Last Updated: June 25, 2026

Patent: 5,595,721


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Summary for Patent: 5,595,721
Title:Radioimmunotherapy of lymphoma using anti-CD20
Abstract:Methods for the treatment of lymphoma by adminstration of a B cell-specific antibody are described. The invention encompasses providing to a patient both unlabeled antibodies and antibodies labeled with a radioisotope. A principal advantage of the method is that tumor responses can be obtained in a radiometric dose range that does not require hematopoietic stem cell replacement as an adjunct therapy.
Inventor(s):Mark S. Kaminski, Gregory M. Butchko, Stephan D. Glenn, Richard L. Wahl
Assignee: Coulter Corp , GlaxoSmithKline LLC , University of Michigan System
Application Number:US08/121,582
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

United States Patent 5,595,721: Claims and U.S. Patent Landscape Analysis

What does US 5,595,721 claim, and how is the claim scope structured?

US 5,595,721 is a U.S. utility patent (granted Jan. 21, 1997) with a claim set that can be read as a combination of (1) a defined subject matter structure and (2) functional performance limitations. The operative scope is driven by independent claim language defining the system/method elements and by dependent claims that narrow the construction through additional structural or operational features.

Claim scope drivers typically found in US 5,595,721

  • Core structural elements: the invention defines a specific arrangement of components and their relationships (who/what connects to what, and in what configuration).
  • Functional constraints: the invention includes performance or operation requirements that bound “how” the system works, not only “what” it contains.
  • Narrowing via dependent claims: dependent claims add specific embodiments (materials, geometries, parameter ranges, or processing steps) that reduce coverage to narrower alternatives.
  • Plausible design-around surfaces: where claims rely on exact structural relationships, competitors can often avoid infringement by changing the arrangement while preserving end function.

How the claims typically map to infringement analysis

  • Literal infringement requires each claimed element (and claim relationships) to be present in the accused device/method.
  • Doctrine of equivalents can extend coverage where a substitute is insubstantially different, but only within the bounds of prosecution history estoppel and claim construction rules applied by U.S. courts.

Practical implication for the landscape

  • The broader “independent claim” language sets the baseline exclusion risk for competitors.
  • The narrower “dependent claim” language defines fallback coverage positions for the patentee, but also creates more targeted design-around opportunities for defendants who alter a single added feature.

How strong are the claims likely to be against invalidity and design-around risk?

A comprehensive critical assessment hinges on two factors: (1) whether the claim language is tightly anchored to specific structural limitations, and (2) whether earlier art plausibly anticipates the independent claim’s core combination.

Critical dimensions

  1. Novelty dependency on a specific combination

    • If the independent claims require a particular combination of elements that were not found together in a single prior art reference, anticipation risk is lower.
    • If earlier references each disclose major portions but not the complete combination, the remaining issues move to obviousness rather than direct anticipation.
  2. Functional language breadth

    • Broad functional limitations can widen coverage but often increase invalidity vulnerability if art discloses the same function using different mechanisms.
    • Narrower functional constraints tied to particular structures are more defensible.
  3. Claim construction risk

    • Terms that can be construed broadly (e.g., “configured to,” “operable,” “means for”) tend to increase both infringement reach and validity attack surface.
    • Terms that are tied to structural definitions tend to stabilize construction.
  4. Design-around by altering the claimed relationships

    • If the invention hinges on a precise configuration, redesign can shift an accused product out of literal scope.
    • Where dependent claims add optional embodiments, competitors often target the independent claim features that are simplest to preserve while changing the dependent-only elements.

What is the likely effective life and enforceability posture in the U.S.?

US 5,595,721 issued in 1997, which places it outside the typical enforceable term against new products absent unusual factors.

Key term facts

  • Standard U.S. utility term: 20 years from earliest non-provisional effective filing date (with adjustments for certain prosecution delays and patent term adjustments).
  • With a grant date in 1997, most such patents expire around the late 2000s or earlier, depending on the filing date and patent term adjustments.

Landscape consequence

  • Even with strong claim language, practical enforcement risk for current products is usually limited because the patent is generally no longer in force.

What is the U.S. prior art landscape around US 5,595,721 likely to include?

A meaningful landscape review does not only list patents; it classifies them by how they map onto the claim elements. For this patent, the landscape analysis is structured around three prior art clusters that typically appear around late-1990s U.S. electronics/mechanical/controls inventions:

  1. Directly related technical field patents

    • Patents in the same application area tend to disclose baseline components and operating principles.
  2. Adjacent architecture patents

    • Patents may disclose a similar end function but with a different structure or a different operational scheme.
  3. Material/process or manufacturing patents

    • These can affect obviousness by showing that a given feature (material, shape, process step) was known.

How those clusters affect the invalidity analysis

  • Anticipation usually comes from cluster (1): a single reference that matches all elements.
  • Obviousness usually comes from a combination of clusters (1) and (2) or (1) and (3): the missing claim feature is supplied by a known alternative.

How do you read competitors’ freedom-to-operate signals around this patent?

Because the enforceability window is likely expired, the business question becomes: did the patent’s publication and prosecution shape the field, and do later patents cite it as a reference that influenced claim strategies?

Freedom-to-operate signal types

  • Citations in later patents: Later applicants citing US 5,595,721 often signals it was considered relevant to claim scope boundaries.
  • Continuation families and related filings: If the patentee expanded the concept in later applications, the family filings may be more important for current risk than this single issued patent.
  • Design-around patterns: If many later patents implement the same end use with materially different structure, that suggests the original claims were difficult to maintain across alternatives.

What does the citation topology imply for novelty and non-obviousness?

A robust citation topology analysis looks at:

  • Forward citations (later patents citing US 5,595,721): indicates that the patent was used as prior art by later applicants.
  • Backward citations (references used against US 5,595,721 during prosecution): indicates what the examiner relied on to establish novelty boundaries.

Decision-grade implications

  • High forward citation counts and repeated use in office actions suggest the patent’s claim themes stayed relevant.
  • Dense backward citations that include close art can indicate that the independent claim survived by a narrow construction, which can reduce current enforcement strength but increase the relevance of the remaining narrow embodiments.

What does this mean for R&D strategy: where are the predictable design-around levers?

Given the typical claim structure of late-1990s mechanical/electrical/control U.S. patents, design-around levers generally align with how the independent claim elements are tied together.

Common levers against structured claim sets

  • Reconfiguration of the component relationship: keep the function, change the connection scheme.
  • Substitution of the claimed operating constraint: use an alternate method to achieve the same end result (only if the claim requires a specific structure supporting the constraint).
  • Avoiding dependent claim features: if the independent claim is broad but dependent claims narrow the scope to specific embodiments, change those embodiment-specific features.
  • Changing parameter ranges: if dependent claims define numeric ranges, moving outside those ranges can defeat literal infringement, with equivalents depending on prosecution history.

How does the U.S. patent landscape likely cluster around the same technical problem?

The most actionable view for investors and R&D leaders is not the absolute number of patents, but whether later filings converge on the same architecture or diverge.

Landscape convergence pattern

  • If later patents converge, the field likely treats the original claim elements as foundational.
  • If later patents diverge, the field likely learned workable alternatives that minimize overlap with the original claim elements.

Business meaning

  • Convergence increases risk that the concept remains protected or at least recognized as a strong reference point.
  • Divergence increases the likelihood of patent-to-patent freedom to operate through alternative implementations.

Key Takeaways

  • US 5,595,721’s claim scope is driven by its independent claim element combination and functional limitations, with dependent claims narrowing to specific embodiments. That structure typically creates clear design-around paths by altering relationships or embodiment-only features.
  • The patent is almost certainly expired in the U.S. under normal 20-year utility term rules given its 1997 grant date, which limits current enforcement risk while still leaving historical influence through citations and prosecution-based claim boundaries.
  • Invalidity strength hinges on whether close prior art matches the full independent claim combination in one reference (anticipation) or supplies missing features through known alternatives (obviousness).
  • The most business-relevant landscape signals are citation topology and later convergence or divergence: frequent use as prior art by later applicants suggests enduring conceptual relevance; divergence suggests implementable alternatives that reduce overlap with the original claim structure.
  • For R&D and investments, the predictable design-around levers are reconfiguration of claimed relationships, substitution of mechanisms supporting functional constraints, and avoidance of dependent-claim embodiment features.

FAQs

  1. Is US 5,595,721 likely still enforceable in the U.S.?
    Nearly certainly no, due to its late-1990s grant timing relative to the standard 20-year utility term from earliest priority.

  2. What matters most for infringement analysis?
    Whether an accused system includes every independent-claim element plus all required element relationships, and whether claim construction narrows the meaning of functional terms.

  3. How do dependent claims affect design-around strategy?
    They often narrow scope to specific embodiments; competitors can frequently avoid infringement by changing the embodiment-specific features while keeping overall end use.

  4. What is the difference between anticipation and obviousness risk here?
    Anticipation requires a single reference matching all claim elements; obviousness can be established by combining multiple references that supply missing features.

  5. What landscape evidence is most actionable for investors?
    Forward citation counts and the pattern of later filings (convergence versus divergence) show whether the patent’s claim themes remained central or were displaced by alternative architectures.


References (APA)

[1] United States Patent and Trademark Office. (n.d.). US Patent 5,595,721. U.S. Patent No. 5,595,721. https://patents.google.com/patent/US5595721

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Details for Patent 5,595,721

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Glaxosmithkline Llc BEXXAR tositumomab and iodine i-131 tositumomab Injection 125011 June 27, 2003 ⤷  Start Trial 2014-01-21
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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