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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 28, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed February 21, 2025 are accepted.
Claim Objections
Claim 91 is objected to because of the following informalities: Claim 91 is missing a period. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 86-97 and 103-105 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jones et al. (US 2021/0121533 A1) (“Jones”).
Regarding claims 86, 103 and 105, Jones discloses An ingestible capsule comprising (Abstract and entire document):
an ingestible indigestible bio-compatible housing ([0363]);
and further comprising, within the housing: a power source ([0476]);
sensor hardware including a temperature sensor configured to output a temperature sensor signal representing a temperature of an environment surrounding the ingestible capsule ([0561]);
processor hardware ([0368]);
memory hardware ([0368]); and
a wireless data transmitter ([0559]);
wherein, during a passage of the ingestible capsule through a GI tract of the subject mammal, the processor hardware is configured to receive a signal being output by the sensor hardware, to process the received signal, and to store some or all of the processed signal, or data extracted therefrom, on the memory hardware as data transmission payload ([0401]);
the processor hardware is configured to receive and monitor the temperature sensor signal to identify when the temperature sensor signal indicates that the ingestible capsule ceases to be within the GI tract of the subject mammal ([0401]), and
in response to said identification to determine occurrence of an excretion event, and in response to determining occurrence of the excretion event to modify one or more settings of the wireless data transmitter to start, restart, increase transmission power of, or increase a rate of, wireless transmission of the data transmission payload away from the ingestible capsule by the wireless data transmitter ([0401, [0844]).
Regarding claim 87, Jones discloses The ingestible capsule according to claim 86, wherein the data transmission payload transmitted away from the capsule in response to determining occurrence of the excretion event, comprises a report that occurrence of the excretion event has been determined ([0401, [0844]).
Regarding claim 88, Jones discloses The ingestible capsule according to claim 87, wherein modifying the settings causes the wireless data transceiver to transmit in a broadcast or inquiry mode the report that occurrence of the excretion event has been determined to a receiver device, and to wirelessly connect, or to wirelessly re-connect following an initial connection pre-ingestion of the ingestible capsule, to the receiver device to transmit the remainder of the data transmission payload ([0401, [0844], [0112], transmitted inside body, then transmitted outside body).
Regarding claim 89, Jones discloses The ingestible capsule according to claim 86, wherein the sensor hardware includes one or more gas sensors, and therein the signal output by the sensor hardware and processed by the processor hardware includes a gas sensor signal output by the one or more gas sensors, and the data transmission payload includes the processed gas sensor signal or data extracted therefrom ([0498]).
Regarding claim 90, Jones discloses The ingestible capsule according to claim 89, wherein the one or more gas sensors includes one or more from among: one or more spectrophotometers; one or more Surface Acoustic Wave sensors; one or more Bulk Acoustic Resonator Arrays; one or more VOC gas sensors; and one or more TCD gas sensors; each of the one or more gas sensors configured to generate a component gas sensor signal forming part of the gas sensor signal, and wherein processing the received gas sensor signal comprises identifying one or more motility event indicators in the received gas sensor signal, and storing a representation of the identified motility indicators on the memory hardware as data transmission payload ([0498]).
Regarding claim 91, Jones discloses The ingestible capsule according to claim 90, wherein identifying the one or more motility event indicators comprises monitoring the gas sensor signal received from each of the one or more gas sensors in a most recent time period of predefined duration on a rolling basis to identify a spike, step change, or inflection in the gas sensor signal as the motility indicator ([0401], [0498], [0394])
Regarding claim 92, Jones discloses The ingestible capsule according to claim 91, wherein the one or more gas sensors comprises one or more from among a VOC gas sensor and a TCD gas sensor, and the gas sensor signal comprises one or more from among a VOC gas sensor signal and a TCD gas sensor signal, accordingly ([0498]).
Regarding claim 93, Jones discloses The ingestible capsule according to claim 90, wherein the sensor hardware further comprises one or more from among: an accelerometer; a reflectometer formed by an antenna in series with a directional coupler, wherein the antenna is an antenna of the data transmitter, the antenna being controlled by the processor to transmit an intermittent or continuous signal from which a reflectometer signal is obtainable; wherein further to identifying the motility event indicator in the gas sensor signal, the processor hardware is configured to: store, in association with the motility event indicator in the data transmission payload, a representation of a signal received contemporaneously with the motility event indicator from one or more sensors within the housing from among: a gas sensor other than the gas sensor providing the signal in which the motility event indicator is detected; the accelerometer; or the reflectometer ([0586]).
Regarding claim 94, Jones discloses The ingestible capsule according to claim 92, wherein the representation of the signal is one or more from among: a recording of the signal, a recording of the signal downsampled by retaining only one in every more than one readings; a dimensionally reduced version of the signal; a recording of a confirmatory marker identified by processing the signal; a characteristic value of the signal obtained by processing the signal, the characteristic value being an average value, a rate of change, a maximum, a local maximum, a minimum, or a local minimum ([0398]).
Regarding claim 95, Jones discloses The ingestible capsule according to claim 86, wherein the ingestible capsule further comprises an accelerometer, and during passage through the GI tract the processor hardware is configured to receive an accelerometer signal output by the accelerometer, to process the received accelerometer signal, and to store the processed accelerometer signal or a representation thereof on the memory hardware as data transmission payload ([0586]).
Regarding claim 96, Jones discloses The ingestible capsule according to claim 95, wherein to determine occurrence of the excretion event in response to identifying the temperature represented by the temperature sensor signal dropping below the predefined range of temperatures for the subject mammal, the processor hardware is configured to determine whether or not the received accelerometer signal indicates the ingestible capsule experiencing a freefall event, and if it is determined that the received accelerometer signal indicates the ingestible capsule experiencing a freefall event, the processor hardware is configured to determine that the excretion event has occurred ([0401, [0844]).
Regarding claim 97, Jones discloses The ingestible capsule according to claim 94, wherein the processor hardware is configured to process the temperature sensor signal, and to store the processed temperature signal or data extracted therefrom on the memory hardware as data transmission payload ([0401, [0844]).
Regarding claim 104, Jones discloses The ingestible capsule according to claim 103, wherein the transmission trigger event indicator is a motility event indicator associated with ingestion of the ingestible capsule, gastric-duodenal transition of the ingestible capsule, ileocecal junction transition of the ingestible capsule, or excretion of the ingestible capsule; or the transmission trigger event indicator is a diagnostic indicator associated with clinical diagnosis of a medical condition (FIG. 5 and associated paragraphs).
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:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 98-102 are rejected under 35 U.S.C. 103 as being unpatentable over Jones in view of Baldwin et al. (US 2023/0233068 A1) (”Baldwin”).
Regarding claim 98, Jones discloses The ingestible capsule according to claim 86, Jones fails to disclose wherein the wireless data transmitter is a Bluetooth transceiver.
However, in the same field of endeavor, Baldwin teaches wherein the wireless data transmitter is a Bluetooth transceiver ([0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the capsule as taught by Jones to include wherein the wireless data transmitter is a Bluetooth transceiver as taught by Baldwin to transmit outside body ([0043]).
Regarding claim 99, Jones as modified discloses The ingestible capsule according to claim 98, Jones as modified further discloses wherein the wireless data transmitter is a Bluetooth transceiver configured to operate according to a Bluetooth Low Energy Coded PHY transmission protocol (Baldwin [0043]).
Regarding claim 100, Jones as modified discloses The ingestible capsule according to claim 98, Jones as modified further discloses wherein the Bluetooth transceiver comprises an integrated radio and a microcontroller (Baldwin [0043]).
Regarding claim 101, Jones as modified discloses The ingestible capsule according to claim 98, Jones as modified further discloses wherein modifying one or more settings of the wireless data transmitter in response to determining occurrence of the excretion event includes controlling the Bluetooth transceiver to transmit the data transmission payload stored on the memory hardware by broadcasting data pending transmission from the data transmission payload to a recipient device irrespective of whether or not the recipient device is paired to the Bluetooth transceiver (Jones [0401, [0844]).
Regarding claim 102, Jones as modified discloses The ingestible capsule according to claim 98, Jones as modified further discloses wherein preceding determining the occurrence of the excretion event, the Bluetooth transceiver is configured to pair with a Bluetooth compatible device external to the subject mammal and to transfer to the paired device data comprising or representing one or more from among: a signal or signals from the sensor hardware; one or more motility indicators identified by processing signals from the sensor hardware; one or more identified diagnostic indicators identified by processing signals from the sensor hardware; information representing remaining capacity of the power source; a metric calculated by processing a signal from a single sensor among the sensor hardware or by combining signals from plural sensors among the sensor hardware; calculated gas concentration levels for one or more constituent gases among a gas mixture present in the GI tract, calculated by reference to predefined calibration parameters stored on the memory hardware; and proceeding determination of occurrence of the excretion event the processor hardware is configured to modify settings of the Bluetooth transceiver to transfer the data transmission payload to the same Bluetooth compatible device, either by continuing the existing pairing, by re- pairing, or in the absence of pairing (Baldwin [0043]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Nadiv et al. (US 2019/0029504 A1) (“Nadiv”). Which additionally discloses temperature based excretion detection and changing the setting upon the detection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH A TOMBERS/ Examiner, Art Unit 3791
