Last Updated: May 11, 2026

Details for Patent: 8,674,825


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Summary for Patent: 8,674,825
Title:Pharma-informatics system
Abstract:Compositions, systems and methods that allow for the detection of the actual physical delivery of a pharmaceutical agent to a body are provided. Embodiments of the compositions include an identifier and an active agent. The invention finds use in a variety of different applications, including but not limited to, monitoring of therapeutic regimen compliance, tracking the history of pharmaceutical agents, etc.
Inventor(s):Mark Zdeblick, Andrew Thompson, Aleksandr Pikelny, Timothy Robertson
Assignee: Otsuka Pharmaceutical Co Ltd
Application Number:US12/404,184
Patent Claim Types:
see list of patent claims
Use; Composition; Device;
Patent landscape, scope, and claims:

United States Patent 8,674,825: Receiver for Conductively Transmitted Identifier Signals and Ingestion Data Logging

United States Patent 8,674,825 has claim coverage concentrated on a receiver that detects a conductively transmitted signal from an identifier that transmits on contact with an internal target physiological site, and then stores ingestion-related data (time, date, and/or identity). Dependent claim scope tightens on signal frequency ranges, electrode-based differential voltage detection, and receiver subsystems (amplifier, filter, demodulator) plus data retransmission to an external device.


What is the core claim invention and what does it cover?

Claim 1 sets the baseline scope

Independent claim 1 defines a receiver with these required elements:

  1. Receiver element configured to receive a conductively transmitted signal emitted by an identifier.
  2. The identifier conductively transmits a signal upon contact with an internal target physiological site.
  3. The receiver includes a data storage element configured to store data comprising at least one of:
    • time
    • date
    • identity of an ingested composition
  4. The receiver element is broadly described (no mandatory electrode architecture in claim 1), with later claims specifying antenna/electrode embodiments.

Practical meaning for infringement/clearance: a product that uses an implantable or internally contacted sensor/transmitter that sends an electrical signal through body tissue (conductive coupling), and a co-located receiver that records ingestion timing and content identity, falls within the claim structure if it matches the conductively transmitted link and the data storage attributes.

Independent claim 15 narrows architecture while keeping the same functional payload

Claim 15 requires the same overall concept (receiver with data storage and ingestion data logging), but specifies the receiver element architecture as:

  • Two electrodes spaced apart to detect a differential voltage
  • plus data storage element, amplifier, demodulator
  • and the receiver is configured to retransmit data to a separate external device.

Claim 15 is a second “center of gravity”: it locks in electrode differential detection and includes retransmission features.

Independent claim 18 extends to system scope

Claim 18 is a system claim combining:

  • Identifier that conducts signal upon contact with an internal target physiological site
  • Receiver with:
    • receiver element configured to receive the conductively transmitted signal
    • data storage storing at least one of time/date/identity of an ingested composition

This claim expands the commercial coverage beyond just receiver hardware to an integrated system.

Independent claim 25 covers methods

Claim 25 is a method claim requiring:

  • receiving a conductively transmitted signal at a receiver
  • the receiver has data storage
  • storing at least one of time/date/identity of an ingested composition

It captures process-level infringement even if no full system is sold as one kit, as long as the steps occur in practice.


How broad are the frequency limitations (claims 2-4 and 19)?

Claim 2: broad band

  • Conductively transmitted signal frequency: 1 kHz to 100 MHz

Claim 3: narrower low-to-mid band

  • Frequency: 1 kHz to 70 kHz

Claim 4: multiple alternative ranges (claim is “either/or”)

Claim 4 states frequency ranges as alternatives:

  • 30 kHz to 300 kHz
  • 160 kHz to 190 kHz
  • 3 kHz to 30 kHz

Because claim 4 includes multiple ranges, it can cover several distinct signal designs that still remain within those windows.

System claim 19 repeats claim 2

  • Frequency: 1 kHz to 100 MHz

Landscape significance: the frequency limitations function less like strict technical gates and more like “covering common electrical signaling bands” for conductive intrabody communication. From a freedom-to-operate angle, a design that avoids the listed bands may reduce risk for these dependent claims, but claim 1 and many method/system elements remain frequency-unconstrained unless a narrower dependent claim is asserted.


What is the electrode/differential voltage architecture coverage (claims 5-6, 20-21, 28-29, and 15)?

Antenna/electrode language differs by claim set

  • Claim 5: receiver element comprises a receiving antenna configured to detect potential differences in a body.
  • Claim 6: receiving antenna comprises two electrodes spaced apart enough to detect a differential voltage.

Claim 15 is explicit: it recites two electrodes spaced apart to detect differential voltage.

Claims 20-21 repeat the system architecture:

  • receiving antenna configured to detect potential differences
  • two electrodes spaced apart to detect differential voltage

Claims 28-29 repeat the method architecture:

  • receiving antenna detects potential differences
  • two electrodes spaced apart to detect differential voltage

Infringement-relevant nuance

If the accused product uses conductive pickup electrodes designed to measure differential voltage within body tissue, it aligns with both the “antenna” and “two electrodes” dependent claim scaffolding. Even if marketed as “bio-sensing” or “electrical coupling,” the legal hook is the electrodes spaced to detect differential voltage and the receiver’s role in capturing the identifier’s conductive signal.


What receiver subsystems are claimed (claims 7-9 and 15)?

Receiver components called out

  • Claim 7: receiver comprises an amplifier
  • Claim 8: receiver comprises a filter
  • Claim 9: receiver comprises a demodulator

Claim 15 combines amplifier and demodulator in one required bundle

Claim 15 recites:

  • receiver element with two electrodes (differential detection)
  • data storage element
  • amplifier
  • demodulator
  • plus retransmission to external device

Practical implication: designs that omit amplification or demodulation could try to avoid dependent claim assertion, but claim 1 does not mandate these elements. Any enforcement strategy can still proceed under broader claim 1 if the amplifier/filter/demodulator features are present only incidentally or are inherently part of signal reception.


How does data retransmission to an external device expand scope (claims 10-11, 15, 24-33)?

Claim 10: receiver retransmits data

  • receiver configured to retransmit data to a separate external device

Claim 11: RF protocol specificity

  • retransmission uses RF circuitry
  • retransmission uses an RF communication protocol

Claim 15 and claim 24 include retransmission

  • Claim 15: retransmit data to separate external device
  • Claim 24: receiver retransmits data to a separate external device

Method claim 32-33 expand the steps

  • Claim 32: method includes retransmitting data
  • Claim 33: includes transmitting a signal from receiver to the separate external device

Landscape read: retransmission creates additional enforcement surface against telemetry-enabled systems (e.g., patch-to-phone or implant-to-external reader). If a product only stores ingestion time/date/identity locally without retransmission, it targets risk away from the dependent claims. Still, claim 1 and claim 25 do not require retransmission.


In vivo vs ex vivo receiver placement (claims 12-13, 16-17)

The patent includes explicit receiver configuration options:

  • Claim 12: receiver configured as in vivo receiver
  • Claim 13: receiver configured as ex vivo receiver
  • Claim 16: claim 15 receiver as in vivo
  • Claim 17: claim 15 receiver as ex vivo

Implication: the patent is designed to cover both:

  • internal or body-placed reception hardware (in vivo), and
  • external pickup readers paired with conductive coupling into the body (ex vivo)

This removes a common “placement” vulnerability where claims are written narrowly for implant-only or reader-only embodiments.


System/receiver method elements mapped to claim language (quick matrix)

Element category Claim 1 Claim 15 Claim 18 Claim 25
Identifier conducts signal on contact with internal target physiological site Required Required Required Required
Receiver receives conductively transmitted signal Required Required Required Required
Data storage stores at least one of time/date/identity of ingested composition Required Required Required Required
Differential voltage via two electrodes Optional (covered in dependent claims) Required Optional (dependent) Optional (dependent)
Amplifier/filter/demodulator Optional (dependent) Amplifier + demodulator required Optional (dependent) Optional (dependent)
Retransmit to separate external device Optional (dependent) Required Optional (dependent) Optional (dependent)
RF protocol specificity Optional (dependent claim 11) Optional (via claim 11 dependency path) Optional (via claim 24/19/20 dependency path) Optional (via claim 32/33 dependency path)
In vivo/ex vivo placement Optional (dependent) Optional (dependent) Not separately recited Not separately recited

What is the practical scope for competitors? (design-around and overlap vectors)

Most central overlap vector

A system that:

  • detects ingestion via conductive signal emitted on internal physiological-site contact, and
  • records time/date/identity in memory at a receiver

falls directly within the center of claim scope.

Secondary overlap vector: electrode differential sensing

If the receiver uses:

  • two spaced electrodes to pick up a differential voltage in the body,

it aligns with claims 6, 15, 21, 29.

Secondary overlap vector: retransmission

If the receiver also:

  • retransmits stored ingestion data to a separate device, especially over RF,

it aligns with claims 10-11, 15, 24, 32-33.

Potential design-around levers (at dependent-claim level)

  • Signal frequency outside 1 kHz to 100 MHz reduces risk for dependent claims 2 and 19, but does not remove claim 1 risk.
  • Avoiding a two-electrode differential-voltage architecture reduces risk for claim 6/15/21/29.
  • Omitting an amplifier/filter/demodulator as distinct functions may help against those specific dependent claims, but not claim 1.
  • Avoiding retransmission avoids dependent claims 10-11 and 24, but not claim 1.

Patent landscape and “who is likely adjacent” based on the claim posture

This patent’s scope is built around a fairly specific technical combination:

  1. conductive signaling triggered by contact with an internal physiological site,
  2. receiver-side logging of ingestion timing and identity, and
  3. (optionally) telemetry to an external reader.

That combination typically puts the patent in the same enforcement neighborhood as:

  • ingestible or internal-contact sensor delivery systems that use conductive coupling rather than optical/acoustic channels,
  • “event detection” systems logging ingestion time and/or composition identity,
  • telemetry receivers that store event data and forward it externally.

Where overlap will likely occur

  • Platforms that claim internal event detection with conductive signal triggering and receiver logging.
  • Systems that use electrode-based differential sensing for intrabody conductive signal reception.
  • Systems with local storage plus external data upload.

Where overlap is less likely

  • Systems using non-conductive modalities for the identifier-to-receiver link (e.g., purely RF broadcast without conductively transmitted contact-trigger behavior).
  • Systems that do not store time/date/identity at the receiver.

Litigation posture inference from claim design

The patent has:

  • one broad independent receiver claim (claim 1),
  • one narrower electrode+differential+amplifier+demodulator+retransmission independent claim (claim 15),
  • one system claim (claim 18),
  • one method claim (claim 25).

That structure is consistent with an intent to cover both product-level and process-level infringement while preserving enforceability even if an accused product changes certain implementation details (for example, still retaining conductive reception and ingestion data storage).


Key Takeaways

  • Claim 1/18/25 establish the core: a receiver that captures a conductively transmitted signal emitted on contact with an internal target physiological site and stores ingestion data (time/date/identity of ingested composition).
  • Dependent claims cover:
    • signal frequency windows (1 kHz to 100 MHz and narrower sub-bands),
    • two-electrode differential voltage reception via “receiving antenna” language,
    • receiver subsystems: amplifier, filter, demodulator,
    • retransmission to a separate external device using RF circuitry and RF protocols.
  • In vivo and ex vivo placement is explicitly supported in dependent claims, increasing practical coverage across hardware architectures.
  • For a competitor, the most direct collision points are: conductive contact-triggered signaling + ingestion data storage. Additional collision risk rises sharply if the design also includes electrode differential sensing and RF retransmission.

FAQs

1) Does the patent require RF for the core receiver function?

No. RF retransmission is required only for dependent claim 11 and related dependent coverage; claim 1’s baseline function is conductive signal reception plus storage of ingestion data.

2) Is a two-electrode differential voltage receiver mandatory?

No for claim 1. Two electrodes and differential voltage are required for the narrower independent claim 15 and are recited in dependent claims 6, 21, and 29.

3) Can the identifier transmit only when it contacts the internal physiological site and still fall within scope?

Yes. The identifier “conductively transmits a signal upon contact with an internal target physiological site” is a required premise in claims 1, 15, 18, and 25.

4) How do frequency limitations apply?

Frequency ranges appear in dependent claims (2-4 and 19). They restrict those dependent claim scopes but do not narrow claim 1’s baseline coverage.

5) Is data retransmission to an external device required?

No for claim 1 and claim 25. It is included in dependent claims 10-11 and claim 15, and is specified in method dependent claims 32-33.


References

[1] United States Patent 8,674,825 (claims as provided in prompt).

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Drugs Protected by US Patent 8,674,825

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-001 Nov 13, 2017 DISCN Yes No 8,674,825 ⤷  Start Trial Y METHOD OF USING A RECEIVER TO RECEIVE A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT ⤷  Start Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-002 Nov 13, 2017 DISCN Yes No 8,674,825 ⤷  Start Trial Y METHOD OF USING A RECEIVER TO RECEIVE A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT ⤷  Start Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-003 Nov 13, 2017 DISCN Yes No 8,674,825 ⤷  Start Trial Y METHOD OF USING A RECEIVER TO RECEIVE A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT ⤷  Start Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-004 Nov 13, 2017 DISCN Yes No 8,674,825 ⤷  Start Trial Y METHOD OF USING A RECEIVER TO RECEIVE A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT ⤷  Start Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-005 Nov 13, 2017 DISCN Yes No 8,674,825 ⤷  Start Trial Y METHOD OF USING A RECEIVER TO RECEIVE A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT ⤷  Start Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-006 Nov 13, 2017 DISCN Yes No 8,674,825 ⤷  Start Trial Y METHOD OF USING A RECEIVER TO RECEIVE A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,674,825

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2006239221 ⤷  Start Trial
Australia 2012282690 ⤷  Start Trial
Australia 2012282772 ⤷  Start Trial
Australia 2012282776 ⤷  Start Trial
Australia 2012282777 ⤷  Start Trial
Australia 2017202754 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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