Strategies For Meeting the Challenge of Patenting Nanobio Inventions

INTRODUCTION
Historically, convergent technology has been a term of art connected to information technology (IT). In IT, it describes the convergence of seemingly incompatible technology platforms that once combined; provide products or services with divergent applications. An example of traditional IT convergence is the combination of personal computers and the world wide web. Apple Computer’s recent launch of the iPhone™ is a more recent example. It epitomizes the convergence of communications and media technologies into one product and promises to be the dawn of the next wave in which voice, data and image technologies are combined. 

Convergent technology is appearing in the life science sector as well. Product-directed applications of biotechnology, nanotechnology, medicine, chemistry and engineering promise new drugs and therapies for a wide range of applications in disease screening, diagnosis, and treatment.¹ Convergent biomedical products are already on the market. For example, drug coated stents are lead products for several multinational health care companies such as Johnson & Johnson, Boston Scientific, and Medtronic.²  Convergent biomedical products are big business; the estimated market size of convergent/combination products in 2004 was around $6 billion and is expected to reach $10 billion by 2009.³

Nanobiotechnology or “nanobio” is a more recent entry into the realm of convergent technologies by combining existing fields such as biology, chemistry and engineering. Although research and development in nanobio is still marginal compared to combination products like drug-coated stents,⁴ its numerous applications in tissue engineering, biomaterials, gene and protein delivery, targeted or personalized medicine have identified it for significant growth. 

THE NANOBIO PATENT
While the promise of nanotechnology may be just around the corner, the challenges to managing the patents that protect the intellectual capital behind the products are here today. Because the use of convergent technology for divergent applications is inherent in this technology, nanobio patents require a thoughtful strategy throughout the application process. Additionally, since patent claims define the ultimate exclusory right, careful attention must be given to describing with sufficient detail how to make and use the technology across the complete range of their potential applications. For example, if one seeks to patent a new nanoparticle for drug delivery, one would likely claim the process of making that particle, the nanoparticle itself, devices incorporating the nanoparticle, processes for incorporating the particle into the devices, use of the nanoparticle in combination with various drugs or formulations incorporating the nanoparticle, diagnostic use of the nanoparticle, therapeutic use of the nanoparticle as well as any non-medical applications.  

When such divergent claims are presented for examination in the United States Patent and Trademark Office, the examining authority will issue a “restriction requirement” requiring the patent applicant to select a single aspect of the invention for initial examination. The remaining claimed inventions are held in abeyance until such time as the applicant elects examination of those inventions through the filing of divisional applications. This one-invention-at-a-time approach serves more narrowly focused technologies quite well, usually because the invention initially claimed at the time of filing may well be the ultimate commercial product. Divergent technologies, however, are not quite so well served because, as explained above, nanobio patent applications are multi-dimensional and likely contain several inventions. Moreover, it is not unusual for a patent applicant’s commercial focus to change from the date of filing an application to patent grant. Thus, the initially elected and examined invention may not provide the necessary protection when issued as a patent. 

INITIAL STRATEGIC PLANNING FOR THE APPLICATION PROCESS
In general, patents are expensive to obtain and maintain. The expense is compounded by the number of distinct “inventions” within a patentable discovery. Thus, while one initial application can be filed claiming the discovery and its applications, the practice of restricting out the separate inventions to separate patents for each invention can exponentially increase the cost of covering the full range of a discovery. As a general rule of thumb, the most commercially valuable embodiment of the claimed invention should be elected and pursued in the first filed application. Secondary technologies (inventions) are pursued in one or more subsequently filed divisional applications. 

Even when the most important invention is pursued first, the time to patenting may be too long, especially when others may be copying or developing the technology or when a patent will facilitate raising capital. The average pendency for nanotechnology patents has increased from approximately 30 months in 1992 to nearly four years in 2005.⁵ Thus, for some inventions where a patent grant cannot be delayed or because commercial strategy has changed from the filing of the initial application, quick and efficient patent examination may be key to a company’s continued success. 

THE ACCELERATED PATENT EXAMINATION
The “Accelerated Examination Procedure”⁶ is available to U.S. patent applicants. It will provide a faster and more focused examination. The procedure⁷ is not a promise of a patent grant but rather a way to achieve a final decision on patentability within 12 months of the initial filing date of the application. 

The applicant who wishes to take advantage of this program must plan and prepare his application before filing. In addition to fulfilling the general requirements for filing a patent application, it additionally requires the filing of a special petition, paying additional fees, filing a limited and concise claim set, filing a special examination support document and agreeing to be available for several discussions or “interviews” during the examination process.  

The applicant must essentially determine up front which “invention” she seeks to patent since the number of claims cannot exceed twenty (20) in total, of which only three (3) can be independent.⁸ The cost for filing the petition is negligible, $130 for all inventors. The additional expense over a traditional patent filing will occur in conducting and analyzing the prior art search and preparing the examination support document. Proper completion of the special examination supporting document requires a detailed search of the prior art. The search must include U.S. patents and patent applications, foreign patent documents, and non-patent literature, both by text and by examination classification. Additionally, the applicant must provide a statement that a pre-examination search was conducted and disclose the search strategy including the terms and search logic. The patent classes that were utilized for the search must be identified as well. If a conventional search resource was not considered, a specific justification also must be provided. Applicants must also correlate the references identified in the search to the claimed elements of the invention and specifically call out the distinctions between the references and the claims.⁹  

In addition to meeting the filing requirements, the applicant must be willing to have a pre-action interview and timely and concisely reply to the examination reports. Failure to meet these provisions will result in the application losing its accelerated status.

CONCLUSION
Nanobio patent applications are multi-dimensional in nature because of the convergence of technologies. A single nanobio application may have to be separated out into multiple inventions each requiring its own patent application.  However, by taking advantage of the accelerated patent examination, an applicant may be able to protect the most commercially valuable embodiment of a nanobio application within a relatively short period of time by pro-actively engaging in the examination process with the patent examiner. 

While the accelerated examination procedure may not be ideal for all applicants or all inventions, it may be beneficial for nanobio inventions.¹⁰ Additionally, the accelerated examination procedure offers the opportunity for earlier and better interaction between the applicant and the examiner than is possible with the traditional examination procedure.¹¹