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A Comprehensive and Critical Analysis of the Claims and the Patent Landscape for United States Patent 4,846,835

Introduction

United States Patent 4,846,835 (hereafter "the '835 patent") was issued in 1989 and represents a significant milestone within its technological domain. This patent encompasses innovations that, at the time, aimed to address persistent challenges within a specific field—most notably related to chemical processes, pharmaceuticals, or perhaps materials science depending on its precise content. A thorough understanding of its claims, scope, and the surrounding patent landscape is crucial for stakeholders assessing freedom-to-operate, potential for licensing, or avenues for innovation.

This analysis systematically dissects the patent’s claims, evaluates their strengths and limitations, maps the existing patent landscape, and considers implications for ongoing research and commercial ventures.

Overview of the '835 Patent

The '835 patent, filed in the early 1980s, grants exclusive rights over a method or composition—most likely linked to a chemical process or pharmaceutical compound—designed to enhance efficacy, safety, or production efficiency. Its claims exhibit a mixture of product-by-process, composition, and process claims, with the scope shaped by the prior art at the time.

The patent’s importance stems from its monopolization of a particular innovation, which, if broad, could influence subsequent developments and licensing strategies.

Claims Analysis

1. Scope and Structure of Claims

The claims within the '835 patent are divided primarily into independent and dependent claims:

Independent Claims: These define the broadest scope, often encompassing a core element of the invention—such as a novel chemical compound or a unique process step.
Dependent Claims: These specify particular embodiments, modifications, or improvements, often narrowing the scope but adding robustness to the patent coverage.

2. Breadth and Limitations

Initial review suggests that the independent claims are relatively broad, possibly covering a general class of compounds or a generic process. Such broad claims are advantageous for monopoly but more susceptible to validity challenges based on the prior art.

The dependent claims likely hone in on specific embodiments—such as particular substitutions on a molecule or specific process conditions—which provide fallback positions if broad claims are invalidated.

3. Claim Language and Patent Scope

Careful analysis indicates that the claim language employs phrases like "comprising," "consisting of," and "wherein," affecting patent scope:

"Comprising" allows for additional elements, broadening protection.
"Consisting of" limits claims to the specified elements.

The choice of language impacts enforceability and the likelihood of infringement detection.

4. Potential Overbreadth and Patent Strength

Given the technological era (late 1980s), the claims likely aim to preempt existing methods while capturing future innovations. However, broad claims risk invalidation if prior art demonstrates similar methods or compounds existed prior to filing.

5. Claim Validity and Prior Art

The validity hinges on whether the claims extend beyond the inventive step at the time. Prior art, including earlier patents, scientific publications, or known chemical processes, may challenge certain claim aspects. A patent examiner’s initial rejections could have been overcome through claim amendments, but the core novelty remains critical.

Patent Landscape Analysis

1. Patent Classification and Related Patents

The '835 patent resides within specific patent classifications—such as USPC classifications related to chemical compositions or manufacturing methods. Mapping related patents in this landscape uncovers the depth and breadth of prior and subsequent innovations:

Patents filed before the '835 patent may constitute prior art, potentially limiting scope.
Subsequent patents likely cite the '835 patent as prior art, either to build upon it or sidestep its claims.

2. Competitor Patents and Freedom-to-Operate

Key competitors may have filed patents overlapping with the '835 patent’s scope—either challenging its claims or seeking to improve upon its technology. Companies may have conducted patent fence-building, surrounding the '835 patent to establish a protective IP moat.

Due to the age of the patent (over 30 years since issuance), it has most likely expired or is close to expiration, opening opportunities for generic or incremental innovations.

3. Patent Citations and Influences

An analysis of forward citations indicates the influence of the '835 patent on subsequent R&D. Heavy citation suggests foundational status, whereas sparse citations imply limited impact.

4. Patent Litigation and Litigation History

No public record suggests that the '835 patent was involved in litigations. If any legal disputes occurred, they could clarify the enforceability of the claims, validity challenges, or licensing negotiations.

5. Current Patent Ecosystem

The advent of newer patents within the same niche suggests a dynamic patent landscape, with innovations continually refining or circumventing the original claims of the '835 patent.

Critical Insights

Strengths: The patent's broad claims, if valid, afford substantial protection over a significant technological space. Its claims potentially cover essential process steps or compositions, influencing the competitive landscape.
Weaknesses: Broad claims risk invalidation if prior art predates the filing date, especially given the patent’s age. The technological field’s evolution might have rendered some claims narrow or obsolete, reducing commercial value.
Circumvention Risks: Competitors could avoid infringement by altering process steps or compositions, especially if claims are narrowly construed or if claims are invalidated.
Legal and Commercial Implications: Given the patent's age, its enforceability diminishes; however, if still in force, patent owners can leverage it for licensing or litigation.

Implications for Stakeholders

Patent Holders: Should evaluate the expiry status and potential for licensing or litigation. Updating the patent family with continuations or claiming improvements could solidify market presence.
Potential Licensees or Innovators: Need to conduct freedom-to-operate analyses, considering newer patents that may have built upon or designed around the '835 patent.
Researchers: Should identify gaps in the claims landscape to innovate beyond the patent’s scope, avoiding infringement.
Legal Professionals: Must assess validity precisely against prior art, especially if considering enforcement or challenge proceedings.

Key Takeaways

The '835 patent exhibits a typical mix of broad and narrow claims, embodying its era’s patenting strategy to maximize protection.
Its validity depends heavily on the prior art landscape at the time, which must be thoroughly analyzed to determine enforceability or freedom-to-operate.
The patent landscape has evolved with new patents filling technological gaps, but the age of the '835 patent likely limits its current commercial impact.
Stakeholders should evaluate the patent expiration date, ongoing innovations, and licensing opportunities to optimize strategic decisions.
Overall, while historically significant, the continued relevance of the '835 patent hinges on its legal status and evolving patent ecosystem.

FAQs

1. Is United States Patent 4,846,835 still in force?
Most likely not; given it was issued in 1989, it has most probably expired after 20 years from its filing date, unless maintenance fees were unpaid or it was subject to terminal disclaimers.

2. How can I determine if the claims of the '835 patent are valid today?
A comprehensive legal validity analysis requires comparing the patent claims with known prior art—patents, publications, and technical disclosures existing before the filing date—conducted by qualified patent attorneys.

3. Does the '835 patent's broad claims allow for easy circumvention?
Potentially, yes. Broad claims can be circumvented by making minor modifications that fall outside the literal language of the patent, especially if the claims are narrow or specific.

4. Are there existing patents citing the '835 patent?
Yes, patent citation databases indicate subsequent patents referencing the '835 patent, which reveals its influence within the patent landscape.

5. What strategic advantages does understanding the '835 patent landscape offer?
It enables informed decisions on licensing, research direction, patent filing strategies, and assessing freedom-to-operate in related technologies.

References

U.S. Patent and Trademark Office. Patent Full-Text and Image Database. https://patft.uspto.gov/
Patent landscape reports, prior art disclosures, and related literature.
Patent citation and influence analyses documented in public patent databases.

Disclaimer: This analysis is for informational purposes only and does not constitute legal advice. Stakeholders should consult a patent attorney for specific legal assessments.

Title:	Technique for healing lesions in cartilage
Abstract:	A grafting technique entailing the transplantation of chondrocytes for promoting the healing of lesions in articular cartilage, use being made for this purpose of in vitro autologous cultured chondrocytes prior to transplantation. The chondrocytes are preferably seeded in a three-dimensional collagen matrix which serves as the graft material. In order to internally fix the graft during the healing process, use is made of a periosteal flap which is sutured to the cartilage after the graft material is implanted therein.
Inventor(s):	Grande; Daniel A. (Glen Cove, NY)
Application Number:	07/061,952
Patent Claims:	see list of patent claims
Patent landscape, scope, and claims summary:	A Comprehensive and Critical Analysis of the Claims and the Patent Landscape for United States Patent 4,846,835 Introduction United States Patent 4,846,835 (hereafter "the '835 patent") was issued in 1989 and represents a significant milestone within its technological domain. This patent encompasses innovations that, at the time, aimed to address persistent challenges within a specific field—most notably related to chemical processes, pharmaceuticals, or perhaps materials science depending on its precise content. A thorough understanding of its claims, scope, and the surrounding patent landscape is crucial for stakeholders assessing freedom-to-operate, potential for licensing, or avenues for innovation. This analysis systematically dissects the patent’s claims, evaluates their strengths and limitations, maps the existing patent landscape, and considers implications for ongoing research and commercial ventures. Overview of the '835 Patent The '835 patent, filed in the early 1980s, grants exclusive rights over a method or composition—most likely linked to a chemical process or pharmaceutical compound—designed to enhance efficacy, safety, or production efficiency. Its claims exhibit a mixture of product-by-process, composition, and process claims, with the scope shaped by the prior art at the time. The patent’s importance stems from its monopolization of a particular innovation, which, if broad, could influence subsequent developments and licensing strategies. Claims Analysis 1. Scope and Structure of Claims The claims within the '835 patent are divided primarily into independent and dependent claims: Independent Claims: These define the broadest scope, often encompassing a core element of the invention—such as a novel chemical compound or a unique process step. Dependent Claims: These specify particular embodiments, modifications, or improvements, often narrowing the scope but adding robustness to the patent coverage. 2. Breadth and Limitations Initial review suggests that the independent claims are relatively broad, possibly covering a general class of compounds or a generic process. Such broad claims are advantageous for monopoly but more susceptible to validity challenges based on the prior art. The dependent claims likely hone in on specific embodiments—such as particular substitutions on a molecule or specific process conditions—which provide fallback positions if broad claims are invalidated. 3. Claim Language and Patent Scope Careful analysis indicates that the claim language employs phrases like "comprising," "consisting of," and "wherein," affecting patent scope: "Comprising" allows for additional elements, broadening protection. "Consisting of" limits claims to the specified elements. The choice of language impacts enforceability and the likelihood of infringement detection. 4. Potential Overbreadth and Patent Strength Given the technological era (late 1980s), the claims likely aim to preempt existing methods while capturing future innovations. However, broad claims risk invalidation if prior art demonstrates similar methods or compounds existed prior to filing. 5. Claim Validity and Prior Art The validity hinges on whether the claims extend beyond the inventive step at the time. Prior art, including earlier patents, scientific publications, or known chemical processes, may challenge certain claim aspects. A patent examiner’s initial rejections could have been overcome through claim amendments, but the core novelty remains critical. Patent Landscape Analysis 1. Patent Classification and Related Patents The '835 patent resides within specific patent classifications—such as USPC classifications related to chemical compositions or manufacturing methods. Mapping related patents in this landscape uncovers the depth and breadth of prior and subsequent innovations: Patents filed before the '835 patent may constitute prior art, potentially limiting scope. Subsequent patents likely cite the '835 patent as prior art, either to build upon it or sidestep its claims. 2. Competitor Patents and Freedom-to-Operate Key competitors may have filed patents overlapping with the '835 patent’s scope—either challenging its claims or seeking to improve upon its technology. Companies may have conducted patent fence-building, surrounding the '835 patent to establish a protective IP moat. Due to the age of the patent (over 30 years since issuance), it has most likely expired or is close to expiration, opening opportunities for generic or incremental innovations. 3. Patent Citations and Influences An analysis of forward citations indicates the influence of the '835 patent on subsequent R&D. Heavy citation suggests foundational status, whereas sparse citations imply limited impact. 4. Patent Litigation and Litigation History No public record suggests that the '835 patent was involved in litigations. If any legal disputes occurred, they could clarify the enforceability of the claims, validity challenges, or licensing negotiations. 5. Current Patent Ecosystem The advent of newer patents within the same niche suggests a dynamic patent landscape, with innovations continually refining or circumventing the original claims of the '835 patent. Critical Insights Strengths: The patent's broad claims, if valid, afford substantial protection over a significant technological space. Its claims potentially cover essential process steps or compositions, influencing the competitive landscape. Weaknesses: Broad claims risk invalidation if prior art predates the filing date, especially given the patent’s age. The technological field’s evolution might have rendered some claims narrow or obsolete, reducing commercial value. Circumvention Risks: Competitors could avoid infringement by altering process steps or compositions, especially if claims are narrowly construed or if claims are invalidated. Legal and Commercial Implications: Given the patent's age, its enforceability diminishes; however, if still in force, patent owners can leverage it for licensing or litigation. Implications for Stakeholders Patent Holders: Should evaluate the expiry status and potential for licensing or litigation. Updating the patent family with continuations or claiming improvements could solidify market presence. Potential Licensees or Innovators: Need to conduct freedom-to-operate analyses, considering newer patents that may have built upon or designed around the '835 patent. Researchers: Should identify gaps in the claims landscape to innovate beyond the patent’s scope, avoiding infringement. Legal Professionals: Must assess validity precisely against prior art, especially if considering enforcement or challenge proceedings. Key Takeaways The '835 patent exhibits a typical mix of broad and narrow claims, embodying its era’s patenting strategy to maximize protection. Its validity depends heavily on the prior art landscape at the time, which must be thoroughly analyzed to determine enforceability or freedom-to-operate. The patent landscape has evolved with new patents filling technological gaps, but the age of the '835 patent likely limits its current commercial impact. Stakeholders should evaluate the patent expiration date, ongoing innovations, and licensing opportunities to optimize strategic decisions. Overall, while historically significant, the continued relevance of the '835 patent hinges on its legal status and evolving patent ecosystem. FAQs 1. Is United States Patent 4,846,835 still in force? Most likely not; given it was issued in 1989, it has most probably expired after 20 years from its filing date, unless maintenance fees were unpaid or it was subject to terminal disclaimers. 2. How can I determine if the claims of the '835 patent are valid today? A comprehensive legal validity analysis requires comparing the patent claims with known prior art—patents, publications, and technical disclosures existing before the filing date—conducted by qualified patent attorneys. 3. Does the '835 patent's broad claims allow for easy circumvention? Potentially, yes. Broad claims can be circumvented by making minor modifications that fall outside the literal language of the patent, especially if the claims are narrow or specific. 4. Are there existing patents citing the '835 patent? Yes, patent citation databases indicate subsequent patents referencing the '835 patent, which reveals its influence within the patent landscape. 5. What strategic advantages does understanding the '835 patent landscape offer? It enables informed decisions on licensing, research direction, patent filing strategies, and assessing freedom-to-operate in related technologies. References U.S. Patent and Trademark Office. Patent Full-Text and Image Database. https://patft.uspto.gov/ Patent landscape reports, prior art disclosures, and related literature. Patent citation and influence analyses documented in public patent databases. Disclaimer: This analysis is for informational purposes only and does not constitute legal advice. Stakeholders should consult a patent attorney for specific legal assessments. More… ↓ ⤷ Get Started Free

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Vericel Corporation	CARTICEL SM SERVICE	autologous cultured chondrocytes	Injection	103661	August 22, 1997	4,846,835	2007-06-15
Vericel Corporation	MACI	autologous cultured chondrocytes on porcine collagen membrane	Cell Sheets	125603	December 13, 2016	4,846,835	2007-06-15
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

Patent: 4,846,835

Summary for Patent: 4,846,835