Stage 4: Build the Prototype—Proof of Concept
Once the CAD models are complete, an actual functioning prototype is produced with approval from the physician inventor, using a 3-D printer. “Reducing” the inventive concept to practice is an important milestone and should mark the start of the patent application filing process. Because patent law changed on March 16, 2013 from “first to invent” to “first to file,” it is imperative that once the prototype has been produced and is taken outside the plant, IP counsel takes the step to file a provisional patent application to ensure you have the earliest filing date. The provisional application should be drafted to fully describe the design and also cover any variations that the competition may contemplate. The application filing will provide protection from third parties trying to preemptively file on the device before the company does.
Stage 5: Prototype Review and Field Assessment
Design engineers will tell you that once a prototype is made, marketing folks constantly try to “borrow” it to show off to target physicians. It is critical that before the new prototype is shown to anyone, a provisional application is filed. It is also key at this point to start investigating product branding. Marketing will likely start to brainstorm during field assessment on branding strategy and what trademarks may be used in association with the new product and instrument line. From an IP due diligence standpoint, it is prudent to initially perform trademark knockout searches, narrowing down the number of possible marks. Then, a more robust trademark search should be performed on the final pool of marks to ensure that another company or individual is not using the mark for the same class of goods or services. After determining that the chosen mark is clear, an in-use or intent to use trademark application should be filed. Having a cleared mark in place before product launch eliminates later costly surprises.
Stage 6: Design Refinement and Physician Recruitment
Now the design is “tweaked” to address target physician demands. Other physicians are brought in to join “the team” with the original disclosing surgeon to review and provide feedback on how the design may function. The corresponding IP due diligence step is for patent counsel to review the design and any improvements suggested by the physician team to confirm that all new patentable ideas are captured in the provisional applications that have been filed. Filing serial applications is an excellent tool to accomplish this. In addition, invention ownership determination is an ongoing process; therefore, it is key that when new physician team members join and participate in early clinical evaluations, appropriate contracts are in place to guarantee that any and all new disclosures will be owned by the company. Failure to ensure that title to all the suggested designs changes/improvements is held by the company may lead to issues once product sales start.