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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 21, 22, 24, 29 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Publication No. 2017/0203030 (“Brewer”)
Regarding Claim 21, Brewer discloses an insulin pump network (inter alia Fig. 1A), comprising:
A mobile computing device (60) configured to execute a mobile application, wherein the mobile application is operable to cause the mobile computing device to communicate via a low energy wireless communication protocol (Par. 47, 69, 72, 73);
a glucose monitor (50) operable to measure patient information (Par. 81); and
an insulin delivery system (15) including a processor (241), a pump (100) and a chipset (247, 702) operable to establish communication connections according to the low energy wireless communication protocol with the glucose monitor and the mobile computing device (Par. 72), wherein the processor of the insulin delivery system is operable to:
receive the measured patient information from the glucose monitor (Par. 44); and
forward the measured patient information to the mobile computing device (Par. 44), and
wherein the mobile application of the mobile computing device is operable to: communicate the patient information to a cloud service (Par. 21, 42, 47).
Regarding Claim 22, Brewer discloses a cloud service (inter alia 402) operable to store patient information over time (Par. 42).
Regarding Claim 24, Brewer discloses the insulin delivery device further comprises one or more integrated sensors (e.g. “motion sensors” – Par. 70).
Regarding Claim 29, Brewer discloses the processor of the insulin delivery system is further operable to:
process the patient information received from the glucose monitor to determine appropriate insulin dosing (Par. 9).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0203030 (“Brewer”) as applied above, and further in view of WO 2005/081170 (“Mathews”).
Regarding Claim 23, Brewer discloses the invention substantially as claimed except that that the cloud service is further operable to generate patient dosing models for use by the processor of the insulin delivery device. However, Mathews discloses a remote server/cloud service (16) which is configured to receive patient data and utilize blood glucose prediction models and insulin dosage prediction models to be used by the diabetic user to alter their insulin delivery profile (Pg. 2, Ln. 6-9; Pg. 4, Ln. 26-31). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the cloud service of the invention of Brewer to provide offsite aggregation of data and calculation of an updated patient dosing model for use by the insulin deliver device to update an insulin dosage schedule, as disclosed by Mathews, in order to allow for large data aggregation to create more accurate and responsive models.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0203030 (“Brewer”) as applied above, and further in view of U.S. Publication No. 2015/0011970 (“Kamen”).
Regarding Claim 25, Brewer, discloses the invention substantially as claimed except that the one or more integrated sensors include at least one of an occlusion sensor, an accelerometer, or a location sensor. However, Kamen discloses a related insulin infusion pump which may include at least one accelerometer (Par. 517) the accelerometer being useful as an input device, i.e. a specific type of motion sensor of the genus contemplated by Brewer. It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the infusion device of Brewer to include an accelerometer, as disclosed by Kamen, in order to allow for the use of motion-based input to the insulin pump using a specific, known species of motion sensor to obtain predictable and expected results in satisfaction of the broader genus suggested by Brewer.
Claim(s) 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0203030 (“Brewer”) as applied above, and further in view of WO 2016/019192 (“Haider”).
Regarding Claim 26-28, Brewer discloses the invention substantially as claimed except that the chipset of the insulin delivery system is further operable to:
periodically connect and disconnect a respective communication connection of the established communication connections with the glucose monitor and/or other peripheral devices. However, Haider discloses a related insulin delivery device (202) which is configured to communicate with various peripheral devices (see e.g. Fig. 1C) to send and receive data, wherein communication can occur continuously, near-continuously, regularly, semi-regularly, or intermittently (Par. 33, 42, 43, 49), wherein communication can occur at intervals of 0.5, 1, 2, 6, 10, 15 or 30 minutes (Par. 33). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the chipset of the insulin delivery system of Brewer to communicate intermittently (i.e. periodically connect and disconnect a respective established communication connection) with the various peripheral devices including a CGM (50), BGM (70), smartpens (80, 82), and mobile computing device (60) at intervals of, for example 5 minutes, as disclosed by Haider, in order to reduce power consumption by reducing data exchange frequency.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0203030 (“Brewer”) as applied above.
Regarding Claim 30, Brewer discloses the invention substantially as claimed except that mobile computing device communicates with the cloud service specifically via one or more of “a mobile data network, a wi-fi network, internet, or combinations thereof”. However, Brewer does intimate that the communication network between the mobile computing device and the server is a long range protocol inclusive to the internet (Par. 5, 21). It would have been obvious for one having ordinary skill in the art at the time the invention was made to utilize the internet for communication between the cloud service and the mobile computing device using well-known smartphone protocols inclusive to WI-FI and mobile cellular data in the invention of Brewer, in order to utilize standard data transfer protocols which allow for secure and efficacious data communication in a known and predictable manner.
Claim(s) 21, 22, 29, 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over EP 1,839,566 (“Frikart”) in view of U.S. Publication No. 2015/0011970 (“Kamen”).
Regarding Claim 21, Frikart discloses an insulin pump network (Fig. 2), comprising:
a mobile computing device (3) configured to execute a mobile application, wherein the mobile application is operable to cause the mobile computing device to communicate via a wireless communication protocol (see 2, 5);
a glucose monitor (10) operable to measure patient information (re: glucose analyte levels); and
an insulin delivery system (1) including a processor, a pump, and a chipset (these components are not explicitly recited but are understood to be present in view of the description of the operations of the insulin pump to wirelessly communicate – particularly via BLUETOOTH - with the blood glucose monitor, wirelessly communicate – particularly via BLUETOOTH - with the mobile computing device, receive inputs at a user interface 16, display information at a user interface 15, and pump insulin responsive to blood glucose levels), wherein the processor of the insulin delivery system is operable to:
receive the measured patient information from the glucose monitor (12); and forward the measured patient information to the mobile computing device (2 – see Par. 11 and 12 – re: <<the insulin pump 1 now either forwards each message 12 of the blood glucose measuring device 10 to the communicate device via the short-distance radio link 2>> in contrast with the <<another embodiment, which is indicated by the arrow 13, the communication of the blood sugar measuring device 10 takes place directly with the communication device 3>>), and
wherein the mobile application of the mobile computing device is operable to: communicate the patient information to a cloud service (6, 8).
Frikart discloses the invention substantially as claimed except that wireless communication protocol between the glucose monitor and the insulin pump and between the insulin pump and the mobile computing device is specifically a “low energy wireless communication protocol”. Frikart does suggest that BLUETOOTH chipsets and protocols may be used (Par. 7), but does not explicitly resolve that such protocols are “low-energy”, e.g. BLE. However, Kamen discloses a related infusion pump (1802) networked system wherein wireless communication can be explicitly made via BLUETOOTH or BLE (Par. 426, 427, 429, 431, 433, 434, 437-444, 447, 448, 456, 532). It would have been obvious for one having ordinary skill in the art at the time the invention was made to utilize BLE chipsets and protocols to provide the wireless communication for the system of Frikart, as disclosed by Kamen, in order to utilize a known, standard of protocols recognized by the prior art for their utility with BLE being understood to reduce power consumption versus alternative high energy protocols, therefore improving battery life of the infusion pump and glucose monitor.
Regarding Claim 22, Frikart discloses a cloud service operable to store patient information over time (Par. 11 – see Fig. 2 – wherein “over time” fails to qualify persistent versus non-persistent storage and is therefore unable to define and distinguish over relaying of the blood glucose monitor messages to the device 8 irrespective of what action(s) the device takes with these messages).
Regarding Claim 29, Frikart that the processor of the insulin delivery system is further operable to: process the patient information received from the glucose monitor to determine appropriate insulin dosing (Par. 11 – re: <<an evaluation and, if appropriate, a reaction of the insulin pump can take place there>>).
Regarding Claim 30, Frikart discloses the mobile computing device of the insulin delivery system is further operable to: communicate with the cloud service via a mobile data network (6 – Par. 9).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over EP 1,839,566 (“Frikart”) in view of U.S. Publication No. 2015/0011970 (“Kamen”) as applied above, and further in view of WO 2005/081170 (“Mathews”).
Regarding Claim 23, Frikart discloses the invention substantially as claimed except that the cloud service is further operable to generate patient dosing models for use by the processor of the insulin delivery device. However, Mathews discloses a remote server/cloud service (16) which is configured to receive patient data and utilize blood glucose prediction models and insulin dosage prediction models to be used by the diabetic user to alter their insulin delivery profile (Pg. 2, Ln. 6-9; Pg. 4, Ln. 26-31). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the cloud service of the invention of Frikart to include a remote server to provide offsite aggregation of data and calculation of an updated patient dosing model for use by the insulin deliver device to update an insulin dosage schedule, as disclosed by Mathews, in order to allow for large data aggregation to create more accurate and responsive models.
Claim(s) 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over EP 1,839,566 (“Frikart”) in view of U.S. Publication No. 2015/0011970 (“Kamen”) as applied above, and further in view of CN 102083483 (“Yodfat”).
Regarding Claim 24-25, Frikart discloses the invention substantially as claimed except that that the insulin delivery device further comprises one or more integrated sensors including at least one of an occlusion sensor, an accelerometer, or a location sensor. However, Yodfat discloses a related insulin pump having an occlusion sensor configured to detect blockages of the delivery path (Par. 36). It would have been obvious for one having ordinary skill in the art at the time the invention was made to include an inclusion sensor in the insulin pump of Frikart, as disclosed by Yodfat, in order to allow the device to detect an occlusion and respond accordingly to ensure that the occlusion is cleared.
Claim(s) 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over EP 1,839,566 (“Frikart”) in view of U.S. Publication No. 2015/0011970 (“Kamen”) as applied above, and further in view of WO 2016/019192 (“Haider”).
Regarding Claim 26-28, Frikart discloses the invention substantially as claimed except that the chipset of the insulin delivery system is further operable to:
periodically connect and disconnect a respective communication connection of the established communication connections with the glucose monitor and/or other peripheral devices. However, Haider discloses a related insulin delivery device (202) which is configured to communicate with various peripheral devices (see e.g. Fig. 1C) to send and receive data, wherein communication can occur continuously, near-continuously, regularly, semi-regularly, or intermittently (Par. 33, 42, 43, 49), wherein communication can occur at intervals of 0.5, 1, 2, 6, 10, 15 or 30 minutes (Par. 33). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the chipset of the insulin delivery system of Frikart to communicate intermittently (i.e. periodically connect and disconnect a respective established communication connection) with the various peripheral devices including a CGM (50), BGM (70), smartpens (80, 82), and mobile computing device (60) at intervals of, for example 5 minutes, as disclosed by Haider, in order to reduce power consumption by reducing data exchange frequency.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R CARPENTER/ Primary Examiner, Art Unit 3783
06/15/2026
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