The science, art and strategy of drafting patent claims

Once you’ve determined your idea is patentable, the first step of moving forward with the preparation of a patent application is to draft the claims.

Claims define the scope of protection that the invention will receive. Of course everyone wants the broadest claims possible because that will provide the largest scope of protection. But for many areas of science and technology – particularly for biotech, pharma, and software-based products and applications — the United States Patent and Trademark Office will view broad claims with skepticism.

Successful patent innovations, therefore, require an in-depth understanding of how the claims will be interpreted, careful use of language and a focused legal strategy.

Here’s why.

Up until 2012, the Supreme Court had decreed that “anything under the sun that is made by man” was patent eligible. Since then, the Supreme Court has started to focus on what is not patentable.

Abstract ideas or concepts, naturally occurring products, a natural phenomenon and laws of nature are not patentable. This includes everything from a rock, snow pinnacle, or DNA to making ice by freezing water, scientific theorems (E=MC2) and algorithms.

Given that the foundations of science and technology are rooted in the natural world and ultimately rely on abstract ideas and laws of nature, it is critical to ensure that the invention will not be found to be directed to non-eligible subject matter.

Further complicating the patenting process is the recent shift in patent laws. Because the United States has moved to a First-Inventor-To-File system, the early filing of applications is far more important than it used to be. However, if an application is filed too early, the description of the innovation may be incomplete. This can be particularly problematic if what is missing is needed to place the invention into the eligible subject matter realm.

Consequently, it is more important than ever to consider timing when filing applications.

Provisional applications help address the timing issue. Too often entrepreneurs think that once a provisional application is filed they don’t have to think again about protecting the invention until it is time to “convert” the provisional application to a standard utility application. Perhaps this is true if the provisional application was drafted as though it actually were a utility application and contains all aspects of the invention except the actual results of the experiments described in the application.

However, this is generally not the case.

Maybe what is missing would remove the innovation from the abstract idea/natural product/natural phenomenon category. Maybe the experiments did not produce the expected results and needed to be redesigned.  Maybe it became evident that another feature was critical to the performance of the invention. Perhaps additional prior art was found that necessitated a rather major change in the invention.  Or – most frequently – the provisional application was drafted in a “hurry-up” fashion with the thought that “we can fix it later.” In any of these cases the provisional application filing date may not support what the utility patent actually describes and claims as the invention.

The adage “file early and often” is actually a good one. The United States Patent and Trademark Office provisional application filing fee is minimal ($260/$130/$65 depending on the size of the business), so multiple provisional applications can be filed and their priority dates claimed in a single utility application. And if the first provisional application is drafted as though it were a utility application, then the changes made in subsequent provisional applications are minimal and not so expensive.

If it later becomes clear that the first provisional application filed is no longer desirable – either because the invention has changed or because additional time is needed to perfect the invention for a utility application – the first provisional application can be abandoned without losing an entire year and subjecting the invention to another year of available prior art.

This is particularly important when the invention is close to “patent-ineligible” subject matter.  As an example, say that the innovation is the discovery that Protein Y, which is produced in extraordinarily low amounts by people having Disease Z, can be chemically synthesized and can actually be used as a treatment for Disease X.  Protein Y is not eligible subject matter because it is a naturally occurring protein (at least in people with Disease Z).  So it makes no sense to file an application to Protein Y because it will not be recognized as patentable subject matter, even if Protein Y is artificially made.

But further experiments show that Protein Y can also be isolated from recombinant E.coli, and has a different phosphorylation pattern then Protein Y that is isolated from patients with Disease Z.  Furthermore, Protein Y is not present in any mammals except for people with Disease Z and is not present in yeast cells.

Entrepreneurs file a provisional application for Protein Y isolated from recombinant E. coli.  Then entrepreneurs find that recombinant expression of Protein Y in yeast provides a different glycosylation pattern than that found in humans and E. coli.  So they file a second provisional application directed to Protein Y with the yeast glycosylation pattern. Even further studies show that the effectiveness of Protein Y for treating Disease X is increased when Protein Y is transported into the cell nucleus via an added transmembrane sequence. Entrepreneurs file a third provisional application directed to Protein Y having an added transmembrane sequence.  Entrepreneurs then file a utility application approximately three months later at the one year date from provisional application number one. The utility application claims priority to provisional applications 1 – 3.

The claims are directed to (1) Protein Y with E. coli phosphorylation, (2) Protein Y with yeast glycosylation, and (3) Protein Y with a transmembrane leader sequence that facilitates transport into the nucleus. Examination begins and the Examiner finds a reference for recombinant Protein Y produced in E. coli that predates provisional application number 1.  She also finds a reference for Protein Y with yeast glycosylation, but this reference is after the filing date of provisional application number two.  Because the second provisional application was filed, the claims to (2) Protein Y with yeast glycosylation are “saved” by the earlier filing date.

Had entrepreneurs waited until the original one year date to add all of the other information discovered during the priority year they would have been prevented from obtaining claims to Protein Y with yeast glycosylation, which happens to be the most effective and least expensive treatment.

While changes in the law make it more difficult to obtain broad protection for innovations, a focused approach to application preparation and filing can ensure that an innovation can obtain solid protection without unduly compromising the scope of the protection.

Susan Gorman, Ph.D., Esq., is principal of Gorman IP Law, a law firm focused on helping companies leverage intellectual property assets to maintain a competitive advantage, enhance market share, plan for growth and better manage resources and expenses. Through a proprietary process, Gorman IP Law helps businesses build a formal IP strategic plan that defines your business goals, establishes benchmarks and allows you to better project costs. Dr. Gorman can be reached at susan.gorman@gormaniplaw.com.

The information contained herein has been prepared by Gorman IP Law, APC, for informational purposes only and is not legal advice.