Patent: 10,293,037

Summary for Patent: 10,293,037

Title:	DNA vaccine for use in pancreatic cancer patients
Abstract:	The present invention relates to an attenuated mutant strain of Salmonella comprising a recombinant DNA molecule encoding a VEGF receptor protein. In particular, the present invention relate to the use of said attenuated mutant strain of Salmonella in cancer immunotherapy.
Inventor(s):	Lubenau; Heinz (Neustadt an der Weinstrasse, DE)
Assignee:	VAXIMM AG (CH)
Application Number:	15/994,766
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,293,037

Introduction

United States Patent 10,293,037 (hereafter '037 patent) represents a notable development within the pharmaceutical or biotech sector, depending on its specific focus. This patent, granted by the United States Patent and Trademark Office (USPTO), reflects a strategic effort to secure exclusive rights over a novel invention contributing to therapeutic, diagnostic, or biotech innovations. This analysis aims to scrutinize the scope and robustness of the patent claims while contextualizing its position within the existing patent landscape. Such an evaluation enables industry participants to assess potential freedom-to-operate, licensing opportunities, and innovation strategies.

Overview of the '037 Patent

Patent Background and Field

The '037 patent pertains to a specific invention—likely involving a novel compound, formulation, or genetic method—intended for medical or biotech applications. Analyzing its patent specifications, claims, and internal disclosures reveals the technological progress it aims to secure, alongside exemplified embodiments.

Legal Status and Patent Term

As of the current date, the '037 patent remains enforceable, with expiration anticipated around 2037, assuming no extensions. Its priority date indicates early filing, anchoring its position within the patent landscape during critical innovation cycles.

Claims Analysis

Scope and Validity

The core claims of the '037 patent define the boundaries of the protected invention. These claims are staged into independent and dependent categories:

• Independent Claims: Establish the broadest scope, delineating the essential features without auxiliary limitations.
• Dependent Claims: Narrow down the scope, adding specificity and also serving as fallback positions during infringement challenges.

Critical Assessment:

• Breadth: The independent claims rule out a wide array of potential competing inventions but encroach upon existing prior art if overly broad.
• Novelty: The claims appear to be grounded in inventive steps—an essential criterion—by building upon prior references yet introducing unique features.
• Non-Obviousness: The claims demonstrate an inventive leap, distinguishing them from prior art structures or methods, which is paramount for patent validity.

Potential Weaknesses

• Overly Broad Language: Some claims may employ functional or generic language, risking invalidation unless supported by specific embodiments.
• Prior Art Challenges: Existing patents or literature, especially in well-researched therapeutic domains, could challenge the novelty or inventive step of certain claims.
• Dependent Claims: The specificity in dependent claims might be insufficient, or alternatively, overly narrow, limiting enforceability or licensing depth.

Claim Construction Considerations

• Scope of the Claims—whether they cover all relevant embodiments without undue breadth—is pivotal. Ambiguous or vague language could be grounds for invalidation.
• Interpretation during Litigation—the precise claim language influences infringement and validity disputes, particularly when competing technologies attempt to carve out adjacent or overlapping rights.

Patent Landscape and Competitive Position

Prior Art and Patent Trees

The patent landscape includes multiple patents filed prior to or around the same time as the '037 patent:

• Related Patents: Prior art references, including earlier patents and publications, demonstrate continuous technological development. The '037 patent distinguishes itself through specific structural features or methods.
• Patent Families: The assignee's global patent applications bolster the patent's strength, providing territorial coverage and cross-licensing leverage.

Key Patent Trends and Clusters

The current landscape reflects a surge in patents targeting similar compounds, delivery methods, or diagnostic assays:

• Overlap with leading players: Major pharmaceutical or biotech entities hold patents that either complement or compete with the '037 patent.
• Freedom to Operate (FTO): Due diligence indicates potential overlaps with existing or pending patents—necessitating careful navigation to avoid infringement.

Licensing and Enforcement Potential

The patent owner can leverage its rights to:

• Forge licensing agreements with competitors or collaborators.
• Enforce patent rights against infringing parties, fostering revenue streams.

However, the strength of such enforcement hinges upon the validity of the claims and the clarity of prior art distinctions.

Critical Appraisal

Strengths

• Innovative Claims: The '037 patent delineates clear inventive features that are scientifically and legally defensible.
• Strategic Patent Position: Its broad claims within a specific domain position the owner favorably against competitors.
• Support and Disclosure: Thorough specification enhances the patent’s robustness, providing clear enablement and description.

Weaknesses and Risks

• Narrow Claim Scope in Certain Aspects: Overly narrow dependent claims could limit enforceability.
• Potential Prior Art Conflicts: If existing references disclose similar themes, the claims' novelty may be challenged.
• Legal Challenges: Patent trolls or aggressive litigants may threaten enforcement, especially if claim validity is marginal.

Opportunities

• Expansion of the Patent Portfolio: Filing continuation applications could broaden patent coverage.
• Cross-Licensing: Establishing cross-licensing agreements might mitigate infringement risks.
• Innovation in Adjacent Fields: Building upon the disclosed technology can create complementary patents.

Threats

• Patent Infringement Litigation: Entrenched competitors may challenge the patent’s scope or validity.
• Emerging Art: Rapid innovation may render current claims narrow or obsolete.
• Invalidity Claims: Challenges based on prior art or obviousness could weaken enforceability.

Implications for Industry Stakeholders

Stakeholders—be they licensees, competitors, or patent holders—must scrutinize the '037 patent’s claims' scope and defend its positioning. Innovators should identify liberties for improvement or design-around strategies, while patent owners must monitor and defend their patent rights vigilantly.

Conclusion

United States Patent 10,293,037 encapsulates a strategic innovation within its field, characterized by carefully drafted claims that balance breadth with specificity. While the claims seem robust, ongoing scrutiny of prior art and patent validity remains essential. The patent landscape surrounding it is dynamic, marked by overlapping rights and technological convergence points.

Active management, including vigilant enforcement, strategic licensing, and continual innovation, will determine its long-term value. Stakeholders should conduct comprehensive freedom-to-operate analyses and consider potential avenues for expansion or defensive strategies to safeguard their interests in this competitive environment.

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Key Takeaways

• The '037 patent’s claims are foundational but require continuous monitoring for validity challenges.
• Its strategic position offers leverage in licensing and enforcement, provided claims remain unchallenged.
• An evolving patent landscape necessitates dynamic IP management and ongoing prior art surveillance.
• Broadening patent families and meticulous claim drafting enhance defensibility.
• Industry players should align patent strategies with innovation pipelines to maximize value and mitigate infringement risks.

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FAQs

1. What are the main factors determining the strength of the '037 patent’s claims?
   The claims’ strength hinges on their novelty, non-obviousness, clarity, and support within the specification. Clear, specific claims supported by detailed disclosure are more defensible.

2. How likely are the claims of the '037 patent to withstand broad prior art challenges?
   If prior art discloses similar elements or methods, claims may face invalidation. However, well-drafted claims with inventive distinctions increase resilience.

3. Can the '037 patent’s claims be circumvented by competitors?
   Yes. Competitors may design around the patent by avoiding claim elements or employing alternative methods not covered by the claims.

4. What strategies can patent holders employ to enforce or expand this patent’s coverage?
   Patent holders can seek licensing agreements, file continuation or divisionals to broaden coverage, and actively monitor for infringement to enforce rights.

5. How does the patent landscape influence future filings related to the '037 patent?
   Landscape analysis guides strategic patenting by identifying gaps, potential overlaps, and areas for expansion, ensuring comprehensive protection and avoiding infringement.

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Sources:

[1] United States Patent and Trademark Office. Patent No. 10,293,037.
[2] Patent Review Reports and Public Patent Databases.
[3] Industry Patent Landscape Analyses and IP Strategy Publications.

Details for Patent 10,293,037

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bavarian Nordic A/s	VIVOTIF	typhoid vaccine live oral ty21a	Capsule	103123	December 15, 1989	10,293,037	2038-05-31