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 .
Response to Arguments
Applicant's arguments filed 1/29/2026 have been fully considered but they are not persuasive. Applicant argues Yoder does not disclose two distinct memory area in the implantable device. Applicant argues Yoder discloses an external device there is no mention of a second memory area of an implantable medical device. Notably Yoder does disclose a distinct memory area in Paragraph [0125], but this memory area participates in the monitoring of telemetry connectivity between the external device and the implantable device. Therefore, Yoder does not disclose or suggest two distinct memory areas, as prescribed by the current claims. The examiner respectfully disagrees as the memory area is not required to be two separate memory units, but is the area in the memory allocated to the code for controlling the diagnostic and or therapy control unit and the memory area of code for controlling the wireless communication interface. Yoder in Paragraph [0076] discloses the implantable medical device analyzes the sensed electrical signals and is configured to provide pacing therapy to the heart (memory are code for controlling the diagnostic and/or therapy). In addition, Yoder et al discloses the telemetry communication protocols employed by the implantable device 104. In particular while Paragraph [0123] discloses reconfiguration information to the implantable device 104 that defines how the implantable device should update its telemetry protocol parameters. Therefore, the implantable medical device has a memory area that contains code for controlling the wireless communication interface. Because these control two distinct elements they are not the same code and therefore have two distinct memory areas.
The examiner notes that the specification objection; 112(b) and 101 rejections have been overcome and are withdrawn.
Claim Rejections - 35 USC § 102
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, and 6-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoder et al (US Publication 2020/0121937).
Referring to Claim 1, Yoder et al teaches a computer implemented method for updating an executable code of an implantable medical device/an implantable medical device (e.g. Paragraph [0003]), comprising: a diagnostic and/or therapeutic control unit (e.g. Paragraph [0030]); a wireless communication interface, operating in a frequency band and/or using a communication protocol supported by consumer mobile communications devices (e.g. Paragraphs [0036] and [0127] discloses using cellular communication protocol and/or Bluetooth protocol); a first memory area, in which executable code for controlling the diagnostic and/or therapy control unit is stored (e.g. Paragraph [0076] discloses memory for controlling the delivery of therapy); a second memory area, in which executable code for controlling the wireless communication interface is stored, wherein the software and/or hardware of the wireless communication interface is configured to update the executable code of the wireless communication interface via the wireless communication interface (e.g. Paragraph [0123] discloses configuration protocol in the IMD for connecting with the external device).
Referring to Claim 2, Yoder et al teaches implantable medical device of claim 1, comprising at least one further wireless communication interface configured to update the executable code for controlling the diagnostic and/or therapeutic control unit, wherein the at least one further wireless communication interface comprises an inductive communication interface and/or a MICS band communication interface (e.g. Paragraph [0033] discloses the external device sending programming information to the implantable device for application by the IMD and Paragraphs [0028] and [0036] discloses using inductive connections).
Referring to Claim 6, Yoder et al teaches implantable medical device of claim 1, wherein the wireless communication interface uses an authentication and/or data encryption method supported by consumer mobile communications devices (e.g. Paragraph [0036]).
Referring to Claim 7, Yoder et al teaches implantable medical device of claim 1, wherein the wireless communication interface is a software-controlled communication interface (e.g. Paragraph [0036]).
Referring to Claim 8, Yoder et al teaches implant communication system, comprising: the implantable medical device of claim 1 (e.g. Paragraph [0036]); a programmer configured to communicate with the implantable medical device using inductive communication or medical RF communication (e.g. Paragraphs [0037] and [0038]); a consumer mobile communication device configured to communicate with the implantable medical device in a frequency band and/or using a communication protocol supported by the consumer mobile communication device (e.g. Paragraphs [0037] and [0038]).
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) 3-5, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoder et al (US Publication 2020/0121937) in view of Healy et al (US Publication 2005/0203582)
Referring to Claim 3, Yoder et al teaches implantable medical device of claim 2, except wherein the at least one further wireless communication interface is configured to authenticate an update of the executable code for controlling the diagnostic and/or therapeutic control unit, wherein an authentication of the update is performed via the inductive communication interface.
Healy et al teaches that it is known to use at least one further wireless communication interface is configured to authenticate an update of the executable code for controlling the diagnostic and/or therapeutic control unit, wherein an authentication of the update is performed via the inductive communication interface as set forth in Figure 1A RF telemetry (far field, elements 40 and 68) and inductive telemetry (near field, elements 42 and 70) and Figure 2 and Paragraphs [0068] and [0057] disclose near field telemetry link 294 to transmit instructions; and Figure 2 and Paragraph [0057] discloses using near field telemetry channel 296 to convey message authentication code to provide improved communication security that the integrity of a message has not been compromised and that the communication session is authorized. 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 Yoder et al, with wherein the at least one further wireless communication interface (inductive) is configured to authenticate an update of the executable code for controlling the diagnostic and/or therapeutic control unit, wherein an authentication of the update is performed via the inductive communication interface as taught by Healy et al, since such a modification would provide the predictable results of improved communication security that the integrity of a message has not been compromised and that the communication session is authorized.
Referring to Claim 4, Yoder et al teaches implantable medical device of claim 1, except wherein the implantable medical device is configured to use a first authentication mechanism for authenticating an update of the executable code for controlling the diagnostic and/or therapeutic control unit, and wherein the implantable medical device is configured to use a second authentication mechanism for authenticating an update of the executable code for controlling the wireless communication interface.
Healy et al teaches that it is known to use the implantable medical device is configured to use a first authentication mechanism for authenticating an update, and wherein the implantable medical device is configured to use a second authentication mechanism for authenticating another update as set forth in Figure 2 and Paragraph [0057] (using far field communication and authentication and near field communication and authentication) to provide improved communication security that the integrity of a message has not been compromised and that the communication session is authorized. 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 Yoder et al, with the implantable medical device is configured to use a first authentication mechanism for authenticating an update, and wherein the implantable medical device is configured to use a second authentication mechanism for authenticating another update as taught by Healy et al, since such a modification would provide the predictable results of improved communication security that the integrity of a message has not been compromised and that the communication session is authorized.
Referring to Claim 5, Yoder et al teaches implantable medical device of claim 1, except wherein the diagnostic and/or therapeutic control unit is configured to prohibit an update of the executable code for controlling the wireless communication interface if a predetermined condition is met and/or if an unauthenticated update attempt is performed. Healy et al teaches that it is known to use a control unit configured to prohibit an update of the executable code if a predetermined condition is met, if an unauthenticated update attempt is performed as set forth in Paragraph [0056] to provide improved communication security that the integrity of a message has not been compromised and that the communication session is authorized. 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 Yoder et al, with a control unit configured to prohibit an update of the executable code if a predetermined condition is met, if an unauthenticated update attempt is performed as taught by Healy et al, since such a modification would provide the predictable results of improved communication security that the integrity of a message has not been compromised and that the communication session is authorized.
Referring to Claim 10, Yoder et al teaches implant communication system of claim 8, except wherein the programmer is configured to authenticate an update of the executable code for controlling the diagnostic and/or therapeutic control unit.
Healy et al teaches that it is known to use the programmer is configured to authenticate an update of the executable code as set forth in Figure 2 and Paragraph [0057]to provide improved communication security that the integrity of a message has not been compromised and that the communication session is authorized. 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 Yoder et al, with the programmer is configured to authenticate an update of the executable code as taught by Healy et al, since such a modification would provide the predictable results of improved communication security that the integrity of a message has not been compromised and that the communication session is authorized.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoder et al (US Publication 2020/0121937) in view of Masoud et al (US Publication 2016/0330573).
Referring to Claim 9, Yoder et al teaches implant communication system of claim 8, except wherein the consumer mobile communication device is configured to authenticate an update of the executable code for controlling the wireless communication interface using an app connected to the implantable medical device.
Masoud et al teaches that it is known to use wherein the consumer mobile communication device, using an app connected to the implantable medical device, is configured to authenticate a user request as set forth in Paragraph [0029] to provide a secure connection with the medical device to protect the user from unauthorized access and changes. 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 Yoder et al, with wherein the consumer mobile communication device is configured to authenticate an update of the executable code for controlling the wireless communication interface using an app connected to the implantable medical device as taught by Masoud et al, since such a modification would provide the predictable results of a secure connection with the medical device to protect the user from unauthorized access and changes.
Conclusion
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William J Levicky/Primary Examiner, Art Unit 3796
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