A patent application is a well-crafted document that has many different requirements for it to be effective. One of the requirements is the written description requirement. The Manual of Patent Examining Procedure states that “to satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention.” To a layperson, this means that an inventor must describe his or her invention in writing sufficiently to show the inventor had possession of the claimed invention.
In Tobinick v. Olmarker (Fed. Cir. 2014), the patent application at issue related to the treatment of spinal nerve injuries, such as those associated with herniated discs. The invention was claimed in such a way as to require a drug to be “administered locally”. The dispute centered around whether the patent application satisfied the written description requirement for claim terms requiring the drug to be “administered locally.”
The patent application described various techniques for administering the drug to the patient. One such technique is an epidural injection adjacent to the site of the disc herniation. The patent application further described that the epidural injection could be as far away as 10 centimeters from the spine. The patent application described other techniques such as systemic administration. The Patent Trial and Appeal Board (PTAB) found that administering locally required administering the antibody directly to the site where the antibody is intended to act, to the location where a “nucleus pulposus” was causing the symptoms of the nerve disorder. The PTAB found that the patent application did not distinguish between administering the drug locally or non-locally, and thus, the patent application lacked adequate written description.
Although the patent specification also described both local and system administration of the drug, the Federal Circuit reversed and held that the written description requirement is satisfied as long as there is at least one embodiment that meets the claim limitation. The specification need not make such a distinction. In this case, since the patent application disclosed administering the drug within the area of the root nerves affected by the herniated disc (i.e., locally administered), the patent application met the written description requirement for the “administered locally” aspect of the claimed invention.
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