Patents are crucial for medical device companies. With the advent of software and AI technology, virtually all medical devices today contain some form of software that provides significant ease of use and functionality for the medical devices. These advances are typically protected using the patent system. However, as a patent attorney who deals with these patent applications on a daily basis, there are traps to watch out for. Read on to better prepare yourself when you are considering patenting medical devices enhanced with software.
Medical Device Software Patenting Basics
Patent protection is available for medical device software. This includes software that is used in therapeutic or diagnostic applications. Medical device software, however, must comply with the regulations of the U.S. Food and Drug Administration before it can be marketed and sold. Next we discuss the different types of patents used for medical device.
Provisional Patent Applications for Medical Devices
If an invention is patentable, the inventor can sell the patent to a third party. The process can be complex. Before you begin the process, it is a good idea to contact a patent attorney.
A provisional patent covering medical device software can also be called “patent pending” (or a “design patent.” Patents that protect the design of a device can also be used to protect its exterior design.
These medical devices include instruments and equipment for surgery, drug delivery systems and patient monitoring devices. Software solutions are often used to develop these types of products. Software can be used for tracking health information as well as hospital management, staff allocation and staff allocation.
A provisional patent is a good option for anyone who wants to patent medical device software. The first is that it’s cheaper. Because the United States Patent and Trademark Office, USPTO (USPTO), does not examine provisional applications, you will pay less for a Patent than for a complete non-provisional one.
A provisional patent also preserves rights while you decide whether to file a full patent request. This allows you test your invention and determine its worth without having to pay for a patent.
Provisional patents can have a negative side effect. They may not offer complete protection. You won’t get full patent protection if you aren’t clear on the scope of your invention. You won’t get a priority date if your invention is only partially disclosed.
Utility Patents for Medical Devices
Utility patents cover an invention. Anyone who discovers a useful invention is eligible to receive a utility patent. Utility patents are often granted for new methods and machine inventions. They also cover new compositions of matter or processes.
Each year, the USPTO receives more than 500,000 patent applications. These applications are mostly nonprovisional utility patent application. These applications are reviewed by a patent examiner before being issued if they satisfy certain patentability requirements.
There are many types of patents for medical devices. A utility patent is the most common. It focuses on how the device functions.
Patents may be granted for medical device software. The software must be unique and not easily copied. Functionality is also a requirement. It must also meet FDA requirements for medical devices. It must, for example, be able track data and perform more functions than just calculate. It will not be eligible to receive a patent if it doesn’t meet the FDA’s requirements.
When drafting a patent request for a software device, it is important to take into account the eligibility criteria for patentability. These criteria were set by the United States Patent and Trademark Office. Patent eligibility is only possible if the invention is novel, useful, and unobvious.
The USPTO published guidelines for mobile apps. To be eligible for a patent, an app must have some type of “inventive idea”. Apps must include a novel, non-obvious technology.
To draft a mobile patent application that has a high likelihood of being granted, it is important to clearly and precisely describe your invention. To help explain the invention’s operation, you should include technical details and drawings.
It is important to make sure that the claims in the application are clear and specific enough to distinguish the invention form prior art.
A patent attorney can help you with the drafting of a medical device patent application that meets all patent eligibility criteria. It can be difficult to obtain a patent for a medical device. It can also be costly. It is recommended that you seek legal advice before considering patent protection.
Design Patents for Medical Devices
Understanding the patent landscape is essential for medical device manufacturers. This can assist them in improving their designs. It can also give insight into the competition in the space.
Design patents are sought by most medical device companies. These patents cover both the design and graphical interfaces of the device. This protects a company against a competitor copying a design.
For medical devices, utility patents can also be granted. These patents are granted to inventors who have created a useful product or process. The invention must be original and not already known by the applicant.
Patent examination can be complicated and time-consuming. Hire an expert to speed up the process. You might be able to get a provisional patent if you don’t have the funds to hire an outside patent attorney. This will allow you to file your patent application within one year. After one year, the patent can be converted to a non-provisional.
To protect the visual elements of a medical device, a design patent can also be obtained. It is less frequently used than a utility patent.
Mobile medical devices have seen a surge in popularity due to the COVID pandemic. These devices can be designed in a way that is attractive and makes them easy to use. These customizations can be used by companies to distinguish their products from others.
Medical device manufacturers have the ability to create innovative products. They must also protect their intellectual property. They must protect their intellectual property, no matter if it’s a utility or design patent.
The FDA is committed towards international harmonization in medical device regulations. The Global Harmonization Task Force (GHTF) has been established by the FDA. It includes representatives from Canada, the European Union and other observing nations.
Patent Eligibility as applied to Medical Device With Software
It is generally easier to obtain a patent for a medical device that includes both hardware and software components, as opposed to just software alone. This is because the hardware component provides a tangible embodiment for the software, which can help to demonstrate that the invention is novel and non-obvious. Additionally, the hardware component can also provide additional functionality that is not present in the software alone, which can further strengthen the patentability of the invention.
However, having a hardware component in the medical device doesn’t necessarily guarantee that the patent will be granted. The patent office will still examine the overall invention and the software component to ensure that they meet the patentability criteria such as novelty, non-obviousness, usefulness, and enablement.
It’s important to keep in mind that the patentability of the medical device depends on the specific details of the invention and how it is described in the patent application. Therefore, it is important to consult with a patent lawyer experienced in medical devices to ensure that the patent application is properly drafted and that all necessary information is included.
You need to be aware that rejections can occur when applying for and obtaining a patent. These rejections include 101 and 102. If the PTO examiner believes your claim is too broad to include abstract ideas, a section 101 rejection may be issued.
One of the greatest challenges in patenting medical technology is eligibility. Because medical device software systems are mathematically complex, they can be included in the USPTO’s definition Abstract ideas. Patent-eligible subject matter must be included in the claimed invention. The patent claim can’t be directed at a court exemption unless the claim contains additional limitations that significantly exceed the exception. These are known as “judicially recognised exceptions” or simply “exceptions”, which refer to subject matter that courts have deemed to be outside the four categories of invention. They can only be used to describe abstract ideas, laws of nature, natural phenomena and products of nature. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013).
The Alice/Mayo 2-part test should be used to determine eligibility. While the machine-or-transformation test is an important clue to eligibility, it should not be used as a separate test for eligibility. It should be included in the Alice/Mayo test for “integration” or “significantly higher” determination. Bilski, 561 U.S. 5, 605, 95 U.S.PQ2d 1001, 1007 (2010). See MPEP SS 2106.04(d) for more information about evaluating whether a claim reciting a judicial exception is integrated into a practical application and MPEP SS 2106.05(b) and MPEP SS 2106.05(c) for more information about how the machine-or-transformation test fits into the Alice/Mayo two-part framework.
It is not sufficient to determine eligibility based on whether a claim cites “useful concrete results.” State Street Bank, 149 F.3d 1308, 1374. 47 USPQ2d 1696. Cir. 1998) (quoting from re Alappat 33F.3d1526. 1544. 31 USPQ2d1545. 1557 (Fed. Cir. Cir. In re Bilski, 545 F.3d 943, 959-60, 88 USPQ2d 1385, 1394-95 (Fed. Cir. 2008) ( En banc), adjudicated Bilski 561 U.S.5,93, 95 U.S.PQ2d 1001 (2010). TLI Communications LLC v. AV Auto LLC 823F.3d 607 & 613 (Fed. Cir. Cir. 33 F.3d at 1506 31 USPQ2d on 1526. (Fed. Cir. Cir. Eon Corp. IP Holdings LLC versus AT&T Mobility LLC 616 and 623, (Fed. Cir. 2015. Cir. Cir. Cir. “[U]tility doesn’t test for patent-eligible materials.” Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1380, 118 USPQ2d 1541, 1548 (Fed. Cir. 2016).
The U.S. Patent and Trademark Office is currently dealing with medical software-related patent application. Over the past year, the Patent Trial and Appeal Board has issued many decisions regarding appeals from rejects by examiners for software patents. The PTAB has not reversed any Section 101-based rejections. This does not necessarily indicate that no software patents are being issued. It does mean that certain patent applications will not be accepted by the examiners. Given the updated PTO Section 101 guidance published in January 2019, and inconsistent handling of Section 101 by courts, this is not surprising.
Ex parte McCann No. 2021-003397 (P.T.A.B. March 7, 2022, the PTAB reviewed claim 1 in the 824 application. It determined that the claim 1 was directed at the abstract idea “certain methods for organizing human activity as exemplified in the commercial and legal interaction management of commercial payment transactions by advising one process payments using an available payment instrument, and post the payment into a ledger, sans significantly more.” Id. 20. The PTAB stated that claims are not eligible even though they contain a recital of cryptographic and Blockchain data. The PTAB stated that the recital of a Blockchain was a generic and traditional blockchain, and is essentially an accounting leadger.
The claims do not provide any information about the technology implementation. The claims mention only the idea of block-chain storage. The PTAB observed that the applicant didn’t claim to have invented block chain technology and that the cryptographic data recital was also generic. It is a simple invocation for the concept of cryptography but doesn’t include any technical details. Id. 14-15. 14-15. The PTAB concluded the claims do not include an inventive concept because they are only limited to the abstract idea cited. Id. Id., 17-19. The PTAB found that claims can be analyzed separately or in an ordered combination to determine if the claims are “purely conventional” and/or ordinary. Id. Id., 17-19.
Section 101 scrutiny will not be satisfied if claims that “do this with a computer” are made to an existing medical or healthcare practice. Section 101 scrutiny is more likely to be satisfied if claimants can demonstrate how their claims will improve computer functionality and operation.
Medical Software and 102/103 Obviousness Rejections
When applying for and obtaining a patent, it is important to know that there are 102/103 rejections. These rejections include:
- 102/103 apparentness rejections (most commonly for all patents).
- 101 prior art rejections (can apply to software technology patents)
To be considered a 102 rejection, you must submit a single document that contains all elements of the claim. This can be difficult if your invention is properly claimed, as it requires an identical invention in prior art. An obviousness rejection under Section 103 can be much more common if the examiner is able to piece together more than one document.
35 U.S.Code Section 103 – Conditions for patentability, non-obvious subject material – states that:
Patents for claimed inventions may not be granted, even if they are not identically disclosed in section 102. However, if the claims as a whole and prior art are so different that it would have been obvious to an ordinary person with ordinary skill in the art, the patent could not be obtained. The manner in which an invention was made does not affect its patentability
Patent Strategies for Medical Device Software Inventions
Software technology is an evolving field. Individuals and companies may have different strategies to protect their medical software-related inventions through patents. These strategies include:
- Early filing for patents: Companies developing medical software technologies might want to file patent applications as soon as possible in order to protect their rights ahead of others.
- Broad patent filing: Companies might file broad patents to cover a broad range of possible uses for their medical software inventions. This will help to prevent other developers from creating similar technologies. It can also give companies a strong bargaining advantage when it comes to licensing or cross-licensing agreements.
- Filing for defensive patents: Companies may file for patents to protect their technology from being copied by others.
- Multiple jurisdictions for patent applications: Because software technology is so widespread, companies might want to file patent applications in multiple countries in order to protect their rights.
These are just a few of the possible patent strategies companies might consider when using software technology with traditional medical hardware. However, it is important to take into account the particular circumstances and business goals for each case.