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 .
Status of the Claims
The office action is in response to the Amendment submitted on March 19, 2026 for the application filed on May 16, 2023, which is a national stage of International Application No. PCT/US2021/060320 filed on November 22, 2021, which claims priority to Provisional Application No. 63/117,214 filed on November 23, 2020. Claims 1 – 14 and 16 – 17 are currently pending and have been examined as discussed below.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 19, 2026 has been entered.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting limitations (i.e., other than the generic placeholder and the functional language) that provide sufficient structure, material or acts to entirely perform the recited function.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. The following terms have been found, in certain circumstances, to be structural generic placeholders that invoke § 112(f): “mechanism for,” “module for,” “device for,” “unit for,” “component for,” “element for,” “member for,” “apparatus for,” “machine for,” and “system for.” See MPEP 2181(I)(A). Such claim limitations include: “communication module” in claims 1 and 7.
The limitation “communication module” includes the term (i.e., “module”) as a structural generic placeholder for the word “means.” See MPEP 2181(I)(A). The term “module” is coupled with the functional language “communication.” Claims 1 and 7 do not recite sufficient structure to perform the claimed function of communicating. While the Office determined that the term “module” is a generic placeholder that is structural in nature, the Office maintains that the term “module” is still a generic placeholder (not sufficient structure) and thus invokes 112(f) under MPEP 2181(I)(A). Furthermore, the generic placeholder “module” is not preceded by a structural modifier, but rather only preceded by the functional language “communication”. Accordingly, 35 U.S.C. 112(f) is invoked for interpreting “communication module,” and the broadest reasonable interpretation of this claim limitation is limited by the description in the specification (e.g., paragraphs [0034] and [0035]) stating that the communication module may be a wireless transceiver, Bluetooth®, Wi-Fi®, Zigbee®, cellular, or another (preferably low power) communication protocol.
In response to an Office action that finds that 35 U.S.C. 112(f) is invoked, if applicant does not want to have the claim limitation interpreted under 35 U.S.C. 112(f), applicant may: (1) present a sufficient showing to establish that the claim limitation recites sufficient structure to perform the claimed function so as to avoid interpretation under 35 U.S.C. 112(f); or (2) amend the claim limitation in a way that avoids interpretation under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function). See MPEP 2181.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 – 3, 5 – 12, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Bartos (U.S. Pub. No. 2019/0307648 A1) in view of Lebrun (U.S. Pub. No. 2022/0287915 A1) and Rieb (U.S. Pat. No. 6,733,095 B1).
Regarding claim 1, Bartos discloses the limitations in bold as:
a medication monitoring system for a user (Abstract of Bartos, A system … for medication adherence management with which a medicament container is held.), comprising:
a container subassembly comprising (Abstract of Bartos, A system … for medication adherence management with which a medicament container is held by a holding apparatus. In the instant application, the broadest reasonable interpretation of “a container subassembly” reads on the holding apparatus of Bartos (Abstract).):
two or more compartments, each compartment being configured to store medical equipment or medications prescribed to the user, wherein a first compartment of the two or more compartments comprises a first size, and wherein a second compartment of the two or more compartments comprises a second size that is different than the first size;
an insert included in at least one of the two or more compartments forming one or more partitions for organization of the stored medical equipment or medications prescribed to the user;
a lid of the container subassembly pivotally mounted on a first edge of the container subassembly and comprising a magnet at a second edge opposite to the first edge (Paragraph [0179] of Bartos, Optionally, the holding apparatus 100 comprises a cover 109 that can be pivotably arranged at the entrance of the receptacle 101. Paragraph [0184] of Bartos, [T]he cover 109 comprises a detection unit 204. Paragraph [0116] of Bartos, Additionally, or alternatively the detection unit 204 can comprise or be formed by a magnet.); and
an electronics subassembly (Paragraph [0096] of Bartos, Preferably, the holding apparatus 100 comprises a detector device 102 and/or a data processing device 103 for wirelessly or remotely recognizing an opening and closing of the medicament container 200.) comprising:
a magnetic sensor coupled to the magnet in the lid of the container subassembly (Paragraph [0116] of Bartos, Additionally, or alternatively the detection unit 204 can comprise or be formed by a magnet that interacts with the detector device 102 which, in this case, preferably comprises a magnetic switch, magnetic sensor or the like.), and
a communication module configured to communicate (Paragraph [0037] of Bartos. In the instant application the broadest reasonable interpretation of “a communication module configured to communicate” reads on the communication device in Bartos (Paragraph [0037]) transmitting data, preferably to a receiver, particularly a server or a data center in a remote location.) with a patient record comprising one or more medication regimens for the user (Paragraphs [0119] – [0120] of Bartos. In the instant application, the broadest reasonable interpretation of “a patient record comprising one or more medication regimens for the user” reads on the medication plan, the preset or prescribed medicament or dose, or the specific or electronic medication plan in Bartos (Paragraphs [0119] – [0120]).), wherein the electronics subassembly comprises a unique identifier configured to associate the electronics subassembly with the container subassembly of the medication monitoring system, wherein the unique identifier is configured to pair the medication monitoring system with the patient record stored in a cloud system prior to the user's receipt of the medication monitoring system such that the one or more medication regimens for the user are preconfigured with the medication monitoring system, and wherein the medication monitoring system is automatically registered to communicate with the cloud system without user action.
Bartos does not appear to explicitly disclose, but Lebrun teaches the limitations in bold as “a container subassembly comprising two or more compartments, each compartment being configured to store medical equipment or medications prescribed to the user, wherein a first compartment of the two or more compartments comprises a first size, and wherein a second compartment of the two or more compartments comprises a second size that is different than the first size” (Paragraph [0064] of Lebrun. In the instant application, the broadest reasonable interpretation of “two or more compartments, each compartment being configured to store medical equipment or medications prescribed to the user” reads on the plurality of receptacles in Lebrun (Paragraph [0064]) for insertion of the removable dose units.).
Bartos does not appear to explicitly disclose, but Rieb teaches the limitations in bold as “a container subassembly comprising two or more compartments, each compartment being configured to store medical equipment or medications prescribed to the user, wherein a first compartment of the two or more compartments comprises a first size, and wherein a second compartment of the two or more compartments comprises a second size that is different than the first size” (Column 6, Line 66 to Column 7, Line 2 and FIG. 11 of Rieb. In the instant application, the broadest reasonable interpretation of “a first compartment of the two or more compartments comprises a first size, and wherein a second compartment of the two or more compartments comprises a second size that is different than the first size” reads on the bins in Rieb (Column 6, Line 66 to Column 7, Line 2; and FIG. 11) having different sizes.)
Bartos does not appear to explicitly disclose, but Lebrun teaches the limitations in bold as “an insert included in at least one of the two or more compartments forming one or more partitions for organization of the stored medical equipment or medications prescribed to the user” (Paragraphs [0053] – [0054] of Lebrun. In the instant application, the broadest reasonable interpretation of “an insert included in at least one of the two or more compartments forming one or more partitions for organization of the stored medical equipment or medications prescribed to the user” reads on the bottom container in Lebrun (Paragraphs [0053] – [0054]) of associated dose units included in the receptacles forming partitions (i.e., separating the medication from the smart pillbox bottom unit) for organization of the stored medical equipment or medications prescribed to the user.)
Bartos does not appear to explicitly disclose, but Lebrun teaches the limitations in bold as “wherein the electronics subassembly comprises a unique identifier configured to associate the electronics subassembly with the container subassembly of the medication monitoring system, wherein the unique identifier is configured to pair the medication monitoring system with the patient record stored in a cloud system prior to the user's receipt of the medication monitoring system such that the one or more medication regimens for the user are preconfigured with the medication monitoring system, and wherein the medication monitoring system is automatically registered to communicate with the cloud system without user action” (Paragraphs [0009], [0074] – [0076], [0088], [0094], and [0103] of Lebrun. In the instant application, the broadest reasonable interpretation of “wherein the electronics subassembly comprises a unique identifier configured to associate the electronics subassembly with the container subassembly of the medication monitoring system, wherein the unique identifier is configured to pair the medication monitoring system with the patient record stored in a cloud system prior to the user's receipt of the medication monitoring system” reads on: the RFID tag, NFC tag, Bluetooth beacon or other unique identifier in Lebrun (Paragraphs [0074] – [0076], see also FIG. 15) attached to carrier tray and correlated to a unique combination of medications or pills, a day, and a scheduled dose time window, whether in local storage on the device or in the cloud-based dose management system. The broadest reasonable interpretation of “the one or more medication regimens for the user are preconfigured with the medication monitoring system” reads on the barcode unique identifier in Lebrun (Paragraph [0094], see also FIG. 16) with the unique identifier encoded within it, and the unique identifier linked to a patient and the dose units and then placing the barcode onto the dose units before shipping. The broadest reasonable interpretation of “the medication monitoring system is automatically registered to communicate with the cloud system without user action” reads on the smart pill organizer device in Lebrun (Paragraphs [0009] and [0088]) being pre-programmed with scheduled doses; the remote server in Lebrun (Paragraph [0103]) keeping connected to the device using a key every 10 seconds. The broadest reasonable interpretation of “the medication monitoring system is automatically registered to communicate with the cloud system without user action” reads on the activities in Lebrun (Paragraphs FIG. 15 – 16 , see also [0074] – [0076]) providing, by the operator (e.g., the manufacturer or pharmacist), unique identifier before shipment.).
Therefore, it would have been obvious to one of ordinary skill in the art of medication monitoring systems at the time of the filing to modify the system of Bartos to: include the two or more compartments, each compartment being configured to store medical equipment or medications prescribed to the user, and include the insert included in at least one of the two or more compartments forming one or more partitions for organization of the stored medical equipment or medications prescribed to the user, and a communication module configured to communicate with a patient record comprising one or more medication regimens for the user, wherein the electronics subassembly comprises a unique identifier configured to associate the electronics subassembly with the container subassembly of the medication monitoring system, wherein the unique identifier is configured to pair the medication monitoring system with the patient record stored in a cloud system prior to the user's receipt of the medication monitoring system such that the one or more medication regimens for the user are preconfigured with the medication monitoring system, and wherein the medication monitoring system is automatically registered to communicate with the cloud system without user action, as taught by Lebrun (Paragraphs [0009], [0053] – [0054], [0064], [0074] – [0076], [0088], [0094], and [0103]) in order to track a patient's adherence to a dosing schedule (Paragraph [0002] of Lebrun); and implement a first compartment of the two or more compartments comprising a first size, and a second compartment of the two or more compartments comprising a second size that is different than the first size, as taught by Rieb (Column 6, Line 66 to Column 7, Line 2 and FIG. 11) in order to provide a storage and dispensing device (i.e., a container of pharmaceutical items) for different applications and aesthetics (Column 2, Lines 63-64; Column 3, Line 45; and Column 6, Line 66 to Column 7, Line 2 of Rieb).).
Regarding claim 2, Bartos in view of Lebrun and as applied to claim 1 teaches the limitation in bold as “the container subassembly is a rigid magnetic cardboard box” (Paragraph [0116] of Bartos, [T]he detection unit 204 can comprise or be formed by a magnet. Paragraph [0177] of Bartos, Particularly, in case of a medicament container 200 in the form of a cardbox package, it can be suitable to provide two or more detection units 204. Paragraph [0174] of Bartos, The cardboard package comprises at least one lid 201 that has to be opened in order to access a blister 205 and the medicament 203.).
Regarding claim 3, Bartos in view of Lebrun and as applied to claim 2 teaches the limitation in bold as “the rigid magnetic cardboard box is made from paper, cardboard, or paperboard” (Paragraph [0116] of Bartos, [T]he detection unit 204 can comprise or be formed by a magnet. Paragraph [0177] of Bartos, Particularly, in case of a medicament container 200 in the form of a cardbox package, it can be suitable to provide two or more detection units 204. Paragraph [0174] of Bartos, The cardboard package comprises at least one lid 201 that has to be opened in order to access a blister 205 and the medicament 203.).
Regarding claim 5, Bartos in view of Lebrun and as applied to claim 1 teaches the limitation in bold as “the two or more compartments in the container subassembly are configurable based on the one or more medication regimens of the user”(Paragraph [0086] of Bartos, [T]he holding apparatus 100 or receptacle 101 can comprise one or more exchangeable parts … that can be changed to adapt the holding apparatus 100 or receptacle 101 to different kinds or sizes of medicament containers 200. It would have been obvious to one of ordinary skill in the art of medication monitoring systems at the time of filing to modify the receptacles 108 of Lebrun (Paragraphs [0064] and [0083]) to include the one or more exchangeable parts of Bartos (Paragraph [0086]) in order to be usable with differently sized and/or shaped containers is very complicated, where certain parts of the system need to be exchanged or replaced (Paragraph [0010] of Bartos).).
Regarding claim 6, Bartos in view of Lebrun and as applied to claim 1 teaches the limitation in bold as “a size or a shape of at least one of the two or more compartments is configurable based on the one or more medication regimens of the user” (Paragraph [0086] of Bartos, [T]he holding apparatus 100 or receptacle 101 can comprise one or more exchangeable parts or inserts that can be changed to adapt the holding apparatus 100 or receptacle 101 to different kinds or sizes of medicament containers 200. It would have been obvious to one of ordinary skill in the art of medication monitoring systems at the time of filing to modify the receptacles 108 of Lebrun (Paragraphs [0064] and [0083]) to include the one or more exchangeable parts of Bartos (Paragraph [0086]) in order to be usable with differently sized and/or shaped containers is very complicated, where certain parts of the system need to be exchanged or replaced (Paragraph [0010] of Bartos).).
Regarding claim 7, Bartos in view of Lebrun and as applied to claim 1 teaches the limitations in bold as the electronics subassembly further comprising:
a. a user interface configured to provide a status of the electronics subassembly to the user (Paragraph [0034] of Bartos, [T]he visualization and/or notification device can be utilized to indicate if the medication adherence management system is operational, e.g., if the medicament container has been inserted correctly into the holding apparatus. Paragraph [0141] of Bartos, Further, the holding apparatus 100, visualization device 104 and/or user interface 105 can allow for more advanced communication with the patient.); and
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b. a battery configured to provide power to the communication module and the user interface (Paragraph [0417] of Bartos, The holding apparatus 100 or housing 108 preferably comprises the control device 115, detector device 102, data processing device 103, memory 103A, time base 103B, visualization device 104, user interface 105, communication device 106, battery 107 and/or any further devices.); and
Regarding claim 8, Bartos in view of Lebrun and as applied to claim 1 teaches the limitation in bold as “the electronics subassembly is assembled inside a wall of a container subassembly during a container manufacturing process”(Paragraph [0227] of Bartos, The detector device 102, data processing device 103 and/or further devices such as a visualization and/or notification device 104, user interface 105, communication device 106 and/or battery 107 are preferably located in one of the sidewalls.).
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Regarding claim 9, Bartos in view of Lebrun and as applied to claim 1 teaches the limitation in bold as “the electronics subassembly is mounted into an electronics case, and wherein the electronics case is rigidly affixed to a wall of the container subassembly” (Paragraph [0227] of Bartos, The detector device 102, data processing device 103 and/or further devices such as a visualization and/or notification device 104, user interface 105, communication device 106 and/or battery 107 are preferably located in one of the sidewalls.).
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Regarding claim 10, Bartos in view of Lebrun and Rieb and as applied to claim 1 teaches the limitation in bold as “the electronic subassembly is configured to generate an event and log the event in the patient record upon a determination that the lid of the container subassembly was opened” (Paragraph [0021] of Bartos, The term “medication activity” refers preferably to an event that is probably a removal of a dose of medicament from the medicament container. The medication activity is preferably detected or registered when both an opening and closing of the container is detected. Paragraph [0096] of Bartos, Preferably, the holding apparatus 100 comprises a detector device 102 and/or a data processing device 103 for wirelessly or remotely recognizing an opening and closing of the medicament container 200 and/or … for registering a medication activity, in particular each time when the medicament container 200 or its lid 201 has been opened and closed. Paragraph [0099], When operating, the medication adherence management system 10 or holding apparatus 100 monitors any opening and closing of the medicament container 200. In particular, the detector device 102 recognizes the opening and closing of the lid 201 of the medicament container 200. This is necessary to access the reservoir 202 of the medicament container 200 in order to remove a dose of the medicament 203. Therefore, it can be concluded that, if an opening and closing is recognized, at least one dose of the medicament 203 has been removed from the medicament container 200 and taken by a patient. This assumed removal of medicament 203 is called medication activity and registered each time when it is recognized or detected that the medicament container 200 is opened and closed.).
Regarding claim 11, Bartos in view of Lebrun and Rieb and as applied to claim 1 teaches the limitation in bold as “the electronic subassembly is configured to provide a reminder to the user based on the one or more medication regimen and a current time” (Paragraph [0015] of Bartos, Preferably, the term “medication adherence” means the “adherence” of a patient to a medication plan, i.e., the extent to which a patient acts in accordance with the prescribed interval and dose of a dosing regimen, as well as the “persistence” of the patient, i.e., the duration of time from initiation to discontinuation of therapy. Paragraph [0034] of Bartos, A visualization device or a notification unit can be utilized to output data from the data processing device, such as the number of detected activities, deviance from or adherence to a medication schedule and/or a notification reminding a patient to take his medicament. Paragraph [0134] of Bartos, Preferably, the holding apparatus 100 or the data processing device 103 can store, display, output and/or communicate the activity information, which may include an indication of a medication activity and related point of time, any division from desired or required schedule, statistical information about the activities, any reminders or notifications, e.g., regarding overdue medication activity, overdue closing of the medicament container 200, expected change or refill of the medicament container 200, expected number of doses already consumed or still contained in the medicament container 200, the current time, the time of the next dose is to be taken, or the like. Paragraph [0136] of Bartos, The visualization device 104 and/or activity information can be used for providing the patient with data such as the number of counted medicine intakes, the time since the last change of the medicament container 200, the time since the last medicament intake, the time until scheduled intake of medicine, the battery charge or the like.).
Regarding claim 12, Bartos in view of Lebrun and Rieb and as applied to claim 1 teaches the limitation in bold as “the insert further comprises a plastic insert to provide a disinfectable surface” (Paragraphs [0011] and [0059] of Lebrun, Material: The material of the dose unit lid 118 and/or bottom container 119 is ideally a food grade or medication-grade plastic material.).
Regarding claim 17, Bartos in view of Lebrun and Rieb and as applied to claim 1 teaches the limitations in bold as:
receiving medicaments based on the one or more medication regimens (Paragraph [0064] of Lebrun, The smart pillbox organizer bottom unit 110 is comprised of: a container 106 comprising a plurality of receptacles or concave cavities 108, for insertion of the removable dose units 102. In the instant application, the broadest reasonable interpretation of “receiving medicaments based on the one or more medication regimens” reads on the container 106 of Lebrun (Paragraphs [0064] and [0083]) comprising a plurality of receptacles or concave cavities 108, for receiving the removable dose units 102 in order to track a patient's adherence to a dosing schedule (Paragraph [0002] of Lebrun).);
monitoring the magnetic sensor to determine whether or not the lid is opened from a remainder of the container subassembly (Paragraph [0116] of Bartos, [T]he detection unit 204 can comprise or be formed by a magnet that interacts with the detector device 102 which, in this case, preferably comprises a magnetic switch, magnetic sensor or the like. By opening the lid 201 the magnet of the detection unit 204 may be moved closer towards or further away from the detector device 102, thereby activating the magnet switch of the detector device 102. This can generate a signal that can be read by the data processing device 103. In the instant application, the broadest reasonable interpretation of “monitoring the magnetic sensor to determine whether or not the lid is opened from a remainder of the container subassembly” reads on the step in Bartos (Paragraph [0116]) of activating the magnet switch of the detector device (i.e., in response to opening the lid 201 and moving the magnet of the detection unit 204 closer towards or further away from the detector device 102) thereby generating a signal that can be read by the data processing device.);
determining whether a current time is a time for medication based on one or more medication regimens (Paragraph [0099] of Bartos, [I]t can be concluded that, if an opening and closing is recognized, at least one dose of the medicament 203 has been removed from the medicament container 200 and taken by a patient. Paragraph [0116] of Bartos, By opening the lid 201 the magnet of the detection unit 204 may be moved closer towards or further away from the detector device 102, thereby activating the magnet switch of the detector device 102. This can generate a signal that can be read by the data processing device 103. Paragraph [0009] of Lebrun, The smart pill organizer device may also be pre-programmed with scheduled doses. If a dose is taken (i.e., at a current time) within a pre-programmed dose interval, then the dose will be automatically recorded and a reminder will not occur… [A] software application of the present invention that is running, e.g. on a system server, may send a reminder if a dose is not recorded, by the pre-programmed time. In the instant application, the broadest reasonable interpretation of “determining whether a current time is a time for medication based on one or more medication regimens” reads on the step in Bartos (Paragraph [0116]) of recording that the dose has been taken (i.e., at a current time) within a pre-programmed dose interval.);
determining whether or not the lid is opened from a remainder of the container subassembly (Paragraph [0116] of Bartos, [T]he detection unit 204 can comprise or be formed by a magnet that interacts with the detector device 102 which, in this case, preferably comprises a magnetic switch, magnetic sensor or the like. By opening the lid 201 the magnet of the detection unit 204 may be moved closer towards or further away from the detector device 102, thereby activating the magnet switch of the detector device 102. This can generate a signal that can be read by the data processing device 103. In the instant application, the broadest reasonable interpretation of “determining whether or not the lid is opened from a remainder of the container subassembly” reads on the step in Bartos (Paragraph [0116]) of activating the magnet switch of the detector device (i.e., in response to opening the lid 201 and moving the magnet of the detection unit 204 closer towards or further away from the detector device 102) thereby generating a signal that can be read by the data processing device.); and
providing a reminder to the user if it is determined that the lid has not been opened from a remainder of the container subassembly (Paragraph [0099] of Bartos, [I]t can be concluded that, if an opening and closing is recognized, at least one dose of the medicament 203 has been removed from the medicament container 200 and taken by a patient. Paragraph [0088] of Lebrun, The smart pill organizer device 90 is able to be pre-programmed with scheduled doses. If a dose is taken within a pre-programmed dose interval, then the dose will be automatically recorded and a reminder will not occur. If the dose is not taken, then the organizer device will emit a reminder… [A] software application of the present invention that is running on a system server may send a reminder if a dose is not recorded by the pre-programmed time.).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bartos in view of Lebrun and Rieb and as applied to claim 3, and further in view of Sundholm (U.S. Pub. No. 2018/0142418 A1).
Bartos in view of Lebrun and Rieb and as applied to claim 3 teaches the limitation in bold as “the paper, cardboard, or paperboard” (Paragraph [0017] of Bartos, The proposed solutions allow for the immediate use of a commercially available medicament container, such as a common pill bottle or a cardboard package often containing a number of single doses on a blister.).
Bartos in view of Lebrun and Rieb and as applied to claim 3 does not appear to explicitly disclose, but Sundholm teaches the limitation in bold as “the paper, cardboard, or paperboard is laminated in a latex material” (Paragraph [0066] of Sundholm, A paperboard product, preferably a barrier packaging paperboard product can be made by using paperboard according to the present invention. By using a multilayer coating process with multiple coating units it is possible to create paperboard suitable for many new end-use areas, currently unforeseen. The new packaging materials thus created from the multilayer coated paperboard with the coating technology of the present invention provide practically unlimited combinations between dispersion and pigment coating formulae and enable entering totally new markets. For example the produced coated paperboard may be suitable for products, such as hot cup, cold cup, espresso cup, medicine pill dosing cup, cereal or powder box, cereal or powder bag, or barrier coated paperboard products. The use of the multilayer paperboard structure of the present invention allows reaching low basis weight, which creates new end use areas, such as medicine pill dosing cups. Paragraph [0026] of Sundholm, According to the present invention a first coating composition is applied on the first surface of the paperboard web in a precoating unit. Thus a precoating layer comprising inorganic mineral filler particles and at least one binder is formed on the first surface. The precoating layer is needed for sealing or closing the pore structure of the paperboard surface. The materials of the succeeding second and third coating compositions are effectively prevented from penetrating into the base paperboard web by using said precoating with the precoating composition. Paragraph [0027] of Sundholm, The binder in the first precoating composition may be synthetic polymer latex, polyvinyl alcohol or starch. Preferably the binder is a synthetic latex or starch, more preferably styrene butadiene latex or polyvinyl acetate latex. Paragraph [0031] of Sundholm, The second coating composition may be latex dispersion, preferably synthetic latex dispersion, polyvinyl alcohol dispersion or polyolefin dispersion. Suitable synthetic latexes that may be used are latexes known in the art, such as styrene butadiene (SB) latex; acrylate latex, such as styrene acrylate (SA) latex or methyl methacrylate latex; or polyvinyl acetate (PVAc) latex, or any of their mixtures, copolymers or derivatives thereof. Paragraph [0036] of Sundholm, The third coating composition comprises a polymer dispersion for producing the heat sealable coating layer... The synthetic hydrocarbon polymer dispersion is preferably polyvinyl acetate latex or styrene-butadiene latex, possibly also styrene acrylate latex. In the instant application, it is determined that the broadest reasonable interpretation of “that the paper, cardboard, or paperboard is laminated in a latex material” reads on the multilayer coating of Sundholm (Paragraphs [0026], [0027], [0031], [0036], and [0066]) having the first, second, and third coating compositions each being a latex).
Therefore, it would have been obvious to one of ordinary skill in the art of medication monitoring systems at the time of the filing to modify the paper, cardboard, or paperboard of Bartos in view of Lebrun and Rieb and as applied to claim 3 such that the paper, cardboard, or paperboard is laminated in a latex material, as taught by Sundholm (Paragraphs [0026], [0027], [0031], [0036], and [0066]) in order to provide method for manufacturing recyclable, preferably fully recyclable, coated paperboard (Paragraph [0007] of Sundholm) and provide recyclable, preferably fully recyclable, coated paperboard, which is durable while having a thin and resistant coating thereon (Paragraph [0008] of Sundholm).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Bartos in view of Lebrun and Rieb and as applied to claim 12, and further in view of NPL Meng (Meng, F., et al., “Design and fabrication of very-low-cost engineering experiments via 3-D printing and vacuum forming,” International Journal of Mechanical Engineering Education. 2019).
Bartos in view of Lebrun and Rieb and as applied to claim 1 teaches the limitation in bold as “a liner for each of the one or more compartments or the plastic insert” (Paragraphs [0011] and [0059] of Lebrun, Material: The material of the dose unit lid 118 and/or bottom container 119 is ideally a food grade or medication-grade plastic material.).
Bartos in view of Lebrun and Rieb does not appear to explicitly disclose, but NPL Meng teaches the limitation in bold as “the plastic insert is made from vacuum-formed glycol-modified polyethylene terephthalate”(Page 253 of NPL Meng, Vacuum forming also brings a number of advantages beyond the ability to produce many identical copies. There are many attractive materials choices amenable to vacuum forming. In this project polyethylene terephthalate glycol (PETG) was chosen as the primary material to vacuum form hardware in.)
Therefore, it would have been obvious to one of ordinary skill in the art of medication monitoring systems at the time of the filing to modify the liner or plastic insert of Bartos in view of Lebrun and Rieb such that the plastic insert is made from vacuum-formed glycol-modified polyethylene terephthalate, as taught by NPL Meng (Page 253) in order to provide blister packaging of retail products that is inexpensive, completely nontoxic, tough, and attractive; provide blister packaging that can be dropped to the ground from chest height without shattering and with no damage; and provide low cost, safe, and very rugged blister packaging (Page 253 of NPL Meng).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Bartos in view of Lebrun and Rieb and as applied to claim 1, and further in view of Akdogan (U.S. Pub. No. 2016/0042151 A1).
Bartos in view of Lebrun and Rieb and as applied to claim 1 teaches the limitation in bold as “the medication comprises an injectable, an inhaler, or a pill”(Paragraph [0019] of Bartos, Preferably, the term “medicament” generally relates to medical resources for the treatment of a patient. Its meaning is therefore not limited to medicine that is to be ingested by the patient, but also includes doses of medicament for injection and/or inhalation as well as additional aids that are needed for the application of a treatment, such as syringes, surgical needles or the like. Paragraph [0020] of Bartos, Preferably, the term “medicament container” relates to a packaging containing multiple preferably pre-metered doses of a medicament. In particular, the packaging can be a bottle, such as a pill bottle, containing multiple tablets, capsules, suppositories or the like. The packaging may be a card box containing a medicament, preferably in the form of tablets, capsules or suppositories, in particular in one or more pocket blisters. Alternatively, the medicament container may optionally contain a liquid, a powder, pre-filled syringes for injections, and/or inhalers, or the like.).
Bartos in view of Lebrun and Rieb and as applied to claim 1 does not appear to explicitly disclose, but Akdogan teaches the limitation in bold as “the medical equipment comprises an alcohol swab, a disinfectant, a bandage, or a lancet” (Paragraph [0026] of Akdogan, While consumables may include items for consumption in the conventional sense of ingestion as described above, consumables may also or instead include disposable items or the like that are intended for one time use. Thus, as used herein a “disposable” may be any consumable intended for a use other than ingestion. This may, for example, include disposable medical items such as dressings, bandages, Band-Aids, gauze, syringes, thermometers, individually packaged units of antibacterials and the like, as well as other items such as hearing aids, contact lenses and so forth that can be dispensed in individual units for one time use. This may also or instead include continuous form items not intended for ingestion including personal care items such as toothpaste, toothpicks, soap, sanitizer, moisturizer, cotton swabs and the like, as well as other household items such as glue, batteries, latex gloves, and so forth. All such disposables may be a form of consumable as those terms are used herein, and consumables may similarly be a form of dispensable.).
Therefore, it would have been obvious to one of ordinary skill in the art of medication monitoring systems at the time of the filing to modify the medical equipment of Bartos in view of Lebrun and Rieb and as applied to claim 1 such that the medical equipment comprises an alcohol swab, a disinfectant, a bandage, or a lancet, as taught by Akdogan (Paragraph [0026]) in order to retrieve and dispense medication and medical equipment from a mixture of one or more dispensable units of arbitrary size, orientation, texture, and weight (Paragraph [0004] of Akdogan).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Bartos in view of Lebrun and Rieb and as applied to claim 1, and further in view of routine optimization under MPEP 2144.05 (II)(A) and (B).
Regarding claim 16, Bartos in view of Lebrun and Rieb and as applied to claim 1 does not appear to explicitly disclose, but it would have been routing optimization to arrive at the limitation of “the unique identifier is a Medium Access Control (MAC) ID or an International Mobile Equipment Identity (IMEI)” because a person of ordinary skill in the art would have a reasonable expectation of success to include the unique identifier in the specific claimed form of a Medium Access Control (MAC) ID or an International Mobile Equipment Identity (IMEI). The unique identifier comprising a MAC ID or IMEI represents a result-effective variable, i.e., a variable which achieves a recognized result (i.e., the claimed functions of the unique identifier). The Office has further determined that there are a finite number of identified, predictable types of unique identifiers, such that a person of ordinary skill has good reason to pursue the known options (i.e., the MAC ID or the IMEI) within his or her technical grasp, and there is a reasonable anticipation that either option would succeed in performing the claimed function of the unique identifier.
Response to Amendment
Applicant's arguments filed March 30, 2026 regarding claims 1 and 7 invoking 35 USC §112(f) have been fully considered but they are not persuasive.
In Applicant’s Response filed on November 18, 2025 (Second Paragraph to Third Paragraph on Page 7), Applicant argued that the claimed “communication module” is a definite structural component that should not be considered under 112(f). Applicant did not respond to the Office’s determination that the word “module” is a generic placeholder or that the word “communication” is functional language (as provided in detail in the Final Office Action dated June 3, 2025, and Non-Final Office Action dated September 23, 2025), but rather made the bare conclusion that the combined limitation “communication module” provides sufficient structure. Thus, the Office respectfully disagrees in view of the detailed analysis required under MPEP 2181, and set forth in the body of the present Office Action.
Applicant's arguments filed March 30, 2026 regarding claims 1 – 14 and 16 – 17 being rejected under 35 USC § 103 have been fully considered but they are not persuasive and are moot in view of the new grounds of rejection.
In Applicant’s Response filed on March 30, 2026, Applicant amended claim 1 to amend the last limitation as follows “wherein the electronics subassembly comprises a unique identifier configured to associate the electronics subassembly with the container subassembly of the medication monitoring system, [[and]] wherein the unique identifier is configured to pair the medication monitoring system stored in a cloud system prior to the user's receipt of the medication monitoring system such that the one or more medication regimens for the user are preconfigured with the medication monitoring system, and wherein the medication monitoring system is automatically registered to communicate with the cloud system without user action,” which thus necessitates the new grounds of rejection and making the action final.
Conclusion
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/V.C.I./Examiner, Art Unit 3686
/DEVIN C HEIN/Examiner, Art Unit 3686
