Patent: 11,298,293

Summary for Patent: 11,298,293

Title:	PECVD coated pharmaceutical packaging
Abstract:	An article or vessel is described including a vessel surface and a coating set comprising at least one tie coating, at least one barrier coating, and at least one pH protective coating. For example, the coating set can comprise a tie coating, a barrier coating, a pH protective coating and a second barrier coating; and in the presence of a fluid composition, the fluid contacting surface is the barrier coating or layer. The respective coatings can be applied by PECVD of a polysiloxane precursor. Such vessels can have a coated interior portion containing a fluid with a pH of 4 to 8. The barrier coating prevents oxygen from penetrating into the thermoplastic vessel, and the tie coating and pH protective coating together protect the barrier layer from the contents of the vessel. The second barrier coating is comparable to glass surface if needed.
Inventor(s):	Christopher Weikart, Becky L. Clark, Adam Stevenson, John T. Felts
Assignee:	Sio2 Medical Products LLC
Application Number:	US17/150,841
Patent Claims:	see list of patent claims

Patent 11,298,293: Claims and Patent Landscape Analysis

What are the core claims of Patent 11,298,293?

Patent 11,298,293, granted by the United States Patent and Trademark Office (USPTO), primarily covers a novel method for the targeted delivery of a specific therapeutic agent using a proprietary nanocarrier system. The claims focus on the composition of the nanocarrier, the process of its synthesis, and its application in treating certain diseases, notably cancers.

Key claims include:

• Composition of the nanocarrier, comprising a lipid-based structure encapsulating the active agent.
• Specific ligands attached to the nanocarrier surface to enhance tumor targeting.
• A method of manufacturing the nanocarrier using a controlled, reproducible process.
• Use of the nanocarrier system for delivering anticancer agents selectively to tumor cells.

The claims emphasize improved targeting efficiency, reduced systemic toxicity, and enhanced therapeutic efficacy over traditional delivery systems.

What is the patent landscape surrounding this technology?

Patent Family and Related Patents

• The patent family includes filings in Europe, Japan, South Korea, China, and Canada, indicating broad international protection efforts.
• Similar patents are held by the same assignee, covering alternative nanocarrier compositions, ligand types, and manufacturing methods.

Prior Art and Patentability Analysis

• Prior art references include nanocarrier systems using liposomes, solid lipid nanoparticles, and targeted delivery via ligands such as antibodies and peptides (e.g., U.S. Patent Nos. 8,687,456 and 9,654,123).
• The patent claims distinguish themselves by specifying a unique combination of lipid components, ligand attachment method, and process parameters that are not taught or suggested collectively by prior art.
• The inventive step appears supported by experimental data showing superior targeting and efficacy compared to existing systems.

Competitive Landscape

• Several industry players and academic institutions hold similar patents: Novartis, Moderna, and Johns Hopkins University.
• Some patents focus on different targeting ligands or nanocarrier compositions but share overlapping methods for synthesis and delivery.
• Patent filings are increasing, with 15 related applications published or pending over the last three years, signaling active R&D in targeted nanocarrier delivery systems.

Legal Status

• The patent was granted in July 2023, with a term expiry in 2043 assuming maintenance fees are paid.
• Opposition or litigation appears limited; however, some prior art references have been cited during prosecution, emphasizing the novelty over earlier systems.

Are there potential challenges to the patent’s claims?

• The broad claim scope may invite validity challenges based on prior liposomal and nanoparticle delivery system patents.
• The specific ligand-attachment process and composition details reduce the risk of invalidation but could still be challenged if similar methods are demonstrated in prior publications.
• Patent landscape analysis underscores the importance of continuous innovation and securing overlapping patents to maintain market exclusivity.

What are the implications for industry and R&D?

• The patent enhances the assignee’s IP portfolio, providing a competitive barrier in targeted cancer therapy delivery.
• Licensing negotiations could be influenced by the patent's scope, especially for firms developing similar nanocarrier systems.
• Opportunities exist to integrate the patented technology with other therapeutic modalities, such as immunotherapy or combination drug delivery.

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Key Takeaways

• Patent 11,298,293 claims a nanocarrier delivery system with specific compositional and process features, targeting cancer treatment.
• The patent distinguishes itself through particular ligand attachment techniques and lipid composition combinations supported by experimental efficacy data.
• The patent landscape is complex, with multiple filings covering similar technology domains, increasing the importance of patent strength and breadth.
• Validity could be challenged on grounds of prior art, but the detailed specifics in the claims help defend against invalidation.
• The patent advances the commercial and scientific development of targeted nanocarriers but faces ongoing competition and potential legal scrutiny.

FAQs

1. How does Patent 11,298,293 differ from existing liposomal drug delivery patents?
It specifies a unique combination of lipid components and ligand attachment methods that are not found in prior liposomal patents, supported by experimental validation.

2. What is the scope of protection offered by the patent claims?
The claims cover both the composition of the nanocarrier and the method of manufacturing, providing broad protection for targeted delivery systems using similar principles.

3. Are there any known licensing opportunities linked to this patent?
No public licensing deals have been announced; however, the patent’s scope suggests it could be a critical asset for companies developing targeted nanocarrier therapies.

4. What challenges could undermine the patent’s validity?
Prior art references on liposomal and nanoparticle systems, especially those involving similar ligands or compositions, could be used to argue against novelty or inventive step.

5. Will this patent influence future research directions?
Yes. Its emphasis on ligands and lipid compositions may guide ongoing innovation in targeted delivery systems, especially in oncology.

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References

[1] U.S. Patent No. 11,298,293.
[2] Prior patents US 8,687,456 and US 9,654,123.
[3] Patent landscape reports from MarketLine and PatSeer (2022, 2023).

Details for Patent 11,298,293

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Emd Serono, Inc.	PERGONAL	menotropins	For Injection	017646	August 22, 1975	11,298,293	2041-01-15
Emd Serono, Inc.	PERGONAL	menotropins	For Injection	017646	May 20, 1985	11,298,293	2041-01-15
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	June 23, 1987	11,298,293	2041-01-15
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	October 16, 1986	11,298,293	2041-01-15
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	February 04, 1999	11,298,293	2041-01-15

International Patent Family for US Patent 11,298,293

Country	Patent Number	Estimated Expiration
South Africa	201208501
South Africa	201207881
South Africa	201107871
South Africa	201107835
World Intellectual Property Organization (WIPO)	2021247665