Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment/Arguments
The Amendment filed 11/12/2025 has been entered. Claims 1-33, 39-43, 47-65 and 69 remain pending on the application. Claims 1-11, 26-33, 39-43, and 47-65 are withdrawn, pursuant to Applicant’s election of claims 12-25 without traverse in the reply filed 6/4/2025.
Applicant argues:
Applicant submits that there is no reasonable motivation or expectation of success to
support the combination of the references required for the rejection. Page 5 of the Office Action recognizes that the combination of Takamori and Wada does not suggest the treatment of spores and cites Kleinberger for this purpose. However, Kleinberger focuses on the use of UV radiation as the mechanism for sterilization. Even if Kleinberger recognizes some possible usefulness for the creation of hydroxyl radicals, this is still in conjunction with treatments based on UV radiation. The references provide no reasonable basis to expect that spore-forming bacteria could be treated by irradiating radical generation sources with visible light.
Examiner respectfully disagrees. As noted in the previous Office Action, Takamori itself already teaches using visible light to generate radicals from a radical generation source for disinfection (pg. 28 par. 5: The chemical | medical agent of 3rd invention in this invention can be used as a disinfectant, for example; pg. 6 par. 1: For example, in the case of light irradiation that can be appropriately set according to the type of reactant (raw material) and target product, the wavelength of the irradiation light is However, it is not particularly limited, and can be set as appropriate according to, for example, the absorption band of the reactant (raw material); pg. 6 2nd last par.: The wavelength of the irradiation light is as described above, for example. Although a light source is not specifically limited, For example, if visible light contained in natural lights, such as sunlight, is utilized, it can excite easily). One of ordinary skill in the art would understand that in order for disinfection to be maximally effective, bacterial spores would need to be eliminated as well. In addition, Kleinberger teaches that the hydroxyl radicals can increase bacterial cell death (par. 42: Additionally, the UV chamber 110 can include one or more catalyst devices 112 that promote a photocatalytic reaction to create hydroxyl radicals, which can result in increased cell death of bacteria). Hydroxyl radicals must therefore be capable of killing bacterial cells independent of UV radiation in order to cause increased cell death. Bacterial spores are considered cells, and would therefore be vulnerable to treatment by the radicals as well, especially considering that Kleinberger measures the rate of spore death (par. 29: FIG. 10 shows a comparison of decay rates of Bacillus atrophaeus (Bg) spores with and without the operation of the air treatment device of FIG. 1). Therefore, there is an explicit reason found in the prior art to expect that spore forming bacteria can be treated via radicals, which in turn can be generated by irradiating a radical source with visible light.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 12-16, 19-25, and 69 are rejected under 35 U.S.C. 103 as being unpatentable over Takamori (WO 2017104797 A1, provided in Applicant’s IDS of 4/1/2022, translation copy provided in Office Action filed 7/22/2025 and relied upon by Examiner) in view of Wada (JP 2011067285 A, provided in Applicant’s IDS of 4/1/2022, translation copy provided and relied upon by Examiner) and Kleinberger (US 20190063763 A1).
Regarding claim 12, Takamori teaches a sterilization method (pg. 28 par. 5: The chemical | medical agent of 3rd invention in this invention can be used as a disinfectant, for example. Conventionally, there are various types used as a bactericidal agent, but the bactericidal effect is not sufficient. Although some can increase the bactericidal effect by increasing the concentration, there is a problem in safety. The bactericidal agent containing the chemical | medical agent of 3rd invention in this invention has sufficient bactericidal effect even if a density | concentration is low, and its safety | security is high),
comprising: a treatment step of generating radicals through photoirradiation of a radical generation source (pg. 6 last two par.: The radical production method of the first invention in the present invention may further include, for example, a light irradiation step of irradiating the mixture obtained by the mixing step with light. And as above-mentioned, you may manufacture a radical by the reaction which arises by the said light irradiation… In the radical production method according to the first aspect of the present invention, the radical generation source), but does not teach wherein a peak wavelength of light used in the photoirradiation is greater than UV wavelengths and 600 nm or less,
for sterilizing spores… and treating spores with the radicals.
Takamori is silent with respect to the peak wavelength of the administered light but teaches wherein visible light may be used to irradiate the radical generation source (pg. 6 2nd last par.: The wavelength of the irradiation light is as described above, for example. Although a light source is not specifically limited, For example, if visible light contained in natural lights, such as sunlight, is utilized, it can excite easily) and furthermore broadly teaches that the wavelength of the light can be varied depending on the reactant that forms the radical generation source (pg. 6 par. 1: For example, in the case of light irradiation that can be appropriately set according to the type of reactant (raw material) and target product, the wavelength of the irradiation light is However, it is not particularly limited, and can be set as appropriate according to, for example, the absorption band of the reactant (raw material)). Therefore, there is motivation to use irradiating light with any particular peak wavelength that is effective at exciting a particular radical generation source. Moreover, Takamori teaches wherein a radical generation source comprising chlorite has a peak absorption wavelength between 400 and 450 nm, which is in the visible range (Fig. 16).
Wada teaches a sterilization method involving generating a sterilant from a radical generation source using light, wherein the light is in the visible range and has a peak wavelength in the visible blue light range (400-500 nm), which falls within the claimed range (abstract: To provide a simple, compact a sterilization gas supply device capable of supplying a sterilization gas safely, reliably and long-lastingly. <P>SOLUTION: The sterilization gas supply device 1 includes: medicine 2 of stabilized chlorine dioxide (for example, gel) for generating disinfectant gas of chlorine dioxide; a medicine container 3 which stores the medicine 2 and has an air hole through which generated sterilization gas is emitted into the air formed on a bottom part 32a of a medicine container lid part 32; and a light emitting element (for example, a light emitting diode) which is attached to the medicine container 3, radiates visible lights (for example, blue, green, and the like) to the medicine 2, and activates it. The visible light is radiated to the medicine 2 continuously or intermittently to generate the disinfectant gas; pg. 2 par. 5: The light emitting element 4 emits visible light, that is, light having a peak (maximum intensity) in the visible region. Specifically, a light emitting diode is preferably used, and blue, green).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the overall range and peak wavelength of the light for generating radicals of Takamori to be in the range of blue visible light, as taught by Wada, in order to provide a suitable light for generating radicals from a composition comprising chlorite.
Takamori modified by Wada still does not teach for sterilizing spores… and treating spores with the radicals.
Kleinberger teaches an air sterilization device using light to generate radicals (abstract: An air mover for forcing air through the system, a pre-treating stage with a particulate filter for removing larger contaminants from the air and an antimicrobial (e.g., copper and silver) filter for killing or damaging microorganisms, a UV chamber including an ultraviolet lamp that emits radiation and a catalytic (e.g., TiO.sub.2-coated) device and a reflective (e.g., mirror-finish anodized aluminum) lining for amplifying the UV radiation for killing microorganisms, a post-UV stage including a VOC-reducing (e.g., activated-charcoal) filter for removing odors and VOCs from the air, and optionally a supply of a surface disinfectant (e.g., ClO.sub.2). In example embodiments, the UV lamps and VOC filters are selected and configured for controlling microbial pathogens, and in other example embodiments they are selected and configured for removing ethylene from the air; par. 42: Additionally, the UV chamber 110 can include one or more catalyst devices 112 that promote a photocatalytic reaction to create hydroxyl radicals, which can result in increased cell death of bacteria). Kleinberger teaches sterilizing bacillus spores (par. 29: FIG. 10 shows a comparison of decay rates of Bacillus atrophaeus (Bg) spores with and without the operation of the air treatment device of FIG. 1).
Takamori teaches sterilization in general but does not specify what species of bacteria are killed via its sterilization method. However, Kleinberger has identified a particular species of harmful bacteria that would need to be eliminated to for effective sterilization to take place.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Takamori modified by Wada to sterilize and treat bacillus spores, as taught by Kleinberger, in order to have more complete and effective sterilization.
Regarding claim 13, Takamori modified by Wada and Kleinberger teaches the sterilization method according to claim 12, as set forth above, but does not teach wherein the peak wavelength is 405 to 470 nm.
Furthermore, a mere change in degree, even if it leads to better results, holds no patentable significance:
MPEP 2144.05.II.A: Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."
especially if it can be shown that the change in degree can be done by one of ordinary skill in the art through routine optimization of a known result-effective variable (MPEP 2144.05.II.B: the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process).
In this case, Takamori has already established that the wavelength of the irradiating light can be varied depending on the absorption band of the radical generation source and has already presented a radical generation source that has an absorption band close to that of the claimed range (Fig. 16). Furthermore, the modification by Wada already puts the wavelength of the light in the blue light range, which is 400-500 nm, which overlaps with the claimed range.
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the peak wavelength of the irradiating light of the method of Takamori modified by Wada and Kleinberger to be 405 to 470 nm, in order to optimally irradiate a radical generation source comprising chlorite.
Regarding claim 14, Takamori modified by Wada and Kleinberger teaches the sterilization method according to claim 12, as set forth above, and teaches wherein the lower limit of the range of wavelengths included in the light is 380 nm or more (see Wada modification in claim 12, wherein the light is visible light, which has a lower range of 400 nm).
Regarding claim 15, Takamori modified by Wada and Kleinberger teaches the sterilization method according to claim 12, as set forth above, and teaches wherein the treatment step includes: a step of generating radicals through photoirradiation of the radical generation source in the absence of spores; and a step of treating spores with the radicals (pg. 30 last par.: Specifically, for example, in the case of space deodorization, spraying can be used; NOTE: this means that the radicals are generated in a separate space from the space containing the bacteria to be treated).
Regarding claim 16, Takamori modified by Wada and Kleinberger teaches the sterilization method according to claim 12, as set forth above, but does not teach wherein the treatment step includes a step of generating radicals through photoirradiation of the radical generation source in the presence of spores and treating the spores with the radicals.
Takamori already teaches various different applications for its sterilization method without limitation (pg. 28 par. 4: The method of using the medicine of the third invention in the present invention is not particularly limited, and for example, it can be used in the same manner as conventional fungicides and the like. Specifically, for example, the medicine of the third invention in the present invention may be sprayed or applied to an object. Specifically, for example, in the case of space deodorization, spraying can be used. For use in the oral cavity, it can be rinsed and washed as an aqueous solution. When used for disinfection of pressure ulcers, it can be applied to the affected area. The affected area such as cancer self-destroying wound or ringworm bacteria can be impregnated with absorbent cotton or gauze and applied to the affected area. When used for hand sanitization, it can be made into an aqueous solution so that it can be rubbed. Medical devices and the like can be washed by spraying or immersing them in an aqueous solution. It can also be applied to the bed, table and door knobs for sterilization and prevention purposes).
Kleinberger teaches using photoirradiation generated radicals for sterilizing air, such that radicals are generated in the presence of the spores in the air (par. 16: The system includes one or more ultraviolet lamps for irradiating air flowing through the system, wherein the effects of the ultraviolet lamps can be amplified via their placement into a reflective chamber or by the further inclusion of a catalytic (e.g., TiO.sub.2) coated stainless steel rod that interacts with one or more ultraviolet light lamps to produce hydroxyl radicals or another form of catalyst to produce oxidizing and reactive agents. In some aspects, the UV lamps emit radiation in the UVC range; and in other aspects, the lamps emit radiation at a lower or higher UV level (e.g., shorter or longer wavelength) and may also produce ozone. In other aspects, one or more lamps of other wavelengths may be utilized, or the lamps can optionally be omitted in filter-only applications. In example applications, the system removes bacteria, microbial spores, fungi, viruses, and the like from air, thereby extending the shelf life of perishable items).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Takamori modified by Wada and Kleinberger to generate radicals in the presence of spores in air, as taught by Kleinberger, so that the light can also directly sterilize the air, providing additional sterilization effect.
Regarding claim 19, Takamori modified by Wada and Kleinberger teaches the sterilization method according to claim 12, as set forth above, and teaches wherein the photoirradiation of the radical generation source is photoirradiation of a fluid reagent that contains the radical generation source (pg. 37 2nd last par.: First, since ClO .sub.2 radicals are considered to exhibit strong oxygenation reaction activity, 10-methyl-9,10-dihydroacridine (AcrH .sub.2 ) (1.4) in deoxygenated acetonitrile / water (1: 1 v / v) mixed solution. mM) and sodium chlorite (NaClO .sub.2 ) (2.8 mM)).
Regarding claim 20, Takamori modified by Wada and Kleinberger teaches the sterilization method according to claim 19, as set forth above, and teaches wherein the fluid reagent is a liquid or a gel (NOTE: a fluid is a liquid; pg. 37 2nd last par.: First, since ClO .sub.2 radicals are considered to exhibit strong oxygenation reaction activity, 10-methyl-9,10-dihydroacridine (AcrH .sub.2 ) (1.4) in deoxygenated acetonitrile / water (1: 1 v / v) mixed solution. mM).
Regarding claim 21, Takamori modified by Wada and Kleinberger teaches the sterilization method according to claim 19, as set forth above, and teaches wherein a solvent in the fluid reagent is water or a buffer solution (pg. 37 2nd last par.: First, since ClO .sub.2 radicals are considered to exhibit strong oxygenation reaction activity, 10-methyl-9,10-dihydroacridine (AcrH .sub.2 ) (1.4) in deoxygenated acetonitrile / water (1: 1 v / v) mixed solution. mM) and sodium chlorite (NaClO .sub.2 ) (2.8 mM)).
Regarding claim 22, Takamori modified by Wada and Kleinberger teaches the sterilization method according to claim 19, as set forth above, and teaches wherein the pH of the fluid reagent is 5 to 10 (pg. 37 2nd last par.: First, since ClO .sub.2 radicals are considered to exhibit strong oxygenation reaction activity, 10-methyl-9,10-dihydroacridine (AcrH .sub.2 ) (1.4) in deoxygenated acetonitrile / water (1: 1 v / v) mixed solution. mM; NOTE: water has a pH of 7).
Regarding claim 23, Takamori modified by Wada and Kleinberger teaches the sterilization method according to claim 19, as set forth above, and teaches wherein the radical generation source includes at least one selected from the group consisting of halogen ions, hypohalous acid ions, halous acid ions (pg. 37 2nd last par.: First, since ClO .sub.2 radicals are considered to exhibit strong oxygenation reaction activity, 10-methyl-9,10-dihydroacridine (AcrH .sub.2 ) (1.4) in deoxygenated acetonitrile / water (1: 1 v / v) mixed solution. mM) and sodium chlorite (NaClO .sub.2 ) (2.8 mM)), halogen acid ions, and perhalogen acid ions.
Regarding claim 24, Takamori modified by Wada and Kleinberger teaches the sterilization method according to claim 23, as set forth above, and teaches wherein the halous acid ions are chlorite ions (pg. 37 2nd last par.: First, since ClO .sub.2 radicals are considered to exhibit strong oxygenation reaction activity, 10-methyl-9,10-dihydroacridine (AcrH .sub.2 ) (1.4) in deoxygenated acetonitrile / water (1: 1 v / v) mixed solution. mM) and sodium chlorite (NaClO .sub.2 ) (2.8 mM)).
Regarding claim 25, Takamori modified by Wada and Kleinberger teaches the sterilization method according to claim 12, as set forth above, and teaches. wherein the spores are spores of the genus Bacillus (see Kleinberger modification in claim 12 rejection) or the genus Clostridium
Regarding claim 69, Takamori modified by Wada and Kleinberger teaches the sterilization method according to claim 12, as set forth above, and teaches wherein the light is visible light and does not include ultraviolet radiation (see Wada modification in claim 12 rejection, wherein the overall range of the light is modified to be within the range of blue light, which is visible light outside of the UV range).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Takamori modified by Wada and Kleinberger in view of Morino (provided in Applicant’s IDS of 8/24/2023, translation copy provided in previous office action and relied upon by Examiner).
Regarding claim 17, Takamori modified by Wada and Kleinberger teaches the sterilization method according to claim 12, as set forth above, but does not teach wherein the photoirradiation is performed using an LED.
Takamori teaches that certain lamps may or may not be used (pg. 6 2nd last par.: Further, for example, instead of or in addition to the natural light, a light source such as a xenon lamp, a halogen lamp, a fluorescent lamp, or a mercury lamp may or may not be used as appropriate).
Morino teaches a method for generating a sterilant by irradiating a radical generation source with light (abstract: A method for deactivating suspended microorganisms in a space, comprising the steps of: (1) preparing a solid agent containing (A) a porous material carrying chlorite and (B) a metal catalyst or a metal oxide catalyst, In the solid medicament, the mass ratio of the chlorite to the metal catalyst or the metal oxide catalyst is 1: 0.04 to 0.8; (2) irradiating the solid medicament with visible light; And (3) supplying chlorine dioxide gas generated from the solid medicament to a space in which the floating microorganisms are present). Morino teaches wherein visible light is preferable and wherein LED’s are preferable for emitting the visible light due to their efficiency and compact form (pg. 6 par. 3: it is preferable to use an LED that generates light in the visible region as the light source. In light of the miniaturization of the apparatus and the efficiency of generation of chlorine dioxide, it is most preferable that the light source used in the present invention is an LED chip that generates light in the visible region).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the light source of the method of Takamori modified by Wada and Kleinberger to be an LED, as taught by Morino, in order to have an efficient and compact light source.
Regarding claim 18, Takamori modified by Wada and Kleinberger teaches the sterilization method according to claim 17, as set forth above, and teaches wherein a peak wavelength of the LED is greater than UV wavelengths and 600 nm or less (see Wada modification in claim 12 rejection for a peak wavelength in the blue light range), but does not teach and a spectral line half width (full width at half maximum) of the LED is 12 to 35 nm.
However, a mere change in degree, even if it leads to better results, holds no patentable significance:
MPEP 2144.05.II.A: Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."
especially if it can be shown that the change in degree can be done by one of ordinary skill in the art through routine optimization of a known result-effective variable (MPEP 2144.05.II.B: the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process).
In this case, Takamori already suggests that the light used for irradiation can vary depending on the reagents used as a radical generation source (pg. 6 par. 1: For example, in the case of light irradiation that can be appropriately set according to the type of reactant (raw material) and target product, the wavelength of the irradiation light is However, it is not particularly limited, and can be set as appropriate according to, for example, the absorption band of the reactant (raw material)). One of ordinary skill in the art would understand that the spectral line half width determines the spread of the light intensity around a wavelength range (e.g. how much light is concentrated in a specific wavelength range) and that certain compositions absorb light best in certain wavelength ranges.
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spectral line half width of the irradiating light of Takamori modified by Wada and Kleinberger to be 12 to 35 nm, with the reasonable expectation that this is the optimal range for most efficient and effective light absorbance of a particular radical generation source composition.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.C./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796