Patent: 8,268,303

Summary for Patent: 8,268,303

Title:	Methods for producing enriched populations of human retinal pigment epithelium cells for treatment of retinal degeneration
Abstract:	This invention relates to methods for improved cell-based therapies for retinal degeneration and for differentiating human embryonic stem cells and human embryo-derived into retinal pigment epithelium (RPE) cells and other retinal progenitor cells.
Inventor(s):	Klimanskaya; Irina V. (Upton, MA), Lanza; Robert P. (Clinton, MA)
Assignee:	Advanced Cell Technology, Inc. (Marlborough, MA)
Application Number:	12/857,911
Patent Claims:	see list of patent claims

Understanding the Patent Landscape: A Comprehensive Analysis of US Patent 8,268,303

Introduction

Patents are a crucial component of intellectual property law, providing inventors and innovators with exclusive rights to their inventions. This article delves into the complexities of the patent landscape, focusing on the specific case of US Patent 8,268,303. We will explore the patent process, the significance of the Leahy-Smith America Invents Act (AIA), patent security reviews, and the implications of patent challenges.

The Patent Process in the United States

The United States Patent and Trademark Office (USPTO) is responsible for reviewing patent applications and granting patents. The process involves several stages, including filing, examination, and potential continuation procedures[1].

Filing and Examination

When an inventor files a patent application, it enters the examination phase where a patent examiner reviews the application to determine its patentability. This involves checking for novelty, nonobviousness, and subject matter eligibility under 35 U.S.C. §§ 102 and 103[3].

Continuation Procedures

If an application is not allowed in its initial form, applicants can use continuation procedures such as Requests for Continued Examination (RCEs) to revise and resubmit their applications. These procedures can significantly impact the outcome of the patent application[1].

The Leahy-Smith America Invents Act (AIA)

The AIA, enacted in 2011, is a landmark legislation that has significantly altered the U.S. patent landscape.

Creation of the Patent Trial and Appeal Board (PTAB)

The AIA established the PTAB, a tribunal within the USPTO that hears administrative challenges to patent validity, including inter partes review (IPR) and post-grant review (PGR). These procedures provide a faster and less expensive alternative to federal court litigation for challenging patent validity[2].

Impact on Patent Litigation

The AIA aimed to improve patent quality and reduce unwarranted litigation costs. PTAB procedures are generally more advantageous for accused infringers due to their speed, lower costs, and lower burden of proof compared to federal court proceedings[2].

Patent Security Reviews

Patent applications can have national security implications, necessitating special reviews.

The Invention Secrecy Act

The Invention Secrecy Act of 1951 mandates the review of patent applications that could be detrimental to national security if publicly disclosed. The USPTO, in collaboration with defense agencies, screens and reviews such applications, and if necessary, imposes Secrecy Orders to prevent disclosure and publication[5].

US Patent 8,268,303: A Case Study

While the specific details of US Patent 8,268,303 are not provided here, we can apply the general principles outlined above to understand its context within the patent landscape.

Technology Field and Allowance Rates

The technology field in which the patent is classified can influence its allowance rate. For instance, applications in fields like Chemical, Drugs and Medical, or Electrical and Electronics may have different allowance rates compared to other fields. Small entities, typically those with 500 or fewer employees, may face lower allowance rates compared to large entities[1].

Examination Process

The patent would have undergone the standard examination process, including checks for prior art, novelty, and nonobviousness. Any continuation procedures, such as RCEs, would have been part of this process.

Potential Challenges

Post-grant, the patent could be subject to challenges via IPR or PGR before the PTAB. These challenges could be initiated by entities accused of infringement or those seeking to invalidate the patent for various reasons, including claims of poor patent quality or lack of innovation[2].

Critical Analysis of Patent Claims

Prior Art and Novelty

Patent claims must be novel and nonobvious over the prior art. The AIA introduced changes to prior art exceptions, particularly under 35 U.S.C. § 102(b), which can affect the patentability of an invention. For example, disclosures made by the inventor or joint inventors within one year of the effective filing date can be excepted from prior art[3].

Subject Matter Eligibility

The patent claims must also meet the subject matter eligibility criteria. The Alice/Mayo test, as applied by the USPTO, determines whether the claims are directed to ineligible subject matter such as laws of nature, natural phenomena, or abstract ideas. If so, the claims must contain an "inventive concept" to be patentable[2].

Continuation Procedures and Allowance Rates

The use of continuation procedures can impact the allowance rate of a patent application. Applications that utilize these procedures may have different outcomes compared to those that do not. For instance, the family allowance rate, which includes the outcomes of continuation applications, can provide a more comprehensive view of the patent's likelihood of being granted[1].

Implications for Inventors and Businesses

Patent Quality and Litigation

The quality of patents, as influenced by the AIA and PTAB procedures, can significantly impact litigation costs and outcomes. High-quality patents are less likely to be challenged, while poor-quality patents may face numerous challenges, potentially leading to their invalidation[2].

National Security Considerations

For inventions with national security implications, the imposition of Secrecy Orders can prevent public disclosure, affecting the patent's utility and the inventor's ability to benefit from their invention[5].

Key Takeaways

• Patent Process Complexity: The patent process involves multiple stages, including examination and potential continuation procedures.
• AIA Impact: The Leahy-Smith America Invents Act has significantly altered the patent landscape, introducing PTAB and changing the dynamics of patent challenges.
• National Security Reviews: Patent applications with national security implications undergo special reviews and may be subject to Secrecy Orders.
• Patent Quality: The quality of patents is crucial, as poor-quality patents can face numerous challenges and potential invalidation.
• Technology Field Influence: The technology field of the patent can influence its allowance rate and the challenges it may face.

FAQs

What is the role of the Patent Trial and Appeal Board (PTAB) in the US patent system?

The PTAB is a tribunal within the USPTO that hears administrative challenges to patent validity, including inter partes review (IPR) and post-grant review (PGR), providing a faster and less expensive alternative to federal court litigation[2].

How do continuation procedures affect the patent application process?

Continuation procedures, such as Requests for Continued Examination (RCEs), allow applicants to revise and resubmit their applications, which can impact the allowance rate and the final outcome of the patent application[1].

What is the significance of the Leahy-Smith America Invents Act (AIA) in patent law?

The AIA is a landmark legislation that introduced significant changes to the US patent system, including the creation of the PTAB, new types of administrative challenges to patent validity, and changes to prior art exceptions[2].

How do national security considerations affect patent applications?

Patent applications with potential national security implications are reviewed by defense agencies, and if necessary, Secrecy Orders are imposed to prevent public disclosure and publication[5].

What are the key factors influencing the allowance rate of a patent application?

The allowance rate can be influenced by factors such as the technology field, the size of the entity filing the application, and the use of continuation procedures[1].

Sources

1. Carley, M., & Hegde, D. (n.d.). What Is the Probability of Receiving a US Patent?. Emory Law Journal.
2. Congressional Research Service. (2024). The Patent Trial and Appeal Board and Inter Partes Review. CRS Reports.
3. United States Patent and Trademark Office. (n.d.). 717-Prior Art Exceptions under AIA 35 U.S.C. 102(b)(1) and (2). Manual of Patent Examining Procedure.
4. PubChem. (n.d.). Pigment epithelial cell of the eye, its production and use in therapy of an eye or CNS disease. PubChem Patent Summary.
5. Defense Technology Security Administration. (n.d.). Patent Security Reviews. DTSA.

Details for Patent 8,268,303

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	PLASMANATE	plasma protein fraction (human)	Injection	101140	October 02, 1958	8,268,303	2024-01-23
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	June 04, 1965	8,268,303	2024-01-23