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
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.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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