DETAILED ACTION
This Office Action has been issued in response to Applicant's Amendment filed December 17, 2025.
Claims 14, 26, and 31 have been amended. Claims 14-33 have been examined and are pending.
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 December 17, 2025 have been fully considered but they are not persuasive.
Applicant argues the references do not disclose the processes being in separate memory space. Paragraph [0059] of Becker discloses in some embodiments, the hardware and/or software of the edge communication device 14 is separated and isolated from the medical device 12. Paragraph [0025] of Ramey discloses the term module may include memory (shared, dedicated, or group) that stores code executed by the processor.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 14-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The amended claims recite “being in a separate memory space of the processor.” Examiner was unable to find support for this in the specification. While there is support for the processes being in a separate memory space, there does not appear to be discussion of those memory spaces being “of the processor.”
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 (i.e., changing from AIA to pre-AIA ) 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 14-33 are rejected under 35 U.S.C. 103 as being unpatentable over US Pub. No. 2020/0135333 to Becker (hereinafter “Becker”) and further in view of US Pub. No. 2012/0095311 to Ramey et al. (hereinafter “Ramey”) and further in view of US Pub. 2019/0102538 to Gentili et al. (hereinafter “Gentili”).
As to Claim 14, Becker discloses a method for remotely accessing a medical device configured to perform a medical procedure, the medical device having a processor with a certain amount of processing capacity, wherein the medical device is controlled by a software system comprising one or more medical processes involved in the operation of the medical device and a remote communication process, the remote communication process and the one or more medical processes being executed by the processor with the remote communication process being in a separate memory space of the processor (Paragraph [0059] of Becker discloses in some embodiments, the hardware and/or software of the edge communication device 14 is separated and isolated from the medical device 12) from the one or more medical processes, wherein the remote communication process is configured to manage communication between the medical device and one or more remote systems, and [wherein the one or more medical processes have a higher priority to the processing capacity of the medical device than the remote communication process] (Paragraph [0019] of Becker discloses system 10 including a medical device 12, an edge communication device 14, and a data consuming device 16. The medical device 12 is in communication with the edge communication device 14 via a data connection 18. The data connection 18 may be wired or wireless. The data connection 18 enables the medical device 12 to transmit data to the edge communication device 14, and in some embodiments, to receive data from the edge communication device 1), the method comprising:
[during booting of the medical device, blocking all requests from remote systems to access the medical device];
after booting of the medical device is complete, enabling at least one access criterion for remotely accessing the medical device (Paragraph [0048] of Becker discloses the security management service 46 implements an authentication and/or an authorization policy of the edge communication device 14. For example, the authentication policy may include a requirement that any data consuming device 16 that attempts to access data stored in, or provided by, the edge communication device 14 must be authenticated and must also be authorized based on an access level of the data consuming device 16);
configuring at least one access criterion for remotely accessing the medical device (Paragraph [0048] of Becker discloses the security management service 46 implements an authentication and/or an authorization policy of the edge communication device 14. For example, the authentication policy may include a requirement that any data consuming device 16 that attempts to access data stored in, or provided by, the edge communication device 14 must be authenticated and must also be authorized based on an access level of the data consuming device 16);
establishing a secure connection between the medical device and a remote system (Paragraph [0027] of Becker discloses the device adaptors 20 are configured to receive data from the medical device 12 and transmit the data to other devices);
receiving, from the remote system, a request to access the one or more medical processes (Paragraph [0027] of Becker discloses the device adaptors 20 are configured to receive data from the medical device 12 and transmit the data to other devices); and
forwarding the request to the one or more medical processes, in response to the request fulfilling the configured at least one access criterion for remotely accessing the medical device (Paragraph [0048] of Becker discloses the security management service 46 implements an authentication and/or an authorization policy of the edge communication device 14. For example, the authentication policy may include a requirement that any data consuming device 16 that attempts to access data stored in, or provided by, the edge communication device 14 must be authenticated and must also be authorized based on an access level of the data consuming device 16).
Becker does not explicitly disclose wherein the one or more medical processes have a higher priority to the processing capacity of the medical device than the remote communication process.
However, Ramey discloses this. Paragraph [0050] of Ramey discloses the arbitration module 508 arbitrates priority between the Bluetooth module 500 and the first communication module 502 in many ways. For example, the arbitration module 508 typically grants permission to communicate to the Bluetooth module 500 and denies permission to communicate to the first communication module 502 when the Bluetooth module 500 and the first communication module 502 request permission to communicate concurrently. This is because the insulin pump 204 delivers therapy (insulin) to the patient 100 and therefore generally takes precedence over the CGM 200, which collects diagnostic data for estimating glucose level of the patient 100. Additionally, while the diagnostic data can be read from the CGM 200 periodically, scheduled delivery of insulin generally cannot be delayed. Paragraph [0055] of Ramey discloses the arbitration module 508 can arbitrate priority based on other events, conditions, and operations of the diabetes manager 104. For example, the arbitration module 508 can deny priority to at least one of the Bluetooth module 500 and the first communication module 502 when the BGM module 400 performs blood glucose measurements. In some implementations, the communication control module 506 may disable communication of the Bluetooth module 500 and the first and second communication modules 502 and 504 when the BGM module 400 performs blood glucose measurements.
It would have been obvious to one of ordinary skill in the art before the effective filing of the invention to combine the medical device as disclosed by Becker, with prioritizing functions as disclosed by Ramey. One of ordinary skill in the art would have been motivated to combine to apply a known technique to a known device. Becker and Ramey are directed toward medical devices and as such it would be obvious to use the techniques of one in the other. Paragraph [0050] of Ramey discloses this is because the insulin pump 204 delivers therapy (insulin) to the patient 100 and therefore generally takes precedence over the CGM 200, which collects diagnostic data for estimating glucose level of the patient 100. Additionally, while the diagnostic data can be read from the CGM 200 periodically, scheduled delivery of insulin generally cannot be delayed. Thus, it is important to prioritize therapy over other communications.
Becker does not explicitly disclose during booting of the medical device, blocking all requests from remote systems to access the medical device.
However, Gentili discloses this. Paragraph [0062] of Gentili discloses firewall mechanisms at particular times, such as immediately contemporaneous with a boot process. Paragraph [0075] of Gentili discloses when the firewall is closed, any access request into the protected area may generate a reset condition, which immediately stops the detected intrusion.
It would have been obvious to one of ordinary skill in the art before the effective filing of the invention to combine the medical device as disclosed by Becker, with using a firewall as disclosed by Gentili. One of ordinary skill in the art would have been motivated to combine to apply a known technique to a known device. Becker and Gentili are directed toward medical devices and as such it would be obvious to use the techniques of one in the other. Paragraph [0077] of Gentili discloses microcontrollers of the type described in the present disclosure may be found in retail devices, consumer devices, industrial equipment, medical devices.
As to Claim 15, Becker-Ramey-Gentili discloses the method according to claim 14 wherein the method comprises starting up the medical device, wherein all requests to access the one or more medical processes are blocked by the remote communication process during the start up (Paragraph [0075] of Gentili discloses when the firewall is closed, any access request into the protected area may generate a reset condition, which immediately stops the detected intrusion).
Examiner recites the same rationale to combine used for claim 14.
As to Claim 16, Becker-Ramey-Gentili disclose the method according to claim 14, wherein the method comprises blocking requests to access the one or more medical processes that fail to fulfill the configured at least one access criterion (Paragraph [0048] of Becker discloses the security management service 46 implements an authentication and/or an authorization policy of the edge communication device 14. For example, the authentication policy may include a requirement that any data consuming device 16 that attempts to access data stored in, or provided by, the edge communication device 14 must be authenticated and must also be authorized based on an access level of the data consuming device 16).
As to Claim 17, Becker-Ramey-Gentili disclose the method according to claim 14, wherein the at least one access criterion comprises at least one of: (i) an authentication of a sender or origin of the request, (ii) that the request includes an allowed request type, (iii) that the request relates to an allowed functionality, and (iv) that a number of received requests per time unit does not exceed a threshold value (Paragraph [0048] of Becker discloses the security management service 46 implements an authentication and/or an authorization policy of the edge communication device 14. For example, the authentication policy may include a requirement that any data consuming device 16 that attempts to access data stored in, or provided by, the edge communication device 14 must be authenticated and must also be authorized based on an access level of the data consuming device 16).
As to Claim 18, Becker-Ramey-Gentili disclose the method according to claim 14, wherein the at least one access criterion comprises individual rules for different senders, types of requests and/or functionality (Paragraph [0048] of Becker discloses the security management service 46 implements an authentication and/or an authorization policy of the edge communication device 14. For example, the authentication policy may include a requirement that any data consuming device 16 that attempts to access data stored in, or provided by, the edge communication device 14 must be authenticated and must also be authorized based on an access level of the data consuming device 16).
As to Claim 19, Becker-Ramey-Gentili disclose the method according to claim 14, wherein configuring the at least one access criterion comprises receiving configuration data from an operator and/or reading configuration data stored in the medical device and configuring the at least one access criterion based on the configuration data (Paragraph [0050] of Becker discloses the authorization and authentication functions of the security management service 46 may be configured and updated through the profile P. For example, the profile P may be updated to change a list of authorized devices for accessing data of the edge communication device 14, or may be updated to change an access level for one or more devices).
As to Claim 20, Becker-Ramey-Gentili disclose the method according to claim 14, wherein forwarding the request comprises forwarding the request using a protocol that is different from and/or independent of a protocol used for the communication between the medical device and a the remote system (Paragraph [0039] of Becker discloses the data collection and processing service 38 may identify a data format or protocol of the data received from the medical device 12, reformat the data into a common data format or a data format expected by a data consuming device 16).
As to Claim 21, Becker-Ramey-Gentili disclose the method according to claim 14, wherein the medical device comprises at least one memory in communication with one or more processor, the one or more processor configured to perform the one or more medical processes and the remote communication process of the software system (Paragraph [0059] of Becker discloses in other embodiments, the edge framework 26 shares hardware with the medical device 12, such as the processor 22, the memory 24, and the device adaptors 20).
As to Claim 22, Becker-Ramey-Gentili disclose the method according to claim 14, wherein the medical device comprises a set of processors, and wherein the one or more medical processes and the remote communication process are executed by the same processor or processors of the set of processors (Paragraph [0059] of Becker discloses in other embodiments, the edge framework 26 shares hardware with the medical device 12, such as the processor 22, the memory 24, and the device adaptors 20).
As to Claim 23, Becker-Ramey-Gentili disclose the method according to claim 14, wherein the remote communication process and the one or more medical processes are separate such that they have separate memory spaces, individual process states and/or communicate using inter process communication (Paragraph [0059] of Becker discloses in some embodiments, the hardware and/or software of the edge communication device 14 is separated and isolated from the medical device 12).
As to Claim 24, Becker-Ramey-Gentili disclose the method according to claim 14, wherein the request to access the one or more medical processes comprises at least one of: a request to remotely control the medical device, a request to update software in the medical device, a request to set a time of the medical device, a request to receive log data from the medical device, a request to update a configuration of the medical device, and a request to update credentials of the medical device (Paragraph [0048] of Becker discloses if the security management service 46 determines that the data consuming device 16 has a sufficiently high access level corresponding to a type of data requested by the data consuming device 16, the security management service 46 may authorize the transmission of the requested data to the data consuming device 16).
As to Claim 25, Becker-Ramey-Gentili disclose the method according to claim 14, wherein the one or more medical processes are assigned the higher priority to the processing capacity of the medical device than the remote communication process in an operating system of the medical device (Paragraph [0050] of Ramey discloses the arbitration module 508 arbitrates priority between the Bluetooth module 500 and the first communication module 502 in many ways. For example, the arbitration module 508 typically grants permission to communicate to the Bluetooth module 500 and denies permission to communicate to the first communication module 502 when the Bluetooth module 500 and the first communication module 502 request permission to communicate concurrently. This is because the insulin pump 204 delivers therapy (insulin) to the patient 100 and therefore generally takes precedence over the CGM 200, which collects diagnostic data for estimating glucose level of the patient 100. Additionally, while the diagnostic data can be read from the CGM 200 periodically, scheduled delivery of insulin generally cannot be delayed. Paragraph [0055] of Ramey discloses the arbitration module 508 can arbitrate priority based on other events, conditions, and operations of the diabetes manager 104. For example, the arbitration module 508 can deny priority to at least one of the Bluetooth module 500 and the first communication module 502 when the BGM module 400 performs blood glucose measurements. In some implementations, the communication control module 506 may disable communication of the Bluetooth module 500 and the first and second communication modules 502 and 504 when the BGM module 400 performs blood glucose measurements).
As to Claim 26, Becker discloses a medical device for performing a medical procedure, comprising:
a set of memory units storing a software system configured to operate the medical device (Paragraph [0059] of Becker discloses processor 22a and/or memory 24a of the medical device 12);
a set of processors in communication with the set of memory units, the set of processors configured to execute the software system and having a certain amount of processing capacity (Paragraph [0059] of Becker discloses processor 22a and/or memory 24a of the medical device 12); and
a communication interface configured to enable communication between the medical device and one or more remote systems, wherein the software system comprises one or more medical processes involved in the operation of the medical device, and a remote communication process that is separate from the one or more medical processes, wherein [during booting of the medical device, all requests from remote systems to access the medical device are blocked] and after booting of the medical device is complete, at least one access criterion is enabled for remotely accessing the medical device (Paragraph [0048] of Becker discloses the security management service 46 implements an authentication and/or an authorization policy of the edge communication device 14. For example, the authentication policy may include a requirement that any data consuming device 16 that attempts to access data stored in, or provided by, the edge communication device 14 must be authenticated and must also be authorized based on an access level of the data consuming device 16), wherein the remote communication process is configured to manage communication between the medical device and one or more remote systems using the at least one access criterion (Paragraph [0019] of Becker discloses system 10 including a medical device 12, an edge communication device 14, and a data consuming device 16. The medical device 12 is in communication with the edge communication device 14 via a data connection 18. The data connection 18 may be wired or wireless. The data connection 18 enables the medical device 12 to transmit data to the edge communication device 14, and in some embodiments, to receive data from the edge communication device 1), and
wherein the medical device is configured such that the remote communication process and the one or more medical processes are executed by the processor with the remote communication process being in a separate memory space of the processor from the one or more medical processes (Paragraph [0059] of Becker discloses in some embodiments, the hardware and/or software of the edge communication device 14 is separated and isolated from the medical device 12)
[wherein the the one or more medical processes has a higher priority to the processing capacity of the medical device than the remote communication process].
Becker does not explicitly disclose wherein the the one or more medical processes has a higher priority to the processing capacity of the medical device than the remote communication process.
However, Ramey discloses this. Paragraph [0050] of Ramey discloses the arbitration module 508 arbitrates priority between the Bluetooth module 500 and the first communication module 502 in many ways. For example, the arbitration module 508 typically grants permission to communicate to the Bluetooth module 500 and denies permission to communicate to the first communication module 502 when the Bluetooth module 500 and the first communication module 502 request permission to communicate concurrently. This is because the insulin pump 204 delivers therapy (insulin) to the patient 100 and therefore generally takes precedence over the CGM 200, which collects diagnostic data for estimating glucose level of the patient 100. Additionally, while the diagnostic data can be read from the CGM 200 periodically, scheduled delivery of insulin generally cannot be delayed. Paragraph [0055] of Ramey discloses the arbitration module 508 can arbitrate priority based on other events, conditions, and operations of the diabetes manager 104. For example, the arbitration module 508 can deny priority to at least one of the Bluetooth module 500 and the first communication module 502 when the BGM module 400 performs blood glucose measurements. In some implementations, the communication control module 506 may disable communication of the Bluetooth module 500 and the first and second communication modules 502 and 504 when the BGM module 400 performs blood glucose measurements.
Examiner recites the same rationale to combine used for claim 14.
Becker does not explicitly disclose during booting of the medical device, all requests from remote systems to access the medical device are blocked.
However, Gentili discloses this. Paragraph [0062] of Gentili discloses firewall mechanisms at particular times, such as immediately contemporaneous with a boot process. Paragraph [0075] of Gentili discloses when the firewall is closed, any access request into the protected area may generate a reset condition, which immediately stops the detected intrusion.
Examiner recites the same rationale to combine used for claim 14.
As to Claim 27, Becker-Ramey-Gentili disclose the medical device of claim 26, wherein the one or more medical processes and the remote communication process are executed by the same processor or processors of the set of processors (Paragraph [0059] of Becker discloses in other embodiments, the edge framework 26 shares hardware with the medical device 12, such as the processor 22, the memory 24, and the device adaptors 20).
As to Claim 28, Becker-Ramey-Gentili disclose the medical device of claim 26, wherein the request to access the one or more medical processes comprises at least one of: a request to remotely control the medical device, a request to update software in the medical device, a request to set a time of the medical device, a request to receive log data from the medical device, a request to update a configuration of the medical device, and a request to update credentials of the medical device (Paragraph [0048] of Becker discloses if the security management service 46 determines that the data consuming device 16 has a sufficiently high access level corresponding to a type of data requested by the data consuming device 16, the security management service 46 may authorize the transmission of the requested data to the data consuming device 16).
As to Claim 29, Becker-Ramey-Gentili disclose the medical device of claim 26, wherein the remote communication process and the one or more medical processes are separate such that they have separate memory spaces, individual process states and/or communicate using inter process communication (Paragraph [0059] of Becker discloses in some embodiments, the hardware and/or software of the edge communication device 14 is separated and isolated from the medical device 12).
As to Claim 30, Becker-Ramey-Gentili disclose the medical device of claim 26, wherein the one or more medical processes are assigned the higher priority to the processing capacity of the set of processors than the remote communication process in an operating system of the medical device (Paragraph [0050] of Ramey discloses the arbitration module 508 arbitrates priority between the Bluetooth module 500 and the first communication module 502 in many ways. For example, the arbitration module 508 typically grants permission to communicate to the Bluetooth module 500 and denies permission to communicate to the first communication module 502 when the Bluetooth module 500 and the first communication module 502 request permission to communicate concurrently. This is because the insulin pump 204 delivers therapy (insulin) to the patient 100 and therefore generally takes precedence over the CGM 200, which collects diagnostic data for estimating glucose level of the patient 100. Additionally, while the diagnostic data can be read from the CGM 200 periodically, scheduled delivery of insulin generally cannot be delayed. Paragraph [0055] of Ramey discloses the arbitration module 508 can arbitrate priority based on other events, conditions, and operations of the diabetes manager 104. For example, the arbitration module 508 can deny priority to at least one of the Bluetooth module 500 and the first communication module 502 when the BGM module 400 performs blood glucose measurements. In some implementations, the communication control module 506 may disable communication of the Bluetooth module 500 and the first and second communication modules 502 and 504 when the BGM module 400 performs blood glucose measurements).
As to Claim 31, Becker discloses a non-transitory, computer-readable medium storing a software system for remotely accessing a medical device, which when executed by a processor, causes the processor to:
configure at least one access criterion for remotely accessing the medical device, the medical device having a certain amount of processing capacity (Paragraph [0048] of Becker discloses the security management service 46 implements an authentication and/or an authorization policy of the edge communication device 14. For example, the authentication policy may include a requirement that any data consuming device 16 that attempts to access data stored in, or provided by, the edge communication device 14 must be authenticated and must also be authorized based on an access level of the data consuming device 16);
establish a secure connection between the medical device and a remote system (Paragraph [0027] of Becker discloses the device adaptors 20 are configured to receive data from the medical device 12 and transmit the data to other devices);
receive, from the remote system, a request to access one or more medical processes of the system (Paragraph [0027] of Becker discloses the device adaptors 20 are configured to receive data from the medical device 12 and transmit the data to other devices); and
forward the request to the one or more medical processes, in response to the request fulfilling the configured at least one access criterion for remotely accessing the medical device (Paragraph [0048] of Becker discloses the security management service 46 implements an authentication and/or an authorization policy of the edge communication device 14. For example, the authentication policy may include a requirement that any data consuming device 16 that attempts to access data stored in, or provided by, the edge communication device 14 must be authenticated and must also be authorized based on an access level of the data consuming device 16), wherein the software system comprises: the one or more medical processes, which are involved in the operation of the medical device, and a remote communication process that is separate from the one or more medical processes, wherein [during booting of the medical device, all requests from remote systems to access the medical device are blocked] and after booting of the medical device is complete, the at least one access criterion is enabled for remotely accessing the medical device (Paragraph [0048] of Becker discloses the security management service 46 implements an authentication and/or an authorization policy of the edge communication device 14. For example, the authentication policy may include a requirement that any data consuming device 16 that attempts to access data stored in, or provided by, the edge communication device 14 must be authenticated and must also be authorized based on an access level of the data consuming device 16), wherein the remote communication process is configured to manage communication between the medical device and one or more remote systems (Paragraph [0019] of Becker discloses system 10 including a medical device 12, an edge communication device 14, and a data consuming device 16. The medical device 12 is in communication with the edge communication device 14 via a data connection 18. The data connection 18 may be wired or wireless. The data connection 18 enables the medical device 12 to transmit data to the edge communication device 14, and in some embodiments, to receive data from the edge communication device 1),
wherein the non-transitory, computer-readable medium is configured such that the remote communication process and the one or more medical processes are executed by the processor with the remote communication process being in a separate memory space of the processor from the one or more medical processes (Paragraph [0059] of Becker discloses in some embodiments, the hardware and/or software of the edge communication device 14 is separated and isolated from the medical device 12)
[wherein the one or more medical processes have a higher priority to the processing capacity of the medical device than the remote communication process].
Becker does not explicitly disclose wherein the one or more medical processes have a higher priority to the processing capacity of the medical device than the remote communication process.
However, Ramey discloses this. Paragraph [0050] of Ramey discloses the arbitration module 508 arbitrates priority between the Bluetooth module 500 and the first communication module 502 in many ways. For example, the arbitration module 508 typically grants permission to communicate to the Bluetooth module 500 and denies permission to communicate to the first communication module 502 when the Bluetooth module 500 and the first communication module 502 request permission to communicate concurrently. This is because the insulin pump 204 delivers therapy (insulin) to the patient 100 and therefore generally takes precedence over the CGM 200, which collects diagnostic data for estimating glucose level of the patient 100. Additionally, while the diagnostic data can be read from the CGM 200 periodically, scheduled delivery of insulin generally cannot be delayed. Paragraph [0055] of Ramey discloses the arbitration module 508 can arbitrate priority based on other events, conditions, and operations of the diabetes manager 104. For example, the arbitration module 508 can deny priority to at least one of the Bluetooth module 500 and the first communication module 502 when the BGM module 400 performs blood glucose measurements. In some implementations, the communication control module 506 may disable communication of the Bluetooth module 500 and the first and second communication modules 502 and 504 when the BGM module 400 performs blood glucose measurements.
Examiner recites the same rationale to combine used for claim 14.
Becker does not explicitly disclose during booting of the medical device, all requests from remote systems to access the medical device are blocked.
However, Gentili discloses this. Paragraph [0062] of Gentili discloses firewall mechanisms at particular times, such as immediately contemporaneous with a boot process. Paragraph [0075] of Gentili discloses when the firewall is closed, any access request into the protected area may generate a reset condition, which immediately stops the detected intrusion.
Examiner recites the same rationale to combine used for claim 14.
As to Claim 32, Becker-Ramey-Gentili disclose the non-transitory, computer-readable medium of claim 31, wherein the at least one access criterion comprises at least one of: (i) an authentication of a sender or origin of the request, (ii) that the request includes an allowed request type, (iii) that the request relates to an allowed functionality, and (iv) that a number of received requests per time unit does not exceed a threshold value (Paragraph [0048] of Becker discloses the security management service 46 implements an authentication and/or an authorization policy of the edge communication device 14. For example, the authentication policy may include a requirement that any data consuming device 16 that attempts to access data stored in, or provided by, the edge communication device 14 must be authenticated and must also be authorized based on an access level of the data consuming device 16).
As to Claim 33, Becker-Ramey-Gentili disclose the non-transitory, computer-readable medium of claim 31, wherein forwarding the request comprises forwarding the request using a protocol that is different from and/or independent of a protocol used for the communication between the medical device and the one or more remote systems (Paragraph [0039] of Becker discloses the data collection and processing service 38 may identify a data format or protocol of the data received from the medical device 12, reformat the data into a common data format or a data format expected by a data consuming device 16).
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 Kevin S Mai whose telephone number is (571)270-5001. The examiner can normally be reached Monday to Friday 9AM to 5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Philip Chea can be reached on 5712723951. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KEVIN S MAI/Primary Examiner, Art Unit 2499