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Japanese Patent Case Summary: 2024 (Gyo-Ke) No. 10012 – Intellectual Property High Court (October 30, 2024)

“Enzyme-Treated Milk Product, Method for Producing Same, Composition, and Product”

Overview:

A case where the IP High Court upheld the decision in an appeal against the final rejection, which determined a lack of inventive step.

Link to a summary and full text of the trial decision (Japanese)

Main Issue:

Whether inventive step can be ensured by reciting the invention relating to “colostrum from cows” disclosed in the primary reference (Invention of Reference 1) as an excluding claim (amended invention of the present case).

Amended Invention of the Present Case

A method of preparing an enzyme-treated milk product comprising a step of bringing a milk into contact with β-galactosidase and sialidase, wherein the milk is milk derived from cows (excluding colostrum from cows).

Invention of Reference 1: Primary Reference

A method of obtaining a bovine colostrum macrophage activating factor (MAF), comprising enzymatically treating colostrum from cows (secreted in the first few days after a delivery) using both β-galactosidase and sialidase.

Technical Matter of Reference 3: Secondary Reference

Treating Gc-globulin with β-galactosidase and sialidase generates a potent macrophage activating factor.

Summary:

(3) Regarding Motivation to Combine the Technical Matter of Reference 3 with the Invention of Reference 1

       a. Commonality of Objective, etc.

…it can be said that Reference 1 and Reference 3 share the common objective of providing something that activates macrophages through glycosylation, and they also have commonalities in terms of function and effects.

…it can be said that Reference 1 and Reference 3 share the common objective of providing something that activates macrophages through glycosylation, and they also have commonalities in terms of function and effects.

       b. Motivation to Use Regular Cow’s Milk

…it can be said that it was well-known art prior to the priority date of the present case that not only “colostrum from cows (secreted in the first few days after a delivery)” mentioned in the invention of Reference 1, but also the cow’s milk secreted thereafter, which is used for drinking and dairy product manufacturing, contains Gc-globulin (also known as vitamin D-binding protein (DBP)) similarly to serum and plasma, and serves as a source of Gc-globulin.

…although the “colostrum from cows (secreted in the first few days after a delivery)” selected in Reference 1 has a relatively high Gc-globulin concentration among cow’s milk, it can be said that its Gc-globulin concentration is lower than that of blood-derived materials such as serum and plasma…

…it must be said that the relatively low concentration of Gc-globulin, etc., in cow’s milk other than the “colostrum from cows (secreted in the first few days after a delivery)” of the invention of Reference 1 and “milk derived from cows (excluding colostrum from cows, which is milk secreted from a mother cow within 10 days after a delivery)” of the amended invention of this case merely serves as one of the factors for a skilled person to consider when determining the priority of what to adopt as a source of Gc-globulin, similarly to the degree of availability of those materials.

       c. Summary on Motivation

…it should be said that there is sufficient motivation, and no teaching-away is recognized.

Comments:

It appears that the applicant wished to assert that there would be a teaching away in the reasoning for the lack of inventive step by excluding “colostrum from cows” which is an essential feature of the primary reference.

Recently, the merits and demerits of “excluding claims” have been brought into focus by the Japan Patent Attorneys Association’s Patent Committee and the Patent Office’s Trial Practitioners Study Group.

Patent Committee, Second subcommittee: Patent 2024 Vol. 77, No. 6, pp. 45-60

“Excluding claims have been found to be useful as an amendment means to overcome the rejection due to lack of inventive step. In particular, when an essential configuration for solving the problem of the cited invention is excluded from the invention according to the claim, a situation is established where ‘to arrive at the invention according to the claim, it is necessary to deliberately not adopt the essential configuration in the cited invention.’ Amending the claim to be an excluding claim and asserting in an argument that there is a teaching away in modifying the cited invention to exclude the essential configuration are effective in overcoming the rejection due to lack of inventive step.” (p. 60)

https://jpaa-patent.info/patent/viewPdf/4435

Trial Practitioners Study Group Report 2023 (March, 2024) p. 41: file p. 81

“Regarding ‘excluding claims,’ many participants expressed concerns about the current situation where ‘excluding claims’ can be used too freely, not only in cases where they are used to ensure novelty against ‘accidental prior art.’”

“There were opinions suggesting that the Patent Office should, from perspectives other than new matter, (i) verify under the support requirement whether the invention after the exclusion still achieves the common effect as a whole and solves the problem, and (ii) carefully examine whether the prior art documents used for the initial rejection can still negate novelty and inventive step, even after the amendment to recite an ‘excluding claim’, which was made in response to a notice of reasons for rejection regarding novelty and inventive step issued during the examination stage.”

https://www.jpo.go.jp/resources/shingikai/kenkyukai/document/sinposei_kentoukai/2023_houkokusyo_honpen.pdf

This case is considered a reasonable decision and judgment, carefully examined in accordance with the request of the Trial Practitioners Study Group to “carefully examine whether the prior art documents used for the initial rejection can still negate novelty and inventive step even after the amendment to recite an “excluding claim.”

 

Akiteru TAMURA

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