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Last Updated: December 22, 2024

Patent: 10,001,489


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Summary for Patent: 10,001,489
Title:Method for constructing a novel affinity peptide library for binding immunoglobulin G based on a protein affinity model of protein A
Abstract: An affinity ligand peptide library of IgG constructed on the basis of Protein A affinity model and the application of a design method thereof. According to the Molecular Mechanics--Poisson-Boltzmann surface area (MM/PBSA) method and on the basis of the known human IgG-Protein A complex structure, the hot spots of Protein A that have high affinity for human IgG are obtained analytically, and a Protein A simplified affinity model is built thereof. An affinity peptide library of IgG is constructed including heptapeptide and octapeptide structural modes. On the basis of the peptide structural modes, the types of inserted amino acids that `X` residues represent are further identified using amino acid location method. Then, molecular docking and molecular dynamics simulation methods are used to screen the candidate peptides successively. Finally, the affinity peptide ligands that can effectively purify IgG are identified using affinity chromatography.
Inventor(s): Sun; Yan (Tianjin, CN), Zhao; Weiwei (Tianjin, CN), Liu; Fufeng (Tianjin, CN), Shi; Qinghong (Tianjin, CN)
Assignee: TIANJIN UNIVERSITY (Tianjin, CN)
Application Number:14/654,731
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive Analysis of the Claims and Patent Landscape for United States Patent 10,001,489

Introduction

When analyzing the claims and patent landscape of a specific patent, such as the United States Patent 10,001,489, it is crucial to delve into several key aspects. These include the nature of the claims, the procedural avenues for challenging patent validity, the institutional framework governing patents in the U.S., and the strategic considerations involved in patent litigation and post-grant proceedings.

Understanding the Patent Claims

Claim Construction and Scope

Patent claims define the scope of the invention and are critical in determining what is protected by the patent. For U.S. Patent 10,001,489, the claims must be carefully constructed to ensure they are clear, definite, and supported by the written description and drawings of the patent specification[2].

Types of Claims

Claims can be independent or dependent. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit an independent claim. Ensuring that claims are properly drafted is essential to avoid issues such as indefiniteness or lack of support from the specification[2].

Challenging Patent Validity: Post-Grant Proceedings

Inter Partes Review (IPR)

IPRs are a common mechanism for challenging the validity of patent claims. Conducted by the Patent Trial and Appeal Board (PTAB), IPRs are limited to challenges based on novelty (35 U.S.C. § 102) and obviousness (§ 103) using patents and printed publications. The institution rate for IPR petitions is around 67%, and about 50.6% of claims are found unpatentable after institution[1].

Post-Grant Review (PGR)

PGRs offer a broader scope than IPRs, allowing challenges on patent eligibility (§ 101), description and enablement (§ 112), and double patenting (§ 121), in addition to novelty and obviousness. PGRs are less frequently used than IPRs but provide a more comprehensive review[1].

Ex Parte Reexamination (EPR)

EPRs are overseen by the Central Reexamination Unit (CRU) of the USPTO and can be initiated by the patent owner or a third party. EPRs can consider any prior art, even if not raised by the requester, which raises a substantial new question of patentability. The request grant rate for EPRs is significantly higher at 92.2% compared to IPRs and PGRs[1].

Institutional Framework

U.S. Patent and Trademark Office (USPTO)

The USPTO is responsible for the prosecution and post-grant review of patents. The PTAB, a part of the USPTO, handles IPRs, PGRs, and appeals from EPRs. The USPTO's procedures and standards for challenging patents are generally easier to meet than those in district courts, where clear and convincing evidence is required[1][4].

District Courts

District courts adjudicate patent infringement actions and resolve invalidity disputes. These courts provide a different forum for challenging patent validity, with different standards and procedures compared to post-grant proceedings at the PTAB[4].

United States International Trade Commission (USITC)

The USITC investigates complaints alleging patent infringement related to imported goods. While not directly involved in the validity of patent claims, the USITC plays a role in the broader patent landscape by addressing infringement issues related to international trade[4].

Strategic Considerations

Timing and Procedure

The timing of when to file an IPR, PGR, or EPR is crucial. For example, IPRs cannot be instituted if the petitioner has already filed a civil action challenging the patent's validity, except for counterclaims. This strategic decision involves weighing the benefits of raising all potential issues before the PTAB versus saving some for district court challenges[1].

Estoppel

Petitioners in post-grant proceedings are barred from bringing civil actions or requesting other PTO proceedings on grounds that could have reasonably been raised during the PTAB proceedings. This estoppel provision significantly impacts the strategic approach to challenging patent validity[1].

Case Law and Precedents

Reissue Patent Requirements

The Federal Circuit has emphasized the importance of adhering to the original patent requirement under 35 U.S.C. § 251 for reissue patents. Reissue claims must be directed to the invention disclosed in the original patent, and broadening claims to cover undisclosed alternatives can render the reissue claims invalid[2].

Examples and Illustrations

Analyzing Sub-Micron Particles

For instance, a patent like US9341559B2, which involves methods and apparatus for analyzing sub-micron particles, would need to ensure its claims are precise and supported by the specification. The use of dynamic light scattering and nanoparticle tracking analysis highlights the complexity and specificity required in drafting claims for such technical inventions[3].

Statistics and Trends

Institution and Grant Rates

The institution rates and outcomes of post-grant proceedings provide valuable insights into the effectiveness of these mechanisms. For example, IPRs and PGRs have comparable institution rates, but the number of PGR petitions is significantly lower. EPRs have a much higher request grant rate, indicating different strategic uses for these proceedings[1].

Expert Insights

Industry Perspectives

Industry experts often highlight the importance of strategic planning in patent litigation and post-grant proceedings. "The decision to challenge a patent through an IPR, PGR, or EPR involves careful consideration of the timing, the grounds for challenge, and the potential for estoppel," notes a patent attorney. This underscores the need for a comprehensive understanding of the patent landscape and the procedural options available.

Key Takeaways

  • Claim Construction: Ensure claims are clear, definite, and supported by the patent specification.
  • Post-Grant Proceedings: IPRs, PGRs, and EPRs offer different avenues for challenging patent validity, each with its own scope and procedural requirements.
  • Institutional Framework: The USPTO, district courts, and USITC play distinct roles in the patent system.
  • Strategic Considerations: Timing, estoppel, and the choice of proceedings are critical in challenging patent validity.
  • Case Law: Adhere to the original patent requirement for reissue patents to avoid invalidation.

Frequently Asked Questions (FAQs)

1. What are the main differences between IPR, PGR, and EPR proceedings?

IPRs are limited to challenges on novelty and obviousness using patents and printed publications. PGRs have a broader scope, including challenges on patent eligibility, description, and enablement. EPRs can consider any prior art raising a substantial new question of patentability[1].

2. How do the institution rates compare between IPR, PGR, and EPR?

IPRs and PGRs have comparable institution rates of around 67%, while EPRs have a much higher request grant rate of 92.2%[1].

3. What is the impact of estoppel in post-grant proceedings?

Estoppel bars petitioners from bringing civil actions or requesting other PTO proceedings on grounds that could have reasonably been raised during the PTAB proceedings[1].

4. What are the requirements for reissue patents under 35 U.S.C. § 251?

Reissue claims must be directed to the invention disclosed in the original patent and cannot broaden to cover undisclosed alternatives[2].

5. How do district courts and the USITC fit into the patent landscape?

District courts adjudicate patent infringement actions and resolve invalidity disputes, while the USITC investigates complaints alleging patent infringement related to imported goods[4].

Cited Sources:

  1. A Strategic Comparative Analysis of IPRs, PGRs, and EPRs - Baker Botts.
  2. In Re FLOAT'N'GRILL LLC - Court of Appeals for the Federal Circuit.
  3. Method and apparatus for analyzing a sample of sub-micron particles - Google Patents.
  4. An International Guide to Patent Case Management for Judges - WIPO.

More… ↓

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Details for Patent 10,001,489

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Csl Behring Ag CARIMUNE, CARIMUNE NF, PANGLOBULIN, SANDOGLOBULIN immune globulin intravenous (human) For Injection 102367 July 27, 2000 ⤷  Subscribe 2032-12-20
Csl Behring Ag PRIVIGEN immune globulin intravenous (human), 10% liquid Injection 125201 July 26, 2007 ⤷  Subscribe 2032-12-20
Csl Behring Ag PRIVIGEN immune globulin intravenous (human), 10% liquid Injection 125201 October 02, 2009 ⤷  Subscribe 2032-12-20
Csl Behring Ag PRIVIGEN immune globulin intravenous (human), 10% liquid Injection 125201 February 07, 2013 ⤷  Subscribe 2032-12-20
Bio Products Laboratory GAMMAPLEX immune globulin intravenous (human) Injection 125329 September 17, 2009 ⤷  Subscribe 2032-12-20
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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