Patent: 6,258,791

Summary for Patent: 6,258,791

Title:	Combination product for enhanced gene delivery comprising a hyaluronidase
Abstract:	The invention relates to a composition, kit and methods of using the compositions and kits. The composition comprises a compound which disorganizes or degrades the extracellular matrix of a cell and a nucleic acid of interest. The composition or kit is contemplated for use in gene transfer and gene therapy.
Inventor(s):	Braun; Serge (Dorlisheim, FR)
Assignee:	Transgene S.A. (Strasbourg, FR)
Application Number:	09/424,741
Patent Claims:	see list of patent claims

Understanding the Claims and Patent Landscape of United States Patent 6,258,791

Introduction

When analyzing a patent, particularly one like United States Patent 6,258,791, it is crucial to delve into the intricacies of the patent claims, the examination process, and the broader patent landscape. This analysis will help in understanding the patent's scope, its potential for enforcement, and the challenges it may face.

Patent Claims: The Heart of the Patent

Patent claims are the core of any patent application, defining the exclusive rights granted to the inventor. They determine the boundaries of what is protected and what is not[3].

Claim Construction and Ambiguity

The construction of patent claims is often a source of ambiguity. Courts and patent offices must interpret these claims to determine their scope, which can be influenced by policy debates over whether patents should be narrow or broad. This ambiguity can lead to inconsistent and judge-dependent outcomes, making the patent system unpredictable[3].

The Examination Process

The examination process for patents in the United States is complex and multi-faceted.

First-Action Allowance Rate and Progenitor Allowance Rate

The USPTO calculates several measures of patent allowance rates, including the first-action allowance rate and the progenitor allowance rate. The first-action allowance rate indicates the proportion of applications allowed without further examination, while the progenitor allowance rate shows the proportion allowed without any continuation procedures[1].

Continuation Procedures

Continuation procedures, such as Request for Continued Examination (RCE), Continued Prosecution Applications (CPAs), and File Wrapper Continuations (FWCs), allow applicants to continue the examination process after initial rejections. These procedures can significantly impact the ultimate allowance rate of a patent application[1].

Technology Fields and Allowance Rates

Patent allowance rates vary across different technology fields. For instance, applications in the Chemical and Drugs and Medical fields may have different allowance rates compared to those in Electrical and Electronics or Computers and Communications fields. Understanding these variations is crucial for predicting the likelihood of a patent being granted[1].

Inventor Types and Allowance Rates

The size and type of the entity filing the patent application also influence the allowance rate. Small entities, defined as those with 500 or fewer employees, generally have lower allowance rates compared to large entities. This disparity highlights the challenges small inventors face in the patent system[1].

Case Study: United States Patent 6,258,791

To conduct a comprehensive analysis, let's consider a hypothetical example using United States Patent 6,258,791, though the specific details of this patent are not provided here.

Claim Analysis

• Claim Scope: Analyze the claims to understand what is specifically protected. Are the claims narrow and focused, or are they broad and encompassing? This will determine the patent's enforceability and potential for infringement.
• Claim Construction: Consider how courts might interpret these claims. Are there any ambiguities or potential for different interpretations? This could impact the patent's validity and enforceability in legal disputes[3].

Examination History

• Application and Examination Process: Review the patent's examination history to see if it underwent any continuation procedures. This can provide insights into the challenges faced during the examination process and the final scope of the granted claims[1].

Infringement and Validity

• Infringement Analysis: Determine if the patent is directly infringed by any products or processes. This involves a two-step analysis: first, identifying whether the accused product or process falls within the scope of the claims, and second, determining if the infringement is literal or under the doctrine of equivalents[2].
• Validity Challenges: Assess any potential validity challenges, such as prior art or obviousness arguments. The patent's validity can be challenged through various legal avenues, including Inter Partes Review (IPR) or court proceedings[5].

Broader Patent Landscape

Understanding the broader patent landscape is essential for navigating the complexities of patent law.

Policy Debates and Judicial Interpretations

Policy debates over the scope of patent exclusion can influence how claims are interpreted. Judges may favor narrower or broader patents, leading to varied case outcomes. Resolving these policy debates could help in clarifying patent boundaries[3].

Industry and Technological Context

The technological field in which the patent operates can also impact its significance and enforceability. For example, in rapidly evolving fields like technology and biotechnology, patents may face more challenges due to the rapid pace of innovation and the presence of prior art[1].

Challenges and Opportunities

Patent holders face several challenges, including:

Enforcement

Enforcing a patent involves proving infringement and defending against validity challenges. The ambiguity in claim construction and the unpredictability of judicial interpretations can complicate this process[3].

Maintenance and Renewal

Patents require periodic maintenance fees to remain in force. Failure to pay these fees can result in the patent lapsing, highlighting the ongoing financial commitment required to maintain patent rights[4].

Key Takeaways

• Claim Clarity: Clear and precise claims are crucial for defining the scope of protection and avoiding ambiguity.
• Examination Process: Understanding the examination history, including any continuation procedures, is vital for assessing the patent's strength.
• Infringement and Validity: Regularly monitoring for potential infringement and being prepared to defend against validity challenges are essential for maintaining the patent's value.
• Policy and Judicial Interpretations: Staying informed about policy debates and judicial interpretations can help in navigating the patent landscape effectively.
• Technological Context: The rapid evolution of technology can impact the patent's significance and enforceability, requiring continuous monitoring and adaptation.

Frequently Asked Questions (FAQs)

Q1: What are the key components of a patent claim?

• A patent claim must particularly point out and distinctly claim the subject matter which the inventor regards as the invention. This includes a written description of the invention and how to make and use it[3].

Q2: How do continuation procedures affect the patent examination process?

• Continuation procedures allow applicants to continue the examination process after initial rejections, potentially leading to multiple patents from a single progenitor application and complicating the calculation of allowance rates[1].

Q3: What is the impact of policy debates on patent claims?

• Policy debates over the scope of patent exclusion can lead to varied and unpredictable judicial interpretations, affecting the clarity and enforceability of patent claims[3].

Q4: How do small entities fare in the patent system compared to large entities?

• Small entities generally have lower allowance rates and face more challenges in the patent system due to limited resources and expertise[1].

Q5: What are the steps involved in determining patent infringement?

• Determining infringement involves a two-step analysis: identifying whether the accused product or process falls within the scope of the claims, and determining if the infringement is literal or under the doctrine of equivalents[2].

Cited Sources

1. Carley, M., & Hegde, D. (n.d.). What Is the Probability of Receiving a US Patent?. Retrieved from https://yjolt.org/sites/default/files/carley_hegde_marco-what_is_the_probability_of_receiving_a_us_patent_0.pdf
2. United States District Court for the District of Delaware. (n.d.). Civil Action No. 20-755-RGA. Retrieved from https://www.ded.uscourts.gov/sites/ded/files/opinions/20-755_4.pdf
3. Wagner, R. P., & Petherbridge, L. (n.d.). The Unresolved Interpretive Ambiguity of Patent Claims. Retrieved from https://scholarship.law.cornell.edu/cgi/viewcontent.cgi?article=2700&context=facpub
4. U.S. Small Business Administration. (n.d.). U.S. Patent & Trade Office #NVSBW24. Retrieved from https://www.sba.gov/event/57033
5. United States Patent and Trademark Office. (n.d.). [e-mail] Paper No. 10 571-272-7822. Retrieved from https://ptacts.uspto.gov/ptacts/public-informations/petitions/1553774/download-documents?artifactId=maoly0kOPNX9nXNW8AwUwDd26iLaGD2DT3-5Sjf4bTF7N8IgPrf_YlM

Details for Patent 6,258,791

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640	May 05, 2004	6,258,791	2017-05-29
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640	December 02, 2004	6,258,791	2017-05-29
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	October 26, 2004	6,258,791	2017-05-29