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 .
Applicant' s arguments, filed 7/21/2025, 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 7/21/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-17 are the currently pending claims hereby under examination. Claims 1, 6-7, 14, and 16 have been amended
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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Myers et al. (US 20170258362 A1), hereto referred as Myers, and further in view of Zdeblick et al. (US 20080284599 A1), hereto referred as Zdeblick, and in further view of Robertson et al. (US-20150048929-A1), hereto referred as Robertson.
Regarding claim 1, Myers teaches that a method for enabling detection of a plurality of capsule ingestions (Myers, Abstract: "Ingestible bio-telemetry communication network and associated systems are described. The communication network can include one or more ingestible bio-telemetry tags", which are associated with a [0033]: "capsule", demonstrating a method for detecting a plurality of capsule ingestions) comprises: for each of a plurality of ingestible capsules including a transmitter and processing hardware to generate and transmit signals (Myers, ¶[0004]: “An ingestible bio-telemetry tag ("TAG") can generate an out-link signal… wherein pulse spacing is directly related to a transmit carrier period…”; ¶[0035]: “The electronic pill 14, and more particularly the TAG 15, has… electronic circuits… that communicates with the external wireless reader”, showing the ingestible capsules include both transmitters and processing hardware): obtaining, by the processing hardware, a serial number for distinguishing between the plurality of ingestible capsules (Myers, ¶[0035]: “the electronic pill 14 can store a patient’s medical history in addition to detailed information about a drug being administered, provide a unique identification number…”, teaching that each capsule includes a unique ID number serving as a serial number); the signal including a series of pulses having a particular pulse space and indicating the serial number (Myers, ¶[0004]: “A controller… on a TAG can provide a gating signal used to modulate a TX carrier with the appropriate pulse reverse keyed symbol based on data content… The gating sets the pulse spacing of the bursts”; ¶[0003]: “An out-link communication format is provided… which includes a fixed relationship between transmitted burst frequency and pulse spacing”, teaching that the generated signal includes a distinct pulse spacing value and separately encodes data such as the serial number), and transmitting the signal to a receiver via the transmitter (Myers, ¶[0039]: “The data link from the TAG 15 to the reader 11 is defined as the 'out-link' path… The out-link channel 52 is a radio frequency signal… received at the reader 11”, describing the transmission of signals from the capsule's transmitter to a receiver).
Myers does not fully teach the method of generating, by the processing hardware, a signal indicating that the capsule has been ingested. Myers teaches an ingestible capsule containing processing hardware and a transmitter that begins communication with an external receiver after the capsule is ingested (Myers, ¶[0034]). However, Myers does not explicitly state that the signal is generated because of ingestion, only that communication begins at some point after ingestion. Zdeblick, who investigates ingestible capsule identifiers, teaches that signal generation occurs in direct response to ingestion. Specifically, the capsule includes a stimulus-responsive identifier that emits a signal upon contact with stomach fluids (Zdeblick, ¶[0095]–[0096]). This establishes that ingestion is the physiological trigger for generating a detectable signal. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Myers in view of Zdeblick to generate, by the processing hardware, a signal indicating that the capsule has been ingested. The combination would have been possible because both Myers and Zdeblick describe ingestible capsule systems with internal electronics and the ability to transmit signals to an external receiver. A skilled artisan would have recognized the benefit of incorporating Zdeblick’s ingestion-triggered signaling mechanism into Myers’ capsule to ensure that the signal accurately corresponds to the moment of ingestion. The benefit of the combination is increased specificity and reliability in detecting ingestion events. By linking signal generation directly to ingestion, the system can ensure that any transmitted data is causally and temporally aligned with capsule ingestion, reducing false positives and improving tracking accuracy.
Also regarding claim 1, Myers does not explicitly teach wherein each of the plurality of ingestible capsules is identified based on a combination of the particular pulse space and the serial number for the ingestible capsule. Rather, Myers discloses that multiple ingestible capsules may be identified by either serial number or pulse spacing (Myers, ¶[0035]; ¶[0004]; ¶[0052]–[0054]), but it does not expressly teach using both identifiers in combination. Importantly, Myers also discusses its concern with transmission overlap and collisions and sets out statistical methods to evaluate and limit this possibility (Myers, ¶[0053]–[0055]). This shows that Myers itself recognized ambiguity in relying on a single discriminator and highlights the need for a more robust identification approach.
Robertson teaches that ingestible telemetry systems may employ two independent communication modules (conductive and non-conductive (Robertson, ¶[0007]–[0008])) as a fail-safe redundancy mechanism (Robertson, ¶[0061]: "A further advantage offered by separation between portions of the RFID communications module and the conductive communications module is a failsafe mechanism"), ensuring reliable data transmission even if one mode fails. While Robertson applies redundancy at the communication-module level rather than the identifier level, the principle is the same: using multiple independent modalities together to increase robustness and reliability.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Myers and Zdeblick in view of Robertson to identify each capsule based on a combination of serial number and pulse spacing. Myers already provides both identifiers as independent discriminators. Robertson supplies the design motivation (redundancy for fail-safe operation in ingestible systems). A skilled artisan would have recognized that applying Robertson’s redundancy principle to Myers’ identifiers would improve reliability and minimize the risk of collision or ambiguity when multiple capsules are ingested.
The benefit of this combination would be improved reliability of capsule identification. If pulse spacing bins overlap, serial number differences still resolve capsule identity. Conversely, if serial numbers collide or transmission errors occur, pulse spacing differences provide a fallback. Together, they ensure a more robust and foolproof identification mechanism.
Regarding claim 2, the combined Myers and Zdeblick teaches that the method further comprises: measuring, by the processing hardware, a battery level of a battery providing power to the processing hardware (Myers, Fig. 18A; ¶[0066]: “GI. Battery voltage measured on chip and digitized. The least significant bit (LSB) is transmitted first”, Myers discloses that the capsule's battery voltage is measured on-chip by the processing hardware; ¶[0072]: “The GI field includes the measured battery voltage”, confirms that each transmission includes battery level information that can be associated with the corresponding capsule; the figure depicts the electronic components and indicates the voltage (Vbat) as part of the power condition linked to GI), wherein generating the signal further includes generating an indication of the battery level (Myers, Fig. 2A; ¶[0039]: “The data link from the TAG 15 to the reader 11 is defined as the 'out-link' path 52. Out-link data to the reader may include, but not be limited to, at least one of GI sensing, pharmaceutical, adherence, signal level, physiologic data, biometric identification data, and address information”, demonstrating that measured battery voltage (as noted in ¶[0066] as GI) may be included in the transmitted out-link data; the figure depicts the recorded battery level (GI) over time for a specific pill/capsule).
The combined Myers, Zdeblick, and Robertson does not fully teach that each of the plurality of ingestible capsules is further identified based on the battery level. Rather, Myers teaches identifying ingestible capsules based on unique serial numbers and pulse spacing (Myers, ¶[0035]; ¶[0004]) and transmitting battery voltage as part of the out-link data (Myers, Fig. 2A; ¶[0066]; ¶[0039]; ¶[0098]). While Myers does not explicitly teach using battery level as a distinguishing identifier for the capsule, it implicitly teaches this concept by transmitting battery level data (GI) alongside capsule identifiers, such that the receiver can correlate the battery level to specific capsules over time. This establishes an implicit association between battery level and capsule identity that could be used to support or reinforce identification. Zdeblick supports this concept by teaching that in certain embodiments, the identifier does not emit a signal in the traditional sense, but instead modulates the amount of broadcast power it transduces. This modulation is detected and used as the identifying signal (Zdeblick, ¶[0097]: “In certain of these embodiments, the identifier may include a power source that transduces broadcast power and a signal generating element that modulates the amount of transduced power, such that a signal is not emitted from the identifier but instead the amount of broadcast power transduced by the identifier is detected and employed as the ‘signal.’”). This demonstrates that a capsule’s internal power state can serve as the distinguishing basis for identification. While Zdeblick does not disclose digitizing or transmitting battery level per se, it shows that power-dependent behavior can convey identity. A skilled artisan would understand that battery level, being a measurable representation of power state, can function as an additional identifier when associated with a specific capsule’s signal. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Myers, Zdeblick, and Robertson in view of Zdeblick to identify each of the plurality of ingestible capsules based on the battery level. The combination would have been possible because Myers already measures and transmits battery level data along with capsule identification information, and Zdeblick supports identification via power-dependent behavior. A skilled artisan would have recognized that if battery level is being transmitted (as in Myers) and power characteristics can support identification (as in Zdeblick), then battery level can logically serve as an additional identifier. The benefit of the combination is increased robustness and granularity in identification. If capsule serial numbers or pulse spacings are duplicated or ambiguous, battery level provides a supplementary trait for distinguishing between capsules in environments where multiple units may be active simultaneously.
Regarding claim 3, the combined Myers, Zdeblick, and Robertson does not fully teach that the battery is powered by chemical energy from fluid within a patient's gastrointestinal tract. Myers discloses that the ingestible capsule contains an electrochemical battery that becomes active after ingestion (Myers, ¶[0094]; ¶[0079]). Although implied, Myers does not explicitly state that the chemical energy comes from gastrointestinal fluid. Zdeblick teaches that the electrochemical battery within the capsule is completed and activated by contact with stomach fluid, which acts as the electrolyte (Zdeblick, ¶[0119]). This establishes a clear link between gastrointestinal fluid and the chemical energy source that powers the battery. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Myers, Zdeblick, and Robertson in view of Zdeblick to use chemical energy from gastrointestinal fluid to power the battery within the capsule. The combination would have been possible because both references disclose ingestible capsules with internal batteries designed to activate in vivo. A skilled artisan would have understood that using GI fluid as the electrolyte in a voltaic cell is a known and practical way to power ingestible electronics. The benefit of the combination is simplification of capsule design and increased reliability, as using naturally occurring stomach fluids eliminates the need for a pre-sealed power source and ensures that activation occurs only upon ingestion.
Regarding claim 4, the combined Myers and Zdeblick teaches that the serial number includes generating, by the processing hardware, a random number as the serial number (Myers, ¶[0071]: “PILL ID is a random address generated once on power up. If a collision occurs, a new random address is generated. This will allow each to be inventoried separately”, showing that the capsule’s processing hardware generates a random number as the serial number for capsule identification).
Regarding claim 5, the combined Myers, Zdeblick, and Robertson does not fully teach that the signal is encoded using pulse amplitude modulation. Rather, Myers teaches a system in which an ingestible capsule transmits signals to an external receiver, but only discloses the use of pulse amplitude modulation (PAM) in a testing environment (Myers, ¶[0092]). Myers uses pulse reversal keying (PRK) as the primary modulation scheme for post-ingestion operational signals and does not disclose the use of PAM under normal runtime conditions (Myers, ¶[0003]). Zdeblick teaches that an identifying signal can be transmitted using amplitude modulation (Zdeblick, ¶[0168]). While Zdeblick does not expressly disclose pulse amplitude modulation (PAM), amplitude modulation is a known category that encompasses PAM as a well-understood subclass. PAM offers a straightforward and effective modulation technique that is well-suited to systems with limited processing resources, particularly those designed for compact, power-constrained environments such as ingestible or implantable devices. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Myers, Zdeblick, and Robertson in view of Zdeblick to use pulse amplitude modulation to encode the signal. The combination would have been possible because both Myers and Zdeblick disclose ingestible capsules that generate identifying signals to external receivers. A skilled artisan would have recognized that since Zdeblick applies amplitude modulation operationally and Myers acknowledges PAM as a compatible format, it would be an obvious design choice to implement PAM as the amplitude modulation technique in Myers. The benefit of the combination is simplified modulation hardware, reduced decoding complexity, and improved signal clarity. PAM provides an efficient alternative suitable for low-power environments and would allow designers to reduce system complexity while maintaining reliable identification in the constrained signal conditions of the gastrointestinal tract. Even if PAM is not explicitly shown in Zdeblick, it is a routine and obvious variation of amplitude modulation well-known in the art.
Regarding claim 6, the combined Myers, Zdeblick, and Robertson teaches that the method further comprises: measuring by the processing hardware, a battery level of a battery providing power to the processing hardware, wherein generating the signal includes generating, by the processing hardware, a message encoded by the pulse amplitude modulated signal including a serial number field and a battery level field (Where claim 5 above teaches a pulse amplitude modulated signal), (Myers, ¶[0065]–[0072]: “START... GI... NEXT ID... RSSI... TRACK ID... RID... PILL ID... END”, showing the defined sequence of fields that make up the structured message transmitted by the capsule; ¶[0066]: “GI. Battery voltage measured on chip and digitized. The least significant bit (LSB) is transmitted first”, confirming the battery level field is included and encoded as a digitized value within the message; ¶[0071]: “PILL ID is a random address generated once on power up. If a collision occurs, a new random address is generated. This will allow each to be inventoried separately”, showing the inclusion of a serial number field in the same message frame; FIG. 4: illustrating the structure and field order of the transmission frame supporting that the capsule transmits a complete message with battery level and serial number in defined sequence).
Claims 7-9 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over by Myers et al. (US 20170258362 A1), hereto referred as Myers, and in further view of Robertson et al. (US-20150048929-A1), hereto referred as Robertson.
Regarding claim 7, Myers teaches a method for identifying a plurality of capsule ingestions (Myers, Abstract: “one or more ingestible bio-telemetry tags; and a reader”; ¶[0035]: “The electronic pill 14 comprises an orally ingestible and biocompatible drug-transporting device with embedded or attached electronic circuits (the TAG 15) that communicates with the external wireless reader 11”, demonstrating a method involving multiple ingested capsules communicating with a receiver for identification), the method comprises: receiving, by processing hardware in a receiver from a first ingestible capsule, a first transmission having a first series of pulses with a first pulse space and including an indication of a first serial number (Myers, ¶[0071]–[0073]: “PILL ID is a random address generated once on power up. With multiple pills, this will allow each to be inventoried separately”; ¶[0040]: “The out-link signal is a frequency stable, outbound telemetry signal that incorporates the desired telemetry data (medication type, dosage, serial number, etc.)”; ¶[0003]–[0004]: “An out-link communication format is provided, referred to herein as ‘pulse reversal keying’, which includes a fixed relationship between transmitted burst frequency and pulse spacing”, collectively showing that the transmitted signal from each capsule includes both a serial number and a defined pulse spacing; see also Fig. 4 and ¶[0065]–[0072] describing the full frame structure); and receiving, by the processing hardware from a second ingestible capsule, a second transmission having a second series of pulses with a second pulse space and including an indication of a second serial number (Myers, ¶[0036]–[0037]: “one or more electronic pills 14 may be taken by a patient 16. The data reader 11 and the one or more TAGs 15 can exchange bidirectional data 50/52... Multiple ingested tags may communicate simultaneously, sequentially, or in other ways... The TAGs 15 communicate their unique identification data”, confirming that multiple capsules can transmit independently and are distinguishable by both signal content and timing).
Also regarding claim 7, Myers does not explicitly teach identifying, by the processing hardware, the first and second transmissions as corresponding to at least two ingestible capsules based on the combination of (i) the first and second pulse spaces, and (ii) the first and second serial numbers. Rather, Myers discloses that multiple ingestible capsules may be identified by either serial number or pulse spacing (Myers, ¶[0035]; ¶[0004]; ¶[0052]–[0054]), but it does not expressly teach using both identifiers in combination. Importantly, Myers also discusses its concern with transmission overlap and collisions and sets out statistical methods to evaluate and limit this possibility (Myers, ¶[0053]–[0055]). This shows that Myers itself recognized ambiguity in relying on a single discriminator and highlights the need for a more robust identification approach.
Robertson teaches that ingestible telemetry systems may employ two independent communication modules (conductive and non-conductive (Robertson, ¶[0007]–[0008])) as a fail-safe redundancy mechanism (Robertson, ¶[0061]: "A further advantage offered by separation between portions of the RFID communications module and the conductive communications module is a failsafe mechanism"), ensuring reliable data transmission even if one mode fails. While Robertson applies redundancy at the communication-module level rather than the identifier level, the principle is the same: using multiple independent modalities together to increase robustness and reliability.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Myers and Zdeblick in view of Robertson to identify each capsule based on a combination of serial number and pulse spacing. Myers already provides both identifiers as independent discriminators. Robertson supplies the design motivation (redundancy for fail-safe operation in ingestible systems). A skilled artisan would have recognized that applying Robertson’s redundancy principle to Myers’ identifiers would improve reliability and minimize the risk of collision or ambiguity when multiple capsules are ingested.
The benefit of this combination would be improved reliability of capsule identification. If pulse spacing bins overlap, serial number differences still resolve capsule identity. Conversely, if serial numbers collide or transmission errors occur, pulse spacing differences provide a fallback. Together, they ensure a more robust and foolproof identification mechanism.
Regarding claim 8, Myers teaches that the method comprises obtaining, by the processing hardware, a plurality of bins each corresponding to a different range of pulse space values (Myers, Fig. 5B; ¶[0052]: "pill 1 and pill 2 fall in different frequency bins", ¶[0055]: “Accordingly, for the case shown in FIG. 8, the bins represent either time or frequency slots that a pill (x) may occupy”, showing the use of frequency or signal characteristic-based bins to separate capsules with the figure showing the population of different available bins); assigning, by the processing hardware, the first pulse space to a first one of the plurality of bins (Myers, Fig. 5B; ¶[0052]: "pill 1 and pill 2 fall in different frequency bins", implies assignment of capsule transmission characteristics to corresponding bins based on observed differences in pulse space; and Fig. 5B: shows the first pill/pulse space in a first bin); assigning, by the processing hardware, the second pulse space to a second one of the plurality of bins (Myers, Fig. 5B; ¶[0052]: "pill 1 and pill 2 fall in different frequency bins", illustrates separate assignments for two ingestible capsules based on pulse spacing differences; and Fig. 5B: shows the second pill/pulse space in a separate bin); wherein the first and second transmissions are identified as corresponding to at least two ingestible capsules based on the first and second bins (Myers, ¶[0055]: “Accordingly, for the case shown in FIG. 8, the bins represent either time or frequency slots that a pill (x) may occupy”, explains that pills can be distinguished based on the bins to which they are assigned, allowing identification of different transmissions based on different bin assignments; and Fig. 5B: shows pill 1 and pill 2 in a separate bins).
Regarding claim 9, Myers teaches that the first and second transmissions are identified as corresponding to at least two ingestible capsules in response to determining that the first and second bins are different (Myers, Fig. 5B; ¶[0052]: "pill 1 and pill 2 fall in different frequency bins", showing that the capsules are differentiated based on their assignment to different bins; ¶[0055]: "Accordingly, for the case shown in FIG. 8, the bins represent either time or frequency slots that a pill (x) may occupy", confirms that capsules may be identified by determining that they occupy distinct bins in the binning process).
Regarding claim 15, Myers teaches that the first and second transmissions are identified as corresponding to at least two ingestible capsules in response to determining that the first and second serial numbers are different (Myers, ¶[0071]: “PILL ID. Random address generated on chip. This field is set once upon power up and remains fixed for life of TAG. Used for multi-pill protocol”, shows that each capsule is assigned a persistent and unique identifier used specifically for distinguishing between multiple capsules in multi-pill scenarios; Myers, ¶[0073]: “PILL ID is a random address generated once on power up. With multiple pills, this will allow each to be inventoried separately”, confirms that the receiver can identify different capsules based on differences in PILL ID fields).
Regarding claim 16, Myers teaches the method of receiving the first transmission further includes receiving, by the processing hardware, an indication of a first battery level of the first ingestible capsule, and receiving the second transmission further includes receiving, by the processing hardware, an indication of a second battery level of the second ingestible capsule (Myers, ¶[0066]: “GI. Battery voltage measured on chip and digitized. The least significant bit (LSB) is transmitted first”, shows that each capsule measures its battery level and includes that data in the transmission; Myers, ¶[0072]: “The GI field includes the measured battery voltage”, confirms that each transmission includes battery level information that can be associated with the corresponding capsule; ¶[0039]: “The data link from the TAG 15 to the reader 11 is defined as the 'out-link' path 52. Out-link data to the reader may include, but not be limited to, at least one of GI sensing, pharmaceutical, adherence, signal level, physiologic data, biometric identification data, and address information”, demonstrating that measured battery voltage (as noted in ¶[0066] as GI) may be included in the transmitted out-link data; Fig. 2A: depicts the recorded battery level (GI) over time for a specific pill/capsule; This protocol applies to each capsule independently, meaning the first and second transmissions—originating from different ingestible capsules—each contain their own GI battery voltage values, enabling the receiver to obtain and distinguish the first and second battery levels).
Claims 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over by Myers et al. (US 20170258362 A1), hereto referred as Myers, and in further view of Robertson et al. (US-20150048929-A1), hereto referred as Robertson, and further in view of Fearon et al. (US 20090268962 A1), hereto referred as Fearon.
The combined Myers and Robertson teaches claims 7 and 8 as described above.
Regarding claim 10, Myers teaches that the first and second transmissions are received in a same detection period (Myers, Fig. 7; ¶[0052]: "this is clear by referring to FIG. 5B where pill 1 and pill 2 fall in different frequency bins", ¶[0053]: "The probability for each of the five bins in region 1 that a pill transmission will occur can be seen in FIG. 6... For the case that 5 simultaneous transmissions occur, it can be shown that the chance that at least 2 occupy the same transmission bin (3.6 MHz) within region (1) is 21%", demonstrates simultaneous or overlapping detection of multiple capsules during a common scanning window); and further comprises detecting, by a first detector in the receiver, the first transmission by identifying a first series of pulses spaced apart by at least a threshold pulse space (Myers, ¶[0004]: “A controller... on a TAG can provide a gating signal used to modulate a TX carrier with the appropriate pulse reverse keyed symbol based on data content... The gating sets the pulse spacing of the bursts”, and Fig. 3 shows that each symbol consists of a defined burst period T, within which the spacing of pulses varies to encode data; under BRI, the receiver’s ability to distinguish these pulse patterns based on their spacing within T corresponds to identifying a series of pulses that meet or exceed a functional threshold spacing for detection).
Also regarding claim 10, the combined Myers and Robertson does not fully teach the method of masking, by a second detector in the receiver, the first transmission; and after masking the first transmission, detecting, by the second detector, the second transmission as a separate transmission by identifying a second series of pulses spaced apart by the at least threshold pulse space. Rather, Myers teaches a receiver that distinguishes transmissions from multiple capsules based on frequency bin assignment and pulse spacing (Myers, Fig. 5B; ¶[0052]; Fig. 3; ¶[0004]). However, Myers does not describe using a second detector to detect a separate transmission after masking a first transmission. Fearon is nonetheless pertinent to the signal separation and detection challenges addressed by the claimed invention, and provides the missing structure and functionality relevant to those problems. It describes applying time-frequency masks to isolate one of several overlapping source signals by suppressing other signals. These masks pass only the regions of the time-frequency domain where a target source is active, enabling separation of individual signals (Fearon, ¶[0038]; ¶[0057]). Fearon also describes two separate sensor subarrays that independently collect signal mixtures (Fearon, ¶[0054]; ¶[0010]–[0012]). These subarrays operate as distinct input channels and under the broadest reasonable interpretation function as separate detectors. Together, these teachings support a configuration where a first detector detects a first transmission based on pulse spacing, a time-frequency mask is applied to suppress the first signal, and a second detector identifies a second transmission (also based on its own pulse spacing) within the same detection period. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Myers and Robertson in view of Fearon to use a second detector that, following masking of a first detected transmission, detects a second transmission as a separate series of pulses spaced apart by at least a threshold pulse space within the same detection period. The combination would have been possible because both references disclose systems capable of identifying overlapping transmissions through structured timing and signal separation. A skilled artisan would have been motivated to integrate Fearon’s masking and dual-detection architecture into Myers’ ingestible capsule monitoring system to improve the resolution and accuracy of signal identification. The benefit of the combination is enhanced reliability in distinguishing overlapping transmissions, reduced collision interference, and improved tracking of multiple ingestible capsule events within shared transmission windows.
Regarding claim 11, the combined Myers, Robertson, and Fearon teaches that the first and second transmissions are identified as corresponding to at least two ingestible capsules further based on detecting the first and second transmissions as separate transmissions (Myers, ¶[0052]: “this is clear by referring to FIG. 5B where pill 1 and pill 2 fall in different frequency bins”, confirms that detection of separate transmissions is based on distinguishing between signals occupying distinct bins; ¶[0053]-[0054]: “For the case that 5 simultaneous transmissions occur, it can be shown that the chance that at least 2 occupy the same transmission bin (3.6 MHz) within region (1) is 21%... Over several hops there is a high probability that at least one of the ensemble will have no slot collisions”, showing that the system distinguishes separate transmissions by assigning them to different frequency bins).
Regarding claim 12, the combined Myers, Robertson, and Fearon does not fully teach that the first and second transmissions are detected within a first detection period, and further comprising in a second detection period: detecting, by the first detector, a third transmission by identifying a third series of pulses spaced apart by at least a threshold pulse space; masking, by the second detector, the third transmission; after masking the third transmission, detecting, by the second detector, a fourth transmission as a separate transmission from the third transmission by identifying a fourth series of pulses spaced apart by the at least threshold pulse space. Rather, Myers teaches a receiver that distinguishes transmissions from multiple ingestible capsules using frequency bin assignment and pulse spacing (Myers, Fig. 5B; ¶[0052]; Fig. 3; ¶[0004]). Additionally, Myers describes that transmission slots may represent time intervals and that, as time progresses, non-colliding transmissions can eventually be detected (Myers, ¶[0054]–[0055]), supporting the notion of temporally distinct detection opportunities. However, Myers does not describe the use of masking or distinct detectors to perform sequential detection of multiple transmissions across detection periods. Fearon teaches the use of time-frequency masking to isolate one signal from overlapping sources by suppressing other signals (Fearon, ¶[0057]). It also discloses two independent subarrays that receive distinct signal mixtures (Fearon, ¶[0054]), which under the broadest reasonable interpretation operate as separate detectors. Myers further explains that pulse spacing is defined by burst timing (Myers, ¶[0004]), supporting the identification of individual transmissions by a threshold pulse space. A person of ordinary skill in the art would have understood from Fearon that its masking and separation methods are not limited to two signals, but are capable of recovering N overlapping signals (Fearon, ¶[0057]). This supports iterative separation across time, where one detector may detect a third transmission, a second detector may mask that transmission, and then detect a fourth transmission as a separate series of pulses spaced apart by at least a threshold pulse space. Myers reinforces the use of time-based slots to support successive detection attempts (Myers, ¶[0054]–[0055]), providing the temporal structure needed to apply Fearon’s masking and dual-detector model across distinct detection periods. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Myers, Robertson, and Fearon in view of Fearon to perform sequential detection across detection periods, using a first detector to identify a third transmission, a second detector to mask that signal, and then detect a fourth signal based on pulse spacing. The combination would have been possible because both references address the challenge of distinguishing overlapping transmissions, and a skilled artisan would have recognized that Fearon’s masking and dual detection structure could be applied within the temporal slotting framework of Myers to scale detection to more than two signals. The benefit of the combination is improved scalability and precision in detecting staggered but overlapping transmissions across detection periods, reducing missed signals and improving tracking of multiple ingestible capsule events.
Regarding claim 13, the combined Myers, Robertson, and Fearon teaches the method of assigning, by the processing hardware, a third pulse space for the third transmission to a third one of the plurality of bins; and assigning, by the processing hardware, a fourth pulse space for the fourth transmission to a fourth one of the plurality of bins (Myers, ¶[0053]: “For the case that 5 simultaneous transmissions occur, it can be shown that the chance that at least 2 occupy the same transmission bin (3.6 MHz) within region (1) is 21%”, showing that the system accounts for assignment of multiple transmissions to separate bins, supporting assignment of third and fourth pulse spaces; Myers further explains that by allowing transmissions to occur over multiple hops, the probability of collision is reduced. This enables each transmission—including third and fourth transmissions—to be uniquely assigned to separate bins without overlap (Myers, ¶[0054]: “Over several hops there is a high probability that at least one of the ensemble will have no slot collisions”)).
Regarding claim 14, the combined Myers, Robertson, and Fearon does not explicitly teach the method wherein the first, second, third, and fourth pulse spaces are assigned to the same bin, and further comprising: determining, by the processing hardware, whether the third or fourth transmissions correspond to a third ingestible capsule in response to determining at least one of: that a third serial number for the third transmission or a fourth serial number for the fourth transmission is different from the first and second serial numbers, or that a combination of the third and fourth serial numbers is different from a combination of the first and second serial numbers. While Myers teaches assigning transmissions to different bins (Myers, ¶[0053]), it also teaches that collisions can occur and that transmissions may initially occupy the same bin (Myers, ¶[0054]). Myers includes a fixed capsule identifier (“PILL ID”) for each transmission (Myers, ¶[0071]) and specifically states that these identifiers are used to support multi-pill inventory (Myers, ¶[0073]). This confirms that serial numbers are essential for distinguishing between multiple capsules in the event of overlapping transmissions or bin reuse. However, Myers does not disclose assigning all four transmissions to the same bin or explicitly comparing combinations of serial numbers to previously observed values to identify a new capsule.
As discussed in Claim 7, Myers already presents both serial numbers and pulse spacing as identifiers, and Robertson teaches that ingestible telemetry systems benefit from redundancy as a fail-safe against failure or overlap. Together these teachings motivate a skilled artisan to apply the redundancy principle in scenarios where bins are reused or collisions occur. In particular, the redundancy rationale established in Claim 7 expressly applies here, since the very problem is transmissions falling into the same bin, where relying on spacing alone would be insufficient.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Myers, Robertson, and Fearon in view of Robertson to compare the serial numbers from the third and fourth transmissions against the first and second transmissions when all transmissions are received in the same bin, in order to determine whether a new capsule is present. Myers supplies the unique serial numbers, while Robertson supplies the motivation that redundancy across independent identifiers is desirable to ensure reliable detection.
The benefit is a more robust and fail-safe identification system in the presence of bin reuse, allowing the system to reliably distinguish capsules using serial numbers even when pulse spacing alone cannot provide separation. This directly addresses the overlap issues Myers itself acknowledges (¶[0053]–[0055]) and aligns with the redundancy motivation emphasized in Robertson.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Myers et al. (US 20170258362 A1), hereto referred as Myers, and in further view of Robertson et al. (US-20150048929-A1), hereto referred as Robertson, and further in view of Zdeblick et al. (US 20080284599 A1), hereto referred as Zdeblick.
The combined Myers and Robertson teaches claims 7 and 16 as described above.
Regarding claim 17, Myers does not fully teach that the first and second transmissions are identified as corresponding to at least two ingestible capsules further based on the first and second battery levels. Rather, Myers teaches identifying ingestible capsules based on unique serial numbers and pulse spacing (Myers, ¶[0035]; ¶[0004]) and transmitting battery voltage as part of the out-link data (Myers, Fig. 2A; ¶[0066]; ¶[0039]; ¶[0072]). While Myers does not explicitly teach using battery level as a distinguishing identifier, it implicitly supports this functionality by transmitting the battery data alongside capsule identifiers, allowing the receiver to correlate and associate battery level information with specific capsules. Zdeblick, who investigates ingestible capsule identifiers, supports this concept by teaching that in certain embodiments, the identifier does not emit a signal in the traditional sense, but instead modulates the amount of broadcast power it transduces. This modulation is detected and used as the identifying signal (Zdeblick, ¶[0097]: “In certain of these embodiments, the identifier may include a power source that transduces broadcast power and a signal generating element that modulates the amount of transduced power, such that a signal is not emitted from the identifier but instead the amount of broadcast power transduced by the identifier is detected and employed as the ‘signal.’”). This demonstrates that a capsule’s internal power state can serve as the distinguishing basis for identification. While Zdeblick does not disclose digitizing or transmitting battery level per se, it shows that power-dependent behavior can convey identity. A skilled artisan would understand that battery level, being a measurable representation of power state, can function as an additional identifier when associated with a specific capsule’s signal. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Myers and Robertson in view of Zdeblick to identify each of the plurality of ingestible capsules based on the battery level. The combination would have been possible because Myers already transmits battery level data associated with each capsule’s signal, and Zdeblick supports power-based identification logic. A skilled artisan would have recognized that battery level, when correlated to specific capsule transmissions, can serve as a secondary identifier. The benefit of the combination is increased robustness in identifying individual capsules, particularly in scenarios where pulse spacing or serial numbers alone are insufficient to distinguish between closely timed or similarly configured ingestible devices.
Response to Arguments
Objections to the Drawings
Applicant's arguments filed 7/21/2025, page 7, regarding the previous Objections to the Figures 4A, 4B, 11A, and 11B have been fully considered and are persuasive. The previous objections to the figures have been withdrawn.
35 U.S.C. §112(b)
Applicant's arguments filed 7/21/2025, pages 7-8, regarding the previous 112(b) Rejections of claims 6, 14, 16, and 17 have been fully considered and are persuasive. The previous 112(b) rejections have been withdrawn.
35 U.S.C. §102
Applicant's arguments filed 7/21/2025, pages 8-9, regarding the previous 102 Rejections of claims 7-9, 15, and 16 have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of rejection.
35 U.S.C. §103
Applicant's arguments filed 7/21/2025, page 9, regarding the previous 103 Rejections of claims 1-6, 10-14, and 17 have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791