DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The action is in response to the application filed on 12/21/2023. Claims 1-21 are pending and examined below.
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.
Claim 13 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.
Regarding claim 13, the claim recites the limitation “wherein the instructions for determining include instructions for the insulin dose calculation further based on sensor data indicating a lactic acid measure”. However, the Specification fails to teach a calculation/algorithm used in sufficient detail to meet the written description requirement. Rather Applicant merely repeats the intended results without sufficient details as to how this is to be accomplished and essentially serves as a black box designed to perform the recited function.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-3, 6-10, 12, 14-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20200101286 A1 (hereinafter referred to as “Windmiller”).
Regarding claim 1, Windmiller, a transcutaneous sensor device, teaches an analyte monitoring system (abstract), comprising:
a sensor control device including an analyte sensor (50; paragraphs [0055], [0168]), first processing circuitry (“wherein the body-worn sensor device further comprises a processor”; claim 23), and a first non-transitory memory (paragraph [0053]), wherein the analyte sensor includes at least a portion configured to be inserted into a user's body (“The body-worn sensor 50 is preferably a subcutaneous”; paragraph [0055]), and wherein the sensor control device is configured to collect first time-correlated data indicative of a glucose level (“a continuous glucose monitor”; paragraph [0053]) and second time-correlated data indicative of a ketone level (“The current solution provides for a body-worn sensor device and method to selectively quantify, in an automated and continuous fashion, a ketone body analyte in a physiological fluid of a wearer”; paragraph [0051]); and
a reader device (smartphone 1208; paragraph [0055]; Figure 1) comprising second processing circuitry and a second non-transitory memory (teaches using a smart phone which has a processor and memory; paragraph [0055]),
wherein at least one of the first or the second non-transitory memory includes instructions that, when executed, cause at least one of the first or the second processing circuitry to perform:
determining, based at least in part on the first and second time-correlated data, at least one of:
an alert condition for one or both of the first and second time-correlated data, an advisory message for output by the reader device, a correction to an analyte state estimate, a malfunction of the sensor control device, a malfunction of an insulin delivery device, a medication dose calculation, or an analytical report based on the first and second time-correlated data (“Should the value measured by said body-worn sensor exceed a pre-defined value or threshold, an alert is tendered”; paragraphs [0053]); and
outputting, by the reader device, an indication of an outcome of the determining (paragraph [0054]-[0055]).
Regarding claim 2, Windmiller teaches wherein the instructions for determining the alert condition include instructions for setting at least one of a threshold of analyte level for the alert condition or an alert enunciation time interval (paragraphs [0052]-[0053], [0130]-[0131]).
Regarding claim 3, Windmiller teaches wherein the instructions for determining the advisory message include instructions for outputting a query by the reader device (paragraph [0147]).
Regarding claim 6, Windmiller teaches further comprising an input device operatively coupled to at least one of the reader device or the sensor control device configured for receiving information defining insulin dosing by a patient wearing the sensor control device, wherein the instructions for determining include instructions for correcting an estimate of the patient's plasma insulin state (paragraph [0154], [0157], [0161]-[0162]).
Regarding claim 7, Windmiller teaches further comprising an input device operatively coupled to at least one of the reader device or the sensor control device configured for receiving a ketone test result, wherein the instructions further cause automatic execution of an insulin dose calculation algorithm in response to receiving the ketone test result (paragraph [0154], [0157], [0161]-[0162]).
Regarding claim 8, Windmiller teaches wherein the instructions for determining include instructions for applying conditional logic defined in a data structure to determine content of the advisory message (paragraph [0157]).
Regarding claim 9, Windmiller teaches wherein the medication dose calculation comprises an insulin dose calculation (paragraph [0157]).
Regarding claim 10, Windmiller teaches wherein the instructions for determining include instructions for the insulin dose calculation based on a current ketone level (paragraph [0157], [0161]-[0162]).
Regarding claim 12, Windmiller teaches wherein the instructions for determining include instructions for the insulin dose calculation based on a current ketone level (paragraph [0154], [0157], [0161]-[0162]).
Regarding claim 14, Windmiller teaches wherein the instructions for determining the advisory message include instructions for performing the determining further based on whether a patient is dosing with SGLT-2i, and for configuring the advisory message to discontinue use of SGLT-2i if ketones are above a threshold (paragraph [0154], [0157], [0161]-[0162]).
Regarding claim 15, Windmiller teaches wherein the instructions are stored on the second non-transitory memory (paragraph [0072]).
Regarding claim 16, Windmiller teaches wherein the instructions are stored on the first non-transitory memory (paragraph [0072]).
Regarding claim 17, Windmiller teaches wherein the sensor control device further includes wireless communications circuitry configured to transmit the first and the second data to the reader device (paragraphs [0065]-[0066]).
Regarding claim 18, Windmiller teaches wherein the wireless communications circuitry is configured to transmit the first and the second data according to a Bluetooth protocol (paragraphs [0065]-[0066]).
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.
Claim(s) 4-5, 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Windmiller as applied to claim 1 above, and further in view of US 20210267506 A1
(hereinafter referred to as “Selander”).
Regarding claim 4, Windmiller does not explicitly teach wherein the instructions for outputting the query include instructions for outputting at least one question about a comfort level of a patient, based on the second time-correlated data indicating a transition from above a high threshold to a low threshold.
However, Selander teaches wherein the instructions for outputting the query include instructions for outputting at least one question about a comfort level of a patient, based on the second time-correlated data indicating a transition from above a high threshold to a low threshold (paragraphs [0169]-[0171]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Windmiller, wherein the instructions for outputting the query include instructions for outputting at least one question about a comfort level of a patient, based on the second time-correlated data indicating a transition from above a high threshold to a low threshold, as taught by Selander, because doing so allows the system to give alerts customized to the user.
Regarding claim 5, Windmiller does not explicitly teach wherein the instructions for outputting the query include instructions for outputting at least one question about prior patient behavior.
However, Selander teaches wherein the instructions for outputting the query include instructions for outputting at least one question about prior patient behavior (paragraphs [0169]-[0171]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Windmiller, wherein the instructions for outputting the query include instructions for outputting at least one question about prior patient behavior, as taught by Selander, because doing so allows the system to give alerts customized to the user.
Regarding claim 20-21, Windmiller does not explicitly teach further comprising a medication delivery device and wherein the medication delivery device comprises an insulin pump.
However, Selander teaches the system further comprises an insulin pump (paragraph [0116]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Windmiller, to have an insulin pump, because doing so allows a user to receive treatment in the form of insulin based on the sensor findings.
Claim(s) 11, 13, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Windmiller as applied to claim 1 above, and further in view of US 20170055906 A1 (hereinafter referred to as “Bremer”).
Regarding claim 11, Windmiller does not explicitly teach wherein the instructions for determining include instructions for the insulin dose calculation comprising a mealtime bolus dose.
However, Bremer teaches wherein the instructions for determining include instructions for the insulin dose calculation comprising a mealtime bolus dose (paragraph [0212]-[0213]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Windmiller, to include instructions for the insulin dose calculation comprising a mealtime bolus dose, as taught by Bremer, because doing so instructs the user about what actions to take in regards to their insulin status.
Regarding claim 13, Windmiller does not explicitly teach wherein the instructions for determining include instructions for the insulin dose calculation further based on sensor data indicating a lactic acid measure.
However, Bremer teaches wherein the instructions for determining include instructions for the insulin dose calculation further based on sensor data indicating a lactic acid measure (paragraph [0212]-[0213]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Windmiller, to include instructions for the insulin dose calculation comprising a mealtime bolus dose, as taught by Bremer, because doing so instructs the user about what actions to take in regards to their insulin status.
Regarding claim 19, Windmiller does not explicitly teach further comprising a third analyte sensor configured to sense a lactic acid level in the bodily fluid (paragraph [0264]-[0265]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Windmiller, to sense a lactic acid level, as taught by Bremer, because doing so adds additional functionality to an analyte sensing device.
Conclusion
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/ABID A MUSTANSIR/Examiner, Art Unit 3791