The #CRISPR Interference: Doudna v Zhang. My thoughts. $EDIT et al.


Hey all,

Having participated in an Interference Proceeding a few years back, I thought I would share some thoughts on the current CRISPR Interference.

1. Interference Proceedings are all about first to invent (F2I). But you knew that already. What you may not have known is the “equation” for proving F2I ---> F2I = Conception (C) + Reduction to Practice (R2P).

2. C = More than just "an idea" in your brain. C has to be so clearly defined that a scientist could practice the claimed invention without undue experimentation. So, while one would obviously conceive of using CRISPR in eukaryotic/mammalian cells (duh, that is where the $ is), this thought alone will not suffice. Invention need more. Specifically, you need R2P.

3. R2P = Can be demonstrated (i) Actually or (ii) Constructively. “Actual” R2P pretty much means one has the functional eukaryotic CRISPR system in their hands. This is similar to 35 USC §112 Written Description (WD). As you would guess, proving WD is hard.

“Constructive” R2P means that while you don't have it in your hands, you describe it in such detail that an ordinary scientist would be convinced that you essentially have eukaryotic CRISPR in your hands. This nearly always happens by filing a US patent application. This is similar to 35 US §112 Enablement (E). E is easier to satisfy than WD.

4. Interferences may consist of both "Priority" issues (who invented first) and "Patentability" issues (e.g., the usual suspects, anticipation (§102), obviousness (§103) and Enablement/Written Description (§112)). One can attack claims on both (i) priority as well as (ii) patentability.

5. Other confusing stuff: Conception & its relationship to Reasonable Diligence (RD). You can be first to C, but last to R2P and still be the true inventor as long as RD existed from time of C to time of R2P without interruption. C ---------------RD----------------->R2P

NOTEWORTHY: Doudna's still pending application was filed less than 24 hours (March 15, 2013) before the new America Invents Act (AIA) patent laws (i.e., first to file) became effective. Zhang's first application was filed 7 months later (October 15, 2013). So, but for 1 day, this could've been a post-AIA "Derivation Proceeding", not an "Interference Proceeding".

NOTE: Presumably, since the claims recite “Cas9”, all other non-Cas9 CRISPR amenable endonucleases are not affected by this Interference. So, no single group will "own" CRISPR.

Bottom Line: The Interference “count” recites “eukaryotic cell” CRISPR methods. A very quick look suggests that pending Doudna application may not be Enabled nor satisfy Written Description for eukaryotic cells (maybe just enabled for in vitro biochemical systems). Realize the most recent Doudna claim set has no eukaryotic/prokaryotic/in vitro claim limitations, so quite broad - maybe too broad IMO.

DrZ


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