DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 ----06/02/2025 has been entered.
Status of Claims
Claims 1-2, 5-6, 12-13 are currently pending and have been examined.
Claims 1, 2, 6, and 12-13 have been amended.
Claims 3-4, 7-11, and 14-20 have been canceled, with claim 4 being newly canceled in the response filed 01/20/2026.
Claims 1-2, 5-6, 12-13 have been rejected.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1-2, 5-6, and 12-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 discloses, “a consumption detection device that is fixedly attached to the machine portion but accessible to the patient in the patient area.” Para 36 of the Applicant’s specification discloses, “Alternatively, when the medication is meant to be consumed immediately, prior to leaving the medication dispensing unit 1, the patient may not wear a consumption detection device but rather the medication dispensing device 1 may include a consumption detection device which may directly detect the signal or change in state of the sensor within the medication when it is swallowed.” Therefore, there is support specifically for “a consumption detection device that is fixedly attached to the machine portion.” However, there is no support for that consumption detection device being “accessible to the patient in the patient area,” when it is fixedly attached to the machine portion. The specification and the drawings do not indicate where the consumption detection device is fixedly attached and thus it is not properly supported that while the consumption detection device is fixedly attached it is also accessible to the patient in the patient area.
Claims 2, 5-6, and 12-13 are further rejected as dependent on a rejected base claim.
Thus, Claims 1-2, 5-6, and 12-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
Claim Rejections - 35 USC § 112(b)
Claims 1-2, 5-6, 12-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “a processor communicatively coupled to the … wearable consumption detection device” in line 13. There is insufficient antecedent basis for this limitation in the claim. The Examiner is interpreting the limitation as “a processor communicatively coupled to the … consumption detection device” to mirror the other amendments of claim 1 where “wearable” was removed. Appropriate correction is required.
Claims 2, 5-6, and 12-13 are rejected as dependent on a rejected base claim.
Thus, Claims 1-2, 5-6, 12-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
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 1-2, 5-6, and 12-13 are subject matter eligible under 35 U.S.C. 101 because the claimed invention is directed to a system, method, or product which are one of the statutory categories of invention and any abstract idea is thus integrated into a practical application based on the controlling of the medication dispensing unit to dispense only after the patient’s identity has been verified by the user identification element and only after the tested breath sample is at an acceptable alcohol level. Thus, claims 1-2, 5-6, and 12-13 are subject matter eligible under 35 U.S.C. 101.
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.
Claims 1-2, 5-6, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Norbeck (US PG Pub 2021/0264716 A1), in view of Evans (US PG Pub 2021/0270804 A1), further in view of Remme (US PG Pub 2019/0163876 A1).
Regarding Claim 1, Norbeck discloses:
A medication dispensing device comprising:
a machine portion in connection with a patient area, the patient area defined by an enclosed area including a door with a lock; (Para 138 discloses the entire kiosk 400 [machine portion, See Figure 8] may be inside a privacy booth system 500 [enclosed patient area] as depicted in FIGS. 9A and 9B. The privacy booth system 500 may have a security door 502 operably linked to a user interface 508. The user interface 508 may have a keyboard, biometric sensor, card reader, or any combination thereof to authenticate the user to unlock the security door 502. )
the machine portion comprising a medication storage unit; a medication dispensing unit communicatively coupled to the medication storage unit; (Para 160 discloses this single dose may be dispensed through dispensing mechanism 414. The kiosk system 400 can either provide this single dose from the patients request or from a request from the health care provider conducting the telemedicine session with the authorized patient. Para 163 discloses the kiosk may also contain temperature regulators and/or refrigerators for medication storage [medication storage unit].)
a breathalyzer for receiving a breath sample from a patient; (Para 138 discloses the kiosk may also include drug testing analyzers such as, for example, but not limited to, capillary blood sensors, biosensors, and drug breathalyzers to test for opioid levels and other controlled substances.)
a user interface accessible from the patient area and communicatively coupled to the machine portion; (Para 126 discloses the kiosk system 400 in FIG. 8 includes a patient facing side 401 that includes an interface or data entry area 403. The patient facing side 401 includes an angled surface 402 that supports a plurality of user interfaces including, but not limited to a camera and retinal scanner 408, a display 406, a microphone and speaker 405, a pharmaceutical agent delivery device exchange port 412, and a charging or docking station 416, 418 (see FIG. 10). Para 139 discloses the telemedicine booth of the kiosk may include user interface devices such as a touch screen interactive computer, software to transmit biometric identification, internet connectivity, memory, video recording, phone, blood pressure cuff, pulse oximeter, technology to administer injectable medications, and a power source.)
a processor communicatively coupled to the medication storage unit, the medication dispensing unit, the breathalyzer, the user interface, and the user identification element; wherein (Para 46 discloses the AD software may improve the accuracy of identifying the authorized user… The AD may serve to confirm dose ingestion by the authorized user which may also be time stamped, in some instances with photo or video confirmation. Para 135 discloses the CPU 422 will run an automated decisioning (AD) software, as described in more detail below. Para 138 discloses the kiosk may also include drug testing analyzers such as, for example, but not limited to, capillary blood sensors, biosensors, and drug breathalyzers to test for opioid levels and other controlled substances [thus the CPU 422 of the kiosk is communicatively coupled to the breathalyzer]. Para 139 discloses the telemedicine booth of the kiosk may include user interface devices such as a touch screen interactive computer. Para 165-166 discloses a method of using the kiosk system 400, the kiosk software, and in particular the AD software begins the interaction by recognizing the patient through biometrics [user identification element]… the AD analytics will be able to detect the changes in behavior, send real-time alerts to the provider, and halt dispensing of the delivery device or a pharmaceutical agent. Para 172 discloses once the requirements have been met and the background AD algorithm has verified that it is appropriate to dispense, [thus 166 and 172 show the CPU is communicatively coupled to the medication storage unit and the medication dispensing unit to dispense or halt dispensing].)
the medication dispensing unit dispenses one or more doses of a medication to a patient only after the patient’s identity has been verified by the user identification element (Para 5 discloses the delivery device has one or more biometric sensor to authenticate the user as an authorized patient to receive the pharmaceutical agent from the device. In some instances, the delivery device has facial recognition for dose confirmation and to authenticate the user.
a (Para 135 discloses the CPU 422 will run an automated decisioning (AD) software, as described in more detail below. Para 172 discloses once the requirements have been met and the background AD algorithm has verified that it is appropriate to dispense, the software will send instructions to the video and infrared cameras for the AD diversion detection system and to the specific medication dispensing mechanism. Paras 175-180 discloses Next, the kiosk system 400 will activate the AD dose ingestion and diversion detection system. This detection system will be an array of both video and infrared thermal cameras, such as through cameras 410 [wherein Fig. 10 illustrates the cameras 410 fixedly attached to the machine portion] that will record the patient's actions with the dispensed medication. The patient's actions during ingestion will be analyzed in real-time by two different systems within the AD dose ingestion and diversion detection system platform: an infrared (IR) thermal image system and the continuous AD video analytics system… Any combination of these IR thermal image sensors and video sensors in combination with software may be used to track the medication to the patient's mouth to determine dose ingestion or diversion… Part of the patient's required procedure may be to open their mouth after ingestion to confirm ingestion. The IR system may then analyze the patient's open mouth to confirm that the tracked thermal target is no longer present.
While Norbeck discloses the above limitations and Para 55 discloses, “the device and remote monitoring component may interact with biosensors, capillary blood, or drug breathalyzers to test for opioid levels and other controlled substances,” a medication dispensing unit dispenses one or more doses of a medication to a patient (See Norbeck Para 160), and “alert health care providers of evidence of withdrawal, progression of abuse… or being under the influence,” (Norbeck Para 45), it does not fully disclose the following limitation that Evans discloses:
wherein when the breathalyzer receives a breath sample from the patient, the breath sample is immediately tested for an acceptable alcohol level; [performing an action] only after the tested breath sample is at an acceptable alcohol level (Para 30 discloses the user starts blowing into a measuring apparatus, typically by means of a sampling tube or pipe made of plastic or other suitable material which is cheap to produce and replaceable, to ensure hygienic conditions to the users. Para 40-41 discloses the blood alcohol concentration BAC may be determined from the blood-to-air partition ratio, i.e. the relation between the amount of alcohol in a given volume of breath and blood. The alcohol measuring apparatus according to the present invention may be made very compact and included in a sobriety interlock device. Such interlock devices are known in the art and will not be described in detail here. The interlock device may comprise means for measuring the temperature, humidity and/or alcohol concentration of the breath of a user, and based on these measurements falling within permitted ranges (corresponding to the user being non-intoxicated by alcohol), the interlock device allows starting up of a vehicle or other machinery connected to the interlock device.)
Norbeck and Evans are analogous art because Norbeck discloses, “utilizing a breathalyzer to test for opioid levels and other controlled substances” (Norbeck Para 138) and Evans discloses, “The interlock device may comprise means for measuring the temperature, humidity and/or alcohol concentration of the breath of a user” (Evans Paras 40-41). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the individual device and system to dispense pharmaceutical agents to an authorized patient as taught by Norbeck with the method for measuring breath alcohol concentration and apparatus therefor as taught by Evans in order to allow the starting up of a machinery connected to an interlock device based on measurements falling within permitted ranges (corresponding to the user being non-intoxicated by alcohol) (Evans para 41) and substitute the vehicle of Evans with the medicine dispensing unit of Norbeck.
While the combination of Norbeck and Evans discloses the above limitations, and Norbeck discloses in Para 129, “In some embodiments, the keyboard 404 also has a card reader 433 or scanner to identify an authorized user. For example, a pharmacy may issue a specific card when collecting the biometric identification information to be associated with a specific patient, such that a retinal scan or a finger print and the specific card are required before the device 100 is ejected from the kiosk,” Para 136 discloses, “in the loading system embodiment, where the docking station 416, 418 includes a refilling feature, the loading system may also provide an electronic, magnetic, or some other mechanism that may securely lock and unlock the device for unloading and reloading,” and Para 164 discloses, “this loading system or docking station may include identification encryption methods to securely connect the contents to the authenticated patient. The loading system or docking station may also provide an electronic, magnetic, or some other mechanism that may securely lock and unlock the delivery device to facilitate reloading with a pharmaceutical agent. This loading system may include identification encryption methods to securely connect the device, cartridge, and its contents to the identified authorized patient. The loading device or docking station may include barcodes and scanning devices,” the combination does not fully disclose the following limitation that Remme discloses:
a user identification element comprising a bar code scanner or a QR code scanner; (Para 65 discloses the patient uses components of the UI of Rx Dispensing Kiosk 110(z) that allows the Rx Dispensing Kiosk 110(z) to read a two (2) dimensional (2D) computer readable symbol, such as a 2D QR code or barcode, from a screen rendering by App 102(x)… Para 90 discloses when the application user travels to the kiosk, as selected using the application, to pick up the order of new and/or refilled prescriptions, the application can be prompted to render a machine readable symbol such as is shown in reference numeral 3500a in FIG. 35 (e.g., QR code). The symbol can be rendered upon activation of one or more icon such as are shown at the bottom of the screen show in reference numeral 3500b in FIG. 35 [wherein Fig. 35 specifically says, “use this secure [QR]code to identify yourself when you go to pick up your meds at the MedCenter”]. An image of the symbol can be captured by the kiosk to identify the order previously placed by the user's use of the application. As such, the symbol can embed various information including, but not limited to, an order identifier and a patient identifier [thus verifying the identity of the patient]. When the order identified by the symbol has been authenticated for the kiosk at which the symbol is captured and read, then the kiosk will initiate the picking of each prescription container in the order from the kiosk's inventory that had been reserved for that order, and then placing a patient-specific label on each picked container. Preferably, a remotely located pharmacist, or agent thereof, will review the internal processing of all material aspects of the process of filling the order by the kiosk, and optionally counseling the patient at the kiosk via the kiosk's teleconferencing capabilities. The remotely located pharmacist will then use subjective and/or objective professional criteria to decide whether or not to initiate a signal that will be transmitted to the kiosk that will instruct the kiosk to: (i) dispense the order of prescription drugs from the kiosk to the kiosk user; or (ii) to move the labeled containers into an internal discard location of the kiosk and thereby refusing to dispense the order of prescription drugs from the kiosk to the kiosk user. As such, the pharmacist will have control and judgement over how, when, and to whom drugs are dispensed from the kiosk to the kiosk user. After the signal is received by the kiosk, memory will be adjusted to reflect to inventory in the kiosk that is available to be dispensed.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of the individual device and system to dispense pharmaceutical agents to an authorized patient as taught by Norbeck and the method for measuring breath alcohol concentration and apparatus therefor as taught by Evans with the kiosk dispenser interactive original order entry software application as taught by Remme in order to dispense an authenticated order by scanning a QR code that contains an order identifier and a patient identifier (and thus authenticating a user’s identity for each prescription that is dispensed).
Regarding Claim 2, this claim recites the limitations of Claim 1 and as to those limitations is rejected for the same basis and reasons as disclosed above. Further, Norbeck discloses:
The device of claim 1 wherein the dispensed medication is a single dose (Para 160 discloses the user will request a single dose of a pharmaceutical agent. In some embodiments this will be an opioid agonist or an opioid antagonist. This single dose may be dispensed through dispensing mechanism 414. The kiosk system 400 can either provide this single dose from the patients request or from a request from the health care provider conducting the telemedicine session with the authorized patient.)
Regarding Claim 5, this claim recites the limitations of Claim 1 and as to those limitations is rejected for the same basis and reasons as disclosed above. Further, Norbeck discloses:
The device of claim 1 further comprising a camera. (Para 129 discloses a third angled surface 411 includes or supports a camera 410 at an orientation that has a field of view of the patient. This camera may be used for security purposes and may be used for facial recognition in the identification sequence of the authorized user. Para 144 discloses the display 406, cameras 410 and retinal scanner 408, the first docking station 416 and second docking station 418, as well as the device exchange port 412 and dispensing mechanism 414 are all coupled to CPU 422, which runs software that enables the kiosk system 400 to authenticate the user and provide the correct pharmaceutical agents or medical responses and communicate with the network 1708 in the cloud.)
Regarding Claim 6, this claim recites the limitations of Claim 5 and as to those limitations is rejected for the same basis and reasons as disclosed above. Further, Norbeck discloses:
The device of claim 5 wherein the device includes data output through a wired or wireless connection, wherein the device provides images or video of the patient interacting with the device or consuming the medication to a remote observer. (Para 180 discloses when the automated decisioning (AD) is unable to confirm ingestion and detects possible diversion, the AD may start a telemedicine session immediately to review the ingestion video in real-time with a remote practitioner. For example, if the infrared thermal image system determines that the medication has moved outside the virtual 3-D box or the AD video analytics identifies that the patient is displaying abnormal behavior when compared to their trend. In some instances the remote practitioner may share and review the video of the questionable activity with the patient. If the patient conforms and the practitioner accepts the patient's actions, the session will end. If the patient does not conform or there is evidence of a diversion attempt, the practitioner may revoke the patient's access to medication at the kiosk and may require them to visit an OTP for their next dose.)
Regarding Claim 12, this claim recites the limitations of Claim 1 and as to those limitations is rejected for the same basis and reasons as disclosed above. Further, Norbeck discloses:
The device of claim 1 wherein the lock comprises a second user identification element. (Para 138 discloses the privacy booth system 500 may have a security door 502 operably linked to a user interface 508. The user interface 508 may have a keyboard, biometric sensor, card reader, or any combination thereof to authenticate the user to unlock the security door 502.)
Regarding Claim 13, this claim recites the limitations of Claim 12 and as to those limitations is rejected for the same basis and reasons as disclosed above. Further, Norbeck discloses:
The device of claim 12 wherein the second user identification element comprises a fingerprint scanner, a retinal scanner, a key pad, a bar code scanner or a QR code scanner. (Para 157 discloses the data collection and transmission portion of the exchange port inputs biometric identification to the new device in order to be able of identifying an authorized patient. In some embodiments, the user will enter the privacy booth system 500 to access the kiosk system 400 by first inputting their biometric data [wherein biometric identification is described as a retinal scanner, facial recognition, a fingerprint scanner, and other biometric sensor techniques] or personal identification number into the user interface 508 to then perform a device exchange as described in this disclosure or interact with a health care provider. In some embodiments, the patient will also have to initiate biometric identification with the kiosk through both a retinal scanner 408, facial recognition, a fingerprint scanner 409, palm vein scan, palm print, and other biometric sensor techniques.)
Response to Arguments
Applicant’s arguments filed 01/20/2026 with respect to 35 U.S.C. § 112(a) have been fully considered. The removal of “wearable” from the claim language means the limitation now reads as, “a consumption detection device that is fixedly attached to the machine portion…” This limitation has proper support as para 36 of the Applicant’s specification discloses, “Alternatively, when the medication is meant to be consumed immediately, prior to leaving the medication dispensing unit 1, the patient may not wear a consumption detection device but rather the medication dispensing device 1 may include a consumption detection device which may directly detect the signal or change in state of the sensor within the medication when it is swallowed.” However, there is no support for that consumption detection device being “accessible to the patient in the patient area,” when it is fixedly attached to the machine portion. As such, the previous 112(a) rejection has been updated above in light of the newly added amendments.
Applicant’s arguments filed 01/20/2026 with respect to 35 U.S.C. § 103 have been fully considered.
The Applicant argues that the cited references do not disclose “a detectable device that is fixedly attached to the machine portion, where the detectable device ‘may directly detect the signal or change in state of the sensor within the medication when it is swallowed.” Examiner notes that detecting a signal or change in state of the sensor within the medication when it is swallowed is not claimed and as such this argument is not persuasive.
The Applicant further argues that none of the references disclose a user identification element that is either a bar code scanner or a QR code scanner as claimed in claim 1. As presented above, Norbeck Para 129 discloses, “In some embodiments, the keyboard 404 also has a card reader 433 or scanner to identify an authorized user. For example, a pharmacy may issue a specific card when collecting the biometric identification information to be associated with a specific patient, such that a retinal scan or a finger print and the specific card are required before the device 100 is ejected from the kiosk” as well as a loading dock containing a barcodes and scanning devices (see Paras 136 and 164). However, the further strengthen the rejection, the examiner presents an additional reference, as taught by Remme, as necessitated by narrowing the limitation of the user identification element of claim 1 to where the user identification element contains only a barcode scanner or a QR code scanner, where the claim then discloses, to paraphrase, only dispensing medication to a patient only after the patient’s identity has been verified by the user identification element. Therefore, the previous 35 U.S.C.
§ 103 rejection has been withdrawn. However, upon further consideration, a new grounds of rejection under 35 U.S.C. § 103 necessitated by Applicant' s amendments is presented as disclosed above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA J MORICE whose telephone number is (703)756-4608. The examiner can normally be reached M-F 8:30-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter H. Choi can be reached on (469)295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA JESSICA MORICE DE VARGAS/Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681