Last Updated: June 25, 2026

Patent: 5,462,535


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Summary for Patent: 5,462,535
Title:Syringe system
Abstract:An insulin injection system comprises a pen shaped syringe with a cartridge containing insulin, and an injection needle. The needle is a G30 needle and the insulin is a type which may freely flow through a G30 needle. When the insulin is the type comprising suspended crystals the maximal dimension of any crystal is 15 μm.
Inventor(s):Frits F. Bonnichsen, Peter N. Jorgensen
Assignee:Novo Nordisk AS
Application Number:US08/323,401
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

United States Patent 5,462,535: Claims, Scope, and US Patent Landscape Analysis for Enforceability and Freedom-to-Operate

US Patent 5,462,535 is an early foundational US patent with claims that define a specific protected subject matter set. A comprehensive, claim-by-claim analysis and a downstream landscape mapping (continuations, related divisionals, claim-implied equivalents, Orange Book relevance, and freedom-to-operate implications) cannot be completed because the claim text was not provided.

What are the exact claims of US Patent 5,462,535 and how do they drive claim scope?

A claim-by-claim construction is required to determine:

  • The essential elements that limit infringement
  • Whether the claims are method, composition, product-by-process, apparatus, or selection claims
  • Whether the claim language supports broad equivalents or is tightly constrained by dependencies

Which claim types appear in US 5,462,535 (composition, method, apparatus, product-by-process)?

Claim type determines:

  • How “making/using/selling” is mapped to accused activity
  • What prior art categories can invalidate the claims
  • Whether design-around is feasible by altering steps or structure

Which elements are likely limiting (preamble, transitional phrase, ranges, functional language)?

Without the actual claim text, the following cannot be determined:

  • Whether range limitations are numeric or functional
  • Whether “comprising” allows partial overlap
  • Whether functional limitations invoke 35 USC 112(f) style construction risk

How strong is the patent estate around US 5,462,535 (family, continuations, priority chain)?

A landscape assessment requires the bibliographic record and the family tree:

  • Priority application(s), filing dates, and jurisdiction chain
  • Continuations and divisionals that may broaden or narrow scope
  • US reissues or certificate amendments affecting claim interpretation

What continuations or divisionals share common priority with US 5,462,535?

Continuations can:

  • Keep earlier priority while changing claim breadth
  • Create multiple enforceable claim sets expiring at different times
  • Expand coverage across formulations, embodiments, and alternative process steps

Which assignees and inventors hold control over enforcement risk?

Enforcement outcomes often turn on:

  • Assignment history and current assignee
  • Ownership splits that affect licensing and litigation standing

What patents and prior art most threaten US 5,462,535 validity?

Critical validity mapping typically includes:

  • Anticipation (single-reference novelty) for each independent claim
  • Obviousness (combination) using the closest prior art for each element
  • Prior public disclosures: patents, publications, and non-patent literature
  • Problem-solution fit based on the claim elements, not on generic field background

How does the novelty hinge on specific limitations?

Without claim language, it is impossible to identify:

  • The exact “inventive concept” as asserted by the claim scope
  • Which claim features are likely to be found in prior patents
  • Whether dependent claims narrow to a non-obvious subcombination

What does the prosecution history likely do to interpretation?

Even when the claim text is available, interpretation depends on:

  • Claim amendments during prosecution
  • Examiner rejections and arguments that can narrow scope via prosecution disclaimer
  • Whether applicants surrendered broader embodiments

When does US 5,462,535 expire, and do any extension mechanisms apply?

Exclusivity and enforcement timing are governed by:

  • Statutory term from filing date (pre-1995) or from grant date (with applicable rules)
  • Patent term adjustments (PTA) from USPTO delays
  • Terminal disclaimers affecting overlap with later patents

Does the patent include PTA or terminal disclaimer constraints?

To determine enforceability windows, the record must be checked for:

  • PTA values and dates of expiration adjustment
  • Terminal disclaimers tying term to a related patent

How does US Patent 5,462,535 affect freedom-to-operate for US manufacturers?

A valid FTO assessment is claim-element driven:

  • Mapping each independent claim element to how an accused product is made, structured, or used
  • Identifying design-arounds by substituting non-essential elements
  • Assessing method-of-use vs product coverage
  • Evaluating whether “equivalents” are realistically available given the claim language and prosecution history

What activities are covered: making, using, selling, or importing?

Coverage differs materially if the claims are:

  • Product claims (manufacture/sale/import)
  • Method claims (use and method performance)
  • Product-by-process claims (scope depends on product identity and process-defined properties)

What design-around routes are likely if the claims are narrow?

Without the claim text, design-around analysis cannot be structured around:

  • Optional steps or non-critical features
  • Range substitutions
  • Structural element swaps
  • Use-case limitations that can be avoided by changing therapeutic or process context

How does US Patent 5,462,535 fit into the broader competitive patent landscape?

A landscape should include:

  • Direct competing patents with overlapping subject matter
  • Substitution technologies that avoid the claim’s key elements
  • Licensing patterns and cross-licensing between incumbents and challengers

Which companies are most likely to own adjacent patents around US 5,462,535?

This depends on the assignee and the field-specific competitor set, determined by the full bibliographic and citation data.

Key Takeaways

  • A comprehensive critical analysis of US Patent 5,462,535 cannot be completed without the actual claim text (independent and dependent claims).
  • Claim language is the gating input for: scope, validity risk, prosecution disclaimer impact, expiration modeling, and freedom-to-operate mapping.
  • A full patent landscape requires the bibliographic record and claim set to correctly align prior art and related patents to each element.

FAQs

  1. How do I determine whether US 5,462,535 is a composition, method, or apparatus patent from the claim language?
  2. What is the fastest way to map each independent claim element to product attributes for infringement analysis?
  3. How do continuations and divisionals typically change the effective enforceable claim set and expiration dates?
  4. What types of prior art combinations most often drive obviousness against early-generation patents like 5,462,535?
  5. How do patent term adjustments and terminal disclaimers change the real-world expiration timeline for enforcement planning?

References (APA)

  1. U.S. Patent and Trademark Office. United States Patent No. 5,462,535.

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Details for Patent 5,462,535

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Novo Nordisk Inc. NOVOLIN R insulin human Injection 019938 June 25, 1991 5,462,535 2014-10-14
Novo Nordisk Inc. NOVOLIN R insulin human Injection 019938 June 01, 2018 5,462,535 2014-10-14
Novo Nordisk Inc. NOVOLIN 70/30 insulin isophane human and insulin human Injection 019991 June 25, 1991 5,462,535 2014-10-14
Novo Nordisk Inc. NOVOLIN 70/30 insulin isophane human and insulin human Injection 019991 June 01, 2018 5,462,535 2014-10-14
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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