Harvesting Engineers’ Ideas through Invention Disclosure

Medical device companies make their money by developing innovative products and selling these products to the surgeon and hospital marketplace. The key precursor to the development step is the “harvesting effort.”

What is the harvesting effort? It is the internal process usually performed jointly with legal and R&D departments in which organic ideas are hatched to meet clinical/marketplace needs. The harvesting effort begins with product development engineers who come forward and submit their ideas for internal review and vetting. Why is this stage of the product development cycle so difficult? Often engineers are so busy that they do not have the time to sit down to brainstorm and document their idea. Many companies have recognized this stumbling block and provide financial incentives to their engineering staff to make the idea disclosure step more attractive. Companies that do so are usually swimming in submitted disclosures, while those that do not provide such incentives have to put forth a significantly higher level of harvesting effort to get any disclosures from their product development engineers.

Remember: Ideas are not patentable. Ideas are a concept, not an invention. An invention, though, is patentable. After a person comes up with an idea, he must put in the effort to move it from a concept to something more complex. This happens by sitting down and further developing the idea to give it more substance until it reaches the point of conception.

An example of this process may look like this: A surgeon comes to a company and complains that he has difficulty holding onto a patella to reset it when doing a total lance procedure. One of the knee engineers has an idea for holding onto the patella. He takes the initial concept and starts reviewing different ways to secure the patella, eliminating the bad ones and retaining the good ones. Finally the engineer decides on a way to hold the patella using a unique construct. He then expands on the construct to develop a user friendly clamping mechanism that can be combined with the construct. The engineer then takes this instrument idea one step further and uses a 3D printer to produce a prototype. EUREKA, the product engineer has moved the idea from a concept to an invention.

Once the idea transitions to an invention, the harvesting effort moves on to the invention disclosure stage. Most companies have their own form style or use the form developed by their outside patent attorney. The invention disclosure process, from which a completed written form is produced, has a definite purpose: (1) Describe the invention in detail, (2) Explain how it operates, (3) State the advantages of the invention, (4) List the names of the inventions, (5) Reveal any prior disclosures, uses or sales, (6) Address questions of existing prior publications, and (7) Identify any known prior art and/or competitors.

Companies may have ulterior motives for asking the engineers to complete the invention disclosure form. This type of document helps the inventor to organize her thoughts and give a clear explanation about her invention. Once completed, the form serves as evidence of “conception” of the invention and arguably could be interpreted as constructive reduction to practice.

When meeting with a new engineer or just refreshing the engineering staff on the reasons to fill out the invention disclosure form, several tips should be emphasized. The first is to describe what specifically makes your invention different from others and provide detailed answers as to why your invention is better and what makes it better. Answers to these questions will help the patent attorney draft the application to emphasize these points as well as use them during prosecution if an obviousness rejection is received. A second tip is to explain any unusual terminology that may be used. The third tip is to describe in detail all of the parts of the invention. If possible, use computer models or sketches to ensure completeness. Also, describe how these parts work together and how they are different from the prior art/competition. The fourth tip is to ask the inventor why he did things in the way described and not in some other manner. Inquire further as to how he could have accomplished the same end but differently. These questions push the inventor to think of alternative designs and methods that in the future may be competitor design-around attempts. The fifth tip dovetails with the fourth in that it also motivates creative forethought on the part of the inventor that can yield predictions regarding the potential derivations of future competitors: Tell the engineer to allow her imagination to run wild when answering these questions and not to limit herself to the existing prototype or computer models.

Explain that they need to think outside of the box (because that is what their competitors will do) and figure out other ways the invention may work, even in less-desirable but still useful ways. A sixth tip is to have the inventor list what is old and what is new with the invention as well as describe any part of the design that has been used before (even if for a different purpose). Ask if the same functionality this invention achieves has been accomplished by anyone else in the past. The seventh tip is to play the devil’s advocate and ask the inventor to describe what the possible problems are with the invention and under what circumstances the invention will not work and why. Also ask the inventor to list the critical parts, design elements, dimensions, etc. of the invention. The final tip is to get drawings, whether sketches or computer generated models of the invention. Having a picture of the invention in front of the inventor when filling out an invention disclosure form facilitates the flow of constructive feedback and explanation.

As a best practice rule, companies should develop a process to maintain control of the harvesting effort. The legal department should control the intake of all the forms, with each being time and date stamped. If possible, the forms should be cross-referenced to an inventor’s lab book. The completed forms should be catalogued and retained in a central location with access limited to only Legal and R&D personnel. The company should also set up a review process to determine whether there is enough information to move forward with the invention evaluation step. This evaluation step is usually performed by a designated individual or a committee, with the decision being to: (a) not move forward, (b) hold the invention, (c) request further development or (d) file a provisional patent application. Once such a decision is made, the Invention Disclosure Form is secured to be available if needed in the future for litigation or inventorship reasons.

An invention disclosure form will ask questions, such as:

    1. Name
    2. Date of Submission of the Disclosure
    3. Invention’s name
    4. Text and drawings of the invention
    5. What is the purpose of your invention (in general terms)?

         •   What is the problem that is to be solved by your invention?
         •   How does your invention solve the problem?
         •   What were the prior methods, techniques or existing devices used to accomplish the purpose or
             comparable intent of your invention?
         •   What were the disadvantages of these methods, techniques or devices?
         •   What are the advantages of your invention over the prior methods, techniques or devices?
         •   Where will your invention be useful and to what extent will it be used?
         •   Does your invention solve any problems related to other prior methods, techniques or inventions?
    6. Provide the earliest date and place your invention was conceived and include a brief description of the circumstances
    7. State the date and present location of first sketch or drawing of invention and first written description.
    8. List whether the invention has been tested or a prototype has been constructed, along with date, place, results and witnesses
    9. State the names and dates of any disclosure of your invention to other persons
    10. Has any publication, submission for publication or written report of your invention been made?
    11. Detailed Description of the Invention

Harvesting new ideas from a company’s workforce is the lifeblood of most medical device companies. A successful effort ensures that all possible inventors are fully informed about what is required to complete an Invention Disclosure Form, how to obtain and submit the form and what may happen post-form submission. Having this knowledge, inventors will feel more comfortable with actively participating in the process.

This article was written for informational purposes only and should not be interpreted as legal advice. Please consult with a licensed attorney, if you have any questions.

John W. Boger is a partner with the boutique Intellectual Property Law Firm of Heslin Rothenberg Farley & Mesiti P.C. and is the Chairman of the firm’s Medical Products and Technology Practice Group. Before attending law school, Mr. Boger worked for eight years with a large orthopedic device manufacturer in various product development and marketing positions. He can be reached at 518-452-5600 or by email.

Heslin Rothenberg Farley & Mesiti P.C.