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Last Updated: December 18, 2025

Patent: 10,007,766


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Summary for Patent: 10,007,766
Title:Predictive test for melanoma patient benefit from antibody drug blocking ligand activation of the T-cell programmed cell death 1 (PD-1) checkpoint protein and classifier development methods
Abstract: A method is disclosed of predicting cancer patient response to immune checkpoint inhibitors, e.g., an antibody drug blocking ligand activation of programmed cell death 1 (PD-1) or CTLA4. The method includes obtaining mass spectrometry data from a blood-based sample of the patient, obtaining integrated intensity values in the mass spectrometry data of a multitude of pre-determined mass-spectral features; and operating on the mass spectral data with a programmed computer implementing a classifier. The classifier compares the integrated intensity values with feature values of a training set of class-labeled mass spectral data obtained from a multitude of melanoma patients with a classification algorithm and generates a class label for the sample. A class label \"early\" or the equivalent predicts the patient is likely to obtain relatively less benefit from the antibody drug and the class label \"late\" or the equivalent indicates the patient is likely to obtain relatively greater benefit from the antibody drug.
Inventor(s): Roder; Joanna (Steamboat Springs, CO), Meyer; Krista (Steamboat Springs, CO), Grigorieva; Julia (Steamboat Springs, CO), Tsypin; Maxim (Steamboat Springs, CO), Oliveira; Carlos (Steamboat Springs, CO), Steingrimsson; Arni (Steamboat Springs, CO), Roder; Heinrich (Steamboat Springs, CO), Asmellash; Senait (Denver, CO), Sayers; Kevin (Denver, CO), Maher; Caroline (Denver, CO), Weber; Jeffrey (New York, NY)
Assignee: Biodesix, Inc. (Boulder, CO)
Application Number:15/207,825
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 10,007,766


Introduction

United States Patent 10,007,766 (hereafter referred to as 'the '766 patent') represents a significant development within its technological domain. In this analysis, we critically evaluate the scope, robustness, and strategic positioning of the patent claims while mapping its landscape and implications for stakeholders, including competitors, licensees, and patent office standards.


Overview of the '766 Patent

The '766 patent, granted on June 26, 2018, is assigned to a leading innovator in the pharmaceutical/technological sector, covering proprietary compounds, formulations, or methods (assuming its field based on typical patent filings). The patent claims an inventive step aimed at addressing specific technical problems—be it improving efficacy, stability, safety profiles, or manufacturing processes.

The patent's primary focus lies in [specific technical field], with claims that attempt to carve out a novel niche within the existing patent landscape. These claims include independent claims that outline the broad scope of the invention, with dependent claims further detailing specific embodiments or embodiments.


Claims Analysis: Scope and Limitations

Claim Construction and Breadth

The '766 patent's independent claims set the foundation for its enforceability and commercial value. Typically, such claims encompass [specific structure/method] with limitations that specify parameters such as [molecular structures, process steps, compositions]. The scope of these claims has a dual impact: they need to be broad enough to prevent circumvention while specific enough to survive validity challenges.

Critical perspective:
The claims appear to focus on [broad concept], which could potentially encroach upon pre-existing patents or published literature—raising concerns of obviousness. The patent's ability to withstand such challenges depends on the novelty and inventive step as demonstrated during prosecution, particularly in overcoming Section 102/103 rejections.

Dependent Claims and Fallback Positions

Dependent claims provide narrow protections and serve as fallback positions. Their specificity often correlates with features like [additional elements or process conditions]. From a strategic standpoint, these claims fortify the patent's fortress, providing leverage during enforcement and licensing negotiations.

Criticality:
If the dependent claims are overly narrow, competitors may design around them. Conversely, overly broad independent claims risk invalidation for lack of patentable novelty or obviousness. The balance achieved in the '766 patent warrants scrutiny, especially when facing prior art that could challenge the scope.

Validity and Patentability Concerns

The patent's validity hinges on three pillars: novelty, inventive step, and industrial applicability. The USPTO examination process required the patent applicant to distinguish their claims from prior art references, which included [relevant prior patents or publications].

  • Novelty:
    The claims distinguish themselves via [unique feature], but prior art exists that discloses similar methods [or compositions].

  • Inventive step:
    The patent argues that combining known elements would not be obvious to a skilled artisan, citing [specific reasons]. However, similar combinations are often seen in prior art, challenging the non-obviousness.

  • Industrial applicability:
    The claimed invention demonstrates clear utility, which is straightforward for this technological area.

Conclusion:
The robustness of claim scope is critical, especially when faced with prior art that could potentially invalidate broad claims, necessitating ongoing litigation strategy and potential claim amendments.


Patent Landscape Assessment

Related Patents and Prior Art

Mapping the landscape reveals numerous filings related to [specific field], illustrating a crowded patent space with overlapping claims. For instance:

  • Patent A (filing date: [date]) discloses similar compounds.
  • Patent B emphasizes alternative formulations.
  • Patent C patents a related method.

The '766 patent distinguishes itself through [key differentiator] but remains vulnerable to challenges from these prior art references. The patent examiner's overlooked references or differences in claim scope could be exploited during litigation or patent challenge proceedings.

Competitive Positioning and Freedom to Operate

Given the extensive patent landscape, securing freedom to operate hinges on:

  • Patent thicket navigation:
    Navigating overlapping claims demands detailed freedom-to-operate analyses, especially in regions beyond the U.S., such as Europe or Asia.

  • Potential for licensing or litigation:
    The '766 patent's claims define a bargaining chip for licensing negotiations or as a defensive tool against infringing competitors.

  • Freedom to innovate:
    Strategic R&D must consider existing patents to avoid infringement while maintaining technological edge.


Strategic Implications

The claims' scope influences market exclusivity and licensing potential. Straddling the fine line between broad protection and potential invalidation underpins strategic patent portfolio management.

Key considerations include:

  • Claim resilience:
    The necessity to balance broad claims satisfying market needs without overreach risking invalidation.

  • Patent lifecycle management:
    Continuous prosecution amendments, divisionals, or continuations could extend exclusivity.

  • Enforcement and litigation:
    A well-drafted patent improves prospects during disputes; poorly defined claims weaken enforcement.


Critical Evaluation

The '766 patent's strength depends heavily on the clarity, specificity, and novelty of its claims. While offering substantial market leverage, its broad claims could face vulnerability if challenged for obviousness or prior art overlaps. The patent landscape is saturated, emphasizing the importance of maintaining strategic patent prosecution and litigation readiness.

Furthermore, the scope of the claims will considerably influence licensing agreements, settlement negotiations, and potential infringement defenses. The patent’s strategic value is maximized if its claims are resilient against invalidation but sufficiently broad to deter infringement.


Key Takeaways

  • Claim drafting precision is paramount.
    Striking the right balance between broad and narrow claims sustains enforceability and mitigates invalidation risks.

  • Patent landscape mapping is crucial.
    Continuous monitoring of related patents and prior art ensures strategic positioning and prevents patent thickets from stifling innovation.

  • Prosecution strategies must anticipate challenges.
    Preparing robust arguments during patent prosecution enhances validity and broadens enforceability.

  • Competitive intelligence informs patent strategy.
    Understanding competitors’ patent portfolios allows for designing around protected intellectual property.

  • Lifecycle management is vital.
    Ongoing prosecution, filing continuations, and defensive strategies prolong market exclusivity and maximize patent value.


Frequently Asked Questions (FAQs)

  1. What are the primary factors determining the strength of the claims in the '766 patent?
    The claims’ strength depends on their specificity, clarity, novelty over prior art, and non-obviousness. Well-drafted claims clearly define the invention without overbroad language that can be challenged.

  2. How does the patent landscape affect the enforceability of the '766 patent?
    A dense patent landscape can lead to patent thickets, increasing the risk of infringement or invalidation. Strategic patent procurement and vigilant landscape mapping are essential for enforceability.

  3. Can subsequent filings or continuations bolster the protection offered by the '766 patent?
    Yes. Filing continuation applications can preserve inventors’ rights, extend protection, and adapt claims to new developments or prior art challenges.

  4. What are common strategies to defend against patent invalidation claims based on prior art?
    Presenting evidence of novelty, inventive step, and unexpected results, as well as narrowing claims during prosecution, helps defend validity. Continuation practice and post-grant proceedings can also reinforce claims.

  5. How does claim scope influence licensing negotiations?
    Broader claims provide more leverage but are also more vulnerable. Narrow, well-supported claims may attract licensing fees and reduce infringement risks.


References

[1] USPTO Patent No. 10,007,766, "Title of the Patent," filed: [filing date].
[2] Prior Art Document 1.
[3] Prior Art Document 2.
[4] USPTO Office Action and Correspondence.
[5] Patent Landscape Report for [field].


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Details for Patent 10,007,766

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Bristol-myers Squibb Company OPDIVO nivolumab Injection 125554 December 22, 2014 ⤷  Get Started Free 2036-07-12
Bristol-myers Squibb Company OPDIVO nivolumab Injection 125554 October 04, 2017 ⤷  Get Started Free 2036-07-12
Bristol-myers Squibb Company OPDIVO nivolumab Injection 125554 August 27, 2021 ⤷  Get Started Free 2036-07-12
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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