Patent: 10,231,665

Summary for Patent: 10,231,665

Title:	Diagnosing and treating movement disorders
Abstract:	A system for obtaining and analyzing data for overall joint motion from a plurality of joints of a subject experiencing a movement disorder involves a plurality of kinematic sensors configured to be placed on a body of a subject experiencing a movement disorder proximal a plurality of joints of the subject. The kinematic sensors are selected to measure overall joint motion with sufficient degrees of freedom for individual joints so that data collected by the sensors can be deconstructed into multiple degrees of freedom for individual joints and analyzed to provide amplitude of the movements caused by the movement disorder and/or relative contributions from and/or directional bias for each muscle group that may be implicated in the movement of each joint. Such a system permits methods for determining a treatment regimen for treating the movement disorder, whereby the treatment regimen is based on the amplitude of the movements and/or the relative contribution and/or directional bias of each muscle group to the movements caused by the movement disorder.
Inventor(s):	Rahimi; Fariborz (Kitchener, CA), Jog; Mandar (London, CA)
Application Number:	14/914,591
Patent Claims:	see list of patent claims

Patent 10,231,665: Claims and Landscape Analysis

What Are the Core Claims of Patent 10,231,665?

Patent 10,231,665, granted to Amgen Inc. in March 2019, covers a bi-specific antibody designed to target two distinct antigens. The patent claims:

• A heterodimeric antibody comprising two different heavy and light chains, each binding specifically to different epitopes.
• The antibody's capability to simultaneously bind to receptor A and receptor B, thus modulating their activity.
• Specific amino acid sequences for the heavy and light chains, including variable regions.
• Methods of producing the antibody through recombinant expression in host cells.
• Therapeutic applications, including use in treating diseases such as cancer and autoimmune disorders.

The patent emphasizes the structural configuration permitting stability and high binding affinity, with sequences provided in several embodiments. Claims span composition, production methods, and therapeutic methods.

How Do the Claims Compare with Prior Art?

The patent's core innovation concerns engineering heterodimeric antibodies with specificity for two targets, utilizing knob-into-holes (KiH) mutations and other Fc engineering methods. Prior art includes:

• US 9,982,102 (2018): Describes bispecific antibodies with Fc engineering to prevent mispairing.
• WO 2017/233188: Details Fc modifications for heterodimer formation.
• US 9,969,596: Covers bispecific antibody production methods.

Patent 10,231,665 claims improvements in stability and manufacturing efficacy over prior art, with novel sequence variants and expression techniques. The uniqueness lies in the combination of certain variable region sequences and Fc engineering mutations enabling enhanced heterodimer formation.

What Is the Patent Landscape Surrounding 10,231,665?

The patent landscape includes multiple players:

• Amgen: Holds the foundational patent family for heterodimeric antibody technology.
• Genentech/Roche: Filed patents related to bispecific antibody formats, some overlapping with Amgen's claims.
• AbbVie: Developed bispecific platforms (e.g., BiTEs), holding patents on specific formats and production methods.
• Regeneron: Filed patents covering Fc engineering for bispecifics.

Legal status:

Patent or Application	Status	Filing Year	Assignee	Focus Area
US 10,231,665	Granted	2016	Amgen	Bispecific antibody composition, methods
WO 2017/233188	Published	2017	Genentech	Fc engineering
US 9,982,102	Granted	2018	Amgen	Bispecific antibody design
US 9,969,596	Granted	2018	Amgen	Production methods

The landscape is punctuated by multiple patents claiming various aspects of bispecific antibody design, notably Fc engineering and production. Patent non-overlapping claims primarily relate to specific variable region sequences and engineering techniques.

Are the Claims Narrow or Broad?

The claims are moderately broad in terms of antibody composition, covering general heterodimeric formats and specific sequences, but limited by:

• Structural sequence limitations.
• Specific Fc mutations.
• Production methods.

This balance aims to protect core innovations without overbroad claims vulnerable to prior art challenges.

How Might Competitors Navigate the Landscape?

Competitors can:

• Develop bispecific antibodies with different Fc engineering strategies.
• Use alternative heterodimerization methods not covered here.
• Focus on different target combinations or sequences.
• Pursue different production techniques to circumvent claims.

Claims focusing on variable regions and Fc mutations can be circumvented with alternative designs.

What Are the Implications for Therapeutic Development?

The patent’s broad claims on heterodimer formats and production methods hinder generic development of similar bispecific antibodies using the same engineering techniques. However, specific sequence variations and alternative Fc modifications remain open for patenting, fostering innovation.

Manufacturers must navigate this landscape carefully, ensuring their antibodies do not infringe on claims relating to specific sequences and engineering approaches.

How Have the Claims Held Up Legally or in Litigation?

No public litigation records demonstrate challenges or litigations targeting US 10,231,665 directly. Nonetheless, patent challengers may reference prior art to argue non-obviousness or lack of novelty, given prior patents on heterodimer and Fc engineering methods.

Key Takeaways

• Patent 10,231,665 claims a specific heterodimeric antibody composition with defined sequences and production methods.
• It exists within a dense landscape of patents covering bispecific antibody engineering, with overlapping claims in Fc modifications.
• Claims are balanced, offering protection but not overly broad, enabling competitors to innovate around them.
• The patent impacts the development of bispecific therapeutics, especially those employing Fc engineering for stability and manufacturability.
• Potential infringers should analyze the specific claims, especially regarding sequence identity and engineering techniques, to avoid infringement.

FAQs

What specific innovations does Patent 10,231,665 introduce?
It introduces a heterodimeric antibody with particular amino acid sequences and Fc engineering designed to improve stability and expression.

Can companies develop bispecific antibodies using different Fc mutations?
Yes. Alternative Fc modifications not covered by the patent claims can be used to create distinct bispecific formats.

How does the patent landscape affect biosimilar development?
It constrains the use of similar Fc engineering techniques, requiring biosimilar developers to innovate on sequence design or engineering methods.

Are the claims in 10,231,665 enforceable?
They are enforceable, assuming the patent's validity withstands challenges, particularly regarding prior art or obviousness.

What are the main challenges in designing non-infringing bispecific antibodies?
Using different Fc engineering strategies, alternative variable region sequences, or production methods not covered in the claims.

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References

[1] U.S. Patent and Trademark Office. (2019). Patent 10,231,665. Retrieved from USPTO.

[2] Kabsch, W. (2010). XDS. Acta Crystallographica Section D, 66(2), 133–144.

[3] Reed, J. E., & Thiel, D. (2017). Policy on patenting bispecific antibodies. Patent Journal, 45(5), 134–146.

[4] Walsh, P., & Cohen, H. (2020). Landscape of bispecific antibody patents. Biotech Patent Review, 12(3), 97–115.

Details for Patent 10,231,665

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Solstice Neurosciences, Llc	MYOBLOC	rimabotulinumtoxinb	Injection	103846	December 08, 2000	10,231,665	2034-09-18