Ann: Investor Presentation, page-548

This is exactly the sort of post I want to read and reply to - but I want to take it in steps because I don't want moderators breaking up my work because fools abuse the report button. I also want to get some credit where its due (just as I will accept criticism where it is due) - its the modding and the character attacking that takes advantage of modding that doesn't read and understand context that is making that hard.

I have all the detail of your post. I've taken it offline in fact. I've read it all.

Can we proceed in steps?

First Danilkovitch et al - is not a patent pending any longer - its a patent granted (in the United States) - has been since 21 November 2023.

You do some good analysis on it (in the post I'n replying to) - but at 2020 your reference is still not at 2023, though claim 1 reads the same and has 27.7 pg/million cells.

I believe I posted the fact that a patent had been granted to both you and whytee on the MSB forum - when I discovered that it had - I discovered it around 28 March 2024 - not earlier - because (I believe) MSB did not announce it.

This patent was not granted at the time of MSB-GVHD001 was running - but nothing important turns on that that I can see.

This might seem like a petty point but I go to some trouble to put good info into the hands of people who I hope can recognize its importance and this was what I hoped I was doing - its very slightly disappointing if you don't remember I thought to make you aware of it.

You wouldn't have needed to cast around looking for older patents with Osiris personnel. Also old patents aren't like old potency assays - MSB has reverted to an older potency assay - but patents are about establishing priority (hence Aggarwal 2005 getting mentioned a lot - 2005 is a long time ago) and substantiating the basis of claims. Its that patents are places where claims - including claims about potency assays are made in technical detail that is the reason I submit we should look into them when we are able and when we want to understand what is going on.

The title of the patent now granted in the US is Mesenchymal Stem Cells Expressing TNF-alpha Receptors.

This is not the main point of your post - you main interest I have not forgotten - is can MSB hope to avoid a third CRL. Can they have enough data to satisfy the FDA - that's your main interest and mine too frankly. But I don't want to miss the importance of this patent granted Danikovitch now that I have already talked about it and you have already found it which is this claim 1 as written could impact Cynata because Cynata's cells are human mesenchymal stem cells and because Cynata is potentially interested in diseases or disorders that have an immunological basis (like GvHD, arguably asthma too, IDB a swag of others but GvHD is particularly timely and pertinent).

You've written this claim but I want to put it out there again so folks cam see its
structure.

Quoting from my hardcopy of the patent GRANTED. (US 11821004 B2) - coloring mine

"The invention claimed is:

1) A method of treating a disease or disorder involving an activated immunological response in a human subject comprising,
(i) determining the amount of cellular membrane-bound TNF-alpha receptor Type 1 expressed by at least one population of human mesenchymal stem cells;
(ii) selecting a population of human mesenchymal stem cells that express cellular membrane-bound TNF-alpa receptor Type 1 in an amount of at least 27.7 pg/10**6 cells; and
(iii) administering to the subject the selected population of mesenchymal stem cells.

I submit CYP would have trouble using TNF-alpha measuring for GvHD without running awry of this method patent as written.

I'm not saying it couldn't be done - but TNF-alpha is a naturally occurring receptor - its the gateway to activation of a pathway going through NFkappaB This seems to me a little bit like Myriad and the Brca1 and Brca2 gene - its potentially blocking a lot of others on the basis of not a lot of discovery work. MSB has done some discovery work (aggarwal and Pittinger 2005 is before 2014) - not taking that away from them - so had Myriad - but (now this patent) its not real hard to sort of mess around with the levels of a key receptor for potency (yes I do accept its part of a potency assay), but much of the pathways working was worked out or discovered by Dorosoroo around 2014. Whatever value of amount of receptor of TNFR1 is optimal was a discoverable detail I'd argue. Useful to not to have to repeat the work - but hardly worth putting a company in a position it could tollway the pathway itself.

Part 2 coming.