Medical Device
Intellectual Property
experienced U.S. patent counsel for medical device innovators
AddyHart works with medical device companies, digital health innovators, universities, and emerging technology companies to protect innovations in the United States. Combining extensive patent prosecution experience with a deep understanding of FDA regulatory considerations, our attorneys help clients build patent portfolios that support product development, regulatory strategy, and successful commercialization.
Protecting Innovation Across the Medical-Device Platform
Medical-device innovation may arise from mechanical architecture, electronics, sensing, software, materials, manufacturing processes, clinical workflows, or the interaction among those technologies. We help clients identify the distinct inventive concepts within a product and develop coordinated patent strategies that support product development, regulatory planning, and commercialization.
Representative Technologies
Diagnostic & Monitoring Systems
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Physiological monitoring
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Diagnostic imaging
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Biosensors
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Point-of-care testing
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Sample analysis
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Remote monitoring
Representative Technologies
Implantable & Wearable Devices
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Implantable electronics
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Wearable sensors
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Prosthetics
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Cardiac devices
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Neuromodulation
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Patient-interface systems
Representative Technologies
Therapeutics &
Drug Delivery
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Infusion systems
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Injectors
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Combination products
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Controlled-release technologies
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Dosing systems
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Treatment methods
Representative Technologies
Surgical & Interventional Devices
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Surgical instruments
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Catheters and delivery systems
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Robotic systems
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Navigation technologies
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Ablation systems
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Minimally invasive devices
Representative Technologies
Digital Health & Medical Software
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Clinical decision support
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Software as a medical device
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AI-assisted diagnosis
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Treatment planning
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Data analytics
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Connected-care platforms
Representative Technologies
Materials & Manufacturing
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Biomaterials
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Coatings
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Sterilization
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Device fabrication
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Packaging systems
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Quality-control technologies
Coordinated claims may be directed to the device, system, software, method of use, manufacturing process, disposable component, or related clinical workflow, depending on the innovation and commercial strategy.
Drafting & Prosecution Workflows
01
Invention & Product Review
We work with inventors, engineers, clinicians, regulatory personnel, and in-house counsel to understand the device, workflow, development status, and commercial objectives.
02
Claim Architecture
We identify potential claims directed to devices, systems, components, methods, software, manufacturing processes, and alternative implementations.
03
Application Drafting
Applications are prepared with detailed embodiments and alternatives intended to support product evolution, continuation practice, and commercially meaningful claim scope.
04
USPTO Examination
We provide recommendations addressing prior art, eligibility, written description, enablement, restriction requirements, and other examination issues.
05
Interviews, Evidence & Appeals
Where appropriate, examiner interviews, technical declarations, appeals, and post-grant experience are used to advance or defend the client’s position.
Please do not provide confidential technical information or substantive legal instructions until conflicts clearance and engagement arrangements have been confirmed.
Supporting Product Generations and International Growth
Medical-device platforms often develop through new indications, configurations, materials, disposables, software features, accessories, and manufacturing methods. Continuation and divisional applications can preserve opportunities to pursue these distinct innovations while maintaining alignment with the commercial product and related international filings.
Product Evolution
✓ New device generations
✓ Accessories and disposables
✓ Software updates
✓ Additional clinical uses
International Coordination
✓ PCT and national-stage strategy
✓ Coordination with foreign counsel
✓ Disclosure consistency
✓ Jurisdiction-specific claim planning
Portfolio
Alignment
✓ Continuations
✓ Divisionals
✓ Bypass continuations
✓ Claims directed to competitors
Coordinated With Legal, Technical and Regulatory Teams
Medical-device patent portfolios often require coordination among engineering, clinical, regulatory, product-development, business, and legal personnel. Divergent can integrate with client-specific invention-review procedures, prosecution guidelines, reporting formats, budgeting systems, and regulatory workflows while maintaining defined responsibility for filings, deadlines, recommendations, and communication.
Transparent Pricing
We believe clients should understand the expected cost of patent prosecution before work begins. Many of our most common services are offered at predetermined professional fees, allowing clients to budget with confidence and avoid unexpected billing.
Standard Office Action Turnaround
No Additional Rush Fee
We target delivery of draft Office Action responses within two weeks after receiving the USPTO communication and the information needed to prepare the response.
Any applicable USPTO extension-of-time fees remain the client’s responsibility.
Read Insights
Application-drafting fees are established in advance based on the technology, complexity, number of embodiments, and anticipated scope of the application.
We target delivery of draft Office Action responses within two weeks after receiving the USPTO communication and the information needed to prepare the response. Routine administrative work—such as issue-fee processing, preparation of standard Information Disclosure Statements, and filing an instructed Request for Continued Examination—is not used as a separate source of professional fees.
Listed amounts are AddyHart professional fees for standard matters within the described scope. USPTO fees, drawings, searches, translations, experts, vendors, appeals, petitions, declarations, litigation, and extraordinary matters are excluded unless expressly stated. All representations are subject to conflicts clearance and a written engagement agreement
Why AddyHart for
Medical Device IP
From early product development through patent issuance, we help medical-device companies identify, protect, and expand the innovations underlying their products and platforms. Our services are designed to support evolving device designs, coordinated hardware, software, and method claims, regulatory considerations, and long-term portfolio growth.
Engineering & Life-Sciences Breadth
Our team brings experience across mechanical systems, electronics, software, chemistry, materials, biology, diagnostics, pharmaceuticals, and regulated technologies.
Patent Strategy Informed by FDA Considerations
We understand that patent disclosures and prosecution positions may intersect with regulatory strategy, product claims, and the development record.
Portfolios Built Around the Commercial Platform
We look beyond a single device to related components, software, methods, disposables, accessories, manufacturing processes, and future product generations.
Experience Across the Patent Lifecycle
Our prosecution, PTAB, appellate, licensing, and post-grant experience helps us evaluate how drafting and examination decisions may affect the long-term strength and usefulness of the portfolio.
Relevant Team
The professionals below bring experience protecting medical-device innovations involving mechanical systems, electronics, software, diagnostics, pharmaceuticals, materials, and regulated product development.
Brandon R. Theiss
Partner · Registered Patent Attorney · Licensed Professional Engineer
A licensed professional engineer and former industrial-control and medical-device engineer, Brandon advises on patent prosecution, § 101 strategy, portfolio development, and post-grant proceedings involving AI, software, cloud systems, medical devices, and automation.
Tom J. Filarski
Senior Counsel · Registered Patent Attorney · Chemist & Chemical Engineer
A chemist and chemical engineer with four decades of experience, Tom develops and coordinates patent strategies for medical devices, pharmaceuticals, chemicals, polymers, semiconductors, energy technologies, and manufacturing systems.
Janet Pioli
Senior Counsel · Registered Patent Attorney · Molecular Biology & Biotechnology Background
A registered patent attorney with more than 30 years of experience and a molecular-biology and biotechnology background, Janet advises on portfolio development, clearance, due diligence, prosecution, and appeals involving medical devices, diagnostics, biotechnology, industrial equipment, and consumer products.
Craig McLaughlin
Senior Counsel · Registered Patent Attorney · Biology Background
A registered patent attorney with a biology background and nearly 30 years of experience, Craig handles utility and design-patent matters involving medical devices, mechanical systems, consumer products, computer hardware, and related post-grant and appellate issues.
Danielle Gross, Ph.D.
Registered Patent Agent · Ph.D. in Biochemistry · Life Sciences & Medical Devices
A registered patent agent with more than a decade of prosecution experience and a Ph.D. in Biochemistry, Danielle helps life-sciences and technology companies draft and prosecute U.S. patent applications, build portfolios, and develop claim strategies grounded in complex science.
Related Publications & Insights
Brandon Theiss is a co-author of FDA and Intellectual Property Strategies for Medical Device Technologies, including both the first and second editions.
Read more about the book and Brandon’s insights on developing IP strategies for regulated medical device technologies.
First Edition
Second Edition
Related Divergent Patent Law Blog Articles
Get In Touch
Whether you are developing a new patent portfolio, transferring existing prosecution work, preparing for a product launch, or responding to a challenge against an issued patent, we would welcome the opportunity to discuss your objectives.
Please do not include confidential information in an initial inquiry. An attorney-client relationship is formed only through a written engagement agreement.