As a patent attorney who helped numerous medical device startups over a 20-year span, a provisional patent application can be a useful tool for inventors of medical devices with the option to protect their invention at a relatively low cost and with a degree of flexibility.
Startups with limited resources can prepare and file a provisional patent application for $70-$140 in PTO fees. The company can then test the invention on the marketplace for the remainder of the year to see if doctors, patients, and other users love the medical device. If traction is shown, the company can then hire a patent attorney to prepare the non-provisional application.
If you are interested in provisional applications, read on to find many tips and tricks to help you succeed with a provisional application for your medical device.
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is a Provisional Patent Application (PPA) appropriate for Medical device inventions?
A provisional patent application is one type of patent application filed with the United States Patent and Trademark Office. It establishes an earlier effective filing date for the invention but does not mature into an issued patent unless a nonprovisional application is filed within one year of the filing date.
Provisional patent applications are less formal than nonprovisional ones. They typically require less detail and more formalities. It is also easier to file. A provisional patent application doesn’t undergo substantive examination by USPTO. It will not be granted a patent unless the USPTO finds the invention to be new and not obvious.
A provisional patent application is useful for inventors who need to establish a priority date on their invention while they are still developing it or testing the market. It is also useful for inventors who are unsure if they wish to file a patent application but still want to retain the option.
The PPA serves as a conduit to your eventual Utility Patent. It also acts as a placeholder for your next non-provisional request, which will eventually become an issued patent if all conditions have been met. This gives you priority over any previous filing date. You may be eligible for maximum protection if you include a detailed description in your patent application.
examples of medical device inventions that started as provisional applications
There are many examples of medical devices that started as provisional patent applications and went on to become successful commercial products. Here are a few examples:
- The DaVinci surgical system: This robotic surgical system, developed by Intuitive Surgical, began as a provisional patent application in 1997. The system has since been used in thousands of surgeries and has been granted multiple patents.
- The Medtronic Infuse Bone Graft: This medical device, used in spinal and orthopedic surgeries, began as a provisional patent application in the 1990s. Medtronic has since been granted multiple patents for the device and it is now widely used in clinical practice.
- The Boston Scientific Taxus Stent: This medical device, used to treat heart disease, began as a provisional patent application in the late 1990s. Boston Scientific has since been granted multiple patents for the device and it is now widely used in clinical practice.
- The HeartWare Ventricular Assist Device: This medical device, used to support the function of the heart, began as a provisional patent application in the early 2000s. HeartWare has since been granted multiple patents for the device and it is now widely used in clinical practice.
These are just a few examples, but there are many other medical devices that have started as provisional patent applications and gone on to become successful commercial products.
Advantages of Provisional Patent Applications for medical devices
There are many benefits to using provisional patents to protect medical device inventions. These include:
- Inexpensive early filing of a provisional application while your invention is still in the early stages of development. Provisional applications are a great way of protecting your invention, and they won’t affect the validity or validity of later patents.
- Ease of filing multiple provisional patent applications. This makes it easier to keep track of and avoid costly errors. You should carefully consider all options and review the USPTO’s detailed fees list.
- Ease of preparation as compared to a full utility, and requires fewer legal resources. A provisional patent application does not require substantive review by the PTO examiner. It is checked for compliance with minimal filing requirements. No prior art search is required.
- Quick and simple so it’s easy to get started. A provisional may be filed within 12 months of your initial application. This gives you ample time to assess your invention and decide if it is worth filing. This type of application is great for small entrepreneurs.
- Provide an additional year of protection for your invention. An issued patent generally lasts for 20 years after it is filed. However, if you combine the provisional one-year period with the nonprovisional patent lifetime of 20 years, you get patent protection for 21.
- DIY provisionals are free of attorney fees and can save you both time and money. You can use it to start developing your product right away.
- Legal use of the term “patent-pending” for one year with a provisional patent application. This will notify the public that you are currently working on a patent. While the term “patent-pending” is valid for one year, it will not grant you exclusive rights to your invention until you file a full patent request. After completing a provisional application, you can file a complete patent application.
- Prevent (or at least delay) competitors from reverse engineering your invention.
- It’s also an inexpensive and easy way to protect your invention. It is important not to wait too long before you file a non-provisional application for a patent. A provisional patent is only valid for 12 months. This will allow you to evaluate the commercial potential of your invention and prevent costly mistakes.
- This is a cost-effective way to protect your invention during the initial stages of development. This can be a great way for you to protect your invention. It’s a smart idea to apply for a provisional Patent if you are considering pursuing a patent.
Provisional patents allow you to hold patent-pending status for your medical device invention for up to one calendar year. You can then decide to invest more money for a complete application (nonprovisional request) which will be reviewed and, if granted, issued as a patent.
On the downside, you will lose your provisional filing priority date if you do not file the non-provisional request within one year. If you make any offers to sell or publicize your invention during the year and do not convert to non-provisional within the 12-month period, you could lose valuable rights. This is the downside of provisional filing.
With a one-year head start, you have enough time to address these issues and avoid delays with a provisional patent application. It allows you to refine your idea before you file a full-fledged patent application.
Disadvantages of Provisional Patent Applications for medical device inventions
Even though the provisional fees may be low, you will have to file international patent applications (and convert to non-provisional) within one year. Since many medical device companies file internationally, the company should budget around $5k to file a PCT international application.
A provisional patent application has another disadvantage. It is not reviewed by the USPTO. Therefore, if you wait one year before you convert to the nonprovisional application your examination will be delayed one year. This delay can be problematic for startups that use AI and deep learning. In such cases, you might want to skip the provisional patent application and file directly as a nonprovisional.
Another potential gotcha is that a provisional patent application will usually be filed quickly in a rush. Unless carefully done, you can inadvertently leave out key components and details of their inventions in the rush. A patent application with insufficiently detailed descriptions can lead to Section 112 enablement problems down the road.
Last but not least, although provisional applications can be relatively inexpensive, they must be followed up with a non-provisional full application within twelve months. The PPA does not confer any utility rights or other patent rights. The PPA protects your rights only for one year. The PPA must be converted to a utility application within one year. For example, suppose you file the PPA and subsequently you publish details about your invention online or put the invention “on-sale” in the United States during the year. However, unless the PPA is not converted to a utility patent application within 12 months, you may lose valuable patent rights in such a situation.
The Recommended Format for A Medical device provisional patent application
Although provisional applications do not have a specific format, we recommend you borrow the format for a non-provisional to facilitate a smooth transition from the provisional to the non-provisional within one year.
Although you don’t have to follow any particular format requirements to make a PPA valid, it is recommended to know the following:
- Titular of the invention
- Background information about the invention
- Description of the product’s purpose and design, as well as any drawings or illustrations.
Your title should contain a brief description of your invention. Your title should not exceed 500 characters to make it clear and concise.
It is essential to outline all details of your invention before you start writing. This will allow you to organize your text in an orderly manner. The USPTO states that drawings must be included in the application to fully understand the invention.
Diagrams, flow sheets, and schematic views may be included in drawings. These can be used to illustrate mechanical or electrical inventions. You can request a PPA by sending photos or informal drawings. Specific drawings are required by the USPTO for utility patent applications.
You must include the description and the claims in a non-provisional application for a patent. The application should contain enough details to enable a skilled person to create a product but not require them to do extensive research in order to implement your invention.
It is important that you demonstrate specific and concrete methods of achieving the desired result. Your detailed explanations and clear understanding will be appreciated by the USPTO.
If you have multiple ways to make your invention work, it is important to identify the best method of construction. It is also important to mention any additional functions your invention may perform.
An abstract helps the reader identify the nature and purpose of technical disclosures that relate to the invention. A summary helps the reader quickly identify the nature of the invention and the technical disclosures. It should not exceed 150 words and should not be more than one paragraph. It provides an overview of your invention.
How to Do a PPA by Yourself
Non-lawyers may offer provisional filing preparation services through sites like Fiverr. However, it is better to prepare the PPA by yourself. To help you with the process, patent software may be a good choice. This software allows you to use a structured approach and provides diagnostics that can help you avoid common mistakes. It also reduces the learning curve. An experienced patent attorney can prepare and file your non-provisional or provisional patent application if you have the funds. They can help you avoid problems down the line and draft a patent request that issues a valuable Patent.
As a guide, you can search the USPTO official website for patents published. Only search patents belonging to the same category of your invention.
You will need the most relevant keywords to search for the correct patent on USPTO’s website. The published patent applications will be displayed along with the issued patents. This will enable you to make a provisional Patent.
Every idea is born from a challenge or a problem that your design solves. While the problem is not required for patent applications, it can be useful to include details to explain the solution.
It is possible to distinguish the unique characteristics of your invention by examining the solutions available, also known under the term “prior art”. It is important that your description contains the essential elements of your invention.
It is possible to describe your invention even though it might seem complicated. These tips will help you make an informed decision about how to file a provisional Patent. Planning is important before you start writing your provisional patent applications. Before you begin writing your application, it is important to plan.
You can break up the entire application into sections, or add additional subsections if needed. The order of your application content should reflect its importance.
It can be beneficial to provide as much detail and information as possible when filing a provisional patent application.
- This will increase your chances of getting a Patent granted. The greater the number of details included in the Provisional Application the higher the chances that the patent office will grant a Patent. This will increase your chances of receiving a patent grant.
- This increases the value and scope of the claims. An application provisional with more detail can help to define the unique features and characteristics of the invention. This can enhance the scope of claims in a non-provisional application.
- It increases the patent’s worth: More information in provisional applications can make it more valuable. Because it covers a wider variety of uses and possible implementations, this is why the patent has a higher value.
- This increases your chances of licensing or selling the invention. It is possible that potential buyers and licensees will be more interested in your invention if you include more information in your provisional applications.
- This will increase your ability to stop others from copying your invention. It is more likely that your invention will be considered unique if you provide more detail in your provisional applications.
- This increases your chances of being able to prove ownership. It is more likely that an invention will not be considered unique if you provide more information in your provisional applications. It can be difficult for others to claim the invention independently.
- This will increase your chances of being able to defend the patent in court. To show that the inventor has conceived the invention, a detailed provisional application may be filed in court. This can be used to defend your patent in court.
If you provide as much detail as possible in a provisional patent application, it can increase your chances of getting a patent granted. It can also expand the scope of the claims and increase the patent’s worth. This will increase the chance of licensing or selling the invention. This can be used to defend the patent before a court.
Questions to Consider While Preparing the PPA
- What is the purpose of this medical device invention?
- What components/parts of the medical device invention are most important?
- Which components are new? Which of these components are they equivalent?
- What are the connections between these components? Is your interconnection unique?
- Which part of the medical device invention took you the longest to create?
- Is there another way to achieve the same function using the invention?
- Is there another option to implement the medical device invention?
- What features are most desired by customers/end-users, and what does the competition offer?
- What are the features that competitors want and what can they offer?
- What makes a product more useful? What can you do for the product to be more useful?
- How can important components or elements of the invention be simplified?
- What component or element do you consider essential? What can you do when these opposites are combined?
- Is the invention as simple and straightforward as you could make it? Is there an alternative design that you could describe in your application?
Optional Parts of a PPA
PPAs can’t be evaluated, so it’s not necessary to include claims or prototypes. It can be left out.
It is mandatory for utility patent applications. However, it is not required for a PPA request. It is not necessary for a PPA request but it should be used to convey the essence of your invention using the smallest parts possible.
These are vital because patent protection depends on the claims you make in your application. These are the boundaries of your patent. These are the guidelines of the USPTO.
If you want to allow others to design around the terms of your patent, they can use the language contained in your application. This allows them to interpret your claims narrowly to prove that they don’t infringe.
They may use variations to achieve the same purpose, but they might not be in line with your claims. To avoid any attempts to circumvent your patent application text, you should include all variations.
For a utility or provisional application, a prototype is not necessary. For a utility or provisional application, a prototype is not required. It is important to let the rest of the world know you have a prototype.
This will enable you to get a valuable patent pioneering license. This can be achieved by providing enough information to avoid delays in prototyping.