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 09/14/2023. Claims 1-17, 20, 22-23 are pending and examined below.
Claim Rejections - 35 USC § 112
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 11, 14, and claims dependent thereof, are 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.
Regarding claims 11 and 14, the claim recites the limitation “the distinguishing cause”.; however the term lacks antecedent basis and it is unclear as to what is meant by the “the distinguishing cause”. As such the claim is indefinite.
For the purposes of this examination it is interpreted as a threshold amount.
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) 1-17, 20, 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20200101286 A1 (cited in IDS; hereinafter referred to as “Windmiller”).
Regarding claim 1, Windmiller, ketone and glucose sensing device, teaches an analyte monitoring system (abstract), comprising:
a sensor control device including an analyte sensor (50; paragraphs [0055], [0168]), 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]), 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 wherein the sensor control device is operatively coupled to a first processing circuitry (“wherein the body-worn sensor device further comprises a processor”; claim 23), and a first non-transitory memory (paragraph [0053]); 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:
making a determination based on the first and second time-correlated data of at least one of:
an alert threshold for one or both of 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]),
a message for output by the reader device, or
a correction to an analyte state estimate; and
outputting, by the reader device, an indication of the determination (paragraph [0054]-[0055]).
Regarding claim 2, Windmiller teaches wherein the instructions for making the determination further cause using a closed-loop state observer form to reconcile measurements at each time step against the predicted values of an estimated state of an analyte of interest, to obtain a corrected state estimation of the analyte of interest (paragraph [0015]).
Regarding claim 3, Windmiller teaches wherein the second time-correlated data comprises data from a ketone sensor (paragraph [0166]).
Regarding claim 4, Windmiller teaches wherein the second time-correlated data comprises data indicating β-hydroxybutyrate (“Specifically, the ketone measurement chosen is β-hydroxybutyrate”; paragraph [0075]).
Regarding claim 5, Windmiller teaches wherein the instructions for making the determination further cause periodically recalculating ketone-on-board based on the data indicating β-hydroxybutyrate (paragraph [0080]).
Regarding claim 6, Windmiller teaches wherein the instructions for making the determination cause selecting the message for output indicating that a patient wearing the sensor control device should conduct a ketone test, based on the data from the sensor for β-hydroxybutyrate exceeding a predetermined level (paragraph [0013], [0016],[0062], [0075]).
Regarding claim 7, Windmiller teaches wherein the second time-correlated data comprises data from a sensor for β-hydroxybutyrate, and 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 for making the determination cause correcting an estimate of β-hydroxybutyrate based on the ketone test result (paragraph [0013], [0016],[0062], [0075]).
Regarding claim 8, 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 making the determination cause correcting an estimate of the patient's plasma insulin state (paragraphs [0157]-[0162]).
Regarding claim 9, 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 (paragraphs [0157]-[0162]).
Regarding claim 10, Windmiller teaches wherein the indication of the determination is an alert condition for one analyte, and wherein the alert condition is based on more than one analyte (“The said ketone alert-generation capability can also be paired with another sensing modality such as, for example, a continuous glucose monitor. The disclosed method facilitates the presentation of alerts to the wearer of a body-worn sensor device should the absolute level or rate-of-change of a singular ketone body (acetoacetate, acetone, D-β-hydroxybutyrate) or plurality of ketone bodies exceed a pre-defined threshold”; paragraph [0053]).
Regarding claim 11, Windmiller teaches wherein the instructions for the distinguishing cause determining whether the first time-correlated data indicates a condition comprising glucose variability below a threshold, high glucose for less than a maximum time threshold, and a ketone level greater than a predetermined threshold (paragraph [0053]).
Regarding claim 12, Windmiller teaches wherein the instructions for the determining cause at least one of suppressing a high ketone alert or reducing an urgency of a high ketone alert (paragraph [0094]).
Regarding claim 13, Windmiller teaches wherein the instructions for the determining cause the message to indicate a time period achieving high ketone levels (paragraph [0053]).
Regarding claim 14, Windmiller teaches wherein the instructions for the distinguishing cause determining whether the first time-correlated data indicates a condition comprising glucose variability above a threshold, high glucose for greater than a maximum time threshold, and a ketone level greater than a predetermined threshold, and if the condition is detected, performing increasing at least one of a frequency or urgency of a message indicating potential occurrence of euglycemic DKA in the patient wearing the sensor control device (paragraphs [0052]-[0053]).
Regarding claim 15, Windmiller teaches wherein the instructions for making the determination further cause estimating whether a patient wearing the sensor control device is a person with Type 1 diabetes mellitus taking an SGLT-2 inhibitor based on comparing a ketone estimate based on the first time-correlated data with a ketone level indicated by the second time-correlated data (paragraphs [0154], [0157], [0161]).
Regarding claim 16, WIndmiller teaches wherein the instructions for making the determination cause determining whether the ketone estimate is consistently lower than the indicated ketone level, and if so, determining the message comprising an indication that the patient should consult with their health care provider regarding use of the SGLT-2 inhibitor (paragraphs [0154], [0157], [0161]; “an alert is tendered to the wearer (and, optionally, their support network—family, healthcare provider, friends, etc)”; paragraph [0053]).
Regarding claim 17, Windmiller teaches wherein the instructions for making the determination further cause determining the message comprising an indication that the lack of a high glucose alert may not achieve the intended purpose (paragraphs [0052]-[0053], [0130]-[0131]).
Regarding claim 20, 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 (paragraph [0055]).
Regarding claim 22, Windmiller teaches wherein the analyte sensor is a first analyte sensor, wherein the sensor control device further includes a second analyte sensor, wherein the first analyte sensor is configured to sense a glucose level in a bodily fluid, and wherein the second analyte sensor is configured to sense a ketone level in the bodily fluid (paragraph [0166]).
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) 23 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 (cited in IDS; hereinafter referred to as “Selander”).
Regarding claim 23, Windmiller does not explicitly teach further comprising 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABID A MUSTANSIR whose telephone number is (408)918-7647. The examiner can normally be reached M-F 10 am to 6 pm Pacific Time.
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, Jason Sims can be reached at 571-272-7540. 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.
/ABID A MUSTANSIR/Examiner, Art Unit 3791