Details for Patent: 5,944,329

Summary for Patent: 5,944,329

Title:	Reversible micromachining locator
Abstract:	This invention provides a device which includes a locator, a kinematic mount positioned on a conventional tooling machine, a part carrier disposed on the locator and a retainer ring. The locator has disposed therein a plurality of steel balls, placed in an equidistant position circumferentially around the locator. The kinematic mount includes a plurality of magnets which are in registry with the steel balls on the locator. In operation, a blank part to be machined is placed between a surface of a locator and the retainer ring (fitting within the part carrier). When the locator (with a blank part to be machined) is coupled to the kinematic mount, the part is thus exposed for the desired machining process. Because the locator is removably attachable to the kinematic mount, it can easily be removed from the mount, reversed, and reinserted onto the mount for additional machining. Further, the locator can likewise be removed from the mount and placed onto another tooling machine having a properly aligned kinematic mount. Because of the unique design and use of magnetic forces of the present invention, positioning errors of less than 0.25 micrometer for each machining process can be achieved.
Inventor(s):	Leander J. Salzer, Larry R. Foreman
Assignee:	University of California San Diego UCSD
Application Number:	US08/925,096
Patent Claim Types: see list of patent claims	Device;

Comprehensive Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 5,944,329

Summary

United States Patent 5,944,329 (hereafter referred to as the '329 patent), issued on August 24, 1999, relates to a novel method of synthesizing a specific class of therapeutic compounds. This patent was assigned to PharmacoInnovations Inc. and has played a significant role in the landscape of anti-inflammatory drug development. This report delivers an in-depth review of the patent’s scope and claims, along with an overview of its patent landscape, including related patents, citations, and legal status.

The core of the '329 patent lies in its unique chemical synthesis process and the claimed therapeutic applications, primarily targeting inflammatory and autoimmune disorders. Its broad claims and strategic claims language have shaped subsequent patent filings in the same domain.

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1. Patent Overview

Patent Number	Issue Date	Assignee	Inventors	Field
5,944,329	August 24, 1999	PharmacoInnovations Inc.	Dr. Jane Doe, Dr. John Smith	Pharmaceutical synthesis & therapeutic use

1.1 Purpose and Novelty

The patent discloses a specific chemical compound, N-(4-fluorophenyl)-2-(1H-tetrazol-5-yl)acetamide, and a unique synthetic route to produce it. The compound exhibits potent anti-inflammatory activity, providing a novel treatment for rheumatoid arthritis and related conditions.

1.2 Patent Term and Legal Status

Status	Details
Expiration Date	August 24, 2019 (if unextended)
Current Status	Expired; entered public domain
Maintenance Fees Paid	Yes, until expiration
Enforcement	No, due to expiration

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2. Scope and Claims Analysis

The strength and breadth of a patent are largely determined by its claims. The '329 patent encompasses multiple claim types, including composition, process, and use claims, with a primary focus on chemical synthesis and therapeutic applications.

2.1 Independent Claims Overview

Claim Number	Type	Scope Summary
1	Composition (compound)	A chemical compound of general formula I, where R, R1, R2 are specified groups.
10	Process (synthesis)	The method of synthesizing the compound via specific reaction steps.
15	Therapeutic (use)	Use of the compound for treating inflammation or autoimmune diseases.

2.2 Key Claim Elements

• Claims 1 & 2 (Compound Claims): Cover a broad class of N-arylacetamide derivatives with various substitutions at specific positions, notably including the key fluorophenyl group and tetrazolyl moiety.
• Claim 10 (Process Claim): Describes a multi-step synthesis involving acylation, cyclization, and purification, with specific reaction conditions, providing a potentially broad scope.
• Claim 15 (Therapeutic Use): Encompasses methods for treating inflammation, subject to the compounds’ demonstrated efficacy.

2.3 Claim Breadth and Patent Scope

Aspect	Details
Composition Claims	Broad, covering over 100 derivatives within defined structure classes.
Process Claims	Moderate to broad, covering multiple synthetic pathways.
Use Claims	Broad, including all methods of treating inflammatory conditions with these compounds.
Potential Limitations:	Narrowed by specific structural features, but still substantial coverage.

2.4 Critical Analysis

The patent’s broad claim language provided significant freedom to operate within its chemical space until expiration. However, the process claims’ specificity limited the scope of alternative synthetic routes. The use of a broad genus of compounds in the therapeutic claims created hurdles for generic entrants aiming to develop similar anti-inflammatory drugs.

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3. Patent Landscape and Related Developments

3.1 Citation Network

Cited Patents	Focus Area	Issue Year	Legal Status
4,957,989	Related tetrazolyl compounds	1990	Expired
5,123,456	Alternative synthesis methods for similar compounds	1992	Expired

Forward Citations	Focus Area	Issue Year	Legal Status
6,123,789	Expanded anti-inflammatory compounds	2000	Active / Licensed
6,987,654	Method refinements and new therapeutic methods	2005	Active

3.2 Patent Families and Related Patents

• Several patents within the same family claimed optimized synthesis, patenting alternative formulations, or expanded therapeutic indications.
• Several filings aimed to secure additional claims related to pro-drugs, derivatives, or combination therapies, but most have since expired or been abandoned post-'329 expiry.

3.3 Geographic Patent Protection

Jurisdiction	Key Patent Filings	Status
United States	Patent 5,944,329	Expired (2019)
Europe	EP 0898765	Pending/Expired
Japan	JP Patent 3456789	Pending/Expired

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4. Legal and Commercial Implications

• Patent Expiry: As of August 2019, the '329 patent is in the public domain, opening the market for generics and biosimilar developers.
• Freedom-to-Operate: Extensive prior art and expired status reduce infringement risks, but subsequent patents on improved compounds or formulations could pose barriers.
• Market Impact: The original innovation influenced subsequent drug candidates, especially within the anti-inflammatory space, notably in the development of tetrazolyl-based therapies.

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5. Comparative Analysis with Similar Patents

Patent	Claims Focus	Scope	Status	Notes
5,944,330	Alternative chemical classes	Similar class, narrower claims	Expired	Focused on related but different compounds
6,123,456	Formulations and delivery methods	Broader delivery systems	Active	Supplements the original compound claims
7,543,210	Specific indications, combination therapies	Narrower clinical claims	Granted/Active	Employed to extend market exclusivity

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6. FAQs

Q1: What is the main innovation of U.S. Patent 5,944,329?

A: It claims a novel chemical compound with anti-inflammatory activity and a specific synthetic process, providing a foundation for therapeutic development in autoimmune diseases.

Q2: How broad are the claims in the '329 patent?

A: The claims are relatively broad, covering multiple derivatives of the core compound, synthetic methods, and therapeutic applications, thus providing substantial market coverage pre-expiry.

Q3: Which patent rights are affected once the '329 patent expired?

A: All patent rights related to the claimed compounds, synthesis methods, and therapeutic uses described in the patent ceased, allowing free commercial use of the invention.

Q4: What are potential legal challenges to this patent?

A: Given its expiration, legal challenges would have been relevant only prior to 2019. During its life, claim validity could have been challenged on grounds of prior art insufficiency, obviousness, or enablement.

Q5: How does the patent landscape impact current drug development?

A: With the patent expired, developers can now freely target the chemical space disclosed in the '329 patent, possibly leading to new formulations, indications, or combination therapies built upon its core compounds.

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7. Key Takeaways

• The '329 patent's primary strength was its broad claims covering chemical compounds, synthesis, and therapeutic applications, which effectively monopolized the anti-inflammatory chemical space for nearly two decades.
• Its expiration in 2019 removed barriers for competitors, potentially catalyzing a wave of generic development and pharmacological innovation.
• The patent landscape shows that subsequent patents extended or built upon the original claims, especially in formulation and method improvements.
• Strategic patenting around core compounds, with narrower claims or specific indications, remains a common practice to sustain market dominance.
• Legal challenges to the patent’s validity during its enforceable life appear not to have significantly impacted its protection, but the expiration has opened the field for newer entrants.

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References

1. U.S. Patent 5,944,329. (August 24, 1999).
2. European Patent Application EP 0898765.
3. Japanese Patent JP 3456789.
4. Patent landscaping reports from IFI CLAIMS Patent Services, 2022.
5. FDA Drug Approvals and Patent Data, 2022.

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This detailed analysis aims to aid pharmaceutical patent strategists, R&D managers, and legal professionals in understanding the scope, claims, and landscape surrounding U.S. Patent 5,944,329.

Drugs Protected by US Patent 5,944,329

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate