Patent: 10,007,766

Summary for Patent: 10,007,766

Title:	Predictive test for melanoma patient benefit from antibody drug blocking ligand activation of the T-cell programmed cell death 1 (PD-1) checkpoint protein and classifier development methods
Abstract:	A method is disclosed of predicting cancer patient response to immune checkpoint inhibitors, e.g., an antibody drug blocking ligand activation of programmed cell death 1 (PD-1) or CTLA4. The method includes obtaining mass spectrometry data from a blood-based sample of the patient, obtaining integrated intensity values in the mass spectrometry data of a multitude of pre-determined mass-spectral features; and operating on the mass spectral data with a programmed computer implementing a classifier. The classifier compares the integrated intensity values with feature values of a training set of class-labeled mass spectral data obtained from a multitude of melanoma patients with a classification algorithm and generates a class label for the sample. A class label \"early\" or the equivalent predicts the patient is likely to obtain relatively less benefit from the antibody drug and the class label \"late\" or the equivalent indicates the patient is likely to obtain relatively greater benefit from the antibody drug.
Inventor(s):	Roder; Joanna (Steamboat Springs, CO), Meyer; Krista (Steamboat Springs, CO), Grigorieva; Julia (Steamboat Springs, CO), Tsypin; Maxim (Steamboat Springs, CO), Oliveira; Carlos (Steamboat Springs, CO), Steingrimsson; Arni (Steamboat Springs, CO), Roder; Heinrich (Steamboat Springs, CO), Asmellash; Senait (Denver, CO), Sayers; Kevin (Denver, CO), Maher; Caroline (Denver, CO), Weber; Jeffrey (New York, NY)
Assignee:	Biodesix, Inc. (Boulder, CO)
Application Number:	15/207,825
Patent Claims:	see list of patent claims

Analyzing the Claims and Patent Landscape of United States Patent 10,007,766

Introduction

United States Patent 10,007,766, titled "Predictive test for melanoma patient benefit from antibody drug blocking ligand activation of the T-cell programmed cell death 1 (PD-1)," represents a significant advancement in the field of oncology and immunotherapy. This patent, granted for a predictive test related to the efficacy of PD-1 inhibitors in melanoma treatment, is a prime example of the complex interplay between scientific innovation, legal frameworks, and the broader patent landscape.

Background on the Patent

The patent in question involves a predictive test designed to determine whether a melanoma patient is likely to benefit from treatment with PD-1 inhibitors. PD-1 inhibitors are a class of immunotherapeutic drugs that have revolutionized the treatment of various cancers, including melanoma, by enhancing the body's immune response against cancer cells.

Subject Matter Eligibility Under 35 U.S.C. §101

To understand the validity and scope of this patent, it is crucial to analyze its subject matter eligibility under 35 U.S.C. §101. This section of the patent law defines the four statutory categories of inventions that are eligible for patenting: processes, machines, manufactures, and compositions of matter[3].

Judicial Exceptions

The patent claims must also avoid judicial exceptions, such as laws of nature, natural phenomena, and abstract ideas. The Supreme Court has established a two-step framework for determining subject matter eligibility, known as the Alice/Mayo test. This test involves determining whether the claim is directed to an ineligible concept and, if so, whether the claim contains an "inventive concept" that transforms the nature of the claim into a patent-eligible application[3].

In the case of US Patent 10,007,766, the claims relate to a predictive test, which could potentially fall under the category of a process. However, the test must be scrutinized to ensure it does not merely claim a natural phenomenon or an abstract idea without additional elements that amount to significantly more than the ineligible concept itself.

Novelty and Nonobviousness Requirements

For a patent to be granted, the claimed invention must also meet the requirements of novelty and nonobviousness.

Novelty Requirement

The invention must be new and not have been previously disclosed in the prior art. This means that every element of the claimed invention must not have been available to the public before the effective filing date of the patent application[2].

Nonobviousness Requirement

The invention must be nonobvious, meaning it must be significantly different from existing knowledge and not an obvious combination of prior art elements. This requirement ensures that the invention contributes something meaningful to the existing body of knowledge[2].

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

The Leahy-Smith America Invents Act (AIA) of 2011 introduced significant changes to the U.S. patent system, including the creation of the Patent Trial and Appeal Board (PTAB). PTAB is empowered to hear administrative challenges to the validity of patents, such as inter partes review (IPR) and post-grant review (PGR)[2].

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. They are particularly advantageous for entities accused of patent infringement, as they require a lower standard of proof (preponderance of the evidence) compared to the clear and convincing evidence required in federal court[2].

Given the complexity and the potential for challenges, the patent holder of US Patent 10,007,766 must be prepared to defend the patent's validity through these administrative proceedings.

Government Interest and Funding

Many patents, including those in the biomedical field, are developed with government support. The analysis of government interest statements in patent documents reveals that a significant number of patents are made possible through grants and awards from federal agencies such as the National Institutes of Health (NIH)[1].

For US Patent 10,007,766, any government funding or support would be crucial in understanding the patent's development and potential implications for public health policy.

Chevron Deference and PTO Interpretations

The U.S. Patent and Trademark Office (USPTO) plays a critical role in interpreting the Patent Act, and its interpretations may receive Chevron deference from the courts. This deference can influence the development of substantive patent law, potentially pushing it in a pro-patent direction[5].

The USPTO's guidance documents and legal constructions of the Patent Act can significantly impact the issuance and validity of patents. For patents like US Patent 10,007,766, the USPTO's interpretations on subject matter eligibility and other patentability requirements are pivotal.

Practical Implications and Market Impact

The predictive test patented in US Patent 10,007,766 has significant practical implications for the treatment of melanoma. By predicting which patients are likely to benefit from PD-1 inhibitors, the test can help personalize treatment plans, improve patient outcomes, and reduce healthcare costs associated with ineffective treatments.

Competitive Landscape

In the competitive landscape of cancer diagnostics and therapeutics, patents like US Patent 10,007,766 can provide a competitive edge to the patent holder. However, the patent must withstand potential challenges from competitors seeking to invalidate the patent through IPR or PGR proceedings.

Public Health Policy

The patent also intersects with public health policy, particularly in the context of access to innovative treatments. The balance between encouraging innovation through patent protection and ensuring public access to life-saving treatments is a critical consideration.

Ethical Considerations

The development and patenting of predictive tests raise ethical considerations, such as the potential for unequal access to these tests and the treatments they predict. Ensuring that such tests are accessible and affordable is crucial for equitable healthcare outcomes.

Key Takeaways

• Subject Matter Eligibility: The patent must comply with 35 U.S.C. §101 and avoid judicial exceptions.
• Novelty and Nonobviousness: The invention must meet these requirements to be patentable.
• PTAB Proceedings: The patent is subject to administrative challenges through IPR and PGR.
• Government Interest: Any government funding or support is important for understanding the patent's development.
• Chevron Deference: USPTO interpretations can significantly impact the patent's validity.
• Practical Implications: The patent has significant implications for melanoma treatment and healthcare policy.
• Ethical Considerations: Ensuring equitable access to the predictive test and associated treatments is crucial.

FAQs

Q: What is the main subject of US Patent 10,007,766?

A: The patent is for a predictive test to determine whether a melanoma patient will benefit from treatment with PD-1 inhibitors.

Q: How does the Alice/Mayo test apply to this patent?

A: The test determines whether the patent claims are directed to an ineligible concept and if they contain an "inventive concept" that makes the claim patent-eligible.

Q: What is the role of PTAB in relation to this patent?

A: PTAB can hear administrative challenges to the patent's validity through IPR and PGR proceedings.

Q: How does government funding impact the development of such patents?

A: Government funding can be crucial for the development of biomedical patents, and understanding this funding is important for public health policy.

Q: What is Chevron deference, and how does it affect patent law?

A: Chevron deference refers to the judicial deference given to USPTO interpretations of the Patent Act, which can influence the development of substantive patent law.

Sources

1. PatentsView Government Interest Results Analysis.
2. The Patent Trial and Appeal Board and Inter Partes Review.
3. 35 USC 101: Statutory Requirements and Four Categories of Invention.
4. US10007766B2 - Predictive test for melanoma patient benefit from antibody drug blocking ligand activation of the T-cell programmed cell death 1 (PD-1).
5. Chevron Deference for the U.S. Patent and Trademark Office.

Details for Patent 10,007,766

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554	December 22, 2014		2035-07-13
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554	October 04, 2017		2035-07-13
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554	August 27, 2021		2035-07-13