Case Studies

Pharmaceutical Formulation Patent Application – Chewables

Challenge: Pharmaceutical formulations can be difficult to patent. There is a limited constellation of ingredients, and in recent years, few openings of novelty. This client had a new idea for a much more efficient manufacturing process for a chewable pharmaceutical formulation, that promised to be considerably less expensive than molding gummy-type formulations. Moreover, the client wanted the patent as fast as possible for the benefit of investors.

Action/Solution: we worked closely with the inventors to draft a suitable patent application. This involved clarifying, to a greater degree than the client originally thought, key aspects of the invention. The application was drafted and filed promptly. “Track One” prioritized examination was elected for this case. The application was allowed within 12 months of the non-provisional filing after two office actions and several calls with the examiner, where all concerns were carefully aired and addressed.

Protein Chemistry Patent Application

This invention from a major academic institution was a method for analyzing a protein sequence and modifying the amino acid sequence in such a way that the protein structure and function was unlikely to be altered, but the crystallization properties would be greatly improved. The invention promises better access to biological mechanisms for any medical indication, including cancer treatments, Alzheimers Disease, and aging conditions.

Challenge: The examiner acknowledged the novelty of the invention but alleged the case was not patentable subject matter under Sec. 101. The examiner alleged the claims were merely an abstract series of steps that only identified natural properties. A major law firm worked on this case for four years and several office actions unsuccessfully.

Action/Solution: after we took over this case, we took the time to make a careful study of the file history and identified several openings for viable arguments to the examiner. Our campaign involved an inventor’s declaration clarifying the issues and several examiner interviews. The case was allowed and has issued as a US patent.