Details for Patent: 8,258,962

Which drugs does patent 8,258,962 protect, and when does it expire?

Patent 8,258,962 protects ABILIFY MYCITE KIT and is included in one NDA.

This patent has twenty-four patent family members in thirteen countries.

Summary for Patent: 8,258,962

Title:	Multi-mode communication ingestible event markers and systems, and methods of using the same
Abstract:	Aspects of the invention include multi-mode communication ingestible event marker devices. Ingestible event marker devices of the invention include an ingestible component comprising a conductive communication module and at least one additional non-conductive communication module. The non-conductive communication module may be integrated with the ingestible component or at least a portion or all of the non-conductive communication module may be associated with a packaging component of the ingestible event marker device. Additional aspects of the invention include systems that include the devices and one or more receivers, as well as methods of using the same.
Inventor(s):	Timothy Robertson, Mark J. Zdeblick
Assignee:	Otsuka Pharmaceutical Co Ltd
Application Number:	US12/398,941
Patent Claim Types: see list of patent claims	Device; Dosage form;

United States Patent 8,258,962: Scope, Claims Architecture, and Patent Landscape for Ingestible Dual-Channel Communication Devices

What does US 8,258,962 claim in plain scope terms?

US 8,258,962 claims devices and systems built around an ingestible component that includes:

• An ingestible “conductive” integrated circuit with a conductive communication module (emits a first signal).
• A “second non-conductive communication module” (emits a second signal) that can be implemented in multiple modalities, including:
  • Optical, specifically an infrared frequency module
  • Wireless RF, specifically RFID
  • Magnetic induction
  • Acoustic
  • Wired
• A receiver used to detect one or both signals and/or communicate information to the non-conductive module, where the receiver is framed broadly across:
  • manufacturing systems
  • supply chain management systems
  • healthcare management systems
  • implantable receiver configurations
  • systems that can be “removably attached to a living being”
• Power options:
  • ingestible component can include a power source
  • power source can be a pair of electrodes fabricated from dissimilar materials
  • device can include a second power source electrically coupled to the non-conductive module, where the second power source can be a coil

The independent claim theme is a dual-channel identification/communication architecture combining a conductive pathway (through an integrated circuit) with a non-conductive pathway (multiple possible communication media), arranged for ingestible deployment and managed by external or embedded receivers.

How are the claims structured and what is the practical claim “stack”?

The claim set is dominated by claim families that repeat the same core structural elements with targeted dependent claim add-ons (optical IR, RFID, power source electrode chemistry, coil coupling, separability, integration into an “identifier component,” and receiver roles).

Core independent/near-independent claim elements (appearing repeatedly)

Across claims 1, 32, 50, 68, 85, and the system claims 19, 103, 111, 123, 136, the recurring core is:

1. Ingestible component comprising:
   • Integrated circuit with conductive communication module
2. Second non-conductive communication module comprising:
   • at least one optical module with infrared frequency module (explicit in claim 1)
   • and/or other modalities (explicit in various dependent claims)
3. Communication and integration relationships:
   • modules are electrically coupled (or coupled to integrated circuits)
   • optionally integrated into an identifier component
4. Non-conductive transmitter concept:
   • non-conductive communication module can include a non-conductive transmitter
   • can be associated with the ingestible component and/or packaging
5. Separability constraint:
   • non-conductive module may be separable from the ingestible component without compromising conductive module function
6. Power architecture:
   • ingestible power source (including dissimilar-electrode pair)
   • second power source for non-conductive module (coil)
7. Second integrated circuit relationship:
   • non-conductive module can be coupled to a second integrated circuit distinct from ingestible integrated circuit
   • the two integrated circuits can be configured to communicate with each other

Claim add-on “levers” (dependent claim features that drive design-in)

The dependent claims add levers that translate into concrete engineering options:

• Optical IR: “optical module comprises an infrared frequency module” (claim 1, and mirrored in claims 35, 53, 71, 88)
• RFID: “wireless radio-frequency module comprises a radio-frequency identification module” (claim 2, and mirrored in claims 34, 52, 70, 87)
• Power source materials:
  • “pair of electrodes fabricated from dissimilar materials” (claims 4, 54, 90, and in the power-centric claim family)
• Coupling power:
  • second power source comprises a coil (claims 6, 37, 55, 75, 92)
• Module placement and packaging association:
  • non-conductive transmitter can be associated with ingestible component or packaging component (claims 12, 43, 61; also 41, 60, 77, 78)
• Modular separation:
  • non-conductive module separable from ingestible component without compromising conductive module function (claims 15, 46, 64, 81, 99)
• System receiver architecture:
  • receiver is part of manufacturing, supply chain, healthcare management systems
  • receiver can be removably attached to living being and include adhesive component (claims 25-26, 108, 120)
  • receiver can be implantable (claims 27, 109, 121, 123, 148)
  • receiver can be an electrical stimulation device (claims 28, 110, 122, 135)
• Data type:
  • first signal comprises non-physiologic data (claims 24, 106, 132, 145)

Duplicative claim families: what they accomplish

The repetition across many dependent claims strongly suggests the patentee designed coverage for multiple implementation “routes”:

• Device claims cover multiple configurations of where communication modules and power sources reside.
• System claims extend the invention into receiver-based use cases tied to real operational workflows (manufacturing, supply chain, healthcare management) and also into “attached/implantable” receiver embodiments.

What is the scope of coverage by communication modality?

US 8,258,962 uses a modality-agnostic “second non-conductive communication module” that is then selectively narrowed in dependent claims. The result is that a product can fall within the claim scope through multiple paths.

Optical (Infrared) coverage

• Claim 1: second non-conductive communication module includes at least one optical module
• Claim 1: optical module comprises an infrared frequency module
• Mirrored dependent cover in claims:
  • 35 (optical IR)
  • 53 (optical IR)
  • 71 (optical IR)
  • 88 (optical IR)

Implication for infringement scope: any ingestible identifier device with an IR optical communication module connected to or co-packaged with a conductive integrated circuit system can map onto the optical limb of the claims.

RF / RFID coverage

• Claim 2: second non-conductive communication module includes at least one wireless RF module
• Claim 2: wireless RF module comprises an RFID module
• Mirrored dependent cover:
  • 34, 52, 70, 87

Implication: RFID is not framed merely as an optional technology; it is a named dependent fallback that anchors “RF” in the claim family.

Other non-conductive modules

Claim 29 adds magnetic induction module; claim 30 adds acoustic module; claim 31 adds wired module. These concepts recur in claims 33 and 51 as part of a “selected from the group consisting of…” list (with wireless RF, magnetic induction, optical, acoustic, wired).

Implication: a design that swaps IR/RFID for magnetic induction, acoustic, or wired can still hit the claim families, as long as the dual “conductive integrated circuit + non-conductive communication module” architecture remains.

How broad is the “conductive communication module” and what does it practically cover?

The claims define an ingestible component with an integrated circuit comprising a conductive communication module. The conductive module is not limited in the provided claim text to a particular conductive signal method (e.g., electrochemical signaling, capacitive coupling, direct electrical contact, etc.). The operative requirements are:

• it exists within the ingestible integrated circuit
• it emits a first signal (system claims)
• it functions with a non-conductive module without being compromised even when the non-conductive module is separable (claim 15 and companions)

Practical consequence: the conductive module is likely treated as a generic conductive communication element within a device identifier that can coordinate with non-conductive comms.

What is the power scope and where does it land?

Power is addressed in two separate ways.

Ingestible power source

• Claim 3: ingestible component comprises a power source
• Claim 4: power source comprises a pair of electrodes from dissimilar materials

This electrode pairing is an important narrowing limitation in the electrode-dependent claim family (claims 32-36).

Second power source coupled to non-conductive module

• Claim 5: device comprises a second power source electrically coupled to non-conductive communication module
• Claim 6: second power source comprises a coil

Implication: designs can meet power needs either via ingestible electrodes or via a coil powering non-conductive comms. The “second power source” limitation is specifically tied to non-conductive module coupling, which matters for architecture decisions.

How is module integration and separation handled?

The claims include three structural “relationship” constraints:

1. Non-conductive module location:
   • ingestible component can include non-conductive communication module (claims 7, 38, 56, 93)
2. Electrical coupling:
   • non-conductive module electrically coupled to ingestible integrated circuit (claims 8, 39, 57, 94)
3. Identifier component integration:
   • ingestible integrated circuit + conductive comm module + at least a portion of non-conductive module integrated into an “identifier component” (claims 9, 40, 58, 95, 76)

Separable non-conductive module

Claims 15 and its companions (46, 64, 81, 99) allow at least a portion of the non-conductive communication module to be separable from the ingestible component without compromising conductive communication module function.

Implication: if the IR/RFID/magnetic induction element is packaged as a separable component while retaining conductive identification function in the ingestible circuit, the separability limitation creates a path to coverage.

What receiver architectures are claimed?

System claims extend device coverage into receiver-based operational contexts. Key receiver scopes:

Manufacturing / supply chain / healthcare framing

• Claim 19: receiver is component of a manufacturing system
• Claim 103: receiver is component of supply chain management system
• Claim 111: receiver is part of a health care management system (within a broader list in claim 114)
• Claim 136: system where receiver is an electrical stimulation device

These claims also require the receiver to:

• receive first and/or second signals
• include communication capability between receiver and at least one of the conductive and non-conductive modules

Receiver types

Dependent claims define receiver composition and association:

• radio-frequency reader (claims 20, 104, 112, 124, 137)
• associated with sorter, encoder, tracker, scanner (claims 22-23, 115-118, 127-131, 139-143, etc.)
• adhesive component (claims 26, 108, 120)
• implantable receiver (claims 27, 109, 121, 123, 148)
• electrical stimulation device receiver (claims 28, 110, 122, 135, 136-148 family)

Implication: receiver-based systems in industrial tracking and in-body monitoring are both within the claim perimeter, as long as the underlying ingestible dual-module communication architecture is present.

What are the claim scope “boundary conditions” that narrow infringement?

Even though many elements are broad, the claims require a very specific combination:

1. Ingestible component must include an integrated circuit with conductive communication module emitting/emitting a first signal (device claims and system claims).
2. A second non-conductive communication module must be present and connected to the system logic.
3. At least one second non-conductive modality must match the selected claim pathway (IR optical, RFID, magnetic induction, acoustic, wired).
4. If the accused product relies on electrode power or coil power, it must meet those power sub-limitations for those dependent claim sets.

In other words, the independent claim set is not “any ingestible RFID”; it is a dual conductive/non-conductive integrated circuit + second non-conductive communication module structure.

Claim-by-claim coverage matrix (from the provided text)

The table maps major limitations to the claim numbers where they are explicitly present.

Limitation	Claims where explicitly recited (examples from provided list)
Conductive comm module in ingestible integrated circuit	1, 32, 50, 68, 85, 103, 111, 123, 136
Second non-conductive comm module includes optical module	1, 33, 51, 69, 86, 88
Optical module is infrared frequency module	1, 35, 53, 71, 88
Second non-conductive comm module includes RF module	2, 33, 51, 69, 86
RF module is RFID	2, 34, 52, 70, 87
Non-conductive module includes magnetic induction	29, 33, 51, 69, 86
Non-conductive module includes acoustic	30, 33, 51, 69, 86
Non-conductive module includes wired	31, 33, 51, 69, 86
Ingestible component includes a power source	3, 32, 72, 89
Power source is pair of dissimilar electrodes	4, 54, 90
Device has second power source coupled to non-conductive module	5, 36, 50, 74, 91
Second power source includes a coil	6, 37, 55, 75, 92
Non-conductive module is included in ingestible component	7, 38, 56, 93
Non-conductive module electrically coupled to ingestible integrated circuit	8, 39, 57, 94
Components integrated into “identifier component”	9, 40, 58, 95, 76
Non-conductive communication module includes non-conductive transmitter	10, 41, 59, 96
Non-conductive transmitter associated with packaging	12, 43, 61, 78, 98
Second integrated circuit distinct from ingestible integrated circuit	13, 44, 62, 79, 85
Second and ingestible integrated circuits configured to communicate	14, 45, 63, 80, 85
At least portion of non-conductive module separable from ingestible component	15, 46, 64, 81, 99
First signal is non-physiologic data	24, 106, 132, 145
Receiver is part of manufacturing system	19
Receiver is part of supply chain management system	103
Receiver is part of healthcare management system	111, 114
Receiver is removably attached to living being	25, 107, 133, 146
Receiver comprises adhesive component	26, 108, 120, 134
Receiver is implantable	27, 109, 121, 123, 148
Receiver configured as electrical stimulation device	28, 110, 122, 135, 136
Receiver is radio-frequency reader	20, 104, 112, 124, 137
Receiver associated with sorter/encoder/tracker/scanner	22-23, 115-118, 127-131, 139-143, 144

What does the broader patent landscape likely look like for this type of claims?

The claim package is tightly aligned to a known industry cluster at the intersection of:

• ingestible identifiers (tablets/capsules with electronics)
• dual-mode identification (contact/conductive and wireless/non-contact)
• supply chain serialization and track-and-trace for pharmaceuticals
• in-process manufacturing scanning/encoding
• patient-adjacent monitoring via wearable/adhesive, implantable, or stimulation-context receivers

However, producing a reliable, citation-backed “patent landscape” for a specific US patent number requires bibliographic metadata (assignee, filing date, priority, continuation relationships, examiner, cited references) and then cross-referencing forward/backward citations and overlapping claim charts across the US and WO families. None of that bibliographic content is included in the provided text, and generating it without verification would produce an incomplete and potentially misleading landscape.

Actionable conclusions for R&D and freedom-to-operate (FTO)

Even without landscape citations, the claim language itself gives clear product design triggers:

1. Dual-module structure is the anchor. Any design that avoids both (a) a conductive integrated circuit communication module and (b) a second non-conductive communication module with at least one specified modality is the most direct way to reduce exposure.

2. Infrared optical and RFID are explicit dependent “landing zones.” Products using IR optical comms or RFID on an ingestible identifier element with a conductive integrated circuit can fall squarely within dependent claim families tied to claims 1-2 and their mirrors.

3. Power architecture matters only if you use it. Electrode-based power and coil-coupled power are explicitly claimed in electrode- and coil-dependent sets. If an alternative power approach is used, those narrower dependencies may not be implicated, but the base dual communication architecture can still trigger broader portions.

4. Receiver integration in manufacturing and tracking workflows is claimed. If a system uses a receiver as part of manufacturing/supply chain/healthcare management and relies on the claimed signal types, system claims can broaden exposure beyond the ingestible device itself.

5. Separable non-conductive modules are still within scope. Splitting the optical/RFID/magnetic/acoustic element into a separable component does not necessarily avoid infringement if the conductive function persists and the separability limitation is met.

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Key Takeaways

• US 8,258,962 covers ingestible electronic identifiers that combine a conductive integrated circuit communication module with a second non-conductive communication module whose modality can be infrared optical, RFID, magnetic induction, acoustic, or wired.
• The claims extend into system-level receiver architectures used in manufacturing, supply chain management, and health care management, including RF readers, attached receivers, adhesive receivers, implantable receivers, and receivers used as electrical stimulation devices.
• Power is a secondary but explicit claim axis, including dissimilar-electrode power and coil-coupled power for the non-conductive module.
• Separability of the non-conductive module is explicitly accommodated, keeping coverage broad even with modular packaging architectures.

FAQs

1. Does the patent require both infrared and RFID?
   No. The claims require a second non-conductive communication module, and dependent claims add specific modalities such as infrared optical and RFID, which create multiple coverage pathways.

2. Is the conductive communication module required to be wireless?
   The claims only require it is a conductive communication module within the ingestible integrated circuit that emits/participates in the first signal. They do not limit the conductive method beyond being conductive.

3. Can the non-conductive module be separate from the ingestible component?
   Yes. The claims permit separability of at least a portion of the non-conductive module as long as it does not compromise the conductive communication module’s function.

4. Are manufacturing and supply chain scanners within scope even if the ingestible device is unchanged?
   The system claims are written to include receivers as components of manufacturing, supply chain management, and healthcare management systems, so system use can be part of the claimed subject matter.

5. What are the two most design-sensitive technical choices?
   The first is the presence of the dual-module architecture (conductive integrated circuit + second non-conductive communication module). The second is which non-conductive modality is used (infrared optical, RFID, magnetic induction, acoustic, wired).

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References

[1] United States Patent 8,258,962 (claims provided in prompt).

Drugs Protected by US Patent 8,258,962

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	8,258,962		Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-002	Nov 13, 2017		DISCN	Yes	No	8,258,962		Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-003	Nov 13, 2017		DISCN	Yes	No	8,258,962		Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017		DISCN	Yes	No	8,258,962		Y

International Family Members for US Patent 8,258,962

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009221781
Canada	2717862
China	102014867
China	104376659