DETAILED ACTION
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 .
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 11, 2025 has been entered.
Status of the Claims
Claims 1-2, 5-15, 21-22, and 24 have been amended; claims 25-26 are new; and claims 3-4 and 23 have been cancelled. Claims 1-2, 5-22, and 24-26 are currently pending and examined herein.
Status of the Rejection
Applicant’s amendments to the Claims have overcome each objection, 112(a) and 112(b) rejections previously set forth in the Final Office Action mailed May 12, 2025.
New grounds of claim objection are necessitated by the amendment.
New grounds of claim rejection under 35 U.S.C. § 112(a) and 112(b) are necessitated by the amendment as outlined below.
All 35 U.S.C. §103 rejections from the previous office action are withdrawn in view of the Applicant’s amendment.
New grounds of rejection under 35 U.S.C. § 103 are necessitated by the amendments as outlined below.
Claim Objection
Claim 26 is objected to because of the following informalities:
Claim 26: please amend “the request” to -- the request tissue treatment--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 5-22 and 24-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “wherein the required concentration provides a concentration of the one or more of the plurality of different species sufficient to have a medical disinfecting effect and/or a deactivation of a microbial or bacterial organisms on the tissue”, and the underlined features of having a medical disinfecting effect and/or a deactivation of a microbial or bacterial organisms on the tissue are only disclosed by background [para. 0003] in PGPub of the instant specification: “Such activated liquids can be used for an indirect plasma treatment. The effect on the tissue to be treated can be a disinfecting effect. Microbial and bacterial organisms can be deactivated by the liquid”. Applicant is supposed to use incorporation by reference to bring prior art features into the specification (see MPEP 2163.07(b) and 608.01(p)). Since the claimed features are only disclosed in background, and are not disclosed in applicant’s device or method, thus, claim 1 and its dependent claims 2, 5-14 and 24-26 are new matters.
Claim 15 recites “delivering the plasma-activated liquid via the requested tissue treatment to a tissue such that the required concentration provides a concentration of the one or more of the plurality of different species sufficient to have a medical disinfecting effect and/or a deactivation of a microbial or bacterial organisms on the tissue”, and the underlined features of having a medical disinfecting effect and/or a deactivation of a microbial or bacterial organisms on the tissue are only disclosed by background [para. 0003] in PGPub of the instant specification: “Such activated liquids can be used for an indirect plasma treatment. The effect on the tissue to be treated can be a disinfecting effect. Microbial and bacterial organisms can be deactivated by the liquid”. Applicant is supposed to use incorporation by reference to bring prior art features into the specification (see MPEP 2163.07(b) and 608.01(p)). Since the claimed features are only disclosed in background, and are not disclosed in applicant’s device or method, thus, claim 15 and its dependent claims 16-21 are new matters.
Claim 22 recites “wherein the required concentration provides a concentration of the one or more of the plurality of different species sufficient to have a medical disinfecting effect and/or a deactivation of a microbial or bacterial organisms on the tissue”, and the underlined features of having a medical disinfecting effect and/or a deactivation of a microbial or bacterial organisms on the tissue are only disclosed by background [para. 0003] in PGPub of the instant specification: “Such activated liquids can be used for an indirect plasma treatment. The effect on the tissue to be treated can be a disinfecting effect. Microbial and bacterial organisms can be deactivated by the liquid”. Applicant is supposed to use incorporation by reference to bring prior art features into the specification (see MPEP 2163.07(b) and 608.01(p)). Since the claimed features are only disclosed in background, and are not disclosed in applicant’s device or method, thus, claim 22 is a new matter.
Claim 25 recites “wherein the medical instrument is configured to provide a plurality of tissue treatments, each requiring different concentrations of the one or more of the plurality of different species”, wherein “each requiring different concentrations of the one or more of the plurality of different species” is not supported by the specification and drawings. The instant specification discloses: “Treatment methods are illustrated by function blocks in FIG. 1, wherein block 13 typifies sub-tissue injection with plasma-activated liquid. Block 14 typifies the alternating treatment of tissue with plasma, e.g. argon plasma, and/or with RF-current as well as plasma-activated liquid. Block 15 typifies the wetting or spraying of tissue with plasma-activated liquid” [para. 0029 in PGPub]. Thus, the specification discloses a plurality of tissue treatments (blocks 13-15), but does not disclose that each requiring different concentrations of the one or more of the plurality of different species. Therefore, claim 25 is a new matter.
Claim 26 recites “the required concentration associated with the requested is a minimum concentration for each of the more than one of the plurality of different species”, which is not supported by the specification and drawings. The instant specification discloses: “On the other hand, if the treatment request comprises predominantly species with short lifetime, it can be determined by means of the sensor device 36 whether these have been created in sufficient concentration in order to supply them immediately to the instrument 11” [para. 0042 in PGPub]. Thus, the specification discloses that the required concentration associated with the requested tissue treatment is sufficient concentration of predominantly species instead of minimum concentration for each of the more than one of the plurality of different species. Therefore, claim 26 is a new matter.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 5-22 and 24-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the amended claim 1 recites “A medical instrument for …, the medical instrument comprising:…, a storage vessel…, and a medical instrument is fluidically connected to the storage vessel”. Thus, it claims a medical instrument comprises a medical instrument fluidically connected to an element (storage vessel) of the medical instrument. It is unclear if the second “a medical instrument” is the same or different than the first medical instrument. If they are the same, it is unclear how a medical instrument comprises itself. If they are different, it is unclear which “medical instrument” does “the medical instrument” in “provide the plasma treated liquid to the medical instrument” refer to. Thus, the scope of claim 1 is indefinite. Claims 2, 5-14 and 24-26 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 1.
Regarding claim 15, claim 15 recites “the one or more of the plurality of different species”, wherein “the one or more” lacks antecedent basis. It is unclear if “the one or more of the plurality of different species” is the same or different than “the at least one of the plurality of different species”. Thus, the scope of claim 15 is indefinite. Claims 16-21 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 15.
Regarding claim 22, the amended claim 22 recites “A medical instrument for …, the medical instrument comprising:…, a plasma application device configured to bring a liquid into contact with the plasma and having an outlet configured to discharge the plasma-activated liquid from the plasma application device to the medical instrument; …, a storage vessel to store the liquid after exposure to the plasma and fluidically connected to the medical instrument; …, the medical instrument is fluidically connected to the storage vessel and adapted to receive the plasma-activated liquid from the storage vessel, …, provide the plasma treated liquid to the medical instrument”. Thus, it claims a medical instrument comprising a plasma application device and a storage vessel. However, from the limitations of the plasma-activated liquid discharged from the plasma application device to the medical instrument and the medical instrument is fluidically connected to the storage vessel, the plasma application device and the storage vessel are not components of the medical instrument. Thus, it is unclear what are included in the medical instrument, and the scope of claim 22 is indefinite.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 7-14 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Yoo et al. (US20200035515A1), and further in view of Kimiya et al. (US 2016/0362317 A1), Ferrell et al. (US20150306258A1) and Pelfrey et al. (US20140322096A1). Suzen et al. (Detection of reactive oxygen and nitrogen species by electron paramagnetic resonance (EPR) technique, Molecules, 2017, 22, 181) is used as an evidence for claim 26.
Regarding claim 1, Yoo teaches a medical instrument (a cleaning solution production system in Fig.1 [para. 0023] for generating plasma treated liquid [para. 0004]; as evidenced by Kimiya: plasma treated liquid can be used to treat an object, for example, a microorganism, or a bacterium [para. 0154]; As evidenced by Ferrell: plasma treated liquid can be used to treat tissue [abstract]; thus the disclosed instrument in Yoo can be used as a medical instrument); the limitation “for supply of a plasma-activated liquid to a tissue” is an intended use limitation [see MPEP 2111.02]. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Yoo teaches the instrument generating a plasma-activated cleaning solution S, which is further used for cleaning an object such as a semiconductor substrate (abstract, [para. 0089]). As evidenced by Kimiya, which teaches a plasma-treated liquid for treating/cleaning an object including a microorganism or a bacterium [para. 0154]. As further evidenced by Ferrell: plasma treated liquid can be used to treat tissue [abstract]. Thus, the disclosed instrument of Yoo is configured to supply a plasma-activated cleaning solution S to a tissue in addition to a semiconductor substrate. The medical instrument comprising:
a plasma generator (first and second electrodes 310, 320 and ignition electrode 330 of the plasma reaction tank 300 in Figs. 1, 4-6 [para. 0039]) adapted to supply a plasma (plasma is formed in the plasma reaction tank in stages by powering the first, second and ignition electrodes 310, 320 and 330 [para. 0055]);
a plasma application device (plasma reaction tank 300 in Figs. 1 and 4 [para. 0023]) configured to bring a liquid into contact with the plasma for a first activation (”configured to bring a liquid into contact with the plasma for a first activation” is a functional recitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Yoo teaches in the example of Fig.1, the liquid forced-transfer portion 120 is a path through which a cleaning solution S generated in the plasma reaction tank 300 and circulated through the first pipe 400, the storage tank 500, the radical sensor 600, and the second pipe 700 is injected into the pressure tank 105 [para. 0025]. Thus, the disclosed plasma reaction tank 300 is configured to bring a liquid into contact with the plasma in the plasma reaction tank 300 for a first activation), and the limitation “wherein the first activation is adapted to create a plurality of different species in the liquid having at least one of a different life time and a different activity” is a functional recitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Yoo teaches when oxygen O2 is injected via the gas inlet 110, the oxygen is coupled to a liquid such that radicals of at least one of OH, O, O2, O3, HO2, H3O, and H may be contained in the cleaning solution S. On the other hand, when other gases are used, radicals of at least one of NO, NO2, NO3, CO2, CO3, Cl, F, Br, BrO, Cl, ClO, and HF2 may be contained in the cleaning solution S. Radicals do not remain stable and may exist for a relatively short lifetime and then disappear [para. 0029-0030]. Thus, the first activation is adapted to create a plurality of different radical species in the cleaning solution S in the plasma reaction tank 300 having at least one of a different lifetime and a different activity (different radicals inherently having different lifetimes and activities);
a storage vessel (storage tank 500 in Fig.1 [para. 0023]) adapted to store the liquid after exposure to the plasma (the storage tank 500 may be a space in which the cleaning solution S containing the radical species generated in the plasma reaction tank 300 is stored [para. 0081]);
a sensor device (a radical sensor 600 in Fig.1 [para. 0023]); “configured to detect a concentration of one or more of the plurality of different species in the plasma-activated liquid in the storage vessel following the first activation” is a functional recitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Yoo teaches the radical sensor 600 which is essentially the same as the sensor device of this instant application, as evidenced by the following rejections of instant claims 9-14 below. Thus, the disclosed sensor device is capable of performing the same functions as the sensor device of the applicant and is configured to detect a concentration of one or more of the plurality of different species in the plasma-activated liquid in the storage vessel following the first activation,
wherein the sensor device is connected to a control device configured to vary a residence time of the plasma-activated liquid in the storage vessel after the first activation (The radical sensor 600 may direct the cleaning solution S to the nozzle when a concentration of particular radicals in the cleaning solution S reaches a reference concentration. For this, the radical sensor 600 may use the first valve 810 and the second valve 820 [para. 0088]. S500-S700 in Fig.12 details the control of the valves 820 and 810 by the radical sensor 600 to circulate the cleaning solution until a concentration of particular radicals in the cleaning solution S reaches the reference concentration [para. 0160-0171 ]. Since the radical sensor 600 controls the open/close of the first and second valves, the radical sensor 600 must connect to a control device configured to open/close the first and second valves and thus vary a residence time of the cleaning solution S in the storage tank 500. The limitation of “a control device” will be further rejected in view of Kimiya in the following),
an object to be cleaned/treated (wafer W mounted on a chunk in Fig.1 [para. 0100-0101]) is fluidically connected to the storage vessel and adapted to receive the plasma-activated liquid from the storage vessel (The nozzle 800 may be connected from the storage tank 500. The nozzle 800 may eject the cleaning solution S including radicals onto a wafer W mounted on a chunk [para. 0100-0101]),
wherein, the control device is configured to compare the concentration of the one or more of the plurality of different species with a required concentration associated with a requested treatment, provide the plasma treated liquid to the object if the concentration of the one or more of the plurality of different species meets the required concentration (see Steps S600-S700 in Fig.12; when it is determined that a concentration of particular radicals in the cleaning solution S reaches a reference concentration, the radical sensor 600 may open the first valve 810 and may close the second valve 820 [para. 0170]; When the concentration of the radicals reaches the reference concentration, the cleaning solution S is discharged [S700 in Fig.12]. For example, the cleaning solution S is discharged to clean the cleaning object [para. 0169]), and bring the plasma-activated liquid into contact with the plasma for a second activation if the concentration of the one or more of the plurality of different species is below the required concentration (See S500-S600 in Fig.12; the circulation pump 710 may allow the cleaning solution S to circulate from the storage tank 500, through the radical sensor 600 and the second pipe 700, back to the plasma reaction tank 300 for a second activation [para. 0095; Fig.1] when a concentration of radicals of the cleaning solution S in the storage tank 500 is not reached a reference concentration).
Yoo teaches the use of the plasma-activated liquid S to clean/treat a semiconductor substrate (see W in Fig.1 and S700 in Fig.12). Thus, Yoo is silent to the following limitations: (1) the object that is fluidically connected to the storage vessel is a medical instrument for a tissue treatment; and (2) wherein the required concentration provides a concentration of the one or more of the different species sufficient to have a medical disinfecting effect and/or a deactivation of a microbial organisms on the tissue.
Kimiya teaches wherein the plasma-treated liquid is discharged from a storage vessel to contact unit 60 which brings the plasma treatment liquid discharged from the outlet 22 into contact with, for example, a material containing an object. The object is, for example, an organic material, a microorganism, or a bacterium. The material containing an object is, for example, medical instrument. Alternatively, the material containing an object is, for example, the human oral cavity containing a pathogen of dental caries or periodental disease; or a food, animal, or a plant containing putrefactive bacteria (abstract, [para. 0154]).
Ferrell teaches the use of plasma-activated liquid for sterilizing tissue 100 with bacteria of Escherichia coli on the endothelial layer of the corneal substrates, wherein the properties of the activated fluid may be adjusted during the activation process itself by altering the gas that is ionized [para. 0018, 0025, 0027-0028, 0032]. As can be seen from Table 1, the settings for samples 3, 4, 8 and 10 resulted in complete kill, represented by an approximate 5.0 log reduction of E. coli ATCC 35150 according to the plasma application regimens for each of those respective samples [para. 0034].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the object to be treated that is fluidically connected to the storage vessel in Yoo with a medical instrument containing a tissue, as taught by combined Kimiya and Ferrell, since it would allow to bring the plasma-activated liquid discharged from the storage vessel into contact with the tissue for sterilizing the tissue [para. 0154 in Kimiya; 0007 in Ferrell]. With the above substitution, the plasma-activated liquid is used for sterilizing a material such as a microorganism or a bacterium contained in a tissue [para. 0154 in Kimiya; 0007 and 0034 in Ferrel].
As outlined in the rejection above, Yoo teaches when it is determined that the concentration of particular radicals in the cleaning solution S reaches the reference concentration, the radical sensor 600 may open the first valve 810 and close the second valve 820 to discharge the plasma-activated liquid to clean the object [para. 0089, 0169]. Yoo further teaches wherein the storage tank configured to store a cleaning solution containing the radical species generated in the plasma reaction tank (claim 1), and the radical species includes at least one of OH, O, O2, O3, HO2, H3O and H (claim 18), and wherein the radical species includes at least one of NO, NO2, NO3, CO2, CO3, Cl, F, Br, BrO, Cl, ClO, and HF2 (claim 19). Ferrel further teaches plasmas may contain superoxide anions [O2.-], which react with H+ in acidic media to form hydroperoxy radicals, HOO., which is a powerful antimicrobial: [O2.-]+[H+]→[HOO.]. Other radical species may include ONOO−, OH. and NO., known for their antimicrobial properties [para. 0016]. Thus, Yoo as evidenced by Ferrel teaches the plasma-activated liquid containing one or more radical species that are antimicrobial.
Pelfrey teaches using plasma activated fluid to sterilize an object (abstract).
Plasmas may contain superoxide anions [O2.-], which react with H+ in acidic media to form hydroperoxy radicals, HOO., which is a powerful antimicrobial: [O2.-] +[H+]→[HOO.]. Other radical species may include OH. and NO. Plasma activated water may contain concentrations of one or more of H2O2, nitrates, and nitrites [para. 0016]. In one embodiment, adjusting the pH levels adjusts the concentrations of radicals allowing for the adjustment of the efficacy of the plasma activated water to kill bacteria [para. 0017]. Pelfrey further teaches as the recirculating pump 424 continues to run, the concentration of activated water 420 increases. After a suitable time, enough of water 420 is activated so that the activated water 420 has acquired suitable properties to kill bacteria that it comes in contact with. Recirculating pump 424 may be turned off when the concentration of activated water is suitable to kill the bacteria it contacts [para. 0023].
Since the plasma-activated liquid is used to sterilize the tissue, and Pelfrey teaches recirculating the plasma-activated liquid (plasma activated water) until the concentration of the one or more radical species in the activated water is enough to kill bacterial, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the required concentration in modified Yoo to be a concentration of the one or more of the different species sufficient to have a medical disinfecting effect and/or a deactivation of a microbial organisms on the tissue, as taught by Pelfrey, since it would ensure the plasma-activated liquid to kill bacteria that it comes in contact with [para. 0023 in Pelfery].
In the above rejection, the control device is inherently present in the device of Yoo since the first and second valves 810/820 and circulation of the cleaning solution S are controlled in response to the concentration of particular radicals measured by the radical sensor 600 (see Steps S500-S700 in Fig.12). The control device is further rejected in view of Kimiya in the following.
Kimiya further teaches wherein the treatment liquid generation apparatus 10 comprises a plasma generator 50, a container 20, and a control circuit 40 (Fig.2; [para. 0116]). The control circuit 40 controls pump and valve [para. 0124]. The control circuit 40 includes, for example, a non-volatile memory storing a program and a processor executing the program. The control circuit 40 may further include a volatile memory, which is a temporary storage area for executing the program, and input and output ports. The control circuit 40 is, for example, a microcomputer [para. 0128]. The control circuit 40 may control, for example, the plasma generator 50. That is, the control circuit 40 controls the timing of generating plasma 92 in the liquid 90 and the period of the plasma generation (i.e., the duration of the plasma treatment). In addition, the control circuit 40 controls, for example, the timing and the amount of the gas supply to the liquid 90 by the gas feeder 56. For example, the control circuit 40 places a liquid to be plasma-treated having a predetermined pH in the container 20 and then instructs the plasma generator 50 to start generation of plasma 92 and to stop the generation of plasma 92 after the elapse of a predetermined time. The control circuit 40 may stop the generation of plasma 92 when the average pH per unit time of the liquid 90 in the container 20 reached 6 or more and 9 or less, instead of measuring the elapsed time [para. 0148-0149]. The container 20 may be provided with a pH sensor for detecting the pH of the liquid 90. The control circuit 40 may receive the pH value of the liquid 90 from the pH sensor and may stop the generation of plasma 92 based on the received pH value [para. 0179].
Given the teachings of Yoo regarding the valves/pump and circulation of the cleaning solution S are controlled in response to the concentration of particular radicals measured by the radical sensor 600 (see Steps S500-S700 in Fig.12), and the teachings of Kimiya regarding the control device 40, which is a microcontroller/microcomputer, connected to a sensor device (pH sensor), wherein the control device configured to control the plasma generator, circulation of the liquid from the storage vessel (container 20) to the plasma generator 50 in response to the measured pH value measured by the sensor device (pH sensor), and valve for discharging the plasma-activated liquid in the container 20 (Fig.5A), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the instrument/device in modified Yoo by adding a microcontroller coupled to the sensor device, wherein the microcontroller is configured to control the plasma generator and pumps/valves of the instrument/device based on the measurement result from the sensor device, and control the operation of the modified instrument/device for generating the plasma-activated liquid with a desired concentration of particular radicals in the activated liquid, as taught by combined Yoo and Kimiya, since the added microcontroller would allow to automate the operation of the plasma generator and pump(s)/valve(s) in response to the measured concentration of the sensor device to generate the activated liquid with a required concentration of particular radicals that is suitable to kill bacteria it contacts [para. 0148-0151 in Kimiya; S500-S600 of Fig.12 in Yoo; para. 0023 in Pelfery], and supply the plasma-activated liquid with the required concentration to sterilize the tissue (S700 of Fig.12 in Yoo, para. 0154 in Kimiya; 0007 and 0034 in Ferrel; and para. 0023 in Pelfery).
Regarding claim 2, modified Yoo teaches the medical instrument according to claim 1, and Yoo is silent to wherein the plasma application device comprises a plasma applicator having a gas channel and at least one electrode being in contact with gas from the gas channel, as well as an electrode being in electrical contact with the liquid, both electrodes being connected to the plasma generator.
Kimiya further teaches wherein the treatment liquid generation apparatus 10 in Fig.2 comprising a plasma applicator device (a reaction tank 57 in Fig.2 [para. 0118]) comprising a plasma applicator (power supply 51, electrodes 52 and 53, insulator 54, holding block 55 and a gas feeder 56 in Fig.2 [para. 0130]) having a gas channel (gas feeder 56) and an electrode 53 wherein the gas that flows from the gas feeder 56 flows around the metal electrode portion 53a ([paras. 0129, 0138, 0142-0143]; Fig. 2), as well as an electrode being in electrical contact with the liquid, both electrodes being connected to the plasma generator (electrode 52 is in contact with the liquid 90 and both electrodes 52/53 are connected to the plasma generator 50 [paras. 0129-0132; Fig. 2]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the plasma generator in modified Yoo with the plasma applicator in Kimiya, and further modify the plasma application device in Yoo to incorporate the substituted plasma generator such that the modified plasma application device comprises the plasma applicator having a gas channel and at least one electrode being in contact with gas from the gas channel, as well as an electrode being in electrical contact with the liquid, both electrodes being connected to the plasma generator, as taught by Kimiya, since Kimiya teaches a suitable alternative plasma generator which would generate plasma in or near the liquid in the container [para. 0087]. The simple substitution of one known element for another (i.e., one plasma generator for another plasma generator) is likely to be obvious when predictable results are achieved (i.e., generating plasma to treat fluid) [MPEP § 2143(I) (B)].
Regarding claim 7, modified Yoo teaches the medical instrument according to claim 2, and Yoo is silent to wherein the gas channel is connected to a gas source having a controllable gas flow.
Yoo further teaches when an intended type of radicals is not generated or an intended concentration of radicals is not formed, a plasma reaction may be adjusted by adjusting a flow rate or type of an injected gas [para. 0068].
Kimiya further teaches the gas feeder 56 is connected to a gas source wherein the control circuit controls the timing and amount of gas supply to the liquid 90 by the gas feeder 56 based upon the measured pH of the liquid measured by the pH sensor [paras. 0148-0150, 0179-0180].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in modified Yoo by connecting the gas channel/gas feeder to a gas source, wherein the control circuit/microcontroller controls the timing and amount of gas supply or a flow rate of an injected gas to the liquid by the gas feeder based on the measured concentration of the radicals, as taught by combined Yoo and Kimiya, since it would allow to generate an intended concentration of radicals in the plasma-treated liquid [para. 0068 in Yoo; para. 0179 in Kimiya].
Regarding claim 8, modified Yoo teaches the medical instrument according to claim 7, wherein the control device is connected to the gas source in order to control its gas flow depending on a detected parameter (as outlined in the rejection of claim 7 above, the microcontroller controls the flow rate of the injected gas based upon the measured concentration of the radicals since a plasma reaction to generate an intended concentration of radicals may be adjusted by adjusting a flow rate of an injected gas [para. 0068 in Yoo]).
Regarding claim 9, modified Yoo teaches the medical instrument according to claim 1, and Yoo teaches wherein the sensor device is configured to detect a chemical composition of particular chemical compounds (a storage tank configured to store a cleaning solution containing the radical species generated in the plasma reaction tank [claim 1]; the radical species includes at least one of OH, O, O2, O3, HO2, H3O, and H [claim 18]; wherein the radical species includes at least one of NO, NO2, NO3, CO2, CO3, Cl, F, Br, BrO, Cl, ClO, and HF2 [claim 19]; the radical sensor 600 may sense a concentration of radicals of the cleaning solution S of the storage tank 500 [para. 0085; claim 2]; thus, the radical sensor 600 is configured to detect a radical species listed above which is a chemical composition of particular chemical compounds [the list of radical species]).
Regarding claim 10, modified Yoo teaches the medical instrument according to claim 1, and Yoo teaches wherein the sensor device is configured to detect a concentration of plasma created substances in the plasma-activated liquid in the form of at least hydroxyl radicals (·OH) (a storage tank configured to store a cleaning solution containing the radical species generated in the plasma reaction tank [claim 1]; the radical species includes OH [claim 18]; the radical sensor 600 may sense a concentration of radicals of the cleaning solution S of the storage tank 500 [para. 0085; claim 2]; thus, the radical sensor 600 is configured to detect a concentration of plasma created substances in the plasma-activated liquid in the form of at least hydroxyl radicals).
Regarding claim 11, modified Yoo teaches the medical instrument according to claim 1, and Yoo teaches wherein the sensor device is configured to detect a concentration of plasma created substances in the plasma-activated liquid by spectroscopy (the radical sensor 600 may sense the concentration of radicals of the cleaning solution S by using a spectroscopic method by using non-dispersive infrared [NDIR] or infrared [IR] spectroscopy [para. 0086]).
Regarding claim 12, modified Yoo teaches the medical instrument according to claim 11, and Yoo teaches wherein the spectroscopy is absorption spectroscopy of electromagnetic radiation (the radical sensor 600 may sense the concentration of radicals of the cleaning solution S by using a spectroscopic method by using non-dispersive infrared [NDIR] or infrared [IR] spectroscopy [para. 0086]; NDIR and/or IR spectroscopy is a form of absorption spectroscopy of electromagnetic radiation).
Regarding claim 13, modified Yoo teaches the medical instrument according to claim 1, and Yoo teaches wherein the sensor device is configured to detect a concentration of plasma created substances in the plasma activated liquid in form of at least one of a singlet oxygen, ozone, oxygen, hydroperoxyl radicals, and nitrogen oxides (a storage tank configured to store a cleaning solution containing the radical species generated in the plasma reaction tank [claim 1]; the radical species includes at least one of O, O2, O3, HO2 [claim 18]; wherein the radical species includes at least one of NO, NO2, NO3 [claim 19]; the radical sensor 600 may sense a concentration of radicals of the cleaning solution S of the storage tank 500 [para. 0085; claim 2]; thus, the radical sensor 600 is configured to detect a concentration of plasma created substances in the plasma activated liquid in form of at least one of a singlet oxygen, ozone, oxygen, hydroperoxyl radicals, and nitrogen oxides).
Regarding claim 14, modified Yoo teaches the medical instrument according to claim 1, and Yoo teaches wherein the sensor device is configured to detect a concentration of plasma creates substances in the plasma activated liquid by means of electron spin resonance spectroscopy (the radical sensor 600 of the cleaning solution production system may measure the concentration of radicals by using EPR. EPR may measure a type and a concentration of radicals by using a magnetic moment measuring method using holes of radicals or spins of electrons [para. 0167]. Note that the claimed ESR spectroscopy is also known as EPR).
Regarding claim 25, modified Yoo teaches the medical instrument according to claim 1, and the limitation “wherein the medical instrument is configured to provide a plurality of tissue treatments, each requiring different concentrations of the one or more of the plurality of different species” is a functional recitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, modified Yoo teaches the medical instrument that generates plasma activated liquid with the required concentration of particular radicals that is suitable to kill bacteria it contacts, and supply/discharge the plasma-activated liquid with the required concentration to sterilize the tissue, as outlined in the rejection of claim 1 above. Yoo further teaches when an intended type of radicals is not generated or an intended concentration of radicals is not formed, a plasma reaction may be adjusted by adjusting a flow rate or type of an injected gas [para. 0068]. Thus, the disclosed medical instrument is capable of generating the plasma-activated liquid to provide a plurality of tissue treatments, each requiring different concentrations of the one or more of the plurality of different species.
Regarding claim 26, modified Yoo teaches the medical instrument according to claim 1, wherein the required concentration associated with the requested is a minimum concentration for each of the more than one of the plurality of different species (as outlined in the rejection of claim 1 above, Pelfrey teaches as the recirculating pump 424 continues to run, the concentration of activated water 420 increases. After a suitable time, enough of water 420 is activated so that the activated water 420 has acquired suitable properties to kill bacteria that it comes in contact with. Recirculating pump 424 may be turned off when the concentration of activated water is suitable to kill the bacteria it contacts [para. 0023]. Yoo further teaches when an intended type of radicals is not generated or an intended concentration of radicals is not formed, a plasma reaction may be adjusted by adjusting a flow rate or type of an injected gas [para. 0068]. Thus, the required concentration associated with the requested is a minimum concentration for each of the more than one of the plurality of different species to kill bacteria),
and the limitation “wherein the sensor device is configured to detect a concentration of more than one of the plurality of different species in the plasma- activated liquid” is a functional recitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Yoo teaches the radical sensor device 600 for sensing a concentration of radicals of the cleaning solution S of the storage tank 500. The radical sensor 600 of the cleaning solution production system according to some exemplary embodiments of the present disclosure may measure the concentration of radicals by using electron paramagnetic resonance (EPR). EPR may measure a type and a concentration of radicals by using a magnetic moment measuring method using holes of radicals or spins of electrons. Through this, the radical sensor 600 may quantitatively and qualitatively analyze radicals of the cleaning solution S [para. 0087]. Note that the disclosed EPR sensor device is the same as that in this instant application, as evidenced by “the sensor device can be an electron spin resonance spectroscopy device” in [para. 0025] in PGPUb of the instant specification. The EPR sensor device is capable of measuring more than one of the plurality of different species in the plasma- activated liquid, as evidenced by Suzen, which teaches EPR for measuring reactive oxygen and nitrogen species and their secondary products (abstract and section 5).
Claims 5-6 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Yoo, Kimiya, Ferrell, and Pelfrey, as applied to claim 1 above, and further in view of Takenoshita et al. (US20140003994A1).
Regarding claim 5, modified Yoo teaches the medical instrument according to claim 1, and is silent to wherein the control device is configured to send a signal to the plasma generator to adjust a supplied crest factor or a supplied waveform of the plasma generator.
Kimiya further teaches a plasma generator comprising electrodes 52 and 53, insulator 54, holding block 55, a gas feeder 56, and a power supply 51 as shown in Fig.2 [para. 0130] in a reaction tank 57 [para. 0118]. The control circuit 40 may control, for example, the plasma generator 50. The control circuit 40 controls, for example, the power supply 51 and the gas feeder 56. The control circuit 40 controls the timing and the period of applying a voltage between the first electrode 52 and the second electrode 53 by the power supply 51. That is, the control circuit 40 controls the timing of generating plasma 92 in the liquid 90 and the period of the plasma generation (i.e., the duration of the plasma treatment) [para. 0148]. The container 20
may be provided with a pH sensor for detecting the pH of the liquid 90. The control circuit 40 may receive the pH value of the liquid 90 from the pH sensor and may stop the generation of plasma 92 based on the received pH value [para. 0179].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the plasma generator in the device of modified Yoo with the plasma generator, as taught by Kimiya, and further modify the plasma reaction tank in modified Yoo to incorporate the substituted plasma generator, since Kimiya teaches a suitable alternative plasma generator which would generate plasma in or near the liquid in the container/plasma reaction tank [para. 0087]. The simple substitution of one known element for another (i.e., one plasma generator for another plasma generator) is likely to be obvious when predictable results are achieved (i.e., generating plasma to treat fluid) [MPEP § 2143(I) (B)].
With the substituted plasma generator, the power source of the plasma generator in Yoo is substituted with the power supply in the plasma generator of Kimiya. The substituted power supply is configured to apply a voltage of different wave forms such as pulse, half sine, and sine waveforms [para. 0131 in Kimiya]. The control device is configured to send a control signal to the plasma generator to control the timing and the period of applying a voltage between the first electrode and the second electrode by the power supply [para. 0148 in Kimiya].
Modified Yoo is still silent to wherein the control device is configured to send a signal to the plasma generator to adjust a supplied crest factor or a supplied waveform of the plasma generator.
Takenoshita teaches a plasma generating device 100 which is configured such that a fluid passing through the fluid circulation holes comes into contact with the plasma, generating ions or radicals, wherein the voltage applying means varies the peak value and/or the pulse width of the pulse voltage applied across the electrodes (abstract; Fig.1). The generation amount of active species per unit time may be increased by means of a method of controlling repetition of the pulse voltage using the drive circuit portion 42. As shown in Fig.7, it may be possible to suppress the generation amount of ozone and increase only the ion number density by performing an intermittent operation which repeats a voltage applying period (“ON operation (TON)” in FIG. 7) which applies the pulse voltage between the pair of electrodes in a predetermined period and an application stop period (“OFF (TOFF)” in FIG. 7) in which no pulse voltage is applied to the pair of electrodes. In other words, it may be possible to control the generation of more dense active species by controlling a time ratio of the ON operation (TON) and the OFF operation (TOFF) (a duty ratio (=TON/(TON+TOFF))), or by uniformizing or varying the pulse repetition period in the ON operation [para. 0064]. Thus, Takenoshita teaches adjusting a supplied crest factor (note that the crest factor of a pulsed voltage depends on the duty ratio) or a supplied waveform (pulsed voltage with different duty ratio) of the voltage applied to the plasma generator to control the generation amount of active species.
Given the teachings of Kimiya regarding the microcontroller configured to send a signal to the plasma generator to control the plasma generator based on the measured pH value; the teachings of Takenoshita regarding controlling a supplied crest factor or a supplied waveform of the voltage applied to the plasma generator for controlling the generation amount of active species; and the teachings of Yoo regarding controlling the generation of the cleaning liquid based on the concentration of particular radical species (S600 in Fig.12), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify
the microcontroller in modified Yoo to send a signal to the plasma generator to adjust a supplied crest factor or a supplied waveform of the plasma generator based on the measured concentration of particular radical species, as taught by combined Yoo, Kimiya, and Takenoshita, since it would allow to control the generation amount of the active species (radical species) [para. 0064 in Takenoshita] to provide the cleaning liquid with the concentration of the particular radical species being the reference concentration/required concentration (S600 in Fig.12 of Yoo).
Regarding claim 6, modified Yoo teaches the medical instrument according to claim 5, wherein the control device is connected to the plasma generator in order to control it dependent on a detected parameter (as outlined in the rejection of claim 5 above, the microcontroller is connected to the plasma generator in order to control the crest factor or the waveform of the voltage applied to the electrodes of the plasma generator based on the measured concentration of the particular radical species such that the concentration of the particular radical species reaches the reference/required concentration [see S600 in Fig.12 of Yoo]).
Regarding claim 24, modified Yoo teaches the medical instrument according to claim 1, and is silent to wherein the control device is further configured to send a signal to the plasma generator to vary a supplied crest factor and/or a supplied waveform of the plasma generator du