To obtain a patent, a patent application must be filed with the United States Patent and Trademark Office (USPTO) and meet the Written Description Requirement under 35 U.S.C. 112. Meeting this requirement isn’t as straightforward as it seems; a lack of sufficient description can render a patent invalid, as shown in Novozymes v. Dupont (Fed. Cir. 2013). To determine if the written description requirement is met, the application must clearly describe the invention in a way that demonstrates the inventor had possession of the claimed invention at the time of filing. The Novozymes case illustrates why this requirement is crucial.
The Case of Novozymes v. Dupont
Novozymes developed and patented a thermo-stable enzyme, initially describing only one or two specific species but broadly indicating that other variants were possible. One variation involved modification at any one of 33 mutation sites. After Novozymes’ initial patent, Dupont researched, identified, and obtained a patent on the preferred mutation site (site 293). In response, Novozymes filed a continuation application, claiming the mutation at site 293 to establish priority to the parent application.
For Novozymes’ continuation patent to be valid, its original application needed to support the specific mutation site 293 in order to avoid the Dupont patent as prior art. Though a jury initially found sufficient written description support for the claim, the court overturned this decision, stating that no reasonable jury could conclude that the original Novozymes application provided sufficient written description for mutation site 293.
The Court’s Perspective on Written Description in Unpredictable Fields
In fields like bioscience, courts require more than a general roadmap; they expect concrete indicators of the specific invention claimed, often supported by data or explicit examples. In Novozymes, although each claim limitation was disclosed in the original application, the court determined that the application failed to describe a functional, thermo-stable alpha-amylase variant meeting all claimed properties. The court noted that, while the original application included each individual limitation, it lacked a clear depiction of a single species or “blaze marks” guiding a skilled investigator toward the specific mutation at site 293 among numerous alternatives.
The court also underscored that the absence of test data weakened Novozymes’ claim to possession of the specific variant. The court stated, “To actually possess the variant enzymes claimed in the ‘723 patent would have required Novozymes to confirm its predictions by actually making and testing individual variants, or at least identifying subclasses of variants likely to possess the claimed properties, which it did not do before filing the [original patent] application.”
Writing Patent Applications in Unpredictable vs. Predictable Fields
For unpredictable fields like biosciences, courts are increasingly looking for test data to confirm that the inventors had possession of the invention at the time of filing. Without sufficient data, an application may not meet the Written Description Requirement if it only broadly suggests possibilities without clear support for specific claims.
In more predictable fields (e.g., mechanical or electrical inventions), courts may be more lenient, allowing for a broader mention of variants that could later be refined in claims. However, even in these fields, it’s advisable to detail as many variations and embodiments as possible, ensuring that key elements have clear descriptions. Including additional examples strengthens the application’s validity, as it provides stronger written description support for any future claims.
The Importance of Consulting a Patent Attorney
Meeting the Written Description Requirement demands detailed, precise descriptions. Consulting a patent attorney can help ensure your application includes the necessary information and examples to support your claimed invention fully. While writing a patent application yourself might save short-term costs, this approach could prove costly during litigation if the validity of your patent is challenged. Hiring a skilled attorney can help secure stronger, more enforceable patents.
I’m here to help with any questions regarding the Written Description Requirement or other aspects of the patent process. Contact me at (949) 433-0900. As an Irvine Patent Attorney, I serve clients across Orange County, Irvine, Los Angeles, San Diego, and surrounding cities. Feel free to share this article with others who may find it useful.