Patent

Date

July 20, 2021

Court

Right

Case

2020 (Gyo-Ke) 10054

Intellectual Property High
Court, Fourth Division

number- A case in which the court found that the structure related to the difference could
have been easily conceived of by a person skilled in the art based on the primary cited
document and secondary cited document and on well-known art and common generaltechnical knowledge as well, and rescinded the JPO Decision that is contrary to theabove.
- A case in which the court made a judgment regarding whether the structure of thecorrected invention that was added by the correction after rendering of a judgment torescind the first trial decision (First Judgment) could have been easily conceived ofby a person skilled in the art based on the binding range of the First Judgment.
Case type: Rescission of Trial Decision (Patent)
Result: Granted
References: Article 123, paragraph (1), item (ii); Article 29, paragraph (2); Article
123, paragraph (1), item (iv); Article 36, paragraph (4), item (i) and paragraph (6),item (i) of the Patent Act
Numbers of related rights, etc.: Patent No. 5463378, Invalidation Trial No. 2017800004
Summary of the Judgment
1. Details leading to this lawsuit are as indicated below.
(1) The Plaintiff requested a trail for patent invalidation (Invalidation Trial No. 2017 800004) concerning the patented invention (Patent No. 5463378; hereinafter the
relevant patent is referred to as the "Patent") titled "Device for nucleolytic degradation"of the Defendant and another company (later, the Defendant received the transfer of thecompany's share of the patent right and the transfer was registered).
Concerning the aforementioned request for a trial for patent invalidation, the Japan
Patent Office (JPO) approved the correction made by the Defendant (First Correction)and rendered a trial decision to maintain the patent (hereinafter referred to as the "FirstJPO Decision"). Dissatisfied with the decision, the Plaintiff filed an appeal for
rescission of the First JPO Decision (Intellectual Property High Court, 2018 (Gyo-Ke)
10064). The Intellectual Property High Court determined, based on Exhibit Ko 1
Invention (Examined Patent Application Publication No. 2010-51692) and Exhibit Ko
2 (International Publication No. 01/026697), that the structure related to the Differencei2, which was found in the First JPO Decision, could have been easily conceived of bya person skilled in the art, and rescinded the First JPO Decision. This judgment thenbecame final and binding.
(2) The JPO conducted a further examination of the aforementioned trial for patent
invalidation, approved the correction by the Defendant "to make inner differential
pressure of the exposed unit constant by negative pressure" for Claim 2 (hereinafterreferred to as the "Correction"; the underlined part is the addition by the Correction) in
addition to the First Correction, and then made a trial decision to maintain the invention
related to Claims 2 through 4 of the Patent and dismiss the request for the trial
concerning the invention related to Claim 1 of the Patent (hereinafter referred to as the"JPO Decision"). Dissatisfied with the decision, the Plaintiff filed the lawsuit seeking
rescission of the secondary decision.
(3) The Plaintiff alleged the grounds for rescission of the JPO Decision as follows: [i]Grounds for Rescission 1-1 (error in judgment on an inventive step of Claim 2 after the
Correction that uses Exhibit Ko 1 as the primary cited document (hereinafter referred
to as "Corrected Invention 2")); [ii] Grounds for Rescission 1-2 (error in judgment oninventive steps of Claims 3 (hereinafter referred to as "Corrected Invention 3") and 4(hereinafter referred to as "Corrected Invention 4") after the Correction that uses
Exhibit Ko 1 as the primary cited document (hereinafter these claims are referred to as"Corrected Invention 3" and "Corrected Invention 4," respectively); [iii] Grounds for
Rescission 2 (error in determination concerning a violation of support requirements);
and [iv] Grounds for Rescission 3 (error in determination concerning a violation of
enablement requirements).
2. This judgment granted the Plaintiff's request by determining that Grounds for
Rescission 1-1 and 1-2 are well-grounded.
(1) Grounds for Rescission 1-1
A. In light of the determination in the First Judgment and the developments of the trial
decision after the First Judgment became final and binding, in order to make a judgment
on an inventive step of Corrected Invention 2, whether the structure of Corrected
Invention 2 "to make inner differential pressure of the exposed unit constant by negative
pressure" can be said to have been easily conceived of by a person skilled in the art
should be examined on the assumption that the structure of Difference 2, which was
found in the First JPO Decision, has been disclosed in Exhibit Ko 2.
B. According to the statement in Exhibit Ko 2, the technical meaning of Exhib it Ko 2
Invention is that it can control formaldehyde gas concentration, humidity, andtemperature in the space subject to sterilization, and can maintain room pressureiiconstant even in cases where room air expands due to increases in room temperature,
thereby showing fully certifiable sterilizing effects. It should be said that the form of
maintaining room pressure at a positive pressure (10 to 20Pa) by a room pressureadjustment device is merely one of the embodiments.
Based on the instruction in the First Judgment, it is found that Exhibit Ko 2 discloses
that a means for detecting inner differential pressure is equipped and that pressure in
the space subject to sterilization is maintained constant by feedback of the informationon the aforementioned inner differential pressure obtained from the results detected by
the means for detecting inner differential pressure to the means to control the exhaustamount and by controlling the exhaust amount of formaldehyde gas that is discharged
from the space subject to sterilization by the aforementioned means to control theexhaust amount.
C. Exhibit Ko 1 discloses that the purpose is to maintain the catalytic reaction
temperature constant for radical formation and to provide a sterilization gas generating
device to generate MR gas at stable concentrations. As mentioned in B. above, Exhibit
Ko 2 discloses that fully certifiable sterilizing effects can be obtained because theadoption of the structure of the formaldehyde gas sterilization device of Exhibit Ko 2
Invention makes it possible to control formaldehyde gas concentration, humidity, andtemperature in the space subject to sterilization at the specified values respectively, andalso to maintain room pressure constant even in cases where room air expands due toincreases in room temperature. Based on the above, a person skilled in the art who
comes across Exhibits Ko 1 and Ko 2 has the motivation to adopt a structure to control
formaldehyde gas concentration, humidity, and temperature in the space subject tosterilization as stated in Exhibit Ko 2 at the specified values respectively and maintainthe room pressure of the space subject to sterilization constant for the purpose ofgenerating sterilization gas at stable concentrations in Exhibit Ko 1 Invention andobtaining fully certifiable sterilization effects.
At the time of the filing date of the application in question, it had been well-known
art that, in cases where there are harmful substances to the human body in a room, suchas in biohazard facilities, chemical hazard facilities, etc., room pressure should becontrolled at a negative pressure against outside pressure so that the substances do notleak from inside the room to outside the room, and that in cases of sterilizing inside aroom using ozone gas that is harmful to the human body, room pressure is controlled at
a negative pressure against outside pressure so that ozone gas does not leak from inside
the room to outside the room. In addition, when using formaldehyde gas for sterilizationand disinfection, it is common general technical knowledge that there are cases whereiiiformaldehyde gas is used under conditions where pressure inside the treatment room is
at a negative pressure against the pressure outside the treatment room. Therefore, when
applying the matters disclosed in Exhibit Ko 2 to Exhibit Ko 1 Invention, in light of theconditions of the space subject to sterilization and the purpose, and in consideration of
the aforementioned well-known art and common general technical knowledge, it can besaid that a person skilled in the art could have easily conceived of maintaining thepressure in the space subject to sterilization at a negative pressure. In addition, there isno evidence to find that any significant effects that a person skilled in the art could notpredict were obtained by applying a structure to maintain "inner differential pressure at
a negative pressure" in the space subject to sterilization as a result of considering andapplying well-known art and common general technical knowledge to Exhibit Ko 1
Invention and the matters disclosed in Exhibit Ko 2.
D. Consequently, based on the matters stated in Exhibits Ko 1 and Ko 2, well-known
art, and common general technical knowledge, an inventive step also cannot be foundin the structure of Corrected Invention 2 "to make inner differential pressure of the
exposed unit constant by negative pressure" out of Difference 1.
(2) Grounds for Rescission 1-2
The JPO Decision determined as follows: Corrected Invention 3 is an invention
citing Corrected Invention 2 and Corrected Invention 4 is an invention citing Corrected
Invention 3; since it cannot be said that a person skilled in the art could have easily
invented Corrected Invention 2, it cannot be said either that a person skilled in the art
could have easily invented Corrected Inventions 3 and 4.
However, there is an error in the determination of the JPO Decision concerningwhether Corrected Invention 2 could have been easily conceived of by a person skilledin the art. As long as it is found that Corrected Invention 2 could have been easily
conceived of by a person skilled in the art, there is an error in the aforementioned
determination of the JPO Decision to deny that Corrected Inventions 3 and 4 could havebeen easily conceived of by a person skilled in the art only on the grounds that Corrected
Invention 2 could not have been easily conceived of by a person skilled in the art.

iv

Judgment rendered on July 20, 2021
2020 (Gyo-Ke) 10054, Case of seeking rescission of the JPO decision
Date of conclusion of oral argument: June 10, 2021
Judgment
Plaintiff: Wingturf Co., Ltd.

Defendant: Sealive, Inc.

Main text
1. The part "Patent No. 5463378 shall be maintained with regard to the invention related
to Claims 2 through 4 of said patent" of the decision made by the Japan Patent Office(JPO) on March 17, 2020, concerning Invalidation Trial No. 2017-800004, shall be
rescinded.
2. The Defendant shall bear the court costs.
Facts and reasonsNo. 1 Claim
Same as the main text.
No. 2 Outline of the case
(Hereinafter documentary evidence is simply referred to as "Exhibition Ko 1," etc.)
1. Procedures, etc. at the JPO (There are no disputes between the parties.)(1) The Defendant and Nobelto Co., Ltd. (hereinafter referred to as "Nobelto") filed apatent application for an invention titled "Device for nucleolytic degradation" (Patent
Application No. 2012-62880; hereinafter referred to as the "Patent Application") on
March 19, 2012, and obtained patent right registration on January 24, 2014 (Patent No.
5463378; number of claims: 4; hereinafter the registered patent is referred to as the"Patent").
(2) The Plaintiff requested a trial for invalidation seeking invalidation of the patent of theinvention related to Claims 1 through 4 of the Patent (Invalidation Trial No. 2017-800004)
on January 17, 2017.
The Defendant and Nobelto received the announcement of the trial decision dated
November 30, 2017, and requested corrections concerning the group of claims consistingof Claims 1 through 4 on December 27, 2017, to correct Claims 2 through 4, to delete
1Claim 1, and to correct descriptions attached to the Patent Application (hereinafterreferred to as "Descriptions," including drawings) (hereinafter this series of corrections isreferred to as the "Primary Corrections").
Subsequently, the JPO approved the aforementioned corrections and made thedecision that "the request for the trial is groundless" (hereinafter referred to as the"Primary JPO Decision") on March 27, 2018 and delivered a certified copy thereof to thePlaintiff on April 5, 2018.
During this period, Nobelto transferred its share of the patent right related to the Patentto the Defendant and the transfer of that fact was registered (acceptance date: January 5,2018).
(3) On May 2, 2018, the Plaintiff filed a litigation seeking a rescission of the Primary JPO
Decision (Intellectual Property High Court, 2018 (Gyo-Ke) 10064).
The Intellectual Property High Court rendered a judgment to rescind the Primary JPO
Decision (hereinafter referred to as the "Primary IP High Court Judgment") on February
28, 2019, and the judgment subsequently became final and binding.
(4) The JPO then conducted an additional examination concerning the aforementioned
trial for invalidation.
The Defendant received the announcement of the trial decision dated September 4,
2019, and requested corrections on November 8, 2019 concerning the group of claimsconsisting of Claims 1 through 4, to correct Claims 2 through 4, to delete Claim 1, and tocorrect the Descriptions (hereinafter referred to as "Corrections").
The JPO approved the Corrections and made the decision to the effect that "Patent No.
5463378 shall be maintained with regard to the invention related to Claims 2 through 4of said patent, and the request for the trial concerning the invention related to Claim 1 ofsaid patent shall be dismissed" (hereinafter referred to as the "JPO Decision") on March
17, 2020, and delivered a certified copy thereof to the Plaintiff on March 26, 2020.
(5) The Plaintiff filed this lawsuit to seek rescission of the part related to Claims 2 through4 of the Patent of the JPO Decision on April 24, 2020.
2. Claims
The statements in Claims 2 through 4 of the Patent after the Corrections are as statedbelow (hereinafter the invention related to Claim 2 after the Corrections is referred to as"Corrected Invention 2," etc.; Corrected Inventions 2 through 4 are referred to as"Corrected Inventions"; and the invention related to Claim 2 after the Primary Corrections
and before the Corrections is referred to as "Primarily Corrected Invention 2"; parts of
the Corrections with the same details as the parts of the Primary Corrections areunderlined and parts that are different than the Primary Corrections are double2

underlined.).
[Claim 2]
A device for nucleolytic degradation with the features that it is composed of amethanol gas generation unit including a nozzle that sprays methanol supplied from amethanol tank in mist form, vaporizes the methanol sprayed through the nozzle, andgenerates methanol gas; a cylindrical unit that is positioned above the methanol gas
generation unit, consists of upper and lower parts that are separated from each other byheat-reflective porous metal material, has an air supply unit for supplying air connectedto the upper part, serves as a flow channel to transfer the methanol gas generated fromthe methanol gas generation unit into the upper part by natural convection, and mixes air
supplied from the air supply unit with the methanol gas at the predetermined ratio; and acatalyst unit that is located above the cylindrical unit and radicalizes the methanol gas
into which air is mixed at the predetermined ratio in the cylindrical unit by catalytic
reaction, wherein the catalyst unit is composed of a biogas generation unit that iscomposed of radical reaction catalysts made from thin metal plates formed into ahoneycomb structure by laminating multiple radical reaction catalysts, and that generates
composite gas by radicalizing the methanol gas mixed with air by catalytic reaction andcontains at least active species derived from methanol (hereinafter referred as "biogas"),a means of controlling the generated gas amount that controls the amount of gas
generated in the biogas generation unit by the amount of supplied air and the amount ofmethanol,an exposure unit into which the biogas generated in the biogas generation unit issupplied,a means of controlling the temperature of the exposed area of the exposure unit,a means of controlling the humidity of the exposed area of the exposure unit,
an exhaust gas treatment unit that exhausts the biogas supplied to the exposure unit,a means of controlling the exhaust biogas amount that controls the amount of biogas
exhausted from the exposure unit by the exhaust gas treatment unit,a means of measuring the formaldehyde component concentration of biogas in the
exposure unit,a means for detecting or measuring odor,
wherein the gas concentration information obtained as measurement results by themeans of measuring the formaldehyde component concentration is fed back to the meansof controlling the generated gas amount, wherein the amount of gas generated in the
biogas generation unit is controlled by the means of controlling the generated gas amountby the amount of supplied air and the amount of methanol so that the biogas is at a3

constant catalyst self-reaction temperature and concentration in the biogas generation unit,
and wherein the chamber gas concentration in the exposure unit is kept constant bycontrolling the amount of biogas exhausted from the exposure unit by the means ofcontrolling the exhaust gas amount, anda means of detecting differential chamber pressure that is generated by exhaust biogas
treatment in the exposure area of the exposure unit by the means of exhaust gas treatment
controlled by the means of controlling the exhaust gas amount,wherein the differential chamber pressure information obtained from detection results
through the means of detecting differential chamber pressure is fed back to the means ofcontrolling the exhaust gas amount, and the differential chamber pressure in the exposure
unit is kept constant at negative pressure by controlling the amount of biogas exhausted
from the exposure unit by the means of controlling the exhaust gas amount.
[Claim 3]
A device for nucleolytic degradation as stated in Claim 2 wherein the biogas
generation unit has the feature of generating composite radical gas composed of active
oxygen containing at least components of methanol, formaldehyde, carbon monoxide,
carbon dioxide, hydrogen, and oxygen, and free radicals.
[Claim 4]
A device for nucleolytic degradation as stated in Claim 3 wherein the biogas
generation unit has the feature of controlling the self-reaction temperature within therange of 400oC to 500oC.
3. Summary of the Primary JPO Decision and the Primary IP High Court Judgment(1) Primary JPO Decision
A. The invention stated in Exhibit Ko 1 (Examined Patent Application Publication No.
2010-51692; laid-open disclosure date: March 11, 2010) that was found by the Primary
JPO Decision (hereinafter referred to as "Exhibit Ko 1 Invention") is as stated in 4. (2) A.
below and common features and differences between Exhibit Ko 1 Invention andPrimarily Corrected Invention 2 are as stated below.
(Common features)
It is "a DNA destruction device that is composed of a methanol gas generation unit
including a nozzle that sprays methanol supplied from a methanol tank in mist form,
vaporizes the methanol sprayed through the nozzle, and generates methanol gas; acylindrical unit that is positioned above the methanol gas generation unit, consists ofupper and lower parts that are separated from each other by heat-reflective porous metalmaterial, has an air supply unit for supplying air connected to the upper part, serves as aflow channel to transfer the methanol gas generated from the methanol gas generation
4

unit to the upper part by natural convection, and mixes air supplied from the air supply
unit with the methanol gas at the predetermined ratio; and a catalyst unit that is locatedabove the cylindrical unit and radicalizes the methanol gas into which air is mixed at thepredetermined ratio in the cylindrical unit by catalytic reaction, wherein the catalyst unit
is composed of an MR gas generation device that is composed of radical reaction catalysts
made from thin metal plates formed into a honeycomb structure by laminating multiple
radical reaction catalysts and that generates MR gas by radicalizing the methanol gas
mixed with air by catalyst reaction, a means of controlling the generated MR gas amountin the MR gas generation device by the amount of supplied air and the amount ofmethanol, and a sterilization tank that supplies MR gas generated from the MR gas
generation device."(Difference 1)
Primarily Corrected Invention 2 has a means of controlling the temperature in thesterilization tank, a means of controlling the humidity in the sterilization tank, an exhaustgas treatment unit that exhausts MR gas supplied to the sterilization tank, a means ofcontrolling the amount of MR gas exhausted from the sterilization tank by the exhaustgas treatment unit, a means of measuring the formaldehyde component concentration of
MR gas in the sterilization tank, and a means for detecting or measuring odor, wherein
the gas concentration information obtained as measurement results by the means ofmeasuring the formaldehyde component concentration is fed back to the means ofcontrolling the generated MR gas amount, the amount of MR gas generated in the MRgas generation device is controlled by the means of controlling the generated MR gas
amount by the amount of supplied air and the amount of methanol so that the MR gas is
at a constant catalyst self-reaction temperature and concentration in the MR gas
generation device, and the chamber gas concentration in the sterilization tank is kept
constant by controlling the amount of MR gas exhausted from the sterilization tank by
the means of controlling the exhaust gas amount. However, said structure is not stated for
Exhibit Ko 1 Invention.
(Difference 2)
Primarily Corrected Invention 2 has a means of detecting differential chamberpressure that is generated from MR gas exhaust treatment in the sterilization tank by themeans of exhaust gas treatment that is controlled by the means of controlling the exhaustgas amount, wherein the differential chamber pressure information obtained fromdetection results by the means of detecting differential chamber pressure is fed back to
the means of controlling the exhaust gas amount and it keeps the differential chamberpressure of the sterilization tank constant by controlling the amount of MR gas exhausted
5

from the sterilization tank by the means of controlling the exhaust gas amount. However,said structure is not stated for Exhibit Ko 1 Invention.
B. Summary of the Primary JPO Decision (however, limited to Grounds for Invalidation
1 [error in the determination of an inventive step of Primarily Corrected Invention 2 thatcites Exhibit Ko 1 as the principal cited document])(A) Regarding Primarily Corrected Invention 2, it is found that Difference 1 could havebeen easily conceived of by a person skilled in the art; however, it is not found that
Difference 2 could have been easily conceived of by a person skilled in the art.
(B) Summary of the determination in the Primary JPO Decision concerning whether
Difference 2 could have been easily conceived of by a person skilled in the art is as statedbelow.
[i] According to the statements in [0143] through [0147] of the Descriptions, "a meansof detecting differential chamber pressure" in Primarily Corrected Invention 2 is found tobe "a means of detecting differential chamber pressure for detecting that the pressure in
the sterilization tank is negative compared to outside the tank and for detecting thedifferential chamber pressure caused by the MR gas exhaust treatment in the sterilizationtank"; [ii] pressure in the sterilization tank is controlled to maintain negative pressure inPrimarily Corrected Invention 2. While it is stated in Exhibit Ko 2 (International
Publication No. 01/026697 (issued on May 7, 2003)) that pressure in the sterilization tankis controlled to maintain positive pressure, keeping the differential chamber pressure in
the sterilization tank constant by controlling the amount of MR gas exhausted from thesterilization tank so that pressure in the sterilization tank is kept at negative pressurecannot be derived from the statements in Exhibit Ko 2. Therefore, even if the invention
stated in Exhibit Ko 2 and well-known art with Exhibit Ko 1 Invention are combined, thestructure of the "means of detecting differential chamber pressure" of Primarily Corrected
Invention 2 related to Difference 2 could not have been easily conceived of by a person
skilled in the art.
(2) Outline of Primary IP High Court Judgment[i] According to statements in the Claims (Claim 2) after the Primary Corrections andstatements in the Descriptions, it should be understood that the "differential chamberpressure" that is subject to detection by "a means of detecting differential chamberpressure" of Primarily Corrected Invention 2 is not limited to a specific range of figures
if it is a differential pressure between the pressure "in the chamber" (in the exposure areaof the exposure unit) and the pressure outside the exposure area and it is not limited to
the range of figures of negative pressure. [ii] "A Micro differential pressure detector 56,"
"a Control unit 58" and "an Exhaust gas amount adjustment solenoid valve 74 and a Fan
6

82," which comprise the second embodiment of "this invention" in Exhibit Ko 2, arerespectively found to be equivalent to "the means of detecting differential chamberpressure," "the means of controlling the exhaust gas amount" to which "the differential
chamber pressure information obtained from detection results by the means of detecting
differential chamber pressure... is fed back," and "the means of exhaust gas treatment
controlled by the means of controlling the exhaust gas amount" in Primarily Corrected
Invention 2. Therefore, it is found that structure of Primarily Corrected Invention 2 related
to Difference 2 is disclosed in Exhibit Ko 2. [iii] It is found that a person skilled in the art
who comes across Exhibits Ko 1 and Ko 2 has the motivation to apply the structure tocontrol the formaldehyde gas concentration, humidity, and temperature in the spacesubject to sterilization as stated in Exhibit Ko 2 and to keep the room pressure of the area
subject to sterilization constant in order to generate sterilization gas at a stableconcentration and to obtain fully certifiable sterilization effects in Exhibit Ko 1 Invention.
[iv] Therefore, it is found that a person skilled in the art could have easily conceived of
the structure of Primarily Corrected Invention 2 related to Difference 2 by applying the
aforementioned structure stated in Exhibit Ko 2 to Exhibit Ko 1 Invention based on
Exhibits Ko 1 and Ko 2.
4. Summary of the JPO Decision(1) The Summary of the JPO Decision is as follows: [i] It cannot be said that Corrected
Invention 2 could have been easily invented by a person skilled in the art by combining
the invention stated in Exhibit Ko 1, which is a publication distributed before the Patent
Application, (Exhibit Ko 1 Invention) and Exhibit Ko 2 Invention and common generaltechnical knowledge; since Corrected Invention 3 is an invention that has all the mattersdefining the invention of Corrected Invention 2 and Corrected Invention 4 is an invention
that has all the matters defining the invention of Corrected Invention 3, and it cannot be
said that a person skilled in the art could have easily invented Corrected Invention 2, andtherefore, it cannot also be said that a person skilled in the art could have easily invented
Corrected Inventions 3 and 4; consequently, it cannot be said that a patent cannot be
granted to the Corrected Invention based on the provisions of Article 29, paragraph (2) ofthe Patent Act. [ii] It can be said that the Claims after the Corrections meet therequirements provided for by Article 36, paragraph (6), item (i) of the Patent Act(hereinafter referred to as the "supporting requirements"). [iii] Statements in the
Descriptions after the Corrections (hereinafter referred to as the "Corrected
Descriptions") meet the requirements provided for by Article 36, paragraph (4), item (i)of the Patent Act (hereinafter referred to as the "enablement requirements").
(2) Exhibit Ko 1 Invention that was found by the JPO Decision and common features and7differences between Corrected Invention 2 and Exhibit Ko 1 Invention are stated below.
A. Exhibit Ko 1 Invention
It is "a sterilization device composed of a methanol gas generation unit including a
nozzle that sprays methanol supplied from a methanol tank in mist form, vaporizes themethanol sprayed through the nozzle, and generates methanol gas; a cylindrical unit thatis positioned above the methanol gas generation unit, consists of upper and lower parts
that are separated from each other by heat-reflective porous metal material, has an air
supply unit for supplying air connected to the upper part, serves as a flow channel totransfer the methanol gas generated from the methanol gas generation unit to the upper
part by natural convection, and mixes air supplied from the air supply unit with themethanol gas at the predetermined ratio; a catalyst unit that is located above thecylindrical unit and radicalizes the methanol gas into which air is mixed at thepredetermined ratio in the cylindrical unit by catalytic reaction, wherein the catalyst unit
is composed of an MR gas generation device that is composed of radical reaction catalysts
made from thin metal plates formed into a honeycomb structure by laminating multiple
radical reaction catalysts and that generates MR gas by radicalizing the methanol gas
mixed with air by catalytic reaction, a means of controlling the MR gas concentration in
the MR gas generation device by the amount of supplied air and the amount of methanol,
and a sterilization tank that implements sterilization using MR gas generated from theMR gas generation device; and a sterilization device that can destroy DNA."B. Common features and differences[Common features]"A device for nucleolytic degradation with the features that it is composed of amethanol gas generation unit including a nozzle that sprays methanol supplied from amethanol tank in mist form, vaporizes the methanol sprayed through the nozzle, andgenerates methanol gas; a cylindrical unit that is positioned above the methanol gas
generation unit, consists of upper and lower parts that are separated from each other byheat-reflective porous metal material, has an air supply unit for supplying air connectedto the upper part, serves as a flow channel to transfer the methanol gas generated fromthe methanol gas generation unit to the upper part by natural convection, and mixes air
supplied from the air supply unit with the methanol gas at the predetermined ratio; and acatalyst unit that is located above the cylindrical unit and radicalizes the methanol gas
into which air is mixed at the predetermined ratio in the cylindrical unit by catalytic
reaction, wherein the catalyst unit is composed of a biogas generation unit that iscomposed of radical reaction catalysts made from thin metal plates formed into ahoneycomb structure by laminating multiple radical reaction catalysts, and that generates
8composite gas that is generated by radicalizing the methanol gas mixed with air by
catalytic reaction and contains at least active species derived from methanol (hereinafterreferred as "biogas"), a means of controlling the generated gas amount in the biogas
generation unit by the amount of supplied air and the amount of methanol, and an
exposure unit into which biogas generated in the biogas generation unit is supplied."[Difference 1]
Corrected Invention 2 has the following features: It has a means of controlling thetemperature of the exposure area of the exposure unit, a means of controlling the humidityof the exposure area of the exposure unit, an exhaust gas treatment unit that exhausts
biogas supplied to the exposure unit, a means of controlling the amount of biogas
exhausted from the exposure unit by the exhaust gas treatment unit, a means of measuring
the formaldehyde component concentration that measures the concentration of theformaldehyde component of biogas in the exposure unit; a means of detecting differential
chamber pressure generated by biogas exhaust treatment in the exposure area of the
exposure unit by the means of exhaust gas treatment that is controlled by the means ofcontrolling the exhaust gas amount, wherein the gas concentration information obtained
as measurement results by the means of measuring the formaldehyde component
concentration is fed back to the means of controlling the generated gas amount, wherein
the amount of gas generated in the biogas generation unit is controlled by the amount of
supplied air and the amount of methanol by the means of controlling the generated gas
amount so that the biogas is at a constant catalyst self-reaction temperature andconcentration in the biogas generation unit, wherein the chamber gas concentration is kept
constant in the exposure unit by controlling the amount of biogas exhausted from theexposure unit by the means of controlling the exhaust gas amount; and it feeds back the
differential chamber pressure information obtained from detection results by the meansof detecting differential chamber pressure to the means of controlling the exhaust gas
amount and it keeps the differential chamber pressure of the exposure unit at constantnegative pressure by controlling the amount of biogas exhausted from the exposure unit
by the means of controlling the exhaust gas amount. However, this structure is not statedfor Exhibit Ko 1 Invention.
[Difference 2]
Corrected Invention 2 has a means for detecting or measuring odor; however, there is
no statement on such structure for Exhibit Ko 1 Invention.
(3) Summary of the JPO Decision related to the allegation of the Plaintiff is stated below.
A. Grounds for Invalidation 1 (Article 123, paragraph (1), item (ii) of the Patent Act)[i] A person skilled in the art who comes across Exhibits Ko 1 and Ko 2 has the9motivation to apply the structure to control the formaldehyde gas concentration, humidity,
and temperature of the area subject to sterilization as indicated in Exhibit Ko 2
respectively at the predetermined values, and to keep the room pressure of the area subject
to sterilization constant in order to generate sterilization gas at a stable concentration andto obtain fully certifiable sterilization effects in Exhibit Ko 1 Invention. [ii] However, it
is found that, out of the structure of Corrected Invention 2 related to Difference 1, Exhibit
Ko 2 discloses that "the invention has the following features: It is composed of a meansof controlling the temperature of the exposure area of the exposure unit, a means ofcontrolling the humidity of the exposed area of the exposure unit, an exhaust gas treatment
unit for exhausting the biogas supplied to the exposure unit, a means of controlling theamount of biogas exhausted from the exposure unit by the exhaust gas treatment unit, ameans of measuring the formaldehyde component concentration of biogas in the exposure
unit, a means of detecting differential chamber pressure caused by biogas exhaust
treatment in the exposure area of the exposure unit by the means of exhaust gas treatmentthat is controlled by the means of controlling the exhaust gas amount, wherein the gas
concentration information obtained as measurement results by the means of measuring
the formaldehyde component concentration is fed back to the means of controlling thegenerated gas amount, wherein the amount of gas generated in the biogas generation unit
is controlled by the amount of supplied air and the amount of methanol by the means ofcontrolling the generated gas amount so that the biogas is at a constant catalyst selfreaction temperature and concentration in the biogas generation unit, and the chamber gas
concentration in the exposure unit is kept constant by controlling the amount of biogas
exhausted from the exposure unit by the means of controlling the exhaust gas amount; itfeeds back the differential chamber pressure information obtained from detection resultsby the means of detecting differential chamber pressure, it controls the amount of biogas
exhausted from the exposure unit by the means of controlling the exhaust gas amount,and thereby it keeps the differential chamber pressure in the exposure unit constant."
However, Exhibit Ko 2 does not disclose that "the differential chamber pressure of the
exposure unit is maintained at constant negative pressure." Therefore, the structure of
Corrected Invention 2 related to Difference 1 is not disclosed in Exhibit Ko 2. Even by
applying the structure stated in Exhibit Ko 2 to Exhibit Ko 1 Invention, a person skilledin the art could not have easily conceived of the structure of Corrected Invention 2 related
to Difference 1. [iii] The demandant (Plaintiff) alleged that it was common generaltechnical knowledge that MR gas, etc. may be used in conditions where treatment roompressure is at negative pressure against the pressure outside the treatment room whenusing MR gas, etc. inside the treatment room, and therefore, taking into consideration the10statements in Exhibit Ko 2 in Exhibit Ko 1 Invention, it was easy to control the differential
chamber pressure at negative pressure. However, controlling the pressure in the treatment
room where MR gas, etc. is used at negative pressure against the pressure outside thetreatment room is not disclosed in any of the documents alleged by the demandant(Exhibits Ko 23 through Ko 27). Therefore, based on these documents, it cannot be said
that the aforementioned points were common general technical knowledge, and in Exhibit
Ko 1 Invention, a person skilled in the art could not have easily conceived of controllingthe differential chamber pressure at negative pressure based on the statements in Exhibit
Ko 2.
B. Grounds for Invalidation 2 (Article 123, paragraph (1), item (iv) of the Patent Act)
Even if none of the spectrum diagrams of "90 min." in Figure 19B and Figure 19C of
the Corrected Descriptions fall under the spectrum of criteria shown in Figure 18 and,according to the spectrum diagram indicated by the demandant (Plaintiff), it is unknown
whether nucleic acid could have been completely dissolved in 90 minutes of exposure
time with these sample amounts, it can be understood from the other spectrum diagrams
shown in Figure 19B and Figure 19C that nucleic acid can be completely dissolved in ashorter period than 90 minutes with any of these sample amounts. Therefore, it can besaid that the Corrected Invention can resolve the problem to be solved by the invention
and the statements in the Corrected Descriptions meet the supporting requirements.
C. Grounds for Invalidation 3 (Article 123, paragraph (1), item (iv) of the Patent Act)The allegation of the demandant (Plaintiff) is based on the premises that there arecases where the Corrected Invention cannot fully dissolve nucleic acid even after 90
minutes have elapsed from the start of treatment. However, there is an error in thepremises as indicated in B. above, and the statements in the Corrected Descriptions meetthe enablement requirements.
(omitted)
No. 4 Judgment of this Court
1. Statements in the Corrected Descriptions
The Corrected Descriptions contain statements as shown in Attachment 1. According
to the statements, it is found that the following matters are disclosed in the Corrected
Descriptions in relation to the Corrected Invention.
(1) A conventional method of nucleolytic degradation using a gas-phase substance (MRgas) derived from radical species methanol required 60 minutes of exposure time or
longer in the range of temperature of 50℃ or higher, and effects and efficacy were11

demonstrated with the formaldehyde component concentration being 2000ppm or higher;
however, there were the following problems: in practical working conditions, thedemanded temperature range was from normal temperature to body temperature anddemonstration of effects and efficacy in a short period of time according to sample types
was demanded ([0009], [0011], and [0012]).
(2) "This invention" aims to provide a device for nucleolytic degradation that can define
conditions to demonstrate high efficacy in a short period of time according to sample
types ([0013]), and it adopted the following structure as a means to solve theaforementioned problems: the device is composed of a methanol gas generation unit, abiogas generation unit that radicalizes the methanol gas into which air is mixed by catalyst
reaction and generates composite gas that contains at least active species derived frommethanol, a means of controlling the generated gas amount that controls the amount ofgas generated in the biogas generation unit by the amount of supplied air and the amountof methanol, an exposure unit into which biogas generated from the biogas generation
unit is supplied, a means of controlling the temperature of the exposure area, a means ofcontrolling the humidity of the exposure area, an exhaust gas treatment unit that exhausts
biogas supplied to the exposure unit, a means of controlling the amount of biogas
exhausted from the exposure unit, a means of measuring the formaldehyde component
concentration of biogas in the exposure unit, a means of detecting or measuring odor, ameans of detecting differential chamber pressure caused by the exhaust gas treatment of
biogas in the exposure area by the means of exhaust gas treatment controlled by the meansof controlling the exhaust gas amount, wherein the gas concentration information
obtained as measurement results by the means of measuring the formaldehyde component
concentration is fed back to the means of controlling the generated gas amount, wherein
the amount of gas generated in the biogas generation unit is controlled by the amount of
supplied air and the amount of methanol by the means of controlling the generated gas
amount, and wherein the chamber gas concentration of the exposure unit is kept constantby controlling the amount of biogas exhausted from the exposure unit by the means ofcontrolling the exhaust gas amount; and it feeds back the differential chamber pressure
information obtained from detection results by the means of detecting differential
chamber pressure to the means of controlling the exhaust gas amount and it keeps thedifferential chamber pressure of the exposure unit at constant negative pressure bycontrolling the amount of biogas exhausted from the exposure unit by the means ofcontrolling the exhaust gas amount (structure of Corrected Invention 2) ([0016], [0017]).
Based on this structure, "this invention" demonstrates the effect that it can perform
quantitative control of the temperature, humidity, and concentration in the exposure area12

of the exposure unit by feedback control and can define conditions to demonstrate highefficacy in a short period of time according to sample types ([0021], [0196]).
2. Statements in Exhibit Ko 1
Exhibit Ko 1 contains statements as shown in Attachment 2. According to thestatements, it is found that the following matters have been disclosed related to Exhibit
Ko 1 Invention.
(1) In the case of a conventional MR gas generation device equipped with a catalyst unit
with the size of approximately 150mm to 180mm, it was difficult to keep the temperaturenecessary for the radicalizing reaction of methanol gas constant and it was impossible togenerate MR gas at a constant concentration. Therefore, it was necessary to equip anelectric heater for heating; however, there were the problems that the size of the catalyst
unit necessarily became large and this made it difficult to downsize the MR gas generation
device to increase convenience ([0006], [0007]).
(2) "This invention" was proposed in consideration of these conventional problems and itaims to keep the catalyst reaction temperature for radicalization constant, to generatesterilization gas at a stable concentration, and to provide a sterilization gas generation
device that can be downsized ([0008]).
The inventors of "this invention" discovered that using a catalyst that has ahoneycomb structure would make it possible to keep catalyst reaction temperature
constant for radicalization and completed "this invention" ([0009]).
"This invention" adopted a structure using radical reaction catalysts made from thinmetal plates formed into a honeycomb structure and thereby increased the surface area ofthe catalyst unit and increased reaction efficiency, making it possible to cause a selfreaction where the catalyst reaction temperature is kept constant and to generate MR gas
at a stable concentration. Furthermore, improvement of reaction efficiency in the catalyst
unit made it possible to downsize the catalyst unit and downsize the sterilization treatment
device itself, thereby demonstrating the effect of increasing convenience ([0013]).
3. Statements in Exhibit Ko 2
Exhibit Ko 2 contains statements as shown in Attachment 3. According to thestatements, it is found that the following matters have been disclosed related to Exhibit
Ko 2.
(1) In order to obtain fully certifiable sterilization effects from the formaldehyde gas
sterilization device, it is necessary to control the concentration, humidity, and temperatureof formaldehyde gas in the area subject to sterilization and to control room pressure since
the area subject to sterilization is a sealed area (room) (Attachment 3, 2 (2)).
"This invention" is composed of the following devices as a means of solving the13

aforementioned problems: a formaldehyde gas supply and exhaust device that supplies
and exhausts formaldehyde gas into and from the sealed room and a room pressureadjustment device that adjusts room pressure; the formaldehyde gas supply and exhaust
device is composed of a formaldehyde gas generator, a formaldehyde gas humidity
adjuster, a formaldehyde gas temperature adjuster, a gas carrier that transports andintroduces formaldehyde gas into the room, an exhaust gas processor that treats exhaustgas exhausted from the room, an exhaust gas ejector, and a control unit that controls theformaldehyde gas concentration, humidity, and temperature in the room at thepredetermined concentration, humidity, and temperature; the room pressure adjustment
device is composed of a unit that supplies air outside the room into the room, a unit thatexhausts room air to outside the room, a means of detecting differences in pressures for
detecting differences in pressures between inside and outside the room, a means ofcontrolling the air supply unit and exhaust air unit based on the values detected by themeans of detecting differences in pressures, and a means of outputting the control statusof the aforementioned room pressure based on the aforementioned detected values.
Based on the structure, the "invention" can control the formaldehyde gas
concentration, humidity, and temperature of the area subject to sterilization respectively
at the predetermined values and can keep room pressure constant even in cases whereroom air expands due to increases in room temperature. Therefore, fully certifiablesterilizing effects can be obtained (Attachment 3, 2. (3) and (4)).
(2) The second embodiment of "this invention" (Figure 2) is a formaldehyde gas
sterilization device that is composed of a Formaldehyde gas supply and exhaust device 4
and a Room pressure adjustment device 6. The Formaldehyde gas supply and exhaust
device 4 has a Controller 24 that controls a Formaldehyde gas generator 36, a Temperatureadjuster 34, a Humidity adjuster 32, and Pumps 26 and 28, based on the values of theformaldehyde gas concentration, humidity, and temperature in the Area subject tosterilization 100 that were obtained from a Concentration sensor 12, a Humidity sensor
14, and a Temperature sensor 16. The Room pressure adjustment device 6 has a Control
unit 58 that controls an Air supply unit 52 and a Gas exhaust unit 54 based on the values
detected by a Minor differential pressure detector 56 that detects differences in thepressure inside the room and the pressure outside the room (Attachment 3, 2. (5) and (7)).
The formaldehyde gas sterilization device related to the second embodiment
maintains room pressure at positive pressure by the Control unit 58 of the Room pressureadjustment device 6, "while the predetermined time, room temperature, humidity, andformaldehyde gas concentration are within a temperature range of 20℃ to 40℃, ahumidity range of 50% to 90% (relative humidity), and a formaldehyde gas concentration14

of 160ppm or higher, respectively" (Attachment 3, 2. (9)).
4. Common general technical knowledge, etc. on or around the date of the Patent
Application(1) A. Exhibits Ko 23 and Ko 82 through Ko 84 that were distributed before the date of
the Patent Application contain statements as shown in Attachment 4, respectively.
B. Combining the statements of the documents mentioned in A. above, it can be foundthat it had been well-known art on or around the date of the Patent Application that, incases where there are substances that are harmful to the human body in a room, such as
in biohazard facilities, chemical hazard facilities, etc., the room pressure should becontrolled at negative pressure against outside pressure so that the substances do not leakfrom inside to outside the room, and that in cases of sterilizing inside a room using ozone
gas that is harmful to the human body, room pressure should be controlled at negative
pressure against outside pressure so that ozone gas does not leak from inside to outside
the room.
(2) A. Exhibits Ko 81, Ko 85, Ko 88, Ko 94, and Ko 95 that were distributed before thedate of the Patent Application contain statements as shown in Attachment 5, respectively.
B. Combining the statements in the documents mentioned in A. above, it can be foundthat it had been well-known on or around the date of the Patent Application thatformaldehyde gas is harmful to human body and it had been common general technicalknowledge on or around the date of the Patent Application that when using formaldehyde
gas in a treatment room for the purpose of sterilization and disinfection, there are cases
where it is used under conditions where the treatment room pressure is set at negative
pressure against the pressure outside the treatment room.
5. Grounds for Rescission 1-1 (error in the determination of an inventive step in Corrected
Invention 2 that cites Exhibit Ko 1 as the principal cited document)(1) When the judgment to rescind a JPO decision becomes final and binding in a litigation
seeking a rescission of a JPO decision concerning a patent invalidation trial case, thehearing officers are required to make an additional examination and decision concerning
the trial case in accordance with the provisions of Article 181, paragraph (2) of the PatentAct. A litigation to rescind a trial decision is subject to the application of the
Administrative Case Litigation Act and therefore the aforementioned judgment
rescinding a trial decision binds the second-round examination and trial decision pursuant
to the provisions of Article 33, paragraph (1) of the Administrative Case Litigation Act,and the binding effect applies to fact finding and legal findings that are essential forderiving the main text of the judgment. Therefore, it is not allowed to make a finding or
determination that infringes on the aforementioned finding and determination of the15

judgment rescinding a trial decision (the judgment of the Third Petty Bench of theSupreme Court rendered on April 28, 1992, Minshu Vol. 46, No. 4, at 245) and adetermination in a litigation seeking a rescission of a trial decision should also be madebased on the above.
As stated in No. 2, 3. (2) above, the Primary IP High Court Judgment determined that[i] "a Micro differential pressure detector 56," "a Control unit 58" and "an Exhaust gas
amount adjustment solenoid valve 74 and a Fan 82," which comprise the second
embodiment of "this invention" in Exhibit Ko 2, are respectively found to be equivalent
to "the means of detecting differential chamber pressure," "the means of controlling theexhaust gas amount" to which "the differential chamber pressure information obtained
from detection results by the means of detecting differential chamber pressure... is fed
back," and "the means of exhaust gas treatment controlled by the means of controlling theexhaust gas amount" in Invention 2 before the Corrections; therefore, it can be said thatthe structure of the invention of Claim 2 before the Corrections related to Difference 2 isdisclosed; [ii] it is found that a person skilled in the art who comes across Exhibits Ko 1
and Ko 2 has the motivation to apply the structure to generate sterilization gas at a stableconcentration in Exhibit Ko 1 Invention, to control the formaldehyde gas concentration,
humidity, and temperature in the area subject to sterilization respectively at thepredetermined values as stated in Exhibit Ko 2 in order to obtain fully certifiablesterilization effects, and to keep the room pressure of the area subject to sterilization
constant; and [iii] therefore, a person skilled in the art could have easily conceived of thestructure of the invention related to Claim 2 before the Corrections related to Difference
2 by applying the aforementioned structure stated in Exhibit Ko 2 to Exhibit Ko 1
Invention.
In the trial procedures after the Primary IP High Court Judgment became final andbinding, the Defendant corrected the wording as stated in No. 2, 2. above to "keeps thedifferential chamber pressure of the exposure unit constant at negative pressure" in Claim
2, in addition to the details of the Primary Corrections (the double-lined part is thecorrected part in question), and the JPO Decision, as stated in No. 2, 4. (2) B. above,
deemed a combination of structures of Difference 1 (excluding Difference 2 that is foundby the JPO Decision) and Difference 2 in the Primary JPO Decision as Difference 1 andadded to Difference 1 the point "the following features: ... to maintain the differential
chamber pressure of the exposure unit at constant negative pressure," which is a structure
added in Corrected Invention 2 by the Corrections.
Based on the aforementioned development, concerning the determination of an
inventive step in Corrected Invention 2, on the assumption that the structure of Difference16

2, which was found by the Primary JPO Decision, is disclosed, a determination should bemade as to whether the structure of Corrected Invention 2 that "maintains the differential
chamber pressure in the exposure unit at constant negative pressure" could have been
easily conceived of by a person skilled in the art.
The examination based on the assumption of the above follows.
(2) Disclosed matters in Exhibit Ko 2
The detailed explanation of the invention in Exhibit Ko 2 [i] contains statements thatthe formaldehyde gas sterilization device in Exhibit Ko 2 Invention has a means ofdetecting differences in pressures between inside and outside the room and a means ofcontrolling the air supply unit and gas exhaust unit based on the values detected by themeans of detecting differences in pressures, and therefore it can keep room pressure
constant even if room air expands due to increases in room temperature (Attachment 3, 2.
(4)) and [ii] discloses that, as a "second embodiment" that is one of "the best embodimentsof the invention," it is composed of a Minor differential pressure detector 56 that detects
differences in pressures inside and outside the room and a Control unit 58 that controls
an Air supply unit 52 and Gas exhaust unit 54 based on the values detected by the Minor
differential pressure detector 56, and that the Control unit 58 controls an Air supply
amount adjustment solenoid valve 62, a Fan 66, an Exhaust gas amount adjustment
solenoid valve 74, and a Fan 82, etc. based on the values detected by the Minor differential
pressure detector 56; and the following modes are disclosed that a Controller 24 adjusts
the room temperature and humidity that are obtained from a Humidity sensor 14 and a
Temperature sensor 16 to be the predetermined temperature range of 20℃ to 40℃ andhumidity range of 50% to 90% (relative humidity) respectively by a Humidity adjuster
32 and a Temperature adjuster 32, maintains the predetermined time by adjusting
formaldehyde gas concentration so that it is maintained at 160ppm or higher by aFormaldehyde gas generator 36 and a Pump 26, and maintains the room pressure atpositive pressure (10Pa to 20Pa) by a room pressure adjustment device while thepredetermined time, room temperature, humidity, and formaldehyde gas concentration
are maintained at the aforementioned figures; and it contains the following statementsthat since differences in pressures inside and outside the room can always be maintained
at 10Pa to 20Pa by a Room controlling device 6, in cases of sterilizing a room withformaldehyde gas, even if the volume of room air is increased due to increases in room
temperature, formaldehyde gas can be prevented from leaking outside the room without
being treated because formaldehyde gas is exhausted after treatment in an Air processing
device 76 (Attachment 3, 2. (7) through (9)).
As mentioned above, the structure that is disclosed in Exhibit Ko 2 to maintain17

pressure inside the room, which is an area subject to sterilization, at positive pressure bya room pressure adjustment device is for the second embodiment. In addition, as mattersdefining the invention, concerning a room adjustment device for adjusting room pressure,
the Claim (Claim 3) in Exhibit Ko 2 only states that room pressure is adjusted by a meansof detecting differences in pressures between inside and outside the room and by a meansof control based on the values detected by the means of detecting differences in pressures,and it does not specify that the area subject to sterilization is controlled at positive
pressure. Based on this fact, the technical meaning of Exhibit Ko 2 Invention is, as statedin 3. (1) above, that it can control the formaldehyde gas concentration, humidity, andtemperature in the area subject to sterilization respectively at the predetermined values,
can maintain constant room pressure even in cases where room air expands due toincreases in room temperature, and can demonstrate fully certifiable sterilizing effects. It
should be said that the form of maintaining room pressure at positive pressure (10Pa to20Pa) by a room pressure adjustment device is merely one of the embodiments.
In consideration of the instructions in the Primary IP High Court Judgment that "aMinor differential pressure detector 56," "a Control unit 58," and "an Exhaust gas amountadjustment solenoid valve 74 and a Fan 82," which comprise the second embodiment of"this invention" in Exhibit Ko 2, are respectively found to be equivalent to "the means ofdetecting differential chamber pressure," "the means of controlling the exhaust gas
amount" to which the "differential chamber pressure information obtained from detection
results by the means of detecting differential chamber pressure... is fed back," and "themeans of exhaust gas treatment that is controlled by the means of controlling the exhaustgas amount" in Invention 2 before the Corrections, it is found that Exhibit Ko 2 discloses
the matters that a means for detecting differential chamber pressure is equipped, that thedifferential chamber pressure information that is obtained from detection results by themeans of detecting differential chamber pressure is fed back to the means of controllingthe exhaust gas amount, and that pressure in the area subject to sterilization (inside thechamber) is kept constant by controlling the amount of formaldehyde gas exhausted fromthe area subject to sterilization by the means of controlling the exhaust gas amount.
(3) Whether Difference 1 could have been easily conceived of by a person skilled in theart
As mentioned in 2. (2) above, Exhibit Ko 1 discloses that the purpose is to keep thecatalytic reaction temperature for radicalization constant and to provide a sterilization gas
generation device to generate MR gas at a stable concentration. As mentioned in 3. (1)above, Exhibit Ko 2 discloses that fully certifiable sterilizing effects can be obtained
because the adoption of the structure of the formaldehyde gas sterilization device of18

Exhibit Ko 2 Invention makes it possible to control the formaldehyde gas concentration,
humidity, and temperature in the area subject to sterilization respectively at thepredetermined values, and also to keep room pressure constant even in cases where room
air expands due to increases in room temperature. Based on the above, a person skilled in
the art who comes across Exhibits Ko 1 and Ko 2 has the motivation to apply the structure
to control the formaldehyde gas concentration, humidity, and temperature in the area
subject to sterilization as stated in Exhibit Ko 2 respectively at the predetermined values
and to keep the room pressure of the area subject to sterilization constant for the purposeof generating sterilization gas at a stable concentration and obtaining fully certifiablesterilization effects in Exhibit Ko 1 Invention.
Based on the above, on or around the date of the Patent Application, it had been wellknown art that, in cases where there are substances that are harmful to the human body ina room, such as in biohazard facilities, chemical hazard facilities, etc., the room pressure
should be controlled at negative pressure against outside pressure so that the substances
do not leak from inside to outside the room, and that in cases of sterilizing inside a room
using ozone gas that is harmful to the human body, room pressure should be controlled at
negative pressure against outside pressure so that ozone gas does not leak from inside tooutside the room (4. (1) above). In addition, when using formaldehyde gas for the purposeof sterilization and disinfection, it is also common general technical knowledge that there
are cases where formaldehyde gas is used under conditions where pressure inside thetreatment room is at negative pressure against the pressure outside the treatment room (4.
(2) above). Therefore, when applying the matters disclosed in Exhibit Ko 2 to Exhibit Ko
1 Invention, in light of the conditions of the space subject to sterilization and the purpose,and in consideration of the aforementioned well-known art and common general technicalknowledge, it can be said that a person skilled in the art could have easily conceived ofmaintaining the pressure in the space subject to sterilization at negative pressure. In
addition, there is no evidence to find that any significant effects that a person skilled in
the art could not predict were obtained by applying a structure to maintain "the differential
chamber pressure at negative pressure" in the area subject to sterilization as a result ofconsidering and applying well-known art and common general technical knowledge to
Exhibit Ko 1 Invention and the matters disclosed in Exhibit Ko 2.
Consequently, based on the matters stated in Exhibits Ko 1 and Ko 2, well-known art,and common general technical knowledge, an inventive step also cannot be found in the
structure of Corrected Invention 2 "to maintain the differential chamber pressure of the
exposed unit at constant negative pressure" out of Difference 1.
(4) Allegation of the Defendant
19

A. The Defendant alleged as follows: As it is stated in No. 3, 1. (2) A. through C. above,
Corrected Invention 2 assumes that the exposure unit of biogas is a narrow area, such asa chamber, etc., and therefore, detailed control is required for the temperature, humidity,
biogas concentration, and differential chamber pressure of the exposure unit; since theinvention adopted a structure wherein it can adjust the generated gas and exhaust gas
amounts based on two pieces of information, i.e., the chamber gas concentration
information and the differential chamber pressure information, wherein it can conduct
quantitative control of the temperature, humidity, concentration, and differential chamberpressure of the exposure area of the exposure unit by feedback control to keep both thechamber gas concentration and the differential chamber pressure constant, thereby
maintaining the differential chamber pressure of the exposure unit at constant negative
pressure by such feedback control, the technical meaning to "maintain the differential
chamber pressure of the exposure unit at constant negative pressure" should bedetermined together with the structure of conducting the feedback control; the documents
listed by the Plaintiff only state that the subject room pressure is to be maintained at
negative pressure when sterilizing the room with ozone or another sterilization gas andthat the treatment room pressure is to be maintained at negative pressure against thepressure outside the room when using MR gas, etc. in the treatment room for the purposeof sterilization and disinfection; and there is no statement or suggestion to conduct the
feedback control as stated for Corrected Invention 2.
However, as found by the Primary IP High Court Judgment, Exhibit Ko 2 discloses
the structure of Difference 2 that was found by the Primary JPO Decision out of thestructure of Corrected Invention 2 (the structure that the invention has a means ofdetecting differential chamber pressure that is caused by MR gas exhaust treatment in thesterilization tank by the means of exhaust gas treatment controlled by the means ofcontrolling the exhaust gas amount, wherein the differential chamber pressure
information obtained from detection results by the means of detecting differential
chamber pressure is fed back to the means of controlling and processing exhaust gas, andit keeps the differential chamber pressure of the sterilization tank constant by controllingthe amount of MR gas exhausted from the sterilization tank by the means of controllingthe exhaust gas amount). The court's determination on this point has binding force asmentioned in (1) above. The Defendant also admitted that the feedback control, which
was alleged by the Defendant as the technical meaning of Corrected Invention 2, isdisclosed in Exhibit Ko 2 (No. 3, 1. (2) C. (A) above). As mentioned in (2) above, Exhibit
Ko 2 discloses the control to keep the pressure of the area subject to sterilization(chamber) constant. If the pressure control is applied to Exhibit Ko 1 Invention as control
20

to maintain the pressure at constant negative pressure in consideration of the well-known
art (4. (1) above) and common general technical knowledge (4. (2) above), a person
skilled in the art could have easily conceived of the structure "to control the differential
chamber pressure at constant negative pressure" of Difference 1, as stated in (3) above.
Therefore, the aforementioned allegation of the Defendant is groundless.
B. The Defendant alleged, as stated in No. 3, 1. (2) D. above, that Exhibit 2 aims to control
pressure at positive pressure; the technical meaning is, as it is found by the JPO Decision,
to prevent air from entering from outside into the treatment room during sterilization andto maintain the cleanliness of the treatment room; if the positive pressure control as statedin Exhibit Ko 2 is changed to negative pressure control, it upsets the technical meaning
to maintain the cleanliness of the area subject to sterilization in Exhibit Ko 2 and therefore
it is a disincentive to changing the differential chamber pressure in Exhibit Ko 2 frompositive pressure control to negative pressure control.
However, although Exhibit Ko 2 contains a statement concerning a mode to maintainroom pressure at positive pressure (10Pa to 20Pa) using the room pressure adjustment
device, it is stated merely as one of the embodiments of the invention and the technicalmeaning of the device related to Exhibit Ko 2 is to demonstrate effects wherein theformaldehyde gas concentration, humidity, and temperature of the area subject tosterilization can be controlled respectively at the predetermined values and the roompressure can be kept constant even in cases where room air expands due to increases inroom temperature, and fully certifiable sterilizing effects can be obtained, as mentionedin (2) above. Based on such technical meaning, it is not a disincentive to controlling thedifferential chamber pressure at negative pressure by using the room pressure adjustment
device in Exhibit Ko 2.
The JPO Decision determined that "Exhibit Ko 23 is public information related toanother patent application of the identical inventor, for which the application date is thesame as the priority date of the patent application related to Exhibit 2. Since the treatment
room pressure of the device that uses formalin gas, etc. for sterilization is controlled at
positive pressure in both cases, it is strongly presumed that the basic idea is common."However, it is well-known art to control room pressure at negative pressure against thepressure outside the room so that ozone gas does not leak from inside to outside the room
when sterilizing inside a room using ozone gas that is harmful to the human body (4. (1)B. above). Concerning a sterilization device using formaldehyde gas (formalin gas) thatis also harmful to the human body, although there is no statement or suggestion of thetechnical meaning to control a room pressure adjustment device at positive pressure in
Exhibit Ko 2, it cannot be found that the technical meaning of positive pressure control,21

which is stated in Exhibit Ko 23 related to another patent application, is the technicalmeaning of the positive pressure control in Exhibit Ko 2 on the grounds that theapplication was filed on the same date as the priority date of Exhibit Ko 2 by the same
inventor as Exhibit Ko 2. Therefore, it must be said that the determination of the JPO
Decision was wrong in that it found the technical meaning in a case where the roompressure control device in Exhibit Ko 23 works as a positive pressure control device as
the technical meaning related to the device in Exhibit Ko 2.
Therefore, there are no grounds in the Defendant's allegation that it is a disincentive
to changing the differential chamber pressure in Exhibit Ko 2 from positive pressure
control to negative pressure control based on the technical meaning of Exhibit Ko 2
Invention that was found by the JPO Decision.
(5) Summary
Based on the above, it is found that a person skilled in the art could have easily
conceived of the structure of Corrected Invention 2 related to Difference 1.
Consequently, since there was an error in the determination of the JPO Decision, there
are grounds for the Plaintiff's Grounds for Rescission 1-1.
6. Grounds for Rescission 1-2 (error in the determination of inventive steps in Corrected
Inventions 3 and 4 that cite Exhibit Ko 1 as the principal cited document)
The JPO Decision determined as follows: Corrected Invention 3 is an invention citing
Corrected Invention 2 and Corrected Invention 4 is an invention citing Corrected
Invention 3; since it cannot be said that a person skilled in the art could have easily
invented Corrected Invention 2, it cannot also be said that a person skilled in the art could
have easily invented Corrected Inventions 3 and 4.
However, as mentioned in 5. above, there is an error in the determination of the JPO
Decision concerning whether Corrected Invention 2 could have been easily conceived ofby a person skilled in the art. As long as it is found that Corrected Invention 2 could havebeen easily conceived of by a person skilled in the art, there is an error in the
aforementioned determination of the JPO Decision that denied that Corrected Inventions
3 and 4 could have been easily conceived of by a person skilled in the art only on the
grounds that Corrected Invention 2 could not have been easily conceived of by a person
skilled in the art.
Consequently, there are reasons for the Plaintiff's Grounds for Rescission 1-2.
7. Conclusion
Based on the above, there are reasons for the Plaintiff's Grounds for Rescission 1-1
and 1-2 and therefore, the JPO Decision should be rescinded without having to makedeterminations on the other remaining points.
22

Consequently, the judgment shall be rendered as indicated in the main text.
Intellectual Property High Court, Fourth Division
Presiding judge: KANNO Masayuki
Judge: NAKAMURA Kyo
Judge: OKAYAMA Tadahiro

23

(Attachment 1)[Detailed explanation of the invention][Technical field][0001]The invention relates to a device for nucleolytic degradation for performing
nucleolytic degradation using a biogas containing an active species derived frommethanol.
[Background art]
[0002]
In conducting a test, study, etc. related to biochemistry, etc., if nucleic acids that are
sparingly water-soluble polymers are unnecessarily attached to the surface of a solid, suchas a container that is used, etc., or are mixed unnecessarily in a liquid, such as a reaction
solution, etc., or if cells are unnecessarily attached to the surface of a solid, such as acontainer, etc., or are mixed unnecessarily in a liquid, such as a reaction solution, etc., it
may have a major impact on the test, study, etc.
[0003]
A sterilization system using radical (methanol radical: MR) gas generated frommethanol by catalytic reaction has a sterilizing power superior to ethylene oxide gas(EOG) or ozone, etc. which have been widely used as a gas for sterilizing medical devices,
etc. It has been confirmed that the system is free from persistence or corrosiveness andhas excellent permeability and diffusivity. And the system has therefore been drawing
attention from many fields today.
[0004]
Biogas is a radical composite gas with a strong sterilizing effect generated frommethanol by a catalyst, has high permeability, and can sterilize the inside of a sterilization
target even at atmospheric pressure. Since it is not a contact sterilization mist, it has
excellent features, such as being free from metal corrosion or plastic deterioration(corrosiveness). It can also be used with non-sterile materials and does not remain insterilization targets (residual properties). It has a wide diffusivity and can expose every
corner evenly, penetrate fine clearances, and expose precision equipment and electronicequipment, etc. even when they are being charged. It has a strong safety record.
[0009]In addition, it has been proposed as a method to resolve nucleic acid effectively in
conditions other than the liquid phase (non-wet state) to irreversibly dissolve andinactivate nucleic acid under temperatures where nucleic acid can survive by using a gas
phase substance (MR gas) derived from radical species methanol containing at least a24

hydroxymethyl radical, a hydroperoxyl radical, a hydrogen radical, and a hydroxyl radical(for example, see Patent Document 3).
[Outline of the invention][Problems to be solved by the invention][0011]
However, in the conventional method of degrading nucleic acids using a non-wet
nucleic acid degrading agent that is proposed in Patent Document 3, 60 minutes of
exposure time or longer was required in the range of temperature of 50°C or higher, andeffects and efficacy were shown (demonstrated) with the formaldehyde component
concentration being 2000ppm or higher.
[0012]
However, in practical working conditions, the demanded temperature range was fromnormal temperature to body temperature and demonstration of effects and efficacy in ashort period of time was demanded.
[0013]
Therefore, in consideration of the aforementioned conventional situation, an object of
this invention is to provide a device for nucleolytic degradation that can define conditions
for demonstrating high efficacy in a short period of time according to sample types.
[0014]
This device for nucleolytic degradation also covers nucleic acid (DNA, RNA) floatingin space as an exposure target while considering it as contamination.
[Means of solving problems][0017]
This invention is a device for nucleolytic degradation that is composed of a methanol
gas generation unit including a nozzle that sprays methanol supplied from a methanoltank in mist form, vaporizes the methanol sprayed through the nozzle, and generates
methanol gas; a cylindrical unit that is positioned above the methanol gas generation unit,
consists of upper and lower parts that are separated from each other by heat-reflective
porous metal material, has an air supply unit for supplying air connected to the upper part,serves as a flow channel to transfer the methanol gas generated from the methanol gas
generation unit into the upper part by natural convection, and mixes air supplied from theair supply unit with the methanol gas at the predetermined ratio; and a catalyst unit thatis located above the cylindrical unit and radicalizes the methanol gas into which air ismixed at the predetermined ratio in the cylindrical unit by catalytic reaction, wherein the
catalyst unit is composed of a biogas generation unit that is composed of radical reaction
catalysts made from thin metal plates formed into a honeycomb structure by laminating25

multiple radical reaction catalysts, and that generates composite gas by radicalizing
methanol gas mixed with air by catalytic reaction and contains at least active species
derived from methanol (hereinafter referred as "biogas"), a means of controlling thegenerated gas amount that controls the amount of gas generated in the biogas generation
unit by the amount of supplied air and the amount of methanol, an exposure unit into
which the biogas generated in the biogas generation unit is supplied, a means ofcontrolling the temperature of the exposed area of the exposure unit, a means ofcontrolling the humidity of the exposed area of the exposure unit, an exhaust gas treatment
unit that exhausts the biogas supplied to the exposure unit, a means of controlling theexhaust biogas amount that controls the amount of biogas exhausted from the exposure
unit by the exhaust gas treatment unit, a means of measuring the formaldehyde component
concentration that measures the formaldehyde component concentration of biogas in the
exposure unit, and a means of detecting or measuring odor, wherein the gas concentration
information obtained as measurement results by the means of measuring theformaldehyde component concentration is fed back to the means of controlling thegenerated gas amount, wherein the generated gas amount in the biogas generation unit iscontrolled by the means of controlling the generated gas amount by the amounts ofsupplied air and the amount of methanol, and wherein the chamber gas concentration of
the exposure unit is kept constant by controlling the amount of biogas exhausted from theexposure unit by the means of controlling the exhaust gas amount, and a means ofdetecting differential chamber pressure that is generated by biogas exhaust treatment in
the exposure area of the exposure unit by the means of exhaust gas treatment controlled
by the means of controlling the exhaust gas amount, wherein the differential chamberpressure information obtained from detection results by the means of detecting
differential chamber pressure is fed back to the means of controlling the exhaust gas
amount and the differential chamber pressure in the exposure area is kept constant at
negative pressure by controlling the amount of biogas exhausted from the exposure unit
by the means of controlling the exhaust gas amount.
[0019]In addition, in the device for nucleolytic degradation related to this invention, thebiogas generation unit can generate composite radical gas that is composed of active
oxygen containing at least the components of methanol, formaldehyde, carbon monoxide,
carbon dioxide, hydrogen, and oxygen, and free radicals.
[0020]
Furthermore, in the device for nucleolytic degradation related to this invention, thebiogas generation unit can control the self-reaction temperature to be in the range of26

400°C to 500°C, for example.
[Effects of the invention][0021]The device for nucleolytic degradation related to this invention can perform
quantitative control of the temperature, humidity, and concentration in the exposure areaof the exposure unit by feedback control and can define conditions to demonstrate highefficacy in a short period of time according to sample types.
[0022]
This device for nucleolytic degradation requires an environmental temperature where
it can demonstrate the effects and efficacy of nucleolytic degradation within the range ofbody temperature of 37℃, has the capacity to effectively dissolve double-stranded DNA
nucleic acid (broken into pieces of 10bp or lower) in a short period of within 15 minutes
and at the formaldehyde component concentration of 100ppm or lower, and it can achieve
nucleolytic degradation by 99.99% to 100% as the gas-phase nucleolytic degradation
method.
[0023]In addition, this device for nucleolytic degradation demonstrates 99.99%
effectiveness with non-wet type agents and 95% effectiveness with wet type agents(100μl).
[0024]
Thanks to advanced technology based on this invention, this invention can be applied
to the highly advanced medicine (cell therapy, gene therapy, regenerative medicine) field,
marine research field, aerospace field, crisis management field (defense, firefighting,police, etc.), as well as fields required to be DNA and RNA-free (decontamination of biobased nucleic acid) in medical care, nursing care, etc. and the field of sterilization anddisinfection by controlling effects and efficacy level.
[Embodiment of the invention][0026]
Hereinafter, embodiments of this invention are explained in detail using drawings. It
is needless to say that this invention is not limited to the following examples, and it canbe changed arbitrarily within a range that does not deviate from the gist of this invention.
[0027]
This invention is applied to a Device for nucleolytic degradation 100 with thestructure shown in Figure 1, for example.
[0028]The Device for nucleolytic degradation 100 performs nucleolytic degradation using27

biogas that contains active species derived from methanol and is composed of a Biogas
generation unit 110, an Exposure unit 120, an Exhaust gas treatment unit 140, and aControl unit 150 that controls the operations of these units.
[0029]In the Device for nucleolytic degradation 100, the Biogas generation unit 110
radicalizes the methanol gas into which air is mixed by a catalyst reaction and generates
biogas that contains at least active species derived from methanol.
[0030]The Biogas generation unit 110, as shown in Figure 2 for example, is composed of a
Vaporizer 10 which is installed under an Inner cylinder 12 and into which methanol, a
raw material, which is drawn in by a Methanol pump 7 from a Methanol sub-tank 3 thatis connected to a detachable Methanol supply tank 1 that supplies methanol via a Directacting on-off valve 2 that is composed of a solenoid valve, is supplied via a Methanol
control valve 17, and a Methanol gas generation unit 11 which has a Catalyst cartridge 18
attached on its top and which is installed in an Outer cylinder 12B.
[0042]
The amount of biogas generated in the Biogas generation unit 110 can be controlled
by the amount of air (an Air pump 9) and the amount of methanol (a Fuel pump 7) thatare supplied to the Methanol gas generation unit 11.
[0044]
That is, the Biogas generation unit 110 is, as shown in Figure 3, composed of a
Vaporizer 10 of a Methanol gas generation unit 11 that has a Nozzle 23 that sprays
methanol supplied from the Methanol sub-tank 3 in mist form, vaporizes the methanol
sprayed through the Nozzle 23, and generates methanol gas; the Cylindrical unit 12A thatis positioned above the Vaporizer 10, consists of upper and lower parts that are separated
from each other by heat-reflective porous metal material, with the Air pump 9 forsupplying air connected to its upper part, serves as a flow channel to transfer the methanol
gas generated from the Methanol gas generation unit 11 to the upper part by naturalconvection, and mixes air supplied from the Air pump 9 with the methanol gas at thepredetermined ratio; and a catalyst unit that is located above the Inner cylinder 12A andradicalizes the methanol gas into which air is mixed at the predetermined ratio in the Inner
cylinder 12A by catalytic reaction; and the catalyst unit is composed of radical reaction
catalysts made from thin metal plates formed into a honeycomb structure and consists ofa Catalyst cartridge 18 formed by laminating multiple radical reaction catalysts.
[0049]
More specifically, when current is applied to a Vaporizer heater 20, a Heat medium
28

21 that electrically connects methanol that is supplied through a Methanol supply
communication tube 24 in Figure 4 from the Methanol sub-tank 3 starts to be heated by
the heat from the Vaporizer heater 20 to 100°C to 200°C. When the methanol supplied
from the Methanol sub-tank 3 passes through the Heat medium 21, the methanol is heatedand vaporized by the heat generated in the Heat medium 21, and methanol gas is
generated. When the methanol gas is generated in this manner, the methanol gas isdispersed through a Vaporizing nozzle 22 and a Vaporizing cover 14 in Figure 3, andmoves to the Catalyst cartridge 18 by natural convection through the Inner cylinder 12A.
[0059]In this procedure, in contrast to the conventional MR gas sterilization treatment, it is
not necessary to keep sterilization environment at the predetermined humidity. The
nucleolytic degradation efficacy that conventionally required exposure at a temperatureof 50℃ or higher and humidity of 75% for 60 minutes can be obtained by exposure at atemperature of 37℃ or higher and humidity of 30% to 45% or higher for 15 minutes.
Therefore, humidity control in sterilization environment (nucleolytic degradation) no
longer needs to be strict, and humidity control is implemented to the extent where nocondensation is generated under the biogas generation environment focused on
temperature control.
[0063]In addition, in order to control the temperature in the Biogas generation unit 11 andto generate and supply biogas stably, an Abnormal temperature sensor 14A in Figure 2 islocated at a lower part of the Inner cylinder 12A and a Catalyst temperature sensor 15 islocated at a lower part of the Inner cylinder 12 A. Temperature is managed and controlled
by supplying each piece of temperature information obtained from the Abnormal
temperature sensor 14A and the Catalyst temperature sensor 15 to the Control unit 150
and thereby it can prevent ignition, etc. of methanol and increase safety.
[0077]
Optimization of ratios of the air amount and the methanol amount depending on the
purpose is structurally possible based on the concentration measurement results, by means
such as setting the amount of supplied air at 4.5L/min. when the capacity of the Exposed
unit 120 is within 1 cubic meter, or at 5.0L/min. or decreasing the methanol amount andreducing the air amount when the capacity is 0.5 cubic meter or lower.
[0080]The Biogas generation unit 110 can control the temperature of the radicalization
catalyst reaction by changing the amount of supplied air. The reaction temperature
required for the radicalization catalyst reaction of methanol gas is approximately 400°C
29

to 500°C. The Biogas generation unit 110 changes the air amount supplied from the
Cylinder upper part 12a in the range of approximately 3.5L/min to 6.0L/min. for an
amount of supplied methanol of approximately 3.0cc. This enables the change of theradicalization catalyst reaction temperature in the range of approximately 400°C to 500°C.
Therefore, the temperature of the radicalization catalyst reaction can be easily controlled
by changing the air amount supplied from the Air pump 9.
[0081]As described above, the Biogas generation unit 110 does not require occasional
heating to maintain the temperature of the radicalization catalyst reaction and cangenerate a radicalization reaction by a stable self-reaction. Therefore, the radicalization
reaction temperature can be controlled easily just by changing the amount of supplied air.
Since the concentration of the generated biogas depends on the radicalization catalyst
reaction temperature, the biogas concentration can be easily controlled by controlling thereaction temperature by changing the amount of supplied air as described above. Thereby,
the biogas concentration can be easily changed depending on the exposure target, andsterilization can be performed on various exposure targets.
[0097]
Moreover, in this Device for nucleolytic degradation 100, the Exposure unit 120 asshown in Figure 8 for example, is composed of a constant temperature and humidity baththat can control temperature and humidity by a Chamber heater 130A and Chamber cooler
130B.
[0101]In addition, outside air (air) is introduced into the Exposure unit 120 from an Outside
air introduction valve 125 via a HEPA filter 124, and external gas, such as nitrogen N2
and carbon dioxide CO2, etc., can be introduced via an External gas introduction valve131. The outside air (air) introduced into the Exposed unit 120 via the HEPA filter 124
can be heated by an Air heater 24A.
[0103]The Exposure unit 120 has various sensors, including a Gas concentration sensor 129,a Chamber pressure sensor 132, a Humidity sensor 133, a Temperature sensor 134, anExposure sensor (nucleic acid sensor) 135, and Odor sensors 136A and 136B, etc. The
gas concentration information, pressure information, humidity information, temperature
information, exposure (effects and efficacy on nucleic acid, etc.) information, and orderinformation (inside and outside) that are obtained from the Gas concentration sensor 129,
Chamber pressure sensor 132, Humidity sensor 133, Temperature sensor 134, Exposure
sensor 135, and Odor sensors 136A and 136B are provided to the Control unit 150.
30

Naturally, the temperature (room temperature) information outside the Exposure unit 120
is also provided to the Control unit 150.
[0104]The biogas supplied to the Exposure unit 120 can be exhausted by opening an Exhaustside open-close valve 128.
[0107]In addition, in the Device for nucleolytic degradation 100, the Exhaust gas treatment
unit 140 exhausts the biogas supplied to the Exposure unit 120. As shown in Figure 9 forexample, it has an Exhaust gas blower 143 that is connected to the Exhaust side openclose valve 128 of the Exposure unit 120 via a Gas introduction tube attachment 141, andan Exhaust gas degradation catalyst unit 145 where the exhaust gas sent from the
Exposure unit 120 by the Exhaust gas blower 143 via the Gas rectifier bath 144 isdegraded, and it exhausts the exhaust gas from an Exhaust gas tube 149 by detoxifying itby catalyst reaction in the Exhaust gas degradation catalyst unit 145.
[0108]The Exhaust gas treatment unit 140 can introduce outside air (air) via the Outside air
introduction valve 142.
[0111]In the Device for nucleolytic degradation 100, the Control unit 150 controls the
Biogas generation unit 110, the Exposure unit 120, and the Exhaust gas treatment unit
140 as follows using the control system shown in Figure 10.
[0140]
While monitoring the chamber pressure of the Exposure unit 120, the Exhaust gas
treatment unit 140 performs exhaust and intake so that the chamber is at negative pressure(-0MPa to -0.01MPa).
[0141]
Subsequently, after the negative pressure is confirmed by the Chamber pressure
sensor 132, the Control unit 150 gives an instruction to the Biogas generation unit 110 toactivate a Methanol supply pump 7 when the temperature of the Biogas generation unit
110, chamber temperature of the Exposure unit 120, and the temperature of the Exhaustgas treatment unit 140 reach the specified values and preparation for activation iscomplete.
[0142]
Gas introduction, stirring, and exhaust gas conditions in the chamber of the Exposure
unit 120 are maintained.
[0143]
31

Then, the Biogas generation unit 110 is controlled as follows based on the gas
concentration information obtained by the Gas concentration sensor 129 so that theconcentration in the chamber of the Exposure unit 120 is kept constant.
[0144]The generated amount of biogas, that is nucleolytic degradation gas, in the Biogas
generation unit 110 is determined by the mixing ratio of the amount of air and the amountof methanol in the Biogas generation unit 110. The amount of supplied air is determinedby the balance between the capacity of the chamber of the Exposure unit 120 and thegeneration time. It is also determined within the balance of the intake and exhaust where
the chamber of the Exposure unit 120 reaches negative pressure. The amount of methanol
is determined within an appropriate range of the catalyst self-reaction temperature.
[0145]
Concerning the negative pressure control in the Exposure unit 120, the balance
between the supplied air amount and the intake amount of the exhaust gas blower is to bewithin the range of -0MPa to -0.01MPa. It is adjusted to the optimal negative pressurebalance based on sample parameters (concentration, time, temperature, humidity).
[0146]
Concerning the gas concentration control in the chamber of the Exposure unit 120,the negative pressure balance is adjusted based on the parameter information of the
exposure target so that the concentration is kept constant.
[0147]
When the intake amount of the Exhaust gas blower 143 of the Exhaust gas treatment
unit 140 is decreased, the concentration increases, and when the intake amount isincreased, the concentration decreases. The intake amount of the Exhaust gas blower 143
is controlled within the negative pressure range of the chamber of the Exposed unit 120.
If it cannot be adjusted within the negative pressure balance range, the amount of supplied
methanol is to be controlled. When the amount of supplied methanol in the Biogas
generation unit 110 is increased, the concentration increases, and when it is decreased,
the concentration decreases. This range is controlled within the catalyst self-reaction
temperature range.
[0148]For example, in the gas concentration control in the chamber of the Exposure unit 120,
the gas concentration information obtained from the Gas concentration sensor 129 is set
as the process value PV, and the concentration in the chamber of the Exposure unit 120 iscontrolled to remain constant by the control system as shown in Figure 12 using thethreshold value SP of the chamber concentration and the process value PV32

[0150]
The gas concentration determined by the amount of supplied methanol GP1 by theMethanol pump 7 and the amount of supplied air by the Air pump 9 is detected by theGas concentration sensor 129 together with the disturbance element in the Exposure unit
120, and the gas concentration information GF obtained from the Gas concentration
sensor 129 is fed back as the process value PV and thereby concentration in the chamberof the Exposure unit 120 is controlled to remain constant.
[0153]For example, in the humidity control in the chamber of the Exposure unit 120, thechamber humidity information obtained from the Humidity sensor 134 is set as theprocess value PV, and the chamber humidity in the Exposure unit 120 is controlled to beconstant by the control system as shown in Figure 13 using the threshold value SP of thechamber humidity and the process value PV.
[0155]
Then, the chamber humidity of the Exposure unit 120 that is controlled by the
dehumidification function of the Cooling zone 121 or the Chamber cooler 130B is
detected by the Temperature sensor 134 together with the disturbance element, and thechamber humidity information GF obtained from the Temperature sensor 134 is fed backas the process value PV and thereby the chamber humidity of the Exposure unit 120 iscontrolled to remain constant.
[0157]In addition, in the chamber temperature control in the Exposure unit 120, the chamber
temperature information that is obtained from the Temperature sensor 134 is set as theprocess value PV, and the chamber temperature of the Exposure unit 120 is controlled toremain constant by the control system as shown in Figure 14 using the threshold value SPof the chamber temperature and the process value PV.
[0159]
The chamber temperatures corresponding to the control by the Chamber heater 130A
and the Chamber cooler 130B are detected by the Temperature sensor 134 together withthe disturbance element in the Exposure unit 120, the chamber temperature GF that is
obtained by the Temperature sensor 314 is fed back as the process value PV, and thereby
chamber temperature of the Exposure unit 120 is controlled to remain constant.
[0161]In addition, in the chamber pressure control in the Exposure unit 120, a follow-up
operation to the target values of the chamber pressure or differential pressure and theexhaust gas reaction temperature is conducted. In this chamber pressure control, the33exhaust gas amount is controlled by the PI control based on the combination of
proportional (P) and integral (I) control. The chamber pressure control is performed withthe target value within the negative pressure range. The target value is determined
automatically based on the exhaust gas reaction temperature.
[0162]For example, in the differential chamber pressure control in the Exposure unit 120,the differential chamber pressure information that is obtained from the Differential
pressure sensor 134 is set as the process value PV, and the differential chamber pressurein the Exposure unit 120 is controlled to remain constant by the control system as shownin Figure 15 using the threshold value SP of the differential chamber pressure and theprocess value PV.
[0163]It means that the open-close degree of the Exhaust gas introduction valve 142 of the
Exhaust gas treatment unit 140 is controlled by the third Control value C13 to which thefirst Control amount C11 responding to the threshold value SP of the differential chamberpressure and the difference between the threshold value SP of the differential chamberpressure and the process value PV as the second Control value C12 are added, and thenumber of rotations of the Exhaust gas blower 143 of the Exhaust gas treatment unit 140
is controlled by the sixth Control amount C23 to which the fourth Control amount C21
responding to the threshold value SP of the differential chamber pressure and thedifference between the threshold value SP of the differential chamber pressure and theprocess value PV as the fifth Control amount C22 are added.
[0164]The differential chamber pressure responding to the control of the open-close degreeof the Exhaust gas introduction valve 142 of the Exhaust gas treatment unit 140 and thenumber of rotations of the Exhaust gas blower 143 is detected by the Differential chamberpressure sensor 132 together with the disturbance element in the Exposure unit 120, thedifferential chamber pressure GF that is obtained from the Differential chamber pressure
sensor 132 is fed back as the process value PV, and thereby the differential chamberpressure of the Exposure unit 120 is controlled to remain constant.
[0182]In addition, the Control unit 150 controls the Exhaust gas treatment unit 140 as
follows when biogas is generated by the Biogas generation unit 110.
[0183]
In other words, when biogas is generated, the Control unit 150 controls the rotationof the Exhaust gas blower 143 so that the chamber pressure is kept at negative pressure34

at a lower level than the chamber pressure that is indicated by the chamber pressure
information that is obtained from the Chamber pressure sensor 132 of the Exposure unit
120. In addition, based on the exhaust gas catalyst temperature information obtained fromthe Exhaust gas catalyst temperature sensor 147, the Exhaust gas catalyst heater 146 iscontrolled so that the exhaust gas catalyst heater temperature reaches a specified value(300°C).
[0196]The Device for nucleolytic degradation 100 with the aforementioned structure canperform quantitative control of the temperature, humidity, and concentration in the
exposure area of the Exposure unit 110 by feedback control and can define conditions todemonstrate high efficacy in a short period of time according to exposure target types.
[0198]In the Device for nucleolytic degradation 100, the Biogas generation unit 110 contains
at least the reaction components of methanol, formaldehyde, carbon monoxide, carbon
dioxide, hydrogen, and oxygen, and generates free radical components (superoxide anion
O2 ・-, hydroxyl radical・OH, hydrogen radical H・, and superoxide (O2-) at least)
composite radical gas.
[0201]The exposure target exposed in the Exposure unit 110 of the Device for nucleolytic
degradation 100 may be an object having a slender tube (such as an endoscope, etc.), an
object having a complicated shape, or a precision instrument, etc.
[0211]In addition, the Device for nucleolytic degradation 100 can perform gas sampling
during operation and halfway sampling of specimens (optional extraction). In addition,
since the operation environment and status can be checked manually as well as
automatically, it is a system where human operators can make a determination and takeactions arbitrarily during automatic operation. In other words, by checking the chamber
environment by sampling after exhaust gas treatment, it is possible to judge the chamber
inlet and outlet conditions in the Exposed unit 120.
[Working examples][0216]
Hereinafter, specific examples using the Device for nucleolytic degradation 100
related to this invention are shown. The following examples and the details explained indetail by the examples are only workings of the invention. They do not limit this invention.
The invention may be changed to the extent that it does not deviate from the scope of thisinvention.
35

[0217]<1. Sample preparation>
The double strand DNA (dsDNA), RNA, and single strand DNA (ssDNA) wereprepared from Human HeLa cell (human cervical cancer).
[0221]<2. Biogas exposure test>
Exposure was conducted using the samples prepared in 1. above by the Device fornucleolytic degradation 100 related to this invention under the conditions as shown in
Figure 17 where the parameters of the exposure time, exposure temperature, and sample
capacity are changed, and the nucleolytic degradation ability of the biogas was evaluated.
Each sample was prepared in a 0.2mL PCR tube and a biogas exposure test was conducted.
[0226]<3. Results><3-1. Results of dsDNA>
Tables 1 through 3 show the Bioanalyzer results with sample amounts of 2μl, 20μl,
and 100μl, respectively. "C" in each table indicates that the nucleic acid was completelydegraded; "+++" indicates that a high degree of partial degradation occurred; "++"
indicates a moderate partial degradation occurred; and "+" indicates that minor partial
degradation occurred. In addition, Figure 18 indicates nucleolytic degradation ability
criteria of dsDNA by Bioanalyzer and Figures 19 through 21 show spectrum diagrams
indicating test results of the nucleolytic degradation ability by Bioanalyzer.
[0234]
Based on the above, it is found that nucleolytic degradation by biogas using theDevice for nucleolytic degradation 100 can highly degrade nucleic acid underapproximately normal temperatures and in a short period of time. In addition, it wassuggested that the dsDNA degradation ability effects by biogas are temperaturedependent (effects increase at high temperature) and volume-dependent (wet conditions).
[0238]On the other hand, when nucleolytic degradation with biogas using the Device fornucleolytic degradation 100 is performed, nucleic acid amplification of GAPDH was notobserved for the exposure for 15 min. under any temperature conditions of 37℃, 45℃,
and 50℃ by the biogas exposure to 2μL of RNA samples, complete degradation effects
of RNA were shown, and the same results were obtained for the exposure for 120 min.
[0241]On the other hand, when nucleolytic degradation with biogas using the Device fornucleolytic degradation 100 is performed, nucleic acid amplification of GAPDH was not36

observed for the exposure for 60 min. under any temperature conditions of 37℃, 45℃,
and 50℃ by the biogas exposure to 2μL of ssDNA samples, complete degradation effects
of ssDNA were shown, and the same results were obtained for the exposure for 120 min.

37

[Figure 1]
100 (Device for nucleolytic degradation)
Treated gas
120 (Exposure unit)
121 (Cooling zone)

110 (Biogas generation unit)
140 (Exhaust gas
treatment unit) Air

Methanol
Air
Generated gas

150 (Control unit)

38

[Figure 2]
110 (Biogas generation unit)
19 (Gas introduction
tube attachment)

11 (Methanol gas
generation unit)

18 (Catalyst
cartridge)

16 (Air control
valve)

9 (Air pump)
8 (Solenoid valve A)

15A (Catalyst heater)

1 (Methanol
supply tank)

15 (Catalyst
temperature sensor)
12A (Inner cylinder)
12B (Outer cylinder)

17 (Methanol
control valve)

14A (Abnormal
temperature sensor)

Air
7 (Methanol pump)

13 (Vaporizer
temperature sensor)

2 (Direct-acting
on-off valve)
3 (Methanol
sub-tank)

10 (Vaporizer)
20 (Vaporizer heater)

5 (Lower liquid surface meter) 4 (Upper liquid surface meter)39

6 (Drain valve)[Figure 3]40

[Figure 8]
120 (Exposure unit)
135 (Exposure sensor)

127 (Stirring fan)

136A (Odor sensor)
126 (Introduction fan)
136B (Odor sensor)
122 (Supply sideopen-close valve)
121 (Cooling zone)

128 (Exhaust sideopen-close valve)

130A (Chamber heater)

Sample123 (Piping valve
humidification
heater)132 (Chamber pressure
sensor)Dehumidification
Precision equipment

129 (Gas concentration
sensor)Gas concentration
Chamber pressure

125 (Outside air
introduction valve)
124 (HEPA filter)
133 (Humidity
sensor)130B (Chambercooler)Temperature
Humidity

124A (Air heater)

134 (Temperature sensor)

41

N2, CO2, etc.
131 (External gas
introduction valve)[Figure 9]
Introduction of outside air

140 (Exhaust gas
treatment unit)

142 (Outside air
introduction valve)
Exhaust gas

149 (Exhaustgas tube)

Chamber gas

141 (Gas introduction
tube attachment)

148 (Exhaust gas
temperature sensor)

146 (Exhaust gas
catalyst heater)

145 (Exhaust gas
degradation
catalyst unit)

147 (Exhaustgas catalyst
temperature
sensor)143 (Exhaust gas
blower)144 (Rectifier bath)

Air volume control
Temperature control
Exhaust gas temperature

42

[Figure 10]
Control unit 150
Exhaust gas treatment
control
Exhaust gas catalyst
temperature control
Gas concentration control
Methanol control
Differential pressure
control
Exhaust gas blower
controlMR gas generation unit
110
Methanol pump 7
Direction changeover
valve B

Air pump B
Air flow

Direction

Direction

Catalyst temperature sensor
15

Temperature andhumidity adjustment

Exhaust gas temperature
sensor 147
Outside air introduction valve
142
Control

Chamber humidity sensor 133

Catalyst unit

Exhaust gas blower 143

Chamber temperature sensor
134
Direction

Gas feed control

Air flow

Supply side open-close valve 122

Vaporizer

Exhaust side open-close valve 128

Vaporizer heater 20
Vaporizer
temperature sensor
13

Exhaust gas catalyst heater
146

Chamber cooler 130B

Catalyst heater 15A

Direction

Differential chamberpressure sensor 132

Chamber heater 130A

Abnormal temperature sensor
14A

Catalyst temperature sensor
15

Gas concentration sensor
129

Exhaust gas treatment unit
140
Exhaust gas catalyst
temperature sensor
147

Exposure unit 120

Direction

Gas flowConstant-temperaturebath attachment

Stirring fan 124
External gas
introduction valve
131

Refresh air from HEPA filter
124

43

Gas flow[Figure 18]

Partial degradation(Minor)Molecule peak shift

Partial degradation(Medium)
Molecule peak shift
Decreases in peak height

Partial degradation(High degree)

Molecule peak shift
Decreases in peak height

Complete degradation
C: Complete

Loss of the peak44

[Figure 19A]

45

[Figure 19B]

46

[Figure 19C]

47

(Attachment 2)[Technical field][0001]
This invention is related to a sterilization gas generation device, a catalyst cartridgethat is installed on the sterilization gas generation device in an exchangeable manner, anda sterilization treatment device that sterilizes targets with radical methanol radical gas(hereinafter referred to as "MR gas") generated from methanol by catalyst reaction.
[Background art]
[0002]
A sterilization system using radical (methanol radical: MR) gas generated frommethanol by catalytic reaction has sterilizing power superior to ethylene oxide gas (EOG)or ozone, etc., which have been widely used as gases for sterilizing medical devices, etc.
It has been confirmed that the system is free from persistence or corrosiveness, and it has
been drawing attention from many fields today.
[0003]
MR gas is a radical gas with a strong sterilizing effect generated from methanol by acatalyst, has high permeability, and can sterilize the inside of a sterilization target even at
atmospheric pressure. It has excellent features, such as being free from metal corrosion
or plastic deterioration. It can also be used with non-sterile materials and does not remain
in sterilization targets. It has a strong safety record.
[Problems to be solved by the invention][0006]
However, since a conventional MR gas generation device had a catalyst unit with asize of approximately 150mm to 180mm in diameter, for example, it was difficult to keep
the temperature necessary for the radicalization reaction of methanol gas constant in the
catalyst unit. Therefore, it was necessary to have an electric heater in the catalyst unit andto control temperature by heating as necessary in order to maintain the temperaturenecessary for the radicalization reaction.
[0007]
With the aforementioned conventional MR gas generation device, temperaturefluctuated widely at the time of the catalyst reaction. As a result, it could not generate MR
gas at a constant concentration. In addition, since it had a catalyst unit with a diameter ofapproximately 150mm to 180mm and it was necessary to have an electric heater forheating as mentioned above, the catalyst unit naturally became large and it was difficult
to downsize the MR gas generation device to increase convenience.
[0008]
48

This invention was proposed in consideration of these conventional problems and itaims to keep the catalyst reaction temperature for radicalization constant, to generatesterilization gas at a stable concentration, and to provide a sterilization gas generation
device that can be downsized, a catalyst cartridge that is used with the sterilization gas
generation device, and a sterilization treatment device.
[Means of solving problems][0009]The inventors of this invention found that using a catalyst that has a honeycomb
structure makes it possible to keep catalyst reaction temperature for radicalization
constant, as a result of conducting studies from various perspectives to resolve theaforementioned problems and completed this invention.
[0010]
In other words, the sterilization gas generation device related to this invention iscomposed of a methanol gas generation unit that vaporizes the methanol and generates
methanol gas; a cylindrical unit that is positioned above the methanol gas generation unit,
serves as a flow channel to transfer the methanol gas generated from the methanol gas
generation unit to the upper part by natural convection and mixes air into the methanol
gas at the predetermined ratio; and a catalyst unit that is located above the cylindrical unit
and radicalizes the methanol gas into which air is mixed at the predetermined ratio in thecylindrical unit by catalytic reaction; and the catalyst unit is composed of radicalization
reaction catalysts made from thin metal plates formed into a honeycomb structure.
[Effects of the invention][0013]
This invention uses radicalization reaction catalysts made from thin metal plates
formed into a honeycomb structure and thereby the surface area of the catalyst unit isincreased and reaction efficiency increased. It can therefore cause a self-reaction where
the catalyst reaction temperature is kept constant and generate MR gas at a stableconcentration. In addition, improvement of reaction efficiency at the catalyst unit makes
it possible to downsize the catalyst unit and to downsize the sterilization treatment device
itself, and thereby convenience can be increased.
[Best embodiment of the invention][0015]
Figure 1 is a frame format indicating an MR gas generation device related to thisembodiment schematically. As shown in Figure 1, the MR gas generation device 10
related to this embodiment is composed of a Methanol gas generation device 11 thatgenerates methanol gas by vaporizing methanol that is supplied from a methanol tank (not49shown in the Figure); a Cylinder 12 that is located above the Methanol gas generation
device 11, mixes air with methanol gas that is generated from the Methanol gas generation
device 11 and forms a flow channel to guide the generated methanol gas to the upper partby natural convection; and a Catalyst cartridge 13 that is installed successively on the
Cylinder 12 at above the flow channel of methanol gas in a detachable manner andradicalizes methanol gas by catalyst reaction and generates MR gas. Each structure is
explained concretely below.
[0016]First, the Methanol gas generation device 11 that composes the MR gas generation
device 10 related to this embodiment is explained. The Methanol gas generation device
11 generates methanol gas that is a reaction substance of radicalization reaction byvaporizing methanol and supplies it to the Cylinder 12.
[0017]
Figure 2 is a frame format indicating the Methanol gas generation device 11
schematically. As shown in Figure 2, the Methanol gas generation device 11 is composedof the Electric heater 20 that is connected to a methanol tank (not shown in the Figure)that holds raw materials, methanol and at least heats and vaporizes methanol; a Heat
medium 21 that is made of temperature stabilization metal, such as sintered metal, etc.,
to control temperature when vaporizing methanol supplied from the methanol tank; aVaporizing nozzle 22 that leads the vaporized methanol to the upper part of the MR gas
generation device 10; and a Nozzle 23 that sprays methanol supplied from the methanoltank in mist form and transfers it to the Heat medium 21.
[0018]In the Methanol gas generation device 11, methanol supplied from the methanol tankis heated and vaporized by the Electric heater 20 under the temperature control by theHeat medium 21 and the methanol gas that is generated by vaporization is emitted fromthe Vaporization nozzle 22. The generated methanol gas goes through the Vaporization
cover 14 and spreads and transfers to the upper part of the MR gas generation device 10,
which is the Catalyst cartridge 13 by natural convection.
[0023]In addition, the Methanol gas generation device 11 has the Nozzle 23 that sprays themethanol that is supplied through a Methanol supply communication tube 24 from themethanol tank using a pump, etc. in mist form to the Heat medium 21. The methanol
supplied from the methanol tank is sprayed from the Nozzle 23 in mist form and the mist
methanol is heated by the Electric heater 20 as mentioned above via the Heat medium 21,
and thereby the temperature is kept constant and methanol can be vaporized in stable50

conditions.
[0024]
By generating methanol gas in stable conditions where the temperature remains
constant in this manner, it prevents the temperature of the Methanol gas generation device
11 from fluctuating. As mentioned above, it effectively controls catalyst reaction
temperature fluctuations in the Catalyst cartridge 13, which is explained in detail below,
and enables the stable generation of MR gas.
[0026]
It is known that the sterilization environment needs to be kept at the predetermined
humidity for sterilization. For example, in cases of preparing a DNA-free environmentby the destruction of DNA, such as viruses, etc., sterilization must be conducted in thesterilization environment where humidity of approximately 75% is maintained. However,when conducting MR gas sterilization, in order to prepare the MR gas exposure
environment in the predetermined humidity condition (for example, approximately 75%),
a certain degree of time for adjustment of the environment is required and it is also
necessary to keep the predetermined humidity environment constant, but it is extremely
difficult to keep a constant humidity environment.
[0027]
Therefore, as mentioned above, in the step of generating methanol gas, thepredetermined amount of water is mixed with the methanol supplied from the methanoltank to generate methanol that contains water at the predetermined ratio, thereby
generating methanol gas from this methanol and generating MR gas. This enables
effective sterilization without adjusting the humidity of the sterilization environment inadvance. In this case, if a Methanol gas generation device 11 in the aforementioned otherembodiment is used, since it has a Mixing nozzle 23' that can mix methanol and waterand can supply methanol which contains water at the predetermined ratio in mist form,
the optimal methanol gas that is maintained at the predetermined humidity can begenerated efficiently and can be supplied to the Catalyst cartridge 13. In addition, if thisMR gas that is generated from the methanol gas by catalyst reaction is used, effectivesterilization can be performed and therefore it is not necessary to manage and keep thepredetermined humidity environment constant.
[0028]As mentioned above, the Methanol gas generation device 11 has the Nozzle 23.
Therefore, it can spray methanol in mist form, can vaporize methanol at the temperature
conditions in a constant range where there is no temperature fluctuation, and can cause astable radicalization catalyst reaction in the Catalyst cartridge 13. The Nozzle 23, for51example, can also be composed as the Mixing nozzle 23' that mixes methanol and waterand can supply the methanol that contains water at the predetermined ratio in mist form.
Therefore, it can effectively generate methanol gas that is maintained at the predetermined
humidity and can generate MR gas that can perform effective sterilization.
[0031]
Next, the Cylinder 12 that composes the MR gas generation device 10 related to thisembodiment is explained. The Cylinder 12 serves as a flow channel that guides to theCatalyst cartridge 13 that serves as a radicalization catalyst reaction site of methanol gas
supplied from the Methanol gas generation device 11 and mixes air into the methanol gas
at the predetermined ratio.
[0037]Air supply in the Cylinder upper part 12a is explained in detail here. The MR gas
generation device 10 related to this embodiment changes the amount of supplied air in
the Cylinder upper part 12a and thereby can control the radicalization catalyst reaction
temperature by self-reaction in the Catalyst cartridge 13, which is explained later.
[0038]The Catalyst cartridge 13 of the MR gas generation device 10, for which the details
are explained later, is composed of the Radical reaction catalyst 30 made from thin metal
plates formed into a honeycomb structure so that reaction efficiency is increased byincreasing the surface area of contact with methanol gas. Just by heating to temperaturesin the approximate range of 230℃ to 250℃ for about ten minutes immediately after thestart of operation, the Catalyst cartridge 13 subsequently enables a stable self-reaction(catalyst burning reaction of methanol gas) that makes it possible to increase thetemperature to the range of 450℃ to 500℃ as necessary for the radicalization reaction,and to maintain the reaction temperature. Therefore, differing from a conventional device,
it is not necessary to continue heating in order to maintain the reaction temperature. As
described above, the MR gas generation device 10 does not require continued heating tomaintain the reaction temperature but can increase the temperature as necessary and keep
it constant by stable self-reaction. Therefore, it can easily control the temperaturenecessary for the radicalization reaction by changing the amount of supplied air in the
Cylinder upper part 12a.
[0039]In addition, apart from a conventional MR gas generation device that has a catalyst
formed by mixing metal pipe and diatomaceous earth, etc. randomly, the MR gas
generation device 10 related to this embodiment causes a radicalization catalyst by
passing methanol gas through the Catalyst cartridge 13 made from thin metal plates
52formed into a honeycomb structure. Therefore, it does not cause a variation in the catalyst
reaction of methanol gas and can easily control the catalyst reaction temperature bychanging the amount of supplied air.
[0040]
In concrete terms, in cases of generating the temperature of 450℃ that is necessary
for the radicalization catalyst reaction by self-reaction, as mentioned above, air is suppliedin direct proportion to the amount of supplied methanol. In concrete terms, if the amountof supplied methanol is 3cc, air is to be supplied at a rate of approximately 3.5L/min.
[0041]At the same time, in cases of generating the temperature of approximately 500°C,
which is higher than the 450°C that is necessary for a radicalization catalyst reaction, by
self-reaction, air is to be supplied at an amount more than the amount that is directly
proportional to the amount of supplied methanol. This makes it possible to increase theburning temperature by self-reaction and to increase the temperature for a radicalization
reaction close to 500°C. In concrete terms, air is supplied in an amount that exceeds therate of the amount of supplied air for generating the temperature of approximately 450°C(the rate where the amount of supplied air is approximately 3.5L/min. when the amountof supplied methanol is 3cc).
[0042]
Figure 5 is a graph to explain that the MR gas generation device 10 related to thisembodiment can control the radicalization catalyst reaction by changing the amount of
supplied air. The reaction temperature range required for the radicalization catalyst
reaction of methanol gas is approximately 450°C to 500°C. As shown in the graph of
Figure 5, the MR gas generation unit 10 changes the amount of air supplied from the
Cylinder upper part 12a in the range of approximately 3.5L/min to 6.0L/min. to an amountof supplied methanol of approximately 3.0cc. This makes it possible to change
radicalization catalyst reaction temperature in the range of approximately 450°C to 500°C.
Therefore, the temperature of the radicalization catalyst reaction can be easily controlled
by changing the amount of air supplied from the air supply unit.
[0043]As mentioned above, the MR gas generation unit 10 related to this embodiment does
not require heating to maintain the temperature of the radicalization catalyst reaction andcan cause a radicalization reaction by a stable self-reaction. Therefore, the radicalization
reaction temperature can be controlled easily by changing the amount of supplied air
alone. Since the concentration of the generated MR gas depends on the radicalization
catalyst reaction temperature, the MR gas concentration can be easily controlled by53

controlling the reaction temperature by changing the amount of supplied air as describedabove. This makes it possible for the MR gas concentration to be changed easily
depending on the sterilization target, and sterilization can be performed on various targets.
[0056]In the MR gas generation device 10 related to this embodiment, as mentioned above,
the Catalyst cartridge 13 is composed of the Radicalization reaction catalyst 30 madefrom thin metal plates formed into a honeycomb structure, the surface area of contact
between methanol gas and the Radical reaction catalyst 30 is increased, and methanol gas
passes through a specified route.
[0057]
Increasing the surface area of contact with methanol gas by forming the Radical
reaction catalyst 30 into a honeycomb structure makes it possible to increase catalyst
reaction efficiency and to minimize the size of Catalyst cartridge 13 that is necessary fora radicalization reaction. In concrete terms, the size of Radical reaction catalyst 30 in the
diameter direction in the Catalyst cartridge 13 can be set at a range of approximately
50mm to 70mm and a radicalization reaction with high reaction efficiency can be caused
within this size range. By minimizing the size of Catalyst cartridge 13, it becomes
possible to create a form that can be exchanged easily. In addition, by making methanol
pass through a specific route, it becomes possible to reduce and keep variation in theradicalization reaction constant, and to control the fluctuations in reaction temperatures.
[0077]In addition, as mentioned above, the Catalyst cartridge 13 enables a radicalization
catalyst reaction by a stable self-reaction. Therefore, by arbitrarily controlling the amountof air supplied from the air supply unit that is connected to the Cylinder 12, it becomes
possible to control the fluctuations in radicalization catalyst reaction temperatures easily
and also change the concentration of MR gas to be generated easily. Thereby, by onlychanging the amount of supplied air to be mixed with methanol gas, MR gas at an
appropriate concentration for sterilization targets can be generated easily and efficientsterilization can be performed on various targets. Additionally, since MR gas with anappropriate concentration can be generated arbitrarily in this way, it becomes possible toreduce the amount of supplied methanol to the minimum necessary, to use the device
more safely, and to achieve sterilization that is suitable for the environment.
[0079]
Figure 13 is a frame format indicating schematically an example of the Sterilization
device 40 to which MR gas generation device 10 related to this embodiment is applied.
As shown in Figure 13, the Sterilization device 40 is composed of the Methanol tank 41,
54

an MR gas generation device 10', and a Sterilization tank 42 that serves as a place formaintaining the MR gas generation device 10' and sterilization targets and for sterilizingthem with MR gas generated from the MR gas generation device 10'.
[0085]In addition, by applying the aforementioned MR gas generation device 10 related tothis embodiment, it is possible to make a sterilization device that does not require placinga Sterilization target 43 in the Sterilization device 40 for sterilization, as indicated in the
Sterilization device 40 as shown in Figure 13. In other words, by placing in a closed areaa sterilization device to which the MR gas generation device 10 related to thisembodiment that enables downsizing is applied, and filling the closed area with the MRgas generated by the radicalization catalyst reaction, it is possible to sterilize that closed
area. By doing this, sterilization becomes possible for areas that were impossible tosterilize with a sterilization device using a conventional MR gas generation device, suchas hospital rooms, car interiors, etc.
[0088]For example, by applying the MR gas generation device related to this embodiment,
an ambulance car that transferred a patient with an infectious disease can be treated as asterilization target. With a conventional sterilization device using MR gas, since thedevice itself was large, it was difficult to carry and took time for sterilization, andtherefore only a limited number of ambulance cars, etc. could not to be sterilized quickly.
However, when using a sterilization device to which the MR gas generation device related
to this embodiment is applied and with which downsizing of the reaction catalyst isachieved by improving reaction efficiency, it is possible to carry the device easily and to
implement sterilization easily.
[0089]In addition, the MR gas generation device 10 related to this embodiment can control
the radicalization reaction temperature by catalyst self-reaction easily by changing theamount of supplied air in the Cylinder upper part 12a, and thereby it can easily change
the concentration of the generated MR gas. Therefore, for example, in cases of exposing
MR gas for the purpose of destructing DNA, such as viruses, etc., the concentration of
MR gas to be generated can be changed by changing the amount of supplied air dependingon the sterilization target, such as, for example, increasing the radicalization reaction
temperature by increasing the amount of supplied air to generate MR gas, etc. at a highconcentration.
[0090]
This invention is not limited to the aforementioned embodiment. Design changes, etc.
55

that do not deviate from the gist of the invention are also included in this invention.

56

[Figure 1][Figure 2]

57

[Figure 13]58

(Attachment 3)
1. [Claims][Claim 3]
A formaldehyde gas sterilization device with the following features: It is composedof a formaldehyde gas supply and exhaust device that supplies and exhausts formaldehyde
gas in the sealed room anda room pressure adjustment device that adjusts the pressure of the room;
wherein the formaldehyde gas supply and exhaust device is composed of aformaldehyde gas generator that generates the formaldehyde gas, a humidity adjuster that
adjusts the humidity of the formaldehyde gas, a temperature adjuster that adjusts thetemperature of the formaldehyde gas, a gas carrier that transfers and introduces theformaldehyde gas into the room, an exhaust gas processor that treats exhaust gas
exhausted from the room, a gas ejector that exhausts the exhaust gas, and a control unitthat controls the concentration, humidity, and temperature of the formaldehyde gas in theroom to the predetermined concentration, humidity, and temperature;
wherein the room pressure adjustment device is composed of an air supply unit that
supplies air from outside the room into the room, an exhaust air unit that exhausts the air
in the room to outside the room, a means of detecting difference in pressures that detects
differences in pressures between inside and outside the room, a means of controlling the
air supply unit and the exhaust air unit based on the values detected by the means ofdetecting differences in pressures, and a means of outputting the control status of the roompressure based on the values detected by the means of detecting differences in pressures.
2. [Detailed explanation of the invention](1) "Technical field
This invention is related to a formaldehyde gas sterilization device that sterilizes thearea subject to sterilization by formaldehyde gas." (Page 4, lines 2 through 4)(2) "Technical backgroundThe conventional method of using formaldehyde gas for the purpose of sterilizing thearea, such as a bio-clean room, surgery room, etc., required the area subject to thesterilization to be a closed area and generated formaldehyde gas by placing aformaldehyde gas generator in the area.
However, sterilization (hereinafter it also means "disinfection" in these descriptions)effects by formaldehyde gas greatly depend on the concentration, humidity, andtemperature of the formaldehyde gas in the area subject to sterilization. Therefore, inorder to obtain fully certifiable sterilization effects, it is not enough to fill the area subject
to sterilization with formaldehyde gas for a specified time.
59

...In addition, the area subject to sterilization is required to be a sealed area (room).
Therefore, it is also necessary to control room pressure." (Page 4, lines 5 through 21)(3) "Disclosure of invention...In addition, the formaldehyde gas sterilization device of this invention is composedof a formaldehyde gas generator that generates formaldehyde gas; a humidity adjusterthat adjusts the humidity of the formaldehyde gas; a temperature adjuster that adjusts thetemperature of the formaldehyde gas; a gas carrier that transfers and introduces theformaldehyde gas into the area subject to sterilization; an exhaust gas processor that treats
exhaust gas exhausted from the area subject to sterilization; a gas ejector that exhausts
the exhaust gas; and a control unit that instructs the formaldehyde gas generator to
generate formaldehyde gas at a concentration in the predetermined range, controls thehumidity of the formaldehyde gas in the predetermined range by the humidity adjuster,
controls the temperature of the formaldehyde gas in the predetermined range by thetemperature adjuster, controls the gas transfer amount by the gas carrier in thepredetermined range, controls the formaldehyde gas amount that is being exhausted by
the exhaust gas treatment device in the predetermined range, and controls the exhaust gas
emission amount by the gas ejector.
The formaldehyde gas sterilization device of this invention controls the concentration,
humidity, and temperature of formaldehyde gas in the area subject to sterilization to thepredetermined concentration, humidity, and temperature by the control unit and therefore
fully certifiable sterilization effects can be obtained." (Page 4, line 22; Page 5, line 17
through page 6, line 3).
(4) "In addition, the formaldehyde gas sterilization device of this invention has thefollowing features: it has a formaldehyde gas supply and exhaust device that supplies andexhausts formaldehyde gas into and from the sealed room and a room pressure adjustment
device that adjusts room pressure; wherein the formaldehyde gas supply and exhaust
device is composed of a formaldehyde gas generator that generates formaldehyde gas, ahumidity adjuster that adjusts the humidity of formaldehyde gas, a temperature adjusterthat adjusts formaldehyde gas temperature, a gas carrier that transfers and introduces
formaldehyde gas into the room, an exhaust gas processor that treats exhausted gas fromthe room, a gas ejector that exhausts the exhaust gas, and a control unit that controls theconcentration, humidity, and temperature of the formaldehyde gas in the room to thepredetermined concentration, humidity, and temperature; wherein the room pressureadjustment device is composed of an air supply unit that supplies air outside the room
into the room, an air exhaust unit that exhausts room air outside the room, a means ofdetecting differences in pressures between inside and outside the room, a means of60

controlling the air supply unit and air exhaust unit based on the values detected by themeans of detecting differences in pressures, and a means of outputting the control statusof the aforementioned room pressure based on the values detected by the means ofdetecting differences in pressures.
...The formaldehyde gas sterilization device of this invention has a room pressureadjustment device and therefore room pressure can be kept constant even if the room air
expands due to increases in room temperature.
In addition, the formaldehyde gas sterilization device of this invention has a treatment
device that treats the air exhausted from the room by the air exhaust unit.
The formaldehyde gas sterilization device of this invention treats formaldehyde gas,etc. that is contained in the room air by the treatment device even if room air is exhausted
in order to adjust room pressure, and therefore, formaldehyde gas can be exhausted
outside the room after it is treated." (Page 6, line 4 through page 7, line 6).
(5) "Best embodiment of the invention
The first embodiment of this invention is explained hereinafter in reference to Figure
1. Figure 1 is a configuration diagram of the Formaldehyde gas sterilization device 2
related to the first embodiment. The Formaldehyde gas sterilization device 2 has a
Housing 10 and can be attached outside the biohazard safety cabinet and can easily
implement sterilization of the area in the cabinet (hereinafter referred to as "Area subject
to sterilization 100"). In this case, the inside of the cabinet must be a closed area by closing
dampers, etc. The cabinet has a Formaldehyde gas inlet 102 for supplying formaldehyde
gas from the Formaldehyde gas sterilization device 2 and an Exhaust gas outlet 104 forexhausting formaldehyde gas.
The Area subject to sterilization 100 has a Formaldehyde gas concentration sensor 12,a Humidity sensor 14, and a Temperature sensor 16, and each monitored value iscommunicated to the Controller 24 via the Control lines 18, 20, and 22.
Outside air is introduced in the Area subject to sterilization 100 from theFormaldehyde gas inlet 102 by the Pump 26 and exhaust gas is exhausted outside fromthe Exhaust gas outlet 104 via the Pump 28. Or, the exhaust gas exhausted from the Pump
28 is introduced again to Pump 26 via a Reflux route 30 and thereby air in the Area subject
to sterilization 100 is circulated." (Page 7, lines 7 through 23)"...For this reason, the formaldehyde gas concentration, humidity, and temperature in
the Area subject to sterilization 100 are monitored by the Concentration sensor 12, theHumidity sensor 14, and the Temperature sensor 16 respectively; necessary calculation isconducted by the Control device 24 based on the obtained values; and the Formaldehyde
gas generator 36, the Temperature adjuster 34, the Humidity adjuster 32, and the Pump
61

26 are controlled through the Control lines 38, 40, 42, and 44. ...
After the predetermined time has elapsed, the Formaldehyde gas generator 36 is
stopped and treatment by the Exhaust gas processor 46 is implemented until theformaldehyde gas concentration in the Area subject to sterilization 100 falls below thepredetermined value. In other words, the gas released from the Pump 28 is introduced
again into the Pump 26 via the Reflux route 30, air in the Area subject to sterilization 100
is circulated, and thereby the formaldehyde gas concentration is decreased gradually to
below the predetermined concentration." (Page 8, lines 1 through 12)(6) "A formaldehyde gas generator that can be used in this invention is not particularly
limited as long as it can generate formaldehyde gas at a high concentration while
controlling humidity and temperature." (Page 8, lines 19 through 21)"Controlling the generation amount of formaldehyde depends on control of thecatalyst temperature, and the amount of supplied methanol, or the vaporizing amount.
Reaction conditions can be optimized by actually generating formaldehyde andmeasuring the appropriate formaldehyde gas concentration." (Page 9, lines 4 through 7)"In this invention, it is preferable to adjust the temperature in the area subject tosterilization in order to maintain formaldehyde gas at an appropriate concentration within
the appropriate temperature range for a long period of time. The means of controlling thetemperature that is installed for this purpose is not particularly limited and a publiclyknown heating or cooling device can usually be used." (Page 9, line 27 through page 10,line 1).
"In this invention, it is preferable to adjust humidity in the sealed area in order tomaintain formaldehyde gas at an appropriate concentration within the appropriate
humidity range for a long period of time. The means of controlling the humidity that is
installed for this purpose is not particularly limited and a publicly-known humidification
or dehumidification device can usually be used." (Page 10, lines 6 through 9)"In this invention, it is necessary to maintain the temperature, humidity, andformaldehyde gas concentration in the area subject to sterilization in the predetermined
range for the predetermined time. The concentration of formaldehyde gas in the area
subject to sterilization is decreased by various reactions, such as the sterilization reaction,etc., in the area subject to sterilization. Therefore, in order to keep the concentration offormaldehyde gas constant, it is necessary to import the temperature, humidity, andformaldehyde gas concentration data within the set period and to control the means ofgenerating formaldehyde so that the concentration is within the specified range. The
control method and control device for this purpose are not particularly limited; however,a manual method or a control device using a computer program may be considered. In
62this invention, it is necessary to maintain formaldehyde at a high concentration for a long
period of time. Therefore, it is preferable to have functions to send signals to theformaldehyde generation device, pump, temperature adjuster, and humidity adjuster,while optimizing them on a timely basis, and to control the concentration. (Page 11, line
19 through the last line)(7) "Next, by referring to Figure 2 and Figure 3, a formaldehyde gas sterilization device
related to the second embodiment of this invention is explained. The formaldehyde gas
sterilization device related to the second embodiment is a Formaldehyde gas supply andexhaust device 4 that has the same structure as the Formaldehyde gas sterilization device
2 related to the first embodiment and that is equipped with the Room pressure adjustment
device 6 that adjusts pressure in the area subject to sterilization, which is formed as asealed room.
Figure 2 is a configuration diagram of the Formaldehyde gas sterilization device 4
related to the second embodiment and the formaldehyde gas sterilization device that
includes the Room pressure adjustment device 6. The Room pressure adjustment device
6 is installed by connecting it to the Room wall 50 and it adjusts pressure of the room
sealed by the Room wall 50. The Room pressure adjustment device 6 is composed of an
Air supply unit 52 that supplies air from outside the room into the room, an Air exhaust
unit 54 that exhausts the air inside the room to outside the room, a Minor differential
pressure detector 56 that detects differences in pressures between inside and outside theroom, and the Control unit 58 that controls the Air supply unit 52 and Air exhaust unit 54
based on the values detected by the Minor differential pressure detector 56.
The Air supply unit 52 has an Air supply grill 60 for intaking air from outside theroom. Three Air supply adjustment solenoid valves 62 that adjust the amount of air
supplied from outside to inside the room are installed downstream from the Air supply
grill 60. In addition, an Air blower 66 and HEPA (high efficiency particulate air) filter 68
are installed sequentially in the Air route 64 downstream from the Air supply amountadjustment solenoid valve 62.
The Air exhaust unit 54 has a HEPA filter 72 in an Air supply route 70 and three
Exhaust gas amount adjustment solenoid valves 74 that adjust the amount of air exhausted
from inside to outside the room are installed downstream from the HEPA filter 72. In
addition, downstream from the Exhaust air amount adjustment solenoid valve 74, an Air
treatment device 76 including a platinum catalyst and a heater, is installed. Air outside
the room is supplied to the Air treatment device 76 via a Solenoid valve 78. The catalyst
temperature can be kept constant by supplying air from outside the room.
In addition, downstream from the Exhaust air amount adjustment solenoid valve 74,
63

an Air blower 82 is installed in order to exhaust the air that went through the Air treatment
device 76 and air that is taken in from the Air supply grill 80 to the outside the Roompressure adjustment device 6." (Page 13, the last line through page 14, the last line).
(8) "The Minor differential pressure detector 56 is installed on the Room wall 50 and isconnected to the Control unit 58 via a signal line. The differences in pressures between
inside and outside the room that are detected by the Minor differential pressure detector
56 are input into the Control unit 58.
The Control unit 58 is connected to the Air supply amount adjustment solenoid valve
62 and the Air blower 66 of the Air supply unit 52 via a signal line and it is also connectedto the Exhaust air amount adjustment solenoid valve 74, the Solenoid valve 78, and the
Air blower 82 of the Exhaust air unit 54. The Control unit 58 controls the Air supply
amount adjustment solenoid valve 62, the Air blower 66, the Exhaust air amountadjustment solenoid valve 74, and the Air blower 82, etc. based on the values detected by
the Minor differential pressure detector 56. The Control unit 58 is connected to a Memory
device 84 that always saves the values detected by the Minor differential pressure detector
56 and is connected to an Output device 86, such as a printer, etc., that outputs detectedvalues that are saved in the Memory device 84." (Page 15, lines 1 through 11)"The Formaldehyde gas sterilization device introduces outside air from the Pump 26of the Formaldehyde gas supply and exhaust device 4 into the room from theFormaldehyde gas inlet 102 and exhausts air from the Exhaust gas outlet 104 to theoutside air through the Pump 28. Room temperature and humidity that are obtained fromthe Humidity sensor 14 and the Temperature sensor 16 are controlled by the Humidity
adjuster 32 and the Temperature adjuster 34 of the Control device 24 so that they arewithin the range of the predetermined temperature of 20°C to 40°C and the range of thepredetermined humidity of 50% to 90% (relative humidity). In addition, theFormaldehyde gas generator 36 and the Pump 26 adjust the formaldehyde gas
concentration so that it maintains the predetermined formaldehyde gas concentration of
160ppm and higher for the predetermined time. For this reason, the formaldehyde gas
concentration, humidity, and temperature are monitored by the Concentration sensor 12,
the Humidity sensor 14, and the Temperature sensor 16 respectively, the necessary
calculations are conducted by the Control device 24 based on the obtained values, and theFormaldehyde gas generator 36, the Temperature adjuster 34, the Humidity adjuster 32,
and the Pump 26 are controlled through the Control lines 38, 40, 42, and 44." (Page 15,
lines 12 through 23)(9) "Room pressure is maintained at positive pressure by the room pressure adjustment
device while the predetermined time, room temperature, humidity, and formaldehyde gas
64concentration are respectively maintained in the temperature range of 20°C to 40°C, inthe humidity range of 50% to 90% (relative humidity) and in the formaldehyde gas
concentration range of 160ppm or higher respectively. In other words, room pressure ismaintained at positive pressure (10Pa to 20Pa) by the treatment shown in the flowchartof Figure 3. Control based on the flowchart is implemented repeatedly by the Control unit
58 with minor time intervals." (Page 15, line 26 through page 16, line 3)"First, the Control unit 58 obtains differences in pressures between inside and outside
the room that is detected by the Minor differential pressure detector 56 (Step S10) andsaves it in the Memory device 84 (Step S11). Next, if the differences in pressures are 10Pa
to 20Pa (Step S12), the pressure is normal and therefore the Control unit 58 returns to thetreatment in Step S10 and continues processes, such as detecting differences in pressures(Step S10), saving detected values (Step S11), etc.
At the same time, if the difference in pressures between inside and outside the roomthat is detected by the Minor differential pressure detector 56 is 10Pa or lower (Step S12),
the room pressure is too low. Therefore, air is to be supplied into the room (Step S14). In
other words, control signals are sent to the Air supply amount adjustment solenoid valve
62 and Air blower 66 to open the Air supply amount adjustment solenoid valve 62 for thepredetermined time and operate the Air blower 66. Through this, the outside air is
supplied...into the room and room pressure increases by the value corresponding to thetime when the Air supply amount adjustment solenoid valve 62 is opened.
If the difference in pressures between inside and outside the room that is detected by
the Minor differential pressure detector 56 is 20Pa or higher (Step S12), the room pressure
is too high. Therefore, air is to be exhausted outside the room (Step S13). In other words,
control signals are sent to the Exhaust air amount adjustment solenoid valve 74 and the
Air blower 82 to open the Exhaust air amount adjustment solenoid valve 74 for thepredetermined time and operate the Air blower 82. Through this, the room air is exhausted
to outside the room via the HEPA filter 72, the Exhaust air amount adjustment solenoid
valve 74, and the Air treatment device 76 and the room pressure will decrease by the value
corresponding to the time when the Exhaust air amount adjustment solenoid valve 74 is
opened." (Page 16, lines 4 through 24)"The Room pressure control device 6 can always maintain the differences in pressures
between inside and outside the room at 10Pa to 20Pa. Therefore, in cases of sterilizing
the room using formaldehyde gas, even if room air volume increases due to increases inroom temperature, formaldehyde gas is exhausted after it is treated by the Air treatment
device 76. Therefore, it can prevent formaldehyde gas from leaking outside the room
without being treated. In addition, since the differences in pressures between inside and65

outside the room are saved in the Memory device 84 in chronological order, the detectedvalues that were saved in the Memory device 84 are output from the Output device 86
and thereby it can guarantee that the room pressure is always maintained at thepredetermined positive pressure based on the output results. Consequently, it is possible
to guarantee that formaldehyde gas has not been released outside the room without being
treated." (Page 16, line 27 through page 17, line 7).
(10) In the aforementioned second embodiment, the Air treatment device 76 is installedon the Room pressure adjustment device 6. Formaldehyde gas can be treated by using the
Exhaust gas processor 46 of the Formaldehyde gas supply and exhaust device 4." (Page17, lines 13 through 15)"The device of this invention has an integrated type housing structure and can beinstalled outside the area subject to sterilization. Therefore, clean emissions can beachieved by introducing formaldehyde gas into the area subject to sterilization andtreating exhaust gas from the area subject to sterilization before emissions. In addition,
the device can be detached easily. Furthermore, the device related to this invention canbe easily moved to the place where the area subject to sterilization is located. Fully
certifiable sterilization can be implemented easily in an ambulance, mobile surgery room(including tent), or bio-clean room." (Page 17, lines 16 through 21)(11) "In addition, the device related to this invention can prevent formaldehyde gas fromleaking outside the room before treatment even in cases where the room air volume
increases due to increases in the room temperature, and fully certifiable sterilization
effects can be obtained." (Page 17, line 28 through page 18, line 2).
(12) "Industrial availability
Based on the above, the formaldehyde gas sterilization device of this invention issuitable for sterilizing the area subject to sterilization to an extent that is fully certifiable."(Page 18, lines 3 through 5)66

[Figure 1]

Temperatureadjuster

Pump

Formaldehyde
gas generator

Humidity
adjuster

Controller

Exhaust gas
treatment
device67

Pump

[Figure 2]

Air supply(into the room)
Air exhaust(from the room)

Control unit
MemorydeviceFormaldehyde gas supply
and exhaust device

68

Outputdevice(Attachment 4)
1. Exhibit Ko 23 (Unexamined Patent Application Publication No. 2001-349586;
Publication date: December 21, 2001)[Claim 1] A Room pressure adjustment device with the following features: It is a roompressure adjustment device that adjusts pressure of the sealed room; andit is composed of an air supply unit that supplies outside air into the room,
an exhaust air unit that exhausts the air in the room to outside the room,a means of detecting differences in pressures between inside and outside the room,a means of controlling the air supply unit and the air exhaust unit based on the values
detected by the means of detecting differences in pressures,a means of outputting the control status of the room pressure based on the values detectedby the means of detecting differences in pressures.
[Claim 2] The control device is a room pressure adjustment device that is stated in Claim
1 and is featured by the function to control the room pressure at positive pressure against
the pressure outside the room.
[Claim 3] The control device is a room pressure adjustment device that is stated in Claim
1 and is characterized by the function to control the room pressure at negative pressure
against the pressure outside the room.
[0002][Conventional art] ...In addition, it is preferred for biohazard rooms, etc. that roompressure is maintained at a lower pressure than outside the room so that air that may becontaminated does not leak outside the room.
[0007] The room pressure adjustment device that is stated in Claim 3 has the feature thatthe control device that controls the room pressure at negative pressure against the pressure
outside the room. The room pressure adjustment device stated in Claim 3 can preventroom air that may be contaminated from being exhausted outside the room by always
maintaining the room at negative pressure in cases where the inside of the room may becontaminated.
[0019] Since the HEPA filter 28 is installed in the Air route 24 of the Air supply unit 12,
in cases of sterilizing a room, etc., even if it is necessary to supply air into the room, suchas the situation where the room pressure becomes too low, etc., it can prevent very fineparticles that exist outside the room from entering the room. In this embodiment, roompressure is controlled to maintain positive pressure; however, it is also possible to control
the room pressure to maintain negative pressure. Negative pressure refers to the casewhere (Room pressure) - (Pressure outside the room) is negative.
[0020] In the biohazard room, chemical hazard room, etc., room air may be contaminated.
69

Therefore, it is necessary to prevent room air from leaking outside the room. The Roompressure control device 2 can always maintain the differences in pressures between insideand outside the room at 10Pa to 20Pa (maintaining room pressure at -10Pa to -20Pa fromthe pressure outside the room) and the detected differences in pressures are saved in the
Memory device 44 in chronological order. Therefore, it can be guaranteed that the roompressure is always maintained at negative pressure based on the output results by
outputting the detected values that are saved in the Memory device 44 by the Output
device 46. Consequently, it can be guaranteed that there is no contamination outside theroom by guaranteeing that the air in the biohazard room, etc. has not leaked outside theroom.
2. Exhibit Ko 82 (Unexamined Patent Application Publication No. 1998-132346;
Publication date: May 22, 1998)[0004] ...Biohazard countermeasure facilities handle microbes that cannot be guaranteed
to be unharmful to the human body, such as general pathogens, tumor viruses, andrecombinant DNA. In biohazard countermeasure facilities, countermeasures have beentaken to prevent disasters that human beings would suffer directly or indirectly frombiohazard or microbe infections. The room pressure of a laboratory, etc. that is subject tobiohazards is maintained at negative pressure so that air flow, including leakage fromclearances, is kept in one direction from outside to inside the room, thereby preventing
the leakage of biohazard sources to the outside. In addition, in chemical hazard
countermeasure facilities, chemical substances that contaminate the environment and areharmful to the human body are handled. Therefore, in the same way that in biohazard
countermeasure facilities, the room pressure of laboratories, etc. are set at negative
pressure, air flow, including leakage from the clearance, is maintained in one direction
from outside to inside the room, and thereby preventing the leakage of chemical hazard
sources from inside to outside the room.
3. Exhibit Ko 83 (Unexamined Patent Application Publication No. 1999-347106;
Publication date: December 21, 1999)[0008][Means of solving problems] The method of the invention is to conduct the
depressurization and introduction of ozone gas alternately regarding the sterilizationchamber where sterilization targets are stored, and to conduct the sterilization of thesterilization targets.
[0064] In other words, maintaining sterilization chamber 5 at a pressure lower than theatmospheric pressure even during the supply of Ozone gas 4 can prevent Ozone gas 4
from leaking outside the Sterilization chamber 5.
70

4. Exhibit Ko 84 (Unexamined Patent Application Publication No. 1992-64846;
Publication date: December 17, 1992)[Claim 1] An aseptic bed device with the following features: It is roughly a rectangularsolid; it has a bed storage area to store a bed, including a bedroom unit that has an opening
end that connects with the bed storage area at least on two side walls, a clean air supply
source that can be detachable to at least one of the opening ends of the bedroom unit andsupplies clean air to the opening end, and an auxiliary unit that is detachable with at least
one of the opening ends of the bedroom unit, has an open-close door, or forms an areathat connects to the bed storage area; wherein the bedroom unit has a sterilization gas
supply port and inner pressure adjustment exhaust port, and supplies the sterilization gas
from the first port to sterilize inside the bedroom, while adjusting, through the second
port, the exhaust gas amount so that the inside of the bedroom is always kept at a negative
pressure, and [that] exhausts the sterilization gas to the air exhaust line via the means ofdetoxifying the sterilization gas, and thereby eliminates the leakage of sterilization gas tothe outside of the aseptic bed device.
[0013] The bedroom unit and the auxiliary unit have a port to supply ozone gas or othersterilization gases and an inner pressure adjustment exhaust port. Inside the bedroom unit
and the auxiliary unit, etc. can be disinfected by supplying ozone or other sterilization
gases through the supply port. The exhaust air amount is adjusted through the innerpressure adjustment exhaust port so that inside the bedroom unit and the auxiliary unit
are always kept at a negative pressure, and thereby preventing ozone from leaking outside.
A deozonizer that is a means of detoxifying is installed on the exhaust line of the gas
exhausted from the inner pressure adjustment exhaust port, thereby detoxifying some ofthe sterilization gas, such as ozone, etc., by changing it to oxygen, and then diffusing andexhausting the detoxified gas into the air. …
[0030] Figure 10 is a system chart for one entire working example of this invention. In
the Bedroom unit 2 or the working example in Figure 10, a Supply port 71 that supplies
ozone, which is a sterilization gas, is installed on the Door unit 4 and the Inner pressureadjustment exhaust port 72 is installed on the Bedroom unit 2. Air from outside or oxygen
through the Ozonizer 73, or ozone that is obtained from the circulation gas from thePipeline 79 are supplied to the Supply port 71 via the Pipeline 74 and the Variable orifice
75 that is a flow rate control valve. This makes it possible to sterilize inside the Bedroom
unit 2 and the Door unit 4. Part of the gas from the Exhaust port 72 is led to the Deozonizer
77 via the Attracting fan 76, and ozone is detoxified into oxygen and diffused into the air.
Using the Attracting fan 76 always keeps the inside of the Bedroom unit 2 and the Door
unit 4 at a negative pressure and thereby prevents ozone from being leaked outside. The
71

pressure in the Bedroom unit 2 is detected by the Pressure detector 78. The opening degreeof the Variable orifice 75 is changed by the Adjustment meter 79 so that the pressure in
the Bedroom unit 2 can be maintained at the predetermined constant negative pressure.
…In this way, inside the Bedroom unit 2 and the Door unit 4 are sterilized when there isno patient and thereby it can prevent leakage of ozone to the outside during disinfection
and the disinfection can be implemented easily. …

72

(Attachment 5)
1. Exhibit Ko 81 ("Kagaku Daijiten (Chemical Dictionary)" (1st edition) (Edited by Ohki
Michinori, et al.; Tokyo Kagaku Dojin; Issued on October 20, 1989)"Formaldehyde: ...A combustible colorless gas with a strong pungent odor. It exists in thesmoke when coal and wood are burnt. It is very irritating to mucosa and is a carcinogen."(P. 2261, right column, lines 23 through 28)
2. Exhibit Ko 85 (JIS T 7328: 2005 Formaldehyde gas disinfectors for medical use)
(Japanese Standards Association/Japan Association of Medical Equipment Industries;
2005)"Formaldehyde gas disinfectors for medical use...
1. Scope of application: This standard stipulates the requirements for the safety,
performance, testing, and labeling of a disinfector for which the use pressure is normalpressure and atmospheric pressure or lower out of formaldehyde gas disinfectors that areused for the disinfection of medical devices (disinfection targets) (hereinafter simply
referred to as a "disinfector"). (Page 3, lines 3 through 7)"4. 2. Disinfector safety
4. 2. 1. The interlock of a door or a cover: A disinfector must have an automatic interlock
structure where it is designed so that gas is not supplied in the chamber when the chamber
door or cover is not locked under normal operating conditions.
4. 2. 2. Prevention of exposure of operators to formaldehyde: A disinfector must conformto 13.1.101 of IEC61010-2-042:1997 in order to prevent exposure of operators.
If a gas leakage occurs, a disinfector should have a structure to stop gas supply, reducepressure in the chamber, and display a warning automatically by interlocking with the gas
leakage alarm that is installed separately. However, a disinfector where gas is supplied at
negative pressure compared to the atmospheric pressure is excluded." (Page 5, lines 20
through 31)
3. Exhibit Ko 88 (Patent No. 2690518; Publication date: August 29. 1997)"Figures 1 and 2 are for explaining this invention, ...Figure 2 is a line map that shows therelationship between the changes in pressures in the sterilization container in association
with the progress of the sterilization and the status of constituent features along with thepassage of time." (Page 2, left column, lines 36 through 39)"When sterilizing, first close the Cover 2 of the Sterilization container 1 after placing thesterilization target in the Sterilization container 1, operate the Vacuum pump 3 to maintainthe inside of the Sterilization container 1 at negative pressure, implement vacuum
procedures to exhaust air in the sterilization target, and thereby make conditions where
sterilization gas can easily enter the sterilization target. After the vacuuming procedures,73

open the Humidification valve 4 only for an appropriate time, conduct humidification
procedures to humidify the sterilization target to make a better fit between the sterilization
gas that is supplied subsequently into the Sterilization container 1 and the sterilization
targets.
After the humidification procedure and humidification vacuum procedure, implement
formalin pulse procedures where the operation of the Quantitative pump 5 for transferringformalin, the release of Solenoid valve 6, turning ON of a vaporization timer to heat andvaporize formalin, and the release of Solenoid valve 7 to send the formaldehyde generated
from vaporization into the Sterilization container 1 are repeated as necessary and wheregenerating formaldehyde for sterilization and sending a rather small amount offormaldehyde into the Sterilization container 1 are implemented repeatedly so that there
is a better fit between the large amount of formaldehyde that is sent subsequently andsterilization targets.
After completing this vacuuming, humidification, humidification and vacuuming, andformalin pulse procedures, send a rather large amount of formaldehyde into the
Sterilization container 1 and sterilize (disinfect) the sterilization targets stored in the
Sterilization container 1. (Page 2, left column, line 42 through right column, line 13 in
the same page).
"Figure 2 is a line map that shows the relationship between the changes in pressures inthe sterilization container in association with the progress of the sterilization and the statusof constituent features along with the passage of time." (Page 3, left column, line 4
through right column, line 1 on the same page)74

[Figure 2]
Preparation

Humidification

Disinfection
Neutralizationof ammonia

Vacuuming

Vacuuming

Humidificationand vacuuming

Humidification

Vacuuming

Formalin pulse

Completion

Cleaning
Steam mix
cleaning

Pulse
cleaningBlowcleaning Aeration

Quantitative pump 5
Solenoid valve 6
Vaporization timer
Solenoid valve 7
Humidification valve 4
Vacuum pump 3
Air valve 8
Solenoid valve 9

4. Exhibit Ko 94 ("Healthcare Seihin no Mekkin oyobi Mekkin Hosho" (Sterilization of
Healthcare Products and Guarantee of Sterilization) (Issued on April 25, 2011)

1.
2.
3.
4.
5.
6.
7.
8.

Cycle start
Start of injecting sterilization materials
Cycle flashing
Display of cycle completion
Post-cycle
Display of cycle completion when door
opening and ejection were delayed
Taking out sterilization targets (conduct
aeration outside the sterilization device asnecessary)
Atmospheric pressure

a.
b.
c.
d.
e.
f.
g.
h.
i.
j.

Sterilization process
Operating cycle
Sterilization cycle
Exposure time
Balance time
Pre-heating
Degassing and conditioning
Retention time
Desorption
Aeration

Figure 7.3 LTSF Sterilization Process"7.6.1.2. Characteristic of the process
Low Temperature Steam and Formaldehyde (LTSF) sterilizer must include the75

following processes. They are shown along with the changes in pressures in the sterilizer
in Figure 7.3.
(1) Air removal(2) Conditioning(3) Injection of sterilizer(4) Balancing time and retention time(5) Desorption(6) Pressure restoration to atmospheric pressure by injecting air.
In order to achieve the sterilization process of LTSF, it is necessary to select theformaldehyde concentration to be used in the range between 2% to 38% and to define thesterilization process based on the concentration. The parameter setting that forms thesterilization process varies by the formaldehyde concentration to be used and there aredifferences in the sterilization performance and drying performance." (Page 308, rightcolumn)"(2) Sterilization operation
After supplying 12% formaldehyde solution at -10kPa, depressurize to -80kPa, heatand vaporize. After maintaining the conditions for 10 minutes, supply filtered air into thechamber and restore pressure to -10kPa.
Due to increases in the pressure, sterilization agents are exposed to the inner cavities
that are difficult to sterilize in the sterilization target. After maintaining the pressure for 5
min., repeat the operation to supply 12% formaldehyde solution and the subsequent seriesof depressurization, heating and vaporizing, and pressure restoration by introducing air
12 times.
Operation time: 180 min.
Use amount of 12% formaldehyde solution: 90mL" (page 317, left column)
5. Exhibit Ko 95. "Formaldehyde Gasu Mekkin no Tokusei to Jitsukizai no Gaiyou"(Characteristics of Sterilization with Formaldehyde and Outline of Equipment" (KansenSeigyo Vol. 7, No. 2; Issued on April 25, 2011)"Formaldehyde is... Its steam is an irritant to mucosa and the respiratory tract when it
exceeds the predetermined concentration. It has been determined to be one of causes ofsick house syndrome. In Japan, the Order for Enforcement of the Industrial Safety and
Health Act and the Regulation on Prevention of Hazards due to Specified Chemical
Substances, etc. are partially enforced and the category of formaldehyde was changed
from Group 3 substances to Group 2 substances of the specified chemical substance. …In
addition, WHO's International Agency for Research on Cancer (IRAC) classifies
formaldehyde into Group 1, which is 'carcinogenic to the human body.'" (Page 119, line76

5 from the bottom of the left column through line 7 from the bottom of the right column)"The treatment method of HS6610 TURBO LTSF is low-temperature steam
formaldehyde sterilization. In other words, inject steam and formalin through a mounted
vaporizer several times so that they disseminate uniformly to the sterilization target in thechamber that is kept at negative pressure. On the other hand, PS140R adopts a prevacuum method to keep the chamber at negative pressure using a pump, vaporize theformalin solution, and have it act on sterilization targets." (Page 120, 13 lines through line
6 from the bottom of the right column)

77