News & Topics

<Invention>

The title of the invention at issue is “Compositions and Methods for the Storage of Red Blood Cells”. Claim-1 is “An aqueous composition for storage of red blood cells at about 1 to about 6°C, the composition comprising: adenine; dextrose; at least one non-metabolizable membrane-protectant sugar; and a pH buffering system, wherein the pH buffering system comprises a combination of physiologically acceptable buffering agents including at least one agent providing bicarbonate anions, at least one agent providing phosphate anions, and at least one agent providing sodium cations, wherein the pH buffering system is present in an amount sufficient for the composition to be operable to maintain a pH of a red blood cell (RBC) suspension to which the composition is added at a value sufficient to establish and maintain during a storage period a reaction equilibrium in the red blood cell that favors glycolysis over synthesis of 2,3-diphosphoglycerate (DPG) from 1,3-DPG, thereby generating a net gain in adenosine tri phosphate (ATP) with respect to the reaction equilibrium during the storage period, and, wherein the composition is substantially free of exogenously derived chloride ions.”

<IP High Court Decision>

(1) Difference between claimed invention and prior invention

One of the differences between claimed invention and prior invention is as follows;

Claimed invention has that “the pH buffering system is present in an amount sufficient for the composition to be operable to maintain a pH of a red blood cell (RBC) suspension to which the composition is added at a value sufficient to establish and maintain during a storage period a reaction equilibrium in the red blood cell that favors glycolysis over synthesis of 2,3-diphosphoglycerate (DPG) from 1,3-DPG, thereby generating a net gain in adenosine tri phosphate (ATP) with respect to the reaction equilibrium during the storage period.” However, citation-1 does not describe such technical matter as above.

(2) Inventive Step

According to IP High Court Decision, “to maintain a pH” in the claim was interpreted as “to maintain pH 6.4 – 7.4” in the specification. On the other hand, citation-1 describes “to maintain pH 6.6 – 7.2” which is included in the claimed invention. Then, “to maintain a pH” was not decided as the substantial difference against the prior invention, and the inventive step was denied.

<Comments>

In this decision, “pH” was expressed in the claim by not the range of pH but the functional manner as “to establish and maintain during a storage period a reaction equilibrium in the red blood cell that favors glycolysis over synthesis of 2,3-diphosphoglycerate (DPG) from 1,3-DPG, thereby generating a net gain in adenosine tri phosphate (ATP) with respect to the reaction equilibrium during the storage period”. Then, according to this IP High Court Decision, “pH” was interpreted as “pH 6.4 – 7.4” in the specification, and “pH 6.4 – 7.4” was compared to the prior invention (pH 6.6 – 7.2).

As a rule, claim should be compared to the prior invention. However, it is allowed that a claim can be interpreted to the more specific concept in the specification, and this specific concept can be compared to the prior invention. This practice is also explained in the Examination Guideline as below.

<Examination Guideline, Part II, Chapter 2, 1-5-4 (2)>

The claimed inventions are identified by comparing the more specific concepts of the claimed inventions to the cited invention to find the corresponding and differing points between them.

This comparison is efficient for determining the novelty of the claimed inventions, such as those containing descriptions that define products by the functions or characteristics or that provide numerical ranges.

http://www.ip.courts.go.jp/app/files/hanrei_jp/111/085111_hanrei.pdf