Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
In the amendment filed 07/24/2026, the following has occurred: claims 13, 15, 18, 20, and 22 have been amended and claim 21 has been canceled. Now, claims 13-20 and 22-33 are pending with claims 26-33 being withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13-20 and 22-25 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 13 and 20 recite “configured to begin broadcasting said advertising packets upon delivering a dose of medication.” Each of these claims previously recite “one or more advertising packets.” Because the initial recitation of “advertising packets” is “one or more,” the subsequent recitation of “said advertising packets” lacks sufficient antecedent basis in the claims because the claims lack antecedent basis for multiple “advertising packets.”
Claims 14-19 and 22-25 are rejected based on their dependencies on claims 13 and 20.
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 13-20 and 22-25 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 mobile phone; determining whether the location of the mobile phone is within a specified distance of at least one specified typical dosing geographic location; upon determining that the location is not within the specified distance of the at least one typical dosing location, prompting a user using the mobile phone 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 mobile phone; determining whether the location of the mobile phone is within a specified distance of at least one specified typical dosing geographic location; upon determining that the location is not within the specified distance of the at least one typical dosing location, ignoring the one or more advertising packets without prompting a user and without including said information event information in a medication log; and upon determining that the location is within the specified distance of the at least one typical dosing location, prompting the user to confirm whether to include said injection event information in said 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 22-25 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea. For example, claim 14 further expands 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 mobile phone, from a wireless communication interface of a medication delivery device, one or more advertising packets.
Claim 15 and 22:
The one or more advertising packets are Bluetooth Low Energy (BLE) advertising packets.
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 and configured to begin broadcasting one or more advertising packets upon delivering a dose of medication.
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.
Distinguishing Subject Matter
Claims 13-20 and 22-25 distinguish over the prior art. The primary reason that claims 13-20 and 22-25 distinguish over the prior art is the inclusion of the combination of limitations of determining whether to prompt a user to confirm inclusion of injection event information in a medication log based on determining whether a location of the user’s mobile phone is within a specific distance of a specified typical dosing geographic location. The closest prior art (Alt and Helgeson) describes determining whether an injection event is within a distance of a typical dose and prompting a user to confirm a recommended location. However, the prior art does not describe determining the specified distance between a mobile phone of the user and a specified typical dosing geographic location being used to determine prompting of the user to confirm inclusion of injection event information. Additionally, Krulevitch, US Patent Application Publication No. 2022/0401657, discloses determining a distance of a drug delivery device from a typical delivery location in the recording of drug delivery events and Mousseau, US Patent Application Publication No. 2021/0134421, discloses determining the geographic location of a user in connection with a dispensed dose of medication. However, the locations in these teachings are not specific to a distance from a mobile phone of the user to the typical injection location. Accordingly, the claims distinguish over the prior art.
Response to Arguments
In the remarks filed 07/24/2026, Applicant argues (1) the claims are not directed to an abstract idea due to the recitations of the “mobile phone” and the delivery devices “configured to begin broadcasting said advertising packets upon delivering a dose of medication”; (2) the claims address the technical problem of multiple delivery devices broadcasting advertising packets in proximity to a user’s mobile phone without being able to differentiate which delivery device belongs to the user by distinguishing between the delivery devices based on determining whether a mobile phone is within a specified distance of the specified typical dosing geographic location; (3) the amended claims distinguish over Alt and Helgeson.
In response to argument (1), the operations of the recited mobile phone are no more than those of a generic computer device. Additionally, the recitation of the dispensing devices being “configured to begin broadcasting said advertising packets upon delivering a dose of medication,” merely link the abstract idea to a particular technological environment. As noted in the rejections, the structure of the delivery device is, including being configured to broadcast advertising packets, is unrelated to any of the following functions which make up the abstract idea. There are no further steps that rely on the advertising packets and the recitations of the mobile phone are only to establish the location and distance. Therefore, the examiner respectfully maintains that the remaining recitations are directed to an abstract idea.
In response to argument (2), while Applicant’s remarks do describe a technical challenge and technical solution, the examiner respectfully submits that the limitations recited in the claim do not accomplish technical solution. First, the claims only require receiving a single advertising packet from a single delivery device. The claims recite receiving “on or more” advertising packets from “a medication delivery device.” While the claims further recite the medication delivery device is “configured to begin broadcasting said advertising packets upon delivering a dose of medication,” there are no further recitations of multiple “advertising packets” being broadcast, nor are there any recitations of multiple medication delivery devices. Second, the location determination and distance of the mobile phone to a specified typical dosing geographic location, as recited in the claims, is unrelated to multiple medication delivery devices. The distance is only used to prompt the user to confirm including the injection event in a medication log. Additionally, the recitations do not require any operation of the mobile phone. Rather, one could observe where the dosing event takes place in relation to a typical location to prompt the user. Therefore, the broadest reasonable interpretation of the limitations recited in the claim do not integrate the abstract idea into a practical application.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Luo et al., Robustness of IoT Gateway Deployment in Smart Hospitals, discusses use of BLE connections of medical devices in medical environments.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached at 571-272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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C. Luke Gilligan
Primary Examiner
Art Unit 3683
/CHRISTOPHER L GILLIGAN/ Primary Examiner, Art Unit 3683
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