Patent

Date

February 9, 2022

Right

Case

2020 (Ne) 10059

Court

Intellectual Property High
Court, Second Division

number- A case in which, with regard to a request for an injunction against an infringing act,
etc. filed based on a patent right for an invention titled "Equol-containing extract,
method for production thereof, method for extraction of equol, and equol-containing
food," the court presumed by applying Article 104 of the Patent Act that theAppellees' Material was produced by the method of the Invention, and determinedthat the presumption is not found to be rebutted.
Case type: Injunction
Result: Reversal of prior instance judgment, granted
References: Article 104 and Article 39, paragraph (2) of the Patent Act
Related rights, etc.: Patent No. 6275313
Judgment of the prior instance: Tokyo District Court, 2018 (Wa) 18555, rendered on
September 17, 2020
Summary of the Judgment
1. In this case, the Appellant, who is the patentee of a patent for an invention of amethod for producing a product, titled "Equol-containing extract, method for
production thereof, method for extraction of equol, and equol-containing food," (the"Patent") alleged that the method by which Appellee A produces the Appellees' Material(the Appellees' Method) falls within the technical scope of the patented invention inquestion, and that Appellee A's acts of producing and transferring the Appellees'
Material and Appellee B's acts of producing the Appellees' Product by using theAppellees' Material purchased from Appellee A and transferring, etc. the Appellees'
Product thus produced infringe the patent right relating to the Patent, and based on these
allegations, the Appellant sought against the Appellees an injunction against production
and transfer, etc. and the disposal of the Appellees' Material and the Appellees' Product,
based on Article 100, paragraphs (1) and (2) of the Patent Act. The judgment in priorinstance dismissed all of the Appellant's claims, holding as follows: in the Invention, it
is regarded necessary for arginine to already be contained in the fermenting material,
along with a daidzein compound at the stage of preparing the fermenting material, but
in the Appellees' Method, arginine is not mixed in at the stage of preparing thefermenting material, but is mixed in for the first time in the subsequent fermentation
process, and therefore the Appellees' Method is determined not to fall within theitechnical scope of the Invention. After the judgment in prior instance, a decision by theJapan Patent Office upholding a request for correction of the Invention became final
and binding. Therefore, in this judgment, the court only examined whether or not theAppellees' Method fulfills the constituent features of the Corrected Invention and theeffectiveness of the Corrected Invention.
2. While a wide range of issues were involved in this case, the court reversed thejudgment in prior instance, determining as follows, and upheld all of the Appellant's
principal claims.
(1) Fulfilment of constituent features
The Corrected Invention is an invention for producing a product, and the produced
product is "fermented powder containing ornithine and equol, wherein not less than 8
mg ornithine and not less than 1 mg equol are produced per gram by dry weight of said
fermented substance, and which is used as a food material," which was not publicly
known as of the priority date. Therefore, the presumption under Article 104 of the Patent
Act applies, and the Appellees are to allege and prove that the product was not producedby the method of the Corrected Invention, in order to rebut the presumption, but it
cannot be said that sufficient proof for rebutting the presumption has been produced inthis case. Meanwhile, the judgment in prior instance determined that, because arginineis already contained in the fermenting material at the stage of preparing the fermenting
material before the fermentation in the case of the Invention, the Appellees' Method (amethod of mixing a treatment solution containing daidzein and a microorganism with aculture solution containing arginine to be fermented), in which arginine appears for the
first time at the fermentation stage, does not fulfill the relevant constituent feature of
the Invention. However, the patent claims and the description in question contain nostatements suggesting any difference between a case of adding a microorganism after
adding arginine to a daidzein compound and a case of mixing a daidzein compound,arginine, and a microorganism at the same time, and the description states that thefermenting material "containing daidzein compounds is not limited by other factors." Itfollows that the "culture solution containing arginine" of the Appellees' Method
constitutes the "fermenting material containing arginine" of the Corrected Invention,and hence there is no proof that the Appellees' Method differs from the method of theCorrected Invention.
(2) Regarding novelty and inventive step
Although a lack of novelty and a lack of inventive step were alleged based on
several cited inventions, none of the cited inventions contained a statement orsuggestion concerning ornithine. Therefore, the cited inventions cannot be regarded toii

be virtually identical to the Corrected Invention and a person skilled in the art could nothave easily conceived of the Corrected Invention from the cited inventions.
(3) Regarding application of the second sentence of Article 39, paragraph (2) of the
Patent Act
Generally, if patent applications are filed for two inventions on the same date, andif the difference of one of the inventions from the other is an addition, deletion, or
replacement of well-known or commonly used art to the other and the invention does
not produce any new effect, the two inventions constitute the "identical inventions"referred to in Article 39, paragraph (2) of the Patent Act. In this case, the Corrected
Invention specifies that arginine is added to a daidzein compound, whereas Claim 4 of
the Appellant's divisional application ("Divisional Invention 4") does not, and as statedin the description in question, the Corrected Invention produces a new effect in that
arginine is converted into ornithine by the fermentation referred to in the Corrected
Invention and therefore the amount of the ornithine produced can be increased byadding arginine. Accordingly, the Corrected Invention and Divisional Invention 4cannot be regarded as identical inventions, and it cannot be said that the Corrected
Invention becomes invalid pursuant to the second sentence of Article 39, paragraph (2)of the Patent Act.
(4) Regarding the need for a request for an injunction and disposal
Appellee B alleges that it has stopped producing the Appellees' Product and it also
has no stock of the product. However, the only evidence produced as the basis of that
allegation is a written statement prepared by Appellee B's employee, and there is no
sufficient evidence to precisely find that no stock of the product exists at present. In
addition, given that there is no change in the product name and in light of the situationof advertising, among other factors, one cannot go so far as to say that Appellee B isunlikely to produce and sell the Appellees' Product in the future. Consequently, theAppellant's request for an injunction and disposal is well-grounded.

iii

Judgment rendered on February 9, 2022
2020 (Ne) 10059 Appeal case of seeking injunction against patent infringement(Court of prior instance: Tokyo District Court, 2018 (Wa) 18555)
Date of conclusion of oral argument: December 2, 2021
Judgment
Appellant (first-instance Plaintiff): Otsuka Pharmaceutical Co., Ltd.

Appellee (first-instance Defendant): Advanced Medical Care Inc. (hereinafter referred to as"Appellee AMC")

Appellee (first-instance Defendant): Daicel Corporation (hereinafter referred to as "Appellee
Daicel")Main text
1. The part of the judgment in prior instance dismissing the Appellant's principal claims shallbe rescinded.
2. Appellee AMC must not produce, transfer, lend out, offer to transfer or lend out, or export
the product stated in the List of the Appellees' Product attached to this judgment.
3. Appellee AMC shall dispose of the product stated in the List of the Appellees' Productattached to this judgment.
4. Appellee Daicel must not produce the material stated in the List of the Appellees' Material
attached to this judgment.
5. Appellee Daicel must not transfer, lend out, offer to transfer or lend out, or export thematerial stated in the List of the Appellees' Material attached to this judgment.
6. Appellee Daicel shall dispose of the material stated in the List of the Appellees' Material
attached to this judgment.
7. The Appellees shall bear the court costs for the first and second instances.

18. This judgment may be provisionally executed as far as paragraphs 2, 4, and 5 of the main
text are concerned.
Facts and reasonsHereinafter, abbreviations of terms and meanings of the abbreviations follow those in
the judgment in prior instance other than those defined in this judgment. The terms"Plaintiff," "Defendant AMC," "Defendant Daicel," "Defendants' Product," "Defendants'
Material, " "Defendants' Method," and "Defendants" in the judgment in prior instance are
deemed to be replaced with "Appellant," "Appellee AMC," "Appellee Daicel," "Appellees'
Product," "Appellees' Material," "Appellees' Method," and "Appellees," respectively. In
addition, the phrase "attached to this judgment" in all of the parts citing the judgment in priorinstance is altered to "attached to the judgment in prior instance."
No. 1 Object of the claim
1. Same as paragraph 1 of the main text.
2. (Principal claim)
Same as paragraph 2 of the main text.
(Alternative claims)(1) Appellee AMC must not use the material stated in the List of the Appellees' Material
attached to this judgment produced by the method stated in the List of the Appellees' Method
attached to the judgment in prior instance.
(2) Appellee AMC must not transfer, lend out, offer to transfer or lend out, or export the
product stated in the List of the Appellees' Product attached to this judgment which uses thematerial stated in the List of the Appellees' Material attached to this judgment produced by
the method stated in the List of the Appellees' Method attached to the judgment in priorinstance.
3. (Principal claim)
Same as paragraph 3 of the main text.
(Alternative claim)
Appellee AMC shall dispose of the product stated in the List of the Appellees' Productattached to this judgment which uses the material stated in the List of the Appellees' Material
attached to this judgment produced by the method stated in the List of the Appellees' Method
attached to the judgment in prior instance.
4. (Principal claim)
Same as paragraph 4 of the main text.
(Alternative claim)

2Appellee Daicel must not use the method stated in the List of the Appellees' Method
attached to the judgment in prior instance.
5. (Principal claim)
Same as paragraph 5 of the main text.
(Alternative claim)
Appellee Daicel must not transfer, lend out, offer to transfer or lend out, or export thematerial stated in the List of the Appellees' Material attached to this judgment produced by
the method stated in the List of the Appellees' Method attached to the judgment in priorinstance.
6. (Principal claim)
Same as paragraph 6 of the main text.
(Alternative claim)
Appellee Daicel shall dispose of the material stated in the List of the Appellees' Material
attached to this judgment produced by the method stated in the List of the Appellees' Method
attached to the judgment in prior instance.
7. The Appellees shall bear the court costs for the first and second instances.
8. Declaration of provisional execution
No. 2 Outline of the case
1. In this case, the Appellant, who is the patentee of a patent for an invention of a method for
producing a product, titled "Equol-containing extract, method for production thereof,
method for extraction of equol, and equol-containing food" (the patent is hereinafter referred
to as the "Patent" and the patent right under that patent is referred to as the "Patent Right"),
alleges that, while the method stated in the List of the Appellees' Method attached to the
judgment in prior instance (the Appellees' Method) carried out by Appellee Daicel falls
within the technical scope of the patented invention relating to the Patent, [i] Appellee
Daicel's acts of producing the material stated in the List of the Appellees' Material attachedto this judgment (the Appellees' Material) by using the Appellees' Method and transferringor otherwise handling it infringe the Patent Right, and [ii] Appellee AMC's acts of producing
the product stated in the List of the Appellees' Product attached to this judgment (hereinafterreferred to as the "Appellees' Product") by using the Appellees' Material and transferring orotherwise handling the Appellees' Product containing the Appellees' Material infringe thePatent Right. Based on these allegations, the Appellant makes the following claims against
the Appellees, based on Article 100, paragraphs (1) and (2) of the Patent Act.
(1) Against Appellee AMC
A. An injunction against production, transfer, lending out, offer to transfer or lend out, or
export (hereinafter collectively referred to as "transfer, etc.") of the Appellees' Product3

(principal claim) or an injunction against use of the Appellees' Material produced by theAppellees' Method (alternative claim) and an injunction against transfer, etc. of theAppellees' Product which uses the Appellees' Material produced by the Appellees' Method(alternative claim)
B. Disposal of the Appellees' Product (principal claim) or disposal of the Appellees' Productwhich uses the Appellees' Material produced by the Appellees' Method (alternative claim)(2) Against Appellee Daicel
A. An injunction against production of the Appellees' Material (principal claim) or an
injunction against use of the Appellees' Method (alternative claim)
B. An injunction against transfer, etc. of the Appellees' Material (principal claim) or an
injunction against transfer, etc. of the Appellees' Material produced by the Appellees' Method(alternative claim)
C. Disposal of the Appellees' Material (principal claim) or disposal of the Appellees' Material
produced by the Appellees' Method (alternative claim)
2. The judgment in prior instance dismissed all of the Appellant's claims by making
determinations including the following: in the invention relating to Claim 1 in the claims of
the Patent before the Correction (hereinafter referred to as the "Invention"), it is regarded asnecessary for arginine to already be contained in the fermenting material, along with adaidzein compound at the stage of preparing the fermenting material, but in the Appellees'
Method, arginine is not mixed in at the stage of preparing the fermenting material, but ismixed in for the first time in the subsequent fermentation process, and therefore theAppellees' Method is determined not to fall within the technical scope of the Invention.
Against this judgment, the Appellant filed an appeal.
As mentioned in 3.(4) below, a decision by the Japan Patent Office (JPO) allowing theCorrection became final and binding on May 20, 2021, after the filing of the appeal inquestion. Therefore, the Appellant only asserts claims based on the Corrected Invention as
the statement of the claims in this instance.
3. Basic facts (the facts other than those for which evidence, etc. has been presented are notdisputed among the parties concerned; documentary evidence with no indication of branchnumbers includes those with branch numbers (the same applies hereinafter))
The basic facts are as described on page 4, line 1 through page 7, line 6 of the judgmentin prior instance, except for making the following corrections, and therefore cited herein.
(1) The phrase "a patent right" on page 4, line 3 of the judgment in prior instance is altered
to "the Patent Right" and the phrase "the patent relating to Claim 1 is hereinafter referred toas the 'Patent'" from line 4 to line 5 on that page is deleted.
(2) The sentence from "The plaintiff" in line 5 to "the establishment of a patent right was4registered on January 19, 2018" in line 6 on page 4 of the judgment in prior instance is altered
to "The Appellant filed a patent application (Patent Application No. 2009-519326(hereinafter referred to as the 'Original Application'), priority claim: June 13, 2007
(hereinafter referred to as the 'Priority Date'), Japan) for an invention titled 'Equol-containing
extract, method for production thereof, method for extraction of equol, and equol-containing
food' on June 13, 2008 (hereinafter referred to as the 'Original Filing Date'), after which it
filed a divisional application for a part of the Original Application as Patent Application No.
2013-108439, then further filed a divisional application for a part thereof as Patent
Application No. 2016-156372, and yet further filed a divisional application for a part thereof
as Patent Application No. 2017-125880 (hereinafter referred to as the 'Application'), and theestablishment of the Patent Right was registered as Patent No. 6275313 on January 19, 2018(the description and drawings relating to the Patent Right (Exhibit Ko 2) are referred to as
the 'Description,' and the paragraphs of the Description are simply referred to as [0001] or
the like)."(3) The part from line 8 through line 11 on page 4 of the judgment in prior instance is altered
to "A. The statement of Claim 1 in the claims of the Patent before the Correction is asfollows:".
(4) The phrase "that correction is referred to as the 'Correction')." on page 5, line 6 of thejudgment in prior instance is altered to "that correction is referred to as the 'Correction'; thedescription and drawings were not corrected in the Correction)."(5) The part from "Meanwhile," on page 5, line 8 of the judgment in prior instance throughthe end of line 12 on that page is altered as follows:"Meanwhile, in the Invalidation Trial, the JPO rendered a decision allowing theCorrection and holding that the request for the trial is groundless on July 19, 2019 (Exhibit
Otsu B31; hereinafter referred to as the 'JPO Decision to Maintain the Patent'). Against thisdecision, Appellee Daicel filed a lawsuit to seek rescission of the JPO decision (Intellectual
Property High Court; 2019 (Gyo Ke) 10112), and Appellee AMC made supportingintervention in the lawsuit, but a judgment dismissing Appellee Daicel's claims was renderedon October 21, 2020 (Exhibit Ko 41; hereinafter referred to as the 'Judgment to Maintain the
Patent'). The Appellees filed petitions for the acceptance of a final appeal against thisjudgment, but a ruling not to accept a final appeal was rendered for both, and the judgment
became final and binding on May 20, 2021. (Exhibits Ko 61 and 62)."(6) The part from "in addition" on page 5, line 23 of the judgment in prior instance through"is referred to as Correction 4" in line 6 of that page is deleted.
(7) A new line is started following line 11 on page 6 of the judgment in prior instance, andthe following sentence is added: "D. Appellee Daicel requested a trial for patent invalidation

5

for the Patent on November 19, 2019 (Invalidation Trial No. 2019-800098; hereinafterreferred to as "Invalidation Trial 2"), and the Appellant filed a request for a correction withthe same content as the Correction on February 7, 2020. The JPO rendered a decision
allowing the correction and holding that the request for the trial for invalidation is groundlesson November 25, 2020 (hereinafter referred to as the 'JPO Decision to Maintain Patent 2')(Exhibit Ko 55)."(8) The part from line 15 through line 17 on page 6 of the judgment in prior instance isaltered as follows:"B. Appellee AMC was producing the product stated in the List of the Appellees' Productattached to this judgment by using the Appellees' Material purchased from Appellee Daicel
and selling the product until July 26, 2021. (Exhibit Otsu A2)"
(9) The following is added at the end of line 26 on page 6 of the judgment in prior instance:"(however, the Appellant alleges that, if the claim interpretation of the Corrected Invention
in the judgment in prior instance is to be applied, α3 of the Appellees' Method should befound in a more specific and detailed manner as described in α3-1 and α3-2 in 5.(1)(Appellant's claims) A. below)."
4. Issues
As mentioned in 2. and 3.(4) above, because the JPO decision allowing the Correction
became final and binding, the Appellant decided to withdraw its claims based on theInvention and to only file claims based on the Corrected Invention, and cited the previous
allegations relating to the Invention to support its arguments in this instance. Therefore, Issue
3 "whether the correction to the Invention can be asserted against the claim of invalidity" inthe prior instance does not become an issue. In this instance, the Appellant added anallegation of infringement under the doctrine of equivalents, and the Appellees added
Grounds for Invalidation 8 through 10 as invalidity defenses, but among the invalidity
defenses, Grounds for Invalidation 9, which allege that the Correction violates therequirements for correction, lost the premise for the allegation. In addition, Appellee AMC
added an assertion that there is no need for an injunction, etc. as it stopped producing andselling the Appellees' Product. Accordingly, the issues in this case are as follows:(1) Whether the Appellees' Method falls within the technical scope of the Corrected
Invention (Issue 1)
A. Whether the Appellees' Material is presumed to have been produced using the method of
the Corrected Invention under Article 104 of the Patent Act (Issue 1-1)
B. Whether the "daidzein compound" "selected" in the Appellees' Method is daidzein
glycosides (fulfillment of Constituent Features A', B'-1, and B'-2) (Issue 1-2)
C. Whether "at least one daidzein compound selected from the group consisting of daidzein

6glycosides, daidzein, and dihydrodaidzein" in Constituent Feature A' is limited to soybean
hypocotyl (fulfillment of Constituent Feature A') (Issue 1-3)
D. Whether the "microorganism" in Constituent Feature B'-2 is limited to a Lactococcus 2092 strain (fulfillment of Constituent Feature B'-2) (Issue 1-4)
E. Whether the "microorganism" in Constituent Feature B'-2 is limited to a microorganism
having the ability to cleave sugar (fulfillment of Constituent Feature B'-2) (Issue 1-5)
F. Whether the culture solution containing arginine in the Appellees' Method constitutes a"fermenting material containing arginine" (fulfillment of Constituent Feature B'-1) (Issue 16)
G. Whether infringement of the Corrected Invention under the doctrine of equivalents exists(Issue 1-7)
(2) Whether the Patent deserves to be invalidated in a trial for patent invalidation (Issue 2)
A. Whether Grounds for Invalidation 1 (lack of novelty based on Exhibit Otsu B3 on thepremise that a priority claim cannot be made) exist (Issue 2-1)
B. Whether Grounds for Invalidation 2 (violation of the support requirement and theenablement requirement in relation to the "microorganism having the ability to produce
ornithine and the ability to produce equol" in the Corrected Invention) exist (Issue 2-2)
C. Whether Grounds for Invalidation 3 (lack of novelty based on Exhibit Otsu B4 and lackof inventive step based on Exhibit Otsu B4 as the primary cited invention) exist (Issue 2-3)
D. Whether Grounds for Invalidation 4 (lack of novelty based on Exhibit Otsu B16 and lackof inventive step based on Exhibit Otsu B16 as the primary cited invention) exist (Issue 24)
E. Whether Grounds for Invalidation 5 (lack of novelty based on Exhibit Otsu B19-1 andlack of inventive step based on Exhibit Otsu B19-1 as the primary cited invention) exist(Issue 2-5)
F. Whether Grounds for Invalidation 6 (lack of novelty based on Exhibit Otsu B24 and lackof inventive step based on Exhibit Otsu B24 as the primary cited invention) exist (Issue 26)
G. Whether Grounds for Invalidation 7 (lack of novelty and inventive step based on Exhibit
Otsu B2 on the premise that the patent application for the Patent violates the requirements
for division of application) exist (Issue 2-7)
H. Whether Grounds for Invalidation 8 (the Description violating the requirement under thedelegated ministerial order) exist (Issue 2-8)
I. Issue 2-9 is skipped (whether Ground for Invalidation 9 (the Correction violating therequirements for correction) exists)
J. Whether Grounds for Invalidation 10 (the second sentence of Article 39, paragraph (2) of7

the Patent Act) exist (Issue 2-10)(3) Issue 3 is skipped (whether the correction to the Invention can be asserted against theclaim of invalidity)(4) Whether it is necessary to seek an injunction and disposal against Appellee AMC (Issue
4)(omitted)
No. 3 Summary of the court decision
1. Regarding the Corrected Invention(1) The Description (Exhibit Ko 2) contains the following statements.
[Technical Field][0001]The present invention relates to an equol-containing extract obtained by extracting
effective components from an equol-containing fermented soybean hypocotyl and a
production method thereof. The present invention also relates to a method for efficiently
purifying an equol-containing substance to obtain a highly pure equol. The present invention
further relates to an equol-containing food material and an equol-containing food.
[Background Art]
[0002]The isoflavones (soybean isoflavones: daidzein, genistein, glycitein) contained insoybeans have structures similar to estradiol, and have anti-estrogen actions associated withbinding to estrogen receptors (hereinafter referred to as ER) and estrogen-like actions. The
ever conducted epidemiological studies and intervention studies of soybean isoflavonessuggest that they have preventive effects due to their anti-estrogen actions on breast cancer,
prostate cancer and other hormone-dependent cancers and improving effects due to theirestrogen-like actions on menopausal disorders, postmenopausal osteoporosis andhyperlipidemia.
[0003]
Recently, it has been pointed out that the active component of the physiological effectsof these soybean isoflavones may be a metabolite of daidzein, i.e., equol. More specifically,it has been reported that equol has an ability to bind to ER (especially to ERβ) greater thansoybean isoflavones and that it has a remarkably high transition capability to target organs
such as breast and prostate tissues (Non-Patent Documents 1 to 4). Moreover, a case-control
study reports that there are significantly less patients who produce equol in the patients ofbreast cancer and prostate cancer. The effects of soybean isoflavones that improve bone8

density and lipid metabolism were examined regarding postmenopausal women categorized
into two groups: those who produce equol and those who do not. A significant improvementin those who produce equol was observed.
[0004]
Equol is produced by metabolism of daidzein by enteric bacteria. The abilities to produce
equol vary between individuals, and the percentage of Japanese who produce equol isreportedly about 50%. That is, about 50% of Japanese are not able to produce equol (nonequol-producing individuals). Such an individual cannot enjoy any useful physiologicalbenefits based on the action of equol even if they ingest soybeans and processed soybean
foods. Therefore, in order to attain useful physiological benefits based on the action of equolin a non-equol-producing individual, ingesting equol itself is thought to be effective.
[Problems to be Solved by the Invention][0006]The present inventors have found that a fermented soybean hypocotyl obtained byfermenting a soybean hypocotyl with an equol-producing microorganism is usable as anequol-containing food material. The fermented soybean hypocotyl contains not only equol
but also isoflavone, saponin and like useful soybean-derived components. The fermented
soybean hypocotyl achieves such effective physiological effects attributable to these usefulcomponents, and therefore is usable as a functional material. The present inventors also
found that the fermented soybean hypocotyl is useful as an allergen-reduced material,
because the allergens attributable to the soybean hypocotyl therein are reduced. The
fermented soybean hypocotyl found by the present inventors exhibits physiological effects
attributable to the useful components, and is hypoallergenic, and therefore it is usable as afunctional food material.
[0007]
In contrast, the content of the equol in the fermented soybean hypocotyl varies dependingon the types of the soybean hypocotyl used for the production of the fermented soybean
hypocotyl, types of the equol-producing microorganism, etc., but it is generally about 1
wt. %. If a material with an increased equol content can be provided, various types of equolcontaining foods become easily available in response to the diversification of foods.
However, the fermented soybean hypocotyl itself is not a known product, and the effective
method for efficiently extracting useful component containing equol from the fermented
soybean hypocotyl has not been found yet.
[0008]
The fermented soybean hypocotyl, which is an equol-containing substance obtained by
the fermentation method describe above, is safer than that obtained by a chemical synthesis

9method, and suitable for industrial production. However, equol-containing substances
obtained by said fermentation method contain metabolites other than equol and various
components derived from raw materials remaining therein. Depending on the type of raw
material used for fermentation, the equol-containing substance obtained by a fermentation
method may contain material that could become an allergen. Therefore, in order to use anequol as an additive for foods or drugs, a technique not only for producing an equol but also
purifying the equol-containing substance so as to obtain a highly pure equol is required.
However, as not many techniques for refining equol have been reported yet, there is ademand for establishing a technique, which is industrially applicable and by which an equol
can be purified easily and efficiently.
[0010]
An object of the present invention is to provide an extract, which contains useful equolcontaining components and which is derived from an equol-containing fermented soybean
hypocotyl, and a method for producing such an extract. The present invention provides amethod for purifying an equol-containing substance to effectively obtain a highly pure equol.
Another object of the present invention is to provide a food material obtained by fermenting
an equol-containing fermented soybean hypocotyl with an equol-producing microorganism
or its extract, in which the flavor is improved. Still another object of the present invention isto provide a food product that contains an equol-containing fermented soybean hypocotyl
and exhibits excellent flavor (in particular, baked confectioneries). Still another object of thepresent invention is to provide various forms of foods that contain an equol-containing
fermented soybean hypocotyl or its extract.
[Effects of the Invention][0023]The method for producing an equol-containing extract of the present invention can
produce an equol-containing extract that is useful as a functional food material by effectively
extracting useful components containing equol from an equol-containing fermented soybean
hypocotyl. By sequentially subjecting an equol-containing fermented soybean hypocotyl to
extraction using an ethanol aqueous solution and ethanol, an equol-containing extract that
contains a high concentration of equol and glycitein, with a reduced amount of saponin thatcauses an unpleasant taste, is obtainable. Accordingly, the equol-containing extract can be
added to foods without adversely affecting the taste.
[0024]The purification method of the present invention makes it possible to readily andefficiently obtain a highly pure equol from the equol-containing substance. In particular, thepurification method of the present invention makes it possible to obtain a highly pure equol

10even when the equol-containing substance contains isoflavones, whose structure is similar
to that of the equol, by removing these isoflavones. Accordingly, the purification method of
the present invention can be suitably employed in obtaining equol from an equol-containing
fermented material that contains a large proportion of isoflavones.
[0025]
Furthermore, the food material obtained by dispersing an equol-containing fermented
soybean hypocotyl or its extract into cacao mass reduces bitterness and exhibits excellent
flavor, although it contains an equol-containing fermented soybean hypocotyl or its extract.
…
[0026]The useful physiological benefits of the various forms of food of the present invention
can be enjoyed based on the useful physiological activity of the equol-containing fermented
soybean hypocotyl or its extract.
[Mode for Carrying Out the Invention][0029]
The following details the present invention.
1. Production Method for Equol-Containing Extract… The following details an equol-containing fermented soybean hypocotyl used as amaterial of the method of the present invention, and describes in detail Production Methods
I and II.
Equol-Containing Fermented Soybean Hypocotyl …
[0030]
An equol-containing fermented soybean hypocotyl is a kind of a fermented soybean
hypocotyl produced by fermenting a soybean hypocotyl using an equol-producing
microorganism.
[0031]The equol-producing microorganism used for the production of the equol-containing
fermented soybean hypocotyl is selected from microorganisms having the ability (metabolic
activity) to produce equol by metabolizing at least one daidzein compound selected from thegroup consisting of daidzein glycosides, daidzein, and dihydrodaidzein. …
[0032]The equol-producing microorganism is not limited and may be any microorganism
having the foregoing ability and permissible in terms of food sanitation. For example, any
publicly known microorganisms, or any microorganisms obtained by a general screening
method, may be used. It is known that such equol-producing microorganisms exist in the
microorganisms belonging to Lactococcus, such as Lactococcus garvieae; microorganisms

11belonging to Streptococcus, such as Streptococcus intermedius or Streptococcus
constellatus; or microorganisms belonging to Bacteroides, such as Bacteroides ovatus.
Among various kinds of equol-producing microorganism, the present invention prefers lactic
acid bacteria belonging to Lactococcus or Streptococcus, further prefers lactic acid bacteria
belonging to Lactococcus, and in particular, lactic acid bacteria belonging to Lactococcus
garvieae. The equol-producing microorganisms may be isolated from, for example, humanfeces, based on the index of the existence of an equol-producing property. The inventors of
the present invention deposited some identified bacteria that had been isolated from humanfeces; namely, Lactococcus 20-92 (FERM BP-10036), Streptococcus E-23-17 (FERM BP6436), Streptococcus A6G225 (FERM-6437), and Bacteroides E-23-15 (FERM BP-6435),
that are available to be used as the equol-producing microorganisms. Among these, thepresent invention particularly prefers Lactococcus 20-92.
[0033]The equol-containing fermented soybean hypocotyl is produced using a soybean
hypocotyl as a fermenting material. The soybean hypocotyl is a part corresponding to theplumule or the radicle on the germination of soybean, and is known to contain a large amountof daidzein compounds such as daidzein glycosides or daidzein. The soybean hypocotyl usedin the present invention is not limited by the producing district of soybean or whether
processed or unprocessed, unless the daidzein compounds inside are significantly lost. For
example, the equol-containing fermented soybean hypocotyl may be a raw hypocotyl, or
may be one isolated from heated, dried or steam-boiled soybean, or one obtained by heating,drying or steam-boiling a hypocotyl that is isolated from unprocessed soybean. Further, thesoybean hypocotyl may be processed by degreasing or deproteinization. The form of thesoybean hypocotyl is not particularly limited, and may be in the form of powder, chunks, or
pulverized or fragmentized grains. A powdery soybean hypocotyl is particularly preferable
because of its efficient equol production.
[0034]
The fermentation of a soybean hypocotyl is carried out by first adjusting the watercontent of the soybean hypocotyl by adding an appropriate amount of water, and theninoculating the equol-producing microorganism to the hypocotyl.
[0036]
Further, if necessary, some additives may be added to the soybean hypocotyl as the raw
material in the fermentation to improve the fermentation efficiency or flavor of the product.
Examples of the additives include nitrogen sources such as a yeast extract, polypeptone, ora meat extract; carbon sources such as glucose or sucrose; inorganic salts such as phosphate,
carbonate or hydrosulfate; vitamins; and nutritional components such as amino acid.

12

Particularly, when using an equol-producing microorganism for converting arginine into
ornithine (hereinafter referred to as an "ornithine/equol-producing microorganism"),arginine is added to the soybean hypocotyl before fermentation so that the fermented
substance contains ornithine. In this case, the amount of arginine is, for example, about 0.5
to 3 parts by weight, based on 100 parts by weight (dry weight) of the soybean hypocotyl.
The ornithine/equol-producing microorganism may be obtained by a publicly-known
screening method using an index of the equol-producing ability and the conversion ability
from arginine into ornithine. The ornithine/equol-producing microorganism may be selectedfrom the group of Lactococcus garvieae, typified by Lactococcus 20-92 (FERM BP-10036).
[0038]
Further, isoflavone containing the above-mentioned daidzein compounds may be added
to the fermenting material (a soybean hypocotyl-containing substance). Such inclusion of
isoflavone in the fermenting material increases the equol content of the fermented soybean
hypocotyl, thereby improving the usability of the fermented soybean hypocotyl.
[0039]
The fermentation of the soybean hypocotyl is carried out under appropriate conditions
according to the growing characteristic of the equol-producing microorganisms. For example,
when the equol-producing microorganisms listed above are used, the fermentation of thesoybean hypocotyl is carried out under anaerobic conditions.
[0040]
The fermentation temperature is not limited as long as it is within an appropriate range
for the equol-producing microorganism to grow. The temperature is generally 20 to 40°C.,
preferably 35 to 40°C., and more preferably 36 to 38°C.
[0041]
The fermentation time is determined depending on the desired production amount of
equol, the residual amount of daidzein compounds, the type of the equol-producing
microorganism or the like. The fermentation time is generally 1 to 10 days, preferably 2 to
7 days, and more preferably 3 to 5 days.
[0042]… The equol content in the fermented soybean hypocotyl varies depending on the typeof the equol-producing microorganism or fermentation conditions. The equol content in thefermented soybean hypocotyl is generally 1 to 20 mg, preferably 2 to 12 mg, and more
preferably 5 to 8 mg, per gram (dry weight) of the fermented soybean hypocotyl.
[0049]The equol-containing fermented soybean hypocotyl also contains saponin derived fromthe soybean hypocotyl. The equol-containing fermented soybean hypocotyl generally

13contains saponin in an amount of 10 to 80 mg, preferably 20 to 50 mg, and more preferably
30 to 40 mg, per gram (dry weight) of the equol-containing fermented soybean hypocotyl.
[0050]
Further, as described above, ornithine is contained in the equol-containing fermented
soybean hypocotyl produced from fermentation with an ornithine/equol-producing
microorganism after adding arginine to a soybean hypocotyl. The ornithine content of theequol-containing fermented soybean hypocotyl is 5 to 20 mg, preferably 8 to 15 mg, andmore preferably 9 to 12 mg, per gram (dry weight) of the equol-containing fermented
soybean hypocotyl.
[0089]
Equol-Containing SubstanceIn the purification method of the present invention, the equol-containing substance to be
subjected to the purification process is not limited as long as it contains equol. For example,
the equol-containing substance used for the method may be a reaction product containing
equol generated by chemical synthesis, or an equol-containing fermented substanceproduced by fermentation. … an equol-containing fermented substance is suitable for anequol-containing substance for the purification method of the present invention.
[0090]
The following explains an equol-containing fermented substance.
[0091]The equol-containing fermented substance was produced through a publicly-known
fermentation method using an equol-producing microorganism. More specifically, a
microorganism with the ability (metabolic activity) to produce equol by metabolizing at least
one daidzein compound selected from the group consisting of daidzein glycosides, daidzein,
and dihydrodaidzein, is inoculated in a fermenting material (material to be subjected to thefermentation) containing the daidzein. The sample is then fermented (cultured) under theconditions suitable to grow the microorganism. The resulting fermented substance contains
equol.
[0092]The equol-producing microorganism is selected from the list of "Equol-Containing
Fermented Soybean Hypocotyl" in the section "1. Production Method for Equol-Containing
Extract."[0093]
The fermenting material containing daidzein compounds is not limited by other factors
as long as it contains daidzein compounds; however, the material is preferably approved forits safety as a food material. Examples of the fermenting material containing daidzein

14compounds include soybeans, a soybean hypocotyl, a soybean hypocotyl extract, tofu, deepfried tofu, soy milk, fermented soybeans, soy sauce, bean paste, a tempeh, and a red clove
or its extract, alfalfa or its extract. A suitable fermenting material containing daidzein
compounds is a soybean hypocotyl because of its high daidzein content.
[0094]
Further, an isoflavone containing any of the above-described daidzein compounds may
be added in advance to the fermenting material containing daidzein compounds. With thisextra addition of isoflavone to the fermenting material, the equol content of the resulting
fermented substance increases.
[0095]
Further, as required, some additives may be used in the fermenting material containing
daidzein compounds to improve fermentation efficiency etc. Examples of the additives
include nitrogen sources such as a yeast extract, poly peptone, or a meat extract; carbon
sources such as glucose or sucrose; inorganic salts such as phosphate, carbonate orhydrosulfate; vitamins; and nutritional components such as amino acid.
[0096]
Various fermentation conditions including water content, time, temperature, andatmosphere in the production of an equol-containing fermented substance are determined
depending on the type of the equol-producing microorganism, the type of the fermenting
material, the production amount of equol, the residual daidzein compound amount, or thelike.
[0097]For the equol-containing substance used for the purification method of the present
invention, the equol-containing fermented soybean hypocotyl … is particularly preferable.
[0142]
3. Food Material
The present invention further provides a food material in which the equol-containing
fermented soybean hypocotyl or its extract is dispersed in cacao mass. The following
describes the details, such as the ingredients, of the food material of the present invention.
[0144]The equol-containing fermented soybean hypocotyl may be used for the food material of
the present invention immediately after the fermentation, or after dried into a dry solid asrequired. … The air-dried equol-containing fermented soybean hypocotyl may be further
processed into powder as required.
[0157]
Use of Food Material

15

The food material of the present invention may be incorporated into various kinds offoodstuffs, as a raw material of an equol-containing food, or as a food additive. The present
invention also provides such equol-containing foods containing the above-described foodmaterial.
[0162]The proportion of the food material of the present invention in the equol-containing foodis not particularly limited, and is adjusted depending on the equol content in the food materialof the present invention, the form of the equol-containing food or the like. The proportion of
the food material of the present invention is generally 3 to 30 wt. %, preferably 5 to 20 wt. %,and more preferably 5 to 8 wt. %, based on the total amount of the materials of the equolcontaining food. Further, the proportion of equol in the equol-containing food is generally
0.002 to 0.1 wt. %, preferably 0.004 to 0.05 wt. %, and more preferably 0.005 to 0.03 wt. %,based on the total amount of the materials of the equol-containing food. By ensuring this
proportion of the food material of the present invention, the useful bioactivity derived fromthe equol-containing fermented soybean hypocotyl is expressed in the food, while
maintaining the good flavor of the equol-containing food.
[0163]The equol-containing food is produced by mixing the food material of the present
invention with a predetermined amount of the other ingredients, and subjecting the mixture
to forming, baking, cooling, etc. depending on the target form of the food product.
[0164]The equol-containing food is made of an equol-containing fermented soybean hypocotyl,
and contains various useful bioactivity materials including equol, thereby expressing various
bioactivities or pharmacological activities. Therefore, the equol-containing food is useful not
only as a general food but also as a food for specified health use, nutritional supplement,functional food, invalid food or the like. The food containing the fermented soybean
hypocotyl of the present invention is particularly useful as a nutraceutical product.
[0165]For example, the equol-containing food has an effect of preventing or treating various
diseases or symptoms including menopausal disorders, osteoporosis, prostatic hypertrophy,
and metabolic syndrome; or for blood cholesterol level reduction, skin-whitening, pimple
treatment, intestinal control, improvement of obesity, and diuresis. Particularly, the equolcontaining food is suitable for prevention or treatment of indefinite complaint or postmenopausal symptoms (e.g., osteoporosis, menopausal disorder) of middle-aged women.
[Examples][0221]

16

The following more specifically explains the present invention with reference toReference Examples, Examples etc. The present invention is however not limited to theseexamples.
[0222]
Reference Examples 1-1 to 1-3 Production of Equol-Containing Fermented Soybean
Hypocotyl
Soybean hypocotyl powder, arginine, and water were mixed to prepare a soybean
hypocotyl solution (material) having a composition as shown in Table 1. A Lactococcus 2092 strain (FERM BP-10036) was inoculated in this soybean hypocotyl solution of 5 ml, andthe sample was subjected to stationary culture for 96 hours at 37°C. under anaerobic
conditions. After that, the resulting fermentation solution (culture solution) was sterilized byheating for a minute at 100°C., followed by drying at 80°C. The dried product was processed
into a powder using a homogenizer to obtain fermented soybean hypocotyl powder.
[0223]
Table 1 shows the viable cell count and pH of the culture solution after a 96-hour culture,
the amount of fermented soybean hypocotyl powder collected and the equol concentrationof the fermented soybean hypocotyl powder. …
[0224][Table 1]
Soybean
Hypocotyl
Powder (dry wt.)

CompositionofSoybeanArginine
Hypocotyl
Water
Solution(Material)
Total AmountPH

Analysis

Ref. Ex. 1-2

Ref. Ex. 1-3

0.25 g0.5 g0.75 g0.005 g0.005 g0.005 gAppropriate
Quantity

Appropriate
Quantity

Appropriate
Quantity

5 ml

5 ml

5 ml

6.75 ± 0.03

6.54 ± 0.02

6.39 ± 0.03

7.9 ± 0.1

8.2 ± 0.1

8.3 ± 0.2

7.00 ± 0.03

6.88 ± 0.01

6.76 ± 0.02

3.85 mg (-)

3.44 mg (-)

5.38 mg (48.9 wt.%)

Viable Bacterial
CountsofAnalytical
ResultFermented
LiquidRef. Ex. 1-1

ofFermented
Liquid(log
cfu/ml)PH of Fermented
Liquidof Equol17Compositionof Fermented
Soybean
Hypocotyl
Powderin
termsofIsoflavone

Daidzein
Compounds

n.d. (-)

n.d. (-)

1.18 mg (10.7 wt.%)

Genistein
Compounds

n.d. (-)

n.d. (-)

1.45 mg (13.2 wt.%)

n.d. (-)

n.d. (-)

3.00 mg (27.2 wt.%)

Glycitein
Compounds# Each Example was performed using three lots of soybean hypocotyl powder (N=3). In theanalysis of isoflavone composition in the table, the value on the left denotes a content (mg)of each isoflavone per gram of the fermented soybean hypocotyl, and the value in the bracket
on the right denotes the ratio (wt. %) of each isoflavone to the gross isoflavone amount (100wt. %) in the fermented soybean hypocotyl. "n.d." indicates that the measurement is not done,and "−" in the bracket indicates that the calculation is not done.
[0225]
Reference Example 1-4 Production of Equol-Containing Fermented Soybean Hypocotyl
A Lactococcus 20-92 strain (FERM BP-10036) was inoculated to a 5 ml soybean
hypocotyl solution containing 10 wt. % of soybean hypocotyl powder and 0.1 wt. % ofarginine, and the sample was subjected to fermentation by carrying out stationary culture for
96 hours at 37°C. under anaerobic conditions. After that, the resulting fermentation solution(culture solution) was sterilized by heating for a minute at 100°C., followed by drying at
80°C. The dried product was processed into powder using a homogenizer to obtainfermented soybean hypocotyl powder.
[0226]The respective components of the soybean hypocotyl powder ("Pre-fermentation" in
Table 2 and Table 3) and of the fermented soybean hypocotyl powder ("Post-fermentation"in Table 2 and Table 3) were analyzed. Table 2 shows an analysis regarding soybean
isoflavones, and Table 3 shows an analysis regarding nutritional components. These tables
show that the fermented soybean hypocotyl obtained by the fermentation of a soybean
hypocotyl using a Lactococcus 20-92 strain has a high equol content. Further,oligosaccharide content for such oligosaccharides as raffinose or stachyose remains
substantially the same after fermentation, which indicates that the fermentation did not
influence the oligosaccharide content. Meanwhile, the tables show that arginine wasconverted into ornithine by the fermentation. Accordingly, by adding arginine to the soybean
hypocotyl before fermentation using a Lactococcus 20-92 strain, the resulting fermented
substance contains not only equol but also ornithine.
[0227]

18

[Table 2]
Soybean Isoflavones

Per 100 g

Component

Pre-fermentation

Post-fermentation

Equol

N.D.

632.0 mg

Daidzin
Malonyldaidzin
Acetyldaidzin
Daidzein
Dihydrodaidzein

566.4 mg
124.9 mg364.8 mg
7.1 mgN.D.

29.7 mg
N.D.
25.4 mg24.4 mg49.4 mg

Genistin111.7 mg

3.2 mgMalonylgenistin
Acetylgenistin
Genistein
Dihydrogenistein

35.1 mg146.1 mg
0.9 mg
N.D.

N.D.
3.7 mg22.5 mg
112.0 mg

Glycitin
Malonylglycitin
Acetylglycitin
Glycitein
Dihydroglycitein

331.7 mg65.0 mg169.2 mg19.1 mg
N.D.

53.6 mg
N.D.
34.8 mg292.3 mg
8.2 mgTotal Isoflavones

1942.0 mg

1291.2 mg

N.D. refers to "Not Detected."[0228][Table 3]
Nutritional Components
Component

Per 100 g
Pre-fermentation

Post-fermentation

Moisture
Protein
Fat
Ash

3.2 g
38.1 g13.0 g
4.3 g

6.2 g
38.3 g14.5 g
4.0 g

Saccharide
Dietary Fiber
EnergySucroseRaffinose
Stachyose

30.9 g10.5 g
414 kcal7.95 g1.37 g9.04 g26.8 g10.2 g
411 kcal
7.42 g1.34 g8.38 g19

Trans Fatty Acids
Phospholipids (as stearooleo-lecithin)
Free Arginine
Free Ornithine
Soyasapogenol A
Soyasapogenol B
Soybean Saponin

N.D.
3.33 gN.D.
2.92 g

881 mg
N.D.
N.D.
N.D.
3.6 g

12 mg
1.06 g
N.D.
N.D.
3.8 g

N.D. refers to "Not Detected."[0229]
Reference Examples 1-5 to 1-11 Production of Equol-Containing Fermented Soybean
Hypocotyl
In these examples, fermented soybean hypocotyl powder (Reference Examples 1-5 to 111) were produced in the same manner as in Reference Example 1-3 except that seven lotsof soybean hypocotyl powder different from the three lots of Reference Example 1-3 wereused. …
[0230][Table 4]
Isoflavone Compositions
Equol

Daidzein
Compounds

Genistein
Compounds

Glycitein
Compounds

Ref. Ex. 1- 6.51 mg
5(62.2 wt. %)0.71 mg(6.8 wt. %)0.53 mg(5.1 wt. %)2.71 mg(25.9 wt. %)Ref. Ex. 1- 6.25 mg
6(61.3 wt. %)0.48 mg(4.7 wt. %)0.35 mg(3.4 wt. %)3.12 mg(30.6 wt. %)Ref. Ex. 1- 5.38 mg
7(48.9 wt. %)1.18 mg(10.7 wt. %)1.45 mg(13.2 wt. %)3.00 mg(27.2 wt. %)Ref. Ex. 1- 6.43 mg
8(63.4 wt. %)0.61 mg(6.0 wt. %)0.48 mg(4.7 wt. %)2.62 mg(25.8 wt. %)Ref. Ex. 1- 6.05 mg
9(64.2 wt. %)0.51 mg(5.4 wt. %)0.30 mg(3.2 wt. %)2.57 mg(27.3 wt. %)Ref. Ex. 1- 6.11 mg
10(65.6 wt. %)0.37 mg(4.0 wt. %)0.10 mg(1.1 wt. %)2.74 mg(29.4 wt. %)Ref. Ex. 1- 6.3 mg
11(60.9 wt. %)0.49 mg(4.73 wt. %)0.37 mg(3.6 wt. %)3.19 mg(30.8 wt. %)20

The value in the upper column denotes the content (mg) of each isoflavone per gram of
the fermented soybean hypocotyl, and the value in the lower column denotes the ratio (wt. %)of each isoflavone to the gross isoflavone amount (100 wt. %) in the fermented soybean
hypocotyl.
[0231]
Reference Experiment Example 1 Allergen Confirmation Test
A soybean hypocotyl is known to contain allergens including Gym4, Gm30K, Gm28K,
7S globulin mix (β-conglycine), oleosin, and trypsin inhibitors. The existence of allergens
in the equol-containing fermented soybean hypocotyl produced in Reference Example 1-1
was examined using the following test.
[0233]
Figs. 1 to 3 show the result. Fig. 1 shows the result for the detection of total protein; Fig.
2 shows the result for the detection of Gym4, Gm30K, and Gm28K; and Fig. 3 shows theresult for the detection of 7S globulin mix, oleosin, and trypsin inhibitors.
[0234]
These results show that the major allergen content of a soybean or a soybean hypocotyl
is reduced in the equol-containing fermented soybean hypocotyl.
(2) Outline of the Corrected Invention
According to the Corrected Invention stated on page 5, lines 13 to 20 of the judgment inprior instance as cited in No. 2, 3. above and according to (1) above, the Corrected Invention
is found to be as follows.
The Corrected Invention relates to a method for producing fermented powder, which isused as a food material containing ornithine and equol that has been suggested to have aneffect of preventing menopausal disorders, etc. ([Claim 1] and paragraphs [0002] and [0003]).
In this method, a fermenting material containing at least one daidzein compound selectedfrom the group consisting of daidzein glycosides, daidzein, and dihydrodaidzein, to whicharginine has been added, is fermented by using a microorganism having the ability to produce
ornithine and the ability to produce equol, to produce fermented powder which contains notless than 8 mg ornithine and not less than 1 mg equol per gram by dry weight of the fermented
substance, and which is used as a food material ([Claim 1] and paragraphs [0001], [0036],[0042], [0050], [0091] through [0096], [0222] through [0227], and [0229]).
The food containing equol and ornithine that is made by using the fermented substanceproduced according to the Corrected Invention as a food material expresses various
bioactivities or pharmacological activities, including prevention or treatment of indefinite
complaint or post-menopausal symptoms (e.g., osteoporosis, menopausal disorder) of21

middle-aged women, and is useful not only as a general food but also as a food for specified
health use, nutritional supplement, functional food, invalid food or the like (paragraphs[0144], [0157], and [0162] through [0165]).
2. Regarding Issue 1 (whether the Appellees' Method falls within the technical scope of theCorrected Invention)(1) Regarding Issue 1-1 (whether the Appellees' Material is presumed to have been produced
using the method of the Corrected Invention under Article 104 of the Patent Act)
A. Regarding application of Article 104 of the Patent Act
Article 104 of the Patent Act provides that, if a patent is granted for an invention that is
a process for producing a product and the product was not publicly known in Japan prior to
the filing of the patent application, any article identical to that product is presumed to havebeen produced using the patented process.
The Patent Claim states as follows: "A method of producing fermented powder
containing ornithine and equol, comprising a step to add arginine to at least one daidzein
compound selected from the group consisting of daidzein glycosides, daidzein, anddihydrodaidzein, and a step to ferment a fermenting material containing said daidzein
compound and said arginine by using a microorganism having the ability to produce
ornithine and the ability to produce equol, wherein not less than 8 mg ornithine and not lessthan 1 mg equol are produced per gram by dry weight of said fermented substance as a resultof the fermentation, and wherein said fermented powder is used as a food material."
Therefore, the Patent constitutes a case in which a patent has been granted for a method of
producing "fermented powder containing ornithine and equol, wherein not less than 8 mg
ornithine and not less than 1 mg equol are produced per gram by dry weight of said fermented
substance, and which is used as a food material" (the product of the Corrected Invention).
Here, the Appellees do not indicate approval or disapproval of the fact that the Appellees'
Material constitutes the above product of the Corrected Invention, and do not make it clearthat they deny the fact, so the Appellees are deemed to have admitted the fact that theAppellees' Material constitutes the above product of the Corrected Invention (Article 159,
paragraph (1) of the Code of Civil Procedure). It follows that, if the product of the Corrected
Invention was not publicly known in Japan prior to the filing of the patent application for
the Patent, the Appellees' Material is presumed to have been produced using the method of
the Corrected Invention. Moreover, the Appellees' Material is found to constitute the above
product of the Corrected Invention also in light of the Appellees' Method, which theAppellees allege to be the production method of the Appellees' Material.
B. Next, examination will be made as to which specific date corresponds to the date of "thefiling of the patent application for the Patent" under Article 104 of the Patent Act, with regard22

to the Corrected Invention.
(A) The following statements are contained in the applications on which the priority claim
for the Patent is based (Exhibits Otsu B1-1 through B1-3; the filing date: June 13, 2007;
hereinafter, regarding the applications on which the priority claim is based and the
documents for those applications, the application pertaining to Exhibit Otsu B1-1 is referred
to as "Basic Application A," the application pertaining to Exhibit Otsu B1-2 is referred to as"Basic Application B," and the application pertaining to Exhibit Otsu B1-3 is referred to as"Basic Application C," and these are collectively referred to as the "Basic Applications").
a. Basic Application A (Exhibit Otsu B1-1)[Title of the Invention] Food product that contains an equol-containing fermented soybean
hypocotyl or its extract[Claim 1] A beverage comprising an equol-containing fermented soybean hypocotyl
obtained by fermenting a soybean hypocotyl with an equol-producing microorganism or its
extract.
[Claim 3]
A creamy food comprising an equol-containing fermented soybean hypocotyl obtainedby fermenting a soybean hypocotyl with an equol-producing microorganism or its extract.
[Technical Field][0001]The present invention relates to various forms of foods that contain an equol-containing
fermented soybean hypocotyl or its extract.
[Problems to be Solved by the Invention][0005]The present inventors have found that a fermented soybean hypocotyl obtained byfermenting a soybean hypocotyl with an equol-producing microorganism is usable as anequol-containing food material. The fermented soybean hypocotyl contains not only equol
but also isoflavone, saponin and like useful soybean-derived components. The fermented
soybean hypocotyl achieves such effective physiological effects attributable to these usefulcomponents, and therefore is usable as a functional material. The present inventors also
found that the fermented soybean hypocotyl is useful as an allergen-reduced material,
because the allergens attributable to the soybean hypocotyl therein are reduced. …
[0006]
It is also known that an extract obtained through solvent extraction of useful components
containing equol from an equol-containing fermented soybean hypocotyl is usable as afunctional food material.
[0007]

23

Accordingly, an object of the present invention is to provide various forms of foods that
contain an equol-containing fermented soybean hypocotyl or its extract.
[Best Mode for Carrying Out the Invention][0012]
Equol-Containing Fermented Soybean Hypocotyl
An equol-containing fermented soybean hypocotyl used for the food material of thepresent invention is a kind of a fermented soybean hypocotyl produced by fermenting asoybean hypocotyl using an equol-producing microorganism.
[0013]The equol-producing microorganism used for the production of the equol-containing
fermented soybean hypocotyl is selected from microorganisms having the ability (metabolic
activity) to produce equol by metabolizing at least one daidzein compound selected from thegroup consisting of daidzein glycosides, daidzein, and dihydrodaidzein. Examples of thedaidzein glycosides here include daidzin, malonyldaidzin, and acetyldaidzin.
[0014]The equol-producing microorganism is not limited and may be any microorganism
having the foregoing ability and permissible in terms of food sanitation. It is known that such
equol-producing microorganisms exist in the microorganisms belonging to Lactococcus,
such as Lactococcus garvieae; microorganisms belonging to Streptococcus, such as
Streptococcus intermedius or Streptococcus constellatus; or microorganisms belonging toBacteroides, such as Bacteroides ovatus. Among various kinds of equol-producing
microorganism, the present invention prefers lactic acid bacteria belonging to Lactococcus
or Streptococcus, further prefers lactic acid bacteria belonging to Lactococcus, and inparticular, lactic acid bacteria belonging to Lactococcus garvieae. The equol-producing
microorganisms may be isolated from, for example, human feces, based on the index of theexistence of an equol-producing property. The inventors of the present invention deposited
some identified bacteria that had been isolated from human feces; namely, Lactococcus 2092 (FERM BP-10036), Streptococcus E-23-17 (FERM BP-6436), Streptococcus A6G225(FERM-6437), and Bacteroides E-23-15 (FERM BP-6435), that are available to be used as
the equol-producing microorganisms. Among these, the present invention particularly
prefers Lactococcus 20-92.
[0015]The equol-containing fermented soybean hypocotyl is produced using a soybean
hypocotyl as a fermenting material. The soybean hypocotyl is a part corresponding to theplumule or the radicle on the germination of soybean, and is known to contain a large amountof daidzein compounds such as daidzein glycosides or daidzein. The soybean hypocotyl used24

in the present invention is not limited by the producing district of soybean or whether
processed or unprocessed, unless the daidzein compounds inside are significantly lost. For
example, the equol-containing fermented soybean hypocotyl may be a raw hypocotyl, or
may be one isolated from heated, dried or steam-boiled soybean, or one obtained by heating,drying or steam-boiling a hypocotyl that is isolated from unprocessed soybean. Further, thesoybean hypocotyl may be processed by degreasing or deproteinization. The form of thesoybean hypocotyl is not particularly limited, and may be in the form of powder, chunks, or
pulverized or fragmentized grains. A powdery soybean hypocotyl is particularly preferable
because of its efficient equol production.
[0016]
The fermentation of a soybean hypocotyl is carried out by first adjusting the watercontent of the soybean hypocotyl by adding an appropriate amount of water, and theninoculating the equol-producing microorganism to the hypocotyl.
[0017]
The amount of water added to the soybean hypocotyl is adjusted depending on the typeof equol-producing microorganism or the type of fermenter. The ratio of water to the soybean
hypocotyl in the beginning of fermentation is 400 to 4,000 parts by weight, preferably 500
to 2,000 parts by weight, more preferably 600 to 1,000 parts by weight, based on 100 parts
by weight (dry weight) of the soybean hypocotyl.
[0018]
Further, if necessary, some additives may be added to the soybean hypocotyl as the raw
material in the fermentation to improve the fermentation efficiency or flavor of the product.
Examples of the additives include nitrogen sources such as a yeast extract, polypeptone, ora meat extract; carbon sources such as glucose or sucrose; inorganic salts such as phosphate,
carbonate or hydrosulfate; vitamins; and nutritional components such as amino acid.
Particularly, when using an equol-producing microorganism for converting arginine into
ornithine (hereinafter referred to as an "ornithine/equol-producing microorganism"),arginine is added to the soybean hypocotyl before fermentation so that the fermented
substance contains ornithine. In this case, the amount of arginine is, for example, about 0.5
to 3 parts by weight, based on 100 parts by weight (dry weight) of the soybean hypocotyl.
Specifically, the equol-producing microorganism for converting arginine into ornithine may
be selected from the group of Lactococcus garvieae, typified by Lactococcus 20-92 (FERM
BP-10036).
[0019]
Further, the pH of the fermenting material (a soybean hypocotyl-containing substance)
is not particularly limited within a range for the equol-producing microorganism to grow;25

however, to secure excellent proliferation of the equol-producing microorganism, the pH of
the fermenting material preferably falls within about 6 to 7, more preferably about 6.3 to 6.8.
[0020]
Further, isoflavone containing the above-mentioned daidzein compounds may be added
to the fermenting material (a soybean hypocotyl-containing substance). Such inclusion of
isoflavone in the fermenting material increases the equol content of the fermented soybean
hypocotyl, thereby improving the usability of the fermented soybean hypocotyl.
[0024]… The equol content in the fermented soybean hypocotyl varies depending on the typeof the equol-producing microorganism or fermentation conditions. The equol content in thefermented soybean hypocotyl is generally 1 to 20 mg, preferably 2 to 12 mg, and more
preferably 5 to 8 mg, per gram (dry weight) of the fermented soybean hypocotyl.
[0025]
Apart from equol, the equol-containing fermented soybean hypocotyl also contains
various isoflavones such as daidzein compounds including daidzin, malonyldaidzin,
acetyldaidzin, daidzein, or dihydrodaidzin (these components are referred to as "daidzein
compounds," hereinafter); or genistein compounds including genistin, malonylgenistin,
acetylgenistin, genistein, dihydrogenistein (these components are referred to as "genistein
compounds," hereinafter). The isoflavones also express the useful physiologic activities. The
content of each isoflavone (incl. equol) in the fermented soybean hypocotyl varies dependingon the type of the equol-producing microorganism or fermentation conditions, but it isgenerally 5 to 20 mg, preferably 5 to 15 mg, and more preferably 8 to 15 mg, per gram (dryweight) of the equol-containing fermented soybean hypocotyl.
[0031]The equol-containing fermented soybean hypocotyl also contains saponin derived fromthe soybean hypocotyl. The equol-containing fermented soybean hypocotyl generally
contains saponin in an amount of 10 to 80 mg, preferably 20 to 50 mg, and more preferably
30 to 40 mg, per gram (dry weight) of the equol-containing fermented soybean hypocotyl.
[0032]
Further, as described above, ornithine is contained in the equol-containing fermented
soybean hypocotyl produced from fermentation with an ornithine/equol-producing
microorganism after adding arginine to a soybean hypocotyl. The ornithine content of theequol-containing fermented soybean hypocotyl is 5 to 20 mg, preferably 8 to 15 mg, andmore preferably 9 to 12 mg, per gram (dry weight) of the equol-containing fermented
soybean hypocotyl.
[0100]

26

The following more specifically explains the present invention with reference toReference Examples, Examples etc. The present invention is however not limited to theseexamples.
Reference Examples 1-1 to 1-3 Production of Equol-Containing Fermented Soybean
Hypocotyl
Soybean hypocotyl powder, arginine, and water were mixed to prepare a soybean
hypocotyl solution (material) having a composition as shown in Table 1. A Lactococcus 2092 strain (FERM BP-10036) was inoculated in this soybean hypocotyl solution of 5 ml, andthe sample was subjected to stationary culture for 96 hours at 37°C. under anaerobic
conditions. After that, the resulting fermentation solution (culture solution) was sterilized byheating for a minute at 100°C., followed by drying at 80°C. The dried product was processed
into a powder using a homogenizer to obtain fermented soybean hypocotyl powder.
[0101]
Table 1 shows the viable cell count and pH of the culture solution after a 96-hour culture,
the amount of fermented soybean hypocotyl powder collected and the equol concentrationof the fermented soybean hypocotyl powder. From the data, it is shown that fermentation ofsoybean hypocotyl powder using equol-producing bacteria produces equol with highefficiency.
[0102][Table 1]
Ref. Ex. 1-1

Ref. Ex. 1-2

Ref. Ex. 1-3

0.25 g0.5 g0.75 g0.005 g0.005 g0.005 gAppropriate
Quantity

Appropriate
Quantity

Appropriate
Quantity

5 ml

5 ml

5 ml

PH

6.75 ± 0.03

6.54 ± 0.02

6.39 ± 0.03

ViableBacterial
Counts of Fermented

7.9 ± 0.1

8.2 ± 0.1

8.3 ± 0.2

7.00 ± 0.03

6.88 ± 0.01

6.76 ± 0.02

385.6 ± 101.5

344.6 ± 62.1

417.5 ± 68.0

Soybean Hypocotyl
Composition of Powder (dry wt.)
Arginine
Soybean
Hypocotyl
Water
Solution(Material)
Total AmountAnalytical
ResultFermented
LiquidAnalytical
ResultFermented

ofLiquid (log cfu/ml)
PH of
LiquidFermented

Equol Concentrationof of the Fermented
Soybean Hypocotyl

27

Soybean
Hypocotyl
PowderPowder (mg/100 g)# Each Example was performed using three lots of soybean hypocotyl powder (N=3). The
analysis results in the table are presented in mean ± standard deviation.
[0103]
Reference Example 1-4 Production of Equol-Containing Fermented Soybean Hypocotyl
A Lactococcus 20-92 strain (FERM BP-10036) was inoculated to a 5 ml soybean
hypocotyl solution containing 10 wt. % of soybean hypocotyl powder and 0.1 wt. % ofarginine, and the sample was subjected to fermentation by carrying out stationary culture for
96 hours at 37°C. under anaerobic conditions. After that, the resulting fermentation solution(culture solution) was sterilized by heating for a minute at 100°C., followed by drying at
80°C. The dried product was processed into powder using a homogenizer to obtainfermented soybean hypocotyl powder.
[0104]The respective components of the soybean hypocotyl powder ("Pre-fermentation" in
Table 2 and Table 3) and of the fermented soybean hypocotyl powder ("Post-fermentation"in Table 2 and Table 3) were analyzed. Table 2 shows an analysis regarding soybean
isoflavones, and Table 3 shows an analysis regarding nutritional components. These tables
show that the fermented soybean hypocotyl obtained by the fermentation of a soybean
hypocotyl using a Lactococcus 20-92 strain has a high equol content. … Meanwhile, thetables show that arginine was converted into ornithine by the fermentation. Accordingly, byadding arginine to the soybean hypocotyl before fermentation using a Lactococcus 20-92
strain, the resulting fermented substance contains not only equol but also ornithine.
[0105][Table 2]
Soybean Isoflavones
Per 100 g
Component

Pre-fermentation

Post-fermentation

Equol

N.D.

632.0 mg

Daidzin
Malonyldaidzin
Acetyldaidzin
Daidzein
Dihydrodaidzein

566.4 mg
124.9 mg364.8 mg
7.1 mgN.D.

29.7 mg
N.D.
25.4 mg24.4 mg49.4 mg

Genistin111.7 mg

3.2 mg28

Malonylgenistin
Acetylgenistin
Genistein
Dihydrogenistein

35.1 mg146.1 mg
0.9 mg
N.D.

N.D.
3.7 mg22.5 mg
112.0 mg

Glycitin
Malonylglycitin
Acetylglycitin
Glycitein
Dihydroglycitein

331.7 mg65.0 mg169.2 mg19.1 mg
N.D.

53.6 mg
N.D.
34.8 mg292.3 mg
8.2 mgTotal Isoflavones

1942.0 mg

1291.2 mg

N.D. refers to "Not Detected."[0106][Table 3]
Nutritional Components
Component

Per 100 g
Pre-fermentation

Post-fermentation

Moisture
Protein
Fat
Ash

3.2 g
38.1 g13.0 g
4.3 g

6.2 g
38.3 g14.5 g
4.0 g

Saccharide
Dietary Fiber
EnergySucroseRaffinose
StachyoseTrans Fatty Acids
Phospholipids (as stearooleo-lecithin)
Free Arginine

30.9 g10.5 g
414 kcal7.95 g1.37 g9.04 g
N.D.
3.33 g26.8 g10.2 g
411 kcal
7.42 g1.34 g8.38 gN.D.
2.92 g

881 mg

12 mg

Free Ornithine
Soyasapogenol A
Soyasapogenol B
Soybean Saponin

N.D.
N.D.
N.D.
3.6 g

1.06 g
N.D.
N.D.
3.8 g

N.D. refers to "Not Detected."29

b. Basic Application B (Exhibit Otsu B1-2)
Paragraphs [0015] through [0020], [0026], [0027], [0033], [0034], and [0070] through[0077] of the filing documents of Basic Application B contain statements corresponding toparagraphs [0013] through [0018], [0024], [0025], [0031], [0032], and [0100] through[0106] of the filing documents of Basic Application A. In addition, the filing documents of
Basic Application B contain the following statements.
[Title of the Invention] Equol-containing food material, and food product using the same
[Claim 1](A) A food material obtained by dispersing an equol-containing fermented soybean
hypocotyl, obtained by fermenting a soybean hypocotyl with an equol-producing
microorganism or its extract, into (B) cacao mass.
c. Basic Application C (Exhibit Otsu B1-3)
Paragraphs [0014] through [0021], [0025], [0026], [0032], [0033], and [0056] through[0059] of the filing documents of Basic Application C contain statements corresponding toparagraphs [0013] through [0020], [0024], [0025], [0031], [0032], and [0100] through[0102] of Basic Application A. In addition, the filing documents of Basic Application C
contain the following statements.
[Title of the Invention] Equol-containing extract, and method for production thereof[Claim 1]
A method for producing an equol-containing extract, comprising Step 1 of extracting anequol-containing fermented soybean hypocotyl by using an ethanol aqueous solution as an
extraction solvent, and collecting the extracted liquid.
(B) Statements added in the Original Application (Exhibit Otsu B2)
Statements corresponding to paragraph [0093] of the Description, which clearly
indicates that a "material containing daidzein compounds" other than a "soybean hypocotyl"
is used as a fermenting material, and statements corresponding to paragraph [0095] of the
Description, which clearly indicates that appropriate nutritional components are added to the"daidzein compounds" did not exist in the Basic Applications, and were added for the firsttime in the Original Application (paragraphs [0091] and [0093] of the Original Application).
In addition, statements corresponding to paragraph [0032] of the Description concerninga publicly-known screening method and statements in paragraph [0036] concerning
obtainment of an "ornithine/equol-producing microorganism" by "a publicly-known
screening method using an index of the equol-producing ability and the conversion ability
from arginine into ornithine" also did not exist in the Basic Applications, and were added forthe first time in the Original Application (paragraphs [0030] and [0034] of the Original
Application).

30

(C) Regarding whether a priority claim can be madeAs mentioned in (A) and (B) above, the only substance clearly indicated as a fermenting
material in the Basic Applications is a "soybean hypocotyl," and a statement clearly
indicating that a substance other than a "soybean hypocotyl" can be used as a fermenting
material was added in the Original Application and in later applications.
However, the Basic Applications state that the invention uses a microorganism having
the ability to produce equol by metabolizing "daidzein compounds," and that the
Lactococcus 20-92 strain used in examples of the Basic Applications is one example of suchmicroorganism (paragraphs [0013] and [0014] of Basic Application A, paragraphs [0015]
and [0016] of Basic Application B, and paragraphs [0014] and [0015] of Basic Application
C). Meanwhile, the Basic Applications state, "… if necessary, some additives may be added
to the soybean hypocotyl as the raw material in the fermentation to improve the fermentation
efficiency or flavor of the product. Examples of the additives include … and nutritional
components ..." (paragraph [0018] of Basic Application A, paragraph [0020] of Basic
Application B, and paragraph [0019] of Basic Application C), and therefore the Basic
Applications do not exclude addition of nutritional components other than "water" and"arginine." Moreover, the Basic Applications state "Further, isoflavone containing the abovementioned daidzein compounds may be added to the fermenting material (a soybean
hypocotyl-containing substance)" (paragraph [0020] of Basic Application A, paragraph[0022] of Basic Application B, and paragraph [0021] of Basic Application C), and it can besaid that they assume using isoflavone containing "daidzein compounds" as a fermenting
material.
As mentioned in (A)a. and b. above, examples in Basic Applications A and B state, alongwith specific experiment results, that by adding arginine to a "soybean hypocotyl" andfermenting it by using a Lactococcus 20-92 strain, equol is produced through metabolism ofdaidzin contained in the "soybean hypocotyl," and fermented powder is obtained as a resultof the strain converting arginine into ornithine (paragraphs [0103] through [0106] of Basic
Application A and paragraphs [0074] through [0077] of Basic Application B). In addition,
the Basic Applications state "The equol content in the fermented soybean hypocotyl is
generally 1 to 20 mg, preferably 2 to 12 mg, and more preferably 5 to 8 mg, per gram (dryweight) of the fermented soybean hypocotyl" and "The ornithine content of the equolcontaining fermented soybean hypocotyl is 5 to 20 mg, preferably 8 to 15 mg, and more
preferably 9 to 12 mg, per gram (dry weight) of the equol-containing fermented soybean
hypocotyl" (paragraphs [0024] and [0032] of Basic Application A, paragraphs [0026] and[0034] of Basic Application B, and paragraphs [0025] and [0033] of Basic Application C),
indicating that the fermented substance generally contains 1 to 20 mg of equol and should31

preferably contain 8 to 15 mg of ornithine per gram (dry weight) of the fermented substance.
Therefore, it can be said that these lower limits are specified in the Corrected Invention.
Moreover, it is clear from the claim statements in Basic Applications A and B that thefermented substance obtained by the inventions of these basic applications is a food material.
Meanwhile, according to evidence (Exhibit Otsu B4 (Journal of Bioscience andBioengineering, Vol. 102, No. 3, 247-250. 2006) and Exhibit Otsu B16 (International
Publication No. 2005/000042)), it is found to have been common general technicalknowledge as of the Priority Date that equol is produced from daidzein, that a Lactococcus
20-92 strain produces equol by metabolizing a daidzein compound, including daidzein
glycosides (e.g., daidzin), daidzein, and dihydrodaidzein, and that, in the case of daidzin,
daidzin is metabolized to liberate daidzein, and the liberated daidzein is further metabolized
to dihydrodaidzein to finally produce equol. It follows that a person skilled in the art is foundto have recognized that, in the Basic Applications, the substance that is metabolized in effectis a "daidzein compound" such as daidzin contained in the "soybean hypocotyl."
For the reasons mentioned above, it should be said that a person skilled in the art who
read the abovementioned statements of Basic Applications A and B could have recognized
the following, by also taking into account the abovementioned common general technicalknowledge as of the Priority Date: even in the case of using a "material containing daidzein
compounds" other than a "soybean hypocotyl" as a fermenting material, if a microorganism
having the ability to produce equol and ornithine, such as a Lactococcus 20-92 strain, is used
to cause the "daidzein compounds" in the fermenting material to be metabolized together
with arginine, it is possible to produce fermented powder which contains not less than 8 mg
ornithine and not less than 1 mg equol per gram by dry weight of the fermented substance,
and which is used as a food material. Therefore, a person skilled in the art is found to havebeen able to understand the Corrected Invention from the statements in Basic Applications
A and B.
Consequently, the Corrected Invention is at least found to be an invention stated orequivalent to have been stated in Basic Applications A and B, and should be regarded to beable to enjoy the effect of the priority claim based on Basic Applications A and B.
It follows that, with regard to application of the provisions of Article 104 of the Patent
Act, the patent application for the Patent is deemed to have been filed on June 13, 2007,
which is the Priority Date. Accordingly, when examining whether the product of theCorrected Invention was "not publicly known" in Japan prior to the filing of the patentapplication as referred to in that Article, Exhibit Otsu B3 (International Publication No.
2007/066655; the international publication date: June 14, 2007), which was published after
the Priority Date, cannot be taken into consideration.

32

C. Whether the product was "not publicly known"
In order for a product to have been "publicly known" as referred to in Article 104 of the
Patent Act, there should at least be a fact that was sufficiently known to enable a person
skilled in the art to acquire clues for producing that product as of the reference date. However,it cannot be said that the product of the Corrected Invention was stated in Exhibit Otsu B16
and Exhibit Otsu B24, which were publicly known as of the Priority Date, and hence a person
skilled in the art could not have easily conceived of the Corrected Invention from Exhibit
Otsu B16 or Exhibit Otsu B24 as mentioned in 3.(4) and (6) below. It follows that a person
skilled in the art who read Exhibit Otsu B16 or Exhibit Otsu B24 could not have been able
to acquire clues for producing the product of the Corrected Invention as of the Priority Date.
The Appellees allege that the product of the Corrected Invention was "publicly known,"
as it is merely a product made by adding "8 mg" of ornithine of "97.48%" purity, which is anutrition enhancing additive, (International Publication (WO2006/051940) of Exhibit Otsu
B67) to "992 mg" of fermented substance wherein "1 mg to 3 mg of equol is produced pergram by dry weight" as referred to in "Example 1" of Exhibit Otsu B16. However, as
mentioned in A. above, the product of the Corrected Invention is "fermented powder
containing ornithine and equol, wherein not less than 8 mg ornithine and not less than 1 mg
equol are produced per gram by dry weight of said fermented substance, and which is used
as a food material." Thus, even if Exhibit Otsu B16 is combined with Exhibit Otsu B67, theproduct of the Corrected Invention does not constitute a product "wherein not less than 8 mg
ornithine and not less than 1 mg equol are produced per gram by dry weight of said fermented
substance," and hence the Appellees' allegations mentioned above are unacceptable.
As the Appellees alleged that the product of the Invention constitutes a publicly known
product based on Exhibit Otsu B4, this point was examined to make certain. As a result of
the examination, it cannot be said that the Corrected Invention was stated in Exhibit Otsu
B4, and that a person skilled in the art could have easily conceived of the Corrected Invention
from Exhibit Otsu B4, as mentioned in 3.(3) below, and it also cannot be said that a person
skilled in the art could have acquired clues for producing the product of the Corrected
Invention from Exhibit Otsu B4.
Consequently, it is determined that the product of the Corrected Invention was "notpublicly known" as of the Priority Date.
D. Regarding the constitution of the Appellees' Method
The Appellees allege that the presumption under Article 104 of the Patent Act does not
apply because their admission has been established regarding the fact that the method for
producing the Appellees' Material is the Appellees' Method stated in the "List of the
Defendants' Method" attached to the judgment in prior instance. On the fourth date for33

preparatory proceedings in the prior instance on June 7, 2019, both parties stated that theconstitution of the Appellees' Method is as stated in the "List of the Defendants' Method"
attached to the judgment in prior instance (a fact evident to this court).
The difference between the Appellees' Method that was found to be not disputed among
the parties concerned in the prior instance and the Appellees' Method alleged by theAppellant in this instance is that the constituent portion "α3 a treatment solution containing
daidzein obtained through said enzyme treatment process and ●●●●●●●●●●●●●●●●●●●●●●●●●● are mixed with a culture solution containing arginine
to be fermented," in the former method is changed to the following constitution in the lattermethod: "α3-1 daidzein obtained through said enzyme treatment process is mixed with othercomponents including arginine to form a medium, and this is sterilized to form a sterilized
medium," and "α3-2 ●●●●●●●●●●●●●●●●●●●●●●●●●●●
is inoculated in this sterilized medium to be fermented." The contents of these α3-1 and α32 are intended to make the contents of α3 more specific and detailed, and the Appellant
asserts that if the claim interpretation of the Corrected Invention in the judgment in priorinstance is to be applied, the constitution of the Appellees' Method should be regarded as α31 and α3-2. Therefore, first, the constitution of the Appellees' Method that was found to be
not disputed among the parties concerned in the prior instance (the method according to α1
through α6, which has not changed α3 to α3-1 and α3-2) will be examined.
E. Regarding rebuttal of presumption
The Appellees are regarded to be making allegations and presenting evidence to theeffect that they are not using the method of the Corrected Invention, on the basis that themethod for producing the Appellees' Material is the Appellees' Method, which differs fromthe method of the Corrected Invention. Accordingly, the question of whether the Appellees'
Method (first of all, the method according to α1 through α6, which has not changed α3 to
α3-1 and α3-2) differs from the method of the Corrected Invention is examined below.
(A) Regarding addition of argininea. The Appellees allege that, in the Appellees' Method, the daidzein compound selected inConstituent Feature A' is the "daidzein glycosides" referred to in Constitution α1, and themethod does not have a step to add arginine to the daidzein glycosides, and therefore it isproven that the method does not fulfill Constituent Features A', B'-1, and B'-2.
b. While the Appellees allege that the Appellees' Method does not have a step to add arginine,
the Appellees' Method has a step wherein a treatment solution containing daidzein and ●●●●●●●●●●●●●●●●●●●●●●●●●● are mixed with a culture
solution containing arginine to be fermented in Constitution α3. Therefore, the question iswhether this step can be regarded as constituting "addition of arginine" (Constituent Feature

34

A').
Constituent Feature A' in the claim statement has a step to "add arginine to at least one
daidzein compound selected from the group consisting of daidzein glycosides, daidzein, anddihydrodaidzein," whereas Constitution α3 of the Appellees' Method has a step to mix atreatment solution containing daidzein with a culture solution containing arginine, and thiscan be regarded as a step to add arginine to daidzein. The Appellees allege that, while the"daidzein glycosides" of Constitution α1 corresponds to "at least one daidzein compound
selected from the group consisting of daidzein glycosides, daidzein, and dihydrodaidzein"of Constituent Feature A', the Appellees' Method does not add arginine to daidzein
glycosides, and hence it does not fulfill the step to "add arginine" in Constituent Feature A'.
However, as mentioned above, the claim states that arginine is added to "at least one daidzein
compound selected from the group consisting of daidzein glycosides, daidzein, anddihydrodaidzein," and provides no reason to limit the daidzein compound to daidzein
glycosides. In Constitution α3, a treatment solution containing "daidzein," which is one of
the abovementioned daidzein compounds, and a culture solution containing "arginine" aremixed. Therefore, it should be said that arginine is added to daidzein, which is a daidzein
compound, in the Appellees' Method. It follows that the Appellees' Method fulfills
Constituent Feature A'.
c. The judgment in prior instance determined that the "culture solution containing arginine"in Constitution α3 does not constitute the "fermenting material containing arginine" inConstituent Features A-2 and A-3 of the Invention, and therefore the Appellees' Method does
not fulfill Constituent Features A-2 and A-3 of the Invention. However, since there is also a"fermenting material containing arginine" in Constituent Feature B'-1 of the Corrected
Invention, the question of whether the "culture solution containing arginine" in α3 constitutes
the "fermenting material containing arginine" in Constituent Feature B'-1 is examined below.
While Constituent Feature B'-1 reads "a fermenting material containing said daidzein
compound and said arginine," it is natural to construe that this refers to the substanceresulting from adding arginine to a daidzein compound in Constituent Feature A'. As
mentioned in b. above, in Constitution α3 of the Appellees' Method, a treatment solution
containing "daidzein" and a culture solution containing "arginine" are mixed with ●●●●●●●●●●●●●●●●●●●●●●●●●● to be fermented, and the mixtureof the treatment solution containing "daidzein" and the culture solution containing "arginine"is "fermented" by using ●●●●●●●●●●●●●●●●●●●●●●●●●●,
which is a "microorganism having the ability to produce ornithine and the ability to produce
equol"; thus, it should be said that the abovementioned mixture constitutes a fermenting
material. It follows that the mixture constitutes "a fermenting material containing said

35

daidzein compound and said arginine," and therefore, even if the Appellees' Method allegedby the Appellees is premised, the method for producing the Appellees' Material fulfills
Constituent Feature B'-1 of the Corrected Invention, and also fulfills Constituent Feature B'2, which is a step to ferment the fermenting material of Constituent Feature B'-1 by using a
microorganism.
In this regard, the judgment in prior instance construed, with regard to the Invention, that
arginine is contained in the fermenting material at the stage of preparing the fermenting
material before the fermentation, and that the "treatment solution containing daidzein" ofConstitution α3 constitutes a fermenting material, whereas the "culture solution containing
arginine" constitutes not a fermenting material, but a nutritional component aimed at
improving the fermentation efficiency, etc. On such basis, the judgment determined that theAppellees' Method does not fulfill the relevant constituent feature of the Invention, as
arginine appears for the first time at the fermentation stage.
However, the Patent Claim and the Description contain no statements suggesting any
difference between a case of adding a microorganism after adding arginine to a daidzein
compound and a case of mixing a daidzein compound, arginine, and a microorganism at thesame time. Meanwhile, looking at the Description, paragraph [0091] states "a fermenting
material (material to be subjected to the fermentation)," but paragraph [0093] states that thefermenting material "containing daidzein compounds is not limited by other factors,"
indicating that there are no particular limitations concerning the fermenting material, andthere are no other statements defining the fermenting material. As mentioned in 1.(2) above,the substances subjected to the fermentation using a microorganism having the ability to
produce ornithine and the ability to produce equol in the Corrected Invention are a "daidzein
compound" and "arginine," and regardless of whether a microorganism is added after adding
arginine to a daidzein compound or arginine and a microorganism are added to a daidzein
compound at the same time, there is no difference in that arginine is subjected tofermentation. It follows that there are no grounds for regarding that the arginine in theAppellees' Method is not a fermenting material.
The judgment in prior instance found that a nutritional component aimed at improving
the fermentation efficiency, etc. is treated as a component different from a fermenting
material, because paragraph [0033] of the Description states "The equol-containing
fermented soybean hypocotyl is produced using a soybean hypocotyl as a fermenting
material," and paragraph [0036] states that "if necessary, some additives may be added to thesoybean hypocotyl as the raw material in the fermentation to improve the fermentation
efficiency or flavor of the product. Examples of the additives include nitrogen sources suchas a yeast extract, polypeptone, or a meat extract; carbon sources such as glucose or sucrose;36

inorganic salts such as phosphate, carbonate or hydrosulfate; vitamins; and nutritional
components such as amino acid. Particularly, when using an equol-producing microorganism
for converting arginine into ornithine (omitted), arginine is added to the soybean hypocotyl
before fermentation so that the fermented substance contains ornithine. In this case, theamount of arginine is, for example, about 0.5 to 3 parts by weight, based on 100 parts byweight (dry weight) of the soybean hypocotyl," indicating that a nutritional component
aimed at improving the fermentation efficiency, etc. may be added to the soybean hypocotyl
to be used as a fermenting material, if necessary. However, there is no contradiction betweena fact that a "soybean hypocotyl" containing a daidzein compound constitutes a fermenting
material and a fact that a treatment solution containing a daidzein compound and a culture
solution containing arginine both constitute a fermenting material. Moreover, the statementin paragraph [0036] is also not contradictory to deeming a substance resulting from adding
arginine to a soybean hypocotyl as a fermenting material. Consequently, it must be said thatthe determination by the judgment in prior instance contains an error.
Then, it is reasonable to find that the "culture solution containing arginine" in α3constitutes the "fermenting material containing arginine" in Constituent Feature B'-1, andhence the allegation that the Appellees' Method does not fulfill Constituent Feature A', B'-1,
and B'-2 is not proven.
(B) Regarding the type of the microorganism
a. Constituent Feature B'-2 reads "comprising a step to ferment … by using a microorganism
having the ability to produce ornithine and the ability to produce equol. The"microorganism" needs to have "the ability to produce ornithine and the ability to produce
equol," but it is not limited to a specific microorganism. When looking at the statements inthe detailed description of the invention in the Description, only a Lactococcus 20-92 strain
is mentioned as the "microorganism" in the [Examples] section, but on the other hand,paragraph [0032] states that some microorganisms having the ability to produce equol were
known as of the time of the filing of the patent application for the Patent, and paragraph[0036] states that a microorganism having the ability to produce ornithine can be obtained
from among those microorganisms by a publicly-known screening method.
Then, it should be regarded that a person skilled in the art who read the statements of the
Patent Claim and the detailed description of the invention in the Description could have beenable to also find a microorganism having "the ability to produce ornithine and the ability to
produce equol" other than a Lactococcus 20-92 strain, within a general extent of trial anderror, by using a publicly-known screening method. Therefore, it should be said that the"microorganism" in Constituent Feature B'-2 is not limited to a Lactococcus 20-92 strain,
and that the enteric bacterium (●●●●●●●●●●●●●●●●●●●●●●●●

37

● ● ● ) used in the Appellees' Method fulfills the abovementioned wording,"microorganism."b. The Appellees allege that the "microorganism" in Constituent Feature B'-2 should beinterpreted to be limited to a Lactococcus 20-92 strain, by indicating matters including thefollowing: although "comprising a step to ferment … by using a microorganism having theability to produce ornithine and the ability to produce equol" in Constituent Feature B'-2 isa statement that covers a wide range of microorganisms as a so-called functional claim, theDescription states that the basic technical idea of the invention lies in the discovery of a
Lactococcus 20-92 strain being an appropriate microorganism, and it has no statement
indicating that all types of microorganisms are covered; given this fact and the information
available on the Appellant's website (Exhibit Otsu B11), it should be said that excessive trial
and error would have been required for a person skilled in the art to find the abovementioned
microorganism other than a Lactococcus 20-92 strain.
However, there are no reasonable grounds to find that the wording of a microorganism
having "the ability to produce ornithine and the ability to produce equol" in Constituent
Feature B'-2 covers a wide range of microorganisms, and as explained in a. above, it should
be regarded that a person skilled in the art who read the statements of the Description, etc.
could have been able to also find a microorganism having "the ability to produce ornithineand the ability to produce equol" other than a Lactococcus 20-92 strain, within a generalextent of trial and error, by using a publicly-known screening method. Therefore, theDescription cannot be regarded to be stating that the basic technical idea of the invention lies
solely in the discovery of a Lactococcus 20-92 strain being an appropriate microorganism.
Moreover, even if it may be difficult to find a microorganism that is excellent enough to be
actually commercialized by looking at the information available on the Appellant's website(Exhibit Otsu B11), the "microorganism" in Constituent Feature B'-2 does not need to be a
microorganism that is excellent enough to be actually commercialized, but a microorganism
having "the ability to produce ornithine and the ability to produce equol" to a certain extent
would suffice, in light of the statements of the Patent Claim and the detailed description of
the invention in the Description, and finding such microorganism would not impose
excessive trial and error on a person skilled in the art.
In addition, the "daidzein compound" in Constituent Feature A' of the Corrected
Invention only needs to be at least one daidzein compound selected from three types ofdaidzein compounds, "daidzein glycosides, daidzein, or dihydrodaidzein," and it does notnecessarily have to be "daidzein glycosides." While the "microorganism" in Constituent
Feature B'‐2 needs to be one having "the ability to produce ornithine and the ability to
produce equol," the claim and the Description contain no statements indicating that the38

abovementioned "microorganism" needs to be one having the ability to cleave sugar.
Although only a Lactococcus 20-92 strain, which is a microorganism having the ability tocleave sugar, is mentioned as the "microorganism" in the [Examples] section of the
Description, the "microorganism" in Constituent Feature B'‐2 is not limited to a Lactococcus
20-92 strain. It follows that the "microorganism" in Constituent Feature B'‐2 does not need
to be one having the ability to cleave sugar.
According to the above, it is reasonable to find that "●●●●●●●●●●●●●●●●●●●●●●●●●●" in α3 constitutes the "microorganism" in Constituent FeatureB'-2, and hence the allegation that the Appellees' Method does not fulfill Constituent FeatureB'-2 is not proven.
(C) As described above, the allegation that the method of the Corrected Invention is not used
for production of the Appellees' Material is not proven. Therefore, the presumption under
Article 104 of the Patent Act cannot be found to have been rebutted.
(2) Conclusion regarding Issue 1
As mentioned in (1) above, the Appellees' Material is presumed to have been produced
using the method of the Corrected Invention. Accordingly, the Appellees' Method isdetermined to fall within the technical scope of the Corrected Invention, without having todetermine other points.
3. Regarding Issue 2 (whether the Patent deserves to be invalidated in a trial for patent
invalidation)(1) Issue 2-1 (whether Grounds for Invalidation 1 (lack of novelty based on Exhibit Otsu B3on the premise that a priority claim cannot be made) exist)
As mentioned in 2.(1)B.(C) above, the Corrected Invention is able to enjoy the effect ofthe priority claim based on Basic Applications A and B.
Consequently, the Appellees' assertion of Grounds for Invalidation 1 lacks a premise,and is groundless.
(2) Issue 2-2 (whether Grounds for Invalidation 2 (violation of the support requirement andthe enablement requirement in relation to the "microorganism having the ability to produce
ornithine and the ability to produce equol" in the Corrected Invention) exist)
A. Regarding the support requirement(A) Whether the claim statement satisfies the support requirement concerning the description
should be determined by comparing the claim statement and the statements in the detailed
description of the invention, and examining whether the invention stated in the claim is theinvention stated in the detailed description of the invention, and whether the extent of
disclosure is such that a person skilled in the art can recognize that the problem to be solvedby the invention can be solved based on the statements in the detailed description of the39invention, and whether the extent of disclosure is such that a person skilled in the art canrecognize that the problem to be solved by the invention can be solved, even without therelevant statements or suggestions, in light of the common general technical knowledge asof the time of the filing of the patent application.
(B) The Description (Exhibit Ko 2) mentions several microorganisms having the ability to
produce equol by metabolizing "daidzein compounds" and states that an ornithine/equolproducing microorganism can be obtained by a publicly-known screening method using an
index of the equol-producing ability and the conversion ability from arginine into ornithine(paragraphs [0032] and [0036]). In addition, the Description states that a "material
containing daidzein compounds" other than a "soybean hypocotyl," such as a soybean
hypocotyl extract, etc., can be used as a fermenting material (paragraph [0093]) and that thefermented substance of a "soybean hypocotyl," which is an example of a "material
containing daidzein compounds," can be used as a food material in the form of powder(paragraph [0144]). The Description also states an example of producing fermented soybean
hypocotyl powder containing equol and ornithine in the amounts specified in the Corrected
Invention by using a substance obtained by adding arginine to a "soybean hypocotyl," which
is an example of a "material containing daidzein compounds," as a fermenting material andalso using a Lactococcus 20-92 strain (paragraphs [0225] through [0228]), as well as various
examples of food products using that fermented substance (paragraphs [0271] through[0616]).
Comprehensively taking into account the statements of the Description and the fact that
it was common general technical knowledge as of the Original Filing Date to produce equolby fermenting a "daidzein compound" or a "material containing daidzein compounds" otherthan a "soybean hypocotyl" by using an equol-producing microorganism, as mentioned in
2.(1)B.(C) above, it can be said that not only the "soybean hypocotyl" but also the "material
containing daidzein compounds" stated in the claim are supported by the Description.
Accordingly, the Appellees' allegation that only the "soybean hypocotyl" is being supported
is unacceptable.
(C) Next, examination is made as to whether an ornithine/equol-producing microorganism
other than the Lactococcus 20-92 strain, which is stated in the examples, is supported interms of the screening method.
a. According to evidence (Exhibits Otsu B4, B10, and B24), it is found that several equolproducing microorganisms, such as the do03 strain, SNU-Julong strain, Bacteroides E-2315, Streptococcus E-23-17, and Streptococcus A6G-225, had been isolated and identified
from human feces, rat cecal content, etc. by the Priority Date. It follows that, because several
microorganisms having the ability to produce equol other than the Lactococcus 20-92 strain

40

had been discovered by the Original Filing Date, it would have been possible to obtain anornithine/equol-producing microorganism also by a method of examining whether theseknown microorganisms having the ability to produce equol had the ability to produce
ornithine. It can be said that there is no particular difficulty in obtaining an ornithine/equolproducing microorganism from among known equol-producing microorganisms by using an
index of the ornithine-producing ability in such manner.
b. Next, examination is made regarding ornithine/equol-producing microorganisms that wereundiscovered as of the Original Filing Date. Paragraph [0036] of the Description states thatan ornithine/equol-producing microorganism may be obtained by "a publicly-known
screening method." According to evidence (Exhibit Ko 16 (FUKUI Saburo, supervising ed.,Baiotekunorojī shirīzu: Sukurīningu gijutsu—Biseibutsu no senzai kinō o saguru(Biotechnology series: Screening technology—Exploring the potential functions of
microorganisms), Kodansha, 1985), Exhibit Ko 17 (ARAI Mamoru et al., "Biseibutsu no
sukurīningu hō I" (Microorganism screening method I), Kagaku to seibutsu (Chemistry andbiology), vol. 5, no. 5, pp. 294–303, 1967)), it is found that a general technique of searchinga microorganism of specific nature by screening was common general technical knowledge
as of the Original Filing Date. In addition, according to evidence (Exhibit Ko 19 (the gazetteof Unexamined Patent Application Publication No. 2006-242602), Exhibit Ko 20 (thegazette of Unexamined Patent Application Publication No. 2008-61584), Exhibit Otsu B10(Journal of intestinal microbiology, vol. 21, no. 3, pp. 217–220, 2007)), it is found that amethod of screening an equol-producing microorganism was known as of the Original Filing
Date and that this method was not particularly different from the abovementioned generaltechnique of searching a microorganism of specific nature by screening.
c. While paragraphs [0224] and [0225] of the Description (Exhibit Ko 2) and evidence(Exhibits Ko 19 and 20, and Exhibits Otsu B4, B10, B16, and B24) state the culture
conditions of various equol-producing microorganisms including a Lactococcus 20-92 strain
and a do03 strain, these culture conditions are not found to have been set specifically foreach strain, and hence it would not have been difficult to set the culture conditions. Moreover,a person skilled in the art is found to have been able to implement the abovementioned
screening by using the culture conditions stated in the evidence above as clues.
Thus, it cannot be said that the search for an equol-producing microorganism would haverequired excessive trial and error.
d. As a result of the examination above, it cannot be said that the Corrected Invention lacks
support by statements in the Description merely because the examples do not disclose thespecific screening method and the like for ornithine/equol-producing microorganisms thatwere undiscovered as of the Original Filing Date.

41

Consequently, it should be said that the Corrected Invention is supported also in termsof the screening method for an ornithine/equol-producing microorganism other than a
Lactococcus 20-92 strain.
(D) Further, the amounts of equol and ornithine in the Corrected Invention are examined.
a. With regard to the amount of equol, paragraphs [0036], [0038], and [0094] through [0096]
of the Description (Exhibit Ko 2) state that an isoflavone which serves as a fermenting
material may be added or nutritional components may be added, as appropriate, so as toincrease the equol content or to improve the fermentation efficiency, and that thefermentation conditions should be determined, as appropriate, according to the type of the
microorganism and the like. Also, paragraph [0224] [Table 1] of the Description shows thatthe production amount of equol increased when the amount of the "soybean hypocotyl" wastripled under the same conditions.
Thus, it can be said that, even if a person skilled in the art uses a strain other than the
Lactococcus 20-92 strain referred to in the examples, the person would recognize that theamount of equol specified in the Corrected Invention can be obtained by increasing theamount of the "daidzein compound," adding nutritional components, or adjusting thefermentation conditions as appropriate based on the abovementioned statements of the
Description and common general technical knowledge concerning fermentation.
b. With regard to ornithine as well, it would not have been so difficult as to require special
ingenuity or creativity for a person skilled in the art to produce ornithine in the amountspecified by the Corrected Invention by increasing the amount of arginine that is used as araw material or adjusting the fermentation conditions as appropriate. Also, this fact would
not be affected by the absence of an upper limit for the ornithine in the Corrected Invention.
Consequently, a person skilled in the art would have recognized that ornithine can beobtained in the amount specified by the Corrected Invention even in the case of using a
microorganism other than a Lactococcus 20-92 strain.
c. Considering that paragraphs [0042] and [0050] of the Description state the production
amounts of ornithine and equol from the viewpoint that they are components having usefulphysiological effects, it also cannot be said that there is a problem in specifying only thelower limits of their production amounts in the Corrected Invention.
(E) As a result of the examination above, the Corrected Invention is found not to be in
violation of the support requirement.
B. Regarding the enablement requirement
According to the examination in A. above, it can be said that a person skilled in the art
could have obtained fermented powder that can be used as a food material containing equoland ornithine in the amounts specified by the Corrected Invention by using a "material

42containing daidzein compounds," other than a "soybean hypocotyl," to which arginine is
added as a fermenting material, and also using a strain other than a Lactococcus 20-92 strain,
without requiring excessive trial and error. Accordingly, the Corrected Invention is found not
to be in violation of the enablement requirement.
The Appellees allege that some microorganisms in the Corrected Invention do not havethe ability to produce equol in the specified amount from daidzin contained in a "soybean
hypocotyl," and therefore a part of the invention fails to satisfy the enablement requirement
in relation to daidzin.
However, the Description states that the Lactococcus 20-92 strain is a strain that can
produce equol from daidzin (paragraph [0227] [Table 2]). In addition, as the "daidzein
compound" in the Corrected Invention also includes daidzein and dihydrodaidzein, amicroorganism that can produce specified amounts of equol and ornithine from such"daidzein compound" other than daidzin and arginine also constitutes the microorganism in
the Corrected Invention, and it cannot be said that a microorganism other than a Lactococcus
20-92 strain would violate the enablement requirement unless it also has the ability to
produce equol from daidzin without fail. Accordingly, the Appellees' abovementioned
allegation is unacceptable.
C. Conclusion regarding Grounds for Invalidation 2
Due to the above, Grounds for Invalidation 2 alleged by the Appellees are groundless.
(3) Issue 2-3 (whether Grounds for Invalidation 3 (lack of novelty based on Exhibit Otsu B4
and lack of inventive step based on Exhibit Otsu B4 as the primary cited invention) exist)
A. Regarding Exhibit Otsu B4 Invention(A) Exhibit Otsu B4 contains the following statements.
"After isolating an equol-producing bacterium, a [precultured GAM broth containing 1%
L-arginine at 37°C for 28 h was added to an equol-assay medium for quantitative
determination containing 59 g of GAM broth and daidzein (final concentration: 200 µM) per
liter of distilled water. Then, the medium was incubated anaerobically at 37°C, extracted andanalyzed by HPLC as described below."(page 248, left column, lines 23 to 29)"An anaerobic gram-positive rod-shaped strain capable of producing equol was isolated
from a rat cecal content. This strain is referred to as the Gram-positive bacterium do03
(AB266102)." (p. 248, right column, lines 8 to 11)"The strain do03 converted 200 µM daidzein to equol … for 4 d at 37°C anaerobically."(p. 248, right column, lines 25 to 26)"In the medium containing arginine, the equol ratio increased to 0.67±0.01 with increases
in OD600 and culture broth pH." (p. 248, right column, lines 38 to 40)"Moreover, for the growth of some bacteria such as E. lentum, arginine is required43

because they obtain energy for growth using the arginine dihydrolase pathway (19). The
bacterial metabolism of arginine produces NH3, which caused the increase in culture broth
pH. Arginine supplementation increased OD600; thus, the strain do03 uses arginine for
growth. Therefore, the increase in equol ratio may be attributed to an increase in the numberof do03 cells. The supplementation of butyric acid and arginine decreased the equol ratio byapproximately 10%. Because culture broth pH increased more than that of the control, thestrain do03 seemed to use arginine; however, OD600 did not increase. Butyric acidsupplementation caused a decrease in OD600. The mechanism of equol production stimulated
by butyric acid supplementation has not yet been reported. Antagonist action seemed tooccur by the supplementation of butyric acid and arginine." (p. 248, right column, lines 45
to 60 and p. 250, line 1)(B) Finding of Exhibit Otsu B4 Invention
As mentioned in (A) above, Exhibit Otsu B4 contains statements about the productionof equol from daidzein by a do03 strain, but contains no statements about obtaining not lessthan 1 mg equol per gram of the fermented substance, about processing the fermented
substance into powder, and about using it as a food material, and also contains no statement
at all about ornithine.
Therefore, the following Exhibit Otsu B4 Invention is found to be stated in Exhibit Otsu
B4.
"A method for obtaining equol from daidzein by adding a gram-positive do03 strain,
which is a microorganism having the ability to produce equol, and arginine to a medium
containing daidzein, and culturing the strain."
B. Comparison between the Corrected Invention and Exhibit Otsu B4 Invention
When the Corrected Invention stated on p. 5, lines 13 to 20 of the judgment in priorinstance cited in No. 2, 3. above and Exhibit Otsu B4 Invention referred to in A.(B) above
are compared, the Corrected Invention and Exhibit Otsu B4 Invention are found to differ inthe following respects.
(Difference 1) In the Corrected Invention, the microorganism is a "microorganism having
the ability to produce ornithine and the ability to produce equol," while "not less than 8 mg
ornithine and not less than 1 mg equol per gram by dry weight of the fermented substance"are produced by fermenting a fermenting material by using a microorganism, and thefermented substance is a substance "containing ornithine and equol," whereas in Exhibit
Otsu B4 Invention, the microorganism is a "microorganism having the ability to produce
equol" and the fermented substance is a substance "containing equol."(Difference 2) In the Corrected Invention, the obtained substance is fermented powderthat is used as a food material, whereas in Exhibit Otsu B4, no such specification is made.

44

C. Regarding Difference 1(A) As mentioned in A.(B) above, Exhibit Otsu B4 contains no statements about the amountof equol in the fermented substance, and also contains no statements about ornithine.
Exhibit Otsu B5 cited in Exhibit Otsu B4 as a reference document states that E. lentum
converts arginine into ornithine by using the arginine dihydrolase pathway, and produces
NH3 and ATP, and Exhibit Otsu B4 states that a do03 strain, similarly to E. lentum,
metabolized arginine and produced NH3.
However, Exhibit Otsu B4 does not disclose a detailed analysis of the arginine metabolic
pathway of the do03 strain. In addition, Professor B, one of the authors of Exhibit Otsu B4,
states in a written opinion (Exhibit Ko 32) that Professor B does not remember paying
attention to production and accumulation of ornithine regarding the do03 strain, and also
does not remember talking about it with the other authors of Exhibit Otsu B4. Likewise,
Professor C, another author of Exhibit Otsu B4, states in a written statement (Exhibits Otsu
B34 and B52) that, although Professor C does not know the amount of accumulation ofornithine in the do03 strain (Exhibit Otsu B34), the production amount of ornithine by amicroorganism tends to be unstable (Exhibit Otsu B52). These statements coincide with eachother in that the amount of accumulation of ornithine is unknown in Exhibit Otsu B4.
(B) Appellee Daicel alleges that it conducted reproduction experiments of Exhibit Otsu B4,
and submitted the results (Exhibits Otsu B6, B29, and B64). However, one cannot go so far
as to say that these are experiments that have accurately reproduced the experimentconditions of Exhibit Otsu B4.
(C) According to the above, one cannot go so far as to say that Exhibit Otsu B4 Invention
discloses a fact that it produces not less than 8 mg ornithine per gram by dry weight of thefermented substance. It follows that at least Difference 1 can be considered to be a
substantive difference, and therefore the Corrected Invention is not regarded to lack novelty
in relation to Exhibit Otsu B4 Invention.
(D) Further, as Exhibit Otsu B4 contains no statements or suggestions about producing "notless than 8 mg ornithine and not less than 1 mg equol per gram by dry weight of the fermented
substance," it cannot be said that Difference 1 would have been easily conceived of by aperson skilled in the art.
D. Regarding Difference 2
When Difference 2 is examined, Exhibit Otsu B4 merely states a method for obtaining
equol and contains no statements or suggestions about processing the culture productcontaining equol and ornithine into fermented powder and using it as a food material, andhence the Corrected Invention is not regarded to lack novelty in relation to Exhibit Otsu B4,
and it cannot be said that the invention would have been easily conceived of by a person

45

skilled in the art.
E. Conclusion regarding Grounds for Invalidation 3
Due to the above, Grounds for Invalidation 3 alleged by the Appellees are groundless.
(4) Regarding Issue 2-4 (whether Grounds for Invalidation 4 (lack of novelty based on
Exhibit Otsu B16 and lack of inventive step based on Exhibit Otsu B16 as the primary citedinvention) exist)
A. Regarding Exhibit Otsu B16 Invention(A) The description and drawings of Exhibit Otsu B16 contain the following statements (thepage numbers are those in the description of Exhibit Otsu B16).
"Field of the Invention
The present invention relates to equol-producing lactic acid bacterial strain, acomposition comprising said lactic acid bacterial strain, and a method for producing equolby utilizing said lactic acid bacterial strain." (page 1, lines 3 to 5)"Background of the Invention" (page 1, line 6)"Based on the above idea, the inventors had conducted intensive investigations andisolated from human stools novel 3 strains of microorganisms and identified them: namely
Bacterioides E-23-15 (FERM BP-6435), Streptococcus E-23-17 (FERM BP-6436), andStreptococcus A6G225 (FERM BP-6437), as equol producing-bacteria suitable for the
expression of said antiestrogen and estrogenic-like effects, among other effects, and applied
for a patent claiming inventions concerning these equol-producing strains of microorganisms
and utilization of the microorganisms (WO99/07392).
Disclosure of Invention
The inventors conducted further studies and succeeded in the isolation andcharacterization of a lactic acid bacterial strain belonging to the genus Lactococcus which iscapable of utilizing daidzein glycoside, daidzein, or dihydrodaidzein to produce equol as anovel strain of microorganism which is fundamentally different from the previously isolated
and identified microorganisms. The present invention has been developed on the basis of theabove isolation and identification of this novel strain of lactic acid bacterium." (page 2, lines
13 to 24)
"The present invention subsumes the following inventions summarized in paragraphs 113.
Item 1. An equol-producing lactic acid bacteria-containing composition comprising, as an
essential component thereof, a lactic acid bacterial strain belonging to the genus Lactococcus
having an ability to utilize at least one daidzein compound selected from the group consistingof daidzein glycosides, daidzein, and dihydrodaidzein to produce equol." (page 2, lines 25
to 29)

46

"Item 9. A method for producing equol comprising the step to let a lactic acid bacterial strain
belonging to the genus Lactococcus having an ability to utilize a daidzein compound to
produce equol act on at least one member selected from the group consisting of daidzein
compounds and daidzein compound-containing ingredients.
Item 10. The method according to Item 9, wherein said lactic acid bacterial strain belonging
to the genus Lactococcus is Lactococcus garvieae." (page 3, lines 11 to 15)"II. Biochemical characteristics…
(13) Arginine dihydrolase: +" (page 4, lines 7 to 20)"(2) Daidzein compounds and daidzein compound-containing ingredients
Daidzein compounds, which are utilized by the present strain Lactococcus 20-92, include
a daidzein glycoside, daidzein, and dihydrodaidzein. A specific example of said daidzein
glycoside is daidzin. Daidzin is an isoflavone glycoside having daidzein as the aglycone(daidzein glycoside). Referring to daidzin, it is utilized by said strain of microorganism toliberate daidzein which is further utilized by the strain to give dihydrodaidzein, from which
equol is finally produced.
In the present invention, said daidzein compound is used as the substrate. The substrate
includes not only daidzein compounds but also various materials or ingredients containing
the same. As a representative example of said material or ingredient containing said daidzein
compounds (referred to as daidzein compound-containing ingredient), soybean isoflavone
can be mentioned. Soybean isoflavone is already available from commercial sources and, inthe present invention, such commercial products, for example "Fujiflavone P10" (registeredtrademark) from Fujicco Co., Ltd., can be used. Moreover, said daidzein compoundcontaining ingredient includes not only soybean isoflavone but also plant tissues as such, e.g.
kudzu (= Pueraria thurbergiana Benth) and root of kudzu (arrowroot), red clove, alfalfa,
etc., and isoflavone derivatives originating therefrom.
Further examples of said daidzein compound-containing ingredient include not only theabove-mentioned food materials such as soybean, kudzu, root of kudzu, red clove, alfalfa,
etc. but also processed products thereof, such as soybean meal (soybean flour), boiled
soybeans, tofu (soybean curd), fried bean curd, soy milk, soybean hypocotyl extract, etc.,
fermentation products thereof, such as natto (fermented soybeans), soy sauce, miso, tempeh,and fermented soy beverages. These materials invariably contain daidzein compounds.
Moreover, these not only contain daidzein compounds but also estrogenic isoflavones, suchas genistein and its glycosides (genistin etc.); glycitein and its glycosides (glycitin etc.);
biochain A and formononetin which are partially methylated daidzein and genisteinprecursors and can be used with advantage in the present invention." (page 9, lines 3 to 28)

47

"(3-1) An equol-producing lactic acid bacteria-containing composition" (page 10, line 1)
All that is necessary for the composition of the invention is that it contains the bacteria(cells or equivalent) as said active component but, if desired, the composition may besupplemented with nutrients suited for the maintenance (or growth) of the microorganism as
said active component. The nutrients mentioned above may for example be the nutrient
media for culture of the respective microorganisms, such as BHI, EG, BL and GAM, as
mentioned hereinbefore.
(omitted)
The above composition of the invention, when taken orally, expresses the desired equolproducing activity in the recipient's body." (page 10, lines 16 to 26)"(3-3) Equol-containing composition of the invention
The composition of the invention may further contain equol.
(omitted)
A preferred specific example of the equol-containing composition of the invention is thefermentation product obtained by a process which comprises adding soybean isoflavone ora food material containing it to a suitable medium and culturing the microorganism of theinvention, preferably Lactococcus 20-92, therein to cause fermentation. More particularly,
such fermentation can be effected by the procedure which comprises adding a predeterminedamount of the microorganism of the invention to a mixture of a sterilized substrate solution
and a nutrient medium favorable for growth of the microorganism, such as BHI, EG, BL or
GAM, or to cow's milk, soy milk, or a vegetable juice which can be used as food, andcarrying out an anaerobic or aerobic fermentation reaction at 37°C under stationary
conditions for about 48-96 hours (where necessary, a pH control agent and a reducing agent(e.g. a yeast extract, vitamin K1, or the like) may be added). In the above procedure, theamount of the substrate may be about 0.01-0.5 mg/ml and the inoculum size of the
microorganism can be selected from the range of about 1% to about 5%.
(omitted)
The presence of equol in the product composition of the invention can be confirmed by
the method described hereinafter in Test Example 1." (page 11, line 25 to page 13, line 1)"Example 1(1) Production of a fermented soy milk beverage
The following ingredients were taken according to the formula and blended to prepare
the composition of the invention in the form of a fermented soy milk beverage.
Fermentative culture of water-soluble soy protein
Vitamins & minerals

48

100 mlq.s.

Flavoring
Water
Total

q.s.
q.s.
150 mlThe above fermentative culture of water-soluble soy protein was obtained by dissolving
13 g of water-soluble soy protein in 100 ml of water, adding 108-109 cells of Lactococcus
20-92 (FERM BP-10036), and carrying out fermentation at 37°C for 24-48 hours. The watersoluble soy protein used contained about 1-2 mg, calculated as daidzein, of daidzein
compounds in each one gram.
(2) Production of a fermented milk
The following ingredients were taken according to the formula and blended to prepare
the composition of the invention in a fermented milk form.
Lactococcus 20-92 fermented milk
Vitamins & minerals
Flavoring
Water
Total

100 ml
q.s.
q.s.
q.s.
150 mlThe Lactococcus 20-92 fermented milk was obtained by adding 108-109 cells of
Lactococcus 20-92 (FERM BP-10036) to 1 L of cow's milk (having a nonfat milk solids
content of 8.5% or greater and a milk fat content of 3.8% or greater) and carrying out
fermentation at 37°C for 24-48 hours.
(3) Production of a freeze-dried powder of fermented soy milk
Using about 109 cells of Lactococcus 20-92 (FERM BP-10036) and 100 g of soy milk(soy solids 10%, daidzein compound content 10-15 mg calculated as daidzein), lactic acidfermentation was carried out at 37°C for 72-96 hours for the production of equol. This
fermentation product was freeze-dried to prepare a powder. The equol content of the powder
as determined by HPLC was 0.1-0.3 wt. %.
The powder obtained above and various other ingredients were weighed out according
to the following formula and blended to prepare the composition of the invention in the
powder form (food form and pharmaceutical product form).
Freeze-dried powder of fermented soy milk
(equol content 0.005 g)
Excipient (corn starch)

49

2.2g
17 g

Vitamins & minerals
Flavoring
Total(page 21, line 14 to page 22, line 20)

q.s.
q.s.
20 g"

"Test Example 1
Test for growth performance, equol-producing ability (activity), and equol output(1) Test protocol
Lactococcus 20-92 strain (107-109 cells/g) was incubated in 5 ml of BHI broth (a liquidmedium for growth (basal medium)) anaerobically at 37°C for 24 hours and the culture wasdiluted to 102 and 104 cells with the basal medium.
The culture obtained at completion of incubation and its dilutions prepared above wererespectively taken, 0.2 ml each, and blended with 5 ml each of daidzein-supplemented basal
medium (daidzein added to BHI broth at a final concentration of 10 µg/ml), cow's milk andsoy milk, respectively, and cultured anaerobically at 37°C. The incubation time was set to 8,
24, 48, 72, and 96 hours in the case of 10 µg/ml daidzein-supplemented basal medium andsoy milk, and 8, 24 and 48 hours in the case of cow's milk.
Before the start of incubation and at the end of each incubation period, 0.1 ml and 0.2 ml
portions of the culture were sampled and respectively subjected to the counting of cells andassay of equol-producing ability (activity). Furthermore, for 10 µg/ml daidzein-containing
basal medium and soy milk, 0.5 ml of each culture was sampled before the start of incubation
and at the end of each incubation period and the amount of equol produced in each sample
was determined.
The number of bacteria was determined in the following manner. Each 0.1 ml sample
was diluted with PBS(-) solution (product of Nissui Co.) to prepare 104, 105, 106 and 107fold dilutions and 0.1 ml each of these dilutions were respectively coated on GAM agar
medium and incubated aerobically at 37°C for 24 hours. The colonies formed on the medium
were counted for use as the number of bacteria.
The equol-producing ability (activity) was assayed as follows. Each 0.2 ml sample wasblended with 5 ml of daidzein-supplemented basal medium (each in triplicate) and incubatedanaerobically at 37°C for 96 hours. At completion of incubation, 0.5 ml samples of therespective cultures were taken and respectively extracted twice with 5 ml portions of ethyl
acetate and the daidzein, dihydrodaidzein (intermediate), and equol in the extract were
quantitated by HPLC. Moreover, based on the total amount, the percentage of equol was
calculated. The results were scored on the following 5-point scale and the average score of
3 samples was used as an index of equol-producing ability (activity).

50

4: Equol (90% or greater)
3: Equol produced, with daidzein diminishing to less than 50% (formation of intermediate)
2: Equol produced, with residual daidzein (50% or greater) (formation of intermediate)
1: Intermediate formed, equol not produced
0: Neither intermediate formed nor equol produced, with daidzein not diminishing
The amount of equol produced was determined as follows. Each 0.5 ml sample was
extracted twice with 5 ml portions of ethyl acetate and the amounts of daidzein,
dihydrodaidzein (intermediate), and equol in the extract were quantitated by HPLC. Then,the respective concentrations were used to calculate the amount of equol produced.
(2) Test Results(2-1) The results of counting of the cells (growth performance) are presented in Fig. 1.
In Fig. 1, (1) represents the result obtained in the case where the daidzein-supplemented
basal medium was used, (2) represents the result obtained in the case where soy milk wasused, and (3) represents the result obtained when cow's milk was used. In each diagram, thehorizontal axis represents incubation time (hr) and the vertical axis represents viable cellcount (Log CFU/ml).
It can be seen from the respective diagrams, the growth performance of the strain of theinvention is good and, regardless of the inoculum size used, the stationary phase of growth
was invariably attained in 8 hours of incubation in all the daidzein-supplemented basal
medium, soy milk and cow's milk. The viable cell count was found to be steady at 109.1-9.4
CFU/ml in the daidzein-supplemented basal medium, 108.5-8.7 CFU/ml in soy milk, and 108.08.4
CFU/ml in cow's milk.
(2-2) The equol-producing ability (activity) values found are presented in Fig. 2.
In Fig. 2, (1) represents the result obtained in the case where the daidzein-supplemented
basal medium was used, (2) represents the result obtained in the case where soy milk wasused, and (3) represents the result obtained in the case where cow's milk was used. In eachdiagram, the horizontal axis represents incubation time (hr) and the vertical axis represents
activity score.
It is obvious from the results presented in Fig. 2 that the equol-producing ability (activity)
tends to increase with time in any of the daidzein-supplemented basal medium, soy milk,
and cow's milk. It could also be confirmed that even in the cases where cow's milk and soy
milk were used, the equol-producing ability (activity) of the strain of the invention issustained.
(2-3) Results of determination of the amount of equol produced

51

The quantities of equol produced in the daidzein-supplemented basal medium and soy
milk (about 80 µg/ml calculated as daidzein) were as shown in Fig. 3.
In Fig. 3, (1) represents the result obtained in the case where the daidzein-supplemented
basal medium was used and (2) represents the result obtained in the case where soy milk wasused. In each diagram, the horizontal axis represents incubation time (hr) and the verticalaxis represents equol concentration (µg/ml).
In both media, the production of equol began to be noticed at hour-48 following the startof incubation. In the case where soy milk was used, the amount of equol produced variedwith inoculum size and particularly at the inoculation level of 4.00%, and the production ofequol was as large as 57.0 µg/ml at hour-96 of incubation.
Although, in soy milk, not less than 90% of daidzein serving as the precursor of equol ispresent in the form of glycoside (in the form of glucose attached), the peak corresponding to
the glycoside was no longer observed on the post-incubation chromatogram and this factsuggests that the strain of the invention decomposes the glycoside (β-glucosidase activity)
to produce daidzein and further metabolizes this daidzein to equol." (page 23, line 22 to page25, last line)"Brief Description of the Drawings(omitted)
Fig. 3 is a diagrammatic representation showing the relationship of incubation time toequol output as determined by the test protocol described in Test Example 1." (p. 20, line 24
to page 21, line 1)[Fig. 3]52

(B) Finding of Exhibit Otsu B16 Invention
As mentioned in (A) above, Exhibit Otsu B16 discloses a method for producing equol
comprising the step to let a lactic acid bacterial strain belonging to the genus Lactococcus
having an ability to utilize a daidzein compound to produce equol act on at least one member
selected from the group consisting of daidzein compounds and daidzein compoundcontaining ingredients as Example 1, and indicates Lactococcus 20-92 (FERM BP-10036)
as a specific example of that lactic acid bacterial strain. Further, as Test Example 1, it statesthat equol was produced as shown in [Fig. 3] as a result of blending Lactococcus 20-92(FERM BP-10036) with a daidzein-supplemented basal medium, soy milk, and so on, andculturing them.
Therefore, the following Exhibit Otsu B16 Invention is found to be stated in Exhibit Otsu
B16.
"A method for producing a fermented substance containing equol, comprising the stepto ferment a fermenting material containing at least one daidzein compound selected fromthe group consisting of daidzein glycosides, daidzein, and dihydrodaidzein (such as soy milkor daidzein-supplemented basal medium) by using Lactococcus 20-92 (FERM BP-10036),
which is a microorganism having the ability to produce equol."
B. Comparison between the Corrected Invention and Exhibit Otsu B16 Invention
When the Corrected Invention stated on p. 5, lines 13 to 20 of the judgment in priorinstance cited in No. 2, 3. above and Exhibit Otsu B16 Invention referred to in A.(B) above
are compared, the Corrected Invention and Exhibit Otsu B16 Invention are found to havecommonalities in that they are "a method for producing a fermented substance containing
equol, comprising the step to ferment a fermenting material containing at least one daidzein
compound selected from the group consisting of daidzein glycosides, daidzein, anddihydrodaidzein by using a microorganism having the ability to produce equol," and differ
in the following respects.
(Difference A1) The Corrected Invention specifies that the microorganism "has the ability to
produce ornithine," whereas Exhibit Otsu B16 Invention specifies that the microorganism is"Lactococcus 20-92 (FERM BP-10036)," but does not specify that it "has the ability to
produce ornithine."(Difference A2) The Corrected Invention specifies that arginine is added to "at least one
daidzein compound selected from the group consisting of daidzein glycosides, daidzein, anddihydrodaidzein" and that the fermenting material containing the daidzein compound andarginine is fermented, whereas Exhibit Otsu B16 Invention specifies that the fermenting
material is soy milk, a daidzein-supplemented basal medium, or the like, but does not specify
that the fermenting material contains arginine as a result of adding arginine to the daidzein

53compound.
(Difference A3) The Corrected Invention specifies that a fermented substance containing
ornithine is produced, whereas Exhibit Otsu B16 Invention does not specify this point.
(Difference A4) The Corrected Invention specifies that not less than 8 mg ornithine and notless than 1 mg equol per gram by dry weight are produced by fermentation, whereas Exhibit
Otsu B16 Invention does not specify this point.
(Difference A5) The Corrected Invention specifies that the fermented substance produced is
powder and that it is used as a food material, whereas Exhibit Otsu B16 Invention does not
specify this point.
C. Regarding Difference A4
In light of the counsel's arguments, Difference A4 (the Corrected Invention specifies that
not less than 8 mg ornithine and not less than 1 mg equol per gram by dry weight are
produced by fermentation, whereas Exhibit Otsu B16 Invention does not specify this point)
is examined below.
(A) Regarding novelty
As mentioned in A. above, the description of Exhibit Otsu B16 (page 22) contains thefollowing statements concerning Example 1: "Using about 109 cells of Lactococcus 20-92(FERM BP-10036) and 100 g of soy milk (soy solids 10%, daidzein compound content 1015 mg calculated as daidzein), lactic acid fermentation was carried out at 37°C for 72-96
hours for the production of equol. This fermentation product was freeze-dried to prepare a
powder. The equol content of the powder as determined by HPLC was 0.1-0.3 wt. %."According to this, in Exhibit Otsu B16 Invention, soy milk was fermented by using
Lactococcus 20-92 (FERM BP-10036) to produce equol, which was then freeze-dried toobtain a powder, and the equol content of the powder was 0.1-0.3 wt. %. This means that "13 mg equol per gram by dry weight was produced by fermentation."
However, Exhibit Otsu B16 does not state that ornithine is produced by fermentation,and contains no statement on the amount of ornithine produced by Example 1. In addition,
while 100 g of soy milk is used in Example 1, according to Exhibit Otsu B17-1 ("Studies on
Quality Index of Aseptic Soymilk on Preservation," Nippon Shokuhin Kogyo Gakkaishi(Journal of food science and technology), 1985, vol. 32, no. 7, pp. 457-462, Table 4), theamount of free arginine in 1 ml of soy milk is less than 0.7 μmol. Therefore, even if all
arginine contained in soy milk was converted into ornithine, only ornithine in an amount lessthan 0.1 mg per 1 ml of soy milk (0,7 μmol × 132.16 (the molecular weight of ornithine) ≒0.09 mg) would be produced. Accordingly, even by considering the fact that the amount ofsoy solids in the soy milk is 10% and the fact that the fermentation product is dried to preparea powder after the fermentation, as mentioned in the statements of Exhibit Otsu B16,

54

Example 1 cannot be found to produce not less than 8 mg ornithine per gram by dry weight.
In addition, Exhibit Otsu B16, including the statements in A. above, contains nosuggestions concerning production of ornithine even in its test examples. Also, according to
the results of experiments (Exhibit Ko 15) conducted according to the conditions of Test
Example 1 of Exhibit Otsu B16 by using Lactococcus 20-92 (FERM BP-10036) and using
soy milk as a fermenting material, the production amount of ornithine was less than 8 mg
per gram by dry weight.
Therefore, it cannot be said that Difference A4 is an equivalent of descriptions in Exhibit
Otsu B16.
(C) Regarding inventive step
When the remaining statements in Exhibit Otsu B16 are examined, they also do notcontain statements suggesting that not less than 8 mg ornithine per gram by dry weight is
produced by fermenting a fermenting material containing at least one daidzein compound
selected from the group consisting of daidzein glycosides, daidzein, and dihydrodaidzein(such as soy milk or daidzein-supplemented basal medium) by using Lactococcus 20-92(FERM BP-10036).
Exhibit Otsu B16 contains no statement at all concerning "ornithine" in the first place.
Thus, it also cannot be said that Exhibit Otsu B16 Invention would have motivated a person
skilled in the art to determine the composition of the fermenting material or the culture
conditions and the like for securing more than a specific production amount of ornithine.
Therefore, it cannot be said that a person skilled in the art could have easily conceivedof Difference A4 based on Exhibit Otsu B16 Invention.
(D) Regarding the Appellees' allegations
a. The Appellees allege that the amount of ornithine produced in Test Example 1 of Exhibit
Otsu B16 is calculated to be 11.4 mg per gram by dry weight of the fermented substance.
The Appellees' allegation is based on the premise that the conversion rate from arginine
to ornithine is far higher than 100% (conversion rate: approx. 159%) in [Table 3] of the
Description. However, [Table 3] of the Description shows the results of inoculating
Lactococcus 20-92 strain (FERM BP-10036) to 5 ml of soybean hypocotyl solution
containing 10 wt. % of soybean hypocotyl powder and 0.1wt. % of L-arginine, andincubating it anaerobically at 37°C for 96 hours under stationary conditions to be fermented(paragraph [0225] of the Description), whereas in the test example of Exhibit Otsu B16,
Lactococcus 20-92 (107-109 cells/g) was incubated in 5 ml of BHI broth (a liquid medium
for growth (basal medium)) anaerobically at 37°C for 24 hours and the culture was diluted
with the basal medium, after which it was blended with 5 ml each of daidzein-supplemented
basal medium (daidzein added to BHI broth at a final concentration of 10 µg/ml), cow's milk

55

and soy milk and cultured. Therefore, their fermenting material and the fermentation
conditions differ. As the dry weight of the fermented substance could vary substantiallydepending on the fermenting material and the content of solid component in the medium,the amount of ornithine per gram by dry weight would also vary if the fermenting materialchanges. Therefore, the amount of ornithine produced per gram by dry weight of thefermented substance could vary substantially between a case of using a soybean hypocotyl
solution and a case of using soy milk as the fermenting material. In addition, if the culture
conditions differ, the conversion rate from arginine to ornithine could also differ.
Accordingly, it cannot be said that it is reasonable to use [Table 3] of the Description asa premise in presuming the amount of ornithine produced in the test example of Exhibit Otsu
B16.
b. The Appellees also allege that, in a reproduction experiment of Figure 3(1) of Exhibit Otsu
B16 (Exhibit Otsu B56-1), the amount of ornithine produced was 13.7 mg per gram by dry
weight of the fermented substance in the case of using "10 mg/L of daidzein," and therefore
the amount of ornithine produced in Exhibit Otsu B16 Invention is not less than 8 mg pergram by dry weight of the fermented substance. However, in a reproduction experimentconducted by the Appellant (Exhibit Ko 15), the amount of ornithine produced was less than
8 mg per gram by dry weight of the fermented substance. As this difference may partly be
owed to the difference in the amounts of arginine and ornithine contained in the medium
before culturing between the two experiments, and as it is not the case where only one of thetwo experiments has a circumstance that makes the reliability of the experiment doubtful, it
can only be said that not less than 8 mg ornithine per gram by dry weight of the fermented
substance is not necessarily produced in Exhibit Otsu B16 Invention, as long as thecomposition of the BHI broth used as a medium is not specified in the test example of Exhibit
Otsu B16.
Accordingly, it cannot be said that Exhibit Otsu B16 Invention "produces not less than 8
mg ornithine per gram by dry weight of the fermented substance."c. The Appellees further allege that it was a well-known fact for a person skilled in the art
from before the Priority Date that, when using a lactic acid bacterial strain, a decrease in pH
should be prevented by adding arginine so that the growth of the strain would not be hindered,among other reasons. According to evidence (Exhibit Otsu B83), preventing a decrease in
pH through adding arginine is found to be based on a mechanism that a lactic acid bacterial
strain liberates ornithine and ammonia from arginine, and that the liberation of ammonia
increases pH. However, according to evidence (Table 5 of Exhibit Ko 56 ("Classification
and Pathogenicity of the Genus Streptococcus," Gyobyō kenkyū (Fish Pathology), 17(1),1982, pp. 1-10) and Table 2 of Exhibit Ko 57 (FEMS Microbiology Letters, 144, 1996, pp.

56

135-140)), it cannot be said that a lactic acid bacterial strain always has arginine dihydrolase
activity (ADH), in other words, that a lactic acid bacterial strain always liberates ornithine
and ammonia from arginine, and hence preventing growth hindrance due to a decrease in pH
by adding arginine to a lactic acid bacterial strain generally cannot be found to be common
general technical knowledge.
d. The Appellees also allege that there is no need to go so far as to grant an exclusive rightto give an incentive for creating a product or method that will sooner or later become
available for use by the general public, even if the intentions for its exploitation vary, andtherefore there is no need for a person skilled in the art to have been motivated to conceiveof exactly the same technical idea as the Corrected Invention, and it is sufficient for a person
skilled in the art to have been motivated to conceive of a technology that is objectively
regarded to be the same in terms of the product or method.
In the case of determining whether the present invention could have been easily made by
applying the secondary cited invention to the primary cited invention, it is reasonable to [i]determine whether there is a motivation to apply the secondary cited invention to the primarycited invention and arrive at the present invention by comprehensively considering thesuggestions in the primary cited invention or the secondary cited invention, the relevance intechnical field, and the commonality in problem, effect, and function, and [ii] also consider
the presence or the absence of factors inhibiting the application as well as the presence or
the absence of unexpected significant effects in making the determination (see Intellectual
Property High Court, 2016 (Gyo-Ke) 10182, 10184, rendered on April 13, 2018). This
principle is also applicable to a case of determining whether the present invention could havebeen easily made by applying well-known art to a cited invention. On such basis, theinvolvement of inventive step should be determined based on whether the invention could
have been easily conceived of by a person skilled in the art as of the reference date, andwhen examining the presence or absence of motivation, it cannot be regarded that an
uncertain circumstance irrelevant to the technical contents of the invention, such as whether
it will sooner or later become available for use by the general public, should affect thedetermination on whether to protect the invention by granting a patent right.
In addition, even if the Appellees' allegation were to be premised, in the present casewhere Exhibit Otsu B16 contains no statements or suggestions on ornithine in the first place,it must be said that it also provides no motivation for conceiving of a technology that is
objectively regarded to be the same in terms of the product or method. This does not affectthe determination that a person skilled in the art could not have easily conceived ofDifference A4.
D. Conclusion regarding Grounds for Invalidation 4

57

Consequently, without having to examine other differences, the Corrected Invention is
not found to be an equivalent of descriptions in Exhibit Otsu B16, and a person skilled in theart is also not found to have been able to easily conceive of the Corrected Invention basedon Exhibit Otsu B16 Invention.
Due to the above, Grounds for Invalidation 4 alleged by the Appellees are groundless.
(5) Regarding Issue 2-5 (whether Grounds for Invalidation 5 (lack of novelty based on
Exhibit Otsu B19-1 and lack of inventive step based on Exhibit Otsu B19-1 as the primarycited invention) exist)
A. Regarding Exhibit Otsu B19 Invention(A) Exhibit Otsu B19-1 contains the following statements (the Japanese translation is basedon Exhibit Otsu B19-2, which can be deemed to be a translation of Exhibit Otsu B19-1;
hereinafter, Exhibit Otsu B19-1 as expressed by the statements in Exhibit Otsu B19-2 issimply referred to as "Exhibit Otsu B19").
[0001]
This invention relates to the making and isolating of enantiomeric equol compounds,
namely S-equol and R-equol, and foods and medicaments containing enantiomeric equol
compounds for treating of disease and conditions in mammals and humans.
[0065]
Biological production of S-equol
S-equol can be produced in bulk, and can be produced in situ in a variety of food products,
using conventional food technology. A base solution media, food product or plant extract canbe provided that comprises daidzein or another related isoflavone from which daidzein canbe derived. The daidzein or other isoflavone can be converted to S-equol by a standard
bacterial or enzyme fermentation process, to provide a bulk solution, food product or plant
extract that comprises S-equol.
[0066]The production of S-equol in a food product can be achieved by utilizing the metabolic
activity of bacteria growing on the food that contains a satisfactory starting material, such as
daidzin, daidzein, formononetin or peurarin, or a conjugate or mixture thereof. As shown in
Figure 2, the conversion of daidzein to equol involves three major steps: 1) hydrolysis ofany glucoside conjugate group, 2) conversion of the isoflavone aglycons to a dihydrointermediate, and 3) conversion of the dihydro-intermediate to equol. The metabolic pathway
and enzymes for each of the three steps required/ may not necessarily be present in one
bacterium. Anecdotal evidence from human studies suggests that there may be one or morebacteria that act in conjunction to perform these reactions, as evidenced from the fact that
often dihydrodaidzein can be present in significant amounts in plasma and urine yet equol58may be low or barely detectable. Although equol may be produced from daidzein by a single
organism it is believed that better or more efficient conversion can be achieved when using
a mixture of bacterial species, each with its own metabolic profile. Important conditions for
effective conversion to S-equol include the selection of the bacterial organism or mixture oforganisms, the temperature of incubation, and the amount of oxygen available to theorganisms. These conditions can be optimized by techniques well known to persons skilledin this art. The organisms used to effect this change can be inactivated by standard techniques
used in the food industry or, alternately, allowed to remain in an active state in the product.
[0067]
Bacteria useful in a fermentation process to convert daidzein and/or other structurally
related isoflavones, or an intermediate compound, to S-equol, can include a bacterial strain
or bacterial strains found to colonize the intestinal tract of a human, horse, rodent, or othermammal that is an 'equol producer'. Since intestinal bacteria in mammals are found in feces,the equol-producing bacteria can also be found in the feces of 'equol producing' mammals.
[0068]
Typical bacteria useful in a fermentation process should demonstrate an optimized
conversion rate and extent of conversion that makes the biological production of equol
efficient.
[0069]
Typically, one or more bacterial strains are required to convert the daidzein (or otherrelated isoflavone) through intermediate products to S-equol, which generally involves one
or more of the three major reactions: the conversion of isoflavone glycone to aglycon
isoflavone; the conversion of aglycon isoflavone to dihydro isoflavone; and the conversionof dihydro isoflavone to the product, equol. For example, a mixed culture of organisms
isolated from equine feces and a mixed culture of organisms derived from the gastrointestinal
tract of a person known to [be] an 'equol producer' can convert, as they do in vivo, theglycone daidzein to the final product, S-equol.
[0070]
Typical bacterial strains that can convert a glycone to an aglycon (such as daidzin todaidzein) include Enterococcus faecalis, Lactobacillus plantarum, Listeria welshimeri, a
mixed culture of organisms isolated from the intestinal tract of an 'equol producing' mammal,
Bacteriodes fragilis, Bifidobacterium lactis, Eubactria limosum, Lactobacillus casei,
Lactobacillus acidophilous, Lactobacillus delbrueckii, Lactobacillus paracasei, Listeria
monocytogenes, Micrococcus luteus, Proprionobacterium freudenreichii and Sacharomyces
boulardii, and mixtures thereof.
[0071]

59

Typical bacterial strains that can convert an aglycon to equol (such as daidzein to Sequol) include Proprionobacteria freundenreichii, a mixed culture containing: [sic]Bifidobacterium lactis, Lactobacillus acidophilus, Lactococcus lactis, Enterococcus faecium,
Lactobacillus casei and Lactobacillus salivarius; and a mixed culture of organisms isolated
from the intestinal tract of an 'equol producing' mammal.
[Example 5][0152]
Bacterial Conversion of Daidzein to Equol in Food
In an experiment to discover bacteria, or combinations of bacteria, that can metabolise
daidzein in a reducing environment, samples of a daidzein-enriched soy milk containing
approximately 20 mg/L of daidzein were inoculated with different bacteria either in pureculture or as a combination of several organisms. The inoculated soy milks were incubatedanaerobically at 37°C for up to 42 hours[.] Samples were withdrawn at intervals throughout
the time period of the experiment and analyzed for isoflavone content, in particular thedaidzein content. Conversion of daidzein to equol would be accompanied by lowering of thelevel of daidzein in the product over time, with the hydrogenated product, equol, taking its
place. No significant changes in isoflavone content, outside of the daidzein level, were foundin any of the inoculated products, which effectively demonstrates the stability of isoflavones(including daidzein when suitable metabolizing bacteria are absent or inactive). The results
are shown in Table D. Of seven different innocula studied, four showed no change indaidzein content during the full incubation period. Three of the inoculated samples
demonstrated substantial lowering of the level of daidzein with corresponding conversion to
the hydrogenated compound. The organisms effecting this change were Proprionobacteria
freundenreichii, a mixed culture containing: Bifidobacterium lactis, Lactobacillus
acidophilus, Lactococcus lactis, Enterococcus faecium, Lactobacillus casei and
Lactobacillus salivarius; and a mixed culture isolated from equine feces. Daidzein loss toapproximately 50% of the initial level occurred in less than 15 hours with the equine feces
mixed culture and took up to 25 hours with the other two cultures[.][0153][Table 4]
Table D
Conversion of Daidzein During Growth of
Various Microorganisms in a Food Base
(Incubation at 37°C under Anaerobic Conditions)
Bacterial species / strain

Time required to60

metabolize 50% of thedaidzein present
Uninoculated Food medium
Propionobacterium acnes
Propionobacterium freundenreichii
Lactobacillus fermentum
Mixed culture from equine feces
Mixed culture containing: Bifidobacterium lactis,
Lactobacillus acidophilus, Lactococcus lactis,
Enterococcus faecium, Lactobacillus casei and
Lactobacillus salivarius
Lactobacillus salivarius
Bacterioides vulgatus

Not metabolized
Not metabolized
25 hours
Not metabolized
15 hours
25 hours

Not metabolized
Not metabolized(B) Finding of Exhibit Otsu B19 Invention
As mentioned in (A) above, [Example 5] in Exhibit Otsu B19 states that equol was
produced as a result of inoculating "a daidzein-enriched soy milk containing daidzein" with"a mixed culture containing: Bifidobacterium lactis, Lactobacillus acidophilus, Lactococcus
lactis, Enterococcus faecium, Lactobacillus casei and Lactobacillus salivarius" andincubating it.
Therefore, the following Exhibit Otsu B19 Invention is found to be stated in Exhibit Otsu
B19.
"A method for producing a fermented substance containing equol, comprising the stepto ferment a daidzein-enriched soy milk containing daidzein by using a "mixed culture"containing Bifidobacterium lactis, Lactobacillus acidophilus, Lactococcus lactis,
Enterococcus faecium, Lactobacillus casei and Lactobacillus salivarius," which aremicroorganisms having the ability to produce equol."
B. Comparison between the Corrected Invention and Exhibit Otsu B19 Invention
When the Corrected Invention stated on p. 5, lines 13 to 20 of the judgment in priorinstance cited in No. 2, 3. above and Exhibit Otsu B19 Invention referred to in A.(B) above
are compared, the Corrected Invention and Exhibit Otsu B19 Invention are found to havecommonalities in that they are "a method for producing a fermented substance containing
equol, comprising the step to ferment a fermenting material containing at least one daidzein
compound selected from the group consisting of daidzein glycosides, daidzein, anddihydrodaidzein by using a microorganism having the ability to produce equol," and differ
in the following respects.

61

(Difference B1) The Corrected Invention specifies that the microorganism "has the ability to
produce ornithine," whereas Exhibit Otsu B19 Invention specifies that the microorganism
includes "Lactococcus lactis," but does not specify that the microorganism "has the ability
to produce ornithine."(Difference B2) The Corrected Invention specifies that arginine is added to "at least one
daidzein compound selected from the group consisting of daidzein glycosides, daidzein, anddihydrodaidzein" and that the fermenting material containing the daidzein compound andarginine is fermented, whereas Exhibit Otsu B19 Invention specifies that the fermenting
material is a daidzein-supplemented basal medium or the like, including soy milk, but does
not specify that the fermenting material contains arginine as a result of adding arginine tothe daidzein compound.
(Difference B3) The Corrected Invention specified that a fermented substance containing
ornithine is produced, whereas Exhibit Otsu B19 Invention does not specify this point.
(Difference B4) The Corrected Invention specifies that not less than 8 mg ornithine and notless than 1 mg equol per gram by dry weight are produced by fermentation, whereas Exhibit
Otsu B19 Invention does not specify this point.
(Difference B5) The Corrected Invention specifies that the fermented substance produced is
powder and that it is used as a food material, whereas Exhibit Otsu B19 Invention does not
specify this point.
C. Regarding Difference B1
Difference B1 (the Corrected Invention specifies that the microorganism "has the ability
to produce ornithine," whereas Exhibit Otsu B19 Invention specifies that the microorganism
includes "Lactococcus lactis," but does not specify that the microorganism "has the ability
to produce ornithine") is examined below.
(A) Exhibit Otsu B19 discloses a "mixed culture" of "Bifidobacterium lactis, Lactobacillus
acidophilus, Lactococcus lactis, Enterococcus faecium, Lactobacillus casei and
Lactobacillus salivarius" as microorganisms having "the ability to produce equol," but it
does not state that any of these microorganisms has the ability to produce ornithine.
Regarding this point, the Appellees allege that it was common general technicalknowledge that "Lactococcus lactis" has "the ability to produce ornithine" whereby itproduces ornithine by metabolizing arginine via the arginine deiminase pathway. While
Lactococcus lactis used to be called Streptococcus lactis (or lactis) in the past (Exhibit Otsu
B21), Exhibit Otsu B20 (Journal of Bacteriology, vol. 150, no.3, 1982, pp. 1024-1032) states"Streptococcus lactis metabolizes arginine via the arginine deiminase pathway, producing
ornithine, ammonia, carbon dioxide, and ATP." Meanwhile, Exhibit Otsu B78 (Journal of
Daily Research, vol.65, 1998, pp.101-107) states "Increased activity of the arginine

62deiminase pathway during late log phase was inferred from increased utilization of Arg andliberation of citrulline and ornithine."
However, as shown in Table 5 of Exhibit Ko 56, Streptococcus lactis includes strains thathave the arginine deiminase pathway activity and those that do not (YIT-2003 is ADH+, but
M-29C is ADH−). Therefore, a Streptococcus lactis strain is not immediately found to havethe ability to produce ornithine.
Accordingly, it must be said that whether Lactococcus lactis in Exhibit Otsu B19 is a
microorganism having the ability to produce ornithine is unclear. With regard to the othermicroorganisms in Exhibit Otsu B19 Invention as well, Exhibit Otsu B19 does not state thatthey have the ability to produce ornithine, and there is no sufficient evidence to find that
there was such common general technical knowledge as of the Priority Date.
Consequently, it cannot be said that Difference B1 is an equivalent of descriptions in
Exhibit Otsu B19.
(B) As mentioned in (A) above, while Difference B1 is a substantive difference, a person
skilled in the art, as of the Priority Date, would have been unable to derive from statements
in Exhibit Otsu B19 that any of the microorganisms stated in Exhibit Otsu B19 has the ability
to produce ornithine.
Moreover, Exhibit Otsu B19 Invention is an invention relating to the making andisolating of enantiomeric equol compounds, namely S-equol and R-equol, and foods andmedicaments containing enantiomeric equol compounds for treating of disease andconditions in mammals and humans (paragraph [0001] of Exhibit Otsu B19), and Exhibit
Otsu B19 contains no statement at all about ornithine, and also contains no statementssuggesting production of ornithine, such as obtaining a fermented substance containing
equol and ornithine by using a microorganism having the ability to produce ornithine andthe ability to produce equol.
Accordingly, it cannot be said that a person skilled in the art could have easily conceivedof Difference B1 from Exhibit Otsu B19 Invention as of the Priority Date.
D. Conclusion regarding Grounds for Invalidation 5
Consequently, without having to examine other differences, a person skilled in the art isalso not found to have been able to easily conceive of the Corrected Invention based on
Exhibit Otsu B19 Invention, and hence a person skilled in the art is not found to have beenable to easily make the Corrected Invention based on the invention stated in Exhibit Otsu
B19 and well-known art.
Due to the above, Grounds for Invalidation 5 alleged by the Appellees are groundless.
(6) Regarding Issue 2-6 (whether Grounds for Invalidation 6 (lack of novelty based on
Exhibit Otsu B24 and lack of inventive step based on Exhibit Otsu B24 as the primary cited63invention) exist)
A. Regarding Exhibit Otsu B24 Invention(A) The description of Exhibit Otsu B24 (the third sheet onward of Exhibit Otsu B24;
hereinafter referred to as "Exhibit Otsu B24 Description") contains the following statements.
"Based on the above findings the inventors did further research and, as a result,
succeeded in the development of a novel composition which comprises a strain of
microorganism having the ability (metabolic activity) to elaborate equol by metabolizing
daidzein and either daidzein or a suitable substance containing daidzein in combination, anda novel composition which comprises equol obtained by causing said strain of
microorganism to metabolize daidzein. The inventors then discovered that the intake ofwhichever of the above compositions is effective in the prevention and alleviation ofunidentified clinical syndrome in middle-aged and older women and have accordingly
developed the instant invention." (page 6, line 18 to page 7, line 4)"The present invention in a second aspect provides a composition, in the form of a foodor a pharmaceutical product, which comprises equol which is obtained by causing a strainof microorganism capable of metabolizing daidzein to equol to act upon a daidzeincontaining substance (this composition will hereinafter be referred to as 'equol-containing
composition')." (page 7, lines 11 to 15)"(3) Streptococcus A6G-225 (FERM BP-6437)
I. Cultural Characteristics(omitted)
II. Physiological Characteristics(omitted)
The above morphological and biochemical characteristics, sugar fermentation test andorganic acid production spectrum suggest that this strain belongs to the gram-positive
Streptococcus intermedius but the strain differentiates itself from the type culture strain of S.
intermedius in the ability to utilize L-rhamnose and D-trehalose. Therefore, the inventors
named the strain Streptococcus A6G-225 and deposited it with National Institute of
Bioscience and Human Technology (NIBH, Higashi 1-1-3, Tsukuba-shi, Ibaraki, Japan) as
of July 7, 1997, with the accession number of FERM P-16314 assigned. This deposit was
subsequently converted to a Budapest deposit as of July 22, 1998 and assigned with theaccession number of FERM BP-6437." (page 19, line 7 to page 23, line 5)"The equol-containing composition of the invention can be produced by culturing saidstrain of microorganism according to conventional fermentation technology utilizing saiddaidzein-containing substance, preferably soybean isoflavone or a food material containing
it, as the substrate.

64More particularly, the technology comprises sterilizing the substrate in solution form,
adding the predetermined strain of microorganism thereto, and incubating the mixture at
37°C either under anaerobic conditions or under aerobic stationary conditions for about 4896 hours to let fermentation proceed. (Where necessary, a pH control agent, a reducing
substance (e.g. a yeast extract, vitamin K1) can be added.)
Taking Streptococcus intermedius as an example, the above cultural process can be more
preferably carried out as follows. First, daidzein is dissolved in the range of 0.01-0.5 mg/ml
in Modified GAM (Modified Gifu Anaerobic Medium) for culture of anaerobic bacteria. A
seed culture prepared by growing the microorganism in Modified GAM for about 14 hours
is then inoculated into the above daidzein-containing Modified GAM. The inoculum size
may be 1/100 by volume of the medium. The incubated medium is incubated aerobically at
37°C under stationary conditions for 48-96 hours.
The present invention further provides a method for producing equol utilizing such a
strain of microorganism.
In the above fermentation system, there may be incorporated a nutrient which isparticularly suited for the maintenance and growth of the microorganism. The nutrient
includes oligosaccharides such as galactosyl-sucrose, soybean-oligosaccharide, lactulose,lactitol, fructo-oligosaccharide, and galacto-oligosaccharide. The amount of said nutrient is
not particularly restricted but is preferably selected from the range of generally about 1-3
wt. % based on the total composition of the invention.
The desired equol-containing culture broth can thus be obtained." (page 27, line 21 topage 29, line 7)"The equol-containing composition of the invention can be produced, in a suitable foodform or pharmaceutical dosage form, by formulating the equol-containing culture brothprepared as above or equol isolated therefrom with other optional food materials.
The food form includes drinks, milk products, fermented milk, bars, granules, powders,
capsules, and tablets." (page 29, lines 13 to 19)"Example 3 Preparation of a Fermented Soy Milk Lyophilizate
Using 1 ml of a suspension of about 107 cells/ml of Streptococcus A6G-225 (FERM BP6437), 100 g of soy milk was caused to undergo lactic acid fermentation at 37°C for 24 hours
to provide equol. This product was lyophilized. The equol content of this freeze-dried
powder was 0.1-0.3 wt. %.
The above powder and other ingredients according to the following recipe were weighed
and blended to provide the composition of the invention in the form of a fermented soy milklyophilizate.

65Fermented soy milk lyophilizate
Excipient
Vitamins & minerals
Flavor
Total

2.2 g
q.s.
q.s.
q.s.
20 g

As the excipient, 17 g of corn starch was used." (page 32, lines 7 to 20)(B) Finding of Exhibit Otsu B24 Invention
As mentioned in (A) above, Exhibit Otsu B24 states the following: the invention"provides a composition, in the form of a food or a pharmaceutical product, which comprises
equol which is obtained by causing a strain of microorganism capable of metabolizing
daidzein to equol to act upon a daidzein-containing substance (this composition will
hereinafter be referred to as 'equol-containing composition')" (page 7, lines 11 to 15 of
Exhibit Otsu B24 Description); the abovementioned microorganism is preferably cultured
by using "Modified GAM" (page 27, line 21 to page 29, line 7); the food form includes"drinks, milk products, fermented milk, bars, granules, powders, capsules, and tablets" (page29, lines 13 to 19); and in Example 3, when "soy milk" was caused to undergo lactic acidfermentation by using "Streptococcus A6G-225 (FERM BP-6437)" to "provide equol," andthe product "was lyophilized," "the equol content of this freeze-dried powder was 0.1-0.3
wt. %," that is, 1-3 mg per gram by dry weight (page 32, lines 7 to 20).
According to the statements above, the following Exhibit Otsu B24 Invention is foundto be stated in Exhibit Otsu B24.
"A method for producing a fermented powder containing equol, comprising the step toferment a fermenting material containing daidzein, such as soy milk, as the substrate in
Modified GAM by using Streptococcus intermedius, particularly Streptococcus A6G-225(FERM BP-6437), which is a microorganism having the ability to produce equol, wherein
1-3 mg equol is produced per gram by dry weight of the fermented powder, and said
fermented substance is used in a food form including drinks, milk products, fermented milk,bars, granules, powders, capsules, and tablets."
B. Comparison between the Corrected Invention and Exhibit Otsu B24 Invention
When the Corrected Invention stated on p. 5, lines 13 to 20 of the judgment in priorinstance cited in No. 2, 3. above and Exhibit Otsu B24 Invention referred to in A.(B) above
are compared, the Corrected Invention and Exhibit Otsu B24 Invention are found to havecommonalities in that they are "a method for producing a fermented powder containing equol,
comprising the step to ferment a fermenting material containing at least one daidzein
compound selected from the group consisting of daidzein glycosides, daidzein, and66

dihydrodaidzein by using a microorganism having the ability to produce equol, wherein said
fermented substance is used as a food material," and differ in the following respects.
(Difference C1) The Corrected Invention specifies that the microorganism "has the ability to
produce ornithine," whereas Exhibit Otsu B24 Invention specifies that the microorganism is"Streptococcus intermedius, particularly Streptococcus A6G-225 (FERM BP-6437)," butdoes not specify that the microorganism "has the ability to produce ornithine."(Difference C2) The Corrected Invention specifies that arginine is added to "at least one
daidzein compound selected from the group consisting of daidzein glycosides, daidzein, anddihydrodaidzein" and that the fermenting material containing the daidzein compound andarginine is fermented, whereas Exhibit Otsu B24 Invention specifies that the fermentation iscarried out in Modified GAM, but does not specify that the fermenting material contains
arginine as a result of adding arginine to the daidzein compound.
(Difference C3) The Corrected Invention specifies that a fermented substance containing
ornithine is produced, whereas Exhibit Otsu B24 Invention does not specify this point.
(Difference C4) The Corrected Invention specifies that not less than 8 mg ornithine and notless than 1 mg equol per gram by dry weight are produced by fermentation, whereas Exhibit
Otsu B24 Invention does not specify this point.
C. Regarding Difference C4
In light of the counsel's arguments, Difference C4 (the Corrected Invention specifies that
not less than 8 mg ornithine and not less than 1 mg equol per gram by dry weight are
produced by fermentation, whereas Exhibit Otsu B24 Invention does not specify this point)
is examined below.
(A) Regarding novelty
Exhibit Otsu B24 Invention uses Streptococcus A6G-225 (FERM BP-6437), which is a
microorganism stated in paragraph [0032] of the Description, but Exhibit Otsu B24 contains
no statements about the fact that ornithine can be obtained by fermentation using thatmicroorganism and the amount of the ornithine produced.
The Appellees allege that Difference C4 is an equivalent of descriptions in Exhibit Otsu
B24, as the amount of ornithine per gram by dry weight of the fermented substance obtainedby performing a culture by using Streptococcus A6G-225 (FERM BP-6437) disclosed in
Exhibit Otsu B24 and Modified GAM is 25.4 mg. However, the Appellees have calculated
the above amount of ornithine on the premise that the main culture is performed by using
daidzein as the fermenting material and also using Modified GAM, and that 100% of thearginine in the medium is converted into ornithine, whereas in Exhibit Otsu B24, a cultureusing Streptococcus A6G-225 (FERM BP-6437) is stated as Example 3, on which Exhibit
Otsu B24 Invention is premised (page 32, lines 7 to 20 of the description of Exhibit Otsu

67B24). In this example, using 1 ml of a suspension of about 107 cells/ml of Streptococcus
A6G-225 (FERM BP-6437), 100 g of soy milk was caused to undergo lactic acidfermentation at 37°C for 24 hours to provide equol, which was then lyophilized to obtain apowder. As the example does not use daidzein as a fermenting material, and also does notuse Modified GAM for the main culture, the Appellees' calculation above is premised on
conditions that differ from those of the example. Even if it is supposed that, in the example,
Modified GAM was used for the culture, 1 ml of Streptococcus A6G-225 including theModified GAM and 100g of soy milk were fermented, and arginine contained in the
Modified GAM used for the culture was converted to produce ornithine, considering thesmall amount of ornithine derived from the Modified GAM used for the culture as comparedto the amount of soy milk, and the amount of the soy milk-derived solid matter contained in
the dried powder, it cannot be found, based on the Appellees' calculation above which
premises conditions, including the fermenting material and the medium, that differ fromthose of the example, that not less than 8 mg of ornithine per gram by dry weight of thefermented substance would be produced in the example.
According to the results of the experiment allegedly conducted by the Appellant basedon Example 3 of Exhibit Otsu B24 (the experiment report of Exhibit Ko 60; however, theexperiment uses a mixture of soy milk and Modified GAM broth for the main culture, so themedium for the main culture differs from that of Example 3), ornithine was found to be
produced, but as the production amount was approximately 0.15-0.16 mg per gram by dry
weight, it cannot be found that not less than 8 mg ornithine is produced per gram by dry
weight in Example 3.
Exhibit Otsu B24 also contains statements that, using Streptococcus intermedius,
daidzein is dissolved in the range of 0.01-0.5 mg/ml in Modified GAM, and a seed culture
prepared by growing the microorganism in Modified GAM for about 14 hours is theninoculated into the daidzein-containing Modified GAM to be incubated aerobically at 37°C
under stationary conditions for 48-96 hours (page 27, line 21 to page 29, line 7), but in thisculture method, the conversion rate from arginine to ornithine and the specific culture
conditions are not necessarily clear, and the conditions cannot be regarded to comply withthe conditions premised in the Appellees' calculation above. Therefore, it cannot be said,
based on these statements, that Exhibit Otsu B24 contains a statement that not less than 8
mg ornithine is produced per gram by dry weight by this culture method.
Accordingly, it cannot be said that Difference C4 is an equivalent of descriptions in
Exhibit Otsu B24.
(B) Regarding inventive step
According to (A) above, Exhibit Otsu B24 contains no descriptions (or equivalents of68

descriptions) that not less than 8 mg ornithine is produced per gram by dry weight byfermentation. Also, given that Exhibit Otsu B24 Invention provides a composition which
comprises equol which is obtained by causing a strain of microorganism capable ofmetabolizing daidzein to equol to act upon a daidzein-containing substance (page 7, lines 11
to 15 of Exhibit Otsu B24 Description) and that Exhibit Otsu B24 contains no statement at
all and no suggestions about ornithine, it cannot be said that a person skilled in the art could
have conceived of changing the culture conditions, etc. in Exhibit Otsu B24 Invention so as
to produce not less than 8 mg ornithine per gram by dry weight of the fermented substance.
Accordingly, it cannot be said that a person skilled in the art could have easily conceivedof Difference C4 based on Exhibit Otsu B24 Invention.
D. Conclusion regarding Grounds for Invalidation 6
Consequently, without having to examine other differences, the Corrected Invention is
not found to be an equivalent of descriptions in Exhibit Otsu B24, and a person skilled in theart is also not found to have been able to easily conceive of the Corrected Invention basedon Exhibit Otsu B24 Invention.
Due to the above, Grounds for Invalidation 6 alleged by the Appellees are groundless.
(7) Regarding Issue 2-7 (whether Grounds for Invalidation 7 (lack of novelty and inventive
step based on Exhibit Otsu B2 on the premise that the patent application for the Patentviolates the requirements for division of application) exist)
A. The Appellees allege that none of [1] the composition of using "at least one daidzein
compound selected from the group consisting of daidzein glycosides, daidzein, anddihydrodaidzein" as a fermenting material, [2] the composition of "adding arginine," and [3]the composition of producing "not less than 8 mg ornithine per gram by dry weight of thefermented substance" adopted in the Corrected Invention is stated in the Original Description,
which is the description, etc. originally attached to the application immediately before filingthe divisional application, and that therefore the requirement to "divide a patent application
containing two or more inventions into one or more new patent application" under Article
44, paragraph (1) of the Patent Act is not satisfied. Therefore, whether the compositions [1]through [3] of the Corrected Invention fall within the scope of the matters stated in theOriginal Description is examined below.
B. The Original Description (Exhibit Otsu B47) contains the following statements.
[0036]
Further, if necessary, some additives may be added to the soybean hypocotyl as the raw
material in the fermentation to improve the fermentation efficiency or flavor of the product.
Examples of the additives include nitrogen sources such as a yeast extract, polypeptone, ora meat extract; carbon sources such as glucose or sucrose; inorganic salts such as phosphate,69

carbonate or hydrosulfate; vitamins; and nutritional components such as amino acid.
Particularly, when using an equol-producing microorganism for converting arginine into
ornithine (hereinafter referred to as an "ornithine/equol-producing microorganism"),arginine is added to the soybean hypocotyl before fermentation so that the fermented
substance contains ornithine. In this case, the amount of arginine is, for example, about 0.5
to 3 parts by weight, based on 100 parts by weight (dry weight) of the soybean hypocotyl.
The ornithine/equol-producing microorganism may be obtained by a publicly-known
screening method using an index of the equol-producing ability and the conversion ability
from arginine into ornithine. The ornithine/equol-producing microorganism may be selectedfrom the group of Lactococcus garvieae, typified by Lactococcus 20-92 (FERM BP-10036).
[0050]
Further, as described above, ornithine is contained in the equol-containing fermented
soybean hypocotyl produced from fermentation with an ornithine/equol-producing
microorganism after adding arginine to a soybean hypocotyl. The ornithine content of theequol-containing fermented soybean hypocotyl is 5 to 20 mg, preferably 8 to 15 mg, andmore preferably 9 to 12 mg, per gram (dry weight) of the equol-containing fermented
soybean hypocotyl.
[0091]The equol-containing fermented substance was produced through a publicly-known
fermentation method using an equol-producing microorganism. More specifically, a
microorganism with the ability (metabolic activity) to produce equol by metabolizing at least
one daidzein compound selected from the group consisting of daidzein glycosides, daidzein,
and dihydrodaidzein, is inoculated in a fermenting material (material to be subjected to thefermentation) containing the daidzein. The sample is then fermented (cultured) under theconditions suitable to grow the microorganism. The resulting fermented substance contains
equol.
[0093]
The fermenting material containing daidzein compounds is not limited by other factors
as long as it contains daidzein compounds; however, the material is preferably approved forits safety as a food material. Examples of the fermenting material containing daidzein
compounds include soybeans, a soybean hypocotyl, a soybean hypocotyl extract, tofu, deepfried tofu, soy milk, fermented soybeans, soy sauce, bean paste, a tempeh, and a red clove
or its extract, alfalfa or its extract. A suitable fermenting material containing daidzein
compounds is a soybean hypocotyl because of its high daidzein content.
[0226]The respective components of the soybean hypocotyl powder ("Pre-fermentation" in70Table 2 and Table 3) and of the fermented soybean hypocotyl powder ("Post-fermentation"in Table 2 and Table 3) were analyzed. Table 2 shows an analysis regarding soybean
isoflavones, and Table 3 shows an analysis regarding nutritional components. These tables
show that the fermented soybean hypocotyl obtained by the fermentation of a soybean
hypocotyl using a Lactococcus 20-92 strain has a high equol content. Further,oligosaccharide content for such oligosaccharides as raffinose or stachyose remains
substantially the same after fermentation, which indicates that the fermentation did not
influence the oligosaccharide content. Meanwhile, the tables show that arginine wasconverted into ornithine by the fermentation. Accordingly, by adding arginine to the soybean
hypocotyl before fermentation using a Lactococcus 20-92 strain, the resulting fermented
substance contains not only equol but also ornithine.
[0228][Table 3]
Nutritional Components
Component

Per 100 g

Pre-fermentation

Post-fermentation

Moisture
Protein
Fat
Ash
Saccharide

3.2 g
38.1 g13.0 g4.3 g30.9 g6.2 g38.3 g14.5 g4.0 g26.8 g

Dietary Fiber
EnergySucroseRaffinose
StachyoseTrans Fatty Acids
Phospholipids (as stearooleo-lecithin)
Free Arginine
Free Ornithine
Soyasapogenol A

10.5 g
414 kcal7.95 g1.37 g9.04 g
N.D.
3.33 g10.2 g
411 kcal
7.42 g1.34 g8.38 gN.D.
2.92 g

881 mg
N.D.
N.D.

12 mg
1.06 gN.D.

Soyasapogenol B
Soybean Saponin

N.D.
3.6 g

N.D.
3.8 g

N.D. refers to "Not Detected."
C. With regard to [1] the composition of using "at least one daidzein compound selected71

from the group consisting of daidzein glycosides, daidzein, and dihydrodaidzein" as afermenting material, as mentioned in B. above, paragraph [0091] of the Original Description
states "a microorganism with the ability (metabolic activity) to produce equol bymetabolizing at least one daidzein compound selected from the group consisting of daidzein
glycosides, daidzein, and dihydrodaidzein," and paragraph [0093] of the description states"The fermenting material containing daidzein compounds is not limited by other factors aslong as it contains daidzein compounds." Therefore, the composition of using "at least one
daidzein compound selected from the group consisting of daidzein glycosides, daidzein, anddihydrodaidzein" as a fermenting material is regarded to be stated in the Original Description.
Accordingly, the composition [1] above is found to fall within the scope of the matters statedin the Original Description.
D. Regarding [2] the composition of "adding arginine"
As mentioned in B. above, paragraph [0036] of the Original Description states"Particularly, when using an equol-producing microorganism for converting arginine into
ornithine (hereinafter referred to as an "ornithine/equol-producing microorganism"),arginine is added to the soybean hypocotyl before fermentation so that the fermented
substance contains ornithine," and paragraph [0226] of the description states "by adding
arginine to the soybean hypocotyl before fermentation using a Lactococcus 20-92 strain, theresulting fermented substance contains not only equol but also ornithine." Based on thesestatements, it can be said that a step to add arginine to the fermenting material is stated in
the Original Description. Accordingly, the composition [2] above is found to fall within thescope of the matters stated in the Original Description.
E. Regarding [3] the composition of producing "not less than 8 mg ornithine per gram by
dry weight of the fermented substance"
As mentioned in B. above, paragraph [0050] of the Original Description states "Theornithine content of the equol-containing fermented soybean hypocotyl is 5 to 20 mg,
preferably 8 to 15 mg, and more preferably 9 to 12 mg, per gram (dry weight) of the equolcontaining fermented soybean hypocotyl," indicating that 8 to 15 mg ornithine per gram by
dry weight of the fermented substance should preferably be contained, and the composition[3] above can be regarded to have been specified by the lower limit value of "8 to 15 mg"that was given as an example in the Original Description.
Furthermore, paragraph [0093] of the Original Description states "The fermenting
material containing daidzein compounds is not limited by other factors as long as it contains
daidzein compounds; however, the material is preferably approved for its safety as a foodmaterial" and "A suitable fermenting material containing daidzein compounds is a soybean
hypocotyl because of its high daidzein content." While a soybean hypocotyl is found to72

constitute an example of a "material containing daidzein compounds" based on thesestatements, paragraph [0050] above is construed to state the ornithine content in the case ofusing a "soybean hypocotyl," which is an example of a "material containing daidzein
compounds."
Accordingly, it can be said that the composition [3] above falls within the scope of thematters stated in the Original Description.
F. Conclusion regarding Grounds for Invalidation 7
Consequently, all of the compositions [1] through [3] fall within the matters stated in theOriginal Description. As the statements in B. above all coincide with the respective
statements in paragraphs [0034], [0048], [0089], [0091], [0224] and [0226], and [Table 3] of[detailed description of the invention] in the domestic re-publication of PCT international
publication for the Original Application (Exhibit Otsu B2), the compositions [1] through [3]are regarded to fall within the scope of the matters stated in the description, etc. of theOriginal Application, and further, they are presumed to fall within the scope of the mattersstated in the respective descriptions of Patent Application No. 2013-108439 filed as adivisional application for a part of the Original Application, and Patent Application No.
2016-156372 further filed as a divisional application for a part thereof. As the Application isfound to have been lawfully filed as a divisional application, it is deemed to have been filedon June 13, 2008, which is the filing date the Original Application.
Meanwhile, Exhibit Otsu B2 is a document that was internationally published on
December 18, 2008, which is after the abovementioned filing date. Therefore, the Corrected
Invention cannot be held to be in violation of the novelty and inventive step requirements
based on Exhibit Otsu B2.
Due to the above, Grounds for Invalidation 7 alleged by the Appellees are groundless.
(8) Regarding Issue 2-8 (whether Grounds for Invalidation 8 (the Description violating therequirement under the delegated ministerial order) exist)
A. Regarding the requirement under the delegated ministerial order
While Article 24-2 of the Regulation for Enforcement of the Patent Act as delegated by
Article 36, paragraph (4), item (i) of the Patent Act provides that statements in the detailed
description of the invention "must be made by stating the matters necessary for a person withordinary skill in the art of the invention to understand the technical meaning of the invention,such as the problem to be solved by the invention and the means for solving the problem,"the Appellees allege that the Corrected Invention violates this requirement under thedelegated ministerial order on the basis that it is unclear from the Description what kind ofproblem was solved by the Corrected Invention using ornithine and how, and that the
problems and effects for overcoming the numerical limitation of "not less than 8 mg

73

ornithine" "per gram by dry weight of the fermented substance" are not stated in the
Description, and hence a person skilled in the art could not have recognized the problem tobe solved by the Corrected Invention and the means for solving the problem.
B. Regarding statements in the Description
As mentioned in 1.(1) above, paragraph [0226] of the Description states that analysis
results "show that arginine was converted into ornithine by the fermentation. Accordingly,
by adding arginine to the soybean hypocotyl before fermentation using a Lactococcus 20-92
strain, the resulting fermented substance contains not only equol but also ornithine." In
addition, paragraph [0228] and [Table 3] also indicate that ornithine is produced fromarginine by fermentation. Moreover, paragraph [0050] states that, in the case of using a"soybean hypocotyl," which is an example of a "material containing daidzein compounds,"
the ornithine content is "5 to 20 mg, preferably 8 to 15 mg, and more preferably 9 to 12 mg,
per gram (dry weight) of the equol-containing fermented soybean hypocotyl." Thus, a person
skilled in the art could have understood that the Corrected Invention adopted the lower limitof this preferable amount range.
According to the above, a person skilled in the art could have understood that thetechnical meaning of the Corrected Invention was in clarifying that not only equol, but also
ornithine can be produced by performing fermentation by using a Lactococcus 20-92 strain
and in providing a method for producing a fermented substance containing equol andornithine (the ornithine content is not less than 8 mg per gram by dry weight), and that theCorrected Invention solved these by performing fermentation. Therefore, it can be said thatthe detailed description of the invention of the Description states the matters necessary for a
person skilled in the art to understand the technical meaning of the invention.
C. Regarding the Appellees' allegation
The Appellees indicate that paragraph [0010] of [Problem to be Solved by the Invention]in the Description contains no statement about ornithine. However, because Article 24-2 ofthe Regulation for Enforcement of the Patent Act is a provision concerning "statements inthe detailed description of the invention" as mentioned above, it is sufficient for a person
skilled in the art to be able to understand the technical meaning of the invention from theentire statements of the Description, and the matters necessary for understanding thetechnical meaning of the invention do not necessarily need to be stated in the "problem to besolved by the invention" section.
D. Conclusion regarding Grounds for Invalidation 8
Accordingly, it can be said that the Description satisfies the requirement under the Orderof the Ministry of Economy, Trade and Industry as delegated under Article 36, paragraph (4),item (i) of the Patent Act (Article 24-2 of the Regulation for Enforcement of the Patent Act).

74

Due to the above, Grounds for Invalidation 8 alleged by the Appellees are groundless.
(9) Regarding Issue 2-10 (whether Grounds for Invalidation 10 (the second sentence ofArticle 39, paragraph (2) of the Patent Act) exist)
A. Regarding Divisional Inventions 1 and 4
The Appellant filed a divisional application from Patent Application No. 2018-147514
on March 8, 2021 (Patent Application No. 2021-36323; the Basic Applications on which thepriority claim is based are the same as those of the Patent), and the application was registeredas Patent No. 6892972 (the number of claims: 6) on June 1, 2021. Claims 1 and 4 of theclaims of that patent contain the following statements. (Exhibit Otsu B88)
[Claim 1]
A method for producing a fermented substance containing ornithine and equol,
comprising a step to ferment daidzein compounds and arginine by using a microorganism
having the ability to produce ornithine and the ability to produce equol,
wherein said fermented substance contains not less than 8 mg ornithine and not less than
1 mg equol per gram by dry weight thereof,
and wherein said daidzein compounds comprise at least one daidzein compound selectedfrom the group consisting of daidzein glycosides, daidzein, and dihydrodaidzein.
[Claim 4]
The production method stated in any of Claims 1 through 3, wherein said fermented
substance is used as a food material.
B. Comparison between the Corrected Invention and Divisional Invention 4
When the Corrected Invention and the invention stated in Claim 4 of the claims of theabovementioned patent (Divisional Invention 4) are compared, they are found to havecommonalities in that they are "a method for producing a fermented substance containing
ornithine and equol, comprising the step to ferment a fermenting material containing at least
one daidzein compound selected from the group consisting of daidzein glycosides, daidzein,
and dihydrodaidzein and arginine by using a microorganism having the ability to produce
ornithine and the ability to produce equol, wherein not less than 8 mg ornithine and not lessthan 1 mg equol per gram by dry weight are produced by the fermentation and said fermented
substance is used as a food material," and differ in the following respects.
(Difference E1) The Corrected Invention specifies a step to "add arginine to at least one
daidzein compound," whereas Divisional Invention 4 has no such specification.
(Difference E2) The Corrected Invention specifies the product to be "fermented powder,"whereas Divisional Invention 4 has no such specification.
C. Regarding Difference E1Generally, if applications are respectively filed for two inventions on the same date, and75

if the difference of either invention from the other constitutes an addition, deletion, or
replacement of well-known or commonly used art to prior art, and it does not produce any
new effect, the two inventions constitute the "identical inventions" referred to in Article 39,
paragraph (2) of the Patent Act.
When this point is examined for the present case, while the Corrected Invention specifies
that arginine is added to a daidzein compound, arginine is converted into ornithine by thefermentation in the Corrected Invention as mentioned in paragraph [0226] of the Description,and it can be said that addition of arginine produces a new effect of increasing the production
amount of ornithine.
It follows that, without having to examine other points, the Corrected Invention andDivisional Invention 4 cannot be regarded as identical inventions. In addition, as Divisional
Invention 1 also has Difference E1, without having to examine other points, the Corrected
Invention and Divisional Invention 1 cannot be regarded as identical inventions.
D. Conclusion regarding Grounds for Invalidation 10
Due to the above, Grounds for Invalidation 10 alleged by the Appellees are groundless.
The Appellant alleges that Appellee Daicel's allegation of Grounds for Invalidation 10
and offer of Exhibit Otsu B88 as evidence should be dismissed as belated allegation andevidence. However, as the allegation and offer of evidence by Appellee Daicel are not foundto delay the conclusion of the lawsuit in light of the progress of the proceedings, theAppellant's abovementioned allegation concerning belated allegation and evidence is
unacceptable.
4 Regarding Issue 4 (whether it is necessary to seek an injunction and disposal against
Appellee AMC)
Appellee AMC alleges that the Appellant's claims against Appellee AMC should bedismissed, because the Appellees' Product which uses the Appellees' Material has all beensold off, including those in stock, and there is no likelihood of producing and selling the
product in the future.
However, the only evidence submitted by Appellee AMC as the basis for the above
allegation is a written statement prepared by the Appellee AMC's employee (Exhibit Otsu
A2), and there is no sufficient evidence to precisely find that no stock of the product exists
at present. In addition, in light of the fact that there is no dispute among the parties concernedthat Appellee AMC was producing and selling the Appellees' Product at least in or until July
2021, there is no sufficient evidence to find that Appellee AMC has no possession at all of
the Appellees' Product. Furthermore, given that Appellee AMC has not changed the productname and the contents of advertisements (a fact not disputed between the Appellant andAppellee AMC), and considering other factors, one cannot go so far as to say that Appellee

76AMC is unlikely to produce and sell the Appellees' Product in the future.
Consequently, the claims for an injunction and disposal, which are the principal claims
against Appellee AMC, are regarded to be well-grounded.
Meanwhile, the Appellant alleges that Appellee AMC's allegations in the Appellees' Brief
No. 1 and offer of Exhibit Otsu A1 and Exhibit Otsu A2 as evidence should be dismissed as
belated allegation and evidence. However, as the allegations and offer of evidence byAppellee AMC are not found to delay the conclusion of the lawsuit, the Appellant's
abovementioned allegation concerning belated allegations and evidence is unacceptable.
5. Conclusion
Due to the reasons above, while all of the Appellant's principal claims are well-grounded
and should be upheld, the part of the judgment in prior instance dismissing the principal
claims is inappropriate, and therefore the present appeal is well-grounded. Accordingly, thepart of the judgment in prior instance dismissing the Appellant's principal claims is rescinded
and all of the principal claims are upheld. With regard to the declaration of provisional
execution, it is not reasonable to apply this declaration to disposal of the Appellees' Product,
and hence the declaration is applied to the extent of transfer, etc. of the Appellees' Product.
Consequently, the judgment is rendered as indicated in the main text.
Intellectual Property High Court, Second Division
Presiding Judge: HONDA Tomonari
Judge: ASAI Ken
Judge: KATSUMATA Kumiko

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(Attachment)
List of the Appellees' Product
Food product containing fermented soy germ extract
Product name: Equol + Lactobionate
Only those for which the best-before date indicated on the package is April 2023 or
earlier or those for which "Energy 4.98 kcal, Protein 0.34 g, Fat 0.03 g, Carbohydrate 0.84
g, Sodium chloride equivalent 0.004 g" is indicated as the nutritional components.
End

78

(Attachment)
List of the Appellees' Material
Fermented soy germ extract
Product name: FlavoCel EQ-5
End79