Types of Claims In Medical Device Patent Applications
In the US, assuming the statutory criteria are met, patents are granted by the US Patent & Trademark Office (USPTO) to an inventor for his or her new invention. The…
[SERVICE]Medical device patents
Medical device patent attorneys
We claim the device, how clinicians use it and how it is made, so a competitor can’t copy one part and leave the rest. Registered patent attorneys, at a flat fee per step.
Your attorneys
Andrew RapackeManaging Partner · Registered Patent AttorneyElectrical and computer engineering. Former Naval Engineering Officer.
Chris WattRegistered Patent Attorney · Former USPTO ExaminerSoftware, AI and machine learning, and MedTech. A full-stack software engineer.
[01]Who it's for
For inventors with a medical device to protect.
Physician-inventors, device startups and growing MedTech companies all start the same way. Find out what is new about the device, then claim it in every form a competitor could copy.
Surgical instruments and implants
A new mechanism, shape or way of placing it, claimed as a device and as a method of use.
Diagnostic and monitoring devices
Hardware that measures, images or tracks a signal, claimed around how it gets a better reading.
Wearables and connected devices
The device on the body and the app or platform it talks to, protected as one system.
Software as a medical device
Software that analyzes patient data or images, claimed as a technical process tied to a clinical result.
Industries we file in
[02]What's patentable
What a medical device patent can cover.
Most devices carry more than one invention. The structure, the way it is used, the way it is made and the kit it ships in can each be claimed, and a strong application claims several of them.
The device also has to be new and non-obvious. The $999 search tells you where you stand before you spend on filing.
Can be patented
- The device and its structureThe parts, how they connect and what makes it work better than what clinicians use today.
- A new way to use itThe steps of using the device, claimed as a method of use.
- How it is madeA new manufacturing or assembly process, claimed as a method of manufacture.
- Systems and kitsThe device working with other equipment, or the set of parts a clinician assembles before use.
Not on its own
- A surgical technique by itselfA procedure claim alone cannot be enforced against doctors who perform it. Pair it with claims on the device.
- A natural correlationNoticing that a marker predicts a condition is a law of nature. Applying it in a specific treatment or device can qualify.
- An obvious change to a known deviceA new size, material or color with no new result is unlikely to pass.
- An idea without the howThe application has to describe how the device works in enough detail to build and use it.
- FDA clearanceClearance lets you market a device. It is not a patent and does not stop copies.
- A new look with no new functionThat is a design patent question, not a utility patent.
[03]Claim types
What type of claim does your medical device invention need?
Usually more than one. Each claim type reaches a different competitor, so a medical device application mixes apparatus, method, system and kit claims around the same invention.
| What it covers | Who it reaches | Example | |
|---|---|---|---|
| Apparatus (device) | The structure. You name the device, list its parts and say how they connect | Anyone who makes, sells, imports or uses the device | A catheter with a new tip geometry |
| Method of use | The steps of using the device on a patient or in a procedure | Whoever performs the steps, with limits for doctors explained below | Placing an implant through a new approach |
| Method of manufacture | How the device is made or assembled | A competitor making the device that way | A molding step that removes a weak seam |
| System | The device working with other equipment it is used with | Whoever sells or runs the complete setup | A sensor, a base station and the software that reads it |
| Kit | A set of parts the buyer assembles before use | Whoever packages and sells the set | A surgical tray with a guide, a driver and implants |
A comprehensive application claims the invention in several of these forms at once. If a competitor designs around one, another still reads on what they sell. More on types of claims in medical device patent applications.
[04]Design patents
Design patents for medical devices.
A design patent protects how a device looks, and in medicine that look often does real work. A distinctive handle, housing or screen helps clinicians tell your device apart and is hard for a competitor to copy closely without infringing.
What a design patent can cover
- The housing, handle or form factor of an instrument or wearable
- The arrangement of buttons and displays on the device
- Graphical user interfaces and icons in device software and mobile health apps
How long it lasts and what it costs
A design patent lasts 15 years from the date it is granted, with no maintenance fees. Our design patent flat fee is $3,200 with every office action included, and it is covered by The RLG Guarantee. If the USPTO denies your design application, you get a full refund.
Many devices are protected by a utility patent on how they work and a design patent on how they look. More on design patents and the value of design patents in a medical device portfolio.
[05]Devices and software
Wearables, connected devices and the apps that run them.
Many medical devices today are two inventions. A device on or in the body, and the app or platform that reads it. We protect both sides, and the way they work together.
Wearables and remote monitoring
A fitness tracker, a portable monitor or an on-body sensor usually has a hardware invention in how it senses and a software invention in how the data is processed and acted on. We claim the device, the method the software performs and the system as a whole, so a competitor cannot copy the device and swap the app, or the other way around.
Software as a medical device
Software that analyzes images, signals or patient data can be patent eligible when it is claimed as a specific technical process, such as how an algorithm cleans a sensor signal or finds a structure in an image. Software that only collects, shows or tracks data is less likely to qualify. Our software patent and medical device practices work these applications together. More on when software becomes a medical device.
Diagnostic methods
Diagnostics need care. A claim that only observes a natural correlation, such as a marker level that predicts a condition, is treated as a law of nature, as the Supreme Court held in Mayo v. Prometheus in 2012. A claim that applies that finding to a particular treatment, or that recites a new way of measuring it, is on firmer ground. The way the application is drafted decides which side of that line it falls on.
More on common patent eligibility rejections for medical device inventions.
[06]How we draft
Claims written around the device you sell.
Every application has independent claims, the broadest statement of the invention, and dependent claims that narrow step by step toward the version you will put on the market. We write both on purpose. Broad claims make the patent harder to design around. At least one claim describes your commercial device closely, so there is a clear claim to point to if someone copies it.
No clinical data needed to file
You do not need FDA clearance, trial results or a finished prototype to file. The application has to describe the device and how it works in enough detail for someone in the field to make and use it. Test data can help support some claims later.
Careful with efficacy claims
What the application says about how well the device works will be read by examiners, the FDA, investors and, one day, a court. We describe the technical result without overstating safety or efficacy, and keep the application consistent with what you tell the FDA. More on statements of efficacy in medical device patents.
What to bring to your first call
- A plain description of the device and the clinical problem it solves
- Sketches, CAD drawings or photos of a prototype, even rough ones
- What is new compared with devices clinicians use today
- Competing devices and patents you already know of
- Any dates you have shown, presented, published, sold or tested the device outside your team
- Where you are on the FDA path, if you know
No prototype is needed. Your attorney turns the call into the description the application needs.
[07]FDA and your patent
How your FDA pathway affects your patent.
The USPTO decides whether you can stop others from making the device. The FDA decides whether anyone can market it. They run on separate tracks, but the FDA path changes when to file, what to say and how long the patent can last.
| 510(k) | De Novo | PMA | |
|---|---|---|---|
| What it is for | Devices substantially equivalent to a legally marketed device | Novel devices with no legally marketed predicate, where general or special controls are enough | Class III devices, the highest risk, on the most stringent pathway |
| What the FDA decides | Whether the device is as safe and effective as the predicate | Which class the new device belongs in | Whether there is valid scientific evidence it is safe and effective |
| Does it decide patentability | No. Equivalence to a predicate is a different question from whether your device is new and non-obvious | No | No |
| Patent term extension | Not available | Not available | Available, if you apply within 60 days of approval |
| When to file the patent | Before any public disclosure | Before any public disclosure | Before any public disclosure, including clinical trial postings |
File before you disclose
In the US, your own disclosure does not count against you if you file within one year of it. Most other countries give no such grace period. A provisional application before a trial posting, conference abstract, investor deck or sales conversation keeps both open.
Competitors can use your device for their FDA work
It is not infringement to make or use a patented device solely for uses reasonably related to developing and submitting information to the FDA. The Supreme Court applied that safe harbor to medical devices in Eli Lilly v. Medtronic in 1990. A competitor can test against your device for its own submission. The exemption ends where those uses end.
Getting back time lost to premarket approval
A patent on a device that went through premarket approval can be extended for part of the time spent in clinical trials and FDA review, up to five years. The application has to be filed within 60 days of FDA approval, so plan it before the approval letter arrives. More on patent term extension for medical devices.
For how the two paths run side by side, see our medical device patent attorneys page and IP and FDA regulatory strategies. General information, not regulatory advice. Your pathway depends on the device and its classification.
[08]The flat-fee path
Search, provisional, full application. A flat fee at each step.
Every step is quoted before any work begins, and the search fee is credited when you file. Most device inventors file a provisional before any public disclosure, then the full application within 12 months.
01Start here
Patentability search
$999
Patentable or your money back. Credited when you file
- An invention discovery call with your attorney
- A search of US and foreign patents and published applications
- A written patentability report and a review call
Report in about 5 days
Not patentable, full refund*02Then
Provisional patent
$2.5k–3.5k
Set by the device. Search fee credited
- A strategy call to capture how the device works
- Drafted by a registered patent attorney
- You review and approve it before filing
Patent pending the day it is filed
Patentability issues, full refund*03Within 12 months
Non-provisional patent
$7k–12k
Drawings and USPTO filing fees included
- Device, method and kit claims written for examination
- Formal drawings and USPTO filing fees
- Complex devices quoted flat on your call
Filed before your 12-month deadline
Flat fee, not covered by the guarantee
*Refunds subject to the RLG Guarantee Policy in your engagement letter. Utility (non-provisional) patents are quoted flat and are not covered by the guarantee. How The RLG Guarantee works
[09]The process
From first call to granted patent.
What happens at each step and who does the work. Timing shown is typical, never a promised date.
Medical device patentSearch to grant
- Day one01Day oneDiscovery callWalk your attorney through the device. No prototype needed.
- $99902$999Patentability searchUS and foreign patents and published applications.
- About 5 days03About 5 daysReport and reviewA written report, then a call on claims and timing.
- $2.5k–3.5k04$2.5k–3.5kProvisional filedFiled before any public disclosure. You are patent pending.
- Month 1205Month 12Full application filedDevice, method and kit claims, before the 12-month deadline.
- USPTO06USPTOExaminationWe answer the examiner and work toward allowance.
- 07Patent grantedOften 2 to 3 years after filing the full application.
[10]Whole-life cost
How much does a medical device patent cost?
Our fees are flat and quoted before work begins. What comes later is USPTO fees and any office action responses, so plan for both.
| Stage | When | What you pay |
|---|---|---|
| Patentability search | Before you file | $999 flat fee, credited toward your application |
| Provisional application | Month 0 | $2,500 to $3,500 flat fee, set by the device |
| Non-provisional application | By month 12 | $7,000 to $12,000 flat fee, with drawings and USPTO filing fees included |
| Design patent, if the look matters | Any time, ideally before launch | $3,200 flat fee, office actions included |
| Office action responses | Often 18 to 24 months after filing | $2,500 to $3,500 per response, quoted flat before any work begins |
| USPTO issue fee | When the patent is allowed | $1,290, or $516 for a small entity and $258 for a micro entity |
| USPTO maintenance fee | 3.5 years after grant | $2,150, or $860 for a small entity and $430 for a micro entity |
| USPTO maintenance fee | 7.5 years after grant | $4,040, or $1,616 for a small entity and $808 for a micro entity |
| USPTO maintenance fee | 11.5 years after grant | $8,280, or $3,312 for a small entity and $1,656 for a micro entity |
USPTO fees are from the USPTO fee schedule effective January 19, 2025, and the USPTO adjusts them from time to time. Small entity status generally applies to companies with fewer than 500 employees, and micro entity status has income and filing limits. If a maintenance fee goes unpaid, the patent expires early. More on small and micro entity status for device companies.
[11]Questions
Questions about medical device patents.
Still deciding? Your first call is free and comes with a straight answer on whether to file.
Book A Free Strategy CallWhat type of claim does my medical device invention need?
Usually several. Apparatus claims cover the device itself, method claims cover how it is used or made, system claims cover it working with other equipment, and kit claims cover a set of parts sold together. A strong application mixes them so a competitor cannot avoid every claim by changing one thing.
How do I patent a medical device?
Start with a patentability search to see what already exists. Then file a provisional application before any public disclosure, which makes you patent pending, and file the full application within 12 months. The USPTO examines the full application, and most patents are granted 2 to 3 years after it is filed.
How much does a medical device patent cost?
With us, a $999 patentability search, a provisional application at $2,500 to $3,500 depending on the device, and a non-provisional application at $7,000 to $12,000 with drawings and USPTO filing fees included. After filing, plan for office action responses, quoted flat before any work begins, the USPTO issue fee and maintenance fees at 3.5, 7.5 and 11.5 years after grant.
Do I need FDA clearance or clinical data before I file?
No. Patent filing and FDA review are separate, and FDA approval is not a requirement for a patent. The application has to describe how the device works well enough for someone in the field to build and use it. Filing first is usually safer, because trial postings and submissions can make the invention public.
Can I patent an improvement to an existing medical device?
Yes, if the improvement is new and not obvious, such as a new mechanism, a new sensor arrangement or a better way of reaching the clinical result. The claims cover the improvement, not the device it builds on. The search shows how close existing devices come.
Can I patent a surgical method?
Yes, a new surgical or treatment method can be patented. But the law bars infringement remedies against doctors and their hospitals for performing a patented procedure, unless the claim covers use of a patented device. That is why we claim the device and the kit alongside the method.
Does a patent let me sell my device?
No. A patent lets you stop others from making, using or selling your invention. It does not clear you to sell, because your device could still use someone else's patented feature, and the FDA decides whether it can be marketed. A freedom to operate review looks at other people's patents before launch.
Can a competitor use my patented device in its own FDA submission?
Yes, within limits. Making or using a patented device solely to develop and submit information to the FDA is not infringement. Once the competitor goes beyond that, for example by selling the device, your patent applies.
How long does a medical device patent last?
A utility patent generally lasts 20 years from the date the full application is filed, with maintenance fees due along the way. A device that went through premarket approval may get part of its FDA review time back through patent term extension. A design patent lasts 15 years from grant.
Can I patent the app that works with my device?
Often, yes. The method the app performs, such as how it processes sensor data or adjusts the device, can be claimed alongside the device, and the look of its screens can be protected with a design patent. An app that only collects or displays data is less likely to qualify on its own. The patentability search tells you where it stands before you file.
What does The RLG Guarantee cover for medical device patents?
The patentability search, the provisional application and design patents. If the search finds your device is not novel, you get a full refund or another search. If patentability issues come up on your provisional, you get a full refund or more searches. If the USPTO denies your design application, you get a full refund. Non-provisional applications are not covered. Refunds are subject to the RLG Guarantee Policy in your engagement letter.
[12]Learning Center
Go deeper on medical device patents.
How To File a Medical Device Patent: A Comprehensive Guide
Learning how to file a medical device patent is crucial for innovators in the MedTech industry, as navigating this complex path can be daunting. This article paves the…
Patenting Medical Devices: Patent Novelty vs. Commercial Novelty
As with any invention, it is important for innovators and medical device companies to understand that there is a difference between patent novelty and commercial novelty…
[13]Client reviews
Inventors who filed with us.
4.7 across 614 public reviews on Google, Trustpilot and Avvo.
#1Top reviewed IP law firm*
Read client reviews“I can safely trust them with scientific and legal integrity regarding ownership and accountability of inventions.”
Hussain AtherPatent · Client review “It gave us peace of mind knowing the total cost for this service was included in their flat-fee proposal.”
Nick P.Provisional patent · Client review “Completed the patent search and utility patent within weeks.”
Michael F.Utility patent · Google
Reviews reflect individual client experiences. Quotes are excerpts. Prior results do not guarantee a similar outcome. *#1 top reviewed means the most public client reviews on Google, Trustpilot and Avvo of any US patent or trademark firm.
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