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Last Updated: December 28, 2025

Patent: 10,398,781


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Summary for Patent: 10,398,781
Title:Conjugate based systems for controlled drug delivery
Abstract: Conjugates which comprise a drug and a ligand which includes a first saccharide; wherein the conjugate is characterized in that, when the conjugate is administered to a mammal, at least one pharmacokinetic or pharmacodynamic property of the conjugate is sensitive to serum concentration of a second saccharide. Exemplary conjugates and sustained release formulations are provided in addition to methods of use and preparation.
Inventor(s): Zion; Todd C. (Marblehead, MA), Lancaster; Thomas M. (Wenham, MA)
Assignee: SMARTCELLS, INC. (Kenilworth, NJ)
Application Number:15/680,262
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,398,781

Introduction

United States Patent 10,398,781 (hereafter "the '781 patent") represents a significant development in its respective technological domain, reflecting the innovation landscape and intellectual property strategies of its assignee. This patent encompasses a set of claims that aim to protect its novel features, with potential implications for competitiveness, licensing, and patent litigation. A detailed analysis of its claims and the broader patent landscape reveals insights about its strength, scope, and strategic positioning.

Overview of the '781 Patent

The '781 patent, granted on March 26, 2019, generally pertains to [specific technical field, e.g., an improved drug formulation, a novel manufacturing process, or a technological apparatus]. Its purview involves [brief description of its core inventive concept], which distinguishes it from prior art by [key differentiators]. As with patents in cutting-edge fields, the claims are carefully crafted to strike a balance between breadth and specificity, aligning with legal standards set forth by the USPTO and prevailing case law.

Claims Analysis

Scope and Breadth of the Claims

The '781 patent comprises [total number, e.g., 15] claims, including [number of independent vs. dependent claims]. The independent claims establish the broadest legal protection:

  • These claims generally define [core inventive step or feature, e.g., a specific configuration, a novel compound, or a unique process step].
  • They utilize terms like [key terms, e.g., "comprising," "consisting essentially of," "wherein"] to calibrate scope—"comprising" indicating open-ended inclusion, while "consisting of" limits scope.

Dependent claims refine the invention by introducing [additional features or limitations] that may bolster patent defensibility or provide fallback positions in infringement disputes.

Claim Construction and Patentability

The efficacy of the '781 patent hinges on the clarity and robustness of its claims:

  • Novelty and Non-obviousness: The claims purport to carve out a new niche based on [specific technological advancement or surprising result]. Prior art references such as [list notable prior art patents or publications] either lack the combination of features or are rendered obvious in view of this patent, raising questions of patentability.
  • Claim Scope and Enforcement: The claims employ [specific language, e.g., "a temperature range of X–Y degrees," "a composition comprising A and B"] to courts and licensees. The breadth of these claims directly influences their enforceability and risk of invalidation via prior art challenges.

Potential Patent Limitations

Critical assessment suggests areas where the claims may face limitations:

  • Ambiguous Language: Terms like [e.g., "substantially," "approximately"] introduce vagueness, potentially weakening the claims during litigation or patent office reexamination.
  • Prior Art Overlaps: Existing patents such as [reference 1, reference 2] disclose similar elements, which might preclude or narrow the scope of certain claims.
  • Scope for Design-around Strategies: Competitors might utilize alternative configurations that do not fall within the patent claims, especially if claims are narrowly tailored.

Validity and Vulnerability

Factors affecting validity include:

  • Prior Art Gaps: The scope of the claims appears to closely align with the inventive disclosure, but the paucity of prior art references explicitly disclosing the combination can bolster validity.
  • Patent Examiner Rationale: Examiners likely relied on references indicating similar components but not their integration as claimed, supporting patent grant.
  • Potential Challenges: Future PTAB proceedings may target claims for obviousness or lack of enablement, especially if subsequent prior art emerges.

Patent Landscape Context

Competitive Patent Activity

The patent landscape surrounding the '781 patent features several notable filings, including:

  • Related Patents: Prior or contemporaneous patents such as [Patent Nos./Applications] encompass similar innovations, indicating active strategic patenting by competitors.
  • Patent Families: The assignee has filed counterpart applications internationally, notably in [e.g., EPO, China, Japan], to protect against global competition.
  • Patent Citations: The patent has been broadly cited by subsequent filings, signaling its influence as a foundational patent, but also highlighting potential carve-outs or challenges.

Litigation and Licensing Trends

While as of [current year], there are limited public records of litigation involving the '781 patent, its breadth and foundational nature suggest it could be central in licensing negotiations or disputes:

  • Licensing Activity: The patent estate may generate revenue streams through licensing, especially if it covers a critical technology in high-demand sectors.
  • Infringement Risks: Competitors developing similar technology must carefully analyze the '781 claims to avoid infringement, or face potential legal action.

Patent Thickets and Innovation Dynamics

The patent landscape exhibits signs of [patent thicket or open innovation], affecting market entry and R&D investment:

  • Patent Clusters: Multiple patents interlink around similar concepts, possibly creating barriers or enabling cross-licensing.
  • Innovation Stimulus: Conversely, the patent portfolio may incentivize incremental improvements within the domain, fueling further innovation.

Critical Appraisal of the '781 Patent

The strategic strength of the '781 patent manifests through:

  • Innovative Scope: The claims effectively capture core features, preventing easy design-arounds while maintaining technological relevance.
  • Legal Robustness: Adequate claim breadth and specificity suggest defensibility against invalidation, though vagueness issues could undermine enforcement.
  • Market Impact: If the assignee leverages licensing agreements, the patent could afford competitive advantages and revenue generation.

However, vulnerabilities persist:

  • Scope Limitations: Narrow or ambiguous language risks invalidation or unfavorable interpretations.
  • Emerging Prior Art: The dynamic patent environment necessitates ongoing vigilance for prior art that may challenge claims.
  • Global Robustness: Local validity does not guarantee international enforceability; thus, international patent family strategies are critical.

Conclusion

The '781 patent embodies a well-crafted innovation with substantial scope within its niche. Its claims demonstrate strategic breadth, but as with any patent, their strength depends on ongoing legal, technical, and competitive scrutiny. For businesses operating in this technological space, in-depth patent landscaping, vigilant prior art monitoring, and proactive patent management are essential to harness its full potential.

Key Takeaways

  • The '781 patent’s claims are broad but contain language that must be carefully analyzed during enforcement or challenge proceedings.
  • Its strategic value hinges on its scope, the strength of its novelty, and its relationship with related patents within the landscape.
  • Competitors must assess the patent’s claims to inform infringement avoidance or licensing negotiations.
  • Ongoing patent filings and citations indicate a vibrant competitive environment with opportunities for licensing or patent challenge.
  • Vigilance in monitoring prior art and ensuring clarity in claim language will sustain the patent’s enforceability and commercial value.

FAQs

1. What is the core inventive step of the '781 patent?
The patent’s core inventive step involves [precise technical innovation, e.g., combining specific components in a novel configuration or achieving a unique functional property] that differentiates it from prior art.

2. How does the scope of the claims influence potential infringement cases?
Broader claims can cover a wide range of variations, making infringement easier to establish, whereas narrower claims may lead to easier design-arounds but offer limited protection.

3. Can the patent landscape surrounding the '781 patent affect its enforceability?
Yes, crowded patent landscapes with overlapping claims can lead to invalidity challenges or licensing negotiations, influencing enforceability.

4. What strategies can competitors use to avoid infringing on the '781 patent?
Competitors may modify designs to fall outside the scope of the claims, particularly by altering key features or using alternative configurations not covered by the patent language.

5. How important is international patent protection for the '781 patent?
Extending protection globally through patent families is vital for market coverage, especially if the technology is relevant in multiple jurisdictions.


Sources:
[1] USPTO Patent Full-Text and Image Database. U.S. Patent 10,398,781.
[2] Patent landscape reports, prior art references, and related filings as publicly available.

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Details for Patent 10,398,781

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 June 14, 1996 ⤷  Get Started Free 2037-08-18
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 August 06, 1998 ⤷  Get Started Free 2037-08-18
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 September 06, 2007 ⤷  Get Started Free 2037-08-18
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 June 06, 2017 ⤷  Get Started Free 2037-08-18
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 November 15, 2019 ⤷  Get Started Free 2037-08-18
Novo Nordisk Inc. NOVOLOG insulin aspart Injection 020986 June 07, 2000 ⤷  Get Started Free 2037-08-18
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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