DETAILED ACTION
Notice to Applicant
This communication is in response to the Request for Continued Examination (RCE) submitted February 20, 2025. Claims 1, 4 – 6, 8 – 11, 14 – 16, and 18 - 21 are amended. Claims 1 – 21 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 20, 2025 has been entered.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3 – 11, and 13 – 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spencer et al., herein after Spencer (U.S. Patent Number 9,980,140 B1) in view of Mairs et al., herein after Mairs (U.S. Publication Number 2018/0137252 A1) further in view of Estes et al., herein after Estes (U.S. Publication Number 2019/0054236 A1) in view of Su et al., herein after Su (U.S. Publication Number 2020/0162896 A1).
Claim 1 (Currently Amended): Spencer teaches a method of pairing devices in an ambulatory infusion pump system, comprising:
initiating a first pairing procedure to wirelessly pair a user-wearable infusion pump with a primary device (column 9, line 65 through column 10, line 19 discloses the information stored locally by the device can be used as a shared secret to securely pair the controller and the device, such as through a BLUETOOTH pairing procedure and/or through a Wi-Fi Direct pairing procedure, indicating wirelessly paired; column 21, lines 60 – 65 discloses the controller and/or the device can initiate the pairing process, where the device may be an insulin pump device, and the computer devices (primary device) may be a computer system and/or smartphones (column 1, lines 18 – 19));
5receiving secure connection information for wirelessly pairing the user-wearable infusion pump with the primary device at the primary device (column 1, line 50 through column 2, line 2 discloses providing secure connections and communication between medical devices (e.g. insulin delivery devices, drug delivery devices, health monitoring devices) and computing devices, such as computer systems, mobile computing devices (e.g. smartphones, tablets); column 9, line 65 through column 10, line 19 discloses the information stored locally by the device can be used as a shared secret to securely pair the controller and the device, such as through a BLUETOOTH pairing procedure and/or through a Wi-Fi Direct pairing procedure, indicating wirelessly paired);
wirelessly pairing the user-wearable infusion pump with the primary device based on the secure connection information received at the primary device (column 9, line 65 through column 10, line 19 discloses the information stored locally by the device can be used as a shared secret to securely pair the controller and the device, such as through a BLUETOOTH pairing procedure and/or through a Wi-Fi Direct pairing procedure, indicating wirelessly paired; column 10, lines 56 – 61 discloses the controller and device, having been paired so they can securely communicate with each other, can seek to verify that they are communicating with devices that are authorized and authenticated with the computer system; column 27, lines 59 – 64 discloses the mobile computing device is in wireless communication with insulin pump assembly, where the mobile computing device where the mobile computing device may be a smart phone (column 1, lines 54 – 55)).
Spencer fails to explicitly teach the following limitations met by Mairs as cited:
10initiating a second pairing procedure to wirelessly pair the user-wearable infusion pump with a secondary device (Figures 3, 4, and 5 disclose pairing of a device and secondary device; paragraph 23 discloses the network is realized as a Bluetooth network, indicating wirelessly paired; paragraph 33 discloses the patient monitoring system may include multiple different sensing arrangements and/or monitoring devices, indicating more than one device (secondary device); paragraph 37 discloses the client application may perform a scan procedure or similar process to discover potential monitoring devices within communications range of the client device and provide a GUI display including a listing of the detected monitoring devices).
It would have been obvious to one of ordinary skill before the effective filing date of the invention to expand the method of Spencer to further include monitoring events or conditions that affect a patient’s physiological condition or sensitivity to a fluid, medication or other potential therapies or lifestyle modifications as disclosed by Mairs.
One of ordinary skill in the art before the effective filing date of the invention would have been motivated to expand the method of Spencer in this way to provide continuous monitoring and integrated event log data to facilitate improved outcomes and minimize the burdens on patients, physicians, or other healthcare providers (Mairs: paragraph 3).
Spencer and Mairs fail to explicitly teach the following limitations met by Estes as cited:
sharing, from the primary device to the secondary device, the secure connection information used for wirelessly pairing the user-wearable infusion pump with the primary device (paragraph 41 discloses an infusion pump assembly that includes a pump device and a removably attachable controller device used together for the purpose of supplying insulin to a patient, in addition to a mobile device configured to execute mobile applications; paragraph 55 discloses wireless communications between the controller device (secondary device) and the mobile device (primary device) that can incorporate one or more security measures to inhibit signal hijacking, a secure communications protocol involving security coded wireless data packets can be implemented in wireless communications between the controller device and the mobile device; paragraph 68 discloses the control circuitry of a medical device can receive input via wireless communication from a mobile device).
It would have been obvious to one of ordinary skill before the effective filing date of the invention to expand the method of Spencer and Mairs to further include a portable infusion pump assembly for dispensing a medication which may be equipped with one or more components to facilitate wireless communication between a mobile communication device and an infusion pump assembly as disclosed by Estes.
One of ordinary skill in the art before the effective filing date of the invention would have been motivated to expand the method of Spencer and Mairs in this way to provide convenient wireless communications while also reducing the likelihood of long-range hijacking of the wireless communications to the infusion pump assembly and to provide safe and reliable wireless control of an infusion pump assembly by a mobile device (Estes: paragraph 16).
Spencer, Mairs, and Estes fail to explicitly teach the following limitations met by Su as cited:
wherein the secure 15connection that was used to wirelessly pair the user-wearable infusion pump with the primary device and information received from the primary device is used to wirelessly pair the secondary device with the user-wearable infusion pump (paragraph 5 discloses providing an embedded OOB (out-of-band) key generation to securely pair an on-body and/or drug delivering device with wireless or mobile devices; paragraph 35 discloses the medical device can be any on-body medical device (e.g. wearable infusion pump, continuous glucose meter) or body area network (BAN) medical devices).
It would have been obvious to one of ordinary skill before the effective filing date of the invention to expand the method of Spencer, Mairs, and Estes to further include a secure wireless pairing between two devices using embedded out-of-band (OOB) key generation to minimize pairing between a device and an unintended device as disclosed by Su.
One of ordinary skill in the art before the effective filing date of the invention would have been motivated to expand the method of Spencer, Mairs, and Estes in this way to provide an effective, low power protocol for wirelessly connecting devices that run on power sources such as those used with wearable devices (Estes: paragraph 4).
Claim 203 (Original): Spencer, Mairs, Estes, and Su teach the method of claim 1. Spencer teaches a method wherein the primary device wirelessly communicates the secure connection information to the secondary device (column 3, lines 5 – 8 discloses a secure wireless communication connection).
Claim 4 (Currently Amended): Spencer, Mairs, Estes, and Su teach the method of claim 1. Spencer teaches a method wherein the second pairing procedure is initiated by the primary device (column 21, lines 60 – 65 discloses the controller and/or the device can initiate the pairing process, where the device may be an insulin pump device, and the computer devices (primary device) may be a computer system and/or smartphones (column 1, lines 18 – 19)).
Claim 5 (Currently Amended): Spencer, Mairs, Estes, and Su teach the method of claim 1.
Spencer fails to explicitly teach the following limitations met by Mairs as cited:
wherein the second pairing procedure is initiated by the secondary device (paragraph 25 discloses the pairing information obtained during the discovery procedure allows either the monitoring device or client device to initiate establishment of a secure communication session).
The motivation to combine the teachings of Spencer, Mairs, Estes, and Su is discussed in the rejection of claim 1, and incorporated herein.
Claim 6 (Currently Amended): Spencer, Mairs, Estes, and Su teach the method of claim 1. Spencer teaches a method wherein the second pairing procedure is initiated by the user-wearable infusion pump (column 21, lines 60 – 51 discloses the controller and/or the device (pump) can initiate the pairing process).
Claim 107 (Original): Spencer, Mairs, Estes, and Su teach the method of claim 1.
Spencer fails to explicitly teach the following limitations met by Mairs as cited:
wherein the secondary device is provided with a different level of control of the user-wearable infusion pump than the primary device (paragraph 26 discloses the second network may be physically and/or logically distinct from the network; claim 1 discloses measurement data is uploaded to a remote device on a second network).
The motivation to combine the teachings of Spencer, Mairs, Estes, and Su is discussed in the rejection of claim 1, and incorporated herein.
Claim 8 (Currently Amended): Spencer, Mairs, Estes, and Su teach the method of claim 1. Spencer teaches a method wherein receiving secure connection information for wirelessly pairing the user-wearable infusion pump with the primary device at the primary device includes the secure 15connection information being manually entered into the primary device (column 8, lines 13 – 33 discloses usernames and passwords to access the computer system; column 9, lines 33 – 38 discloses verifying the controller and user by verifying username, password, verify authentication certificate for the controller and its application; column 9, line 65 through column 10, line 19 discloses the information stored locally by the device can be used as a shared secret to securely pair the controller and the device, such as through a BLUETOOTH pairing procedure and/or through a Wi-Fi Direct pairing procedure; column 10, lines 56 – 61 discloses the controller and device, having been paired so they can securely communicate with each other, can seek to verify that they are communicating with devices that are authorized and authenticated with the computer system).
Spencer fails to explicitly teach the following limitations met by Mairs as cited:
wherein sharing the secure connection information with the secondary device includes the secondary device being wirelessly paired with the user-wearable infusion pump without the secure connection information being manually entered into the secondary device (paragraph 20 discloses manually logging or journaling events, activities, or other conditions or contextual information that may influence the user’s glucose levels; paragraph 23 discloses the network is realized as a Bluetooth network, indicating wirelessly paired).
The motivation to combine the teachings of Spencer, Mairs, Estes, and Su is discussed in the rejection of claim 1, and incorporated herein.
Claim 209 (Currently Amended): Spencer, Mairs, Estes, and Su teach the method of claim 1. Spencer teaches a method wherein the primary device is a smartphone (column 1, lines 50 – 55 discloses mobile computing devices, including a smartphone).
Claim 10 (Currently Amended): Spencer, Mairs, Estes, and Su teach the method of claim 9. Spencer teaches a method further comprising:
displaying the secure connection information at the user-wearable infusion pump (column 2, lines 27 – 42 discloses when securely pairing a medical device with a computing device via a BLUETOOTH connection, one of the devices can output a code (e.g., PIN code) that will then be input through a user interface on the other device to provide a shared secret between the devices. This shared secret can be used to compute values that are used to authenticate the two devices with each other during a BLUETOOTH challenge/response process) (i) responsive to initiating the first pairing procedure (column 9, line 65 through column 10, line 19 discloses the information stored locally by the device can be used as a shared secret to securely pair the controller and the device, such as through a BLUETOOTH pairing procedure and/or through a Wi-Fi Direct pairing procedure; column 21, lines 60 – 65 discloses the controller and/or the device can initiate the pairing process) and (ii) prior to receiving the secure connection information (column 2, lines 27 – 42 discloses when securely pairing a medical device with a computing device via a BLUETOOTH connection, one of the devices can output a code (e.g., PIN code) that will then be input through a user interface on the other device to provide a shared secret between the devices, indicating displaying the code to be input to initiate the secure connection, prior to the connection being secured).
Method claims 11 and 13 – 20 repeat the subject matter of claims 1 and 3 – 10. As the underlying processes of claims 11 and 13 – 20 have been shown to be fully disclosed by the teachings of Spencer, Mairs, Estes, and Su in the above rejections of claims 1 and 3 – 10; as such, these limitations (11 and 13 – 20) are rejected for the same reasons given above for claims 1 and 3 – 10 and incorporated herein.
Claim 21 (Currently Amended): Spencer teaches a control device configured to control an ambulatory infusion pump system, the control device comprising:
a processor (column 14, lines 11 – 13 discloses one or more processors) configured to execute a plurality of operations associated with connecting with a user-wearable infusion pump (column 33, lines 31 – 46 discloses one or more microprocessors are configured to execute computer readable instructions stored on one or more memory devices) such that the processor is configured to:
initiate a first pairing procedure to wirelessly pair the user-wearable infusion pump with the control device (column 9, line 65 through column 10, line 19 discloses the information stored locally by the device can be used as a shared secret to securely pair the controller and the device, such as through a BLUETOOTH pairing procedure and/or through a Wi-Fi Direct pairing procedure; column 21, lines 60 – 65 discloses the controller and/or the device can initiate the pairing process);
receive, at the control device, secure connection information for wirelessly pairing the user-wearable infusion pump with the control device (column 1, line 50 through column 2, line 2 discloses providing secure connections and communication between medical devices (e.g. insulin delivery devices, drug delivery devices, health monitoring devices) and computing devices, such as computer systems, mobile computing devices (e.g. smartphones, tablets); column 9, line 65 through column 10, line 19 discloses the information stored locally by the device can be used as a shared secret to securely pair the controller and the device, such as through a BLUETOOTH pairing procedure and/or through a Wi-Fi Direct pairing procedure);
wirelessly pair the user-wearable infusion pump with the control device based on the secure connection information (column 9, line 65 through column 10, line 19 discloses the information stored locally by the device can be used as a shared secret to securely pair the controller and the device, such as through a BLUETOOTH pairing procedure and/or through a Wi-Fi Direct pairing procedure; column 10, lines 56 – 61 discloses the controller and device, having been paired so they can securely communicate with each other, can seek to verify that they are communicating with devices that are authorized and authenticated with the computer system; column 27, lines 59 – 64 discloses the mobile computing device is in wireless communication with insulin pump assembly, where the mobile computing device where the mobile computing device may be a smart phone (column 1, lines 54 – 55)).
Spencer fails to explicitly teach the following limitations met by Mairs as cited:;
initiate a second pairing procedure to wirelessly pair the user-wearable infusion pump with a secondary device (Figures 3, 4, and 5 disclose pairing of a device and secondary device; paragraph 23 discloses the network is realized as a Bluetooth network, indicating wirelessly paired; paragraph 33 discloses the patient monitoring system may include multiple different sensing arrangements and/or monitoring devices, indicating more than one device (secondary device); paragraph 37 discloses the client application may perform a scan procedure or similar process to discover potential monitoring devices within communications range of the client device and provide a GUI display including a listing of the detected monitoring devices).
It would have been obvious to one of ordinary skill before the effective filing date of the invention to expand the method of Spencer to further include monitoring events or conditions that affect a patient’s physiological condition or sensitivity to a fluid, medication or other potential therapies or lifestyle modifications as disclosed by Mairs.
One of ordinary skill in the art before the effective filing date of the invention would have been motivated to expand the method of Spencer in this way to provide continuous monitoring and integrated event log data to facilitate improved outcomes and minimize the burdens on patients, physicians, or other healthcare providers (Mairs: paragraph 3).
Spencer and Mairs fail to explicitly teach the following limitations met by Estes as cited:
share, from the control device to the secondary device, the secure connection information used for wirelessly pairing the user-wearable infusion pump with the control device (paragraph 41 discloses an infusion pump assembly that includes a pump device and a removably attachable controller device used together for the purpose of supplying insulin to a patient, in addition to a mobile device configured to execute mobile applications; paragraph 55 discloses wireless communications between the controller device (secondary device) and the mobile device (primary device) that can incorporate one or more security measures to inhibit signal hijacking, a secure communications protocol involving security coded wireless data packets can be implemented in wireless communications between the controller device and the mobile device; paragraph 68 discloses the control circuitry of a medical device can receive input via wireless communication from a mobile device).
Spencer, Mairs, and Estes fail to explicitly teach the following limitations met by Su as cited:
wherein the secure 15connection that was used to wirelessly pair the user-wearable infusion pump with the primary device and information received from the primary device is used to wirelessly pair the secondary device with the user-wearable infusion pump (paragraph 5 discloses providing an embedded OOB (out-of-band) key generation to securely pair an on-body and/or drug delivering device with wireless or mobile devices; paragraph 35 discloses the medical device can be any on-body medical device (e.g. wearable infusion pump, continuous glucose meter) or body area network (BAN) medical devices).
The motivation to combine the teachings of Spencer, Mairs, Estes, and Su is discussed in the rejection of claim 1, and incorporated herein.
Claim(s) 2 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spencer et al., herein after Spencer (U.S. Patent Number 9,980,140 B1) in view of Mairs et al., herein after Mairs (U.S. Publication Number 2018/0137252 A1) further in view of Estes et al., herein after Estes (U.S. Publication Number 2019/0054236 A1) and Su et al., herein after Su (U.S. Publication Number 2020/0162896 A1) further in view of Klem (U.S. Patent Number 10,524,110 B1).
Claim 2 (Original): Spencer, Mairs, Estes, and Su teach the method of claim 1.
Spencer, Mairs, Estes, and Su fail to explicitly teach the following limitations met by Klem as cited:
wherein receiving secure connection information at the primary device includes receiving an alphanumeric security key (Fig 5; column 11, lines 2 – 7 discloses one or more security keys are exchanged between the peripheral device and the central device; Klem does not expressly show alphanumeric security keys. However these differences are only found in the nonfunctional descriptive material and are not functionally involved in the steps recited. The security key would be performed the same regardless of the data. Thus, this descriptive material will not distinguish the claimed invention from the prior art in terms of patentability, see In re Gulack, 703 F.2d 1381, 1385, 217 USPQ 401, 401 (Fed. Cir. 1983); In re Lowry, 32 F.3d 1579, 32 USPQ2d 1031 (Fed. Cir. 1994)).
It would have been obvious to one of ordinary skill before the effective filing date of the invention to expand the method of Spencer, Mairs, Estes, and Su to further affirmative device pairing systems to complete an authenticated wireless communication between medical devices and method of use as disclosed by Klem.
One of ordinary skill in the art before the effective filing date of the invention would have been motivated to expand the method of Spencer, Mairs, Estes, and Su in this way to permit wireless communication pairing in a manner that prevents interferences from such unintended devices as possible connection points, which may otherwise connect to a peripheral device and disrupt an intended pairing (Klem: column 1, lines 25 - 30).
Method claim 12 repeats the subject matter of claim 2. As the underlying processes of claim 12 has been shown to be fully disclosed by the teachings of Spencer, Mairs, Estes, Su, and Klem in the above rejections of claim 2; as such, these limitations (12) are rejected for the same reasons given above for claim 2 and incorporated herein.
Response to Arguments
Applicant's arguments filed February 20, 2025 have been fully considered but they are not persuasive. The Applicant’s arguments have been addressed in the order in which they were presented.
Rejections under 35 USC § 103
The Applicant argues the references, either alone or in combination, do not teach or suggest “sharing, from the primary device to the secondary device, the secure connection information used for pairing the user-wearable infusion pump with the primary device, wherein the secure connection information that was used to pair the user-wearable infusion pump with the primary device and received from the primary device is used to pair the secondary device with the user-wearable infusion pump”. The Examiner respectfully submits the published specification discloses the “…. a primary device such as, for example, a smartphone” (paragraph 9). The Examiner also submits the published specification discloses: the primary device is a smartphone, secondary devices can include, for example, a dedicated remote controller, a continuous glucose monitor, a glucose meter, a fitness tracking device, a tablet or laptop, and an electronic watch” (paragraph 40). Estes discloses an infusion pump assembly that includes a pump device and a removably attachable controller device used together for the purpose of supplying insulin to a patient, in addition to a mobile device configured to execute mobile applications (paragraph 41) as well as wireless communications between the controller device (secondary device) and the mobile device (primary device) that can incorporate one or more security measures to inhibit signal hijacking, a secure communications protocol involving security coded wireless data packets can be implemented in wireless communications between the controller device and the mobile device (paragraph 55). These features indicate a secure wireless connection between a primary and secondary device. Thus, Applicant’s argument is not persuasive and the rejection is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Zheng et al. (U.S. Patent Number 11,039,491 B2) discloses systems, apparatuses, and methods for secure inductive pairing between two devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINE K RAPILLO whose telephone number is (571)270-3325. The examiner can normally be reached Monday - Friday 7:30 - 4 pm.
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KRISTINE K. RAPILLO
Examiner
Art Unit 3626
/KRISTINE K RAPILLO/Examiner, Art Unit 3682