By Ana Gonzalez (M3)

            In the process of creating a novel invention, medical device innovators must ensure that they understand the essentials of intellectual property. Once a new idea has been generated,  innovators must begin familiarizing themselves with the literature in their field to ensure their invention is patentable. An invention will only become patentable once it meets three distinct criteria: utility, novelty, and obviousness. Establishing the novelty of a particular invention is difficult for medical innovators as it requires a heavy, time-consuming patent search. Additionally, in the US, disclosure of all pre-existing patents, devices, or publicly available disclosures (generally known as prior art) is legally required. However, before a patent search begins, innovators must have a clear understanding of their invention and be able to give a detailed summary describing the key functions.

            Since a patent grants exclusive rights to a creator, prior art must be researched by innovators to ensure no other innovator has created the same device. What makes this tricky for innovators, however, is that this concept of novelty extends not only to filed patents, but also applies to any form of public disclosure at any place or point in time. A scientist across the world could give a presentation about an invention in a different language that is similar to the innovator’s device, and unless an innovator can prove that their invention has a new concept, use, or feature, it is not considered novel. This makes patent searching extensive as it applies to the 8 million and plus patents globally as well as any published or unpublished disclosures. One can begin by researching patent databases, such as Google Patent search, as the majority of medically significant inventions will have patents; however, this search must also include expired or abandoned patents as well. Afterwards, innovators can utilize various databases and research engines to find non-patented public disclosures like PubMed, Google, and Google Scholar. Finding unpublished public disclosures is tricky and will also require a comprehensive Google search, although speaking to experts in the field of interest could also help discover unpublished public disclosures.             

Patent searching is a complex, ongoing process that involves different types of searches performed during specific times of development. The first step is to identify the primary patents of interest in a broad search. In the early stages there are 2 main types of searches: the patentability search and the freedom to operate search. A patentability search involves finding past patents, literature, or disclosures to ensure the invention is new and not obviously derived from a pre existing device. To understand a freedom to operate search one must first understand the term freedom to operate. This term explains why being granted a patent for a novel medical device does not necessarily grant freedom to market the technology if the device depends on other patented materials, features, or devices to function. A new invention only has freedom to operate once it has been confirmed it does not include features that have current claims from other active patents. Claims are a core component of patents and intellectual property as they list the precise features of an idea or device that are granted exclusive rights by the patent. Additionally, the claims of a patent may also list features of a device that are not granted exclusive rights. They explicitly state what the patent protects from being duplicated by another inventor without proper patent licensing. Patent licensing is the mutual agreement between the patent owner or ‘licensor’ and the person requesting the license or ‘licensee’ that allows commercial make, use, and sell of an invention by a licensee for a specific time period. For example, if someone wanted to create a device that utilized a pre-existing patented guidewire with a layer consisting of a radiopaque material, they would either have to design around this feature with their own invention or obtain a patent license from the original inventor.  Patent claims can be found at the end of every patent in numbered paragraphs and can range from broad to detailed. Claims are what a freedom to operate search investigates, and as they are the primary target of patent litigations, they require a comprehensive search if an innovator wishes freedom to market the technology. 

    In addition to types of searches, there are two ways of approaching a search. The first approach is the familiar “text” or “keyword searching” involving the input of keywords into a search engine like the Google Patent Search. Initially, the keywords may involve descriptive characteristics about the invention, such as the need addressed by the invention (atherosclerosis for a novel angioplasty catheter), the structure of the invention (catheter) or the function of the invention (dilates, removes blockage), however, later on, they could involve the names of known inventors, companies, or assignees creating similar devices. Using these keywords related to the structure, function, and need for the invention will yield results related to your idea. Text searching can be optimized by combining keywords with boolean logic operators such as AND or OR. Using our angioplasty catheter for atherosclerosis, we could search “atherosclerosis AND angioplasty.” Additionally, innovators must be careful to search all the versions of a keyword such as ‘stent graft’ versus ‘stent-graft.’ Fortunately, search engines have an algorithm to combat this problem named wild card symbols or truncation limiters where one can use a word root to find other keywords containing the same root. The second approach involves classification searching, where patent agencies like the USPTO and Google Patent Search will group and code patents that share either the same industry, structure, function or intention. An innovator could benefit by starting their patent search using the classification approach to gain an initial brief but significant understanding of prior work. 

This first search using keywords and classification systems to search patentability and freedom to operate can be expanded by using the citations of each patent and the patent number itself to look both in the past and future, respectively, to identify other relevant patents. Every patent has its own list of prior art and citations from the inventor’s own patent search, and each patent has a unique patent number that can be used in a patent number search on USPTO and Google Patent Search. The result will be a final list of hundreds to thousands of patents.  A comprehensive and thorough review of this list can narrow down the list to even 10 or 20 patents of interest that have inventions with similar structure, function, or needs addressed as the new innovation in question. The next search involves finding new patents based on this refined list by using the citations of all the new patents and/or classifications of the invention. This search will produce another lengthy list of patents, but typically smaller than the first. Another detailed and thorough review of these patents will result in a small number of new patents of interest, and potentially the removal of some from the primary list. This entire process is not linear and meant to be repeated again numerous times, until a final list of ~5-15 core patents is derived. 

Throughout this process, innovators will become familiar with which search terms result in the most relevant results regarding their innovation. These search terms should be entered and refreshed either weekly or monthly to keep up with new developments. Ideally, keeping track of all the search terms used and the amount of results derived from each term may help gain insight into the quality of the search terms.  Furthermore, it is important to have a systematic method for recording the output of these searches onto a kind of worksheet or spreadsheet. This tracking method should at the very least include the patent number, title, assignee, key claims, inventor(s), the dates of publication and patent filing, agency classification, and a summary of the invention with some key claims. Additionally, in order to reduce redundancy, one should track previous patents that were reviewed and later removed from the core list as it is likely innovators will come across them in future searches. 

    Patent searching is a cyclical and ongoing process throughout all stages of innovation. Inventors would benefit by dividing tasks of the patent search, such as the classification search and the keyword search, among team members that all utilize the same collective tracking method for output. Patience will be a necessary virtue during this time consuming process, and working as a team will aid in ensuring its adequate completion. It is important to realize that during this process it is inherently certain that innovators will discover an invention similar to their own; however, one should not be discouraged as this can lead to a refined or altered invention that results in a valid patent application. For example, an innovator creating a balloon catheter discovers its pre-existence and adds a drug-eluting feature to the balloon catheter improving the overall patient outcome. Finding this prior art early on in the patent search can save money on resources that would have been utilized on a non-patentable concept. 

 During the late stages of device innovation, inventors should contract a professional search by either an attorney or patent agent as it is difficult for one team (including professional teams) to uncover all the information pertinent to the invention. Combined efforts during a patent search will obtain a more complete picture to ensure proper patentability.