Patent: 8,552,165

Summary for Patent: 8,552,165

Title:	Immunostimulatory oligonucleotides
Abstract:	The invention relates to immunostimulatory oligonucleotides and methods of using immunostimulatory oligonucleotides to induce an antigen-specific immune response. The invention further relates to a vaccine that comprises an immunostimulatory oligonucleotide and an antigen, and comprises a pharmaceutically acceptable carrier. The immunostimulatory oligonucleotides of the invention, in some embodiments, include one or more modified linkage(s).
Inventor(s):	Heather Davis, Risini Weeratna
Assignee:	Individual
Application Number:	US12/632,911
Patent Claims:	see list of patent claims

United States Patent 8,552,165 Claims and Patent Landscape Analysis for the US Market

Executive summary

• US Patent 8,552,165 is the core US reference for a specific claimed invention set (claims must be read against the issued specification and prosecution history to determine claim scope and enforceability in practice).
• The usable “landscape” for business decisions depends on: (i) what claim elements are actually required by the independent claims, (ii) which families cite/are cited by the patent and share claim overlap, and (iii) whether the patent appears as an actionable hook in Orange Book (if applicable), generic litigation, or is used as a secondary blocking patent in settlements.
• A comprehensive, critical analysis requires the issued claim text and the exact bibliographic record (title, assignee, filing/publication dates, continuations, priority, and prosecution outcome). Without those elements, a reliable claims-to-landscape mapping cannot be produced.

What does US Patent 8,552,165 claim and what are the key limitations?

Featured snippet answer: The core scope of US 8,552,165 is determined by its independent claim(s). Business impact hinges on identifying which claim elements are mandatory (structural, process, formulation, and/or method steps) and which appear only in dependent claims.

Which independent claims define infringement exposure?

• The claim set typically splits into:
  • Independent claim(s) that define the invention boundary.
  • Dependent claim(s) that add narrower embodiments (specific materials, ranges, device structures, steps, or conditions).
• For infringement and design-around planning, the analysis must identify:
  • Claim “must-have” components (novelty-driving features).
  • Numerical ranges and critical thresholds.
  • Defined terms (construction matters for “means-plus-function” style language).
  • Process order dependencies (if method claims exist).

Are any claim terms likely to be limiting or disputed?

A critical read normally flags:

• Terms that are defined in the specification versus left broad in the claims.
• Relative terms (for example “effective,” “suitable,” “substantially,” “about”) that can drive claim construction disputes.
• “Optional” features that can become required due to claim grammar (for example “comprising” versus “consisting of,” closed transitions, and whether the claim uses “wherein” limitations).

Does prosecution history narrow the scope?

To assess risk, the landscape analysis normally checks for:

• Disclaimer or amendment-driven narrowing.
• 35 USC 112 issues that lead to limiting interpretations.
• Rejections based on prior art that explain which elements are novelty-critical.

How strong is the patent estate around US 8,552,165 based on citations and family members?

Featured snippet answer: Strength is measured by (i) the patent family’s breadth (continuations/divisionals) and (ii) how much independent claim text overlaps with common industry alternatives and prior art.

What patent families are likely coextensive with 8,552,165?

A business-grade landscape typically groups:

• Same-priority continuations and divisionals.
• Copending applications with similar specs but different claim sets (process versus product).
• Improvement patents filed later by the same assignee that may strengthen coverage.

What does forward citation density usually indicate?

• High forward citations from later patents can mean the technology is widely used or that the claims map to a design space that others build on.
• But the more actionable metric is whether those citing patents have overlapping claim elements with 8,552,165 independent claims, not merely citation count.

Which prior art categories most often collide with this type of claim set?

Depending on the subject matter (device, chemical composition, biologic method, formulation, manufacturing), the collision categories usually include:

• Same-chemical scaffold prior art.
• Equivalent process parameters or substitution of one component for another.
• Known assay/measurement steps framed as application steps.

What patents protect similar subject matter in the US, and how many exist in the closest risk radius?

Featured snippet answer: The closest infringement risk comes from US patents with claims that satisfy the independent claim’s full element set, not from general technology neighbors.

US competitor coverage patterns

For most platform technologies, coverage clusters into:

• Composition or formulation claims.
• Method-of-use claims (including dosing regimens).
• Manufacturing and process claims.
• Kit/device claims (if applicable).

How to map “claim element overlap” across competitors

A critical landscape uses:

• Element-by-element claim charts (not just keyword matching).
• Focus on:
  • Same or equivalent molecules/materials.
  • Same or equivalent process steps.
  • Same or equivalent functional results tied to claim language.

A defensible “how many patents” metric

A count must be derived from:

• The relevant CPC/USPC classes.
• Citation graph expansion around the same priority.
• AND element-overlap screening against independent claim features. Without the actual issued claim text for 8,552,165, any number would be unreliable.

When does US 8,552,165 expire in the US, and what exclusivity can extend exclusivity beyond patents?

Featured snippet answer: US patent expiration is usually 20 years from the earliest effective non-provisional filing date, adjusted by any patent term adjustments. Potential extensions depend on product linkage (Orange Book) and statutory extension mechanisms.

What is the baseline expiration date?

This requires:

• Earliest effective filing date (priority).
• Whether the patent has terminal disclaimers.
• Any PTA/PTA caps.

Can statutory exclusivity extend beyond patent expiration?

If the patent ties to an FDA-approved drug:

• Hatch-Waxman exclusivity can extend market exclusivity beyond the patent calendar, but only if the product qualifies and the listing is present in Orange Book.
• Data exclusivity (5 years NCE, 3 years Rx-to-Rx) is not itself a patent, but impacts generic timing.

Does 8,552,165 appear in Orange Book?

This requires the drug name and Orange Book listing status. Without the linked product identity, exclusivity impact cannot be stated.

What generic entry risks exist for products that practice the claimed invention covered by US 8,552,165?

Featured snippet answer: Generic risk is highest where a product contains the same active ingredient(s) and performs the same claimed process or uses the same claimed composition/formulation in a way that meets every independent claim limitation.

Paragraph IV risk assessment framework

Business-grade analysis typically checks:

• Whether 8,552,165 is listed for the relevant NDA/BLA in Orange Book.
• Whether any Abbreviated New Drug Applications (ANDAs) filed Paragraph IV certifications against it.
• Whether litigation reached:
  • Court findings of noninfringement or invalidity.
  • Settlement and “triggered” launch dates.
  • Appellate outcomes affecting the remaining claim set.

Design-around analysis

Key design-around levers depend on claim structure:

• Substitute non-equivalent component.
• Change process parameter outside claimed range.
• Avoid required structural features.
• Alter formulation characteristics such that a functional limitation is no longer satisfied.

What patent litigation affects US 8,552,165, including settlements and court outcomes?

Featured snippet answer: Actionability depends on whether 8,552,165 is asserted in the US against specific accused products and whether a final judgment or settlement constrains enforcement.

Litigation-driven claim narrowing and estoppel

Critical review normally identifies:

• Which claims were asserted.
• Claim construction outcomes.
• Invalidity grounds (anticipation/obviousness, indefiniteness, written description, enablement).
• Whether the court narrowed claim scope through construction.

Settlement terms that change launch timing

When settlements occur, they usually constrain:

• Product launch dates.
• Exclusivity “carve-outs” for design-around products.
• License coverage for specific products or manufacturing methods.

Without access to the specific litigation docket history tied to US 8,552,165, no accurate case list can be produced.

How does US 8,552,165 compare with other patents in the same technology area?

Featured snippet answer: Competitive differentiation is identified by which claims are broader or narrower across the independent-claim boundary: composition versus method versus process, and which functional results are tied to claim limitations.

Side-by-side claim scope dimensions

The landscape comparison typically uses:

• Claim type: product/composition, method-of-use, process/manufacturing.
• Structural scope: breadth of defined components and substitutions allowed.
• Functional scope: whether “results” are required and how measured.
• Practical manufacturability: whether process claims cover standard industrial variants.

Who is likely to have overlapping freedom-to-operate?

Infringement risk tends to concentrate around:

• Same assignee’s commercial line extensions.
• Competitors with filings that mirror the invention’s core element set.
• Generics attempting to enter the market around the same active ingredient or formulation channel.

Which companies are challenging or licensing around US 8,552,165?

Featured snippet answer: The highest relevance parties are those who (i) cite the patent, (ii) filed competing patent families with overlapping claim element sets, and (iii) litigate or settle in ways that mention the patent number.

Licensing patterns tied to this type of patent

Common licensing drivers:

• Need to clear device/process bottlenecks.
• Need to secure product approvals around a core formulation or method.
• Portfolio cross-licenses where multiple patents are bundled for freedom-to-operate.

A verified company list requires direct linkage from the patent’s bibliographic record and citation/litigation sources. That is not available in the provided input.

What formulations, dosages, or manufacturing methods are protected by US 8,552,165?

Featured snippet answer: The protected subject matter is limited to what the issued claims require, including any defined compositions, process parameters, or method steps.

If the claims cover a composition or formulation

A landscape needs:

• Defined ingredients and optional ingredients.
• Chemical form or polymorph/crystal form if claimed.
• Particle size, solubility, concentration, excipient composition.
• Stability and storage conditions if tied to method claims.

If the claims cover a method of use

A landscape needs:

• Patient population or indication.
• Dosing regimen (mg/kg, once-daily/once-weekly, duration).
• Routes of administration.
• Companion diagnostic conditions if included as limitations.

If the claims cover manufacturing

A landscape needs:

• Reaction steps and order.
• Purification steps and yield thresholds.
• Process conditions (temperature, pressure, pH).
• In-process controls tied to claim limitations.

Without claim text, the protected category cannot be accurately mapped.

What regulatory status matters for enforcement of US 8,552,165 in the US?

Featured snippet answer: Regulatory linkage affects market timing and enforcement leverage only if the patent is listed with an FDA-approved product or asserted in an ANDA/BLA context.

NDA/BLA listing and Orange Book status

• If listed, 8,552,165 can trigger Hatch-Waxman litigation leverage through Paragraph IV certifications.
• If not listed, enforcement may still occur via direct infringement suits but without the standard regulatory launch timing mechanics.

FDA pathway and generic risk

• 505(b)(2) and 505(j) timing affects “early entry” pressure but still depends on patent listing and litigation.

Orange Book and FDA pathway status cannot be stated without the product identity.

Key Takeaways

• US 8,552,165’s actionable scope is defined by its issued independent claim limitations and any prosecution-driven narrowing; claims text is the controlling input for both infringement and design-around assessment.
• A defensible “patent landscape” requires element-by-element overlap mapping across citing families and competitor claim sets, not just citation counts.
• Expiration and exclusivity impacts depend on earliest effective filing date, terminal disclaimers/PTA, and any FDA Orange Book listing; those can’t be tied to 8,552,165 without the patent’s bibliographic record and product linkage.
• Litigation leverage hinges on whether and how 8,552,165 is asserted against specific products and on the case outcomes; these require a docket-linked history.

FAQs

1. How do I determine the likely infringement “core” within US 8,552,165 without relying on dependent claims?
2. What claim constructions most often narrow method-of-use claims similar to US 8,552,165 in US district courts?
3. What is the typical role of continuation patents in extending enforcement around a single core grant like US 8,552,165?
4. When does Orange Book listing materially change generic launch risk for a patent like US 8,552,165?
5. How do settlements usually translate into enforceable launch dates when US 8,552,165 is asserted?

References (APA)

1. U.S. Patent and Trademark Office. US Patent 8,552,165. (Bibliographic record and full text required for claim-level and landscape analysis).

Details for Patent 8,552,165

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Emergent Product Development Gaithersburg, Inc.	CYFENDUS	anthrax vaccine adsorbed, adjuvanted	Injection	125761	July 20, 2023		2029-12-08

International Patent Family for US Patent 8,552,165

Country	Patent Number	Estimated Expiration
South Africa	201104048
World Intellectual Property Organization (WIPO)	2010067262
United States of America	2010143400
United States of America	2015086610
United States of America	9453059
Taiwan	201026323