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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 on 06/04/2026 has been entered. (Examiner's Note: Claims and arguments filed 05/08/2026)
Claims Pending
Applicants cancellation of withdrawn claim 7 in the response filed 05/08/2026 and previous withdrawal of claims 4-6 and 14-20 is acknowledged.
Claims 1-3 and 8-13 are the current claims hereby under examination.
Claim Interpretation – Previously Withdrawn
Applicant’s arguments, filed 11/12/2025, have been fully considered, and the previous interpretation withdrawn.
(Examiner's Note: The applicant’s argument, that “circuit” did not invoke 112f was considered, and deemed as persuasive).
(Examiner's Note: The applicant’s claims are viewed in light of the specification, and as such, the “digestible circuit” is considered to be an edible circuit made of graphene, nanobots, or vitamins (Par. 36 of applicant’s spec.)).
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 1-3 and 8-13 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 “wherein the first circuit transmits the information related to the first medication for a same duration as the second thickness of the second digestible material takes to dissolve in the gastric juices of the user”, which fails to effectively define the metes and bounds of the claim as it is unclear as to the duration that the first circuit transmits. As is presented within the claim, the claim indicates that these are the same duration. However, what is this duration? Does “same duration” signify that they occur at the same time? Do they occur at different times? Do they just each individually last for the same quantity of time? Claim 1 further recites “wherein the first circuit stops transmitting the information after a predetermined duration in response to the first circuit being dissolved”, which indicates an ending to the transmission, however, where did the transmission begin? The applicant’s specification does state “first edible circuit 125 transmits for the same duration as second layer 120 takes to dissolve” (Par. 42 of the applicant’s spec.). As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as “At time T1, first layer 110 is sufficiently dissolved to expose second layer 120 and first edible circuit 125 to the gastric juices. As time progresses from time T1 to time T2, second layer 120 dissolves and first edible circuit 125 transmits.” (Par. 41 of the applicant’s spec.), wherein “first edible circuit 125 transmits for the same duration as second layer 120 takes to dissolve” (Par. 42 of applicant’s spec.), and wherein the circuit stops transmitting upon dissolving (Par. 39 of applicant’s spec.).
Claim 1 recites the limitation “wherein the first circuit stops transmitting the information after a predetermined duration in response to the first circuit being dissolved”, which fails to effectively defines the metes and bounds of the claim as it is unclear as to the meaning behind the word “dissolved”. For example, from the moment the circuit is dissolved, is there then a time period in which the circuit is still functioning? How is there a duration that the circuit still functions after it has been dissolved? For example, the applicant’s specification states “when a particular layer of material (coating) is dissolved, an edible circuit will be exposed to gastric juices and, after a certain duration, the edible circuit will be dissolved and will stop sending signals.” (Par. 39 of applicant’s spec.), which appears to indicate that the circuit stops transmitting upon being dissolved. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as the circuit stopping transmission of signals upon being dissolved (Par. 39 of applicant’s spec.).
Claim 1 recites the limitation “wherein the first circuit stops transmitting the information after a predetermined duration in response to the first circuit being dissolved”, which fails to effectively defines the metes and bounds of the claim as it is unclear as to whether this “predetermined duration” is the “same duration” as previously recited within the claim, or if it is an entirely different duration. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this limitation will be interpreted as the circuit stopping transmission of signals upon being dissolved (Par. 39 of applicant’s spec.).
Claim 1 recites the limitation “wherein the first circuit stops transmitting the information after a predetermined duration”, which fails to effectively define the metes and bounds of the claim, as it is unclear as to the exact “information” being referred to. Is this the “information related to the first medication”? Or is this a different piece of information? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, the “information” will be interpreted as being -the information related to the first medication-.
Claim 8 recites the limitation “wherein the transmitting by the first circuit begins as a result of the first circuit being contacted by the gastric juices of the user”, which fails to effectively define the metes and bounds of the claim as it is unclear as to the duration that the first circuit transmits. For example, claim 1, which claim 8 is dependent on, recites “wherein the first circuit transmits the information related to the first medication for a same duration as the second thickness of the second digestible material takes to dissolve in the gastric juices of the user”, which indicates that the first circuit transmits for a “same duration” where the second digestible material also dissolves in the gastric juices. However, claim 8 recites “wherein the transmitting by the first circuit begins as a result of the first circuit being contacted by the gastric juices of the user”, which only indicates that the first circuit is contacted by the gastric juices. Does this also include the second digestible material being contacted by the gastric juices? Does the moment the gastric juices contact the first circuit, the second digestible material begin to dissolve? Does this involve the “same duration” as indicated in claim 1 above? Does this occur at a separate time other than that of the “same duration”? As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as involving the same duration as in claim 1, which includes the second digestible material being contacted by the gastric juices.
Claims 2-3 and 8-13 are dependent on claim 1, and as such are also rejected.
Claim Rejections - 35 USC § 103 - Withdrawn
The claims are generally directed towards a method of transmitting information regarding medication ingested by a user. The transmission is performed by digestible circuits that are covered by a digestible materials.
Applicant’s amendments, filed 05/08/2026, have been fully considered and the previous rejection withdrawn.
Allowable Subject Matter
Claims 1-3 and 8-13 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The closest prior art of record includes over Nunez (US Pub. No. 20090009332) hereinafter Nunez, Hafezi (US Pub. No. 20100298668) hereinafter Hafezi, Savage (US Pub. No. 20200229758) hereinafter Savage, Ayer (US Pub. No. 20050131281) hereinafter Ayer, Belsky (US Pub. No. 20080188837) hereinafter Belsky, Lewis (US Pub. No. 20030198677) hereinafter Lewis, Euliano (US Pat. No. 10521561) hereinafter Euliano, and Skulason (US Pub. No. 20020173993) hereinafter Skulason.
Regarding claim 1, Nunez discloses a method (Par. 41, Fig. 13 (the manner in which the device transmits)) comprising:
transmitting, by a first circuit (Par. 41, (RFID tag – 314)) to outside a user's body, information related to a first medication ingested by the user (Par. 41, “In one embodiment, second coating layer 308 is modified within the gastrointestinal system before first coating layer 306 is modified within the gastrointestinal system such that additional RFID tag 314 generates a signal that is transmitted to an external receiver indicative of ingestion by the subject of the medication to which multiple RFID tag assembly 310 is coupled”), the first circuit being covered by a first thickness of a first material (Par. 41, “In one embodiment, second coating layer 308 is modified within the gastrointestinal system before first coating layer 306 is modified within the gastrointestinal” (the coating layer modified within the gastrointestinal system is a digestible material)) (Fig. 13, (observable that RFID – 314 is covered by second coating layer – 308)) (Par. 35 “coating layer…” “…is modified, such as dissolved or absorbed, within the patient's gastrointestinal system” (the coating layer being modified within the gastrointestinal system also means the coating layer is dissolved or absorbed within the gastrointestinal system, meaning that it is a digestible material)); and
transmitting, by a second circuit to outside the user's body (Par. 41, (RFID tag – 302)), information related to a second medication ingested by the user (Par. 41, “After first coating layer 306 is modified within the subject's gastrointestinal system, RFID tag 302 generates a signal that is transmitted to an external receiver indicative of digestion by the subject of the medication to which multiple RFID tag assembly 310 is coupled.”), the second circuit being covered by a second thickness of a second material and the first thickness of the first material (Par. 41, “After first coating layer 306 is modified within the subject's gastrointestinal system, RFID tag 302 generates a signal that is transmitted to an external receiver indicative of digestion by the subject of the medication to which multiple RFID tag assembly 310 is coupled”(the coating layer modified within the gastrointestinal system is a digestible material)) (Fig. 13, (observable that RFID – 302 is covered by second coating layer – 308 and first coating layer 314 in a vertical direction)) (Par. 35 “coating layer…” “…is modified, such as dissolved or absorbed, within the patient's gastrointestinal system” (the coating layer being modified within the gastrointestinal system also means the coating layer is dissolved or absorbed within the gastrointestinal system, meaning that it is a digestible material)).
Nunez fails to explicitly disclose the first circuit being digestible by gastric juices of the user and the second circuit being digestible by gastric juices of the user.
However, Nunez does teach the circuit being digestible by gastric juices of the user (Par. 7, “Other conventional methods for monitoring medication compliance include a digestible RFID tag that breaks up within the gastrointestinal system when the medicine is processed”).
Hafezi teaches the circuit being digestible by gastric juices of the user (Par. 21, “In certain embodiments, one or more of the ingestible materials of the circuits are digestible materials.”).
Modified Nunez fails to explicitly disclose a first digestible material and a second digestible material.
However, Nunez highly suggests a first digestible material (Par. 41, “In one embodiment, second coating layer 308 is modified within the gastrointestinal system before first coating layer 306 is modified within the gastrointestinal” (it is highly suggested that the coating layer modified within the gastrointestinal system is a digestible material)) and a second digestible material (Par. 41, “After first coating layer 306 is modified within the subject's gastrointestinal system, RFID tag 302 generates a signal that is transmitted to an external receiver indicative of digestion by the subject of the medication to which multiple RFID tag assembly 310 is coupled”) (The embodiment of Par. 35 states “coating layer 112 is modified, such as dissolved or absorbed, within the patient's gastrointestinal system”, which highly suggests that when Nunez states “second coating layer 308 is modified within the gastrointestinal system before first coating layer 306 is modified within the gastrointestinal system” (Par. 41), that Nunez also means that coating layers 308 and 306 are also able to be absorbed within the patients gastrointestinal system).
Modified Nunez fails to explicitly disclose wherein the first circuit stops transmitting the information after a predetermined duration in response to the first circuit being dissolved. (Examiner's Note: Interpreted under 112b as indicated above).
However, Nunez does teach information after a predetermined duration in response to the circuit being disintegrated (Par. 45, “As shown in FIG. 20, RFID tag device 400 is modified as medication tablet 414 is digested within the patient's gastrointestinal system. Substrate layer 404 and medication tablet 414 are dissolved or disintegrated in an alternate embodiment wherein the circuit stops transmitting the during the digestion process, resulting in the breakup of RFID tag 402 into disconnected pieces, such as piece 430 and piece 432 of RFID tag 402. The loss or cessation of the signal due to the breakup of RFID tag 402, as determined by the external receiver and/or the external transmitter, facilitates confirming that medication tablet 414 has been digested by the subject”) (Par. 41, “FIG. 20 shows a breakup, such as a disassociation, dissolution or disintegration, of RFID tag 402 after digestion by the subject of the medication tablet including RFID tag device 400.”) (Par. 7, “Other conventional methods for monitoring medication compliance include a digestible RFID tag that breaks up within the gastrointestinal system when the medicine is processed, resulting in a loss of the RFID signal and, thus, an indication that the medicine has been digested”).
However, Savage teaches wherein the first circuit stops transmitting the information after a predetermined duration in response to the first circuit being dissolved (Par. 75, “As dissolution of the tablet/pill composition 312 exposes metal layers 304 and 306, power is supplied to the IC of the IEM 300, which begins to operate and continues to operate until metal layers 304 and 306 or the circuit itself are sufficiently dissolved by digestive processes and acids to become non-functional. When power is supplied, the IEM 300 may transmit its identifying signal (e.g., IEM identifier code) via transmitter electrodes 308 and 310. Eventually, any remains of the IEM 300 are naturally excreted from the body.”).
Modified Nunez fails to explicitly disclose wherein the first circuit transmits the information related to the first medication for a same duration as the second thickness of the second digestible material takes to dissolve in the gastric juices of the user. (Examiner's Note: Interpreted under 112b as indicated above).
Nunez does disclose a substate layer that breaks up during digestion, which results in a signal cessation by the RFID (Par. 45, “As shown in FIG. 20, RFID tag device 400 is modified as medication tablet 414 is digested within the patient's gastrointestinal system. Substrate layer 404 and medication tablet 414 are dissolved or disintegrated in an alternate embodiment wherein the circuit stops transmitting the during the digestion process, resulting in the breakup of RFID tag 402 into disconnected pieces, such as piece 430 and piece 432 of RFID tag 402. The loss or cessation of the signal due to the breakup of RFID tag 402…”) (Par. 41, “FIG. 20 shows a breakup, such as a disassociation, dissolution or disintegration, of RFID tag 402 after digestion by the subject of the medication tablet including RFID tag device 400.”) (Par. 7, “Other conventional methods for monitoring medication compliance include a digestible RFID tag that breaks up within the gastrointestinal system when the medicine is processed, resulting in a loss of the RFID signal and, thus, an indication that the medicine has been digested”). However, Nunez makes no indication that the transmission occurs during the same duration that the digestible material takes to dissolve.
Ayer teaches dissolvable layers and dissolvable circuits that dissolve at varying rates (Par. 29, “the number of dissolvable layers and/or the number of dissolvable circuit elements may be greater than one and their removal may be spaced in time (e.g. they may dissolve at different rates). In such embodiments, as the object 1 is affected by the environment of the digestive system, several data are transmitted to the sensor 2 as different layers or elements are removed at different times. The data-carrying capacity of the circuit 5 is thus effectively increased.”).
Wang teaches switching to an on or off configuration after a coating is sufficiently dissolved (Par. 280, “the RFID chip 202 of the ingestible apparatus 100 may continuously transmit RF signals during the entire health-related-substance-delivery process. In the initial state T.sub.A, the switches S.sub.1 and S.sub.2 are configured to their open or off configuration and the RFID chip 202 transmits a first RF signal with a first set of property settings (such as amplitude, frequency, modulation, coding, and/or the like). When the shell 102 and the coating 104 are sufficiently deformed and the ingestible apparatus 100 is in the state T.sub.C, the first switch S.sub.1 is configured to its closed or on configuration by the gastrointestinal content which triggers the RFID chip 202 to transmit a second RF signal with a second set of property settings”).
Lewis teaches a controlled release tablet with varying release profiles (Par. 81, 83 (varying thickness and release rate)) (Par.85, Fig. 6A-B (varied Layer thickness)) (Par. 93 (differing release profiles)).
The prior art of record fails to disclose, teach, or suggest “wherein the first circuit transmits the information related to the first medication for a same duration as the second thickness of the second digestible material takes to dissolve in the gastric juices of the user” (Examiner's Note: Interpreted under 112b above).
Response to Arguments
Applicant's amendments filed 05/08/2026, regarding the previous 103 rejection, have been fully considered, and the previous rejection withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Sarkar (US Pub. No. 20210128013), Kartoun (US Pub. No. 20220168551).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARI SINGH KANE PADDA whose telephone number is (571)272-7228. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ARI S PADDA/ Examiner, Art Unit 3791
/JASON M SIMS/ Supervisory Patent Examiner, Art Unit 3791
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