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February 16, 2017

Comments

If the expectation of success of CRISPR/CAS9 in eukaryotes is the deciding factor, the following reference published 29 January 2013 might help UCB's case, if not used already. In this reference HEK 293T and HeLa cells were used. HEK 293T cells are human kidney cells (eukaryotic)(https://www.atcc.org/Products/All/CRL-11268.aspx), HeLa cells are Henrietta Lacks' cervical cancer cells (also eukaryotic)(http://www.the-scientist.com/?articles.view/articleNo/48492/title/Henrietta-Lacks-s-Family-Seeks-Compensation/):

Abstract: "the CRISPR-Cas system of Streptococcus pyogenes as programmable RNA-guided endonucleases (RGENs) to cleave DNA in a targeted manner for genome editing in human cells. We show that complexes of the Cas9 protein and artificial chimeric RNAs efficiently cleave two genomic sites and induce indels with frequencies of up to 33%."
Cho et al., Targeted genome engineering in human cells with the Cas9 RNA-guided endonuclease, Nature Biotechnology 31, 230–232 (2013), Published online 29 January 2013.

Supporting Information: Targeted genome engineering in human cells with RNA-guided endonucleases (http://www.nature.com/nbt/journal/v31/n3/extref/nbt.2507-S1.pdf).

"HEK 293T cells were co-transfected with Cas9-encoding plasmid (0.8 μg) and the RFP-GFP reporter plasmid (0.2 μg) in a 24-well plate using Lipofectamine 2000 (Invitrogen). At 12h post-transfection, sgRNA (1 μg) prepared by in vitro transcription was transfected using Lipofectamine 2000. At 3 d post-transfection, transfected cells were subjected to flow cytometry and cells expressing both RFP and GFP were counted.

HeLa cells transfected with the C4BPB-specific RGEN (160 μg sgRNA) were fixed on glass slides and incubated first with anti-TP53BP1 rabbit polyclonal antibodies (Bethyl Laboratories) and then with Alexa Fluor 488-conjugated secondary antibodies (InvitrogenMolecular Probes). Cells were mounted in the presence of DAPI (Sigma) and examined under an immunofluorescence microscope (Zeiss). DAPI (blue) and TP53BP1 (green)
images were merged. Etoposide (1 μM) was used as a positive control. The average number of foci per cell and the standard error of the mean are shown at the bottom of each picture.

Dear CIP: I think the priority date in question was in 2012, so this (like many of the references cited by UC/Berkeley) was post-filing. The question is whether the skilled worker would have had a reasonable expectation of success at that time, so the Board was correct in not crediting this evidence as showing or supporting such an expectation.

Thanks for the comment.

"Involved Applications and Patents" (see "Decision on Motions" pg 51 http://patentdocs.typepad.com/files/decision-on-motions.pdf)

UC
Application Number Filing Date
13/842,859, 15 March 2013 (61/652,086 provisional priority date May 25, 2012).

61/652,086 [00127] Non-limiting examples of suitable eukaryotic promoters (promoters functional in a eukaryotic cell) include those from cytomegalovirus (CMV) immediate early, herpes simplex virus (HSV) thymidine kinase, early and late SV40, long terminal repeats (LTRs) from retrovirus, and mouse metallothionein-1. Selection of the appropriate vector and promoter is well within the level of ordinary skill in the art. The expression vector may also contain a ribosome binding site for translation initiation and a transcription terminator. The expression vector may also include appropriate sequences for amplifying expression. The expression vector may also include nucleotide sequences encoding protein tags (e.g., 6xHis tag, hemagglutinin tag, green fluorescent protein, etc.) that are fused to the site-directed modifying polypeptide, thus resulting in a chimeric polypeptide.
[00152], [00165],[00175], [00198], [00202], [00216],[00218],
claim 69. The method of Claim 68, wherein the cell is a human cell. claims 99-109.

Yes, the provisional priority date was May 25, 2012. This is related to the Jinik reference discussed in the opinion. By the time they filed their March 15, 2013 application they had included the eukaryotic disclosure but UC did not have that disclosure in their original filing.

Moreover there were no claims directed to eukaryotic embodiments. That was the basis for the decision as I understand it.

Thanks for following up.

Thanks, Kevin.
Based on what you indicated, is it fair to conclude that the listed claims and paragraphs from the provisional 61/652,086 [00127], [00152], [00165],[00175], [00198], [00202], [00216],[00218], claims 68- 69 and 99-109 etc. that I cited in my comment for support do not provide support and were invalid/unpatentable for lack of enabling disclosure (section 112?), i.e., the cited paragraphs are not enough to get a claim for Eukaryotes?

Jinek et al., A Programmable Dual-RNA–Guided
DNA Endonuclease in Adaptive Bacterial Immunity, 2012 publication was focussed on prokaryote, without any mention of the above paragraphs from the provisional app.

http://genetics.wustl.edu/bio5491/files/2013/03/Jinek-et.-al.-2012.pdf


I thought that the Patent Trial and Appeal Board declared "No interference" because the patent granted by USPTO to the Broad Institute, MIT and Harvard concerning CRISPR editing of eukaryotic genomes did not interfere with patent claims filed by UC Berkeley and the University of Vienna, clearing the way for UC Berkeley to receive patent on CRISPR-Cas9 gene editing; indicating species/genus relationship to Broad/UC claims (citing Abbvie); setting a stage for mutual licensing (both having claims to Eukaryotes, but different for interference purpose).
https://www.linkedin.com/post/edit/6238102651297427456.

The Board indicated that there was no dispute that UC/Berkeley did not have sufficient support to claim the eukaryotic embodiments at their earliest priority date and that this is the reason why there was no interference-in-fact.

I'm sure UC/Berkeley will challenge this conclusion as part of the appeal.

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