DETAILED ACTION
The present office action represents a nonfinal action on the merits.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/21/2026 has been entered.
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 .
Priority
This application claims the priority date of a European Patent Application EP20315481.0 of December 2, 2020, and 371 of PCT/EP2021/083678 of December 1, 2021.
Status of Claims
Claims 17, 27, 31-32, and 35, are amended, claims 18, 22, 30, 33, and 36 are cancelled, claims 37-41 are added, and claims 17, 19-21, 23-29, 31-32, 34-35, and 37-41 are pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 17, 19-21, 23-29, 31-32, 34-35, and 37-41 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 17, 19-21, 23-29, and 39-41 are drawn to a user device configured to communicate wirelessly with a storage device, which is within the four statutory categories (i.e., machine), Claim 31 is drawn to a user device configured to communicate wirelessly with a storage device, which is within the four statutory categories (i.e., machine), Claims 32, 34-35, 37-38 are drawn to a method of operating a user device configured to communicate wirelessly with a storage device, which is within the four statutory categories (i.e., process).
Claims 17, 19-21, 23-29, and 39-41 recite a user device configured to communicate wirelessly with a storage device, the storage device configured to store one or more drug delivery devices, the user device comprising:
a processor;
a memory; and
a wireless transceiver,
wherein the user device is configured to:
receive, from the storage device separate from the user device, countdown information indicating a number of days remaining until a next injection of a drug delivery device that is stored in the storage device is due;
receive, via a display, a user input comprising a countdown reset command;
reset the number of days remaining until the next injection is due to a predefined initial value on the user device;
automatically in response to receiving the user input comprising the countdown reset command, send the countdown reset command to the storage device to cause the storage device to overwrite the countdown information on the storage device to the predefined initial value on the storage device;
determine that a number of drug delivery devices stored in the storage device is below a threshold number; and
in response to determining that the number of drug delivery devices stored in the storage device is below the threshold number before the next injection is due, re-order at least one drug delivery device.
Claim 31 recites a user device configured to communicate wirelessly with a storage device, the storage device configured to store one or more drug delivery devices, the user device comprising:
a processor;
a memory; and
a wireless transceiver,
wherein the user device is configured to:
receive, at the processor by the wireless transceiver from the storage device separate from the user device, countdown information indicating a number of days remaining until a next injection of a medicament from the one or more drug delivery devices that is stored in the storage device is due;
receive, at the processor and via a display, a user input comprising a countdown adjustment command;
adjust, in the memory, the number of days remaining until the next injection of the medicament from the one or more drug delivery devices is due on the user device according to the countdown adjustment command;
automatically in response to receiving the user input comprising the countdown adjustment command, send, by the wireless transceiver, updated countdown information to the storage device to cause the storage device to overwrite the countdown information on the storage device to be updated;
determine that a number of drug delivery devices stored in the storage device is below a threshold number; and
in response to determining that the number of drug delivery devices stored in the storage device is below the threshold number before the next injection is due, re-order at least one drug delivery device.
Claims 32, 34-35, 37-38 recite a method of operating a user device configured to communicate wirelessly with a storage device, the storage device configured to store one or more drug delivery devices,
wherein the method comprises:
receiving, from the storage device separate from the user device, countdown information indicating a number of days remaining until a next injection of a drug delivery device that is stored in the storage device is due;
receiving, via a display a user input comprising a countdown reset command;
resetting the number of days remaining until the next injection is due to a predefined initial value on the user device;
automatically in response to receiving the user input comprising the countdown reset command, sending the countdown reset command to the storage device to cause the storage device to overwrite the countdown information on the storage device to the predefined initial value on the storage device;
determining that a number of drug delivery devices stored in the storage device is below a threshold number; and
in response to determining that the number of drug delivery devices stored in the storage device is below the threshold number before the next injection is due, re-ordering at least one drug delivery device.
The bolded limitations, given the broadest reasonable interpretation, cover a certain method of organizing human activity (e.g., gathering patient information; managing patient information, in this case patient medication dosage information.). The underlined limitations are not part of the identified abstract idea (the method of organizing human activity) and are deemed “additional elements,” and will be discussed in further detail below.
Dependent claims 19-21, 23-29, 34-35, and 37-41 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
The dependent claims include additional limitations, but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent claims 17, 31, and 32.
The additional elements from claims 17, 31 and 32 include:
a user device configured to (apply it, MPEP 2106.05(f)).
a storage device (generally linking, MPEP 2106.05(e)).
the storage device configured to store one or more drug delivery devices (generally linking, MPEP 2106.05(e)).
drug delivery device (generally linking, MPEP 2106.05(e)).
via a display (apply it, MPEP 2106.05(f)).
at least one drug delivery device (generally linking, MPEP 2106.05(e)).
The additional elements from claims 17 and 31 include:
a processor (apply it, MPEP 2106.05(f)).
a memory (apply it, MPEP 2106.05(f)).
a wireless transceiver (apply it, MPEP 2106.05(f)).
The dependent claims include other additional elements:
Claim 20 include:
a second processor (apply it, MPEP 2106.05(f)).
a second memory (apply it, MPEP 2106.05(f)).
a second wireless transceiver (apply it, MPEP 2106.05(f)).
Claims 20 and 24 include:
a user interface (apply it, MPEP 2106.05(f)).
Claims 17, 19-21, 23-29, 31-32, 34-35, and 37-41 are not integrated into a practical application because the additional elements (i.e., the limitations not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of “user device”, “a processor”, “a memory”, “a wireless transceiver”, “a user interface”, which amounts to merely invoking a computer as a tool to perform the abstract idea e.g. see Specification Pages 7-8, 15, 25-27 (see MPEP 2106.05(f));
amount to generally linking – for example, the recitation of “a storage device” and “drug delivery devices” see Specification Pages 7-8. (see MPEP 2106.05(e)).
Furthermore, the claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e., the elements other than the abstract idea) amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification discloses that the additional elements are well-understood, routine, and conventional in nature (i.e., Pages 7-8, 15, 25-27, of the Specification discloses that the additional elements (i.e., “user device”, “a processor”, “a memory”, “a wireless transceiver”, “a user interface”) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions that are well understood routine, and conventional activities previously known to the pertinent industry (i.e., healthcare);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. MPEP 2106.05(d)(II):
Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention acquires prescription medication data.
Dependent claims 19-21, 23-29, 34-35, and 37-41 include other limitations, but none of these functions are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims similarly represent no more than those found in the independent claims.
Thus, taken alone, the additional elements do not amount to “significantly more” than the above identified abstract idea. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves a user device configured to communicate wirelessly with a storage device, to act as an injection reminder system and to override or re-program the storage device or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 17, 19-21, 23-29, 31-32, 34-35, and 37-41 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 17, 19-21, 24-25, 29, 31-32, and 34-35, 37-41 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (U.S. Pub. No. 2021/0308384 A1) in view of Conley (U.S. Pub. No. 2010/0305750 A1), Patel (2021/0090730 A1), and Albertini (U.S. Pub. No. 2022/0361758 A1).
Regarding claim 17, Wang discloses a user device configured to communicate wirelessly with a storage device, the storage device configured to store one or more drug delivery devices, the user device comprising (Paragraphs [0025] and [0027]-[0028] discuss an external handling unit may be a smart mobile device and the communication circuit may use wireless technology whereby the mobile devices may transmit data from a case (Examiner interprets the case as the storage device) containing medicament containers for the medicament delivery device.):
a processor (Paragraph [0029] discusses processors of the smart mobile devices.);
a memory (Paragraph [0029] discusses storage elements of the smart mobile device.); and
a wireless transceiver (Paragraphs [0027]-[0028] discuss wireless technologies of the smart mobile device.),
wherein the user device is configured to (Paragraph [0027] discusses the smart mobile device.):
receive, from the storage device separate from the user device, information indicating a number of days remaining until a next injection of a drug delivery device that is stored in the storage device is due (Paragraphs [0007], [0013], [0037]-[0038] discuss a system for monitoring administration of medicaments from a medicament delivery device is provided, where the system comprises a case for the medicament delivery device. The case may comprise a holder for holding a medicament delivery device, the case may further comprise communication elements for transmitting data to and from external data handling units and information regarding delivered dose and remaining dose volume may be stored and the case is provided with the information and the handling elements document a time-stamp capable of calculating when the subsequent dose delivery operation is due.); and
send the information to the storage device to the predefined initial value on the storage device (Paragraphs [0015] and [0037]-[0038] discuss the case and communication elements transmit data to a smart device and the information regarding administered dose quantity and remaining dose quantity as well as the time stamps and when the subsequent dose delivery is due may be transmitted.);
determine that a number of drug delivery devices stored in the storage device is a number (Paragraphs [0038] discuss the case is provided with a communication circuit, the information regarding administered dose quantity and remaining dose quantity as well as the time stamps may be transmitted to external data storage and handling facilities.).
Wang does not explicitly disclose:
countdown information indicating a number of days remaining until a next injection is due;
receive, via a display, a user input comprising a countdown reset command;
reset the number of days remaining until the next injection is due to a predefined initial value on the user device; and
automatically in response to receiving the user input comprising the countdown reset command, send the countdown reset command to the storage device to cause the storage device to overwrite the countdown information on the storage device;
drug delivery devices stored in the storage device is below a threshold number; and
in response to determining that the number of drug delivery devices stored in the storage device is below the threshold number before the next injection is due, re-order at least one drug delivery device.
Conley teaches:
countdown information indicating a number of days remaining until a next injection is due (Paragraph [0036] discusses a countdown clock that displays the time remaining until the next permitted dose.);
reset the number of days remaining until the next injection is due to a value on the user device (Paragraphs [0036], [0056], and [0067] discuss the dosing clock can be reset after each dose is administered and for example, a physician may modify the minimum dosing interval or the dosage on a laptop/tablet computer.); and
the countdown reset (Paragraphs [0036] and [0056] discuss the dosing clock can be reset after each dose is administered and for example, a physician may modify the minimum dosing interval or the dosage; a countdown clock that displays the time remaining until the next permitted dose.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include countdown information indicating a number of days remaining until a next injection is due, reset the number of days remaining until the next injection is due to a value on the user device, and the countdown reset with the number of days remaining until the next injection is due to be reset to the value, as taught by Conley, in order to allow a patient to timely and safely self-administer medication. (Conley Paragraph [0005].).
Patel teaches:
receive, via a display, a user input comprising a countdown reset command (Paragraphs [0234], [0238], [0271], [0277], [0283]-[0285] and FIGS. 18-20D discuss a therapy change user interface, therapy change input can be an input provided by the user that may cause the insulin or glucagon infusion pump to start infusing an amount of insulin or glucagon into the user, affect the therapy delivery at future time, modify the rate of insulin or glucagon infusion, cancel insulin or glucagon infusion into the user, a request to change a control parameter; allow user to suspend therapies for a period of time, resumption condition, etc., defined by the user.).
automatically in response to receiving the user input comprising the command, send the command to the storage device to cause the storage device to overwrite the countdown information on the storage device (Paragraphs [0087], [0238], [0270]-[0271], [0277], [0488], and FIG. 43 discuss a therapy change user interface, therapy change input can be an input provided by the user that may allow user to suspend therapies for a period of time defined by the user that is sent to the device and suspends operation of the medicament device; further, medical device displays a countdown prior to delivery, a cancel button is provided for the user to cancel the therapy at any time, the interface enabling user to modify one or more therapy settings of the medicament device.).
drug delivery devices stored in the storage device is below a threshold number (Paragraphs [0167] and [0200] discuss the computing system may detect an alarm condition, the alert threshold condition may relate to a quantity of medicament remaining in a medicament cartridge.);
in response to determining that the number of drug delivery devices stored in the storage device is below the threshold number before the next injection is due, re-order at least one drug delivery device (Paragraphs [0167] and [0200] discuss the therapy data may trigger an automatic response by the computing system, for example, the AMD may determine that a medicament is running low based on the received data and may automatically reorder the medicament.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include, receive, via a display, a user input comprising a countdown reset command, automatically in response to receiving the user input comprising the command, send the command to the storage device to cause the storage device to overwrite the countdown information on the storage device, drug delivery devices stored in the storage device is below a threshold number, and in response to determining that the number of drug delivery devices stored in the storage device is below the threshold number before the next injection is due, re-order at least one drug delivery device, as taught by Patel, in order to implement features that improve the user experience. (Patel Paragraph [0004].).
Albertini teaches:
to a predefined initial value (Paragraph [0032] discusses dosing parameter can be updated and reset to default dosing parameters.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include to a predefined initial value, as taught by Albertini, in order consider the amount of dose given and the time frame over which the dose is delivered to administer a safe amount of the drug to the patient. (Albertini Paragraph [0002].).
Regarding claim 19, Wang discloses wherein the user device is further configured to:
receive a communication from the storage device indicating that the number of days remaining until the next injection is due on the storage device (Paragraphs [0037]-[0039] discuss the communication circuit allows the case to communicate with the smart mobile device and information regarding delivered dose and remaining dose volume may be stored and the case is provided with the information and the handling elements document a time-stamp capable of calculating when the subsequent dose delivery operation is due.).
Wang does not explicitly disclose:
a reset notification that the next injection is due has been reset to the predefined initial value; and
in response, reset the number of days remaining until the next injection is due to the predefined initial value on the user device.
Conley teaches:
a reset command that the next injection is due has been reset (Paragraphs [0030], [0036] and [0056] discuss a countdown clock displays time remaining until next dose and a user can enter ordered dosing interval via an input device and the dosing clock can be reset after each dose is administered, for example, a physician may modify the dosing interval or the dosage.).
in response, reset the number of days remaining until the next injection is due on the user device (Paragraphs [0030], [0036] and [0056] discuss a countdown clock displays time remaining until next dose and a user can enter ordered dosing interval via an input device and the dosing clock can be reset after each dose is administered, for example, a physician may modify the dosing interval or the dosage.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include a reset command that the next injection is due has been reset and in response, reset the number of days remaining until the next injection is due on the user device, as taught by Conley, in order to allow a patient to timely and safely self-administer medication. (Conley Paragraph [0005].).
Albertini teaches:
notification (Paragraph [0278] discusses the drug administration device can provide a user notification of a received authorized update request on a user interface.).
to a predefined initial value (Paragraph [0032] discusses dosing parameter can be updated and reset to default dosing parameters.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include notification and to a predefined initial value, as taught by Albertini, in order consider the amount of dose given and the time frame over which the dose is delivered to administer a safe amount of the drug to the patient. (Albertini Paragraph [0002].).
Regarding claim 20, Wang discloses wherein the storage device comprising (Paragraphs [0025] and [0027]-[0028] discuss an external handling unit may be a smart mobile device and the communication circuit may use wireless technology whereby the mobile devices may transmit data from a case.):
a second processor (Examiner notes that the prior art does not specifically state “first” or “second” or “third”, Examiner interprets “processors” to include multiple processors.) (Paragraph [0029] discusses processors of the smart mobile devices.);
a second memory (Paragraph [0029] discusses storage elements of the smart mobile device.); and
a second wireless transceiver (Paragraphs [0027]-[0028] discuss wireless technologies of the smart mobile device.), and
wherein the storage device is configured to (Paragraph [0027] discusses the smart mobile device.):
send information indicating the number of days remaining until the next injection is due to the user device; and receive, from the user device (Paragraphs [0015] and [0038] discuss the case and communication elements transmit data to a smart device and the information regarding administered dose quantity and remaining dose quantity as well as the time stamps and when the subsequent dose delivery is due may be transmitted.).
Wang does not explicitly disclose:
the countdown reset command and in response,
reset the number of days remaining until the next injection is due the predefined initial value.
Conley teaches:
reset the number of days remaining until the next injection is due (Paragraphs [0036] and [0056] discuss the dosing clock can be reset after each dose is administered and for example, a physician may modify the minimum dosing interval or the dosage.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include, reset the number of days remaining until the next injection is due, as taught by Conley, in order to allow a patient to timely and safely self-administer medication. (Conley Paragraph [0005].).
Patel teaches:
the countdown reset command and in response (Paragraphs [0234], [0238], [0271], [0277], [0283]-[0285] and FIGS. 18-20D discuss a therapy change user interface, therapy change input can be an input provided by the user that may cause the insulin or glucagon infusion pump to start infusing an amount of insulin or glucagon into the user, affect the therapy delivery at future time, modify the rate of insulin or glucagon infusion, cancel insulin or glucagon infusion into the user, a request to change a control parameter; allow user to suspend therapies for a period of time, resumption condition, etc., defined by the user.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include, the countdown reset command and in response, as taught by Patel, in order to implement features that improve the user experience. (Patel Paragraph [0004].)
Albertini teaches:
to a predefined initial value (Paragraph [0032] discusses dosing parameter can be updated and reset to default dosing parameters.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include notification, as taught by Albertini, in order consider the amount of dose given and the time frame over which the dose is delivered to administer a safe amount of the drug to the patient. (Albertini Paragraph [0002].).
Regarding claims 21, Wang discloses wherein the user device is further configured to,
in response to receiving the information, create a time stamp and to store the time stamp in the memory, and the user device comprises a user interface allowing a user to view a history of time stamps (Examiner notes that Wang does not explicitly disclose “reset time stamps” but it is implied that all time stamps are transmitted to external data storage.) (Paragraphs [0037]-[0039] discuss information regarding delivered and remaining dose as well as time-stamps may be stored in suitable storage elements and handling facilities, the data may be accessible to the physician of the patient, who is able to monitor the patient's adherence to the treatment scheme; the smart mobile device may in turn be provided with an app that is capable of communicating with data storage and handling facilities.).
Wang does not explicitly disclose:
the reset notification, create a reset time stamp and to store the reset time stamp.
Conley teaches:
reset (Paragraphs [0036] and [0056] discuss the dosing clock can be reset after each dose is administered and for example, a physician may modify the minimum dosing interval or the dosage.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include reset, as taught by Conley, in order to allow a patient to timely and safely self-administer medication. (Conley Paragraph [0005].).
Albertini teaches:
notification (Paragraph [0278] discusses the drug administration device can provide a user notification of a received authorized update request on a user interface.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include notification, as taught by Albertini, in order consider the amount of dose given and the time frame over which the dose is delivered to administer a safe amount of the drug to the patient. (Albertini Paragraph [0002].).
Regarding claim 24, Wang does not explicitly disclose wherein the user device comprises a user interface allowing a user to change the predefined initial value.
Conley teaches:
wherein the user device comprises a user interface allowing a user to change the value (Paragraphs [0036] and [0056] discuss the dosing clock can be reset after each dose is administered and for example, a physician may modify the minimum dosing interval or the dosage.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include (Paragraphs [0036] and [0056] discuss the dosing clock can be reset after each dose is administered and for example, a physician may modify the minimum dosing interval or the dosage.), as taught by Conley, in order to allow a patient to timely and safely self-administer medication. (Conley Paragraph [0005].).
Albertini teaches:
the predefined initial value (Paragraph [0032] discusses dosing parameter can be updated and reset to default dosing parameters.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include the predefined initial value, as taught by Albertini, in order consider the amount of dose given and the time frame over which the dose is delivered to administer a safe amount of the drug to the patient. (Albertini Paragraph [0002].).
Regarding claim 25, Wang does not explicitly disclose wherein the user device is further configured to:
receive a second user input changing the predefined initial value; and
in response, send a signal to the storage device configured to cause the number of days remaining until the next injection is due to be adjusted on the storage device based on the changed initial value.
Conley teaches:
receive a second user input changing the value (Paragraphs [0030], [0036] and [0056] discuss an input device receiving and storing dosing interval and nursing staff entering data in the input device and the dosing clock can be reset after each dose is administered and for example, a physician may modify the minimum dosing interval or the dosage.); and
in response, send a signal to the storage device configured to cause the number of days remaining until the next injection is due to be adjusted on the storage device based on the changed value (Paragraphs [0028], [0036], [0056], and [0059] discuss receiving and transmitting signals and the dosing clock can be reset after each dose is administered and for example, a physician may modify the minimum dosing interval or the dosage.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include receive a second user input changing the value and in response, send a signal to the storage device configured to cause the number of days remaining until the next injection is due to be adjusted on the storage device based on the changed value, as taught by Conley, in order to allow a patient to timely and safely self-administer medication. (Conley Paragraph [0005].).
Albertini teaches:
the predefined initial value (Paragraph [0032] discusses dosing parameter can be updated and reset to default dosing parameters.).
changed initial value (Paragraph [0032] discusses dosing parameter can be updated and reset to default dosing parameters.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include the predefined initial value and changed initial value, as taught by Albertini, in order consider the amount of dose given and the time frame over which the dose is delivered to administer a safe amount of the drug to the patient. (Albertini Paragraph [0002].).
Regarding claim 29, Wang discloses wherein the user device is further configured to:
monitor the number of days remaining until the next injection is due (Paragraphs [0037]-[0038] discuss information regarding delivered dose and remaining dose volume may be stored and the case is provided with the information and the handling elements document a time-stamp capable of calculating when the subsequent dose delivery operation is due and the data may be accessible to the physician of the patient, who is able to monitor the patient's adherence to the treatment scheme in a very convenient way. Also the data may be used for monitoring the patient's supply of medicament in order to renew prescriptions and inform the patient that medicament prescriptions are available.); and
when the number of days remaining until the next injection is due passes below a predetermined threshold, display an injection reminder on a display of the user device (Paragraphs [0015] and [0037]-[0038] discuss the case and communication elements transmit data to a smart device and the information regarding administered dose quantity and remaining dose quantity as well as the time stamps and when the subsequent dose delivery is due may be transmitted and the electronic circuit may be arranged with user alert functions such as a loudspeaker or buzzer that can alert a user when it is time for a dose to be administered.).
Regarding claim 31, Wang discloses a user device configured to communicate wirelessly with a storage device, the storage device configured to store one or more drug delivery devices, the user device comprising (Paragraphs [0025] and [0027]-[0028] discuss an external handling unit may be a smart mobile device and the communication circuit may use wireless technology whereby the mobile devices may transmit data from a case (Examiner interprets the case as the storage device) containing medicament containers for the medicament delivery device.):
a processor (Paragraph [0029] discusses processors of the smart mobile devices.);
a memory (Paragraph [0029] discusses storage elements of the smart mobile device.); and
a wireless transceiver (Paragraphs [0027]-[0028] discuss wireless technologies of the smart mobile device.),
wherein the user device is configured to (Paragraph [0027] discusses the smart mobile device.):
receive, at the processor by the wireless transceiver from the storage device separate from the user device, information indicating a number of days remaining until a next injection of a medicament from the one or more drug delivery devices that is stored in the storage device is due (Paragraphs [0007], [0029], [0037]-[0039] discuss processors of the smart mobile devices, a system for monitoring administration of medicaments from a medicament delivery device is provided, where the system comprises a case for the medicament delivery device. The case may comprise a holder for holding a medicament delivery device, the case may further comprise communication elements for transmitting data to and from external data handling units and the communication circuit may include wireless networks and information regarding delivered dose and remaining dose volume may be stored and the case is provided with the information and the handling elements document a time-stamp capable of calculating when the subsequent dose delivery operation is due from the medicament delivery device.);
send information to the storage device to be provided (Paragraphs [0015] and [0038] discuss the case and communication elements transmit data to a smart device and the information regarding administered dose quantity and remaining dose quantity as well as the time stamps and when the subsequent dose delivery is due may be transmitted.);
determine that a number of drug delivery devices stored in the storage device is a number (Paragraphs [0038] discuss the case is provided with a communication circuit, the information regarding administered dose quantity and remaining dose quantity as well as the time stamps may be transmitted to external data storage and handling facilities.).
Wang does not explicitly disclose:
countdown information indicating a number of days remaining until a next injection is due;
receive, at the processor and via a display, a user input comprising a countdown adjustment command;
adjust, in the memory, the number of days remaining until the next injection of the medicament from the one or more drug delivery devices is due on the user device according to the countdown adjustment command;
automatically in response to receiving the user input comprising the countdown adjustment command, send, by the wireless transceiver, updated countdown information to the storage device to cause the storage device to overwrite the countdown information on the storage device to be updated; and
drug delivery devices stored in the storage device is below a threshold number; and
in response to determining that the number of drug delivery devices stored in the storage device is below the threshold number before the next injection is due, re-order at least one drug delivery device.
Conley teaches:
countdown information indicating a number of days remaining until a next injection is due (Paragraphs [0030], [0036] and [0056] discuss a countdown clock displays time remaining until next dose and a user can enter ordered dosing interval via an input device and the dosing clock can be reset after each dose is administered, also, a physician may modify the dosing interval or the dosage.);
adjust, in the memory, the number of days remaining until the next injection of the medicament from the one or more drug delivery devices is due on the user device according to the countdown adjustment command (Paragraphs [0030], [0036] [0056], and [0067] discuss a countdown clock displays time remaining until next dose and a user can enter ordered dosing interval via an input device and the dosing clock can be reset after each dose is administered, also, a physician may modify the dosing interval or the dosage on a laptop/tablet computer.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include, countdown information indicating a number of days remaining until a next injection is due and adjust, in the memory, the number of days remaining until the next injection of the medicament from the one or more drug delivery devices is due on the user device according to the countdown adjustment command, as taught by Conley, in order to allow a patient to timely and safely self-administer medication. (Conley Paragraph [0005].).
Patel teaches:
receive, at the processor and via a display, a user input comprising a countdown adjustment command (Paragraphs [0234], [0238], [0271], [0277], [0283]-[0285] and FIGS. 18-20D discuss a therapy change user interface, therapy change input can be an input provided by the user that may cause the insulin or glucagon infusion pump to start infusing an amount of insulin or glucagon into the user, affect the therapy delivery at future time, modify the rate of insulin or glucagon infusion, cancel insulin or glucagon infusion into the user, a request to change a control parameter; allow user to suspend therapies for a period of time, resumption condition, etc., defined by the user.).
automatically in response to receiving the user input comprising the command, send, by the wireless transceiver, updated information to the storage device to cause the storage device to overwrite the information on the storage device to be updated (Paragraphs [0119], [0238], [0270]-[0271], [0277], [0488], and FIG. 43 discuss a therapy change user interface, therapy change input can be an input provided by the user that may allow user to suspend therapies for a period of time defined by the user that is sent to the device and suspends operation of the medicament device; further, medical device displays a countdown prior to delivery, a cancel button is provided for the user to cancel the therapy at any time.).
drug delivery devices stored in the storage device is below a threshold number (Paragraphs [0167] and [0200] discuss the computing system may detect an alarm condition, the alert threshold condition may relate to a quantity of medicament remaining in a medicament cartridge.);
in response to determining that the number of drug delivery devices stored in the storage device is below the threshold number before the next injection is due, re-order at least one drug delivery device (Paragraphs [0167] and [0200] discuss the therapy data may trigger an automatic response by the computing system, for example, the AMD may determine that a medicament is running low based on the received data and may automatically reorder the medicament.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include, receive, at the processor and via a display, a user input comprising a countdown adjustment command, automatically in response to receiving the user input comprising the command, send, by the wireless transceiver, updated information to the storage device to cause the storage device to overwrite the information on the storage device to be updated, drug delivery devices stored in the storage device is below a threshold number, and in response to determining that the number of drug delivery devices stored in the storage device is below the threshold number before the next injection is due, re-order at least one drug delivery device, as taught by Patel, in order to implement features that improve the user experience. (Patel Paragraph [0004].)
Regarding claim 32, Wang discloses operating a user device configured to communicate wirelessly with a storage device, the storage device configured to store one or more drug delivery devices, wherein it comprises (Paragraphs [0025] and [0027]-[0028] discuss an external handling unit may be a smart mobile device and the communication circuit may use wireless technology whereby the mobile devices may transmit data from a case containing medicament containers for the medicament delivery device.):
receiving, from the storage device separate from the user device, information indicating a number of days remaining until a next injection of a drug delivery device that is stored in the storage device is due (Paragraphs [0037]-[0038] discuss information regarding delivered dose and remaining dose volume may be stored and the case is provided with the information and the handling elements document a time-stamp capable of calculating when the subsequent dose delivery operation is due.);
sending the information to the storage device to be provided to the storage device (Paragraphs [0015] and [0038] discuss the case and communication elements transmit data to a smart device and the information regarding administered dose quantity and remaining dose quantity as well as the time stamps and when the subsequent dose delivery is due may be transmitted.);
determining that a number of drug delivery devices stored in the storage device is a number (Paragraphs [0038] discuss the case is provided with a communication circuit, the information regarding administered dose quantity and remaining dose quantity as well as the time stamps may be transmitted to external data storage and handling facilities.).
Wang does not explicitly disclose:
a method;
countdown information indicating a number of days remaining until a next injection is due;
receiving, via a display, a user input comprising a countdown reset command;
resetting the number of days remaining until the next injection is due to a predefined initial value on the user device;
automatically in response to receiving the user input comprising the countdown reset command, sending the countdown reset command to the storage device to cause the storage device to overwrite the countdown information on the storage device to the predefined initial value on the storage device;
drug delivery devices stored in the storage device is below a threshold number; and
in response to determining that the number of drug delivery devices stored in the storage device is below the threshold number before the next injection is due, re-ordering at least one drug delivery device
Conley teaches:
a method (Claim 18 discusses a method for dispensing a medication dose from a medication dispenser.);
countdown information indicating a number of days remaining until a next injection is due (Paragraph [0036] discusses a countdown clock that displays the time remaining until the next permitted dose.);
resetting the number of days remaining until the next injection is due to a value on the user device (Paragraphs [0036], [0056], and [0067] discuss the dosing clock can be reset after each dose is administered and for example, a physician may modify the minimum dosing interval or the dosage on a laptop/tablet computer.); and
the countdown reset (Paragraphs [0036] and [0056] discuss the dosing clock can be reset after each dose is administered and for example, a physician may modify the minimum dosing interval or the dosage.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include a method, countdown information indicating a number of days remaining until a next injection is due, resetting the number of days remaining until the next injection is due to a value on the user device, and the countdown reset, as taught by Conley, in order to allow a patient to timely and safely self-administer medication. (Conley Paragraph [0005].).
Patel teaches:
receiving, via a display, a user input comprising a countdown reset command (Paragraphs [0234], [0238], [0271], [0277], [0283]-[0285] and FIGS. 18-20D discuss a therapy change user interface, therapy change input can be an input provided by the user that may cause the insulin or glucagon infusion pump to start infusing an amount of insulin or glucagon into the user, affect the therapy delivery at future time, modify the rate of insulin or glucagon infusion, cancel insulin or glucagon infusion into the user, a request to change a control parameter; allow user to suspend therapies for a period of time, resumption condition, etc., defined by the user.).
automatically in response to receiving the user input comprising the countdown reset command, sending the countdown reset command to the storage device the countdown information on the storage device (Paragraphs [0119], [0238], ], [0262], [0270]-[0271], [0277], [0488], and FIG. 43 discuss a therapy change user interface, therapy change input can be an input provided by the user that may allow user to suspend therapies for a period of time defined by the user that is sent to the device and suspends operation of the medicament device; further, medical device displays a countdown prior to delivery, a cancel button is provided for the user to cancel the therapy at any time, various determination of next time therapy is to be delivered, based on scheduled therapy, a therapy change request.);
drug delivery devices stored in the storage device is below a threshold number (Paragraphs [0167] and [0200] discuss the computing system may detect an alarm condition, the alert threshold condition may relate to a quantity of medicament remaining in a medicament cartridge.);
in response to determining that the number of drug delivery devices stored in the storage device is below the threshold number before the next injection is due, re-order at least one drug delivery device (Paragraphs [0167] and [0200] discuss the therapy data may trigger an automatic response by the computing system, for example, the AMD may determine that a medicament is running low based on the received data and may automatically reorder the medicament.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include, receiving, via a display, a user input comprising a countdown reset command, automatically in response to receiving the user input comprising the countdown reset command, sending the countdown reset command to the storage device the countdown information on the storage device, drug delivery devices stored in the storage device is below a threshold number, and in response to determining that the number of drug delivery devices stored in the storage device is below the threshold number before the next injection is due, re-order at least one drug delivery device, as taught by Patel, in order to implement features that improve the user experience. (Patel Paragraph [0004].)
Albertini teaches:
to a predefined initial value (Paragraph [0032] discusses dosing parameter can be updated and reset to default dosing parameters.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include to a predefined initial value, as taught by Albertini, in order consider the amount of dose given and the time frame over which the dose is delivered to administer a safe amount of the drug to the patient. (Albertini Paragraph [0002].).
Regarding claim 34, Wang discloses further comprising:
receiving communication from the storage device indicating that the number of days remaining until the next injection is due has been reset to the predefined initial value on the storage device (Paragraphs [0037]-[0039] discuss the communication circuit allows the case to communicate with the smart mobile device and information regarding delivered dose and remaining dose volume may be stored and the case is provided with the information and the handling elements document a time-stamp capable of calculating when the subsequent dose delivery operation is due.).
Wang does not explicitly disclose:
a reset notification that the next injection is due has been reset to the predefined initial value; and
in response, resetting the number of days remaining until the next injection is due to a predefined initial value on the user device.
Conley teaches:
a reset command that the next injection is due has been reset (Paragraphs [0030], [0036] and [0056] discuss a countdown clock displays time remaining until next dose and a user can enter ordered dosing interval via an input device and the dosing clock can be reset after each dose is administered, for example, a physician may modify the dosing interval or the dosage.).
in response, reset the number of days remaining until the next injection is due on the user device (Paragraphs [0030], [0036] and [0056] discuss a countdown clock displays time remaining until next dose and a user can enter ordered dosing interval via an input device and the dosing clock can be reset after each dose is administered, for example, a physician may modify the dosing interval or the dosage.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include a reset command that the next injection is due has been reset and in response, reset the number of days remaining until the next injection is due on the user device, as taught by Conley, in order to allow a patient to timely and safely self-administer medication. (Conley Paragraph [0005].).
Albertini teaches:
notification (Paragraph [0278] discusses the drug administration device can provide a user notification of a received authorized update request on a user interface.).
to a predefined initial value (Paragraph [0032] discusses dosing parameter can be updated and reset to default dosing parameters.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include notification and to a predefined initial value, as taught by Albertini, in order consider the amount of dose given and the time frame over which the dose is delivered to administer a safe amount of the drug to the patient. (Albertini Paragraph [0002].).
Regarding claim 35, Wang discloses further comprising:
in response to receiving the information, creating a time stamp and storing the time stamp in a memory (Paragraphs [0037]-[0038] discuss information regarding delivered and remaining dose as sell as time-stamps may be stored in suitable storage elements.); and
providing a user interface allowing a user to view a history of time stamps (Paragraphs [0037]-[0039] discuss information regarding delivered and remaining dose as well as time-stamps may be stored in suitable storage elements and handling facilities, the data may be accessible to the physician of the patient, who is able to monitor the patient's adherence to the treatment scheme; the smart mobile device may in turn be provided with an app that is capable of communicating with data storage and handling facilities.).
Wang does not explicitly disclose:
the reset notification, creating a reset time stamp and to store the reset time stamp.
Conley teaches:
reset (Paragraphs [0036] and [0056] discuss the dosing clock can be reset after each dose is administered and for example, a physician may modify the minimum dosing interval or the dosage.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include reset, as taught by Conley, in order to allow a patient to timely and safely self-administer medication. (Conley Paragraph [0005].).
Albertini teaches:
notification (Paragraph [0278] discusses the drug administration device can provide a user notification of a received authorized update request on a user interface.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include notification, as taught by Albertini, in order consider the amount of dose given and the time frame over which the dose is delivered to administer a safe amount of the drug to the patient. (Albertini Paragraph [0002].).
Regarding claim 37, Wang discloses comprising administering a medicament from at least one drug delivery device of the one or more drug delivery devices when the next injection is due (Paragraphs [0024]-[0025] and [0037] discuss a medicament delivery device for expelling does of medicament through medicament delivery members and information regarding delivered dose volume, calculating when subsequent dose is due.).
Regarding claim 38, Wang does not explicitly disclose wherein receiving the user input comprising the countdown reset command occurs after administering the medicament from the at least one drug delivery device.
Conley teaches:
the countdown reset (Paragraphs [0030], [0036] and [0056] discuss a countdown clock displays time remaining until next dose and a user can enter ordered dosing interval via an input device and the dosing clock can be reset after each dose is administered, for example, a physician may modify the dosing interval or the dosage.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include the countdown reset, as taught by Conley, in order to allow a patient to timely and safely self-administer medication. (Conley Paragraph [0005].).
Patel teaches:
wherein receiving the user input comprising the command occurs after administering the medicament from the at least one drug delivery device (Paragraphs [0047], [0238], [0270]-[0271], and [0277] discuss a therapy change user interface allow a user to change a setting, therapy change input can be an input provided by the user that may allow user to suspend therapies for a period of time defined by the user that is sent to the device and suspends operation of the medicament device.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include, wherein receiving the user input comprising the command occurs after administering the medicament from the at least one drug delivery device, as taught by Patel, in order to implement features that improve the user experience. (Patel Paragraph [0004].).
Regarding claim 39, Wang discloses a system comprising:
the user device of claim 17 (Paragraphs [0034] and [0039] discuss smart mobile device uses with the medicament delivery device.); and
the storage device of claim 17, wherein the storage device is configured to receiving the command from the user device (Paragraphs [0039] discuss smart mobile device with an app capable of communicating with data storage and handling facilities.).
Wang does not explicitly disclose:
wherein the storage device is configured to overwrite the countdown information on the storage device in response to receiving the countdown reset command from the user device.
Conley teaches:
the countdown reset command (Paragraphs [0036] and [0056] discuss the dosing clock can be reset after each dose is administered and for example, a physician may modify the minimum dosing interval or the dosage.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include, the countdown reset command, as taught by Conley, in order to allow a patient to timely and safely self-administer medication. (Conley Paragraph [0005].).
Patel teaches:
wherein the storage device is configured to overwrite the countdown information on the storage device in response to receiving the command from the user device (Paragraphs [0238], [0270]-[0271], [0277], [0488], and FIG. 43 discuss a therapy change user interface, therapy change input can be an input provided by the user that may allow user to suspend therapies for a period of time defined by the user that is sent to the device and suspends operation of the medicament device; further, medical device displays a countdown prior to delivery, a cancel button is provided for the user to cancel the therapy at any time.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include, wherein the storage device is configured to overwrite the countdown information on the storage device in response to receiving the countdown reset command from the user device, as taught by Patel, in order to implement features that improve the user experience. (Patel Paragraph [0004].).
Regarding claim 40, Wang discloses wherein at least one drug delivery device of the one or more drug delivery devices contains a medicament, the at least one drug delivery device is configured to administer the medicament, and the number of days remaining until the next injection is due is indicative of the number of days remaining until the next injection of the medicament is due (Paragraphs [0025], [0037]-[0038] discuss a medicament delivery device that has medicament containers for expelling doses of medicament and information regarding delivered dose and remaining dose volume may be stored and the case is provided with the information and the handling elements document a time-stamp capable of calculating when the subsequent dose delivery operation is due.).
Regarding claim 41, Wang discloses comprising the one or more drug delivery devices (Paragraph [0024] discusses at least one medicament delivery devices.).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Conley, Patel, and Albertini and in further view of Schuster (U.S. Pub. No. 2016/0129182 A1).
Regarding claim 23, Wang does not explicitly disclose wherein the predefined initial value is 7 days or 14 days or 28 days.
Schuster teaches:
wherein the predefined initial value is 7 days or 14 days or 28 days (Paragraph [0009] discusses some drugs are dosed at prescribed dosing intervals, such as once a month, once a week, once a day, etc.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include wherein the predefined initial value is 7 days or 14 days or 28 days, as taught by Schuster, in order to determine whether patients are self-administering their medications properly. (Schuster Paragraph [0005].).
Claims 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Conley, Patel, and Albertini and in further view of Starr (U.S. Pat. No. 9692829 B2).
Regarding claim 26, Wang discloses wherein the user device is further configured to:
a temperature for the storage device (Paragraphs [0003] and [0025] discuss cases have cooling elements to keep medication below room temperature or at storage temperatures.); and
the temperature to be stored in the storage device (Paragraphs [0003] and [0025] discuss cases have cooling elements to keep medication below room temperature or at storage temperatures.).
Wang does not explicitly disclose:
receive a third user input setting an acceptable temperature range for the storage device; and
in response, send a signal to the storage device configured to cause the acceptable temperature range to be stored in the storage device.
Starr teaches:
receive a third user input setting an acceptable temperature range for the storage device (Column 2 lines 18-24 discuss the sensor circuit includes a temperature sensor configured to detect the temperature of the environment surrounding the medication device and the application compares the detected temperature to a selected temperature range.).
in response, send a signal to the storage device configured to cause the acceptable temperature range to be stored in the storage device (Column 5 lines 24-33 discuss for example, with respect to a medication such as Epinephrine, the approved temperature range is approximately 15-30 degrees C and in circumstances that the temperature sensor detects that the temperature of the medication is reading is outside of a pre-selected approved range, an alarm, alert, or message via an interface is provided on the transmission hub, or external device provided on the medication device or carrier.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include receive a third user input setting an acceptable temperature range for the storage device and in response, send a signal to the storage device configured to cause the acceptable temperature range to be stored in the storage device, as taught by Starr, in order monitor or track the amount of drug administered to a patient. (Starr Column 1 lines 28-29.).
Regarding claim 27, Wang discloses wherein the user device is further configured to:
the storage device, temperature information of the storage device (Paragraphs [0003] and [0025] discuss cases have cooling elements to keep medication below room temperature or at storage temperatures.).
Wang does not explicitly disclose:
receive, from the storage device, temperature information indicating a current temperature of the storage device; and
when the current temperature is outside of the acceptable temperature range, emit a temperature alarm signal.
Starr teaches:
receive, from the storage device, temperature information indicating a current temperature of the storage device (Column 2 lines 18-24 discuss the sensor circuit includes a temperature sensor configured to detect the temperature of the environment surrounding the medication device and the application compares the detected temperature to a selected temperature range.).
when the current temperature is outside of the acceptable temperature range, emit a temperature alarm signal (Column 5 lines 24-33 discuss for example, with respect to a medication such as Epinephrine, the approved temperature range is approximately 15-30 degrees C and in circumstances that the temperature sensor detects that the temperature of the medication is reading is outside of a pre-selected approved range, an alarm, alert, or message via an interface is provided on the transmission hub, or external device provided on the medication device or carrier.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include receive, from the storage device, temperature information indicating a current temperature of the storage device and when the current temperature is outside of the acceptable temperature range, emit a temperature alarm signal, as taught by Starr, in order monitor or track the amount of drug administered to a patient. (Starr Column 1 lines 28-29.).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Conley, Patel, and Albertini and in further view of Spurlin (U.S. Pub. No. 2007/0040449 A1).
Regarding claim 28, Wang discloses wherein the user device is further configured to:
the storage device has a battery (Paragraph [0030] discusses the case has a power source like batteries.).
Wang does not explicitly disclose:
receive, from the storage device, battery level information indicating a current battery level of the storage device; and
when the current battery level is below a predefined threshold, emit a battery alarm signal.
Spurlin teaches:
receive, from the storage device, battery level information indicating a current battery level of the storage device (Paragraph [0083] discuss the battery is monitored to determine if a low voltage battery threshold has been met.).
when the current battery level is below a predefined threshold, emit a battery alarm signal (Paragraphs [0036] and [0083] discuss the battery is monitored to determine if a low voltage battery threshold has been met and an alarm may alert the user to any problem or malfunction.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Wang to include receive, from the storage device, battery level information indicating a current battery level of the storage device and when the current battery level is below a predefined threshold, emit a battery alarm signal, as taught by Spurlin, in order to ensure that a user of a portable electronic device for medical reasons has enough time to find a replacement battery. (Spurlin Paragraph [0006].).
Response to Arguments
Applicant’s arguments filed May 21, 2026 have been fully considered.
Rejections under 35 U.S.C. 101:
With respect to claim 17 and the Prong 1 35 U.S.C. 101 rejection, Applicant’s amendment fails to overcome the previous rejection. Claim 17 as amended recites an abstract idea, a method of organizing human activity. See MPEP 2106.04(a)(2)(II)(C) Managing Personal Behavior or Relationships or Interactions Between People. Applicant states, “As discussed during the interview, claim 17 recites a "practical application" relating to "re-order[ing] at least one drug delivery device." Independent claims 31 and 32, although different in scope than independent claim 1, have been amended to recite similar features and are patentable subject matter for at least the same reasons as claim 17. The other claims recite patentable subject matter for at least the same reasons as the independent claims.” (Remarks, page 10). Examiner respectfully disagrees. Here, the improvement is to the abstract idea. Examiner notes that as detailed in the 5/5/2026 Interview Summary, “Examiner noted that the storage device contains a locking mechanism in the Spec page 14, and potentially if somehow the lock is used and there is a nexus to the invention, it may overcome the 101.” (See 5/5/2026 Examiner Interview Summary).
While practical application is a way to overcome the Prong 2 35 U.S.C. 101 rejection, claim 17 as written fails to result in a practical application. Examiner notes that determining a threshold number of drug delivery devices and re-ordering the drug delivery devices is part of the abstract idea. Here, the application is organizing human activity, directed to the abstract idea of a user device communicating with a storage device, to override data in the storage device. The additional elements in claim 17 include a storage device, a user device, a processor, and a memory, however, they do not result in a practical application as they are recited at an apply it level, as stated above. All components in the claims are being used for their intended purpose and as written do not result in a practical application or significantly more than the abstract idea. There is no technical improvement. For the reasons stated above, claims 31-32 similarly fail to overcome the 35 U.S.C. 101 rejection.
Rejections under 35 U.S.C. 103:
Applicant argues the amendments overcome the previous rejection. Examiner concedes that the amendments overcome the prior rejection. Applicant states, “The Office Action, at p. 9, alleges that Wang discloses the feature of "receive, from the storage device, information indicating a number of days remaining until a next injection is due" at paragraphs [0037] and [0038]. Applicant respectfully disagrees. Wang at paragraph [0037] recites "handling elements can document a time-stamp when the image was taken and are capable of calculating when the subsequent dose delivery operation is due. This information may for instance be visible on the display 42 [of the case 10]." However, Wang's display 42 is on the outer surface of the case 10 (Wang, paragraph [0030]). Wang does not disclose a user device receiving any "countdown information indicating a number of days remaining until a next injection of a drug delivery device that is stored in the storage device is due" from a storage device separate from the user device, as recited by amended independent claim 17.” (Remarks, pages 10-11). Examiner respectfully disagrees. Examiner notes that Wang in view of Conley and Albertini includes the limitation, “receive, from the storage device separate from the user device, information indicating a number of days remaining until a next injection of a drug delivery device that is stored in the storage device is due”. See Wang, Paragraphs [0007], [0013], [0037]-[0038] discuss a system for monitoring administration of medicaments from a medicament delivery device is provided, where the system comprises a case for the medicament delivery device. The case may comprise a holder for holding a medicament delivery device, the case may further comprise communication elements for transmitting data to and from external data handling units and information regarding delivered dose and remaining dose volume may be stored and the case is provided with the information and the handling elements document a time-stamp capable of calculating when the subsequent dose delivery operation is due. See Conley Paragraph [0036] discusses a countdown clock that displays the time remaining until the next permitted dose. Albertini teaches to a predefined initial value. See Albertini Paragraph [0032] discusses dosing parameter can be updated and reset to default dosing parameters. Applicant’s arguments with respect to amended claim 17 have been considered and the Examiner’s rejection has been amended to address Applicant’s claim 17 amendments.
Applicant’s arguments with respect to claims 17 and 31-32 have been considered and overcome the previous rejection. Examiner’s rejection has been amended to address Applicant’s claim 17 and 31-32 amendments.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWN TRINAH HAYNES whose telephone number is (571)270-5994. The examiner can normally be reached M-F 7:30-5:15PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Dunham can be reached on (571)272-8109. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAWN T. HAYNES/
Art Unit 3686
/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
Prosecution Insights