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 .
Claims Pending
Applicant's arguments, filed 11/24/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 11/24/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicant’s previous cancellation of claims 2-4, 22-30, 33, and 35-67 is acknowledged.
Claims 1, 5-21, 31-32, 34, and 68-73 the current claims hereby under examination
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 claims are generally directed towards an ingestible device. The device comprises a housing, an actuation assembly to collect or discharge substances, a delay structure, and a circuit to provide RF signals to indicate states of the ingestible device.
Claim(s) 1, 5, 7-9, 11-12, 21, 31-32, 34, 68-69, and 72-73 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jones (US Pub. No. 20180070857) hereinafter Jones, and further in view of Arora (US Pat. No. 10588823) hereinafter Arora.
Regarding claim 1, Jones discloses An ingestible apparatus (ingestible device – 100) for collecting samples from a target area of a gastrointestinal (GI) tract of a human or mammal (Par. 493, “This may allow ingestible device 65100 to obtain a fluid sample from the GI tract, or release a substance into the GI tract, through opening 65116.”) and/or for delivering a health-related substance thereto (Par. 5), the ingestible apparatus comprising:
a housing (Fig. 1, housing – 101) comprising at least one first port (Fig. 1, port – 107) and at least a first compartment (Par. 315, storage reservoir – 135, “a storage reservoir that stores the dispensable substance 105”) communicable with the at least one first port (Par. 315, “In this way, the membrane or traveling plunger 104 may push the dispensable substance 105 out of the housing via a dispensing outlet 107.”);
an actuation assembly (combination of piston - 134 and gas-generating cell – 103) for changing one or more conditions of the first compartment to collect the samples and/or discharge the health-related substance through the at least one first port (Par. 315, “The traveling plunger or the membrane 104 may move (when the membrane 104 is a piston) or deform (when the membrane 104 is a diaphragm) towards a direction of the end 102a of the housing…” “…the membrane or traveling plunger 104 may push the dispensable substance 105 out of the housing via a dispensing outlet 107.”)(Fig. 3, Par. 334, “In this way, gas generation from the gas-generating cell 103 may propel the piston 134 to move towards the other end 102b of the housing 101”, (the propulsion of the piston is removing the substance from the compartment)), the actuation assembly having at least a first position (Fig. 3, Par. 334, “In this way, gas generation from the gas-generating cell 103 may propel the piston 134 to move towards the other end 102b of the housing 101” (position when storage reservoir – 134 is full)) and a second position (Fig. 3, Par. 334, “The storage reservoir 135 may have a volume of approximately 600 μL or even more dispensable substance, which may be dispensed at one shot, or gradually over a period of time.” (position when storage reservoir 134 is empty) (Par. 334, “In this way, gas generation from the gas-generating cell 103 may propel the piston 134 to move towards the other end 102b of the housing 101”).
Jones fails to explicitly disclose a delay structure for delaying the actuation assembly to change the one or more conditions of the first compartment until the ingestible apparatus is within the target area.
However, Jones teaches in an alternative embodiment a delay structure (Par. 405, short-delay enteric coating- 371b, long-delay enteric coating – 371a) for delaying the actuation assembly to change the one or more conditions of the first compartment until the ingestible apparatus is within the target area (Par. 406, (the piston is actuated after the enteric coating is dissolved))(Par. 474, “will dissolve the short delay enteric coating. With proper design of the capsule 6300, it can be ensured that the coating will fully dissolve as the capsule 6300 reaches the target area.” (the enteric coating delays dissolving until it is at the target area)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the apparatus of Jones with that of Jones to include a delay structure for delaying the actuation assembly to change the one or more conditions of the first compartment until the ingestible apparatus is within the target area through the combination of embodiments as it would have yielded the predictable result of dissolving and actuating depending on the pH level (Jones (Par. 310)).
Modified Jones fails to explicitly disclose a circuit structure, the circuit structure having a first configuration when the actuation assembly is in the first position to provide a radio-frequency (RF) signal having a first set of property settings to indicate a first state of the ingestible apparatus and having a second configuration when the actuation assembly is in the second position to provide an RF signal having a second set of property settings to indicate a second state of the ingestible apparatus.
However, Jones does disclose when the actuation assembly is in the first position (Fig. 3, Par. 334, “In this way, gas generation from the gas-generating cell 103 may propel the piston 134 to move towards the other end 102b of the housing 101” (position when storage reservoir – 134 is full)) and when the actuation assembly is in the second position (Fig. 3, Par. 334, “The storage reservoir 135 may have a volume of approximately 600 μL or even more dispensable substance, which may be dispensed at one shot, or gradually over a period of time.” (position when storage reservoir 134 is empty) (Par. 334, “In this way, gas generation from the gas-generating cell 103 may propel the piston 134 to move towards the other end 102b of the housing 101”).
However, Arora teaches a circuit structure (Col. 6, lines 24-32 (passive RF transceiver and antenna)), the circuit structure having a first configuration when the actuation assembly is in the first position to provide a radio-frequency (RF) signal having a first set of property settings to indicate a first state of the ingestible apparatus (Col. 9-10, lines 38-10 (RF signals at ingestion state)) (Fig. 7-9 (programable encapsulation)) (Col. 11, lines 44-67 (ingestion time)) (Fig. 3 (programmable encapsulation 301)) (Col. 6, lines 13-37 (ingestion state)) and having a second configuration when the actuation assembly is in the second position to provide an RF signal having a second set of property settings to indicate a second state of the ingestible apparatus (Col. 9-10, lines 38-10 (RF signals at release state)) (Fig. 7-9 (programable encapsulation)) (Col. 11, lines 44-67 (release time)) (Fig. 3 (programmable encapsulation 301)) (Col. 6-7, lines 60-6 (release)).
Jones and Arora are considered to be analogous art to the claimed invention as they are both involved with ingestible devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the apparatus of Jones with that Arora to include a circuit structure, the circuit structure having a first configuration when the actuation assembly of Jones is in the first position to provide a radio-frequency (RF) signal having a first set of property settings to indicate a first state of the ingestible apparatus and having a second configuration when the actuation assembly of Jones is in the second position to provide an RF signal having a second set of property settings to indicate a second state of the ingestible apparatus through the combination of references as passive and active RFID chips are known in their use for low power requirements (Arora (Col. 6, lines 24-32)) and it would have yielded the predictable result of monitoring the status of the medication (Arora (Col. 9-10, lines 38-10)(Col. 11, lines 44-67)).
Regarding claim 5, modified Jones further discloses wherein the circuit structure further comprises a first detection-circuit for detecting a gastrointestinal content in the GI tract as arrival of the ingestible apparatus within the target area (Jones (Par. 501, “pH measurements (e.g., via a pH meter within ingestible device 65300)”)).
Regarding claim 7, modified Jones further discloses wherein the delay structure (Jones (Par. 310, “The housing 101 may or may not have a pH-sensitive enteric coating to detect or otherwise be sensitive to a pH level of the environment external to the ingestible device.”))comprises an isolation structure configured for isolating the first detection-circuit (Jones (Par. 501, (pH meter is inside of the housing)) from the gastrointestinal content (Jones (Par. 310, (the enteric coating surrounds the entire device))), the isolation structure dissolvable when contacting the gastrointestinal content (Jones (Par. 310 (enteric coating))).
Regarding claim 8, modified Jones further discloses wherein the actuation assembly comprises:
a piston, at least a portion of the piston movably received in the housing (Jones (Par. 334, Fig. 3, piston – 134, housing – 101)); and
a first actuation structure (Jones (Par. 334, gas generating cell – 103)) for actuating the piston along a first direction to change the volume of the first compartment (Jones (storage reservoir – 134)) between a first volume (Jones (when storage reservoir – 134 is full)) and a second volume (Jones (Par. 334, “In this way, gas generation from the gas-generating cell 103 may propel the piston 134 to move towards the other end 102b of the housing 101”) (Par. 334, “The storage reservoir 135 may have a volume of approximately 600 μL or even more dispensable substance, which may be dispensed at one shot, or gradually over a period of time.”) (when storage reservoir – 134 is empty)).
Regarding claim 9, modified Jones further discloses wherein the actuation assembly comprises:
a piston, at least a portion of the piston movably received in the housing (Jones (Par. 334, Fig. 3, piston – 134, housing – 101)); and
a first actuation structure (Jones (Par. 334, gas generating cell – 103)) for actuating the piston along a first direction to change the volume of the first compartment (Jones (storage reservoir – 134)) between a first volume (Jones (when storage reservoir – 134 is full)) and a second volume (Jones (Par. 334, “In this way, gas generation from the gas-generating cell 103 may propel the piston 134 to move towards the other end 102b of the housing 101”) (Par. 334, “The storage reservoir 135 may have a volume of approximately 600 μL or even more dispensable substance, which may be dispensed at one shot, or gradually over a period of time.”) (when storage reservoir – 134 is empty)).
Regarding claim 11, modified Jones fails to explicitly disclose the limitations of the claim.
However, Jones teaches an alternate embodiment wherein the first actuation structure comprises one or more biased springs (Jones (Par. 460, spring -5503)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the apparatus of Jones and Arora with that of Jones to include wherein the first actuation structure comprises one or more biased springs through the combination of references as it would have yielded the predictable result of providing a rapid delivery of the substance to the patient (Jones (Par. 460)).
Regarding claim 12, modified Jones fails to explicitly disclose the limitations of the claim.
However, Jones further teaches an alternate embodiment wherein the delay structure comprises a latch retaining the piston in a first position (Jones (Fig. 21 (the enteric coating – 187 is holding the latch and the entire device together))), the latch dissolvable when contacting the gastrointestinal content (Jones (Par. 369)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the apparatus of Jones and Arora with that of Jones to include wherein the delay structure comprises a latch retaining the piston in a first position, the latch dissolvable when contacting the gastrointestinal content through the combination of references as it would have yielded the predictable result of releasing the entirety of the substance all at once (Jones (Par. 369)).
Regarding claim 21, modified Jones further discloses further comprising a sealable component for sealably closing the at least one first port (Jones (hole -171)) to seal the first compartment (Jones (Par. 340, “The hole 171 may be sealed with thin wax or silicone, which may be broken by a force from inside of the housing 101 such that the dispensable substance can be released”)).
Regarding claim 31, modified Jones fails to explicitly disclose the limitations of the claim.
However, Jones does teach additional embodiments further comprising a second actuation structure (Jones (Gas channels – 303)) for actuating the piston along a second direction opposite to the first direction (Jones (Par. 381, The direction of piston 104 movement may be reversed, e.g., from one end of the ingestible device towards the center of the ingestible device.”) (Par. 493)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the apparatus of Jones and Arora with that of Jones to include further comprising a second actuation structure for actuating the piston along a second direction opposite to the first direction through the combination of embodiments as it would have yielded the predictable result of both sampling and releasing a substance (Jones (Par. 493)).
Regarding claim 32, modified Jones fails to explicitly disclose the limitations of the claim.
However, Jones does further teach an alternative embodiment further comprising a retaining block (Jones (Par. 104, (second enteric coating)))for retaining the second actuation structure at a biased configuration (Jones (Par. 104)), the retaining block dissolvable in a gastrointestinal content so as to allow the second actuation structure to actuate the piston after the piston is actuated by the first actuation structure (Jones (Par. 104)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the apparatus of Jones and Arora with that of Jones to include further comprising a retaining block for retaining the second actuation structure at a biased configuration, the retaining block dissolvable in a gastrointestinal content so as to allow the second actuation structure to actuate the piston after the piston is actuated by the first actuation structure for the reasoning as indicated in claim 31 above.
Regarding claim 34, Modified Jones fails to explicitly disclose the limitations of the claim.
However, Jones does teach in alternative embodiments wherein the ingestible apparatus (Jones (ingestible device – 100)) is configured for collecting samples from the target area of the GI tract of the human or mammal and for delivering the health-related substance thereto (Jones (Par. 493, “This may allow ingestible device 65100 to obtain a fluid sample from the GI tract, or release a substance into the GI tract, through opening 65116.”) (Par. 5) (Par. 494, “in some embodiments, the storage sub-unit 65118-3 may be loaded with a medicament or other substance prior to the ingestible device 65100 being administered to a subject.”)),
wherein the first compartment is configured for containing therein the health-related substance at an initial state (Jones (Par. 494, “in some embodiments, the storage sub-unit 65118-3 may be loaded with a medicament or other substance prior to the ingestible device 65100 being administered to a subject.”)) and is reconfigurable for receiving therein the samples after the health-related substance therein is discharged (Jones (Par. 494, “In some embodiments, the storage sub-unit 65118-3 may be configured to hold a fluid sample obtained from the GI tract.”) (Par. 493, “This may allow ingestible device 65100 to obtain a fluid sample from the GI tract, or release a substance into the GI tract, through opening 65116.”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the apparatus of Jones and Arora with that of Jones to include wherein the ingestible apparatus is configured for collecting samples from the target area of the GI tract of the human or mammal and for delivering the health-related substance thereto, wherein the first compartment is configured for containing therein the health-related substance at an initial state and is reconfigurable for receiving therein the samples after the health-related substance therein is discharged for the reasoning as indicated in claim 31 above.
Regarding claim 68, modified Jones fails to explicitly disclose the limitations of the claim. However, Arora further teaches wherein the circuit structure is configured to detect the first and second states of the ingestible apparatus based on a position of the actuation assembly (Arora (Col. 9-10, lines 38-10 (RF signals at ingestion state and release state)) (Fig. 7-9 (programable encapsulation)) (Col. 11, lines 44-67 (ingestion time and release)) (Col. 6, lines 13-37 (ingestion state)) (Fig. 3 (programmable encapsulation 301)) (Col. 6-7, lines 60-6 (release))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the apparatus of Jones and Arora with that of Arora to include wherein the circuit structure is configured to detect the first and second states of the ingestible apparatus based on a position of the actuation assembly of Jones through the combination of references for the reasoning as indicated in claim 1 above.
Regarding claim 69, modified Jones fails to explicitly disclose the limitations of the claim. However, Arora further teaches wherein the circuit structure (Arora (Col. 6, lines 24-32 (passive RF transceiver and antenna))) is configured to trigger a first signal-event when the ingestible apparatus arrives within the target area (Arora (Col. 9-10, lines 38-10 (RF signals at ingestion state)) (Fig. 7-9 (programable encapsulation)) (Col. 11, lines 44-67 (ingestion time)) (Fig. 3 (programmable encapsulation 301)) (Col. 6-7, lines 13-37 (ingestion state)))and to trigger a second signal-event when the sample collecting and/or the health-related-substance discharging is at an end (Col. 9-10, lines 38-10 (RF signals at release state)) (Fig. 7-9 (programable encapsulation)) (Col. 11, lines 44-67 (release time)) (Fig. 3 (programmable encapsulation 301)) (Col. 6-7, lines 60-6 (release)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the apparatus of Jones and Arora with that of Arora to include wherein the circuit structure is configured to trigger a first signal-event when the ingestible apparatus arrives within the target area and to trigger a second signal-event when the sample collecting and/or the health-related substance discharging is at an end through the combination of references for the reasoning as indicated in claim 1 above.
Regarding claim 72, modified Jones fails to explicitly disclose wherein the circuit structure comprises a passive radio-frequency identification (RFID) chip.
However, Arora further teaches wherein the circuit structure comprises a passive radio-frequency identification (RFID) chip (Arora (Col. 6, lines 24-32 (passive RF transceiver and antenna))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the apparatus of Jones and Arora with that of Arora to include wherein the circuit structure comprises a passive radio-frequency identification (RFID) chip for the reasoning as indicated in claim 1 above.
Regarding claim 73, modified Jones fails to explicitly disclose the limitations of the claim.
However, Arora further teaches wherein one or more of the RF signal having the first set of property settings to indicate the first state of the ingestible apparatus and the RF signal having the second set of property settings to indicate the second state of the ingestible apparatus (As indicated in claim 1 above) are provided using the RFID chip (Arora (Col. 6, lines 24-32 (passive RF transceiver and antenna))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the apparatus of Jones and Arora with that of Arora to include wherein one or more of the RF signal having the first set of property settings to indicate the first state of the ingestible apparatus and the RF signal having the second set of property settings to indicate the second state of the ingestible apparatus are provided using the RFID chip for the reasoning as indicated in claim 1 above.
Claim(s) 6, 10, 14-15, 18-19, and 70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jones in view of Arora as applied to claims 5, 1, and 12 above, and further in view of Trovato (US Pub. No. 20080194912) hereinafter Trovato.
Jones and Arora teach the apparatus of claim 5 above.
Regarding claim 6, modified Jones fails to explicitly disclose the limitations of the claim. However, Trovato teaches wherein the first detection-circuit (sensor module 902) comprises a first set of spaced electrodes (Par. 148, “sensors 904 of sensor module 902 may be disposed on the shell 102 and/or may be enclosed within the shell 102”) (Par. 152, “one of the sensors 904 is a pH sensor for sensing pH levels,”) forming a first switch in an off configuration, the first switch being switchable to an on configuration for triggering a signal-event (Par. 152, “The control signal may be provided, for example, to the medicament dispensing system 901 for dispensing the medicament or a portion thereof.”, (the release of the medication is the “on” condition)) when the first set of spaced electrodes engage the gastrointestinal content (Par. 152, “The pH control software module monitors sensing signals output by the pH sensor for determining when the capsule 900 has reached a desired location in the alimentary tract”).
Jones, Arora, and Trovato are considered to be analogous art to the claimed invention as they are involved with ingestible devices.
Therefore, it would have been further obvious to modify the apparatus of Jones and Arora with that of Trovato to include wherein the first detection-circuit comprises a first set of spaced electrodes forming a first switch in an off configuration, the first switch being switchable to an on configuration for triggering a signal-event when the first set of spaced electrodes engage the gastrointestinal content through the combination of references as it would have yielded the predictable result of releasing the medication at the optimal location in the GI tract (Trovato (Par. 152)).
Jones and Arora teach the apparatus of claim 1 above.
Regarding claim 10, modified Jones fails to explicitly disclose the limitations of the claim.
However, Trovato teaches wherein the one or more conditions of the first compartment (reservoir – 104) comprises at least a volume of the first compartment (Par. 84, “the cumulative quantity of medicament dispensed from the beginning of the dispensing time period to a particular moment in time of the dispensing time period;”) (Par. 167, “The individual chambers 1402 may be equipped with a sensor for sensing the presence of a fluid sample or a volume of the sample”).
Therefore, it would have been further obvious to modify the apparatus of Jones and Arora with that of Trovato to include wherein the one or more conditions of the first compartment comprises at least a volume of the first compartment through the combination of references as it would have yielded the predictable result of directly informing the user on the quantity of medication that is left to be dispensed.
Jones and Arora teach the apparatus of claim 12 above.
Regarding claim 14, modified Jones fails to explicitly disclose the limitations of the claim.
However, Trovato teaches wherein the circuit structure further comprises a second detection-circuit for detecting a movement of the actuation assembly as an end of the sample collecting and/or the health related-substance discharging (Par. 167, “The individual chambers 1402 may be equipped with a sensor for sensing the presence of a fluid sample or a volume of the sample, which may function to trigger the associated closure member(s) 1406 to close.”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the apparatus of Jones and Arora with that of Trovato to include wherein the circuit structure further comprises a second detection-circuit for detecting a movement of the actuation assembly as an end of the sample collecting and/or the health related-substance discharging through the combination of references as it would have yielded the predictable result of directly informing the provider when the device is finished with providing the medication.
Regarding claim 15, modified Jones fails to explicitly disclose the limitations of the claim.
However, Trovato further teaches wherein the second detection- circuit comprises a second set of spaced electrodes forming a second switch in an off configuration (Trovato (closure members – 966)), the second switch being switchable to an on configuration when the second set of spaced electrodes engage an electrically conductive surface after the movement of the actuation assembly (Trovato (Claim 6, “wherein respective closure members (966) comprise an artificial muscle including a polymer which selectably contracts and expands in response to an electrical stimulus for achieving the open and closed states of the respective closure member (966)”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the apparatus of Jones, Arora, and Trovato with that of Trovato to include wherein the second detection- circuit comprises a second set of spaced electrodes forming a second switch in an off configuration, the second switch being switchable to an on configuration when the second set of spaced electrodes engage an electrically conductive surface after the movement of the actuation assembly as it would have yielded the predictable result of providing the capability to finely control the flow of medication (Trovato (Par. 113)).
Regarding claim 18, modified Jones further discloses wherein the isolation structure (Jones (Par. 310, (the enteric coating surrounds the entire device)))is further configured for isolating the latch and the second detection-circuit from the gastrointestinal content (Jones (Fig. 20, (the latch is on the inside of the device with the internal circuit components, and as such they are isolated from the GI content))).
Regarding claim 19, modified Jones further discloses wherein the isolation structure is a shell (Jones (Par. 310, (the enteric coating surrounds the entire device, forming a shell))) receiving therein the housing (Jones (Housing – 101)), the actuation assembly (Jones (combination of the piston – 134 and gas-generating cell – 103)) , the latch (Jones (Par. 135)(latch – 186)), the first actuation structure (Jones (Piston – 134)), and the circuit structure (Jones (PCB – 132) (Fig. 3 (observable that all of the above indicated components are inside the housing, which is surrounded by the enteric coating))).
Jones and Arora teach the apparatus of claim 1 above.
Regarding claim 70, modified Jones fails to explicitly disclose wherein the ingestible apparatus is configured for delivering the health-related substance to the target area of the GI tract of the human or mammal.
However, Jones does teach in alternative embodiments wherein the ingestible apparatus (Jones (ingestible device – 100)) is configured for delivering the health-related substance to the target area of the GI tract of the human or mammal (Jones (Par. 493, “This may allow ingestible device 65100 to obtain a fluid sample from the GI tract, or release a substance into the GI tract, through opening 65116.”) (Par. 5) (Par. 494, “in some embodiments, the storage sub-unit 65118-3 may be loaded with a medicament or other substance prior to the ingestible device 65100 being administered to a subject.”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the apparatus of Jones and Arora with that of Jones to include wherein the ingestible apparatus is configured for delivering the health-related substance to the target area of the GI tract of the human or mammal for the reasoning as indicated in claim 31 above.
Modified Jones fails to explicitly disclose wherein the circuit structure is configured to begin transmitting an RF signal when the ingestible apparatus arrives within the target area and stop transmitting the RF signal when the health-related-substance discharging is at an end, the RF signal having the first set of property settings or the second set of property settings. However, Trovato teaches wherein the circuit structure is configured to begin transmitting an RF signal when the ingestible apparatus arrives within the target area and stop transmitting the RF signal when the health-related-substance discharging is at an end (Par. 170, “determination of the capsule's location at the time of the sampling may be in accordance with the interval of time passed between ingestion of the capsule and opening/closing of the opened closure member 1406, statistical baseline information for similar patients, a triangulated location using signals emitted by the capsule 1400 (e.g., RF signals)”, (transmitting within the time frame as when it is in the location)), the RF signal having the first set of property settings or the second set of property settings (Par. 75, RF communication circuitry – 504) (Par. 93, “Communication circuitry 504 is preferably included in control circuitry 906 or in communication with control circuitry 906 for interfacing between the antenna 502 and the control circuitry 906 and/or between the piezo-electric element 510a and the control circuitry 906.”) (Par. 84, “The communication circuitry 504 includes a transmitter for transmitting signals from the capsule 500.”) (Par. 170 (determination of capsule location with RF signals)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the apparatus of Jones and Arora with that of Trovato to include wherein the circuit structure is configured to begin transmitting an RF signal when the ingestible apparatus arrives within the target area and stop transmitting the RF signal when the health-related-substance discharging is at an end, the RF signal having the first set of property settings or the second set of property settings through the combination of references as it would have yielded the same or similar results of the circuit of Arora of informing the user on the location of the device (Trovato (Par. 86)) and monitoring the status of the medication (Arora (Col. 9-10, lines 38-10)(Col. 11, lines 44-67)).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jones in view of Arora as applied to claim 12 above, and further in view of Houzego (US Pub. No. 20040215171) hereinafter Houzego.
Jones and Arora teach the apparatus of claim 12 above.
Regarding claim 13, modified Jones fails to explicitly disclose the limitations of the claim.
However, Houzego teaches wherein the latch (latch – 18) is sandwiched between a retaining shoulder of the piston (piston – 16) and the housing (outer housing – 11) (Fig. 1 (observable that the latch is between the piston and the housing)).
Jones, Arora, and Houzego are considered to be analogous art to the claimed invention as they are involved with ingestible devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the apparatus of Jones and Arora with that of Houzego to include wherein the latch is sandwiched between a retaining shoulder of the piston and the housing through the combination of references as it would have yielded the predictable result of keeping the device in a high potential energy state prior to the time in which the substance needs to be released (Houzego (Par. 46)).
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jones in view of Arora and Trovato as applied to claim 14 above, and further in view of Amoako-Tuffour (US Pat. No. 10172598) hereinafter Yaw.
Jones and Trovato teach the apparatus of claim 14 above.
Regarding claim 16, modified Jones fails to explicitly disclose the limitations of the claim.
However, Yaw teaches wherein the second detection-circuit (PCB -44) comprises a Hall-effect sensor (Col. 19, lines 30-38) or a sliding rheostat having a slider coupled to the actuation assembly (Col. 9, lines 56-60).
Jones, Arora, Trovato, and Yaw are considered to be analogous art to the claimed invention as they are involved with ingestible devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the apparatus of Jones, Arora, and Trovato with that of Yaw to include wherein the second detection-circuit comprises a Hall-effect sensor or a sliding rheostat having a slider coupled to the actuation assembly through the combination of references, as it would have yielded the predictable result of expanding the functionality of the device (Yaw (Col. 23-24, lines 64-14)).
Regarding claim 17, modified Jones fails to explicitly disclose the limitations of the claim.
However, Yaw teaches wherein the second detection-circuit (PCB - 44) comprises a Hall-effect sensor (Col. 19, lines 30-38) or a sliding rheostat having a slider coupled to the piston (Col. 9, lines 56-60 (motor)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the apparatus of Jones, Arora, and Trovato with that of Yaw to include wherein the second detection-circuit comprises a Hall-effect sensor or a sliding rheostat having a slider coupled to the piston through the combination of references as it would have yielded the predictable result of expanding the functionality of the device (Yaw (Col. 23-24, lines 64-14)).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jones in view of Arora and Trovato as applied to claim 19 above, and further in view of Wrigglesworth (US Pub. No. 20160038086) hereinafter Wrigglesworth.
Jones, Arora, and Trovato teach the apparatus of claim 19 above.
Regarding claim 20, modified Jones fails to explicitly disclose the limitations of the claim.
However, Wrigglesworth teaches wherein the shell (Par. 52 (first layer)) is coated with a dissolvable coating (Par. 51, 52 (second layer)).
Jones, Arora, Trovato, and Wrigglesworth are considered to be analogous art to the claimed invention as they are involved with ingestible devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the apparatus of Jones, Arora, and Trovato with that of Wrigglesworth to include wherein the shell is coated with a dissolvable coating as a separate structure from the shell through the combination of references as it would have yielded the predictable result of dissolving at the correct location (Wrigglesworth (Par. 54-55)).
Claim(s) 71 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jones in view of Arora as applied to claim 1 above, and further in view of Yaw.
Jones and Arora teach the apparatus of claim 1 above.
Regarding claim 71, modified Jones fails to explicitly disclose the limitations of the claim.
However, Yaw teaches wherein the circuit structure is configured to detect a start and an end of said changing of the one or more conditions of the first compartment as an arrival of the ingestible apparatus within the target area and an end of the sample collecting and/or the health-related-substance discharging, respectively (Col. 43, lines 4-24)(Fig. 9D, step 686, 680).
Jones, Arora, and Yaw are considered to be analogous art to the claimed invention as they are involved with ingestible devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the apparatus of Jones and Arora with that of Yaw to include wherein the circuit structure is configured to detect a start and an end of said changing of the one or more conditions of the first compartment as an arrival of the ingestible apparatus within the target area and an end of the sample collecting and/or the health-related-substance discharging, respectively through the combination of references as it would have yielded the predictable result of directly informing the user on the status of the sample delivery.
Response to Arguments
Applicant's arguments filed 11/05/2025 and 11/24/2025, regarding the previous 103 rejection have been fully considered but they are not persuasive.
The applicant’s arguments, that the prior art does not teach the added limitations to claim, have been fully considered and deemed as not persuasive. As the limitation was not previously addressed, the limitation has been addressed in the 103 rejection as indicated above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Mercure (US Pub. No. 20060289640) hereinafter Mercure.
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 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