DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/24/25 has been entered.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 1, 3-17 and 19-20 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. There does not appear to be support in the specification or in the claims as originally filed for the negative limitation of when operating in the second operating mode, the user is not enabled to determine insulin dosing based on the first glucose data. The specification supports not providing bolus recommendation or controlling a pump in a second mode of operation but this does not stop a user from being able to determine dosing based on a reading.
Claim 5 is 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. There does not appear to be support in the specification for the user input to switch to on-demand or the second transmission mode is a second glucose concentration of the user. The specification and original claims only support that the input is a user request.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. It is unclear how a first transmission mode comprises a glucose sensor signal. How is a transmission mode just a signal?
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.
Claim(s) 1, 3-6, 8-17 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jollota et al. US 2007/0258395 in view of Katsuki et al. US 2012/0029942.
Regarding claim 1, 17 and 20, Jollota discloses a computer-implemented method comprising:
receiving, at a computing device, first glucose data from a glucose sensor ([¶59] sensor 130) operating in a first data transmission mode ([¶184] sensor transmits glucose data), the first glucose data indicating a glucose concentration of a user ([¶63]);
evaluating the first glucose concentration against transition criteria ([¶263-266,288-289] the transmission modes can change based on device conditions or data and one of those is the physiological data trends or concentrations);
operating the computing device in a first operating mode when the first glucose concentration of the user satisfies the transition criteria ([¶263-266,288-289] time and modes are changed);
operating the computing device in a second operating mode when the first glucose data does not satisfy the transition criteria ([¶273,288] the mode can change based on operating conditions or glucose data trends. The glucose level is not specifically mentioned for changing a mode but it would have been obvious to one of ordinary skill in the art to change the transmission mode based on the glucose level as change the transmission timing based on glucose level data is important to not miss serious changes. The same principle would apply for the transmission mode itself); and
displaying, on a user interface of the computing device, the glucose concentration of the user and an operating mode indicator indicating whether the computing device operates in the first operating mode or the second operating mode ([¶66,113] glucose levels and wireless link or mode indicators can be displayed), wherein:
when operating in the first operating mode, the user is enabled to determine insulin dosing based on the first glucose data ([¶262-266] the reliable link provides data to an insulin pump for dosing), and
when operating in the second operating mode, the user is not enabled to determine insulin dosing based on the first glucose data ([¶263-266,288-289] the unreliable link mode does not provide information to the pump until back in the first mode of operation).
Jollota does not disclose the first data transmission mode of the first operating mode that comprises a mode during which the glucose sensor communicates the first glucose data to the computing device at regular periodic intervals.
Katsuki teaches a similar physiological sensor that has an automatic transmission mode and an on demand transmission mode ([¶74] transmission can be automatic or on demand). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Jollota with the teachings of Katsuki in order to allow the device data to be updated by the user request or automatically if the user is unable to manual initiate ([¶93]). Additionally, Jollota discusses ways to alter its transmission as needed for various circumstances ([¶288-289]) including low power intermittent transmission to conserve power ([¶162,263]) and Katsuki provides such a way.
Regarding claim 3, Katsuki teaches the glucose sensor continues to operate in the first data transmission mode while the computing device concurrently receives a second glucose data in a second data transmission mode, wherein the user is enabled to determine insulin dosing based on the second glucose data ([¶74] data can be transmitted automatically or on demand together).
Regarding claim 4, Jollota discloses the second data mode comprises user input to a user interface displayed at the computing device ([¶72,139,253] user input comes from the user interface for communication schemes).
Regarding claim 5, Jollota discloses the user input comprises a second glucose concentration of the user ([¶72,139,253] user input triggers the mode).
Regarding claim 6, Jollota discloses the glucose sensor communicates the first glucose data to the computing device using a Bluetooth communication scheme in the first transmission mode ([¶63,91]).
Regarding claims 8-10, Jollota discloses the transition criteria corresponds to the glucose concentration of the user deviating low or high ([¶64,73,288] the device can determine high and low levels and alerts and the transmission protocol can be changed based on the physiological data like levels or trends) and diagnostic reliability data ([¶86,197]).
Regarding claim 11, Jollota discloses displaying, in a user interface displayed at the computing device, an indication of the glucose concentration of the user being low ([¶64,73] alerts or alarms can be presented for high or low levels).
Regarding claim 12, Jollota discloses displaying, in the user interface displayed at the computing device, a request that instructs the user to confirm that the glucose concentration of the user is low via a device swipe ([¶139] the alerts can require user interaction).
Regarding claim 13, Jollota discloses the first glucose data is used to control an insulin pump to automatically deliver insulin to the user while the computing device is operating in the first transmission mode ([¶64]).
Regarding claim 14, Jollota discloses controlling the insulin pump to suspend delivery of insulin to the user when the glucose concentration of the user is low ([¶84,87] the low glucose alarms and alerts can activate or deactivate the pump).
Regarding claim 15, Jollota discloses the glucose sensor and the insulin pump operate in a therapeutic mode while the computing device is operating in the first operating mode, and wherein the computing device and the insulin pump operate in an adjunctive mode while the glucose sensor is operating in the second mode ([¶84,87] under normal operation the sensor sends data to control the pump but in a low or high state the alarms and alerts can deactivate the pump).
Regarding claim 16, Katsuki teaches switching between an automatic transmission mode and an on demand transmission mode ([¶74] transmission can be automatic or on demand).
Claim(s) 7 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jollota et al. US 2007/0258395 in view of Katsuki et al. US 2012/0029942 further in view of Yuen et al. US 20120083714.
Regarding claims 7 and 19, Jollota discloses using Bluetooth communication ([¶63,91]) but does not disclose the second glucose data to the computing device using an NFC communication scheme in the second transmission mode. Yuen teaches a similar body worn monitoring device that uses NFC communication ([¶212,222]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to combine the device of Jollota with the teachings of Yuen as it is no more than the use of known technique to improve similar devices in the same way and Jollota discloses using a plethora of wireless communication protocols ([¶94]).
Response to Arguments
Applicant's remaining arguments filed 12/24/25 have been fully considered but they are not persuasive.
Regarding Applicants arguments that neither of the references teach changing an operating mode based on the glucose data meeting a transition criteria, Examiner respectfully disagrees. Jollota specifically discloses changing its modes based on various information related to the device’s operation ([¶278]). Jollota also discloses changing transmission times and processes based on the glucose level ([¶288-289]) which can also be considered a different mode of operation as the modes have not been further defined. While the glucose level is not specifically mentioned for changing a mode, it would have been obvious to one of ordinary skill in the art at the time of filing to change the transmission mode based on the glucose level as change the transmission timing based on glucose level data is important to not miss serious changes. The same principle would apply for the transmission mode itself.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached 10-6pm.
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/MICHAEL A CATINA/Examiner, Art Unit 3791
/TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791