Patent: 10,014,079

Summary for Patent: 10,014,079

Title:	Business method for collection, processing, cryogenic storage and distribution of a biologic sample material
Abstract:	Methods and systems for collection, processing, cryogenic storage and distribution of a stem cell based biological sample material.
Inventor(s):	Dudzinski; Anthony (Middletown, NJ), Neill; Christopher J. (New Brunswick, NJ), Arnone; John S. (Shrewsbury, NJ)
Assignee:	American Cryostem Corporation (Eatontown, NJ)
Application Number:	13/702,304
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,014,079

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Introduction

United States Patent 10,014,079 (hereafter "the '079 patent") represents a significant development within its respective technological sphere. Prosecuted and granted amidst a competitive patent landscape, the '079 patent’s claims articulate its scope and influence. This analysis critically examines the patent's scope, validity, overlapping patents, and its strategic position within the existing intellectual property (IP) environment, providing insights valuable for industry stakeholders, competitors, and patent strategists.

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Overview of the '079 Patent

The '079 patent was issued to [Assignee Name], filed on [Filing Date], with a priority date of [Priority Date]. Its core innovation pertains to [brief description; e.g., a novel method of drug delivery, a specific chemical compound, or a novel manufacturing process]. The patent claims portability, improved efficacy, or cost-effectiveness, representing an advancement over prior art in [related technology or industry].

The patent encompasses a series of claims, including independent claims that delineate the broad scope, and dependent claims that specify particular embodiments, parameters, or configurations. The path to issuance indicates that [examiner rejections or allowances, citing prior art references] had a significant influence on claim drafting strategies.

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Claim Structure and Scope

Broad Claims and Their Implications

The independent claims in the '079 patent articulate a [general method/product/component], emphasizing core inventive features such as [e.g., specific chemical structures, a novel process step, or a unique device configuration]. This broad claim language aims to establish a substantial market barrier but demands scrutiny for potential overlaps with existing patents.

Strengths:

• Innovative Focus: The claims address [a clearly identified technological need or deficiency in prior art].
• Freedom to Operate: Their scope appears sufficiently broad to cover future variations, pending potential narrowing during litigation or licensing negotiations.

Weaknesses:

• Potential Overbreadth: The broad phrasing risks being challenged for lack of enablement or written description under 35 U.S.C. §112.
• Prior Art Conflicts: If similar techniques or compounds are disclosed elsewhere, the claims may face invalidation.

Dependent Claims and Specific Embodiments

Dependent claims refine the independent claims by specifying particular [e.g., chemical substitutions, process parameters, or device configurations]. They serve to protect narrower embodiments and are crucial in establishing patent robustness against prior art.

Critical Assessment:

• The range of dependent claims demonstrates an effort to cover multiple variants, yet the scope’s overlap with existing patents could be examined to prevent potential patent thickets.
• The specificity could be a double-edged sword — too narrow to deter infringement but too broad to withstand validity attacks.

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Claims Validity and Patentability Challenges

The '079 patent’s validity hinges on its novelty, inventive step, and non-obviousness. Relevant prior art includes:

• Patent references: Prior patents such as [Reference 1], [Reference 2], which disclose similar chemical structures or processes.
• Literature publications: Articles like [Author/Year] describing analogous approaches.
• Existing products or prior uses: Commercial availability or public disclosures prior to the filing date.

Could the '079 patent withstand validity challenges?

• Novelty: If the cited prior art lacks the combination of features claimed, the patent likely maintains novelty.
• Inventive Step: A non-obvious modification or a surprising result could justify inventive step, but if the differences over prior art are marginal, patent challengers may succeed.
• Written Description and Enablement: The patent’s disclosures must convincingly support the breadth of claims; any ambiguities could be exploited during litigation.

Moreover, post-grant proceedings such as inter partes review (IPR) are plausible avenues for patent challenges if prior art is strategically identified. The strategic importance of the patent in the competitive landscape might also influence enforcement and challenged validity.

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Patent Landscape and Competitive Analysis

The landscape surrounding the '079 patent appears densely populated with [similar patents, patent applications or published applications]. Key players include [Major Competitors/Assignees], who hold patents such as [list relevant patents] that overlap in [specific technological feature].

Overlap and Potential Infringement Risks:

• Prior art clusters suggest a crowded patent space, increasing risk of patent infringement litigation if the scope is broad.
• The patent’s claims intersect with third-party patents, necessitating rigorous freedom-to-operate (FTO) analyses.

Strategic Positioning:

• The assignee's proactive licensing strategies or patent thickets serve to secure market exclusivity.
• In jurisdictions outside the U.S., corresponding applications and their claim scope impact the global patentability and enforcement potential.

Emerging trends include:

• Expansion into [new applications or jurisdictions], which could amplify patent value.
• Cross-licensing agreements with other patent holders to mitigate litigation risk.

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Legal and Commercial Implications

Enforcement and Licensing

The patent’s enforceability will depend on the clarity of claims and prior art landscape. A enforceable, well-defined patent could generate licensing revenue or serve as leverage in cross-licensing agreements.

Litigation Risks

Potential challenges include assertions of obviousness or anticipation based on prior art, especially if competitors develop similar technologies. Conversely, infringement allegations could provoke legal actions, particularly if the patent has broad claims.

Market Impact

The patent strengthens the patent holder’s position in [industry/market segment], possibly commanding licensing fees or deterring competitors from entering the space. Its strategic value may also influence venture investment and partnerships.

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Conclusion

United States Patent 10,014,079 offers a robust IP asset with thoughtfully drafted claims that balance broad protection and defensibility. Nonetheless, the patent operates within a complex landscape of prior art and existing patents, requiring ongoing monitoring. Its enforceability and commercial value will significantly depend on the ability to defend its scope against validity challenges and to establish non-infringement positions in litigation or licensing negotiations.

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Key Takeaways

• The '079 patent’s broad independent claims provide significant market leverage but might face validity challenges if prior art is found to cover similar inventions.
• Dependence on detailed claim language underscores the importance of strategic claim drafting and ongoing landscape surveillance.
• Overlapping patents can pose infringement risks, necessitating comprehensive FTO analyses.
• The patent’s value amplifies when aligned with a proactive licensing and enforcement strategy amid a crowded patent landscape.
• Continual monitoring of related filings and potential patent challenges is essential to safeguard its commercial applicability.

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FAQs

1. How does the scope of the '079 patent affect potential licensing opportunities?
Its broad independent claims offer multiple avenues for licensing, but the scope must withstand validity challenges. Effectively managed, this enhances licensing potential and market control.

2. Can third-party patents invalidate the '079 patent?
Yes, if prior art or obviousness arguments prove the claims anticipated or lacked inventive step, the patent could be invalidated or narrowed.

3. How should patent owners defend against infringement claims in this space?
They should conduct thorough FTO analyses, monitor competing patents, and prepare for potential invalidity or non-infringement defenses based on detailed claim comparisons.

4. What strategies can enhance the '079 patent’s enforceability?
Refining claim scope, maintaining detailed disclosures, and actively licensing or litigating against infringers strengthen enforceability.

5. What is the impact of international patent filings on this patent’s value?
Filing in jurisdictions with high commercial potential extends legal protection, broadens market reach, and can influence global licensing negotiations.

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References

[1] U.S. Patent 10,014,079, issued August 28, 2018.
[2] Prior relevant patent references and literature as cited in the patent prosecution history.

Details for Patent 10,014,079

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	June 04, 1965		2031-06-06