With reduced adaptability, strategic planning will prove essential for successful biotech prosecution. Begin with drafting a focused application that provides a strong starting point for prosecution.
In this initial process, companies should work closely with their patent attorneys to define the invention carefully. Searches should routinely be done to identify patentable features of the invention. In this way the specifications and claims can be centered around truly novel features of the invention.
In some cases patentability assessments may identify distinct inventions that could form the basis for separate filings. If independent applications are made, the claimed inventions and text in each should be distinct. Overlapping text sometimes creates a presumption that the applications contain patentably indistinct claims, triggering extra burdens. Patentability searches may prove to be a worthwhile investment that can ultimately reduce long-term prosecution costs.
A comprehensive original claim set capturing all aspects of the invention maximizes an applicant’s opportunities to pursue divisional applications, which are not subject to the same restrictions as continuation applications or RCEs. By also filing an SRR, an applicant can encourage an examiner to issue a restriction requirement, permitting the subsequent filing of divisional applications, and can include claims beyond the 5/25 limit.
Strategic planning also requires judicious use of permitted continuations and RCEs, as each one represents a valuable opportunity to restart prosecution and to introduce the latest evidence or claims.
For each application, instead of claims of the broadest scope, companies should consider first focusing on the most valuable but realistic claims to ensure that they get the necessary protection for their business. Focusing exclusively on broad claims at the expense of narrower claims of substantial value may lead to missed opportunities.
A concerted effort should be made to persuade the examiner of as many claims as possible. When he or she rejects claims, all arguments for patentability should be presented. A discussion can be extremely helpful both for understanding the examiner’s concerns and for identifying what claims he/she may accept.
Inventors should also prepare cases for appeal at an early stage of prosecution. Because of the limited opportunities to file a continuation or RCE, this may prove to be a viable alternative. Applicants should promptly introduce any helpful evidence such as declarations or scientific literature at the first available opportunity.
If such details are presented late, the examiner may refuse their admission unless an RCE or continuation is filed. If the appeal is successful, the rejections will be withdrawn and in many cases the patent will issue. Even an unsuccessful appeal can suggest evidence or claim language that may be useful in a continuation.
Remembering the big picture of a company’s IP landscape and its relationship to various business plans will become even more important for prosecution under the new rules. Companies should consider consolidating related patent applications with one person or one law firm. This strategy may also be important for compliance with the duty of disclosure and the new responsibility related to notification of related applications.
Companies should also use the two continuation opportunities to reevaluate the claims and their correspondence with current and future business needs. If the original claims no longer correspond to the changed business plan, a comprehensive new claim set should be drafted and filed in a continuation to cover future needs.
Biotech patent prosecution may indeed face a tougher road ahead. Successful strategic planning, however, could turn new challenges into opportunities for speedy prosecution, reduced long-term prosecution costs, and stronger patents.