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 .
Election/Restrictions
Applicant’s election without traverse of claims 13-15 in the reply filed on 03/16/2026 is acknowledged.
Claims 26-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/16/2026.
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 13-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 2A Prong One
Claim 13 recites receiving injection event information associated with an injection event; determining a location of the computing device; determining whether the location of the computing device is within a specified distance of at least one typical dosing location; upon determining that the location is not within the specified distance of the at least one typical dosing location, prompting a user to confirm whether to include said injection event information in a medication log.
Claim 20 recites receiving injection event information associated with an injection event; determining a location of the computing device; determining whether the location of the computing device is within a specified distance of at least one typical dosing location; upon determining that the location is not within the specified distance of the at least one typical dosing location, ignoring the advertising packet without prompting a user and without including said information event information in a medication log.
These limitations, as drafted, given the broadest reasonable interpretation, encompass managing personal behavior or relationships or interactions between people, which is a subgrouping of Certain Methods of Organizing Human Activity. For example, the claims encompass receiving information related to medication delivery and, based on proximity of a computing device to a typical medication dosing location, having a user either record or not record the medication event in a log. Additionally, ignoring the advertising packet and not prompting the user encompasses simply taking no action. Such a step, therefore, is part of the abstract idea. These manual steps encompass Certain Methods of Organizing Human Activity.
Claims 14-19 and 21-25 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea. For example, claims 14 and 21 further expand on including or confirming the injection event in the log. Claims 16-17, 19 and 23-24 further expand on the typical dosing location and injection event. Claim 18 repeats the above steps for a second location. As explained above, these manual steps encompass Certain Methods of Organizing Human Activity.
Step 2A Prong Two
This judicial exception is not integrated into a practical application because the remaining elements amount to no more than generally linking the abstract idea to a particular technological environment and insignificant, extra-solution data gathering activity.
Claims 13-25, directly or indirectly, recite the following additional elements at a high level of generality, involving no more that extra-solution data gathering activity:
Claim 13 and 20:
Receiving at a computing device, from a wireless communication interface of a medication delivery device, an advertising packet.
Claim 15 and 22:
The advertising packet is a Bluetooth Low Energy (BLE) advertising packet.
These additional elements are recited at a high degree of generality and are merely involved in insignificant extra solution data gathering and transmitting of data over a generic computer network. Specifically, the received information being received at a “computing device” from a “wireless communication interface” in the form of a “Bluetooth Low Energy (BLE) advertising packet” amounts to no more than pre-solution data gathering activity. As set forth in MPEP 2106.05(g) insignificant, extra-solution activity, such as insignificant acquisition and data transmission, is an example of when an abstract idea has not been integrated into a practical application.
Claims 13-25, directly or indirectly, recite the following additional elements at a high level of generality, generally linking the abstract idea to a particular technological environment:
Claims 13 and 20:
The medication delivery device comprises (a) a reservoir configured to hold medication, (b) an actuating button for initiating an injection of the medication, and (c) a processing circuit in communication with the wireless communication interface.
The “medication delivery device” is recited as the source of the “injection event information” that is received. The recited components of the “medication delivery device,” (a) – (c) are unrelated to the receiving step or any other steps within the claims other than a “processing circuit” being “in communication with the wireless communication interface.” Therefore, considering these recitations in combination with the claim as a whole, there is no indication that the combination provides any type of technical improvement to the medication device itself, the computing device that recites the information, or any other technical field. These recitations merely link the abstract idea to a particular technological environment.
The written description discloses that the recited computer components encompass generic components including “Processing circuit 108 may be configured to allow injection device 20 to communicate wirelessly with an external device (such as, for example, a mobile phone, a wearable device, a laptop, and/or server database). For example, BLE circuit 628 and BLE antenna 104 may allow processing circuit 108 to send wireless BLE advertising packets to an external device 650” (see paragraph 00062). As set forth in the MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application.
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as discussed above with respect to integration into a practical application, the additional elements are recited at a high level of generality, and the written description indicates that these elements are generic computer components. Using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.”).
Insignificant, extra solution, data gathering activity (e.g. receiving information over wireless communication) has been found to not amount to significantly more than an abstract idea (see MPEP 2106.05(g) and Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016)).
Generally linking the abstract idea to a particular technological environment (e.g. including a medication delivery device) does not amount to significantly more than the abstract idea (see MPEP 2016.05(h) and Affinity Labs of Texas v. DirecTV, LLC, 838 F.3d 1253, 120 USPQ2d 1201 (Fed. Cir. 2016)).
Additionally, the aforementioned additional elements, considered in combination, do not provide an improvement to a technical field or provide a technical improvement to a technical problem. These additional elements merely carry out the abstract idea through data collection. Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 13-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alt, US Patent Application Publication No. 2022/0351821 in view of Helgeson, US Patent Application Publication No. 2022/0105282.
As per claim 13, Alt teaches a computerized method, comprising: receiving at a computing device, from a wireless communication interface of a medication delivery device, an advertising packet comprising injection event information associated with an injection event generated by the medication delivery device (see paragraphs 0123; supplementary device 2 (attached to drug delivery device 1 – paragraph 0073) broadcasts advertising packet in response to injection event), wherein the medication delivery device comprises (a) a reservoir configured to hold medication (see paragraph 0177; drug reservoir adapted for use with drug delivery device), (b) an actuating button for initiating an injection of the medication (see paragraph 0070; injection button 11), and (c) a processing circuit in communication with the wireless communication interface (see paragraph 0073 and Figure 3; shows processor and wireless unit); determining a location of the computing device (see paragraph 0145; mobile device is determined to be in proximity to the injection device); determining whether the location of the computing device is within a specified distance of at least one typical dosing location (see paragraphs 0074 and 0104; injection devices performs injections at a variety of locations; mobile device is proximal to the injection device, which is encompassed by a “specified distance of at least one typical dosing location”).
Alt does not explicitly teach upon determining that the location is not within the specified distance of the at least one typical dosing location, prompting a user to confirm whether to include said injection event information in a medication log.
Helgeson teaches upon determining that a location is not within the specified distance of at least one typical dosing location, prompting a user to confirm whether to include said injection event information in a medication log (see paragraphs 0071 and 0080; determines an injection even at a location that should be a different location (not within a specified distance of a typical dosing location) and prompts user to confirm recommended location for storing in a medication log – paragraph 0099). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to use injection location data for storing records of medication dosing in Alt with the motivation of further improving the assistance provided to users for managing determinations and recommendations related to medication administration (see paragraph 0012 of Helgeson).
As per claim 14, Alt and Helgeson teaches the method of claim 13 as described above. Alt further teaches upon determining that the location is within the specified distance of the at least one typical dosing location, including said injection event information in said medication log without prompting the user (see paragraphs 0074 and 0104; injection devices performs injections at a variety of locations; mobile device is proximal to the injection device, which is encompassed by a “specified distance of at least one typical dosing location”).
As per claim 15, Alt and Helgeson teaches the method of claim 13 as described above. Alt further teaches the advertising packet is a Bluetooth Low Energy (BLE) advertising packet (see paragraph 0109; advertising packet broadcast via Bluetooth).
As per claim 16, Alt and Helgeson teaches the method of claim 13 as described above. Alt does not explicitly teach the at least one typical dosing location is automatically determined based on past injection locations associated with the user. Helgeson further teaches the at least one typical dosing location is automatically determined based on past injection locations associated with the user (see paragraph 0064; recommended dosing location based on previously used locations). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to use injection location data for storing records of medication dosing in Alt for the reasons given above with respect to claim 13.
As per claim 17, Alt and Helgeson teaches the method of claim 13 as described above. Alt does not explicitly the at least one typical dosing location is pre-set by the user. Helgeson further teaches the at least one typical dosing location is automatically determined based on past injection locations associated with the user (see paragraph 0064; recommended dosing location based on previously used locations confirmed by user). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to use injection location data for storing records of medication dosing in Alt for the reasons given above with respect to claim 13.
As per claim 18, Alt and Helgeson teaches the method of claim 13 as described above. Alt further teaches ignoring the advertising packet without prompting the user based on typical dosing location (see paragraphs 0109-0110; mobile device receives or “ignores” advertising packet based on its proximity to injection device). Alt does not explicitly teach the specified distance is a first specified distance, the method further comprising: determining whether the location of the computing device is within a second specified distance of the at least one typical dosing location; determining that the location is not within the second specified distance of the at least one typical dosing location (see paragraphs 0071 and 0080; determines an injection even at a location that should be a different location (not within a specified distance of a typical dosing location). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to use injection location data for storing records of medication dosing in Alt for the reasons given above with respect to claim 13.
As per claim 19, Alt and Helgeson teaches the method of claim 13 as described above. Alt further teaches the injection event information comprises at least one of a date and a time of the injection event (see paragraph 0035; dose record includes time and date).
As per claim 20, Alt teaches a computerized method, comprising: receiving at a computing device, from a wireless communication interface of a medication delivery device, an advertising packet comprising injection event information associated with an injection event generated by the medication delivery device (see paragraphs 0123; supplementary device 2 (attached to drug delivery device 1 – paragraph 0073) broadcasts advertising packet in response to injection event), wherein the medication delivery device comprises (a) a reservoir configured to hold medication (see paragraph 0177; drug reservoir adapted for use with drug delivery device), (b) an actuating button for initiating an injection of the medication (see paragraph 0070; injection button 11), and (c) a processing circuit in communication with the wireless communication interface (see paragraph 0073 and Figure 3; shows processor and wireless unit); determining a location of the computing device (see paragraph 0145; mobile device is determined to be in proximity to the injection device); determining whether the location of the computing device is within a specified distance of at least one typical dosing location (see paragraphs 0074 and 0104; injection devices performs injections at a variety of locations; mobile device is proximal to the injection device, which is encompassed by a “specified distance of at least one typical dosing location”); and ignoring the advertising packet without prompting the user based on typical dosing location (see paragraphs 0109-0110; mobile device receives or “ignores” advertising packet based on its proximity to injection device).
Alt does not explicitly teach upon determining that the location is not within the specified distance of the at least one typical dosing location, not including said injection event information in a medication log.
Helgeson teaches upon determining that a location is not within the specified distance of at least one typical dosing location, prompting a user to confirm whether to include said injection event information in a medication log see paragraphs 0071 and 0080; determines an injection even at a location that should be a different location (not within a specified distance of a typical dosing location). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to use injection location data for storing records of medication dosing in Alt with the motivation of further improving the assistance provided to users for managing determinations and recommendations related to medication administration (see paragraph 0012 of Helgeson).
As per claim 21, Alt and Helgeson teaches the method of claim 13 as described above. Alt does not explicitly teach upon determining that the location is not within the specified distance of the at least one typical dosing location, prompting a user to confirm whether to include said injection event information in a medication log. Helgeson teaches upon determining that a location is not within the specified distance of at least one typical dosing location, prompting a user to confirm whether to include said injection event information in a medication log (see paragraphs 0071 and 0080; determines an injection even at a location that should be a different location (not within a specified distance of a typical dosing location) and prompts user to confirm recommended location for storing in a medication log – paragraph 0099). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to use injection location data for storing records of medication dosing in Alt for the reasons given above with respect to claim 20.
As per claim 22, Alt and Helgeson teaches the method of claim 20 as described above. Alt further teaches the advertising packet is a Bluetooth Low Energy (BLE) advertising packet (see paragraph 0109; advertising packet broadcast via Bluetooth).
As per claim 23, Alt and Helgeson teaches the method of claim 20 as described above. Alt does not explicitly teach the at least one typical dosing location is automatically determined based on past injection locations associated with the user. Helgeson further teaches the at least one typical dosing location is automatically determined based on past injection locations associated with the user (see paragraph 0064; recommended dosing location based on previously used locations). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to use injection location data for storing records of medication dosing in Alt for the reasons given above with respect to claim 13.
As per claim 24, Alt and Helgeson teaches the method of claim 20 as described above. Alt does not explicitly the at least one typical dosing location is pre-set by the user. Helgeson further teaches the at least one typical dosing location is automatically determined based on past injection locations associated with the user (see paragraph 0064; recommended dosing location based on previously used locations confirmed by user). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to use injection location data for storing records of medication dosing in Alt for the reasons given above with respect to claim 13.
As per claim 25, Alt and Helgeson teaches the method of claim 20 as described above. Alt further teaches the injection event information comprises at least one of a date and a time of the injection event (see paragraph 0035; dose record includes time and date).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Yang, Chinese Publication No. 107441594 A, discloses a medication injection device with confirmation of accurate positioning.
Kietzmann, US Patent Application Publication No. 2024/0055115, discloses recording injection location on the body of a patient.
Walker, US Patent Application Publication No. 2023/0081577, discloses recording injection event information including the location at which an injection was administered.
Paramanandam, US Patent Application Publication No. 2022/0347398, discloses recording injection information based on proximity to a drug delivery device.
Binier, US Patent No. 10,232,123, discloses user confirmation before storing injection dose information.
Amschler, US Patent Application Publication No. 2019/0054244, discloses determining if an injection was administered at an incorrect location.
Boggild-Damkvist, US Patent Application Publication No. 2018/0311445, discloses determining and registering a location of an injection device for an injection event.
Boyden, US Patent Application Publication No. 2014/0121637, discloses guiding locations of injection events and recording the events.
Axelrod, US Patent Application Publication No. 2012/0259237, discloses accurately locating an injection device at an anatomical location prior to recording the injection event.
Gu et al., Predicting Injectable Medication Adherence via a Smart Sharps Bin and Machine Learning, discloses recording injection events for injections at a site on the body of a patient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to C. Luke Gilligan whose telephone number is (571)272-6770. The examiner can normally be reached Monday through Friday 9:00 - 5:00.
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C. Luke Gilligan
Primary Examiner
Art Unit 3683
/CHRISTOPHER L GILLIGAN/ Primary Examiner, Art Unit 3683
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