Start with prior art
It seems that innovation in the medical device field generally enjoys a greater probability of making it to the marketplace. When a particular area of technology has a greater chance of making money, you can expect more patent filings. So expect the prior art of medical device patents to be crowded.
So what are we looking for in the prior art? It depends on whether we are searching for purposes of determining patentability or infringement, or both. A patentability search (novelty search) will cost less and provide guidance on whether or not your medical device might be patentable. A Freedom-To-Operate (FTO) search will cost substantially more and assess the risks of patent infringement.
Claiming medical devices: apparatus vs. method claims
Let’s assume a patentability search conducted for your medical device invention did not find any close prior art that would discourage from you applying. So you are now ready to file a utility nonprovisional patent application on your medical device concept. Perhaps you have filed one or more provisional applications which you are now ready to convert into a nonprovisional application.
Patent practitioners each have their own way of drafting a patent application. My preference is start with drafting the claims before writing the detailed description. Even before drafting claims, I might prepare a claim outline that details core features followed by subsets of each core feature, along with any secondary features. A good claim outline provides a helpful structural framework for writing the actual claims. The claim outline is the skeleton and drafting claims based on the outline is like putting meat on the bones.
Medical devices lend themselves to both apparatus (structure) and method claims. While it may make sense to pursue both types of claims, you should confer with your patent professional on whether you want to include both apparatus and method claims in the same application, which can invite a Restriction Requirement. You can file multiple patent applications concurrently, with each application containing the same omnibus specification but different claims.
Responding to Office Actions citing medical device prior art
So we know the prior art is replete with medical device patents, and chances are that many of those prior art references will be cited in an Office Action rejecting your application. When it comes to medical device patent applications, it would be wise to hope for the best, but expect the worst. In other words, hope for an early allowance, but expect multiple Office Actions rejections.
How to reduce Office Actions
Medical device patent applicants may be encouraged to know that some measures can be taken to reduce the number of Office Actions and the duration of the application process. As mentioned above, a patentability search conducted prior to filing may avoid overly broad claims in the initial filing. By narrowing the scope of the original claims to gain a more realistic chance of acceptance, you also force the patent examiner to find closer prior art.
While the first Office Action is almost inevitable, subsequent Office Actions may be avoided or minimized by conducting an Examiner Interview to discuss the cited prior art and proposed claim amendments. It helps when your patent team includes a former USPTO patent examiner who can speak their language and gain rapport.
Strategies for broader medical device patents
When it comes to getting medical device patent applications allowed, our firm adheres to a simple principle of taking what we can get. We generally advise our clients to take allowable subject matter that is meaningful, which means that the allowed claims are not so narrow as to be worthless in the marketplace. Assuming the allowable claims have some value, then we often recommend taking the allowable claims now and deferring any other claim amendments or arguments.
The applicant can file a continuation application to continue pursuing broader or different claims than those allowed in the parent application. That way, your medical device company gets a patent granted sooner while still reserving the right to pursue additional claims against competitors.
Filing continuations is a fairly common practice with medical device patents. Competitors are constantly checking each other’s IP and exploring any potential design-around products.
