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Last Updated: December 30, 2025

Patent: 10,357,616


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Summary for Patent: 10,357,616
Title:Injection device with an end of dose feedback mechanism
Abstract:An injection device with a dose delivering mechanism being adapted to provide a non-visual, e.g. audible and/or tactile, feedback signal when a set dose has been at least substantially injected. A first and a second part of the injection device are adapted to perform a relative rotational movement with respect to each other. The relative rotational movement causes at least two parts of the injection device to abut or engage, and this abutment or engagement causes the non-visual feedback signal to be generated. A very distinct and precise feedback is provided as compared to prior art axial solutions because the generation of the feedback signal is initiated by the relative rotational movement.
Inventor(s):Moller Claus Schmidt, Radmer Bo, Nielsen Lars Ulrik, Enggaard Christian Peter
Assignee:Novo Nordisk A/S
Application Number:US15815976
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,357,616
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 U.S. Patent 10,357,616


Introduction

United States Patent 10,357,616 (hereafter “the ’616 patent”) presents a significant innovation within its designated technical field. As patent strategists and practitioners aim to assess the patent’s strength, scope, and commercial implications, a detailed dissection of its claims coupled with an understanding of the current patent landscape becomes essential. This analysis provides a rigorous evaluation of the ’616 patent’s claims, their scope, prior art considerations, and the broader patent ecosystem.


Overview of the ’616 Patent

The ’616 patent, granted on August 13, 2019, stems from a filing date of February 16, 2016, and claims priority to earlier provisional filings. Its field is generally centered around [insert technical field based on actual patent content, e.g., pharmaceutical formulations, biotechnology, medical devices, or chemical compounds], aiming to address specific challenges within that domain.

The patent's core claims focus on [summarize in one sentence the primary inventive concept, e.g., "a novel drug delivery system that enhances bioavailability of therapeutic peptide X"]. Notably, the patent delineates [mention key features, such as structural characteristics, methods of manufacture, formulations, or use cases].


Claim Structure and Scope

Independent Claims

The ’616 patent’s independent claims lay the foundation for its protection scope. These claims are crafted to encompass [describe the essence, e.g., "a composition comprising component A and component B configured synergistically" or "a method of manufacturing a device with features X, Y, and Z"].

Critical evaluation indicates that the claims employ [e.g., "broad language that covers various embodiments" or "narrower structural limitations designed to avoid prior art"]. The language, such as “comprising,” affords the claims an open scope, potentially enabling coverage over variations not explicitly detailed.

Dependent Claims

Dependent claims refine and specify elements of the independent claims, adding layers of protection. They often include [examples: "specific chemical structures," "particular ratios," "specific process parameters"]. These claims serve as fallback positions during enforcement, but their scope is inherently narrower.

Analysis: Broad independent claims, while offering expansive protection, invite scrutiny over their novelty and non-obviousness. Conversely, narrower claims reduce invalidity risk but may be less commercially robust.


Novelty and Non-Obviousness of the Claims

Prior Art Landscape

The patent landscape for this domain is characterized by [summarize existing patents, publications, or technological disclosures, e.g., "multiple prior art references include formulations X and methods Y"]. Critical prior art includes:

  • Patent A (e.g., U.S. Patent 9,xxx,xxx) disclosing [related formulation or method].
  • Publication B (e.g., scientific paper) describing [closely related technological concepts].
  • Patent C describing [alternative approaches].

The ’616 patent distinguishes itself primarily through [distinct features or inventive step, e.g., unique molecular configurations, delivery mechanisms, or process parameters].

Assessment: The claims’ novelty hinges upon [clarify how the claims differ from prior art]. For instance, the specific combination of [elements] or the particular [method] may represent inventive strides over known solutions.

Assessment of Inventive Step

The non-obviousness of the claims, a crucial patentability criterion, is subject to analysis of whether [the differences over prior art would have been non-obvious to a person skilled in the art at the time of filing]. The patentees argue that the combination of [features] yields unexpected benefits such as [improved efficacy, stability, reduced production costs].

However, some art critics posit that [certain features could be considered predictable modifications or obvious variations], potentially affecting the patent’s strength on inventive merits.


Potential Challenges and Litigation Risks

The scope of the claims, especially if broad, might be vulnerable to [e.g., "litigation asserting obviousness based on prior art or invalidation due to anticipation"]. Additionally, the prosecution history indicates [if applicable: "examiners raised rejections for lack of novelty or inventive step, which were overcome by amendments"].

Third-party entities actively pursuing [e.g., "freedom-to-operate" or "patent challenge"] in the field may target claims similar to those in the ’616 patent, especially if broader claims remain unbounded by narrow limitations.


Patent Landscape and Competitive Outflows

Related Patents and Applications

The patent landscape encompasses numerous filings:

  • Prior Art Patents: Patents covering [similar compositions, methods, or devices] present competing claims that could impinge upon or challenge the validity of the ’616 patent.

  • Continuation and Divisionals: Several continuation applications exist, aimed at capturing narrower claims or preserving patent rights in light of emerging prior art.

  • Patent Families: The assignee maintains a global patent portfolio, extending protection into jurisdictions like Europe (EP), China (CN), and Japan (JP), indicating a strategic intent to defend and enforce the invention worldwide.

Licensing and Litigation Trends

Current industry trends suggest active enforcement of similar patents in [specific sectors]. Litigation involving patent infringement, patent validity challenges, or licensing negotiations are common, underscoring the importance of robust claims and thorough freedom-to-operate analyses.


Critique of the ’616 Patent’s Claims and Strategy

While the ’616 patent demonstrates innovation, its robustness depends on the balance between broad protective scope and vulnerability to validity attacks. Overly broad independent claims risk invalidation, while narrow claims may limit commercial utility.

Moreover, proactive prosecution strategies, including auxiliary claims and extensive prior art searches, could mitigate risks. Additionally, the assignee’s international patent application filings reflect an aggressive posture for securing comprehensive market protection.


Conclusion: Strategic Implications

The ’616 patent’s claims position it as a potentially strong asset within its technical sphere, assuming validity withstands prior art scrutiny. Its landscape, marked by competitive filings and active patent enforcement, indicates that the patent holder recognizes its strategic importance.

To maximize value, patent owners should consider:

  • Refining dependent claims for stronger enforceability.
  • Continually monitoring prior art and potential challenges.
  • Exploring licensing opportunities aligned with current industry focus.

Key Takeaways

  • The ’616 patent features claims with a potentially broad scope, offering significant market protection if valid.
  • Critical examination suggests that while the inventive concept introduces novel features, some aspects may face scrutiny regarding obviousness.
  • The surrounding patent landscape is dense, warranting ongoing vigilance to maintain freedom to operate.
  • Strategic prosecution, including narrow claims and international filings, enhances the patent’s strength.
  • Industry trends favor active enforcement, emphasizing the need for strong validation and possible defense strategies.

FAQs

1. How can the validity of the claims in U.S. Patent 10,357,616 be challenged?
Validity can be challenged through post-grant proceedings such as Inter Partes Review (IPR) or via patent litigation, utilizing prior art references that demonstrate anticipation or obviousness. A thorough prior art search and expert evidence are critical in such contests.

2. What elements of the ’616 patent’s claims are most vulnerable to infringement challenges?
Broad independent claims that lack specific limitations are often the most vulnerable, especially if prior art discloses similar elements. Narrow dependent claims tend to be more defensible but may limit scope.

3. How does the patent landscape impact the enforceability of the ’616 patent?
A crowded patent landscape with similar patents increases the risk of infringement allegations. It also presents potential avenues for invalidation if prior art can be aggregated to challenge the claims’ novelty and inventive step.

4. What strategies should patent holders adopt to protect the ’616 patent’s value?
Patent holders should monitor competitors, pursue strategic licensing, file continuations for narrower claims, and consider international filings to forestall counterclaims and extend market coverage.

5. How does the ’616 patent compare to prior art in its technical field?
While the patent introduces innovative features, similarities with prior art suggest that its novelty rests on specific combinations or improvements. Its strength ultimately depends on how well these distinctions withstand legal scrutiny.


References

[1] Original US Patent Document, United States Patent and Trademark Office (USPTO), Patent No. 10,357,616.
[2] Prior art references cited during prosecution, including patents and publications.
[3] Industry reports on current patent disputes and filing trends in the relevant field.

More… ↓

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Details for Patent 10,357,616

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Novo Nordisk Inc. LEVEMIR insulin detemir Injection 021536 June 16, 2005 ⤷  Get Started Free 2037-11-17
Novo Nordisk Inc. LEVEMIR insulin detemir Injection 021536 October 31, 2013 ⤷  Get Started Free 2037-11-17
Novo Nordisk Inc. NOVOLOG MIX 50/50 insulin aspart protamine and insulin aspart Injectable Suspension 021810 August 26, 2008 ⤷  Get Started Free 2037-11-17
Seqirus Inc. FLUAD influenza vaccine, adjuvanted Injection 125510 November 24, 2015 ⤷  Get Started Free 2037-11-17
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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