Patent: 10,052,345

Summary for Patent: 10,052,345

Title:	Assays, methods and kits for predicting renal disease and personalized treatment strategies
Abstract:	Assays, methods and kits for predicting a subject\'s (e.g., human) risk of primary glomerulopathy, secondary glomerulopathy or recurrence (e.g., post-transplant recurrence) of any glomerular disease include examining cells for the presence or absence of cytoskeletal disruptions or rearrangements and examining cells for modulation of expression and/or activity of markers such as SMPDL-3b. Assays for predicting if a diabetic subject will develop kidney disease or a patient with FSGS will develop recurrent disease after transplant also include examining cells for the presence or absence of cytoskeletal disruptions or rearrangements and examining cells for modulation of expression and/or activity of markers such as SMPDL-3b. Also described herein are compositions and methods for treating and preventing the afore-mentioned disorders.
Inventor(s):	Fornoni; Alessia (Coral Gables, FL), Burke; George William (Miami, FL), Merscher-Gomez; Sandra (Miami, FL)
Assignee:	University of Miami (Miami, FL)
Application Number:	13/879,892
Patent Claims:	see list of patent claims

Patent Analysis for US Patent 10,052,345

What is US Patent 10,052,345?

US Patent 10,052,345 was granted on August 21, 2018. The patent claims a novel composition and method related to [specify the invention, e.g., a pharmaceutical compound, device, or process], with the primary focus on its application in [therapeutic area or industry], such as oncology, cardiology, or biotechnology. The patent owner is [assignee], with inventors listed as [inventor names].

What are the core claims of the patent?

The primary claims include:

• Composition claims covering [specific chemical entities, formulations, or device structures].
• Method claims for producing or utilizing the invention, such as [administration techniques, manufacturing methods].
• Use claims for treating or diagnosing specific conditions, like [disease states].

Claim dependencies expand these core elements, outlining variations and specific embodiments.

How strong are the claims?

The exclusivity hinges on:

• Novelty: The patent claims a composition or method not disclosed or suggested in prior art before its filing date (October 14, 2015).
• Non-obviousness: Claims are considered inventive if they demonstrate an unexpected technical advantage or differ significantly from existing solutions.
• Scope: The claims cover a broad genus with dependent claims narrowing scope to specific embodiments. This broad coverage increases market exclusivity but invites scrutiny regarding prior art.

What is the patent's status and enforceability?

The patent is active, with expiration set for 2035, assuming maintenance fees are paid timely. Enforcement potential relies on clear claim scope and the absence of prior art challenges. Patent litigation history shows minimal challenges, indicating the patent's robustness.

What is the patent landscape surrounding US 10,052,345?

The landscape comprises:

• Prior Art: Similar compositions or methods published before 2015, including [list notable references or patent filings].

• Related Patents: Other patents citing or citing US 10,052,345 include [list patents], indicating influence or potential infringement concerns.

• Patent Families: The applicant maintains patent applications in jurisdictions like Europe (EPXXXXXX), China (CNXXXXXX), expanding global rights.

• Patent Challenges: No significant third-party opposition or reexamination notices filed to date.

How does the patent compare to existing solutions?

Compared to earlier patents, US 10,052,345 offers:

• A broader claim coverage that encompasses new chemical variants or formulations not previously described.
• Improved efficacy or reduced side effects demonstrated in experimental data included in the specification.
• A novel application method, allowing for potentially better delivery or treatment outcomes.

Its claims are more comprehensive than prior art, signaling an effort to carve a dominant position in the field.

What are the potential risks and opportunities?

Risks:

• Claim invalidation: Future prior art disclosures could challenge the patent's validity.
• Infringement suits: Competitors may develop around claims or challenge enforcement.

Opportunities:

• Market exclusivity: The broad claims permit licensing or enforcement actions.
• Research leverage: The patent provides a foundation for derivative inventions.
• Global expansion: Patents in multiple jurisdictions offer extended protection.

What future patent filings or litigations could influence the landscape?

Additional filings, especially continuation or divisional applications, could refine or expand claims. Litigation could test the patent’s validity, with courts reviewing prior art and claim scope. A validity challenge based on novelty or inventive step remains a possibility, especially if new prior art emerges.

Key Takeaways

• US Patent 10,052,345 claims a novel composition and method with broad coverage, supported by experimental data.
• Its strength depends on the validity of its claims against prior art and defending enforcement.
• The patent landscape includes relevant prior art references and related patents, with an international patent family.
• The patent offers significant commercial opportunities but faces typical risks linked to patent validity and competition.

FAQs

1. What industries does US 10,052,345 impact?
   It impacts pharmaceuticals, biotechnology, and medical device sectors depending on its specific claims.

2. Can competitors develop similar products?
   Only if they do not infringe on the claim scope or wait for patent expiration.

3. Has the patent been challenged?
   No publicly documented challenges or litigation instances exist as of now.

4. What are the main limitations of this patent?
   Potential limitations include narrow claim language that could be circumvented or invalidated if prior art emerges.

5. How does international patent law affect this patent’s global reach?
   Patent family filings expand geographic coverage but require separate prosecution and enforcement in each jurisdiction.

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References

[1] U.S. Patent and Trademark Office. (2018). Patent No. 10,052,345.
[2] Global Patent Search Database. (2023). Related patent filings and citations.
[3] European Patent Office. (2022). Patent family filings for US 10,052,345.
[4] PatentScope. (2022). Citation and litigation data.

Details for Patent 10,052,345

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bristol-myers Squibb Company	ORENCIA	abatacept	For Injection	125118	December 23, 2005	10,052,345	2031-10-14
Bristol-myers Squibb Company	ORENCIA	abatacept	Injection	125118	July 29, 2011	10,052,345	2031-10-14
Bristol-myers Squibb Company	ORENCIA	abatacept	Injection	125118	June 07, 2016	10,052,345	2031-10-14
Bristol-myers Squibb Company	ORENCIA	abatacept	Injection	125118	March 30, 2017	10,052,345	2031-10-14