When do biologic drug patents expire and when will biosimilars launch?

United States Patent 6,036,944: What It Claims and How the US Landscape Stacks Up

What does US 6,036,944 claim?

US Patent 6,036,944 is a United States grant in the 6,0xx,xxx series. A complete, claim-by-claim infringement and novelty analysis requires the exact text of (1) the independent claims, (2) all dependent claims, (3) the claim construction anchors used during prosecution, and (4) the specification passages that define key terms. Without the patent’s claim set and specification text, an analysis cannot be made “complete and accurate” under a strict patent-analytics standard.

What is the patent’s role in the US patent landscape?

A landscape assessment depends on:

the patent’s publication/application number and earliest priority dates,
the CPC/USPC classification(s) tied to the claims,
the closest forward citations (what later patents build on),
the closest backward citations (what the examiner used as prior art),
maintenance status, assignee history, and claim scope as actually allowed.

None of these inputs can be derived from the patent number alone in a way that meets the standard of accurate and complete analysis required here.

Which prior art likely constrains novelty and non-obviousness?

An examiner-grade analysis must map each element of the independent claims to:

specific cited documents in the patent’s prosecution record,
the most relevant issued US patents and published applications in the same technology family,
non-patent literature incorporated by reference or cited on the face of record.

Without the text of the claims and the citation set, no defensible, element-by-element prior-art mapping is possible.

What do forward citations suggest about claim scope?

Forward citation analysis requires:

citation counts by year,
the subject-matter clusters of citing patents,
whether later claims track the same technical features or pivot to design-arounds.

US 6,036,944’s forward citations must be pulled from a citation dataset tied to the specific patent record. Without that dataset, forward-citation conclusions would be non-verifiable.

Are there easy design-arounds or competing families?

Design-around mapping requires claim elements and their functional limitations, plus competitor claim texts. Without the patent’s claim language, a “critical” assessment of workarounds (for example, alternative materials, alternative process windows, alternative architectures) cannot be produced without guessing.

Bottom-line assessment

No complete and accurate claim-and-landscape analysis can be generated from the patent number alone under a strict standard that forbids speculation. To proceed with a full, critical analysis, the record-level claim text and citation/prosecution data are required.

Key Takeaways

US 6,036,944 cannot be analyzed claim-by-claim without the patent’s claim set and specification definitions.
A credible novelty, obviousness, and design-around assessment requires mapped claim elements to identified cited documents.
Forward- and backward-citation landscape conclusions must be derived from record-specific citation lists and classification fields.

FAQs

1) What information is required to analyze US 6,036,944 accurately?
The patent’s independent and dependent claims, key specification definitions for claim terms, the prosecution/citation record, and assignee/priority details.

2) Can a landscape study be done using only the patent number?
Not at a level that is complete and accurate for litigation-grade or investment-grade decisions.

3) What makes a claim-by-claim mapping decisive?
Each claim element must be tied to a specific prior-art disclosure or a design feature, which requires the exact claim language.

4) How do forward citations affect enforcement value?
They show how later innovators used or avoided the claimed concepts, but only if the citation set and claim themes are extracted.

5) What determines the strength of novelty and non-obviousness?
The most relevant citations against each independent claim element and their combination rationale during prosecution.

References

[1] United States Patent 6,036,944. (Patent record required for claim text, prosecution history, and citation dataset.)

Title:	Processes for the remineralization and mineralization of teeth
Abstract:	A method for remineralizing one or more subsurface lesions in a tooth and/or mineralizing one or more exposed dentinal tubules in the tooth involves dispensing effective amounts of at least one water-soluble calcium salt, at least one water-soluble non-toxic divalent metal compound wherein the divalent metal is other than calcium, at least one water-soluble phosphate salt and, optionally, a water-soluble fluoride salt; mixing the salts and compound to form a non-carbonated mixture having a pH in water such that a non-carbonated aqueous solution containing the mixture has a pH of from 4.5 to about 7.0; and then applying the non-carbonated mixture as the non-carbonated aqueous solution to a surface of the tooth for a sufficient period of time to allow sufficient amounts of calcium, phosphate and, if present, fluoride, ions in the solution to diffuse into the subsurface of the tooth where the diffused ions then react to form an insoluble precipitate onto the lesions and/or exposed tubules, thereby remineralizing the lesions and/or mineralizing the tubules.
Inventor(s):	Anthony E. Winston, Norman Usen
Assignee:	Church and Dwight Co Inc
Application Number:	US09/301,364
Patent Claims:	see list of patent claims
Patent landscape, scope, and claims summary:	United States Patent 6,036,944: What It Claims and How the US Landscape Stacks Up What does US 6,036,944 claim? US Patent 6,036,944 is a United States grant in the 6,0xx,xxx series. A complete, claim-by-claim infringement and novelty analysis requires the exact text of (1) the independent claims, (2) all dependent claims, (3) the claim construction anchors used during prosecution, and (4) the specification passages that define key terms. Without the patent’s claim set and specification text, an analysis cannot be made “complete and accurate” under a strict patent-analytics standard. What is the patent’s role in the US patent landscape? A landscape assessment depends on: the patent’s publication/application number and earliest priority dates, the CPC/USPC classification(s) tied to the claims, the closest forward citations (what later patents build on), the closest backward citations (what the examiner used as prior art), maintenance status, assignee history, and claim scope as actually allowed. None of these inputs can be derived from the patent number alone in a way that meets the standard of accurate and complete analysis required here. Which prior art likely constrains novelty and non-obviousness? An examiner-grade analysis must map each element of the independent claims to: specific cited documents in the patent’s prosecution record, the most relevant issued US patents and published applications in the same technology family, non-patent literature incorporated by reference or cited on the face of record. Without the text of the claims and the citation set, no defensible, element-by-element prior-art mapping is possible. What do forward citations suggest about claim scope? Forward citation analysis requires: citation counts by year, the subject-matter clusters of citing patents, whether later claims track the same technical features or pivot to design-arounds. US 6,036,944’s forward citations must be pulled from a citation dataset tied to the specific patent record. Without that dataset, forward-citation conclusions would be non-verifiable. Are there easy design-arounds or competing families? Design-around mapping requires claim elements and their functional limitations, plus competitor claim texts. Without the patent’s claim language, a “critical” assessment of workarounds (for example, alternative materials, alternative process windows, alternative architectures) cannot be produced without guessing. Bottom-line assessment No complete and accurate claim-and-landscape analysis can be generated from the patent number alone under a strict standard that forbids speculation. To proceed with a full, critical analysis, the record-level claim text and citation/prosecution data are required. Key Takeaways US 6,036,944 cannot be analyzed claim-by-claim without the patent’s claim set and specification definitions. A credible novelty, obviousness, and design-around assessment requires mapped claim elements to identified cited documents. Forward- and backward-citation landscape conclusions must be derived from record-specific citation lists and classification fields. FAQs 1) What information is required to analyze US 6,036,944 accurately? The patent’s independent and dependent claims, key specification definitions for claim terms, the prosecution/citation record, and assignee/priority details. 2) Can a landscape study be done using only the patent number? Not at a level that is complete and accurate for litigation-grade or investment-grade decisions. 3) What makes a claim-by-claim mapping decisive? Each claim element must be tied to a specific prior-art disclosure or a design feature, which requires the exact claim language. 4) How do forward citations affect enforcement value? They show how later innovators used or avoided the claimed concepts, but only if the citation set and claim themes are extracted. 5) What determines the strength of novelty and non-obviousness? The most relevant citations against each independent claim element and their combination rationale during prosecution. References [1] United States Patent 6,036,944. (Patent record required for claim text, prosecution history, and citation dataset.) More… ↓ ⤷ Start Trial

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Biomarin Pharmaceutical Inc.	ALDURAZYME	laronidase	Injection	125058	April 30, 2003	6,036,944	2019-04-29
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

Patent: 6,036,944

Summary for Patent: 6,036,944