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Nov 1, 2007 (Vol. 27, No. 19)

Tough Road for Biotech Patent Prosecution

Strategic Planning Essential Under Amended USPTO Rules for Continuations and Claims

  • The USPTO in August released its new rules governing claims and continuations for patent applications. This new paradigm implements some of the most significant changes in the recent history of U.S. patent law practice. These include limiting continuation applications and the number of claims that can be filed.

    The changes significantly restrict flexibility in the patent application process. Many fear these amendments may wreak havoc in the biotechnology industry, as companies have heavily relied on flexibility in the past to protect their complex technologies.

  • Latest Rules Bring New Limits, Duties, and Tools

    The new rules become effective on November 1 and will impact not only applications filed after that date but also many pending patent applications.

    The amended regulations will normally permit no more than two continuations and one request for continued examination (RCE) in an application. In general, no more than five independent claims and 25 total claims (the 5/25 limit) will be permitted in one filing. Claims pending in related applications that are deemed to contain at least one patentably indistinct claim also count against the 5/25 limit.

    If inventors wish to pursue claims beyond the 5/25 limit, they will now have to search and examine their own applications and submit the results as an examination support document (ESD).

    An ESD must include a search statement including search strings and databases used, a list of references deemed most closely related to the subject matter of each claim, an identification of limitations disclosed by each reference, a detailed explanation of patentability, and a showing of support in the specification of each limitation. Preparing an ESD will prove to be so burdensome that it will rarely be a viable option.

    The latest requirements also included a duty for applicants to keep the USPTO informed of commonly owned relevant pending applications or patents. If they have filing or priority dates within two months of each other and at least one common inventor, details must be disclosed on a timely basis.

    If the commonly owned applications have substantially overlapping disclosure and a common filing or priority date, the new paradigm creates a rebuttable presumption that they contain at least one patentably indistinct claim. If the applicant cannot successfully argue against this assumption, all these claims will be counted against the 5/25 limit.

    The new rules allow an inventor to file an unlimited number of divisional applications as long as they contain only claims that are deemed to cover disclosed but distinct inventions.

    Intriguingly, the changed guidelines will create a tool, called a suggested requirement for restriction (SRR), to facilitate divisional application practice. If a filing contains claims directed to more than one invention, the petitioner may file an SRR suggesting how the claims should be grouped into distinct inventions. An SRR, however, must be accompanied by an election of an invention containing no more than five independent claims and 25 total claims.

    The biggest challenge facing the biotech industry is that the new rules take away the flexibility needed to prosecute its often complex applications. Under the old decree, continuations or RCEs were often used to introduce novel evidence and claim limitations to address issues raised during prosecution.

    In addition, because biotech companies typically file their applications at an early stage of business development, RCEs and continuations were often used to restart prosecution when they needed new claims to correspond more closely to a revised business plan. Generally, more claims are presented in a biotech application to provide a range of protection and to cover the many aspects of complicated inventions. Without such flexibility many fear prosecution will be handicapped.

  • Strategic Planning

    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.

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