12:00 AM
Aug 27, 2007
 |  BioCentury  |  Regulation

PTO narrows the fairway

The U.S. Patent and Trademark Office issued a final rule last week that limits the number of continuations and claims allowed for patent applications. Although PTO's goal is to make the patent examination process more efficient and effective, IP specialists say the rule will cost more in time and money for developers of early-stage platform technologies - typically small biotech companies and universities that have the least resources to spare - and increase the chances that an invention will be eclipsed by prior art.

Ron Eisenstein, a partner at Nixon Peabody LLP, noted it can take years to flesh out a proper description of an early-stage platform technology in a patent application. The applicant often needs a few rounds of discussion with the PTO before an examiner starts to understand the invention.

After this first set of interactions, he said, the examiner often rejects some or all of the claims. Before the new rule, the applicant could have filed an unlimited number of requests for continued examination (RCE).

Alternatively, an applicant could have refiled the claims under an unlimited number of continuation applications. If new data were being added, for example from animal studies, then the applicant could refile the package as a continuation-in-part (CIP) application or an RCE.

Under the old regime, all of these applications would have maintained the original application's filing date, which is important because it made them senior in an interference proceeding in the U.S., gave them a priority date in an international patent application, and meant that they would not be invalidated by art that was published after that date.

But the ability to use these tools will change...

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