Patent: 10,316,282

Summary for Patent: 10,316,282

Title:	Method for producing a product (e.g. polypeptide) in a continuous cell culture fermentation process
Abstract:	A method for improving productivity in microbial fermentations and mammalian cell culture bioreactors.
Inventor(s):	Laustsen; Mads (Gentofte, DK)
Assignee:	CMC BIOLOGICS A/S (Soborg, DK)
Application Number:	14/778,222
Patent Claims:	see list of patent claims

Understanding the Patent Landscape: A Comprehensive Analysis of US Patent 10,316,282

Introduction

Patents are a cornerstone of innovation, providing inventors and companies with the exclusive rights to their creations. To navigate the complex landscape of patent law, it is crucial to understand the various components and processes involved. This article will delve into the specifics of US Patent 10,316,282, analyzing its claims, the broader patent landscape, and the key sections of U.S. patent law that govern its validity.

The Patent in Question: US Patent 10,316,282

While the specific details of US Patent 10,316,282 are not provided here, a general analysis can be conducted based on common practices and legal frameworks.

Patent Claims

Patent claims are the heart of any patent application, defining the scope of the invention and the rights granted to the patentee. For a patent like 10,316,282, the claims must be carefully crafted to meet the criteria set forth by U.S. patent law.

• Section 101: Patentable Subject Matter

  • The claims must align with Section 101 of the U.S. Patent Act, which defines what constitutes patentable subject matter. This includes ensuring that the invention is not directed to abstract ideas, laws of nature, or natural phenomena unless it contains an "inventive concept" that transforms the nature of the claim[4][5].

• Section 102: Novelty

  • The claims must also satisfy the novelty requirements of Section 102. This involves demonstrating that the invention is new and not obvious in light of the prior art. A thorough prior art search and analysis are essential to ensure that the claims are novel and non-obvious[2].

• Section 103: Non-Obviousness

  • Section 103 requires that the invention must be non-obvious to a person having ordinary skill in the relevant art. This involves showing that the invention is significantly different from existing solutions and that it would not have been obvious to combine prior art elements to achieve the same result[2].

Strategic Patent Drafting

Crafting patent applications with a focus on clarifying the non-obvious aspects of the invention is pivotal. Here are some key strategies:

• Clear Differentiation

  • The claims should clearly differentiate the inventive steps from the prior art. Meticulous illustration of the differences is essential to demonstrate non-obviousness[2].

• Prior Art Analysis

  • Conducting extensive prior art searches and analyzing existing patents and publications in the relevant field helps identify potential obstacles and refine claims to reinforce novelty and non-obviousness[2].

• Broad yet Specific Claims

  • Crafting claims that are broad enough to offer substantial protection while being specific enough to circumvent prior art is key. The focus should be on highlighting the unique aspects of the invention that render it eligible, novel, and non-obvious[2].

The Broader Patent Landscape

Patent Allowance Rates

The probability of receiving a U.S. patent varies significantly depending on several factors, including the technology field and the type of entity filing the application. Studies have shown that only about 55.8% of patent applications filed at the USPTO are eventually granted without using continuation procedures[1].

• Technology Fields

  • The allowance rate has decreased substantially over time, particularly for applications in fields like "Drugs and Medical Instruments" and "Computers and Communications"[1].

• Entity Size

  • The size of the entity filing the application also impacts the allowance rate. Small entities, defined as those with 500 or fewer employees, may face different challenges and have different success rates compared to large entities[1].

The Role of the Patent Trial and Appeal Board (PTAB)

The PTAB, established by the Leahy-Smith America Invents Act (AIA) in 2011, plays a crucial role in the patent landscape by providing a mechanism for challenging the validity of patents.

• Inter Partes Review (IPR) and Post-Grant Review (PGR)

  • PTAB processes like IPR and PGR allow anyone to challenge patents before the USPTO. These processes are often faster and less expensive than judicial proceedings and require a lower burden of proof to invalidate patents[4].

• Impact on Patent Quality

  • The creation of PTAB was intended to improve patent quality and provide a more efficient system for challenging patents that should not have issued. This has significant implications for patent holders and those challenging patents[4].

Recent Updates in USPTO Guidance

2024 USPTO Guidance Update on AI Patents

The USPTO has recently updated its guidance on the patent eligibility of AI-related inventions, prompted by Executive Order 14110.

• Abstract Ideas and Practical Applications

  • The updated guidance focuses on evaluating whether a claim integrates a judicial exception into a practical application. This involves assessing additional elements in the claim to determine if they impose meaningful limits on the exception, transforming the claim into patent-eligible subject matter[5].

• AI-Assisted Inventions

  • The method of invention development, including the use of AI, does not impact subject matter eligibility. The focus remains on the claimed invention itself, ensuring that AI-assisted inventions are evaluated on equal footing with other technologies[5].

Practical Insights for Patent Applicants

Aligning with Section 101

To navigate the nuances of Section 101, innovators should focus on highlighting the tangible and applicable aspects of the invention. Providing clear, concrete embodiments of the invention and explicitly detailing its practical applications can help circumvent issues related to abstract ideas[2].

Effective Argumentation

Building compelling arguments around eligibility, novelty, and non-obviousness is crucial. This involves explaining the technological advancements brought about by the invention and distinguishing it clearly from the existing state of the art[2].

Key Takeaways

• Patent Claims Must Be Precise: Claims must be carefully crafted to meet the criteria of Sections 101, 102, and 103 of U.S. patent law.
• Prior Art Analysis Is Essential: Conducting thorough prior art searches is vital to ensure novelty and non-obviousness.
• PTAB Plays a Critical Role: The Patent Trial and Appeal Board provides an efficient mechanism for challenging patent validity.
• Recent Updates Impact AI Patents: The 2024 USPTO guidance update clarifies the patent eligibility of AI-related inventions.
• Strategic Drafting Is Key: Crafting broad yet specific claims and aligning innovations with Section 101 requirements are crucial for successful patent applications.

FAQs

What is the overall allowance rate for patent applications filed at the USPTO?

The overall allowance rate for patent applications filed at the USPTO is approximately 55.8% without using continuation procedures[1].

How does the size of the entity filing the patent application impact the allowance rate?

The size of the entity can impact the allowance rate, with small entities (those with 500 or fewer employees) potentially facing different challenges and success rates compared to large entities[1].

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

The PTAB provides a mechanism for challenging the validity of patents through processes like Inter Partes Review (IPR) and Post-Grant Review (PGR), which are often faster and less expensive than judicial proceedings[4].

How does the 2024 USPTO guidance update impact AI-related patent applications?

The update clarifies the patent eligibility of AI-related inventions by focusing on whether the claim integrates a judicial exception into a practical application and ensuring that AI-assisted inventions are evaluated on equal footing with other technologies[5].

What are the key sections of U.S. patent law that govern the validity of a patent?

The key sections are Section 101 (patentable subject matter), Section 102 (novelty), and Section 103 (non-obviousness)[2][4].

Sources

1. Carley, M., Hegde, D., & Marco, A. (2015). What Is the Probability of Receiving a US Patent? Yale Journal of Law & Technology, 17, 203.
2. TT Consultants. (2023, October 5). Exploring Sections 101, 102, & 103 of U.S. Patent Law.
3. USPTO. (2024, August 19). USPTO Datasets.
4. Congressional Research Service. (2024, May 28). The Patent Trial and Appeal Board and Inter Partes Review.
5. Mintz. (2024, July 25). Understanding the 2024 USPTO Guidance Update on AI Patent.

Details for Patent 10,316,282

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	KOATE, KOATE-DVI	antihemophilic factor (human)	For Injection	101130	January 24, 1974		2033-03-19
Takeda Pharmaceuticals U.s.a., Inc.	HEMOFIL M	antihemophilic factor (human)	For Injection	101448	March 14, 2001		2033-03-19
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	November 26, 1997		2033-03-19
Novartis Pharmaceuticals Corporation	SIMULECT	basiliximab	For Injection	103764	May 12, 1998		2033-03-19
Novartis Pharmaceuticals Corporation	SIMULECT	basiliximab	For Injection	103764	January 02, 2003		2033-03-19
Swedish Orphan Biovitrum Ab (publ)	SYNAGIS	palivizumab	For Injection	103770	June 19, 1998		2033-03-19
Swedish Orphan Biovitrum Ab (publ)	SYNAGIS	palivizumab	Injection	103770	July 23, 2004		2033-03-19