive near-field communication, a Bluetooth connection, or a wireless local area network (e.g. Paragraph [0071] discloses communication with Bluetooth).
Referring to Claims 14 and 15, Rondoni et al in view of Durrant et al and Horton et al teaches the system of claim 1, except wherein the second security protocol authenticates the user device to communicate with the implantable medical device and wherein the authentication includes at least one of one or more passwords and two-factor or multi-factor authentication.
Horton et al teaches that it is known to use 2 factor input or multi-factor authentication to authenticate a device as set forth in Paragraphs [0045], [0108], [0204], and [0214] to provide a simple substitution of one known security protocol for another to provide secure communications and reduce unwanted access. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Rondoni et al, with using 2 factor input or multi-factor authentication to authenticate a device as taught by Horton et al, since such a modification would provide the predictable results of a simple substitution of one known security protocol for another to provide secure communications and reduce unwanted access.
Referring to Claim 20, Rondoni et al teaches a method for using a clinician programmer to remotely program an implantable medical device configured to deliver therapy according to user-programmable therapy parameters (e.g. Paragraphs [0060] and [0171] states the trusted authority (TA) service provider includes a user interface which allows a user (e.g. clinician) to modify IMD parameters via the first secure communications), the method comprising: establishing, using a first security protocol (e.g. Figures 1 or 3, channel 70B or 1070B and Figure 1D, cloud 161 and Paragraph [0193] discloses the security protocol between the communication platform and the TA service provider (clinician programmer) is further encrypted using security protocols (first security protocol)), a first encrypted communication channel between the clinician programmer and a user device through at least one cloud server (e.g. Figure 1D, cloud 161), wherein the user device includes a smart phone or a tablet with a downloadable app in the smart phone or the tablet (e.g. Paragraph [0042]), wherein the user device is configured to wirelessly communicate with the implantable medical device through a secure wireless connection, wherein the secure wireless connection includes inductive near-field communication, a Bluetooth connection, or a wireless local area network, and wherein the first security protocol authenticates entities and establishes a first key set for encrypting and decrypting messages transmitted within the first encrypted communication channel (e.g. Paragraph [0071]); establishing, using a second security protocol, a second encrypted communication channel at least partially within the first encrypted communication channel, wherein the second encrypted communication channel extends between implantable medical device and the clinician programmer, wherein the establishing the second encrypted communication channel includes establishing at least a first secret key for exchanging encrypted messages (e.g. Figures 1A or 3, Element 70A and 70B or 1070A and 1070B and Paragraphs [0052], [0074]-[0075] discloses cryptographic protection protocol (second security protocol)for communication between 60 and IMD 20 and intermediary communication platform 40 does not have access to the content of the secure communications and Paragraph [0193] discloses the security protocol between the communication platform and the TA service provider 60 (clinician programmer) is further encrypted using security protocols (first security protocol)); using the clinician programmer to program the implantable medical device by: encrypting digital data using the second security protocol to create second encrypted messages (e.g. Figures 1A or 3, Element 70A and 70B or 1070A and 1070B and Paragraphs [0052], [0074]-[0075]); encrypting the second encrypted messages using the first security protocol to create first encrypted messages (e.g. Paragraph [0193] further encrypted); communicating between the clinician programmer and the user device using the first encrypted messages within the first encrypted communication channel (e.g. Paragraph [0193] discloses further encrypted communication between platform 40 (1040) and TA/programmer 60 and Paragraph [0075] discloses platform 40 cannot decrypt the second encryption), and communicating between the clinician programmer and the implantable medical device using the second encrypted messages within the second encrypted communication channel (e.g. Figures 1A or 3, Element 70A and 70B or 1070A and 1070B and Paragraphs [0052], [0074]-[0075] discloses cryptographic protection protocol for communication between 60 and IMD 20 and intermediary communication platform 40 does not have access to the content of the secure communications). However, Rondoni et al does not explicitly disclose the use security protocol including Transport Layer Security (TLS); wherein the first security protocol uses certificate-based mutual authentication between the clinician programmer and the user device, wherein the clinician programmer and the user device each possess digital certificates issued by a certificate authority and the certificates are verifiable with the issuing certificate authority, and wherein the clinician programmer authenticates itself to the user device by presenting its digital certificate. Durrant et al teaches that it is known to use certificate-based mutual authentication between two devices, wherein the first device and the second device each possess digital certificates issued by a certificate authority and the certificates are verifiable with the issuing certificate authority, and wherein the first device authenticates itself to the second device by presenting its digital certificate and used in EAP-TLS as set forth in Figure 8 and Paragraphs [0093]-[0095] to provide a simple substitution of one known security protocol for anther in order to establish a secure channel. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Rondoni et al, with security protocol including Transport Layer Security (TLS); wherein the certificate-based mutual authentication between two devices, wherein the first device and the second device each possess digital certificates issued by a certificate authority and the certificates are verifiable with the issuing certificate authority, and wherein the first device authenticates itself to the second device by presenting its digital certificate as taught by Durrant et al, since such a modification would provide the predictable results of a simple substitution of one known security protocol for anther in order to establish a secure channel.
Horton et al teaches that it is known to use a remote monitoring server where CP 3 is used to remotely program medical device 7 (if in the alternative, that the modifying of IMD parameters is not programming therapy parameters as taught by Rondoni) as set forth in Figure 1 and Paragraph [0181] to provide improved quality of care for the patients and efficiency in the clinic workflow; and it is known to use security protocol that include TLS as an alternative as set forth in Paragraph [0188] to provide a simple substitution of one known security protocol for another to provide secure communications and reduce unwanted access to the IMD. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Rondoni et al, with using a remote clinician programmer to program the implantable medical device; and with security protocol that include TLS as taught by Horton et al, since such a modification would provide the predictable results of improved quality of care for the patients and efficiency in the clinic workflow; and as a simple substitution of one known security protocol for another to provide secure communications and reduce unwanted access to the IMD.
Claim(s) 3 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rondoni et al (US Publication 2020/086128) in view Durrant et al (US Publication 2016/0321400) and Horton et al (US Publication 2022/0392630) as applied above, and further in view of Horton et al (US Publication 2021/0383922) hereby referred to as “Horton ‘922).
Referring to Claims 3 and 18, Rondoni et al in view of Durrant et al and Horton et al teaches the claimed invention, except wherein: the first secret key is used to exchange encrypted messages within the second encrypted communication channel between the clinician programmer and the user device, the second encrypted communication channel is established by establishing a second secret key used to exchange encrypted messages between the implantable medical device and the user device, and the user device is configured to use the first secret key to decipher messages between the clinician programmer and the implantable medical device, and is further configured to relay the deciphered messages to the implantable medical device using the second secret key .
Horton ‘922 teaches that it is known to use a patient device that receives and deciphers the encrypted communication from the clinician programmer and uses a second key to relay the deciphered message to the IMD as set forth in Figure 3 and Paragraphs [0027] and [0039] to provide verification of the authenticity of each of the signals along the communication route. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Rondoni et al, with a patient device that receives and deciphers the encrypted communication from the clinician programmer and uses a second key to relay the deciphered message to the IMD as taught by Horton ‘922, since such a modification would provide the predictable results of verification of the authenticity of each of the signals along the communication route.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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/William J Levicky/Primary Examiner, Art Unit 3796
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