As former Chief Judge Giles Rich proclaimed, “The name of the game is the claim.” In Part II of “Myriad, Mayo, Chakrabarty, Oh My: Strategies for Life Sciences Diagnostics” (link to Part I can be found here), we will look at claiming strategies.

Often times, the number of claims that protect an invention is overlooked and not necessarily a discussion point when drafting a patent application. And, gone are the days of 100 plus claims due to excess claim fees, but that does not mean applicants should be limited to three independent claims and a total of twenty claims, i.e., the number of claims allotted with the basic filing fee; definitely not. In an earlier post, we discussed examining the number of claims that protect an invention; the post can be found here. The number of claims should also be a strategic tool when addressing Section 101 rejections.

That is, do not be hindered by the twenty claims and instead, use claims of varying scope to see where an examiner draws the line for subject matter eligibility. Additionally, use claims of varying statutory class. Having different statutory classes may present some challenges for diagnostics but considering the diagnosis in different contexts may provide an opportunity for new independent claims and potential claim amendments. For example, using additional steps such as administering a composition with diagnosis, identifying certain compositions for administration based on diagnosis, or identifying certain subpopulations for testing may present claim opportunities. Utilizing claims of varying scope and class, it becomes more apparent what elements or combinations are triggering the rejection, and it presents an opportunity to discuss the examiner’s rationale and whether it is in-line with current precedent.

In drafting and prosecuting patent applications, the mantra is to use terms and particularly, claim terms, consistently and to define terms judiciously in view of patentability and infringement considerations. But, practitioners should also “think outside the box” or “think outside the claims”; meaning, look beyond the way in which the invention is claimed. Is there another way the invention with the necessary claim elements can be recited but from a different perspective or angle. Look at the claims with fresh eyes and try to reformulate an independent claim. The claim structure may be a sticking point and evaluating that structure may be an avenue to solve the patent eligibility issue.

Claim terms, claim scope, claim class, and claim drafting are wildly important from a patent eligibility perspective and just as important, from a post-grant proceeding and litigation perspective. Applicant does not want to overcome patent eligibility at the expense of creating targets for post-grant proceedings and/or litigation attacks. “The name of the game is the claim” still rings true today. Next up, in Part III, we will look at the USPTO life sciences examples and what we can learn from them.