Myriad, Mayo, Chakrabarty, Oh My: Strategies for Life Sciences Diagnostics - Part III

In Part III of “Myriad, Mayo, Chakrabarty, Oh My:  Strategies for Life Sciences Diagnostics” (links to Part I can be found here and Part II here), we consider the use of examiner interviews and how they can assist into obtaining allowable diagnostic claims. An examiner interview is not a new tool for the prosecutor; it gives an applicant an opportunity to discuss the prior art, the invention, and potential claim amendments in one instance with an examiner. While the gold standard is an in-person interview, telephone interviews are the norm due to today’s prosecution budgets and the USPTO hoteling options for examiners.

Regardless of the type of interview conducted, it’s an opportunity to gain an examiner’s undivided attention and directly discuss the stumbling blocks facing the application. While an Office Action sets forth the basics of the rejection from an examiner, it may not necessarily provide the entire picture an applicant needs to fully address the examiner’s concerns. Further, applicant and examiner may read aspects of the rejection differently or with different emphasis. Now, add to the mix the current flux of what constitutes patentable subject matter; the scale tips in favor of conducting an examiner interview when faced with a 101 rejection.

The USPTO’s website contains examination guidelines, examples, and other materials directed to subject matter eligibility. (Prosecution Pointer:  The USPTO’s webpage includes a summary chart of recent 101 court decisions that is updated regularly.) But, just as an applicant and examiner can read Office Actions differently, examiners often view and apply the guidance materials differently. Interviews enable an applicant to gain understanding on how a particular examiner is applying the guidelines and what it will take to overcome the subject matter eligibility rejection. Is the 101 rejection a brick wall, a mountain, or a mole hill?

Each art group unit has a “101 specialist.” Depending on the situation, it may be beneficial to request to have a “101 specialist” present during the interview. Given the specialist’s experience in the 101 arena, he/she may be able to shed more light on what is triggering the rejection, the Office’s rationale, potential claim amendments, and other options. Claim amendments are another tool for overcoming 101 and can be a discussion point during the interview. Look beyond the dependent claims for claim amendments; review and mine the specification for additional options for amendments. Another consideration is whether to model claims after those in the USPTO examples. In Part IV, we will examine the USPTO’s life sciences examples and the claims.