DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Newly submitted claim 84-86 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claims 84+ and claims 68+ are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case claim 84 can be practiced at least in part, including receiving data and detecting an event, by hand.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 84-86 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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.
Claims 68-83 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.
Claim 68 calls for the processor to “display a list of adverse glucose events of the subject, including the detected adverse glucose event” – it remains unclear where the data for the other events is acquired from or how these events are even identified. Does the system as claimed only exist after the subject has experienced a number of adverse events before the adverse event used to define the system? Are these events input from some other source or are they also identified via the processor circuitry during some other iteration? Clarification is required.
Claim 76 recites “the list of adverse glucose events further includes a plurality of links, wherein each link of the plurality of links corresponds with a corresponding adverse glucose event in the list of adverse glucose events, and wherein each link is configured to pop-up the event-based notification for the corresponding adverse glucose event.” As presented, only the single detected adverse glucose event has a corresponding notification; there is no indication that these other unspecified adverse events also have corresponding notifications. As this claim requires the other events to also have notifications, is the system as claimed configured to perform the notification multiple times? As presented, it is configured for performance of a single iteration of the steps. Clarification is required.
Claim 78 calls for display of “a periodic notification comprising one or more past detected adverse glucose events”. It remains unclear how these “events” relate to any other part of the invention as claimed – are these past events part of the “list of adverse glucose events” as recited in claim 68 or are these other, unrelated events? Still further, how can the notification comprise an event itself? It appears that at least this part of the claim should define that the notification is related to or indicative of or displaying some sort of data related to these events, not displaying the events themselves, but this does not resolve the issues of the type of event and the source of data relating to these events. Clarification and correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 68, 69, 71, 73-75, 77, 81, 83 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Say (2003/0187338) in view of Brown (US 5960403).
Regarding claim 68, Say discloses a continuous glucose monitoring system for detecting adverse glucose events, the continuous glucose monitoring system comprising:
(1) a sensor control unit (element 44) configured to be worn on skin of a subject (figure 14, 17), the sensor control unit comprising:
a partially implantable glucose sensor configured to sense in vivo glucose levels of the subject (element 42); and
a wireless communication circuitry of the sensor control unit (element 98) configured to wirelessly transmit data indicative of the in vivo glucose levels of the subject to a receiver according to a wireless communication protocol (paragraphs [0268]-[0271]); and
(2) the receiver (elements 46, 48; paragraph [0303]), comprising;
a display (element 154);
a wireless communication circuitry of the receiver configured to receive the data indicative of the in vivo glucose levels of the subject from the sensor control unit (element 150);
processor circuitry (element 152) communicatively coupled with the wireless communication circuitry of the receiver, the display, and a non-transitory memory (figure 22), wherein the non- transitory memory is configured to store a plurality of instructions (paragraph [0314]) that, when executed by the processor circuitry, cause the processor circuitry to:
detect an adverse glucose event in the received data indicative of the in vivo glucose levels of the subject (paragraph [0314], [0318]-[0321]);
in response to the detection of the adverse glucose event, automatically output to the display an event-based notification (paragraph [0318]-[0321], [0324]) comprising an entry field configured to allow the subject to input a response (paragraph [0324]);
receive a response in association with the detected adverse glucose event and store in the non-transitory memory the inputted response in association with the detected adverse glucose event (paragraph [0324]); and
retrieve from the non-transitory memory and output to the display a list of adverse glucose events of the subject, including the detected adverse glucose event and the inputted response (paragraph [0324], “for evaluation of trends”).
Say does not specifically disclose the event-based notification comprising a picklist of one or more selectable responses, wherein the one or more selectable responses include a meal event and an exercise event; and an entry field configured to allow the subject to input a custom response.
Brown teaches a glucose monitoring system for detecting adverse glucose events, the glucose monitoring system comprising:
(1) a sensor control unit, the sensor control unit comprising:
a glucose sensor configured to sense in vivo glucose levels of the subject (element 16, 420); and
a communication circuitry of the sensor control unit configured to transmit data indicative of the in vivo glucose levels of the subject to a receiver (element 10); and
(2) the receiver (element 12, 320), comprising;
a display (column 13, lines 26-28);
a communication circuitry of the receiver configured to receive the data indicative of the in vivo glucose levels of the subject from the sensor control unit (column 13, lines 41-48);
processor circuitry communicatively coupled with the wireless communication circuitry of the receiver, the display, and a non-transitory memory (column 5, lines 26-32; column 13, lines 26-32), wherein the non- transitory memory is configured to store a plurality of instructions that, when executed by the processor circuitry, cause the processor circuitry to:
detect an “adverse” glucose event relating to the received data indicative of the in vivo glucose levels of the subject (elements 540, 620; as no constraints have been defined as to what makes an event “adverse”, Brown’s findings of events which include hypoglycemic events per figure 5 are thus detections of “adverse” events);
in response to the detection of the adverse glucose event, output to the display an event-based notification comprising:
(a) a picklist of one or more selectable responses, wherein the one or more selectable responses include a meal event and an exercise event (figure 5, see elements 640); and
(b) an entry field configured to allow the subject to input a custom response (element 710);
receive a selected response and/or an inputted custom response in association with the detected adverse glucose event and store in the non-transitory memory the at least one of a selected response and an inputted custom response in association with the detected adverse glucose event (column 14, lines 39-56); and
retrieve from the non-transitory memory and output to the display a list of adverse glucose events, including the detected adverse glucose event and the at least one of the selected response and the inputted custom response (figure 10, see table 101).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Say with the event-based notification comprising a picklist of selectable responses and a custom response entry field, as taught by Brown, as Say does not provide specifics of how the “data of the particular event” is to be entered into the system and Brown’s notifications enable capture of a number of potentially appropriate responses.
Regarding claim 69, Say further discloses that the detected adverse glucose event comprises a glucose pattern (paragraph [0314]; the Examiner notes that the disclosure of the instant invention defines “other glucose patterns, such as high rates-of-change” in paragraph [0063] as filed).
Regarding claim 71, Say further discloses that the detected adverse glucose event is an episodic pattern comprising a high rate of change of the in vivo glucose levels (paragraph [0314]).
Regarding clam 73, Brown further teaches that the picklist comprises a check box list configured to allow the subject to select one or more selectable responses (elements 640). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have made the system of Say, as modified above, with the picklist comprising a check box list with one or more selectable responses, as further taught by Brown, in order to allow accurate capture of all circumstances around the event.
Regarding claim 74, Brown further teaches that the event-based notification further comprises a confirmation button configured to, when depressed, cause storage of the at least one of the selected response and the inputted custom response in association with the detected adverse glucose event (element 740). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have made the system of Say, as modified, and further included a confirmation button configured to cause storage of the inputted responses, as further taught by Brown, in order to ensure data is captured.
Regarding claim 75, Brown further teaches that the list of adverse glucose events further includes associated corresponding event times (figure 10). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have made the system of Say, as modified, and included corresponding event times in the list of adverse glucose events, as further taught by Brown, in order to allow potential recognition of patterns.
Regarding claim 77, Say further discloses that the event-based notification is outputted to the display in real-time (paragraph [0314], [0318]).
Regarding claim 81, Say further discloses that the event-based notification further comprises information regarding a self-care management consideration relating to the one or more selectable responses (paragraph [0315]).
Regarding claim 83, Say further discloses that the wireless communication circuitry of the receiver is further configured to transmit the data indicative of the in vivo glucose levels of the subject to a server (paragraph [0324]).
Claim 76 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Say, as modified and applied above, and further in view of Sabato (US 2009/0199118).
Regarding claim 76, Say, as modified, does not disclose that the list of adverse glucose events further includes a plurality of links, wherein each link of the plurality of links corresponds with a corresponding adverse glucose event in the list of adverse glucose events, and wherein each link is configured to pop-up the event-based notification for the corresponding adverse glucose event. Sabato teaches a system comprising a processor (paragraph [0040]) configured to display a list of events (figures 2, 3), where the list of events further includes a plurality of links corresponding to each of the events, the links being configured to pop up an event-based notification for each event (paragraph [0029]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have made the system of Say, as modified above, with the list of events including a plurality of links corresponding to each event and configured to pop up notifications for each event, as taught by Sabato, in order to provide additional information about each of the events when viewing the list.
Claims 78-80 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Say, as modified and applied above, and further in view of Hayter (US 2008/0288180).
Regarding claim 78, Hayter teaches a continuous glucose monitoring system comprising a partially implantable glucose sensor configured to sense in vivo glucose levels (paragraph [0033]) and a receiver with a processor configured to receive data from the sensor and to detect adverse glucose events from the received data (paragraph [0050]), and to output to a display a periodic notification comprising one or more past detected adverse events (paragraphs [0090], [0093], “review of historical data such as glucose data, alarms events”). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have made the system of Say, as modified above, with the processor being further configured to periodically display past detected adverse events, as taught by Hayter, in order to remind the patient of past incidents.
Regarding claim 79, Hayter further teaches that the periodic notification can be provided during a predetermined or ongoing routine (paragraphs [0090], [0093]), where that routine may be periodic calibration (paragraph [0093]), which takes place once per day (paragraph [0147]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Say, as modified, and configured the periodic notification to be provided daily, as further taught by Hayter, in order to ensure the patient is aware of previous events.
Regarding claim 80, Hayter further teaches that a detected adverse glucose event would result in a real-time output to the display of an event-based notification for that event (step 1030) whereas the periodic notification is performed in its normal context as part of the predetermined routine (paragraphs [0090]-[0093]), where that routine may be periodic calibration (paragraph [0093]), which takes place once per day (paragraph [0147]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have made the system of Say, as modified above, with a detected adverse glucose event having its notification displayed in real-time while the periodic notification is configured to take place daily, as further taught by Hayter, in order to ensure that ongoing events are treated while providing a regular reminder of previous events.
Claim 82 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Say, as modified and applied above, and further in view of Mastrotaro (US 2008/0139910).
Regarding claim 82, Say, as modified above, does not disclose the receiver being a smart phone. Mastrototaro teaches a continuous glucose monitoring system comprising a continuous glucose sensor (paragraph [0052]) and a receiver configured to receive data indicative of in vivo glucose levels from the sensor’s control unit, where the receiver is a smart phone (paragraph [0056]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Say, as modified, with the receiver being a smart phone, in order to increase the portability and processing capabilities of that receiver.
Response to Arguments
Applicant's arguments filed 13 January 2026 have been fully considered but they are not persuasive.
Regarding the rejections under 112, the Examiner notes that the amendments have not fully resolved all issues in the affected claims, as set forth above.
Regarding the art rejections, Applicant’s argument (1) is that Say does not disclose “outputting to the display an event-based notification comprising an entry field configured to allow the subject to input a response” as “para. 0324 does mention that event markers may be generated through input by the patient, there is no mention of ‘an entry field configured to allow the subject to input a custom response.’” The Examiner notes that Say is not relied upon to disclose an entry field configured to allow the subject to input a custom response, such that this argument is moot. Say discloses allowing the subject to input a response; Brown teaches an entry field allowing input of a custom response, as set forth above.
Applicant’s argument (2) asserts that Brown “does not teach or suggest automatically outputting to the display an event-based notification comprising a picklist and an entry field”; Brown is not relied upon to teach automatic output of such a notification, such that this argument is also moot. Say discloses an automatic notification, as set forth above; Brown teaches additional data entries that could be included as part of an event-based notification, but, again, is not relied upon to teach that such a notification is automatically output.
The claims remain rejected.
The Examiner notes that Applicant’s remarks do not address any teachings of Sabato, Hayter, or Mastrototaro.
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.
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/KAREN E TOTH/Examiner, Art Unit 3791