DETAILED ACTION
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 21-28, 30-37, 39, and 41-43 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.
Claims 21, 30, and 39 recites the limitation "sufficient power to perform the adjusted alerting". There is insufficient antecedent basis for this limitation in the claims. The claims recite adjusting the “glucose threshold levels and/or … characteristics of … predetermined alerts”; no step of “alerting” has been recited prior to this limitation.
Claim 39 recites determining “whether the system … has sufficient battery power” and “prompting the charging of the system”. The system as claimed
Claim 41 recites the limitation "adjusting alerting" in line 3. There is insufficient antecedent basis for the “alerting” limitation in the claim.
Claim 43 recites “automatically alerting medical personnel in response to determining that the patient has failed to acknowledge a warning alert and that the patient has progressed into a low risk state or has been hypoglycemic for a predetermined time period. It is unclear why a progression into a “low risk” state would merit clinical attention, particularly as the rest of the claim seems directed to when the user is going into a high risk state. Clarification is required.
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) 21-22, 24-28, 30-31, 33-37, 39, and 41-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saidara et al. (US 2005/0038332) in view of Mittal et al. (US 2015/0084778) and Khan (US 2013/0002441).
As to claims 21, 30, and 39, Saidara teaches a method, comprising: identifying, by at least one processor, one or more glucose threshold levels, wherein each of the one or more glucose threshold levels is associated with a different predetermined alert of one or more predetermined alerts (Fig. 4A – multiple thresholds; [0120] - each with a different alarm); in response to determining, by the at least one processor, a commencement of a predetermined time period during which a patient is expected to have a decreased level of responsiveness ([0146] – manual or automatic activation of night mode): adjusting, by the at least one processor, the one or more glucose threshold levels and/or one or more characteristics of at least one of the one or more predetermined alerts associated with the one or more glucose threshold levels ([0150] – setting different alarm thresholds, [0149] – different tone or audibility); identifying, by the at least one processor, a current glucose level of the patient; and generating, by the at least one processor, an alert based on the one or more predetermined alerts in response to a comparison of the current glucose level of the patient to the adjusted one or more glucose threshold levels ([0148]). Saidara teaches programs, processors, and memory to carry out the method ([0067-0068]).
Saidara does not expressly teach determining, by the at least one processor, whether a computing device comprising the at least one processor has sufficient battery power to perform the adjusted alerting through an end of the predetermined time period; and in response to determining that the computing device does not have sufficient battery power to perform the adjusted alerting through the end of the predetermined time period, generating, by the at least one processor, a notification to a remote monitoring device associated with the patient prompting the charging of the computing device;
Mittal teaches a portable electronic device which identifies “a future interval of usage” of the device and estimates “an amount of charge that is necessary for the power source to power the use of the … device through the future interval”, as well as “producing a user alert indicating that the PE device will require charging” (Abstract) which will “allow the user to take corrective action before the future interval ([0064]; Fig. 4). It would have been obvious to modify Saidara with Mittal to prevent the specific failure mode of a glucose alarm device powering off partway through the sleep period during which the user is least able to detect the failure.
The above combination does not expressly teach that the resulting notification is generated to a remote monitoring device associated with the patient. Khan teaches system in which, upon detecting a low battery state of a mobile device, a “low battery update may be sent to a presence server to enable the low battery update to be provided to one or more contacts associated with the mobile device” as well as providing these contacts with “alerts upon detecting that the mobile device has been recharged” (Abstract). This alert may be presented as a “recharge alert icon” that is displayed on a user interface ([0073]). It would have been obvious to modify the above combination with Khan to allow the notification be generated to remote devices, as taught by Khan, to allow the generation of the alert to other devices and/or contacts to ensure that corrective action be taken.
As to claims 22 and 31, Saidara teaches the one or more characteristics of the at least one of the one or more predetermined alerts include a volume of the predetermined alert, a sound generated by the predetermined alert, a frequency of the predetermined alert, an implementation of a vibrating alert, an implementation of a flashing screen, and an option to contact medical personnel ([0149]).
As to claims 24 and 33, Saidara teaches enabling at least one of the one or more predetermined alerts in response to the commencement of the predetermined time period ([0150] – a higher low blood glucose alarm threshold resulting in a different alert).
As to claims 25 and 34, Saidara teaches the predetermined time period comprises a user- designated night mode time period ([0146]).
As to claims 26 and 35, Saidara teaches receiving, by the at least one processor, one or more selections of the one or more predetermined alerts in association with the user- designated night mode time period ([0115], [0125]).
As to claims 27 and 36, Saidara teaches adjusting the one or more glucose threshold levels and/or the one or more characteristics comprises adjusting a glucose threshold level associated with a low glucose level alert; and a glucose threshold level associated with a high glucose level alert is not adjusted in response to determining the commencement of the predetermined time period ([0150] – while a higher low blood glucose alarm is mentioned, no such change for the high blood glucose alarm is mentioned).
As to claims 28 and 37, Saidara teaches adjusting the one or more glucose threshold levels and/or the one or more characteristics comprises at least one of increasing a low glucose threshold level or decreasing a high glucose threshold level ([0150]).
As to claim 41, Saidara teaches that the adjusting comprises, during the predetermined time period, adjusting alerting for a low glucose condition to cause a low glucose level alert to be generated earlier or more frequently and adjusting alerting for a high glucose condition to cause a high glucose level alert to be generated less frequently ([0115],[0150]).
As to claim 42, Saidara teaches, in response to determining the commencement of the predetermined time period, sending, by the at least one processor, a message to an insulin pump associated with the patient and in communication with the at least one processor, the message causing the insulin pump to use a different insulin delivery profile during the predetermined time period ([0085], [0145-0146]).
As to claim 43, Saidra teaches during night time hours, automatically alerting medical personnel in response to determining that the patient has failed to acknowledge a warning alert and that the patient has progressed into a low risk state or has been hypoglycemic for a predetermined time period ([0020], [0119], [0125], [0146] – as the device allows for a night mode, along with particular alarms active only during selected portions of the day, it allows for automatic alert of medical personnel during night time hours.
Claim(s) 23 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saidara et al. (US 2005/0038332), Mittal et al. (US 2015/0084778) and Khan (US 2013/0002441), and further in view of Johnson et al. (US 2011/0201911).
As to claims 23 and 32, Saidara does not necessarily teach deactivating at least one of the one or more predetermined alerts in response to the commencement of the predetermined time period, although it does teach that the user can set a “blackout” period ([0115]). However, Johnson, in addition to teaching that the length, volume, or type of alert may be changed depending on the selected mode ([0087]), teaches additional modes such as “do not disturb” ([0084]), which would deactivate any alerts during the predetermined time period. As such, it would have been obvious to modify Saidara with Johnson to enable the selection of other types of modes for greater selection and control over how alerts are presented to the user for ease of use.
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/Primary Examiner, Art Unit 3791 8/10/26
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