Lisa A. A. Haile J.D., Ph.D. Partner, DLA Piper Co-Chair, Global Life Sciences Sector

Changes to the count system, which tracks examiners’ workflow, grant them one more hour to conduct interviews.

In today’s world of social media and technology, it seems that we don’t have nearly as many telephone or in-person conversations as we used to. In certain instances, there is no substitute for having a conversation and providing the opportunity to ask questions and answer them in real time. In the 20 plus years that I have been handling biotechnology-related patent matters, this issue has always been a problem between patent practitioners and the examiners at the USPTO.

On September 30, the USPTO set forth a proposal that would change the agency’s count system. The USPTO director, David Kappos, previously announced that “creating an examiner count system that gives examiners the time they need to do their job properly and that incentivizes compact prosecution including the use of interviews is currently job number one for the agency.” Imagine, providing a program in 2009 that would allow examiners to “do their job properly?” I was under the impression that they were doing their job properly all along.

While the proposed changes are not substantial on the face of it, they may provide for better quality examination up front during the patent-examination process, which is especially critical in areas of complex technologies including biotech.

The Count System Revamped

The count system at the USPTO provides examiners with points, or credits, that are important in their reviews and evaluations. The counts provide supervisors with an indication of whether the examiners are moving cases along and keeping up with their workload. The counts, however, are not necessarily indicative of the quality of examination or whether patent cases are actually moving forward to the issuance process versus continuing at the USPTO over many years.

The proposed changes to the count system include the granting of one additional hour to examiners to prepare for and conduct interviews. Statistics have shown that for patent cases, an interview, whether by phone or in person, can help the examiner and the applicant get to the point of patentability much quicker. Without an interview, examiners tend to recast their rejections in a similar manner as in prior office actions or even provide them verbatim with no additional information as to why an applicant’s arguments were not persuasive.

When conducting interviews, we often encourage the use of an introduction from one of the inventors; in biotechnology it would often be a Ph.D.- or M.D.-level person. The examiners typically appear more amenable to listening to these qualified individuals as opposed to hearing the same information from the attorney of record even though most biotech patent attorneys are at the Masters or Ph.D. level.

For example, recently I facilitated a telephone interview for a cardiac stem cell technology. The examiner had been hesitant to agree with our arguments on paper over the last 2–3 years. Once the inventor was on the phone, though, explaining why her stem cell technology was new and not obvious over the references cited by the examiner, the examiner seemed to arrive at the gee-whiz moment much more quickly than reading the arguments on paper.

In fact, the examiner became excited about the possibilities of the invention and tried to work with us to arrive at claim language that he felt would overcome the existing prior-art rejections and satisfy his supervisor.

That examiner interview was not unlike many I have conducted over the years in various fields including diagnostics and therapeutics. More often than not, there is that moment with examiners where they truly appreciate the technology and the invention because they take the time to listen and ask questions.

Let’s hope that the proposed changes will afford the examiners more opportunities to listen to the inventors (and attorneys!). Perhaps an atmosphere will be created where examiners feel they are doing their job properly, morale will improve, attrition will decrease, and there will be more consistency and efficiency in the U.S. patent examination process.

Lisa A. Haile, J.D., Ph.D., is a partner at DLA Piper LLP U.S. and co-chair of the firm’s global life sciences sector group. Email: [email protected].

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