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 .
Response to Amendment
Claims 21-23 have been added and claims 10 and 13-14 have been cancelled. Claims 1-9, 11-12, and 15-23 remain pending.
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 22 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 is no disclosure in the filed specification of the removable smart cap being configured to initialize or reinitialize the processor of the mobile device, or more specifically based on the universal concept of time, in any scenario as claimed. There are mentions in the specification of the internal clock of the medical delivery device being reinitialized, or the mobile application clock being reinitialized, but this does not appear to be the requirements of the claim (note that the claim requirements are also unclear and indefinite as called out immediately below). This constitutes new matter as the claim appears to require limitations which are not supported or made clear by Applicant’s original disclosure.
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 22 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.
In addition to claim 22 being new matter as indicated above, it is also unclear. The claim appears to be requiring that the smart end cap is configured for the initialization/reinitialization of the processor of the mobile device; it is not clear how the smart cap is to be so configured, particularly since there is no such support for such a configuration. It is also unclear as other claims refer to time-based structures, such as clocks, being based on the universal concept of time, and not the overall processor being based on the universal concept of time. For the purposes of compact prosecution, Examiner has understood the claim to mean that the processor is configured for reinitialization based on the universal concept of time after a power loss or a signal loss of the mobile device. Examiner notes that, if Applicant amended the claim to clarify that this is what is meant, this would also constitute new matter as there is no support for the processor of the mobile device being so configured.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 6-9, 11-12, 15-17, 20, and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radmer et al. (US 20180272072, henceforth Radmer) in view of Estes et al. (US 20160038675, henceforth Estes), Thukral et al. (US 20090006061, henceforth Thukral), and Carlsgaard et al. (US 20140321246, henceforth Carlsgaard).
Regarding claim 1, Radmer discloses a medication delivery system (drug delivery device 100, fig. 1, cap device 200, fig. 2, and the smartphone of [0054]) comprising: 1. a medication delivery device (drug delivery device 100, fig. 1) adapted to dispense medication (see [0046] and [0047]), the medication delivery device comprising memory (see [0053] and [0054], cap device 200 comprises flexible PCB 230 which comprises memory) to store recorded medication delivery information (see [0054] and [0055], the memory can be used to store information such as the time since the last dose) such as a time-dependent schedule ([0055], reminders stored in the memory are a time-dependent schedule) along with timestamps (see [0029]), wherein the medication delivery device comprises a medication delivery pen (drug delivery device 100, fig. 1) and a removable smart cap (cap device 200, fig. 2) that includes the memory (see [0053] and [0054], cap device 200 comprises flexible PCB 230 which comprises memory) and that is releasably coupleable to the medication delivery pen (see [0049] and [0053], cap device 200 can be coupled and uncoupled from pen device 100), and wherein the removable smart cap comprises an internal clock (see at least [0055], the smart cap can keep track of time since last dose, meaning it must have some kind of internal clock which is capable of keeping time); and a mobile device (external device such as a smartphone as in [0054]) in communication with the medication delivery device (in communication via communication means as in [0054]) which can receive information such as the schedule from the medication delivery device ([0054]) and present a visual display of the received information (see [0054] and [0055]).
Radmer does not disclose 1.) the time-dependent schedule being a time-dependent medication delivery schedule or 2.) the mobile device having a processor coupled to memory storing instructions that when executed cause the processor to: receive the time-dependent medication delivery schedule from the medication delivery device, and present a visual display of the time-dependent medication delivery schedule along with times.
Estes teaches a medication delivery system (infusion pump system 10, fig. 1) for treatment of diabetes and administration of insulin (see at least [0006], [0012], and [0028]) comprising: a medication delivery device (pump assembly 20, fig. 1) adapted to dispense medication ([0028]), the medication delivery device comprising memory (see [0029]-[0030] and fig. 1, pump assembly 20 comprises controller 23 which includes memory 24) to store a time-dependent medication delivery schedule ([0051], “the amount of medicine to be dispensed at a particular time or date” is a schedule as claimed which must be stored in the memory since it can be displayed by the controller), the schedule being stored along with timestamps ([0051], the data includes the amounts to be dispensed at a particular time or date, where the particular time or date are timestamps); and 2. a mobile application (dosage calculator application 44, fig. 1) executed by a processor (controller 43, fig. 1) of a mobile device (mobile device 40, fig. 1), where the mobile device is in communication with the medication delivery device (see [0028], they are in wireless communication), the processor configured to operate the mobile device (see at least [0036], [0039], and [0041]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the simple timestamp functionality of Radmer ([0055]) with the mobile device processing functionality and timestamps of Estes as Radmer generally said it can be used in embodiments with mobile devices and smartphones ([0054]) and because the application of Estes and functionalities attributed with it allow for suggested optimized dosing (see [0005]-[0007]) and provide a user with additional information about their upcoming and previous insulin dosage and blood glucose level (see [0081]-[0084]). Such a modified system would include the addition of the blood glucose monitor of Estes as this is used with the mobile application of Estes for determining of blood glucose. Additionally, such a modified system would include the use of a time-dependent medication delivery schedule as this is used for Estes’ dosage calculations in the application. Additionally, this modified system would then include the processor of the mobile device being configured to allow the mobile device to be capable of receiving the time-dependent medication delivery schedule from the medication delivery device and presenting this schedule as a visual display.
Radmer as modified by Estes does not disclose that the timestamps are based on a universal concept of time that is independent of a time zone in which the medication delivery device is located. Thukral teaches a system (system 10 of fig. 2) comprising transferring and storage of medical information (event of [0133]-[0135], which is transferred and stored as in [0064]-[0068]) where the medical information is stored and transferred along with timestamps (see [0133], intrinsic to an event is the time of the event) based on a universal concept of time ([0133], “The time of the event is provided as absolute time which in general acts as the absolute reference” and “The absolute UTC time is used as the "reference time" to which the event is associated”) that is independent of a time zone in which the medication delivery device is located (UTC time which is the reference time of [0133] is different than local time as disclosed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the timestamps be based on the universal concept of time as claimed for the benefit of being able to properly correlate other events as in Thukral ([0133]).
Radmer as modified does not explicitly disclose that the internal clock is configured to maintain the universal concept of time, or that the times displayed with the time-dependent medication delivery schedule are determined using the timestamps based in the universal concept of time which are adjusted based on a current time zone of the mobile device.
Carlsgaard teaches a medication delivery system (system of fig. 1) wherein a handheld medical device (blood glucose meter 12, fig. 1) is configured to maintain an internal device clock (RTC of meter 12, see [0030]-[0034]). Additionally, Thukral teaches that it is beneficial for internal clocks to be based on the universal concept of time (see [0133], events are based on internal clocks in the modified system and since events are transferred in UTC, it is understood that the internal clocks are in or based on UTC) which is used to determine a current local time ([0133]), while displays should be provided in local time ([0133]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the internal clock of Carlsgaard to the medication delivery device of Radmer since it is also a handheld medical device with a display and to have based the internal clock on UTC as in Thukral to allow for determination of local time and to have provided the times on the display of the mobile device for providing more information to the user and allowing for local time setting on the medication delivery device’s display as Thukral teaches that displays should be in local time ([0133]).
Regarding claim 2, Radmer as modified by Estes, Thukral, and Carlsgaard (henceforth Radmer as modified) discloses the medication delivery system wherein: 1. the medication delivery device is further configured to receive glucose data (see Estes [0058], “the monitoring device 50a can communicate information indicative of the user's blood glucose level to the pump assembly 20 via a wireless connection”) from a continuous glucose monitor (monitoring device 50a, fig. 1) and store the glucose data along with timestamps (see Estes at least [0038], [0042], [0055], and [0078]; since the dosage calculator application 44 uses recent blood glucose level and rate of change of the blood glucose level, it must be at least temporarily storing measured or input glucose levels such as to be able to make these comparisons; mobile device 40 and application 44 thereon receive this information via pump assembly 20 in Estes) based on the universal concept of time that is independent of the time zone in which the medication delivery device is located (in the modified system, it has been previously established that internal timestamps should be maintained in UTC to be able to properly correlate other events together, see rejection of claim 1 above); and 2. the processor is further configured to receive the timestamped glucose data from the medication delivery device (see Estes [0038] and [0058]; since it is disclosed that the dosage calculator application 44 is using recent blood glucose level to determine insulin dosing and this information comes from pump assembly 20 as in [0081] and [0082], thus this is also disclosed in the modified system).
Radmer as modified does not disclose the system wherein the processor is further configured to present a visual display of the glucose data along with times based on the universal concept of time at which the glucose data was received adjusted based on the current time zone setting of the mobile device. Carlsgaard teaches a system (system of fig. 1) comprising a processor on a mobile device (diabetes management application 14, fig. 1) which is executed by a device (mobile phone 16, fig. 1) wherein the processor is configured to present a visual display of glucose data (glucose history report 416, fig. 10) along with times at which the glucose data was received (see the graphical glucose history report shown in fig. 10; it says that the blood glucose measurements are displayed over the last 7 days, meaning that the times are shown along the x-axis of the graph; they are additionally shown as text below the graph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the processor of the mobile device to present a visual display of the glucose data along with times for communicating the user glucose history report with the user (Carlsgaard [0090]). Keeping with the teachings of Thukral above, such an addition would then include the times being based on the universal concept of time at which the glucose data was received as claimed since the Thukral teaches the use of UTC for timestamps as being important for being able to properly correlate other events ([0133]).
Radmer as modified does not explicitly disclose the system wherein the times presented on the visual display are adjusted based on the current time zone setting of the mobile application. Thukral teaches that local time should be used for display purposes ([0133]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have adjusted the displayed times in the mobile app from the UTC time stamps to the local time as Thukral teaches that local times should be used for display which take into account time zones and day light saving ([0133]).
Regarding claim 3, Radmer as modified discloses the medication delivery system wherein the timestamps are based on the universal concept of time (see rejection of claim 1 above).
Radmer as modified does not disclose the medication delivery system wherein the processor is further configured to convert the timestamps for the time-dependent medication delivery schedule from times based on the universal concept of time to times based on the current time zone of the mobile device using a mobile application clock maintained by a mobile application, the mobile application clock distinct from an operating system clock of the mobile device. Carlsgaard teaches a system (system of fig. 1) comprising a mobile application (diabetes management application 14, fig. 1) which is executed by a mobile device (mobile phone 16, fig. 1) which uses timestamps (see time measurements of meter 12 in [0030], elapsed time counter of mobile phone 16 in [0031], and snapshot time 14 of diabetes management application 14 in [0032], these are all timestamps) based on a universal concept of time (time measurements of meter 12 are measured with respect to a RTC which internal and thus universal; the elapsed time counter of mobile phone 16 is set to GMT, which is the same as UTC in Thukral and is a universal time setting; and the snapshot time of diabetes management application 14 is tied to GMT) and is configured to convert the timestamps for the timestamped medication delivery information from times based on the universal concept of time to different times based on the device (“The diabetes management application 14 is configured to determine an accurate time that a glucose measure was taken based on the difference between the RTC of the meter 12 and the time on the internal clock of the diabetes management application 14”, [0034]) using a mobile application clock maintained by the mobile application (“the internal clock of the diabetes management application 14”, [0034]), the mobile application clock distinct from an operating system clock of the mobile device (“the display clock of the mobile phone 16 may differ from the internal clock of the diabetes management application 14”, [0034]). Additionally, Thukral teaches that the time which should be adjusted to should be the local time of the device ([0133], [0136], 0137]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have converted the timestamps for the timestamped medication delivery information from times based on the universal concept of time to times based on the current time zone setting of the device using a mobile application clock as in Carlsgaard as this allows the mobile application to accurately display the correct time to the user that the events occurred, and further because Thukral teaches that it is preferable to display times in a mobile application in local time instead of a time measurement based on a universal concept of time ([0133], [0136], [0137]).
Regarding claim 6, Radmer as modified discloses the medication delivery system wherein the mobile application executing on the mobile device is configured to initialize the mobile application clock using a time based on the universal concept of time received from a server (see Carlsgaard [0033], the internal clock of the diabetes management application 14 is the amount of time elapsed since the snapshot time, and thus is based on the snapshot time; the snapshot time is based on a trusted time source as in [0031] and is GMT time as derived from a computing device remotely located from mobile phone 16 as in [0032]).
Regarding claim 7, Radmer as modified discloses the medication delivery system wherein the mobile application executing on the mobile device is configured to initialize the mobile application clock using timestamped information received from the medication delivery device (see Carlsgaard [0033], “When the mobile phone 16 is not connected to a network, the snapshot time is set to be equal to an RTC time of the meter 12”, where the RTC time is by nature timestamped information).
Regarding claim 8, Radmer as modified does not disclose the medication delivery system wherein the timestamps for the timestamped information received from the medication delivery device are based on the universal concept of time.
However, Thukral teaches that reference times should be based on UTC time, which is the universal concept of time ([0133]).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have additionally correlated the RTC timestamps of Carlsgaard with UTC time as in Thukral in the medication delivery system of Radmer using the mobile application of Estes for providing the best therapy possible since Thukral teaches that timing of measurement is central to providing good therapy ([0137]).
Regarding claim 9, Radmer as modified discloses the medication delivery system wherein the mobile application executing on the mobile device is configured to maintain the universal concept of time for the mobile application clock by monitoring (1) an elapsed time since the device was started or (2) an elapsed time since the mobile application was initialized and comparing the elapsed time associated with information from the medication delivery device that indicates the universal concept of time to (3) a current amount of elapsed time (see Carlsgaard [0030]-[0037]; the first claimed elapsed time (1) correlates with the disclosed snapshot time, and it is compared to the disclosed elapsed time which correlates with the second claimed elapsed time (3) to make the disclosed delta time).
Regarding claim 11, Radmer as modified discloses the medication delivery system wherein the medication delivery device is configured to initialize the internal clock using time information received from the mobile device (since initialization requiring coordination with UTC requires a connection to a network as disclosed in Carlsgaard [0033], and since this connection to a network is done via the mobile device 40 in Estes as in [0087], it is understood that the correlation between the RTC of Carlsgaard and UTC as in the modified device is done through networking via device 40 as in Estes).
Regarding claim 12, Radmer as modified does not disclose the medication delivery system wherein the mobile device automatically sets the current time zone and a current time for the current time zone.
Carlsgaard teaches a medication delivery system (system of fig. 1) comprising a mobile device (mobile phone 16, fig. 1) wherein the device has automatically sets the current time zone and a current time for the current time zone (see [0031], the display clock of the phone can be automatically set).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the mobile to have automatically set the current time zone and current time for the current time zone as in Carlsgaard as Carlsgaard teaches this to be an art effective method for setting such a display clock ([0031]) and because configuring the mobile device as such would have yielded the predictable result of the current time and time zone being set in the mobile device.
Regarding claim 22, Radmer as modified discloses the system wherein the processor uses clocks based on the universal concept of time (see rejection of claim 1 above).
Radmer as modified does not explicitly disclose that the processor is configured to reinitialize based on the universal concept of time after a power loss or a signal loss of the mobile device. Carlsgaard teaches that processors of mobile devices are initialized based on the universal concept of time ([0031], automatic setting of times on mobile devices is known and can be based on GMT, which is the same as UTC, and thus the initialization is based on the universal concept of time as claimed). Additionally, Thukral teaches that after a failure, devices are known to reinitialize themselves ([0260]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the processor of Radmer as modified to have reinitialized itself based on the universal concept of time after a power loss or a signal loss of the mobile device as these represent failures and Thukral teaches that after failures, devices are configured to reinitialize themselves which by definition means repeating their initialization steps ([0260]), and since initialization is taught by Carlsgaard to be based on the universal concept of time ([0031]), reinitialization would similarly be based on the universal concept of time.
Regarding claim 23, Radmer as modified discloses the system wherein the removable smart cap is configured to display a time of a most recent dose (see Radmer [0029], events such as switch changes caused by dosing can be displayed on the smart cap in a HH:MM format).
Radmer as modified does not explicitly disclose that a corresponding time zone at which the most recent dose was determined is configured to be displayed. However, Thukral teaches local times should be used for display purposes which take into account time zones and day light saving ([0133]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have set the time displayed on the smart cap in the HH:MM format to have been in the corresponding time zone at which the dose was determined as claimed as this would allow for a user to time of their last injection in their local time when they are in the same time zone as the time zone displayed on the smart cap. This would then constitute showing their time zone as claimed because the time is adjusted from UTC to local time (the current time zone) in keeping with the teachings of Thukral and Radmer as modified.
Regarding claim 15, Radmer discloses a method, comprising: receiving, by a mobile device, information (see [0055], the mobile device can be a smartphone) from a medication delivery device (drug delivery device 100, fig. 1) adapted to dispense medication (see [0046] and [0047]), the mobile device being separate from the medication delivery device (see [0055], the devices are physically separate which is why they are connected wirelessly), the information comprising recorded medication delivery information (see [0054] and [0055], memory can be used to store information such as the time since the last dose) such as a time-dependent schedule ([0055], reminders stored in the memory are a time-dependent schedule) along with timestamps (see [0029]), wherein the medication delivery device comprises a medication delivery pen (drug delivery device 100, fig. 1) and a removable smart cap (cap device 200, fig. 2) that includes memory (see [0053] and [0054], cap device 200 comprises flexible PCB 230 which comprises memory) storing the recorded medication delivery information (see [0054] and [0055], the memory can be used to store information such as the time since the last dose) and that is releasably coupleable to the medication delivery pen (see [0049] and [0053], cap device 200 can be coupled and uncoupled from pen device 100), and wherein the removable smart cap comprises an internal clock (see at least [0055], the smart cap can keep track of time since last dose, meaning it must have some kind of internal clock which is capable of keeping time); and presenting, by the mobile device, a visual display of the information by the mobile device from the medication delivery device (see [0054] and [0055]). Radmer additionally discloses that its device can be used for the treatment of diabetes and the administration of insulin (see [0004], [0005], [0033], and [0047]).
Radmer does not disclose 1.) the time-dependent schedule being a time-dependent medication delivery schedule or 2.) the mobile device having a processor coupled to memory storing instructions that when executed cause the processor to: receive the time-dependent medication delivery schedule from the medication delivery device, and present a visual display of the time-dependent medication delivery schedule along with times.
Estes teaches a medication delivery system (infusion pump system 10, fig. 1) for treatment of diabetes and administration of insulin (see at least [0006], [0012], and [0028]) comprising: a medication delivery device (pump assembly 20, fig. 1) adapted to dispense medication ([0028]), the medication delivery device comprising memory (see [0029]-[0030] and fig. 1, pump assembly 20 comprises controller 23 which includes memory 24) to store a time-dependent medication delivery schedule ([0051], “the amount of medicine to be dispensed at a particular time or date” is a schedule as claimed which must be stored in the memory since it can be displayed by the controller), the schedule being stored along with timestamps ([0051], the data includes the amounts to be dispensed at a particular time or date, where the particular time or date are timestamps); and 2. a mobile application (dosage calculator application 44, fig. 1) executed by a processor (controller 43, fig. 1) of a mobile device (mobile device 40, fig. 1), where the mobile device is in communication with the medication delivery device (see [0028], they are in wireless communication), the processor configured to operate the mobile device (see at least [0036], [0039], and [0041]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the simple timestamp functionality of Radmer ([0055]) with the mobile device processing functionality and timestamps of Estes as Radmer generally said it can be used in embodiments with mobile devices and smartphones ([0054]) and because the application of Estes and functionalities attributed with it allow for suggested optimized dosing (see [0005]-[0007]) and provide a user with additional information about their upcoming and previous insulin dosage and blood glucose level (see [0081]-[0084]). Such a modified system would include the addition of the blood glucose monitor of Estes as this is used with the mobile application of Estes for determining of blood glucose. Additionally, such a modified system would include the use of a time-dependent medication delivery schedule as this is used for Estes’ dosage calculations in the application. Additionally, this modified system would then include the processor of the mobile device being configured to allow the mobile device to be capable of receiving the time-dependent medication delivery schedule from the medication delivery device and presenting this schedule as a visual display.
Radmer as modified by Estes does not disclose that the timestamps are based on a universal concept of time that is independent of a time zone in which the medication delivery device is located. Thukral teaches a system (system 10 of fig. 2) comprising transferring and storage of medical information (event of [0133]-[0135], which is transferred and stored as in [0064]-[0068]) where the medical information is stored and transferred along with timestamps (see [0133], intrinsic to an event is the time of the event) based on a universal concept of time ([0133], “The time of the event is provided as absolute time which in general acts as the absolute reference” and “The absolute UTC time is used as the "reference time" to which the event is associated”) that is independent of a time zone in which the medication delivery device is located (UTC time which is the reference time of [0133] is different than local time as disclosed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the timestamps be based on the universal concept of time as claimed for the benefit of being able to properly correlate other events as in Thukral ([0133]).
Radmer as modified does not explicitly disclose that the internal clock is configured to maintain the universal concept of time, or that the times displayed with the time-dependent medication delivery schedule are determined using the timestamps based in the universal concept of time which are adjusted based on a current time zone of the mobile device.
Carlsgaard teaches a medication delivery system (system of fig. 1) wherein a handheld medical device (blood glucose meter 12, fig. 1) is configured to maintain an internal device clock (RTC of meter 12, see [0030]-[0034]). Additionally, Thukral teaches that it is beneficial for internal clocks to be based on the universal concept of time (see [0133], events are based on internal clocks in the modified system and since events are transferred in UTC, it is understood that the internal clocks are in or based on UTC) which is used to determine a current local time ([0133]), while displays should be provided in local time ([0133]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the internal clock of Carlsgaard to the medication delivery device of Radmer since it is also a handheld medical device with a display and to have based the internal clock on UTC as in Thukral to allow for determination of local time and to have provided the times on the display of the mobile device for providing more information to the user and allowing for local time setting on the medication delivery device’s display as Thukral teaches that displays should be in local time ([0133]).
Regarding claim 16, Radmer as modified discloses the method further comprising receiving, by the processor, timestamped glucose data (see Estes [0058], “the monitoring device 50a can communicate information indicative of the user's blood glucose level to the pump assembly 20 via a wireless connection”; additionally see at least [0038], [0042], [0055], and [0078]; since the dosage calculator application 44 uses recent blood glucose level and rate of change of the blood glucose level, it must be at least temporarily storing measured or input glucose levels such as to be able to make these comparisons) from the medication delivery device (monitoring device 50a, fig. 1; note that the medication delivery device cited in claim 15 includes monitoring device 50a).
Radmer as modified does not disclose the method wherein the processor presents a visual display of the glucose data along with times based on the universal concept of time at which the glucose data was received adjusted based on the current time zone of the mobile device. Carlsgaard teaches a system (system of fig. 1) comprising a mobile application (diabetes management application 14, fig. 1) which is executed by a mobile device (mobile phone 16, fig. 1) wherein the mobile application is configured to present a visual display of glucose data (glucose history report 416, fig. 10) along with times (see the graphical glucose history report shown in fig. 10; it says that the blood glucose measurements are displayed over the last 7 days, meaning that the times are shown along the x-axis of the graph; they are additionally shown as text below the graph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the processor to control the mobile application to present a visual display of the blood glucose level information along with times for communicating the user glucose history report with the user (Carlsgaard [0090]). Keeping with the teachings of Thukral above, such an addition would then include the times being based on the universal concept of time at which the blood glucose levels were determined as claimed since the Thukral teaches the use of UTC for timestamps as being important for being able to properly correlate other events ([0133]).
Radmer as modified does not explicitly disclose the system wherein the times presented on the visual display are adjusted based on the current time zone setting of the mobile application. Thukral teaches that local time should be used for display purposes ([0133]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have adjusted the displayed times in the mobile app from the UTC time stamps to the local time as Thukral teaches that local times should be used for display which take into account time zones and day light saving ([0133]).
Regarding claim 17, Radmer as modified discloses the method wherein the timestamps are based on the universal concept of time (see rejection of claim 15 above).
Radmer as modified does not disclose the medication delivery system wherein the processor is configured to convert the timestamps for the time-dependent medication delivery schedule from times based on the universal concept of time to times based on the current time zone of the mobile device using a mobile application clock maintained by a mobile application, the mobile application clock distinct from an operating system clock of the mobile device. Carlsgaard teaches a system (system of fig. 1) comprising a mobile application (diabetes management application 14, fig. 1) which is executed by a mobile device (mobile phone 16, fig. 1) which uses timestamps (see time measurements of meter 12 in [0030], elapsed time counter of mobile phone 16 in [0031], and snapshot time 14 of diabetes management application 14 in [0032], these are all timestamps) based on a universal concept of time (time measurements of meter 12 are measured with respect to a RTC which internal and thus universal; the elapsed time counter of mobile phone 16 is set to GMT, which is the same as UTC in Thukral and is a universal time setting; and the snapshot time of diabetes management application 14 is tied to GMT) and is configured to convert the timestamps for the time-dependent medication delivery schedule from times based on the universal concept of time to different times based on the mobile device (“The diabetes management application 14 is configured to determine an accurate time that a glucose measure was taken based on the difference between the RTC of the meter 12 and the time on the internal clock of the diabetes management application 14”, [0034]) using a mobile application clock maintained by the mobile application (“the internal clock of the diabetes management application 14”, [0034]), the mobile application clock distinct from an operating system clock of the device (“the display clock of the mobile phone 16 may differ from the internal clock of the diabetes management application 14”, [0034]). Additionally, Thukral teaches that the time which should be adjusted to should be the local time of the device ([0133], [0136], 0137]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have converted the timestamps for the timestamped medication delivery information from times based on the universal concept of time to times based on the current time zone setting of the device using a mobile application clock as in Carlsgaard as this allows the mobile application to accurately display the correct time to the user that the events occurred, and further because Thukral teaches that it is preferable to display times in a mobile application in local time instead of a time measurement based on a universal concept of time ([0133], [0136], [0137]).
Regarding claim 20, Radmer as modified discloses the method further comprising initializing, by the mobile application, the mobile application clock using timestamped information received from the medication delivery device (see Carlsgaard [0033], “When the mobile phone 16 is not connected to a network, the snapshot time is set to be equal to an RTC time of the meter 12”, where the RTC time is by nature timestamped information).
Claim(s) 4-5, 18-19, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable Radmer et al. (US 20180272072, henceforth Radmer) in view of Estes et al. (US 20160038675, henceforth Estes), Thukral et al. (US 20090006061, henceforth Thukral), and Carlsgaard et al. (US 20140321246, henceforth Carlsgaard) as applied to claims 3 and 17 above, respectively, and further in view of Teucher et al. (US 20150161339, henceforth Teucher).
Regarding claim 4, Radmer as modified discloses the medication delivery system wherein the mobile application clock is configured to determine a current time for the mobile device independent of time zone settings of the mobile device (see Thukral [0133], [0136], [0137], it is preferable to display times in a mobile application in local time instead of a time measurement based on a universal concept of time, and see the rejection of claim 3 above; note also Carlsgaard [0031] which discloses that time zone settings of the device can be automatic or can be manually set by the patient, meaning that the mobile application clock and the time zone settings of the device can be independent especially when the time zone settings of the device are done manually).
Radmer as modified does not disclose the medication delivery system wherein the mobile application clock is configured to use information indicating a current time zone for the mobile device to determine a current time for the current time zone of the mobile device independent of time zone settings of the mobile device. Teucher teaches the use of information indicating a current time zone for the device to determine a current time for the current time zone of the device (see [0080], GPS location, which is information indicating a current time zone for a device, can be used to determine the time-zone of the device, or alternatively the time zone of the device could be provided, thus the use of GPS location is independent of the time zone settings of the device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used information indicating a current time zone for the mobile device to determine a current time for the current time zone of the mobile device independent of time zone settings of the mobile device as in Teucher as Teucher teaches this to be an acceptable way to derive the local time ([0080]) and since Thukral teaches that it is preferable to display times in a mobile application in local time instead of a time measurement based on a universal concept of time ([0133], [0136], [0137]).
Regarding claim 5, Radmer as modified discloses the medication delivery system wherein the mobile application clock is configured to determine a current time for the mobile device independent of time zone settings of the mobile device (see Thukral [0133], [0136], [0137], it is preferable to display times in a mobile application in local time instead of a time measurement based on a universal concept of time, and see the rejection of claim 3 above; note also Carlsgaard [0031] which discloses that time zone settings of the device can be automatic or can be manually set by the patient, meaning that the mobile application clock and the time zone settings of the mobile device can be independent especially when the time zone settings of the device are done manually).
Radmer as modified does not disclose the medication delivery system wherein the mobile application clock is configured to use information indicating a current time zone for the mobile device to determine a current time for the current time zone of the mobile device independent of manual time settings of the mobile device. Teucher teaches the use of information indicating a current time zone for the mobile device to determine a current time for the current time zone of the mobile device (see [0080], GPS location, which is information indicating a current time zone for a mobile device, can be used to determine the time-zone of the mobile device, or alternatively the time zone of the mobile device could be provided, thus the use of GPS location is independent of the time zone settings of the mobile device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used information indicating a current time zone for the mobile device to determine a current time for the current time zone of the mobile device independent of manual time settings of the mobile device as in Teucher as Teucher teaches this to be an acceptable way to derive the local time ([0080]) and since Thukral teaches that it is preferable to display times in a mobile application in local time instead of a time measurement based on a universal concept of time ([0133], [0136], [0137]).
Regarding claim 21, Radmer as modified discloses the system wherein the current time zone is used to adjust the timestamps based on the universal concept of time (see rejection of claim 1 above).
Radmer as modified does not disclose the system wherein the processor is configured to determine the current time zone of the mobile device based on location information determined by or received at the mobile device. Teucher teaches the use of location information indicating a current time zone received by a mobile device to determine a current time zone of the mobile device (see [0080], GPS location, which is information indicating a current time zone for a mobile device, can be used to determine the time-zone of the mobile device, or alternatively the time zone of the mobile device could be provided, thus the use of GPS location is independent of the time zone settings of the mobile device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used location information indicating a current time zone received by a mobile device to determine a current time zone of the mobile device as claimed as Teucher teaches this to be an acceptable way to derive the local time zone and local time ([0080]) and since Thukral teaches that it is preferable to display times in a mobile application in local time instead of a time measurement based on a universal concept of time ([0133], [0136], [0137]).
Regarding claim 18, Radmer as modified discloses the method wherein the mobile application clock determines a current time for the device independent of time zone settings of the mobile device (see Thukral [0133], [0136], [0137], it is preferable to display times in a mobile application in local time instead of a time measurement based on a universal concept of time, and see the rejection of claim 17 above; note also Carlsgaard [0031] which discloses that time zone settings of the mobile device can be automatic or can be manually set by the patient, meaning that the mobile application clock and the time zone settings of the mobile device can be independent especially when the time zone settings of the mobile device are done manually).
Radmer as modified does not disclose the method wherein the mobile application clock uses information indicating a current time zone for the mobile device to determine a current time for the current time zone of the mobile device independent of time zone settings of the mobile device. Teucher teaches the use of information indicating a current time zone for the mobile device to determine a current time for the current time zone of the mobile device (see [0080], GPS location, which is information indicating a current time zone for a mobile device, can be used to determine the time-zone of the mobile device, or alternatively the time zone of the mobile device could be provided, thus the use of GPS location is independent of the time zone settings of the mobile device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used information indicating a current time zone for the mobile device to determine a current time for the current time zone of the mobile device independent of time zone settings of the mobile device as in Teucher as Teucher teaches this to be an acceptable way to derive the local time ([0080]) and since Thukral teaches that it is preferable to display times in a mobile application in local time instead of a time measurement based on a universal concept of time ([0133], [0136], [0137]).
Regarding claim 19, Radmer as modified discloses the method wherein the mobile application clock determines a current time for the mobile device independent of time zone settings of the mobile device (see Thukral [0133], [0136], [0137], it is preferable to display times in a mobile application in local time instead of a time measurement based on a universal concept of time, and see the rejection of claim 17 above; note also Carlsgaard [0031] which discloses that time zone settings of the mobile device can be automatic or can be manually set by the patient, meaning that the mobile application clock and the time zone settings of the device can be independent especially when the time zone settings of the mobile device are done manually).
Radmer as modified does not disclose the method wherein the mobile application clock uses information indicating a current time zone for the mobile device to determine a current time for the current time zone of the mobile device independent of manual time settings of the mobile device. Teucher teaches the use of information indicating a current time zone for the mobile device to determine a current time for the current time zone of the mobile device (see [0080], GPS location, which is information indicating a current time zone for a mobile device, can be used to determine the time-zone of the mobile device, or alternatively the time zone of the mobile device could be provided, thus the use of GPS location is independent of the time zone settings of the mobile device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used information indicating a current time zone for the mobile device to determine a current time for the current time zone of the mobile device independent of manual time settings of the mobile device as in Teucher as Teucher teaches this to be an acceptable way to derive the local time ([0080]) and since Thukral teaches that it is preferable to display times in a mobile application in local time instead of a time measurement based on a universal concept of time ([0133], [0136], [0137]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 11,452,813 in view of Radmer et al. (US 20180272072, henceforth Radmer).
Regarding claims 1 and 15, claim 14 of the ‘813 patent includes all features except the limitation of “wherein the medication delivery device comprises a medication delivery pen and a removable smart cap that includes the memory and that is affixed to cover a needle of the medication delivery pen”, where there are references to the remote computing device instead of the mobile application in the instant claims which are instead claimed as the remote computing device in claim 1 of the ’813 patent, and there are references to the delivery device clock instead of the internal clock in the instant claims which are instead claimed as the delivery device clock in claim 14 of the ‘813 patent..
Radmer teaches a system for delivering drugs (drug delivery device 100 and cap device 200, figs. 1 and 2) comprising a medication delivery device (drug delivery device 100 and cap device 200, figs. 1 and 2) wherein the medication delivery device comprises a medication delivery pen (drug delivery device 100, fig. 1A) and a removable smart cap (cap device 200, fig. 2) that includes memory (see [0053] and [0054], cap device 200 comprises flexible PCB 230 which comprises memory) and that is affixed to cover a needle of the medication delivery pen (see figs. 1A and 2 and see [0049]; cap device 200 is meant to replace the pictured standard cap 120 which is affixed to cover a needle of drug delivery device 100; note also [0050] which says that the needle is mounted and covered which is why it can damage the interior of cap device 200).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the pen and removable smart cap of Radmer for the actual medication delivery device of the claimed system of the ‘813 patent for providing a low-power delivery device (see Radmer at least at Abstract and [0012]) and since using a pen and smart cap as in Radmer for the medicament delivery device of ‘813 claim 1 would have yielded the predictable result of a device which can delivering drugs into a patient’s body when needed.
Regarding the differences between references to the mobile application in the instant application and the remote computing device in claim 1 of the ‘813 patent, since it is claimed in claim 1 of the ‘813 patent that the mobile application of ‘813 claim 1 is executed on the remote computing device and since the remote computing device of ‘813 claim 1 has identical functional capabilities as those required in the mobile application of the instant claim, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the mobile application which is executing on the mobile device (or the remote computing device) to have the same functional capabilities as the remote computing device which it is executed on such as to allow the system to function fully.
Response to Arguments
Applicant has amended the independent claims and argued against the previous rejection of claims under 35 U.S.C. §101. The amendment has rendered the previous rejection moot, and thus Examiner withdraws the previous rejection under 35 U.S.C. §101.
Applicant's arguments filed 09/30/2025 have been fully considered but they are not persuasive.
Applicant has argued that Radmer in view of Estes, Thukral, and Carlsgaard does not disclose the internal clock as claimed. Examiner respectfully disagrees. Carlsgaard teaches the use of an internal clock which is a real time clock and teaches that it is beneficial to use such a clock to minimize timing errors in a medicament delivery system as indicated in the rejection above. Thukral teaches that it is beneficial to base internal clocks and database clocks on UTC (the universal concept of time) to maintain consistency in systems which can move across time zones as indicated in the rejection above. Thus, it is the Examiner’s position that it would have been obvious to have configured the internal clock from Carlsgaard (which is added into the modified system of Radmer) to be based on the universal concept of time as claimed.
Applicant has additionally argued, regarding the non-statutory double patenting, that Worden as modified by Radmer did not disclose the claimed features; Examiner respectfully disagrees as indicated in the rejection above as the internal device clock being based on the universal concept of time as claimed in the instant application is anticipated by the medication delivery device being configured to maintain a current time based on the universal concept of time since the maintained current time based on the universal concept of time of claim 14 in the cited patent can be considered to be an internal clock as claimed where both the internal clock and the maintained current time are based on the universal concept of time as claimed.
Thus, Examiner respectfully finds Applicant’s arguments unpersuasive and rejects the claims as indicated in the rejection above.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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