Last Updated: May 11, 2026

Details for Patent: 8,961,412


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Summary for Patent: 8,961,412
Title:In-body device with virtual dipole signal amplification
Abstract:Virtual dipole signal amplification for in-body devices, such as implantable and ingestible devices, is provided. Aspects of the in-body deployable antennas of the invention include antennas configured to go from a first configuration to a second configuration following placement in a living body, e.g., via ingestion or implantation. Embodiments of the in-body devices are configured to emit a detectable signal upon contact with a target physiological site. Also provided are methods of making and using the devices of the invention.
Inventor(s):Hooman Hafezi, Benedict James Costello, Timothy L. Robertson, Maria Casillas Holen
Assignee: Otsuka Pharmaceutical Co Ltd
Application Number:US12/238,345
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Scope, Claim Interpretation, and US Patent Landscape for US 8,961,412

What is US 8,961,412 and what does it claim?

US 8,961,412 claims an ingestible event marker and a detection system built around a dipole-engineering concept: an identifier produces (1) an actual dipole defined by the opposing signal transmission elements and (2) a larger virtual dipole created by placing an electrically insulative signal amplification element between the opposing transmission elements. The virtual dipole length is larger than the actual dipole length.

The core structural/functional feature across the independent claims is:

  • Two opposing signal transmission elements arranged with a spaced relationship
  • The opposing elements are configured to produce an actual dipole with a predefined length
  • An electrically insulative signal amplification element sits between the opposing elements and causes a virtual dipole that has a length defined by the amplification element, where:
    • virtual dipole length > actual dipole length
  • The identifier emits a signal when it contacts a target site, including embodiments activated by contact with target-site fluid

Claim set provided (1-17) is consistent with a single invention theme: “dipole length amplification” via insulative electrical structures for ingestible signaling.


What is the invention’s claim scope in plain technical terms?

1) Independent claim 1: ingestible event marker

Claim 1 defines the event marker as:

(A) Identifier configured to emit a signal when it contacts a target site

  • “Contacts a target site” is a triggering condition.
  • The identifier includes signal generation, or at minimum the structure that enables signal emission upon contact.

(B) Identifier includes two opposing signal transmission elements

  • A first signal transmission element
  • A second signal transmission element arranged in an opposing spaced relationship to the first

(C) Actual dipole defined by the opposing transmission elements

  • The opposing elements are configured to produce an actual dipole having a predefined dipole length.
  • A dependent claim clarifies the actual dipole is defined between the opposing elements.

(D) Virtual dipole created by an electrically insulative amplification element

  • An electrically insulative signal amplification element is disposed between the first and second signal transmission elements.
  • This amplification element is configured to produce a virtual dipole:
    • virtual dipole length is defined by the signal amplification element
    • virtual dipole length is larger than actual dipole length

(E) Functional relationship of electric fields Claim 12 adds the mechanism detail: the virtual dipole is defined by “conducting an electrical current” between the signal transmission elements about the insulative amplification element. This reads like a configuration where the insulative body guides field/current paths to extend effective dipole length.

2) Dependent claim structure: tightening device form factors

Key dependent constraints:

  • Claim 2: Activation occurs upon contact with target-site fluid present at the target site.
  • Claim 3: virtual dipole length is 2x or more the “first dipole length” (interpretable as the actual dipole length or the dipole length associated with the first/actual element set).
  • Claims 4-6: electrodes can be planar and positioned on opposing sides of a solid support, with the solid support between electrodes.
    • Claim 5: solid support can include an integrated circuit
    • Claim 6: first and second opposing electrodes are planar electrodes
  • Claims 7-8: amplification element geometry
    • Claim 7: planar structure outer edge extends beyond the edge of the first/second transmission elements
    • Claim 8: amplification element can be a two-dimensional signal amplification element
  • Claim 9: adds an active agent stably associated with a signal generation element coupled to the first/second transmission elements.
  • Claim 10: adds additional spaced electrodes for multiple dipoles (second actual dipole and a third actual dipole).
  • Claim 11: actual dipole is defined between the first and second opposing transmission elements.
  • Claim 12: mechanism for virtual dipole via current conducted between transmission elements about the insulative element.

3) Independent claim 13: system claim

Claim 13 is a system with:

  • (a) the same ingestible event marker identifier structure described in claim 1
  • (b) a receiver configured to detect the signal produced

Dependent claims 14-15 specify receiver types:

  • Claim 14: receiver is in vivo
  • Claim 15: receiver is external

Claims 16-17 repeat dipole definition and virtual dipole mechanism language in system context.


Where is the legal “center of gravity” of claim scope?

The claim’s novelty anchor is the dipole-length relationship

The strongest, most limiting feature is:

  • “electrically insulative signal amplification element disposed between” opposing transmission elements
    AND
  • “virtual dipole length is larger than actual dipole length”

Everything else is either:

  • activation context (fluid contact), or
  • physical packaging (planar electrodes, solid support with IC), or
  • scaling (virtual dipole is 2x+), or
  • receiver implementation.

Claim construction pressure points (practical)

Based on the claim language provided, the scope will turn on how these are interpreted:

  1. “electrically insulative”: covers materials/devices that are insulating in the relevant operating context.
  2. “disposed between”: likely requires physical placement between the opposing transmission elements (not merely adjacent).
  3. “produce a virtual dipole … length defined by the signal amplification element”: the amplification element must define or parameterize the virtual dipole effective length.
  4. “virtual dipole length larger”: requires a measurable or determinable mapping from structure geometry and/or current path to an effective dipole length.
  5. “actual dipole … predefined dipole length”: fixed by electrode spacing/geometry in the device.

The independent claims are not limited to a particular transmitter/receiver modality

Claim 13 does not constrain the nature of the receiver beyond detection and being in vivo or external. The signal emission mechanism is described at a high level through the identifier’s configuration and emission upon contact.


What are the most enforceable claim limitations for infringement analysis?

The most infringement-critical limitations are those that define the electrical structure:

  • Two opposing signal transmission elements producing an actual dipole
  • Insulative amplification element between them producing a virtual dipole longer than the actual dipole
  • Contact activation at the target site
  • For certain embodiments: planar electrodes and geometry (2D amplification element, outer edge beyond transmission elements)

If an accused device does not create a virtual dipole longer than the actual dipole via an insulative element disposed between the electrodes, it likely misses the core.


How broad is the scope across the dependent claims?

Broadest interpretation (claim 1 + minimal dependencies)

Under the broad reading of claim 1 (without adding dependent constraints), a design only needs:

  • opposing spaced transmission elements (first + second)
  • a between-disposed electrically insulative amplification structure
  • a virtual dipole longer than actual dipole, defined by the amplification structure
  • an ingestible trigger that emits upon contacting the target site

Narrowing constraints (claims 3-8, 10)

The device can get narrower with additional requirements:

  • Claim 3: virtual dipole length must be 2x or more the “first dipole length”
  • Claims 4-6: planar electrodes on opposing sides of a solid support, possibly an integrated circuit
  • Claims 7-8: planar/2D insulative amplification element extending beyond electrode edges

Additional functionality (claim 9)

Claim 9 broadens device capabilities by adding:

  • a signal generation element and an active agent stably associated with it

This could support infringement for formulations where ingestion event markers carry a biological or chemical actuation component tied to signaling.

Multi-dipole extension (claim 10)

Claim 10 extends scope to architectures with:

  • a third opposing signal transmission element
  • multiple actual dipoles (second and third actual dipole)

This matters for competitors designing multi-electrode ingestibles.


What is covered by the system claim vs the device claim?

Device claim (claim 1)

Covers the ingestible marker structure.

System claim (claim 13)

Covers:

  • the ingestible marker structure, plus
  • a receiver detecting signal produced by that identifier

This means a competitor selling only the marker may fall under claim 1 exposure, while a competitor deploying a full readout system (in vivo or external) can be closer to claim 13 exposure.


Patent landscape: how to map competitive risk around US 8,961,412

Because you requested a “patent landscape” but only provided the claim text (no assignee, filing history, priority, publication number, family members, or cited references), a complete landscape with specific named patents and prosecution citations cannot be produced without introducing unverifiable external sourcing.

So the landscape analysis below stays anchored to claim-driven competitor design space and the likely saturation points in ingestible event marker patents.

Competitive design space segments (claim-relevant)

Most ingestible marker and ingestible sensor families cluster around a few technical approaches that can be compared directly to the claim language:

  1. Tuning-based dipole antennas without “virtual dipole length amplification”

    • Many ingestible electronic markers use small antennas, tuning, or resonant elements.
    • If they do not use an electrically insulative amplification element disposed between opposing electrodes to create a longer virtual dipole, they likely avoid claim 1’s unique limitation.
  2. Electrode arrays with non-insulative field extenders

    • If a “field extender” is conductive, resistive, or not “insulative” in the relevant sense, it diverges from “electrically insulative signal amplification element.”
  3. Capacitive coupling sensors

    • Capacitive event markers sometimes use insulative layers, but the claim requires:
      • insulative amplification element
      • producing a virtual dipole with length defined by the insulative element
      • virtual dipole length larger than actual dipole length
  4. Multi-electrode dipole architectures

    • Claim 10 can be a differentiator for multi-dipole ingestible markers. Devices using additional electrodes for multi-channel fields may land closer.
  5. Readout architectures

    • Claim 13 supports both in vivo and external receivers. Competitors with external readout are not immunized.

Practical infringement risk map

Below is a threat matrix using the claim’s key limitations as gates.

Competitor approach Opposing electrodes (actual dipole) Insulative amplification between electrodes Virtual dipole length > actual dipole length Likely match to independent claims
Simple opposing electrode ingestible signalers Likely yes Unclear Unclear Partial at best unless virtual dipole is longer
Dipole antenna with conductive extension Likely yes No (not insulative) Unlikely via insulative element Low for claim 1’s insulative amplification limitation
Capacitive sensor with insulative layer Yes Yes Must demonstrate longer virtual dipole length Medium if “virtual dipole length” maps to extender
Design with an insulative field extender producing longer effective dipole Yes Yes Yes (by definition) High to independent claim 1 and dependent geometry
Multi-dipole electrode marker Yes Yes Possibly Higher if also has claim 10’s third element and multiple actual dipoles
System sold with receiver (external/in vivo) Marker exists Marker exists Marker exists High to claim 13 exposure if receiver detects marker signal

Scope audit: what variants are likely inside vs outside

Likely inside (based on the literal claim structure)

  • Opposing electrodes separated by a solid support, where an insulating amplification element lies between them and extends the effective dipole length.
  • Amplification geometry that is planar or 2D, including cases where the amplification element’s outer edge exceeds the electrodes.
  • Architectures where virtual dipole length is quantified or constrained such that it exceeds actual dipole length, including a 2x or greater relation.

Likely outside

  • Designs where the amplification element is not insulating (conductive/semiconductive in the relevant pathway).
  • Designs where the “effective dipole length” is not longer than the actual dipole length as defined by the opposing transmission elements.
  • Designs where the event marker requires a different triggering mechanism than “contacts a target site” (unless still met via fluid contact embodiments).

Key Takeaways

  • US 8,961,412 centers on dipole length amplification: an electrically insulative element between opposing electrodes creates a virtual dipole that is longer than the actual dipole.
  • The most enforceable limitations are the between-disposed insulative amplification element and the condition virtual dipole length > actual dipole length.
  • Dependent claims narrow packaging (planar electrodes, solid support including IC, 2D amplification element), activation (target-site fluid), scaling (virtual dipole 2x+), and expand to multi-dipole configurations.
  • The system claim adds receiver coverage (external or in vivo), raising exposure for full-solution offerings.

FAQs

1) What is the single most important limitation in US 8,961,412?

The identifier includes first and second opposing signal transmission elements that form an actual dipole, and an electrically insulative signal amplification element disposed between them that creates a virtual dipole with length larger than the actual dipole length.

2) Does the patent require a specific receiver type?

No. Claim 13 covers any receiver configured to detect the signal, with dependent claims specifying in vivo or external receivers.

3) What does “virtual dipole length defined by the signal amplification element” imply for design checks?

The insulative amplification element must parameterize the effective dipole length (not merely provide insulation). The effective length must be derivable from the amplification element configuration.

4) How do claims 7 and 8 affect product design freedom?

They narrow embodiments to planar or 2D amplification structures, including configurations where the amplification element outer edge extends beyond the electrodes.

5) What is the scope difference between claims 1 and 13?

Claim 1 is the ingestible marker structure. Claim 13 covers the system by adding a receiver that detects the emitted signal.


References

[1] United States Patent US 8,961,412, claims 1-17 (text provided).

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Drugs Protected by US Patent 8,961,412

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 8,961,412 ⤷  Start Trial Y ⤷  Start Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-002 Nov 13, 2017 DISCN Yes No 8,961,412 ⤷  Start Trial Y ⤷  Start Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-003 Nov 13, 2017 DISCN Yes No 8,961,412 ⤷  Start Trial Y ⤷  Start Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-004 Nov 13, 2017 DISCN Yes No 8,961,412 ⤷  Start Trial Y ⤷  Start Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-005 Nov 13, 2017 DISCN Yes No 8,961,412 ⤷  Start Trial Y ⤷  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 8,961,412

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Denmark 2192946 ⤷  Start Trial
European Patent Office 2192946 ⤷  Start Trial
European Patent Office 4011289 ⤷  Start Trial
Spain 2928197 ⤷  Start Trial
Finland 2192946 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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