T 0213/23 - Diluted seawater

Key points

• D10 is "D10: L'Eau de Mer... 1904 Rene Quinton Book"
• "D10 is a book published in 1904 and written by Mr Quinton. It indicates that the composition of seawater is different depending on its origin (see page 217). Page 219 of D10 shows the composition of seawater of different origins, while page 223 indicates that seawater contains nitrite or nitrate. The Table of D10 reproduced by the appellant on page 21 of its statement of grounds of appeal gives the concentrations of elements in seawater which do not fall under the scope of the claim. For instance, it can be easily calculated from the amounts of NaCl in 1L of seawater of different sources that the concentration of chlorine or sodium, is above 400 mmol/L."
• Claim 1:  "1. Isotonic crystalloid aqueous solution, comprising Na**(+) ions in a range comprised between 50 and 200 mmol/ L, K**(+) ions in a range comprised between 1 and 10 mmol/ L, Cl**(-) ions in a range comprised between 50 and 200 mmol/L, characterized in that it has nitrate ions or nitrite ions or mixtures thereof in a range comprised between 0.0001 mmol/L and 1 mmol/L and at least a chemistry element selected from: Li, Be, B, Al, Si, P, Sc, V, Cr, Mn, Fe, Co, Ni, Cu, Zn, As, Br, Rb, Sr, Y, Zr, Mo, Pd, Ag, Sn, Sb, I, Cs, Ba, Ce, Au, Tl, Pb, Bi, Th and U."
• "D11 and D12 are extracts of the "Dictionnaire Vidal" from respectively 1966 and 1975. They indicate that the "Plasma de Quinton" is a dilution of natural seawater which can be either isotonic or hypertonic, and which can be used as blood reconstitution product. None of these documents gives however the exact composition of the product "Plasma de Quinton". Furthermore, none of these documents indicates how much the seawater was diluted to obtain the product Plasma de Quinton."
• "Consequently, it is not possible to conclude that the product "Plasma de Quinton" is novelty-destroying in the absence of any precise qualitative or quantitative information on its constituents."
• The opponent is  "Laboratoires Quinton International, SL" 
• It currently sells "Plasma de Quinton is a 100% natural seawater isotonic solution. It is a dietary supplement made from pure seawater, collected from phytoplankton vortexes and subsequently diluted with spring water, which has very low mineralization. It undergoes a cold microfiltration process at 0.22 microns in order to ensure total safety." (https://quintonmedical.com/quinton-plasma) 
• Of course, this does not give any information about the composition of this commercial product. 
• " The claimed invention relates to an isotonic crystalloid aqueous solution used to replace fluids, primarily blood, which does not present oncotic pressure per se and which intends to yield better results than the already known blood substitute solutions or a solution of ionic solutes"
• "D10 as closest prior art - D10 is a book dated 1904 and relating to seawater which comprises 519 pages. The appellant cited page 459 as possible starting point, where it is disclosed that seawater can be injected to treat different diseases, without any mention of the use as blood substitute. There is furthermore no information, neither in D10, nor in D11/D12 on the degree of dilution of the seawater in the product "Plasma de Quinton" or of the origin of the seawater, and therefore on the final concentration of all possible elements originating from seawater. In the Board's view, assessing inventive step starting from a document that does not provide any clear information regarding the composition and pharmacological properties of the relevant product can only be made with the benefit of hindsight."

• " Accordingly, the Board considers that the claimed invention is inventive over D10. In the Board's view, there is indeed no teaching in any of documents D10, D11 or D12 to adapt or change the concentrations of the seawater elements in order to arrive at the claimed subject-matter. The argument of the appellant that the different elements can be easily changed with distilled water is a clear ex post facto analysis and cannot be followed."" 

• "D1 discloses physiologically acceptable aqueous solutions for use as plasma substitute comprising a carboxylic acid as a dynamic buffering system, an oncotic agent selected from a simple sugar or hydroxyethylstarch (hetastarch), and a buffer"

• "The patent provides a comparison between a composition according to the invention shown in Table 1 and the Plasmalyte® solution which does not comprise any nitrite/nitrate and/or metal, but includes acetate and gluconate (cf. Table 2 of the specification). The solution of the present invention showed an effect comparable to the administration of whole blood and a clear improvement with regard to the Plasmalyte® solution "

• "In view of these results, the Board is of the opinion that the problem over D1 should be defined as the provision of an improved blood substitute composition."

• " There is no suggestion or incentive in D1 to add other compounds such as a metal compound or a known vasodilator, such as a nitrite or a nitrate, or to replace the oncotic agent in the disclosed compositions. Accordingly, the claimed solution appears to be inventive over D1."

• The appeal of the opponent is dismissed.

EPO 

The link to the decision can be found after the jump.

https://www.epo.org/en/boards-of-appeal/decisions/t230213eu1